AVASTIN

País: Indonèsia

Idioma: indonesi

Font: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

ingredients actius:

BEVACIZUMAB

Disponible des:

MENARINI INDRIA LABORATORIES - Indonesia

Designació comuna internacional (DCI):

BEVACIZUMAB

Dosis:

25 MG

formulario farmacéutico:

INJEKSI

Unidades en paquete:

DUS, 1 VIAL @ 4 ML

Fabricat per:

F. HOFFMANN-LA ROCHE LTD. - Switzerland

Data d'autorització:

2021-11-28

Fitxa tècnica

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