Chloramphenicol 1% w/w Eye Ointment

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Chloramphenicol

থেকে পাওয়া:

Martindale Pharmaceuticals Ltd

এটিসি কোড:

S01AA; S01AA01

INN (আন্তর্জাতিক নাম):

Chloramphenicol

ডোজ:

1 percent weight/volume

ফার্মাসিউটিকাল ফর্ম:

Ointment

প্রেসক্রিপশন টাইপ:

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

থেরাপিউটিক এলাকা:

Antibiotics; chloramphenicol

অনুমোদন অবস্থা:

Not marketed

অনুমোদন তারিখ:

2001-01-26

তথ্য লিফলেট

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

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Chloramphenicol 1% w/w Eye Ointment.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 gram of ointment contains 10 mg of chloramphenicol (1% w/w).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye Ointment.
Smooth yellow ointment of firm consistency with a slight odour of wool
fat.
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
The eye ointment is to be applied every 3 hours or more frequently, if
required. Alternatively, when used in
conjunction with other treatments, the ointment may be applied at
night with appropriate eye drops or other treatment
used during the day.
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 Ointment for topical administration. A thin line of ointment to be
placed along the inside of the lower lip.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Patients with a known personal or family history of blood dyscrasias
including aplastic anaemia should avoid use of
this product.
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
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