OPTILAST Eye drops (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Optilast. 0.5 mg/ml, Eye Drops, solution.
Qualitative and quantitative composition
Azelastine hydrochloride 0.05% (0.5 mg/ml). Each drop contains 0.015 mg azelastine hydrochloride. Excipient with known effect: 1 ml contains 0.125 mg benzalkonium chloride. For the full list of excipients ...
Pharmaceutical form
Eye drops, solution. Clear, colourless solution.
Therapeutic indications
Treatment and prevention of the symptoms of seasonal allergic conjunctivitis in adults and children 4 years and older. Treatment of the symptoms of non-seasonal (perennial) allergic conjunctivitis in adults ...
Posology and method of administration
Seasonal allergic conjunctivitis: The usual dosage in adults and children 4 years and older is one drop in each eye twice daily that can be increased, if necessary to four times daily. If allergen exposure ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Optilast is not intended for treatment of eye infections. Further warnings see 4.5 and 4.6. Optilast eye drops contains the preservative benzalkonium chloride. Benzalkonium chloride may cause eye irritation, ...
Interaction with other medicinal products and other forms of interaction
No specific interaction studies with Optilast have been performed. Interaction studies at high oral doses of Azelastine have been performed however they bear no relevance to Optilast, as systemic levels, ...
Fertility, pregnancy and lactation
Fertility Effects on human fertility have not been investigated Pregnancy There is insufficient information available to establish the safety of azelastine in human pregnancy. At high oral doses azelastine ...
Effects on ability to drive and use machines
The mild, transient irritation which can be experienced after application of Optilast is unlikely to affect vision to any greater extent. However, if there are any transient effects on vision, the patient ...
Undesirable effects
The assessment of undesirable effects is based on the following frequencies: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) ...
Overdose
No specific reactions after ocular overdosage are known, and with the ocular route of administration, overdosage reactions are not anticipated. There is no experience with the administration of toxic doses ...
Pharmacodynamic properties
Antiallergic ATC code: S01GX07 Azelastine, a phthalazinone derivative is classified as a potent long-acting anti-allergic compound with selective H1 antagonist properties. An additional anti-inflammatory ...
Pharmacokinetic properties
General characteristics (systemic pharmacokinetics) Following oral administration azelastine is rapidly absorbed showing an absolute bioavailability of 81%. Food has no influence on absorption. The volume ...
Preclinical safety data
Azelastine hydrochloride displayed no sensitising potential in the guinea pig. Azelastine demonstrated no genotoxic potential in a battery of in vitro and in vivo tests, nor any carcinogenic potential ...
List of excipients
Benzalkonium chloride (preservative) Disodium edetate Hypromellose Sorbitol (crystallising) Sodium hydroxide Water for injections
Incompatibilities
None known.
Shelf life
3 years. Do not use for longer than 4 weeks after first opening.
Special precautions for storage
No special precautions for storage.
Nature and contents of container
10 ml opaque HDPE bottle and LDPE dropper with white HDPE screw cap. One bottle contains either 6 ml, 8 ml or 10 ml solution. Not all volume fill sizes are marketed in all Member States.
Special precautions for disposal and other handling
This medicinal product does not require any special storage conditions.
Marketing authorization holder
Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Marketing authorization number(s)
PL 46302/0136
Date of first authorization / renewal of the authorization
1<sup>st</sup> August 2009
Date of revision of the text
October 2018
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