ANABACT Cutaneous Gel 0.75%w/w %w/w

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

METRONIDAZOLE

متاح من:

Cambridge Healthcare Supplies Limited

جرعة:

0.75%w/w %w/w

الشكل الصيدلاني:

Cutaneous Gel

تاريخ الترخيص:

1998-11-13

خصائص المنتج

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