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RASAGLININE MYLAN Tablets (2019)

Αναφορές

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

Πηγαίο έγγραφο

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