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SPC, UK: Lumigan 0.3mg/ml eye drops, solution (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Allergan Ltd
Διεύθυνση :
Marlow International, The Parkway, Marlow, Bucks, SL7 1YL, UK
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Δωρεάν εγγραφή

Name of the medicinal product

LUMIGAN 0.3 mg/ml eye drops, solution.

Qualitative and quantitative composition

One ml of solution contains 0.3 mg bimatoprost. Excipient: One ml of solution contains 0.05 mg benzalkonium chloride. For the full list of excipients, see section 6.1.

Pharmaceutical form

Eye drops, solution. Colourless solution.

Therapeutic indications

Reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension in adults (as monotherapy or as adjunctive therapy to beta-blockers).

Posology and method of administration

Posology The recommended dose is one drop in the affected eye(s) once daily, administered in the evening. The dose should not exceed once daily as more frequent administration may lessen the intraocular ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Ocular Before treatment is initiated, patients should be informed of the possibility of eyelash growth, darkening of the eyelid skin and increased iris pigmentation since these have been observed during ...

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed. No interactions are anticipated in humans, since systemic concentrations of bimatoprost are extremely low (less than 0.2 ng/ml) following ocular dosing with ...

Pregnancy and lactation

Pregnancy There are no adequate data from the use of bimatoprost in pregnant women. Animal studies have shown reproductive toxicity at high maternotoxic doses (see section 5.3). LUMIGAN should not be used ...

Effects on ability to drive and use machines

LUMIGAN has negligible influence on the ability to drive and use machines. As with any ocular treatment, if transient blurred vision occurs at instillation, the patient should wait until the vision clears ...

Undesirable effects

In clinical studies, over 1800 patients have been treated with LUMIGAN 0.3 mg/ml eye drops, solution. On combining the data from phase III monotherapy and adjunctive LUMIGAN 0.3 mg/ml eye drops, solution ...

Overdose

No case of overdose has been reported, and is unlikely to occur after ocular administration. If overdose occurs, treatment should be symptomatic and supportive. If LUMIGAN is accidentally ingested, the ...

Pharmacodynamic properties

Pharmacotherapeutic group: Ophthalmologicals, prostaglandin analogues ATC code: S01EE03 Mechanism of action The mechanism of action by which bimatoprost reduces intraocular pressure in humans is by increasing ...

Pharmacokinetic properties

Absorption Bimatoprost penetrates the human cornea and sclera well in vitro. After ocular administration in adults, the systemic exposure of bimatoprost is very low with no accumulation over time. After ...

Preclinical safety data

Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. Monkeys administered ocular ...

List of excipients

Benzalkonium chloride Sodium chloride Sodium phosphate dibasic heptahydrate Citric acid monohydrate Hydrochloric acid or sodium hydroxide (to adjust pH) Purified water

Incompatibilities

Not applicable.

Shelf life

2 years. 4 weeks after first opening.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

White opaque low density polyethylene bottles with polystyrene screw cap. Each bottle has a fill volume of 3 ml. The following pack sizes are available: cartons containing 1 or 3 bottles of 3 ml solution. ...

Special precautions for disposal and other handling

No special requirements for disposal.

Marketing authorization holder

Allergan Pharmaceuticals Ireland Castlebar Road Westport Co. Mayo Ireland

Marketing authorization number(s)

EU/1/02/205/001-002

Date of first authorization / renewal of the authorization

8 March 2002 / 20 February 2007

Date of revision of the text

July 2012