BENZAC AC Gel (2018)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
1. Name of the medicinal product
BENZAC AC Gel.
2. Qualitative and quantitative composition
Benzoyl peroxide 25 mg/g, 50mg/g and 100 mg/g.
3. Pharmaceutical form
BENZAC AC Gel contains benzoyl peroxide 25mg/g or 50mg/g or 100mg/g in a white to off-white smooth gel.
4.1. Therapeutic indications
As an aid in the treatment of mild to moderate acne vulgaris.
4.2. Posology and method of administration
Wash and dry affected areas. Apply the gel in a thin layer to cover the affected areas once daily, leaving on the skin for 2 hours then wash off with water. After three days if no discomfort is felt, apply ...
4.3. Contraindications
BENZAC AC Gel is contraindicated in patients with a history of hypersensitivity to any of its ingredients.
4.4. Special warnings and precautions for use
For external use only. A mild burning sensation will probably be felt on first application and some reddening and peeling of the skin will occur within a few days. During the first weeks of treatment a ...
4.5. Interaction with other medicinal products and other forms of interaction
There are no known interactions with other medications which might be used cutaneously and concurrently with BENZAC AC Gel, however drugs with desquamative, irritant and drying effects should not be used ...
4.6. Fertility, Pregnancy and lactation
There is no safety concern relating to the effects of cutaneously applied benzoyl peroxide on reproductive function, fertility, teratogenicity, embryotoxicity, or peri- and post- natal development from ...
4.7. Effects on ability to drive and use machines
BENZAC AC Gel has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
The adverse reactions resulting from clinical trials are all skin disorders. They are reversible when treatment is reduced in frequency or discontinued. The following categories are used to indicate the ...
4.9. Overdose
If the medication is applied excessively, no more rapid or better results will be obtained and severe irritation might develop. In this event treatment must be discontinued and appropriate symptomatic ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Anti-acne preparations for topical use <b>ATC Code:</b> D10AE01 Benzoyl peroxide has been shown to have potent broad spectrum antimicrobial activity, particularly against ...
5.2. Pharmacokinetic properties
The percutaneous penetration of benzoyl peroxide in rat, rabbit, monkey and man is low. The majority of the penetrated benzoyl peroxide is converted into benzoic acid which after absorption into the systemic ...
5.3. Preclinical safety data
In animal studies by the cutaneous route, benzoyl peroxide is associated with a minimal to moderate skin irritation potential including erythema and oedema. Phototoxic and photoallergic reactions have ...
6.1. List of excipients
Docusate sodium, disodium edetate, poloxamer 182, carbomer 940, propylene glycol, acrylates copolymer, glycerol, purified water, citric acid and/or sodium hydroxide.
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
24 months.
6.4. Special precautions for storage
Store below 25°C.
6.5. Nature and contents of container
50g plastic tube contained in a carton for each strength.
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
Sponsor and distributor in New Zealand: Healthcare Logistics, 58 Richard Pearse Drive, Airport Oaks, Auckland, New Zealand, Ph (09) 918 5100, Fax (09) 918 5101 For: Galderma Australia Pty Ltd, Suite 4, ...
9. Date of first authorization / renewal of the authorization
6 June 1996
10. Date of revision of the text
19 November 2018
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