Quadramet
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
03-06-2015
Vara einkenni
(SPC)
03-06-2015
Opinber matsskýrsla
(PAR)
31-03-2008
Virkt innihaldsefni:
samarium (153Sm) lexidronam pentasodium
Fáanlegur frá:
CIS bio international
ATC númer:
V10BX02
INN (Alþjóðlegt nafn):
samarium [153Sm] lexidronam pentasodium
Meðferðarhópur:
Therapeutic radiopharmaceuticals
Lækningarsvæði:
Pain; Cancer
Ábendingar:
Quadramet is indicated for the relief of bone pain in patients with multiple painful osteoblastic skeletal metastases which take up technetium [99mTc]-labelled biphosphonates on bone scan.The presence of osteoblastic metastases which take up technetium [99mTc]-labelled biphosphonates should be confirmed prior to therapy.
Vörulýsing:
Revision: 15
Leyfisstaða:
Authorised
Leyfisdagur:
1998-02-04
Upplýsingar fylgiseðill
18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
QUADRAMET 1.3 GBQ/ML SOLUTION FOR INJECTION
Samarium (
153
Sm) lexidronam pentasodium.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or your pharmacist.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Quadramet is and what it is used for
2.
What you need to know before you take Quadramet
3.
How to take Quadramet
4.
Possible side effects
5.
How to store Quadramet
6.
Contents of the pack and other information
1.
WHAT QUADRAMET IS AND WHAT IT IS USED FOR
Quadramet is a medicinal product for therapeutic use only.
This radiopharmaceutical is used for the treatment of bone pain due to
your disease.
Quadramet has a high affinity for skeletal tissue. Once injected it
concentrates in bone lesions.
Because Quadramet contains small amounts of a radioactive element,
samarium-153, radiations are
delivered locally to the bone lesions, allowing to develop the
palliative action on bone pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUADRAMET
DO NOT TAKE QUADRAMET:
•
If you are allergic to ethylene diamine tetramethylene phosphonic acid
(EDTMP) or similar
phosphonate compounds or any of the other ingredients of this medicine
(listed in section 6),
•
If you are pregnant,
•
If you have received chemotherapy or hemibody field external radiation
therapy in a preceding
period of 6 weeks.
20
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Quadramet.
Your doctor will take blood samples weekly for at least 8 weeks to
check your platelets, white and red
blood cell counts which may slightly decrease due to the therapy.
During 6 hours following the injection of Quadramet, your physician
will encourage you to drink and
void as often as possible.
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1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Quadramet 1.3 GBq/mL solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 1.3 GBq Samarium (
153
Sm) lexidronam pentasodium at the reference date
(corresponding to 20 to 80 µg/ml of samarium per vial)
Samarium specific activity is approximately 16 – 65 MBq/µg of
samarium.
Each vial contains 2-4 GBq at the reference date.
Samarium-153 emits both medium-energy beta particles and an imageable
gamma photon, and has a
period of 46.3 hours (1.93 days). The primary radiation emissions of
samarium-153 are shown in
Table 1.
TABLE 1 : SAMARIUM-153 PRINCIPAL RADIATION EMISSION DATA
Radiation
Energy (keV)*
Abundance
Beta
640
30%
Beta
710
50%
Beta
810
20%
Gamma
103
29%
*
Maximum energies are listed for the beta emissions, the average beta
particle energy is
233 keV.
Excipient with known effect: sodium 8.1 mg/mL.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to light amber solution with pH ranging between 7.0
and 8.5.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Quadramet is indicated for the relief of bone pain in patients with
multiple painful osteoblastic skeletal
metastases which take up technetium (
99m
Tc)-labelled biphosphonates on bone scan.
The presence of osteoblastic metastases which take up technetium (
99m
Tc)-labelled biphosphonates
should be confirmed prior to therapy.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Quadramet should only be administered by physicians experienced in the
use of radiopharmaceuticals
and after full oncological evaluation of the patient by qualified
physicians.
Posology
The recommended dose of Quadramet is 37 MBq per kg body weight.
_Paediatric population _
Quadramet is not recommended for use in children below the age of 18
years due to a lack of data on
safety and efficacy.
Method of administration
Quadramet is to be administered by slow intravenous route through an
established intrave
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