BENLYSTA belimumab 120 mg powder for injection vial

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

Belimumab, Quantity: 120 mg

Dostopno od:

GlaxoSmithKline Australia Pty Ltd

INN (mednarodno ime):

Belimumab

Farmacevtska oblika:

Injection, powder for

Sestava:

Excipient Ingredients: sodium citrate dihydrate; sucrose; citric acid monohydrate; polysorbate 80

Pot uporabe:

Intravenous Infusion

Enote v paketu:

5 mL

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

BENLYSTA is indicated for:,add-on therapy for reducing disease activity in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g. ANA titre greater than or equal to 1:80 and/or anti-dsDNA titre greater than or equal to 30 IU/mL) despite standard therapy.,treatment of active lupus nephritis in adult patients who are receiving standard therapy.,The safety and efficacy of BENLYSTA have not been evaluated in patients with severe active central nervous system lupus.

Povzetek izdelek:

Visual Identification: A white to off-white cake.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 60 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status dovoljenje:

Registered

Datum dovoljenje:

2012-10-18

Navodilo za uporabo

BENLYSTA
_FOR INJECTION_
_belimumab (rmc) 120 mg and 400 mg powder; belimumab (rmc) 200 mg in 1
mL solution_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you are given BENLYSTA.
This leaflet answers some common
questions about BENLYSTA. It does
not contain all of 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 expected benefits of you being
given BENLYSTA against the risks
this medicine could have for you.
IF YOU HAVE ANY CONCERNS ABOUT
RECEIVING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT BENLYSTA IS
USED FOR?
BENLYSTA contains belimumab
which belongs to a group of
medicines called monoclonal
antibodies.
BENLYSTA is used to treat lupus
(systemic lupus erythematosus, SLE)
in adults (18 years of age and over).
Lupus is a disease of the immune
system (the body system that fights
infection). People with active lupus
often have high levels of a protein
called BLyS in their blood.
BENLYSTA binds to BLyS and
limits the activity of BLyS.
You will be given BENLYSTA as
well as your usual treatment for
lupus.
Your doctor may have prescribed
BENLYSTA for another reason.
BENLYSTA is not addictive.
BEFORE YOU ARE GIVEN
BENLYSTA
_DO NOT RECEIVE IF:_
YOU MUST NOT RECEIVE BENLYSTA
IF:
•
you have ever had an allergic
reaction to belimumab or any of
the ingredients listed toward the
end of this leaflet. (See
"Ingredients"). Check with your
doctor if this applies to you.
•
the expiry date (EXP) printed on
the pack has passed.
•
the packaging is torn or shows
signs of tampering.
_TELL YOUR DOCTOR IF:_
YOU MUST TELL YOUR DOCTOR IF YOU
HAVE OR HAVE HAD ANY OF THE
FOLLOWING MEDICAL CONDITIONS:
•
you have had an allergic reaction
(hypersensitivity) to foods, dyes,
preservatives or any other
medicines or injections. You may
be given medicines before you
are given BENLYSTA to help
reduce any inf

Lastnosti izdelka

1
AUSTRALIAN PRODUCT INFORMATION
BENLYSTA (BELIMUMAB) POWDER FOR INJECTION
BENLYSTA (BELIMUMAB) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Belimumab (rmc).
_ _
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Belimumab is a human IgG1

monoclonal antibody specific for soluble human B Lymphocyte
Stimulator protein (BLyS). It has a molecular weight of approximately
147 kDa.
Belimumab is produced by recombinant DNA technology in a mammalian
cell expression
system.
POWDER FOR INTRAVENOUS INFUSION
Each vial contains a sufficient amount of belimumab to deliver 120 mg
in 1.5 mL or 400 mg in
5
mL
when
reconstituted
as
recommended
with
sterile
Water
for
Injections.
After
reconstitution, each mL of solution contains 80 mg belimumab.
SOLUTION FOR SUBCUTANEOUS INJECTION
Each pre-filled syringe or auto-injector delivers 200 mg belimumab in
1 mL (200 mg/mL).
LIST OF EXCIPIENTS WITH KNOWN EFFECT
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
POWDER FOR INTRAVENOUS INFUSION
BENLYSTA is a sterile, white to off-white lyophilized powder in a
single-use vial.
SOLUTION FOR SUBCUTANEOUS INJECTION
A clear to opalescent, colourless to pale yellow solution in a
single-use, pre-filled syringe or
auto-injector.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BENLYSTA is indicated as add-on therapy for reducing disease activity
in adult patients with
active, autoantibody-positive systemic lupus erythematosus (SLE) with
a high degree of
disease activity (e.g. ANA titre ≥ 1:80 and/or anti-dsDNA titre
≥30 IU/mL) despite standard
therapy.
2
The safety and efficacy of BENLYSTA have not been evaluated in
patients with severe active
lupus nephritis or severe active central nervous system lupus.
4.2
DOSE AND METHOD OF ADMINISTRATION
POWDER FOR INTRAVENOUS INFUSION
BENLYSTA treatment should be initiated and supervised by a healthcare
professional
experienced in the diagnosis and treatment of SLE. BENLYSTA infusions
should be
administered in an environment where full resuscitation facilities are
avai