METHYLENE BLUE INJECTION SOLUTION

देश: कनाडा

भाषा: अंग्रेज़ी

स्रोत: Health Canada

सक्रिय संघटक:

METHYLENE BLUE

थमां उपलब्ध:

PHEBRA PTY LTD

ए.टी.सी कोड:

V03AB17

INN (इंटरनेशनल नाम):

METHYLTHIONINIUM CHLORIDE

डोज़:

10MG

फार्मास्यूटिकल फॉर्म:

SOLUTION

रचना:

METHYLENE BLUE 10MG

प्रशासन का मार्ग:

INTRAVENOUS

पैकेज में यूनिट:

15G/50G

प्रिस्क्रिप्शन प्रकार:

Ethical

चिकित्सीय क्षेत्र:

ANTIDOTES

उत्पाद समीक्षा:

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

प्राधिकरण का दर्जा:

APPROVED

प्राधिकरण की तारीख:

2019-04-30

उत्पाद विशेषताएं

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