CELLUVISC Eye drops, solution (2014)
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Περιεχόμενα
Name of the medicinal product
Celluvisc 0.5% w/v, eye drops, solution, unit dose.
Qualitative and quantitative composition
1 ml contains 5mg carmellose sodium. For the full list of excipients, see section 6.1.
Pharmaceutical form
Eye drops, solution in single-dose container. Clear, colourless to slightly yellow solution.
Therapeutic indications
Tear substitute. Treatment of the symptoms of dry eye.
Posology and method of administration
Instil 1-2 drops in the affected eye/s 4 times a day or as needed. Ensure that the single-dose container is intact before use. The eye drop solution should be used immediately after opening. To avoid contamination ...
Contraindications
Hypersensitivity to carmellose sodium or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
If irritation, pain, redness or changes in vision occur or if the patients condition is worsened treatment discontinuation should be considered and a new assessment made.
Interaction with other medicinal products and other forms of interaction
None known. For the use of concomitant ocular products, see section 4.2.
Pregnancy and lactation
Pregnancy and Breast-feeding Due to the negligible systemic exposure and the lack of pharmacological activity Celluvisc can be used during pregnancy and breast-feeding.
Effects on ability to drive and use machines
Celluvisc may cause transient blurring of vision which may impair the ability to drive or operate machines. The patient should wait until their vision has cleared before driving or using machinery.
Undesirable effects
The frequency of adverse reactions documented during clinical trials is given. The frequency is defined as follows: Very Common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1,000, <1/100); Rare (≥1/10,000, ...
Overdose
Accidental overdose will present no hazard.
Pharmacodynamic properties
Pharmacotherapeutic group: Other ophthalmologicals ATC code: S01XA20 Carmellose sodium has no pharmacological effect. Carmellose sodium has a high viscosity resulting in an increased retention time on ...
Pharmacokinetic properties
Due to the high molecular weight (approx. 90,000 Daltons) carmellose sodium is unlikely to penetrate the cornea.
Preclinical safety data
There are no preclinical data considered relevant to clinical safety beyond data included in other sections of the SPC.
List of excipients
Sodium chloride Sodium lactate Potassium chloride Calcium chloride dihydrate Magnesium chloride hexahydrate Sodium hydroxide or hydrochloric acid (for pH adjustment) Purified water
Incompatibilities
Not applicable.
Shelf life
Shelf life: 18 months. After first opening: Use immediately.
Special precautions for storage
Do not store above 25ºC.
Nature and contents of container
0.4 ml in LDPE single-dose container. Pack sizes: 5, 30 or 90 single-dose containers. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Discard any unused solution in opened container i.e. do not re-use container for subsequent doses.
Marketing authorization holder
Allergan Pharmaceuticals Ireland, Castlebar Road, Westport, County Mayo, Ireland
Marketing authorization number(s)
PL 41443/0011
Date of first authorization / renewal of the authorization
21/05/2010
Date of revision of the text
May 2014. Version 3.
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