SAFLUTAN Eye drops, solution (2019)
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Περιεχόμενα
Name of the medicinal product
Saflutan 15 micrograms/ml eye drops, solution.
Qualitative and quantitative composition
One ml of solution contains 15 micrograms of tafluprost. One drop contains about 0.45 micrograms of tafluprost. For the full list of excipients, see section 6.1.
Pharmaceutical form
Eye drops, solution (eye drops). A clear, colourless solution, practically free from visible particles with a pH between 5.5 and 6.7, and an osmolality of 260-300 mOsmol/kg.
Therapeutic indications
Reduction of elevated intraocular pressure in open angle glaucoma and ocular hypertension. As monotherapy in patients: who would benefit from preservative free eye drops insufficiently responsive to first ...
Posology and method of administration
Posology The recommended dose is one drop of Saflutan in the conjunctival sac of the affected eye(s) once daily in the evening. The dose should not exceed once daily as more frequent administration may ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Before treatment is initiated, patients should be informed of the possibility of eyelash growth, darkening of the eyelid skin and increased iris pigmentation. Some of these changes may be permanent, and ...
Interaction with other medicinal products and other forms of interaction
No interactions are anticipated in humans, since systemic concentrations of tafluprost are extremely low following ocular dosing. Therefore, specific interaction studies with other medicinal products have ...
Fertility, pregnancy and lactation
Women of childbearing potential/contraception Saflutan must not be used in women of childbearing age/potential unless adequate contraceptive measures are in place (see section 5.3). Pregnancy There are ...
Effects on ability to drive and use machines
Tafluprost has minor influence on the ability to drive and use machines. If transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machinery. ...
Undesirable effects
In clinical studies, over 1,400 patients have been treated with preserved tafluprost either as monotherapy or as adjunctive therapy to timolol 0.5%. The most frequently reported treatment-related adverse ...
Overdose
Overdose is unlikely to occur after ocular administration. If overdose occurs, treatment should be symptomatic.
Pharmacodynamic properties
Pharmacotherapeutic group: Antiglaucoma preparations and miotics, prostaglandin analogues ATC code: S01EE05 Mechanism of action Tafluprost is a fluorinated analogue of prostaglandin F2α. Tafluprost acid, ...
Pharmacokinetic properties
Absorption After once daily administration of one drop of unpreserved tafluprost 0.0015% eye drops to both eyes for 8 days, plasma concentrations of tafluprost acid were low and had similar profiles on ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, systemic repeated dose toxicity, genotoxicity and carcinogenic potential. As with other PGF2 ...
List of excipients
Glycerol Sodium dihydrogen phosphate dihydrate Disodium edetate Polysorbate 80 Hydrochloric acid and/or sodium hydroxide (for pH adjustment) Water for injections
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years. After first opening the bottle: 28 days.
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. After opening: Store below 25°C. Store in the original carton in order to protect from light.
Nature and contents of container
Transparent low-density polyethylene (LDPE) bottles with white Aptar OSD (polyethylene, polypropylene, cyclic olefin copolymer) with blue polyethylene cap packed in a PET coated aluminium/polyethylene ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Santen Oy, Niittyhaankatu 20, 33720, Tampere, Finland
Marketing authorization number(s)
PL 16058/0026
Date of first authorization / renewal of the authorization
11/02/2019
Date of revision of the text
16/12/2019
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