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Provedye® Methylene Blue Dye-2ml ampoule. Sterile Solution for local application

ProveDye ®, Class IIa medical device, obtained a CE marking as Visualization aid for surgical procedures such as the delineation of tissues and operative pieces, seal tests for sutures, detection of leaks and fistula detection.

Territories: Nordics

Use

ProveDye ® can be used for nonspecific coloration during surgical procedures in areas such as urology, gynecology, gastroenterology or ENT. It allows the visualization of anatomical structures and anatomical disorders by coloration and helps to detect seals, leaks or fistula and to test sutures patency. ProveDye meets general and specialist surgeons’ needs in the mentioned domains.

Pack Size

ProveDye ® is available in Europe in packs of 5 or 20 ampoules of 2ml.

More Information

www.provepharm.com/provedye-r.html

Healthcare Professional Information-Summary of the products Characteristics(SmPC)

As the product is approved by The European Medicines Agency (EMA) in all EU member states, the SPC can be found in each of the member state languages on the following website under ‘Product Information’:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002108/human_med_001444.jsp&mid=WC0b01ac058001d124

Patient Information Leaflet(PIL)

Please note

Whilst the Patient Information Leaflets (PIL) and Summary of Product Characteristics (SmPC) product information is intended to be helpful, we stress that this is not intended to, and should not, replace the advice of a qualified medical professional.

If you experience any side effects that cause you concern as a result of the use of any of our products and wish to notify us directly please get in touch via our contact page.

Disclaimer

Please note that the above links are relevant to the local marketing authorisation requirements only. Patients and carers in Denmark can find similar information at www.medicin.dk however, if you are from outside Denmark, your local country requirements may differ. Please refer to your local country patient information leaflet(PIL) or summary product characteristic (SPC), if you are a patient or health care professional (HCP) respectively, for further guidance.

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