Teslascan
mangafodipir
Mangafodipir trisodium
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
What TESLASCAN is and what it is used for.
Before you use TESLASCAN.
How to use TESLASCAN.
Possible side effects.
How to store TESLASCAN.
Further information.
Medicinal product no longer authorised
TESLASCAN is a paramagnetic contrast medium used in connection with Magnetic Resonance Imaging (MRI), to improve the diagnostic information.
TESLASCAN is used in magnetic resonance imaging (MRI) to detect certain lesions in the liver and pancreas.
Pregnancy
Allergy (hypersensitivity) to the active substance or any of the other ingredients of TESLASCAN
Pheochromocytoma
Breast-feeding
Severe kidney disease
Severe liver disease
Severe heart disease - in particular heart failure or when there is a risk of disorders of heart rhythm
- in patients with injuries of the blood brain barrier and severe cerebral disease
Rarely, hypersensitivity reactions (urticaria and other possible allergic phenomena) may occur.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
TESLASCAN must not be used if you are pregnant.
The amount of TESLASCAN in breast milk is not known. As a precaution, to prevent exposing infants to the medicine, breast-feeding should be stopped from the time of dosing and all milk should be discarded for the first 14 days afterwards.
No effects are known. There is no reason why you cannot drive after the investigation, unless you feel dizzy or are unsure of yourself.
This medicine contains 5.5 mmol (126 mg) sodium per normal dose of 35 ml. To be taken into consideration by patients on a controlled sodium diet.
TESLASCAN is for use in patients over the age of 18 years.
Medicinal product no longer authorised
The amount given will depend on the weight of the patient: 0.5 ml/kg body weight is the recommended dosage for adults and elderly.
TESLASCAN is for intravenous use and will be infused before the MRI examination. TESLASCAN may be infused into a vein, normally an arm vein, via a thin plastic tube. The administration may last for up to 15-20 minutes.
TESLASCAN should be visually inspected for particulate matter and for the integrity of the container prior to use. Vials are intended for single use only. The medicinal product should not be mixed with other medicinal products. Any unused portions must be discarded.
There is no known antidote to this contrast medium. Treatment of any overdose will be performed at the hospital. Treatment will be supportive to relieve the symptoms.
High doses of manganese can make the heart pump less efficiently, dilate the blood vessels, as well as induce disturbances of heart rhythm.
Like all medicines, TESLASCAN can cause side effects, although not everybody gets them. The reported side effects are usually mild and of short duration:
Common (1 in 100 to 1 in 10 patients experiences the side effect):
Headache
Nausea
Feeling of warmth/flushing
Uncommon (1 in 1,000 to 1 in 100 patients experiences the side effect):
Hypersensitivity reactions (e.g., skin reactions, rhinitis (nasal catarrh) pharyngitis (throat inflammation))
Fever
Diarrhoea
Vomiting
Dizziness
Palpitation
Paraesthesia (sensation of tingling)
Abdominal pain
Injection site pain
Taste sensations
Rare (1 in 10,000 to 1 in 1,000 patients experiences the side effect):
Hypertension
Very rare (less than 1 in 10,000 patients experiences the side effect):
Visual disturbances
Chest pain
Flatulence
Anaphylactoid reactions (wheeziness, difficulty in breathing or tightness or pain in the chest) may occur.
Medicinal product no longer authorised
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell the radiologist/radiographer or your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not use TESLASCAN after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
Keep the vial in the outer carton in order to protect from light.
Once opened the product should be used immediately. For single use only. Any unused portion should be discarded.
Do not use Teslascan if the colour changes from dark yellow to brown.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
ml of solution contains 7.57 mg mangafodipir trisodium anhydrous (corresponding to 0.01 mmol per ml)
- The other ingredients are ascorbic acid, sodium chloride, sodium hydroxide and/or hydrochloric acid (for pH adjustment) and water for injections.
Solution for infusion.The solution is clear and bright to dark yellow in colour. The medicine is supplied in pack of:
1 vial of 50 ml
10 vials of 50 ml
Not all pack sizes may be marketed
GE Healthcare AS Nycoveien 1-2
Medicinal product no longer authorised
P.O. Box 4220 Nydalen NO-0401 OSLO, Norway
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
BE-1831 Diegem
Tél/Tel: + 32 (0) 2 719 74 01
BE-1831 Diegem België/Belgique/Belgien Tél/Tel: + 32 (0) 2 719 74 01
GE Healthcare SCE Handels GmbH Representative Office Bulgaria World Trade Centre, Office 405-406 бул. Драган Цанков 36
София 1040
Teл.: + 35 92 973 3170
GE Healthcare SCE Handels GmbH Hungary Representative Office Akron u.2.
H-2040 BUDAÖRS Tel. + 36 23 410 410
GE Healthcare SCE Handels GmbH Branch Office Czech Republic Vyskočilova 1422/1a
CZ-140 28 Praha 4
Tel: + 420 224 446 179
Pharma-Cos Ltd Triq C. Portanier
MT-Santa Venera HMR 11 Tel: +356 21 441870
GE Healthcare A/S Huginsvej 8
DK-3400 Hillerød Tlf: + 45 70 22 22 03
GE Healthcare Buchler GmbH & Co. KG Gieselweg 1
D-38110 Braunschweig Tel: + 49 5307 9300
GE Healthcare BV Cygne Centre
De Rondom 8
NL-5612 AP Eindhoven Tel: + 31 40 299 10 00
GE Healthcare AS Nycoveien 1-2 NO-0401 Oslo
Tlf: + 47 23 18 50 50
GE Healthcare Estonia OÜ Mustamäe tee 46
EE – 10621 Tallinn Tel: + 372 6260 061
GE Healthcare Handels GmbH Europlaza, Gebäude E Technologiestrasse 10
A-1120 Wien
Tel: + 43 1 972 72-0
GE Healthcare A.E.
Πλαπούτα 139 & Λαμίας
GR – 141 21 Ν. ΗΡΑΚΛΕΙΟ ΑΘΗΝΑ
Τηλ: +30 210 805 08 64
GE Healthcare SCE Handels GmbH Poland Representative Office
Stawki Str.
PL – 00193 Warszawa
Tel.: + 48 22 635 6886/6113
GE Healthcare Bio-Sciences, S.A. Avda. de Europa, 22
Medicinal product no longer authorised
Parque Empresarial ”La Moraleja” E-28108 Alcobendas, Madrid
Tel: + 34 91 663 25 00
Satis Lda.
Av. Do Forte, No 4
P-2795-502 Carnaxide Tel: + 351 214 25 1300
GE Healthcare SA
11, avenue Morane Saulnier F-78 140 Velizy Villacoublay Tél: + 33 1 34 49 54 54
GE Healthcare Limited Amersham Place
Little Chalfont HP7 9NA - UK Tel: + 44 (0) 1 494 54 4000
GE Healthcare SCE Handels GmbH Representative Office Romania
Str. Navodari Nr. 42 Sc.2, et.2
RO-014108 BUCHAREST Tel: + 40 21 23 211 53
HIGIEA d.o.o.
Blatnica 10 SI-1236 Trzin
Tel: + 386 1 589 7221
IS-110 Reykjavik Sími: +354 540 8024
GE Healthcare SCE Handels GmbH Branch Office Slovakia
Floriánske nám. 2
SK-811 07 Bratislava
Tel: + 421 2 5542 5948
GE Healthcare Srl Via Galeno 36
I-20126 Milano
Medicinal product no longer authorised
Tel: + 39 02 26001 111
Oy GE Healthcare Bio-Sciences Ab Kuortaneenkatu 2
FIN-00510 Helsinki Puh/Tel: + 35 810 394 11
Κύπρος Phadisco Ltd Λεωφόρος Γιάννου Κρανιδιώτη | 185 | Sverige GE Healthcare AB Solna Strandväg 98 |
CΥ-2235 Λατσιά Τηλ: +357 22 715000 | S-171 75 Stockholm Tel: + 46 8 559 504 00 | |
Latvija Instrumentarium Medical SiA Meza Str. 4 LV-1048 Riga Tel: + 371 780 7086 | United Kingdom GE Healthcare Limited Amersham Place Little Chalfont HP7 9NA – UK Tel: + 44 (0) 1 494 54 4000 | |
Lietuva Nycomed East Europe Marketing Service GmbH Šeimyniškiu 3 LT – 09312 Vilnius Tel. +370 5210 9071 |