Methylene Blue Injection

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

METHYLENE BLUE

Beschikbaar vanaf:

Macarthys Laboratories Limited Bampton Road, Harold Hill, Romford Essex, RM3 8UG, United Kingdom

ATC-code:

V03AB17

INN (Algemene Internationale Benaming):

METHYLENE BLUE 1 % (W/V)

farmaceutische vorm:

SOLUTION FOR INJECTION

Samenstelling:

METHYLENE BLUE 1 % (W/V)

Prescription-type:

POM

Therapeutisch gebied:

ALL OTHER THERAPEUTIC PRODUCTS

Autorisatie-status:

Withdrawn

Autorisatie datum:

2007-07-09

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER 
C91229
Methylthioninium Chloride
IN THIS LEAFLET: 
1.  What Methylthioninium Chloride Injection is and what it is
used for
2.  Before you are given Methylthioninium Chloride Injection
3.  How Methylthioninium Chloride Injection is given
4.  Possible side effects
5.  How to store Methylthioninium Chloride Injection
6. Further 
information
1.  WHAT METHYLTHIONINIUM CHLORIDE INJECTION IS
AND WHAT IT IS USED FOR
This medicine is a blue liquid, which will be given to you by
injection to treat problems with your blood. 
If your blood contains too much methaemoglobin, your blood
will not be able to transport oxygen around your body effectively.
This medicine will help your blood return to normal.
2.  BEFORE YOU ARE GIVEN METHYLTHIONINIUM
CHLORIDE INJECTION
YOU SHOULD NOT BE GIVEN METHYLTHIONINIUM CHLORIDE
INJECTION IF:
• you are allergic to methylthioninium chloride 
• your doctor has told you that your body does not produce
enough of the enzyme G6PD (glucose-6-phosphate
dehydrogenase).
• your blood disorder has been caused by sodium nitrite
SPECIAL CARE MUST BE TAKEN WITH METHYLTHIONINIUM CHLORIDE
INJECTION IF:
• you suffer from severe kidney problems
If any of the above applies to you, please consult your doctor.
TAKING OTHER MEDICINES
Tell your doctor or nurse if you are taking or have recently taken
any other medicines, including medicines obtained without a
prescription.
If you have any doubts about whether this medicine should be
given to you, consult your doctor.
PREGNANCY AND BREAST-FEEDING
Ask your doctor for advice before you are given this medicine.
DRIVING AND USING MACHINES
Please speak to your doctor before driving or using machines.
3.  HOW METHYLTHIONINIUM CHLORIDE INJECTION WILL
BE GIVEN
Your doctor will inject this medicine into a vein (intravenously)
slowly over a period of several minutes. They will inject the
solution through a filter.
ADULTS AND THE ELDERLY
The usual dose is 0.1-0.2 ml per kilo

Productkenmerken

Page 1 of  4 
SUMMARY OF PRODUCT CHARACTERISTICS 

PRODUCT SUMMARY 

1. 
TRADE NAME OF THE MEDICINAL PRODUCT 

Methylthioninium Chloride Injection USP 1% w/v 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Contains: 
Methylthioninium Chloride USP 1% w/v 

3. 
PHARMACEUTICAL FORM 

Sterile Aqueous Injection 

CLINICAL PARTICULARS 

4.1. 
THERAPEUTIC INDICATIONS 

Drug induced methaemoglobinaemia 

4.2. 
POSOLOGY AND METHOD OF ADMINISTRATION 

Inject Methylthioninium Chloride very slowly over several minutes. 
Route of administration: 
Intravenous Injection. 

Adults and the elderly  

Children 

0.1 - 0.2ml/kg body weight.   

Not recommended 

4.3. 
CONTRA-INDICATIONS 

Not to be administered by intra-spinal injection or subcutaneous injection.  Glucose-6-
phosphate dehydrogenase deficiency and sodium nitrite induced methaemaglobinaemia. 

4.4. 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 

Methylthioninium Chloride must be injected very slowly over a period of several minutes to 
prevent  high  local  concentrations  of  the  compound  from  producing  additional 
methaemoglobin.    Do  not  exceed  the  recommended  dosage.  Severe  renal  impairment  and 
aniline-induced  methaemaglobinaemia  as  his  may  precipitate  Heinz  body  formation  and 
haemolytic anaemia. 

Page 2 of  4 
4.5. 
INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION 

Adverse CNS effects including confusion, disorientation, agitation, expressive aphasia, 
altered muscle tone in limbs, hypoxia, ocular symptoms, and depressed level of 
consciousness have been reported following intravenous infusion of methylthioninium 
chloride for parathyroid surgery.The use of methylthioninium for localisation in