product overview - ROTOP Pharmaka AG

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ROTOP Pharmaka AG
Technetium-99m kits

ROTOP – Technetium-99m kits
Please consider the Summaries of Product Characteristics!
www.rotop-pharmaka.de
Nanotop
ROTOP-HSA
Mikrosphären B20
ROTOP-MDP
ROTOP-Neurospect
Neuroscan
MAG-3 Kit
NephroMAG
Mertioscan
ROTOP-DTPA ROTOP-DMSA ROTOP-EHIDA
Indication
scintigraphic imaging and
assessment of sentinel lymph
nodes in tumor diseases
lung perfusion scintigraphy bone scintigraphy brain perfusion scintigraphy functional and static renal
scintigraphy
quantitative determination of
glomerular filtration rate
static renal scintigraphy
hepatobiliary function
scintigraphy
Active pharmaceutical
ingredient
human albumin, denaturated
0.5 mg
more than 95 % smaller
than 80 nm
human albumin, denaturated
2.5 mg
(300,000 – 500,000
microspheres,
diameter 10 - 30 μm)
medronic acid (MDP)
5.0 mg
exametazime (d,l HMPAO)
0.5 mg
mertiatide
0.20 mg
vial (2) contains:
phosphate buffer solution
2.5 ml
pentetic acid, sodium salt
manufactured from
Pentetic acid: 5 mg
Sodium hydroxide: 1.32 mg
succimer (DMSA)
1.0 mg
etifenin (EHIDA)
20.0 mg
Exipients
stannous chloride dihydrate
0.2 mg
stannous chloride dihydrate
0.1 mg
stannous chloride dihydrate
0.48 mg
stannous chloride dihydrate
0.0076 mg
stannous chloride dihydrate
0.06 mg
stannous chloride dihydrate
0.25 mg
stannous chloride dihydrate
0.42 mg
stannous chloride dihydrate
0.2 mg
glucose
15 mg
poloxamer 238
2 mg
sodium phosphate
0.55 mg
sodium phytate
0.25 mg
polysorbate 80
0.648 mg
rose bengal disodium
0.003 mg
nitrogen (protective gas)
ascorbic acid
0.5 mg
hydrochloric acid 36%
0.04 mg
sodium hydroxide
2.97 mg
nitrogen (protective gas)
sodium chloride
4.05 mg
nitrogen (protective gas)
sodium (R,R)-tartrate dihydrate
22.0 mg
sodium hydroxide
1.72 mg
hydrochloric acid 36 %
0.11 mg
nitrogen (protective gas)
ascorbic acid
0.15 mg
sodium chloride
0.06 mg
nitrogen (protective gas)
ascorbic acid
0.1 mg
sodium hydroxide
0.2 mg
hydrochloric acid 36 %
0.02 mg
nitrogen (protective gas)
ascorbic acid
0.1 mg
sodium hydroxide
4.94 mg
hydrochloric acid 36 %
3.6 μl
nitrogen (protective gas)
Adult dose
(for children dose see
recommendation of the
Paediatric Task Group,
EANM, 1990)
Intravenous use:
Bone marrow scanning:
185 - 500 MBq
Inflammation imaging:
370 - 500 MBq
Subcutaneous
administration:
Lymphoscintigraphy:
18.5 -110 MBq
40 - 200 MBq 500 MBq
(Benign disease)
700 MBq
(Malign disease)
400 - 500 MBq 10 - 200 MBq 1.8 - 3.7 MBq 70 MBq 150 MBq
(normal liver function)
up to 420 MBq
(serum bilirubin value
> 25 μmol/l)
Scintigraphy of sentinel
lymph nodes in tumors:
40 – 300 MBq
Labelling activity up to 5.55 GBq 1.85 GBq 11.1 GBq 1 GBq 2.5 GBq 11.1 GBq 3 GBq 8 GBq
Labelling volume 1-5 ml 5 ml (max.) 1 - 5 ml 5 ml 2 ml 1 - 5 ml 5 ml 3 ml (max.)
Incubation time 10 min 15 min 10 min 5 min 15 min (no heating) 10 min 10 min 30 min
Final dilution up to
up to
1:50 with saline solution
(0.9%)
10 ml 10 ml 8 ml 10 ml 10 ml 10 ml 6 ml
Shelf life after labelling 6 hrs 6 hrs 6 hrs 0.5 hrs 6 hrs 6 hrs 4 hrs 3 hrs
Storage conditions 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 5 5 5 5 5 5 5 5

NANOTOP
Name of the medicinal product: NANOTOP Composition: 1 vial contains as active substance: 0.5 mg human albumin, denatured excipients: stannous chloride, dihydrate 0.2 mg,
glucose (anhydrous), Poloxamer 238, sodium phosphate (dibasic, anhydrous), sodium phytate (anhydrous) Indications: scintigraphic imaging and assessment of sentinel lymph nodes
in tumor diseases (Sentinel Node Mapping), of the integrity of the lymphatic system and differentiation of venous from lymphatic obstruction, of the bone marrow (the product is not
suitable to study the haematopoietic activity of the bone marrow) and for inflammation scanning (for examination of inflammation areas in the abdomen the product cannot be used).
Contraindications: In case you are hypersensitive (allergic) to human albumin derivatives or to any of the excipients of NANOTOP. In patients with complete lymph obstruction lymph node
scintigraphy is not advisable because of the danger of radiation necroses at the site of injection. Side effects: Very rare: slight and temporary hypersensitivity reactions, which can express
symptoms as at the administration area/skin: local reactions, rush, itching, immune system disease: vertigo, blood pressure decrease, other diseases: Exposure to ionisation radiation is
linked with cancer induction and a potential for development of hereditary defects. Marketing Authorization Holder: ROTOP Pharmaka AG, Bautzner Landstraße 400, 01328 Dresden
Marketing Authorization Number (Germany): 82367.00.00 Available on medical prescription only.
ROTOP - Neurospect / Neuroscan
Name of the medicinal product: ROTOP-NEUROSPECT Composition: 1 vial contains as active substance: 0.5 mg exametazime; exipients: stannous chloride dihydrate, sodium chloride,
nitrogen. Indications: brain scan for the investigation of the cerebral blood flow. Contraindications: None known. Side 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 AG, Bautzner Landstraße 45, 01454 Radeberg, GERMANY Marketing Authorization Number (Germany): 3003669.00.00 Available on medical prescription only.
ROTOP-MDP
Name of the medicinal product: ROTOP-MDP Composition: 1 vial contains as 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, inflammatory 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. Side 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 AG, Bautzner Landstraße 45, 01454 Radeberg, GERMANY Marketing Authorization
Number (Germany): 3004418.00.00 Pharmacy only medicine.
ROTOP-HSA Mikrosphären B20
Name 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); exipients: 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. Side 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 AG, Bautzner Landstraße 45, 01454
Radeberg, GERMANY Marketing Authorization Number (Germany): 303667.00.00 Available on medical prescription only.
MAG-3 Kit / NephroMAG / Mertioscan
Name of the medicinal product (Germany): MAG-3 Kit Composition: The kit contains two different vials: (1) and (2). Vial (1) contains as active substance: 0.20 mg of mercaptoacetyltriglycine
(mertiatide). Vial (2) contains 2.5 ml phosphate buffer solution. Exipients vial (1): stannous chloride dihydrate, sodium (R,R)-tartrate dihydrate, sodium hydroxide, hydrochloric acid 36 %,
nitrogen. Exipients vial (2): sodium monohydrogenphosphate dihydrate (Ph. Eur.), sodium dihydrogenphosphate dihydrate, hydrochloric acid 36 %, water for injection. Indications: evaluation of
nephrological and urological disorders in particular for the study of function, morphology and perfusion of the kidneys and characterisation of urinary outflow. Contraindications: Hypersensitivity
to the active substance or to any of the excipients. Side effects: Very rarely (< 0.01 %) mild anaphylactoid reactions (uriticarial rash, nausea partly with vomiting, itching, vasovagal reactions, sudden
feeling of faintness, swelling of eyelids, coughing and headache), local reactions at the injection site, low probability of cancer and hereditary defects.
Marketing Authorization Number (Germany): 55268.00.00 (country specific MA numbers). Available on medical prescription only.
ROTOP-DTPA
Name 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 filtration rate;
Contraindications: None known. Side 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 AG, Bautzner Landstraße 45, 01454 Radeberg, GERMANY Marketing Authorization
Number: 3003664.00.00 Pharmacy only medicine.
ROTOP - DMSA
Name 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 sufficient 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, confirmation of a missing kidneyfunction on multicystic kidneys; Contraindications: None known. Side 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 AG, Bautzner Landstraße 45, 01454 Radeberg, GERMANY Marketing Authorization Number: 3003663.00.00 Pharmacy only medicine.
ROTOP-EHIDA
Name 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. Side effects: None known. For related substances as disofenin and mebrofenin isolated cases of hypersensitivity reactions such as
flu-like symptoms, nausea and pruritus have been reported; low probability of cancer and hereditary defects. Marketing Authorization Holder: ROTOP Pharmaka AG, Bautzner Landstraße
45, 01454 Radeberg, GERMANY Marketing Authorization Number: 3003665.00.00 Pharmacy only medicine.
Please see the Package Leaflet and Summary of Product Characteristics included with your product for full details.
ROTOP Pharmaka AG
Bautzner Landstraße 400
01328 Dresden
Germany
Phone +49 (0) 35 1 – 26 310 210
Telefax +49 (0) 35 1 – 26 310 313
info@rotop-pharmaka.de
www.rotop-pharmaka.de
Produktübersicht-INT-eng-02