RYDAPT Soft capsule (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Rydapt 25 mg soft capsules.
Qualitative and quantitative composition
Each soft capsule contains 25 mg midostaurin. Excipients with known effect: Each soft capsule contains approximately 83 mg ethanol anhydrous and 415 mg macrogolglycerol hydroxystearate. For the full list ...
Pharmaceutical form
Soft capsule (capsule). Pale orange, oblong capsule with red imprint PKC NVR. The dimensions of the capsule are approximately 25.4 9.2 mm.
Therapeutic indications
Rydapt is indicated: in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single ...
Posology and method of administration
Treatment with Rydapt should be initiated by a physician experienced in the use of anti-cancer therapies. Before taking midostaurin, AML patients must have confirmation of FLT3 mutation (internal tandem ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Concomitant administration of potent CYP3A4 inducers, e.g. rifampicin, St. Johns Wort (Hypericum perforatum), ...
Special warnings and precautions for use
Neutropenia and infections Neutropenia has occurred in patients receiving Rydapt as monotherapy and in combination with chemotherapy (see section 4.8). Severe neutropenia (ANC <0.5 10<sup>9</sup>/l) was ...
Interaction with other medicinal products and other forms of interaction
Midostaurin undergoes extensive hepatic metabolism mainly through CYP3A4 enzymes which are either induced or inhibited by a number of concomitant medicinal products. Effect of other medicinal products ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential should be informed that animal studies show midostaurin to be harmful to the developing foetus. Sexually active women of childbearing potential ...
Effects on ability to drive and use machines
Rydapt has minor influence on the ability to drive and use machines. Dizziness and vertigo have been reported in patients taking Rydapt and should be considered when assessing a patients ability to drive ...
Undesirable effects
Summary of the safety profile AML The safety evaluation of Rydapt (50 mg twice daily) in patients with newly diagnosed FLT3-mutated AML is based on a phase III, randomised, double-blind, placebo-controlled ...
Overdose
Reported experience with overdose in humans is very limited. Single doses of up to 600 mg have been given with acceptable acute tolerability. Adverse reactions observed were diarrhoea, abdominal pain and ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors ATC code: L01XE39 Mechanism of action Midostaurin inhibits multiple receptor tyrosine kinases, including FLT3 and KIT kinase. ...
Pharmacokinetic properties
Midostaurin is a compound with good absorption and poor solubility. Two of its metabolites demonstrated pharmacological activities (CGP52421 and CGP62221). Following multiple doses, the pharmacokinetics ...
Preclinical safety data
Due to dose-limiting toxicity, clinical therapeutic exposure levels could not be reached in animals. All animal findings described below were observed at midostaurin exposure significantly lower than therapeutic ...
List of excipients
Capsule content: Macrogolglycerol hydroxystearate Macrogol Ethanol anhydrous Maize oil mono-di-triglycerides All-rac-alpha-tocopherol Capsule shell: Gelatin Glycerol Titanium dioxide (E171) Iron oxide ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
This medicinal product does not require any special temperature storage conditions. Store in the original container in order to protect from moisture.
Nature and contents of container
PA/Al/PVC-Al blisters. One blister contains 4 soft capsules. Packs containing 56 (2 packs of 28) or 112 (4 packs of 28) soft capsules. Not all pack sizes may be marketed.
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
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Marketing authorization number(s)
EU/1/17/1218/001-002
Date of first authorization / renewal of the authorization
18 September 2017
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