CHOLFEN EYE OINTMENT chloramphenicol 10 mg/g eye ointment tube

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

chloramphenicol, Quantity: 10 mg/g

Dostupné s:

Alphapharm Pty Ltd

Léková forma:

Eye Ointment

Složení:

Excipient Ingredients: liquid paraffin; Wool fat; white soft paraffin

Podání:

Ophthalmic

Jednotky v balení:

5 g

Druh předpisu:

(S3) Pharmacist Only Medicine

Terapeutické indikace:

For the treatment of bacterial conjunctivitis and other superficial ocular infections caused by chloramphenicol-sensitive organisms.

Přehled produktů:

Visual Identification: Pale yellow opaque ointment; Container Type: Tube; Container Material: Epoxy-coated Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Stav Autorizace:

Registered

Datum autorizace:

2021-12-06

Informace pro uživatele

CHOLFEN EYE OINTMENT
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ACTIVE INGREDIENT: _chloramphenicol_
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet provides important information about using
CHOLFEN EYE OINTMENT. YOU SHOULD ALSO SPEAK TO
YOUR DOCTOR OR PHARMACIST OR OPTOMETRIST IF YOU WOULD
LIKE FURTHER INFORMATION OR IF YOU HAVE ANY CONCERNS OR
QUESTIONS ABOUT USING CHOLFEN EYE OINTMENT.
WHERE TO FIND INFORMATION IN THIS LEAFLET:
1. Why am I using CHOLFEN EYE OINTMENT?
2.
What
should
I
know
before
I
use
CHOLFEN
EYE
OINTMENT?
3. What if I am taking other medicines?
4. How do I use CHOLFEN EYE OINTMENT?
5.
What
should
I
know
while
using
CHOLFEN
EYE
OINTMENT?
6. Are there any side effects?
7. Product details
1.
WHY AM I USING CHOLFEN EYE
OINTMENT?
CHOLFEN EYE OINTMENT CONTAINS THE ACTIVE INGREDIENT
CHLORAMPHENICOL, a synthetic antibiotic.
CHOLFEN EYE OINTMENT is used to treat an eye infection
called bacterial conjunctivitis, which is a bacterial infection
involving the mucous membrane of the surface of the eye.
The most common symptom is the presence of a sticky
yellow-white discharge with mucus and pus (or glued eyes,
especially in the morning on waking). Other symptoms
include a gritty sensation in the eye, redness, irritation and
watering of the eyes. The infection usually starts in one eye
and then spreads to the other.
2.
WHAT SHOULD I KNOW BEFORE I USE CHOLFEN
EYE OINTMENT?
WARNINGS
DO NOT USE CHOLFEN EYE OINTMENT:
•
if you are allergic to chloramphenicol, or any of the
ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use
this medicine.
Some of the symptoms of an allergic reaction to
CHOLFEN EYE OINTMENT may include irritation, pain
and swelling in the eye. Skin rashes, blisters and fever
may also occur.
•
in children under 2 years of age unless your doctor or
optometrist tells you.
•
after the expiry date (EXP.) printed on the pack.
•
if the packaging is torn, broken or shows signs of
tampering.
CHECK WITH YOUR DOCTOR OR PHARMACIST IF:
•
YOU OR YOUR FAMILY

Charakteristika produktu

AUSTRALIAN PRODUCT INFORMATION
CHOLFEN EYE OINTMENT
_Chloramphenicol eye ointment _
1
NAME OF THE MEDICINE
Chloramphenicol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CHOLFEN EYE OINTMENT 10 mg/g tube contains: 1 % w/w chloramphenicol in
a sterile oculentum base.
Contains no preservatives.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Eye Ointment
CHOLFEN EYE OINTMENT is a pale yellow semisolid mass.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of bacterial conjunctivitis. For use under medical
supervision only in the treatment of other
superficial ocular infections caused by chloramphenicol-sensitive
organisms.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN 2 YEARS AND OVER:
Apply 1.5 cm of ointment into the affected eye(s) every 3 hours. If
ointment is used together with drops for day and night coverage, 1.5
cm should be applied before bedtime,
while using the drops during the day. Continue treatment for at least
48 hours after the eye appears normal.
Do not use for more than 5 days in total except on medical advice. To
minimise contamination do not allow
the tip to contact the surface of the eye.
CHOLFEN EYE OINTMENT
is not recommended for children under 2 years except on medical
advice.
4.3
CONTRAINDICATIONS
Chloramphenicol is contraindicated in individuals with a history of
hypersensitivity to any excipients and/or
toxic reaction to the drug.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
IDENTIFIED PRECAUTIONS
Bone marrow hypoplasia, including aplastic anaemia and death, has been
rarely reported following local
application of chloramphenicol. Chloramphenicol should not be used
when less potentially dangerous agents
would be expected to provide effective treatment. Ophthalmic agents
may retard corneal wound healing.
The use of this antibiotic, as with other antibiotics, may result in
the overgrowth of nonsusceptible organisms,
including fungi. If infections caused by nonsusceptible organisms
appear during therapy, its use should be