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ROSICED Cream (2015)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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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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