VARILRIX Powder and solvent for solution for injection (2021)
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Περιεχόμενα
Name of the medicinal product
Varilrix powder and solvent for solution for injection in pre-filled syringe. Varicella vaccine (live).
Qualitative and quantitative composition
<u>After reconstitution, one dose (0.5 mL) contains:</u> Varicella virus<sup>1</sup> Oka strain (live, attenuated) not less than 10<sup>3.3</sup> PFU<sup>2</sup>. 1 produced in human diploid cells (MRC-5) ...
Pharmaceutical form
Powder and solvent for solution for injection in pre-filled syringe. Before reconstitution, the powder is slightly cream to yellowish or pinkish coloured cake and the solvent is a clear colourless liquid. ...
Therapeutic indications
Varilrix is indicated for active immunisation against varicella: In healthy individuals from 9 to 11 months of age (see section 5.1), under special circumstances; In healthy individuals from the age of ...
Posology and method of administration
Posology The immunisation schedules for Varilrix should be based on official recommendations. Healthy individuals Infants from 9 months to 11 months of age (inclusive) Infants from 9 to 11 months of age ...
Contraindications
Varilrix is contraindicated in individuals with severe humoral or cellular (primary or acquired) immunodeficiency such as (see also section 4.4.): subjects with immunodeficiency states with a total lymphocyte ...
Special warnings and precautions for use
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. As with other vaccines, the administration ...
Interaction with other medicinal products and other forms of interaction
If tuberculin testing has to be done it should be carried out before or simultaneously with vaccination since it has been reported that live viral vaccines may cause a temporary depression of tuberculin ...
Fertility, pregnancy and lactation
Pregnancy Pregnant women should not be vaccinated with Varilrix. However, foetal damage has not been documented when varicella vaccines have been given to pregnant women. Women of child-bearing potential ...
Effects on ability to drive and use machines
No studies on the effects of Varilrix on the ability to drive and use machines have been performed. Varilrix has no or negligible influence on the ability to drive and use machines. However, some of the ...
Undesirable effects
Clinical trial data Healthy individuals More than 7,900 individuals have participated in clinical trials evaluating the reactogenicity profile of the vaccine administered subcutaneously either alone or ...
Overdose
Cases of accidental administration of more than the recommended dose of Varilrix have been reported. Amongst these cases, the following adverse events were reported: lethargy and convulsions. In the other ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Viral vaccines, Varicella zoster vaccines <b>ATC code:</b> J07BK01 Mechanism of action Varilrix produces an attenuated clinically inapparent varicella infection in susceptible ...
Pharmacokinetic properties
Evaluation of pharmacokinetic properties is not required for vaccines.
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on general safety tests performed in animals.
List of excipients
<u>Powder:</u> Amino acids (containing phenylalanine) Lactose anhydrous Sorbitol (E420) Mannitol (E421) <u>Solvent:</u> Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
2 years. After reconstitution, it is recommended that the vaccine be injected as soon as possible. However, it has been demonstrated that the reconstituted vaccine may be kept for up to 90 minutes at room ...
Special precautions for storage
Store and transport refrigerated (2°C to 8°C). Store in the original package in order to protect from light. For storage conditions after reconstitution of the medicinal product, see section 6.3.
Nature and contents of container
Powder in a single-dose glass vial (type I glass) with a stopper (bromobutyl rubber). 0.5 ml of solvent in a pre-filled syringe (type I glass) with plunger stopper (bromobutyl rubber), with or without ...
Special precautions for disposal and other handling
The solvent and the reconstituted vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance before administration. In the event of either being observed, ...
Marketing authorization holder
SmithKline Beecham Ltd, 980, Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom Trading as: GlaxoSmithKline UK
Marketing authorization number(s)
Vaccine: PL 10592/0121 Diluent: PL 10592/0021
Date of first authorization / renewal of the authorization
Date of first authorisation: 25 June 2002 Date of last renewal: 12 March 2009
Date of revision of the text
15 October 2021
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