ANABACT Cutaneous Gel 0.75%w/w %w/w
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
METRONIDAZOLE
Available from:
Cambridge Healthcare Supplies Limited
Dosage:
0.75%w/w %w/w
Pharmaceutical form:
Cutaneous Gel
Authorization date:
1998-11-13
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anabact
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Metronidazole 0.75% w/w
For excipients see 6.1.
3 PHARMACEUTICAL FORM
Gel.
Pale yellow clear gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the deodorisation of malodorous fungating tumours.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
_Adults and Elderly:_
Clean the wound thoroughly. Apply
the gel over the complete area with a non-adherent dressing.
Use once or twice as
necessary.
_Children:_
Not recommended
4.3 CONTRAINDICATIONS
In patients known to be sensitive to metronidazole, Bronopol,
hydroxybenzoic acid esters, hydroxyethylcellulose,
propylene glycol or phosphoric acid.
Use in patients with disease of the peripheral nervous system.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Strong sunlight should be avoided
because metronidazole is unstable under ultra-violet light.
Contact with the eyes
should be avoided. If contact with the eyes occurs,
the gel should be carefully washed out with water.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
A disulfiram-like reaction has been reported in
a small number of patients taking oral metronidazole and
alcohol
concomitantly. Anticoagulants and antiepileptics may also interact.
Concurrent use with keratolytics is not
recommended.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 03/08/2005_
_CRN 2012710_
_page number: 1_
4.6 PREGNANCY AND LACTATION
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.
4.7 EFFECTS ON ABILITY TO DRIVE AND US
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