LEMTRADA Concentrate for solution for infusion (2020)
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Περιεχόμενα
Name of the medicinal product
LEMTRADA 12 mg concentrate for solution for infusion.
Qualitative and quantitative composition
Each vial contains 12 mg alemtuzumab in 1.2 ml (10 mg/ml). Alemtuzumab is a monoclonal antibody produced in mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium by recombinant ...
Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate). A clear, colourless to slightly yellow concentrate with pH 7.0–7.4.
Therapeutic indications
LEMTRADA is indicated as a single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (RRMS) for the following patient groups: Patients with highly active disease ...
Posology and method of administration
LEMTRADA treatment should only be initiated and supervised by a neurologist experienced in the treatment of patients with multiple sclerosis (MS) in a hospital with ready access to intensive care. Specialists ...
Contraindications
Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1. Human Immunodeficiency Virus (HIV) infection. Patients with severe active infection until complete resolution. ...
Special warnings and precautions for use
LEMTRADA is not recommended for patients with inactive disease or those stable on current therapy. Patients treated with LEMTRADA must be given the Package Leaflet, the Patient Alert Card and the Patient ...
Interaction with other medicinal products and other forms of interaction
No formal drug interaction studies have been conducted with LEMTRADA using the recommended dose in patients with MS. In a controlled clinical trial in MS patients recently treated with beta interferon ...
Fertility, pregnancy and lactation
Women of childbearing potential Serum concentrations were low or undetectable within approximately 30 days following each treatment course. Therefore, women of childbearing potential have to use effective ...
Effects on ability to drive and use machines
LEMTRADA has minor influence on the ability to drive and use machines. Most patients experience IARs which occur during or within 24 hours after treatment with LEMTRADA. Some of the IARs (e.g. dizziness) ...
Undesirable effects
Summary of the safety profile in clinical studies A total of 1,486 patients treated with LEMTRADA (12 mg or 24 mg) constituted the safety population in a pooled analysis of MS clinical studies with a median ...
Overdose
In controlled clinical trials two MS patients accidentally received up to 60 mg LEMTRADA (i.e. total dose for initial treatment course) in a single infusion and experienced serious reactions (headache, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Immunosuppressants, Selective immunosuppressants ATC code: L04AA34 Mechanism of action Alemtuzumab, is a recombinant DNA-derived humanised monoclonal antibody directed against ...
Pharmacokinetic properties
The pharmacokinetics of alemtuzumab were evaluated in a total of 216 patients with RRMS who received intravenous infusions of either 12 mg/day or 24 mg/day on 5 consecutive days, followed by 3 consecutive ...
Preclinical safety data
Carcinogenesis and mutagenesis There have been no studies to assess the carcinogenic or mutagenic potential of alemtuzumab. Fertility and reproduction Treatment with intravenous alemtuzumab at doses up ...
List of excipients
Disodium phosphate dihydrate (E339) Disodium edetate Potassium chloride (E508) Potassium dihydrogen phosphate (E340) Polysorbate 80 (E433) Sodium chloride Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life Concentrate: 3 years. Diluted solution: Chemical and physical in-use stability has been demonstrated for 8 hours at 2°C-8°C. From a microbiological point of view, it is recommended that the ...
Special precautions for storage
Concentrate: Store in a refrigerator (2°C-8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light. For storage conditions after dilution of the medicinal product, see section ...
Nature and contents of container
LEMTRADA is supplied in a clear, 2 ml glass vial, with a butyl rubber stopper and aluminium seal with a plastic flip-off cap. Pack size: carton with 1 vial
Special precautions for disposal and other handling
The vial contents should be inspected for particulate matter and discoloration prior to administration. Do not use if particulate matter is present or the concentrate is discoloured. Do not shake the vials ...
Marketing authorization holder
Sanofi Belgium, Leonardo Da Vincilaan 19, B-1831, Diegem, Belgium
Marketing authorization number(s)
EU/1/13/869/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 12 September 2013 Date of latest renewal: 2 July 2018
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