MEDOVIR Cream (2019)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Medovir 5% w/w cream.

2. Qualitative and quantitative composition

Each 5 g or 10 g tube of cream contains aciclovir 5% w/w. Excipients with known effect: propylene glycol and cetostearyl alcohol. Each 1 g of Medovir cream contains 0.15 g propylene glycol. Each ...

3. Pharmaceutical form

Cream. White, soft, homogenous, smooth, odourless cream for cutaneous use.

4.1. Therapeutic indications

Medovir cream is indicated for the treatment of Herpes Simplex virus infections of the skin including initial and recurrent genital herpes and herpes labialis.

4.2. Posology and method of administration

Posology Adults and children Medovir cream should be applied five times daily, at approximately four hourly intervals, omitting the night time application. Medovir Cream should be applied to the lesions ...

4.3. Contraindications

Hypersensitivity to the active substance, valaciclovir or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Aciclovir cream is not recommended for application to mucous membranes such as in the mouth, eye or vagina, as it may be irritant. Particular care should be taken to avoid accidental introduction into ...

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

No clinically significant interactions have been identified.

4.6. Fertility, pregnancy and lactation

Pregnancy A post-marketing aciclovir pregnancy registry has documented pregnancy outcomes in women exposed to any formulation of aciclovir. The registry findings have not shown an increase in the number ...

4.7. Effects on ability to drive and use machines

Not applicable.

4.8. Undesirable effects

The following convention has been used for the classification of undesirable effects in terms of frequency: very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥1/1000 to <1/100, rare ≥1/10,000 to <1/1000, ...

4.9. Overdose

No untoward effects would be expected if the entire contents of a 10-gram tube of aciclovir cream containing 500 mg of aciclovir were ingested orally. However, the accidental, repeated overdose of oral ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antivirals, Chemotherapeutics For Topical Use ATC code: D06BB03 Aciclovir is an antiviral agent which is highly active in vitro against Herpes simplex ...

5.2. Pharmacokinetic properties

Pharmacology studies have shown only minimal systemic absorption of aciclovir following repeated topical administration of aciclovir cream.

5.3. Preclinical safety data

The results of a wide range of mutagenicity tests in vitro and in vivo indicate that aciclovir does not pose a genetic risk to man. Aciclovir was not found to be carcinogenic in long term studies in the ...

6.1. List of excipients

Medovir cream also contains: Cetostearyl alcohol White petrolatum Mineral oil Simethicone Triethanolamine Glycerol Propylene glycol Poloxamer 407 Carbopol 5984EP (carboxypolymethylene) Purified ...

6.2. Incompatibilities

None known.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store below 25°C, in the original package, in order to protect from light and moisture.

6.5. Nature and contents of container

Aluminium flexible tubes with a plastic screw cap in a carton with the patient information leaflet. Tubes of 5g and 10 g are available. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

8. Marketing authorization number(s)

20372

9. Date of first authorization / renewal of the authorization

17/07/08

10. Date of revision of the text

05/08/2019

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