LUTIGEST Vaginal tablet (2014)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Lutigest 100 mg vaginal tablets.
Qualitative and quantitative composition
1 vaginal tablet contains 100 mg progesterone. Excipient with known effect: 1 vaginal tablet contains approximately 760 mg lactose monohydrate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Vaginal tablet. White to off-white flat and oval tablet with the inscriptions FPI on one side and 100 on the other side. The vaginal tablets are supplied with one polyethylene vaginal applicator.
Therapeutic indications
Lutigest is indicated for luteal support as part of an Assisted Reproductive Technology (ART) treatment program for infertile women.
Posology and method of administration
Posology Adults The dose of Lutigest is 100 mg administered vaginally three times daily starting at oocyte retrieval. The administration of Lutigest should be continued for 30 days, if pregnancy has been ...
Contraindications
Lutigest should not be used in individuals with any of the following conditions: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Undiagnosed vaginal bleeding ...
Special warnings and precautions for use
Lutigest should be discontinued if any of the following conditions are suspected: myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism (venous thromboembolism or pulmonary ...
Interaction with other medicinal products and other forms of interaction
Drugs known to induce the hepatic cytochrome-P450-3A4 system (e.g. rifampicin, carbamazepine or St. Johns wort (Hypericum perforatum)-containing herbal products) may increase the elimination rate and thereby ...
Fertility, pregnancy and lactation
Pregnancy Lutigest vaginal tablets are only indicated during the first trimester of pregnancy for use as part of an assisted reproduction (ART) regimen. There is yet limited and inconclusive data on the ...
Effects on ability to drive and use machines
Lutigest has minor or moderate influence on the ability to drive and use machines. Progesterone may cause drowsiness and/or dizziness; therefore caution is advised in drivers and users of machines.
Undesirable effects
The most frequently reported adverse drug reactions during treatment with Lutigest in IVF patients during clinical trials are headache, vulvovaginal disorders and uterine spasm, reported in 1.5%, 1.5% ...
Overdose
High doses of progesterone may cause drowsiness. Treatment of overdosage consists of discontinuation of Lutigest together with institution of appropriate symptomatic and supportive care.
Pharmacodynamic properties
Pharmacotherapeutic group: Sex hormones and modulators of the genital system; Progestogens; Pregnen-(4) derivatives ATC code: G03DA04 Mechanism of action Progesterone is a naturally occurring steroid that ...
Pharmacokinetic properties
Absorption Progesterone serum concentrations increased following the administration of the Lutigest vaginal tablets in 12 healthy premenopausal females. On day 1 of treatment, the mean C<sub>max</sub> ...
Preclinical safety data
Progesterone is a well known natural reproductive steroidal hormone in humans and animals, with no known toxicological effects. Therefore no toxicity studies have been performed with this progesterone ...
List of excipients
Silica, hydrophobic colloidal Lactose monohydrate Pregelatiniszed maize starch Povidone K29/32 Adipic acid Sodium hydrogen carbonate Sodium laurilsulfate Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Store in the original container in order to protect from light. This medicinal product does not require any special temperature storage conditions.
Nature and contents of container
Alu/Alu blisters of 3 vaginal tablets. The blisters are available in cartons with 21 or 90 vaginal tablets with 1 vaginal applicator. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom
Marketing authorization number(s)
PL 03194/0103
Date of first authorization / renewal of the authorization
19/11/2009
Date of revision of the text
October 2014
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