Chloramphenicol 1% eye ointment

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Chloramphenicol

Tilgjengelig fra:

Medicom Healthcare Ltd

ATC-kode:

S01AA01

INN (International Name):

Chloramphenicol

Dosering :

10mg/1gram

Legemiddelform:

Eye ointment

Administreringsrute:

Ocular

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 11030100; GTIN: 5060119660002

Informasjon til brukeren

Patient Information Leaflet
In this leaflet.
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1
Ointment is and what it is used for
2. Before you use Chloramphenicol
Eye Ointment
3. How to use Chloramphenicol Eye
Ointment
4. Possible side effects
5. How to store Chloramphenicol Eye
Ointment
6. Further information
1. What Chloramphenicol Eye
Ointment is and what it is
used for
Chloramphenicol Eye Ointment can be used
by children, adults and the elderly to treat
acute bacterial conjunctivitis, which is an
infection of the outer surface of eye that
causes redness, discomfort and discharge
from the affected eye. Your doctor can
provide further advice about these symptoms.
The active ingredient of Chloramphenicol
Eye ointment is chloramphenicol, which is
an antibiotic.
2. Before you use
Chloramphenicol Eye Ointment
Do not use Chloramphenicol Eye
Ointment if you:
• wear any type of contact lenses.
Take special care with
Chloramphenicol Eye ointment if you:
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ingredients in this product
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pregnant
• are breast-feeding
• are taking other medicines
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(in particular very low numbers of blood
cells) after taking chloramphenicol
Taking other medicines
Please tell your doctor or pharmacist if
you are applying any other type of eye
drops or eye ointment before you start to
use this medicine. Your medicine may
affect their action and could alter
their effect.
Please tell your doctor or pharmacist if
you are taking or have recently taken
any other medicines, including medicines
obtained without any prescription.
Pregnancy and breast-feeding
Chloramphenicol Eye Ointment should
not be used by pregnant women or
women who are breast-feeding unless
necessary. If you are pregnant or breast-
feeding you should discuss this with your
doctor before you start to apply the
ointment.
Driving and using machines
Do not drive or operate machines if you
have bl

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Chloramphenicol Eye Ointment BP
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of ointment contains 10 mg Chloramphenicol (1% w/w)
For excipients see Section 6.1
3
PHARMACEUTICAL FORM
Eye Ointment
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of bacterial conjunctivitis in both adults and children,
caused by the
organisms Escherichia coli, Haemophilus influenzae, Staphylococcus
aureus,
Streptococcus haemolyticus, Morax-Axenfield and others.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dosage for adults, children and infants of all age
groups is a small
amount of ointment to be applied to the affected eye every three hours
or more
frequently if required. Treatment should be continued for at least 48
hours after eye
appears normal.
_Paediatric population _
Dosage adjustment may be necessary in newborn infants because of
reduced systemic
elimination due to immature metabolism and the risk of dose-related
adverse effects.
The maximum duration of treatment is 10-14 days.
4.3
CONTRA-INDICATIONS
Hypersensitivity to chloramphenicol or any of the excipients listed in
section 6.1.
Patients who have experienced myelosuppression during previous
exposure to
chloramphenicol.
Patients with a family history of blood dyscrasias.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Chloramphenicol is absorbed systemically from the eye and toxicity has
been
reported following chronic exposure. Bone marrow hypoplasia, including
aplastic
anaemia and death, has been reported following topical use of
chloramphenicol.
Whilst the hazard is a rare one, it should be borne in mind when
assessing the benefits
expected from the use of the compound. Where chloramphenicol eye
ointment is used
on a long-term or intermittent basis, it may be advisable to perform a
routine blood
profile before therapy and at appropriate intervals thereafter to
detect haemopoietic
abnormalities.
In severe infections the topical use of chloramphenicol should be
supplemented