M-M-R II Vaccine

Lub npe dav: Cov tshuaj tiv thaiv kab mob qhua pias, mumps, thiab rubella nyob
Dosage form: njection, hmoov, lyophilized, rau kev ncua
Chav kawm tshuaj: Cov tshuaj tiv thaiv ua ke



Ntawm nplooj ntawv no
Nthuav

Cov lus qhia thiab kev siv tshuaj tiv thaiv M-M-R II

M-M-R®II yog ib qho tshuaj tiv thaiv kab mob rau kev txhaj tshuaj tiv thaiv kab mob qhua pias, mumps, thiab rubella rau cov tib neeg hnub nyoog 12 hli thiab laus dua.



M-M-R II Vaccine Dosage and Administration

Tsuas yog siv rau subcutaneously.

Dose thiab Teem caij

Txhua 0.5 mL koob tshuaj yog muab tshuaj subcutaneously.



Thawj koob tshuaj yog muab rau thaum muaj hnub nyoog 12 txog 15 lub hlis. Ib koob thib ob yog muab rau thaum muaj hnub nyoog 4 txog 6 xyoo.

Qhov koob thib ob tuaj yeem muab tshuaj ua ntej hnub nyoog 4 xyoos, yog tias muaj qhov tsawg kawg ntawm ib hlis ntawm kev txhaj tshuaj tiv thaiv kab mob qhua pias, mumps thiab rubella, nyob { ib - ob }.

Cov menyuam yaus uas tau txais thawj koob tshuaj tiv thaiv kab mob qhua pias, mumps thiab rubella ua ntej lawv thawj hnub yug yuav tsum tau txhaj tshuaj tiv thaiv ntxiv thaum muaj hnub nyoog 12-15 lub hlis thiab thaum muaj hnub nyoog 4-6 xyoos kom tiav cov tshuaj tiv thaiv kab mob.[saib Kev Kawm Kho Mob (14.2) ].



Rau kev tiv thaiv tom qab kis tus kab mob qhua pias, muab tshuaj tiv thaiv M-M-R II hauv 72 teev tom qab kis tau.

Kev Npaj thiab Kev Tswj Xyuas

Siv cov tshuaj tua kab mob tsis muaj tshuaj tua kab mob, tshuaj tua kab mob, thiab tshuaj ntxuav tes rau txhua qhov kev txhaj tshuaj thiab / lossis rov kho cov tshuaj tiv thaiv vim tias cov tshuaj no tuaj yeem ua rau cov tshuaj tiv thaiv kab mob tsis muaj sia. Txhawm rau rov ua dua, tsuas yog siv cov tshuaj diluent muab nrog rau cov tshuaj tiv thaiv vim nws tsis muaj tshuaj tua kab mob lossis lwm yam tshuaj tiv thaiv kab mob uas yuav ua rau cov tshuaj tiv thaiv tsis tau.

Tshem tag nrho cov ntim ntawm cov khoom siv diluent los ntawm nws lub vial thiab txhaj rau hauv cov tshuaj tiv thaiv lyophilized vial. Agitate kom yaj tag. Muab pov tseg yog tias cov tshuaj tiv thaiv lyophilized tsis tuaj yeem yaj.

Tshem tag nrho cov ntim ntawm cov tshuaj tiv thaiv rov tsim dua thiab txhaj tshuaj subcutaneously rau sab nraud ntawm sab caj npab ( cheeb tsam deltoid) lossis mus rau thaj tsam siab dua ntawm tus ncej puab.

Cov khoom siv tshuaj parenteral yuav tsum raug tshuaj xyuas qhov pom ntawm qhov teeb meem thiab cov xim tsis zoo ua ntej kev tswj hwm, thaum twg cov tshuaj thiab cov thawv tso cai. Saib xyuas cov tshuaj tiv thaiv ua ntej thiab tom qab kho dua tshiab ua ntej kev tswj hwm. Ua ntej rov tsim kho dua tshiab, cov tshuaj tiv thaiv lyophilized yog lub teeb daj daj me me crystalline plug, thaum rov ua dua tshiab, yog cov kua ntshiab daj. Muab pov tseg yog tias pom muaj cov teeb meem me me lossis cov xim tsis zoo hauv cov tshuaj tiv thaiv uas tau tsim dua tshiab.

Txhawm rau txo qis zog, muab M-M-R II sai li sai tau tom qab hloov kho. Yog tias tsis siv tam sim ntawd, cov tshuaj tiv thaiv rov tsim dua tuaj yeem khaws cia ntawm 36 ° F txog 46 ° F (2 ° C txog 8 ° C), tiv thaiv los ntawm lub teeb, ntev txog 8 teev. Tshem tawm cov tshuaj tiv thaiv rov tsim dua yog tias nws tsis siv li ntawm 8 teev.

Daim ntawv siv tshuaj thiab muaj zog

M-M-R II Vaccine yog ib qho kev ncua rau kev txhaj tshuaj raws li ib koob tshuaj vial ntawm cov tshuaj tiv thaiv lyophilized yuav tsum tau rov tsim dua siv cov tshuaj uas tsis muaj tshuaj lom.[saib Dosage thiab Administration (2.2) thiab Yuav Siv Li Cas / Khaws thiab Ua Haujlwm (16) ]. Ib koob tshuaj ib zaug tom qab rov kho dua yog 0.5 mL.

Contraindications

Mob siab heev

Tsis txhob muab tshuaj tiv thaiv M-M-R II rau cov tib neeg uas muaj keeb kwm ntawm kev mob siab rau ib qho ntawm cov tshuaj tiv thaiv (xws li gelatin) { 3 } los yog leej twg tau ntsib ib qho kev mob tshwm sim tom qab kev tswj hwm ntawm koob tshuaj M-M-R II yav dhau los lossis lwm yam kab mob qhua pias, mumps thiab rubella-muaj tshuaj tiv thaiv. Tsis txhob muab tshuaj tiv thaiv M-M-R II rau cov tib neeg uas muaj keeb kwm ntawm anaphylaxis rau neomycin[saib Description (11) ].

Kev tiv thaiv kab mob

Tsis txhob muab tshuaj tiv thaiv M-M-R II rau cov tib neeg uas tsis muaj zog tiv thaiv kab mob lossis tiv thaiv kab mob vim muaj kab mob lossis kev kho mob. Measles inclusion body encephalitis { 4 } (MIBE), pneumonitis { 5 } thiab kev tuag raws li qhov tshwm sim ncaj qha ntawm kev tshaj tawm cov tshuaj tiv thaiv kab mob qhua pias kis tau tus kab mob tau tshaj tawm hauv cov neeg uas muaj kev tiv thaiv kab mob tiv thaiv kab mob tsis ua haujlwm nrog cov tshuaj tiv thaiv kab mob qhua pias. Hauv cov pej xeem no, cov kab mob qog nqaij hlav thiab cov kab mob rubella tau tshaj tawm.

Mob hnyav los yog mob hnyav Febrile

Tsis txhob muab tshuaj tiv thaiv M-M-R II rau cov tib neeg uas muaj tus mob febrile ua npaws > 101.3 ° F (> 38.5 ° C).

Active Untreated Tuberculosis

Tsis txhob muab tshuaj tiv thaiv M-M-R II rau cov tib neeg uas tsis muaj kev kho mob tuberculosis (TB).

Kev xeeb tub

Tsis txhob muab M-M-R II rau cov tib neeg uas cev xeeb tub lossis cov uas npaj yuav xeeb tub hauv lub hlis tom ntej[saib Siv hauv Cov Pej Xeem Tshwj Xeeb (8.1) thiab Cov Ntaub Ntawv Qhia Txog Tus Neeg Mob (17) ].

Ceeb toom thiab ceev faj

Febrile Seizure

Muaj kev pheej hmoo ua npaws thiab mob febrile qaug dab peg hauv thawj 2 lub lis piam tom qab txhaj tshuaj tiv thaiv M-M-R II. Rau cov menyuam yaus uas tau ntsib tus mob febrile yav dhau los (los ntawm ib qho laj thawj) thiab cov tsev neeg keeb kwm ntawm febrile qaug dab peg muaj qhov pheej hmoo ntawm febrile qaug dab peg tom qab tau txais tshuaj tiv thaiv M-M-R II.[saib Kev tsis pom zoo (6) ].

Hypersensitivity rau qe

Cov tib neeg uas muaj keeb kwm ntawm anaphylactic, anaphylactoid, lossis lwm yam kev tshwm sim tam sim ntawd (xws li, khaus khaus, o ntawm qhov ncauj thiab caj pas, ua tsis taus pa, hypotension, lossis poob siab) tom qab noj qe yuav muaj kev pheej hmoo siab ntawm cov tshuaj tiv thaiv tam sim ntawd. tau txais tshuaj tiv thaiv M-M-R II. Cov kev pheej hmoo thiab cov txiaj ntsig paub yuav tsum raug ntsuas ua ntej txiav txim siab txhaj tshuaj tiv thaiv rau cov neeg no.

Thrombocytopenia

Transient thrombocytopenia tau tshaj tawm nyob rau hauv 4-6 lub lis piam tom qab txhaj tshuaj tiv thaiv kab mob qhua pias, mumps thiab rubella. Ua tib zoo tshuaj xyuas qhov muaj feem pheej hmoo thiab txiaj ntsig ntawm kev txhaj tshuaj rau cov menyuam yaus uas muaj thrombocytopenia lossis hauv cov neeg uas muaj thrombocytopenia tom qab txhaj tshuaj tiv thaiv kab mob qhua pias, mumps, thiab rubella { 6 - 8 }[saib Kev tsis pom zoo (6) ].

Tsev Neeg Keeb Kwm ntawm Immunodeficiency

Kev txhaj tshuaj tiv thaiv yuav tsum tau ncua rau cov tib neeg uas muaj keeb kwm hauv tsev neeg muaj keeb kwm los yog keeb kwm ntawm kev tiv thaiv kab mob tiv thaiv kab mob kom txog thaum tus neeg tiv thaiv kab mob tau raug tshuaj xyuas thiab tus neeg tau pom tias muaj kev tiv thaiv kab mob.

Immune Globulins thiab Transfusions

Immune Globulins (IG) thiab lwm yam khoom siv ntshav yuav tsum tsis txhob muab ib txhij nrog M-M-R II.[saib Kev Sib Tham Txog Tshuaj (7.2) ]. Cov khoom no tuaj yeem muaj cov tshuaj tiv thaiv kab mob uas cuam tshuam nrog cov tshuaj tiv thaiv kab mob rov ua dua thiab txo qhov kev cia siab tiv thaiv kab mob.

Pawg Neeg Tawm Tswv Yim Txog Kev Tiv Thaiv Kab Mob (ACIP) muaj cov lus pom zoo tshwj xeeb rau lub sijhawm nruab nrab ntawm kev tswj hwm cov tshuaj tiv thaiv kab mob uas muaj cov khoom lag luam thiab cov tshuaj tiv thaiv kab mob muaj sia.

Kev Phem Tsis Zoo

Cov kev cuam tshuam tsis zoo hauv qab no suav nrog cov uas tau txheeb xyuas thaum kuaj mob lossis tshaj tawm thaum kev pom zoo tom qab siv tshuaj tiv thaiv M-M-R II lossis nws cov khoom ntiag tug.

Lub cev tag nrho

Panniculitis; atypical qhua pias; ua npaws; syncope; mob taub hau; kiv taub hau; qaug zog; chim siab.

Cardiovascular System

Vasculitis.

Digestive System

Pancreatitis; raws plab; ntuav; parotitis; xeev siab.

Hematology thiab Lymphatic Systems

Thrombocytopenia; purpura; regional lymphadenopathy; leukocytosis.

Immune System

Anaphylaxis, anaphylactoid cov tshuaj tiv thaiv, angioedema (nrog rau peripheral lossis lub ntsej muag edema) thiab bronchial spasm.

Musculoskeletal System

Mob caj dab; arthralgia; myalgia.

Nervous System

Kev mob hlwb; encephalopathy; measles inclusion body encephalitis (MIBE) subacute sclerosing panencephalitis (SSPE); Guillain-Barré Syndrome (GBS); acute disseminated encephalomyelitis (ADEM); transverse myelitis; febrile convulsions; febrile convulsions los yog qaug dab peg; ataxia; polyneuritis; polyneuropathy; ocular palsies; paresthesia.

Ua pa system

Mob ntsws o; mob ntsws; mob caj pas; hnoos; mob rhinitis.

Daim tawv nqaij

Stevens-Johnson syndrome; mob hemorrhagic edema ntawm me nyuam mos; Henoch-Schönlein purpura; erythema multiforme; urticaria; ua pob liab vog; mob qhua pias zoo li pob khaus; pruritus; qhov chaw txhaj tshuaj (mob, erythema, o thiab vesiculation).

ntau npaum li cas benadryl yuav ib tug aub muaj

Tshwj xeeb - Pob ntseg

Nerve tsis hnov ​​tsw; otitis media.

Tshwj xeeb Senses — Eye

Retinitis; optic neuritis; papillitis; conjunctivitis.

Urogenital System

Epididymitis; orchitis.

Kev Sib Tham Tshuaj

Corticosteroids thiab Immunosuppressive Tshuaj

Cov tshuaj tiv thaiv M-M-R II yuav tsum tsis txhob muab rau cov tib neeg uas tau txais kev tiv thaiv kab mob, suav nrog cov tshuaj corticosteroids siab. Kev txhaj tshuaj tiv thaiv kab mob M-M-R II tuaj yeem ua rau kis tau tus kab mob vim yog tshuaj tiv thaiv kab mob qhua pias rau cov tib neeg ntawm cov tshuaj tiv thaiv kab mob.[saib Contraindications (4.2) ].

Immune Globulins thiab Transfusions

Kev tswj hwm ntawm cov tshuaj tiv thaiv kab mob globulins thiab lwm yam khoom siv ntshav ua ke nrog M-M-R II Cov Tshuaj Tiv Thaiv tuaj yeem cuam tshuam nrog kev cia siab tiv thaiv kab mob { 9 - kaum ib }[saib Ceeb toom thiab ceev faj (5.5) ].ACIP muaj cov lus qhia tshwj xeeb rau lub sijhawm nruab nrab ntawm kev tswj hwm cov tshuaj tiv thaiv kab mob uas muaj cov khoom lag luam thiab cov tshuaj tiv thaiv kab mob muaj sia.

Tuberculin Daim tawv nqaij kuaj

Nws tau raug tshaj tawm tias cov tshuaj tiv thaiv kab mob qhua pias, kab mob qog noj ntshav thiab rubella tau muab ib tus zuj zus tuaj yeem ua rau muaj kev nyuaj siab ib ntus ntawm cov tawv nqaij rhiab heev ntawm tuberculin. Yog li ntawd, yog tias yuav tsum tau ua ib qho kev sim tuberculin daim tawv nqaij nrog tuberculin purified protein derivative (PPD), nws yuav tsum tau muab tshuaj ua ntej, ib txhij nrog, lossis tsawg kawg 4 mus rau 6 lub lis piam tom qab txhaj tshuaj tiv thaiv nrog M-M-R II Vaccine.

Siv nrog Lwm Cov Tshuaj Tiv Thaiv Kab Mob Nyob

Cov tshuaj tiv thaiv M-M-R II tuaj yeem siv tau ib txhij nrog lwm cov tshuaj tiv thaiv kab mob. Yog tias tsis tau muab ib txhij, txhaj tshuaj M-M-R II yuav tsum tau muab ib hlis ua ntej lossis ib hlis tom qab kev tswj hwm lwm cov tshuaj tiv thaiv kab mob hauv lub cev kom tsis txhob muaj peev xwm tiv thaiv kab mob.

Siv rau hauv cov neeg tshwj xeeb

Kev xeeb tub

Risk Summary

Cov tshuaj tiv thaiv M-M-R II yog contraindicated rau kev siv rau cov poj niam cev xeeb tub vim hais tias kev kis kab mob thaum cev xeeb tub nrog cov kab mob qus tau cuam tshuam nrog cov txiaj ntsig tsis zoo ntawm leej niam thiab tus menyuam hauv plab.

Kev rho menyuam tawm sai sai, tseem yug me nyuam, yug ntxov ntxov thiab kev xeeb tub tau raug pom zoo tom qab kis kab mob measles qus thaum cev xeeb tub. { 12 , 13 } Cov kab mob mumps qus thaum thawj peb lub hlis twg ntawm cev xeeb tub tuaj yeem ua rau muaj kev rho menyuam tawm sai.

Kev kis tus kab mob rubella qus thaum cev xeeb tub tuaj yeem ua rau nchuav menyuam lossis yug menyuam. Yog tias tus kab mob rubella tshwm sim thaum thawj peb lub hlis twg ntawm cev xeeb tub, nws tuaj yeem ua rau muaj mob loj heev, Congenital Rubella Syndrome (CRS). Congenital Rubella Syndrome nyob rau hauv tus me nyuam mos muaj xws li tab sis tsis txwv rau qhov tshwm sim ntawm qhov muag (cataracts, glaucoma, retinitis), congenital plawv tsis xws luag, hnov ​​tsis hnov ​​lus, microcephaly, thiab kev txawj ntse. M-M-R II Vaccine muaj cov kab mob qhua pias, kab mob qog noj ntshav thiab rubella. Nws tsis paub tias koob tshuaj M-M-R II tuaj yeem ua rau muaj kev phom sij rau menyuam hauv plab thaum siv rau tus poj niam cev xeeb tub. Tsis muaj kev tshawb fawb txaus thiab tswj tau zoo ntawm M-M-R II Kev Tswj Xyuas Tshuaj Tiv Thaiv rau cov poj niam cev xeeb tub.

Txhua lub cev xeeb tub muaj kev pheej hmoo ntawm kev yug menyuam, poob lossis lwm yam tshwm sim tsis zoo. Hauv Teb Chaws Asmeskas cov pej xeem, kwv yees keeb kwm kev pheej hmoo ntawm kev yug me nyuam loj thiab nchuav menyuam hauv kev kuaj mob pom zoo yog 2% mus rau 4% thiab 15% mus rau 20%, feem.

Muaj cov ntaub ntawv qhia tias tus nqi ntawm kev yug me nyuam loj thiab nchuav menyuam hauv cov poj niam uas tau txais tshuaj tiv thaiv M-M-R II tsis pub dhau 30 hnub ua ntej cev xeeb tub lossis thaum cev xeeb tub yog ua raws li kev kwv yees keeb kwm yav dhau los.(saib Cov ntaub ntawv ).

Cov ntaub ntawv

Tib neeg cov ntaub ntawv

Ib qho kev soj ntsuam ntawm cov ntawv tshaj tawm tom qab kev lag luam rau M-M-R II Tshuaj Tiv Thaiv los ntawm daim ntawv tso cai 01 Lub Plaub Hlis 1978 txog 31 Lub Kaum Ob Hlis 2018, tau txheeb xyuas 796 cov ntawv ceeb toom ntawm kev tswj hwm tsis pom zoo ntawm M-M-R II Tshuaj Tiv Thaiv tshwm sim 30 hnub ua ntej lossis txhua lub sijhawm thaum cev xeeb tub nrog cov txiaj ntsig ntawm cev xeeb tub. Ntawm cov kev xeeb tub yav tom ntej uas tau paub txog lub sijhawm ntawm kev txhaj tshuaj M-M-R II, 425 tus poj niam tau txais tshuaj tiv thaiv M-M-R II thaum 30 hnub ua ntej xeeb tub mus txog peb lub hlis thib ob. Cov txiaj ntsig rau cov 425 yav tom ntej yuav ua raws li kev xeeb tub suav nrog 16 tus menyuam mos uas muaj kev yug me nyuam loj, 4 tus menyuam hauv plab tuag thiab 50 tus neeg nchuav menyuam. Tsis muaj qhov txawv txav sib xws nrog congenital rubella syndrome tau raug txheeb xyuas hauv cov neeg mob uas tau txais tshuaj tiv thaiv M-M-R II. Cov tshuaj tiv thaiv kab mob rubella tuaj yeem hla cov placenta, ua rau muaj mob asymptomatic ntawm tus menyuam hauv plab. Cov tshuaj tiv thaiv kab mob mumps kuj tau pom tias kis tus kab mob qog nqaij hlav { 14 }, tab sis tsis muaj pov thawj tias nws ua rau muaj kev tsis haum xeeb los yog kab mob hauv tus menyuam hauv plab los yog menyuam mos.

CDC tau tsim Cov Tshuaj Tiv Thaiv Kab Mob Hauv Kev Tso Npe (1971-1989) ntawm cov poj niam uas tau txais cov tshuaj tiv thaiv rubella hauv 3 lub hlis ua ntej lossis tom qab xeeb tub. Cov ntaub ntawv ntawm 1221 inadvertently txhaj tshuaj tiv thaiv cov poj niam cev xeeb tub tsis pom muaj pov thawj ntawm kev nce hauv fetal abnormalities los yog kis ntawm Congenital Rubella Syndrome (CRS) nyob rau hauv cov poj niam cuv npe { kaum tsib }.

lactation

Risk Summary

Nws tsis paub tias kab mob qhua pias los yog kab mob mumps yog tso rau hauv tib neeg cov kua mis. Cov kev tshawb fawb tau pom tias cov poj niam cev xeeb tub tom qab yug me nyuam tau txhaj tshuaj tiv thaiv kab mob rubella nyob hauv lub cev tuaj yeem tso tus kab mob hauv cov kua mis thiab xa mus rau cov menyuam mos noj mis. { 16 , 17 } Hauv cov menyuam mos noj mis nrog cov pov thawj serological ntawm cov tshuaj tiv thaiv kab mob rubella strain antibodies, tsis muaj tus kab mob hnyav; Txawm li cas los xij, ib qho kev kuaj mob me me xws li kis tau tus mob rubella. { 18 , 19 }

Cov txiaj ntsig ntawm kev loj hlob thiab kev noj qab haus huv ntawm kev pub niam mis yuav tsum tau txiav txim siab nrog rau leej niam qhov kev xav tau ntawm M-M-R II, thiab muaj peev xwm cuam tshuam rau tus me nyuam pub niam mis los ntawm M-M-R II los yog los ntawm leej niam leej txiv. Rau cov tshuaj tiv thaiv kab mob, tus kab mob hauv lub hauv paus ntawm leej niam yog susceptibility rau kab mob tiv thaiv los ntawm cov tshuaj tiv thaiv.

Kev siv menyuam yaus

Kev txhaj tshuaj M-M-R II tsis raug pom zoo rau cov tib neeg muaj hnub nyoog qis dua 12 lub hlis. Kev nyab xeeb thiab kev ua tau zoo ntawm cov tshuaj tiv thaiv kab mob qhua pias hauv cov menyuam mos hnub nyoog qis dua 6 lub hlis tsis tau tsim[saib Clinical Studies (14) ]. Kev nyab xeeb thiab kev ua tau zoo ntawm cov tshuaj tiv thaiv kab mob qog thiab rubella hauv cov menyuam mos hnub nyoog qis dua 12 lub hlis tsis tau tsim.

Kev siv Geriatric

Cov kev tshawb fawb soj ntsuam ntawm M-M-R II tsis suav nrog cov naj npawb txaus ntawm cov neeg muaj hnub nyoog 65 xyoos thiab tshaj los txiav txim seb lawv teb txawv ntawm cov neeg hluas.

M-M-R II Vaccine Description

M-M-R II Vaccine yog ib qho sterile lyophilized npaj ntawm (1) Measles Virus Vaccine Live, a attenuated line of measles virus, derived from Enders' attenuated Edmonston strain and propagated in chick embryo cell culture; (2) Mumps Virus Vaccine Live, Jeryl Lynn™ (B level) strain of mumps virus propagated in chick embryo cell culture; thiab (3) Rubella Virus Vaccine Live, Wistar RA 27/3 strain of live attenuated rubella virus propagated in WI-38 human diploid lung fibroblasts. { nees nkaum , nees nkaum ib } Cov hlwb, cov kab mob hauv lub pas dej, cov neeg ua ke ntawm cov ntshav albumin thiab fetal bovine serum siv hauv kev tsim khoom raug kuaj thiab txiav txim siab kom tsis txhob muaj cov tshuaj lom neeg.

Tom qab rov kho dua, txhua koob tshuaj 0.5 mL muaj tsis pub tsawg dua 3.0 teev10TCIDtsib caug(cov kab mob kab mob kis kab mob) ntawm tus kab mob qhua pias; 4.1 log10TCIDtsib caugntawm kab mob mumps; thiab 3.0 log10TCIDtsib caugntawm tus kab mob rubella.

Txhua koob tshuaj suav nrog sorbitol (14.5 mg), sucrose (1.9 mg), hydrolyzed gelatin (14.5 mg), recombinant human albumin (≦0.3 mg), fetal bovine serum (<1 ppm), approximately 25 mcg of neomycin and other buffer and media ingredients. The product contains no preservative.

M-M-R II Vaccine - Clinical Pharmacology

Mechanism ntawm Action

Kev txhaj tshuaj M-M-R II induces antibodies rau qhua pias, mumps, thiab rubella txuam nrog kev tiv thaiv uas yuav ntsuas tau los ntawm neutralization assays, hemagglutination-inhibition (HI) assays, los yog enzyme linked immunosorbent assay (ELISA). Cov txiaj ntsig tau los ntawm kev tshawb fawb txog kev ua tau zoo lossis kev tshawb fawb txog kev ua tau zoo uas tau ua yav dhau los rau cov tshuaj tiv thaiv ntawm M-M-R II tau siv los txheeb xyuas cov qib ntawm cov tshuaj tiv thaiv kab mob uas cuam tshuam nrog kev tiv thaiv kab mob qhua pias, mumps, thiab rubella.[saib Clinical Studies (14) ].

Kev pheej hmoo ntawm cov tshuaj tiv thaiv kab mob tom qab txhaj tshuaj tiv thaiv

Neutralizing thiab ELISA cov tshuaj tiv thaiv rau qhua pias, mumps, thiab rubella kab mob tseem tuaj yeem kuaj pom hauv 95-100%, 74-91%, thiab 90-100% ntawm cov tib neeg feem, 11 txog 13 xyoo tom qab txhaj tshuaj tiv thaiv thawj zaug. { 22 - 28 }

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Cov tshuaj tiv thaiv M-M-R II tsis tau raug tshuaj xyuas rau cov kab mob carcinogenic lossis mutagenic muaj peev xwm lossis ua tsis taus ntawm fertility.

Kev tshawb fawb soj ntsuam

Clinical Efficiency

Cov tshuaj tiv thaiv kab mob qhua pias, mumps, thiab rubella tau tsim muaj nyob rau hauv cov kev sim ob qhov muag tsis pom kev. { 29 - 3. 4 } Cov kev tshawb fawb no kuj tsim tau tias seroconversion teb rau kev txhaj tshuaj tiv thaiv kab mob qhua pias, mumps thiab rubella paralleled tiv thaiv. { 35 - 38 }

Immunogenicity

Cov kev tshawb fawb soj ntsuam rau cuv npe 284 triple seronegative menyuam yaus, 11 lub hlis txog 7 xyoo, pom tau tias M-M-R II Vaccine yog immunogenic. Hauv cov kev tshawb fawb no, ib qho kev txhaj tshuaj tiv thaiv kab mob qhua pias HI cov tshuaj tiv thaiv kab mob hauv 95%, mumps neutralizing cov tshuaj tiv thaiv hauv 96%, thiab rubella HI cov tshuaj tiv thaiv hauv 99% ntawm cov neeg raug mob.

Kev tshawb fawb ntawm cov menyuam mos hnub nyoog 6 hli thiab 15 lub hlis yug los rau cov niam uas tau txhaj tshuaj tiv thaiv kab mob qhua pias thaum yau, pom tau tias, tom qab txhaj tshuaj tiv thaiv menyuam mos thiab menyuam me nrog Measles Virus Vaccine, Live (yav dhau los US- ntawv tso cai, tsim los ntawm Merck) , 74% ntawm cov menyuam mos muaj hnub nyoog 6 hli tau tsim cov tshuaj tiv thaiv kab mob tsis zoo thaum lub sijhawm 100% ntawm cov menyuam mos hnub nyoog 15 hli tau txhaj tshuaj tiv thaiv kab mob Measles Virus Vaccine, Live lossis M-M-R II Vaccine tsim neutralizing antibodies { 39 }. Thaum cov me nyuam muaj hnub nyoog 6 hli ntawm cov niam uas tau txhaj tshuaj tiv thaiv kab mob tau rov txhaj tshuaj dua 15 lub hlis nrog M-M-R II Vaccine, lawv tau tsim cov tshuaj tiv thaiv kab mob zoo ib yam li cov menyuam me uas tau txhaj tshuaj tiv thaiv yav dhau los thaum muaj hnub nyoog 15 hli.

REFERENCES

  1. Cov Lus Qhia dav dav txog kev txhaj tshuaj tiv thaiv kab mob, Cov lus pom zoo ntawm Pawg Neeg Tawm Tswv Yim Txog Kev Tiv Thaiv Kab Mob, MMWR 43(RR-1): 1-38, Lub Ib Hlis 28, 1994.
  2. Measles, Mumps, and Rubella — Kev Siv Tshuaj Tiv Thaiv thiab Cov Tswv Yim rau Kev Tshem Tawm Kab Ntsig, Rubella, thiab Congenital Rubella Syndrome thiab Tswj Mumps: Cov Lus Pom Zoo ntawm Pawg Kws Pab Tswv Yim Txog Kev Txhaum Cai (ACIP), MMWR 47(RR-8): Tsib Hlis 22, Xyoo 1998.
  3. Kelso, J.M.; Jones, R.T.; Yunginger, JW.: Anaphylaxis rau qhua pias, mumps, thiab rubella tshuaj tiv thaiv los ntawm IgE rau gelatin, J. Allergy Clin. Immunol. 91: 867-872, 1993.
  4. Bitnum, A.; thiab al: Measles Inclusion Body Encephalitis Ua los ntawm Cov Tshuaj Tiv Thaiv Kab Mob Measles Virus. Clin. Kab mob. Dis. 29: 855-861, 1999.
  5. Angel, J.B.; thiab al: Tshuaj Tiv Thaiv Kab Mob Sib Kis Pneumonitis hauv Cov Neeg Laus nrog AIDS. Annals of Internal Medicine, 129: 104-106, 1998.
  6. Cecinati V, et al. Kev tswj hwm tshuaj tiv thaiv thiab kev loj hlob ntawm kev tiv thaiv kab mob thrombocytopenic purpura hauv cov menyuam yaus. Human Vaccines & Immunotherapeutics 9:5, 2013.
  7. Mantadakis E, Farmaki E, Buchanan GR. Thrombocytopenic Purpura tom qab txhaj tshuaj tiv thaiv kab mob qhua pias-Mumps-Rubella: Kev Ntsuam Xyuas Txheej Txheem ntawm Cov Ntawv Sau thiab Cov Lus Qhia rau Kev Tswj. J Ped 156(4): 2010.
  8. Andrews N, Stowe J, Miller E, Svanstrom H, Johansen K, Bonhoeffer J, et al. Ib txoj hauv kev sib koom tes los tshawb xyuas qhov kev pheej hmoo ntawm thrombocytopenic purpura tom qab txhaj tshuaj tiv thaiv kab mob qhua pias-mob-rubella hauv tebchaws Askiv thiab Denmark. Tshuaj tiv thaiv. 2012; 30:3042-6.
  9. Kev Tiv Thaiv Kab Mob Rubella: Kev Pom Zoo ntawm Pawg Neeg Saib Xyuas Kev Tiv Thaiv Kab Mob (ACIP), MMWR 39(RR-15): 1-18, Kaum Ib Hlis 23, 1990.
  10. Peter, G.; et al (eds): Daim ntawv ceeb toom ntawm Pawg Neeg Saib Xyuas Kab Mob Sib Kis, Kaum Ib Hlis Plaub, American Academy of Pediatrics, 344-357, 1997.
  11. Kev Tiv Thaiv Kabmob: Cov Lus Pom Zoo ntawm Pawg Neeg Saib Xyuas Kev Tiv Thaiv Kab Mob (ACIP), MMWR 38(S-9): 5-22, Kaum Ob Hlis 29, 1989.
  12. Eberhart-Phillips, J.E.; thiab al: Measles hauv cev xeeb tub: kev piav qhia txog 58 tus neeg mob. Obstetrics thiab Gynecology, 82(5): 797-801, Kaum Ib Hlis 1993.
  13. Jespersen, C.S.; thiab al: Measles raws li qhov ua rau muaj qhov tsis xws luag ntawm fetal: Kev tshawb nrhiav rov qab txog kaum tus kab mob qhua pias nyob hauv Greenland. Acta Paediatr Scand. 66: 367-372, Tsib Hlis 1977.
  14. Yamauchi T, Wilson C, Geme JW Jr. Kev kis tus kab mob nyob, ua rau tus kab mob mumps rau tib neeg lub cev. N Engl J Med. 1974; 290(13): 710-712.
  15. Kev txhaj tshuaj Rubella thaum cev xeeb tub - Tebchaws Meskas, 1971-1988. JAMA. 1989; 261(23): 3374–3383.
  16. Losonsky, G.A.; Fishaut, J.M.; Strussenber, J. Ogra, PL: Cov nyhuv ntawm kev txhaj tshuaj tiv thaiv rubella ntawm cov khoom lactation. II. Kev sib cuam tshuam ntawm niam-poj niam-neonatal, J. Kab mob. Dis. 145: 661-666, 1982.
  17. Losonsky, G.A.; Fishaut, J.M.; Strussenber, J. Ogra, PL: Cov nyhuv ntawm kev txhaj tshuaj tiv thaiv rubella ntawm cov khoom lactation. I. Kev loj hlob thiab tus yam ntxwv ntawm cov tshuaj tiv thaiv kab mob hauv cov kua mis, J. Kab mob. Dis. 145: 654-660, 1982.
  18. Landes, R.D.; Bass, J. W.; Millunchick, E. W.; Oetgen, W.J.: Neonatal rubella tom qab kev txhaj tshuaj rau niam txiv tom qab yug menyuam, J. Pediatr.97 ib: 465-467, 1980.
  19. Lerman, S.J.: Neonatal rubella tom qab kev txhaj tshuaj rau niam txiv tom qab yug menyuam, J. Pediatr.98: 668, 1981. (Lab ntawv)
  20. Plotkin, S.A.; Cornfeld, D.; Ingalls, T.H.: Kev tshawb fawb ntawm kev txhaj tshuaj tiv thaiv kab mob rubella nyob: Kev sim hauv cov menyuam yaus uas muaj kab mob los ntawm tus menyuam hauv plab rho menyuam, Am. J. Dis. Me nyuam. 110: 381-389, 1965.
  21. Plotkin, S.A.; Farquhar, J.; Kas, M.; Ingalls, T.H.: Tus kab mob rubella tshiab tau loj hlob hauv tib neeg fibroblasts: Cov pov thawj rau txo qis nasopharyngeal excretion, Am. J. Epidemiol. 86: 468-477, 1967.
  22. Weibel, R.E.; Carlson, AJ; Villarejos, V.M.; Buynak, E.B.; McLean, UA; Hilleman, MR.: Clinical and Laboratory Studies of Combined Live Measles, Mumps, and Rubella Vaccines Siv RA 27/3 Rubella Virus, Proc. Soc. Exp. Biool. Med. 165: 323-326, 1980.
  23. Watson, J.C.; Pearson, J.S.; Erdman, D.D.; thiab al: Kev Ntsuam Xyuas Kev Kho Mob Me Me Ntawm Cov Me Nyuam Hnub Nyoog Tsev Kawm Ntawv, 31st Interscience Conference on Antimicrobial Agents and Chemotherapy, Abstract #268, 143, 1991.
  24. Cov ntaub ntawv tsis tau tshaj tawm los ntawm cov ntaub ntawv ntawm Merck Research Laboratories.
  25. Davidkin, ib.; Jokinen, S.; Broman, M. et al.: Persistence of Measles, Mumps, and Rubella Antibodies in an MMR-Vaccinated Cohort: A 20-Year Follow-up, JID 197:950–6, Plaub Hlis Ntuj 2008.
  26. LeBaron, W. Beeler J.; Sullivan, IB; thiab al.: Persistence of Measles Antibodies After 2 Doses of Measles Vaccine in a Postelimination Environment, Arch Pediatr Adolesc Med. 161:294-301, Peb 2007.
  27. LeBaron, C.; Forgani, B.; Beck, C. et al.: Persistence of Mumps Antibodies after 2 Doses of Measles-Mumps-Rubella Vaccine, JID 199:552– 60 , Lub Ob Hlis 2009.
  28. LeBaron, W. Forgani, B.; Matter, L. et al.: Persistence of Rubella Antibodies after 2 Doses of Measles-Mumps-Rubella Vaccine, JID 200:888–99, Cuaj Hlis 2009.
  29. Hilleman, M.R. Buynak, E.B.; Weibel, R.E.; thiab al: Kev Txhim Kho thiab Kev Ntsuas ntawm Moraten Measles Virus Vaccine, JAMA 206(3): 587-590, 1968.
  30. Weibel, R.E.; Stokes, J.; Buynak, E.B.; et al: Live, Attenuated Mumps Virus Vaccine 3. Kev Kho Mob thiab Kev Kho Mob Hauv Kev Ntsuam Xyuas Field, N. Engl. J. Med. 276: 245-251, 1967.
  31. Hilleman, M.R. Weibel, R.E.; Buynak, E.B.; et al: Live, Attenuated Mumps Virus Vaccine 4. Kev Tiv Thaiv Kev Ua Tau Zoo raws li ntsuas hauv Kev Ntsuam Xyuas Field, N. Engl. J. Med. 276: 252-258, 1967.
  32. Cutts, F.T.; Henderson, R.H.; Clements, C.J. thiab al: Cov Ntsiab Cai ntawm Kev Tiv Thaiv Kab Mob Measles, Bull WHO 69(1): 1-7, 1991.
  33. Weibel, R.E.; Buynak, E.B.; Stokes, J.; thiab al: Kev Ntsuam Xyuas Ntawm Cov Tshuaj Tiv Thaiv Kab Mob Nyob Hauv Tus Kheej, Hom Jeryl Lynn, Thawj Lub Rooj Sib Tham Thoob Ntiaj Teb ntawm Tshuaj Tiv Thaiv Kab Mob thiab Kab Mob Rickettsial ntawm Txiv neej, World Health Organization, No. 147, Tsib Hlis 1967.
  34. Leibhaber, H.; Ingalls, T.H.; LeBouvier, G. L.; thiab al: Kev txhaj tshuaj Nrog RA 27/3 Rubella Vaccine, Am. J. Dis. Me nyuam. 123: 133-136, Lub Ob Hlis 1972.
  35. Rosen, L.: Hemagglutination and Hemagglutination-Inhibition with Measles Virus, Virology 13:139-141, Ib Hlis Ntuj 1961.
  36. Brown, G.C.; et al: Fluorescent-Antibody Marker for Vaccine-Induced Rubella Antibodies, Infection and Immunity 2(4): 360-363, 1970.
  37. Buynak, E.B.; et al: Live Attenuated Mumps Virus Vaccine 1. Vaccine Development, Proceedings of the Society for Experimental Biology and Medicine, 123: 768-775, 1966.
  38. Hilleman MR., Studies of Live Attenuated Measles Virus Vaccine in Man: II. Kev soj ntsuam kev ua tau zoo. Amer. J. of Public Health, 52(2): 44-56, 1962.
  39. Johnson, C.E.; et al: Measles Vaccine Immunogenicity in 6- Versus 15-Hloov-Hloov Me Nyuam Yug Rau Cov Niam Txiv Hauv Cov Tshuaj Tiv Thaiv Measles Era, Pediatrics, 93(6): 939-943, 1994.

Yuav Ua Li Cas Muab / Cia thiab tuav

No. 4681 — M-M-R II Vaccine yog muab raws li hauv qab no:
(1) ib lub thawv ntawm 10 ib koob tshuaj tiv thaiv kab mob lyophilized (pob A), NDC 0006-4681-00
(2) ib lub thawv ntawm 10 vials ntawm diluent (pob B)

Kev raug teeb pom kev tuaj yeem ua rau cov kab mob tiv thaiv tsis tau.

Txhawm rau kom muaj zog, M-M-R II yuav tsum khaws cia ntawm -58 ° F thiab +46 ° F (-50 ° C txog +8 ° C). Kev siv cov dej khov qhuav tuaj yeem raug M-M-R II kom txias dua -58 ° F (-50 ° C).

Ua ntej rov tsim kho, tso cov tshuaj tiv thaiv lyophilized ntawm 36 ° F txog 46 ° F (2 ° C txog 8 ° C).

Khaws cov khoom ntim nrog rau hauv lub tub yees (36 ° F txog 46 ° F, 2 ° C txog 8 ° C) lossis hauv chav sov (68 ° F txog 77 ° F, 20 ° C txog 25 ° C).Tsis txhob khov lub diluent.

Siv tshuaj tiv thaiv M-M-R II kom sai li sai tau tom qab hloov kho. Yog tias tsis muab tshuaj tam sim ntawd, cov tshuaj tiv thaiv rov tsim dua tuaj yeem khaws cia ntawm 36 ° F txog 46 ° F (2 ° C txog 8 ° C), tiv thaiv los ntawm lub teeb, ntev txog 8 teev. Tshem tawm cov tshuaj tiv thaiv rov tsim dua yog tias nws tsis siv li ntawm 8 teev.

10 325 ntsiav tshuaj dawb

Yog xav paub ntxiv txog cov khoom lossis cov lus nug txog kev cia khoom, hu rau 1-800-MERCK-90 (1-800-637-2590).

Cov Ntaub Ntawv Qhia Txog Tus Neeg Mob

Qhia tus neeg mob kom nyeem cov ntawv pom zoo rau tus neeg mob FDA (Patient Package Insert).

Sib tham txog cov hauv qab no nrog tus neeg mob:

  • Muab cov ntaub ntawv tshuaj tiv thaiv uas xav tau rau tus neeg mob, niam txiv, lossis tus saib xyuas.
  • Qhia rau tus neeg mob, niam txiv, lossis tus saib xyuas txog cov txiaj ntsig thiab kev pheej hmoo cuam tshuam nrog kev txhaj tshuaj.
  • Nug tus neeg mob, niam txiv, lossis tus neeg saib xyuas txog kev cuam tshuam rau yav dhau los koob tshuaj M-M-R II Vaccine lossis lwm yam kab mob qhua pias-, mumps-, lossis tshuaj tiv thaiv kab mob rubella.
  • Nug cov poj niam ntawm kev muaj peev xwm xeeb tub txog qhov muaj peev xwm xeeb tub. Qhia rau cov poj niam cov neeg mob kom tsis txhob xeeb tub rau 1 lub hlis tom qab txhaj tshuaj tiv thaiv[saib Contraindications (4.5) thiab Siv hauv Cov Pej Xeem Tshwj Xeeb (8.1) ].
  • Qhia rau tus neeg mob, niam txiv, lossis tus neeg saib xyuas tias kev txhaj tshuaj M-M-R II yuav tsis muaj kev tiv thaiv 100% ntawm tus mob qhua pias, mumps, thiab rubella.
  • Qhia cov neeg mob, cov niam txiv, lossis cov neeg saib xyuas kom tshaj tawm cov kev cuam tshuam tsis zoo rau lawv tus kws kho mob. Lub Tsev Haujlwm Saib Xyuas Kev Noj Qab Haus Huv thiab Tib Neeg hauv Teb Chaws Asmeskas tau tsim Lub Tsev Haujlwm Saib Xyuas Kev Noj Qab Haus Huv (Vaccine Adverse Event Reporting System) (VAERS) los lees txais tag nrho cov ntawv ceeb toom ntawm qhov xav tias muaj xwm txheej tshwm sim tom qab kev tswj hwm cov tshuaj tiv thaiv, suav nrog tab sis tsis txwv rau kev tshaj tawm cov xwm txheej xav tau los ntawm National Childhood Vaccine Injury Txoj Cai Xyoo 1986. Yog xav paub ntaub ntawv lossis ib daim qauv ntawm daim ntawv qhia tshuaj tiv thaiv, hu rau VAERS tus xov tooj hu dawb ntawm 1-800-822-7967, lossis tshaj tawm online ntawm https://www.vaers.hhs.gov.

Muab faib los ntawm: Merck Sharp & Dohme Corp., ib lub koom haum ntawm
MERCK & CO., INC.,Whitehouse Station, NJ 08889, USA

Rau cov ntaub ntawv patent: www.merck.com/product/patent/home.html

uspi-v205c-i-2012r011

Cov Ntaub Ntawv Tus Neeg Mob
M-M-R®II (pronounced em em ar too)
Measles, Mumps, and Rubella Virus Vaccine Live

Nov yog cov ntsiab lus ntawm M-M-R®II. Koj yuav tsum tau nyeem ua ntej koj lossis koj tus menyuam tau txais cov tshuaj tiv thaiv. Yog tias koj muaj lus nug txog cov tshuaj tiv thaiv tom qab nyeem daim ntawv no, koj yuav tsum nug koj tus kws kho mob. Qhov no yog cov ntsiab lus xwb. Tsis txhob tham txog M-M-R II nrog koj tus kws kho mob, tus nais maum, lossis lwm tus kws kho mob. Tsuas yog koj tus kws kho mob tuaj yeem txiav txim siab seb M-M-R II puas yog rau koj lossis koj tus menyuam.

M-M-R II yog dab tsi thiab nws ua haujlwm li cas?

M-M-R II tseem hu ua Measles, Mumps, thiab Rubella Virus Vaccine Live. Nws yog ib qho tshuaj tiv thaiv kab mob muaj sia uas tau txhaj tshuaj. Qhov tshuaj tiv thaiv no feem ntau yog muab rau cov neeg muaj hnub nyoog ib xyoos lossis laus dua. Nws yog tsim los pab tiv thaiv qhua pias (rubeola), mumps, thiab rubella (German measles).

M-M-R II muaj cov ntaub ntawv tsis muaj zog ntawm tus kab mob qhua pias, kab mob mumps, thiab tus kab mob rubella.

M-M-R II ua haujlwm los ntawm kev pab lub cev tiv thaiv kab mob tiv thaiv koj lossis koj tus menyuam kom tsis txhob kis mob qhua pias, mumps, lossis rubella.

M-M-R II yuav tsis tiv thaiv txhua tus neeg uas tau txais cov tshuaj tiv thaiv. M-M-R II tsis kho mob qhua pias, mumps, lossis rubella thaum koj lossis koj tus menyuam muaj lawv.

Kuv yuav tsum paub dab tsi txog qhua pias, mumps, thiab rubella?

Measles tseem hu ua rubeola. Nws yog mob hnyav. Tus kab mob qhua pias tuaj yeem kis mus rau lwm tus yog tias koj muaj. Cov kab mob qhua pias tuaj yeem ua rau koj kub taub hau, hnoos, thiab ua pob khaus. Tus kab mob tuaj yeem kav ntev li 1 mus rau 2 lub lis piam. Muaj tsawg zaus, nws kuj tuaj yeem ua rau mob hlwb. Qhov no tuaj yeem ua rau qaug dab peg, hnov ​​​​lus tsis txaus, kev txawj ntse, thiab kev tuag.

Mumps kuj kis tau mus rau lwm tus. Tus kab mob no tuaj yeem ua rau kub taub hau thiab mob taub hau. Nws tseem tuaj yeem ua rau cov qog nqaij hlav hauv qab koj lub puab tsaig o thiab ua rau mob. Tus mob feem ntau kav ntev li ob peb hnub. Qee zaum, mumps tuaj yeem ua rau cov noob qes o thiab mob. Qee zaum, nws tuaj yeem ua rau mob meningitis, uas yog qhov o ntawm lub paj hlwb thiab qaum qaum.

Rubella tseem hu ua German measles. Nws feem ntau yog mob me. Tus kab mob rubella tuaj yeem ua rau kub taub hau me me, qog o hauv caj dab, mob thiab o ntawm cov pob qij txha, thiab cov pob liab liab uas tshwm sim rau lub sijhawm luv luv. Nws tuaj yeem txaus ntshai yog tias tus poj niam cev xeeb tub ntes nws. Cov poj niam uas ntes tau German measles thaum cev xeeb tub tuaj yeem muaj cov menyuam mos uas tseem yug los. Tsis tas li ntawd, cov menyuam mos yuav dig muag lossis lag ntseg, lossis muaj kab mob plawv lossis kev tsis taus kev txawj ntse.

Leej twg yuav tsis tau M-M-R II?

Tsis txhob tau txais M-M-R II yog tias koj lossis koj tus menyuam:

  • tsis haum rau ib qho ntawm nws cov khoom xyaw. (Qhov no suav nrog gelatin. Saib daim ntawv teev cov khoom muaj nyob rau qhov kawg ntawm daim ntawv no.)
  • muaj lub cev tiv thaiv kab mob tsis muaj zog (uas suav nrog kev noj tshuaj steroids los ntawm qhov ncauj lossis txhaj tshuaj).
  • ua npaws.
  • muaj active tuberculosis uas tsis kho.
  • cev xeeb tub los yog npaj yuav xeeb tub hauv lub hlis tom ntej.

Koj yuav tsum qhia dab tsi rau koj tus kws kho mob ua ntej tau txais M-M-R II?

Qhia rau koj tus kws kho mob yog tias koj lossis koj tus menyuam:

  • muaj lossis muaj teeb meem kho mob.
  • muaj keeb kwm qaug dab peg lossis ib tus neeg hauv koj tsev neeg muaj keeb kwm qaug dab peg.
  • tau txais cov ntshav los yog ntshav ntshav los yog tib neeg cov ntshav globulin.
  • noj tej tshuaj. (Qhov no suav nrog cov tshuaj uas tsis yog tshuaj thiab tshuaj noj.)
  • muaj kev ua xua.
  • muaj kev fab tshuaj rau lwm yam tshuaj tiv thaiv.
  • muaj los yog muaj cov ntshav platelet tsawg.
  • ua xua rau qe.

M-M-R II muab li cas?

M-M-R II yog txhaj rau cov neeg muaj hnub nyoog ib xyoos lossis laus dua. Qhov koob tshuaj tiv thaiv yog tib yam rau txhua tus. Yog tias koj tus menyuam tau txhaj tshuaj thaum nws muaj ib xyoos lossis laus dua, raug pom zoo kom txhaj koob thib ob. Feem ntau, koob thib ob raug muab ua ntej tus menyuam mus kawm ntawv theem pib (4 txog 6 xyoo), tab sis yuav muab ua ntej ntev npaum li qhov koob thib ob yog tsawg kawg ib hlis tom qab thawj koob tshuaj.

Yog tias koj tus menyuam muaj hnub nyoog qis dua ib xyoos thaum nws thawj zaug txhaj tshuaj, yuav tsum tau txhaj koob thib ob thaum lawv muaj 12 txog 15 lub hlis. Tom qab ntawd, yuav tsum tau txhaj koob thib peb ntawm 4 thiab 6 xyoo. Koj tus kws kho mob yuav txiav txim siab lub sijhawm zoo tshaj plaws thiab tus lej txhaj tshuaj los ntawm kev siv cov lus pom zoo.

Yog tias tsis noj tshuaj, koj tus kws kho mob yuav qhia rau koj paub thaum twg koj yuav tsum tau.

Dab tsi yog qhov tshwm sim ntawm M-M-R II?

Qhov tshwm sim feem ntau ntawm kev txhaj tshuaj nrog M-M-R II yog qhov mob ntawm qhov chaw txhaj tshuaj rau lub sijhawm luv luv.

Lwm cov kev mob tshwm sim tuaj yeem suav nrog:

  • Ua npaws
  • Raj

Cov kev mob tshwm sim tsawg dua tuaj yeem suav nrog:

  • o ntawm cov noob qes
  • Mob pob qij txha thiab / lossis o

Qee qhov kev mob tshwm sim tsis tshua muaj tab sis tuaj yeem loj heev. Koj yuav tsum hu rau koj tus kws kho mob yog tias koj pom muaj teeb meem hauv qab no:

  • Ua pa nyuaj, hawb pob, khaus khaus, lossis pob khaus ntawm daim tawv nqaij tuaj yeem yog cov cim qhia ntawm kev tsis haum tshuaj
  • Los ntshav los yog bruising nyob rau hauv daim tawv nqaij
  • Kev qaug dab peg, mob taub hau hnyav, hloov tus cwj pwm lossis kev nco qab, lossis taug kev nyuaj

Lwm yam kev mob tshwm sim kuj tshwm sim. Koj tus kws kho mob muaj ib daim ntawv teev tag nrho cov kev mob tshwm sim rau M-M-R II.

Hu rau koj tus kws kho mob lossis tus kws kho mob yog tias koj lossis koj tus menyuam muaj cov tsos mob tshiab lossis txawv txav tom qab tau txais M-M-R II.

Qhia cov hauv qab no rau koj tus kws kho mob lossis koj tus menyuam tus kws kho mob:

  • raug M-M-R II thaum cev xeeb tub
  • raug M-M-R II thaum lub hli ua ntej cev xeeb tub

Koj kuj tseem tuaj yeem tshaj tawm cov kev cuam tshuam tsis zoo rau koj tus kws kho mob lossis koj tus menyuam tus kws kho mob lossis xa daim ntawv qhia ncaj qha mus rau Vaccine Adverse Event Reporting System (VAERS). VAERS tus xov tooj hu dawb yog 1-800-822-7967 lossis koj tuaj yeem tshaj tawm online rau www.vaers.hhs.gov.

Cov khoom xyaw ntawm M-M-R II yog dab tsi?

Cov khoom xyaw nquag: tsis muaj zog ntawm cov kab mob qhua pias, mumps, thiab rubella kab mob.

Cov khoom xyaw uas tsis muaj zog: sorbitol, sucrose, hydrolyzed gelatin, recombinant human albumin, fetal bovine serum, lwm yam tsis thiab cov khoom xyaw, neomycin.

Kuv yuav tsum paub dab tsi ntxiv txog M-M-R II?

Nplooj ntawv no qhia txog cov ntsiab lus tseem ceeb ntawm M-M-R II.

Yog tias koj xav paub ntau ntxiv, tham nrog koj tus kws kho mob lossis hu rau 1-800-622-4477.

Dist. los ntawm: Merck Sharp & Dohme Corp., ib lub koom haum ntawm
MERCK & CO., INC.,Whitehouse Station, NJ 08889, USA

Rau cov ntaub ntawv patent: www.merck.com/product/patent/home.html

usppi-v205c-i-2006r205

Cov Ntaub Ntawv Tus Neeg Mob no tau pom zoo los ntawm US Food and Drug Administration. Kho tshiab: 06/2020

PRINCIPAL DISPLAY PANEL - 0.5 mL Vial Carton

NWS 0006-4681-00

10 Ib koob tshuaj 0.5-mL vials

MEASLES, MUMPS, THIAB RUBELLA Virus VACCINE LIVE
M-M-R® II

Measles: attenuated Enders 'strain/chick embryo cell culture.
Mumps: Jeryl Lynnstrain/chick embryo cell culture.
Rubella: Wistar RA 27/3 strain / WI-38 human diploid ntsws fibroblasts.
tsis muaj preservative
Rx xwb

A

M-M-R II
tshuaj tiv thaiv kab mob qhua pias, mumps, thiab rubella nyob txhaj, hmoov, lyophilized, rau kev ncua
Cov ntaub ntawv khoom
Yam khoom Tshuaj tiv thaiv Yam khoom Code (Source) NDC: 0006-4681
Txoj kev tswj hwm SUBCUTANEOUS DEA Teem caij
Cov khoom xyaw nquag / Active Moiety
Cov khoom xyaw npe Lub hauv paus muaj zog Lub zog
MEASLES VIRUS STRAIN ENDERS 'ATTENUATED EDMONSTON LIVE ANTIGEN (MEASLES VIRUS STRAIN ENDERS 'ATTENUATED EDMONSTON LIVE ANTIGEN) MEASLES VIRUS STRAIN ENDERS 'ATTENUATED EDMONSTON LIVE ANTIGEN 1000 [TCID_50] at 0.5 mL
MUMPS VIRUS STRAIN B LEVEL JERYL LYNN LIVE ANTIGEN (MUMPS VIRUS STRAIN B LEVEL JERYL LYNN LIVE ANTIGEN) MUMPS VIRUS STRAIN B LEVEL JERYL LYNN LIVE ANTIGEN 12500 [TCID_50] in 0.5 mL
RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN (RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN) RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN 1000 [TCID_50] at 0.5 mL
Cov khoom xyaw uas tsis muaj zog
Cov khoom xyaw npe Lub zog
ALBUMIN BOVINE
ALBUMIN HMOOB 0.3 mg ntawm 0.5 mL
GELATIN, tsis paub meej 14.5 mg 0.5 mL
NEOMYCIN 25 thiab 0.5 mL
SODIUM chloride
SODIUM PHOSPHATE
SORBIOL 14.5 mg 0.5 mL
SUCROSE 1.9 mg 0.5 mL
Cov yam ntxwv ntawm cov khoom
Xim YELLOW (ntshiab yellow) Cov qhab nias
Cov duab Loj
Nplaim Imprint Code
Muaj
Ntim
# Yam khoom Code Pob piav qhia
ib NDC: 0006-4681-00 10 VIAL, SINGLE-DOSE hauv 1 CARTON
ib NDC: 0006-4681-01 0.5 mL hauv 1 VIAL, SINGLE-DOSE
Cov ntaub ntawv lag luam
Kev lag luam qeb Daim ntawv thov Number los yog Monograph Citation Hnub pib ua lag luam Hnub Kawg Ua Lag Luam
BLA BLA101069 04.21.1971 dr hab
Labeler -Merck Sharp & Dohme Corp. (001317601)
Merck Sharp & Dohme Corp.