AVAXIM Suspension for injection in a prefilled syringe (2021)
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Περιεχόμενα
1. Name of the medicinal product
AVAXIM 160 U, suspension for injection in prefilled syringe. Hepatitis A vaccine (inactivated, adsorbed).
2. Qualitative and quantitative composition
One dose (0.5 ml) contains: Hepatitis A virus, GBM strain* (inactivated): 160 ELISA units* * Cultured on MRC-5 human diploid cells ** Adsorbed on hydrated aluminium hydroxide (0.3 milligrams of Al) *** ...
3. Pharmaceutical form
Suspension for injection in a prefilled syringe. The hepatitis A vaccine (inactivated, adsorbed) is a turbid and whitish suspension.
4.1. Therapeutic indications
This vaccine is indicated for active immunisation against infection caused by the hepatitis A virus in adolescents from 16 years of age and in adults. This vaccine should be administered in accordance ...
4.2. Posology and method of administration
Posology The recommended dosage for subjects from 16 years of age is 0.5 ml. The initial protection is obtained after one single injection. In order to obtain a long-term protection against infections ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients or to neomycin (that may be present as traces in each dose due to its use during the manufacturing process). Hypersensitivity following ...
4.4. Special warnings and precautions for use
As with all injectable vaccines, available appropriate medical treatment and subject monitoring are recommended in case of an anaphylactic reaction after vaccine administration. AVAXIM 160 U has not been ...
4.5. Interaction with other medicinal products and other forms of interaction
Concomitant administration of immunoglobulins and this vaccine in two separate sites may be performed. Seroprotection rates are not modified but antibody titres may be lower than those obtained when the ...
4.6. Pregnancy and lactation
Pregnancy No reliable data are available on teratogenesis in animals. To date, there are no sufficiently relevant clinical data available to assess a potential vaccine-related malformation or foetotoxic ...
4.7. Effects on ability to drive and use machines
The effects on the ability to drive and use machines have not been studied.
4.8. Undesirable effects
The undesirable effects are derived from clinical studies and worldwide post-marketing experience. The undesirable effects are ranked under headings of frequency using the following convention: Very common ...
4.9. Overdose
A few cases of overdose have been reported with AVAXIM 160 U, with no specific undesirable effects.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Vaccine against hepatitis A <b>ATC code:</b> J07BC02 This vaccine is prepared from hepatitis A virus cultured, purified and then inactivated by formaldehyde. It confers ...
5.2. Pharmacokinetic properties
Not applicable.
5.3. Preclinical safety data
Non clinical data reveal no special hazard for humans based on conventional studies of acute toxicity, repeated dose toxicity, local tolerance and hypersensitivity.
6.1. List of excipients
2-Phenoxyethanol, ethanol, formaldehyde, and Hanks 199 medium*, water for injections, polysorbate 80, hydrochloric acid and sodium hydroxide for pH adjustment. * Hanks 199 medium (without phenol red) is ...
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. If frozen, the vaccine should be discarded. Keep in the original packaging, protected from light.
6.5. Nature and contents of container
0.5 ml of suspension in prefilled syringe (type I glass) with a plunger stopper (chlorobutyl or bromobutyl), and an attached needle. Box of 1, 5, 10 or 20. 0.5 ml of suspension in prefilled syringe (type ...
6.6. Special precautions for disposal and other handling
Shake before injection, until a homogenous suspension is obtained. For the syringes without attached needles, the separate needle should be fitted firmly to the syringe, rotating it by one quarter turn. ...
7. Marketing authorization holder
SANOFI PASTEUR, 14 Espace Henry Vallee, 69007 Lyon, France
8. Marketing authorization number(s)
17602
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 13/03/1998 iDate of latest renewal: 12/05/2009
10. Date of revision of the text
18 May 2021
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