Benlysta Powder for Solution for Infusion 120mg

Quốc gia: Malaysia

Ngôn ngữ: Tiếng Anh

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

Thành phần hoạt chất:

BELIMUMAB

Sẵn có từ:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Tên quốc tế):

BELIMUMAB

Các đơn vị trong gói:

5ml mL

Sản xuất bởi:

GlaxoSmithKline Manufacturing S.p.A

Tờ rơi thông tin

Not Applicable

Đặc tính sản phẩm

CONFIDENTIAL
[GSK logo]
BENLYSTA
BELIMUMAB
QUALITATIVE AND QUANTITATIVE COMPOSITION
120 mg vial
Each vial contains 120 mg belimumab (80 mg/mL after reconstitution).
Belimumab is a human, IgG1λ monoclonal antibody specific for soluble
human B Lymphocyte
Stimulator protein (BLyS). Belimumab is produced by recombinant DNA
technology in a
mammalian cell expression system.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to off-white powder.
CLINICAL PARTICULARS
INDICATIONS
_BENLYSTA _is indicated for:
•
reducing disease activity in adult patients with active autoantibody
positive systemic
lupus erythematosus (SLE) who are receiving standard therapy.
•
treatment of active lupus nephritis in adult patients in combination
with background
immunosuppressive therapies (_see Dosage and Administration_).
Benlysta has not been studied and is therefore not recommended in
patients with severe
active central nervous system lupus.
DOSAGE AND ADMINISTRATION
_BENLYSTA _is administered intravenously by infusion, and must be
reconstituted and
diluted
prior to administration (_see Use and Handling_).
_BENLYSTA _treatment should be initiated and supervised by a qualified
physician
experienced
in the diagnosis and treatment of SLE._ _
_ _
_BENLYSTA _
should
be
administered
by
a
healthcare
professional
prepared
to
treat
hypersensitivity reactions including anaphylaxis.
_ _
_BENLYSTA _should be infused over a 1-hour period.
_ _
_BENLYSTA _must not be administered as an intravenous push or bolus.
The infusion rate may be slowed or interrupted if the patient develops
an infusion
reaction. The
infusion must be discontinued immediately if the patient experiences a
potentially life-
threatening adverse reaction (_see Contraindications, Warnings and_
_ _
_Precautions_).
CONFIDENTIAL
Patients should be monitored during and for an appropriate period of
time after
administration
of _BENLYSTA _(see _Warnings and Precautions, Adverse Reactions_).
PREMEDICATION FOR PATIENTS WITH ALLERGIES
Premedication with an oral ant