PROVEBLUE SOLUTION FOR INJECTION 5MG/ML [SIN16319P]

Product Info

PROVEBLUE SOLUTION FOR INJECTION 5MG/ML

[SIN16319P]

Indication

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.

Dosing

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.

Use in Renal impairment

In infants above 4 months, children and adolescents and in adults, the recommended dosage in patient with:

• Moderate renal impairment (eGFR 30–59 ml/min/1.73 m²) is 1–2 mg/kg per body weight. If a 1 mg/kg dose is given, a repeat dose of 1 mg/kg may be given one hour after the first dose in cases of persistent or recurrent symptoms or if methaemoglobin levels remain significantly higher than the normal clinical range. The maximum recommended cumulative dose for the course of treatment is 2 mg/kg (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• severe renal impairment (eGFR 15–29 ml/min/1.73 m²) is a single dose of 1 mg/kg per body weight. The maximum recommended cumulative dose for the course of treatment is 1 mg/kg.

No dose adjustment is recommended in patients with mild renal impairment (eGFR 60–89 ml/min/1.73 m²).

The safety and efficacy of methylthioninium chloride in patients with end stage renal disease with and without dialysis has not yet been established. No data are available.

Use in Hepatic impairment

The safety and efficacy of methylthioninium chloride in patients with hepatic impairment has not yet been established. No data are available.

Contraindications

4.3 CONTRAINDICATIONS

Proveblue® is contraindicated in the following circumstances:

• known hypersensitivity to the drug or any other thiazide dyes

• 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).