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