Brolene

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Propamidine isetionate 0.1%{relative}

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Propamidine isetionate 0.1% w/v

Dosage:

0.1 %

Pharmaceutical form:

Eye drops, solution

Composition:

Active: Propamidine isetionate 0.1%{relative} Excipient: Ammonium chloride Benzalkonium chloride Sodium chloride Sodium hydroxide Water for injection

Units in package:

Bottle, dropper, 10 mL

Class:

Pharmacy only

Prescription type:

Pharmacy only

Manufactured by:

Aventis Pharma Dagenham Ltd

Product summary:

Package - Contents - Shelf Life: Bottle, dropper, - 10 mL - 24 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C

Authorization date:

1969-12-31

Patient Information leaflet

BROLENE
®
1
BROLENE
® EYE DROPS
_(BRO-LEEN) _
_propamidine isethionate _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Brolene.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor or pharmacist
has weighed the risks of you using
this medicine against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT BROLENE IS USED
FOR
Brolene is a type of antibiotic used to
treat eye infections.
Your doctor, however, may
recommend Brolene for another
purpose.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
IT HAS BEEN RECOMMENDED TO YOU.
BEFORE YOU USE IT
_WHEN YOU MUST NOT USE IT _
DO NOT USE BROLENE WHEN YOU ARE
WEARING SOFT OR GAS-PERMEABLE
CONTACT LENSES.
DO NOT USE BROLENE IF YOU ARE
ALLERGIC TO IT OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
Some symptoms of an allergic
reaction include skin rash, itching,
shortness of breath or swelling of the
face, lips or tongue, which may cause
difficulty in swallowing or breathing.
DO NOT USE IT AFTER THE EXPIRY DATE
(EXP) PRINTED ON THE PACK.
If you use it after the expiry date has
passed, it may not work as well.
DO NOT USE IT IF THE PACKAGING IS
DAMAGED OR SHOWS SIGNS OF
TAMPERING.
_BEFORE YOU USE IT _
TELL YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ALLERGIES TO ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET
TELL YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ALLERGIES TO OTHER
SUBSTANCES, SUCH AS FOODS,
PRESERVATIVES OR DYES.
TELL YOUR DOCTOR OR PHARMACIST IF
BROLENE WILL BE USED IN INFANTS.
Brolene should not be used in infants
except on medical advice.
TELL YOUR DOCTOR OR PHARMACIST IF
YOU ARE PREGNANT OR INTEND TO
BECOME PREGNANT.
Your doctor or pharmacist will
discuss the risks and benefits of using
it if you are preg

Summary of Product characteristics

New Zealand Data Sheet
Brolene – propamidine isetionate/dibromopropamidine isetionate
brolene-ccdsv1-dsv5-20dec21
Page 1
DATA SHEET
1
PRODUCT NAME
Brolene eye drops, solution, 0.1%.
Brolene eye ointment, 0.15% (non-marketed).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Brolene eye drops contain 1 mg/mL propamidine isetionate in a sterile,
aqueous vehicle, the
resultant solution being isotonic with lacrimal secretion.
Brolene eye ointment contains 1.5 mg/g dibromopropamidine isetionate
in an eye ointment base
B.P.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Brolene Eye Drops are a colourless solution.
Brolene Eye Ointment is a deep yellow, smooth ointment.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Brolene Eye Drops are for the treatment of eye infections such as
acute and chronic conjunctivitis,
and for the prevention of infection resulting from minor injuries to
the eye caused by foreign
bodies, etc. Useful for the initial treatment of ophthalmia
neonatorum.
Brolene Eye Ointment is particularly suitable for the treatment of
eyelid infections such as
blepharitis and for the treatment of minor injuries to the eyes,
particularly for night-time
application. A useful indication is to relieve 'sticky eyes' very
commonly experienced with babies.
New Zealand Data Sheet
Brolene – propamidine isetionate/dibromopropamidine isetionate
brolene-ccdsv1-dsv5-20dec21
Page 2
4.2
DOSE AND METHOD OF ADMINISTRATION
Before the application of Brolene, it is advisable, where practical,
to cleanse the affected eye with
warm water or saline solution which has previously been boiled.
Brolene Eye Drops should be instilled into the infected eye at the
rate of one or two drops four
times a day for not more than a week.
Brolene Eye Ointment should be applied to the eyelids or conjunctival
sacs two or three times
daily for not more than one week.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or any of the excipients. For
the full list of excipients, see
section 6.1.
4.4
SPECIAL WARNINGS A