Technescan PYP 20 mg kit for radiopharmaceutical preparation

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Sodium pyrophosphate decahydrate

Предлага се от:

Curium Netherlands B.V.

АТС код:

V09GA; V09GA06

INN (Международно Name):

Sodium pyrophosphate decahydrate

дозиране:

20 milligram(s)

Лекарствена форма:

Kit for radiopharmaceutical preparation

Вид предписание :

Product subject to Restricted Prescription (C)

Терапевтична област:

Technetium (99mTc) compounds; technetium (99mTc) stannous agent labelled cells

Статус Оторизация:

Marketed

Дата Оторизация:

2001-06-29

Листовка

19 CON 4342 Ireland PIL 18032021-Clean
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Package leaflet: Information for the patient
TECHNESCAN PYP 20 MG
Kit for radiopharmaceutical preparation,
sodium pyrophosphate decahydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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. See
section 4.
WHAT IS IN THIS LEAFLET:
1.
What TechneScan PYP is and what it is used for
2.
What you need to know before TechneScan PYP is used
3.
How TechneScan PYP is used
4.
Possible side effects
5.
How TechneScan PYP is stored
6.
Content of the pack and other information
1.
W
HAT
T
ECHNE
S
CAN
PYP IS AND WHAT IT IS
USED FOR
This medicine is a radiopharmaceutical product for DIAGNOSTIC USE
only.
TechneScan PYP is used through a scan to examine the:
∙
SPLEEN
∙
HEART FUNCTION
∙
BLOOD FLOW through the organs
∙
hidden ABDOMEN OR BOWEL BLEEDING
∙
BLOOD VOLUME
This medicine is a non-radioactive powder. When prepared by qualified
people, it is used to induce a “stannous loading” of red blood
cells prior to
the use of radioactive solution of sodium pertechnetate (
99m
Tc) required for
the labelling of red blood cells. When injected into the body, it
collects in
certain organs such as, the spleen or red blood cells.
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 organ and body. This also gives the doctor
valuable information about the structure and function of that organ.
The use of TechneScan PYP followed by sodium pertechnetate (
99m
Tc)
does involve exposure to small amounts of radioactivity. Your doctor
and
the nuclear medicine doctor have considered that the clinical benefit
that
you will obtai

Данни за продукта

Health Products Regulatory Authority
20 June 2022
CRN00CSM6
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Technescan PYP 20 mg kit for radiopharmaceutical preparation
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 20 mg sodium pyrophosphate decahydrate and 4 mg
stannous chloride dihydrate (corresponding to 2.1 mg
stannous).
The radionuclide is not part of the kit.
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation.
Powder for solution for injection.
Off-white to slightly yellow lyophilizate.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
a) Red blood cell labelling for blood pool scintigraphy.
Major indications are:

Angiocardioscintigraphy for:

evaluation of ventricular ejection fraction,

evaluation of global and regional cardiac wall motion,

myocardial phase imaging.

Organ perfusion and vascular abnormalities imaging for the detection
of hemangioma.

Diagnosis and localization of occult gastro intestinal bleeding.
b) Determination of blood volume.
c) Spleen scintigraphy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
Adults
1.
_Blood pool scintigraphy_
The average activity administered by intravenous injection for _in
vivo_ or after _in vitro_ labelling is 890 MBq (740‑925 MBq).
_b)Determination of blood volume_
The average activity administered by intravenous injection after _in
vitro_ labelling is 3 MBq (1‑5 MBq
_c) Spleen scintigraphy_
The average activity administered by intravenous injection after
_invitro_ labelling of denaturated erythrocytes is 50 MBq (20-70
MBq).
Health Products Regulatory Authority
20 June 2022
CRN00CSM6
Page 2 of 10
The optimal amount of non-radioactive stannous tin for preparation of
red blood cells (RBCs) _in vivo_ or _in vitro_ is 10 to 20
µg/kg body weight in adults. Especially in cases of _in vitro_
labelling this dose should not be exceeded. Sodium pertechnetate
(
99m
Tc) should be in