Phebra METHYLENE BLUE 50 mg/5 mL injection vial

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

methylene blue, Quantity: 50 mg

Inapatikana kutoka:

Phebra Pty Ltd

INN (Jina la Kimataifa):

Methylene blue

Dawa fomu:

Injection, solution

Tungo:

Excipient Ingredients: water for injections; hydrochloric acid; sodium hydroxide

Njia ya uendeshaji:

Intravenous

Vitengo katika mfuko:

10 vials

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

Methylene Blue Injection USP 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 strain as a dye in diagnostic procedures such as fistula detection; for the delineation of certain body tissues during surgery.

Bidhaa muhtasari:

Visual Identification: clear blue coloured solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Idhini hali ya:

Licence status A

Idhini ya tarehe:

2014-10-01

Taarifa za kipeperushi

METHYLENE BLUE
INJECTION 50 MG IN 5 ML
CONTAINS 50 MG/ 5 ML METHYLENE BLUE TRIHYDRATE
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Methylene Blue
Injection. 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 Methylene Blue
Injection 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 METHYLENE BLUE
INJECTION IS USED FOR
Methylene Blue Injection 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.
Methylene Blue Injection 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.
Methylene Blue Injection is not
recommended for long-term use.
This medicine is only available with a
doctor’s prescription.
BEFORE YOU ARE GIVEN
METHYLENE BLUE
INJECTION
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU SHOULD NOT BE GIVEN METHYLENE
BLUE INJECTION 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 inherited condition.
YOU SHOULD NOT BE GIVEN THIS
MEDICINE IF YOU HAVE KIDNEY
PROBLEMS.
YOU SHOULD NOT BE GIVEN THIS
MEDICINE

Tabia za bidhaa

PRODUCT INFORMATION
Australian Product Information - Methylene Blue Injection
Page 1 of 8
Version 02
METHYLENE BLUE INJECTION
(METHYLENE BLUE)
1
NAME OF THE MEDICINE
Methylene blue (also known as methylthioninium chloride)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Methylene blue is a dark blue or dark green crystalline powder with a
metallic sheen. It is soluble in water, alcohol
and chloroform. Methylene Blue Injection is a sterile solution of
methylene blue trihydrate 50 mg
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Methylene Blue Injection is a sterile solution for oral/intravenous
use. The pH of the solution ranges between 3.0
and 4.5.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Methylene Blue Injection is indicated_: _
•
for the treatment of drug-induced methaemoglobinaemia
•
for the treatment of idiopathic methaemoglobinaemia (in which a
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
D
OSE AND METHOD OF ADMINISTRATION
Methylene Blue Injection may be administered orally or by intravenous
injection. In the treatment of acute
methaemoglobinaemia, the intravenous 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 a 1% solution in doses
of 1 mg to 2 mg per kg bodyweight injected over a period of several
minutes. A repeat dose may be given after
one hour if required. A maximum dose of 7 mg/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.
PRODUCT INFORMATION
METHYLENE BLUE INJECTION
Australian Product Information - Methylene Blue Injectio