TESLASCAN 0.01 mmol/ml solution for infusion

TESLASCAN is a paramagnetic contrast medium used in connection with Magnetic Resonance Imaging (MRI), to improve the diagnostic information.

This medicine is for diagnostic use only.

TESLASCAN is used in magnetic resonance imaging (MRI) to detect certain lesions in the liver and pancreas.

Do not use TESLASCAN if one of the following conditions exists:

• Pregnancy
• Allergy (hypersensitivity) to the active substance or any of the other ingredients of TESLASCAN
• Pheochromocytoma
• Breast-feeding
• Severe kidney disease
• Severe liver disease

Take special care with TESLASCAN if one of the following conditions exists:

• 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.

Using other medicines:

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

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.

Driving and using machines:

No effects are known. There is no reason why you cannot drive after the investigation, unless you feel dizzy or are unsure of yourself.

Important information about some of the ingredients of Teslascan

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.

Dosage:

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.

Overdose

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.

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 orpharmacist.

Keep out of the reach and sight of children.

Expiry date

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.

Storage precautions

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.

What TESLASCAN contains

• The active substance is mangafodipir trisodium.1 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.

What TESLASCAN looks like and contents of the pack

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

Marketing Authorization Holder and Manufacturer:

GE Healthcare AS
Nycoveien 1-2
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.

BelgiëBelgiqueBelgien GE Healthcare BVBA Kouterveldstraat 20 BE-1831 Diegem TélTel 32 0 2 719 74 01 LuxembourgLuxemburg GE Healthcare BVBA Kouterveldstraat 20 BE-1831 Diegem BelgiëBelgiqueBelgien TélTel 32 0 2 719 74 01

Magyarország GE Healthcare SCE Handels GmbH Hungary Representative Office Akron u.2. H-2040 BUDAÖRS Tel. 36 23 410 410 GE Healthcare SCE Handels GmbH Representative Office Bulgaria World Trade Centre, Office 405-406 . 36 1040 Te. 35 92 973 3170

Malta Pharma-Cos Ltd Triq C. Portanier MT-Santa Venera HMR 11 Tel 356 21 441870 eská republika GE Healthcare SCE Handels GmbH Branch Office Czech Republic Vyskoilova 14221a CZ-140 28 Praha 4 Tel 420 224 446 179

Danmark GE Healthcare AS Huginsvej 8 DK-3400 Hillerød Tlf 45 70 22 22 03 Nederland GE Healthcare BV Cygne Centre De Rondom 8 NL-5612 AP Eindhoven Tel 31 40 299 10 00 Deutschland GE Healthcare Buchler GmbH Co. KG Gieselweg 1 D-38110 Braunschweig Tel 49 5307 9300 Norge GE Healthcare AS Nycoveien 1-2 NO-0401 Oslo Tlf 47 23 18 50 50

Eesti GE Healthcare Estonia OÜ Mustamäe tee 46 EE 10621 Tallinn Tel 372 6260 061 Österreich GE Healthcare Handels GmbH Europlaza, Gebäude E Technologiestrasse 10 A-1120 Wien Tel 43 1 972 72-0

GE Healthcare A.E. 139 GR 141 21 . 30 210 805 08 64 Polska GE Healthcare SCE Handels GmbH Poland Representative Office 2 Stawki Str. PL 00193 Warszawa Tel. 48 22 635 68866113

Portugal Satis Lda. Av. Do Forte, No 4 P-2795-502 Carnaxide Tel 351 214 25 1300 España GE Healthcare Bio-Sciences, S.A. Avda. de Europa, 22 Parque Empresarial La Moraleja E-28108 Alcobendas, Madrid Tel 34 91 663 25 00

France GE Healthcare SA 11, avenue Morane Saulnier F-78 140 Velizy Villacoublay Tél 33 1 34 49 54 54 Ireland GE Healthcare Limited Amersham Place Little Chalfont HP7 9NA - UK Tel 44 0 1 494 54 4000 România 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 Slovenija HIGIEA d.o.o. Blatnica 10 SI-1236 Trzin Tel 386 1 589 7221

Ísland Isfarm ehf. Lyngháls 13 IS-110 Reykjavik Sími 354 540 8024 Slovenská republika GE Healthcare SCE Handels GmbH Branch Office Slovakia Floriánske nám. 2 SK-811 07 Bratislava Tel 421 2 5542 5948

Italia GE Healthcare Srl Via Galeno 36 I-20126 Milano Tel 39 02 26001 111 SuomiFinland Oy GE Healthcare Bio-Sciences Ab Kuortaneenkatu 2 FIN-00510 Helsinki PuhTel 35 810 394 11

Phadisco Ltd 185 C-2235 357 22 715000 Sverige GE Healthcare AB Solna Strandväg 98 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
?eimyni?kiu 3
LT ? 09312 Vilnius
Tel. +370 5210 9071

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