Yttriga

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 

 



2 

1. NAME OF THE MEDICINAL PRODUCT 
 
Yttriga radiopharmaceutical precursor, solution. 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
1 ml sterile solution contains 0.1-300 GBq Yttrium (90Y) on the reference date and time 
(corresponding to 0.005-15 micrograms of Yttrium [90Y]) (as Yttrium [90Y] chloride). 
 
Each 3ml vial contains 0.1-300 GBq, corresponding to 0.005-15 micrograms of Yttrium (90Y), at 
reference date and time. The volume is 0.02-3 ml.  
Each 10ml vial contains 0.1-300 GBq, corresponding to 0.005-15 micrograms of Yttrium (90Y), at 
reference date and time. The volume is 0.02-5 ml.  
The theoretical specific activity is 20 GBq/microgram of Yttrium (90Y) (see section 6.5). 
 
Yttrium (90Y) chloride is produced by decay of its radioactive precursor Strontium (90Sr). It decays by 
emission of beta radiation of 2.281 MeV (99.98 %) of maximal energy to stable Zirconium (90Zr). 
Yttrium (90Y) has a half-life of 2.67 days (64.1 hours). 
 
For a full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Radiopharmaceutical precursor, solution. 
 
Clear colourless solution, free of particulate matter. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
To be used only for the radiolabelling of carrier molecules, which have been specifically developed 
and authorised for radiolabelling with this radionuclide. 
 

Radiopharmaceutical precursor - Not intended for direct use in patients. 
 
4.2 Posology and method of administration 
 
Yttriga is only to be used by specialists experienced with in vitro radiolabelling. 
 
Posology 
 
The quantity of Yttriga required for radiolabelling and the quantity of Yttrium (90Y)-labelled medicinal 
product that is subsequently administered will depend on the medicinal product radiolabelled and its 
intended use. Refer to the Summary of Product Characteristics/package leaflet of the particular 
medicinal product to be radiolabelled. 
 
 
Method of administration 
 
Yttriga is intended for in vitro labelling of medicinal products which are subsequently administered by 
the approved route. 
Further information on the preparation of the product is given in section 12. 
 



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4.3 Contraindications 
 
Do not administer Yttriga directly to the patient. 
Yttriga is contraindicated in the following cases: 
- Hypersensitivity to Yttrium (90Y) chloride or to any of the excipients 
 
Yttrium (90Y)-labelled medicinal products are contraindicated in the following case: 
- Established or suspected pregnancy or when pregnancy has not been excluded (see section 4.6) 
 
For information on contraindications to particular Yttrium (90Y)-labelled medicinal products prepared 
by radiolabelling with Yttriga refer the Summary of Product Characteristics/package leaflet of the 
particular medicinal product to be radiolabelled. 
 
4.4 Special warnings and precautions for use 
 
The contents of the vial of Yttriga is not to be administered directly to the patient but must be used for 
the radiolabelling of carrier molecules, such as monoclonal antibodies, peptides or other substrates. 
 
Radiopharmaceuticals should be received, used and administered only by authorised persons in 
designated clinical settings and receipt, storage, use, transfer and disposal are subject to the regulations 
and appropriate licences of the competent authorities. 
 
Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety 
and pharmaceutical quality requirements. 
 
For information concerning special warnings and special precautions for use of Yttrium (90Y)-labelled 
medicinal products refer to the Summary of Product Characteristics/package leaflet of the medicinal 
product to be radiolabelled. 
 
Particular care should be taken when administering radioactive medicinal products to children and 
adolescents (from 2 to 16 years old). 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No interaction studies of Yttrium (90Y) chloride with other medicinal products have been performed, 
because Yttriga is a precursor solution for radiolabelling medicinal products. 
 
For information concerning interactions associated with the use of Yttrium (90Y)-labelled medicinal 
products refer to the Summary of Product Characteristics/package leaflet of the medicinal product to 
be radiolabelled. 
 
4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential  
Women of childbearing potential have to use effective contraception during and after treatment. 
 
Pregnancy 
Yttrium (90Y)-labelled medicinal products are contraindicated in established or suspected pregnancy or 
when pregnancy has not been excluded (see section 4.3). 
 
Breast-feeding 
Before administering a radioactive medicinal product to a mother who is breast-feeding, consideration 
should be given to whether the investigation could be reasonably delayed until the mother has ceased 
breast-feeding. If the administration cannot be delayed, a lactating mother should be advised to stop 
breast-feeding. 



4 

Further information concerning the use of a Yttrium (90Y)-labelled medicinal products in pregnancy 
and breast-feeding is specified in the Summary of Product Characteristics of the medicinal product to 
be radiolabelled. 
 
Fertility 
Further information concerning the use of a Yttrium (90Y)-labelled medicinal concerning fertility is 
specified in the Summary of Product Characteristics of the medicinal product to be radiolabelled. 
 
 
4.7 Effects on ability to drive and use machines 
 
Effects on ability to drive and to use machines following treatment by Yttrium (90Y)-labelled 
medicinal products will be specified in the Summary of Product Characteristics/package leaflet of the 
medicinal product to be radiolabelled. 
 
 
4.8 Undesirable effects 
 
Possible adverse reactions following the intravenous administration of a Yttrium (90Y)-labelled 
medicinal product prepared by radiolabelling with Yttriga, will be dependent on the specific medicinal 
product being used. Such information will be supplied in the Summary of Product 
Characteristics/package leaflet of the medicinal product to be radiolabelled. For each patient, exposure 
to ionising radiation must be justifiable on the basis of likely clinical benefit. The activity administered 
must be such that the resulting radiation dose is as low as reasonably achievable bearing in mind the 
need to obtain the intended therapeutic result. 
 
Exposure to ionising radiation is linked with cancer induction and a potential for development of 
hereditary defects. 
 
The radiation dose resulting from therapeutic exposure may result in higher incidence of cancer and 
mutations. In all cases, it is necessary to ensure that the risks of the radiation are less than from the 
disease itself. 
 
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. 
 
 
4.9 Overdose 
 
The presence of free Yttrium (90Y) chloride in the body after an inadvertent administration of Yttriga 
will lead to increased bone marrow toxicity and haematopoietic stern cell damage. 
Therefore, in case of an inadvertent administration of Yttriga, the radiotoxicity for the patient must be 
reduced by immediate (i. e. within 1 hour) administration of preparations containing chelators like Ca-
 DTPA or Ca-EDTA in order to increase the elimination of the radionuclide from the body. 
 
The following preparations must be available in medical institutions, which use Yttriga for labelling of 
carrier molecules for therapeutic purposes: 
- Ca-DTPA (Trisodium calcium diethylenetriaminepentaacetate) or 
- Ca-EDTA (Calcium disodium ethylenediaminetetraacetate) 
 
These chelating agents suppress yttrium radiotoxicity by an exchange between the calcium ion and the 
yttrium due to their capacity of forming water soluble complexes with the chelating ligands (DTPA, 
EDTA). These complexes are rapidly eliminated by the kidneys. 
 

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


5 

1 g of the chelating agents should be administered by slow intravenous injection over 3 – 4 minutes or 
by infusion (1 g in 100 – 250 ml of dextrose, or normal saline). 
 
The chelating efficacy is greatest immediately or within one hour of exposure when the radionuclide is 
circulating in or available to tissue fluids and plasma. However, a post-exposure interval > 1 hour does 
not preclude the administration and effective action of chelator with reduced efficiency. 
Intravenous administration should not be protracted over more than 2 hours. 
 
In any case the blood parameters of the patient have to be monitored and the appropriate actions 
immediately taken if there is evidence of damage to the blood marrow. 
 
The toxicity of the free Yttrium (90Y) due to in-vivo release from the labelled biomolecule in the body 
during therapy could be reduced by post-administration of chelating agents. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Other therapeutic radiopharmaceuticals, ATC code:  V10X. 
The pharmacodynamic properties of Yttrium (90Y)-labelled medicinal products prepared by 
radiolabelling with Yttriga, prior to administration, will be dependent on the nature of the medicinal 
product to be radiolabelled. Refer to the Summary of Product Characteristics/package leaflet of the 
particular medicinal product to be radiolabelled. 
 
5.2 Pharmacokinetic properties 
 
The pharmacokinetic properties of Yttrium (90Y)-labelled medicinal products prepared by 
radiolabelling with Yttriga, prior to administration, will be dependent on the nature of the medicinal 
product to be radiolabelled. 
 
In the rat, following intravenous administration, Yttrium (90Y) chloride is rapidly cleared from the 
blood. At 1 and 24 hours, blood radioactivity decreases from 11.0 % to 0.14 % of the administered 
activity. The two main organs where Yttrium (90Y) chloride distributes are the liver and bones. In the 
liver, 18 % of the injected activity is taken up 5 min after injection. Liver uptake decreases then to 
8.4 % 24 hours after injection. In bone, percentage of injected activity increases from 3.1 % at 5 min 
to 18 % at 6 hours and then decreases with time. Faecal and urinary elimination is slow: about 31 % of 
the administered activity is eliminated in 15 days. 
 
5.3 Preclinical safety data 
 
The toxicological properties of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling 
with Yttriga prior to administration, will be dependent on the nature of the medicinal product to be 
radiolabelled. 
 
There are no data available on the toxicity of Yttrium (90Y) chloride nor on its effects on reproduction 
in animals or its mutagenic or carcinogenic potential. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Hydrochloric acid (0.04 M) 
 
 
 



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6.2 Incompatibilities 
 
Radiolabelling of medicinal products, such as monoclonal antibodies, peptides or other substrates, 
with Yttrium (90Y) chloride is very sensitive to the presence of trace metal impurities. 
It is important that all glassware, syringe needles etc, used for the preparation of the radiolabelled 
medicinal product are thoroughly cleaned to ensure freedom from such trace metal impurities. Only 
syringe needles (for example, non-metallic) with proven resistance to dilute acid should be used to 
minimise trace metal impurity levels. 
 
6.3 Shelf life 
 
Up to 12 days from the date of manufacture. 
 
6.4 Special precautions for storage 
 
Storage should be in accordance with national regulation on radioactive material. 
 
6.5 Nature and contents of container 
 
Colourless type I glass vial of 3 ml with a V-shapped bottom or a colourless type I glass vial of 10 ml 
with a flat bottom with a silicon stopper, closed with an aluminium seal.  
 
Pack size: 1 vial   
Not all presentations may be marketed.  
 
6.6 Special precautions for disposal 
 
The vial may contain high pressure due to radiolysis (see section 12). 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Str. 10 
D-13125 Berlin 
Germany 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/05/322/001 (3 ml V-shaped vial) 
EU/1/05/322/002 (10 ml flat bottom vial) 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 19/01/2006  
Date of renewal: 06/01/2011 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
11.  DOSIMETRY 
 
The radiation dose received by the various organs following intravenous administration of an 
Yttrium (90Y)-labelled medicinal product is dependent on the specific medicinal product being 



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radiolabelled. Information on radiation dosimetry of each different medicinal product following 
administration of the radiolabelled preparation will be available in the Summary of Product 
Characteristics/package leaflet of the particular medicinal product to be radiolabelled. 
 
The dosimetry table below is presented in order to evaluate the contribution of non-conjugated 
Yttrium (90Y) to the radiation dose following the administration of Yttrium (90Y)-labelled medicinal 
product or resulting from an accidental intravenous injection of Yttriga. 
 
The dosimetry estimates were based on a rat distribution study and the calculations were effected in 
accordance with MIRD/ICRP 60 recommendations. Time-points for measurements were 5 min, 1, 6, 
24, 96 and 360 hours. 
 
 

Absorbed dose per unit activity administered (mGy/MBq) 
 

 
Organ 
 

 
Adult  
(70 kg) 

 
15 years  
(50 kg) 

 
10 years  
(30 kg) 

 
5 years 
(17 kg) 

 
1 year 
(10 kg) 

 
Newborn 
(5 kg) 

Adrenals 7.23 E-01 1.09 E+00 2.53 E+00 3.62 E+00 7.23 E+00 2.17 E+01 
Blood 4.20 E-02 6.29 E-02 1.47 E-01 2.10 E-01 4.19 E-01 1.26 E+00 
Bone marrow 2.58 E+00 3.88 E+00 9.05 E+00 1.29 E+01 2.58 E+01 7.75 E+01 
Brain 8.60 E-03 1.29 E-02 3.01 E-02 4.30 E-02 8.60 E-02 2.58 E-01 
Carcass 5.82 E-01 8.72 E-01 2.04 E+00 2.91 E+00 5.82 E+00 1.75 E+01 
Colon 2.30 E-02 3.46 E-02 8.06 E-02 1.15 E-01 2.30 E-01 6.91 E-01 
Femur 7.76 E+00 1.16 E+01 2.72 E+01 3.88 E+01 7.76 E+01 2.33 E+02 
Gastro-intestinal 
content 

 
1.22 E-01 

 
1.83 E-01 

 
4.26 E-01 

 
6.09 E-01 

 
1.22 E+00 

 
3.66 E+00 

Heart 2.53 E-01 3.79 E-01 8.85 E-01 1.26 E+00 2.53 E+00 7.59 E+00 
Ileum 1.16 E-02 1.74 E-02 4.06 E-02 5.81 E-02 1.16 E-01 3.48 E-01 
Kidneys  2.35 E+00 3.53 E+00 8.24 E+00 1.18 E+01 2.35 E+01 7.06 E+01 
Liver 1.27 E+00 1.91 E+00 4.46 E+00 6.37 E+00 1.27 E+01 3.82 E+01 
Lungs 4.23 E-01 6.34 E-01 1.48 E+00 2.11 E+00 4.23 E+00 1.27 E+01 
Ovaries 3.33 E-01 4.99 E-01 1.17 E+00 1.66 E+00 3.33 E+00 9.99 E+00 
Pancreas 7.90 E-02 1.18 E-01 2.76 E-01 3.95 E-01 7.90 E-01 2.37 E+00 
Skeletal muscle 6.12 E-04 9.17 E-04 2.14 E-03 3.06 E-03 6.12 E-03 1.83 E-02 
Skin 1.02 E-01 1.53 E-01 3.58 E-01 5.11 E-01 1.02 E+00 3.06 E+00 
Spleen  4.90 E-01 7.36 E-01 1.72 E+00 2.45 E+00 4.90 E+00 1.47 E+01 
Stomach 6.47 E-02 9.70 E-02 2.26 E-01 3.23 E-01 6.47 E-01 1.94 E+00 
Thymus 7.34 E-02 1.10 E-01 2.57 E-01 3.67 E-01 7.34 E-01 2.20 E+00 
Thyroids 9.99 E-01 1.50 E+00 3.50 E+00 5.00 E+00 9.99 E+00 3.00 E+01 
Urinary bladder 3.62 E-01 5.44 E-01 1.27 E+00 1.81 E+00 3.62 E+00 1.09 E+01 
Uterus 1.51 E-02 2.26 E-02 5.28 E-02 7.55 E-02 1.51 E-01 4.53 E-01 
Effective Dose 
(mSv/MBq) 

 
6.65 E-01 

 
9.98 E-01 

 
2.33 E+00 

 
3.33 E+00 

 
6.65 E+00 

 
1.99 E+1 

 
 
For this product the effective dose to a 70 kg adult resulting from an intravenously injected activity of 
1 GBq is 665 mSv. 
 
 
12.  INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS 
 
Before use, packaging and radioactivity should be checked. Activity may be measured using an 
ionisation chamber. Yttrium (90Y) is a beta pure emitter. Activity measurements using an ionisation 
chamber are very sensitive to geometric factors and, therefore, should be performed only under 
geometric conditions which have been appropriately validated. 



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Usual precautions regarding sterility and radioactivity should be respected. 
 
The vial should never be opened and must be kept inside its lead shielding. The product should be 
aseptically withdrawn through the stopper using sterilised single use needle and syringe after 
disinfecting the stopper. 
Appropriate aseptic precautions should be taken, complying with the requirements of Good 
Pharmaceutical Manufacturing Practice, in order to maintain the sterility of Yttriga and to maintain 
sterility throughout the labelling procedures. 
The administration of radioactive medicinal products 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 product or waste material should be disposed of in accordance with local requirements. 
 
Detailed information on this product is available on the website of the European Medicines Agency 
http://www.ema.europa.eu 



9 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 
A. MANUFACTURING AUTHORISATION HOLDER 

RESPONSIBLE FOR BATCH RELEASE 
 
B. CONDITIONS OF THE MARKETING AUTHORISATION 
 



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A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH 
RELEASE 

 
Name and address of the manufacturer responsible for batch release 
 
Eckert & Ziegler Radiopharma GmbH 
Branch Braunschweig 
Gieselweg 1 
D-38110 Braunschweig 
Germany 
 
 
B CONDITIONS OF THE MARKETING AUTHORISATION 
 
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON 

THE MARKETING AUTHORISATION HOLDER 
 
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. 
 
 
 
 



11 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



12 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



13 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
TIN CAN AND LEAD POT 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Yttriga radiopharmaceutical precursor, solution. 
Yttrium (90Y) chloride 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Yttrium (90Y) chloride 
 
Act.: (Y) GBq/vial 
 
Cal.: {DD/MM/YYYY} (12h CET) 
 
Specific activity at calibration: (Y) GBq/vial 
 
3. LIST OF EXCIPIENTS 
 
Hydrochloric acid (0.04 M) 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Radiopharmaceutical precursor, solution. 
 
1 vial 
Vol.: {Z} ml 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For in vitro radiolabelling. Read the package leaflet before use. 
NOT INTENDED FOR DIRECT ADMINISTRATION TO PATIENTS 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children.  
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 

 
 
The vial may contain high pressure due to radiolysis. 
 
 
 



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8. EXPIRY DATE 
 
EXP {MM/YYYY} (12h CET) 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in the original package. 
 
Storage should be in accordance with local regulations for radioactive substances. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Any unused product or waste material should be disposed of in accordance with local requirements. 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND 

MANUFACTURER 

Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Str. 10 
D-13125 Berlin 
Germany 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/05/322/001 
 
 
13. BATCH NUMBER 
 
BN 
 
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 



15 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL ON PERSPEX SHIELD 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Yttriga radiopharmaceutical precursor, solution. 
Yttrium (90Y) chloride 
 
 
2. METHOD OF ADMINISTRATION 
 
For in vitro radiolabelling.  
Read the package leaflet before use. 
NOT INTENDED FOR DIRECT APPLICATION TO PATIENTS 
 
 
3. EXPIRY DATE 
 
EXP  (12h CET) 
 
4. BATCH NUMBER 
 
BN 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
Vol.: {Z} ml 
Act.: {Y}________GBq/vial Cal.: {DD/MM/AAAA} (12h CET) 
 
 
6. OTHER 
 

 



16 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Yttriga solution 
Yttrium (90Y) chloride  
 
 
2. METHOD OF ADMINISTRATION 
 
in vitro labelling 
 
 
3. EXPIRY DATE 
 
Exp 
 
4. BATCH NUMBER 
 
BN 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
Vol.: {Z} ml 
Act.: {Y}________GBq/vial Cal.: {DD/MM/AAAA} (12h CET) 
 
 
6. OTHER 
 

 



17 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
TIN CAN AND LEAD POT 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Yttriga radiopharmaceutical precursor, solution. 
Yttrium (90Y) chloride 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Yttrium (90Y) chloride 
 
Act.: (Y) GBq/vial 
 
Cal.: {DD/MM/YYYY} (12h CET) 
 
Specific activity at calibration: (Y) GBq/vial 
 
3. LIST OF EXCIPIENTS 
 
Hydrochloric acid (0.04 M) 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Radiopharmaceutical precursor, solution. 
 
1 vial 
Vol.: {Z} ml 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For in vitro radiolabelling. Read the package leaflet before use. 
NOT INTENDED FOR DIRECT ADMINISTRATION TO PATIENTS 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children.  
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 

 
 
The vial may contain high pressure due to radiolysis. 
 
 
 



18 

8. EXPIRY DATE 
 
EXP {MM/YYYY} (12h CET) 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in the original package. 
 
Storage should be in accordance with local regulations for radioactive substances. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Any unused product or waste material should be disposed of in accordance with local requirements. 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND 

MANUFACTURER 

Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Str. 10 
D-13125 Berlin 
Germany 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/05/322/002 
 
 
13. BATCH NUMBER 
 
BN 
 
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 



19 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL ON PERSPEX SHIELD 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Yttriga radiopharmaceutical precursor, solution. 
Yttrium (90Y) chloride 
 
 
2. METHOD OF ADMINISTRATION 
 
For in vitro radiolabelling.  
Read the package leaflet before use. 
NOT INTENDED FOR DIRECT APPLICATION TO PATIENTS 
 
 
3. EXPIRY DATE 
 
EXP  (12h CET) 
 
4. BATCH NUMBER 
 
BN 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
Vol.: {Z} ml 
Act.: {Y}________GBq/vial Cal.: {DD/MM/AAAA} (12h CET) 
 
 
6. OTHER 
 

 



20 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Yttriga solution 
Yttrium (90Y) chloride  
 
 
2. METHOD OF ADMINISTRATION 
 
in vitro labelling 
 
 
3. EXPIRY DATE 
 
Exp 
 
4. BATCH NUMBER 
 
BN 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
Vol.: {Z} ml 
Act.: {Y}________GBq/vial Cal.: {DD/MM/AAAA} (12h CET) 
 
 
6. OTHER 
 

 
 



21 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 



22 

 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

 
Yttriga radiopharmaceutical precursor, solution. 

Yttrium (90Y) chloride 
 

 
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 Yttriga is and what it is used for 
2. Before you use Yttriga 
3. How to use Yttriga. 
4. Possible side effects 
5. How to store Yttriga 
6. Further information 
 
 
1. WHAT YTTRIGA IS AND WHAT IT IS USED FOR  
 
Yttriga is a radioactive medicine used in combination with another medicine which targets specific 
body cells. 
When the target is reached, Yttriga gives tiny radiation doses to these specific sites. 
 
For further information regarding the treatment and possible effects caused by the radiolabelled 
medicinal product, please refer to the package leaflet of the medicinal product used as combination 
partner.  
 
 
2. BEFORE YOU USE YTTRIGA  
 
Do not use Yttriga:  
 
- if you are allergic (hypersensitive) to Yttrium (90Y) chloride or any of the other ingredients of 

Yttriga. 
- if you are pregnant or if there is a possibility that you may be pregnant (see below). 
 
Take special care with Yttriga  
- Yttriga is a radioactive medicine and is only used in combination with another medicinal product. It 

is not intended for direct use in patients. 
- Because there are strict laws covering the use, handling and disposal of radiopharmaceuticals, 

Yttriga will always be used in a hospital or a similar setting. It will only be handled and 
administered by people who are trained and qualified in the safe handling of radioactive material. 

 
Particular care should be taken when administering radioactive medicinal products to children and 
adolescents (from 2 to 16 years old). 
 
 
Taking other medicines  
Please tell your doctor or pharmacist, if you are taking or have recently taken any other medicines, 
including medicines obtained without a prescription. 
No interactions of Yttrium (90Y) chloride with other medicines are known as no clinical studies are 
available.  
 



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Pregnancy  
Yttriga is contraindicated in Pregnancy. 
 
Please tell your doctor if there is any possibility that you are pregnant. If you have missed a period, 
you should assume to be pregnant until a pregnancy test conducted is negative.  
 
Your doctor will consider alternative techniques which do not involve ionising radiation. 
 
Women of childbearing potential should use effective contraception during and after treatment. 
 
Breast-feeding 
Your doctor will ask you to stop breast-feeding.  
 
Ask your doctor or pharmacist for advice before taking any medicine. 
 
 
3. HOW TO USE YTTRIGA  
 
Your doctor will not administer Yttriga directly. 
 
Dose 
Your physician will decide on the amount of Yttriga, which you will receive for the treatment. 
 
Method of administration 
Yttriga is intended for radiolabelling of medicinal products to treat specific diseases, which are 
subsequently administered by approved route. 
 
If Yttriga is administered inadvertently 
Yttriga is administered after being combined with another medicine by your doctor under strictly 
controlled conditions. The risk to receive a possible overdose is small. However, should this occur, 
you will receive appropriate treatment from your doctor. 
 
4. POSSIBLE SIDE EFFECTS  
 
Like all medicines, Yttriga can cause side effects, although not everybody gets them. 
 
For more information, refer to the package leaflet of the particular medicinal product to be 
radiolabelled. 
 
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. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects 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 TO STORE YTTRIGA 
 
Keep out of the reach and sight of children.  
 
Do not use Yttriga after the expiry date and time which is stated on the label after EXP. 
 
Store in accordance with local regulations for radioactive substances. 
 
Any unused product or waste material should be disposed of in accordance with local requirements. 

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


24 

 
 
6. FURTHER INFORMATION 
 
What Yttriga contains 
 
- The active substance is Yttrium (90Y) chloride. 
- 1 ml sterile solution contains 0.1-300 GBq Yttrium (90Y) on the reference date and time 
 (corresponding to 0.005-15 micrograms of Yttrium [90Y]) (as Yttrium [90Y] chloride). 
- The other ingredient is hydrochloric acid (0.04 M). 
 
What Yttriga looks like and contents of the pack 
 
Colourless type I glass vial of 3 ml with a V-shapped bottom or a colourless type I glass vial of 10 ml 
with a flat bottom with a silicon stopper, closed with an aluminium seal.  
 
 
Radiopharmaceutical precursor, solution. 
Colourless clear sterile solution. 
 
Marketing Authorisation Holder 
 
Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Str. 10 
D-13125 Berlin 
Germany 
 
Tel +49-30-941084-280 
Fax +49- 30-941084-470 
e-mail: radiopharma@ezag.de 
 
Manufacturer 
 
Eckert & Ziegler Radiopharma GmbH 
Branch Braunschweig 
Gieselweg 1 
D-38110 Braunschweig 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Straße 10 
D-13125 Berlin 
Tél/Tel: +49-30-941084-280 
radiopharma@ezag.de 

Lietuva 
Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Straße 10 
D-13125 Berlin 
Tel: +49-30-941084-280 
radiopharma@ezag.de 
 

България 
Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Straße 10 
D-13125 Berlin 
Teл.: +49-30-941084-280 
radiopharma@ezag.de 
 
 

Luxembourg/Luxemburg 
Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Straße 10 
D-13125 Berlin 
Tél/Tel: +49-30-941084-280 
radiopharma@ezag.de 
 

mailto:radiopharma@ezag.de


25 

Česká republika 
Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Straße 10 
D-13125 Berlin 
Tel: +49-30-941084-280 
radiopharma@ezag.de 
 

Magyarország 
Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Straße 10 
D-13125 Berlin 
Tel: +49-30-941084-280 
radiopharma@ezag.de 
 

Danmark 
Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Straße 10 
D-13125 Berlin 
Tlf: +49-30-941084-280 
radiopharma@ezag.de 
 

Malta 
Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Straße 10 
D-13125 Berlin 
Tel: +49-30-941084-280 
radiopharma@ezag.de 
 

Deutschland 
Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Straße 10 
D-13125 Berlin 
Tel: +49-30-941084-280 
radiopharma@ezag.de 
 

Nederland 
Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Straße 10 
D-13125 Berlin 
Tel: +49-30-941084-280 
radiopharma@ezag.de 
 

Eesti 
Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Straße 10 
D-13125 Berlin 
Tel: +49-30-941084-280 
radiopharma@ezag.de 
 

Norge 
Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Straße 10 
D-13125 Berlin 
Tlf: +49-30-941084-280 
radiopharma@ezag.de 

Ελλάδα 
Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Straße 10 
D-13125 Berlin 
Τηλ: +49-30-941084-280 
radiopharma@ezag.de 
 

Österreich 
Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Straße 10 
D-13125 Berlin 
Tel: +49-30-941084-280 
radiopharma@ezag.de 
 

España 
NUCLIBER, S.A.  
C/ Hierro, 33 
E-28045 Madrid 
Tel: +34 915 062 940 
info@nucliber.com 

Polska 
Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Straße 10 
D-13125 Berlin 
Tel: +49-30-941084-280 
radiopharma@ezag.de 
 

France 
Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Straße 10 
D-13125 Berlin 
Tél: +49-30-941084-280 
radiopharma@ezag.de 
 

Portugal 
Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Straße 10 
D-13125 Berlin 
Tel: +49-30-941084-280 
radiopharma@ezag.de 

Hrvatska 
Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Straße 10 
D-13125 Berlin 
Tel: +49-30-941084-280 
radiopharma@ezag.de 
 
 

România 
Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Straße 10 
D-13125 Berlin 
Tel: +49-30-941084-280 
radiopharma@ezag.de 
 

mailto:info@nucliber.com


26 

Ireland 
Advanced Accelerator Applications (UK & 
Ireland) Ltd. 
Edison House, 223-231 Old Marylebone Road, 
London, NW1 5QT – UK 
Tel: +44 (0)2072585252 
customerservices.UK@adacap.com 
 

Slovenija 
Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Straße 10 
D-13125 Berlin 
Tel: +49-30-941084-280 
radiopharma@ezag.de 
 

Ísland 
Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Straße 10 
D-13125 Berlin 
Sími: +49-30-941084-280 
radiopharma@ezag.de 
 

Slovenská republika 
Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Straße 10 
D-13125 Berlin 
Tel: +49-30-941084-280 
radiopharma@ezag.de 
 

Italia 
Campoverde srl 
Via Quintiliano, 30 
I-20138 Milano 
Tel: +39-02-58039045 
vendite@campoverde-group.com 
 

Suomi/Finland 
Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Straße 10 
D-13125 Berlin 
Puh/Tel: +49-30-941084-280 
radiopharma@ezag.de 
 

Κύπρος 
Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Straße 10 
D-13125 Berlin 
Τηλ: +49-30-941084-280 
radiopharma@ezag.de 
 

Sverige 
Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Straße 10 
D-13125 Berlin 
Tel: +49-30-941084-280 
radiopharma@ezag.de 
 

Latvija 
Eckert & Ziegler Radiopharma GmbH 
Robert-Rössle-Straße 10 
D-13125 Berlin 
Tel: +49-30-941084-280 
radiopharma@ezag.de 
 

United Kingdom 
Advanced Accelerator Applications (UK & 
Ireland) Ltd. 
Edison House, 223-231 Old Marylebone Road, 
London, NW1 5QT – UK 
Tel: +44 (0)2072585252 
customerservices.UK@adacap.com 
 

  
This leaflet was last revised in {MM/YYYY}. 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.  
 
This leaflet is available in all EU/EEA languages on the European Medicines Agency website. 

mailto:customerservices.UK@adacap.com
mailto:customerservices.UK@adacap.com

	SUMMARY OF PRODUCT CHARACTERISTICS
	A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
	B CONDITIONS OF THE MARKETING AUTHORISATION
	A. LABELLING
	B. PACKAGE LEAFLET

ANNEX I


SUMMARY OF PRODUCT CHARACTERISTICS


1.
NAME OF THE MEDICINAL PRODUCT

Yttriga radiopharmaceutical precursor, solution.


2.
QUALITATIVE AND QUANTITATIVE COMPOSITION


1 ml sterile solution contains 0.1-300 GBq Yttrium (90Y) on the reference date and time (corresponding to 0.005-15 micrograms of Yttrium [90Y]) (as Yttrium [90Y] chloride).


Each 3ml vial contains 0.1-300 GBq, corresponding to 0.005-15 micrograms of Yttrium (90Y), at reference date and time. The volume is 0.02-3 ml. 

Each 10ml vial contains 0.1-300 GBq, corresponding to 0.005-15 micrograms of Yttrium (90Y), at reference date and time. The volume is 0.02-5 ml. 

The theoretical specific activity is 20 GBq/microgram of Yttrium (90Y) (see section 6.5).


Yttrium (90Y) chloride is produced by decay of its radioactive precursor Strontium (90Sr). It decays by emission of beta radiation of 2.281 MeV (99.98 %) of maximal energy to stable Zirconium (90Zr).


Yttrium (90Y) has a half-life of 2.67 days (64.1 hours).

For a full list of excipients, see section 6.1.


3.
PHARMACEUTICAL form

Radiopharmaceutical precursor, solution.


Clear colourless solution, free of particulate matter.


4.
Clinical particulars

4.1
Therapeutic indications

To be used only for the radiolabelling of carrier molecules, which have been specifically developed


and authorised for radiolabelling with this radionuclide.


		Radiopharmaceutical precursor - Not intended for direct use in patients.





4.2
Posology and method of administration

Yttriga is only to be used by specialists experienced with in vitro radiolabelling.

Posology


The quantity of Yttriga required for radiolabelling and the quantity of Yttrium (90Y)-labelled medicinal product that is subsequently administered will depend on the medicinal product radiolabelled and its intended use. Refer to the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.


Method of administration


Yttriga is intended for in vitro labelling of medicinal products which are subsequently administered by the approved route.


Further information on the preparation of the product is given in section 12.


4.3
Contraindications

Do not administer Yttriga directly to the patient.


Yttriga is contraindicated in the following cases:


-
Hypersensitivity to Yttrium (90Y) chloride or to any of the excipients


Yttrium (90Y)-labelled medicinal products are contraindicated in the following case:


-
Established or suspected pregnancy or when pregnancy has not been excluded (see section 4.6)

For information on contraindications to particular Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with Yttriga refer the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.


4.4
Special warnings and precautions for use

The contents of the vial of Yttriga is not to be administered directly to the patient but must be used for the radiolabelling of carrier molecules, such as monoclonal antibodies, peptides or other substrates.


Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings and receipt, storage, use, transfer and disposal are subject to the regulations and appropriate licences of the competent authorities.


Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.


For information concerning special warnings and special precautions for use of Yttrium (90Y)-labelled medicinal products refer to the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.


Particular care should be taken when administering radioactive medicinal products to children and adolescents (from 2 to 16 years old).


4.5
Interaction with other medicinal products and other forms of interaction

No interaction studies of Yttrium (90Y) chloride with other medicinal products have been performed, because Yttriga is a precursor solution for radiolabelling medicinal products.


For information concerning interactions associated with the use of Yttrium (90Y)-labelled medicinal products refer to the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.


4.6
Fertility, pregnancy and lactation

Women of childbearing potential 


Women of childbearing potential have to use effective contraception during and after treatment.

Pregnancy


Yttrium (90Y)-labelled medicinal products are contraindicated in established or suspected pregnancy or when pregnancy has not been excluded (see section 4.3).

Breast-feeding


Before administering a radioactive medicinal product to a mother who is breast-feeding, consideration should be given to whether the investigation could be reasonably delayed until the mother has ceased breast-feeding. If the administration cannot be delayed, a lactating mother should be advised to stop breast-feeding.


Further information concerning the use of a Yttrium (90Y)-labelled medicinal products in pregnancy and breast-feeding is specified in the Summary of Product Characteristics of the medicinal product to be radiolabelled.


Fertility


Further information concerning the use of a Yttrium (90Y)-labelled medicinal concerning fertility is specified in the Summary of Product Characteristics of the medicinal product to be radiolabelled.


4.7
Effects on ability to drive and use machines

Effects on ability to drive and to use machines following treatment by Yttrium (90Y)-labelled medicinal products will be specified in the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.


4.8
Undesirable effects


Possible adverse reactions following the intravenous administration of a Yttrium (90Y)-labelled medicinal product prepared by radiolabelling with Yttriga, will be dependent on the specific medicinal product being used. Such information will be supplied in the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled. For each patient, exposure to ionising radiation must be justifiable on the basis of likely clinical benefit. The activity administered must be such that the resulting radiation dose is as low as reasonably achievable bearing in mind the need to obtain the intended therapeutic result.


Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.


The radiation dose resulting from therapeutic exposure may result in higher incidence of cancer and mutations. In all cases, it is necessary to ensure that the risks of the radiation are less than from the disease itself.


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.

4.9
Overdose

The presence of free Yttrium (90Y) chloride in the body after an inadvertent administration of Yttriga will lead to increased bone marrow toxicity and haematopoietic stern cell damage.


Therefore, in case of an inadvertent administration of Yttriga, the radiotoxicity for the patient must be reduced by immediate (i. e. within 1 hour) administration of preparations containing chelators like Ca- DTPA or Ca-EDTA in order to increase the elimination of the radionuclide from the body.


The following preparations must be available in medical institutions, which use Yttriga for labelling of carrier molecules for therapeutic purposes:


-
Ca-DTPA (Trisodium calcium diethylenetriaminepentaacetate) or


-
Ca-EDTA (Calcium disodium ethylenediaminetetraacetate)


These chelating agents suppress yttrium radiotoxicity by an exchange between the calcium ion and the yttrium due to their capacity of forming water soluble complexes with the chelating ligands (DTPA, EDTA). These complexes are rapidly eliminated by the kidneys.


1 g of the chelating agents should be administered by slow intravenous injection over 3 – 4 minutes or by infusion (1 g in 100 – 250 ml of dextrose, or normal saline).


The chelating efficacy is greatest immediately or within one hour of exposure when the radionuclide is circulating in or available to tissue fluids and plasma. However, a post-exposure interval > 1 hour does not preclude the administration and effective action of chelator with reduced efficiency.


Intravenous administration should not be protracted over more than 2 hours.


In any case the blood parameters of the patient have to be monitored and the appropriate actions immediately taken if there is evidence of damage to the blood marrow.


The toxicity of the free Yttrium (90Y) due to in-vivo release from the labelled biomolecule in the body during therapy could be reduced by post-administration of chelating agents.


5.
PHARMACOLOGICAL PROPERTIES

5.1 
Pharmacodynamic properties

Pharmacotherapeutic group: Other therapeutic radiopharmaceuticals, ATC code:  V10X.

The pharmacodynamic properties of Yttrium (90Y)-labelled medicinal products prepared by


radiolabelling with Yttriga, prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled. Refer to the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.


5.2
Pharmacokinetic properties

The pharmacokinetic properties of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with Yttriga, prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.


In the rat, following intravenous administration, Yttrium (90Y) chloride is rapidly cleared from the blood. At 1 and 24 hours, blood radioactivity decreases from 11.0 % to 0.14 % of the administered activity. The two main organs where Yttrium (90Y) chloride distributes are the liver and bones. In the liver, 18 % of the injected activity is taken up 5 min after injection. Liver uptake decreases then to 8.4 % 24 hours after injection. In bone, percentage of injected activity increases from 3.1 % at 5 min to 18 % at 6 hours and then decreases with time. Faecal and urinary elimination is slow: about 31 % of the administered activity is eliminated in 15 days.


5.3
Preclinical safety data

The toxicological properties of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with Yttriga prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.


There are no data available on the toxicity of Yttrium (90Y) chloride nor on its effects on reproduction in animals or its mutagenic or carcinogenic potential.


6.
PHARMACEUTICAL PARTICULARS


6.1
List of excipients

Hydrochloric acid (0.04 M)

6.2
Incompatibilities

Radiolabelling of medicinal products, such as monoclonal antibodies, peptides or other substrates, with Yttrium (90Y) chloride is very sensitive to the presence of trace metal impurities.


It is important that all glassware, syringe needles etc, used for the preparation of the radiolabelled medicinal product are thoroughly cleaned to ensure freedom from such trace metal impurities. Only syringe needles (for example, non-metallic) with proven resistance to dilute acid should be used to minimise trace metal impurity levels.

6.3
Shelf life

Up to 12 days from the date of manufacture.


6.4
Special precautions for storage

Storage should be in accordance with national regulation on radioactive material.


6.5
Nature and contents of container

Colourless type I glass vial of 3 ml with a V-shapped bottom or a colourless type I glass vial of 10 ml with a flat bottom with a silicon stopper, closed with an aluminium seal. 

Pack size: 1 vial  

Not all presentations may be marketed. 

6.6
Special precautions for disposal

The vial may contain high pressure due to radiolysis (see section 12).

7.
MARKETING AUTHORISATION HOLDER

Eckert & Ziegler Radiopharma GmbH


Robert-Rössle-Str. 10

D-13125 Berlin

Germany


8.
MARKETING AUTHORISATION NUMBER(S) 


EU/1/05/322/001 (3 ml V-shaped vial)

EU/1/05/322/002 (10 ml flat bottom vial)


9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 19/01/2006 

Date of renewal: 06/01/2011

10.
DATE OF REVISION OF THE TEXT


11. 
DOSIMETRY

The radiation dose received by the various organs following intravenous administration of an


Yttrium (90Y)-labelled medicinal product is dependent on the specific medicinal product being


radiolabelled. Information on radiation dosimetry of each different medicinal product following administration of the radiolabelled preparation will be available in the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.


The dosimetry table below is presented in order to evaluate the contribution of non-conjugated Yttrium (90Y) to the radiation dose following the administration of Yttrium (90Y)-labelled medicinal product or resulting from an accidental intravenous injection of Yttriga.


The dosimetry estimates were based on a rat distribution study and the calculations were effected in accordance with MIRD/ICRP 60 recommendations. Time-points for measurements were 5 min, 1, 6, 24, 96 and 360 hours.


		Absorbed dose per unit activity administered (mGy/MBq)




		Organ




		Adult 


(70 kg)

		15 years 


(50 kg)

		10 years 


(30 kg)

		5 years


(17 kg)

		1 year


(10 kg)

		Newborn


(5 kg)



		Adrenals

		7.23 E-01

		1.09 E+00

		2.53 E+00

		3.62 E+00

		7.23 E+00

		2.17 E+01



		Blood

		4.20 E-02

		6.29 E-02

		1.47 E-01

		2.10 E-01

		4.19 E-01

		1.26 E+00



		Bone marrow

		2.58 E+00

		3.88 E+00

		9.05 E+00

		1.29 E+01

		2.58 E+01

		7.75 E+01



		Brain

		8.60 E-03

		1.29 E-02

		3.01 E-02

		4.30 E-02

		8.60 E-02

		2.58 E-01



		Carcass

		5.82 E-01

		8.72 E-01

		2.04 E+00

		2.91 E+00

		5.82 E+00

		1.75 E+01



		Colon

		2.30 E-02

		3.46 E-02

		8.06 E-02

		1.15 E-01

		2.30 E-01

		6.91 E-01



		Femur

		7.76 E+00

		1.16 E+01

		2.72 E+01

		3.88 E+01

		7.76 E+01

		2.33 E+02



		Gastro-intestinal content

		1.22 E-01

		1.83 E-01

		4.26 E-01

		6.09 E-01

		1.22 E+00

		3.66 E+00



		Heart

		2.53 E-01

		3.79 E-01

		8.85 E-01

		1.26 E+00

		2.53 E+00

		7.59 E+00



		Ileum

		1.16 E-02

		1.74 E-02

		4.06 E-02

		5.81 E-02

		1.16 E-01

		3.48 E-01



		Kidneys 

		2.35 E+00

		3.53 E+00

		8.24 E+00

		1.18 E+01

		2.35 E+01

		7.06 E+01



		Liver

		1.27 E+00

		1.91 E+00

		4.46 E+00

		6.37 E+00

		1.27 E+01

		3.82 E+01



		Lungs

		4.23 E-01

		6.34 E-01

		1.48 E+00

		2.11 E+00

		4.23 E+00

		1.27 E+01



		Ovaries

		3.33 E-01

		4.99 E-01

		1.17 E+00

		1.66 E+00

		3.33 E+00

		9.99 E+00



		Pancreas

		7.90 E-02

		1.18 E-01

		2.76 E-01

		3.95 E-01

		7.90 E-01

		2.37 E+00



		Skeletal muscle

		6.12 E-04

		9.17 E-04

		2.14 E-03

		3.06 E-03

		6.12 E-03

		1.83 E-02



		Skin

		1.02 E-01

		1.53 E-01

		3.58 E-01

		5.11 E-01

		1.02 E+00

		3.06 E+00



		Spleen 

		4.90 E-01

		7.36 E-01

		1.72 E+00

		2.45 E+00

		4.90 E+00

		1.47 E+01



		Stomach

		6.47 E-02

		9.70 E-02

		2.26 E-01

		3.23 E-01

		6.47 E-01

		1.94 E+00



		Thymus

		7.34 E-02

		1.10 E-01

		2.57 E-01

		3.67 E-01

		7.34 E-01

		2.20 E+00



		Thyroids

		9.99 E-01

		1.50 E+00

		3.50 E+00

		5.00 E+00

		9.99 E+00

		3.00 E+01



		Urinary bladder

		3.62 E-01

		5.44 E-01

		1.27 E+00

		1.81 E+00

		3.62 E+00

		1.09 E+01



		Uterus

		1.51 E-02

		2.26 E-02

		5.28 E-02

		7.55 E-02

		1.51 E-01

		4.53 E-01



		Effective Dose


(mSv/MBq)

		6.65 E-01

		9.98 E-01

		2.33 E+00

		3.33 E+00

		6.65 E+00

		1.99 E+1





For this product the effective dose to a 70 kg adult resulting from an intravenously injected activity of 1 GBq is 665 mSv.



12. 
INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

Before use, packaging and radioactivity should be checked. Activity may be measured using an ionisation chamber. Yttrium (90Y) is a beta pure emitter. Activity measurements using an ionisation chamber are very sensitive to geometric factors and, therefore, should be performed only under geometric conditions which have been appropriately validated.


Usual precautions regarding sterility and radioactivity should be respected.


The vial should never be opened and must be kept inside its lead shielding. The product should be aseptically withdrawn through the stopper using sterilised single use needle and syringe after disinfecting the stopper.


Appropriate aseptic precautions should be taken, complying with the requirements of Good


Pharmaceutical Manufacturing Practice, in order to maintain the sterility of Yttriga and to maintain sterility throughout the labelling procedures.


The administration of radioactive medicinal products 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 product or waste material should be disposed of in accordance with local requirements.


Detailed information on this product is available on the website of the European Medicines Agency


http://www.ema.europa.eu

ANNEX II


A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE


B. CONDITIONS OF THE MARKETING AUTHORISATION


A
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE


Name and address of the manufacturer responsible for batch release


Eckert & Ziegler Radiopharma GmbH


Branch Braunschweig


Gieselweg 1


D-38110 Braunschweig


Germany


B
CONDITIONS OF THE MARKETING AUTHORISATION


· CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER


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.


ANNEX III


LABELLING AND PACKAGE LEAFLET

A. LABELLING


		PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING


TIN CAN AND LEAD POT





		1.
NAME OF THE MEDICINAL PRODUCT





Yttriga radiopharmaceutical precursor, solution.


Yttrium (90Y) chloride


		2.
STATEMENT OF ACTIVE SUBSTANCE(S)





Yttrium (90Y) chloride


Act.: (Y) GBq/vial


Cal.: {DD/MM/YYYY} (12h CET)


Specific activity at calibration: (Y) GBq/vial


		3.
LIST OF EXCIPIENTS





Hydrochloric acid (0.04 M)


		4.
PHARMACEUTICAL FORM AND CONTENTS





Radiopharmaceutical precursor, solution.

1 vial


Vol.: {Z} ml


		5.
METHOD AND ROUTE(S) OF ADMINISTRATION





For in vitro radiolabelling. Read the package leaflet before use.


NOT INTENDED FOR DIRECT ADMINISTRATION TO PATIENTS


		6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN





Keep out of the reach and sight of children. 


		7.
OTHER SPECIAL WARNING(S), IF NECESSARY







The vial may contain high pressure due to radiolysis.


		8.
EXPIRY DATE





EXP {MM/YYYY} (12h CET)


		9.
SPECIAL STORAGE CONDITIONS





Store in the original package.


Storage should be in accordance with local regulations for radioactive substances.


		10.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE





Any unused product or waste material should be disposed of in accordance with local requirements.


		11.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND MANUFACTURER





Eckert & Ziegler Radiopharma GmbH


Robert-Rössle-Str. 10

D-13125 Berlin

Germany


		12.
MARKETING AUTHORISATION NUMBER(S)





EU/1/05/322/001

		13.
BATCH NUMBER





BN


		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 


		MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS


VIAL LABEL ON PERSPEX SHIELD





		1.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION





Yttriga radiopharmaceutical precursor, solution.


Yttrium (90Y) chloride


		2.
METHOD OF ADMINISTRATION





For in vitro radiolabelling. 

Read the package leaflet before use.

NOT INTENDED FOR DIRECT APPLICATION TO PATIENTS


		3.
EXPIRY DATE





EXP  (12h CET)


		4.
BATCH NUMBER





BN


		5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT





Vol.: {Z} ml


Act.: {Y}________GBq/vial
Cal.: {DD/MM/AAAA} (12h CET)


		6.
OTHER







		MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS


VIAL





		1.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION





Yttriga solution

Yttrium (90Y) chloride 

		2.
METHOD OF ADMINISTRATION





in vitro labelling


		3.
EXPIRY DATE





Exp


		4.
BATCH NUMBER





BN

		5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT





Vol.: {Z} ml


Act.: {Y}________GBq/vial
Cal.: {DD/MM/AAAA} (12h CET)


		6.
OTHER







		PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING


TIN CAN AND LEAD POT





		1.
NAME OF THE MEDICINAL PRODUCT





Yttriga radiopharmaceutical precursor, solution.


Yttrium (90Y) chloride


		2.
STATEMENT OF ACTIVE SUBSTANCE(S)





Yttrium (90Y) chloride


Act.: (Y) GBq/vial


Cal.: {DD/MM/YYYY} (12h CET)


Specific activity at calibration: (Y) GBq/vial


		3.
LIST OF EXCIPIENTS





Hydrochloric acid (0.04 M)


		4.
PHARMACEUTICAL FORM AND CONTENTS





Radiopharmaceutical precursor, solution.

1 vial


Vol.: {Z} ml


		5.
METHOD AND ROUTE(S) OF ADMINISTRATION





For in vitro radiolabelling. Read the package leaflet before use.


NOT INTENDED FOR DIRECT ADMINISTRATION TO PATIENTS


		6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN





Keep out of the reach and sight of children. 


		7.
OTHER SPECIAL WARNING(S), IF NECESSARY







The vial may contain high pressure due to radiolysis.


		8.
EXPIRY DATE





EXP {MM/YYYY} (12h CET)


		9.
SPECIAL STORAGE CONDITIONS





Store in the original package.


Storage should be in accordance with local regulations for radioactive substances.


		10.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE





Any unused product or waste material should be disposed of in accordance with local requirements.


		11.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND MANUFACTURER





Eckert & Ziegler Radiopharma GmbH


Robert-Rössle-Str. 10

D-13125 Berlin

Germany


		12.
MARKETING AUTHORISATION NUMBER(S)





EU/1/05/322/002


		13.
BATCH NUMBER





BN


		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 


		MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS


VIAL LABEL ON PERSPEX SHIELD





		1.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION





Yttriga radiopharmaceutical precursor, solution.


Yttrium (90Y) chloride


		2.
METHOD OF ADMINISTRATION





For in vitro radiolabelling. 


Read the package leaflet before use.

NOT INTENDED FOR DIRECT APPLICATION TO PATIENTS


		3.
EXPIRY DATE





EXP  (12h CET)


		4.
BATCH NUMBER





BN


		5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT





Vol.: {Z} ml


Act.: {Y}________GBq/vial
Cal.: {DD/MM/AAAA} (12h CET)


		6.
OTHER







		MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS


VIAL





		1.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION





Yttriga solution

Yttrium (90Y) chloride 

		2.
METHOD OF ADMINISTRATION





in vitro labelling


		3.
EXPIRY DATE





Exp


		4.
BATCH NUMBER





BN


		5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT





Vol.: {Z} ml


Act.: {Y}________GBq/vial
Cal.: {DD/MM/AAAA} (12h CET)


		6.
OTHER







B. PACKAGE LEAFLET


PACKAGE LEAFLET: INFORMATION FOR THE USER


Yttriga radiopharmaceutical precursor, solution.


Yttrium (90Y) chloride


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 Yttriga is and what it is used for


2. Before you use Yttriga


3. How to use Yttriga.


4. Possible side effects


5. How to store Yttriga


6. Further information


1.
WHAT YTTRIGA IS AND WHAT IT IS USED FOR 


Yttriga is a radioactive medicine used in combination with another medicine which targets specific body cells.

When the target is reached, Yttriga gives tiny radiation doses to these specific sites.

For further information regarding the treatment and possible effects caused by the radiolabelled medicinal product, please refer to the package leaflet of the medicinal product used as combination partner. 

2.
BEFORE YOU USE YTTRIGA 


Do not use Yttriga: 


-
if you are allergic (hypersensitive) to Yttrium (90Y) chloride or any of the other ingredients of Yttriga.


-
if you are pregnant or if there is a possibility that you may be pregnant (see below).


Take special care with Yttriga 


-
Yttriga is a radioactive medicine and is only used in combination with another medicinal product. It is not intended for direct use in patients.


-
Because there are strict laws covering the use, handling and disposal of radiopharmaceuticals, Yttriga will always be used in a hospital or a similar setting. It will only be handled and administered by people who are trained and qualified in the safe handling of radioactive material.


Particular care should be taken when administering radioactive medicinal products to children and adolescents (from 2 to 16 years old).


Taking other medicines 


Please tell your doctor or pharmacist, if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.


No interactions of Yttrium (90Y) chloride with other medicines are known as no clinical studies are available. 

Pregnancy 


Yttriga is contraindicated in Pregnancy.


Please tell your doctor if there is any possibility that you are pregnant. If you have missed a period, you should assume to be pregnant until a pregnancy test conducted is negative. 

Your doctor will consider alternative techniques which do not involve ionising radiation.

Women of childbearing potential should use effective contraception during and after treatment.

Breast-feeding

Your doctor will ask you to stop breast-feeding. 

Ask your doctor or pharmacist for advice before taking any medicine.


3.
HOW TO USE YTTRIGA 


Your doctor will not administer Yttriga directly.


Dose

Your physician will decide on the amount of Yttriga, which you will receive for the treatment.


Method of administration

Yttriga is intended for radiolabelling of medicinal products to treat specific diseases, which are subsequently administered by approved route.


If Yttriga is administered inadvertently


Yttriga is administered after being combined with another medicine by your doctor under strictly controlled conditions. The risk to receive a possible overdose is small. However, should this occur, you will receive appropriate treatment from your doctor.

4.
POSSIBLE SIDE EFFECTS 


Like all medicines, Yttriga can cause side effects, although not everybody gets them.

For more information, refer to the package leaflet of the particular medicinal product to be radiolabelled.

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.

Reporting of side effects


If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects 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 TO STORE YTTRIGA


Keep out of the reach and sight of children. 


Do not use Yttriga after the expiry date and time which is stated on the label after EXP.


Store in accordance with local regulations for radioactive substances.


Any unused product or waste material should be disposed of in accordance with local requirements.


6.
FURTHER INFORMATION


What Yttriga contains


-
The active substance is Yttrium (90Y) chloride.


-
1 ml sterile solution contains 0.1-300 GBq Yttrium (90Y) on the reference date and time 
(corresponding to 0.005-15 micrograms of Yttrium [90Y]) (as Yttrium [90Y] chloride).

-
The other ingredient is hydrochloric acid (0.04 M).


What Yttriga looks like and contents of the pack


Colourless type I glass vial of 3 ml with a V-shapped bottom or a colourless type I glass vial of 10 ml with a flat bottom with a silicon stopper, closed with an aluminium seal. 


Radiopharmaceutical precursor, solution.


Colourless clear sterile solution.

Marketing Authorisation Holder

Eckert & Ziegler Radiopharma GmbH


Robert-Rössle-Str. 10


D-13125 Berlin


Germany


Tel +49-30-941084-280

Fax +49- 30-941084-470

e-mail: radiopharma@ezag.de


Manufacturer


Eckert & Ziegler Radiopharma GmbH

Branch Braunschweig


Gieselweg 1


D-38110 Braunschweig


Germany


For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:


		België/Belgique/Belgien

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Straße 10

D-13125 Berlin

Tél/Tel: +49-30-941084-280

radiopharma@ezag.de

		Lietuva

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Straße 10

D-13125 Berlin

Tel: +49-30-941084-280

radiopharma@ezag.de






		България

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Straße 10

D-13125 Berlin

Teл.: +49-30-941084-280

radiopharma@ezag.de



		Luxembourg/Luxemburg

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Straße 10

D-13125 Berlin

Tél/Tel: +49-30-941084-280

radiopharma@ezag.de





		Česká republika

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Straße 10

D-13125 Berlin

Tel: +49-30-941084-280

radiopharma@ezag.de



		Magyarország

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Straße 10

D-13125 Berlin

Tel: +49-30-941084-280

radiopharma@ezag.de





		Danmark

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Straße 10

D-13125 Berlin

Tlf: +49-30-941084-280

radiopharma@ezag.de



		Malta


Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Straße 10

D-13125 Berlin

Tel: +49-30-941084-280

radiopharma@ezag.de





		Deutschland

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Straße 10

D-13125 Berlin

Tel: +49-30-941084-280

radiopharma@ezag.de



		Nederland

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Straße 10

D-13125 Berlin

Tel: +49-30-941084-280

radiopharma@ezag.de





		Eesti


Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Straße 10

D-13125 Berlin

Tel: +49-30-941084-280

radiopharma@ezag.de



		Norge

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Straße 10

D-13125 Berlin

Tlf: +49-30-941084-280

radiopharma@ezag.de



		Ελλάδα

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Straße 10

D-13125 Berlin

Τηλ: +49-30-941084-280

radiopharma@ezag.de



		Österreich

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Straße 10

D-13125 Berlin

Tel: +49-30-941084-280

radiopharma@ezag.de





		España


NUCLIBER, S.A. 


C/ Hierro, 33


E-28045 Madrid


Tel: +34 915 062 940


info@nucliber.com

		Polska

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Straße 10

D-13125 Berlin

Tel: +49-30-941084-280

radiopharma@ezag.de





		France


Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Straße 10

D-13125 Berlin

Tél: +49-30-941084-280

radiopharma@ezag.de



		Portugal

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Straße 10

D-13125 Berlin


Tel: +49-30-941084-280


radiopharma@ezag.de



		Hrvatska

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Straße 10

D-13125 Berlin

Tel: +49-30-941084-280

radiopharma@ezag.de



		România

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Straße 10

D-13125 Berlin

Tel: +49-30-941084-280

radiopharma@ezag.de







		Ireland

Advanced Accelerator Applications (UK & Ireland) Ltd.

Edison House, 223-231 Old Marylebone Road, London, NW1 5QT – UK

Tel: +44 (0)2072585252

customerservices.UK@adacap.com



		Slovenija

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Straße 10

D-13125 Berlin

Tel: +49-30-941084-280

radiopharma@ezag.de





		Ísland

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Straße 10

D-13125 Berlin

Sími: +49-30-941084-280

radiopharma@ezag.de



		Slovenská republika

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Straße 10

D-13125 Berlin

Tel: +49-30-941084-280

radiopharma@ezag.de





		Italia

Campoverde srl


Via Quintiliano, 30


I-20138 Milano


Tel: +39-02-58039045


vendite@campoverde-group.com



		Suomi/Finland

Eckert & Ziegler Radiopharma GmbH


Robert-Rössle-Straße 10


D-13125 Berlin


Puh/Tel: +49-30-941084-280


radiopharma@ezag.de





		Κύπρος

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Straße 10

D-13125 Berlin

Τηλ: +49-30-941084-280

radiopharma@ezag.de



		Sverige


Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Straße 10

D-13125 Berlin

Tel: +49-30-941084-280

radiopharma@ezag.de





		Latvija

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Straße 10

D-13125 Berlin

Tel: +49-30-941084-280

radiopharma@ezag.de



		United Kingdom

Advanced Accelerator Applications (UK & Ireland) Ltd.

Edison House, 223-231 Old Marylebone Road, London, NW1 5QT – UK

Tel: +44 (0)2072585252

customerservices.UK@adacap.com





		

		





This leaflet was last revised in {MM/YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. 

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

1