EXTAVIA Powder and solvent for solution for injection (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Extavia 250 microgram/ml powder and solvent for solution for injection.
Qualitative and quantitative composition
Extavia contains 300 microgram (9.6 million IU) of recombinant interferon beta-1b per vial*. After reconstitution, each ml contains 250 microgram (8.0 million IU) of recombinant interferon beta1b. * produced ...
Pharmaceutical form
Powder and solvent for solution for injection. Powder white to off-white in colour. Solvent clear/colourless solution.
Therapeutic indications
Extavia is indicated for the treatment of: Patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, ...
Posology and method of administration
The treatment with Extavia should be initiated under the supervision of a physician experienced in the treatment of the disease. Posology Adults and adolescents from 12-17 years of age The recommended ...
Contraindications
Hypersensitivity to natural or recombinant interferon beta, human albumin or to any of the excipients listed in section 6.1. Patients with current severe depression and/or suicidal ideation (see sections ...
Special warnings and precautions for use
Traceability In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Immune system disorders The administration ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. The effect of alternate-day administration of 250 microgram (8.0 million IU) Extavia on drug metabolism in multiple sclerosis patients is unknown. Corticosteroid ...
Fertility, pregnancy and lactation
Pregnancy A large amount of data (more than 1,000 pregnancy outcomes) from interferon beta registries, national registries and post-marketing experience indicates no increased risk of major congenital ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Adverse events related to the central nervous system associated with the use of Extavia might influence the ability ...
Undesirable effects
Summary of the safety profile At the beginning of treatment adverse reactions are common but in general they subside with further treatment. The most frequently observed adverse reactions are a flu-like ...
Overdose
Interferon beta-1b has been given to adult cancer patients at individual doses as high as 5,500 microgram (176 million IU) intravenously three times a week without serious adverse events compromising vital ...
Pharmacodynamic properties
Pharmacotherapeutic group: Immunostimulants, interferons ATC Code: L03AB08 Interferons belong to the family of cytokines, which are naturally occurring proteins. Interferons have molecular weights ranging ...
Pharmacokinetic properties
Extavia serum levels were followed in patients and volunteers by means of a bioassay that was not completely specific. Maximum serum levels of about 40 IU/ml were found 1-8 hours after subcutaneous injection ...
Preclinical safety data
No acute toxicity studies have been performed. As rodents do not react to human interferon beta, repeated dose studies were carried out with rhesus monkeys. Transitory hyperthermia was observed, as well ...
List of excipients
Powder: Human albumin Mannitol (E421) Solvent: Sodium chloride Water for injection
Incompatibilities
This medicinal product must not be mixed with other medicinal products except for the supplied solvent mentioned in section 6.6.
Shelf life
2 years. After reconstitution immediate use is recommended. However, in-use stability has been demonstrated for 3 hours at 2°C-8°C.
Special precautions for storage
Do not store above 25°C. Do not freeze. For storage conditions after reconstitution of the medicinal product, see section 6.3.
Nature and contents of container
Powder: 3 ml vial (clear type I glass) with a butyl rubber stopper (type I) and aluminium overseal containing 300 microgram (9.6 million IU) of (recombinant interferon beta-1b) powder. Solvent: 2.25 ml ...
Special precautions for disposal and other handling
The tip cap of the pre-filled syringe contains a derivative of natural rubber latex. Therefore, the tip cap may contain natural rubber latex, which should not be handled by persons sensitive to this substance. ...
Marketing authorization holder
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Marketing authorization number(s)
EU/1/08/454/008-014
Date of first authorization / renewal of the authorization
Date of first authorisation: 20 May 2008 Date of latest renewal: 20 May 2013
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