ROSICED Cream (2015)
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Περιεχόμενα
Name of the medicinal product
ROSICED 7.5 mg/g Cream.
Qualitative and quantitative composition
1 g of cream contains 7.5 mg of metronidazole (0.75% m/m). For excipients, see 6.1.
Pharmaceutical form
Cream. Smooth white to off-white cream.
Therapeutic indications
For the topical treatment of inflammatory papulo-pustules rosacea related.
Posology and method of administration
Cutaneous use. Adults and elderly Apply and gently rub the cream into the affected skin of the face in a thin film twice daily for a usual duration of treatment of 6 to 12 weeks. If necessary, treatment ...
Contraindications
ROSICED 7.5 mg/g Cream is contraindicated during the first third of pregnancy. ROSICED 7.5 mg/g Cream must not be taken by patients with hypersensitivity to medicinal products containing metronidazole ...
Special warnings and precautions for use
Avoid contact with the eyes or any mucocutaneous application. If contact occurs, the cream should be washed out carefully with water. If irritation does occur the patient should be advised to use Rosiced ...
Interaction with other medicinal products and other forms of interaction
Interactions with other topically applied medicinal products are not known. Interaction with systemic medication is unlikely because absorption of metronidazole following cutaneous application of Rosiced ...
Pregnancy and lactation
The safety of the use of metronidazole during pregnancy is not sufficiently proven. Contradictory reports are available especially regarding early pregnancy. Some studies have yielded indications of an ...
Effects on ability to drive and use machines
Based upon the pharmacodynamic profile and clinical experience performance related to driving and using machines should not to be affected.
Undesirable effects
The following spontaneous adverse experiences have been reported, and within each system organ class, are ranked by frequency, using the following convention: Very common (≥1/10), Common (≥1/100 <1/10), ...
Overdose
Overdose is extremely unlikely. The cream should be removed by washing with warm water. No data exist about overdose in humans. Acute oral toxicity studies with topical gel formulation containing 0.75% ...
Pharmacodynamic properties
Pharmacotherapeutic group: Chemotherapeutics for topical use ATC-code: D06BX01 When applied topically metronidazole is active against the inflammatory aspect of rosacea. Metronidazole belongs to the group ...
Pharmacokinetic properties
The systemic concentration of metronidazole following topical administration of ROSICED 7.5 mg/g Cream to 18 healthy volunteers ranged from 19 ng/ml to 107 ng/ml with a mean C<sub>max</sub> of 49 ng/ml ...
Preclinical safety data
Acute toxicity Acute toxicity was tested in mice in two different routes of administration. If administered orally, the LD<sub>50</sub> values were 3 800 mg/kg body weight and if administered intraperitoneally ...
List of excipients
Glyceryl monolaurate Glyceryl monomyristate Propylene glycol Citric acid anhydrous (pH adjuster) Sodium hydroxide (pH adjuster) Carbomers Purified water
Incompatibilities
Not applicable.
Shelf life
24 months. After first opening: 8 weeks.
Special precautions for storage
Do not store above 30°C. Do not refrigerate or freeze.
Nature and contents of container
MDPE tubes fitted with polypropylene caps containing 25 g, 30 g, 40 g or 50 g of cream. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Pierre Fabre Dermatologie, 45 place Abel Gance, 92100 Boulogne, France
Marketing authorization number(s)
PL 20693/0007
Date of first authorization / renewal of the authorization
Date of first authorisation: 05/12/2001 Date of renewal: 06/06/2007
Date of revision of the text
25/03/2015
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