BENLYSTA Solution for injection (2019)
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Περιεχόμενα
Name of the medicinal product
Benlysta 200 mg solution for injection in pre-filled pen. Benlysta 200 mg solution for injection in pre-filled syringe.
Qualitative and quantitative composition
<u>Pre-filled pen:</u> Each 1-ml pre-filled pen contains 200 mg of belimumab. <u>Pre-filled syringe:</u> Each 1-ml pre-filled syringe contains 200 mg of belimumab. Belimumab is a human, IgG1λ monoclonal ...
Pharmaceutical form
Solution for injection in pre-filled pen (injection). Solution for injection in pre-filled syringe (injection). A clear to opalescent, colourless to pale yellow solution, with a pH of 6.
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 ...
Posology and method of administration
Benlysta treatment should be initiated and supervised by a qualified physician experienced in the diagnosis and treatment of SLE. It is recommended that the first subcutaneous injection of Benlysta should ...
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 subcutaneous pharmacokinetic parameters below are based on population parameter estimates from 661 subjects, comprised of 554 SLE patients and 107 healthy subjects, who received Benlysta subcutaneously. ...
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
Arginine hydrochloride Histidine Histidine monohydrochloride Polysorbate 80 Sodium chloride Water for injections
Incompatibilities
None known.
Shelf life
3 years.
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. A single Benlysta pre-filled syringe or pre-filled pen can be stored at temperatures up ...
Nature and contents of container
Pre-filled pen: 1 ml solution in a type 1 glass syringe with a fixed needle (stainless steel) in a pre-filled pen. Available in packs of 1 or 4 pre-filled pens and multipack containing 12 single-dose pre-filled ...
Special precautions for disposal and other handling
Comprehensive instructions for subcutaneous administration of Benlysta in a pre-filled pen or pre-filled syringe are provided at the end of the package leaflet (see Step-by-step instructions). Any unused ...
Marketing authorization holder
GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Marketing authorization number(s)
EU/1/11/700/003 1 pre-filled pen EU/1/11/700/004 4 pre-filled pens EU/1/11/700/005 12 (3x4) pre-filled pens (multipack) EU/1/11/700/006 1 pre-filled syringe EU/1/11/700/007 4 pre-filled syringes
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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