Land: Armenien
Sprog: engelsk
Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
purified rabies antigen
Serum Institute of India Pvt Ltd.
J07BG01
purified rabies antigen
2,5IU/ml
powder lyophilized for solution for injection and solvent
(1) glass vial and (1) solvent in ampoule 1ml, (5) glass vials and (5) solvent in ampoules 1ml, (50) glass vials, (50) solvent in ampoules 1ml
Prescription
Registered
2019-08-08
@ sеrчm Inýtitute of India Pvt- Ltd. Rabieý vассiпс Inactivated (Freeze-Dried) S!mmаlY ofProduct characteristicý 1. NAME оF тнЕ MnDlcINAL PRODUсT Proprietaly Name: Rabies vaccine lnactivated (Freeze_Dried) Non-Ploprietary Name., Rabies Vaccine lnactivated (Гrееzе-Driеd) Rabies vaccine lnactivated (Frееzе dried) iS а stelile, purified inactivated Rabjes vaccine pfepaled оп чеrо ce]ls, Rabies vaccine Inactivated iý freeze dlied аtrd is ргочidеd \rith diluent (l dose of роwdег in visl and 1 ml of diluent in ampoule). The vaccine has the арреаrапсе of а White dry cake. The vaccine сопfогms to the World Health organization (W.H.o.) rеqчirеmепts. 2. QUALITЛTIVE AND QUANTITATIVE COMPOSITION васh dose of l ml contains: 3. PHARMAсEUTIсAL FORM LyophiIizcd vaccine 1о beIeconstifut9d With Diluent-Sterile water fоI Injeations I.P, D€ýc.ipt;o!] оftеr гесоislitчtiоп:'Сlеаг colorless solution. 4. CLINICAL PARTICULARS 4.1. ?herapeutic indicationý Rabies vaccino Inactivated (Fre9ze-Dried) iý indicated fог the ргечбпtiоп of rabieý in сhildrеп and аdцlls, lt сап Ье used befo.e оr аftсrехроsurе, as а рrimаrу immчпizаtiол оr as а boosteгdose. а) Рrе-Ехроsцrc prophylaxis Рге-ехроsчге vaccination should Ье offered to subjects at hi8h risk of contamination Ьу the ýpecification Active/ Non- aGtive Rеаsоп fог iпсlчsiоп Purified Rabies Antigen (Rabies чirчs Pitrran_Moore stгаiп З2l8_ vERo adapted and дояtr оп vею cells, inactivaLed Ьу using В propiolactone) Not less than 2.5 lU ln-ho!se Active Immunogen Glycine 40 mg IP/BP/Ph.Eur Non-active StabiIizer ýucrose 40 mg ВРДh.ЕчI Non_active stabilizer HsA 10 g IP/BP/Ph.E чг/ USP/In- house Non-active stabilizer Su!пmаlа ofProduct с h aracteristicý Rabies vдссiпе Inactivated (Freeze-)ried) ýеrчm Institute of India Pvt Ltd. rabies virus. This vaccination is partioularly rесоmmепdеd fог_чеtеri Læs hele dokumentet