Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: PROVEPHARM SAS, 22 rue Marc Donadille, 13013, Marseille, France
Methylthioninium chloride Proveblue 5 mg/ml solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Clear dark blue solution with a pH value between 3.0 and 4.5. Osmolality is usually between 10 and 15 mOsm/kg. |
Each ml of solution contains 5 mg methylthioninium chloride.
Each 10 ml ampoule contains 50 mg methylthioninium chloride.
Each 2 ml ampoule contains 10 mg methylthioninium chloride.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Methylthioninium chloride |
In vivo, in low concentration, methylthioninium chloride speeds up the conversion of methaemoglobin to haemoglobin. Methylthioninium chloride has been observed to stain tissues selectively. |
| List of Excipients |
|---|
|
Water for injections |
Type I glass ampoules.
Each carton contains a tray with 5 ampoules of 10 ml in blister.
Each carton contains a tray with 5 or 20 ampoules of 2 ml in blister.
Not all pack sizes may be marketed.
PROVEPHARM SAS, 22 rue Marc Donadille, 13013, Marseille, France
EU/1/11/682/001
EU/1/11/682/002
EU/1/11/682/003
Date of first authorisation: 06 May 2011
Date of latest renewal: 08 February 2016
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