Lantheus Gallium (67Ga) Citrate Injection

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Kupite ga zdaj

Navodilo za uporabo Navodilo za uporabo (PIL)
24-05-2024
Lastnosti izdelka Lastnosti izdelka (SPC)
24-05-2024

Aktivna sestavina:

Gallium(67Ga) citrate

Dostopno od:

Lantheus MI Australia Pty Ltd

Razred:

Medicine Registered

Navodilo za uporabo

                                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 
you
                                
                                Preberite celoten dokument
                                
                            

Lastnosti izdelka

                                515286-0411 
 
April 2011 
 
 
GALLIUM CITRATE GA 67  
INJECTION, U.S.P. 
AUSTRALIA 
 
 
FOR DIAGNOSTIC USE 
 
 
DESCRIPTION:  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, 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. 
 
PHYSICAL CHARACTERISTICS 
Gallium Ga 67 decays to stable Zinc Zn 67 by electron
capture with a physical half-life of 
78 hours.  
 
TABLE 1. PRINCIPAL RADIATION EMISSION DATA 
Radiation 
 
Mean % Disintegration 
 
Mean Energy (keV) 
Gamma-2 
 
 
38.3   
 
 
 
  93.3 
Gamma-3 
 
 
20.9   
 
 
 
184.6 
Gamma-5 
 
 
16.8   
 
 
 
300.2 
Gamma-6 
 
 
  4.7   
 
 
 
393.5 
 
 
TABLE 2. GALLIUM GA 67 DECAY CHART HALF-LIFE 78 HOURS 
 
              Fraction 
 
 
 
  Fraction 
 
 
  Fraction 
Hours  Remaining 
 
 
Hours  Remaining 
 
Hours  Remaining 
-48 
1.53   
 
 
30 
0.77   
 
90 
0.45 
-36 
1.38   
 
 
36 
0.73   
 
96 
0.43 
-24 
1.24   
 
 
42 
0.69   
 
108 
0.38 
-12 
1.11   
 
 
48 
0.65   
 
120 
0.35 
-6 
1.05   
 
 
54 
0.62   
 
132 
0.31 
0* 
1.00   
 
 
60 
0.59   
 
144 
0.28 
6 
0.95   
 
 
66 
0.56   
 
156 
0.25 
12 
0.90   
 
 
72 
0.53   
 
168 
0.23 
515286-0411 
 
April 2011 
18 
                                
                                Preberite celoten dokument
                                
                            

Opozorila o iskanju, povezana s tem izdelkom