Products

Methylthioninium Chloride Proveblue ™

It is indicated for the treatment of medicinal and chemical products - induced methaemoglobinaemia.

Formulations: 5 ampoules each containing 10 ml
Territories: Nordics

Use

Acute symptomatic treatment of methaemoglobinemia induced by drugs and chemical products.

Product Information

Methylthioninium Chloride Proveblue™ is the only approved methylthioninium chloride product that meets the strict European Pharmacopeia specifications for content of heavy metals.

Methaemoglobinaemia is characterised by a reduced ability of the blood to carry oxygen because of reduced levels of normal haemoglobin. Therefore, this condition manifests as tissue hypoxia and ischemia. Methaemoglobinaemia can be either inherited or acquired following the exposure to toxic agents, the latter being more common.

Acquired methaemoglobinaemia is a rare condition with an approximate estimate of 75 patients suffering from acquired methaemoglobinaemia per year in Europe. Acute methaemoglobinaemia may be life-threatening and requires an emergency treatment. Pharmanovia is the exclusive distributor in the Nordic area.

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

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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