TYSABRI Concentrate for solution for infusion (2019)
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Περιεχόμενα
Name of the medicinal product
TYSABRI 300 mg concentrate for solution for infusion.
Qualitative and quantitative composition
Each ml of concentrate contains 20 mg of natalizumab. When diluted (see section 6.6), the solution for infusion contains approximately 2.6 mg/ml of natalizumab. Natalizumab is a recombinant humanised anti-α4-integrin ...
Pharmaceutical form
Concentrate for solution for infusion. Colourless, clear to slightly opalescent solution.
Therapeutic indications
TYSABRI is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: Patients with highly active disease despite ...
Posology and method of administration
TYSABRI therapy is to be initiated and continuously supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions, in centres with timely access to MRI. Patients ...
Contraindications
Hypersensitivity to natalizumab or to any of the excipients listed in section 6.1. Progressive multifocal leukoencephalopathy (PML). Patients with increased risk for opportunistic infections, including ...
Special warnings and precautions for use
Traceability In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded. Progressive Multifocal Leukoencephalopathy ...
Interaction with other medicinal products and other forms of interaction
TYSABRI is contraindicated in combination with other DMTs (see section 4.3). Immunisations In a randomised, open label study of 60 patients with relapsing MS there was no significant difference in the ...
Fertility, pregnancy and lactation
Pregnancy Studies in animals have shown reproductive toxicity (see section 5.3). Data from clinical trials, a prospective pregnancy registry, post-marketing cases and available literature do not suggest ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed with TYSABRI. However, given that dizziness has been commonly reported, patients who experience this adverse reaction ...
Undesirable effects
Summary of the safety profile In placebo-controlled trials in 1,617 MS patients treated with natalizumab for up to 2 years (placebo: 1,135), adverse events leading to discontinuation of therapy occurred ...
Overdose
No case of overdose has been reported.
Pharmacodynamic properties
Pharmacotherapeutic group: Selective immunosuppressive agents ATC code: L04AA23 Pharmacodynamic effects Natalizumab is a selective adhesion-molecule inhibitor and binds to the α4-subunit of human integrins, ...
Pharmacokinetic properties
Following the repeat intravenous administration of a 300 mg dose of natalizumab to MS patients, the mean maximum observed serum concentration was 110 ± 52 μg/ml. Mean average steady-state trough natalizumab ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity. Consistent with the pharmacological activity of natalizumab, ...
List of excipients
Sodium phosphate, monobasic, monohydrate Sodium phosphate, dibasic, heptahydrate Sodium chloride Polysorbate 80 (E433) Water for injections
Incompatibilities
TYSABRI must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life Unopened vial: 4 years. Diluted solution: After dilution with sodium chloride 9 mg/ml (0.9%) solution for injection, immediate use is recommended. If not used immediately, the diluted solution ...
Special precautions for storage
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 6.3.
Nature and contents of container
15 ml concentrate in a vial (type I glass) with a stopper (chlorobutyl rubber) and a seal (aluminium) with a flip-off cap. Pack size of one vial per carton.
Special precautions for disposal and other handling
Instructions for use: Inspect the TYSABRI vial for particles prior to dilution and administration. If particles are observed and/or the liquid in the vial is not colourless, clear to slightly opalescent, ...
Marketing authorization holder
Biogen Netherlands B.V., Prins Mauritslaan 13, 1171 LP Badhoevedorp, The Netherlands
Marketing authorization number(s)
EU/1/06/346/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 27<sup>th</sup> June 2006 Date of latest renewal: 18<sup>th</sup> April 2016
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