BEOVU brolucizumab (rbe) 120 mg/mL solution for injection in vial

দেশ: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

brolucizumab, Quantity: 120 mg/mL

থেকে পাওয়া:

Novartis Pharmaceuticals Australia Pty Ltd

ফার্মাসিউটিকাল ফর্ম:

Injection, solution

রচনা:

Excipient Ingredients: sodium citrate; sucrose; polysorbate 80; water for injections

প্রশাসন রুট:

Intravitreal-Within The Vitreous Cavity Of The Eye

প্যাকেজ ইউনিট:

1 unit pack containing 1 vial and 1 filter needle

প্রেসক্রিপশন টাইপ:

(S4) Prescription Only Medicine

থেরাপিউটিক ইঙ্গিত:

Beovu is indicated for the treatment of: - neovascular (wet) age-related macular degeneration (AMD). - diabetic macular oedema (DME)

পণ্য সারাংশ:

Visual Identification: Sterile, clear to slightly opalescent, colourless to slightly brownish yellow and preservative free aqueous solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

2020-01-16

পণ্য বৈশিষ্ট্য

1
This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any suspected
adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION – BEOVU
® (BROLUCIZUMAB)
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Brolucizumab (_rbe_)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL solution for injection contains 120 mg of brolucizumab*.
*Brolucizumab is a humanised monoclonal single-chain Fv (scFv)
antibody fragment with a molecular
weight of ~26 kDa, produced in _Escherichia coli_ cells by recombinant
DNA technology.
Beovu 120 mg/mL solution for injection in pre-filled syringe
Each pre-filled syringe contains 19.8 mg brolucizumab in 0.165 mL
solution. This provides a usable
amount to deliver a single dose of 0.05 mL containing 6 mg of
brolucizumab.
Beovu 120 mg/mL solution for injection in vial
Each vial contains 27.6 mg brolucizumab in 0.230 mL solution. This
provides a usable amount to
deliver a single dose of 0.05 mL containing 6 mg of brolucizumab.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Solution for injection.
Sterile, clear to slightly opalescent, colourless to slightly
brownish-yellow and preservative-free
aqueous solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Beovu is indicated for the treatment of:
•
Neovascular (wet) age-related macular degeneration (AMD),
•
Diabetic macular oedema (DME).
4.2
D
OSE AND METHOD OF ADMINISTRATION
Beovu must be administered by a qualified ophthalmologist experienced
in administering intravitreal
injections.
▼

2
DOSAGE
_WET AMD _
The recommended dose is 6 mg brolucizumab (0.05 mL solution)
administered by intravitreal
injection every 4 weeks (monthly) for the first 3 doses. Thereafter,
the physician may individualise
treatment intervals based on disease activity as assessed by visual
acuity and/or anatomical
parameters. A disease activity assessment is sugg