NEUROLITE KIT FOR THE PREPARATION OF Tc99m BICISATE FOR INJECTION

Land: Singapore

Sprog: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv bestanddel:

BICISATE DIHYDROCHLORIDE (ECD.2HCl) (in Vial A- LIGAND))

Tilgængelig fra:

QT INSTRUMENTS (S) PTE LTD

ATC-kode:

NA

Dosering:

0.9 mg/vial

Lægemiddelform:

INJECTION, POWDER, FOR SOLUTION

Sammensætning:

BICISATE DIHYDROCHLORIDE (ECD.2HCl) (in Vial A- LIGAND)) 0.9 mg/vial

Indgivelsesvej:

INTRAVENOUS

Recept type:

Prescription Only

Fremstillet af:

BRISTOL-MYERS SQUIBB HOLDINGS PHARMA LTD

Autorisation status:

ACTIVE

Autorisation dato:

2005-01-20

Indlægsseddel

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

Produktets egenskaber

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