Simulect 20mg powder and solvent for solution for injection vials

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Basiliximab

זמין מ:

Novartis Pharmaceuticals UK Ltd

קוד ATC:

L04AC02

INN (שם בינלאומי):

Basiliximab

כמות:

20mg

טופס פרצבטיות:

Powder and solvent for solution for injection

מסלול נתינה (של תרופות):

Intravenous

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 08020200; GTIN: 5010678588101

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
SIMULECT
® 20 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION OR INFUSION
basiliximab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, nurse or
pharmacist.
-
If you get any side effects, talk to your doctor, nurse or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Simulect is and what it is used for
2.
What do you need to know before you are given Simulect
3.
How Simulect is given
4.
Possible side effects
5.
How to store Simulect
6.
Contents of the pack and other information
1.
WHAT SIMULECT IS AND WHAT IT IS USED FOR
Simulect belongs to a group of medicines called immunosuppressants. It
is given in hospital to adults,
adolescents and children who are having a kidney transplant.
Immunosuppressants reduce the body’s
response to anything that it sees as “foreign” – which includes
transplanted organs. The body’s
immune system thinks a transplanted organ is a foreign body and will
try to reject it. Simulect works
by stopping the immune cells that attack transplanted organs.
You will only be given two doses of Simulect. These will be given in
hospital, around the time of your
transplant operation. Simulect is given to stop your body from
rejecting the new organ during the first
4 to 6 weeks after the transplant operation, when rejection is most
likely. You will be given other
medicines to help protect your new kidney during this time, such as
ciclosporin and corticosteroids
and after you leave hospital.
2.
WHAT DO YOU NEED TO KNOW BEFORE YOU ARE GIVEN SIMULECT
Follow your doctor’s instructions carefully. If you are unsure about
anything, ask your doctor, nurse or
pharmacist.
YOU MUST NOT BE GIVEN SIMULECT
-
if you are allergic (hypersensitive) to basiliximab or any of the
other ingredients of Simulect
listed in

מאפייני מוצר

OBJECT 1
SIMULECT 10MG POWDER AND SOLVENT FOR SOLUTION
FOR INJECTION OR INFUSION
Summary of Product Characteristics Updated 10-May-2018 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Simulect
®
10 mg powder and solvent for solution for injection or infusion
Simulect
®
20 mg powder and solvent for solution for injection or infusion
2. Qualitative and quantitative composition
Each vial contains 10 or 20 mg basiliximab*.
One ml of the reconstituted solution contains 4 mg basiliximab.
* recombinant murine/human chimeric monoclonal antibody directed
against the interleukin-2 receptor α-
chain (CD25 antigen) produced in a mouse myeloma cell line by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder and solvent for solution for injection or infusion
White powder
4. Clinical particulars
4.1 Therapeutic indications
Simulect is indicated for the prophylaxis of acute organ rejection in
_de novo_ allogeneic renal
transplantation in adult and paediatric patients (1-17 years) (see
section 4.2). It is to be used
concomitantly with ciclosporin for microemulsion- and
corticosteroid-based immunosuppression, in
patients with panel reactive antibodies less than 80%, or in a triple
maintenance immunosuppressive
regimen containing ciclosporin for microemulsion, corticosteroids and
either azathioprine or
mycophenolate mofetil.
4.2 Posology and method of administration
Simulect should be prescribed only by physicians who are experienced
in the use of immunosuppressive
therapy following organ transplantation. Simulect should be
administered under qualified medical
supervision.
Simulect MUST NOT be administered unless it is absolutely certain that
the patient will receive the graft and
concomitant immunosuppression.
Simulect is to be used concomitantly with ciclosporin for
microemulsion- and corticosteroid-based
immunosuppression. It can be used in a ciclosporin for microemulsion-
and corticosteroid-based triple
immunosuppressive regimen including azathioprine