JETREA Concentrate for solution for injection (2019)
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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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