REBETOL Hard capsule (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Rebetol 200 mg hard capsules.
Qualitative and quantitative composition
Each hard capsule contains 200 mg of ribavirin. Excipient with known effect: Each hard capsule contains 40 mg of lactose monohydrate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Hard capsule (capsule). White, opaque and imprinted with blue ink.
Therapeutic indications
Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4, and 5.1). Rebetol is indicated in combination with other ...
Posology and method of administration
Treatment should be initiated, and monitored, by a physician experienced in the management of chronic hepatitis C. Posology Rebetol must be used in combination therapy as described in section 4.1. Please ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Pregnancy (see sections 4.4, 4.6 and 5.3). In females of childbearing potential, Rebetol must not be initiated ...
Special warnings and precautions for use
Rebetol must be used in combination with other medicinal products (see section 5.1). Please refer to the SmPC of (peg)interferon alfa for details on the recommendations of monitoring and management regarding ...
Interaction with other medicinal products and other forms of interaction
Interaction studies have only been performed in adults. Results of in vitro studies using both human and rat liver microsome preparations indicated no cytochrome P450 enzyme mediated metabolism of Rebetol. ...
Fertility, pregnancy and lactation
Women of childbearing potential/contraception in males and females Female patients Rebetol must not be used by females who are pregnant (see sections 4.3 and 5.3). Extreme care must be taken to avoid pregnancy ...
Effects on ability to drive and use machines
Rebetol has no or negligible influence on the ability to drive and use machines; however, other medicinal products used in combination may have an effect. Thus, patients who develop fatigue, somnolence, ...
Undesirable effects
Summary of the safety profile The salient safety issue of Rebetol is haemolytic anaemia occurring within the first weeks of therapy. The haemolytic anaemia associated with Rebetol therapy may result in ...
Overdose
In clinical trials with Rebetol used in combination with peginterferon alfa-2b or interferon alfa-2b, the maximum overdose reported was a total dose of 10 g of Rebetol (50 200 mg capsules) and 39 MIU ...
Pharmacodynamic properties
Pharmacotherapeutic group: antivirals for systemic use, antivirals for treatment of HCV infections ATC code: J05AP01 Mechanism of action Ribavirin (Rebetol) is a synthetic nucleoside analogue which has ...
Pharmacokinetic properties
In a single dose, crossover study of ribavirin in healthy adult subjects, the capsule and oral solution formulations were found to be bioequivalent. Absorption Ribavirin is absorbed rapidly following oral ...
Preclinical safety data
Ribavirin Ribavirin is embryotoxic or teratogenic, or both, at doses well below the recommended human dose in all animal species in which studies have been conducted. Malformations of the skull, palate, ...
List of excipients
Capsule contents: Microcrystalline cellulose Lactose monohydrate Croscarmellose sodium Magnesium stearate Capsule shell: Gelatine Titanium dioxide Capsule imprint: Shellac Propylene glycol Ammonium hydroxide ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 2 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
Rebetol capsules are packaged in blisters consisting of polyvinyl chloride (PVC)/polyethylene (PE)/polyvinylidene chloride (PVdC). Packs of 84, 112, 140 and 168 capsules. Not all pack sizes may be marketed. ...
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
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Marketing authorization number(s)
EU/1/99/107/001 84 hard capsules EU/1/99/107/005 112 hard capsules EU/1/99/107/002 140 hard capsules EU/1/99/107/003 168 hard capsules
Date of first authorization / renewal of the authorization
Date of first authorisation: 07 May 1999 Date of latest renewal: 23 April 2009
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