ZINDACLIN Gel (2014)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Zindaclin 1% Gel.
2. Qualitative and quantitative composition
1g of gel contains 10mg clindamycin (1% w/w) equivalent to 11.88 mg clindamycin phosphate. Zindaclin 1% Gel also contains 40% w/w propylene glycol. For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Gel. A white translucent gel.
4.1. Therapeutic indications
Zindaclin is indicated for the treatment of mild to moderate acne vulgaris.
4.2. Posology and method of administration
Adults and adolescents Apply a thin film of Zindaclin once daily to the affected area. Patient response should be reviewed after 6-8 weeks of treatment and the duration of treatment should be limited to ...
4.3. Contraindications
Zindaclin is contra-indicated in patients with a hypersensitivity to the active substance clindamycin or to any of the excipients in the medicinal product. Although cross-sensitisation to lincomycin has ...
4.4. Special warnings and precautions for use
Oral and parenteral clindamycin, as well as most other antibiotics, have been associated with severe pseudomembranous colitis. Topical clindamycin has very rarely been associated with pseudomembranous ...
4.5. Interaction with other medicinal products and other forms of interaction
<em>In vitro</em>, antagonism has been demonstrated between erythromycin and clindamycin, synergy has been shown with metronidazole and both antagonistic and synergistic effects have been observed with ...
4.6. Pregnancy and lactation
For clindamycin applied cutaneously no clinical data on exposed pregnancies are available. Data on a limited number of pregnancies exposed to clindamycin administered by other routes indicate no adverse ...
4.7. Effects on ability to drive and use machines
Not relevant.
4.8. Undesirable effects
Approximately 10% of patients can be expected to experience an adverse reaction. These reactions are typical of irritant dermatitis. The incidence of these is likely to increase if an excess of gel is ...
4.9. Overdose
It is not expected that overdose would occur in normal use. Irritant dermatitis may occur when excessive quantities of Zindaclin are applied. The use of a suitable moisturiser may be of benefit in these ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Anti-infectives for treatment of acne <b>ATC code:</b> D10AF01 Zindaclin contains clindamycin phosphate which is hydrolysed in the skin to the active constituent clindamycin. ...
5.2. Pharmacokinetic properties
The Zindaclin formulation results in a reduction in the extent of systemic absorption of clindamycin. An in vitro study with Zindaclin with normal human skin has shown the in vitro absorption of radiolabelled ...
5.3. Preclinical safety data
Preclinical data for clindamycin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or toxicity to reproduction.
6.1. List of excipients
Propylene glycol Purified water Ethanol 96% Zinc acetate dihydrate Hydroxyethylcellulose Sodium hydroxide 30% (w/w)
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
No special precautions for storage.
6.5. Nature and contents of container
Zindaclin is packaged in 15g, 30g, 60g laminate tubes with a high-density polyethylene inner layer and a peelable membrane laminate seal covering the orifice. The tube is fitted with a white opaque polypropylene ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Crawford Healthcare Ltd, Kind Edward Court, Kind Edward Road, Knutsford, Cheshire, WA16 0BE, United Kingdom
8. Marketing authorization number(s)
PA 1098/001/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 22 November 2002 Date of last renewal: 16 August 2006
10. Date of revision of the text
May 2014
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