NEUROLITE bicisate dihydrochloride 0.9mg/mL kit for the preparation of technetium [99Tc] bicisate

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

bicisate dihydrochloride, Quantity: 0.9 mg

Dostępny od:

Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific

Forma farmaceutyczna:

Injection, solution

Skład:

Excipient Ingredients: dibasic sodium phosphate heptahydrate; monobasic sodium phosphate; water for injections

Droga podania:

Intravenous

Sztuk w opakowaniu:

2 vials (B), 2 vials (A), 5 vials (B), 5 vials (A)

Typ recepty:

Not scheduled. Not considered by committee

Wskazania:

[99mTc]-bicisate scintigraphy is indicated in the evaluation and localisation of regional perfusion abnormalities in adult patients with the central nervous system disorders of stroke and dementia.

Podsumowanie produktu:

Visual Identification: Clear colourless liquid.; Container Type: Vial; Container Temperature: Store below 25 degrees Celsius

Status autoryzacji:

Registered

Data autoryzacji:

2000-08-24

Ulotka dla pacjenta

NEUROLITE

1
NEUROLITE
 BICISATE DIHYDROCHLORIDE 0.9MG/ML KIT
FOR THE PREPARATION OF TECHNETIUM [99TC] BICISATE
INJECTION VIAL COMPOSITE PACK
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING NEUROLITE

?
NEUROLITE

contains the active ingredient bicisate dihydrochloride. NEUROLITE

is used in the evaluation and localisation of
regional perfusion abnormalities in adult patients with the central
nervous system disorders of stroke and dementia.
For more information, see Section 1. Why am I using NEUROLITE

? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NEUROLITE

?
Do not use if you have ever had an allergic reaction to NEUROLITE

or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
NEUROLITE

? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with NEUROLITE

and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE NEUROLITE

?
•
Your doctor or health care professional will decide how much NEUROLITE

you will be given. Dosage administered will be
dependent on your weight.
•
NEUROLITE

is given by intravenous injection.
More instructions can be found in Section 4. How do I use NEUROLITE

? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NEUROLITE

?
THINGS YOU
SHOULD DO
•
Remind any doctor, or health care professional you visit if you suffer
from any renal impairment that
may interfere with the excretion of NEUROLITE

.
•
Let your doctor or health care professional know before administration
if you are or plan to become
pregnant and if you are breastfeeding or plan to breastf

Charakterystyka produktu

1
AUSTRALIAN PRODUCT INFORMATION – NEUROLITE
KIT FOR THE
PREPARATION OF TECHNETIUM [
99M
TC] BICISATE INJECTION VIAL
COMPOSITE PACK (BICISATE DIHYDROCHLORIDE) INTRAVENOUS
INJECTION POWDER
1
NAME OF THE MEDICINE
bicisate dihydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
This kit formulation consists of two nonradioactive vials: Vial A
contains bicisate dihydrochloride (N,
N’-1,2-ethylenediylbis-L-cysteine diethyl ester dihydrochloride) and
a reducing agent as a lyophilized
solid and Vial B contains a buffer solution. Both vials are sterile,
non-pyrogenic, and contain no
preservative.
VIAL A –
Bicisate Dihydrochloride
0.9 mg
Mannitol
24 mg
Disodium edetate
0.36 mg
Stannous chloride, dihydrate
72 μg
The contents of vial A are lyophilized and stored under nitrogen. The
pH of the solution before
lyophilization is 2.7 ± 0.25.
VIAL B –
Dibasic sodium phosphate heptahydrate
4.1 mg
Monobasic sodium phosphate monohydrate
0.46 mg
Water for Injection
qs1 mL
The contents of vial B are stored under air. The pH of the solution is
7.6 ± 0.4.
3
PHARMACEUTICAL FORM
White powder, crystalline material or plug for the preparation of
(99mTc) Bicisate intravenous
injection
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
[
99m
Tc] Bicisate scintigraphy is indicated in the evaluation and
localization of regional perfusion
abnormalities in adult patients with the central nervous system
disorders of stroke and dementia.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
This drug is administered by intravenous injection for diagnostic use
after reconstitution with sterile,
non-pyrogenic, Sodium Pertechnetate [
99m
Tc]Injection BP.
The recommended dose for intravenous administration after preparation
with Sodium
Pertechnetate [
99m
Tc] Injection BP, in the average patient (70 kg) is 740 MBq.
Scintigraphy should be
carried out within 6 hours of administration.
The patient dose should be measured by a suitable radioactivity
calibration prior to patient
administration. It is recommended to check the radiochemical purity
prior to