BENLYSTA Powder for concentrate for solution for infusion (2019)
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Περιεχόμενα
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
Benlysta 120 mg powder for concentrate for solution for infusion: Each vial contains 120 mg of belimumab. After reconstitution, the solution contains 80 mg belimumab per ml. Benlysta 400 mg powder for ...
Pharmaceutical form
Powder for concentrate for solution for infusion. White to off-white powder.
Therapeutic indications
Benlysta is indicated as add-on therapy in patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti-dsDNA ...
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
Traceability In order to improve traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded. Benlysta has not been studied ...
Interaction with other medicinal products and other forms of interaction
No in vivo interaction studies have been performed. The formation of some CYP450 enzymes is suppressed by increased levels of certain cytokines during chronic inflammation. It is not known if belimumab ...
Fertility, pregnancy and lactation
Women of childbearing potential/Contraception in males and females Women of childbearing 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 belimumab. The clinical status of ...
Undesirable effects
Summary of the safety profile The safety of belimumab in patients with SLE has been evaluated in 3 pre-registration, placebo-controlled intravenous studies, 1 placebo-controlled subcutaneous study, and ...
Overdose
There is limited clinical experience with overdose of Benlysta. Adverse reactions reported in association with cases of overdose have been consistent with those expected for belimumab. Two doses up to ...
Pharmacodynamic properties
Pharmacotherapeutic group: Selective immunosuppressants ATC code: L04AA26 Mechanism of action Belimumab is a human IgG1λ monoclonal antibody specific for soluble human B Lymphocyte Stimulator protein (BLyS, ...
Pharmacokinetic properties
The intravenous 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 ...
Preclinical safety data
Non-clinical 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
Benlysta is not compatible with 5% glucose. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life Unopened vials: 5 years. Reconstituted solution: After reconstitution with water for injections, the reconstituted solution, if not used immediately, should be protected from direct sunlight, ...
Special precautions for storage
Store in a refrigerator (2°C to 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 product, see ...
Nature and contents of container
Benlysta 120 mg powder for concentrate for solution for infusion: Type 1 glass vials (5 ml), sealed with a siliconised chlorobutyl rubber stopper and a flip-off aluminum seal containing 120 mg of powder. ...
Special precautions for disposal and other handling
Preparation of 120 mg solution for infusion Reconstitution Reconstitution and dilution must be carried out under aseptic conditions. Allow 10 to 15 minutes for the vial to warm to room temperature (15°C ...
Marketing authorization holder
GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Marketing authorization number(s)
EU/1/11/700/001 1 vial – 120 mg EU/1/11/700/002 1 vial – 400 mg
Date of first authorization / renewal of the authorization
Date of first authorisation: 13 July 2011 Date of latest renewal: 18 February 2016
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