TechneScan HDP 3mg, kit for radiopharmaceutical preparation

Երկիր: Իռլանդիա

Լեզու: անգլերեն

Աղբյուրը: HPRA (Health Products Regulatory Authority)

Ակտիվ բաղադրիչ:

Oxidronate disodium

Հասանելի է:

Curium Netherlands B.V.

ATC կոդը:

V09BA; V09BA01

INN (Միջազգային անվանումը):

Oxidronate disodium

Դոզան:

3 milligram(s)

Դեղագործական ձեւ:

Kit for radiopharmaceutical preparation

Ռեկվիզորի տեսակը:

Product subject to prescription which may not be renewed (A)

Թերապեւտիկ տարածք:

Technetium (99mTc) compounds; technetium (99mTc) oxidronic acid

Լիազորման կարգավիճակը:

Marketed

Հաստատման ամսաթիվը:

1993-11-19

Տեղեկատվական թերթիկ

PA 0690-004-001 Approved PIL
DRN 4366
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TECHNESCAN HDP
Kit for radiopharmaceutical preparation.
sodium oxidronate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU WILL BE ADMINISTERED
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 Nuclear medicine doctor
who will supervise the procedure.

If you get any side effects, talk to your Nuclear medicine doctor.
This includes any possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Technescan HDP is and what it is used for
2.
What you need to know before Technescan HDP is used
3.
How Technescan HDP is used
4.
Possible side effects
5.
How Technescan HDP is stored
6.
Contents of the pack and other information
1.
WHAT TECHNESCAN HDP IS AND WHAT IT
IS USED FOR
This medicine is a radiopharmaceutical product for diagnostic use
only.
Technescan HDP is used through a scan to examine the:

BONES
The use of Technescan HDP does involve exposure to small amounts of
radioactivity. Your doctor and the Nuclear medicine doctor have
considered that the clinical benefit that you will obtain from the
procedure with the radiopharmaceutical outweights the risk due to
radiation.
This medicine is a powder. When mixed by qualified people, with a
solution of the radioactive substance, sodium pertechnetate (
99m
Tc) it
forms Technetium (
99m
Tc) oxidronate. When administered into the body
it collects in certain organs such as the bones.
The radioactive substance can be photographed from outside the body,
using special cameras which take a scan. This scan shows the
distribution of radioactivity within the body. This gives the doctor
valuable information about the structure and function of a specific
part of
the body.
2.
WHAT YOU NEED TO KNOW BEFORE
TECHNESCAN HDP IS USED
TECHNESCAN HDP MUST NOT BE USED

if you are allergic (hypersensitive) to sodium oxidronate or any of
the
other ingredients of this me

Ապրանքի հատկությունները

Health Products Regulatory Authority
13 December 2021
CRN00CMFV
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
TechneScan HDP 3 mg, kit for radiopharmaceutical preparation
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Oxidronate 3.0 mg
The radionuclide is not part of the kit.
Excipients:
Sodium 12 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation. Powder for solution for
injection.
Grey-white lyophilized powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
After radiolabelling with sodium pertechnetate (
99m
Tc) solution, the agent may be used for bone scintigraphy, where it
delineates areas of altered osteogenesis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The average activity administered by single intravenous injection is
500 MBq (300 - 740 MBq) in a 70 kg adult. Other activities
may be justifiable. It should be noted that in each country physicians
should follow the Diagnostic Reference Levels and the
rules set out by local law.
_Elderly population_
There is no special dosage regimen for the elderly patient.
_Paediatric population_
The use in paediatric children and adolescents has to be considered
carefully, based upon clinical needs and assessing the
risk/benefit ratio in this patient group. The activities to be
administered to children and to adolescents were calculated
according to the EANM dosage card (2014) by using the following
Formula:
_A_[_MBq_]Administered = _Baseline Activity _x _Multiple_ (with a
baseline activity of 35.0)
The resulting activities to be administered may be found in the
following table:
Weight (kg)
Activity (MBq)
Weight (kg)
Activity (MBq)
Weight (kg)
Activity (MBq)
3
40
22
185
42
320
4
40
24
200
44
335
6
60
26
215
46
350
8
75
28
225
48
360
10
95
30
240
50
375
12
110
32
255
52 - 54
395
14
125
34
270
56 - 58
420
16
140
36
280
60 - 62
445
18
155
38
295
64 - 66
470
Health Products Regulatory Authority
13 Decemb