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Benlysta 120 mg and 400 mg powder for concentrate for solution for infusion (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
GlaxoSmithKline UK
Διεύθυνση :
Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Δωρεάν εγγραφή

Name of the medicinal product

Benlysta 120 mg powder for concentrate for solution for infusion. Benlysta 400 mg powder for concentrate for solution for infusion.

Qualitative and quantitative composition

Each vial contains 120 mg of belimumab. After reconstitution, the solution contains 80 mg belimumab per ml. Each vial contains 400 mg of belimumab. After reconstitution, the solution contains 80 mg belimumab ...

Pharmaceutical form

Powder for concentrate for solution for infusion. White to off-white powder.

Therapeutic indications

Benlysta is indicated as add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g positive anti-dsDNA and low complement) ...

Posology and method of administration

Benlysta treatment should be initiated and supervised by a qualified physician experienced in the diagnosis and treatment of SLE. Benlysta infusions should be administered by a qualified healthcare professional ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Benlysta has not been studied in the following patient groups, and is not recommended in: severe active central nervous system lupus severe active lupus nephritis (see section 5.1) HIV a history of, or ...

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

Fertility, pregnancy and lactation

Women of childbearing potential/Contraception in males and females Women of child-bearing potential must use effective contraception during Benlysta treatment and for at least 4 months after the last treatment. ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. No detrimental effects on such activities are predicted from the pharmacology of Benlysta. The clinical status of ...

Undesirable effects

Summary of the safety profile The safety of Benlysta in patients with SLE has been evaluated in 3 placebo-controlled studies. The data described below reflect exposure to Benlysta 10 mg/kg in 674 patients ...

Overdose

There is no clinical experience with overdose of Benlysta. Two doses up to 20 mg/kg administered 21 days apart by intravenous infusion have been given to humans with no increase in incidence or severity ...

Pharmacodynamic properties

Pharmacotherapeutic group: Selective immunosuppressants ATC code: L04AA26 Mechanism of action Benlysta is a human IgG1λ monoclonal antibody specific for soluble human B Lymphocyte Stimulator protein (BLyS, ...

Pharmacokinetic properties

The pharmacokinetic parameters quoted below are based on population parameter estimates for the 563 patients who received Benlysta 10 mg/kg in the two Phase III studies. Absorption Benlysta is administered ...

Preclinical safety data

Nonclinical data reveal no special hazard for humans based on studies of repeated dose toxicity and toxicity to reproduction. Intravenous and subcutaneous administration to monkeys resulted in the expected ...

List of excipients

Citric acid monohydrate (E330) Sodium citrate (E331) Sucrose Polysorbate 80

Incompatibilities

Belimumab is not compatible with 5% glucose. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Ημερομηνία λήξης

Unopened vials: 4 years. Reconstituted solution After reconstitution with water for injections, the reconstituted solution, if not used immediately, should be protected from direct sunlight, and stored ...

Special precautions for storage

Unopened vials: Store in a refrigerator (2°C 8°C). Do not freeze. Store in the original carton in order to protect from light. For storage conditions after reconstitution and dilution of the medicinal ...

Nature and contents of container

120 mg vial: Type 1 glass vials (5 ml), sealed with a latex-free, siliconised chlorobutyl rubber stopper and a flip-off aluminum seal. 400 mg vial: Type 1 glass vials (20 ml), sealed with a latex-free, ...

Special precautions for disposal and other handling

Preparation of the solution for infusion Reconstitution Reconstitution and dilution must be carried out under aseptic conditions. Allow 10-15 minutes for the vial to warm to room temperature (15°C 25°C). ...

Marketing authorization holder

Glaxo Group Limited Glaxo Wellcome House Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom

Marketing authorization number(s)

Benlysta 120 mg Powder for concentrate for solution for infusion: EU/1/11/700/001 Benlysta 400 mg Powder for concentrate for solution for infusion: EU/1/11/700/002

Date of first authorization / renewal of the authorization

Date of first authorisation: 13 July 2011

Date of revision of the text

24th October 2012
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