BROCHLOR Eye drops (2021)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | SANOFI |
|---|---|
| Διεύθυνση | 1 Onslow Street, Guildford, Surrey, GU1 4YS, UK |
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Περιεχόμενα
1. Name of the medicinal product
Brochlor 0.5% w/v Eye Drops. Brolene Antibiotic 0.5% w/v Eye Drops.
2. Qualitative and quantitative composition
Chloramphenicol 0.5% w/v. <u>Excipients with known effect:</u> Borax: 40 mg per 10mL. Boric acid: 150 mg per 10mL. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Eye drops.
4.1. Therapeutic indications
Treatment of acute bacterial conjunctivitis.
4.2. Posology and method of administration
For ocular use. The recommended dosage for adults (including the elderly) and children aged 2 years and over is one drop to be applied to the affected eye every two hours for the first 48 hours and 4 hourly ...
4.3. Contraindications
Chloramphenicol eye drops should not be administered to patients hypersensitive to chloramphenicol or any other ingredients in the formulation, or given to those with a known personal or family history ...
4.4. Special warnings and precautions for use
Prolonged use of chloramphenicol eye drops should be avoided as it may increase the likelihood of sensitisation and emergence of resistant organisms. Do not use for more than 5 days without consulting ...
4.5. Interaction with other medicinal products and other forms of interaction
The concomitant administration of chloramphenicol with other drugs liable to depress bone marrow function should be avoided.
4.6. Pregnancy and lactation
The safety of Chloramphenicol Eye Drops during pregnancy and lactation has not been established. Chloramphenicol may be absorbed systemically following the use of eye drops and may cross the placenta and ...
4.7. Effects on ability to drive and use machines
Chloramphenicol eye drops may cause transient blurring of vision when applied to the eye. Patients should be warned not to drive or operate hazardous machinery unless their vision is clear.
4.8. Undesirable effects
<u>Eye disorders:</u> Chloramphenicol eye drops may cause transient stinging and irritation when applied to the eye. <u>Blood and lymphatic system disorder:</u> Bone marrow depression, including irreversible ...
4.9. Overdose
Not applicable.
5.1. Pharmacodynamic properties
Chloramphenicol is a broad spectrum antibiotic with bacteriostatic activity and is effective against a wide range of Gram-negative and Gram-positive organisms.
5.2. Pharmacokinetic properties
Not applicable to a topical (ophthalmic) preparation.
5.3. Preclinical safety data
Preclinical safety data does not add anything of further significance.
6.1. List of excipients
Borax Boric acid Water for injections
6.2. Incompatibilities
Not known.
6.3. Shelf life
24 months from the date of manufacture. The in-use shelf life is 28 days, however the patient should be advised to discard any remaining contents after the 5-day course of treatment.
6.4. Special precautions for storage
Protect from light. Store between 2°C and 8°C.
6.5. Nature and contents of container
A flexible polypropylene bottle incorporating a polyethylene plug and cap assembly. The bottles contain 10ml.
6.6. Special precautions for disposal and other handling
None.
7. Marketing authorization holder
Aventis Pharma Limited, trading as Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, United Kingdom
8. Marketing authorization number(s)
PL 04425/0366
9. Date of first authorization / renewal of the authorization
July 2004
10. Date of revision of the text
18/08/2021
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