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PERTECTOR 2.3 - 57.1 GBQ RADIONUCLIDE GENERATOR

Active substance(s): SODIUM MOLYBDATE MO 99 / SODIUM PERTECHNETATE TC 99M

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2.

What you need to know before the sodium
99m
pertechnetate ( Tc) solution obtained with Pertector
is used
99m

Radiopharmaceutical

Package leaflet: Information for the patient

Pertector 2.3 - 57.1 GBq radionuclide generator
99m

Sodium pertechnetate (

Tc) solution

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 y ou get a ny s ide effects talk t o y our nu clear m edicine
doctor. T his i ncludes a ny pos sible s ide effects not l isted i n
this leaflet. See Section 4.
What is in this leaflet:
1.
2.
3.
4.
5.
6.
1.

What Pertector is and what it is used for
What you need to know before the sodium pertechnetate
99m
( Tc) solution obtained with Pertector is used.
99m
Tc) so lution o btained w ith
How s odium per technetate (
Pertector is used
Possible side effects
How Pertector is stored
Contents of the pack and other information
What Pertector is and what it is used for

The sodium pertechnetate ( Tc) solution obtained with
Pertector must not be used
99m
- if you ar e al lergic t o s odium pertechnetate ( Tc) or any of
the other ingredients of this medicine (listed in section 6).
Warning and precautions
Inform your nuclear medicine doctor in the following cases:
- if you suffer from allergies, as a few cases of allergic
reactions have been observed after administration of sodium
99m
pertechnetate ( Tc) solution
- if you suffer from kidney disease
- if you are pregnant or believe you may be pregnant
- if you are breast-feeding
You nuc lear medicine doctor will i nform you i f you need t o take
any special precautions after using this medicine. Talk to your
nuclear medicine doctor if you have any questions.
99m

Tc) s olution
Before administration of s odium pertechnetate (
you should:
- drink pl enty o f w ater b efore t he s tart of the ex amination i n
order t o ur inate as of ten a s possible d uring the f irst h ours
after the study.
- You should be fasting for 3 to 4 hours before Meckel's
diverticulum s cintigraphy t o k eep t he s mall bowel per istalsis
low.
Children and adolescents
In c hildren a nd ad olescents, par ticular c are i s r equired when
assessing the diagnostic information that is expected to be
obtained and weighing this against the risks of radiation
exposure.
Please talk t o your nuclear medicine doctor i f you are under 18
year old.
99m

This m edicine i s a r adiopharmaceutical pr oduct f or diagnostic
use only.
99m

Pertector is a technetium ( Tc) generator, which means it is a
device used to obtain a solution for injection of sodium
99m
pertechnetate ( Tc). When this radioactive solution is injected,
it te mporarily c ollects i n c ertain areas of t he b ody. T he l ow
quantity of r adioactivity i njected c an be detected o utside of the
body by special cameras. The nuclear medicine doctor will then
take an image (scan) of the concerned organ which can give him
valuable i nformation about the s tructure and t he f unction of t his
organ.
99m

After injection the sodium pertechnetate ( Tc) solution is used
to obtain images of various body parts such as the:
- thyroid gland
- salivary glands
- appearance of stomach t issue i n an ab normal location
(Meckel diverticulum)
- tear ducts of the eyes
- to t est the p atency of v entricular shunts in hy drocephalus
(shunt scintigraphy):.
99m

The sodium pertechnetate ( Tc) solution can also be used in
combination with another product to prepare another
radiopharmaceutical medicine. In this case, please refer to the
corresponding package leaflet.
The nuc lear medicine do ctor w ill e xplain t o y ou w hat t ype of
examination will be performed with this product.
99m

The us e of s odium p ertechnetate ( Tc) s olution do es i nvolve
exposure to small amounts of radioactivity. Your doctor and the
nuclear medicine doctor have considered that the clinical benefit
that y ou w ill o btain from the procedure w ith t he
radiopharmaceutical outweighs the risk due to radiation.

Other medicines and sodium pertechnetate ( Tc) solution
Tell your nuclear medicine doctor if you are taking, have recently
taken or might take any other medicines since they may interfere
with the interpretation of the images; and especially the following
medicines:
- atropine, used for example:
- to reduce stomach, bowel or gall bladder spasms
- to reduce pancreas secretions
- in ophthalmology
- before administering an anaesthesia
- to treat reduced heart beat or
- as an antidote
- isoprenaline, a medicine to treat reduced heart beat
- pain killers
- laxatives (they s hould no t be t aken dur ing t his pr ocedure
since they irritate the gastrointestinal tract)
- if you had contrast-enhanced studies (e.g. with the contrast
agent barium) or upper gastro-intestinal examination (as
these s hould be av oided within 48h pr ior t o M eckel’s
diverticulum scintigraphy)
- antithyroid medicines (e.g. c arbimazole or other i midazole
derivatives such as propylthiouracil), salicylates, steroids,
sodium nitroprusside, sodium sulfobromophtalein,
perchlorate) (as they should not be taken for 1 week prior to
scintigraphy)
- phenylbutazone to treat fever, pain and inflammation in the
body ( as i t should n ot be t aken f or 2 w eeks pr ior t o
scintigraphy)
- expectorants (as they should not be taken for 2 weeks prior
to scintigraphy)
- natural or synthetic thyroid preparations (e.g. sodium
thyroxine, s odium l iothyronine, t hyroid extract) ( as t hey
should not be taken for 2-3 weeks prior to scintigraphy)
- amiodarone an a ntiarrhythmic ag ent ( as i t s hould not be
taken for 4 weeks prior to scintigraphy)
- benzodiazepines used f or example for sedation, or as antianxiety or ant i-convulsion or muscle r elaxant m edication or

-

lithium used as a mood stabiliser in manic-depressive illness
(as bo th s hould not be t aken for 4 weeks prior to
scintigraphy)
intravenous contrast agents for radiologic examinations of
the body (as they should not have been administered for 1-2
months prior to scintigraphy)
methotrexate, commonly used for chemotherapy or
rheumatoid arthritis

Most important incompatibilities
99m
Sodium ( Tc) pertechnetate and preparations labelled with this
compound must not be mixed or administered together with other
medicinal products or components. A latency period of at least 8
days is indicated after prior nuclear medicine procedures using a
kit f or a r adiopharmaceutical t hat c ontains t in(II), as t his m ay
otherwise result in undesired labelling of red blood cells.
Please as k y our nu clear m edicine d octor bef ore t aking any
medicines.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your nuclear medicine doctor
for advice before you are given this medicine.
You must inform the nuclear medicine doctor before the
99m
administration of sodium pertechnetate ( Tc) solution if there is
a pos sibility y ou m ight b e pr egnant, i f y ou hav e missed your
period or if you are breast-feeding. When in doubt, it is important
to c onsult y our nu clear m edicine doctor w ho w ill s upervise t he
procedure.
If y ou ar e pr egnant, y our n uclear m edicine do ctor w ill only
administer t his m edicine during pregnancy if a benefit is
expected which would far outweigh the risks.
If y ou ar e br east-feeding, pl ease tell your nuc lear m edicine
doctor, a s h e/she w ill advise y ou t o s top doing so un til t he
radioactivity has left your body. This t akes about 12 hours. The
expressed m ilk s hould be discarded. R esuming br east-feeding
should be in agreement with the specialist in Nuclear Medicine
who will supervise the procedure.
Driving and using machines
99m
Sodium pertechnetate ( Tc) solution has no influence on the
ability to drive and use machines.
Sodium pertechnetate solution contains sodium
Sodium pertechnetate solution contains 3.6 mg/mL of s odium.
Depending on the volume injected, the limit of 1 mmol (23 mg) of
sodium per dose administered m ay be ex ceeded. This m ust be
taken into account if you are on a low-salt diet.
3.

How the sodium pertechnetate (
obtained with Pertector is used

99m

Tc) solution

There ar e strict laws on t he us e, handling a nd d isposal o f
radiopharmaceutical pr oducts. Pertector will onl y be used i n
special c ontrolled ar eas. T his pr oduct w ill onl y be h andled and
given t o y ou by peo ple w ho are trained a nd qu alified to u se i t
safely. T hese per sons w ill t ake s pecial c are f or t he s afe u se of
this product and will keep you informed of their actions.
The nuc lear medicine d octor s upervising t he pr ocedure w ill
99m
decide on t he qu antity of sodium per technetate ( Tc) s olution
to be used in your case. It will be the smallest quantity necessary
to get the desired information.
The quant ity us ually r ecommended to be ad ministered f or an
adult ranges depending on the test to be performed, and ranges
between 2 an d 40 0 M Bq ( megabecquerel, t he u nit u sed t o
express radioactivity).
Use in children and adolescents
In children and adolescents, the quantity to be adm inistered will
be adapted to the child’s weight.

99m

Administration of sodium pertechnetate ( Tc) solution and
conduct of the procedure
Depending on the purpose of the examination, the product will be
administered by injection into an arm vein or may be instilled into
the eyes in the form of drops.
One administration is sufficient to conduct the test that your
doctor needs.
Duration of the procedure
Your nuc lear medicine do ctor w ill i nform y ou a bout t he usual
duration of the procedure.
Scans c an b e per formed at any t ime, be tween t he t ime of
injection and for up t o 24 hours af ter the administration,
depending on the type of examination.
99m

After administration of sodium pertechnetate ( Tc)
solution has been performed, you should:
- avoid any c lose c ontact w ith y oung c hildren and pr egnant
women for the 12 hours following the injection
- urinate frequently in order to eliminate the product from your
body
- after administration, you will be offered a dr ink and a sked to
urinate immediately preceding the test.
The nuc lear medicine doctor will i nform you i f you need t o t ake
any s pecial precautions af ter receiving this m edicine. C ontact
your nuclear medicine doctor if you have any questions.
99m

If you have been given more sodium pertechnetate ( Tc)
solution obtained with Pertector than you should
An overdose is almost impossible because you will only receive
99m
a single dose of sodium pertechnetate ( Tc) solution precisely
controlled by t he n uclear medicine d octor s upervising t he
procedure. However, in the case of an overdose, you will receive
the appropriate treatment. In particular, the nuc lear m edicine
doctor in charge of the procedure may recommend that you drink
plenty of f luids t o r emove t he t races of radioactivity f rom y our
body.
Should you have any further questions on the use of this product,
please ask nuclear medicine doctor who supervises the
procedure.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Frequency n ot known, c annot be es timated f rom t he available
data:
- allergic reactions, with symptoms such as
- skin rash, itching
- hives
- swelling at various locations, e.g. of the face
- shortness of breath
- redness of the skin
- coma
- circulatory reactions, with symptoms such as
- rapid heart beat, slow heart beat
- fainting
- blurred vision
- dizziness
- headache
- flushing
- gastrointestinal disorders, with symptoms such as
- being sick (vomiting)
- feeling sick (nausea)
- diarrhoea
- injection site reactions, with symptoms such as
- skin inflammation
- pain
- swelling
- redness
This radiopharmaceutical w ill del iver l ow am ounts o f i onising
radiation associated with t he least risk of cancer and hereditary
abnormalities.

Reporting of side effects
If you get any side effects, talk to your nuclear medicine doctor.
This includes any possible s ide ef fects n ot l isted i n t his leaflet.
You can also report side effects directly via Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard. By r eporting side ef fects
you c an help provide more information on the safety of this medicine.
5.

How Pertector is stored

Keep this medicine out of the sight and reach of children.

Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder
ROTOP Pharmaka GmbH
Bautzner Landstraße 400
01328 Dresden
Germany
Tel:
+49 (0) 351 - 26 310 100
Fax:
+49 (0) 351 - 26 310 303
E-Mail:
service@rotop-pharmaka.de

You will not have to store this medicine. This medicine is stored
under the responsibility of the specialist in appropriate premises.
Storage of r adiopharmaceuticals w ill be i n ac cordance with
national regulation on radioactive materials.

Manufacturer
National Centre for Nuclear Research
Andrzej Sołtan 7
05-400 Otwock
Poland

The information is intended for the specialist only.

This leaflet was last revised in August 2015

The radionuclide generator and the associated sodium chloride
solution and t he ev acuated i njection v ials us ed f or e lution must
not be u sed af ter t he ex piry dat es which are stated o n t he
relevant labels. The ex piry dat e r efers t o t he l ast day of t hat
month.

--------------------------------------------------------------------------------------

If at any time in the preparation of this product the integrity of the
generator or of the vials are compromised, it should not be used.
6.

Contents of the pack and other information

The following information is intended for healthcare professionals
only:
The c omplete S mPC of Pertector is pr ovided as a separate
document in the product package, with the objective to pr ovide
healthcare professionals w ith ot her ad ditional s cientific and
practical i nformation a bout t he adm inistration a nd us e o f t his
radiopharmaceutical.
Please refer to the SmPC.

What Pertector contains
-

The t echnetium-99m i s gener ated f rom s odium
99
[ Mo]molybdate adsorbed onto an a luminium oxide c olumn.
The gener ator column i s el uted w ith s terile s odium chloride
solution to produce the active substance

-

The active s ubstance is sodium pertechnetate (
Tc)
solution.
At the point of calibration, 1 radionuclide generator contains
99
Sodium ( Mo) molybdate
2.3 - 57.1 GBq
99m
Sodium ( Tc) pertechnetate
2.0 - 50.0 GBq
(elutable activity at equilibrium)

-

The
other
ingredients
are:
aluminium
oxide,
benzododecinium br omide, s odium c hloride, w ater for
injection, nitric acid, sodium hydroxide.

99m

What Pertector looks like and contents of the pack
99m
The product is sodium pertechnetate ( Tc) solution provided by
a radionuclide generator.

Pack sizes
Radionuclide generator with activities of 2.3, 4.6, 5.7, 6.9, 8.5,
9.1, 1 1.4, 13.7, 14. 9, 1 7.1, 19. 4, 21. 1, 2 2.9, 26.3, 28.6,
34.3,
40.0, 45
.7 or 57. 1 GBq molybdenum-99 a nd
corresponding variable t echnetium-99m activities on t he date of
calibration. The activity of the generator at the point of calibration
is indicated on each pack.
The following material is supplied with the generator:

16 injection vials of elution solution (0.9% NaCl solution)
and 16 evacuated i njection v ials (receptacles f or t he
eluate). The injection vials (sodium chloride solution and
vacuum) are 10 ml glass vials with rubber stoppers and
a cap.

Shielding canister that acts a s a hol der f or t he e lution
injection vial.

PL-Pertector-UK-eng-01

Pertector has t o be eluted a nd t he obt ained s olution may be
used itself or to radiolabel some particular kits for
radiopharmaceutical preparation.

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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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