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IKERVIS Eye drops, emulsion (2017)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

IKERVIS 1 mg/mL eye drops, emulsion.

Qualitative and quantitative composition

One mL of emulsion contains 1 mg of ciclosporin. Excipient with known effect: One mL of emulsion contains 0.05 mg cetalkonium chloride (see section 4.4). For the full list of excipients, see section 6.1. ...

Pharmaceutical form

Eye drops, emulsion. Milky white emulsion.

Therapeutic indications

Treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes (see section 5.1).

Posology and method of administration

IKERVIS treatment must be initiated by an ophthalmologist or a healthcare professional qualified in ophthalmology. Posology Adults The recommended dose is one drop of IKERVIS once daily to be applied to ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active or suspected ocular or peri-ocular infection.

Special warnings and precautions for use

IKERVIS has not been studied in patients with a history of ocular herpes and should therefore be used with caution in such patients. Contact lenses Patients wearing contact lenses have not been studied. ...

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed with IKERVIS. Combination with other medicinal products that affect the immune system Co-administration of IKERVIS with eye drops containing corticosteroids could ...

Fertility, pregnancy and lactation

Women of childbearing potential/contraception in females IKERVIS is not recommended in women of childbearing potential not using effective contraception. Pregnancy There is no data from the use of IKERVIS ...

Effects on ability to drive and use machines

IKERVIS 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 ...

Undesirable effects

Summary of the safety profile In five clinical studies including 532 patients who received IKERVIS and 398 who received IKERVIS vehicle (control), IKERVIS was administered at least once a day in both eyes, ...

Overdose

A topical overdose is not likely to occur after ocular administration. If overdose with IKERVIS occurs, treatment should be symptomatic and supportive.

Pharmacodynamic properties

Pharmacotherapeutic group: Ophthalmologicals, other ophthalmologicals ATC code: S01XA18 Mechanism of action and pharmacodynamic effects Ciclosporin (also known as ciclosporin A) is a cyclic polypeptide ...

Pharmacokinetic properties

Formal pharmacokinetic studies have not been conducted in humans with IKERVIS. Blood concentrations of IKERVIS were measured using a specific high-pressure liquid chromatography-mass spectrometry assay. ...

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, ...

List of excipients

Medium-chain triglycerides Cetalkonium chloride Glycerol Tyloxapol Poloxamer 188 Sodium hydroxide (to adjust pH) Water for injections

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Do not freeze. After opening of the aluminium pouches, the single-dose containers should be kept in the pouches in order to protect from light and avoid evaporation. Any opened individual single-dose container ...

Nature and contents of container

IKERVIS is supplied in 0.3 mL single-dose, low-density polyethylene (LDPE) containers presented in a sealed laminate aluminium pouch. One pouch contains five single-dose containers. Pack sizes: 30 and ...

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

SANTEN Oy, Niittyhaankatu 20, 33720, Tampere, Finland

Marketing authorization number(s)

EU/1/15/990/001 EU/1/15/990/002

Date of first authorization / renewal of the authorization

Date of first authorisation: 19 March 2015

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