Scintimun

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 
 
 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Scintimun 1 mg kit for radiopharmaceutical preparation  
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each vial of Scintimun contains 1 mg of besilesomab. 
 
Besilesomab is an anti-granulocyte monoclonal antibody (BW 250/183), produced in murine cells.  
 
The radionuclide is not part of the kit. 
 
Excipients with known effect: 
Each vial of Scintimun contains 2 mg of sorbitol. 
One mL of the radiolabelled solution contains less than 4 mg of sodium. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Kit for radiopharmaceutical preparation. 
 
Scintimun: white powder  
Solvent for Scintimun: white powder  
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
This medicinal product is for diagnostic use only. 
 
After radiolabelling with sodium pertechnetate (

99m
Tc) solution, the technetium (

99m
Tc) besilesomab 

solution obtained is indicated in adults for scintigraphic imaging, in conjunction with other appropriate 
imaging modalities, for determining the location of inflammation/infection in peripheral bone in adults 
with suspected osteomyelitis. 
 
Scintimun should not be used for the diagnosis of diabetic foot infection.  
 
4.2 Posology and method of administration 
 
This medicinal product is for use in designated nuclear medicine facilities only, and should only be 
handled by authorised personnel. 
 
Posology 
Adults 
The recommended activity of technetium (99mTc) besilesomab should be between 400 MBq and 
800 MBq.  
This corresponds to the administration of 0.25 to 1 mg of besilesomab.  
 
For repeated use, see section 4.4. 
 
Elderly 
No dose adjustment is required. 
 



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Renal impairment / Hepatic impairment 
Formal studies have not been performed in patients with renal or hepatic impairment. However, due to 
the nature of the molecule and the short half-life of technetium (99mTc) besilesomab, dose adjustment 
is not necessary in such patients. 
 
Paediatric population 
The safety and efficacy of Scintimun in children and adolescents have not yet been established. 
No data are available. 
 
Method of administration 
The radiolabelled solution should be administered intravenously as a single dose only. 
 
This medicinal product should be reconstituted and radiolabelled before administration to the patient. 
For instructions on reconstitution and radiolabelling of the medicinal product before administration, 
see section 12. 
 
For patient preparation, see section 4.4.  
 
Image acquisition 
Images acquisition should start 3 to 6 hours after administration. An additional acquisition 24 hours 
after initial injection is recommended. Acquisition can be performed using planar imaging.  
 
4.3 Contraindications 
 
Hypersensitivity to the active substance, to other murine antibodies, to any of the excipients listed in 
section 6.1 or to any of the components of the labelled radiopharmaceutical. 
 
Positive screening test for human anti-mouse antibody (HAMA).  
 
Pregnancy (see section 4.6). 
 
4.4 Special warnings and precautions for use 
 
Potential for hypersensitivity or anaphylactic reactions 
If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be 
discontinued immediately and intravenous treatment initiated, if necessary. To enable immediate 
action in emergencies, the necessary medicinal products and equipment such as endotracheal tube and 
ventilator must be immediately available.  
Since allergic reactions to the murine protein cannot be excluded, cardiovascular treatment, 
corticosteroids, and antihistamines must be available during administration of the product. 
 
Individual benefit/risk justification 
For each patient, the radiation exposure must be justifiable by the likely benefit. 
The activity administered should in every case be as low as reasonably achievable to obtain the 
required diagnostic information. 
 
Patient preparation 
Scintimun should be given to sufficiently hydrated patients. In order to obtain images of best quality 
and to reduce the radiation exposure of the bladder, patients should be encouraged to drink sufficient 
amounts and to empty their bladder prior to and after the scintigraphic examination. 
 
An interval of at least 2 days must be observed between any previous scintigraphy with other 
technetium (99mTc)-labelled agents and administration of Scintimun.  
 



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Interpretation of images 
There are currently no criteria to distinguish infection and inflammation by means of Scintimun 
imaging. Scintimun images should be interpreted in the context of other appropriate anatomical and/or 
functional imaging examinations.  
 
Only limited data is available about binding of technetium (99mTc) besilesomab to CarcinoEmbryonic 
Antigen (CEA) expressing tumours in vivo. In vitro, besilesomab cross-reacts with CEA. False 
positive findings in patients with CEA expressing tumours cannot be excluded. 
 
False results may be obtained in patients with diseases involving neutrophil defects and to patients 
with haematological malignancies including myeloma. 
 
After the procedure 
Close contact with infants and pregnant women should be restricted during the first 12 hours after the 
injection. 
 
Specific warnings 
 
Fructose intolerance 
Scintimun contains sorbitol therefore patients with rare hereditary problems of fructose intolerance 
should not be administered this product. 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-
free’. 
 
Human Anti-Mouse Antibodies (HAMA) 
Administration of murine monoclonal antibodies can lead to the development of Human Anti-Mouse 
Antibodies (HAMA). Patients who are HAMA positive may have a greater risk for hypersensitivity 
reactions. Inquiry on possible previous exposure to murine monoclonal antibodies and a HAMA test 
should be made prior to administration of Scintimun; a positive response would contraindicate the 
administration of Scintimun (see section 4.3). 
 
Repeated use 
Data on repeated dosing of Scintimun are very limited. Scintimun should only be used once in a 
patient’s lifetime.  
 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Active substances which inhibit inflammation or affect the haematopoietic system (such as antibiotics 
and corticosteroids) may lead to false negative results.  
 
Such substances should therefore not be administered together with, or a short time before the 
injection of Scintimun. 
 
 
4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential 
When an administration of radiopharmaceuticals to a woman of childbearing potential is intended, it is 
important to determine whether or not she is pregnant. Any woman who has missed a period should be 
assumed to be pregnant until proven otherwise. . If in doubt about her potential pregnancy (if the 
woman has missed a period, if the period is very irregular, etc.), alternative techniques not using 
ionising radiation (if there are any) should be offered to the patient. 
 
Pregnancy  
The use of besilesomab is contraindicated in pregnant women (see section 4.3).  



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Breast-feeding  
It is not known if the product is excreted in human milk. A risk to a breast-fed child cannot be 
excluded. 
 
Before administering radiopharmaceuticals to a mother who is breast-feeding, consideration should be 
given to the possibility of delaying the administration of radionuclide until the mother has ceased 
breast-feeding and to what is the most appropriate choice of radiopharmaceuticals, bearing in mind the 
secretion of activity in breast milk. If the administration is considered necessary, breast-feeding should 
be interrupted for three days and the expressed feeds discarded. These three days correspond to 
10 half-lives of technetium (99mTc) (60 hours). At that time the remaining activity represents about 
1/1000 of the initial activity in the body.  
 
Close contact with infants should be restricted during the first 12 hours after the injection. 
 
4.7 Effects on ability to drive and use machines 
 
Scintimun has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
In the most recent clinical study in which 123 patients were administered Scintimun, the most 
commonly reported adverse reaction was the development of anti-mouse antibodies (HAMA) in 14 % 
of the patients, after a single administration (16 positive over 116 assayed one and/or three months 
after the administration). 
 
The table below reports adverse reactions by MedDRA system organ classes. The frequencies are 
based on the most recent clinical trial and non interventional safety survey. 
 
The frequency listed below is defined using the following convention: 
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) 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
 
MedDRA System Organ 
Classes 

Adverse reactions Frequency  

Immune system disorders Anaphylactic/anaphylactoid reaction Rare 
 Hypersensitivity, including angioedema, 

urticaria 
Uncommon 

Vascular disorders Hypotension Common 
Musculoskeletal and connective 
tissue disorders 

Myalgia, arthralgia Rare 

Investigations Human anti-mouse antibody positive Very common 
 
Exposure to ionising radiation is linked with cancer induction and a potential for development of 
hereditary defects. For diagnostic nuclear medicine investigations the frequency of these adverse 
reactions is not known. As the effective dose is about 6.9 mSv when the maximal  recommended 
activity of 800 MBq is administered these adverse reactions are expected to occur with a low 
probability.  
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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4.9 Overdose 
 
No case of overdose has been reported. 
 
In the event of administration of a radiation overdose with technetium (99mTc) besilesomab, the 
absorbed dose to the patient should be reduced where possible by increasing the elimination of the 
radionuclide from the body by forced diuresis and frequent bladder voiding, and by the use of 
laxatives to promote faecal excretion. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Diagnostic radiopharmaceuticals, inflammation and infection detection, 
Technetium (99mTc) compounds. ATC code: V09HA03 
 
Mechanism of action 
Besilesomab is a murine immunoglobulin of IgG1 isotype that specifically binds to NCA-95 (non 
specific cross-reacting antigen 95), an epitope expressed at the cell membrane of granulocytes and 
granulocyte precursors. Besilesomab cross-reacts with tumours expressing carcinoembryonic antigen 
(CEA). Besilesomab has no effect on activation of complement, granulocyte function or platelets.  
 
Pharmacodynamic effects 
At the recommended activities, it does not exert any clinically relevant pharmacodynamic effects. 
 
Clinical efficacy 
In a randomised cross-over trial comparing blinded reading of Scintimun and 99mTc-White Blood Cells 
(WBCs) images in 119 patients with suspected osteomyelitis, the agreement rate between the two 
methods was 83 % (lower 95 % confidence interval limit: 80 %). However, based on the investigator’s 
diagnosis after one month of follow-up, Scintimun had a slightly lower specificity (71.8 %) than 
99mTc-WBCs (79.5 %). 
 
There are insufficient data on the use of Scintimun for the diagnosis of diabetic foot infection. 
 
5.2 Pharmacokinetic properties 
 
Distribution 
Whole blood concentration-time radioactivity curves show a two-phase course, which can be 
subdivided into an early phase (0-2 h) and a late phase (5-24 h). After correcting for the decay of 
radionuclide, the calculated half-life of the early phase is 0.5 h whereas the late phase shows a half-life 
of elimination of 16 h. 
 
Organ uptake 
Six hours after injection, about 1.5 % of the whole body radioactivity is found in the liver whereas 
about 3.0 % is found in the spleen. Twenty-four hours after injection, the percentages of radioactivity 
are 1.6 % in the liver and 2.3 % in the spleen. 
 
Non pathological unusual accumulations may be observed in the spleen (up to 6 % of the patients), in 
the bowel (up to 4 % of the patients), in the liver and bone marrow (up to 3 % of the patients), and in 
the thyroid and kidneys (up to 2 % of patients). 
 

http://www.whocc.no/atc_ddd_index/?code=V09HA


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Elimination 
Measurement of radioactivity levels in urine shows that up to 14 % of the administered activity is 
excreted via the bladder during the 24 h post-injection. The low renal clearance of activity (0.2 L/h for 
a glomerular filtration rate around 7 L/h) indicates that the kidney is not the major route of 
besilesomab elimination. 
 
5.3 Preclinical safety data 
 
Preclinical toxicity and safety studies were performed using commercial kits reconstituted with 
decayed technetium (99mTc) and thus the effect of radiation has not been assessed. 
 
Preclinical data obtained with the non-radioactive compound reveal no special hazard for humans 
based on conventional studies of safety pharmacology, single-dose and repeated-dose toxicity, 
although antimurine antibodies were found in all dose groups (including controls) in a repeated-dose 
study in monkeys. Genotoxicity studies conducted to test for potentially genotoxic impurities were 
also negative. Long-term carcinogenicity studies and toxicity to reproduction have not been carried 
out. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Scintimun vial: 
Sodium dihydrogen phosphate, anhydrous 
Disodium monohydrogen phosphate, anhydrous 
Sorbitol E420 
Under nitrogen atmosphere 
 
Solvent for Scintimun vial: 
1, 1, 3, 3-propane tetraphosphonic acid, tetrasodium salt, dihydrate (PTP) 
Stannous chloride dihydrate 
Sodium hydroxide / Hydrochloric acid (for pH adjustment) 
Nitrogen 
 
6.2 Incompatibilities 
 
This medicinal product must not be mixed with other medicinal products except those mentioned in 
section 12. 
 
6.3 Shelf life 
 
3 years. 
After radiolabelling: 3 hours.  
Do not store above 25 °C after radiolabelling. 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2 °C – 8 °C). 
 
Keep the vial in the outer carton in order to protect from light. 
 
For storage conditions after reconstitution and radiolabelling of the medicinal product, see section 6.3. 
 
Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive 
materials. 
 



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6.5 Nature and contents of container 
 
Scintimun vial: 
15 mL, colourless, type I glass vial, closed with chlorobutyl rubber stopper and aluminium crimped 
capsule (green) containing 5.02 mg of powder. 
 
Solvent for Scintimun  
15 mL, colourless, type I glass vial, closed with chlorobutyl rubber stopper and crimped aluminium 
capsule (yellow) containing 2.82 mg of powder. 
 
Pack sizes:  
Kit of one multidose vial of Scintimun and one vial of solvent. 
Kit of two multidose vials of Scintimun and two vials of solvent. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
General warning 
Radiopharmaceuticals should be received, used and administered only by authorised persons in 
designated clinical settings. Their receipt, storage, use, transfer and disposal are subject to the 
regulations and/or appropriate licences of the competent official organisation. 
 
Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety 
and pharmaceutical quality requirements. Appropriate aseptic precautions should be taken. 
 
Contents of the vial are intended only for use in the preparation of technetium(99mTc) besilesomab and 
are not to be administered directly to the patient without first undergoing the preparative procedure. 
 
For instructions on reconstitution and radiolabelling of the medicinal product before administration, 
see sections 12. 
 
If at any time in the preparation of this product the integrity of this vial is compromised it should not 
be used. 
 
Administration procedures should be carried out in a way to minimise risk of contamination of the 
medicinal product and irradiation of the operators. Adequate shielding is mandatory. 
 
The content of the kit before reconstitution is not radioactive. However, after sodium 
pertechnetate (99mTc) is added, adequate shielding of the final preparation must be maintained. 
 
The administration of radiopharmaceuticals creates risks for other persons from external radiation or 
contamination from spills of urine, vomiting, etc. Radiation protection precautions in accordance with 
national regulations must therefore be taken. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
CIS bio international 
B.P.32 
F-91192 Gif-sur-Yvette Cedex 
France 
 
 



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8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/09/602/001 
EU/1/09/602/002 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 11 January 2010 
Date of latest renewal: 26 August 2014 
 
 
10. DATE OF REVISION OF THE TEXT 
 
{MM/YYYY} 
 
 
11. DOSIMETRY 
 
Technetium (99mTc) is produced by means of a (99Mo/99mTc) generator and decays with the emission of 
gamma radiation with a mean energy of  140 keV and a half-life of 6.02 hours to technetium (99Tc) 
which, in view of its long half-life of 2.13 x 105 years can be regarded as quasi stable. 
 
For each organ, or group of organs, the absorbed doses have been calculated using the methodology 
developed by the MIRD (Medical Internal Radiation Dose).  
 
The effective dose has been calculated by using the absorbed doses determined for each individual 
organ, taking into account the weighting factors (radiation and tissue) to use according to the 
recommendations of the ICRP (International Commission of Radiological Protection, 
Publication 103). 
 



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Table 1: Values of the absorbed doses calculated for the individual male and female of reference. 
 

Organ mSv/MBq 
 Reference male Reference female 
Brain 0.00236 0.00312 
Heart 0.00495 0.00597 
Colon 0.00450 0.00576 
Stomach 0.00445 0.00535 
Liver 0.0100 0.0126 
Small Intestine 0.00480 0.00575 
Bone marrow (red) 0.0242 0.0229 
Muscles 0.00317 0.00391 
Ovaries  0.00594 
Pancreas 0.00690 0.00826 
Skin 0.00178 0.00216 
Lungs 0.0125 0.0160 
Spleen 0.0271 0.0324 
Kidney 0.0210 0.0234 
Breast  0.00301 
Adrenal 0.00759 0.00937 
Testis 0.00182  
Thymus 0.00351 0.00423 
Thyroid 0.00279 0.00321 
Bone 0.0177 0.0227 
Uterus  0.00501 
Gallbladder 0.00591 0.00681 
Bladder 0.00305 0.00380 
Whole body 0.00445 0.00552 
Effective Dose   0.00863 mSv / MBq 

 
The effective dose resulting from the administration of an activity of 800 MBq for an adult weighing 
70 kg is 6.9 mSv. 
For an administered activity of 800 MBq the typical radiation dose to the target organ bone is 
14.2 mGy and the typical radiation doses to the critical organs, bone marrow, spleen and kidneys are 
19.4 mGy, 21.7 mGy, and 16.8 mGy respectively. 
 
 
12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS 
 
Scintimun is a sterile powder containing 1 mg of besilesomab per vial Scintimun. 
 
Withdrawals should be performed under aseptic conditions. The vials must not be opened. 
After disinfecting the stopper, the solution should be withdrawn via the stopper using a single dose 
syringe fitted with suitable protective shielding and a disposable sterile needle or using an authorised 
automated application system.  
If the integrity of this vial is compromised, the product should not be used 
 
Method of preparation 
To ensure the highest radiolabelling efficiency: 
- Radiolabelling is performed using freshly eluted sodium pertechnetate (99mTc).  
- Eluates should only be taken from a technetium (99mTc)-generator that has been eluted within 

the past 24 hours (i.e. with less than 24 h in-grow).  
- The first eluate taken from a technetium (99mTc)-generator that has not been eluted over the 

weekend must NOT be used. 
 



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Procedure 
1. Take a vial of Solvent for Scintimun (yellow crimped aluminium capsule) from the kit. 

Disinfect the septum and allow drying. Using a syringe, introduce through the rubber seal 5 mL 
of 0.9% sodium chloride solution. Without removing the needle, withdraw an equivalent 
volume of air in order to avoid excess pressure in the vial. Shake smoothly.  

2. After complete dissolution, disinfect the septum and allow drying. Transfer 1 mL of this 
solution with a hypodermic syringe into a vial of Scintimun (green crimped aluminium 
capsule). Without removing the needle, withdraw an equivalent volume of air in order to avoid 
excess pressure in the vial. Swirl carefully; the content of the vial of Scintimun will dissolve 
within one minute (DO NOT shake). 

3. After 1 min, check that the content of the vial of Scintimun has completely dissolved. Place the 
vial of Scintimun in an appropriate lead shielding container. Disinfect the septum and allow 
drying. Using a hypodermic syringe, introduce through the rubber seal 2-7 mL of 
pertechnetate (99mTc) (the eluate complies with the requirements of current Eur. Ph.). Without 
removing the needle, withdraw an equivalent volume of air in order to avoid excess pressure in 
the vial. Swirl carefully to mix the whole solution (DO NOT shake). The activity must be 
between 400 and 1800 MBq depending on the volume of pertechnetate (99mTc). The total 
volume in the vial of Scintimun equals 3 to 8 mL. 

4. Fill in the enclosed label and fix it to the radiolabelled solution. 
5. 10 min after the addition of pertechnetate (99mTc) the solution is ready for injection.  
 
Notes on the instructions 
- Solvent for Scintimun must NEVER be radiolabelled first and then added to Scintimun. 
- The final radiolabelled injection solution must be protected from oxygen. 
 
After reconstitution with the solvent provided and the radiolabelling with sodium pertechnetate (99mTc) 
injection, the resulting clear and colourless solution for injection of technetium (99mTc)-besilesomab 
has a pH of 6.5-7.5.  
 
Quality control 
The radiochemical purity of the final radiolabelled preparation can be tested according to the 
following procedure: 
 
Method 
Instant thin layer chromatography or paper chromatography. 
 
Materials and reagents 
- Adsorbent: strips (2.5 x 20 cm) for thin layer chromatography coated with silica gel (ITLC-SG) 

or for paper chromatography (RBM-1). Trace a starting line 2.5 cm from the bottom of the 
paper strip. 

- Solvent: methyl ethyl ketone (MEK) 
- Containers: appropriate containers such as chromatography tank or 1 000 mL Erlenmeyer 

flasks. 
- Miscellaneous: forceps, scissors, syringes, appropriate counting assembly. 
 
Procedure 
Do not let air enter the vial to be tested and store all vials containing radioactive solution in lead 
shielding. 
1. Introduce the solvent into the chromatography tank to a depth of approximately 2 cm. Cover the 

tank and allow to equilibrate for at least 5 minutes. 
2. Apply a spot (2 µL) of the radiolabelled solution to the starting line of the ITLC-SG or RBM-1 

paper strip using a syringe and a needle.  
3. Introduce the ITLC-SG or RBM-1 paper strip immediately into the chromatography tank using 

forceps to avoid formation of pertechnetate (99mTc) due to oxygen. DO NOT let the spot dry. 
4. When the solvent has reached the top of the strip (about 10 minutes), use the forceps to remove 

the strip and dry in the air.  
5. Cut the strip in two separate parts at Rf = 0.5. 



12 
 

6. Separately count each cut part of the strip and record the obtained values (use an appropriate 
detection apparatus with a constant counting time, and known geometry and background noise). 

7. Calculations 
 The radiochemical purity corresponds to the percentage of bound technetium (99mTc) and is 

calculated as follows after correcting data for background noise: 
 

% bound technetium (99mTc) = 100 % - % free Technetium (99mTc) 
 

Where, % free technetium (99mTc) =   x 100 
 
 

8. The radiochemical purity (the percentage of bound Technetium (99mTc)) must be more than or 
equal to 95 %. 

9. The solution should be inspected visually prior to use. Only clear solutions, free of visible 
particles should be used. 

 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency  http://www.ema.europa.eu 
 
  

strip ofactivity  Total
1.0 Rf  to0.5 Rf from stripcut  ofActivity  

http://www.ema.europa.eu/


13 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 

MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 

 B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 



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A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturer of the biological active substance 
 
GLYCOTOPE Biotechnology GmbH 
Czerny-Ring, 22 
69115 HEIDELBERG 
GERMANY 
 
Name and address of the manufacturer responsible for batch release 
 
CIS bio international 
B.P. 32 
F-91192 Gif-sur-Yvette Cedex 
France 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product 
Characteristics, Section 4.2). 
 
 
C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic Safety Update Reports 
 
The requirements for submission of periodic safety update reports for this medicinal product are 
set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of 
Directive 2001/83/EC and any subsequent updates published on the European medicines web-
portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT   
 
• Risk Management Plan (RMP) 
 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in 
the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed 
subsequent updates of the RMP. 
  
An updated RMP should be submitted: 
• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

 



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• Additional risk minimisation measures  
 
The Marketing Authorisation Holder shall ensure that, at launch, all physicians experienced in nuclear 
medicine who are expected to prescribe/use Scintimun are provided with a Direct Healthcare 
Professional Communication (DHPC), which includes information regarding potential risks of human 
anti-mouse antibody (HAMA) generation, hypersensitivity reactions and risks of acute hypotension, as 
agreed by CHMP. 
 
The DHPC also includes 3 copies of a Patient Alert Card completed by the Healthcare Professional 
and provided to each patient. 
 



16 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 
 

  



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A. LABELLING 
  



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
CARTON BOX 
 
contains Blue Box 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Scintimun 1 mg kit for radiopharmaceutical preparation 
besilesomab 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each vial of Scintimun contains 1 mg of besilesomab 
 
 
3. LIST OF EXCIPIENTS 
 
Scintimun 
Excipients: Sodium dihydrogen phosphate anhydrous, disodium monohydrogen phosphate anhydrous, 
sorbitol, under nitrogen atmosphere. 
 
Solvent for Scintimun 
1, 1, 3, 3-propane tetraphosphonic acid tetrasodium salt dihydrate, stannous chloride dihydrate, 
sodium hydroxide, hydrochloric acid, nitrogen. 
 
Read the leaflet for further information before use. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Kit for radiopharmaceutical preparation  
 
Contains one multidose vial Scintimun and one vial solvent for Scintimun 
Contains two multidose vials Scintimun and two vials solvent for Scintimun  
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Intravenous use 
 
Reconstitute Scintimun with its solvent first and then radiolabel with a sodium pertechnetate (99mTc) 
solution. 
Read the package leaflet before use. 
 
 



19 
 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 
 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
 
8. EXPIRY DATE 
 
EXP 
 
Use within 3 hours after radiolabelling. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator (2 °C – 8 °C). 
 
Keep the vial in the outer carton in order to protect from light. 
 
Do not store the reconstituted and radiolabelled product above 25 °C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Dispose of radioactive waste in accordance with local regulations. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
CIS bio international 
B.P.32 
F-91192  Gif-sur-Yvette Cedex 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/09/602/001 one multidose vial Scintimun and one vial solvent for Scintimun 
EU/1/09/602/002 two multidose vials Scintimun and two vials solvent for Scintimun 
 
 
13. BATCH NUMBER 
 
Lot: 
 



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14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted 
 
  



21 
 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
GLASS VIAL Scintimun 
 
 
no Blue Box included 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Scintimun 1 mg kit for radiopharmaceutical preparation 
Besilesomab 
Intravenous use 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP  
 
Use within 3 hours after radiolabelling. 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 mg 
 
 
6. OTHER 
 
CIS bio international 
 
  



22 
 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
GLASS VIAL Solvent for Scintimun 
 
no Blue Box included 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Solvent for Scintimun 
 
 
2. METHOD OF ADMINISTRATION 
 
Not intended for direct application to patients. 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
2.82 mg 
 
 
6. OTHER 
 
CIS bio international 
 
  



23 
 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
Additional label after reconstitution and radiolabelling with sodium pertechnetate (99mTc) 
solution 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
(99mTc)- Scintimun 
 
 
2. METHOD OF ADMINISTRATION 
 
 
 
 
3. EXPIRY DATE 
 
 
 
 
4. BATCH NUMBER 
 
 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
99mTc 
 MBq 
 ml 
 hour/date 
 
 
6. OTHER 
 

    
 
 
CIS bio international 
 
  



24 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



25 
 

Package leaflet: information for the patient 
 

Scintimun 1 mg kit for radiopharmaceutical preparation  
besilesomab 

 
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 doctor or the nuclear medicine specialist who will 

supervise the procedure. 
-  If you get any side effects, talk to your nuclear medicine doctor or pharmacist. This includes 

any possible side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Scintimun is and what it is used for 
2. What you need to know before you are given Scintimun  
3. How Scintimun is given  
4. Possible side effects 
5 How Scintimun is stored 
6. Contents of the pack and other information 
 
 
1. What Scintimun is and what it is used for 
 
Scintimun is a medicine containing an antibody (besilesomab) used to target specific cells called 
granulocytes (a type of white blood cells involved in the inflammation process) in your body. 
Scintimun is used for the preparation of a radioactive solution for injection of technetium(99mTc)-
besilesomab. Technetium(99mTc) is a radioactive element allowing the organs where besilesomab 
accumulates to be seen using a special camera. 
 
This medicine is a radiopharmaceutical product for diagnostic use only in adults. 
After injection into your vein, your doctor can obtain pictures (scans) of your organs that give more 
information about the detection of sites of inflammation and/or infection. However Scintimun should 
not be used for the diagnosis of diabetic foot infection. 
The use of Scintimun 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 outweights the risk due to radiation. 
 
 
2. What you need to know before you are given Scintimun  
 
Scintimun must not be used: 
- if you are allergic to besilesomab, to antibody from mouse origin or any other antibodies, or to 

sodium pertechnetate (99mTc) solution or any of the other ingredients of this medicine listed in 
section 6. 

- if you have a positive response to a test detecting human anti-mouse antibodies (HAMA test). 
Ask your doctor if you are not sure. 

- if you are pregnant. 
 



26 
 

Warnings and precautions  
Talk to the nuclear medicine specialist before using Scintimun: 
- if you have previously been administered Scintimun, because you should only be administered 

Scintimun once in your lifetime. If you are not sure if you have been given this medicine before, 
please let your doctor know. 

- if you have had a scintigraphy with technetium in the last 2 days. 
- if you have a tumoral pathology involving a secretion of carcino-embryonic antigen (CEA) 

which could interfere with this investigation. 
- if you have any blood disease. 
- if you are breast-feeding. 
 
Before administration of Scintimun 
In order to obtain images of best quality and to reduce the radiation exposure of your bladder, you 
should drink sufficient amounts and empty your bladder prior to and after the scintigraphic 
examination. 
 
Children and adolescents 
This medicine is not recommended for use in patients below 18 years of age because the safety and 
efficacy of the product have not been established. 
 
Other medicines and Scintimun 
Tell your nuclear medicine doctor if you are taking,  have recently taken  or might take any other 
medicines, including medicines obtained without a prescription, since they may interfere with the 
interpretation of the images. 
Medicines reducing inflammation and medicines affecting the production of your blood cells (such as 
corticosteroids or antibiotics) may affect the results of your examination. 
 
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 administration of Scintimun if there is a 
possibility you might be pregnant, if you have missed your period or if you are breast-feeding. When 
in doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure. 
 
If you are pregnant you must not be given Scintimun. 
Investigations in nuclear medicine may involve a risk to the unborn. 
 
If you are breast-feeding you must stop breast-feeding for 3 days after your injection and the expressed 
milk should be discarded. If you wish, you can express and store your breast milk before your 
injection. This will protect your child from the radiation that may be present in your breast milk. 
Please ask your nuclear medicine doctor when you can resume breast-feeding. 
Moreover you must avoid close contact with your child during the first 12 hours after the injection. 
 
Driving and using machines 
It is considered unlikely that Scintimun will affect your ability to drive or to use machines. 
 
Scintimun contains sorbitol and sodium 
If you have an intolerance to some sugars (for example fructose or sorbitol), tell your doctor before 
you are given Scintimun. 
 
Scintimun contains less than 1 mmol of sodium (23 mg) per vial, i.e. essentially ‘sodium- free’. 
 
 



27 
 

3. How Scintimun is given  
 
There are strict laws on the use, handling and disposal of radiopharmaceutical products. Scintimun 
will only be used in special controlled areas. This product will only be handled and given to you by 
people who are trained and qualified to use it safely. These persons will take special care for the safe 
use of this product and will keep you informed of their actions. 
 
The nuclear medicine doctor supervising the procedure  will decide on the quantity of 
technetium(99mTc)- besilesomab to be used in your case. It will be the smallest quantity necessary to 
get the desired information.  
The quantity to be administered usually recommended for an adult ranges from 400 to 800 MBq 
(megabecquerel, the unit used to express radioactivity).  
 
Administration of Scintimun and conduct of the procedure 
Scintimun is administered intravenously. 
A single injection into a vein in your arm is sufficient to conduct the test your doctor needs. 
 
Duration of the procedure 
Your Nuclear medicine doctor will inform you about the usual duration of the procedure.  
 
After administration of Scintimun 
Because you could emit radiation especially harmful to young children during the first 12 hours after 
the injection, you should avoid close contact with young children and pregnant women during this 
period of time. 
 
The nuclear medicine doctor will inform you if you need to take any special precautions after 
receiving this medicine. Contact your nuclear medicine doctor if you have any questions. 
 
If you have been given more Scintimun than you should 
An overdose is unlikely because injection is prepared as a single dose by the hospital personnel, under 
strictly controlled conditions. However, in the case of an overdose, you will be asked to drink plenty 
of water and to take laxatives to increase the elimination of the product from your body. 
 
Should you have any further questions on the use of Scintimun, please ask the 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. 
 
This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk 
of cancer and hereditary abnormalities. 
 
About 14 out of 100 patients having this injection have been found to produce antibodies in their 
blood reacting against the antibody present in Scintimun. This may increase the risk of allergic 
reactions in case of repeated administration of Scintimun. Therefore you should not receive Scintimun 
a second time. 
In case of allergic reaction you will receive appropriate treatment from your doctor. 
 
Possible side effects are listed in the order of their frequency below: 
 
Very common (may affect more than 1 in 10 people): 

Development of human anti-mouse antibodies reacting against the antibody in Scintimun 
(antibody of the mouse cells) with a risk of allergic reaction 
 



28 
 

Common (may affect up to 1 in 10 people): 
Low blood pressure 
 

Uncommon (may affect up to 1 in 100  people): 
Allergic reaction, including swelling of the face, hives (urticaria) 

 
Rare (may affect up to 1 in 1,000 people): 
• Serious allergic reaction which causes difficulty in breathing or dizziness 
• Muscle or joint pain 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or  the specialist in nuclear medicine. This includes any 
possible side effects not listed in this leaflet. You can also report side effects directly via directly via 
the national reporting system listed in Appendix V. By reporting side effects you can help provide 
more information on the safety of this medicine. 
 
 
5.  How Scintimun is stored 
 
You will not have to store this medicine. This medicine is stored under the responsibility of the 
specialist in appropriate premises. Storage of radiopharmaceuticals will be in accordance with national 
regulation on radioactive materials. 
 
 
6.  Contents of the pack and other information 
 
What Scintimun contains 
- The active substance is besilesomab (anti-granulocyte monoclonal antibody from mouse 

origin).  
 One vial of Scintimun contains 1 mg of besilesomab. 
- The other ingredients are (see section 2 “Scintimun contains sorbitol and sodium”): 
 
Scintimun 
 Sodium dihydrogen phosphate, anhydrous 
 Disodium monohydrogen phosphate, anhydrous 
 Sorbitol E420 
 Under nitrogen atmosphere 
 
Solvent for Scintimun 
 1, 1, 3, 3-propane tetraphosphonic acid, tetrasodium salt, dihydrate (PTP) 
 Stannous chloride dihydrate 
 Sodium hydroxide / Hydrochloric acid  
 Nitrogen 
 
What Scintimun looks like and contents of the pack 
Scintimun is a kit for radioactive preparation. 
The vial of Scintimun contains a white powder.  
The vial of solvent for Scintimun contains a white powder. 
 
The kit contains one or two multidose vials of Scintimun with one or two vials of solvent. 
 
Not all pack-sizes may be marketed. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


29 
 

Marketing Authorisation Holder and Manufacturer 
CIS bio international 
B.P. 32 
F-91192 Gif-sur-Yvette Cedex 
France 
 
This leaflet was last revised in {MM/YYYY}. 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu 
 
--------------------------------------------------------------------------------------------------------------------------- 
 
The following information is intended for healthcare professionals only: 
The complete SmPC of Scintimun is provided as a tear-off section at the end of the printed leaflet in 
the product package, with the objective to provide healthcare professionals with other additional 
scientific and practical information about the administration and use of this radiopharmaceutical. 
Please refer to the SmPC. 

http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT  
	A. LABELLING
	B. PACKAGE LEAFLET

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    /TUR <FEFF0130015f006c006500200069006c00670069006c0069002000620065006c00670065006c006500720069006e0020006700fc00760065006e0069006c0069007200200062006900e70069006d006400650020006700f6007200fc006e007400fc006c0065006e006d006500730069006e0065002000760065002000790061007a0064013100720131006c006d006100730131006e006100200075007900670075006e002000410064006f006200650020005000440046002000620065006c00670065006c0065007200690020006f006c0075015f007400750072006d0061006b0020006900e70069006e00200062007500200061007900610072006c0061007201310020006b0075006c006c0061006e0131006e002e0020004f006c0075015f0074007500720075006c0061006e002000500044004600200064006f007300790061006c0061007201310020004100630072006f006200610074002000760065002000410064006f00620065002000520065006100640065007200200036002e003000200076006500200073006f006e00720061006b00690020007300fc007200fc006d006c0065007200690079006c00650020006100e70131006c006100620069006c00690072002e>
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
    /ENU (Use these settings to create Adobe PDF documents suitable for reliable viewing and printing of business documents.  Created PDF documents can be opened with Acrobat and Adobe Reader 6.0 and later.)
    /FRA <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>
  >>
>> setdistillerparams
<<
  /HWResolution [600 600]
  /PageSize [612.000 792.000]
>> setpagedevice