Chloramphenicol 1% w/w Eye Ointment

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Chloramphenicol

זמין מ:

Ethypharm

קוד ATC:

S01AA; S01AA01

INN (שם בינלאומי):

Chloramphenicol

כמות:

1 percent weight/weight

טופס פרצבטיות:

Eye ointment

איזור תרפויטי:

Antibiotics; chloramphenicol

מצב אישור:

Not marketed

תאריך אישור:

2001-01-26

מאפייני מוצר

Health Products Regulatory Authority
10 June 2019
CRN008YG5
Page 1 of 4
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 thefulllist of excipients,seesection 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