SIMULECT basiliximab (rmc) 20mg powder for injection vial and diluent ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Basiliximab, Quantity: 20 mg

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sucrose; mannitol; glycine; monobasic potassium phosphate; sodium chloride; dibasic sodium phosphate

Administration route:

Intravenous

Units in package:

1 x 5mL diluent ampoule, 1 x vial of powder

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Simulect is indicated for the prophylaxis of acute organ rejection in renal transplantation.

Product summary:

Visual Identification: White powder; Container Type: Multiple containers; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

1999-02-18

Patient Information leaflet

SIMULECT
®
_basiliximab_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Simulect.
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.NOVARTIS.COM.AU.
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 having Simulect
against the benefits they expect it
will give you.
IF YOU HAVE ANY CONCERNS ABOUT
HAVING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT SIMULECT IS USED
FOR
Simulect is used for people who have
had a kidney transplant, to prevent
the body from rejecting the new
organ.
Two doses of Simulect injection will
be given to you around the time of
the transplant operation, while you
are still in hospital. You will also be
given other medicines to help protect
your new kidney and you will need
to continue taking some of these
medicines every day after you leave
hospital.
Simulect belongs to a group of
medicines called immuno-
suppressants. These medicines help
to control your body's immune
system.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU HAVE
SIMULECT
_WHEN YOU MUST NOT HAVE IT_
DO NOT HAVE SIMULECT IF YOU HAVE
EVER HAD AN ALLERGIC REACTION TO
BASILIXIMAB, THE ACTIVE INGREDIENT
IN SIMULECT, OR TO ANY OF THE OTHER
INGREDIENTS OF SIMULECT LISTED AT THE
END OF THIS LEAFLET.
Some of the symptoms of an allergic
reaction may include rash, itching or
hives on the skin,

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – SIMULECT (BASILIXIMAB)
POWDER FOR INJECTION WITH DILUENT
1
NAME OF THE MEDICINE
Basiliximab (rmc)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of Simulect contains 20 mg basiliximab as a sterile
freeze-dried powder for reconstitution
with water for injections.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Powder for Injection with diluent.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Simulect is indicated for the prophylaxis of acute organ rejection in
renal transplantation.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ADULT DOSE
The adult dose of Simulect is 40 mg, given as two 20 mg doses, by
intravenous injection. The first 20
mg dose is given within 2 hours prior to transplantation surgery.
Simulect must not be administered
unless it is absolutely certain that the patient will receive the
graft and concomitant
immunosuppression. The second 20 mg dose is given 4 days after
transplantation. The second dose
should be withheld if severe hypersensitivity reactions to Simulect or
post-operative complications
such as graft loss occur (see Section 4.4 Special Warnings and
Precautions for Use).
PAEDIATRIC DOSE
In paediatric patients weighing less than 35 kg, the recommended total
dose of Simulect is 20 mg,
given in two doses of 10 mg each. In paediatric patients weighing 35
kg or more, the recommended
dose is the adult dose, i.e. a total dose of 40 mg, given in two doses
of 20 mg each. The first dose is
given within 2 hours prior to transplantation surgery. Simulect must
not be administered unless it is
absolutely certain that the patient will receive the graft and
concomitant immunosuppression. The
second dose is given 4 days after transplantation. The second dose
should be withheld if severe
hypersensitivity reactions to Simulect or post-operative complications
such as graft loss occur (see
Section 4.4 Special Warnings and Precautions for Use).
2
INSTRUCTIONS FOR USE
Simulect is reconstituted and administered either as an intr