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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

JETREA Concentrate for solution for injection (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

JETREA 0.5 mg/0.2 mL concentrate for solution for injection.

Qualitative and quantitative composition

Each vial contains 0.5 mg of ocriplasmin* in 0.2 mL solution. After dilution with 0.2 mL of sodium chloride 9 mg/mL (0.9%) solution for injection, 0.1 mL of the diluted solution contains 0.125 mg ocriplasmin. ...

Pharmaceutical form

Concentrate for solution for injection (sterile concentrate). Clear and colourless solution.

Therapeutic indications

JETREA is indicated in adults for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns (see section 5.1).

Posology and method of administration

JETREA must be prepared and administered by a qualified ophthalmologist experienced in intravitreal injections. The diagnosis of vitreomacular traction (VMT) should comprise of a complete clinical picture ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active or suspected ocular or periocular infections.

Special warnings and precautions for use

Post-injection monitoring JETREA is administered by intravitreal injection only. Intravitreal injections have been associated with intraocular inflammation/infection, intraocular haemorrhage and increased ...

Interaction with other medicinal products and other forms of interaction

No formal interaction studies have been performed. Ocriplasmin is a proteolytic enzyme with serine protease activity which could be present in the eye for several days after intravitreal injection (see ...

Fertility, pregnancy and lactation

Pregnancy There are no data for the use of JETREA in pregnant women. No reproductive toxicology studies have been performed. The systemic exposure of JETREA is expected to be very low after intravitreal ...

Effects on ability to drive and use machines

The intravitreal injection of JETREA may have a moderate influence on the ability to drive and use machines due to possible temporary visual disturbances (see section 4.8). In these cases, patients should ...

Undesirable effects

Summary of the safety profile Over 1400 patients have been treated with the recommended dose of 0.125 mg of JETREA in interventional clinical studies. All adverse reactions were ocular. In 3 clinical studies ...

Overdose

The clinical data on the effects of JETREA overdose are limited. One case of accidental overdose of 0.250 mg ocriplasmin (twice the recommended dose) has been reported. The patient had a decrease in BCVA ...

Pharmacodynamic properties

Pharmacotherapeutic group: Ophthalmologicals, Other ophthalmologicals ATC code: S01XA22 Mechanism of action Ocriplasmin has a proteolytic activity against protein components of the vitreous body and the ...

Pharmacokinetic properties

Ocriplasmin levels in the vitreous decrease rapidly after intravitreal administration. In a clinical study in patients scheduled for vitrectomy receiving 0.125 mg JETREA (corresponding to a theoretical ...

Preclinical safety data

The intravitreal toxicity of ocriplasmin has been evaluated in rabbits, monkeys and minipigs. Ocriplasmin induced an inflammatory response and transient ERG changes in rabbits and monkeys, while no inflammation ...

List of excipients

Mannitol Citric acid Sodium hydroxide (NaOH) (for pH adjustment) Water for injections

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, other than sterile, preservative-free, non-buffered diluent sodium chloride 9 mg/mL (0.9%) ...

Shelf life

3 years when stored in a freezer (-20°C ± 5°C). After thawing: The medicinal product should be diluted and used immediately. However, chemical and physical in-use stability of unopened product in the original ...

Special precautions for storage

Store in a freezer (-20°C ± 5°C). For storage conditions after thawing and opening/dilution of the medicinal product, see section 6.3.

Nature and contents of container

0.2 mL solution in a vial (type I glass) closed with a chlorobutyl rubber stopper and an orange polypropylene flip-off cap. Pack containing 1 vial.

Special precautions for disposal and other handling

Vials are for single use only. To prepare JETREA for intravitreal injection, adhere to the following instructions: 1. Remove the vial from the freezer and allow to thaw at room temperature (takes about ...

Marketing authorization holder

Oxurion NV, Gaston Geenslaan 1, B-3001, Leuven, Belgium

Marketing authorization number(s)

EU/1/13/819/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 13 March 2013 Date of latest renewal: 8 December 2017

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