Byooviz

Country: New Zealand

Bahasa: Inggeris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Ranibizumab 10 mg/mL

Boleh didapati daripada:

Samsung Bioepis NZ Limited

Dos:

10 mg/mL

Borang farmaseutikal:

Solution for injection

Komposisi:

Active: Ranibizumab 10 mg/mL Excipient: Histidine Histidine hydrochloride monohydrate Polysorbate 20 Trehalose dihydrate Water for injection

Jenis preskripsi:

Prescription

Tanda-tanda terapeutik:

Byooviz is indicated for: - the treatment of neovascular (wet) age-related macular degeneration (AMD), - the treatment of visual impairment due to diabetic macular oedema (DME), - treatment of proliferative diabetic retinopathy (PDR), - the treatment of visual impairment due to choroidal neovascularisation (CNV), - the treatment of visual impairment due to choroidal neovascularisation (CNV) secondary to pathologic myopia (PM), - the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO).

Ringkasan produk:

Package - Contents - Shelf Life: Vial, glass, Vial closed with rubber stopper and flip-off cap - 0.23 mL - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 1 months unopened stored at or below 30°C protect from light

Tarikh kebenaran:

2022-01-19

Risalah maklumat

_ _
Byooviz
TM
Version 0.1
_Byooviz - ranibizumab_
Page 1 / 4
BYOOVIZ
TM
_Ranibizumab (rbe) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Byooviz.
It does not contain all the
available information. It does
not take the place of talking to
your doctor or pharmacist.
The information in this leaflet
was last updated on the date
listed on the final page. More
recent information on the
medicine may be available.
YOU SHOULD ENSURE THAT YOU
SPEAK TO YOUR PHARMACIST OR
DOCTOR TO OBTAIN THE MOST UP-
TO-DATE INFORMATION ON THE
MEDICINE. YOU CAN ALSO
DOWNLOAD THE MOST UP-TO-
DATE LEAFLET FROM
WWW.MEDSAFE.GOVT.NZ
Those updates may contain
important information about
the medicine and its use of
which you should be aware.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you being
given Byooviz against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT BEING GIVEN THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT BYOOVIZ IS USED
FOR
Byooviz is used to treat problems
with your vision due to damage
to the retina (light-sensitive layer
at the back of the eye) caused by
growth of leaky, abnormal blood
vessels (choroidal
neovascularisation, CNV), in
diseases that may cause
decreased vision such as:
•
Wet age related macular
degeneration (wet AMD)
•
Diabetic macular edema
(DME), or edema due to
retinal vein occlusion
(RVO) where fluid
accumulates into the back
of the eye
•
Proliferative diabetic
retinopathy (PDR)
•
CNV secondary to
pathologic myopia (PM)
•
CNV due to causes such
as angioid streaks, post-
inflammatory
retinochoroidopathy,
central serous
chorioretinopathy, and
inflammatory CNV
Byooviz contains the active
substance ranibizumab, which
is part of an antibody.
Antibodies are proteins which
specifically recognise and bind
to other unique proteins in the
body. Ranibizumab binds
selectively to a protein called
human vascular endothelial
growth factor A (V

Ciri produk

NEW ZEALAND DATA SHEET
Page 1 of 32
1 PRODUCT NAME
BYOOVIZ
TM
Ranibizumab 10 mg/mL solution for injection
BYOOVIZ
TM
is a biosimilar medicine.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance
One mL contains 10 mg ranibizumab.
Each vial contains 2.3 mg of ranibizumab in 0.23 mL solution.
Ranibizumab is a humanised monoclonal antibody fragment produced in
Escherichia coli cells by
recombinant DNA technology.
For the full list of excipients, see section 6.1 List of excipients.
BYOOVIZ
TM
is a biosimilar medicine. The prescribing physician should be involved
in any decision
regarding interchangeability. For further information see:
www.medsafe.govt.nz/profs/RIss/Biosimilars.asp.
For more information on biosimilarity of
BYOOVIZ
TM
to Lucentis, see section 5.1, Clinical efficacy and safety.
3 PHARMACEUTICAL FORM
Solution for injection.
BYOOVIZ
TM
is supplied in a vial.
Sterile, clear, colourless to pale yellow and preservative-free
aqueous solution with pH range of 5.5
±0.3. The osmolality of the solution is 309 ± 69 mOsm/kg.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
BYOOVIZ
TM
is indicated for:

the treatment of neovascular (wet) age-related macular degeneration
(AMD),

the treatment of visual impairment due to diabetic macular oedema
(DME),

the treatment of proliferative diabetic retinopathy (PDR),

the treatment of visual impairment due to choroidal neovascularization
(CNV),

the treatment of visual impairment due to choroidal neovascularisation
(CNV) secondary to
pathologic myopia (PM),

the treatment of visual impairment due to macular oedema secondary to
retinal vein
occlusion (branch RVO or central RVO).
NEW ZEALAND DATA SHEET
Page 2 of 32
4.2
Dose and method of administration
Dosage regimen
Single-use vial for intravitreal use only. Use of more than one
injection from a vial can lead to
product contamination and subsequent ocular infection.
BYOOVIZ
TM
must be administered by a qualified ophthalmologist experienced in
intravitreal
injections.
The recommended dose for BYO