ZELBORAF Film-coated tablet (2020)
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Περιεχόμενα
Name of the medicinal product
Zelboraf 240 mg film-coated tablets.
Qualitative and quantitative composition
Each tablet contains 240 mg of vemurafenib (as a co-precipitate of vemurafenib and hypromellose acetate succinate). For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet (tablet). Pinkish white to orange white, oval, biconvex film-coated tablets of approximately 19 mm, with VEM engraved on one side.
Therapeutic indications
Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma (see section 5.1).
Posology and method of administration
Treatment with vemurafenib should be initiated and supervised by a qualified physician experienced in the use of anticancer medicinal products. Before taking vemurafenib, patients must have BRAF V600 mutation-positive ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Before taking vemurafenib, patients must have BRAF V600 mutation-positive tumour status confirmed by a validated test. The efficacy and safety of vemurafenib in patients with tumours expressing rare BRAF ...
Interaction with other medicinal products and other forms of interaction
Effects of vemurafenib on Drug Metabolizing Enzymes Results from an in vivo drug-drug interaction study in metastatic melanoma patients demonstrated that vemurafenib is a moderate CYP1A2 inhibitor and ...
Fertility, pregnancy and lactation
Women of childbearing potential / Contraception in females Women of childbearing potential have to use effective contraception during treatment and for at least 6 months after treatment. Vemurafenib might ...
Effects on ability to drive and use machines
Vemurafenib has minor influence on the ability to drive and use machines. Patients should be made aware of the potential fatigue or eye problems that could be a reason for not driving.
Undesirable effects
Summary of the safety profile The most common adverse drug reactions (ADR) of any grade (> 30%) reported with vemurafenib include arthralgia, fatigue, rash, photosensitivity reaction, alopecia, nausea ...
Overdose
There is no specific antidote for overdose of vemurafenib. Patients who develop adverse reactions should receive appropriate symptomatic treatment. No cases of overdose have been observed with vemurafenib ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitor ATC code: L01XE15 Mechanism of action and pharmacodynamic effects Vemurafenib is an inhibitor of BRAF serine-threonine kinase. ...
Pharmacokinetic properties
Vemurafenib is a Class IV substance (low solubility and permeability), using the criteria described in the Biopharmaceutics Classification System. The pharmacokinetic parameters for vemurafenib were determined ...
Preclinical safety data
The preclinical safety profile of vemurafenib was assessed in rats, dogs, and rabbits. Repeat-dose toxicology studies identified the liver and bone marrow as target organs in the dog. Reversible toxic ...
List of excipients
Tablet core: Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate Hydroxypropylcellulose Film-coating: Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350 Talc Iron oxide red (E172) ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Store in the original package in order to protect from moisture.
Nature and contents of container
Aluminium/Aluminium perforated unit dose blisters. Pack-size: 56 1 film-coated tablets (7 blisters of 8 1 tablet)
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
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
Marketing authorization number(s)
EU/1/12/751/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 17 February 2012 Date of latest renewal: 22 September 2016
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