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PROVEBLUE SOLUTION FOR INJECTION 5MG/ML [SIN16319P]
Active ingredients: PROVEBLUE SOLUTION FOR INJECTION 5MG/ML
Last updated 26 October 2025
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Product Info
PROVEBLUE SOLUTION FOR INJECTION 5MG/ML
[SIN16319P]
Product information
Active Ingredient and Strength | METHYLTHIONINIUM CHLORIDE TRIHYDRATE (METHYLENE BLUE) - 5 MG/ML |
Dosage Form | INJECTION, SOLUTION |
Manufacturer and Country | CENEXI SAS - FRANCE |
Registration Number | SIN16319P |
Licence Holder | PHARM-D SINGAPORE PRIVATE LIMITED |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | V03AB17 |
4.1 THERAPEUTIC INDICATIONS
Proveblue® is indicated:
for the treatment of drug and chemical products-induced methaemoglobinaemia
as a dye in diagnostic procedures such as fistula detection
for the delineation of certain body tissues during surgery.
4.2 DOSE AND METHOD OF ADMINISTRATION
Dosage
Proveblue® may be administered by intravenous (IV) injection.
In the treatment of acute methaemoglobinaemia, the IV route of administration is usually preferred because it provides a more rapid onset of effect.
Adults and children: In the treatment of methaemoglobinaemia, methylene blue is administered intravenously as the 0.5 % solution in doses of 1 to 2 mg per kg bodyweight injected over a period of 5 minutes. A repeat dose may be given after one hour if required. A maximum dose of 7mg/kg bodyweight is recommended. The use of methylene blue is not recommended in infants under 4 months of age.
A dose of 5 mg/kg diluted in 500 mL of glucose 5% infused over 1 hour has been used successfully to stain and identify the parathyroid glands.
Proveblue® should not be diluted with sodium chloride 0.9% (saline) as precipitation may occur (due to presence of chloride ions which have been shown to reduce the solubility of methylene blue).
Use immediately following dilution.
The Proveblue® ampoules should be inspected visually prior to administration. The product should not be used if the solution is discoloured, cloudy, turbid or if a precipate or particles are present.
Each ampoule is for single use in one patient only. Discard any residue. Proveblue® contains no antimicrobial agents.
4.3 CONTRAINDICATIONS
Proveblue® is contraindicated in the following circumstances:
known hypersensitivity to the drug or any other thiazide dyes
patients with severe renal impairment
patients with glucose-6-phosphate dehydrogenase deficiency
methaemoglobinaemia due to chlorate poisoning
methaemoglobinaemia during treatment of cyanide poisoning
Intrathecal and subcutaneous injection of methylene blue are also contraindicated as they can result in neural damage (intrathecal administration) and necrotic abscess (subcutaneous administration).