PEGINTRON Powder and solvent for solution for injection (2018)
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Περιεχόμενα
Name of the medicinal product
PegIntron 50 micrograms powder and solvent for solution for injection. PegIntron 80 micrograms powder and solvent for solution for injection. PegIntron 100 micrograms powder and solvent for solution for ...
Qualitative and quantitative composition
PegIntron 50 micrograms powder and solvent for solution for injection: Each vial contains 50 micrograms of peginterferon alfa-2b as measured on a protein basis. Each vial provides 50 micrograms/0.5 ml ...
Pharmaceutical form
Powder and solvent for solution for injection. White powder. Clear and colourless solvent.
Therapeutic indications
Adults (tritherapy) PegIntron in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adult patients (18 years of age ...
Posology and method of administration
Treatment should be initiated and monitored only by a physician experienced in the management of patients with hepatitis C. Posology PegIntron should be administered as a once weekly subcutaneous injection. ...
Contraindications
Hypersensitivity to the active substance or to any interferon or to any of the excipients listed in section 6.1; A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac ...
Special warnings and precautions for use
Psychiatric and Central Nervous System (CNS) Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during PegIntron therapy, and even ...
Interaction with other medicinal products and other forms of interaction
Interaction studies have only been performed in adults. Telbivudine A clinical trial investigating the combination of telbivudine, 600 mg daily, with pegylated interferon alfa-2a, 180 micrograms once weekly ...
Fertility, pregnancy and lactation
Women of childbearing potential/contraception in males and females PegIntron is recommended for use in fertile women only when they are using effective contraception during the treatment. Combination therapy ...
Effects on ability to drive and use machines
Patients who develop fatigue, somnolence or confusion during treatment with PegIntron are cautioned to avoid driving or operating machines.
Undesirable effects
Adults Tritherapy Refer to the SmPC for boceprevir. Bitherapy and monotherapy Summary of the safety profile The most common treatment-related adverse reactions reported during clinical trials with PegIntron ...
Overdose
Doses up to 10.5 times the intended dose have been reported. The maximum daily dose reported is 1,200 µg for one day. In general, the adverse events seen in overdose cases involving PegIntron are consistent ...
Pharmacodynamic properties
Pharmacotherapeutic group: Immunostimulants, Interferons ATC code: L03AB10 Recombinant interferon alfa-2b is covalently conjugated with monomethoxy polyethylene glycol at an average degree of substitution ...
Pharmacokinetic properties
PegIntron is a well characterized polyethylene glycol-modified (pegylated) derivative of interferon alfa-2b and is predominantly composed of monopegylated species. The plasma half-life of PegIntron is ...
Preclinical safety data
PegIntron Adverse events not observed in clinical trials were not seen in toxicity studies in monkeys. These studies were limited to four weeks due to the appearance of anti-interferon antibodies in most ...
List of excipients
Powder: Disodium phosphate, anhydrous Sodium dihydrogen phosphate dihydrate Sucrose Polysorbate 80 Solvent: Water for injections
Incompatibilities
This medicinal product should only be reconstituted with the solvent provided (see section 6.6). In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. ...
Shelf life
Before reconstitution: 3 years. After reconstitution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8ºC. From a microbiological point of view, the product is to be used ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). For storage conditions of the reconstituted medicinal product, see section 6.3.
Nature and contents of container
The powder is contained in a 2 ml vial (Type I flint glass) with a butyl rubber stopper in an aluminium flip-off seal with a polypropylene bonnet. The solvent is presented in a 2 ml ampoule (Type I flint ...
Special precautions for disposal and other handling
PegIntron 50 micrograms powder and solvent for solution for injection: Each vial is to be reconstituted with 0.7 ml of water for injections for administration of up to 0.5 ml of solution. A small volume ...
Marketing authorization holder
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN, Haarlem, The Netherlands
Marketing authorization number(s)
PegIntron 50 micrograms powder and solvent for solution for injection: EU/1/00/131/001 EU/1/00/131/002 EU/1/00/131/003 EU/1/00/131/004 EU/1/00/131/005 EU/1/00/131/026 PegIntron 80 micrograms powder and ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 25 May 2000 Date of latest renewal: 25 May 2010
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