PROVEBLUE methylene blue 50 mg/10 mL injection ampoule

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

methylene blue, Quantity: 50 mg

Disponible desde:

Clinect Pty Ltd

Designación común internacional (DCI):

Methylene blue

formulario farmacéutico:

Injection

Composición:

Excipient Ingredients: water for injections

Vía de administración:

Intravenous, Oral

Unidades en paquete:

5 ampoules

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

PROVEBLUE is indicated: For the treatment of drug-induced methaemoglobinaemia. For the treatment of idiopathic methaemoglobinaemia (in which structural abnormality of haemoglobulin is not present). As a bacterial stain. As a dye in diagnostic procedures such as fistula detection. For the delineation of certain body tissues during surgery.

Resumen del producto:

Visual Identification: A sterile, clear blue solution for injection in 10 mL glass type I ampoules; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Estado de Autorización:

Licence status A

Fecha de autorización:

2015-07-23

Información para el usuario

PROVEBLUE
®
_50 MG/10 ML_
_methylene blue injection_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PROVEBLUE. It
does not contain all the available
information. It does not take the
place of talking to your doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given
PROVEBLUE against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET IN A SAFE PLACE.
You may need to read it again.
WHAT PROVEBLUE IS
USED FOR
PROVEBLUE is used to treat
abnormal blood pigment levels.
These abnormal blood pigments do
not carry oxygen properly.
This medicine belongs to a group of
medicines called dyes.
PROVEBLUE is also used:
•
to stain bacteria to make them
easier to see
•
as a visible dye to help in the
diagnosis of a number of
conditions
•
as a stain to dye certain body
tissues during surgery
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
PROVEBLUE is not recommended
for long-term use.
The use of methylene blue in infants
under 4 months of age is not
recommended. Your doctor will
discuss use of this medicine in
infants younger than 4 months if
needed.
This medicine is only available with
a doctor's prescription.
BEFORE YOU ARE GIVEN
PROVEBLUE
_WHEN YOU MUST NOT BE GIVEN_
_IT_
•
if your blood disorder has been
caused by cyanide
•
if your blood disorder has been
caused by chlorate poisoning
YOU SHOULD NOT BE GIVEN
PROVEBLUE IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
methylene blue
•
any other dyes
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
YOU SHOULD NOT BE GIVEN THIS
MEDICINE IF YOU HAVE GLUCOSE-6-
PHOSPHATE DEHYDROGENASE
DEFICIENCY.
This is an in

Ficha técnica

1
AUSTRALIAN PRODUCT INFORMATION - PROVEBLUE
®
(METHYLENE BLUE SOLUTION FOR INJECTION)
1. NAME OF THE MEDICINE
Methylene blue (also known as methylthioninium chloride)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
PROVEBLUE
®
injection 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. 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.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PROVEBLUE
®
is indicated:
•
for the treatment of drug-induced methaemoglobinaemia
•
for the treatment of idiopathic methaemoglobinaemia (in which
structural abnormality of haemoglobin is
not present)
•
as a bacteriological stain
•
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 orally or 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
precipitati