LUMIGAN Eye drops, solution (2019)
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Περιεχόμενα
Name of the medicinal product
LUMIGAN 0.1 mg/ml eye drops, solution.
Qualitative and quantitative composition
One ml of solution contains 0.1 mg bimatoprost. Excipient with known effect: One ml of solution contains 0.2 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. LUMIGAN 0.1 mg/ml is contraindicated in patients who have had a suspected previous adverse reaction to benzalkonium ...
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 a 12-month Phase III clinical study approximately 38% of patients treated with LUMIGAN 0.1 mg/ml eye drops, solution experienced adverse reactions. The most frequently reported adverse reaction was ...
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/1/02/205/003-004
Date of first authorization / renewal of the authorization
07 January 2010
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