METROSA Gel (2020)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Metrosa 0.75% Gel.

2. Qualitative and quantitative composition

1 g of gel contains 7.5 mg Metronidazole. Excipient with known effect: propylene glycol. This medicine contains 30 mg propylene glycol in 1 g gel (which is equivalent to 50 mg per application). ...

3. Pharmaceutical form

Gel. A smooth clear to turbid colourless to faintly yellow gel.

4.1. Therapeutic indications

For the topical treatment of Rosacea (inflammatory papulopustules rosacea related).

4.2. Posology and method of administration

Posology Paediatric population Not recommended as clinical trials have not been undertaken. Method of administration Cutaneous use. Apply a thin film of the gel to the affected facial areas twice daily ...

4.3. Contraindications

Topical metronidazole therapy is contraindicated in individuals with a history of hypersensitivity to metronidazole or other ingredients of the formulation.

4.4. Special warnings and precautions for use

Contact with eyes and mucous membranes should be avoided. If eye-contact should occur, wash out of the eyes carefully with warm water. If irritation does occur the patient should be advised to use Metrosa ...

4.5. Interaction with other medicinal products and other forms of interaction

Interaction with systemic medication is unlikely because absorption of metronidazole following cutaneous application of Metrosa 0.75% Gel is low. Nevertheless, it should be mentioned that disulfiram-like ...

4.6. Pregnancy and lactation

There has been no experience to date with the use of topical metronidazole in pregnant patients. In case of oral administration, metronidazole crosses the placental barrier and enters foetal circulation ...

4.7. 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 be affected.

4.8. 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), ...

4.9. Overdose

No data exist about overdose in humans. Acute oral toxicity studies with topical gel formulation containing 0.75% w/w metronidazole in rats have shown no toxic action with doses of up to 5g of finished ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Chemotherapeutics for topical use ATC Code: D06BX01 Metronidazole is a 5-nitroimidazole derivative with activity against anerobic protozoa and bacteria, due probably ...

5.2. Pharmacokinetic properties

The gel is applied topically for its local action. In humans, systemic absorption of 1g gel with 7.5mg Metronidazole after topical application is low (1% of oral dose). Quantifiable serum levels are in ...

5.3. Preclinical safety data

Single dose studies in mouse and rat by oral, intraperitoneal and intravenous routes show a low order of toxicity. Repeat dose studies (oral and intravenous) in mouse, rat, dog, and monkey indicate a no-effect ...

6.1. List of excipients

Phenoxyethanol (Ph.Eur.) Propylene glycol Hypromellose (E464) Purified water

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

5 years. Shelf life after first opening is 3 months.

6.4. Special precautions for storage

Do not refrigerate or freeze.

6.5. Nature and contents of container

Aluminium tube, fitted with a polyethylene (HDPE) screw cap. Not all pack sizes are marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

10. Date of revision of the text

05/2020

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