PertectorMo-99/Tc-99m radionuclide generator

Mo-99

2.3 GBq 4.6 GBq 5.7 GBq6.9 GBq 8.5 GBq 9.1 GBq 11.4 GBq 12.5 GBq 13.7 GBq 14.9 GBq

Mo-99

17.1 GBq 18.2 GBq19.4 GBq 21.1 GBq 22.9 GBq 26.3 GBq 28.6 GBq 34.3 GBq 40.0 GBq 45.7 GBq

Mo-99

51.3 GBq 57.1 GBq 66.2 GBq 73.0 GBq 73.5 GBq 75.7 GBq 85.3 GBq 94.6 GBq

Tc-99m

2 GBq4 GBq5 GBq6 GBq

7.5 GBq8 GBq

10 GBq11 GBq12 GBq13 GBq

Tc-99m

45 GBq50 GBq57 GBq63 GBq64 GBq66 GBq74 GBq82 GBq

Tc-99m

15 GBq16 GBq17 GBq

18.5 GBq20 GBq23 GBq25 GBq30 GBq35 GBq40 GBq

Activities on the day of delivery:

Tetrofosmin ROTOP 0.23 mgName of the medicinal product: Tetrofosmin ROTOP 0.23 mg, Kit for radiopharmaceutical preparation Composition: The kit contains two different vials: Vial 1 and Vial 2. Vial 1 contains as active substance: 0.23 mg of tetrofosmin as tetrofosmin (bis)tetrafl uoroborate. Vial 2 contains 2.5 ml sodium hydrogen carbonate solution (0.2 M). Excipients: Vial 1: Stannous chloride dihydrate, Disodium sulphosalicylate trihydrate, Sodium gluconate, Mannitol; Vial 2: Sodium hydrogen carbonate, Water for injection Indications: This medicinal product is for diagnostic use only. It is indicated for adults. After radiolabelling with sodium pertechne-tate (99mTc) solution, the solution of technetium (99mTc) tetrofosmin obtained is indicated for: Myocardial Imaging: Technetium (99mTc) tetrofosmin is a myocardial perfusion agent indicated as an adjunct in the diagnosis and localization of myocardial ischaemia and/ or infarction. In patients undergoing myocardial perfusion scintigraphy, ECG-gated SPECT can be used for assessment of left ventricular function (left ventricular ejection fraction and wall motion). Breast Tumour Imaging: Technetium (99mTc) tetrofosmin is indicated as an adjunct to the initial assessments (e.g. palpation, mammography, or alternative imaging modalities and/or cytology) in the characterisation of malignancy of suspected breast lesions where all these other recommended tests were inconclusive. Contraindications: Hypersensitivity to the active substance, to any of the excipients or to any of the components of the labelled radiopharmaceutical. Pregnancy. Undesirable effects: Very rare (less than 1 in 10,000): Immune system disorders: Face oedema, hypersensitivity reaction, allergic reaction, anaphylactic reaction; Nervous system disorders: Headache, dizziness, taste metallic, disturbances of smell and taste; Vascular disorders: Flushing, hypotension; Respiratory, thoracic and mediastinal disorders: Dyspnoea; Gastrointestinal disorders: Vomiting, nausea, burning mouth; Skin and subcutaneous tissue disorder: Urticaria, itching, erythematous rash; General disorders and administration site condition: Feelingof warmth; Investigations: White blood cell count increased Marketing Authorization Holder: ROTOP Pharmaka GmbH, Bautzner Landstraße 400, 01328 Dresden, Germany Marketing Authorization Number: PL 41222/0004 (GB) Available on medical prescription only.

_high reliability in supply

_preselection of elution volume

_easy handling

_high radiation safety

ROTOP Pharmaka GmbHProduct overview

www.rotop-pharmaka.deNanoHSA-ROTOPName of the medicinal product: NanoHSA-ROTOP, 0,5 mg Composition: 1 vial contains as active substance: 0.5 mg human albumin, denatured excipients: stannous chloride (dihydrate), glucose, Poloxamer 238, Poloxamer 238, disodium phosphate dihydrate (E339), sodium phytate Indications: Lymphatic scanning to demonstrate the integrity of the lymphatic system and differentiation of venous from lymphatic obstruction, Sentinel node detection in malignant melanoma and breast cancer Contraindications: Hypersensitivity to the active substance or to any of the excipients. In particular, the use of 99mTc-human albumin colloidal particles is contraindicated in persons with a history of hypersensitivity to products containing human albumin. In patients with complete lymph obstruction lymph node scintigraphy is not advisable because of the danger of radiation necroses at the site of injection. Pregnancy. Undesirable effects: Very rare: slight and temporary hypersensitivity reactions, which can express symptoms as at the administration area/skin: local reactions, rash, itching, as immune system disease: vertigo, hypotension; other diseases: Exposure to ionisation radiation is linked with cancer induction and a potential for development of hereditary defects. Marketing Authorization Holder: ROTOP Pharmaka GmbH, Bautzner Landstraße 400, 01328 Dresden, Germany Marketing Authorization Number: 82367.00.00 (Germany) Available on medical prescription only.

TEKTROTYDName of the medicinal product: TEKTROTYD 16 micrograms kit for radiopharmaceutical preparation Composition: Tektrotyd is supplied as kit consisting of two vials which cannot be used separately. Vial I contains the active substance: 16 µg of HYNIC-[D-Phe1, Tyr3-octreotide] TFA salt. Vial II contains the active substance: 10 mg of EDDA (Ethylenediamine-N,N’-diacetic acid) excipients: Vial I: Tricine (N-[tris(hydroxymethyl)methyl]-glycine), Stannous chloride dihydrate, Mannitol, Nitrogen (as protective gas). Vial II: Disodium hydrogen phosphatedodecahydrate, Sodium hydroxide, Nitrogen (as protective gas) Indications: This medicinal product is for diagnostic use only. 99mTc-EDDA/HYNIC-TOC specifi cally binds to somatostatin receptors. After radiolabelling with sodium pertechnetate (99mTc) solution, the solution of 99mTc-EDDA/HYNIC-TOC obtained is indicated in adult patients with gastro-entero-pancreatic neuroendocrine tumours (GEP-NET) for localizing primary tumours and their metastases. Contraindications: Hypersensitivity to HYNIC-[D-Phe1, Tyr3-octreotide]TFA salt, to EDDA (Ethylenediamine-N,N’-diacetic acid) or to any of the excipients or sodium pertechnetate (99mTc) solution for injection. Undesirable effects: Very rarely (<1/10,000) transient headache or epigastric pain may occur directly after administration of 99mTc-EDDA/HYNIC-TOC. Exposure to ionisation radiation is linked with cancer induction and a potential for development of hereditary defects. As the effective dose is about 3.7 mSv when the maximal recommended activity of 740 MBq is administered these adverse events are expected to occur with a low probability. Marketing Authorisation Holder: ROTOP Pharmaka GmbH, Bautzner Landstraße 400, 01328 Dresden, Germany Marketing Authorisation Number: 88709.00.00 (Germany) Available on medical prescription only.

CardioTOPName of the medicinal product: CardioTOP 1 mg, kit for radiopharmaceutical preparation Composition: 1 vial contains as active substance: [tetrakis (1-isocyanide-2-methoxy-2-methylpropyl) copper(I)] tetrafl uoroborate excipients: Stannous chloride dihydrate, L-cysteine hydrochloride monohydrate, Sodium citrate dihydrate, D-mannitol Indications: After radiolabelling with sodium pertechnetate (99mTc) solution, the solution of technetium (99mTc) Sestamibi obtained is indicated for Myocardial perfusion scintigraphy for the detection and localisation of coronary artery disease (angina pectoris and myocardial infarction); Assessment of global ventricular function. First-pass technique for determination of ejection fraction and/or ECG-triggered, gated SPECT for evaluation of left ventricular ejection fraction, volumes and regional wall motion; Scintimammography for the detection of suspected breast cancer when mammography is equivocal, inadequate or indeterminate.; Localisation of hyperfunctioning parathyroid tissue in patients with recurrent or persistent disease in both primary and secondary hyperparathyroidism, and in patients with primary hyperparathyroidism scheduled to undergo initial surgery of the parathyroid glands. Contraindications: Hypersensitivity to the active substance or to any of the excipients. In myocardial scintigraphy investigations under stress conditions, the general contraindications associated with the induction of ergometric or pharmacological stress should be considered. Undesirable effects: Cardiac disorders: Uncommon: Chest pain/angina pectoris, abnormal ECG. Rare: Arrhythmia. Nervous system disorders: Uncommon: Headache. Rare: Seizures (shortly after administration), syncope. Gastrointestinal disorders: Uncommon: Nausea; Rare: Abdominal pain. Skin and subcutaneous tissue disorders: Rare: local reactions at the injection site, hypoaesthesia and paraesthesia, fl ushing. Not known (cannot be estimated from the available data): Erythema multiforme. General disorders and administration site conditions: Common: Immediately after injection, a metallic or bitter taste may be noticed, partly in combination with dry mouth and an alteration in the sense of smell. Rare: Fever, fatigue, dizziness, transient arthritic-like pain, dyspepsia. Immune system disorders: Rare: Severe hypersensitivity reactions such as dyspnoea, hypotension, bradycardia, asthenia and vomiting (usually within two hours of administration), angioedema. Other hypersensitivity reactions (allergic skin and mucosa reactions with exanthema (pruritus, urticaria, oedema), vasodilatation). Very rare: Other hypersensitivity reactions have been described in predisposed patients. Other disorders: Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. As the effective dose is 16.4 mSv when the maximal recommended activity of 2000 MBq (500 at rest and 1500 MBq at stress) for a 1-day protocol is administered these adverse reactions are expected to occur with a low probability. Marketing Authorization Holder: National Centre for Nuclear Research, Andrzej Soltan 7, 05-400 Otwock, Poland Marketing Authorization Number: 69086.00.00 (Germany) Prescription only medicine.

ROTOP - MDPName of the medicinal product: ROTOP-MDP Composition: 1 vial contains 8.99 mg of powder with the active substance: 5.0 mg medronic acid; excipients: stannous chloride dihydrate, ascorbic acid, hydrochloric acid 36%, sodium hydroxide, nitrogen. Indications: bone scintigraphy for the detection of areas of altered osteogenesis associated with bone metastasis and primary bone tumor, infl ammatory skeleton- and degenerative joint disease, traumatic bone changes, which are not able to be diagnosed by X-rays, osteonecrosis and degenerative skeletonchanges, reklaxation of endoprosthesis and for vitality test of bone transplantation, systemic diseases concerning bone metabolism. Contraindications: None known. Undesirable effects: very rarely (< 0.01 %) hypersensitivity reactions such as skin irritation, itching, drop in blood pressure, headache, nausea, vomiting, cutaneous vasodilatation, oedema in the extremities, joint pain; low probability of cancer and hereditary defects. Marketing Authorization Holder: ROTOP Pharmaka GmbH, Bautzner Landstraße 400, 01328 Dresden, Germany Marketing Authorization Number: 3004418.00.00 (Germany) Pharmacy only medicine.

ROTOP - HSA Microspheres B20Name of the medicinal product: ROTOP-HSA Mikrosphären B20 Composition: 1 vial contains as active substance: 2.5 mg human albumin, denaturated (300.000 - 500.000 microspheres, Ø: 10 - 30 µm); excipients: stannous chloride dihydrate, polysorbate 80, rose bengal disodium, nitrogen as protective gas. Indications: lung perfusion scintigraphy for diagnosis and exclusion of pulmonary embolism, follow-up after pulmonary embolism. Contraindications: None known. Undesirable effects: very rarely (< 0.01 %) hypersensitivity reactions (urticaria, ague, fever, nausea, facial rash, sweating), impairment of cardiovascular function (change of the respiration, the pulse, blood pressure and collapse), local allergic reactions at the injection site; severe anaphylactic reactions, low probability of cancer and hereditary defects. Marketing Authorization Holder: ROTOP Pharmaka GmbH, Bautzner Landstraße 400, 01328 Dresden, Germany Marketing Authorization Number: 3003667.00.00 (Germany) Available on medical prescription only.

ROTOP-NeurospectName of the medicinal product: ROTOP-Neurospect Composition: 1 vial contains 4.56 mg of powder with the active substance: Exametazime, 0.5 mg (d,l-hexametylpropyleneamine oxime); excipients: stannous chloride dihydrate, sodium chloride, nitrogen. Indications: The radiopharmaceutical is used in brain scans for the examination of the cerebral blood fl ow. Considering the risks compared to interventional procedures, the use of the drug in children and young people must be examined in each individual case. It is, in particular, indicated for preoperative clarifi cation in epilepsy when other non-invasive procedures without ionizing radiation are exhausted. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Undesirable effects: very rarely (< 0.01%) mild hypersensitivity reactions in form of urticarial erythema, in rare cases (< 1%) generalized exantheme, face edema and fever; low probability of cancer and hereditary defects. Marketing Authorization Holder: ROTOP Pharmaka GmbH, Bautzner Landstraße 400, 01328 Dresden, Germany Marketing Authorization Number: 3003669.00.00 Available on medical prescription only.

MAG-3 KitName of the medicinal product: MAG-3 Kit, 0,2 mg, kit for radiopharmaceutical preparation Composition: The kit contains two different vials: vial(1) and vial(2). Vial(1) contains as active substance: 0.20 mg of the mertia-tide (mercaptoacetyltriglycine). Vial(2) contains 2.5 ml phosphate buffer solution. Excipients vial (1): Stannous chloride dihydrate, Disodium (R,R)-tartrate dihydrate, Sodium hydroxide, Hydrochloric acid Excipients vial (2): Sodium monohydrogenphosphate dihydrate, Sodium dihydrogenphosphate dihydrate, Hydrochloric acid, Water for injections Indications: After radiolabelling with sodium pertechnetate(99mTc) solution, the solution of technetium-(99mTc) mertiatide, is used for the evaluation of nephrological and urological disorders in particular for the study of function, morphology and perfusion of the kidneys and characterisation of urinary outfl ow. Contraindications: Hypersensitivity to the active substance, to any of the excipients or to any of the components of the labelled radiopharmaceutical. Undesirable effects: Very rare mild anaphylactoid reactions have been reported (< 0.01 %), characterised by uriticarial rash, swelling of eyelids and coughing. Occasionally vasovagal reactions of a mild nature have been reported. A cerebral convulsion in a sedated fi fteen days old child has been reported, but causative relation with the administration of the radiopharmaceutical was not proven. Exposure to ionisation radiation is linked with cancer induction and a potential for development of hereditary defects. For diagnostic nuclear medicine investigations current evidence suggests that these adverse effects might only occur with low frequency because of the low radiation doses incurred. Marketing Authorization Holder: ROTOP Pharmaka GmbH, Bautzner Landstraße 400, 01328 Dresden, Germany Marketing Authorization Number: 55268.00.00 (Germany). Available on medical prescription only.

ROTOP-DTPAName of the medicinal product: ROTOP-DTPA Composition: 1 vial contains as active substance: pentetic acid and sodium salt manufactured from pentetic acid 5.0 mg and sodium hydroxide 1.32 mg; excipients: stannous chloride dihydrate, ascorbic acid, sodium chloride, nitrogen as protective gas. Indications: quantitative determination of the glomerular fi ltration rate; Contraindications: None known. Undesirable effects: very rarely (< 0.01 %) hypersensitivity reactions such as sensation of heat, dizziness, dyspnoea, pruritis, urticaria, rise or fall of blood pressure; low probability of cancer and hereditary defects. Marketing Authorization Holder: ROTOP Pharmaka GmbH, Bautzner Landstraße 400, 01328 Dresden, Germany Marketing Authorization Number: 3003664.00.00 (Germany) Pharmacy only medicine.

ROTOP-DMSAName of the medicinal product: ROTOP-DMSA Composition: 1 vial contains as active substance: 1.0 mg succimer; excipients: stannous chloride dihydrate, ascorbic acid, sodium hydroxide, hydrochloric acid 36 %, nitrogen. Indications: renal scintigraphy, in case that other diagnostic methods (e.g. ultrasonography) are not suffi cient enough for a diagnosis; detection of change of focal renal parenchyma (e.g. on renal infarction), detection of normvariation such as atypic double-kidney, small kidney, dysplastic kidney, horseshoe kidney as well as for detection of ectopical kidneys, confi rmation of a missing kidneyfunction on multicystic kidneys; Contraindications: Hypersensitivity to the active substance or to any of the excipients. Undesirable effects: very rarely (< 0.01 %) hypersensitivity reactions such as localized or generalized rash, itching, hypotension, headache, dizziness, nausea and vomiting; low probability of cancer and hereditary defects. Marketing Authorization Holder: ROTOP Pharmaka GmbH, Bautzner Landstraße 400, 01328 Dresden, Germany Marketing Authorization Number: 3003663.00.00 (Germany) Pharmacy only medicine.

ROTOP-EHIDAName of the medicinal product: ROTOP-EHIDA Composition: 1 vial contains as active substance: 20.0 mg etifenin; excipients: stannous chloride dihydrate, ascorbic acid, sodium hydroxide, hydrochloric acid 36 %, nitrogen. Indications: hepatobiliary function scintigraphy by suspicion of acute cholecystitis, chronic gall duct changes, occlusion of ductus choledochus, congenital aberrances of gall duct system e.g. atresia, evidence of bile leak, for differential diagnosis of intrahepatic space occupying (suspicion of focal nodular hyperplasia versus suspicion of liver cell cancer); Contraindications: None known. Undesirable effects: None known. For related substances as disofenin and mebrofenin isolated cases of hypersensitivity reactions such as fl u-like symptoms, nausea and pruritus have been reported; low probability of cancer and hereditary defects. Marketing Authorization Holder: ROTOP Pharmaka GmbH, Bautzner Landstraße 400, 01328 Dresden, Germany Marketing Authorization Number: 3003665.00.00 (Germany) Pharmacy only medicine.

ROTOP-AdenosinName of the medicinal product: ROTOP-Adenosin, 5 mg/ml, solution for injection / infusion. Composition: 1 ml ROTOP-Adenosin contains as active substance: 5 mg adenosine excipients: 50 mg mannitol (Ph. Eur.) and water for injection (Ph. Eur.) Indications: Termination of paroxysmal supraventricular tachycardia (PSVT) involving the AV-node; induction of brief AV-block for detection and location of accessory pathways with preex-citation; pharmacological provocation of myocardial ischemia in conjunction with myocardial radio-isotope scanning in patients (Thallium or Technetium), which are not suffi ciently physically stressable or where a stress test is not indicated. It can also be used in conjunction with echocardiography in cases where other pharmacological stress agents are not applicable. Contraindications: Hypersensitivity to adenosine or mannitol. Pre-vious adverse reactions to adenosine. AV-block II and III and sick sinus syndrome in patients who do not have a functioning pacemaker. Severe hypotension. Unstable angina pectoris. Decompensated heart failure. Only for infusions: Raised intracranial pressure. Hypovolaemia. Concomitant treatment with dipyridamole. Undesirable effects: Intravenous injection: Any side-effects are mild and disappear rapidly (usually within 30 seconds). Common side effects (>1/100, <1/10): headache, vertigo, chest pain, fl ush, refl ex tachycardia, nausea, dyspnoea, chest pressure, paraesthesiae; uncommon side effects (>1/1,000, <1/100): perspiration, palpitations, hy-potension, metallic taste, pressure in the groin, hyperventilation, agitation, blurred vision; rare side effects (>1/10,000, <1/1,000): marked hypotension and arrhythmias including ventricular fi brillation, ventricular extra sys-tolic beats and atrial fi brillation, aggravation of bronchial asthma. Intravenous infusion: Intravenous infusion causes a higher frequency of side-effects. However, most are mild and disappear rapidly (within a few minutes). common side effects (>1/100, <1/10): Pain in the head, chest and jaw, vertigo, fl ush, AV Block I-II, ST-depression, nausea, epigastric pain, dyspnoea; uncommon side effects (>1/1,000, <1/100): Palpitation, hypotension, AV Block III, hyperventilation; rare side effects (>1/10,000, <1/1,000): marked hypotension and ventricular arrhythmias including ventricular fi brillation, ventricular extra systolic beats and atrial fi brillation, bronchospasm. Marketing Authorization Holder: ROTOP Pharmaka GmbH, Bautzner Landstraße 400, 01328 Dresden, Germany Marketing Authorization Number: 81856.00.00 (Germany) Available on medical prescription only.

Please consider the complete information in the Package Leafl et and the Summary of Product Characteristics which you can fi nd online at www.rotop-pharmaka.de.

ROTOP Pharmaka GmbH | Bautzner Landstraße 400 | 01328 Dresden | GermanyPhone +49 (0) 351 – 26 310 210 | Fax +49 (0) 351 – 26 310 313service@rotop-pharmaka.de | www.rotop-pharmaka.de

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Registered in the following countries:AT, BG, BY, CH, CO, CZ, DE, DK, ES, GE, GR, LV, MT, PL, PT, RO, RU, SE, SL, TW, UA, UK

To speak with a member of our Customer Services team please call +49 351 26 310 212.

Pertector Name of the medicinal product: Pertector 2.3 - 57.1 GBq radionuclide generator Composition: Pertector radionuclide generator contains as active substance: sodium molybdate (99Mo) / sodium pertechnetate (99mTc) excipients: Sodium chloride, Water for injection, Benzododecinium bromide (bacteriostatic solution), Nitric acid (pH adjustment), Sodium hydroxide (pH adjustment) Indications: This medicinal product is for diagnostic use only. The eluate from the radionuclide generator (sodium pertechnetate (99mTc) injection) is indicated for: labelling of various kits for radiopharmaceutical preparation developed and approved for radiolabelling with such solution; Thyroid scintigraphy: direct imaging and measurement of thyroid uptake to give information on the size, position, nodularity and function of the gland in case of thyroid disease; Salivary gland scintigraphy: diagnosis of chronic sialadenitis (e.g. Sjögren's Syndrom) as well as assessment of salivary gland function and duct patency in salivary glands disorders and monitoring of the response to therapeutic interventions (in particular radio iodine therapy); Location of ectopic gastric mucosa (Meckel's diverticulum); Lacrimal duct scintigraphy: to assess functional disorders of lacrimation and monitoring of the response to therapeutic interventions; Shunt scintigraphy: after injection of the sterile sodium(99mTc)pertechnetate solution into a Rickham reservoir to test the patency of ventricular shunts in hydrocephalus. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Information on the contraindications to the use of a kit for a radiopharmaceutical for radiolabelling can be found in the summary of product characteristics and the package leafl et for the kit. Undesirable effects: Immune system disorders: Frequency unknown: Anaphylactoid reactions (e.g. dyspnoea, coma, urticaria, erythema, rash, pru-ritus, oedema at various location e.g. face oedema); Nervous system disorders: Frequency unknown: Vasovagal reactions (e.g. syncope, tachycardia, bradycardia, dizziness, headache, vision blurred, fl ushing); Gastrointestinal disorders: Frequency unknown: Vomiting, nausea, diarrhea; General disorders and administration site conditions: Frequency unknown: Injection site reactions due to extravasation (e.g. cellulitis, pain, erythema, swelling). Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. As the effective dose is 5.2 mSv when the maximal recommended activity of 400 MBq is administered these adverse reactions are expected to occur with a low probability. Marketing Authorisation Holder: ROTOP Pharmaka GmbH, Bautzner Landstraße 400, 01328 Dresden, Germany Marketing Authorisation Number: 80873.00.00 (Germany) Available on medical prescription only.

Our service contains

// lead shielding for one or two generators

// 16 injection vials containing elution solution (0.9 % NaCl-solution, 10 ml)

// 16 evacuated 10 ml vials as receptables for eluate

// lead shielding for the elution

// weekend deliveries (on demand)

// return of the old generator

Produktübersicht_2018_engl.indd 1 24.09.18 09:09

Tetrofosmin ROTOP NanoHSA / Nanotop TEKTROTYD CardioTOP /Cardiovis/ Mibispect/ Cardiomibi

ROTOP-MDP ROTOP-HSA Microspheres B20

ROTOP-Neurospect/Neuroscan

MAG-3 Kit/ NephroMAG/ Mertioscan/ IELMAG3

ROTOP-DTPA ROTOP-DMSA ROTOP-EHIDA

Indication Myocardial perfusion scintigraphy, Breast Imaging

Sentinel Node detection in malignant melanoma and breast

cancer, lymphatic scanning

Localization of primary tumours and their metastases (GEP-NET)

Myocardial perfusion scintigraphy,Scintimammography, Localisation

of hyperfunctioning parathyroid tissue, Assessment of global

ventricular function

Bone scintigraphy Lung perfusion scintigraphy Brain perfusion scintigraphy Evaluation of function, morphologyand perfusion of the kidneys;

Characterisation of urinary outflow

Quantitative determination ofglomerular filtration rate

Static renal scintigraphy Hepatobiliary functionscintigraphy

Active pharmaceutical ingredient

Vial 1 contains:tetrofosmin as tetrofosmin

(bis)tetrafluoroborate0,23 mg

Vial 2 contains:no API, see excipients

human albumin, colloidal particles0.5 mg

more than 95 % smallerthan 80 nm

Vial 1 contains: HYNIC-[D-Phe1, Tyr3-octreotide] TFA salt

16 µg

Vial 2 contains:EDDA (Ethylenediamine-N,N’-

diacetic acid)10 mg

[tetrakis (1-isocyanide-2-methoxy-2-methylpropyl) copper(I)]

tetrafluoroborate1 mg

medronic acid (MDP)5.0 mg

human albumin, denaturated2.5 mg

300,000 - 500,000 microspheres,diameter 10 - 30 μm

exametazime (d,l HMPAO) 0.5 mg

Vial 1 contains:mertiatide

0.20 mg

Vial 2 contains:no API, see excipients

pentetic acid, sodium salts

manufactured fromPentetic acid: 5.0 mg

Sodium hydroxide: 1.32 mg

succimer (DMSA)1.0 mg

etifenin (EHIDA)20.0 mg

Excipients Vial 1:Stannous chloride dihydrate

Disodium sulphosalicylate trihydrate Sodium gluconate

Mannitol

Vial 2:Sodium hydrogen carbonate,

Water for injection

Stannous chloride dihydrate

Glucose

Poloxamer 238

Disodium phosphate dihydrate, E339

Sodium phytate

Vial 1:Tricine (N-[tris(hydroxymethyl)-

methyl]glycine)Stannous chloride dihydrate

MannitolNitrogen (as protective gas)

Vial 2:Disodium hydrogen

phosphatedodecahydrateSodium hydroxide

Nitrogen (as protective gas)

Stannous chloride dihydrate

L-cysteine hydrochloride monohydrate

Sodium citrate dihydrate

D-mannitol

Stannous chloride dihydrate

Ascorbic acid

Hydrochloric acid 36%

Sodium hydroxide

Nitrogen (protective gas)

Stannous chloride dihydrate

Polysorbate 80

Rose bengal disodium

Nitrogen (protective gas)

Stannous chloride dihydrate

Sodium chloride

Nitrogen (protective gas)

Vial 1:Stannous chloride dihydrate

Disodium (R,R)-tartrate dihydrateSodium hydroxideHydrochloric acid

Vial 2:Sodium monohydrogenphosphate

dihydrateSodium dihydrogenphosphate dihydrate

Hydrochloric acidWater for injections

Other active ingredients:Stannous chloride dihydrate

Ascorbic acid

Other ingredients:Sodium chloride

Nitrogen (protective gas)

Stannous chloride dihydrate

Ascorbic acid

Sodium hydroxide

Hydrochloric acid 36 %

Nitrogen (protective gas)

Stannous chloride dihydrate

Ascorbic acid

Sodium hydroxide

Hydrochloric acid 36 %

Nitrogen (protective gas)

Adult dose

(for paediatric dose see recommendation of the Paediatric Task Group, EANM, 1990)

Myocardial Imaging:One-day protocol:

First dose: 250 – 400 MBqSecond dose: 600 – 800 MBq(total activity max. 1,200 MBq)

Two-day protocol:400 – 600 MBq

Breast Imaging:500 – 750 MBq

Subcutaneous administration:Lymphoscintigraphy:

18.5 - 110 MBq

Sentinel node detection:10 - 110 MBq

(Malignant Melanoma)

5 - 200 MBq(Breast Cancer)

370 - 740 MBq Diagnosis of reduced coronaryperfusion and myocardial infarction:

400 - 900 MBq

Assessment of globalventricular function:

600 - 800 MBqinjected as a bolus

Scintimammography:700 - 1000 MBq

injected as a bolus usually in the arm opposite to the lesion

Localisation of hyperfunctioning parathyroid tissue:

200 - 700 MBqinjected as a bolus

500 MBq(Benign disease)

700 MBq(Malign disease)

planar: 40 - 150 MBq

SPECT: 40 - 200 MBq

Recommended number of particles:

100,000 - 200,000

400 - 500 MBqor

5.7 - 7.1 MBq/kg

40 - 200 MBq 1.8 - 3.7 MBq 70 MBq 150 MBq(normal liver function)

up to 420 MBq(serum bilirubin value

> 25 µmol/l)

Labelling activity up to 12,1 GBq 5.55 GBq 1.6 GBq 11 GBq 11.1 GBq 1.85 GBq 1.11 GBq 4 GBq 11.1 GBq 3 GBq 8 GBq

Labelling volume 3.5 – 5.5 ml 1 - 5 ml 1 ml 1 - 5 ml 1 - 5 ml max. 5 ml 5 ml 8 ml 1 - 5 ml 5 ml max. 3 ml

Incubation 15 min 10 min boiling: 10 min at 100 °CCool down to room temperature:

30 minutes

boiling: 10 – 12 minthermal cycler:

automated heating/ cooling cycle

10 min 15 min 5 min 15 min (no heating) 10 min 10 min 30 min

Final dilution up to 10 ml 1:50 5 ml 10 ml 10 ml 10 ml 8 ml _ 10 ml 10 ml 6 ml

Shelf life after labelling

12 hrs< 25°C

6 hrs< 25 °C

4 hrs< 25 °C

12 hrs< 25 °C

6 hrsat 15 - 25 °C

6 hrsat 15 - 25 °C

0.5 hrsat 15 - 25 °C

8 hrs< 25 °C

6 hrsat 15 - 25 °C

4 hrsat 15 - 25 °C

3 hrsat 15 - 25 °C

Storage conditions 2 °C - 8 °C below 25 °C 2 - 8 °C 2 - 8 °C 2 - 8 °C 2 - 8 °C 2 - 8 °C 2 - 8 °C 2 - 8 °C 2 - 8 °C 2 - 8 °C

Vials/ kit 2 x 2 vials / 5 x 2 vialsfor combined use

5 2 vialsfor combined use

3 or 6 5 5 3 or 5 5 x 2 vialsfor combined use

5 5 5

Shelf life after production

12 months 24 months 12 months 12 months 24 months 9 months 24 months (DE)12 months (CZ)

15 months 15 months 15 months 12 months

Registered in AT, BE, DE, FI, NL, PT, SE, UK

pending:ES, GR, IT

AT, DE, DK, ES, FI,FR, IT, NO, PT, SE, UK

AT, BG, CO, CR, CY, CZ, DE, DK, EE, ES, FI, FR, GR, HU, IT, MT,

NO, PL, PT, RO, SE, SK, UK

AT, BY, CO, CY, DE, ES, FI, FR, GE, GR, IN, IT, NO, PL, SE, TR, UK

DE DE DE, CZ AT, BE, BG, CH, CO, CR, DE, DK, ES, FI, FR, GR, KR, HK, HU, IE, IT,

LU, NL, NO, PT, SE, TR, UK

DE DE CO, DE

www.rotop-pharmaka.de

PRODUCT OVERVIEWPlease consider the complete information in the Summary of Product Characteristics and the Package Leaflet!

Adenosine

Indication Termination of PSVT, pharmacological provocation of myocardial ischemia, Induction

of brief AV-block

Active pharmaceuticalingredient

adenosine5 mg/ ml

Excipients Mannitol (Ph. Eur.)50 mg

Water for injection (Ph. Eur.)

Adult dose Pharmacological provocation of myocardial ischemia:

140 µg/kg/min (4 - 6 min)

PSVT:5 mg as a bolus (1 - 2 sec)

Induction of a brief AV- block:5 - 15 mg

Storage at room temperature

Package sizes 1x 15 ml (N1)1 x 50 ml (N1)

10 x 10 ml (N2)10 x 15 ml (N2)10 x 50 ml (N2)

Shelf life after production

3 years

Registered in DE

Produktübersicht_2018_engl.indd 2 24.09.18 09:09