Methylthioninium chloride Proveblue

methylthioninium chloride

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This is a summary of the European public assessment report (EPAR) for Methylthioninium chloride Proveblue. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Methylthioninium chloride Proveblue.

What is Methylthioninium chloride Proveblue?

Methylthioninium chloride Proveblue is a solution for injection that contains the active substance methylthioninium chloride (5 mg/ml).

Methylthioninium chloride Proveblue is a ‘hybrid generic medicine’. This means that it is similar to a reference medicine, containing the same active substance but in a different concentration. The reference medicine for Methylthioninium chloride Proveblue is Methylthioninium Chloride Injection USP 1% w/v.

What is Methylthioninium chloride Proveblue used for?

Methylthioninium chloride Proveblue is used in adults and children of all ages as an antidote to treat symptoms of methaemoglobinaemia caused by exposure to medicines or chemicals.

Methaemoglobinaemia is a condition where there is too much of an abnormal form of haemoglobin in the blood that is not able to transport oxygen effectively. Substances that may cause methaemoglobinaemia include some antibiotics, local anaesthetics, nitrates in drinking water and pesticides.

The medicine can only be obtained with a prescription.

How is Methylthioninium chloride Proveblue used?

Methylthioninium chloride Proveblue is injected slowly into a vein over a period of five minutes. It must be given by a healthcare professional.

The usual dose for adults and children aged above three months is 1 to 2 mg per kg body weight. A repeat dose may be given one hour after the first dose if symptoms persist or come back, or if the level of methaemoglobin in the blood stays higher than normal.

The dose in children aged three months or less is 0.3 to 0.5 mg/kg. They may also be given a repeat dose after one hour.

How does Methylthioninium chloride Proveblue work?

To carry oxygen in the blood, haemoglobin needs to contain an atom of iron in the ‘ferrous’ form (Fe2+). Exposure to certain medicines or chemicals can cause the iron in the haemoglobin to change to the ‘ferric’ form (Fe3+) seen in methaemoglobinaemia.

The active substance in Methylthioninium chloride Proveblue, methylthioninium chloride (also called methylene blue), helps speed up the conversion of abnormal haemoglobin back into normal haemoglobin. It does this by accepting negatively charged electron particles through an enzyme called ‘NADPH methaemoglobinaemia reductase’. The electrons are then transferred to the iron atoms in the abnormal haemoglobin, converting them into the normal ferrous form.

How has Methylthioninium chloride Proveblue been studied?

Because methylthioninium chloride has been used in the European Union for several decades to treat methaemoglobinaemia, the company presented data on the use of methylthioninium chloride from published literature.

What benefit has Methylthioninium chloride Proveblue shown during the studies?

Reports from published literature confirmed that methylthioninium chloride is effective in treating methaemoglobinaemia that has been caused by exposure to a medicine or chemical in adults and children.

What is the risk associated with Methylthioninium chloride Proveblue?

The most common side effects with methylthioninium chloride are nausea (feeling sick), abdominal and chest pain, headache, dizziness, tremors, anxiety, confusional state, dyspnoea (difficulty breathing), tachycardia (rapid heartbeat), hypertension (high blood pressure), hyperhidrosis (excessive sweating), pain at the site of injection or in a limb, and the formation of methaemoglobinaemia. For the full list of all side effects reported with methylthioninium chloride, see the package leaflet.

Methylthioninium chloride Proveblue must not be used in people who are hypersensitive (allergic) to methylthioninium chloride, or to any other thiazine dyes (the group to which methylthioninium chloride belongs). It must not be used in patients with the following conditions:

  • glucose-6-phosphate dehydrogenase deficiency (G6PD);
  • methaemoglobinaemia caused by nitrite during treatment of cyanide poisoning;
  • methaemoglobinaemia caused by chlorate poisoning;
  • deficiency in the enzyme NADPH reductase.
Why has Methylthioninium chloride Proveblue been approved?

The Committee concluded the long experience with the active substance, methylthioninium chloride, shows that it is effective in treating methaemoglobinaemia. The CHMP decided that the medicine’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Methylthioninium chloride Proveblue?

A risk management plan has been developed to ensure that Methylthioninium chloride Proveblue is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Methylthioninium chloride Proveblue, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Methylthioninium chloride Proveblue

The European Commission granted a marketing authorisation valid throughout the European Union for Methylthioninium chloride Proveblue on 6 May 2011.

For more information about treatment with Methylthioninium chloride Proveblue, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Methylthioninium chloride Proveblue : EPAR - Summary for the public BG = bălgarski 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Summary for the public ES = español 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Summary for the public CS = čeština 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Summary for the public DA = dansk 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Summary for the public DE = Deutsch 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Summary for the public ET = eesti keel 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Summary for the public EL = elliniká 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Summary for the public EN = English 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Summary for the public FR = français 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Summary for the public IT = italiano 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Summary for the public LV = latviešu valoda 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Summary for the public LT = lietuvių kalba 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Summary for the public HU = magyar 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Summary for the public MT = Malti 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Summary for the public NL = Nederlands 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Summary for the public PL = polski 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Summary for the public PT = português 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Summary for the public RO = română 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Summary for the public SK = slovenčina 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Summary for the public SL = slovenščina 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Summary for the public FI = suomi 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Summary for the public SV = svenska 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Summary for the public HR = Hrvatski 06/06/2011 21/03/2016

This EPAR was last updated on 21/03/2016 .

Authorisation details

Product details

Product details for Methylthioninium chloride Proveblue
NameMethylthioninium chloride Proveblue
Agency product numberEMEA/H/C/002108
Active substance

methylthioninium chloride

International non-proprietary name (INN) or common name

methylthioninium chloride

Therapeutic area Methemoglobinemia
Anatomical therapeutic chemical (ATC) code V03AB17
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Methylthioninium chloride Proveblue
Marketing-authorisation holder

Provepharm SAS

Revision12
Date of issue of marketing authorisation valid throughout the European Union06/05/2011

Contact address:

Provepharm SAS
ProveCube
22 Rue Marc Donadille
13013 Marseille
France

Product information

Product information

18/02/2016  Methylthioninium chloride Proveblue -EMEA/H/C/002108 -PSUSA/00002029/201505

Name Language First published Last updated
Methylthioninium chloride Proveblue : EPAR - Product Information HR = Hrvatski 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Product Information HR = Hrvatski 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Product Information HR = Hrvatski 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Product Information HR = Hrvatski 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Product Information HR = Hrvatski 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Product Information HR = Hrvatski 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Product Information HR = Hrvatski 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Product Information HR = Hrvatski 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Product Information HR = Hrvatski 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Product Information HR = Hrvatski 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Product Information HR = Hrvatski 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Product Information HR = Hrvatski 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Product Information HR = Hrvatski 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Product Information HR = Hrvatski 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Product Information HR = Hrvatski 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Product Information HR = Hrvatski 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Product Information HR = Hrvatski 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Product Information HR = Hrvatski 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Product Information HR = Hrvatski 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Product Information HR = Hrvatski 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Product Information HR = Hrvatski 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Product Information HR = Hrvatski 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Product Information HR = Hrvatski 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Product Information HR = Hrvatski 06/06/2011 21/03/2016
Methylthioninium chloride Proveblue : EPAR - Product Information HR = Hrvatski 06/06/2011 21/03/2016

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Methylthioninium chloride Proveblue : EPAR - All Authorised presentations HR = Hrvatski 06/06/2011 03/01/2014
Methylthioninium chloride Proveblue : EPAR - All Authorised presentations HR = Hrvatski 06/06/2011 03/01/2014
Methylthioninium chloride Proveblue : EPAR - All Authorised presentations HR = Hrvatski 06/06/2011 03/01/2014
Methylthioninium chloride Proveblue : EPAR - All Authorised presentations HR = Hrvatski 06/06/2011 03/01/2014
Methylthioninium chloride Proveblue : EPAR - All Authorised presentations HR = Hrvatski 06/06/2011 03/01/2014
Methylthioninium chloride Proveblue : EPAR - All Authorised presentations HR = Hrvatski 06/06/2011 03/01/2014
Methylthioninium chloride Proveblue : EPAR - All Authorised presentations HR = Hrvatski 06/06/2011 03/01/2014
Methylthioninium chloride Proveblue : EPAR - All Authorised presentations HR = Hrvatski 06/06/2011 03/01/2014
Methylthioninium chloride Proveblue : EPAR - All Authorised presentations HR = Hrvatski 06/06/2011 03/01/2014
Methylthioninium chloride Proveblue : EPAR - All Authorised presentations HR = Hrvatski 06/06/2011 03/01/2014
Methylthioninium chloride Proveblue : EPAR - All Authorised presentations HR = Hrvatski 06/06/2011 03/01/2014
Methylthioninium chloride Proveblue : EPAR - All Authorised presentations HR = Hrvatski 06/06/2011 03/01/2014
Methylthioninium chloride Proveblue : EPAR - All Authorised presentations HR = Hrvatski 06/06/2011 03/01/2014
Methylthioninium chloride Proveblue : EPAR - All Authorised presentations HR = Hrvatski 06/06/2011 03/01/2014
Methylthioninium chloride Proveblue : EPAR - All Authorised presentations HR = Hrvatski 06/06/2011 03/01/2014
Methylthioninium chloride Proveblue : EPAR - All Authorised presentations HR = Hrvatski 06/06/2011 03/01/2014
Methylthioninium chloride Proveblue : EPAR - All Authorised presentations HR = Hrvatski 06/06/2011 03/01/2014
Methylthioninium chloride Proveblue : EPAR - All Authorised presentations HR = Hrvatski 06/06/2011 03/01/2014
Methylthioninium chloride Proveblue : EPAR - All Authorised presentations HR = Hrvatski 06/06/2011 03/01/2014
Methylthioninium chloride Proveblue : EPAR - All Authorised presentations HR = Hrvatski 06/06/2011 03/01/2014
Methylthioninium chloride Proveblue : EPAR - All Authorised presentations HR = Hrvatski 06/06/2011 03/01/2014
Methylthioninium chloride Proveblue : EPAR - All Authorised presentations HR = Hrvatski 06/06/2011 03/01/2014
Methylthioninium chloride Proveblue : EPAR - All Authorised presentations HR = Hrvatski 06/06/2011 03/01/2014
Methylthioninium chloride Proveblue : EPAR - All Authorised presentations HR = Hrvatski 06/06/2011 03/01/2014
Methylthioninium chloride Proveblue : EPAR - All Authorised presentations HR = Hrvatski 06/06/2011 03/01/2014

Pharmacotherapeutic group

All other therapeutic products

Therapeutic indication

Acute symptomatic treatment of medicinal and chemical products- induced methaemoglobinaemia.

Methylthioninium chloride Proveblue is indicated in adults, children and adolescents (aged 0 to 17 years old).

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Methylthioninium chloride Proveblue : EPAR - Public assessment report HR = Hrvatski 06/06/2011  
CHMP summary of positive opinion for Methylthioninium chloride Proveblue HR = Hrvatski 18/02/2011  

Authorised

This medicine is approved for use in the European Union

More information on Methylthioninium chloride Proveblue