VIDISIC 0.2% w/w Eye gel (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Vidisic 0.2% w/w Eye Gel.
2. Qualitative and quantitative composition
The product contains carbomer 0.2% w/w. For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Eye gel. Sterile, colourless, clear, aqueous eye gel, without visible particles.
4.1. Therapeutic indications
For symptomtic relief of dry eyes associated with the sicca syndrome.
4.2. Posology and method of administration
Posology One drop into the conjunctive sac 3-5 times per day. Children and adolescents aged to 18 years The safety and efficacy of Vidisic 0.2% w/w Eye Gel in children and adolescents at the posology recommended ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Should not be used for undiagnosed conjunctivitis.
4.4. Special warnings and precautions for use
Wearers of contact lenses should remove their lenses before Vidisic is instilled and should wait for 15 minutes before they insert them again. Intolerance reactions to one of the ingredients may be seen ...
4.5. Interaction with other medicinal products and other forms of interaction
Vidisic may prolong the contact-time of topically applied drugs in ophthalmology. Concomitant ocular medication should be administered 15 minutes prior to the instillation of Vidisic. Vidisic should always ...
4.6. Pregnancy and lactation
Safety of Carbomer for use in pregnancy and lactation has not been established. Vidisic gel should not be used in pregnancy and lactation unless it is considered by the patients physician that the benefits ...
4.7. Effects on ability to drive and use machines
Even when administered as directed, this product may cause a transient blurring in vision and patients should exercise caution when driving or operating machinery.
4.8. Undesirable effects
Vidisic Gel is generally well tolerated. The following adverse reactions have been reported rarely: Local burning, irritation, stinging, swelling, redness and inflammation of the eye. If Vidisic Gel causes ...
4.9. Overdose
Not relevant.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Ophthalmologicals: other ophthalmologicals <b>ATC code:</b> S0lXA20 Mechanism of action Vidisic Gel is a substitute for lacrimal fluid. The gel structure has high water-binding ...
5.2. Pharmacokinetic properties
Absorption In pharmacokinetic studies, radioactive carbomer was administered to rats. It could be shown that only a small amount of carbomer is absorbed. As systemic absorption of ocular administration ...
5.3. Preclinical safety data
The LD<sub>50</sub> value could not be ascertained due to the low toxicity. In studies on rats, no deaths were observed at a concentration of 625 mg/kg carbomer. Oral doses of 0.5, 1.0 and 3.0 g/kg bodyweight ...
6.1. List of excipients
Cetrimide Sorbitol Water for injections Sodium hydroxide
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years as packaged for sale. Discard tube 1 month after first opening.
6.4. Special precautions for storage
Do not store above 30°C.
6.5. Nature and contents of container
Polyfoil (HDPE-lined, aluminium, co-polymer layered) tube with HDPE cap. <u>Pack size:</u> 10 g.
6.6. Special precautions for disposal and other handling
Avoid contamination during use. Sterile until opened. Hold the tube in an upright position so that a small drop, which falls easily from the tip, is formed. Any unused medicinal product or waste material ...
7. Marketing authorization holder
Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
8. Marketing authorization number(s)
PA22698/002/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 11<sup>th</sup> August 1993 Date of last renewal: 11<sup>th</sup> August 2008
10. Date of revision of the text
30 June 2020
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