PLEGRIDY Solution for injection (2023)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Plegridy 63 micrograms solution for injection in pre-filled syringe. Plegridy 94 micrograms solution for injection in pre-filled syringe. Plegridy 125 micrograms solution for injection in pre-filled syringe. ...
Qualitative and quantitative composition
<u>Plegridy 63 micrograms solution for injection in pre-filled syringe (for subcutaneous use):</u> Each pre-filled syringe contains 63 micrograms of peginterferon beta-1a* in 0.5 mL solution for injection. ...
Pharmaceutical form
Solution for injection (injection). Clear and colourless solution with pH 4.5-5.1.
Therapeutic indications
Plegridy is indicated in adult patients for the treatment of relapsing remitting multiple sclerosis (see section 5.1).
Posology and method of administration
Treatment should be initiated under supervision of a physician experienced in the treatment of multiple sclerosis. Plegridy may be administered subcutaneously (SC) using a single-use pre-filled pen or ...
Contraindications
Hypersensitivity to natural or recombinant interferon beta or peginterferon or to any of the excipients listed in section 6.1. Patients with current severe depression and/or suicidal ideation (see sections ...
Special warnings and precautions for use
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Hepatic injury Elevated serum hepatic ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. The clinical studies indicate that multiple sclerosis patients can receive peginterferon beta-1a and corticosteroids during relapses. Interferons have been reported ...
Fertility, pregnancy and lactation
Pregnancy A large amount of data (more than 1,000 pregnancy outcomes) from registries and post-marketing experience indicates no increased risk of major congenital anomalies after pre-conception exposure ...
Effects on ability to drive and use machines
Peginterferon beta-1a has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of safety profile The most common adverse drug reactions (ADR) (at a higher incidence than placebo) for Peginterferon beta-1a 125 micrograms subcutaneously every 2 weeks were injection site erythema, ...
Overdose
In case of over-dose, patients may be hospitalized for observation and appropriate supportive treatment should be given.
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antineoplastic and immunomodulating agents, immunostimulants, interferons <b>ATC code:</b> L03AB13 Peginterferon beta-1a is an interferon beta-1a conjugated with a single, ...
Pharmacokinetic properties
The serum half-life of peginterferon beta-1a is prolonged compared with non-pegylated interferon beta-1a. Serum concentration of peginterferon beta-1a was dose-proportional in the range of 63 to 188 micrograms ...
Preclinical safety data
Toxicity Following repeated subcutaneous administration of peginterferon beta-1a in rhesus monkeys at doses up to 400-fold (based on exposure, AUC) the recommended therapeutic dose; no effects other than ...
List of excipients
Sodium acetate trihydrate Acetic acid, glacial Arginine hydrochloride Polysorbate 20 Water for injections
Incompatibilities
Not applicable.
Shelf life
3 years. Plegridy can be stored at room temperature (up to 25°C) for up to 30 days as long as it is stored away from light. If Plegridy is at room temperature for a total of 30 days, it should be used ...
Special precautions for storage
Store in a refrigerator (2°C to 8°C). Do not freeze. Store in the original package in order to protect from light. See section 6.3 for additional information on storage at room temperature.
Nature and contents of container
Pre-filled syringe / pre-filled pen (subcutaneous) 1 mL pre-filled syringe made of glass (Type I) with a bromobutyl rubber stopper and thermoplastic and polypropylene rigid needle shield, containing 0.5 ...
Special precautions for disposal and other handling
Plegridy prefilled syringes (for IM and SC administration) and pen (for SC administration) are for single-use only. Before use check the dosage form to be used. It should not have any cracks or damage ...
Marketing authorization holder
Biogen Netherlands B.V., Prins Mauritslaan 13, 1171 LP Badhoevedorp, The Netherlands
Marketing authorization number(s)
EU/1/14/934/001 EU/1/14/934/002 EU/1/14/934/003 EU/1/14/934/004 EU/1/14/934/005 EU/1/14/934/006 EU/1/14/934/007 EU/1/14/934/008
Date of first authorization / renewal of the authorization
Date of first authorisation: 18 July 2014 Date of latest renewal: 25 March 2019
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