Optrex Bacterial Conjunctivitis 1% eye ointment

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Chloramphenicol

Prieinama:

Reckitt Benckiser Healthcare (UK) Ltd

ATC kodas:

S01AA01

INN (Tarptautinis Pavadinimas):

Chloramphenicol

Dozė:

10mg/1gram

Vaisto forma:

Eye ointment

Vartojimo būdas:

Ocular

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 11030100; GTIN: 5011417566411

Pakuotės lapelis

December 2019
9-COLOP-36-GB-PV2
December

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Chloramphenicol 1% w/w Eye Ointment
Golden Eye Antibiotic 1% w/w Eye Ointment
Optrex Bacterial conjunctivitis 1% w/w Eye ointment
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of ointment contains 10 mg Chloramphenicol (1% w/w)
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Eye Ointment
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of acute bacterial conjunctivitis in adults and
children aged 2 years
and over
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Topical administration to the eye only.
Adults, children aged 2 years and over and elderly
The recommended dose is a small amount of ointment (~ 1cm) to be
applied to the
affected eye(s). The ointment should be applied either at night if eye
drops are used
during the day, or 3 to 4 times a day if eye ointment is used alone
The pharmacist will advise on the most suitable treatment. Treatment
should continue
for 5 days even if symptoms improve.
4.3
CONTRAINDICATIONS
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 systemic
toxicity has
been reported (see section 4.8).
In severe bacterial conjunctivitis and in cases where infection is not
confined to the
conjunctivae, the topical use of chloramphenicol should be
supplemented by
appropriate systemic treatment. Therefore, the patient should be
referred to seek
medical advice.
The use of topical chloramphenicol may occasionally result in
overgrowth of non-
susceptible organisms including fungi. If any new infection appears
during treatment,
the patient should be referred to the doctor.
Prolonged or frequent intermittent topical application of
chloramphenicol should be
avoided since it may increase the likelihood of sens