Țară: Indonezia
Limbă: indoneziană
Sursă: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
BEVACIZUMAB
MENARINI INDRIA LABORATORIES - Indonesia
BEVACIZUMAB
25 MG
INJEKSI
DUS, 1 VIAL @ 4 ML
F. HOFFMANN-LA ROCHE LTD. - Switzerland
2021-11-28
RANCANGAN LEAFLET AVAXIM 80 U PEDIATRIC INACTIVATED ADSORBED HEPATITIS A VACCINE COMPOSITION The active ingredient is inactivated** hepatitis A virus (GBM strain)*………………………………..………....80U*** For one 0.5 ml dose * cultured on MRC-5 human diploid cells. ** adsorbed on aluminium hydroxide (quantity equivalent to 0.15 mg of aluminium). *** antigenic units measured according to the manufacturer’s internal method The other ingredients are phenoxyethanol, formaldehyde, Hanks medium 199 containing, among others, a complex mixture of amino acids, mineral salts, vitamins, hydrochloric acid or sodium hydroxide to maintain pH between 6.8 and 7.8 water for injections. MARKETING AUTHORIZATION HOLDER AND MANUFACTURE SANOFI PASTEUR SA 2, avenue Pont Pasteur 69007 Lyon – France I. WHAT IS AVAXIM 80U PEDIATRIC AND WHAT IS IT USED FOR? AVAXIM 80U Pediatric comes in the form of a suspension for injection in a prefilled syringe (0.5 ml) or multi- dose vial (ten 0.5 ml doses). This vaccine is recommended in the prevention of infection induced by hepatitis A virus in children from 2 years to 15 years inclusive. 2. WHAT INFORMATION IS REQUIRED BEFORE USING AVAXIM 80U PEDIATRIC? DO NOT USE AVAXIM 80U PEDIATRIC IF YOU ARE/YOUR CHILD IS: – allergic to the active ingredient, to any of the excipients, to neomycin, or to polysorbate or if you have / your child has already experienced an allergic reaction following a previous vaccine administration, – suffering from a febrile disease, acute disease, progressive chronic disease (it is preferable to postpone vaccination). BE PARTICULARLY CAREFUL TO AVAXIM 80U PEDIATRIC: Inform your doctor if you are/your child is: – immunocompromised. This vaccine must never be administered by the intravascular or intradermal route. PREGNANCY AND LACTATION: Pregnant women should not use this medicinal product. Vaccination with this vaccine is not recommended to breasfeeding. _Ask your doctor or pharmacist for advice before taking any medicinal product_ DRIVING AND USING MA Citiți documentul complet