JETREA RTU ocriplasmin (ryp) 0.375 mg/0.3 mL solution for intravitreal injection vial

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

ocriplasmin, Quantity: 1.25 mg/mL

متاح من:

I-Care Pharma Distributors Pty Ltd

الشكل الصيدلاني:

Injection, solution

تركيب:

Excipient Ingredients: mannitol; citric acid monohydrate; sodium chloride; sodium hydroxide; hydrochloric acid; water for injections

طريقة التعاطي:

Intraocular

الوحدات في الحزمة:

0.3 mL

نوع الوصفة الطبية :

(S4) Prescription Only Medicine

الخصائص العلاجية:

JETREA RTU 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.

ملخص المنتج:

Visual Identification: Clear, colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at minus 20 plus or minus 5 degrees Celsius (deep freeze); Container Closure: Neither child resistant closure nor restricted flow insert

الوضع إذن:

Licence status A

تاريخ الترخيص:

2017-12-13

نشرة المعلومات

JETREA® RTU
0.375 MG/0.3 ML
SOLUTION FOR INTRAVITREAL INJECTION
_ocriplasmin _
CONSUMER MEDICINE INFORMATION
Jetrea RTU CMI Jul 19
1
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Jetrea RTU. 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 RTU
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 JETREA RTU IS USED
FOR
Jetrea RTU 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 RTU contains the active
ingredient 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 RTU for
you, your doctor will have
examined the eye and decided that
Jetrea RTU is the right medicine
for your eye condition.
Ask your doctor if you ha

خصائص المنتج

Jetrea RTU, version 10, July 2020
Page
1
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AUSTRALIAN PRODUCT INFORMATION – JETREA RTU
(OCRIPLASMIN) 0.375 MG/0.3 ML SOLUTION FOR INTRAVITREAL
INJECTION
1
NAME OF THE MEDICINE
JETREA® RTU (Ready To Use) solution for injection.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
Each vial contains 0.375 mg ocriplasmin and 0.1575 mg citric acid,
0.5625 mg mannitol, 1.35 mg
sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric
acid (for pH adjustment) and
water for injections with a pH of 3.1.
3
PHARMACEUTICAL FORM
JETREA RTU is a sterile, clear and colourless solution with no
preservatives in a single-use glass vial
containing 0.375 mg ocriplasmin in 0.3 mL fill product.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
JETREA RTU 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.
4.2
D
OSE 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 RTU solution for injection must be prepared and administered by
a qualified
ophthalmologist experienced in intravitreal injections. Single use
vial is for intravitreal use only.
ONLY 0.1 ML (0.125 MG) OF THE TOTAL 0.3 ML SOLUTION IN THE VIAL IS TO
BE 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. Administration to both eyes
concurrently or within 7 days of the initial injection is not
recommended in order to monitor the post-
injection course including the potential for decreased vision in the
injected eye. Repeated
administration in the sa