COTELLIC Film-coated tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Cotellic 20 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains cobimetinib hemifumarate equivalent to 20 mg cobimetinib. Excipient with known effect: Each film-coated tablet contains 36 mg lactose monohydrate. For the full list of ...
Pharmaceutical form
Film-coated tablet. White, round film-coated tablets of approximately 6.6 mm diameter, with COB debossed on one side.
Therapeutic indications
Cotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).
Posology and method of administration
Treatment with Cotellic in combination with vemurafenib should only be initiated and supervised by a qualified physician experienced in the use of anticancer medicinal products. Before starting this treatment, ...
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 Cotellic in combination with vemurafenib, patients must have BRAF V600 mutationpositive tumour status confirmed by a validated test. Cotellic in combination with vemurafenib in patients who ...
Interaction with other medicinal products and other forms of interaction
Effects of other medicinal products on cobimetinib CYP3A inhibitors Cobimetinib is metabolized by CYP3A and cobimetinib AUC increased approximately 7 fold in the presence of a strong CYP3A inhibitor (itraconazole) ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential should be advised to use two effective contraceptive methods, such as a condom or other barrier method (with spermicide, if available) during ...
Effects on ability to drive and use machines
Cotellic has minor influence on the ability to drive or use machines. Visual disturbances have been reported in some patients treated with cobimetinib during clinical trials (see sections 4.4 and 4.8). ...
Undesirable effects
Summary of the safety profile The safety of Cotellic in combination with vemurafenib has been evaluated in 247 patients with advanced BRAF V600 mutated melanoma in Study GO28141.The median time to onset ...
Overdose
There is no experience with overdose in human clinical trials. In case of suspected overdose, cobimetinib should be withheld and supportive care instituted. There is no specific antidote for overdosage ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents ATC code: L01XE38 Mechanism of action Cobimetinib is a reversible, selective, allosteric, oral inhibitor that blocks the mitogen-activated protein kinase ...
Pharmacokinetic properties
Absorption Following oral dosing of 60 mg in cancer patients, cobimetinib showed a moderate rate of absorption with a median T<sub>max</sub> of 2.4 hours. The mean steady-state C<sub>max</sub> and AUC ...
Preclinical safety data
Carcinogenicity studies have not been conducted with cobimetinib. Standard genotoxicity studies with cobimetinib were negative. No dedicated fertility studies in animals have been performed with cobimetinib. ...
List of excipients
Tablet core: Lactose monohydrate Microcrystalline cellulose (E460) Croscarmellose sodium (E468) Magnesium stearate (E470b) Film coating: Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350 Talc (E553b) ...
Incompatibilities
Not applicable.
Shelf life
5 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Transparent PVC/PVDC blisters containing 21 tablets. Each pack contains 63 tablets.
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/1/15/1048/001
Date of first authorization / renewal of the authorization
20 November 2015
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