TRAVATAN Eye drops, solution (2018)
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Περιεχόμενα
Name of the medicinal product
TRAVATAN 40 micrograms/mL eye drops, solution.
Qualitative and quantitative composition
Each mL of solution contains 40 micrograms of travoprost. Excipient(s) with known effect: Each mL of solution contains polyquaternium-1 (POLYQUAD) 10 microgram, propylene glycol 7.5 mg, polyoxyethylene ...
Pharmaceutical form
Eye drops, solution. (eye drops) Clear, colourless solution.
Therapeutic indications
Decrease of elevated intraocular pressure in adult patients with ocular hypertension or open-angle glaucoma (see section 5.1). Decrease of elevated intraocular pressure in paediatric patients aged 2 months ...
Posology and method of administration
Posology Use in adults, including elderly population The dose is one drop of TRAVATAN in the conjunctival sac of the affected eye(s) once daily. Optimal effect is obtained if the dose is administered in ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Eye colour change TRAVATAN may gradually change the eye colour by increasing the number of melanosomes (pigment granules) in melanocytes. Before treatment is instituted, patients must be informed of the ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Fertility, pregnancy and lactation
Women of child-bearing potential/contraception TRAVATAN must not be used in women of child bearing age/potential unless adequate contraceptive measures are in place (see section 5.3). Pregnancy Travoprost ...
Effects on ability to drive and use machines
TRAVATAN has no or negligible influence on the ability to drive and use machines, however as with any eye drop, temporary blurred vision or other visual disturbances may affect the ability to drive or ...
Undesirable effects
Summary of the safety profile In clinical trials with TRAVATAN, the most common adverse reactions were ocular hypearemia and iris hyperpigmentation, occurring in approximately 20% and 6% of patients respectively. ...
Overdose
No cases of overdose have been reported. A topical overdose is not likely to occur or to be associated with toxicity. A topical overdose of TRAVATAN may be flushed from the eye(s) with lukewarm water. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Ophthalmologicals-antiglaucoma preparations and miotics-prostaglandin analogues ATC code: S01EE04 Mechanism of action Travoprost, a prostaglandin F<sub>2α</sub> analogue, is ...
Pharmacokinetic properties
Absorption Travoprost is an ester prodrug. It is absorbed through the cornea where the isopropyl ester is hydrolysed to the active free acid. Studies in rabbits have shown peak concentrations of 20 ng/mL ...
Preclinical safety data
In ocular toxicity studies in monkeys, administration of travoprost at a dose of 0.45 microgram, twice a day, was shown to induce increased palpebral fissure. Topical ocular administration of travoprost ...
List of excipients
Polyquaternium-1 Polyoxyethylene hydrogenated castor oil 40 (HCO-40) Boric acid (E284) Mannitol (E421) Sodium chloride Propylene glycol (E1520) Sodium hydroxide and/or hydrochloric acid (for pH-adjustment) ...
Incompatibilities
None known. Specific in vitro interaction studies were performed with TRAVATAN and medicinal products containing thiomersal. No evidence of precipitation was observed.
Shelf life
Shelf life: 2 years. Discard 4 weeks after first opening.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
4 mL oval Polypropylene (PP) or Low Density Polyethylene (LDPE) bottle and PP or LDPE dispensing plug with a PP screw cap, presented in an overwrap. Each 4 mL bottle will contain 2.5 mL of solution. Cartons ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Marketing authorization number(s)
EU/1/01/199/001-004
Date of first authorization / renewal of the authorization
Date of first authorisation: 27 November 2001 Date of latest renewal: 06 October 2006
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