PROVEBLUE SOLUTION FOR INJECTION 5MGML

Država: Singapur

Jezik: engleski

Izvor: HSA (Health Sciences Authority)

Aktivni sastojci:

Methylthioninium chloride trihydrate (methylene blue)

Dostupno od:

PHARM-D SINGAPORE PRIVATE LIMITED

ATC koda:

V03AB17

Farmaceutski oblik:

INJECTION, SOLUTION

Sastav:

Methylthioninium chloride trihydrate (methylene blue) 5mg/ml

Administracija rute:

ORAL, PARENTERAL

Tip recepta:

Prescription Only

Proizveden od:

Cenexi SAS

Status autorizacije:

ACTIVE

Datum autorizacije:

2021-09-03

Svojstava lijeka

1
PACKAGE INSERT (PI) - PROVEBLUE
®
5 MG/ML, SOLUTION
FOR INJECTION
1. NAME OF THE MEDICINE
Methylene blue (also known as methylthioninium chloride)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Proveblue
®
is a sterile solution containing 50 mg methylene blue trihydrate
(equivalent to 42.77 mg of
methylene blue anhydrous) in water for injections to 10 mL or 10 mg
methylene blue trihydrate (equivalent to
8.55 mg of methylene blue anhydrous) in water for injections to 2 mL.
The pH of the solution ranges
between 3.0 and 4.5.
Methylene blue is a dark blue, crystalline powder with a
copper-coloured sheen, or green crystals with
a bronze-coloured sheen. It is slightly soluble in water and slightly
soluble in ethanol.
3. PHARMACEUTICAL FORM
Proveblue
®
is a clear blue solution and contains methylene blue trihydrate 50
mg/10 mL or 10 mg/2 mL.
4. CLINICAL PARTICULARS
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
2
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