Optrex Infected Eyes 0.5% eye drops

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Chloramphenicol

Sẵn có từ:

Reckitt Benckiser Healthcare (UK) Ltd

Mã ATC:

S01AA01

INN (Tên quốc tế):

Chloramphenicol

Liều dùng:

5mg/1ml

Dạng dược phẩm:

Eye drops

Tuyến hành chính:

Ocular

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 11030100; GTIN: 0000050483464

Đặc tính sản phẩm

OBJECT 1
OPTREX INFECTED EYE DROPS
Summary of Product Characteristics Updated 26-Jun-2015 | Reckitt
Benckiser Healthcare (UK) Ltd
1. Name of the medicinal product
Optrex Infected Eye Drops
2. Qualitative and quantitative composition
Chloramphenicol 0.5% w/v.
For excipients, see 6.1.
3. Pharmaceutical form
Eye drops, solution. A clear, slightly yellow solution.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of acute bacterial conjunctivitis.
4.2 Posology and method of administration
ADULTS, CHILDREN AGED 2 YEARS AND OVER AND ELDERLY
One drop instilled into the infected eye every 2 hours for the first
48 hours and 4 hourly thereafter. To be
used during waking hours only. The course of treatment is 5 days.
Treatment should continue for 5 days even if symptoms improve.
For ocular use.
4.3 Contraindications
Chloramphenicol eye drops must not be administered to:
• Patients who have a history of hypersensitivity to chloramphenicol
or to any other ingredient of the
drops.
• 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 sensitisation and emergence of resistant
organisms.
Do not use for more than 5 days without consulting your doctor.
The label will state: