Brolene 0.15 % w/w Eye Ointment

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

DIBROMPROPAMIDINE ISETIONATE

제공처:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC 코드:

S01AX; S01AX14

INN (International Name):

DIBROMPROPAMIDINE ISETIONATE

복용량:

0.15 percent weight/weight

약제 형태:

Eye ointment

처방전 유형:

Product not subject to medical prescription

치료 영역:

Other antiinfectives; dibrompropamidine

승인 상태:

Marketed

승인 날짜:

1983-04-01

환자 정보 전단

_I_
TURN
OVER
PACKAGE LEAFLET:
INFORMATION FOR THE USER
BROLENE® 0.15% W/W
EYE OINTMENT
dibrompropamidine
isethionate
IS THIS LEAFLET HARD TO
SEE OR READ?
PHONE [phone] FOR
HELP
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START USING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
ALWAYS USE THIS MEDICINE EXACTLY AS DESCRIBED
IN THIS LEAFLET OR AS YOUR DOCTOR OR PHARMACIST
HAVE TOLD YOU.
• Keep this leaflet. You may need to read it
again
• Ask your
pharmacist
if
you need more
information or advice
• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel
better or if you feel worse after 2 days
IN THIS LEAFLET:
1. What Brolene Eye Ointment is and what it
is used for
2. What you need to know before you use
Brolene Eye Ointment
3. How to use Brolene Eye Ointment
4. Possible side effects
5. How to store Brolene Eye Ointment
6. Contents of the pack and other information
1. WHAT BROLENE EYE OINTMENT
IS AND WHAT IT IS USED FOR
Brolene Eye Ointment
contains a medicine
called dibrompropamidine
isetionate.
This
belongs
to
a
group of
medicines
called
disinfectants
and antifungals.
It
works
by
stopping the growth of bacteria, allowing your
body to fight off the infection.
It is used for
minor infections of
the eye or eyelid.
Signs
include sore, red or inflamed eyes, stickiness or
a crust on the eyelids.
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE BROLENE EYE OINTMENT
DO NOT USE THIS MEDICINE AND TELL YOUR
DOCTOR OR PHARMACIST IF:
You are allergic (hypersensitive) to dibrom-
propamidine isetionate or any of the other
ingredients of Brolene Eye Ointment (listed
in Section 6 below)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling
of
your
lips,
face,
throat,
tongue
and
worsening of redness, itching or swelling of
the eye or eyelid
You wear contact lenses.
You should not
wear
contact
lenses
while
using
this
ointment
Do not use

제품 특성 요약

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.
Excipients: contains Wool fat 9.7% w/w.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye ointment.
A pale yellow, smooth, sterile ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an anti-infective for use in local infections of the superficial
structures of the eye due to microorganisms sensitive to
its action.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For ocular use.
Adults, elderly persons, and children: Cleanse the affected area and
apply the ointment topically to the eyelid or
conjunctival sac once or twice daily, for not more than 2 days.
4.3 CONTRAINDICATIONS
Hypersensitivity to any component of the preparation.
Use of contact lenses.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If there is no significant improvement within 2 days medical advice
should be sought.
There is always the possibility, although rare, of a sensitisation
reaction resulting from the use of Brolene preparations.
In such an event treatment should be discontinued immediately. Should
erythema or other evidence of increased
inflammation occur application should cease immediately and medical
opinion should be sought.
If problems of visual acuity occur or its symptoms are detected, the
doctor should be consulted immediately.
Brolene Ointment contains wool fat, which may cause local skin
reactions (e.g. contact dermatitis).
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None stated.
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