Lub npe dav: antihemophilic yam, recombinant
Dosage form: txhaj tshuaj
Chav kawm tshuaj: Lwm yam coagulation modifiers
Ntawm nplooj ntawv no
- Indications thiab siv
- Dosage thiab Administration
- Daim ntawv siv tshuaj thiab muaj zog
- Contraindications
- Ceeb toom thiab ceev faj
- Cov Kev Phem Tsis Zoo/Sib Phem
- Siv nyob rau hauv cov neeg tshwj xeeb
- Kev piav qhia
- Clinical Pharmacology
- Nonclinical Toxicology
- Kev tshawb fawb soj ntsuam
- Cov ntaub ntawv
- Yuav Ua Li Cas Muab / Cia thiab tuav
- Cov Ntaub Ntawv Qhia Txog Tus Neeg Mob
Kev taw qhia thiab kev siv rau Helixate FS
Helixate®FS yog ib qho tshuaj antihemophilic recombinant qhia rau:
- •
- Kev kho mob raws li qhov xav tau thiab kev tswj cov ntshav tawm hauv cov neeg laus thiab cov menyuam yaus uas muaj hemophilia A.
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- Perioperative tswj los ntshav hauv cov neeg laus thiab cov menyuam yaus uas muaj hemophilia A.
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- Kev tiv thaiv niaj hnub los txo qhov zaus los ntshav hauv cov menyuam yaus uas muaj hemophilia A thiab txo qhov kev pheej hmoo ntawm kev puas tsuaj rau cov menyuam yaus yam tsis muaj kev puas tsuaj ua ntej.
- •
- Kev tiv thaiv niaj hnub los txo qhov zaus ntawm kev los ntshav hauv cov neeg laus nrog hemophilia A.
Helixate FS tsis qhia rau kev kho mob ntawm tus kab mob von Willebrand.
Helixate FS Dosage thiab Administration
Rau kev siv cov tshuaj tua kab mob tom qab kho dua tshiab nkaus xwb.
Koob tshuaj
Kev noj tshuaj thiab lub sijhawm ntawm kev kho mob yog nyob ntawm qhov hnyav ntawm qhov tsis txaus VIII, qhov chaw thiab qhov twg los ntshav, thiab tus neeg mob qhov chaw kho mob.ibKev tswj xyuas kev hloov kho kom zoo yog qhov tseem ceeb tshwj xeeb tshaj yog thaum muaj kev phais loj lossis kev ua rau lub neej los ntshav.
Txhua lub vial ntawm Helixate FS muaj qhov sib xyaw ua ke VIII (rFVIII) potency hauv thoob ntiaj teb units (IU, unit) teev nyob rau hauv daim ntawv lo. Ib qho IU (unit), raws li tau hais los ntawm World Health Organization tus qauv rau cov ntshav coagulation yam VIII, tib neeg, yog kwv yees li sib npaug rau qib ntawm qhov kev ua haujlwm VIII pom hauv 1 mL ntawm cov ntshav plasma tshiab.
Qhov xav taunyobKev nce siab tshaj plaws hauv qib VIII qhia tau tias yog IU / dL (lossis % ib txwm) tuaj yeem kwv yees siv cov qauv hauv qab no:
Dosage (units) = lub cev qhov hnyav (kg) × qhov xav tau VIII nce (IU / dL lossis % ntawm qhov qub) × 0.5 (IU / kg ib IU / dL)
los yog
IU/dL (los yog % normal) = Total Dose (IU)/lub cev hnyav (kg) × 2 [IU/dL]/[IU/kg]
Titrate koob tshuaj rau tus neeg mob qhov chaw kho mob. Cov neeg mob yuav txawv ntawm lawv cov tshuaj pharmacokinetic (piv txwv li, ib nrab lub neej,nyobrov qab) thiab cov lus teb kho mob rau Helixate FS.2, 3, 4Txawm hais tias qhov koob tshuaj tuaj yeem kwv yees los ntawm cov kev suav sau saum toj no, nws tau pom zoo tias cov kev sim tshuaj tsim nyog, suav nrog kev ntsuas kev ua haujlwm VIII, raug ua.[saib Ceeb toom thiab ceev faj (5.3) thiab Clinical Pharmacology (12.3) ].
On-Demand Treatment and Control of Blood Episodes
Ib qho kev qhia rau kev noj Helixate FS rau kev kho mob raws li qhov xav tau thiab kev tswj cov ntshav los ntshav yog muaj nyob rau hauv Table 1. Lub hom phiaj ntawm kev kho mob yog tswj hwm qib plasma yam VIII kev ua haujlwm ntawm lossis siab dua cov qib ntshav (hauv % ntawm ib txwm lossis hauv IU / dL) tau piav qhia hauv Table 1.
| Hom Ntshav Qab Zib | Factor VIII Theem Yuav Tsum Tau (IU/dL lossis % ntawm qhov qub) | Cov koob tshuaj (IU / kg) | Ntau zaus ntawm koob tshuaj (teev) | Duration ntawm Kev Kho Mob (hnub) |
|---|---|---|---|---|
| Me me | 20–40 : kuv | 10–20 | Rov muab tshuaj dua yog tias muaj pov thawj tias los ntshav ntxiv. | Kom txog thaum los ntshav |
| Nruab nrab | 30–60 : kuv | 15–30 : kuv | 12–24 : kuv | Kom txog thaum los ntshav |
| Major | 80-100 : kuv | Pib: 40-50 | 8–12 | Kom txog thaum los ntshav |
Perioperative Management ntawm Ntshav
Cov lus qhia rau kev siv tshuaj Helixate FS thaum lub sij hawm phais (perioperative tswj los ntshav) yog muaj nyob rau hauv Table 2. Lub hom phiaj ntawm kev kho mob yog kom tswj tau cov ntshav plasma yam VIII kev ua ub no nyob rau hauv los yog siab tshaj plasma theem (nyob rau hauv % ntawm ib txwm los yog nyob rau hauv IU/dL) tau piav qhia hauv Table 2.
| Hom Kev phais | Factor VIII Theem Yuav Tsum Tau (IU/dL lossis % ntawm qhov qub) | Cov koob tshuaj (IU / kg) | Ntau zaus ntawm koob tshuaj (teev) | Duration ntawm Kev Kho Mob (hnub) |
|---|---|---|---|---|
| Me me | 30–60 : kuv | 15–30 : kuv | 12–24 : kuv | Kom txog thaum los ntshav. |
| Major | 100 | tsib caug | 6 - 12 kom khaws FVIII cov dej num hauv qhov xav tau | Txog thaum kho kom tiav. |
Routine Prophylaxis nyob rau hauv cov neeg laus
Cov koob tshuaj pom zoo rau niaj hnub prophylaxis yog 25 units ib kg ntawm lub cev hnyav peb zaug hauv ib lub lis piam.
Routine Prophylaxis hauv Me Nyuam
Cov koob tshuaj pom zoo rau kev tiv thaiv niaj hnub yog 25 IU / kg ntawm lub cev hnyav txhua hnub.5
Kev npaj thiab rov tsim dua tshiab
Helixate FS yog siv los ntawm kev txhaj tshuaj rau hauv cov hlab ntsha tom qab kev kho dua tshiab. Cov neeg mob yuav tsum ua raws li cov kev hloov kho tshiab thiab cov txheej txheem kev tswj hwm los ntawm lawv cov kws kho mob.
Rov ua dua thiab tswj hwm Helixate FS nrog cov khoom siv nrog txhua pob. Yog tias ib qho khoom ntawm lub pob qhib los yog puas, tsis txhob siv cov khoom no.
Cov khoom tsim kho dua tshiab, kev tswj hwm, thiab kev tswj hwm cov txheej txheem tswj hwm thiab cov koob yuav tsum tau ua nrog ceev faj vim tias percutaneous puncture nrog rab koob uas muaj cov ntshav tuaj yeem kis tau cov kab mob sib kis, suav nrog HIV (AIDS) thiab kab mob siab. Muab cov koob tso rau hauv lub thawv ntse tom qab siv ib zaug. Tshem tawm tag nrho cov khoom siv, suav nrog cov khoom siv Helixate FS, hauv ib lub thawv tsim nyog. Tau txais kev kho mob tam sim yog tias raug mob.
Yog muaj lus nug txog kev tuav, kho dua tshiab thiab kev tswj hwm ntawm Helixate FS, hu rau CSL Behring Medical Affairs ntawm 1-800-504-5434.
Rau cov lus qhia, cov neeg mob yuav tsum ua raws li cov lus pom zoo hauv FDA-pom zoo Tus Neeg Mob Labeling.
Cov txheej txheem hauv qab no yog muab raws li cov lus qhia dav dav rau kev kho dua tshiab ntawm Helixate FS.
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- Ua haujlwm ntawm qhov chaw tiaj tus huv si thiab ntxuav tes kom huv si siv xab npum thiab dej sov ua ntej ua cov txheej txheem.
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- Reconstitute cov khoom nrog cov khoom uas muab nrog rau txhua pob. Yog tias ib qho khoom ntawm lub pob qhib los yog puas, tsis txhob siv cov khoom no.
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- Lim cov khoom rov tsim dua ua ntej kev tswj hwm kom tshem tawm cov khoom muaj feem cuam tshuam hauv cov tshuaj. Lim tuaj yeem ua tiav los ntawm kev siv Mix2Vial®vial adapter.
Vacuum Transfer thiab Reconstitution
| ib. | Npaj cov khoom nyob rau hauv aseptic mob. | |
| ob. | Ua kom sov lub diluent uas tsis tau qhib thiab cov concentrate rau qhov kub tsis tshaj 37 ° C lossis 99 ° F. | |
| 3. | Muab cov khoom vial, diluent vial thiab Mix2Vial rau ntawm qhov chaw tiaj tus. | |
| Plaub. | Xyuas kom cov khoom thiab diluent vial flip caps raug tshem tawm thiab cov stoppers raug kho nrog tshuaj aseptic thiab tso cai kom qhuav ua ntej qhib pob Mix2Vial. | |
| 5. | Qhib lub pob Mix2Vial los ntawm kev tshem tawm lub hau (Fig. 1). |  |
| Tawm hauv Mix2Vial hauv pob ntshiab. Muab lub diluent vial rau ntawm ib qho chaw sib luag thiab tuav lub vial kom nruj. Tuav lub Mix2Vial ua ke nrog lub pob thiab snap lub xiav kawg mus rau lub diluent stopper (Fig. 2). |  | |
| 6. ib 627 puag ncig cov tshuaj dawb | Ua tib zoo tshem cov pob ntshiab los ntawm Mix2Vial teeb. Nco ntsoov tias koj tsuas rub lub pob thiab tsis yog Mix2Vial teeb (Fig. 3). |  |
| 7. | Nrog cov khoom vial ruaj khov rau ntawm qhov chaw, thim rov qab lub diluent vial nrog lub teeb txuas thiab snap lub pob tshab adapter mus rau cov khoom vial stopper (Fig. 4). Lub diluent yuav cia li hloov mus rau hauv cov khoom vial. |  |
| 8. | Nrog lub diluent thiab cov khoom vial tseem txuas nrog, maj mam swirl cov khoom vial kom ntseeg tau tias cov hmoov yog yaj tag (Daim duab 5). Tsis txhob co vial. |  |
| 9. | Nrog ib txhais tes tuav cov khoom-sab ntawm Mix2Vial teeb thiab nrog rau lwm txhais tes tuav lub xiav diluent-sab ntawm Mix2Vial teeb thiab unscrew lub teeb rau hauv ob daim (Fig. 6) |  |
| 10. | Kos cua mus rau hauv ib qho khoob, tsis muaj menyuam. Thaum cov khoom vial yog upright, ntsia hlau syringe rau Mix2Vial teeb. Txhaj cua rau hauv cov khoom vial. Thaum tuav lub syringe plunger nias, tig lub kaw lus upside down thiab kos cov concentrate rau hauv lub syringe los ntawm rub lub plunger rov qab maj mam (Daim duab 7). |  |
| kaum ib. | Tam sim no hais tias cov concentrate tau raug xa mus rau hauv lub syringe, nrees tuav lub chim ntawm lub syringe (ua kom lub syringe plunger pem hauv ntej) thiab unscrew lub syringe los ntawm Mix2Vial teeb (Fig. 8). Txuas lub syringe rau ib qho kev tswj hwm uas ua nrog microbore tubing. Kev siv lwm cov txheej txheem tswj hwm yam tsis muaj microbore tubing tuaj yeem ua rau muaj kev tuav pov hwm ntau dua hauv cov txheej txheem tswj hwm. |  |
| 12 | Yog tias tib tus neeg mob yuav tsum tau txais ntau tshaj ib lub raj mis, cov ntsiab lus ntawm ob lub raj mis yuav raug kos rau hauv tib lub syringe los ntawm ib qho kev sib cais uas tsis siv Mix2Vial teeb ua ntej muab cov koob txhaj tshuaj. |
Kev tswj hwm
Rau kev siv cov tshuaj tua kab mob tom qab kho dua tshiab nkaus xwb.
- •
- Tshawb xyuas Helixate FS pom qhov muag rau cov teeb meem tshwj xeeb thiab kev hloov xim ua ntej kev tswj hwm, thaum twg los xij thiab cov thawv tso cai. turbid los yog discolored tov yuav tsum muab pov tseg.
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- Khaws cov Helixate FS rov ua dua tshiab ntawm chav tsev kub ua ntej kev tswj hwm, tab sis ua haujlwm hauv 3 teev.
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- Thawj Tswj Hwm Helixate FS nyob rau lub sijhawm 1 txog 15 feeb. Kho tus nqi ntawm kev tswj hwm rau cov lus teb ntawm txhua tus neeg mob. Txiav txim siab tus mem tes ua ntej thiab thaum lub sij hawm tswj hwm ntawm Helixate FS. Yog tias muaj qhov nce siab hauv cov mem tes, txo tus nqi ntawm kev tswj hwm lossis tso tseg ib ntus tso cai rau cov tsos mob ploj mus sai.
Daim ntawv siv tshuaj thiab muaj zog
Helixate FS muaj nyob rau hauv cov hmoov lyophilized nyob rau hauv ib leeg siv iav vials uas muaj nominally 250, 500, 1000, 2000, thiab 3000 International Units (IU, unit).
Txhua lub vial ntawm Helixate FS tau sau npe nrog cov kev ua haujlwm antihemophilic recombinant qhia hauv International Units ib vial. Txoj haujlwm muaj zog no siv cov txheej txheem VIII mloog zoo uas tau hais txog WHO International Standard for factor VIII concentrates, thiab raug soj ntsuam los ntawm cov txheej txheem tsim nyog los xyuas kom meej cov txiaj ntsig.
Contraindications
Helixate FS yog contraindicated nyob rau hauv cov neeg mob uas muaj lub neej-kev hem thawj hypersensitivity tshwm sim, xws li anaphylaxis rau nas los yog hamster protein los yog lwm yam khoom ntawm cov khoom (sucrose, glycine, histidine, sodium, calcium chloride, polysorbate 80, imidazole, tri-n-butyl phosphate. , thiab tooj).
Ceeb toom thiab ceev faj
Hypersensitivity Reactions
Cov tshuaj tiv thaiv hypersensitivity, suav nrog anaphylaxis tau tshaj tawm nrog Helixate FS. Cov tsos mob tshwm sim muaj xws li lub ntsej muag o, tawm hws, khaus khaus, txo cov ntshav siab, xeev siab, ua pob liab vog, tsis xis nyob, ua tsis taus pa, tachycardia, nruj ntawm lub hauv siab, tingling, urticaria, thiab ntuav.
Helixate FS muaj cov lej ntawm nas immunoglobulin G (MuIgG) thiab hamster (BHK) cov proteins [saib Description (11) ]. Cov neeg mob kho nrog cov khoom no tuaj yeem tsim kev kub siab rau cov proteins uas tsis yog tib neeg tsiaj txhu.
Txiav tawm Helixate FS yog tias cov tsos mob tshwm sim thiab nrhiav kev kho mob sai sai.
Neutralizing Antibodies
Neutralizing antibodies (inhibitors) tau tshaj tawm tom qab kev tswj hwm ntawm Helixate FS, feem ntau hauv cov neeg mob tsis tau kho (PUPs) [saib Kev tsis pom zoo (6) ]. Ua tib zoo saib xyuas cov neeg mob rau kev txhim kho cov txiaj ntsig VIII inhibitors, siv cov kev soj ntsuam tsim nyog thiab kev sim kuaj.6Yog tias qhov xav tau plasma yam VIII qib kev ua haujlwm tsis tau txais, lossis yog tias ntshav tsis tswj tau nrog qhov xav tau, ua qhov kev ntsuam xyuas uas ntsuas qhov ntsuas VIII inhibitor concentration [saib Ceeb toom thiab ceev faj (5.4) ].
Kev pheej hmoo mob plawv
Cov neeg mob hemophilic uas muaj cov kab mob plawv lossis cov kab mob tuaj yeem ua rau muaj kev pheej hmoo ntawm kev mob plawv raws li cov neeg mob uas tsis yog hemophilic thaum cov ntshav txhaws tau normalized los ntawm kev kho mob nrog yam VIII.
Kev soj ntsuam kuaj kuaj
- •
- Saib xyuas plasma factor VIII theem kev ua haujlwm los ntawm ib-theem kev kuaj ntshav kom paub meej tias qhov txaus ntshai VIII theem tau ua tiav thiab tswj xyuas, thaum kho mob qhia [saib Dosage thiab Administration (2) ].
- •
- Saib xyuas kev txhim kho ntawm yam VIII inhibitors. Ua qhov kev ntsuam xyuas los txiav txim seb puas muaj VIII inhibitor tam sim no. Yog tias qhov kev xav tau VIII cov ntshav plasma qib tsis tau txais lossis yog tias ntshav tsis tswj tau nrog qhov xav tau ntawm Helixate FS, siv Bethesda Units (BU) rau titer inhibitors.
- •
- Yog tias tus inhibitor tsawg dua 10 BU ib mL, kev tswj hwm ntawm Helixate FS concentrates ntxiv tuaj yeem ua rau txo qis cov inhibitor thiab tuaj yeem tso cai rau cov lus teb rau hemostatic.
- •
- Yog tias inhibitor titers siab dua 10 BU ib mL, txaus hemostasis yuav tsis ua tiav. Tus inhibitor titer tuaj yeem nce tom qab Helixate FS infusion raws li qhov tshwm sim ntawm cov lus teb anamnestic rau yam VIII. Kev kho mob raws li qhov xav tau thiab kev tswj cov ntshav hauv cov neeg mob zoo li no yuav tsum tau siv lwm txoj kev kho mob thiab cov neeg sawv cev.
Kev Phem Tsis Zoo
Cov kev phiv loj heev uas pom nrog Helixate FS yog cov tshuaj tiv thaiv kab mob siab, nrog rau cov tshuaj tiv thaiv bronchospastic thiab / los yog hypotension thiab anaphylaxis, thiab kev loj hlob ntawm high-titer inhibitors yuav tsum tau kho lwm txoj kev kho rau yam VIII.
Feem ntau cov kev phiv tshwm sim (≧ 4%) pom nyob rau hauv kev sim tshuaj yog inhibitor tsim nyob rau hauv yav tas los cov neeg mob uas tsis kho (PUPs) thiab tsawg kho cov neeg mob (MTPs), cov tawv nqaij-xws li rhiab heev tshwm sim (xws li, pob khaus, pruritus), infusion site tshua (xws li. , mob, mob), thiab central venous access device (CVAD) cuam tshuam cov kab mob.
Kev sim tshuaj ntsuam xyuas
Vim tias qhov kev sim tshuaj ntsuam xyuas tau ua nyob rau hauv cov xwm txheej sib txawv, qhov tshwm sim tsis zoo tshwm sim hauv kev sim tshuaj ntawm cov tshuaj tsis tuaj yeem raug piv ncaj qha rau cov nqi hauv kev sim tshuaj ntawm lwm cov tshuaj thiab yuav tsis cuam tshuam cov nqi uas tau pom hauv kev kho mob.
Yav dhau los Cov Neeg Kho Mob (PTPs)
Thaum lub sij hawm qhib-label kev tshawb fawb soj ntsuam ua nyob rau hauv 73 PTPs, muaj 24 cov kev phiv tshwm sim qhia nyob rau hauv lub chav kawm ntawm 24,936 infusions.
Cov kev phiv tshwm sim los ntawm ≧ 4% ntawm cov neeg mob tau teev tseg hauv Table 3 hauv qab no.
| MedDRA Thawj SOC | Lub sij hawm nyiam | N = 73 AWG (%) |
|---|---|---|
| SOC = System Organ Class | ||
| Cov tawv nqaij thiab cov ntaub so ntswg subcutaneous | Rash, pruritus | 6 (8.2%) |
| General Disorders thiab Administration Site Conditions | Infusion site cov tshuaj tiv thaiv | 3 (4.1%) |
Yav dhau los Cov Neeg Mob Tsis Muaj Kev Kho Mob (PUPs) thiab Cov Neeg Mob Tsawg Tsawg (MTPs)
Hauv kev tshawb fawb soj ntsuam nrog rau cov menyuam yaus PUPs thiab MTPs, muaj 29 qhov tsis zoo tshwm sim qhia nyob rau hauv chav kawm ntawm 9,389 infusions.
Cov kev phiv tshwm sim tau tshaj tawm los ntawm ≧ 4% ntawm cov neeg mob tau teev nyob rau hauv Table 4 hauv qab no.
| MedDRA Thawj SOC | Lub sij hawm nyiam | N = 61 AR (%) |
|---|---|---|
| SOC = System Organ Class | ||
| ||
| Cov tawv nqaij thiab cov ntaub so ntswg subcutaneous | Ua pob khaus, khaus, urticaria | 10 (16%) |
| Ntshav thiab Lymphatic System Disorders | Factor VIII inhibition (neutralizing antibodies) | 9 (15%) * |
| General Disorders thiab Administration Site Conditions | Infusion site cov tshuaj tiv thaiv | 4 (7%) |
Yam tsawg kawg nkaus kho cov neeg mob (MTPs) hauv Kev Tshawb Fawb Txog Kev Tshawb Fawb
Hauv Kev Tshawb Fawb Txog Kev Tshawb Fawb nrog rau menyuam yaus MTPs kho nrog kev tiv thaiv niaj hnub lossis kev kho mob kho mob rau 5.5 xyoo, 46 ntawm 65 tus neeg mob randomized ntsib cov xwm txheej tsis zoo nyob rau lub sijhawm kawm.
| MedDRA Thawj SOC | Lub sij hawm nyiam | Prophylaxis Arm N = 32 AR (%) | Enhanced Episodic Arm N = 33 AR (%) |
|---|---|---|---|
| SOC = System Organ Class | |||
| |||
| Cov txheej txheem phais thiab kho mob | Central venous catheterization, tshem tawm catheter | 19 (59%) | 18 (55%) * |
| Kab mob thiab kab mob | Central kab kab mob | 6 (19%) | 6 (18%) |
| General Disorders thiab Administration Site Conditions | Pyrexia | 1 (3%) | 4 (12%) |
Immunogenicity
Hauv kev tshawb fawb soj ntsuam nrog 73 PTPs (txhais tias muaj ntau tshaj 100 hnub raug pom), ib tus neeg mob muaj cov tshuaj tiv thaiv ua ntej. Hauv lwm tus neeg mob 72, ua raws li 4 xyoos, tsis muajduainhibitors tau pom.
Hauv kev tshawb fawb soj ntsuam nrog rau menyuam yaus PUPs thiab MTPs, inhibitor kev loj hlob tau pom nyob rau hauv 9 ntawm 60 tus neeg mob (15%), 6 yog siab titer.ib(> 5 BU) thiab 3 yog qis-titer inhibitors. Inhibitors tau kuaj pom ntawm tus lej nruab nrab ntawm 7 hnub raug pom (ntau 2 txog 16 hnub raug).
Hauv Kev Tshawb Fawb Txog Kev Tshawb Fawb nrog Helixate FS,5 duainhibitor txoj kev loj hlob tau pom nyob rau hauv 8 ntawm 64 cov neeg mob uas muaj qhov tsis zoo hauv paus ntsiab lus (12.5%), 2 cov neeg mob tau tsim cov titer siab.ib(> 5 BU) thiab raug tshem tawm ntawm txoj kev kawm. Rau cov neeg mob tau tsim cov tshuaj tiv thaiv qis-titer. Cov tshuaj tiv thaiv tau kuaj pom ntawm tus lej nruab nrab ntawm 44 hnub raug mob (ntau 5 txog 151 hnub raug).
Inhibitor cov ntaub ntawv nyob rau hauv PUPs tau sau nyob rau hauv ob peb postmarketing registries [saib Postmarketing Kev Paub (6.2) ].
Kev kuaj pom ntawm cov tshuaj tiv thaiv kab mob yog nyob ntawm qhov rhiab heev thiab qhov tshwj xeeb ntawm qhov kev ntsuam xyuas. Tsis tas li ntawd, qhov pom tshwm sim ntawm cov tshuaj tiv thaiv kab mob (xws li cov tshuaj tiv thaiv tsis zoo) hauv qhov kev ntsuam xyuas yuav cuam tshuam los ntawm ntau yam xws li kev soj ntsuam, kev coj ua qauv, sij hawm sau cov qauv, cov tshuaj sib xyaw ua ke, thiab kab mob hauv qab. Rau cov laj thawj no, kev sib piv ntawm qhov tshwm sim ntawm cov tshuaj tiv thaiv rau Helixate FS nrog rau qhov tshwm sim ntawm cov tshuaj tiv thaiv rau lwm yam khoom yuav ua rau tsis raug.
Postmarketing Experience
Vim tias muaj kev phiv tshwm sim tuaj yeem raug tshaj tawm los ntawm cov pej xeem ntawm qhov tsis meej, nws tsis yog ib txwm ua tau kom ntseeg tau tias lawv cov zaus los yog tsim kom muaj kev sib raug zoo rau kev siv tshuaj. Cov tshuaj tiv thaiv kab mob hauv qab no tau raug txheeb xyuas thaum pom zoo siv Helixate FS:
Sensory System - Dysgeusia
Immunogenicity - Postmarketing Registries
Cov ntaub ntawv los ntawm Kev Tshawb Fawb Txog Kev Txiav Txim Siab ntawm Kev Txhim Kho Kev Txhim Kho (RODIN).7, Fabkis National Registry (FranceCoag)8thiab United Kingdom Haemophilia Center Kws Kho Mob Lub Koom Haum (UKHCDO)9Kev sau npe tau tshaj tawm txog kev txhim kho tus nqi inhibitor hauv PUPs rau Hexliate FS ntawm 38%, 50% thiab 35%, feem, uas yog piv rau yav dhau los qhia txog inhibitor tus nqi.10rau cov khoom FVIII. Cov kev tshawb fawb sau npe no qhia txog qhov sib txawv ntawm kev pheej hmoo ntawm kev txhim kho inhibitor hauv PUPs, piv rau cov khoom siv rFVIII. Kev tshawb fawb ntawm Canadian hemophilia chaw zov me nyuamkaum ib(2005 txog 2012) thiab muaj cov ntaub ntawv los ntawm European Haemophilia Safety Surveillance (EUHASS)12Kev sau npe los ntawm 2009 txog 2013, qhia txog kev txhim kho tus nqi inhibitor hauv PUPs rau Helixate FS ntawm 42% thiab 31%, feem, tsis muaj qhov sib txawv tseem ceeb ntawm cov khoom siv FVIII.
Siv rau hauv cov neeg tshwj xeeb
Kev xeeb tub
Cev xeeb tub qeb C
Kev tshawb fawb txog tsiaj yug tsiaj tsis tau ua nrog Helixate FS. Nws tseem tsis tau paub tias Helixate FS tuaj yeem ua rau muaj kev puas tsuaj rau menyuam hauv plab thaum noj rau tus poj niam cev xeeb tub lossis cuam tshuam rau kev muaj peev xwm ntawm kev tsim menyuam. Helixate FS yuav tsum tau muab rau tus poj niam cev xeeb tub nkaus xwb yog tias xav tau.
Kev Ua Haujlwm thiab Kev Xa Khoom
Tsis muaj ntaub ntawv qhia txog qhov cuam tshuam ntawm qhov kev hloov pauv VIII ntawm kev ua haujlwm thiab kev xa khoom. Helixate FS yuav tsum tau siv tsuas yog yog xav tau kev kho mob.
Niam laus
Nws tsis paub tias cov tshuaj no puas tawm mus rau hauv tib neeg cov kua mis. Vim tias muaj ntau yam tshuaj tau tawm mus rau hauv tib neeg cov kua mis, yuav tsum tau ceev faj yog tias Helixate FS raug muab rau tus poj niam laus.
Kev siv menyuam yaus
Kev tshawb fawb txog kev nyab xeeb thiab kev ua tau zoo tau ua tiav hauv cov neeg mob uas tsis tau kho thiab kho tsawg kawg nkaus. Cov menyuam yaus, piv rau cov neeg laus, tam sim no ntau dua qhov VIII tshem tawm qhov tseem ceeb thiab, yog li, qis dua ib nrab-lub neej thiab rov qab los ntawm qhov VIII. Qhov no yuav yog vim qhov sib txawv ntawm lub cev muaj pes tsawg leeg.13Tus account rau qhov sib txawv ntawm kev tshem tawm thaum noj lossis ua raws li qib VIII hauv cov menyuam yaus [saib Clinical Pharmacology (12.3) ].
Kev kho mob prophylactic niaj hnub hauv cov menyuam hnub nyoog 0-2.5 xyoo uas tsis muaj kev puas tsuaj ua ntej ua ntej tau pom tias yuav txo qis kev sib koom tes los ntshav thiab kev pheej hmoo ntawm kev puas tsuaj ntawm pob qij txha. Cov ntaub ntawv no tuaj yeem muab ntxiv rau cov hnub nyoog> 2.5-16 xyoo rau cov menyuam yaus uas tsis muaj kev puas tsuaj rau kev sib koom ua ke [saib Clinical Studies (14) ].
Kev siv Geriatric
Kev tshawb fawb soj ntsuam nrog Helixate FS tsis suav nrog cov neeg mob hnub nyoog 65 thiab tshaj saud. Kev xaiv koob tshuaj rau tus neeg mob laus yuav tsum yog tus kheej.
Helixate FS Description
Helixate FS Antihemophilic Factor (Recombinant) yog ib qho coagulation yam VIII uas tsim los ntawm recombinant DNA technology. Nws yog tsim los ntawm Baby Hamster raum (BHK) hlwb rau hauv uas tib neeg qhov tseem ceeb VIII noob tau qhia.14Lub cell kab lis kev cai nruab nrab muaj Human Plasma Protein Solution (HPPS) thiab recombinant insulin, tab sis tsis muaj cov proteins uas tau los ntawm cov tsiaj txhu. Helixate FS yog purified glycoprotein uas muaj ntau yam peptides nrog rau 80 kD thiab ntau yam txuas ntxiv ntawm 90 kD subunit. Nws muaj tib yam kev ua haujlwm lom neeg raws li qhov tseem ceeb VIII muab los ntawm tib neeg plasma. Tsis muaj tib neeg lossis tsiaj cov proteins, xws li albumin, ntxiv rau lub sijhawm ua kom huv thiab tsim cov txheej txheem ntawm Helixate FS.
Cov txheej txheem purification muaj xws li cov kuab tshuaj / tshuaj ntxuav cov kab mob uas tsis ua haujlwm ntxiv rau kev siv cov txheej txheem purification ntawm ion txauv chromatography, monoclonal antibody immunoaffinity chromatography, nrog rau lwm cov kauj ruam chromatographic tsim los purify recombinant factor VIII thiab tshem tawm cov kab mob.
Tsis tas li ntawd, cov txheej txheem tsim khoom raug tshawb xyuas rau nws lub peev xwm los txo qhov kev kis tus kab mob ntawm tus neeg ua haujlwm sim ntawm kev kis tus kab mob spongiform encephalopathy (TSE), suav tias yog tus qauv rau vCJD thiab CJD cov neeg ua haujlwm.15-19Ob peb tus neeg tsim khoom thiab cov khoom siv raw cov kauj ruam hauv Helixate FS cov txheej txheem tsim khoom tau pom tias yuav txo qis TSE kab mob ntawm tus neeg ua haujlwm sim ua qauv. Cov kauj ruam txo TSE no suav nrog Fraction II + III cais cov kauj ruam rau HPPS (6.0 log10) thiab anion pauv chromatography kauj ruam (3.6 cav10).
Helixate FS yog formulated nrog cov hauv qab no ua stabilizers (saib Table 6 )nyob rau hauv lub thawv kawg thiab ces lyophilized. Cov khoom kawg tsis muaj cov tshuaj tiv thaiv. Nws yog sterile, nonpyrogenic hmoov npaj rau intravenous txhaj. Intravenous tswj ntawm sucrose muaj nyob rau hauv Helixate FS yuav tsis cuam tshuam rau cov ntshav qabzib.
| Stabilizer | 250 IU, 500 IU, 1000 IU Nominal Vial Loj | 2000 IU, 3000 IU Nominal Vial Loj |
|---|---|---|
| Sucrose | 0.9-1.3% yog ' | 0.9-1.2% yog ' |
| Glycine | 21-25 mg/ml | 20-24 mg/ml |
| Histidine | 18-23 mmol / L | 17-22 mmol / L |
Table 7 teev cov khoom xyaw uas tsis muaj zog / excipients kuj muaj nyob rau hauv cov khoom kawg.
| Cov khoom xyaw tsis muaj zog / Excipient | 250 IU, 500 IU, 1000 IU | 2000 IU, 3000 IU |
|---|---|---|
| Sodium | 27-36 mEq/L | 26-34 mEq/L |
| Calcium | 2.0-3.0 mmol / L yog | 1.9-2.9 mmol / L |
| Chloride | 32-40 mEq/L | 31-38 mEq/L |
| Polysorbate 80 | 64-96 Μg/ml | 64-96 Μg/ml |
| Sucrose | 28 mg / vial | 52 mg / vial |
| Imidazole, tri-n-butyl phosphate, thiab tooj liab | Cov lej | Cov lej |
Helixate FS - Clinical Pharmacology
Mechanism ntawm Action
Helixate FS ib ntus hloov cov ntshav txhaws uas ploj lawm VIII uas yuav tsum tau ua kom zoo hemostasis.
Pharmacodynamics
Lub sijhawm ua haujlwm ib nrab thromboplastin lub sijhawm (aPTT) yog ntev rau cov neeg mob hemophilia. Kev txiav txim siab ntawm aPTT yog ib qho piv txwvhauv vitroKev ntsuam xyuas rau kev ua haujlwm lom neeg ntawm yam VIII. Kev kho mob nrog Helixate FS normalizes aPTT nyob rau lub sijhawm noj tshuaj.
Pharmacokinetics
Cov tshuaj pharmacokinetic ntawm Helixate FS tau tshawb xyuas hauv ob qhov kev tshawb fawb cais hauv cov neeg laus thiab menyuam yaus yav dhau los kho cov neeg mob (PTPs).
Pharmacokinetic cov kev tshawb fawb nrog Helixate FS tau ua nyob rau hauv 20 PTPs (hnub nyoog 12 txog 33 xyoo) nrog mob hemophilia A. Cov tshuaj pharmacokinetic tsis tau rau Helixate FS tau ntsuas hauv qhov kev sim sib txawv, hla kev soj ntsuam nrog cov khoom ua ntej HELIXATE siv ib koob tshuaj ntawm 50 IU. rau kg. Tom qab 24 lub lis piam, tib koob tshuaj Helixate FS tau muab rau tib neeg mob. Cov ntaub ntawv rov qab thiab ib nrab-lub neej rau Helixate FS tsis hloov pauv tom qab 24 lub lis piam ntawm kev kho mob txuas ntxiv nrog kev ua tau zoo thiab tsis muaj pov thawj ntawm qhov VIII inhibition (saib Table 8 ).
| Parameter | Helixate FS | HELIXATE | |
|---|---|---|---|
| Thawj PK (Mean ± SD) | PK ntawm lub lim tiam 24 (Mean ± SD) | Kev siv (Mean ± SD) | |
| AUC (IU∙h/dL) thaum twg yuav tsum tau noj tshuaj dramamine | 1588.05 ± 344.32 | 1487.08 ± 381.73 | 1879.02 ± 412.32 |
| Cmax (IU / dL) | 114.95 ± 20.19 | 109.42 ± 20.09 | 127.40 ± 33.21 |
| Ib nrab neej (h) | 13.74 ± 1.82 | 14.60 ± 4.38 | 14.07 ± 2.62 |
| Hauv Vivo Rov Qab (IU / dL / IU / kg) | 2.20 ± 0.34 | 2.11 ± 0.37 | 2.43 ± 0.60 |
Cov tshuaj pharmacokinetics ntawm Helixate FS tau tshawb xyuas hauv cov menyuam yaus PTPs (4.4-18.1 xyoo, hnub nyoog nruab nrab 12).13Pharmacokinetic tsis nyob rau hauv cov menyuam yaus piv rau cov neeg laus qhia qhov sib txawv ntawm kev tshem tawm ntau dua, qis qis duanyobfactor VIII rov qab thiab luv dua qhov VIII ib nrab-lub neej. Pharmacokinetic tsis tau piav qhia hauv Table 9.
| Parameter | Qhov nruab nrab (ntau) |
|---|---|
| AUC (IU∙h/dL) | 1320.0 Nws |
| Kev tshem tawm (mL / h∙kg) | 4.1 |
| Ib nrab neej (h) | 10.7 (7.8–15.3) Nws. |
| Hauv Vivo Rov Qab (IU / dL / IU / kg) | 1.9 (1.25–2.76). |
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
Tsis muaj kev tshawb fawb tau ua nrog Helixate FS los ntsuas nws cov mutagenic lossis carcinogenic muaj peev xwm thiab kev ua tsis taus ntawm fertility. Los ntawm kev xav, cov khoom ua ntej HELIXATE thiab Helixate FS yuav tsum muaj qhov sib npaug ntawm mutagenic thiab carcinogenic peev xwm.
Cov khoom lag luam ua ntej tsis pom qhov hloov pauv hloov pauv lossis chromosomal aberrations ntawm cov koob tshuaj ntau dua li qhov siab tshaj qhov xav tau tshuaj kho mob.nyobKev soj ntsuam nrog cov khoom lag luam ua ntej hauv cov tsiaj uas siv cov koob tshuaj li ntawm 10 thiab 40 npaug ntawm qhov kev cia siab hauv kev kho mob siab tshaj plaws kuj tau qhia tias cov khoom lag luam ua ntej tsis muaj peev xwm mutagenic. Kev tshawb nrhiav ntev ntev ntawm qhov muaj peev xwm carcinogenic hauv cov tsiaj tsis tau ua vim lub cev tiv thaiv kab mob rau cov protein ntau heterologous hauv txhua hom tsiaj uas tsis yog tib neeg tsiaj.
Tsiaj Toxicology thiab/los yog Pharmacology
Cov kev tshawb fawb soj ntsuam kuaj xyuas Helixate FS hauv hemophilia A nrog nas, nas, luav, thiab dev pom tau tias muaj kev nyab xeeb thiab ua haujlwm zoo ntawm hemostasis. Cov koob tshuaj ntau ntau dua li cov tshuaj kho mob pom zoo (txog rau lub cev qhov hnyav) tsis pom muaj qhov mob hnyav lossis subacute tshuaj lom rau Helixate FS hauv cov tsiaj kuaj.
Helixate FS tau pom tias muaj kev sib piv rau cov khoom lag luam ua ntej HELIXATE nrog rau nws cov khoom siv biochemical thiab physiochemical, nrog rau nws cov khoom tsis zoo hauv vivo pharmacology thiab toxicology.
Kev tshawb fawb soj ntsuam
Yav dhau los Cov Neeg Mob Kho Mob (PTPs) Kev Kawm Kho Mob
Tag nrho ntawm 73 tus neeg mob uas muaj mob hnyav (≦ 2% FVIII) hemophilia A, hnub nyoog 12-59, uas tau raug kho yav dhau los nrog lwm cov tshuaj recombinant lossis nrog cov khoom siv plasma-derived AHF, tau kho txog li 54 lub hlis hauv kev tshawb fawb qhib nrog Helixate FS. . Tag nrho ntawm 5,684 lub sijhawm los ntshav tau raug kho thaum lub sijhawm kawm; 92.7% ntawm cov ntshav tau kho nrog ib qho (79.7%) lossis ob (13.0%) infusions. Cov neeg mob tuaj yeem kho nrog kev xav tau lossis kev tiv thaiv. Kev kho mob prophylaxis tsis tu ncua sawv cev 76% ntawm tag nrho cov infusions (kev kho mob ntawm 2-3 infusions ib lub lis piam).
Tag nrho ntawm 30 tus neeg mob tau txais Helixate FS rau 41 cov txheej txheem phais thaum lub sij hawm kev tshawb fawb PTP. Muaj ob hom kev phais me thiab loj, 16 thiab 25 feem. Kev ua tau zoo tau ntsuas los ntawm tus kws phais mob uas tuaj koom nrog kev sib piv ntawm kev kwv yees cov ntshav poob los ntawm kev paub nrog cov neeg mob uas tsis yog hemophilic tau ua cov txheej txheem zoo sib xws. Tus kws phais lossis tus kws kho mob tau muab qhov ntsuas rau cov txiaj ntsig hemostatic raws li 4 pawg: 'zoo heev (cov ntshav poob qis dua li qhov xav tau),' 'zoo (ntshav poob raws li qhov xav tau),' 'mob (cov ntshav poob ntau tshaj qhov xav tau),' lossis 'tsis muaj (los ntshav tsis tswj tau).' Hemostasis tau ntsuas raws li qhov txaus siab ('zoo heev' lossis 'zoo') hauv txhua kis.
Yav dhau los Cov Neeg Mob Tsis Muaj Kev Kho Mob (PUPs) thiab Cov Neeg Kho Mob Tsawg (MTPs) Kev Tshawb Fawb
Helixate FS tau siv rau hauv kev kho mob los ntshav hauv cov menyuam yaus PUPs thiab MTPs nrog hnyav (<2% FVIII) hemophilia A. There were 37 PUPs and 24 MTPs (defined as having equal to or less than 4 exposure days) treated with a total of 9,419 infusions of Helixate FS for a follow up duration up to 3.1 years. A total of 1047 bleeding episodes were treated; the bleeds were treated with one (73%) or two (15%) infusions.
Tag nrho ntawm 27 cov txheej txheem phais tau ua nyob rau hauv 22 tus neeg mob thaum lub sijhawm PUPs thiab MTPs kawm. Muaj ob hom kev phais me thiab loj, 21 thiab 6 feem. Tus kws phais neeg tuaj koom tau ntsuas qhov ua tau zoo thiab muab qhov ntsuas rau cov txiaj ntsig hemostatic raws li 4 pawg raws li tau piav qhia saum toj no rau PTPs. Hemostasis tau ntsuas raws li qhov txaus siab ('zoo heev' lossis 'zoo') hauv txhua kis.
famotidine, nws yog dab tsi rau?
Adult Prophylaxis rau ntshav ntshav txo qis
Ib xyoo 3-xyoo, multicenter, qhib-label, parallel-pab pawg, yav tom ntej, randomized, tswj kev soj ntsuam kev tshawb fawb txog cov txiaj ntsig ntawm kev tiv thaiv niaj hnub nrog Helixate FS piv rau qhov xav tau siv los ntshav ntau zaus hauv cov neeg laus thiab cov tub ntxhais hluas suav nrog 84 PTPs nrog Hemophilia A. (FVIII qib<1 IU/dL), age 15 to 50 years. Patients were matched at baseline on demographic and disease characteristics. The median number of bleeds in the year before enrollment was 18.
Cov neeg mob tau randomized 1: 1 rau prophylaxis (25 units ib kg peb zaug hauv ib lub lis piam) lossis kev thov siv Helixate FS. Kev nce qib ntawm cov tshuaj tiv thaiv kab mob los ntawm 5 units ib kg / infusion tom qab xyoo 1 thiab 2, mus txog qhov siab tshaj plaws ntawm 35 units ib kg / infusion, tau tso cai.
Cov ntshav ntau zaus tau txheeb xyuas nyob rau hauv cov neeg mob siab rau kev kho mob tom qab lub sijhawm nruab nrab ntawm 1.4 xyoo. Cov neeg mob uas tau txais kev tiv thaiv kev tiv thaiv tau muaj kev txheeb xyuas los ntshav tsawg dua (p<0.0001) compared to patients treated on-demand regardless of baseline subgroups examined including age, bleeding history, and presence or absence of target joints. The ratio of the mean bleeding frequency was 15.2 (95% CI: 8.5, 27.2; p<0.0001) for on-demand versus prophylaxis, indicating that patients who received on-demand treatment experienced on average 15.2 times as many bleeds compared to patients treated with prophylaxis. The mean annualized bleed rates (bleeds/subject/year) were 37 in the on-demand group versus 2 in the prophylaxis group. The median annualized bleed rate (bleeds/subject/year) in the on-demand group was 33 versus zero in the prophylaxis group. Most of the bleeding occurred in joints: the median joint bleed rate (joint bleeds/subject/year) was 24 in the on-demand group versus zero in the prophylaxis group. The mean annualized joint bleed rate was 29 in the on-demand group versus 2 in the prophylaxis group.
Nees nkaum ob ntawm 42 (52%) cov neeg tiv thaiv kev tiv thaiv tsis tau los ntshav, thiab 12 ntawm 42 (29%) cov neeg tiv thaiv kev tiv thaiv tsuas yog 1-2 los ntshav thaum lub sijhawm ua raws. Ntawm cov neeg mob prophylaxis qhov nruab nrab tus naj npawb ntawm infusions / lub lis piam yog 2.8, thiab qhov nruab nrab koob tshuaj rau prophylaxis infusion yog 26 units ib kg.
Pediatric Prophylaxis rau Joint Damage Risk txo
Tag nrho ntawm 65 tus tub hluas hnub nyoog qis dua 30 lub hlis uas muaj mob hemophilia A (FVIII theem ≦ 2 IU / dL) thiab nrog ≦ 2 los ntshav rau hauv txhua qhov kev sib koom ua ke thiab cov duab hauv qab ib txwm muaj, tau soj ntsuam txog li 5.5 xyoo hauv ntau qhov chaw, qhib-label, yav tom ntej, randomized, tswj kev soj ntsuam kev kawm.5Cov neeg mob tau txais 25 IU ib kg ib hnub twg (thawj prophylaxis; n = 32) los yog tsawg kawg yog 3 koob tshuaj tag nrho ntawm qhov tsawg kawg nkaus ntawm 80 IU ib kg thaum lub sij hawm los ntshav (ntau dua episodic; n = 33). Kev puas tsuaj ntawm kev sib koom tes tau soj ntsuam los ntawm kev sib nqus resonance imaging (MRI) lossis radiography, nrog rau qhov zaus ntawm cov ntshav ntu. Kev puas tsuaj los ntawm MRI lossis duab hluav taws xob hauv pob taws, hauv caug, thiab lub luj tshib (piv txwv li, cov pob qij txha index) tau qis dua (p = 0.002) rau cov neeg uas tau txais kev kho mob prophylactic (7%) dua li cov neeg tau txais kev kho mob episodic (42%). Qhov no sib haum mus rau 6.29-fold tus txheeb ze kev pheej hmoo ntawm kev puas tsuaj rau kev sib koom ua ke rau cov neeg mob kho nrog kev kho kom zoo dua qub piv rau kev tiv thaiv kab mob. Qhov nruab nrab tus nqi ntawm kev sib koom ua ke hemorrhages rau cov ncauj lus ntawm kev kho mob episodic yog 4.89 los ntshav hauv ib xyoos, piv rau 0.63 los ntshav hauv ib xyoos pom hauv caj npab prophylaxis. Peb ntawm 33 (9.1%) cov neeg kawm nyob rau hauv lub caj npab episodic tau ntsib txoj sia uas tshwm sim los ntshav (intracranial, gastrointestinal) piv rau tsis muaj cov ntsiab lus hauv caj npab prophylaxis. Nyob rau hauv ib qho kev sib koom ua ke, cov pob qij txha nyob rau hauv ib txwm prophylaxis caj npab yog 8-fold ntau dua yuav nyob twj ywm tsis muaj kev puas tsuaj ntau dua li cov hauv caj npab episodic. Kev puas tsuaj feem ntau tau pom nyob rau hauv pob taws pob qij txha thiab tau kuaj pom ntawm tus nqi siab dua los ntawm MRI dua li ntawm radiography. Cov pob qij txha kuj yog qhov sib koom ua ke uas pom tau tias muaj qhov tshwm sim los ntshav ntau tshaj plaws hauv txoj kev tshawb no (sab laug pob taws, txhais tau tias 2.7 hemorrhages; pob taws sab xis, txhais tau tias 2.6 hemorrhages).
Raws li qhia hauv Table 10 hauv qab no, qhov tshwm sim ntawm kev puas tsuaj ntawm kev sib koom ua ke tau qis dua hauv pawg prophylactic piv rau pawg kho mob episodic thaum soj ntsuam los ntawm MRI, lossis MRI lossis radiography, siv cov txheej txheem ua ntej (piv txwv li hauv qab no) los tsim kev puas tsuaj ntawm kev sib koom tes. Txawm li cas los xij, tsis muaj qhov sib txawv tseem ceeb ntawm ob pawg thaum sib koom ua ke puas tsuaj raug soj ntsuam los ntawm radiography ib leeg.
Txhawm rau ntsuas qhov kev puas tsuaj sib koom ua ke, MRIs tau qhab nia siv qhov ntsuas tsim los ntawm Nuss li al.,nees nkaumthiab X-rays tau qhab nia siv txoj kev Pettersson li al.nees nkaum ibOb qhov ntsuas tau raug lees paub nyob rau hauv ntau yam kev sim tshuaj thiab yog siv niaj hnub rau kev ntsuam xyuas kev puas tsuaj hauv hemophilacs. Kev puas tsuaj ntawm pob txha tau txhais tias yog pob txha thiab / lossis pob txha pob txha puas tsuaj nrog rau cov kab mob subchondral, erosions thiab pob txha mos poob nrog qhov chaw sib koom ua ke. Qhov no suav nrog tag nrho MRI cov qhab nia ntawm ≧ 7 lossis X-ray qhab nia ntawm ≧1 nyob rau hauv ib qho ntawm cov pawg hauv qab no: subchondral cysts, erosions ntawm cov pob qij txha los yog nqaim ntawm qhov sib koom ua ke. Cov duab tau nyeem cais los ntawm ob tus kws tshaj lij hluav taws xob ywj pheej hauv nruab nrab. Ib qho kev nyeem ntawv tsis sib xws tau nyeem los ntawm tus kws kho hluav taws xob thib peb uas tsis paub txog qhov kev nyeem thawj zaug. Kev nyeem ntawv sib txuas ntawm ob ntawm peb tus neeg nyeem tau siv los ntsuas lub hom phiaj.
| Kev ntsuas qhov kawg | Kev tiv thaiv kab mob | Kev Kho Mob Episodic | p-nqi | ||
|---|---|---|---|---|---|
| Qhov tshwm sim (%) | Tus txheeb ze Risk (95% CI) | Qhov tshwm sim (%) | Tus txheeb ze Risk (95% CI) | ||
| Relative Risk yog qhov kev pheej hmoo ntawm kev puas tsuaj rau ib lossis ntau qhov sib koom ua ke ntawm cov kev kho mob muab piv rau lwm txoj kev kho. P-tus nqi yog los ntawm 2-sided Fisher Exact Test piv qhov tshwm sim ntawm kev puas tsuaj sib koom ntawm pab pawg kho mob. | |||||
| MRI | 2/27 (7%) | 0.17 (0.04, 0.67) | 13/29 (45%) | 6.05 (1.50, 24.38) dr hab. | 0.002 ib |
| Xov tooj cua | 1/28 (4%) | 0.19 (0.02, 1.55 hli) | 5/27 (19%) | 5.19 (0.65, 41.54). | 0.101 ib |
| MRI lossis Radiography | 2/30 (7%) | 0.16 (0.04, 0.65) | 13/31 (42%) | 6.29 (1.55, 25.55). | 0.002 ib |
REFERENCES
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- Abildgaard CF, Simone JV, Corrigan JJ, thiab al: Kev kho mob hemophilia nrog glycine-precipitated Factor VIII.N Engl J Med275(9): 471–5, 1966.
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- Schwartz RS, Abildgaard CF, Aledort LM, et al: Human recombinant DNA-derived antihemophilic factor (factor VIII) in the treatment of hemophilia A. Recombinant Factor VIII Study Group.N Engl J Med323(26): 1800-5, 1990.
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- Dawb GC 2nd, Courter S, Bray GL, thiab al: Ib qho kev tshawb fawb ntawm ntau qhov chaw ntawm recombinant factor VIII (Recombinate) nyob rau hauv yav tas los kho cov neeg mob nrog hemophilia A. Cov Recombinate Previously Treated Patient Study Group.Thromb Haemost77(4): 660-667, 1997.
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- Manco-Johnson MJ, Abshire TC, Shapiro AD, Riske B, Hacker MR, Kilcoyne R, et al. Prophylaxis piv rau kev kho mob episodic los tiv thaiv kab mob sib koom ua ke hauv cov tub hluas uas muaj hemophilia hnyav.N Engl J Med2007; 357(6:535-44).
- •
- Kasper CK: Teeb meem ntawm hemophilia A kev kho mob: yam VIII inhibitors.Ann NY Acad Sci614: 97-105, 1991.
- •
- Gouw SC, van den Berg HM, et al: Kev siv zog ntawm kev kho mob VIII thiab inhibitor kev loj hlob ntawm cov menyuam yaus uas muaj hemophilia A: txoj kev tshawb fawb RODIN.Ntshav121(20): 4046-4055, 2013.
- •
- Calvez T, Chambost H, et al: Recombinant factor VIII khoom thiab inhibitor txoj kev loj hlob nyob rau hauv yav tas los cov tub hluas uas tsis tau kho mob hemophilia A.Ntshav124(23): 3398-3408, 2014.
- •
- Collins PW, Palmer BP, et al: Factor VIII hom thiab qhov tshwm sim ntawm yam VIII inhibitors hauv UK cov menyuam yaus uas tsis tau kho mob hemophilia A, 2000-2011.Ntshav124(23): 3389-3397, 2014.
- •
- Franchini M, Coppola A, et al: Systematic Review of the Role of FVIII Concentrates in Inhibitor Development in Yav tas los Untreated Patients with Severe Hemophilia A: A 2013 Update.Semin Throm Hemost(39): 752-766, 2013.
- •
- Vezina C, Carcao M, et al: Cov xwm txheej thiab qhov muaj feem cuam tshuam rau kev txhim kho inhibitor hauv cov neeg mob uas tsis tau kho mob haemophilia A yav dhau los yug ntawm 2005 thiab 2010.Hemophilia20(6): 771-776, 2014.
- •
- Fisher K, Lassila, R, et al. Inhibitor txoj kev loj hlob nyob rau hauv haemophilia raws li kev mloog zoo: Plaub-xyoo kev tshwm sim los ntawm European HAemophilia Safety Surveillance (EUHASS) project.Thromb Haemost113.4, 2015.
- •
- Barnes C, Lillicrap D, Pazmino-Canizares J, thiab al: Pharmacokinetics ntawm recombinant factor VIII (Helixate-FS®) nyob rau hauv cov me nyuam thiab ua rau inter-patient pharmacokinetic variability.Hemophilia12 (Suppl. 4): 40-49, 2006.
- •
- Lawn RM, Vehar GA: Molecular genetics of hemophilia.Sci Am254(3): 48–54, 1986.
- •
- Stenland CJ, et al: Kev faib tawm ntawm tib neeg thiab yaj cov ntaub ntawv ntawm cov kab mob prion protein thaum lub sij hawm ntxuav cov proteins ntawm cov ntshav plasma tib neeg.Hloov ntshav42(11): 1497-500, 2002.
- •
- Lee DC, Miller JL, Petteway SR: Kab mob kev nyab xeeb ntawm kev tsim cov txheej txheem rau cov khoom siv roj ntsha: tshwj xeeb rau HELIXATE®Bayer.Hemophilia8(Suppl. 2:6–9, 2002.
- •
- Lee DC, Stenland CJ, Miller JL, thiab al: Ib qho kev sib raug zoo ncaj qha ntawm kev faib cov kab mob prion protein thiab kis tau tus kab mob spongiform encephalopathy thaum lub sij hawm ntxuav cov plasma proteins.Hloov ntshav41(4): 449-55, 2001.
- •
- Cai K, Miller JL, Stenland CJ, et al: Solvent-dependent precipitation of prion protein.Biochim Biophys Acta1597(1): 28-35, 2002.
- •
- Trejo SR, Hotta JA, Lebing W, thiab al: Kev ntsuam xyuas tus kab mob thiab prion txo nyob rau hauv cov txheej txheem tshiab intravenous immunoglobulin manufacturing txheej txheem.Vox Sang84(3): 176-87, 2003.
- •
- Nuss R, Kilcoyne RF, Geraghty S, thiab al: MRI tshawb pom hauv cov pob qij txha haemophilic kho nrog radiosynoviorthesis nrog kev txhim kho ntawm MRI nplai ntawm kev puas tsuaj.Hemophilia6:162-169, 2000.
- •
- Pettersson H, Ahlberg A, Nilsson IM: Kev faib tawm radiologic ntawm hemophilia arthropathy.Clin Orthop Relat Res149: 153-159, 1980.
Yuav Ua Li Cas Muab / Cia thiab tuav
Yuav Ua Li Cas
Helixate FS muaj nyob rau hauv cov khoom siv hauv qab no ib zaug siv iav vial ntau thiab tsawg. Lub ntim haum ntawm Sterile Dej rau Txhaj Tshuaj, USP thiab Mix2Vial®lim hloov khoom siv yog muab rau hauv cov khoom siv.
| Kit NDC Number | Kwv yees FVIII Kev Ua Haujlwm (IU) | Diluent (mL) |
|---|---|---|
| 0053-8131-02 | 250 | 2.5 |
| 0053-8132-02 | 500 | 2.5 |
| 0053-8133-02 | 1000 | 2.5 |
| 0053-8134-02 ib | 2000 | 5.0 |
| 0053-8135-02 | 3000 | 5.0 |
Qhov ua tau tiag tiag VIII hauv IU yog teev rau ntawm daim ntawv lo ntawm txhua Helixate FS vial. Siv qhov tseeb potency raws li qhia ntawm lub vial daim ntawv lo los xam cov koob tshuaj.
Cia thiab tuav
Cov khoom vial thiab diluent vial tsis yog ua los ntawm ntuj roj hmab latex.
Khoom raws li Ntim rau Muag
- •
- Khaws Helixate FS ntawm +2 ° C txog +8 ° C (36 ° F txog 46 ° F) txog li 30 lub hlis txij li hnub tsim khoom. Hauv lub sijhawm no, Helixate FS tuaj yeem khaws cia rau lub sijhawm ntev txog 12 lub hlis ntawm qhov kub txog +25 ° C lossis 77 ° F.
- •
- Sau hnub pib ntawm chav tsev kub cia rau ntawm lub thawv khoom tsis tau qhib. Thaum khaws cia ntawm chav tsev kub, tsis txhob xa cov khoom rov qab mus rau lub tub yees. Lub txee-lub neej ces tas sij hawm tom qab cia ntawm chav tsev kub, los yog tom qab hnub tas sij hawm ntawm cov khoom vial, qhov twg yog ua ntej.
- •
- Tsis txhob siv Helixate FS tom qab hnub tas sij hawm qhia ntawm lub vial.
- •
- Tsis txhob khov.
- •
- Tiv thaiv los ntawm kev raug mob rau lub teeb thiab khaws cov lyophilized hmoov rau hauv lub thawv ua ntej siv.
Cov khoom tom qab Reconstitution
- •
- Tom qab rov tsim kho dua tshiab, khaws cov tshuaj Helixate FS ntawm chav sov thiab ua haujlwm hauv 3 teev.
Cov Ntaub Ntawv Qhia Txog Tus Neeg Mob
- •
- Qhia tus neeg mob kom nyeem cov ntawv pom zoo los ntawm FDA rau tus neeg mob (Cov Ntaub Ntawv Tus Neeg Mob thiab Cov Lus Qhia rau Kev Siv).
- •
- Qhia cov neeg mob kom tshaj tawm cov kev phiv los yog teeb meem tom qab Helixate FS kev tswj hwm rau lawv tus kws kho mob lossis tus kws kho mob.
- •
- Kev ua xua-hom hypersensitivity tshwm sim tau raug tshaj tawm nrog Helixate FS. Ceeb toom rau cov neeg mob ntawm cov tsos mob thaum ntxov ntawm hypersensitivity tshwm sim [xws li khaus khaus khaus khaus), generalized urticaria, nruj ntawm lub hauv siab, hawb pob, hypotension] thiab anaphylaxis. Qhia cov neeg mob kom tsis txhob siv cov khoom lag luam yog tias cov tsos mob no tshwm sim thiab nrhiav kev kho mob sai sai nrog cov kev ntsuas resuscitative xws li kev tswj hwm ntawm epinephrine thiab oxygen.
- •
- Inhibitor tsim tuaj yeem tshwm sim txhua lub sijhawm hauv kev kho tus neeg mob hemophilia A. Qhia cov neeg mob hu rau lawv tus kws kho mob lossis chaw kho mob rau kev kho mob ntxiv thiab / lossis kev ntsuam xyuas, yog tias lawv muaj qhov tsis txaus ntawm kev kho mob teb rau yam VIII hloov kho, raws li qhov no tej zaum yuav yog ib qho kev tshwm sim ntawm tus inhibitor.
- •
- Qhia cov neeg mob kom sab laj nrog lawv tus kws kho mob ua ntej mus ncig. Thaum mus ncig qhia cov neeg mob kom nqa cov khoom txaus ntawm Helixate FS raws li lawv cov kev kho mob tam sim no.
FDA pom zoo PATIENT LABELING
PATIENT INFORMATION
Helixate FS (he-liks-āt)
Antihemophilic Factor (Recombinant)
Formulated nrog sucrose
Daim ntawv no qhia txog cov ntaub ntawv tseem ceeb ntawm Helixate FS. Thov nyeem kom zoo ua ntej siv cov tshuaj no. Cov ntaub ntawv no tsis yog qhov chaw ntawm kev tham nrog koj tus kws kho mob, thiab nws tsis suav nrog tag nrho cov ntaub ntawv tseem ceeb ntawm Helixate FS. Yog tias koj muaj lus nug tom qab nyeem qhov no, nug koj tus kws kho mob.
Tsis txhob sim ua rau nws tus kheej yog tias koj tau txais kev qhia los ntawm koj tus kws kho mob lossis chaw kho mob hemophilia.
Helixate FS yog dab tsi?
Helixate FS yog cov tshuaj siv los hloov cov ntshav txhaws (factor VIII lossis antihemophilic factor) uas ploj lawm hauv cov neeg muaj hemophilia A (tseem hu ua 'classic' hemophilia). Hemophilia A yog ib qho kab mob los ntshav uas tiv thaiv cov ntshav los ntawm kev ua kom tsis muaj zog.
Helixate FS yog siv los kho thiab tswj cov ntshav hauv cov neeg laus thiab cov menyuam yaus uas muaj hemophilia A. Koj tus kws kho mob yuav muab Helixate FS rau koj thaum koj tau phais. Helixate FS tuaj yeem txo cov ntshav los ntshav thaum siv tsis tu ncua (prophylaxis). Helixate FS tuaj yeem txo qhov kev pheej hmoo ntawm kev puas tsuaj rau cov menyuam yaus.
Helixate FS tsis yog siv los kho tus kab mob von Willebrand.
Leej twg yuav tsum tsis txhob siv Helixate FS?
Koj yuav tsum tsis txhob siv Helixate FS yog tias koj
- •
- ua xua rau nas (xws li nas thiab hamsters).
- •
- ua xua rau cov khoom xyaw hauv Helixate FS.
Qhia rau koj tus kws kho mob yog tias koj cev xeeb tub lossis pub niam mis vim Helixate FS tej zaum yuav tsis zoo rau koj.
Kuv yuav tsum qhia dab tsi rau kuv tus kws kho mob ua ntej kuv siv Helixate FS?
Qhia rau koj tus kws kho mob txog tag nrho koj cov mob.
Qhia rau koj tus kws kho mob thiab tus kws muag tshuaj txog txhua yam tshuaj uas koj noj, suav nrog tag nrho cov tshuaj noj thiab cov tshuaj tsis yog tshuaj, xws li tshuaj tom khw muag khoom, tshuaj ntxiv, lossis tshuaj ntsuab tshuaj ntsuab.
Qhia rau koj tus kws kho mob yog tias koj tau hais tias koj muaj kab mob plawv lossis muaj kev pheej hmoo rau mob plawv.
Qhia rau koj tus kws kho mob yog tias koj tau raug qhia tias koj muaj cov tshuaj tiv thaiv rau VIII (vim Helixate FS yuav tsis ua haujlwm rau koj).
Dab tsi yog qhov tshwm sim ntawm Helixate FS?
Koj tuaj yeem muaj kev fab tshuaj rau Helixate FS. Hu rau koj tus kws kho mob tam sim ntawd thiab tso tseg kev kho mob yog tias koj tau txais
- •
- ua pob khaus lossis khaus khaus
- •
- khaus
- •
- nruj ntawm lub hauv siab los yog caj pas
- •
- ua tsis taus pa
- •
- teeb taub hau, kiv taub hau
- •
- xeev siab
- •
- txo cov ntshav siab
Koj lub cev kuj tuaj yeem tsim cov tshuaj tiv thaiv, hu ua 'inhibitors,' tawm tsam Helixate FS, uas tuaj yeem txwv Helixate FS ua haujlwm zoo. Tham nrog koj tus kws kho mob kom paub tseeb tias koj tau ua tib zoo saib xyuas nrog kev kuaj ntshav rau kev txhim kho cov inhibitors rau yam VIII.
Lwm yam kev mob tshwm sim ntawm Helixate FS yog
- •
- Qhov chaw txhaj tshuaj hauv zos (mob, o, khaus ntawm qhov chaw infusion)
- •
- Kab mob los ntawm implanted txhaj tshuaj
Qhia rau koj tus kws kho mob txog cov kev mob tshwm sim uas cuam tshuam rau koj lossis qhov ntawd tsis ploj mus.
Nrhiav cov leeg rau txhaj tshuaj yuav nyuaj rau cov menyuam yaus. Thaum yuav tsum tau txhaj tshuaj ntau zaus koj tus menyuam tus kws kho mob yuav hais kom muaj ib lub tshuab phais tso rau hauv qab ntawm daim tawv nqaij kom yooj yim nkag mus rau hauv cov hlab ntsha. Cov cuab yeej no yuav ua rau muaj kab mob.
Cov no tsis yog tag nrho cov teebmeem tshwm sim nrog Helixate FS.
Koj tuaj yeem nug koj tus kws kho mob txog cov ntaub ntawv uas tau sau rau cov kws kho mob.
Kuv yuav khaws Helixate FS li cas?
Tsis txhob khov Helixate FS.
Khaws Helixate FS ntawm +2 ° C txog +8 ° C (36 ° F txog 46 ° F) txog li 30 lub hlis txij li hnub tsim khoom. Hauv lub sijhawm no, Helixate FS tuaj yeem khaws cia rau lub sijhawm ntev txog 12 lub hlis ntawm qhov kub txog +25 ° C lossis 77 ° F.
Sau hnub pib ntawm chav tsev kub cia rau ntawm lub thawv khoom tsis tau qhib. Thaum khaws cia ntawm chav tsev kub, tsis txhob xa cov khoom rov qab mus rau lub tub yees. Cov khoom siv tas sij hawm tom qab khaws cia hauv chav tsev kub, lossis tom qab hnub tas sij hawm ntawm cov khoom vial, qhov twg yog qhov ua ntej. Khaws cov vials rau hauv lawv lub thawv qub thiab tiv thaiv lawv los ntawm kev raug teeb pom kev zoo.
ip 109 ntsiav tshuaj nws yog dab tsi
Cov khoom siv rov ua dua tshiab (tom qab sib xyaw cov khoom qhuav nrog cov dej ntub dej) yuav tsum siv li ntawm 3 teev thiab tsis tuaj yeem khaws cia.
Pov tseg tej yam tsis siv Helixate FS tom qab hnub tas sij hawm.
Tsis txhob siv Helixate FS rov tsim dua yog tias nws tsis meej rau me ntsis huab thiab tsis muaj xim.
Dab tsi ntxiv kuv yuav tsum paub txog Helixate FS thiab hemophilia A?
Cov tshuaj muaj qee zaum raug muab rau cov hom phiaj uas tsis yog cov npe ntawm no. Tsis txhob siv Helixate FS rau ib qho xwm txheej uas nws tsis tau sau tseg. Tsis txhob qhia Helixate FS rau lwm tus neeg, txawm tias lawv muaj cov tsos mob zoo ib yam uas koj muaj.
Daim ntawv no qhia txog cov ntaub ntawv tseem ceeb tshaj plaws txog Helixate FS. Yog tias koj xav paub ntau ntxiv, tham nrog koj tus kws kho mob. Koj tuaj yeem nug koj tus kws kho mob lossis tus kws muag tshuaj rau cov ntaub ntawv hais txog Helixate FS uas tau sau rau cov kws kho mob.
Cov lus qhia rau kev siv
Kuv yuav tsum noj Helixate FS li cas?
Tsis txhob sim ua rau nws tus kheej yog tias koj tau txais kev qhia los ntawm koj tus kws kho mob lossis chaw kho mob hemophilia.
Saib cov lus qhia ua ntu zus rau kev rov tsim kho Helixate FS thaum kawg ntawm nplooj ntawv no thiab Mix2Vial®lim hloov ntaus ntawv qhia daim ntawv qhia.
Koj yuav tsum ua raws li cov lus qhia tshwj xeeb uas tau muab los ntawm koj tus kws kho mob. Cov kauj ruam hauv qab no yog cov lus qhia dav dav rau kev siv Helixate FS. Yog tias koj tsis paub meej txog cov txheej txheem, thov hu rau koj tus kws kho mob ua ntej siv.
Hu rau koj tus kws kho mob tam sim ntawd yog tias cov ntshav tsis tswj tau tom qab siv Helixate FS.
Koj tus kws kho mob yuav sau cov koob tshuaj uas koj yuav tsum tau noj.
Koj tus kws kho mob yuav tsum tau kuaj ntshav ib ntus.
Tham nrog koj tus kws kho mob ua ntej mus ncig. Koj yuav tsum npaj kom nqa Helixate FS txaus rau koj txoj kev kho mob lub sijhawm no.
Ua tib zoo lis Helixate FS. Pov tseg tag nrho cov ntaub ntawv, suav nrog cov khoom seem uas tau muab kho dua tshiab Helixate FS, hauv ib lub thawv tsim nyog.
Kev kho dua tshiab thiab siv Helixate FS
Ib txwm ua haujlwm ntawm qhov chaw tiaj tus huv si thiab ntxuav koj txhais tes ua ntej ua cov txheej txheem hauv qab no. Siv tsuas yog cov khoom siv rau kev hloov kho thiab kev tswj hwm uas tau muab nrog txhua pob ntawm Helixate FS. Yog tias lub pob qhib lossis puas lawm, tsis txhob siv cov khoom no. Yog tias cov khoom no siv tsis tau, thov hu rau koj tus kws kho mob. Yog tias koj muaj lus nug txog Helixate FS hu rau CSL Behring Customer Support 1-800-683-1288.
| ib. | Ua kom sov lub diluent uas tsis tau qhib thiab cov concentrate rau qhov kub tsis tshaj 37 ° C lossis 99 ° F. | |
| ob. | Muab cov khoom vial, diluent vial thiab Mix2Vial®ntawm ib qho chaw tiaj tus. | |
| 3. | Xyuas kom cov khoom thiab diluent vial flip caps raug tshem tawm thiab cov stoppers raug kho nrog tshuaj aseptic thiab tso cai kom qhuav ua ntej qhib pob Mix2Vial. | |
| Plaub. | Qhib pob Mix2Vial los ntawm kev tshem tawm lub hau (Fig. 1) |  |
| . | Tawm hauv Mix2Vial hauv pob ntshiab. Muab lub diluent vial rau ntawm ib qho chaw sib luag thiab tuav lub vial kom nruj. Tuav lub Mix2Vial ua ke nrog lub pob thiab snap lub xiav kawg mus rau lub diluent stopper (Fig. 2). |  |
| 5. | Ua tib zoo tshem cov pob ntshiab los ntawm Mix2Vial teeb. Nco ntsoov tias koj tsuas rub lub pob thiab tsis yog Mix2Vial teeb (Fig. 3). |  |
| 6. | Nrog cov khoom vial ruaj khov rau ntawm qhov chaw, thim rov qab lub diluent vial nrog lub teeb txuas thiab snap lub pob tshab adapter mus rau cov khoom vial stopper (Fig. 4). Lub diluent yuav cia li hloov mus rau hauv cov khoom vial. |  |
| 7. | Nrog lub diluent thiab cov khoom vial tseem txuas nrog, maj mam swirl cov khoom vial kom ntseeg tau tias cov hmoov yog yaj tag (Daim duab 5). Tsis txhob co vial. |  |
| 8. | Nrog ib txhais tes tuav cov khoom-sab ntawm Mix2Vial teeb thiab nrog rau lwm txhais tes tuav lub xiav diluent-sab ntawm Mix2Vial teeb thiab unscrew lub teeb rau hauv ob daim (Fig. 6). |  |
| 9. | Kos cua mus rau hauv ib qho khoob, tsis muaj menyuam. Thaum cov khoom vial yog upright, ntsia hlau syringe rau Mix2Vial teeb. Txhaj cua rau hauv cov khoom vial. Thaum tuav lub syringe plunger nias, tig lub kaw lus upside down thiab kos cov concentrate rau hauv lub syringe los ntawm rub lub plunger rov qab maj mam (Daim duab 7). |  |
| 10. | Tam sim no hais tias cov concentrate tau raug xa mus rau hauv lub syringe, nrees tuav lub thoob ntawm lub syringe (ua kom lub syringe plunger tig xub ntiag) thiab unscrew lub koob txhaj tshuaj los ntawm Mix2Vial teeb (Fig. 8). Txuas lub syringe rau ib qho kev tswj hwm uas ua nrog microbore tubing. Kev siv lwm cov txheej txheem tswj hwm yam tsis muaj microbore tubing tuaj yeem ua rau muaj kev tuav pov hwm ntau dua hauv cov txheej txheem tswj hwm. |  |
| kaum ib. | Yog tias tib tus neeg mob yuav tsum tau txais ntau tshaj ib lub raj mis, cov ntsiab lus ntawm ob lub raj mis yuav raug kos rau hauv tib lub syringe los ntawm ib qho kev sib cais uas tsis siv Mix2Vial teeb ua ntej muab cov koob txhaj tshuaj. | |
| 12. | Helixate FS yuav tsum tau kuaj pom qhov pom ntawm qhov teeb meem thiab kev hloov xim ua ntej kev tswj hwm. |
Tus nqi ntawm kev tswj hwm
Tag nrho cov koob tshuaj Helixate FS feem ntau tuaj yeem ua rau hauv 1 txog 15 feeb. Txawm li cas los xij, koj tus kws kho mob yuav txiav txim siab tus nqi ntawm kev tswj hwm uas zoo tshaj rau koj.
Cov peev txheej ntawm CSL Behring muaj rau tus neeg mob:
Hu rau Kev Qhia Tsis Txaus Siab:
CSL Behring Pharmacovigilance Department ntawm 1-866-915-6958
Hu rau CSL Behring kom tau txais cov ntaub ntawv ntau ntxiv txog cov khoom lag luam:
Cov Neeg Siv Khoom 1-888-508-6978
Kev Pab Txhawb Cov Neeg Siv Khoom 1-800-683-1288
Kev Pab Nyiaj Them Rov Qab 1-800-676-4266
Yog xav paub ntxiv, mus saib hauv www.HelixateFS.com
Tsim los ntawm:
Bayer HealthCare LLC Whippany, NJ 07981 USA
US Daim Ntawv Tso Cai No 8 (License Holder: Bayer Corporation)
Muab faib los ntawm:
CSL Behring LLC Kankakee, IL 60901 USA
Mix 2Vial®yog lub cim lag luam ntawm West Pharmaceutical Services, Inc. hauv Tebchaws Meskas.
PRINCIPAL DISPLAY PANEL - 250 IU Range Carton
250 IU Ntau
NWS 0053-8131-02
Helixate® FS
Antihemophilic Factor
(Recombinant)
Formulated nrog sucrose
Recombinant Factor VIII nrog
2.5 ml yog '
CSL Sib
PRINCIPAL DISPLAY PANEL - 500 IU Range Carton
500 IU Ntau
NWS 0053-8132-02
Helixate® FS
Antihemophilic Factor
(Recombinant)
Formulated nrog sucrose
Recombinant Factor VIII nrog
2.5 ml yog '
CSL Sib
PRINCIPAL DISPLAY PANEL - 1000 IU Range Carton
1000 IU Ntau
NDC 0053-8133-02
Helixate® FS
Antihemophilic Factor
(Recombinant)
Formulated nrog sucrose
Recombinant Factor VIII nrog
2.5 ml yog '
CSL Sib
PRINCIPAL DISPLAY PANEL - 2000 IU Range Carton
2000 IU Range
NWS 0053-8134-02
Helixate® FS
Antihemophilic Factor
(Recombinant)
Formulated nrog sucrose
Recombinant Factor VIII nrog
5 ml dilu
CSL Sib
PRINCIPAL DISPLAY PANEL - 3000 IU Range Carton
3000 IU Ntau
NWS 0053-8135-02
Helixate® FS
Antihemophilic Factor
(Recombinant)
Formulated nrog sucrose
Recombinant Factor VIII nrog
5 ml dilu
CSL Sib
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| Helixate FS antihemophilic factor, cov khoom siv recombinant | |||||||||||||||||||||
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| Helixate FS antihemophilic factor, cov khoom siv recombinant | |||||||||||||||||||||
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| Helixate FS antihemophilic factor, cov khoom siv recombinant | |||||||||||||||||||||
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| Labeler -CSL Behring LLC (058268293) |
| Sau npe -Bayer HealthCare LLC (127769128) |
| Kev tsim kho | |||
| Lub npe | Chaw nyob | ID/FEI | Kev ua haujlwm |
| Bayer HealthCare LLC | 127769128 ib | MANUFACTURE (0053-8131, 0053-8132, 0053-8133, 0053-8134, 0053-8135) |
