RAPTIVA Powder and solvent for solution for injection (2009)
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Περιεχόμενα
Name of the medicinal product
Raptiva 100 mg/ml powder and solvent for solution for injection.
Qualitative and quantitative composition
Each vial contains a retrievable amount of 125 mg of efalizumab. Reconstitution with the solvent yields a solution containing efalizumab at 100 mg/ml. Efalizumab is a recombinant humanized monoclonal antibody ...
Pharmaceutical form
Powder and solvent for solution for injection. The powder is a white to off white cake. The solvent is a clear, colourless liquid. The pH of the reconstituted solution is 5.9-6.5.
Therapeutic indications
Treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, ...
Posology and method of administration
Treatment with Raptiva should be initiated by a physician specialised in dermatology. An initial single dose of 0.7 mg/kg body weight is given followed by weekly injections of 1.0 mg/kg body weight (maximum ...
Contraindications
Hypersensitivity to efalizumab or to any of the excipients. Patients with history of malignancies. Patients with active tuberculosis and other severe infections. Patients with specific forms of psoriasis ...
Special warnings and precautions for use
Effects on the immune system Infections Raptiva is a selective immunosuppressor that alters T-lymphocyte function and may affect host defences against infections. It has the potential to increase the risk ...
Interaction with other medicinal products and other forms of interaction
There have been no formal drug interaction studies performed with Raptiva. Limited data are available on the effects of vaccination in patients receiving Raptiva. In a study of 66 patients with moderate ...
Pregnancy and lactation
Pregnancy In general, immunoglobulins are known to cross the placental barrier. There are no adequate data from the use of efalizumab in pregnant women. Animal studies indicate an impairment of the immune ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Based on the pharmacological mechanism of action of efalizumab, the use of Raptiva is not expected to affect patient ...
Undesirable effects
The most frequent symptomatic adverse drug reactions (ADRs) observed during Raptiva therapy were mild to moderate dose-related acute flu-like symptoms including headache, fever, chills, nausea and myalgia. ...
Overdose
In clinical study, where subjects were exposed to higher doses of efalizumab (up to 10 mg/kg intravenous), one subject receiving 3 mg/kg intravenous dose experienced hypertension, chills, and fever on ...
Pharmacodynamic properties
Pharmacotherapeutic group: selective immunosuppressive agents ATC code: L04AA21 Mechanism of action Efalizumab is a recombinant humanized monoclonal antibody that binds specifically to the CD11a subunit ...
Pharmacokinetic properties
Absorption After subcutaneous administration of efalizumab peak plasma concentrations are reached after 1-2 days. Comparison with intravenous data indicated an average bioavailability of about 50% at the ...
Preclinical safety data
Efalizumab does not cross-react with CD11a from species other than humans and chimpanzees. Therefore, conventional non-clinical safety data with the medicinal product are limited and do not allow for a ...
List of excipients
Powder for solution for injection: Polysorbate 20 Histidine Histidine hydrochloride monohydrate Sucrose Solvent: Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 4 years. After reconstitution, an immediate use is recommended (see also section 6.4).
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Store in the original package in order to protect from light. From a microbiological point of view, the product should be used immediately after first ...
Nature and contents of container
Powder: Colourless type I glass vial with a butyl rubber stopper, and aluminium seal fitted with a flip-off plastic cap. Solvent: Type I glass pre-filled syringe. Raptiva is available in: Packs of 1 vial ...
Special precautions for disposal and other handling
Raptiva is for single use only. One vial of Raptiva should be reconstituted with the solvent before use. Reconstitution of the singleuse vial with 1.3 ml of the supplied water for injections yields approximately ...
Marketing authorization holder
Serono Europe Ltd., 56 Marsh Wall, London E14 9TP, United Kingdom
Marketing authorization number(s)
EU/1/04/291/001 EU/1/04/291/002 EU/1/04/291/003
Date of first authorization / renewal of the authorization
Date of first authorisation: 20 September 2004
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