DRN 4362 Technescan DTPA United Kingdom Page 1 of 2

Package leaflet: Information for the user

TechneScan® DTPA

powder for solution for injection

Active substance: Calcium trisodium diethylenetriamine pentaacetate

2. Before you use TechneScan® DTPA

Do not use TechneScan® DTPA

if you have/are

*    allergic (hypersensitive) to calcium trisodium diethylenetriamine pentaacetate or any of the other ingredients

Take special care with TechneScan® DTPA

Inform your doctor if you have

•    reduced kidney function

This medicine does involve treatment with radioactivity. Your doctor will only give you this medicine if the benefit outweighs the risk.

TechneScan® DTPA is given by specialists, who will take responsibility for any necessary precautions. You will not be given this medicine in certain areas around the spinal cord and brain, known as subarachnoid space.

Your doctor will inform you if you need to take any special precautions after using this medicine. Contact your doctor if you have any questions.

in this leaflet, please tell your doctor or pharmacist,

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 DTPA examination:

•    medicines to reduce high blood pressure such as medicines with active substance names ending in “pril” like captopril

Your doctor will monitor your blood pressure during the examination.

•    medicines to increase water output, such as frusemide

•    medicines which influence mood, emotional status and disposition

Pregnancy and breast-feeding

•    Pregnancy

Tell your doctor if you are pregnant or think you could be. Your doctor will only administer TechneScan® DTPA during pregnancy if it is absolutely necessary, as it could harm the unborn child.

•    Breast-feeding

Tell your doctor if you are breast-feeding as he may delay treatment until 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

TechneScan® DTPA is unlikely to impair the ability to drive and operate machinery.

3. How to use TechneScan® DTPA

TechneScan® DTPA will always be used in a hospital or similar setting. It will only be administered to you by qualified people trained to safe handle radioactive material.

Your doctor will decide the TechneScan® DTPA amount to be used. The dose administered will depend on the procedure you are having and other factors such as the kind of administration.

The lowest dose possible will be used to produce adequate X-ray images

The usual dose is:

Approximate doses for adults and the elderly are:

•    1.8-1000 MBq

MBq is the unit used to measure radioactivity, and defines the activity of a quantity of radioactive material.

04362006BYS1 Ib.docx

22 CON 4362 United Kingdom SPC 24102014/24 CON 4362 United Kingdom PiL 13012015

Children under 18 years

Lower doses are used for children according to their body weight. Method of use

One administration is usually sufficient. Technescan DTPA is

•    injected into the vein for imaging kidneys or the brain

•    taken orally for stomach or oesophagus investigations

•    inhaled for lung examinations.

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

If you use more TechneScan® DTPA than you should

It is unlikely that overdose will occur as this medicine is given under control by a doctor. However, if this happens you will receive appropriate treatment from your doctor.

If you have any further questions on the use of this product, ask your doctor.

4.    Possible side effects

Like all medicines, TechneScan® DTPA can cause side effects, although not everybody gets them.

Frequency unknown, from the data available

•    mild allergic reactions, with symptoms such as skin reactions, nausea or vomiting, tissue swelling, reduced blood pressure or other allergy-type symptoms

Your hospital staff will treat these reactions, if they occur.

•    minor fainting episodes

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5,    now to store TechneScan® DTPA

Do not use TechneScan® DTPA after the expiry date stated on the label. Hospital staff will ensure that the product is correctly stored: not above 25°C and away from light.

6_b    Further information

What TechneScan® DTPA contains

•    The active substance is calcium trisodium diethylenetriamine pentaacetate. Each vial contains 25 mg of calcium trisodium diethylenetriamine pentaacetate,

•    The other ingredients are: gentisic acid, tin(ll)chloride, sodium chloride and nitrogen.

What TechneScan® DTPA looks like and contents of the pack

TechneScan® DTPA is a clear to slightly opalescent, colourless aqueous solution.

It is packaged in 10 ml glass vials closed with a butyl rubber lyophilisation stopper and sealed with an aluminium cap. It is supplied in one pack containing 5 vials,

Marketing Authorisation Holder and Manufacturer

•    Marketing Authorisation Holder

Mallinckrodt Medical B.V., Westerduinweg 3 1755 LE Petten, The Netherlands

PL 12288/0011

•    Manufacturer

Mallinckrodt Medical B.V., Westerduinweg 3 1755 LE Petten, The Netherlands

This leaflet was last approved in 11/2014.

04362006BYS11 b.docx

22 CON 4362 United Kingdom SPC 24102014/24 CON 4362 United Kingdom PIL13012015