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HSA Approval

PROVEBLUE SOLUTION FOR INJECTION 5MG/ML

SIN16319P

PROVEBLUE SOLUTION FOR INJECTION 5MG/ML

PROVEBLUE SOLUTION FOR INJECTION 5MG/ML

September 3, 2021

PHARM-D SINGAPORE PRIVATE LIMITED

PHARM-D SINGAPORE PRIVATE LIMITED

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantPHARM-D SINGAPORE PRIVATE LIMITED
Licence HolderPHARM-D SINGAPORE PRIVATE LIMITED

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

INJECTION, SOLUTION

**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.

ORAL, PARENTERAL

Medical Information

**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.

**4.3 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).

V03AB17

methylthioninium chloride

Manufacturer Information

PHARM-D SINGAPORE PRIVATE LIMITED

Cenexi SAS

Active Ingredients

Methylthioninium chloride trihydrate (methylene blue)

5mg/ml

Methylene blue

Documents

Package Inserts

Proveblue PI.pdf

Approved: September 3, 2021

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PROVEBLUE SOLUTION FOR INJECTION 5MG/ML - HSA Approval | MedPath