VERKAZIA Eye drops, emulsion (2020)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
1. Name of the medicinal product
Verkazia 1 mg/mL eye drops, emulsion.
2. Qualitative and quantitative composition
One mL of emulsion contains 1 mg of ciclosporin. <u>Excipient with known effect:</u> One mL of emulsion contains 0.05 mg cetalkonium chloride (see section 4.4). For the full list of excipients, see section ...
3. Pharmaceutical form
Eye drops, emulsion. Milky white emulsion.
4.1. Therapeutic indications
Treatment of severe vernal keratoconjunctivitis (VKC) in children from 4 years of age and adolescents.
4.2. Posology and method of administration
Verkazia treatment must be initiated by an ophthalmologist or a healthcare professional qualified in ophthalmology. Posology Children from 4 years of age and adolescents The recommended dose is one drop ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Ocular or peri-ocular malignancies or premalignant conditions Active or suspected ocular or peri-ocular infection. ...
4.4. Special warnings and precautions for use
Contact lenses Patients wearing contact lenses have not been studied. Therefore, the use of Verkazia with contact lenses is not recommended. Concomitant therapy Co-administration of Verkazia with eye drops ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed with Verkazia. Combination with other medicinal products that affect the immune system Co-administration of Verkazia with eye drops containing corticosteroids ...
4.6. Fertility, pregnancy and lactation
Women of childbearing potential/contraception in females Verkazia is not recommended in women of childbearing potential not using effective contraception. Pregnancy There are no data from the use of Verkazia ...
4.7. Effects on ability to drive and use machines
Verkazia has moderate influence on the ability to drive and use machines. This medicinal product may induce temporary blurred vision or other visual disturbances which may affect the ability to drive or ...
4.8. Undesirable effects
Summary of the safety profile The most common adverse reactions in the clinicial trials with Verkazia were eye pain (11%) and eye pruritus (9%) which were usually transitory and occurred during instillation. ...
4.9. Overdose
A topical overdose is not likely to occur after ocular administration. If overdose with Verkazia occurs, treatment should be symptomatic and supportive.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Ophthalmologicals, other ophthalmologicals <b>ATC code:</b> S01XA18 Mechanism of action and pharmacodynamic effects Following ocular administration, ciclosporin is passively ...
5.2. Pharmacokinetic properties
Formal pharmacokinetic studies have not been conducted in humans with Verkazia. Blood concentrations of Verkazia were measured using a specific high-pressure liquid chromatography-mass spectrometry assay. ...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, phototoxicity and photoallergy, genotoxicity, carcinogenic potential, ...
6.1. List of excipients
Medium-chain triglycerides Cetalkonium chloride Glycerol Tyloxapol Poloxamer 188 Sodium hydroxide (to adjust pH) Water for injections
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not freeze. Store below 30°C. Keep single-dose containers in the pouch in order to protect from light and avoid evaporation. Discard the opened single-dose container immediately after use.
6.5. Nature and contents of container
0.3 mL single-dose, low-density polyethylene (LDPE) containers in a sealed laminate aluminium pouch. One pouch contains 5 single-dose containers. Pack sizes of 30, 60, 90 or 120 single-dose containers. ...
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Santen Oy, Niittyhaankatu 20, 33720 Tampere, Finland
8. Marketing authorization number(s)
EU/1/17/1219/001 EU/1/17/1219/002 EU/1/17/1219/003 EU/1/17/1219/004
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