OPATANOL Eye drops, solution (2022)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Opatanol 1 mg/mL eye drops, solution.
Qualitative and quantitative composition
One mL of solution contains 1 mg olopatadine (as hydrochloride). <u>Excipient(s) with known effect:</u> Benzalkonium chloride 0.1 mg/ml. Disodium phosphate dodecahydrate (E339) 12.61 mg/ml (equivalent ...
Pharmaceutical form
Eye drops, solution (eye drops). Clear, colourless solution.
Therapeutic indications
Treatment of ocular signs and symptoms of seasonal allergic conjunctivitis.
Posology and method of administration
Posology The dose is one drop of Opatanol in the conjunctival sac of the affected eye(s) twice daily (8 hourly). Treatment may be maintained for up to four months, if considered necessary. Use in elderly ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Opatanol is an antiallergic/antihistaminic agent and, although administered topically, is absorbed systemically. If signs of serious reactions or hypersensitivity occur, discontinue the use of this treatment. ...
Interaction with other medicinal products and other forms of interaction
No interaction studies with other medicinal products have been performed. <em>In vitro</em> studies have shown that olopatadine did not inhibit metabolic reactions which involve cytochrome P-450 isozymes ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of ophthalmic olopatadine in pregnant women. Studies in animals have shown reproductive toxicity following systemic administration (see section ...
Effects on ability to drive and use machines
Opatanol has no or negligible influence on the ability to drive and use machines. As with any eye drop, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. ...
Undesirable effects
Summary of safety profile In clinical studies involving 1680 patients, Opatanol was administered one to four times daily in both eyes for up to four months as monotherapy or adjunctive therapy to loratadine ...
Overdose
No data are available in humans regarding overdose by accidental or deliberate ingestion. Olopatadine has a low order of acute toxicity in animals. Accidental ingestion of the entire contents of a bottle ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> ophthalmologicals; decongestant and antiallergics; other antiallergics <b>ATC code:</b> S01GX09 Olopatadine is a potent selective antiallergic/antihistaminic agent that ...
Pharmacokinetic properties
Absorption Olopatadine is absorbed systemically, as are other topically administered medicinal products. However, systemic absorption of topically applied olopatadine is minimal with plasma concentrations ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction. ...
List of excipients
Benzalkonium chloride Sodium chloride Disodium phosphate dodecahydrate (E339) Hydrochloric acid (E507) (to adjust pH) Sodium hydroxide (E524) (to adjust pH) Purified water
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
<u>Shelf-life:</u> 3 years. <u>Shelf-life after first opening:</u> Discard four weeks after first opening.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
5 ml opaque low density polyethylene bottles with polypropylene screw caps. Cartons containing 1 or 3 bottles. Not all pack sizes may be marketed.
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/1/02/217/001-002
Date of first authorization / renewal of the authorization
Date of first authorisation: 17 May 2002 Date of latest renewal: 22 May 2007
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