NEXAVAR Film-coated tablet (2022)
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Περιεχόμενα
Name of the medicinal product
Nexavar 200 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 200 mg of sorafenib (as tosylate). For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet (tablet). Red, round, biconvex film-coated tablets, debossed with Bayer cross on one side and 200 on the other side.
Therapeutic indications
Hepatocellular carcinoma Nexavar is indicated for the treatment of hepatocellular carcinoma (see section 5.1). Renal cell carcinoma Nexavar is indicated for the treatment of patients with advanced renal ...
Posology and method of administration
Nexavar treatment should be supervised by a physician experienced in the use of anticancer therapies. Posology The recommended dose of Nexavar in adults is 400 mg sorafenib (two tablets of 200 mg) twice ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Dermatological toxicities Hand foot skin reaction (palmar-plantar erythrodysaesthesia) and rash represent the most common adverse drug reactions with sorafenib. Rash and hand foot skin reaction are usually ...
Interaction with other medicinal products and other forms of interaction
Inducers of metabolic enzymes Administration of rifampicin for 5 days before administration of a single dose of sorafenib resulted in an average 37% reduction of sorafenib AUC. Other inducers of CYP3A4 ...
Fertility, pregnancy and lactation
Pregnancy There are no data on the use of sorafenib in pregnant women. Studies in animals have shown reproductive toxicity including malformations (see section 5.3). In rats, sorafenib and its metabolites ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. There is no evidence that sorafenib affects the ability to drive or to operate machinery.
Undesirable effects
The most important serious adverse reactions were myocardial infarction/ischaemia, gastrointestinal perforation, drug induced hepatitis, haemorrhage, and hypertension/hypertensive crisis. The most common ...
Overdose
There is no specific treatment for sorafenib overdose. The highest dose of sorafenib studied clinically is 800 mg twice daily. The adverse events observed at this dose were primarily diarrhoea and dermatological ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors ATC code: L01XE05 Sorafenib is a multikinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties ...
Pharmacokinetic properties
Absorption and distribution After administration of sorafenib tablets the mean relative bioavailability is 38-49% when compared to an oral solution. The absolute bioavailability is not known. Following ...
Preclinical safety data
The preclinical safety profile of sorafenib was assessed in mice, rats, dogs and rabbits. Repeat-dose toxicity studies revealed changes (degenerations and regenerations) in various organs at exposures ...
List of excipients
<u>Tablet core:</u> Croscarmellose sodium Microcrystalline cellulose Hypromellose Sodium laurilsulfate Magnesium stearate <u>Tablet coating:</u> Hypromellose Macrogol (3350) Titanium dioxide (E171) Ferric ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
112 film-coated tablets (4 28) in transparent (PP/Aluminium) blister packs.
Special precautions for disposal and other handling
This medicinal product could have potential risk for the environment. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Bayer AG, 51368, Leverkusen, Germany
Marketing authorization number(s)
EU/1/06/342/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 19 July 2006 Date of latest renewal: 21 July 2011
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