ALLERCROM Eye drops, solution (2020)

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Περιεχόμενα

1. Name of the medicinal product

Allercrom 2% w/v Eye Drops.

2. Qualitative and quantitative composition

Active substance: Sodium cromoglicate (equivalent to 20.0 mg/ml anhydrous Sodium Cromoglicate). [Sodium Cromoglicate 2.0% w/v] Excipient(s) with known effect: Benzalkonium chloride 0.10 mg/ml For ...

3. Pharmaceutical form

Eye drops, solution. A clear, colourless solution. Free from visible particulate matter.

4.1. Therapeutic indications

For the relief and treatment of the eye symptoms of hayfever.

4.2. Posology and method of administration

Allercrom Eye Drops should not be used continuously for more than 14 days except on the advice of a doctor or pharmacist. Adults and Children over 6 years One or two drops to be administered into each ...

4.3. Contraindications

Patients with known hypersensitivity to any of the ingredients listed in section 6.1.

4.4. Special warnings and precautions for use

This formulation of Sodium Cromoglicate Eye Drops contains 0.1mg/ml (4.5 micrograms per dose) benzalkonium chloride as a preservative which may be deposited in soft contact lenses. Hence, soft contact ...

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

None known.

4.6. Fertility, pregnancy and lactation

Fertility It is not known whether sodium cromoglicate has any effect on fertility. Pregnancy Cumulative experience with sodium cromoglicate suggests that it has no adverse effects on foetal development. ...

4.7. Effects on ability to drive and use machines

Instillation may cause transient stinging or blurring of vision. Do not drive or operate machinery until normal vision is restored.

4.8. Undesirable effects

Transient stinging and burning on instillation of the drops. Rarely, other symptoms of local irritation. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation ...

4.9. Overdose

Overdosage is very unlikely. In the event of accidental ingestion, symptomatic treatment is recommended.

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Ophthalmologicals; Other antiallergics ATC code: S01GX01 In vitro and in vivo animal studies have shown that Sodium cromoglicate inhibits the degranulation of sensitised ...

5.2. Pharmacokinetic properties

Sodium cromoglicate is poorly absorbed. When multiple doses of Sodium cromoglicate ophthalmic solution are instilled into normal rabbit eyes, less than 0.07% of the administered dose of Sodium cromoglicate ...

5.3. Preclinical safety data

None stated.

6.1. List of excipients

Benzalkonium chloride Disodium edetate Sodium Chloride Polysorbate 80 Water for Injection

6.2. Incompatibilities

None known.

6.3. Shelf life

Unopened: 24 months. Opened: Discard solution 28 days after opening the bottle.

6.4. Special precautions for storage

Do not store above 30°C, protected from direct sunlight. To avoid contamination do not touch dropper tip to any surface.

6.5. Nature and contents of container

Low Density Polyethylene BFS bottles with a polystyrene spiked cap which contains 5 mL and 10 mL of Sodium Cromoglicate 2 % w/v Eye Drops solution. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special instructions.

7. Marketing authorization holder

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

8. Marketing authorization number(s)

PL 15872/0008

9. Date of first authorization / renewal of the authorization

16 May 2007 / 05 March 2012

10. Date of revision of the text

6 November 2020

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