Quadramet samarium (153Sm) [153 Sm] lexidronam pentasodium 6.0 GBq/3mL injection vial

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

samarium (153Sm), Quantity: 2 GBq/mL

Disponibil de la:

Australian Nuclear Science and Technology Organisation T/A ANSTO

INN (nume internaţional):

samarium (153Sm)

Forma farmaceutică:

Injection

Compoziție:

Excipient Ingredients: sodium hydroxide; hydrochloric acid; water for injections; ethylenediaminetetramethylenephosphonic acid monohydrate; calcium hydroxide

Calea de administrare:

Intravenous

Unități în pachet:

1x10mL vial contains 6GBq in 3mL

Clasă:

Medicine Registered

Tip de prescriptie medicala:

Not scheduled. Not considered by committee

Indicații terapeutice:

INDICATIONS: Quadramet is indicated for the relief of bone pain in patients with painful osteoblastic skeletal metastases as indicated by positive bone scan. The presence of bone metastases should be confirmed prior to therapy.

Rezumat produs:

Visual Identification: Frozen, colourless to light amber solution; Container Type: Vial; Container Material: Glass; Container Life Time: 48 Hours; Container Temperature: Store between minus 10 - minus 20 degrees Celsius

Statutul autorizaţiei:

Registered

Data de autorizare:

1997-12-18

Prospect

1
QUADRAMET
SAMARIUM (
153
SM) LEXIDRONAM PENTASODIUM INJECTION
6.0GBQ/3ML INJECTION VIAL
WHAT IS THIS LEAFLET
This leaflet answers some common questions about Quadramet. It does
not contain all the
available information. It does not take the place of you talking to
your nuclear medicine
specialist.
All medicines have risks and benefits. Your physician has weighed the
small risk of you
being treated with Quadramet against the benefits it is expected that
you will receive.
If you have any concerns about being given this injection, discuss
them with your nuclear
medicine specialist.
KEEP THIS LEAFLET. You may need to read it again.
WHAT QUADRAMET IS USED FOR
Quadramet is used to help in relieving the pain caused by tumour
deposits in the bone. The
drug is taken up particularly strongly in injured bone, which is often
where the tumour is
located. The radioactive component of the drug gives off radiation,
which reduces tumour
activity and associated pain.
The purpose of Quadramet is to relieve pain caused by tumour in bone.
It is not a cure for
cancer and will not have any effect upon tumour not in the bone.
How long the relief will last is unpredictable, and may vary from
weeks to months. Not all
pain is due to tumour in bone, and this drug will not help relieve
pain caused by tumour
outside the bone.
Quadramet is usually given following other treatments. Ask your
specialist to explain why
this treatment has been proposed for you.
For more information, ask for a copy of the booklet _Nuclear Medicine
– Answering Your _
_Questions, _available from the hospital, clinic or supplier. QUADRAMET -
SAMARIUM (
153
SM) LEXIDRONAM PENTASODIUM INJECTION 6.0GBQ/3ML INJECTION VIAL
••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••
2
BEFORE YOU ARE GIVEN IT
Tell the

Caracteristicilor produsului

DESCRIPTION
Quadramet is supplied in single dose vials,
containing 6 GBq of radioactive Samarium-153
complexed with ethylenediaminetetra
methylenephosphonic acid monohydrate
(EDTMP) in 3 ml, as a frozen, sterile, colourless
to light amber, preservative free, isotonic
solution for intravenous injection. It contains
no antimicrobial agent.
Each ml of solution contains:
• less than 200 µg of total Samarium
• 35 mg EDTMP (calculated as the
monohydrate)
• 2.9 mg calcium ion
• 8.1 mg sodium ion and chloride ion as a
result of the manufacturing process.
The radioactive concentration is between
1.8 - 2.2 GBq/ml at calibration.The pH of the
solution is 7.0 to 8.5
Due to the neutron flux limitations at the
Australian Nuclear reactor Quadramet
manufactured in Australia has a lower specific
activity of total Samarium (<200µg/ml )
compared with 20-46µg/ml for the USA and
European products.
The structural formula is:
PHYSICAL CHARACTERISTICS OF
153
SM
Samarium -153 is produced in high yield and
purity by neutron irradiation of isotopically
enriched samarium-152 oxide. It emits both
medium energy beta particles and an imageable
gamma photon, and has a physical half-life of
46.7 hours. Samarium -153 has average and
maximum beta particle ranges in water
of 0.5 mm and 3.0 mm, respectively.The
primary radiation emissions of Samarium 153
are shown in Table 1.
TABLE 1: PRINCIPAL RADIATION EMISSION DATA
Principal
Energy
Abundance
Radiation
(keV)
Beta
640
30%
Beta
710
50%
Beta
810
20%
Gamma
103
29%
Maximum energies are listed for the beta
particles ie E
max.,
The average beta particle
energy is 233 keV.
TABLE 2.
PHYSICAL DEC AY CHART
Time(hr)*
Factor
Time(hr)*
Factor
* Time = hours before(-) or after(+) calibration.
_PI_
P
RODUCT
I
NFORMATION
-48.0
-36.0
-24.0
-20.0
-16.0
-12.0
-8.0
-6.0
-4.0
-3.0
-2.0
-1.0
2.05
1.71
1.43
1.35
1.27
1.20
1.13
1.09
1.06
1.05
1.03
1.02
+1.0
+2.0
+3.0
+4.0
+6.0
+8.0
+12.0
+16.0
+20.0
+24.0
+36.0
+48.0
0.99
0.97
0.96
0.94
0.91
0.89
0.84
0.80
0.74
0.70
0.58
0.49
EXTERNAL RADIATION
The specific gam