FOTIVDA Hard capsule (2019)
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Περιεχόμενα
Name of the medicinal product
Fotivda 890 microgram hard capsules. Fotivda 1340 microgram hard capsules.
Qualitative and quantitative composition
Fotivda 890 microgram hard capsules: Each hard capsule contains tivozanib hydrochloride monohydrate equivalent to 890 microgram tivozanib. Excipients with known effect: Each hard capsule contains trace ...
Pharmaceutical form
Hard capsule. Fotivda 890 microgram hard capsules: Hard capsule with dark blue opaque cap and bright yellow opaque body, printed with yellow ink TIVZ on the cap and with dark blue ink LD on the body. ...
Therapeutic indications
Fotivda is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression ...
Posology and method of administration
Fotivda should be supervised by a physician experienced in the use of anticancer therapies. Posology The recommended dose of tivozanib is 1340 microgram once daily for 21 days, followed by a 7-day rest ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Co-administration with herbal preparations containing St. Johns wort (Hypericum perforatum) (see section 4.5). ...
Special warnings and precautions for use
Hypertension In clinical studies with tivozanib, hypertension (including persistent severe hypertension) has occurred (see section 4.8). In approximately one-third of the patients, hypertension developed ...
Interaction with other medicinal products and other forms of interaction
Contraindication of concomitant use Herbal preparations containing St. Johns wort (Hypericum perforatum) are contraindicated. If a patient is already taking St Johns wort, this should be stopped before ...
Fertility, pregnancy and lactation
Women of childbearing potential/contraception in males and females Women of childbearing potential should avoid becoming pregnant while on tivozanib. Female partners of male patients taking tivozanib should ...
Effects on ability to drive and use machines
Tivozanib may have a minor influence on the ability to drive and use machines. Patients should be advised to be cautious when driving or using machines if they experience asthenia, fatigue, and/or dizziness ...
Undesirable effects
Summary of the safety profile Pooled data of 674 patients with advanced RCC who continued to receive tivozanib as their initial on trial therapy in the five core RCC monotherapy studies have been evaluated ...
Overdose
Two patients received excessive doses of tivozanib during the monotherapy studies. A patient with a history of hypertension experienced aggravated uncontrolled hypertension that was fatal after taking ...
Pharmacodynamic properties
Pharmacotherapeutic group: antineoplastic agents, protein-kinase inhibitors ATC code: L01XE34 Mechanism of action Tivozanib potently and selectively blocks all 3 Vascular Endothelial Growth Factor receptors ...
Pharmacokinetic properties
Absorption Following oral administration of tivozanib, peak serum levels are achieved after approximately 2 to 24 hours. After a single 1340 microgram dose, mean C<sub>max</sub> was 10.2 to 25.2 ng/mL ...
Preclinical safety data
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows. In repeat-dose ...
List of excipients
Fotivda 890 microgram hard capsules Capsule content: Mannitol Magnesium stearate Capsule shell: Gelatin Titanium dioxide (E171) Indigo carmine (E132) Yellow iron oxide (E172) Printing ink (yellow): Shellac ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 5 years.
Special precautions for storage
Keep the bottle tightly closed in order to protect from moisture.
Nature and contents of container
White HDPE bottle with a child resistant closure containing 21 hard capsules. Each pack contains 1 bottle.
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
EUSA Pharma (Netherlands) B.V., Johannes Vermeerplein 11, 1071 DV, Amsterdam, Netherlands
Marketing authorization number(s)
Fotivda 890 microgram hard capsules: EU/1/17/1215/001 Fotivda 1340 microgram hard capsules: EU/1/17/1215/002
Date of first authorization / renewal of the authorization
24/08/2017
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