Pagenax 120mgml Solution For Injection

Country: Malasja

Lingwa: Ingliż

Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredjent attiv:

Brolucizumab

Disponibbli minn:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Isem Internazzjonali):

Brolucizumab

Unitajiet fil-pakkett:

1 Vials

Manifatturat minn:

NOVARTIS PHARMA STEIN AG

Karatteristiċi tal-prodott

Novartis
Page 2
Malaysia Package Leaflet
13-Sep-2021
Pagenax
2
1.
NAME OF THE MEDICINAL PRODUCT
Pagenax 120 mg/ml solution for injection
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 produced in
_Escherichia coli_
cells by recombinant DNA technology.
Pagenax 120 mg/ml solution for injection
Each vial contains 27.6 mg brolucizumab in 0.23 ml solution. This
provides a usable amount to deliver
a single dose of 0.05 ml solution containing 6 mg of brolucizumab.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear to slightly opalescent, colourless to slightly brownish-yellow
aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pagenax is indicated in adults for the treatment of

neovascular (wet) age-related macular degeneration (AMD) (see section
5.1)

visual impairment due to diabetic macular oedema (DME) (see section
5.1)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Pagenax must be administered by a qualified ophthalmologist
experienced in intravitreal injections.
Posology
_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 suggested 16 weeks (4 months) after
treatment start. In patients without
disease activity, treatment every 12 weeks (3 months) should be
considered. In patients with disease
activity, treatment every 8 weeks (2 months) should be considered (see
sections 4.4 and 5.1).
If visual and anatomical outcomes indicate that the patient is not
benefiting from continued treatment,
Pagenax should be discontinued.
_DME _
The recommended dose is 6 mg brolucizumab (0.05 ml solution)
administered by intravit