VANIQA Cream (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Vaniqa 11.5% cream.
Qualitative and quantitative composition
Each gram of cream contains 115 mg of eflornithine (as hydrochloride monohydrate). Excipients with known effect: Each gram of cream contains 47.2 mg of cetostearyl alcohol, 14.2 mg of stearyl alcohol, ...
Pharmaceutical form
Cream. White to off white cream.
Therapeutic indications
Treatment of facial hirsutism in women.
Posology and method of administration
Posology Vaniqa cream should be applied to the affected area twice daily, at least eight hours apart. Efficacy has only been demonstrated for affected areas of the face and under the chin. Application ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Excessive hair growth can result from serious underlying disorders (e.g. polycystic ovary syndrome, androgen secreting neoplasm) or certain active substances (e.g. cyclosporin, glucocorticoids, minoxidil, ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Pregnancy and lactation
Pregnancy Throughout clinical trials data from a limited number of exposed pregnancies (22) indicate that there is no clinical evidence that treatment with Vaniqa adversely affects mothers or foetuses. ...
Effects on ability to drive and use machines
Vaniqa has no or negligible influence on the ability to drive and use machines.
Undesirable effects
The mostly skin related adverse reactions reported were primarily mild in intensity and resolved without discontinuation of Vaniqa or initiation of medical treatment. The most frequently reported adverse ...
Overdose
Given the minimal cutaneous penetration of eflornithine (see section 5.2), overdose is highly unlikely. However, should very high dose cutaneous administration or accidental oral ingestion occur, attention ...
Pharmacodynamic properties
Pharmacotherapeutic group: other dermatological preparations ATC code: D11AX16 Mechanism of action Eflornithine irreversibly inhibits ornithine decarboxylase, an enzyme involved in the production of the ...
Pharmacokinetic properties
Steady state cutaneous penetration of eflornithine in women from Vaniqa on facial skin of shaving women was 0.8%. The steady state plasma half-life of eflornithine was approximately 8 hours. Steady state ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of repeat dose toxicity, genotoxicity and carcinogenic potential, including one photocarcinogenicity study in mice. In ...
List of excipients
Cetostearyl alcohol Macrogol cetostearyl ether Dimeticone Glyceryl stearate Macrogol stearate Methyl parahydroxybenzoate (E218) Liquid paraffin Phenoxyethanol Propyl parahydroxybenzoate (E216) Purified ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years. Shelf-life after first opening: 6 months.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
High density polyethylene tube with a polypropylene screw cap containing 15 g, 30 g or 60 g of cream. 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
Almirall, S.A., Ronda General Mitre, 151, 08022, Barcelona, Spain
Marketing authorization number(s)
EU/1/01/173/001-003
Date of first authorization / renewal of the authorization
Date of first authorisation: 20 March 2001 Date of latest renewal: 07 March 2011
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