BROLENE 0.15% W/W EYE OINTMENT
Active substance(s): DIBROMPROPAMIDINE ISETIONATE
NAME OF THE MEDICINAL PRODUCT
Brolene 0.15% w/w Eye Ointment
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dibrompropamidine isetionate 0.15% w/w.
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.
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.
Hypersensitivity to dibrompropamidine or any component of the preparation.
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.
Interaction with other Medicinal Products and other Forms of Interaction
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.
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.
Hypersensitivity may occur, in which case treatment should be discontinued
Topical overdose not applicable. Oral ingestion of a full 5g tube is unlikely to
cause any toxic effects.
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.
No data available.
Pre-clinical Safety Data
No relevant data.
List of excipients
Paraffin, white soft
24 months. Use within 4 weeks of first opening
Special Precautions for Storage
Store below 25°C.
Nature and Content of Container
Printed, internally lacquered aluminium collapsible tubes with screw capped
nozzle fitted with a polythene cap containing 5g ointment.
Instructions for Use, Handling and Disposal
No relevant instructions.
MARKETING AUTHORISATION HOLDER
Aventis Pharma Limited
Trading as Aventis Pharma or Rhône-Poulenc Rorer
One Onslow Street
Or trading as:
Sanofi-aventis or Sanofi
One Onslow Street
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION / RENEWAL OF THE
22 July 2002
DATE OF REVISION OF THE TEXT