ZIDOVAL Vaginal gel (2018)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Zidoval 7.5 mg/g vaginal gel.

2. Qualitative and quantitative composition

Metronidazole 0.75% w/w, 7.5 mg/g. Excipients with known effect: Methyl parahydroxybenzoate (E218) 0.8 mg/g. Propyl parahydroxybenzoate (E216) 0,2 mg/g. Propylene glycol (E1520) 30.0 mg/g. For the ...

3. Pharmaceutical form

Vaginal gel. A colourless to straw coloured gel.

4.1. Therapeutic indications

Zidoval vaginal gel is indicated for the treatment of bacterial vaginosis.

4.2. Posology and method of administration

Posology For vaginal administration. Adults One application of Zidoval vaginal gel (5g) inserted into the vagina once daily, at bedtime, for 5 consecutive days. Elderly Bacterial vaginosis is not commonly ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to other nitroimidazoles or parabens.

4.4. Special warnings and precautions for use

Use during menses is not recommended. Known or previously unrecognised candidiasis may present more prominent symptoms during therapy with Zidoval vaginal gel and may require treatment with a candicidal ...

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

Oral metronidazole has been associated with a disulfiram-like reaction in combination with alcohol. Acute psychotic reactions and confusion have occurred during concomitant use of disulfiram with oral ...

4.6. Pregnancy and lactation

Pregnancy Data on a large number (several hundred) of exposed pregnancies indicate no adverse effects of metronidazole on the foetus/newborn child. There have been no formal studies with Zidoval vaginal ...

4.7. Effects on ability to drive and use machines

Zidoval has no influence on the ability to drive and use machines.

4.8. Undesirable effects

In controlled clinical trials involving 759 patients, the most commonly reported ADRs were urogenital (26%) and gastrointestinal (14%). The following spontaneous adverse experiences have been reported, ...

4.9. Overdose

There is no human experience of overdosage with Zidoval vaginal gel. There is no specific treatment. Metronidazole is readily removed from the plasma by haemodialysis.

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Gynecological anti-infectives and antiseptics ATC code: G01AF01 Metronidazole is a synthetic antibacterial agent which also possesses amoebicidal activity. Zidoval ...

5.2. Pharmacokinetic properties

Bioavailability studies on the administration of a single 5 gram dose of Zidoval vaginal gel into the vagina of 12 normal subjects showed a mean Cmax serum concentration of 237 nanogram/ml or ...

5.3. Preclinical safety data

At high doses metronidazole has been found to be mutagenic in bacteria but not in mammalian cells in vitro or in vivo. A carcinogenic potential has been demonstrated in mouse and rat ...

6.1. List of excipients

Carbomer (Carbopol) 974P Disodium edetate Methyl parahydroxybenzoate Propyl parahydroxybenzoate Propylene glycol Sodium hydroxide Purified water

6.2. Incompatibilities

None known.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

Aluminium tubes lined with an epoxy phenolic resin with polyethylene screw caps containing 40 g product. The product is packaged with 5 disposable vaginal applicators, each to deliver 5 g of gel.

6.6. Special precautions for disposal and other handling

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

7. Marketing authorization holder

Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

8. Marketing authorization number(s)

PL 46302/0153

9. Date of first authorization / renewal of the authorization

31 January 1997 / 15 February 2010

10. Date of revision of the text

June 2018

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