MONOPOST Eye drops, solution (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
MONOPOST 50 micrograms/ml eye drops, solution in single-dose container.
2. Qualitative and quantitative composition
1 ml eye drops solution contains 50 micrograms of latanoprost. One drop contains approximately 1.5 micrograms of latanoprost. <u>Excipient with known effect:</u> 1 ml eye drops solution contains 50 mg ...
3. Pharmaceutical form
Eye drops, solution in single-dose container. The solution is a slightly yellow and opalescent solution. pH: 6.5–7.5 Osmolality: 250-310 mosmol/kg.
4.1. Therapeutic indications
Reduction of elevated intraocular pressure in patients with open angle glaucoma and ocular hypertension.
4.2. Posology and method of administration
Posology Recommended dosage for adults (including the elderly) Recommended therapy is one eye drop in the affected eye(s) once daily. Optimal effect is obtained if MONOPOST is administered in the evening. ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Latanoprost may gradually change eye colour by increasing the amount of brown pigment in the iris. Before treatment is instituted, patients should be informed of the possibility of a permanent change in ...
4.5. Interaction with other medicinal products and other forms of interaction
Definitive drug interaction data are not available. There have been reports of paradoxical elevations in intraocular pressure following the concomitant ophthalmic administration of two prostaglandin analogues. ...
4.6. Fertility, pregnancy and lactation
Fertility Latanoprost has not been found to have any effect on male or female fertility in animal studies (see section 5.3). Pregnancy The safety of this medicinal product for use in human pregnancy has ...
4.7. Effects on ability to drive and use machines
No studies on the effect of this medicinal product on the ability to drive have been conducted. In common with other eye preparations, instillation of eye drops may cause transient blurring of vision. ...
4.8. Undesirable effects
a. Summary of the safety profile The majority of adverse events relate to the ocular system. In an open 5-year latanoprost reference product safety study, 33% of patients developed iris pigmentation (see ...
4.9. Overdose
Apart from ocular irritation and conjunctival hyperaemia, no other ocular side effects are known if MONOPOST is overdosed. If MONOPOST is accidentally ingested the following information may be useful: ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> ANTIGLAUCOMA PREPARATIONS AND MIOTICS; Prostaglandin analogues <b>ATC code:</b> S01EE01 Mechanism of action The active substance latanoprost, a prostaglandin F2αanalogue, ...
5.2. Pharmacokinetic properties
Latanoprost (mw 432.58) is an isopropyl ester prodrug which per se is inactive, but after hydrolysis to the acid of latanoprost becomes biologically active. Absorption The prodrug is well absorbed through ...
5.3. Preclinical safety data
The ocular as well as systemic toxicity of latanoprost has been investigated in several animal species. Generally, latanoprost is well tolerated with a safety margin between clinical ocular dose and systemic ...
6.1. List of excipients
Macrogolglycerol hydroxystearate 40 Sorbitol Carbomer 974 P Macrogol 4000 Disodium edetate Sodium hydroxide (for pH adjustment) Water for injections
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years in the outer packaging. After first opening of the sachet, use the single-dose containers within 10 days. After first opening of the single-dose container: use immediately and discard the single-dose ...
6.4. Special precautions for storage
Store below 25°C. For storage after first opening of the medicinal product, see section 6.3.
6.5. Nature and contents of container
5 or 10 single-dose containers (LDPE) containing 0.2 ml of eye drops solution are packed in sachet (copolymers/aluminium/polyethylene/paper or PE/aluminium/polyethylene/PET). A pack size contains 5 (1x5), ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
LABORATOIRES THEA, 12 RUE LOUIS BLERIOT, 63017 CLERMONT-FERRAND CEDEX 2, France
8. Marketing authorization number(s)
PL 20162/0015
9. Date of first authorization / renewal of the authorization
09/11/2012
10. Date of revision of the text
10/04/2020
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