देश: सिंगापुर
भाषा: अंग्रेज़ी
स्रोत: HSA (Health Sciences Authority)
BICISATE DIHYDROCHLORIDE (ECD.2HCl) (in Vial A- LIGAND))
QT INSTRUMENTS (S) PTE LTD
NA
0.9 mg/vial
INJECTION, POWDER, FOR SOLUTION
BICISATE DIHYDROCHLORIDE (ECD.2HCl) (in Vial A- LIGAND)) 0.9 mg/vial
INTRAVENOUS
Prescription Only
BRISTOL-MYERS SQUIBB HOLDINGS PHARMA LTD
ACTIVE
2005-01-20
512368-0503 331 Treble Cove Road N. Billerica, Massachusetts 01862 USA NEUROLITE ® KIT FOR THE PREPARATION OF TECHNETIUM TC-99M BICISATE FOR INJECTION FOR DIAGNOSTIC USE QUALITATIVE AND QUANTITATIVE COMPOSITION VIAL A Bicisate dihydrochloride (ECD•2 HCl) 0.9 mg Stannous chloride, dihydrate, theoretical (SnCl2•2H2O) 72 µg Edetate disodium, dihydrate 0.36 mg Mannitol 24 mg Total Tin, (stannous and stannic), dihydrate (as SnCl2•2H2O) 83 µg VIAL B Sodium phosphate dibasic heptahydrate 4.1 mg Sodium phosphate monobasic monohydrate 0.46 mg Water for injection qs 1 mL PHARMACEUTICAL FORM Vial A: Powder for injection Vial B: Buffer solution. CLINICAL PARTICULARS INDICATIONS Tc-99m Bicisate scintigraphy is indicated in the evaluation of regional cerebral perfusion abnormalities in adult patients with central nervous system disorders. CONTRAINDICATIONS Sensitivity to the radiopharmaceutical preparation. SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Radiopharmaceuticals should be used only by physicians who are quali- fied by training and experience in the safe handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides where appropriate. Contents of the vials are intended only for use in the prepara- tion of Technetium Tc-99m Bicisate and are not to be administered direct- ly to the adult patient without first undergoing the preparative procedure. Tc-99m Bicisate as well as other radioactive drugs must be handled with care, and appropriate safety measures should be used to minimize radia- tion exposure to clinical personnel and adult patients. Safety and effec- tiveness in children below the age of 18 years have not been established. Safety and effectiveness have not been established in adult patients with renal function impairment. High cerebral blood flow might be underestimated. INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION None known. PREGNANCY AND LACTATION Animal reproducti पूरा दस्तावेज़ पढ़ें
512368-0503 331 Treble Cove Road N. Billerica, Massachusetts 01862 USA NEUROLITE ® KIT FOR THE PREPARATION OF TECHNETIUM TC-99M BICISATE FOR INJECTION FOR DIAGNOSTIC USE QUALITATIVE AND QUANTITATIVE COMPOSITION VIAL A Bicisate dihydrochloride (ECD•2 HCl) 0.9 mg Stannous chloride, dihydrate, theoretical (SnCl 2 •2H 2 O) 72 µg Edetate disodium, dihydrate 0.36 mg Mannitol 24 mg Total Tin, (stannous and stannic), dihydrate (as SnCl 2 •2H 2 O) 83 µg VIAL B Sodium phosphate dibasic heptahydrate 4.1 mg Sodium phosphate monobasic monohydrate 0.46 mg Water for injection qs 1 mL PHARMACEUTICAL FORM Vial A: Powder for injection Vial B: Buffer solution. CLINICAL PARTICULARS INDICATIONS Tc-99m Bicisate scintigraphy is indicated in the evaluation of regional cerebral perfusion abnormalities in adult patients with central nervous system disorders. CONTRAINDICATIONS Sensitivity to the radiopharmaceutical preparation. SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Radiopharmaceuticals should be used only by physicians who are quali- fied by training and experience in the safe handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides where appropriate. Contents of the vials are intended only for use in the prepara- tion of Technetium Tc-99m Bicisate and are not to be administered direct- ly to the adult patient without first undergoing the preparative procedure. Tc-99m Bicisate as well as other radioactive drugs must be handled with care, and appropriate safety measures should be used to minimize radia- tion exposure to clinical personnel and adult patients. Safety and effec- tiveness in children below the age of 18 years have not been established. Safety and effectiveness have not been established in adult patients with renal function impairment. High cerebral blood flow might be underestimated. INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION None known. PREGNANCY AND LACTATION Animal reproductive पूरा दस्तावेज़ पढ़ें