Chloramphenicol 0.5% w/v Eye Drops

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Chloramphenicol

Dostępny od:

Martindale Pharmaceuticals Ltd

Kod ATC:

S01AA; S01AA01

INN (International Nazwa):

Chloramphenicol

Dawkowanie:

0.5 percent weight/volume

Forma farmaceutyczna:

Eye drops, solution

Typ recepty:

Product subject to prescription which may not be renewed (A)

Dziedzina terapeutyczna:

Antibiotics; chloramphenicol

Status autoryzacji:

Not marketed

Data autoryzacji:

2001-01-26

Ulotka dla pacjenta

PACKAGE LEAFLET
CHLORAMPHENICOL 1.0% W/W EYE OINTMENT
CHLORAMPHENICOL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START THIS MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or
nurse.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Chloramphenicol Eye Ointment is and what it is used for
2. What you need to know 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. Contents of the pack and other information
1. WHAT CHLORAMPHENICOL EYE OINTMENT IS AND WHAT IT IS USED FOR
Chloramphenicol belongs to a group of medicines called antibiotics. An
antibiotic is
a medicine which is used for the treatment of a variety of infections
caused by bacteria.
Chloramphenicol Eye Ointment are used in both adults and children for
the treatment of a
wide
range of eye infections caused by bacteria.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CHLORAMPHENICOL EYE OINTMENT
DO NOT USE THE OINTMENT IF:
•
You are allergic to Chloramphenicol or any of the other ingredients of
this medicine listed
in section 6
•
You or a member of your family has had problems with their blood or
bone
marrow. These problems can include a severe reduction in red blood
cells or
lower than normal blood count.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Chloramphenicol Eye
Ointment if:
• you have visual disturbances
• you have severe pain in the eye
• you are sensitive to light
• your eye is inflamed and you have a rash on the scalp or face
• your eye looks cloudy
• your black or coloured part of the eye look

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Chloramphenicol 0.5% w/v Eye Drops.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml of the drops contains 5mg of chloramphenicol (0.5%w/v)
Excipients with known effect
Contains Phenylmercuric Nitrate 0.02mg/ml (0.002% w/v).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
Clear aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Chloramphenicol is a broad spectrum antibiotic for the treatment of
bacterial conjunctivitis caused by chloramphenicol
susceptible organisms including:_ Escherichia coli, Haemophilus
influenzae, Staphylococcus aureus, Streptococcus,_
_haemolyticus, Morax-axenfeld,_ Klebsiella/Enterobacter species and
others.
Chloramphenicol is indicated in both adults and children.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults, including the elderly and children
One or two drops applied to each affected eye up to 6 times daily or
more frequently if required.
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.
Method of administration
Eye Drops for topical administration
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
a known personal or family history of blood dyscrasias including
aplastic anaemia.
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
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