Jetrea

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Ocriplasmin 2.5 mg/mL

Tilgjengelig fra:

Pharmaco (NZ) Ltd

INN (International Name):

Ocriplasmin 2.5 mg/mL

Dosering :

2.5 mg/mL

Legemiddelform:

Concentrate for injection

Sammensetning:

Active: Ocriplasmin 2.5 mg/mL Excipient: Citric acid monohydrate Mannitol Sodium hydroxide Water for injection

Resept typen:

Prescription

Produsert av:

Fujifilm Diosynth Biotechnologies UK Ltd

Indikasjoner:

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.

Produkt oppsummering:

Package - Contents - Shelf Life: Vial, glass, - 0.2 mL - 36 months from date of manufacture stored below -20°C (Deep freeze) protect from light

Autorisasjon dato:

2013-04-16

Informasjon til brukeren

JETREA* CONSUMER MEDICINE INFORMATION
PAGE 1
JETREA* (OCRIPLASMIN 0.5 MG/0.2 ML)
CONCENTRATED SOLUTION FOR INTRAVITREAL INJECTION AFTER DILUTION
)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about JETREA*. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using JETREA
against the benefits it is expected
to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT IS JETREA USED
FOR?
JETREA is used to treat adults with
an eye disease called
vitreomacular traction (VMT),
including when it is associated with
a small to medium macular hole in
the macular (central part of the
light-sensitive layer at the back of
the eye).
As a person gets older, the vitreous
(jelly-like material in the centre of
the eye) shrinks and separates
from the retina (the light-sensitive
layer in the back of the eye). VMT
occurs when the vitreous remains
attached to the central part of the
retina (called macula). The macula
provides central vision that is
needed for everyday tasks such as
driving, reading and recognising
faces.
The symptoms of VMT include
distorted, blurred or decreased
vision and potentially a defect in
central vision. When the disease
progresses, the shrinking vitreous
may pull the macula away from the
back of the eye and eventually may
result in the formation of a hole in
the macula (called macular hole).
JETREA contains active ingredient
called ocriplasmin, which works by
separating the vitreous from the
macula and helping to close the
macular hole, if one is present,
which may decrease symptoms
caused by VMT.
Ocriplasmin is a form of human
plasmin which is an enzyme.
Before prescribing JETREA
for
you, your doctor will have
examined the eye and decided that
JETREA is the right medicine for
your eye condition.
Ask

Preparatomtale

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
JETREA® (ocriplasmin 0.5 mg/0.2 mL) Concentrated Solution for
Intravitreal Injection after
Dilution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
JETREA is a sterile, clear and colourless solution with no
preservatives in a single-use glass
vial containing 0.5 mg ocriplasmin* in 0.2 mL fill product.
JETREA drug product solution is to be diluted with an equal volume of
0.9% (w/v) sodium
chloride prior to use. After dilution with 0.2 mL of 0.9% sodium
chloride (preservative-free),
0.1 mL of the diluted solution contains 0.125 mg ocriplasmin.
*Ocriplasmin (ryp) is a recombinant truncated form of human plasmin
with a molecular
weight of 27.2 kDa produced by recombinant DNA technology in a Pichia
pastoris expression
system.
The chemical structure of ocriplasmin (ryp) is:
Molecular weight: 27.2 kDa
Chemical name: microplasmin; recombinant truncated human plasmin
CAS Number: 1048016-09-6
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for intravitreal injection (sterile
concentrate).
Clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
JETREA is indicated in adults for the treatment of vitreomacular
traction (VMT), including
2
when associated with macular hole of diameter less than or equal to
400 microns.
4.2
DOSE AND METHOD OF ADMINISTRATION
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).
JETREA
®
solution for injection must be prepared and administered by a
qualified
ophthalmologist experienced in intravitreal injections. Single use
vial is for intravitreal
use only.
DOSE
The recommended dose is 0.125 mg (0.1 mL of the diluted 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. Administratio