ZINBRYTA Solution for injection (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Zinbryta 150 mg solution for injection in pre-filled syringe. Zinbryta 150 mg solution for injection in pre-filled pen.
Qualitative and quantitative composition
Each pre-filled syringe contains 150 mg of daclizumab beta in 1 mL solution for injection. Each pre-filled pen contains a pre-filled syringe, containing 150 mg of daclizumab beta in 1 mL solution for injection. ...
Pharmaceutical form
Solution for injection (injection). Colourless to slightly yellow, clear to slightly opalescent liquid with pH 6.
Therapeutic indications
Zinbryta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) who have had an inadequate response to at least two disease modifying therapies (DMTs) and for ...
Posology and method of administration
Treatment should be initiated by a physician experienced in the management of multiple sclerosis. Posology The recommended dose of Zinbryta is 150 mg injected subcutaneously once a month. In case a dose ...
Contraindications
Zinbryta is contraindicated in patients with a history of severe hypersensitivity (e.g. anaphylaxis or anaphylactoid reactions) to all forms of daclizumab or to any of the excipients in Zinbryta (see section ...
Special warnings and precautions for use
Hepatic injury Due to the risk of hepatic injury, the use of Zinbryta is restricted (see section 4.1). Serious hepatic injury including elevations of serum transaminases and fatal cases of autoimmune hepatitis ...
Interaction with other medicinal products and other forms of interaction
Zinbryta is not expected to undergo metabolism by hepatic enzymes or renal elimination. There is limited data on concomitant use of Zinbryta with MS symptomatic therapies. Hepatic injury Cases of hepatic ...
Fertility, pregnancy and lactation
Pregnancy There are limited data from the use of Zinbryta in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reprotoxicity (see section 5.3). Zinbryta ...
Effects on ability to drive and use machines
Zinbryta has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile In the placebo-controlled study (the SELECT study), 417 patients received Zinbryta (150 mg, n=208; 300 mg, n=209; every 4 weeks) for up to 1 year. In the active-controlled ...
Overdose
Reported experience with overdose is limited. The safety of doses above 300 mg administered subcutaneously and 400 mg intravenously have not been evaluated. Doses up to this level were well tolerated with ...
Pharmacodynamic properties
Pharmacotherapeutic group: immunosuppressants, interleukin inhibitors ATC code: L04AC01 Mechanism of action Daclizumab beta is a humanised IgG1 monoclonal antibody that binds to CD25 (IL-2Rα), and prevents ...
Pharmacokinetic properties
Daclizumab beta pharmacokinetics are well described by a two-compartment model with first-order absorption and elimination. Absorption Following subcutaneous administration of daclizumab beta, the median ...
Preclinical safety data
Preclinical safety studies were conducted in cynomolgus monkeys due to species specificity of daclizumab beta binding only to human or primate CD25. Carcinogenesis Carcinogenicity studies with daclizumab ...
List of excipients
Sodium succinate Succinic acid Sodium chloride Polysorbate 80 Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product should not be mixed with other products.
Shelf life
Shelf life: 3 years. Zinbryta can be stored at room temperature (up to 30°C) in the original pack for 30 days. Do not place Zinbryta back into the refrigerator after warming to room temperature. If Zinbryta ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Store in the original package in order to protect from light. For additional information on storage at room temperature, see section 6.3.
Nature and contents of container
Pre-filled syringe made of glass (Type 1) with a rubber stopper and thermoplastic rigid needle shield containing 1 mL of solution. A 29 gauge, 0.5 inch staked needle is pre-affixed to the syringe. Pack ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
BIOGEN IDEC Limited, Innovation House, 70 Norden Road, Maidenhead, Berkshire, SL6 4AY, United Kingdom
Marketing authorization number(s)
EU/1/16/1107/001 EU/1/16/1107/002 EU/1/16/1107/003 EU/1/16/1107/004
Date of first authorization / renewal of the authorization
Date of first authorisation: 01 July 2016
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