Tacrolimus Sandoz 1mg capsule

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TACROLIMUS

Boleh didapati daripada:

SANDOZ PRODUCTS MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

TACROLIMUS

Unit dalam pakej:

50 Capsules; 100 Capsules

Dikeluarkan oleh:

Sandoz Private Limited

Risalah maklumat

TACROLIMUS SANDOZ
Tacrolimus (0.5mg, 1mg, 5mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Tacrolimus Sandoz is used for
2.
How Tacrolimus Sandoz works
3.
Before you use Tacrolimus Sandoz
4.
How to use Tacrolimus Sandoz
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Tacrolimus
Sandoz
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT TACROLIMUS SANDOZ IS USED FOR
Tacrolimus Sandoz is used to control
your body’s immune response enabling
your body to accept the transplanted liver
or kidney.
Tacrolimus Sandoz is often used in
combination with other medicines that
also suppress the immune system.
You may also be given Tacrolimus
Sandoz for an ongoing rejection of your
transplanted liver or kidney, or if any
previous treatment you were taking was
unable to control this immune response
after your transplantation.
HOW TACROLIMUS SANDOZ WORKS
Tacrolimus Sandoz contains an active
ingredient called tacrolimus. It belongs
to a group of medicines called
immunosuppressants. Tacrolimus Sandoz
reduces your body’s own defense
mechanism to stop you rejecting your
transplanted organ.
BEFORE YOU USE _TACROLIMUS SANDOZ_
-
_When you must not use it _
•
If you are allergic (hypersensitive)
to tacrolimus or any of the other
ingredients of Tacrolimus Sandoz
•
If you are allergic (hypersensitive)
to macrolide antibiotics (e.g.
erythromycin, clarithromycin,
josamycin).
_ _
_PREGNANCY AND LACTATION _
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your
doctor
or pharmacist for advice before taking
this medicine.
Tacrolimus Sandoz is excreted into
breast milk. Therefore you should not
breast-feed whilst receiving Tacrolimus
Sandoz.
Tacrolimus Sandoz contains lactose. If
you have been told by your doctor that
you have an intolerance to some sugars,
contact your doctor before taking
Tacrolimus Sandoz.
-
_Before you start to use it _
Talk to your doctor or pharmacist before
tak

Ciri produk

1
1.
NAME OF THE MEDICINAL PRODUCT
Tacrolimus Sandoz 0.5 mg capsule
Tacrolimus Sandoz 1 mg capsule
Tacrolimus Sandoz 5 mg capsule
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tacrolimus Sandoz 0.5 mg capsule
Each capsule contains 0.5 mg tacrolimus (as tacrolimus monohydrate).
Excipient(s): Each capsule contains 48.5 mg lactose monohydrate.
Tacrolimus Sandoz 1 mg capsule
Each capsule contains 1 mg tacrolimus (as tacrolimus monohydrate).
Excipient(s): Each capsule contains 47.4 mg lactose monohydrate.
Tacrolimus Sandoz 5 mg capsule
Each capsule contains 5 mg tacrolimus (as tacrolimus monohydrate).
Excipient(s): Each capsule contains 236.9 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules, hard.
Tacrolimus Sandoz 0.5 mg capsule
White to off-white powder filled in size “4” capsule with white
opaque body imprinted with ‘0.5’ in black and
ivory opaque cap.
Tacrolimus Sandoz 1 mg capsule
White to off-white powder filled in size “4” capsule with white
opaque body imprinted with ‘1’ in black and
light brown opaque cap.
Tacrolimus Sandoz 5 mg capsule
White to off-white powder filled in size “3” capsule with white
opaque body imprinted with ‘5’ in black and
Swedish orange opaque cap.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Primary immunosuppression in liver and kidney allograft recipients and
liver and kidney allograft rejection
resistant to conventional immunosuppressive agents. It is recommended
that Tacrolimus Sandoz be used
concomitantly with adrenal corticosteroids.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Tacrolimus Sandoz therapy requires careful monitoring by adequately
qualified and equipped personnel. The
medicinal product should only be prescribed, and changes in
immunosuppressive therapy initiated, by
physicians experienced in immunosuppressive therapy and the management
of transplant patients.
The dosage recommendations given below for oral and intravenous
administration are intended to act as a
guideline. Tacrolimus San