Tektrotyd 20 mikrogram Beredningssats för radioaktivt läkemedel

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

HYNIC-(D-Phe-1-Tyr-3-oktreotid)-trifluoroacetat (1:2)

Tillgänglig från:

Narodowe Centrum Badan Jadrowych

ATC-kod:

V09IA07

INN (International namn):

HYNIC- (D-Phe-1-Tyr-3-octreotide) trifluoroacetate (1: 2)

Dos:

20 mikrogram

Läkemedelsform:

Beredningssats för radioaktivt läkemedel

Sammansättning:

mannitol Hjälpämne; HYNIC-(D-Phe-1-Tyr-3-oktreotid)-trifluoroacetat (1:2) 50 mikrog Aktiv substans

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Injektionsflaska, I+II

Bemyndigande status:

Godkänd

Tillstånd datum:

2016-11-29

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TEKTROTYD 20 MICROGRAMS, KIT FOR RADIOPHARMACEUTICAL PREPARATION
HYNIC-[D-Phe
1
, Tyr
3
-Octreotide] trifluoroacetate
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.
WHAT IS IN THIS LEAFLET:
1.
What Tektrotyd is and what it is used for
2.
What you need to know before Tektrotyd is used
3.
How Tektrotyd is used
4.
Possible side effects
5.
How Tektrotyd is stored
6.
Contents of the pack and other information
1.
WHAT TEKTROTYD IS AND WHAT IT IS USED FOR
This medicine is a radiopharmaceutical product used to help identify
(diagnose) some medical
problems.
In particular, it is used to make images of specific cells in the
stomach, bowel and pancreas such as:
•
ABNORMAL TISSUE OR
•
TUMOURS
Tektrotyd bound to radioactive isotope attaches to abnormal or tumour
cells that have receptors for it
(somatostatin receptors). Later, radiation-measuring device
(gamma-camera) detects the radiation, and
makes pictures showing where the abnormal/tumour cells are in the
body.
The use of Tektrotyd 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 outweighs the risk due to
radiation.
2.
WHAT YOU NEED TO KNOW BEFORE TEKTROTYD IS USED
TEKTROTYD MUST NOT BE USED
-
if you are allergic to the active substance of Tektrotyd
_,_
or to any of the excipients of this medicine
(listed in section 6) or to sodium pertechnetate (
99m
Tc) solution for injection.
-
if you are pregnant or believe you may be pregnant
-
if you are breast-feeding. Please see the section “Pregnancy and
breas

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tektrotyd, 20 micrograms, kit for radiopharmaceutical preparation
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vial I contains 20 micrograms of HYNIC-[D-Phe
1
,Tyr
3
-Octreotide] trifluoroacetate
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
White or almost white lyophilisates
For radiolabelling with sodium pertechnetate (
99m
Tc) solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
After radiolabelling with sodium pertechnetate (
99m
Tc) solution, the solution of
99m
Tc-
Tektrotyd obtained is indicated for use in adults as adjunct in the
diagnosis and
management of somatostatin receptor bearing neuroendocrine tumours
(NET), by
aiding their localization.
Tumours which do not bear somatostatin receptors will not be
visualised (see section
4.4, “image interpretation”).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
The suggested activity range is 370 to 740 MBq in one single
intravenous injection.
The activity to be administered depends on the available equipment.
Elderly population (above 65 years)
No dose adjustment is required for elderly.
Renal impairment
Careful consideration of the activity to be administered is required
since an increased
radiation exposure is possible in these patients, see section 4.4.
Hepatic impairment
Dosage reduction in hepatic impairment is not necessary, see section
5.2.
Paediatric population
There are no data on safety and efficacy of
99m
Tc-Tektrotyd for the use in paediatric
patients.
If alternative techniques not using ionising radiation are not
available, the use in
children and adolescents has to be considered carefully, based upon
clinical needs and
assessing the risk/benefit ratio in this patient group. Because of the
potential hazard of
ionising radiation,
99m
Tc-Tektrotyd should not be used in children under 18 years of
age, unles