Țară: Uniunea Europeană
Limbă: engleză
Sursă: EMA (European Medicines Agency)
ocriplasmin
Inceptua AB
S01XA22
ocriplasmin
Ophthalmologicals
Retinal Diseases
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.
Revision: 15
Authorised
2013-03-13
23 B. PACKAGE LEAFLET 24 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT JETREA 0.375 MG/0.3 ML SOLUTION FOR INJECTION Ocriplasmin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Jetrea is and what it is used for 2. What you need to know before you are given Jetrea 3. How Jetrea is given 4. Possible side effects 5. How Jetrea is stored 6. Contents of the pack and other information 1. WHAT JETREA IS AND WHAT IT IS USED FOR Jetrea contains the active substance ocriplasmin. Jetrea is used to treat adults with an eye disease called vitreomacular traction (VMT), including when it is associated with a small hole in the macula (central part of the light-sensitive layer at the back of the eye). VMT is caused by traction resulting from a persistent attachment of the vitreous humour (jelly-like material in the back of the eye) to the macula. The macula provides central vision that is needed for everyday tasks such as driving, reading and recognising faces. VMT can cause symptoms such as distorted or decreased vision. When the disease progresses the traction may eventually result in the formation of a hole in the macula (called a macular hole). Jetrea works by separating the vitreous humour from the macula, and helping to close the macular hole if one is present, which may decrease the symptoms caused by VMT. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN JETREA YOU MUST NOT BE GIVEN JETREA - if you are allergic to ocriplasmin or any of the other ingredients of this medicine (listed in section 6); - if you have (or suspect you may have) an infection in or around your eye. WARNINGS AND PRECAUTIONS Talk to your doctor/ophthalmologist before you are given Jetrea. Jetrea is given as an inject Citiți documentul complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT JETREA 0.375 mg/0.3 mL solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 0.375 mg of ocriplasmin * in 0.3 mL solution (1.25 mg/mL). This provides a usable amount to deliver a single dose of 0.1 mL containing 0.125 mg ocriplasmin. * Ocriplasmin is a truncated form of human plasmin produced by recombinant DNA technology in a Pichia pastoris expression system. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear and colourless solution. 4. CLINICAL PARTICULARS 4.1 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). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION JETREA must be administered by a qualified ophthalmologist experienced in intravitreal injections. The diagnosis of vitreomacular traction (VMT) should comprise of a complete clinical picture including patient history, clinical examination and investigation using currently accepted diagnostic tools, such as optical coherence tomography (OCT). Posology JETREA 0.375 mg/0.3 mL solution for injection is a ‘ready-diluted’ formulation, no further dilution is required. The recommended dose is 0.125 mg in 0.1 mL of the solution administered by intravitreal injection to the affected eye once as a single dose. Each vial should only be used once and for the treatment of a single eye. Treatment with JETREA in the other eye is not recommended concurrently or within 7 days of the initial injection in order to monitor the post-injection course including the potential for decreased vision in the injected eye. Repeated administration in the same eye is not recommended (see section 4.4). See section 4.4 for instructions on post-injection monitoring. Special populations Renal impairment No formal studies have been conducted with JETREA in patien Citiți documentul complet