国: シンガポール
言語: 英語
ソース: HSA (Health Sciences Authority)
TACROLIMUS
ASTELLAS PHARMA SINGAPORE PTE. LTD.
D11AH01
5 mg/ml
INJECTION
TACROLIMUS 5 mg/ml
INTRAVENOUS
Prescription Only
Astellas IRELAND Co., LTD
ACTIVE
1998-02-18
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 完全なドキュメントを読む
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 完全なドキュメントを読む