ZADITEN Eye drops, solution (2020)
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Περιεχόμενα
Name of the medicinal product
Zaditen 0.25 mg/ml, eye drops, solution.
Qualitative and quantitative composition
One ml contains 0.345 mg ketotifen fumarate corresponding to 0.25 mg ketotifen. Each drop contains 8.5 microgram ketotifen fumarate. Excipient(s) with known effect: Benzalkonium chloride (0.1 mg/ml). ...
Pharmaceutical form
Eye drops, solution. Clear, colourless to faintly yellow solution.
Therapeutic indications
Symptomatic treatment of seasonal allergic conjunctivitis.
Posology and method of administration
Posology Adults, elderly and children (age 3 and older) One drop of Zaditen into the conjunctival sac twice a day. Paediatric population The safety and efficacy of Zaditen in children aged from birth to ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
This medicine contains 2.6 micrograms benzalkonium chloride in each drop. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. Remove contact lenses ...
Interaction with other medicinal products and other forms of interaction
If Zaditen is used concomitantly with other eye medications there must be an interval of at least 5 minutes between the two medications. The use of oral dosage forms of ketotifen may potentiate the effect ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of ketotifen eye drops in pregnant women. Animal studies using maternally toxic oral doses showed increased pre-and postnatal mortality, but no teratogenicity. ...
Effects on ability to drive and use machines
Any patient who experiences blurred vision or somnolence should not drive or operate machines.
Undesirable effects
Adverse reactions are ranked under heading of frequency, using the following convention: 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 ...
Overdose
No case of overdose has been reported. Oral ingestion of the contents of a 5 ml bottle would be equivalent to 1.25 mg of ketotifen which is 60% of a recommended oral daily dose for a 3 year old child. ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Ophthalmologicals, other anti-allergics <b>ATC code:</b> S01GX08 Ketotifen is a histamine H<sub>1</sub>-receptor antagonist. <em>In vivo</em> animal studies and <em>in ...
Pharmacokinetic properties
In a pharmacokinetic study conducted in 18 healthy volunteers with Zaditen eye drops, plasma levels of ketotifen after repeated ocular administration for 14 days were in most cases below the limit of quantitation ...
Preclinical safety data
Preclinical data reveal no special hazard which is considered relevant in connection with use of Zaditen eye drops in humans based on conventional studies of safety pharmacology, repeated dose toxicity, ...
List of excipients
Benzalkonium chloride Glycerol (E422) Sodium hydroxide (E524) Water for injections
Incompatibilities
Not applicable.
Shelf life
<u>Unopened bottle:</u> 2 years. <u>After opening:</u> 4 weeks.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
The container is a white-coloured LDPE bottle with a transparent LDPE dropper and a white HDPE screw cap with an integrated safety ring. One bottle contains 5 ml of the solution.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Laboratoires Thea, 12, rue Louis Blériot, 63017 Clermont-Ferrand Cedex 2, France
Marketing authorization number(s)
PA1107/010/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 24 November 2000 Date of last renewal: 30 June 2010
Date of revision of the text
October 2020
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