YENTREVE Hard gastro-resistant capsule (2019)
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Περιεχόμενα
Name of the medicinal product
YENTREVE 20 mg hard gastro-resistant capsules.
Qualitative and quantitative composition
Each capsule contains 20 mg of duloxetine (as hydrochloride). Excipient(s) with known effect: Each capsule may contain up to 37 mg sucrose. For the full list of excipients, see section 6.1.
Pharmaceutical form
Hard gastro-resistant capsule. Opaque blue body, imprinted with 20 mg and an opaque blue cap, imprinted with 9544.
Therapeutic indications
YENTREVE is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI). YENTREVE is indicated in adults. For further information see section 5.1.
Posology and method of administration
Posology The recommended dose of YENTREVE is 40 mg twice daily without regard to meals. After 2-4 weeks of treatment, patients should be re-assessed in order to evaluate the benefit and tolerability of ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Liver disease resulting in hepatic impairment (see section 5.2). YENTREVE should not be used in combination with ...
Special warnings and precautions for use
Mania and seizures YENTREVE should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/or seizures. Serotonin syndrome As with other serotonergic agents, serotonin ...
Interaction with other medicinal products and other forms of interaction
Monoamine oxidase inhibitors (MAOIs) Due to the risk of serotonin syndrome, duloxetine should not be used in combination with non-selective irreversible monoamine oxidase inhibitors (MAOIs), or within ...
Fertility, pregnancy and lactation
Fertility Duloxetine had no effect on male fertility, and effects in females were only evident at doses that caused maternal toxicity. Pregnancy There are no adequate data on the use of duloxetine in pregnant ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. YENTREVE may be associated with sedation and dizziness. Patients should be instructed that if they experience sedation ...
Undesirable effects
Summary of the safety profile The most commonly reported adverse events in patients treated with YENTREVE in clinical trials in SUI and other lower urinary tract disorders were nausea, dry mouth fatigue ...
Overdose
Cases of overdoses, alone or in combination with other medicinal products, with duloxetine doses of 5400 mg were reported. Some fatalities have occurred, primarily with mixed overdoses, but also with duloxetine ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other antidepressants ATC code: N06AX21 Mechanism of action Duloxetine is a combined serotonin (5-HT) and noradrenaline (NA) reuptake inhibitor. It weakly inhibits dopamine reuptake ...
Pharmacokinetic properties
Duloxetine is administered as a single enantiomer. Duloxetine is extensively metabolised by oxidative enzymes (CYP1A2 and the polymorphic CYP2D6), followed by conjugation. The pharmacokinetics of duloxetine ...
Preclinical safety data
Duloxetine was not genotoxic in a standard battery of tests and was not carcinogenic in rats. Multinucleated cells were seen in the liver in the absence of other histopathological changes in the rat carcinogenicity ...
List of excipients
Capsule content: Hypromellose Hypromellose acetate succinate Sucrose Sugar spheres Talc Titanium dioxide (E171) Triethyl citrate Capsule shell: Gelatin Sodium lauryl sulfate Titanium dioxide (E171) Indigo ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Store in the original package in order to protect from moisture. Do not store above 30°C.
Nature and contents of container
Polyvinylchloride (PVC), polyethylene (PE), and polychlorotrifluoroethylene (PCTFE) blister sealed with an aluminium foil. Packs of 28, 56 and 98 capsules. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Marketing authorization number(s)
EU/1/04/280/001 EU/1/04/280/007 EU/1/04/280/008
Date of first authorization / renewal of the authorization
Date of first authorisation: 11 August 2004 Date of latest renewal: 24 June 2009
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