METHYLENE BLUE INJECTION SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

METHYLENE BLUE

Dostupné s:

PHEBRA PTY LTD

ATC kód:

V03AB17

INN (Mezinárodní Name):

METHYLTHIONINIUM CHLORIDE

Dávkování:

10MG

Léková forma:

SOLUTION

Složení:

METHYLENE BLUE 10MG

Podání:

INTRAVENOUS

Jednotky v balení:

15G/50G

Druh předpisu:

Ethical

Terapeutické oblasti:

ANTIDOTES

Přehled produktů:

Active ingredient group (AIG) number: 0106816001; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2019-04-30

Charakteristika produktu

Methylene Blue Injection 1% w/v
Page 1 of 4
PRESCRIBING INFORMATION
METHYLENE BLUE INJECTION
1% W/V (10 MG/ML)
STERILE SOLUTION
_British Pharmacopoeia _(B.P.)_ _
Methemoglobinemia / Diagnostic Aid
Phebra Pty Ltd
19 Orion Road
Lane Cove West
Australia, 2066
Canadian Importer:
ICON Plc
4 Innovation Drive
Dundas, Ontario
L9H 7P3
Date of Preparation:
April 30, 2019
Submission Control No: 222283
Methylene Blue Injection 1% w/v
Page 2 of 4
PRESCRIBING INFORMATION
METHYLENE BLUE INJECTION
10 MG/ML
METHEMOGLOBINEMIA
DIAGNOSTIC AID
L.V.
PHARMACOLOGY
Methylene Blue activates a normally dormant reductase enzyme system
which reduces
the methylene blue to leucomethylene blue, which in turn is able to
reduce
methemoglobin to hemoglobin. Methylene Blue is absorbed from the
gastrointestinal
tract. It is believed to be reduced in the tissue to the Ieuco form
which is slowly excreted,
mainly in the urine together with some unchanged drug. Methylene Blue
imparts a blue
colour to urine and faeces. In large doses Methylene Blue can produce
methemoglobinemia.
INDICATIONS
Used in the treatment of methemoglobinemia. Also used as a
bacteriological stain, as a
dye in diagnostic procedures such as fistula detection, and for the
delineation of certain
body tissues during surgery.
CONTRAINDICATIONS
In patients with severe renal impairment or a known hypersensitivity
to the drug.
PRECAUTIONS
Methemoglobin concentration should be closely monitored during
treatment as
Methylene Blue can produce methemoglobinemia in large doses.
Methylene Blue should be used with caution in the treatment of toxic
methemoglobinemia; high doses can cause hemolytic anemia and patients
with glucose-
6-phosphate dehydrogenase (G6PD) deficiencies are particularly
susceptible.
A rapid disappearance of cyanosis in response to Methylene Blue would
be expected
within one hour but might not occur if the patient has erythrocyte
G6PD or NADPH-
diaphorase deficiency or if methemoglobinemia is due to the ingestion
of compounds
such as aniline or dapsone. A second dose has been