Vividrin Eye Drops 2% sodium cromoglicate (2007)

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης	Bausch & Lomb U.K Limited
Διεύθυνση	Bausch & Lomb House, 106 London Road, Kingston-upon-Thames, Surrey, KT2 6TN, UK

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Name of the medicinal product

Vividrin Eye Drops. Vividrin Hay Fever Eye Drops.

Qualitative and quantitative composition

Active: Sodium cromoglycate EP 2.00% w/v.

Pharmaceutical form

Sterile Preserved Multidose Eye Drops.

Therapeutic indications

Vividrin Eye Drops are for the prophylaxis and symptomatic treatment of acute allergic conjunctivitis, chronic allergic conjunctivitis and vernal kerato conjunctivitis. Vividrin Hay Fever Eye Drops are ...

Posology and method of administration

Route of Administration: For topical administration to the eye. Adults, Children and the Elderly One or two drops into each eye up to four times daily.

Contraindications

Known hypersensitivity to benzalkonium chloride, sodium cromoglycate or other constituents.

Special warnings and precautions for use

The solution should be discarded 1 month after first opening the bottle or if any turbidity develops. Do not use if the bottle has been opened prior to receipt. Vividrin Eye Drops and Vividrin Hay Fever ...

Interaction with other medicinal products and other forms of interaction

None known.

Pregnancy and lactation

Use in Pregnancy: Vividrin Eye Drops and Vividrin Hay Fever Eye Drops should be used cautiously during pregnancy and lactation. The widespread use of sodium cromoglycate has yet to reveal any adverse effects ...

Effects on ability to drive and use machines

Transient stinging or blurred vision may occur on instillation. Do not drive or operate machinery until proper vision is restored.

Undesirable effects

Transient stinging and burning may occur after instillation, other symptoms of local irritation have been reported rarely.

Overdose

As sodium cromoglycate is absorbed only to a very limited extent from eye drops, no action other than medical observation should be necessary.

Pharmacodynamic properties

Sodium cromoglycate has neither anti-histaminic or anti-inflammatory activity. Evidence suggests that sodium cromoglycate inhibits the release of mediators of the allergic reaction by stabilising the membranes ...

Pharmacokinetic properties

Due to lipid insolubility, sodium cromoglycate is poorly absorbed following administration to the eye. In normal volunteers approximately 0.03% is systemically absorbed. Absorbed sodium cromoglycate is ...

Preclinical safety data

The results of the studies do not add to the information needed by the prescriber, consequently, they are not repeated in the SPC.

List of excipients

Benzalkonium chloride EP Edetic acid disodium salt 2H2O EP Polysorbate 80 EP Sorbitol EP Sodium hydroxide EP Purified water EP

Incompatibilities

Sodium cromoglycate forms insoluble complexes with metal ions resulting in solution turbidity.

Shelf life

Unopened: 36 months. Once opened for the first time: 1 month.

Special precautions for storage

Store below 25ºC, out of direct sunlight.

Nature and contents of container

Vividrin Eye Drops – 13.5ml polyethylene multidose eye dropper bottle with polyethylene cap. Vividrin Hay Fever Eye Drops – 10.0ml polyethylene multidose eye dropper bottle with polyethylene cap.

Special precautions for disposal and other handling

The following instructions for use are included in the patient leaflet: Before using your Vividrin Eye Drops (Vividrin Hay Fever Eye Drops) you should wash your hands. You may find it helps to sit in front ...

Marketing authorization holder

Pharma Global Limited Hudson Road Sandycove Co Dublin Ireland

Marketing authorization number(s)

PL 11185/0004

Date of first authorization / renewal of the authorization

13th December 1996

Date of revision of the text

Not applicable.