Brolene 0.15% W/W Eye Ointment
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Brolene 0.15% w/w Eye Ointment
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Dibrompropamidine isetionate 0.15% w/w.
3. PHARMACEUTICAL FORM
Ointment.
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
Dibrompropamidine isetionate is an aromatic diamidine which is active against Gram-positive non-spore forming organisms, but less active against Gram-negative bacteria and spore forming organisms. It also has antifungal properties. It may be used topically for the treatment of minor eye infections such as conjunctivitis and blepharitis.
4.2. Posology and Method of Administration
Adults, elderly persons and children: for the treatment of minor eye infections.
Apply topically once or twice daily. Medical advice should be obtained if there has been no significant improvement after two days.
4.3. Contra-Indications
Hypersensitivity to dibrompropamidine or any component of the preparation.
4.4. Special Warnings and Special Precautions For Use
If vision is disturbed or symptoms become worse during therapy, discontinue use and consult a physician.
If there is no significant improvement after two days’ therapy, discontinue use and consult a physician.
The eye ointment is unsuitable for use with hard contact lenses.
4.5. Interaction with other Medicinal Products and other Forms of Interaction
None known.
4.6. Pregnancy and Lactation
Safety of use in pregnancy and lactation has not been established. Use during pregnancy and lactation only if considered essential by a physician.
4.7. Effects on Ability to Drive and Use Machines
Eye ointment will cause blurring of vision on instillation. Warn patients not to drive or operate hazardous machinery unless vision is clear.
4.8. Undesirable Effects
Hypersensitivity may occur, in which case treatment should be discontinued immediately.
4.9 Overdose
Topical overdose not applicable. Oral ingestion of a full 5g tube is unlikely to cause any toxic effects.
PHARMACOLOGICAL PROPERTIES
5.
5.1. Pharmacodynamic Properties
Dibrompropamidine is a member of the aromatic diamidine group of compounds which possess bacteriostatic properties against a wide range of fungi and bacteria. These diamidines exert antibacterial action against pyrogenic cocci, antibiotic resistant staphylococci and some Gram-negative bacilli. The activity of the diamidines is retained in the presence of organic matter such as pus and blood.
5.2. Pharmacokinetic Properties
No data available.
5.3. Pre-clinical Safety Data
No relevant data.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Paraffin, white soft Paraffin, liquid Wool fat Phenylethanol Water, purified
6.2. Incompatibilities
None known.
6.3
Shelf life
24 months. Use within 4 weeks of first opening
6.4. Special Precautions for Storage
Store below 25°C.
6.5. Nature and Content of Container
Printed, internally lacquered aluminium collapsible tubes with screw capped nozzle fitted with a polythene cap containing 5g ointment.
6.6. Instructions for Use, Handling and Disposal
No relevant instructions.
7 MARKETING AUTHORISATION HOLDER
Aventis Pharma Limited
Trading as Aventis Pharma or Rhone-Poulenc Rorer
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
Or trading as:
Sanofi-aventis or Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
8. MARKETING AUTHORISATION NUMBER(S)
PL 04425/0198
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE
AUTHORISATION
22 July 2002
10
DATE OF REVISION OF THE TEXT
24/02/2012