RADPHARM DTPA kit for production of Technetium (99mTc) pentetate powder for injection multidose vial

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

pentetic acid, Quantity: 5 mg

Saatavilla:

Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific

INN (Kansainvälinen yleisnimi):

Pentetic acid

Lääkemuoto:

Injection, powder for

Koostumus:

Excipient Ingredients: stannous chloride

Antoreitti:

Intravenous

Kpl paketissa:

8mL x 5

Prescription tyyppi:

Not scheduled. Not considered by committee

Käyttöaiheet:

INDICATIONS AS AT 25 SEPTEMBER 1996: Technetium (99mTc) pentetate may be used as a renal perfusion imaging pharmaceutical.

Tuoteyhteenveto:

Visual Identification: Lyophilised white powder; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 1 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

1991-09-05

Pakkausseloste

RADPHARM DTPA
1
RADPHARM DTPA KIT FOR PRODUCTION OF TECHNETIUM
(99MTC) PENTETATE POWDER FOR INJECTION MULTIDOSE
VIAL
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 RADPHARM DTPA?
RADPHARM DTPA contains the active ingredient Pentetic acid. RADPHARM
DTPA after mixing with Technetium (99mTc) is used
in renal perfusion imaging.
For more information, see Section 1. Why am I using RADPHARM DTPA? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE RADPHARM DTPA?
Do not use if you have ever had an allergic reaction to RADPHARM DTPA
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
RADPHARM DTPA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with RADPHARM DTPA 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 RADPHARM DTPA?
•
Your doctor or health care provider will decide how much RADPHARM DTPA
you will be given. This depends on your
condition and other factors, such a weight
More instructions can be found in Section 4. How do I use RADPHARM
DTPA? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING RADPHARM DTPA?
THINGS YOU
SHOULD DO
•
Inform your doctor or health care provider immediately if you do not
feel well during the injection or
after being given RADPHARM DTPA.
THINGS YOU
SHOULD NOT DO
•
Do not take any other medicines until advised by your doctor.
DRIVING OR USING
MACHINES
•
Do not drive or operate machinery until you know how RADPHARM DTPA
affects you.
For more information, see Section 5. What should I know while using
RADPHARM DTPA? in the full CMI.
6.
ARE THERE ANY SIDE EFFECTS?
Reported side effects of RADPHAR

Valmisteyhteenveto

1
AUSTRALIAN PRODUCT INFORMATION – RADPHARM DTPA KIT FOR
THE PRODUCTION OF TECHNETIUM (99MTC) PENTETATE POWDER
FOR INJECTION MULTIDOSE VIAL (PENTETIC ACID)
1
NAME OF THE MEDICINE
Pentetic acid
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
RADPHARM DTPA Kit consists of sterile, pyrogen free, lyophilised
ingredients which need
reconstitution with sodium pertechnetate (99mTc) injection to produce
a technetium
[99mTc] pentetate complex. The precise structure of the technetium[
99m
Tc] pentetate
complex is not known at this time.
Each vial contains the following active ingredient and excipient as a
lyophilized powder:
Active Ingredient
5 mg of Pentetic acid
Excipient
1 mg of stannous chloride
The product contains no preservatives.
3
PHARMACEUTICAL FORM
Radpharm DTPA is available as a dry white lyophilised powder in
multi-dose 8mL vacuum
sealed vials for intravenous injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Technetium[99mTc] pentetate may be used as a renal perfusion imaging
pharmaceutical.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
Recommended intravenous dose for the normal adult is 200MBq.
RADIATION DOSIMETRY
Table 1.
Estimated Absorbed Dose from Intravenous Administration of
Technetium[
99m
Tc] Pentetate
Organ
mGy/200MBq
Adrenals
0.28
Bladder wall
13
Bone surfaces
0.34
Breast
0.19
GI-tract:
Stomach wall
Small intestine
ULI wall
LLI wall
0.26
0.52
0.44
0.84
Kidneys
0.88
Liver
0.26
Lungs
0.2
Ovaries
0.86
Pancreas
0.3
Red marrow
0.5
Spleen
0.28
Testes
0.56
Thyroid
0.16
Uterus
1.58
Other Tissue
0.34
EFFECTIVE DOSE
1.04 MSV/200MBQ
Reference for Estimated Absorbed Dose: ICRP Publication 53, Radiation
Dose to Patients from Radiopharmaceuticals
(1987).
Reference for Effective Dose: ICRP Publication 62, Radiological
Protection in Biomedical Research (1993).
PROCEDURE
NOTE: If there is no vacuum, discard vial and do not deliver the
sodium
pertechnetate[
99m
Tc] injection.
1.
Place Radpharm DTPA vial in a shielding container.
2.
Draw a suitable volume (1 to 4 mL) of sodium pertechnetate [
99m
Tc]
injection e