Anabact 0.75% W/W Gel
Anabact 0.75% w/w Gel
Active ingredient Metronidazole 0.75% w/w Ph Eur
The preservative agent Bronopol (2, bromo-2-nitro propan- 1, 3-diol) and hydroxybenzoic acid esters, incorporated at a level of 0.06% w/v, and 0.13% respectively together with hydroxyethylcellulose, propylene glycol, and purified water
A pale yellow water-based clear gel containing 0.75% w/w metronidazole for topical application
The deodorisation of malodorous fungating tumours, gravitational ulcers and decubitus ulcers
Children: Not recommended for children under 12 years of age.
Adults: Clean the wound thoroughly. Apply the gel over the complete area and cover with a non-adherent dressing. Use once or twice daily until the odour has been completely eradicated. Studies have shown that offensive odour is usually controlled with application of topical metronidazole gel 0.75% within two weeks.
Elderly: As detailed for other adults
In patients known to be sensitive to metronidazole, Bronopol, hydroxybenzoic acid
esters, hydroxyethylcellulose, phosphoric acid or propylene glycol.
Strong sunlight should be avoided because metronidazole is unstable under ultraviolet light. Contact with the eyes should be avoided.
A disulfiram-like reaction in a small number of patients taking oral metronidazole and alcohol concomitantly. Anticoagulants and antiepileptics may also interact.
The safety of metronidazole in pregnancy and lactation has not been adequately established. The gel should not therefore be used in these circumstances unless the physician considers it essential. Medication should be stopped if pregnancy occurs.
4.8. Undesirable Effects
May cause dryness of the skin, local stinging or irritation.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard).
Overdose is extremely unlikely. If necessary medication should be removed by washing with warm water.
Metronidazole is an established antibacterial agent. It is effective against a variety of organisms including anaerobic bacteria which are responsible for the distressing symptoms of malodorous full thickness wounds.
The systemic concentration of metronidazole following the topical administration of 1 g of a 0.75% metronidazole gel to 10 patients with rosacea ranged from 25ng/ml (limit of detection) to 66ng/ml, with a mean c/max of 40.6ng/mf The corresponding mean c/max following oral administration of a solution containing 30mg of metronidazole was 850ng/ml (equivalent to 212ng/ml if dose corrected). The mean Tmax for the topical formulation was 6.0 hours compared to 0.97 hours for the oral solution. The proposed formulation would be expected to afford minimal serum concentrations of metronidazole.
No published data are available on the irritancy and tolerance of topical metronidazole in animal. It was, therefore, considered more appropriate to investigate the potential irritancy and tolerance of topical application of the proposed marketing formulation of metronidazole 0.75% gel in human volunteers.
Hydroxybenzoic Acid Esters Hydroxyethylcellulose Propylene Glycol Phosphoric Acid Purified Water
The unopened shelf-life is 2 years.
The opened shelf-life is 28 days.
Do not store above 25°C. Keep container in outer carton.
The gel is packaged in internally lacquered membrane sealed aluminium tubes each fitted with a low density polyethylene cap.
Anabact is licensed in 5g, 10g, 15g, 25g, 30g and 40g pack sizes.
Cambridge Healthcare Supplies Ltd Unit 1 Chestnut Drive Wymondham
Norfolk NR18 9SB
8. MARKETING AUTHORISATION NUMBER
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10 DATE OF REVISION OF THE TEXT