LANTHEUS GALLIUM(67Ga) CITRATE 74MBq/mL injection USP

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gallium (67Ga) citrate, Quantity: 74 MBq/mL

Available from:

Global Medical Solutions Australia Pty Limited

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: benzyl alcohol; hydrochloric acid; sodium hydroxide; sodium citrate dihydrate; sodium chloride; water for injections

Administration route:

Intravenous

Units in package:

326MBq/4.4mL, 733MBq/9.9mL, 244MBq/3.3mL, 488MBq/6.6mL

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

INDICATIONS AS AT 23 DECEMBER 2003: Gallium Citrate Ga67 Injection, U.S.P. may be useful in demonstrating the presence of the following malignancies; Hodgkins disease, lymphomas and bronchogenic carcinoma. Positive Ga67 uptake in the absence of prior symptoms warrants follow-up as an indication of a potential disease state.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 14 Days; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-09-26

Patient Information leaflet

GALLIUM CITRATE GA 67 INJECTION, USP
Gallium Citrate Ga 67
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions about Gallium
Citrate Ga 67. It
does not contain all of the available information about Gallium
Citrate Ga 67. It does
not replace talking to your doctor.
All medicines have risks and benefits. Your doctor has weighed the
risks of you
receiving Gallium Citrate Ga 67 against the benefits he or she expects
it will have.
IF YOU HAVE ANY CONCERNS ABOUT HAVING THIS MEDICINE, ASK YOUR DOCTOR.
KEEP THIS LEAFLET. You may need to read it again.
WHAT IS GALLIUM CITRATE GA 67
Gallium Citrate ga67 Injection contains an isotope of the element
Gallium and
belongs to a group of medicines called radiopharmaceutical agents,
which are all
radioactive.
WHAT GALLIUM CITRATE GA 67 IS USED FOR
Gallium Citrate Ga 67 is used to demonstrate the presence of following
malignancies:
Hodgkins disease, lymphomas and bronchogenic carcinoma. Positive Ga 67
uptake in
the absence of prior symptoms warrants follow-up as an indication of a
potential
disease state.
Your doctor may have prescribed Gallium Citrate Ga 67 for another
purpose. Ask
your doctor if you have any questions about why Gallium Citrate Ga 67
has been
prescribed for you. If you have any concerns, you should discuss these
with your
doctor.
This medicine is only available with a doctor’s prescription.
BEFORE YOU ARE GIVEN GALLIUM CITRATE GA 67
Before you are given Gallium Citrate Ga 67 your doctor will explain to
you the
procedure you are about to undergo, and the radioactive medicine you
will be given.
You must discuss any concerns you have with your doctor.
Gallium Citrate Ga 67 is not recommended for patients less than 18
years of age. If
your doctor believes it is necessary to give Gallium Citrate Ga 67 to
a patient under
18, he or she will discuss the benefits and risks with you.
2
YOU MUST TELL YOUR DOCTOR IF YOU HAVE ALLERGIES TO:

any other medicines

any other substances such as foods, preservatives or dye

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – GALLIUM (GALLIUM 67GA
CITRATE) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Gallium (67Ga) citrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Gallium Citrate Ga 67 Injection, U.S.P. is supplied in isotonic
solution as a sterile, non-pyrogenic
diagnostic radiopharmaceutical for intravenous administration. Each
milliliter of the isotonic
solution contains 74 MBq of Gallium Ga 67 on the calibration date, as
a complex formed from 9ng
Gallium Chloride Ga 67, 2 mg of sodium citrate dihydrate, 6.8mg sodium
chloride, and 0.9% benzyl
alcohol w/v added as preservative. The pH is adjusted to between 4.5-8
with hydrochloric acid
and/or sodium hydroxide solution. Gallium Ga 67, with a half-life of
78 hours, is cyclotron produced
by the proton irradiation of enriched zinc oxide, is essentially
carrier-free and contains negligible
concentrations of other radioactive isotopes.
This medical product is for diagnostic use only.
3
PHARMACEUTICAL FORM
Gallium Citrate Ga 67 Injection, U.S.P is a clear, colourless
intravenous injection solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Gallium Citrate Ga 67 Injection, U.S.P. may be useful in demonstrating
the presence of the following
malignancies: Hodgkins disease, lymphomas and bronchogenic carcinoma.
Positive Ga 67 uptake in
the absence of prior symptoms warrants follow-up as an indication of a
potential disease state.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The recommended adult (70 kg) dose of Gallium Citrate Ga 67 Injection,
U.S.P. is 74-185 MBq.
Gallium Citrate Ga 67 Injection, U.S.P. is intended for intravenous
administration only.
Approximately 10% of the administered dose is excreted in the feces
during the first week after
injection. Daily laxatives and/or enemas are recommended during the
first week after injection until
the final images are obtained in order to cleanse the bowel of
radioactive material and minimize the
possibility of false positive studies.
Studies indicate the optimal tumor to background concentration ratios