ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
DaTSCAN 74 MBq/ml solution for injection
Each ml of solution contains ioflupane (
123
I) 74 MBq at reference time (0.07 to 0.13 μg/ml of ioflupane).
Each 2.5
ml single dose vial contains 185 MBq ioflupane (
123
I) (specific activity range 2.5 to 4.5 x 10
14
Bq/mmol) at reference time.
Each 5 ml single dose vial contains 370 MBq ioflupane (
123
I) (specific activity range 2.5 to 4.5 x
10
14
Bq/mmol) at reference time.
Excipients:
This medicinal product contains 39.5 g/l ethanol.
For a full list of excipients see section 6.1
Solution for injection.
Clear colourless solution.
4.
This medicinal product is for diagnostic use only.
DaTSCAN is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum:
•
In adult patients with clinically uncertain Parkinsonian Syndromes, in order to help differentiate
Essential Tremor from Parkinsonian Syndromes related to idiopathic Parkinson’s Disease,
Multiple System Atrophy and Progressive Supranuclear Palsy.
DaTSCAN is unable to discriminate between Parkinson's Disease, Multiple System Atrophy and
Progressive Supranuclear Palsy.
•
In adult patients, to help differentiate probable dementia with Lewy bodies from Alzheimer’s
disease.
DaTSCAN is unable to discriminate between dementia with Lewy bodies and Parkinson’s disease
dementia.
Prior to administration appropriate resuscitation equipment should be available.
DaTSCAN should only be used in adult patients referred by physicians experienced in the management
of movement disorders and/or dementia. DaTSCAN should only be used by qualified personnel with the
appropriate government authorisation for the use and manipulation of radionuclides within a designated
clinical setting.
2
Posology
Clinical efficacy has been demonstrated across the range 111 to 185 MBq. Do not exceed 185 MBq and
do not use when the activity is below 110 MBq.
Patients must undergo appropriate thyroid blocking treatment prior to injection to minimise thyroid
uptake of radioactive iodine, for example by oral administration of approximately 120 mg potassium
iodide 1 to 4 hours prior to injection and again 12 to 24 hours post-injection of DaTSCAN.
Special populations
Renal and hepatic impairment
Formal studies have not been carried out in patients with significant renal or hepatic impairment. No
data are available (see section 4.4).
Paediatric populations
The safety and efficacy of DaTSCAN in children aged 0 to 18 years has not been established. No data
are available.
Method of Administration
For intravenous use.
DaTSCAN should be used without dilution. To minimise the potential for pain at the injection site
during administration, a slow intravenous injection (not less than 15 to 20 seconds) via an arm vein is
recommended.
SPECT imaging should take place between three and six hours post-injection. Images should be
acquired using a gamma camera fitted with a high-resolution collimator and calibrated using the
159 keV photopeak and a ± 10% energy window. Angular sampling should preferably be not less than
120 views over 360 degrees. For high resolution collimators the radius of rotation should be consistent
and set as small as possible (typically 11-15cm). Experimental studies with a striatal phantom, suggest
that optimal images are obtained with matrix size and zoom factors selected to give a pixel size of
3.5-4.5 mm for those systems currently in use. A minimum of 500k counts should be collected for
optimal images. Normal images are characterised by two symmetrical crescent-shaped areas of equal
intensity. Abnormal images are either asymmetric or symmetric with unequal intensity and/or loss of
crescent.
-
Hypersensitivity to the active substance or to any of the excipients.
-
Pregnancy (see section 4.6).
If hypersensitivity reactions occur, the administration of the medicinal product must be discontinued
immediately and, if necessary, intravenous treatment intiated. Resuscitative medicinal products and
equipment (e.g. endotracheal tube and ventilator) have to be readily available.
This radiopharmaceutical may be received, used and administered only by authorised persons in
designated clinical settings. Its receipt, storage, use, transfer and disposal are subject to the regulations
and the appropriate licences of the local competent official organisations.
For each patient, exposure to ionising radiation must be justifiable on the basis of likely benefit. The
activity administered must be such that the resulting dose is as low as reasonably achievable bearing in
mind the need to obtain the intended diagnostic result.
3
Formal studies have not been carried out in patients with significant renal or hepatic impairment. In the
absence of data, DaTSCAN is not recommended in cases of moderate to severe renal or hepatic
impairment.
This medicinal product contains 39.5 g/l (5% volume) ethanol (alcohol), up to 197 mg per dose,
equivalent to 5 ml beer or 2 ml wine. Harmful for those suffering from alcoholism. To be taken into
account in high-risk groups such as patients with liver disease or epilepsy.
No interaction studies have been performed in humans.
Ioflupane binds to the dopamine transporter. Medicines that bind to the dopamine transporter with high
affinity may therefore interfere with DaTSCAN diagnosis. These include amfetamine, benzatropine,
buproprion, cocaine, mazindol, methylphenidate, phentermine
and sertraline.
Medicines shown during clinical trials not to interfere with DaTSCAN imaging include amantadine,
trihexyphenidyl, budipine, levodopa, metoprolol, primidone, propranolol and selegiline. Dopamine
agonists and antagonists acting on the postsynaptic dopamine receptors are not expected to interfere
with DaTSCAN imaging and can therefore be continued if desired. Medicinal products shown in animal
studies not to interfere with DaTSCAN imaging include pergolide.
Women of childbearing potential
Where it is necessary to administer radioactive medicinal products to women of childbearing potential,
information should always be sought about pregnancy. Any woman who has missed a period should be
assumed pregnant until proven otherwise. Where uncertainty exists, it is important that radiation
exposure should be the minimum consistent with achieving satisfactory imaging. Alternative techniques
which do not involve ionising radiation should be considered.
Pregnancy
Animal reproductive toxicity studies have not been performed with this product. Radionuclide
procedures carried out on pregnant women also involve radiation doses to the foetus. Administration of
185 MBq of ioflupane (
123
I) results in an absorbed dose to the uterus of 3.0 mGy. DaTSCAN is
contraindicated in pregnancy (see section 4.3).
Breastfeeding
It is not known whether ioflupane (
123
I) is excreted in human milk. Before administering a radioactive
medicinal product to a breast-feeding mother, consideration should be given as to whether the
investigation could be reasonably delayed until the mother has ceased breast-feeding and as to whether
the most appropriate choice of radiopharmaceutical has been made, bearing in mind the secretion of
radioactivity in breast milk. If administration is considered necessary, breast-feeding should be
interrupted for 3 days and substituted by formula feeding. During this time, breast milk should be
expressed at regular intervals and the expressed feeds should be discarded.
Fertility
No fertility studies have been performed. No data are available.
DaTSCAN has no known influence on the ability to drive and use machines.
4
Summary of the safety profile
No serious adverse reactions related to DaTSCAN administration have been reported.
Tabulated summary of adverse reactions
The frequencies of adverse reactions are defined as follows:
Very common (
≥
1/10), common (
≥
1/100 to <1/10), uncommon (
≥
1/1,000 to <1/100), rare (
≥
1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available
data). Within each frequency grouping, undesirable effects are presented in order of decreasing
seriousness.
Immune system disorders
Not known: Hypersensitivity
Metabolism and nutrition disorders
Common: Appetite increased
Nervous system disorders
Common: Headache, formication (paraesthesia)
Ear and labyrinth disorders
Common: Vertigo
General disorders and administration site conditions
Uncommon: Injection site pain (intense pain following administration into small veins)
Exposure to ionising radiation is linked with cancer induction and a potential for development of
hereditary defects. As most diagnostic nuclear medicinal product investigations are done with low
radiation doses of less than 20 mSv these adverse events are expected to occur with a low probability.
The effective dose is 4.35 mSv when the maximal recommended activity of 185 MBq is administered.
In cases of overdose of radioactivity, frequent micturition and defaecation should be encouraged in
order to minimise radiation dose to the patient. Care should be taken to avoid contamination from the
radioactivity eliminated by the patient using such methods.
5.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Diagnostic radiopharmaceutical central nervous system,
ATC code: V09AB03.
Due to the low quantities of ioflupane injected, pharmacological effects are not expected following
intravenous administration of DaTSCAN at the recommended dosage.
Ioflupane is a cocaine analogue. Studies in animals have shown that ioflupane binds with high affinity to
the presynaptic dopamine transporter and so radiolabelled ioflupane (
123
I) can be used as a surrogate
marker to examine the integrity of the dopaminergic nigrostriatal neurons. Ioflupane also binds to the
serotonin transporter on 5-HT neurons but with lower (approximately 10-fold) binding affinity.
There is no experience in types of tremor other than essential tremor.
5
Clinical studies in patients with dementia with Lewy bodies
In a pivotal clinical trial including evaluation of 288 subjects with dementia with Lewy bodies (DLB)
(144 subjects), Alzheimer’s disease (124 subjects), vascular dementia (9 subjects) or other (11 subjects),
the results of an independent, blinded visual assessment of the DaTSCAN images were compared to the
clinical diagnosis as determined by physicians experienced in the management and diagnosis of
dementias. Clinical categorisation into the respective dementia group was based on a standardised and
comprehensive clinical and neuropsychiatric evaluation. The values for the sensitivity of DaTSCAN in
determining probable DLB from non-DLB ranged from 75.0% to 80.2% and specificity from 88.6% to
91.4%. The positive predictive value ranged from 78.9% to 84.4% and the negative predictive value
from 86.1% to 88.7%. Analyses in which both possible and probable DLB patients were compared with
non-DLB dementia patients demonstrated values for the sensitivity of DaTSCAN ranging from 75.0%
to 80.2% and specificity from 81.3% to 83.9% when the possible DLB patients were included as
non-DLB patients. The sensitivity ranged from 60.6% to 63.4% and specificity from 88.6% to 91.4%
when the possible DLB patients were included as DLB patients.
5.2 Pharmacokinetic properties
Ioflupane (
123
I) is cleared rapidly from the blood after intravenous injection; only 5% of the
administered activity remains in whole blood at 5 minutes post-injection. Uptake in the brain is rapid,
reaching about 7% of injected activity at 10 minutes post-injection and decreasing to 3% after 5 hours.
About 30% of the whole brain activity is attributed to striatal uptake. At 48 hours post-injection,
approximately 60% of the injected radioactivity is excreted in the urine, with faecal excretion calculated
at approximately 14%.
5.3 Preclinical safety data
Acute toxicity studies employing ioflupane at dosage levels of 0.06 mg/kg, in excess of 6,500 times the
maximum human (70 kg) single dose on a bodyweight basis, failed to reveal any mortality or signs of
systemic toxicity in rats or rabbits. In 14 day repeat dose studies no evidence of toxicity was observed in
rats or rabbits following daily doses of 0.6 mg/kg ioflupane, more than 65,000 times the maximum
human (70 kg) single dose on a bodyweight basis. Behavioural effects due to pharmacological activity
were observed in these studies. Studies on reproductive toxicity have not been conducted. Ioflupane
showed no evidence of mutagenic potential in
in vitro
or
in vivo
mutagenicity studies. Studies to assess
the carcinogenic potential of ioflupane have not been performed.
6.
6.1 List of excipients
Acetic acid
Sodium acetate
Ethanol
Water for injections
6.2 Incompatibilities
Not applicable
6
6.3 Shelf-life
2.5 ml vial
: 7 hours from the activity reference time stated on the label (35 hours from the end of
manufacture).
5 ml vial
: 20 hours from the activity reference time stated on the label (48 hours from the end of
manufacture).
6.4 Special precautions for storage
Do not store above 25
o
C. Do not freeze.
6.5 Nature and contents of container
2.5 or 5 ml solution in a single colourless 10 ml glass vial sealed with a rubber closure and metal
overseal.
Pack size of 1.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
Normal safety precautions for handling radioactive materials should be observed. After use, all
materials associated with the preparation and administration of radiopharmaceuticals, including any
unused product and its container, should be decontaminated or treated as radioactive waste and disposed
of in accordance with the conditions specified by the local competent authority. Contaminated material
must be disposed of as radioactive waste via an authorised route.
7.
GE Healthcare Limited
Little Chalfont
Bucks HP7 9NA
United Kingdom
8.
EU/1/00/135/001 (2.5 ml)
EU/1/00/135/002 (5 ml)
9.
Date of first authorisation: 27 July 2000
Date of latest renewal:
7
11 DOSIMETRY
Iodine-123 has a physical half-life of 13.2 hours. It decays emitting gamma radiation with a predominant
energy of 159 keV and X-rays of 27 keV.
The estimated absorbed radiation doses to an average adult patient (70 kg) from intravenous injection of
ioflupane (
123
I) are listed below. The values are calculated assuming urinary bladder emptying at
4.8-hour intervals and appropriate thyroid blocking (Iodine-123 is a known Auger electron emitter).
Frequent bladder emptying should be encouraged after dosing to minimise radiation exposure.
Target Organ
Absorbed radiation dose
μ
Gy/MBq
Adrenals
Brain
Breasts
Gallbladder wall
Lower large intestine wall
Small intestine
Stomach
Upper large intestine wall
Heart wall
Kidneys
Liver
Lungs
Muscle
Ovaries
Pancreas
Bone marrow
Bone surfaces
Skin
Spleen
Testes
Thymus
Thyroid
Urinary bladder wall
Uterus
Total body
13.1
18.1
8.0
25.7
42.4
20.6
11.4
38.1
13.1
11.1
28.3
42.5
9.6
17.0
13.2
9.8
17.4
6.3
10.6
8.8
10.3
9.2
53.5
16.3
11.5
Effective Dose
23.5 μSv/MBq
The effective dose (E) resulting from administration of 185 MBq of DaTSCAN injection is 4.35 mSv
(per 70 kg individual). The above data are valid in normal pharmacokinetic behaviour. When renal or
hepatic function is impaired, the effective dose and the radiation dose delivered to organs might be
increased.
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Any unused product or waste material should be disposed of in accordance with local requirements. See
also section 6.6.
Detailed information on this product is available on the website of the European Medicines Agency
http://www.ema.europa.eu
8
ANNEX II
A.
MANUFACTURING AUTHORISATION HOLDER
RESPONSIBLE FOR B
ATCH RELEASE
B.
CONDITIONS OF THE MARKETING AUTHORISATION
9
A.
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
GE Healthcare B.V.
Den Dolech 2
NL-5612 AZ, Eindhoven
The Netherlands
B.
CONDITIONS OF THE MARKETING AUTHORISATION
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product
Characteristics, section 4.2).
•
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE
USE OF THE MEDICINAL PRODUCT
Not applicable
10
ANNEX III
LABELLING AND PACKAGE LEAFLET
11
A. LABELLING
12
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
5 ml presentation
1.
DaTSCAN 74 MBq/ml solution for injection.
Ioflupane (
123
I)
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Each ml of solution contains ioflupane (
123
I) 74 MBq at reference time (0.07 to 0.13 μg/ml of ioflupane).
3.
LIST OF EXCIPIENTS
5% ethanol (see leaflet for further information), acetic acid, sodium acetate, water for injections.
4.
Solution for injection
1 vial
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Intravenous use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of reach and sight of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
EXP: 20 h post-ref.
Ref.: 370 MBq/5 ml at 2300 CET on DD/MM/YYYY
13
9.
SPECIAL STORAGE CONDITIONS
Do not store above 25°C.
Do not freeze.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Handling and disposal – see package leaflet.
GE Healthcare Limited
Little Chalfont
HP7 9NA
UK
EU/1/00/135/002
13. BATCH NUMBER
Lot:
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS FOR USE
16. INFORMATION IN BRAILLE
Justification for not including Braille accepted
14
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
5 ml presentation
1.
DaTSCAN 74 MBq/ml solution for injection.
Ioflupane (
123
I)
Intravenous use
2.
METHOD OF ADMINISTRATION
3.
EXPIRY DATE
EXP: 20 h post-ref.
Ref.: 370 MBq/5 ml ioflupane (
123
I) at 2300 CET on DD/MM/YYYY.
4.
BATCH NUMBER
Lot:
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
5 ml
6.
OTHER
GE Healthcare B.V.
Den Dolech 2
NL-5612 AZ, Eindhoven
The Netherlands
15
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
2.5 ml presentation
1.
DaTSCAN 74 MBq/ml solution for injection
Ioflupane (
123
I)
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Each ml of solution contains ioflupane (
123
I) 74 MBq at reference time (0.07 to 0.13 μg/ml of ioflupane).
3.
LIST OF EXCIPIENTS
5% ethanol (see leaflet for further information), acetic acid, sodium acetate, water for injections.
4.
Solution for injection
1 vial
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Intravenous use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of reach and sight of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
EXP: 7 h post-ref.
Ref.: 185 MBq/2.5 ml at 1200 CET on DD/MM/YYYY
16
9.
SPECIAL STORAGE CONDITIONS
Do not store above 25°C.
Do not freeze.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Handling and disposal – see package leaflet.
GE Healthcare Limited
Little Chalfont
HP7 9NA
UK
EU/1/00/135/001
13. BATCH NUMBER
Lot:
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS FOR USE
16. INFORMATION IN BRAILLE
Justification for not including Braille accepted
17
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
2.5 ml presentation
1.
DaTSCAN 74 MBq/ml solution for injection
Ioflupane (
123
I)
Intravenous use
2.
METHOD OF ADMINISTRATION
3.
EXPIRY DATE
EXP: 7 h post-ref.
Ref.: 185 MBq/2.5 ml ioflupane (
123
I)at 1200 CET on DD/MM/YYYY
4.
BATCH NUMBER
Lot:
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
2.5 ml
6.
OTHER
GE Healthcare B.V.
Den Dolech 2
NL-5612 AZ, Eindhoven
The Netherlands
18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET: INFORMATION FOR THE USER
DaTSCAN 74 MBq/ml solution for injection
Ioflupane (
123
I)
Read all of this leaflet carefully before you start using this medicine
.
−
Keep this leaflet. You may need to read it again.
−
If you have any further questions, ask your doctor or pharmacist.
−
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.
In this leaflet
:
1.
What DaTSCAN is and what it is used for
2.
Before you use DaTSCAN
3.
How DaTSCAN is used
4.
Possible side effects
5.
How DaTSCAN is stored
6.
Further information
1.
WHAT DaTSCAN IS AND WHAT IT IS USED FOR
DaTSCAN contains the active substance ioflupane (
123
I) which is used to help identify (diagnose)
conditions in the brain. It belongs to a group of medicines called “radiopharmaceuticals”, which contain
a small amount of radioactivity.
•
When a radiopharmaceutical is injected, it collects in a specific organ or area of the body for a
short time.
•
Because it contains a small amount of radioactivity it can be detected from outside the body using
special cameras.
•
A picture, known as a scan, can be taken. This scan will show exactly where the radioactivity is
inside the organ and the body. This can give the doctor valuable information about how that organ
is working.
When DaTSCAN is injected into an adult, it is carried around the body in the blood. It collects in a small
area of your brain. Changes in this area of the brain occur in:
•
Parkinsonism (including Parkinson’s disease) and
•
dementia with Lewy bodies.
A scan will give your doctor information about any changes in this area of your brain. Your doctor may
feel that the scan would help in finding out more about your condition and deciding on possible
treatment.
When DaTSCAN is used, you are exposed to small amounts of radioactivity. This exposure is less than
in some types of X-ray investigation. Your doctor will always consider the possible risks and benefits of
DaTSCAN.
This medicine is used for diagnostic use only. It is used only to identify illness.
20
2.
BEFORE YOU USE DaTSCAN
Do not use DaTSCAN if
:
•
you are allergic (hypersensitive) to ioflupane or any of the other ingredients of DaTSCAN (see
Section 6: Further Information).
•
you are pregnant
Take special care with DaTSCAN
DaTSCAN is not recommended for:
•
people with moderate or severe problems with their kidneys or liver
Use in Children
DaTSCAN is not recommended for:
•
children aged 0 to 18 years
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines
obtained without a prescription.
Some medicines or substances can affect the way that DaTSCAN works. These include:
•
buproprion (used to treat depression (sadness))
•
benzatropine (used to treat Parkinson’s disease)
•
mazindol (reduces appetite, as a means to treat obesity)
•
sertraline (used to treat depression (sadness))
•
methylphenidate (used to treat hyperactivity in children and narcolepsy (excessive sleepiness))
•
phentermine (reduces appetite, as a means to treat obesity)
•
amfetamine (used to treat hyperactivity in children and narcolepsy (excessive sleepiness);also a
drug of abuse)
•
cocaine (sometimes used as an anaesthetic for nose surgery; also a drug of abuse)
Some medicines may reduce the quality of the picture obtained. The doctor may ask you to stop taking
them for a short time before you receive DaTSCAN.
Pregnancy and breast-feeding
Do not use DaTSCAN if you are pregnant or think you may possibly be pregnant. This is because the
child may receive some of the radioactivity. Tell your doctor if you think you might be pregnant.
Alternative techniques which do not involve radioactivity should be considered.
If you are breast-feeding, your doctor may delay the use of DaTSCAN, or ask you to stop breast-feeding.
It is not known whether ioflupane (
123
I) is passed into breast milk.
•
You should not breast-feed your child for 3 days after DaTSCAN is given.
•
Instead use formula feed for your child. Express your breast milk regularly and throw away any
breast milk you have expressed.
•
You will need to continue to do this for 3 days, until the radioactivity is no longer in your
body.
21
Driving and using machines
DaTSCAN has no known influence on the ability to drive and use machines.
Important information about some of the ingredients of DaTSCAN
DaTSCAN contains alcohol (ethanol) 5 % by volume. Each dose contains up to 197 mg alcohol. This is
about the same as 5 ml beer, or 2 ml wine. This is harmful for those suffering from alcoholism. To be
taken into account in pregnant or breastfeeding women, children and high risk groups such as patients
with liver disease or epilepsy. Tell your doctor if any of these apply to you.
3.
HOW DaTSCAN IS USED
There are strict laws on the use, handling and disposal of radioactivity. DaTSCAN will always be used
in a hospital or a similar place. It will only be handled and given to you by people who are trained and
qualified to use it safely. They should tell you anything you need to do for the safe use of this medicine.
Your doctor will decide the dose that is best for you.
Before you receive DaTSCAN, your doctor will ask you to take some tablets or liquid that contain
iodine. These stop the radioactivity building-up in your thyroid gland. It is important that you take the
tablets or liquid as the doctor tells you.
DaTSCAN is given to you as an injection, usually into a vein in your arm. The recommended
radioactivity given by injection is between 111 to 185 MBq (megabequerel or MBq is a unit used to
measure radioactivity). A single injection is enough. The camera pictures are usually taken 3 to 6 hours
after the injection of DaTSCAN.
If you get more DaTSCAN than you should
Since DaTSCAN is given by a doctor under controlled conditions, it is unlikely that you will get an
overdose. Your doctor will suggest that you drink plenty of fluids to help the body get rid of the
medicine. You will need to be careful with the water (urine) that you pass - your doctor will tell you
what to do
.
This is normal practice with medicines like DaTSCAN. Any ioflupane (
123
I) which remains
in your body will naturally lose its radioactivity.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.
POSSIBLE SIDE-EFFECTS
Like all medicines, DaTSCAN can cause side effects, although not everybody gets them.
The frequency of side effects is:
Common: affects 1 to 10 users in 100
- Increased appetite
- Headache
- A brief irritating feeling similar to ants crawling over your skin (formication)
- Vertigo
Uncommon: affects 1 to 10 users in 1,000
- Intense pain on injection. This has been reported among patients receiving DaTSCAN into a
small vein
22
Not known: frequency cannot be estimated from the available data.
The amount of radioactivity in the body from DaTSCAN is very small. It will be passed out of the body
in a few days without need for you to take special precautions.
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.
HOW DaTSCAN IS STORED
•
Keep out of the reach and sight of children.
•
Do not store above 25°C.
•
Do not freeze.
Do not use DaTSCAN after the expiry date, which is stated on the carton and vial after EXP. Hospital
staff will ensure that the product is stored and thrown away correctly and not used after the expiry date
stated on the label.
6.
FURTHER INFORMATION
What DaTSCAN contains
•
The active substance is ioflupane (
123
I). Each ml of solution contains ioflupane (
123
I) 74 MBq at
reference time (0.07 to 0.13 μg/ml of ioflupane).
•
The other ingredients are acetic acid, sodium acetate, ethanol and water for injections.
What DaTSCAN looks like and contents of the pack
DaTSCAN is a 2.5 or 5 ml colourless solution for injection, supplied in a single colourless 10 ml glass
vial sealed with a rubber closure and metal overseal.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GE Healthcare Limited
Little Chalfont
Bucks HP7 9NA
United Kingdom
Manufacturer:
GE Healthcare B.V.
Den Dolech 2
NL-5612 AZ, Eindhoven
The Netherlands
For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder:
23
-
Hypersensitivity (allergic)
België/Belgique/Belgien
GE Healthcare BVBA
Kouterveldstraat 20
BE-1831 Diegem
Tél/Tel: +32 (0) 2 719 7410
Lietuva
GE Healthcare
c/o Nycomed Lithuania
Seimyniskiu 3
LT-2005 Vilnius
Tel.: +370 68 726 753
България
GE Healthcare (South Central Europe)
Handels GmbH
Representative Office Bulgaria
36 Dragan Tsankov blvd,
World Trade Centre,
Office B/405-406,
Sofia 1040
Тел.: + 3592 973 3174
Luxembourg/Luxemburg
GE Healthcare BVBA
Kouterveldstraat 20
BE-1831 Diegem
België/Belgique/Belgien
Tél/Tel: + 32 (0) 2 719 7410
Česká republika
GE Healthcare (South Central Europe) Handels
GmbH
Branch Office Czech Republic
Vyskocilova 1422/1a
CZ 140 28 Praha 4
Tel: +420 224 446 179
Magyarország
GE Healthcare (South Central Europe)
Handels GmbH
Representative Office Hungary
Akron u. 2
H-2040 Budaörs
Tel: +36 23 410 412
Danmark
GE Healthcare A/S
Huginsvej 8
DK-3400 Hillerød
Tlf: +45 70 2222 03
Malta
Pharma-Cos Ltd.
Pharma-Cos House
Triq C. Portanier
MT Santa Venera HMR 11
Tel: +356 21441 870
Deutschland
GE Healthcare Buchler GmbH & Co. KG
Gieselweg 1
D-38110 Braunschweig
Tel: +49 (0) 5 307 93 00
Norge
GE Healthcare AS
Nycoveien 1-2
NO-0401 Oslo
Tlf: + 47 23 18 50 50
Eesti
GE Healthcare Estonia OÜ
Mustamäe tee 46
EE - 10621 Tallinn
Tel: +372 6260 061
Nederland
GE Healthcare B.V.
De Rondom 8
NL-5612 AP, Eindhoven
Tel: +31 (0) 40 299 10 00
Ελλάδα
GE Healthcare A.E.
Πλαπούτα 139 & Λαμίας
GR – 141 21 Ν. ΗΡΑΚΛΕΙΟ
ΑΘΗΝΑ
Τηλ: +30 (2)10 805 08 64
Österreich
GE Healthcare Handels GmbH
Europlaza Gebäude E
Wienerbergstrasse 41 / Technologiestrasse 10
A-1120 Wien
Tel: +43 (0) 1 97272-0
España
GE Healthcare Bio-Sciences, S.A.
C/ Gobelas, 35-37
28023 Madrid
Tel: +34 91 663 25 00
Polska
GE Healthcare (South Central Europe)
Handels GmbH
Representative Office Poland
2, Stawki
24
PL-00 193 Warszawa
Tel.: +48 22 6356886/611
France
GE Healthcare SA
11 avenue Morane Saulnier
F-78140 Vélizy Villacoublay
Tél: +33 1 34 49 54 54
Portugal
Satis – GE Healthcare
Edifico Ramazzotti
Av. Do Forte nº 6-6A
2790-072 Carnaxide
Tel: + 351 214251352
Ireland
GE Healthcare Limited
Amersham Place
Little Chalfont HP7 9NA - UK
Tel: +44 (0) 1494 54 40 00
România
GE Healthcare (South Central Europe)
Handels GmbH
Representative Office
Str.Navodari No.42
Sc.2 et.2
014108 Bucharest
Tel: 0040 21 2321153
Ísland
Icepharma
Lynghálsi 13
IS-110 Reykjavik
Sími: + 354 540 8000
Slovenija
Higiea d.o.o
Blatnica 10
SI-1236 Trzin
Tel: + 386 1 589 7221/25
Italia
GE Healthcare S.r.l.
Via Galeno 36
I-20126 Milano
Tel: +39 02 26001 111
Slovenská republika
GE Healthcare (South Central Europe)
Handels GmbH
Branch Office Slovakia
Florianske nám 2
SK-811 07 Bratislava
Tel: +421 2 5542 5948
Κύπρος
Phadisco Ltd
Λεωφόρος Γιάννου Κρανιδιώτη 185
CY-2235 Λατσιά
Τηλ: +357 22 715000
Suomi/Finland
Oy GE Healthcare Bio-Sciences Ab
Kuortaneenkatu 2
FIN-00510 Helsinki
Puh/Tel: +358 10 39411
Latvija
General Electric International Inc.
Meza Str.4
Riga, LV-1048
Tel: +371 780 7086
Sverige
GE Healthcare AB
Solna Strandväg 98
S-171 54 Solna
Tel: + 46 (0) 8 559 504 00
United Kingdom
GE Healthcare Limited
Amersham Place
Little Chalfont HP7 9NA-UK
Tel: +44 (0) 1494 54 40 00
This leaflet was last approved in MM/YYYY
Detailed information on this product is available on the website of the European Medicines
Agency
http://www.ema.europa.eu
25
Source: European Medicines Agency
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