RASAGLININE MYLAN Tablets (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Rasagiline Mylan 1 mg tablets.
Qualitative and quantitative composition
Each tablet contains rasagiline tartrate corresponding to 1 mg rasagiline. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. White to off-white, oblong (approximately 11.5 mm x 6 mm) biconvex tablets, debossed with R9SE on one side and 1 on the other side.
Therapeutic indications
Rasagiline Mylan is indicated for the treatment of idiopathic Parkinsons disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations. ...
Posology and method of administration
Posology Rasagiline is administered orally, at a dose of 1 mg once daily with or without levodopa. Elderly No change in dose is required for elderly patients. Hepatic impairment Rasagiline use in patients ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients (listed in section 6.1). Concomitant treatment with other monoamine oxidase (MAO) inhibitors (including medicinal and natural products ...
Special warnings and precautions for use
The concomitant use of rasagiline and fluoxetine or fluvoxamine should be avoided (see section 4.5). At least five weeks should elapse between discontinuation of fluoxetine and initiation of treatment ...
Interaction with other medicinal products and other forms of interaction
There are a number of known interactions between non-selective MAO inhibitors and other medicinal products. Rasagiline must not be administered along with other MAO inhibitors (including medicinal and ...
Pregnancy and lactation
Pregnancy For rasagiline no clinical data on exposed pregnancies is available. Animals studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Patients should be cautioned about operating hazardous machines, including motor vehicles, until they are reasonably ...
Undesirable effects
Summary of the safety profile In the rasagiline clinical program overall, 1,361 patients were treated with rasagiline for 3,076.4 patient years. In the double blind placebo-controlled studies, 529 patients ...
Overdose
Symptoms Symptoms reported following overdose of rasagiline in doses ranging from 3 mg to 100 mg included dysphoria, hypomania, hypertensive crisis and serotonin syndrome. Overdose can be associated with ...
Pharmacodynamic properties
Pharmacotherapeutic group: Anti-Parkinson drugs, Monoamine oxidase-B inhibitors ATC code: N04BD02 Mechanism of action Rasagiline was shown to be a potent, irreversible MAO-B selective inhibitor, which ...
Pharmacokinetic properties
Absorption Rasagiline is rapidly absorbed, reaching peak plasma concentration (C<sub>max</sub>) in approximately 0.5 hours. The absolute bioavailability of a single rasagiline dose is about 36%. Food does ...
Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity and reproduction toxicity. Rasagiline did not present genotoxic potential ...
List of excipients
Cellulose, microcrystalline Tartaric acid Maize starch Starch, pregelatinised maize Talc Stearic acid
Incompatibilities
Not applicable.
Shelf life
Shelf life: 30 months.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
oPA/Al/PVC/Al. Blister packs of 7, 10, 28, 30, 100 or 112 tablets. PVC/PVDC/Al. Blister packs of 7, 10, 28, 30, 100 or 112 tablets. PVC/PVDC/Al. Perforated unit dose blister packs of 7 1, 10 1, 28 1, ...
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Mylan S.A.S., 117, Allée des Parcs, 69800 Saint-Priest, France
Marketing authorization number(s)
EU/1/16/1090/001 (7 tablets oPA/alu/PVC/alu) EU/1/16/1090/002 (10 tablets oPA/alu/PVC/alu) EU/1/16/1090/003 (28 tablets oPA/alu/PVC/alu) EU/1/16/1090/004 (30 tablets oPA/alu/PVC/alu) EU/1/16/1090/005 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 4 April 2016
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