- Approval Id
- 567738d42ef98222
- Drug Name
- PROVEBLUE SOLUTION FOR INJECTION 5MG/ML
- Product Name
- PROVEBLUE SOLUTION FOR INJECTION 5MG/ML
- Approval Number
- SIN16319P
- Approval Date
- 2021-09-03
- Registrant
- PHARM-D SINGAPORE PRIVATE LIMITED
- Licence Holder
- PHARM-D SINGAPORE PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- **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.
- Route Of Administration
- ORAL, PARENTERAL
- Indication Info
- **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.
- Contraindications
- **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).
- Atc Code
- V03AB17
- Atc Item Name
- methylthioninium chloride
- Pharma Manufacturer Name
- PHARM-D SINGAPORE PRIVATE LIMITED
- Company Detail Path
- /organization/bb74300459b19b8f/pharm-d-singapore-private-limited
