Advagraf Prolonged Release Hard Capsules 5 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Tacrolimus monohydrate 5.1 mg eqv anhydrous Tacrolimus 5.0 mg

Available from:

ASTELLAS PHARMA SINGAPORE PTE. LTD.

ATC code:

L04AD02

Dosage:

5.0 mg

Pharmaceutical form:

CAPSULE, EXTENDED RELEASE

Composition:

Tacrolimus monohydrate 5.1 mg eqv anhydrous Tacrolimus 5.0 mg 5.0 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Astellas Ireland Co., Ltd

Authorization status:

ACTIVE

Authorization date:

2012-04-16

Patient Information leaflet

NAME OF THE MEDICINAL PRODUCT
1
ADVAGRAF® 0.5 mg prolonged-release hard capsules
2
ADVAGRAF® 3 mg prolonged-release hard capsules
3
ADVAGRAF® 1 mg prolonged-release hard capsules
4
ADVAGRAF® 5 mg prolonged-release hard capsules
5
6
DESCRIPTION
7
Each prolonged-release hard capsule contains 0.5 mg, 1 mg, 3mg or 5 mg
tacrolimus (as
8
monohydrate)
9
Not all strengths may be marketed.
10
11
CLINICAL PARTICULARS
12
THERAPEUTIC INDICATIONS
13
Prophylaxis of transplant rejection in adult kidney or liver allograft
recipients and treatment of
14
kidney
or
liver
allograft
rejection
resistant
to
treatment
with
other
immunosuppressive
15
medicinal products in adult patients.
16
17
POSOLOGY AND METHOD OF ADMINISTRATION
18
Advagraf is a once-a-day oral formulation of tacrolimus. Advagraf
therapy requires careful
19
monitoring by adequately qualified and equipped personnel. This
medicinal product should
20
only be prescribed, and changes in immunosuppressive therapy
initiated, by physicians
21
experienced in immunosuppressive therapy and the management of
transplant patients.
22
23
Inadvertent, unintentional or unsupervised switching of immediate- or
prolonged-release
24
formulations of tacrolimus is unsafe. This can lead to graft rejection
or increased incidence of
25
side
effects,
including
under-
or
over-immunosuppression,
due
to
clinically
relevant
26
differences in systemic exposure to tacrolimus. Patients should be
maintained on a single
27
formulation
of
tacrolimus
with
the
corresponding
daily
dosing
regimen;
alterations
in
28
formulation or regimen should only take place under the close
supervision of a transplant
29
specialist (see Special warnings and precautions for use and
Undesirable effects). Following
30
conversion to any alternative formulation, therapeutic drug monitoring
must be performed and
31
dose adjustments made to ensure that systemic exposure to tacrolimus
is maintained.
32
33
Posology
34
The recommended initial doses presented below are intended to act
solely as a guideline.
35
Advagraf is routinel

Summary of Product characteristics

NAME OF THE MEDICINAL PRODUCT
ADVAGRAF
®
0.5 mg prolonged-release hard capsules
ADVAGRAF
®
3 mg prolonged-release hard capsules
ADVAGRAF
®
1 mg prolonged-release hard capsules
ADVAGRAF
®
5 mg prolonged-release hard capsules
DESCRIPTION
Each prolonged-release hard capsule contains 0.5 mg, 1 mg, 3 mg or 5
mg tacrolimus (as
monohydrate)
Not all strengths may be marketed.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Prophylaxis of transplant rejection in adult kidney or liver allograft
recipients and treatment of
kidney or liver allograft rejection resistant to treatment with other
immunosuppressive
medicinal products in adult patients.
POSOLOGY AND METHOD OF ADMINISTRATION
Advagraf is a once-a-day oral formulation of tacrolimus. Advagraf
therapy requires careful
monitoring by adequately qualified and equipped personnel. This
medicinal product should
only be prescribed, and changes in immunosuppressive therapy
initiated, by physicians
experienced in immunosuppressive therapy and the management of
transplant patients.
Inadvertent, unintentional or unsupervised switching of immediate- or
prolonged-release
formulations of tacrolimus is unsafe. This can lead to graft rejection
or increased incidence of
side
effects,
including
under-
or
over-immunosuppression,
due
to
clinically
relevant
differences in systemic exposure to tacrolimus. Patients should be
maintained on a single
formulation
of
tacrolimus
with
the
corresponding
daily
dosing
regimen;
alterations
in
formulation or regimen should only take place under the close
supervision of a transplant
specialist (see Special warnings and precautions for use and
Undesirable effects). Following
conversion to any alternative formulation, therapeutic drug monitoring
must be performed and
dose adjustments made to ensure that systemic exposure to tacrolimus
is maintained.
Posology
The recommended initial doses presented below are intended to act
solely as a guideline.
Advagraf is routinely administered in conjunction with other
immunosuppressive agents in the
initial post-opera