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TECHNESCAN DTPA

Active substance(s): CALCIUM TRISODIUM DIETHYLENETRIAMINE PENTAACETATE / CALCIUM TRISODIUM DIETHYLENETRIAMINE PENTAACETATE / CALCIUM TRISODIUM DIETHYLENETRIAMINE PENTAACETATE

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DRN 4362

Technescan OTPA Un ited Kingdom & Northern Ireland

DRN 4362

Page 1 of 2

Package leanet: Information for the user

TechneScan®DTPA
powder for solution for injection
Active substance: Calcium trisodium dielhylenelriamine pentaacelale
Read all of this leaflet carefully before you start using this medicine.

- Keep this leaflet. Yoo may need to read il again.
- If you have any fu rther questions, ask your doctor or pharmacist.
· If any of the side effects gels serious, or if you notice any side effects not listed in this leaflel. please tell your doctor or pharmacist.
In this leaflet:

1. What TechneScan00TPA is and what 11 is used for
2. Before yoo use TechneScan€lDTPA
3. How 1 use TechneScan®DTPA
0
4. Possible side effects
5. How \0 slore TecimeScan 0DTPA
6. Further information

1.

What TechneScan®DTPA is and what it
is used for

This medicine is for diagnostic use only_
TechneScan® OTPA is used through a scan [0 examine the:
• kidneys,

• brain,
• lungs,
• stomach-oesophagus reflux and stomach emptying ,

This medicine Is a powder. When mixed by qualified people, with a solulion
of the radioactive substance, sodium pertechnetate (9'l'nTc) it forms
Technetium [99mTc! penlelate. When administered inlo the body it collects

Using other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other mediCines, including medicines obtained
without a prescription.
The following medicines can particularly Influence the TechneScan
OTPA e){amlnallon:
• medicines to reduce high blood pressure such as medicines
with active substance names ending in 'pril' like captopril
Your doctor will monilor your blood pressure during the
e){amination.
" medicines to Increase water output, such as frusemide
"medicines which Influence mood, emotional status and
disposition

in certain organs such as, the kidneys or the brain.

The radioactive substance can be photographed from outside the body,
using special cameras which lake a scan. This scan shows the distributioll
of radioactivity within the organ and body. This also gives the doctor
valuable informatioo about the structure and function of thai organ.

2.

Before you use TechneScan®DTPA

Do not use TechneScan~ DTPA
if you have/are
• allergic (hypersensitive) to calcium Irisodium dielhylenetriamine
pentaacetate or any of the other ingredients

Take special care with TechneScan«l DTPA
Inform your doctor If you have
• reduced kidney function

Pregnancy and breast·feeding
• Pregnancy
Tell your doctor if you are pregnant or think you could be. Your
doctor will only administer TechneScan(l OTPA during pregnancy
if it Is absolutely necessary, as il could harm the unborn child.
• Breast·feedlng
Tell your doclor if you are breast-feeding as he may delay
treatment unlil breast-feeding is finished . He may also ask you
to stop breast-feeding for 12 hours and discard this milk, until
the radioactivity is no longer in your body,
Ask your doctor or pharmacist for advice before taking any
medicine.

Driving and using machines
TechneScanlt OTPA is unlikely to impair lhe ability to drive and
operate machinery,

This medicine does involve treatment with radioacti~ity, Your doctor - - - - - - - - - - - - - - - - - - - - - will only give [OJ you this medicine if the benefit outweighs the risk.
How to use Tech neScan®OTPA

3.

TechneScanQl OTPA Is given [Ojby specialists, who will take
responsibility lor any necessary precautions.[OI [OjYou will nol be
given this medicine in certain areas around the spinal cord and brain,
known as subarachnoid space.
Your doclor will inform you if you need 10 take any special
precautions after using this medicine. Contact your doctor if you
have any questions.

TechneScan$ DTPA wi!! always be used in a hospital or similar selling. It
will only be administered to you by qualified people trained to safe
handle radioactive material.
Your doctor will decide the TechneScarl® OTPA amount to be used.
The dose administered will depend on Ihe procedure you are
having and other factors such as the kind of adminislralion.
The lowest dose possible will be used to produce adequate X-ray
images
The usual dose is:
Appro){imate doses for adults and the elderly are:
• 1.8-1000 MBq
MBq is the unit used to measure radioactivity, and defines the
activity 01 a quantily 01 radioactive malerial.

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111 ~ 1 21 21

CQN U II2UK PI!. 11102012

DRN 4362

Technescan DTPA United Kingdom & Northern Ire land

Children under 18 years
Lower doses are used for children according to their body weight.

Method of use
One administration is usually sufficient Technescan OTPA is
• injeded into the vein for imaging kidneys or the bfain

• taken orally for stomach or oesophagus investigations
• inhaled for lung examinations.

Drink and urinate as much as possible before and after Ireat·
menl. This will prevent active substance gathering in the bladder.

If you use more TechneScan~ OTPA than you should
11 is unlikely thai overdose will occur as lhis medicine is given under control
by a doctor. However, If this happens you will receive appropriate treatment

from your doctor.
If you have any funller questions on the use of this product, ask your
doctOl'.

4.

Possible side effects

Like all medicines, TechneScan' OTPA can cause side effecls, although
not everybody gets them.

Frequency unknown, from the data available
• mitd allergic reactions, with symptoms such as skin reactions, nat/sea or
vomiting, tissue swelting, reduced blood pressure or other allergy-type
symploms
Your hospital stalf wiU Iseat these reactions, if they occur.
• rnioor fainting episodes
If any of the stde effects gels serious, Of If you OOlite any side effeds not
listed in this leaflet, please tell your doctor or pharmacist.

5.

How to store TechneScan®OTPA

Do not use TechneScane OTPA afler lhe expiry date stated on the tabel.
Hospital staff will ensure that the pi'odllClls correctly stored: not above 2S"C
allcl 'iNlay from light.

6•

Further information

What TechneScan' OTPA contains
• The active substance is calcium trisodium diethylenetriamine pentaacetale.
Each vial contains 25 mg 01 calcium trisodium diethylenetriamine
pentaacelate.
• The other ingredients are: gentisic acid, tio(lI)chloride, sodium chloride
and nitrogen.
What TechneSca ne DTPA looks like and contents of the pack
TechneScan8 DTPA is a dear 10 slighUy opalescent, colourless aqueous
solution.
II is packaged in 10 mI glass vials closed with a butyl rubber lyophilisation
stopper and sealed with an aluminium cap. 1\ is supplied in one pack
containing 5 vials.

Marketing Authorisation Holder and Manufacturer
• Marketing Authorisation Holder
Mallinckrodt UK Commercial lid.
4500 Parkway, Whiteley, Fareham,
Hampshire, POlS 7NY
United Kingdom
Tel: -t44(0)1329224477, Fax: -t44(0)1329224442
PL 41 744/0015
• Manufacturer
Mallinckrodl Medical B.V., Westerduinweg 3
1755 LE Pellen, The Netherlands
This leaflet was lasl approved In 10/2012.

IIII

Pag e 2 of 2

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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