CLOROGEN Eye drops, solution (2022)

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Περιεχόμενα

1. Name of the medicinal product

Clorogen Eye Drops 0.5% w/v.

2. Qualitative and quantitative composition

Clorogen Eye Drops 0.5% w/v contains 5mg/ml Chloramphenicol Excipients with known effect: Phenylmercuric Nitrate 0.002 % w/v, Borax and Boric acid (one ml of solution contains 3.075 mg boron). ...

3. Pharmaceutical form

Eye Drops, solution. A bright, colourless to faint yellow aqueous solution.

4.1. Therapeutic indications

Chloramphenicol is broad spectrum antibiotic indicated in both adults and children aged 2 years and over for the treatment of acute bacterial conjunctivitis.

4.2. Posology and method of administration

Posology Adults, children aged 2 years and over and the elderly One drop to be instilled into the infected eye every 2 hours for the first 48 hours and 4 hourly thereafter. To be used during waking hours ...

4.3. Contraindications

Chloramphenicol eye drops must not be administered to patients who have: Hypersensitivity to chloramphenicol or to any other ingredient of the drops listed in section 6.1. Myelosuppression during previous ...

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, ...

4.5. Interaction with other medicinal products and other forms of interaction

Bone marrow suppressant drugs.

4.6. Pregnancy and lactation

Pregnancy The safety of chloramphenicol eye drops during pregnancy and lactation has not been established. As this product is for sale without prescription it is not recommended for use during pregnancy. ...

4.7. Effects on ability to drive and use machines

Transient blurring of vision may occur immediately after use and driving or using machinery should not occur until the vision is clear.

4.8. Undesirable effects

Eye disorders Transient irritation, burning, stinging and sensitivity reactions such as itching and dermatitis. Immune system disorders Hypersensitivity reactions including angioedema, anaphylaxis, urticaria, ...

4.9. Overdose

In view of the relatively small amount of chloramphenicol in Clorogen Eye Drops, overdosage with this product is unlikely to constitute a hazard. No specific treatment would be required.

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Ophthalmological antibiotics ATC Code: S01AA01 Chloramphenicol is a broad spectrum antibiotic with bacteriostatic activity and is effective against a wide range ...

5.2. Pharmacokinetic properties

Following topical application to the eye, chloramphenicol may be absorbed into the aqueous humour. Sufficient chloramphenicol may be absorbed from the eye to appear in the systemic circulation. Specific ...

5.3. Preclinical safety data

Nothing of relevance which is not included in other sections of the SPC.

6.1. List of excipients

Borax Boric acid Phenylmercuric nitrate Water for injection

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

Unopened: 24 months. Although the shelf life once opened is 28 days, patients should be advised to discard the medicine after a 5 day course of treatment.

6.4. Special precautions for storage

Store at 2°C to 8°C. Store in the original carton to protect from light.

6.5. Nature and contents of container

Pack Type A: 10 ml Low density polyethylene bottle with polystyrene spiked cap. Pack Type B: Low density polyethylene (LDPE )vial with insert-cap assembly, comprising of white coloured, HDPE screw-cap ...

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

FDC International Ltd, Unit 6 Fulcrum 1, Solent Way, Whiteley, Fareham, Hampshire, PO15 7FE, United Kingdom

8. Marketing authorization number(s)

PL 15872/0015

9. Date of first authorization / renewal of the authorization

27 September 2010

10. Date of revision of the text

13 July 2021

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