CANESPOR Cream (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Canespor 10 mg/g Cream.
2. Qualitative and quantitative composition
Contains bifonazole 1% w/w. 1 g of cream contains 10 mg bifonazole. <u>Excipient(s) with known effect:</u> Cetostearyl alcohol 100 mg/g Benzyl alcohol 20mg/g For the full list of excipients, see section ...
3. Pharmaceutical form
Cream. White cream.
4.1. Therapeutic indications
Canespor 10mg/g Cream is indicated in adults for the treatment of tinea pedis including treatment of an exposed nailbed following keratolytic removal of the nail.
4.2. Posology and method of administration
Posology To achieve a lasting cure, treatment with Canespor Cream must be carried out reliably and over an adequate period. The usual periods of treatment are summarized in the table below: Indication ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Patients with a history of hypersensitivity reactions to other imidazole antifungal agents (e.g. econazole, clotrimazole, miconazole) must take bifonazole containing products with caution. Antimycotic ...
4.5. Interaction with other medicinal products and other forms of interaction
Limited data suggest that an interaction between topical bifonazole and warfarin may be possible, leading to increases in INR. If Canespor Cream is used in a patient on anticoagulant therapy, such as warfarin, ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of bifonazole in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Canespor cream is not recommended during ...
4.7. Effects on ability to drive and use machines
Canespor Cream has no or negligible influence on the ability to drive or use machines.
4.8. Undesirable effects
Frequencies of side-effects observed in clinical studies are defined according to the MedDRA frequency convention: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, ...
4.9. Overdose
Absorption of orally administered imidazole antimycotics may lead to systemic toxicity. Studies with bifonazole suggest a low level of absorption after topical application to healthy skin. The preparation ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antifungals for topical use imidazole and triazole derivatives <b>ATC code:</b> D01AC10 Bifonazole is an imidazole derivative which is active against fungi such as dermatophytes. ...
5.2. Pharmacokinetic properties
Absorption Bifonazole penetrates well into infected skin layers. 6 hours after administration concentrations in the various skin layers reach from 1000 µg/cm<sup>3</sup> in the top layer of the epidermis ...
5.3. Preclinical safety data
Preclinical data reveal no special hazards for humans based on conventional studies of single dose toxicity and genotoxicity. Effects on the liver (enzyme induction, fatty degeneration) were observed in ...
6.1. List of excipients
Benzyl alcohol Cetostearyl alcohol Cetyl palmitate Octyldodecanol Polysorbate 60 Purified water Sorbitan stearate
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years. After opening, Canespor Cream can be used for up to 16 months.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
Aluminium tube with inner lacquer (epoxy phenolic resin) and polyethylene (PE) screw cap. A membrane is also included to guarantee the first opening of the tube. Pack sizes of 20 g or 30 g. Not all pack ...
6.6. Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Bayer Limited, The Atrium, Blackthorn Road, Dublin 18, Ireland
8. Marketing authorization number(s)
PA1410/083/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 9th March 2018
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