Teslascan - patient leaflet, side effects, dosage

2. BEFORE YOU USE T

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 fe 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 consideration by patients on a controlled sodium diet.

3. HOW TO USE TESLASCAN

TESLASCAN is for use in patients over the age of 18 years.

Dosage:

The amount given will depend on the weight of 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 insper 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.

his contrast medium. Treatment of any overdose will be performed at ill be supportive to relieve the symptoms.

anese can make the heart pump less efficiently, dilate the blood vessels, as well as s of heart rhythm.

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

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 or pharmacist.

5. HOW TO STORE TESLASCAN

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.

• 6. FURTHER INFORMATION

What TESLASCAN contains

• - The active substance is mangafodipir trisodium.

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

Tel: + 420 224 446 179

Danmark

GE Healthcare A/S

Huginsvej 8

DK-3400 Hillerod

Tlf: + 45 70 22 22 03

Deutschland

GE Healthcare Buchler GmbH & Co. KG

Gieselweg 1

D-38110 Braunschweig

Tel: + 49 5307 9300

Eesti

GE Healthcare Estonia OÜ

Mustamäe tee 46

EE – 10621 Tallinn

Tel: + 372 6260 061

EÀÀàôa

GE Healthcare A.E.

nXanoÛTa 139 & Aapiaç GR – 141 21 N. HPAKAEIO A0HNA

Tql: +30 210 805 08 64

Nederland

GE Healthcare BV Cygne Centre

De Rondom 8

NL-5612 AP Eindhoven Tel: + 31 40 299 10 00

Österreich

GE Healthcare Handels GmbH

Europlaza, Gebäude E

Technologiestrasse 10

A-1120 Wien

Tel: + 43 1 972 72–0

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 lthcare Limited

am Place

halfont HP7 9NA – UK

4 (0) 1 494 54 4000

and

arm ehf.

Lyngháls 13

IS-110 Reykjavik

Sími: +354 540 8024

Portugal

Satis Lda.

Av. Do Forte, No 4

P-2795–502 Carnaxide

Tel: + 351 214 25 1300

Romania

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

Slovenská republika

GE Healthcare SCE Handels GmbH

Branch Office Slovakia

Floriánske nám. 2

SK-811 07 Bratislava

Tel: + 421 2 5542 5948

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