PEGASYS Solution for injection (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Pegasys 90 micrograms solution for injection in pre-filled syringe. Pegasys 135 micrograms solution for injection in pre-filled syringe. Pegasys 180 micrograms solution for injection in pre-filled syringe. ...
Qualitative and quantitative composition
Pegasys 90 micrograms solution for injection in pre-filled syringe: Each syringe of 0.5 ml solution contains 90 micrograms peginterferon alfa-2a*. Pegasys 135 micrograms solution for injection in pre-filled ...
Pharmaceutical form
Solution for injection (injection). The solution is clear and colourless to light yellow.
Therapeutic indications
Chronic hepatitis B Adult patients Pegasys is indicated for the treatment of hepatitis B envelope antigen (HBeAg)-positive or HBeAgnegative chronic hepatitis B (CHB) in adult patients with compensated ...
Posology and method of administration
Treatment should be initiated only by a physician experienced in the treatment of patients with hepatitis B or C. Refer also to the Summary of Product Characteristics of the medicinal products that are ...
Contraindications
Hypersensitivity to the active substance, to alfa interferons, or to any of the excipients listed in section 6.1. Autoimmune hepatitis. Severe hepatic dysfunction or decompensated cirrhosis of the liver ...
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 Pegasys therapy, and even after ...
Interaction with other medicinal products and other forms of interaction
Interaction studies have only been performed in adults. Administration of Pegasys 180 micrograms once weekly for 4 weeks in healthy male subjects did not show any effect on mephenytoin, dapsone, debrisoquine ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of peginterferon alfa-2a in pregnant women. Studies in animals with interferon alfa-2a have shown reproductive toxicity (see section 5.3) and ...
Effects on ability to drive and use machines
Pegasys has minor or moderate influence on the ability to drive and use machines. Patients who develop dizziness, confusion, somnolence or fatigue should be cautioned to avoid driving or operating machinery. ...
Undesirable effects
Summary of the safety profile Chronic hepatitis B in adult patients In clinical trials of 48 weeks treatment and 24 weeks follow-up, the safety profile for Pegasys in CHB was similar to that seen in CHC. ...
Overdose
Overdoses involving between two injections on consecutive days (instead of weekly interval) up to daily injections for 1 week (i.e., 1260 micrograms/week) have been reported. None of these patients experienced ...
Pharmacodynamic properties
Pharmacotherapeutic group: Immunostimulants, interferons ATC code: L03AB11 Mechanism of action The conjugation of PEG reagent (bis-monomethoxypolyethylene glycol) to interferon alfa-2a forms a pegylated ...
Pharmacokinetic properties
Absorption Following a single subcutaneous injection of Pegasys 180 micrograms in healthy subjects, serum concentrations of peginterferon alfa-2a are measurable within 3 to 6 hours. Within 24 hours, about ...
Preclinical safety data
The non-clinical toxicity studies conducted with Pegasys were limited due to species specificity of interferons. Acute and chronic toxicity studies have been carried out in cynomolgus monkeys, and the ...
List of excipients
Sodium chloride Polysorbate 80 Benzyl alcohol Sodium acetate Acetic acid Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life Pegasys 90 micrograms solution for injection in pre-filled syringe: 3 years. Pegasys 135 micrograms solution for injection in pre-filled syringe: 4 years. Pegasys 180 micrograms solution for ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light.
Nature and contents of container
0.5 ml of solution for injection in pre-filled syringe (siliconised Type I glass) with a plunger stopper and tip cap (butyl rubber laminated on the product facing side with fluororesin) with a needle. ...
Special precautions for disposal and other handling
The solution for injection is for single use only. It should be inspected visually for particulate matter and discoloration before administration. Any unused medicinal product or waste material should ...
Marketing authorization holder
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
Marketing authorization number(s)
Pegasys 90 micrograms solution for injection in pre-filled syringe: EU/1/02/221/017 Pegasys 135 micrograms solution for injection in pre-filled syringe: EU/1/02/221/005 EU/1/02/221/006 EU/1/02/221/009 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 20 June 2002 Date of latest renewal: 20 June 2007
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