VYDURA Oral lyophilisate (2022)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
VYDURA 75 mg oral lyophilisate.
2. Qualitative and quantitative composition
Each oral lyophilisate contains rimegepant sulfate, equivalent to 75 mg rimegepant. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral lyophilisate. The oral lyophilisate is white to off-white, circular, diameter 14 mm and debossed with the symbol
4.1. Therapeutic indications
VYDURA is indicated for the Acute treatment of migraine with or without aura in adults; Preventive treatment of episodic migraine in adults who have at least 4 migraine attacks per month.
4.2. Posology and method of administration
Posology <u>Acute treatment of migraine:</u> The recommended dose is 75 mg rimegepant, as needed, once daily. <u>Prophylaxis of migraine:</u> The recommended dose is 75 mg rimegepant every other day. ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Hypersensitivity reactions, including dyspnoea and rash, have occurred in less than 1% of patients treated with rimegepant in clinical studies (see section 4.8). Hypersensitivity reactions, including serious ...
4.5. Interaction with other medicinal products and other forms of interaction
Rimegepant is a substrate of CYP3A4, P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) efflux transporters (see section 5.2). CYP3A4 inhibitors Inhibitors of CYP3A4 increase plasma concentrations ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are limited data from the use of rimegepant in pregnant women. Animal studies demonstrate that rimegepant is not embryocidal, and no teratogenic potential has been observed at clinically ...
4.7. Effects on ability to drive and use machines
VYDURA has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile The most common adverse reaction was nausea for acute treatment (1.2%) and for migraine prophylaxis (1.4%). Most of the reactions were mild or moderate in severity. Hypersensitivity, ...
4.9. Overdose
There is limited clinical experience with rimegepant overdose. No overdose symptoms have been reported. Treatment of an overdose of rimegepant should consist of general supportive measures including monitoring ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Analgesics, calcitonin gene-related peptide (CGRP) antagonists <b>ATC code:</b> N02CD06 Mechanism of action Rimegepant selectively binds with high affinity to the human ...
5.2. Pharmacokinetic properties
Absorption Following oral administration, rimegepant is absorbed with the maximum concentration at 1.5 hours. Following a supratherapeutic dose of 300 mg, the absolute oral bioavailability of rimegepant ...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for rimegepant in humans based on conventional studies of safety pharmacology, repeat-dose toxicity, genotoxicity, phototoxicity, reproduction or development, ...
6.1. List of excipients
Gelatin Mannitol (E421) Mint flavour Sucralose
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 30°C. Store in the original package in order to protect from moisture.
6.5. Nature and contents of container
Blisters made of polyvinyl chloride (PVC), oriented polyamide (OPA) and aluminium foil and sealed with a peelable aluminum foil (8-count). Unit dose blisters made of polyvinyl chloride (PVC), oriented ...
6.6. Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Biohaven Pharmaceutical Ireland DAC, 6<sup>th</sup> Floor, South Bank House, Barrow Street, Dublin D04 TR29, Ireland
8. Marketing authorization number(s)
EU/1/22/1645/001 EU/1/22/1645/002
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