PROGRAF CAPSULE 0.5 mg

מדינה: סינגפור

שפה: אנגלית

מקור: HSA (Health Sciences Authority)

מרכיב פעיל:

TACROLIMUS

זמין מ:

ASTELLAS PHARMA SINGAPORE PTE. LTD.

קוד ATC:

D11AH01

כמות:

0.5 mg

טופס פרצבטיות:

CAPSULE

הרכב:

TACROLIMUS 0.5 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

Prescription Only

תוצרת:

ASTELLAS IRELAND CO., LTD

מצב אישור:

ACTIVE

תאריך אישור:

2001-02-09

עלון מידע

1
NAME OF THE MEDICINAL PRODUCT
Prograf capsules 0.5mg
Prograf capsules 1mg
Prograf capsules 5mg
Prograf concentrate for infusion 5mg/ml
QUALITATIVE AND QUANTITATIVE COMPOSITION
PROGRAF CAPSULES
Hard gelatin capsules containing 0.5mg, 1mg and 5mg tacrolimus.
Excipient with known effect: lactose monohydrate
Other excipients of capsule content: Hypromellose, Croscarmellose
sodium, Magnesium stearate
PROGRAF CONCENTRATE FOR INFUSION 5 mg/ml
Concentrate for intravenous infusion containing tacrolimus 5mg per
1ml.
Excipients with known effect: polyoxyethylene hydrogenated castor oil
and dehydrated alcohol.
THERAPEUTIC INDICATION
Primary immunosuppression in liver and kidney allograft recipients and
liver and kidney
allograft rejection resistant to conventional immunosuppressive
agents.
POSOLOGY AND METHOD OF ADMINISTRATION
Only physicians experienced in immunosuppressive therapy and the
management of organ
transplant patients should prescribe Prograf. Patients receiving the
drug should be managed in
facilities equipped and staffed with adequate laboratory and
supportive medical resourced. The
physician responsible for maintenance therapy should have complete
information requisite for
the follow up of the patient.
The dosage recommendations given below for oral and intravenous
administration are intended
to act as a guideline. Prograf doses should be adjusted according to
individual patient
requirements.
Dosing should commence orally, if necessary via an intranasal gastric
tube. If the clinical
condition of the patient does not allow oral therapy, initial
intravenous dosing may be necessary.
DOSAGE RECOMMENDATIONS
PRIMARY IMMUNOSUPPRESSION DOSE LEVELS – ADULTS
Liver and kidney transplantation: Oral tacrolimus therapy should
commence at 0.10 – 0.20
mg/kg/day for liver transplantation and at 0.15 – 0.30 mg/kg/day for
kidney transplantation
administered as two divided doses. Administration should start
approximately 6 hours after the
completion of liver transplant surgery and within 24 hours after
completion of kidne

מאפייני מוצר

1
NAME OF THE MEDICINAL PRODUCT
Prograf capsules 0.5 mg
Prograf capsules 1 mg
Prograf capsules 5 mg
Prograf concentrate for infusion 5 mg/ml
QUALITATIVE AND QUANTITATIVE COMPOSITION
PROGRAF CAPSULES
Hard gelatin capsules containing 0.5 mg, 1 mg and 5 mg tacrolimus.
Excipient with known effect: Lactose monohydrate.
Other excipients of capsule content: Hypromellose, Croscarmellose
sodium, Magnesium
stearate.
PROGRAF CONCENTRATE FOR INFUSION 5 mg/ml
Concentrate for intravenous infusion containing tacrolimus 5 mg per 1
ml.
Excipients with known effect: Polyoxyethylene hydrogenated castor oil
and dehydrated
alcohol.
THERAPEUTIC INDICATION
Primary immunosuppression in liver and kidney allograft recipients and
liver and kidney
allograft rejection resistant to conventional immunosuppressive
agents.
POSOLOGY AND METHOD OF ADMINISTRATION
Only physicians experienced in immunosuppressive therapy and the
management of organ
transplant patients should prescribe Prograf. Patients receiving the
drug should be managed in
facilities equipped and staffed with adequate laboratory and
supportive medical resources. The
physician responsible for maintenance therapy should have complete
information requisite for
the follow up of the patient.
The dosage recommendations given below for oral and intravenous
administration are intended
to act as a guideline. Prograf doses should be adjusted according to
individual patient
requirements.
Dosing should commence orally, if necessary via an intranasal gastric
tube. If the clinical
condition of the patient does not allow oral therapy, initial
intravenous dosing may be
necessary.
DOSAGE RECOMMENDATIONS
PRIMARY IMMUNOSUPPRESSION DOSE LEVELS – ADULTS
Liver and kidney transplantation: Oral tacrolimus therapy should
commence at 0.10
–
0.20 mg/kg/day
for
liver
transplantation
and
at
0.15
–
0.30
mg/kg/day
for
kidney
transplantation administered as two divided doses. Administration
should start approximately
6 hours after the completion of liver transplant surgery and within 24
hours after completi