PRODUCT CATALOGUE. A complete palette in Nuclear Medicine. Oncology. Cardiology. Neurology

Transcription

1 PRODUCT CATALOGUE A complete palette in Nuclear Medicine Oncology Cardiology Neurology

2 INTERNATIONAL CATALOGUEALOGUE This is a comprehensive list of all products. Some products may not be available in your country, depending upon registration status. IBA reserves the right to modify the availability date of the products contained herein. Please contact your local distributor for further information. Approved SPC are available for download at: 2 IBA Molecular

3 Contents PRODUCT INDEX BY INDICATION BY NUCLIDE PRODUCT SPECIFICATIONS PET Radiopharmaceuticals SPECT & THERAPY Radiopharmaceuticals Cold kits Generators Accessories RADIOCHEMICAL PACKAGING SERVICES GENERAL INFORMATION COMMERCIAL INFORMATION SCIENTIFIC AND TECHNICAL INFORMATION UNITS DEFINITIONS NUCLIDE INDEX RADIOACTIVE DECAY TABLE LOCATIONS AND CONTACTS IBA Molecular

4 INTERNATIONAL CATALOGUEALOGUE 4 IBA Molecular

5 Product index By indication By nuclide Offering a comprehensive range in Nuclear Medicine Fulfilling the needs of our customers can not be conceived in part only. Our product offering reflects our commitment to offer a complete radiopharmaceutical solution to nuclearists, from widespread to niche indications. With major applications in Oncology, Cardiology and Neurology, in PET, SPECT and Therapy, our range is one of the most comprehensive in the industry. 5 IBA Molecular

6 INTERNATIONAL CATALOGUEALOGUE Products by indication Brain DOPACIS Cardio-vascular system ANGIOCIS SERALB-125 STAMICIS TL-201-S-1 VASCULOCIS Thyroid CAPSION I-123-S-2 I-131-S-1 I-131-S-2 Adrenal glands/kidneys NORCHOL-131 PENTACIS RENOCIS EDICIS 2 mg Sentinel nodes NANOCIS Lymphatic system NANOCIS Lung PENTACIS PULMOCIS VENTIBOX VENTICIS II Joints (various sizes) ERMM-1 RE-186-MM-1 YMM-1 Liver PHYTACIS Inflammation/ infection GA-67-MM-1 SCINTIMUN 1 mg Bones CISNAF OSTEOCIS TECEOS QUADRAMET Others ELUMATIC III ( 18 F)-FDG MIBG-131-D MIBG-131-T TEKCIS YTRACIS ZEVALIN 6 IBA Molecular

7 PET Radiopharmaceuticals CISNAF p 12 Sodium Fluoride ( 18 F) is used with positron emission tomography (PET) in bone imaging. DOPACIS p 12 ( 18 F) Fluorodopa is a solution used with positron emission tomography in neurology and oncology. FARNA FDG 3000 p 13 Fludeoxyglucose ( 18 F) is indicated for use with positron emission tomography. FDG-IBA P 13 Fludeoxyglucose ( 18 F) is indicated for use with positron emission tomography in Oncology, Cardiology, Neurology and Infectious. FLUORSCAN 3000 p 14 Fludeoxyglucose ( 18 F) is indicated for use with positron emission tomography. SPECT and Therapy Radiopharmaceuticals DIAGNOSIS GA-67-MM-17 p 17 Gallium ( 67 Ga) citrate : - non-specific tumor imaging and/or localizing agent. - localization of inflammatory lesions. I-123-S-2 p 17 Sodium iodide ( 123 I) for functional and morphological study of the thyroid gland. MIBG-131-D p 19 Iobenguane ( 131 I) for calculation of a therapeutic iobenguane ( 131 I) dose from a prior tracer-dose. NORCHOL-131 p iodomethylnorcholesterol ( 131 I) for investigation of adrenocortical diseases. SERALB-125 p 21 Iodinated ( 125 I) human serum albumin for determination of plasma and total blood volume, and examination of albumin turnover. TL-201-S-1 p 22 Thallium ( 201 Tl) chloride for myocardial scintigraphy. THERAPY CAPSION p 16 Sodium iodide ( 131 I) capsules for thyroid therapy. ERMM-1 p 16 Erbium ( 169 Er) citrate for isotopic radiation synovectomy (small size joints). I-131-S-1 p 18 Oral sodium iodide ( 131 I) for thyroid therapy. I-131-S-2 p 18 Sodium iodide ( 131 I) injection for thyroid diagnosis and therapy. MIBG-131-T p 19 Radiation therapy of tumour-tissue that is capable of retaining iobenguane. QUADRAMET p 20 Samarium ( 153 Sm)-EDTMP for the relief of bone pain in patients with multiple painful osteoblastic skeletal metastases which take up technetium ( 99m Tc)-labelled bisphosphonates on bone scan. RE-186-MM-1 p 21 Rhenium ( 186 Re) sulphide for isotopic radiation synovectomy (medium size joints). YMM-1 p 23 Yttrium ( 90 Y) citrate colloidal suspension for isotopic radiation synovectomy (big size joints). YTRACIS p 23 Yttrium ( 90 Y) chloride radiopharmaceutical precursor solution for the radiolabelling of carrier molecules. Kits for radiopharmaceutical preparation ANGIOCIS p 26 Kit for radiopharmaceutical preparation. EDICIS 2 mg p 26 Kit for radiopharmaceutical preparation. NANOCIS p 27 Kit for radiopharmaceutical preparation. OSTEOCIS p 27 Kit for radiopharmaceutical preparation. PENTACIS p 28 Kit for radiopharmaceutical preparation. PHYTACIS p 28 Kit for radiopharmaceutical preparation. PULMOCIS p 29 Kit for radiopharmaceutical preparation. RENOCIS p 29 Kit for radiopharmaceutical preparation. SCINTIMUN 1 mg p 30 Kit for radiopharmaceutical preparation. STAMICIS p 31 Kit for radiopharmaceutical preparation. TECEOS p 33 Kit for radiopharmaceutical preparation. VASCULOCIS p 33 Kit for radiopharmaceutical preparation. ZEVALIN p 34 Radiopharmaceutical preparation for infusion (labelleing with yttrium ( 90 Y)). Generators ELUMATIC III p 36 Technetium ( 99m Tc) generator 2-20GBq. TEKCIS p GBq radionuclide generator. Accessories ELUMATIC/TEKCIS ACCESSORIES CONT-ELU p 40 Lead shielding for elution vial. CONT-ELU-SP p 40 All lead glass shielding for elution vial. PROTEC-ELU p 40 Lead shielding for ELUMATIC III generator supplied in parts. OTHER VENTICIS II RADIOAEROSOL DELIVERY SYSTEM p 41 Radioaerosol delivery system for lung investigation supplied in box of 5 circuits. Medical device, class IIa, in compliance with the Medical Devices Directive 93/42/EEC VENTIBOX p 41 Lead shielded box for one VENTICIS II System. CAPSION accessories p 42 EDICIS accessories p 42 SCINTIMUN accessories p 43 STAMICIS accessories p 43 Radiochemical upon request I-123-MPUP p 46 Other possibilities upon request. The availability of these products is dependant upon their registration status in each country. Please contact your local IBA Molecular representative for more information. Please refer to the Summary of Product Caracteristics available on for complete product information 7 IBA Molecular

8 INTERNATIONAL CATALOGUEALOGUE Products by nuclide Radiopharmaceuticals 169 Er ERMM-1 p 16 Erbium ( 169 Er) citrate for isotopic radiation synovectomy (small size joints). 18 F CISNAF p 12 Sodium Fluoride ( 18 F) is used with positron emission tomography (PET) in bone imaging. DOPACIS p 12 ( 18 F) Fluorodopa is a solution used with positron emission tomography in neurology and oncology. FARNA FDG 3000 p 13 Fludeoxyglucose ( 18 F) is indicated for use with positron emission tomography. FDG-IBA P 13 Fludeoxyglucose ( 18 F) is indicated for use with positron emission tomography in Oncology, Cardiology, Neurology and Infectious. FLUORSCAN 3000 p 14 Fludeoxyglucose ( 18 F) is indicated for use with positron emission tomography. 67 Ga GA-67-MM-17 p 17 Gallium ( 67 Ga) citrate: - non-specific tumor imaging and/or localizing agent. - localization of inflammatory lesions. 123 I I-123-S-2 p 17 Sodium iodide ( 123 I) for functional and morphological study of the thyroid gland. 125 I SERALB-125 p 21 Iodinated ( 125 I) human serum albumin for determination of plasma and total blood volume, and examination of albumin turnover. 131 I CAPSION p 16 Sodium iodide ( 131 I) capsules for thyroid therapy. I-131-S-1 p 18 Oral sodium iodide ( 131 I) for thyroid therapy. I-131-S-2 p 18 Sodium iodide ( 131 I) injection for thyroid diagnosis and therapy. MIBG-131-D p 19 Iobenguane ( 131 I) for calculation of a therapeutic iobenguane ( 131 I) dose from a prior tracer-dose. MIBG-131-T p 19 Radiation therapy of tumour-tissue that is capable of retaining iobenguane. NORCHOL-131 p 20 6-iodomethylnorcholesterol ( 131 I) for investigation of adrenocortical diseases. 186 Re RE-186-MM-1 p 21 Rhenium ( 186 Re) sulphide for isotopic radiation synovectomy (medium size joints). 153 Sm QUADRAMET p 20 Samarium ( 153 Sm)-EDTMP for the relief of bone pain in patients with multiple painful osteoblastic skeletal metastases which take up technetium ( 99m Tc)-labelled bisphosphonates on bone scan. 99m Tc ANGIOCIS p 26 Kit for radiopharmaceutical preparation. EDICIS 2 mg p 26 Kit for radiopharmaceutical preparation. ELUMATIC III p 36 Technetium ( 99m Tc) generator 2-20GBq. NANOCIS p 27 Kit for radiopharmaceutical preparation. OSTEOCIS p 27 Kit for radiopharmaceutical preparation. PENTACIS p 28 Kit for radiopharmaceutical preparation. PHYTACIS p 28 Kit for radiopharmaceutical preparation. PULMOCIS p 29 Kit for radiopharmaceutical preparation. RENOCIS p 29 Kit for radiopharmaceutical preparation. SCINTIMUN 1 mg p 30 Kit for radiopharmaceutical preparation. STAMICIS p 31 Kit for radiopharmaceutical preparation. TECEOS p 33 Kit for radiopharmaceutical preparation. TEKCIS p GBq radionuclide generator VASCULOCIS p 33 Kit for radiopharmaceutical preparation. ZEVALIN p 34 Radiopharmaceutical preparation for infusion (labelling with Yttrium ( 90 Y)) 201 Tl TL-201-S-1 p 22 Thallium ( 201 Tl) chloride for myocardial scintigraphy. 90 Y YMM-1 p 23 Yttrium ( 90 Y) citrate colloidal suspension for isotopic radiation synovectomy (big size joints). YTRACIS p 23 Yttrium ( 90 Y) chloride radiopharmaceutical precursor solution for the radiolabelling of carrier molecules. Radiochemical 123 I p 46 Upon request. The availability of these products is dependant upon their registration status in each country. Please contact your local IBA Molecular representative for more information. Please refer to the Summary of Product Caracteristics available on for complete product information 8 IBA Molecular

9 Product specifications PET Radiopharmaceuticals SPECT & Therapy Radiopharmaceuticals Cold kits Generators Accessories Radiochemical 45 Packaging 47 Services 51 9 IBA Molecular

10 INTERNATIONAL CATALOGUEALOGUE 10 IBA Molecular

11 PET Radiopharmaceuticals 11 IBA Molecular

12 INTERNATIONAL CATALOGUEALOGUE CISNAF Fluorine-18 T1/2 = min Sodium Fluoride ( 18 F) solution for injection Availability Ordering deadline Radioactive concentrations Calibration Available quantities Expiry Volume per vial Radiochemical purity ph and composition Storage Indication Depending upon regions Please, contact your local IBA representative Depending upon regions Please, contact your local IBA representative 100 MBq/mL at the date and time of calibration 6 to 10 hours from the time of production 50 to 1500 MBq per vial at calibration time 14 hours from the date of production 0.5 to 15 ml 98,5% ; Sodium fluoride ( 18 F), sodium chloride and water for injections Store in the original packaging Medicinal product for diagnostic use only. Indicated for use with positron emission tomography (PET) in bone imaging. Please, refer to the SPC. DOPACIS Fluorine-18 T1/2 = min Fluorodopa ( 18 F) SOLUTION FOR INJECTION Availability Ordering deadline Radioactive concentrations Calibration Available quantities Expiry Volume per vial Radiochemical purity ph and composition Storage Indication Depending upon regions Please, contact your local IBA representative Depending upon regions Please, contact your local IBA representative 90 MBq/mL at the date and time of calibration 2 to 3 hours from the time of production 90 to 900 MBq per vial at calibration time 8 hours from the date of production 1 to 10 ml 95% ; Fluorodopa ( 18 F), acetic acid, sodium acetate, ascorbic acid and water for injections Store in the original lead shielding. After first withdrawal, store in refrigerator (2 C to 8 C). Medicinal product for diagnostic use only. Indicated for use with positron emission tomography in neurology and oncology. Please, refer to the SPC. 12 IBA Molecular IMPORTANT: Read package leaflet before using the radiopharmaceutical product. Availability of the products in the different countries according to the registration status.

13 FARNA FDG 3000 Fluorine-18 T1/2 = min Fludeoxyglucose ( 18 F) SOLUTION FOR INJECTION Availability Ordering deadline Radioactive concentrations Calibration Available quantities Expiry Radiochemical purity ph and composition Storage Indication From Monday to Friday Variable, depending on production sites 3000 MBq/mL at calibration End of synthesis From 1.0 to 10.0 ml per vial 14 hours from the end of synthesis 95% ; Fludeoxyglucose ( 18 F); sodium chloride, sodium dihydrogen phosphate dihydrate and water for injections, Ethanol. No special conditions are required Medicinal product for diagnostic use only. Fludeoxyglucose ( 18 F) is indicated for use with positron emission tomography. Please, refer to the SPC FDG-IBA Fluorine-18 T1/2 = min Fludeoxyglucose ( 18 F) SOLUTION FOR INJECTION Availability Ordering deadline Radioactive concentration Calibration Available quantities Expiry Radiochemical purity ph and composition Storage Indication From Monday to Friday (Saturday in some instances) Variable, depending on production sites 185 MBq/mL at time and date of calibration 5h, 5h30, 6h, 7h up to 9 hours from production From 0.5 to 10.0 ml per vial (90 to 1850 MBq/mL) 12 hours from the time of production 95% ; Fludeoxyglucose ( 18 F), sodium chloride and water for injections Store in the original package. After first withdrawal, store below 25 C and use within 12 hours without exceeding the expiry time. Medicinal product for diagnostic use only. Fludeoxyglucose ( 18 F) is indicated for use with Positron Emission Tomography. Please, refer to the SPC IMPORTANT: Read package leaflet before using the radiopharmaceutical product. Availability of the products in the different countries according to the registration status. 13 IBA Molecular

14 INTERNATIONAL CATALOGUEALOGUE FLUORSCAN 3000 Fluorine-18 T1/2 = min Fludeoxyglucose ( 18 F) SOLUTION FOR INJECTION Availability Ordering deadline Radioactive concentrations Calibration Available quantities Expiry Radiochemical purity ph and composition Storage Indication From Monday to Friday Variable, depending on production sites 3000 MBq/mL at time and date of calibration End of synthesis From 1.0 to 10.0 ml per vial 14 hours from the end of synthesis 95% ; Fludeoxyglucose ( 18 F); sodium chloride, sodium dihydrogen phosphate dihydrate and water for injections, Ethanol. No special conditions are required. Medicinal product for diagnostic use only. Fludeoxyglucose ( 18 F) is indicated for use with positron emission tomography. Please, refer to the SPC 14 IBA Molecular IMPORTANT: Read package leaflet before using the radiopharmaceutical product. Availability of the products in the different countries according to the registration status.

15 SPECT & Therapy Radiopharmaceuticals 15 IBA Molecular

16 INTERNATIONAL CATALOGUEALOGUE CAPSION Iodine-131 T1/2 = 8.02 d SODIUM IODIDE ( 131 I) CAPSULE FOR THERAPY Availability Ordering deadline Available quantities Calibration Expiry Specific activity at calibration Radiochemical purity Radionuclidic purity Storage Indication Every working day Shipment Ordering deadline Monday Wednesday week before (before am) Tuesday Thursday week before (before am) Wednesday Thursday week before (before am) Thursday Monday week before (before am) Friday Tuesday (before am) From 50 MBq to 3700 MBq per capsule at calibration (100 mci maxi per capsule) On request 1-4 days 21 days after the manufacturing date 185 GBq/mg of iodine at calibration Iodide : 98% 131 I 99.9%; 130 I I I 0.1% Not above 25 C, in its original packaging. Treatment of Graves disease, toxic multinodular goitre or autonomous nodules Treatment of papillary and follicular thyroid carcinoma including metastatic disease ERMM-1 Erbium-169 T1/2 = 9.4 d ERBIUM ( 169 Er) CITRATE SUSPENSION FOR INJECTION (THERAPY) Availability Ordering deadline Radioactive concentration Calibration Available quantities Expiry Specific activity ph and composition Storage Indication Tuesday Friday before 11 a.m. 111 MBq/mL (3 mci/ml) at calibration date Saturday 12 a.m. From 37 to 1110 MBq 18 days from the manufacting date 37 to 1110 MBq/mg (1 to 30 mci/mg) at calibration date in sodium chloride solution Do not store above 25 C After first withdrawal, store at 2-8 C and use within 8 hours. Treatment of rheumatoid mono or oligo-arthritis involving one or few of the small joints of the hands and feet following failure of intra-articular corticosteroid therapy or when the latter is contra-indicated 16 IBA Molecular IMPORTANT: Read package leaflet before using the radiopharmaceutical product. Availability of the products in the different countries according to the registration status.

17 GA-67-MM-1 Gallium-67 T1/2 = 3.26 d GALLIUM ( 67 Ga) CITRATE SOLUTION FOR INJECTION Availability Ordering deadline Radioactive concentration Calibration Available quantities Expiry Specific activity Radiochemical purity Radionuclidic purity ph and composition Storage Indication Monday, Friday Thursday week before (before am CET) 74 MBq/mL (2 mci/ml) Monday (next week) Friday (next week) 12 a.m. From 37 to 1110 MBq 14 days after the manufacturing date Carrier free 95 % 99 %; 66 Ga 0.2 % 5-8 in sodium citrate solution Not above 25 C 2-8 C after the first withdrawal and use within the working day. Non-specific tumor imaging and/or localising agent Localisation of inflammatory lesions I-123-S-2 Iodine-123 T1/2 = 13.2 h SODIUM IODIDE ( 123 I) SOLUTION FOR INJECTION Availability Ordering deadline Radioactive concentration Calibration Available quantities Expiry Specific activity Radiochemical purity Radionuclidic purity ph and composition Storage Indication Every working day except Friday and the day before a french banking holiday One day before (before 11 a.m.) 18,5 MBq/mL Following day at 5 p.m. 37 to 185 MBq 2 days after the manufacturing date Carrier free 95 % 99.7 % phosphate-thiosulfate buffer C Functional and morphological study of the thyroid gland IMPORTANT: Read package leaflet before using the radiopharmaceutical product. Availability of the products in the different countries according to the registration status. 17 IBA Molecular

18 INTERNATIONAL CATALOGUEALOGUE I-131-S-1 Iodine-131 T1/2 = 8.02 d SODIUM IODIDE ( 131 I) ORAL SOLUTION Availability Ordering deadline Radioactive concentration Calibration Available quantities Expiry Specific activity at calibration Radiochemical purity Radionuclidic purity at calibration ph and composition Storage Indication Tuesday / Wednesday Thursday week before (before 4.00 pm CET) 1110 MBq/mL (30 mci/ml) at calibration date Wednesday (following week) 12 a.m. From to MBq 29 days after the manufacturing date 185 GBq/mg iodine Iodide : 95 % 99.9 %; 133 I I + other alpha impurities 0.1 % 7-10 in sterile solution with carbonate-thiosulfate buffer Not above 25 C Diagnostic Estimation of thyroid uptake and effective half life Identification of thyroid remnant and metastases (after ablation) Therapy Treatment of Graves disease, toxic multinodular goitre or autonomous nodules Treatment of papillary and follicular thyroid carcinoma including metastatic disease I-131-S-2 Iodine-131 T1/2 = 8.02 d SODIUM IODIDE ( 131 I) SOLUTION FOR INJECTION Availability Ordering deadline Radioactive concentration Calibration Available quantities Expiry Specific activity Radiochemical purity Radionuclidic purity at calibration ph and composition Storage Indication Thursday Tuesday week before (before am CET) 111 MBq/mL (3 mci/ml) Friday (following week) 12 a.m. From 74 to 1110 MBq 29 days after the manufacturing date 185 GBq/mg at calibration Iodide : 95 % 99.9 %; 133 I I + other alpha impurities 0.1 % 6-8 in phosphate-thiosulfate buffer Not above 25 C Diagnostic Estimation of thyroid uptake and effective half life Management of thyroid carcinoma : identification of thyroid remnant and metastases (after ablation) Therapy Treatment of Graves' disease, toxic multinodular goitre or autonomous nodules Treatment of papillary and follicular thyroid carcinoma including metastatic disease 18 IBA Molecular IMPORTANT: Read package leaflet before using the radiopharmaceutical product. Availability of the products in the different countries according to the registration status.

19 MIBG-131-D Iodine-131 T1/2 = 8.02 d IOBENGUANE ( 131 I) SOLUTION FOR INJECTION (DIAGNOSIS) Availability Ordering deadline Radioactive concentration Calibration Precalibred quantities Expiry Specific activity Radiochemical purity Radionuclidic purity at calibration ph and composition Storage Indication Monday (one batch on 2 weeks) Wednesday 11 a.m., the week before the shipment day 9.25 MBq/mL (0.25 mci/ml) Tuesday (following week) 12 a.m. Monodose of MBq (1.25 mci) 19 days after the manufacturing date MBq/vial = 54.5 GBq of 131 I/g iobenguane at calibration 94 % 131 I 99.9 % ; 133 I I + other impurities 0.1 % 4-6 in saline acetate buffer At - 18 C Calculation of a therapeutic iobenguane ( 131 I) dose from a prior tracer-dose (used for dosimetry in pheochromocytomas, neuroblastomas, carcinoids and medullary carcinomas of the thyroid gland) MIBG-131-T Iodine-131 T1/2 = 8.02 d IOBENGUANE ( 131 I) SOLUTION FOR INJECTION (THERAPY) Availability Ordering deadline Radioactive concentration Calibration Available quantities Maximum activity / vial Expiry Specific activity Radiochemical purity Radionuclidic purity ph and composition Storage Indication Two first Tuesday of each month Wednesday week before (before am CET) 370 MBq/mL (10 mci/ml) Thursday 12 a.m and 5550 MBq ( and 150 mci) 5550 MBq (150 mci) 7 days after the manufacturing date 400 GBq of 131 I/g iobenguane at calibration 92 % at expiry 131 I 99.9 % ; 133 I I + other impurities 0.1% in saline acetate buffer At - 18 C Radiation therapy of tumour-tissue that is capable of retaining metaiodobenzylguanidine: pheochromocytomas, neuroblastomas, carcinoids and medullary carcinomas of the thyroid gland IMPORTANT: Read package leaflet before using the radiopharmaceutical product. Availability of the products in the different countries according to the registration status. 19 IBA Molecular

20 INTERNATIONAL CATALOGUEALOGUE NORCHOL-131 Iodine-131 T1/2 = 8.02 d ( 131 I) IODOMETHYLNORCHOLESTEROL SOLUTION FOR INJECTION Availability Ordering deadline Radioactive concentration Calibration Available quantities Expiry Specific activity Radiochemical purity Radionuclidic purity ph Storage Indications Thursday Friday, before 11 a.m MBq/mL ( mci/ml) at calibration Wednesday 12 a.m. From 37 to 74 MBq per vial at calibration 14 days after the manufacturing date MBq/mg ( mci/mg) 85 % 99.9 % 3.5 to 8.5 At - 18 C Diagnostic evaluation of the functional state of adrenal cortical tissue Differentiation between metastatic disease to the adrenals ( cold area ) and non-malignant adrenal enlargement in cancer patients Detection of remnants of functioning tissue in hypercortisonism after adrenalectomy, or of ectopic endocrine tissue Detection and follow-up of euadrenal tumours QUADRAMET Samarium-153 T1/2 = 46.3 h SAMARIUM ( 153 Sm) LEXIDRONAM PENTASODIUM SOLUTION FOR INJECTION (THERAPY) Composition Available activities Posology and method of administration Availability and Calibration Ordering deadline Expiry Storage Therapeutic indications ( 153 Sm-EDTMP) : 1.3 GBq/mL (at calibration date) (Corresponding to 20 to 80 µg/ml of samarium) Total EDTMP (as EDTMP.H20) : 33 mg/ml Calcium-EDTMP sodium salt (as Ca) Total sodium (as Na) Water for injections 2 to 4 GBq per vial at calibration date 37 MBq per kg body weight Slow intravenous route through an established intravenous line over a period of one minute Should not be diluted before use On Monday calibrated Thursday 12 a.m. Friday week before (before am CET) 4 days after the manufacturing date (1 day after the calibration date) Delivered frozen in dry ice, should be stored frozen at -10 C to -20 C in its original packaging Use within 6 hours of thawing After thawing, do not freeze again Relief of bone pain in patients with multiple painful osteoblastic skeletal metastases which take up technetium ( 99m Tc)-labelled biphosphonates on bone scan 20 IBA Molecular IMPORTANT: Read package leaflet before using the radiopharmaceutical product. Availability of the products in the different countries according to the registration status.

21 RE-186-MM-1 Rhenium-186 T1/2 = 3.77 d RHENIUM ( 186 Re) SULPHIDE SUSPENSION FOR INJECTION (THERAPY) Availability Ordering deadline Radioactive concentration Calibration Available quantities Expiry Specific activity Radiochemical purity Radionuclidic purity ph and composition Storage Indication Tuesday Friday before 11 a.m. 220 to 335 MBq/mL (6 to 9 mci/ml) at calibration date Saturday 12 a.m. From 37 to 3700 MBq 10 days after the manufacturing date 2000 to 7400 MBq/mg (54 to 200 mci/mg) 95 % 186 Re 99 %; 184 Re Re 1% , colloidal suspension stabilised with gelatine Not above 25 C Treatment of rheumatoid mono or oligo arthritis involving mediumsized joints (shoulders, elbows, wrists, ankles, hips) and particularly rheumatoid polyarthritis Treatment of haemophilic or chronic arthropathy associated with articular chondrocalcinosis. SERALB-125 Iodine-125 T1/2 = 59.9 d IODINATED ( 125 I) HUMAN ALBUMIN SOLUTION FOR INJECTION Availability Ordering deadline Radioactive concentration Calibration Available quantities Expiry Radiochemical purity Radionuclidic purity ph and composition Storage Indication Thursday (once a month) Monday, before 11 a.m. 185 kbq/ml (5 µci/ml) at calibration date Saturday (2 weeks after) 12 a.m. Per 4 vials of 320 kbq (8.6 µci) 49 days after the manufacturing date 80 % 99 % 5-9 At 2 to 8 C in its original packaging Determination of plasma volume and total blood volume Examination of albumin turnover. IMPORTANT: Read package leaflet before using the radiopharmaceutical product. Availability of the products in the different countries according to the registration status. 21 IBA Molecular

22 INTERNATIONAL CATALOGUEALOGUE TL-201-S-1 Thallium-201 T1/2 = 3.05 d THALLIUM ( 201 Tl) CHLORIDE SOLUTION FOR INJECTION Availability and calibration Ordering deadline Radioactive concentration Available quantities Expiry Specific activity Radiochemical purity Radionuclidic purity On Monday calibrated Friday noon On Tuesday calibrated Sunday noon On Wednesday calibrated Tuesday noon On Thursday calibrated Wednesday noon On Friday calibrated Thursday noon 1 day before the shipment day, before 11 a.m. 37 MBq/mL (1mCi/mL) From 185 to 555 MBq 14 days after the manufacturing date 3.7 MBq/µg (0.1 mci/µg) 95 % 97 % Release Expiry 200 Tl < 0.25 % < 0.01 % 202 Tl < 0.50 % < 2.00 % 203 Pb < 0.10 % < 0.05 % ph and composition Storage Indication 4-7 in sterile isotonic solution Between C in its original packaging. 2-8 C after the first withdrawal and used within 24h. Myocardial scintigraphy in the evaluation of coronary perfusion and cellular viability. Scintigraphy of the muscles. Parathyroid scintigraphy. Thallium avid tumour visualisation in different organs, especially for the brain tumours and thyroid tumours and metastases. 22 IBA Molecular IMPORTANT: Read package leaflet before using the radiopharmaceutical product. Availability of the products in the different countries according to the registration status.

23 YMM-1 Yttrium-90 T1/2 = 2.67 d YTTRIUM ( 90 Y) CITRATE SUSPENSION FOR INJECTION (THERAPY) Availability Ordering deadline Radioactive concentration Calibration Available quantities Expiry Specific activity Non filtrable fraction of Yttrium-90 citrate colloidal suspension ph and composition Storage Indication Tuesday Friday before 11 a.m. 145 to 370 MBq/mL (1 to 10 mci/ml) at calibration date Saturday 12 a.m. From 37 to 3700 MBq 15 days after the manufacturing date 59 to 300 MBq/mg 85% at release - 80% at expiry in sodium chloride solution Not above 25 C Therapeutic irradiation of synovial hypertrophy of knee joints mainly for mono- or oligo-articular arthritis of chronic inflammatory rheumatism particularly rheumatoid polyarthritis YTRACIS Yttrium-90 T1/2 = 2.67 d YTTRIUM ( 90 Y) CHLORIDE RADIOPHARMACEUTICAL PRECURSOR SOLUTION Availability Ordering deadline Radioactive concentration Calibration Available quantities Expiry Specific activity Radiochemical purity Acidity Storage Indication Tuesday Thursday before 2 p.m GBq/mL Friday 12 a.m. CET to GBq/vial 7 days after the manufacturing date Carrier free 97 % 0.035M-0.045M Store in its original packaging To be used only for in vitro radiolabelling of medicinal products which are subsequently administered by approved route. IMPORTANT: Read package leaflet before using the radiopharmaceutical product. Availability of the products in the different countries according to the registration status. 23 IBA Molecular

24 INTERNATIONAL CATALOGUEALOGUE 24 IBA Molecular

25 SPECT Cold kits (Kits for radiopharmaceutical preparation) 25 IBA Molecular

26 INTERNATIONAL CATALOGUEALOGUE ANGIOCIS Kit for radiopharmaceutical preparation Each vial contains : Sodium pyrophosphate decahydrate mg Stannous chloride dihydrate Volume of 0.9% sodium chloride sterile solution to use for reconstitution 3 ml Storage 12 months at 2 to 8 C Stability of reconstituted product 6 h at 2 to 8 C Indications /Posology Angiocardioscintigraphy Organ perfusion and vascular abnormality imaging Diagnosis and localisation of occult gastro-intestinal bleeding Activity injected for blood pool scintigraphy ( MBq) Time between injection of Angiocis and 30 minutes before administration of pertechnetate 99m Tc pertechnetate 99m Tc Time between injection and examination Immediatly after injection of the tracer (pertechnetate 99m Tc) Availability From stock Number of radiolabelled preparations per kit 5 EDICIS 2 mg Kit for radiopharmaceutical preparation Each vial 1 contains: Ethylene-dicysteine: 2 mg Disodium phosphate dihydrate (E339) D-mannitol (E421) Ascorbic acid (E300) Disodium edetate dihydrate Each vial 2 contains: Reducing agent: Stannous chloride dihydrate (E512) Tartaric acid (E334) Ascorbic acid (E300) Each vial 3 contains: Buffering agent: Potassium dihydrogen phosphate (E340) Ascorbic acid (E300) Volume of pertechnetate 99m Tc to use for reconstituton 2 ml Radiochemical purity 95% Storage 1 year at 2-8 C Activity per vial 0,8 to 1,6 GBq Indications /Posology Dynamic scintigraphy in adults for: Evaluation of nephropathies and uropathies especially for assessing relative kidney function, renal morphology, and renal perfusion. Drainage of the upper urinary tract. The recommended activity for a patient of 70 kg average body weight is between 90 MBq and 120 MBq injected intravenously Stability of labelled product 8 hours not above 25 C Time between injection and examination The scintigraphic examination begins immediately after injection of the product. The total duration of the examination is approximately 30 minutes. Availability From stock Number of radiolabelled preparations 4 26 IBA Molecular IMPORTANT: Read package leaflet before using the kit. Availability of the products in the different countries according to the registration status

27 NANOCIS Kit for radiopharmaceutical preparation Each vial A contains Rhenium sulfide (as Re element 0.15 mg) 0.24 mg Gelatin Ascorbic acid Water for injections Concentrated hydrochloric acid Each vial B contains Sodium pyrophosphate decahydrate Stannous chloride dihydrate Sodium hydroxide Particle size 31.6 nm < 70% < 178 nm Volume of pertechnetate 99m Tc to add into vial A 1 to 2 ml Radiochemical purity 95% Aspect of reconstituted product Dark brown colloidal solution Storage 6 months at 2-8 C Stability of labelled product 4 h at 2-8 C Activity per vial 370 to 5550 MBq Indications /Posology Imaging and detection of sentinel lymph node : 5 to 200 MBq: activity and volume injected depending on the indication. Lymphatic flow scintigraphy : 20 to 200 MBq in 0.2 to 0.3 ml / site Vol max/injection site: 0.5 ml Gastro Oesophageal Reflux : 3.5 to 12 MBq Availability From stock Number of radiolabelled preparations per kit 5 OSTEOCIS Kit for radiopharmaceutical preparation Each vial contains : Sodium oxidronate (HMDP) 3.0 mg Stannous chloride dihydrate Ascorbic acid Sodium chloride Under nitrogen atmosphere Volume of pertechnetate 99m Tc to use for reconstitution 2 to 10 ml Radiochemical purity 95 % Storage 12 months at 2 to 8 C Activity per vial 0.74 to 11.1 GBq Indications / Posology Bone scintigraphy 300 to 700 MBq / 50 or 70kg adult 500 MBq average activity Stability of labelled product 8h at 2-8ºC Time between injection and examination Not earlier than 2h after injection Availability From stock Number of radiolabelled preparations per kit 5 IMPORTANT: Read package leaflet before using the kit. Availability of the products in the different countries according to the registration status 27 IBA Molecular

28 INTERNATIONAL CATALOGUEALOGUE PENTACIS Kit for radiopharmaceutical preparation Each vial contains : Calcium trisodium pentetate (DTPA Ca Na 3 ) 9.10 mg Stannous chloride dihydrate Sodium chloride Under a nitrogen atmosphere Volume of pertechnetate 99m Tc to use for reconstitution 5 ml Radiochemical purity 95% Storage 12 months at 2-8 C Activity per vial 3.7 to 2000 MBq Indications / Posology 1) Intravenous use : - Renal glomerular filtration 1.8 to 3.7 MBq (plasma) - Renal glomerular filtration 37 to 370 MBq (scanning) - Brain scanning 185 to 740 MBq 2) Oral use : Study of gastro-oesophageal reflux and gastric emptying : 10 to 20 MBq Stability of labelled product 4h at 2-8 C with a maximum of 5 withdrawals per vial Time between administration and examination Optimal static renal imaging : 1 hour Renal and brain sequential scanning : immediately Brain static images : Dynamic recording : Availability From stock Number of radiolabelled preparations per kit 5 1 hour to several hours first minutes up to 120 minutes for gastroduodenal transit. PHYTACIS Kit for radiopharmaceutical preparation Each vial contains : Sodium phytate 20 mg Stannous chloride dihydrate Sodium hydroxide Under nitrogen atmosphere Volume of pertechnetate 99m Tc to use for reconstitution 10 ml max. Radiochemical purity 95% Storage 6 months at 2-8 C Stability of labelled product 6 h at 2-8 C Activity per vial 9250 MBq max. Indications /Posology Hepatic scintigraphy : 37 to 100 MBq Time between injection and examination 10 to 60 min Availability From stock Number of radiolabelled preparations per kit 5 28 IBA Molecular IMPORTANT: Read package leaflet before using the kit. Availability of the products in the different countries according to the registration status

29 PULMOCIS Kit for radiopharmaceutical preparation Each vial contains : Human Albumin Macroaggregates (MAA) 2.0 mg Stannous chloride dihydrate Sodium chloride Non denaturated human albumin Under nitrogen atmosphere Particles number per vial 2 to 4 million Particle size Number of MAA 150 m : 0 Number of MAA 100 m : 0.2 % Volume of pertechnetate 99m Tc to use for reconstitution ml Radiochemical purity* 90 % Colour Whitish homogeneous suspension Storage 12 months at 2-8 C Activity per vial 92.5 to 3700 MBq Indications Pulmonary perfusion scintigraphy Venoscintigraphy Posology 37 to 185 MBq Stability of labelled product 8 h at 2-8 C Time between injection and examination Immediately Availability from stock Number of radiolabelled preparations per kit 5 *Non filterable radioactivity RENOCIS Kit for radiopharmaceutical preparation Each vial contains : Dimercaptosuccinic acid (DMSA) 1.0 mg Stannous chloride dihydrate Inositol Ascorbic acid Sodium hydroxide (ph adjustment) Under nitrogen atmosphere Volume of pertechnetate 99m Tc to use for reconstitution 1 to 6 ml Radiochemical purity 95 % Storage 12 months at 2 to 8 C Stability of labelled product 8 h at 2-8 C Activity per vial Maximum 3.7 GBq Indications /Posology Static planar or tomographic renal imaging : - Morphological studies of renal cortex - Individual kidney function - Location of ectopic kidney 30 to 120 MBq Time between injection and examination Image acquisitions : 1 to 3 h Where there is renal impairment or obstruction, delayed views may be needed (6 to 24 hours respectively) Availability From stock Number of radiolabelled preparations per kit 5 IMPORTANT: Read package leaflet before using the kit. Availability of the products in the different countries according to the registration status 29 IBA Molecular

30 INTERNATIONAL CATALOGUEALOGUE SCINTIMUN 1 mg Kit for radiopharmaceutical preparation Each vial 1 contains 5.02 mg dry substance : Besilesomab 1 mg Disodium hydrogen phosphate, anhydrous Sodium dihydrogen phosphate, anhydrous Under nitrogen atmosphere Sorbitol E420 Each vial 2 contains 2.82 mg dry substance : 1,1,3,3-propane tetraphosphonic acid, tetrasodium salt, dihydrate (PTP) 2.7 mg Tin (II) chloride dihydrate Sodium hydroxyde 1N (ph adjustment) Hydrochloric acid 1N (ph adjustment) Under nitrogen atmosphere Volume of pertechnetate 99m Tc to use for reconstitution into vial 1 2 to 7 ml Radiochemical purity 95 % Storage 2 years at 2-8 C, protected from light Stability of labelled product 3 h not above 25 C, protected from light Activity per vial 400 to 1800 MBq Indications /Posology In conjunction with other appropriate imaging modalities determination of the location of inflammation/infection peripheral bone in adults with suspected osteomyelitis ( MBq). Should not be used for the diagnosis of diabetic foot infection Time between injection and examination 3 to 6h and late image 24h Availability From stock Number of radiolabelled preparations per kit 2 30 IBA Molecular IMPORTANT: Read package leaflet before using the kit. Availability of the products in the different countries according to the registration status

31 STAMICIS Kit for radiopharmaceutical preparation Each vial 2 contains Tetrakis (2-methoxy isobutyl isonitrile) 1.0 mg copper (I) tetrafluoroborate Stannous chloride dihydrate L-cysteine hydrochloride monohydrate Sodium Citrate Dihydrate Mannitol Volume of 99m Tc pertechnetate to use for reconstitution 1 to 3 ml Radiochemical purity > 94% Indications /Posology Adults The suggested activity range for intravenous use to a patient of average weight (70 kg) is: Myocardial perfusion scintigraphy: MBq Assessment of global ventricular function: MBq injected as a bolus. For diagnosis of ischaemic heart disease two injections (stress and rest) are required in order to differentiate transiently from persistently reduced myocardial uptake. The recommended activity range for diagnosis of ischaemic heart disease according to the European procedural guideline is: - Two-day protocol: MBq/study - One-day protocol: MBq for the first injection, three times more for the second injection. Not more than a total of 2000 MBq should be administered for a one-day protocol and 1800 MBq for a two-day-protocol. For a one day protocol, the two injections (stress and rest) should be done at least two hours apart but may be performed in either order. After the stress injection, exercise should be encouraged for an additional one minute (if possible). For diagnosis of myocardial infarction one injection at rest may be sufficient. The injection of activities greater than local DRLs (Diagnostic Reference Levels) should be justified. Scinti-mammography for the detection of suspected breast cancer: MBq injected as a bolus in the arm opposite to the lesion. Localisation of hyperfunctioning parathyroid tissue: MBq injected as a bolus (the activity used should in every case be as low as reasonably practical). The typical activity is 740 MBq. Children and adolescents For pediatric use, please refer to the full SPC. Time between injection and examination Myocardial perfusion scintigraphy If possible, patients should fast for at least four hours prior to the study. It is recommended that patients eat a light fatty meal or drink a glass or two of milk after each injection, prior to imaging. This will promote rapid hepatobiliary clearance of technetium ( 99m Tc) sestamibi resulting in less liver activity in the image. Imaging should begin approximately after 60 min after injection to allow for hepatobiliary clearance. Longer delay can be required for resting images and for stress with vasodilatators alone because of the risk of higher subdiaphragmatic 99m Tc activity. There is no evidence for significant changes in myocardial tracer concentration or redistribution, therefore imaging for up to 6 hours post injection is possible. Test may be done in a one day or two days protocol. Preferably tomographic imaging (SPECT) with or without ECG IMPORTANT: Read package leaflet before using the kit. Availability of the products in the different countries according to the registration status 31 IBA Molecular

32 INTERNATIONAL CATALOGUEALOGUE STAMICIS (continued) gating should be performed according to current international guidelines. Breast imaging The product is administered in an arm vein contralateral to the breast with the suspected abnormality. If the disease is bilateral, the injection is ideally administered in a dorsal vein of the foot. Breast imaging is optimally initiated 5 to 10 minutes post injection with the patient in the prone position with breast freely pendant. A 10 minute lateral image of the breast suspected of containing cancer should be obtained with the camera face as close to the breast as practical. The patient should then be repositioned so that the contralateral breast is pendant and a lateral image of it should be obtained. An anterior supine image may then be obtained with the patient s arms behind her head. Parathyroid imaging Acquisition depends on the protocol chosen. The most used studies are either the dual-phase and/or the subtraction techniques, which can be performed together. Subtraction technique of the activity of the thyroid: In order to visualize the parathyroid, either pertechnetate( 99m Tc) or iodine ( 123 I) can be given first, followed by technetium ( 99m Tc) sestamibi, or technetium ( 99m Tc) sestamibi can be given first, followed by pertechnetate ( 99m Tc). When iodine ( 123 I) is used, 10 to 20 MBq of oral iodine ( 123 I) are administered. Four hours after the administration of 123 I, neck and thorax images are obtained. After iodine ( 123 I) image acquisition, 185 to 370 MBq of technetium ( 99m Tc) sestamibi are injected and images are acquired 10 minutes post injection in double acquisition with 2 peaks of gamma energy (140 kev for technetium ( 99m Tc) and 159 kev for iodine ( 123 I)). When pertechnetate ( 99m Tc) is used to visualize the parathyroid, MBq of sodium pertechnetate( 99m Tc) are injected and neck and thorax images are acquired 30 minutes later. Then MBq of technetium ( 99m Tc) sestamibi are injected and a second acquisition of images is acquired 10 minutes later. Dual-phase study: MBq of technetium ( 99m Tc) sestamibi are injected. Early (10 min. postinjection) and delayed ( h postinjection) highcount images are obtained. In case of kidney failure, exposure to ionising radiation can be increased. This must be taken into account when calculating the activity to be administered. In general, activity selection for patients with a decreased hepatic function should be cautious, usually starting at the low end of the dosing range. Storage 1 year not above 25 C. Keep the vial in the outer carton, in order to protect from light. Stability of labelled product 10 h not above 25 C. Activity per vial 200 MBq to 11 GBq Availability From stock Number of radiolabelled preparations per kit 5 32 IBA Molecular IMPORTANT: Read package leaflet before using the kit. Availability of the products in the different countries according to the registration status

33 TECEOS Kit for radiopharmaceutical preparation Each vial contains : 3,3-diphospho - 1,2 -propanedicarboxylic acid, tetrasodium salt (DPD) 13.0 mg tin (II) - oxide N - (4 - aminobenzoyl) - L - glutamic acid, monosodium salt Volume of pertechnetate 99m Tc to use for reconstitution 2 to 10 ml Radiochemical purity 95 % Storage 13 months, not above 25 C Stability of labelled product 8 h not above 25 C. Activity per vial 0.37 to 11.1 GBq Indications /Posology Bone scintigraphy 500 MBq ( MBq) Time between injection and examination Late phase static scintigraphy should be performed not earlier than 2 hours Availability From stock Number of radiolabelled preparations per kit 5 VASCULOCIS Kit for radiopharmaceutical preparation Each vial contains : Human Serum Albumin (HSA) 10 mg Stannous chloride dihydrate Sodium chloride Under nitrogen atmosphere Volume of pertechnetate 99m Tc to use for reconstitution 1 to 8 ml Radiochemical purity 95 % Storage 12 months at 2 to 8 C Activity per vial 92.5 to 2220 MBq Indications /Posology 1) Static blood pool imaging : 111 to 185 MBq 2) Angiography : 370 to 740 MBq 3) Circulation, blood flow studies : 18.5 to 185 MBq 4) Ventriculography : 185 to 925 MBq Stability of labelled product 8 h not above 25 C Time between injection and examination Shortly or immediately Availability From stock Number of radiolabelled preparations per kit 5 IMPORTANT: Read package leaflet before using the kit. Availability of the products in the different countries according to the registration status 33 IBA Molecular

34 INTERNATIONAL CATALOGUEALOGUE ZEVALIN Kit for radiopharmaceutical preparations for infusion Vial 1: Ibritumomab tiuxetan 3 ml glass septum vial containing 2 ml ibritumomab tiuxetan (1.6 mg/ml) in 0.9% NaCl solution Vial 2: Sodium acetate 3 ml glass septum vial containing 2 ml 50 mm sodium acetate which is used to adjust the 90 Y-chloride solution to ph 4 Vial 3: Formulation buffer Glass septum vial containing 10 ml PBS (ph 7.2) with 7.5% human serum albumin and 1 mm DTPA Vial 4: Reaction vial: 10 ml empty glass septum vial Storage Components stored in refrigerator (2 8 ºC). Do not freeze! Indications [ 90 Y]-radiolabelled Zevalin is indicated as consolidation therapy after remission induction inpreviously untreated patients with follicular lymphoma. The benefit of Zevalin following rituximab in combination with chemotherapy has not been established. [90Y]-radiolabelled Zevalin is indicated for the treatment of adult patients with rituximab relapsed or refractory CD20+ follicular B- cell non-hodgkin s lymphoma (NHL). Stability After radiolabelling, an immediate use is recommended. Chemical and physical in-use stability has been demonstrated for 8 hours at 2 C - 8 C and protected from light. Number of radiolabeled preparations per kit 1 34 IBA Molecular IMPORTANT: Read package leaflet before using the kit. Availability of the products in the different countries according to the registration status

35 SPECT Generators 35 IBA Molecular

36 INTERNATIONAL CATALOGUEALOGUE ELUMATIC III / TEKCIS are automatic and highly protected generators which produce a sterile and pyrogen free 99m Tc solution, in the form of sodium pertechnetate (T = 6.02 h). This solution is eluted from an alumina chromatographic column on which fission 99 Mo is fixed (T = 66 h). The ELUMATIC III / TEKCIS GENERATORS have an activity expressed in 99m Tc at the date indicated on the label. Elution solution : aqueous sterile and pyrogen free 0.9 % sodium chloride and 0.005% sodium nitrate solution. ELUMATIC III Technetium 99m Tc generator Availability and Calibration Ordering deadline Expiry Elution volume Radiochemical purity Radionuclidic purity ph Storage Precalibred quantities Indications on Monday calibrated Saturday 12 a.m. on Tuesday calibrated Saturday or Wednesday (following week) 12 a.m. on Wednesday calibrated Wednesday (following week) 12 a.m. on Thursday calibrated Wednesday 12 a.m. on Friday calibrated Wednesday or Saturday (following week) 12 a.m. 5 days before the shipment day, before 11 a.m. 20 days from the date of manufacturing. 5, 10 or 15 ml 95 % 99 Mo 0.1 %, 131 I %, 103 Ru %, 89 Sr %, 90 Sr %, emitting impurities %, other gamma-emitting impurities 0,01 % Generator : 20 days between +15 C and +25 C - Sodium ( 99m Tc) pertechnetate solution : store at 2-8 C and use within 10 hours after elution GBq 1.Reagent for labelling various kits to be used with 99m Tc 2.Administered intravenously the eluate might be used in: Thyroid scintigraphy Salivary gland scintigraphy Localization of ectopic gastric mucosa Cerebral scintigraphy 3.In conjunction with a reducing agent for labelling red blood cells for : Cardiac and vascular scintigraphy Diagnosis and localisation of occult gastrointestinal bleeding 4.Administered by instillation into the eye for: Lacrymal duct scintigraphy 36 IBA Molecular IMPORTANT: Read package leaflet before using the kit. Availability of the products in the different countries according to the registration status

37 TEKCIS 2-50 GBq radionuclide generator Availability and Calibration Ordering deadline Expiry Elution volume Radiochemical purity Storage Precalibrated activity Indications Every working days Calibration 5 and 8 days 5 days before the shipment day, before 11 a.m. CET 21 days after manufacturing date 5, 10 or 15 ml 95 % This medicinal product does not require any special storage conditions GBq Labelling of various kits for radiopharmaceutical preparation developed and approved for radiolabelling with such solution. Thyroid scintigraphy: Salivary gland scintigraphy Location of ectopic gastric mucosa (Meckel's diverticulum). Lacrimal duct scintigraphy. IMPORTANT: Read package leaflet before using the kit. Availability of the products in the different countries according to the registration status 37 IBA Molecular

38 INTERNATIONAL CATALOGUEALOGUE 38 IBA Molecular

39 SPECT Accessories 39 IBA Molecular

40 INTERNATIONAL CATALOGUEALOGUE ELUMATIC III / TEKCIS generators accessories CONT - ELU Lead container for the protection of vacuum vials for the elution of the ELUMATIC III / TEKCIS generators (with a flat lead glass window). TC - ELU Kit containing 10 vials of 5 ml vacuum, sterile and pyrogen free, for the elution of the ELUMATIC III / TEKCIS generators. TC - ELU CONT - ELU - SP Total vision lead glass and lead container for the protection of vacuum vials for the elution of the ELUMATIC III / TEKCIS generators. PROTEC - ELU Kit containing 10 vials of 10 ml vacuum, sterile and pyrogen free, for the elution of the ELUMATIC III / TEKCIS generators. TC - ELU Kit containing 10 vials of 15 ml vacuum, sterile and pyrogen free, for the elution of the ELUMATIC III / TEKCIS generators. Additional shielding for storage and elution of the ELUMATIC III / TEKCIS generators (160 kg). Depending on national regulations. ELUMATIC III ELU-TIPS Package of 10 units of sterilized needle caps are to protect the elution needle of ELUMATIC III (+ filter). TEKCIS PROT-STE-ELU Plastic container for the protection of sterile vial (STE-ELU). STE-ELU Kit containing 5 protective vials of sterile elution needle for 99m Tc. 40 IBA Molecular

41 Venticis II and accessories VENTICIS II - RADIOAEROSOL DELIVERY SYSTEM Venticis is an aerosol generator intended for - Study of pulmonary ventilation - Study of alveolar-capillary permeability using radiopharmaceutical products labelled with technetium 99m Tc. Medical device, class IIa, CE marked, in compliance with the Medical Devices Directive 93/42/EEC Nebulizer 2 - Air supply tubing 3 - External loader 4 - Reservoir bag 5 - Valves 6 - Mouthpiece 7 - Filter trap 8 - Lead shielded box 99m Tc aérosol inhalé Inhaled 99m Tc aerosol 99m Tc aérosol exhalé Exhaled 99m Tc aerosol Availability : from stock, by 5 units VENTIBOX - LEAD SHIELDED BOX FOR ONE VENTICIS II SYSTEM Size closed box l. : 220 mm w. : 154 mm h. : 360 mm w. : 16 kg 41 IBA Molecular

42 INTERNATIONAL CATALOGUEALOGUE CAPSION accessories Tong Lead transportation pot for 131 Iodine capsule Perforator Guide EDICIS accessory EDI-STRIPS Chromatographic paper Whatman 31 ET chr (10 per unit) for EDICIS QC 42 IBA Molecular

43 SCINTIMUN accessory HAMA-POCT Quick HAMA kit (5 tests per kit) STAMICIS accessories Tong Wet boiler QC strips (according to SPC) Lead protection for Stamicis vials 43 IBA Molecular

44 INTERNATIONAL CATALOGUEALOGUE 44 IBA Molecular

45 Radiochemical I-123-MPUP 45 IBA Molecular

46 INTERNATIONAL CATALOGUEALOGUE I-123-MPUP Iodine-123 T1/2 = 13.2 h SODIUM IODIDE ( 123 I) SOLUTION FOR LABELLING Availability Ordering deadline Radioactive concentration Calibration Precalibred quantities Expiry Specific activity Radiochemical purity Radionuclidic purity ph and composition Storage Indication Every working day except Thursday, Friday and the day before a day off One day before (before 11 a.m.) 3700 MBq/mL (100 mci/ml) Following day at 5 p.m MBq mci 2 days after the manufacturing date Carrier free 95 % 99.7 % 7 in sodium hydroxide 0.02 M Not above 25 C Labelling of radiopharmaceuticals API (Active Pharmaceutical Ingredients) 46 IBA Molecular

47 Packaging PET SPECT 47 IBA Molecular

48 INTERNATIONAL CATALOGUEALOGUE FDG-IBA PET Vial Lead pot Box 48 IBA Molecular

49 Radiopharmaceuticals SPECT 15 ml penicillin type vial Lead shields (according to nominal activities) Metallic box (easy open system) Packaging ELUMATIC III TEKCIS Drum Plastic packaging 49 IBA Molecular

50 INTERNATIONAL CATALOGUEALOGUE 50 IBA Molecular

51 Services 51 IBA Molecular

52 INTERNATIONAL CATALOGUEALOGUE Imagem Imagem is a web plateform on molecular imaging proposing a unique database on Molecular Imaging (scientific articles, news and events) updated daily by information specialists. Molecular imaging review Molecular Imaging Review consolidates the key information published in the Molecular Imaging world. It includes PET/SPECT scientific articles in the major clinical axis (books, abstracts, events, news/press). Frequency: Monthly 52 IBA Molecular

53 General Information Commercial information Scientific and technical information Units Definitions Nuclides index Radioactive decay table Locations and contacts IBA Molecular