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SPC: VOTRIENT Film-coated tablets (2020)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα

Name of the medicinal product

Votrient 200 mg film-coated tablets. Votrient 400 mg film-coated tablets.

Qualitative and quantitative composition

Votrient 200 mg film-coated tablets: Each film-coated tablet contains 200 mg pazopanib (as hydrochloride). Votrient 400 mg film-coated tablets: Each film-coated tablet contains 400 mg pazopanib (as hydrochloride). ...

Pharmaceutical form

Film-coated tablet. Votrient 200 mg film-coated tablets: Capsule-shaped, pink, film-coated tablet with GS JT debossed on one side. Votrient 400 mg film-coated tablets: Capsule-shaped, white, film-coated ...

Therapeutic indications

Renal cell carcinoma (RCC) Votrient is indicated in adults for the first-line treatment of advanced renal cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease. ...

Posology and method of administration

Votrient treatment should only be initiated by a physician experienced in the administration of anti-cancer medicinal products. Posology Adults The recommended dose of pazopanib for the treatment of RCC ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Hepatic effects Cases of hepatic failure (including fatalities) have been reported during use of pazopanib. Administration of pazopanib to patients with mild or moderate hepatic impairment should be undertaken ...

Interaction with other medicinal products and other forms of interaction

Effects of other medicinal products on pazopanib In vitro studies suggested that the oxidative metabolism of pazopanib in human liver microsomes is mediated primarily by CYP3A4, with minor contributions ...

Pregnancy and lactation

Pregnancy/Contraception in males and females There are no adequate data from the use of pazopanib in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential ...

Effects on ability to drive and use machines

Votrient has no or negligible influence on the ability to drive and use machines. A detrimental effect on such activities cannot be predicted from the pharmacology of pazopanib. The clinical status of ...

Undesirable effects

Summary of the safety profile Pooled data from the pivotal RCC study (VEG105192, n=290), the extension study (VEG107769, n=71), the supportive Phase II study (VEG102616, n=225) and the randomised, open-label, ...

Overdose

Pazopanib doses up to 2000 mg have been evaluated in clinical studies. Grade 3 fatigue (dose-limiting toxicity) and Grade 3 hypertension were each observed in 1 of 3 patients dosed at 2000 mg and 1000 ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, protein kinase inhibitors ATC code: L01XE11 Mechanism of action Pazopanib is an orally administered, potent multi-target tyrosine ...

Pharmacokinetic properties

Absorption Upon oral administration of a single pazopanib 800 mg dose to patients with solid tumours, maximum plasma concentration (C<sub>max</sub>) of approximately 19 ± 13 μg/ml was obtained after median ...

Preclinical safety data

The preclinical safety profile of pazopanib was assessed in mice, rats, rabbits and monkeys. In repeat dose studies in rodents, effects in a variety of tissues (bone, teeth, nail beds, reproductive organs, ...

List of excipients

Votrient 200 mg film-coated tablets: Tablet core: Magnesium stearate Microcrystalline cellulose Povidone (K30) Sodium starch glycolate Tablet coating: Hypromellose Iron oxide red (E172) Macrogol 400 Polysorbate ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 2 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Votrient 200 mg film-coated tablets: HDPE bottles with polypropylene child resistant closures containing either 30 or 90 tablets. Votrient 400 mg film-coated tablets: HDPE bottles with polypropylene child ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization number(s)

Votrient 200 mg film-coated tablets: EU/1/10/628/001 EU/1/10/628/002 Votrient 400 mg film-coated tablets: EU/1/10/628/003 EU/1/10/628/004

Date of first authorization / renewal of the authorization

Date of first authorisation: 14 June 2010 Date of latest renewal: 08 January 2018

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση: