MAXALT Tablet (2018)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
MAXALT 5 mg Tablets. MAXALT 10 mg Tablets.
Qualitative and quantitative composition
MAXALT 5 mg Tablets Each tablet contains 7.265 mg of rizatriptan benzoate (corresponding to 5 mg of the rizatriptan). Excipient(s) with known effect: Lactose monohydrate 30.25 mg in the 5 mg tablet. MAXALT ...
Pharmaceutical form
Tablet. <u>MAXALT 5 mg tablets:</u> 5 mg tablets are pale pink, capsule shaped, coded MSD on one side and 266 on the other. <u>MAXALT 10 mg tablets:</u> 10 mg tablets are pale pink, capsule-shaped, coded ...
Therapeutic indications
Acute treatment of the headache phase of migraine attacks with or without aura in adults.
Posology and method of administration
Method of administration MAXALT should not be used prophylactically. The oral tablets should be swallowed whole with liquid. Effect of Food The absorption of rizatriptan is delayed by approximately 1 hour ...
Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Concurrent administration of monoamine oxidase (MAO) inhibitors or use within two weeks of discontinuation ...
Special warnings and precautions for use
MAXALT should only be administered to patients in whom a clear diagnosis of migraine has been established. MAXALT should not be administered to patients with basilar or hemiplegic migraine. MAXALT should ...
Interaction with other medicinal products and other forms of interaction
Ergotamine, ergot derivatives (including methysergide), other 5-HT<sub>1B/1D</sub> receptor agonists Due to an additive effect, the concomitant use of rizatriptan and ergotamine, ergot derivatives (including ...
Fertility, pregnancy and lactation
Fertility Effects on human fertility have not been investigated. Animal studies only revealed minimal effects on fertility at plasma concentrations far in excess of human therapeutic concentrations (more ...
Effects on ability to drive and use machines
Migraine or treatment with MAXALT may cause somnolence in some patients. Dizziness has also been reported in some patients receiving MAXALT. Patients should, therefore, evaluate their ability to perform ...
Undesirable effects
MAXALT (as the tablet and oral lyophilisate formulation) was evaluated in 8630 adult patients for up to one year in controlled clinical studies. The most common side effects evaluated in clinical studies ...
Overdose
Rizatriptan 40 mg (administered as either a single dose or as two doses with a two-hour interdose interval) was generally well tolerated in over 300 adult patients; dizziness and somnolence were the most ...
Pharmacodynamic properties
Pharmacotherapeutic group: antimigraine preparations, selective serotonin (5HT<sub>1</sub>) agonist ATC-code: N02CC04 Mechanism of action: Selective Serotonin (5-HT<sub>1B/1D</sub>) agonists Rizatriptan ...
Pharmacokinetic properties
Absorption Rizatriptan is rapidly and completely absorbed following oral administration. The mean oral bioavailability of the tablet is approximately 40-45%, and mean peak plasma concentrations (C<sub> ...
Preclinical safety data
Preclinical data indicate no risk for humans based on conventional studies of repeat dose toxicity, genotoxicity, carcinogenic potential, reproductive and developmental toxicity, safety pharmacology, and ...
List of excipients
Lactose monohydrate Microcrystalline cellulose (E460a) Starch, pregelatinised Iron oxide red (E172) Magnesium stearate (E572)
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
All aluminium blister push through, packs of 2, 3, 6, 12 or 18 tablets. 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
Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK
Marketing authorization number(s)
Tablet 5 mg: PL 00025/0369 Tablet 10 mg: PL 00025/0370
Date of first authorization / renewal of the authorization
Date of first authorisation: June 1998 Date of latest renewal: 12 May 2014
Date of revision of the text
06 July 2018
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
