País: Israel
Idioma: anglès
Font: Ministry of Health
LIVE ATTENUATED MEASLES VIRUS; LIVE ATTENUATED MUMPS VIRUS; LIVE ATTENUATED RUBELLA VIRUS; LIVE ATTENUATED VARICELLA VIRUS
GLAXO SMITH KLINE (ISRAEL) LTD
J07BD54
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
LIVE ATTENUATED MEASLES VIRUS 10^ 3.0 CCID50; LIVE ATTENUATED MUMPS VIRUS 10^ 4.4 CCID50; LIVE ATTENUATED RUBELLA VIRUS 10^ 3.0 CCID50; LIVE ATTENUATED VARICELLA VIRUS 10^ 3.3 PFU
S.C
Required
GLAXO SMITH KLINE BIOLOGICALS S.A
MEASLES, COMBINATIONS WITH MUMPS, RUBELLA AND VARICELLA, LIVE ATTENUATED
MEASLES, COMBINATIONS WITH MUMPS, RUBELLA AND VARICELLA, LIVE ATTENUATED
Priorix-Tetra is indicated for active immunisation against measles, mumps, rubella and varicella in children from the age of 12 months up and including 12 years of age.
2023-07-31
ל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה ל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה ל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה אפור אפור אפור ןכדועמ( ןכדועמ( ןכדועמ( 05.2013 05.2013 05.2013 ) ) ) ךיראת : 10/12/2017 תילגנאב רישכת םש : TETRA PRIORIX םושירה רפסמ : 00 - 31847 - 98 - 138 םושירה לעב םש : GLAXOSMITHKLINE (ISRAEL) LTD ! דבלב תורמחהה טורפל דעוימ הז ספוט אפורל ןולעב אפורל ןולעב אפורל ןולעב תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט INTERACTION WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION ---------- 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION … Due to an increased risk of fever, tenderness at the injection site, change in eating habits and - irritability when Bexsero was co Tetra, - administered with Priorix separate vaccinations can be considered when possible. ... תושקובמה תורמחהה תונמוסמ ובש ,ןולעה ב"צמ .בוהצ עקר לע עבצב )ןולעב( ונמוס תורמחה רדגב םניאש םייוניש קורי . Llegiu el document complet
Page 1 of 13 _ _ PRIORIX TETRA 1. NAME OF THE MEDICINAL PRODUCT Priorix Tetra – powder and solvent for solution for injection. Measles, mumps, rubella and varicella vaccine (live) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose (0.5 ml) contains: Measles virus 1 Schwarz strain (live, attenuated) not less than 10 3.0 CCID 50 3 Mumps virus 1 RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated) not less than 10 4.4 CCID 50 3 Rubella virus 2 Wistar RA 27/3 strain (live, attenuated) not less than 10 3.0 CCID 50 3 Varicella virus 2 OKA strain (live, attenuated) not less than 10 3.3 PFU 4 1 produced on chick embryo cells 2 produced on human diploid (MRC-5) cells 3 Cell culture infective dose 50% 4 Plaque forming units This vaccine contains a trace amount of neomycin. See section 4.3. Excipient with known effect The vaccine contains 14 mg of sorbitol per dose The vaccine contains 6.5 nanograms of para-aminobenzoic acid per dose and 583 micrograms of phenylalanine per dose (see section 4.4). . For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. Before reconstitution, the powder is a white to slightly pink coloured cake and the solvent is a clear colourless liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Priorix Tetra is indicated for active immunisation against measles, mumps, rubella and varicella in children from the age of 12 months up and including 12 years of age. Use in infants aged 9-11 months could be considered under special circumstances. See section 4.2. Note: The use of Priorix Tetra should be based on official recommendations. Page 2 of 13 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _Children from 12 months up to 12 years _ Infants and children aged from 12 months up to 12 years should receive two doses (each of 0.5 ml) of Priorix-Tetra. The age at which infants or children may receive Priorix Tetra should reflect applicable official recommendations*, which vary according to the epid Llegiu el document complet