Jetrea

Šalis: Europos Sąjunga

kalba: anglų

Šaltinis: EMA (European Medicines Agency)

Veiklioji medžiaga:

ocriplasmin

Prieinama:

Inceptua AB

ATC kodas:

S01XA22

INN (Tarptautinis Pavadinimas):

ocriplasmin

Farmakoterapinė grupė:

Ophthalmologicals

Gydymo sritis:

Retinal Diseases

Terapinės indikacijos:

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.

Produkto santrauka:

Revision: 15

Autorizacija statusas:

Authorised

Leidimo data:

2013-03-13

Pakuotės lapelis

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

Prekės savybės

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