Methylthioninium chloride Proveblue

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

methylthioninium chloride

Available from:

Provepharm SAS

ATC code:

V03AB17

INN (International Name):

methylthioninium chloride

Therapeutic group:

All other therapeutic products

Therapeutic area:

Methemoglobinemia

Therapeutic indications:

Acute symptomatic treatment of medicinal and chemical products- induced methaemoglobinaemia.Methylthioninium chloride Proveblue is indicated in adults, children and adolescents (aged 0 to 17 years old).

Product summary:

Revision: 26

Authorization status:

Authorised

Authorization date:

2011-05-06

Patient Information leaflet

20
B. PACKAGE LEAFLET
21
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
METHYLTHIONINIUM CHLORIDE PROVEBLUE 5 MG/ML SOLUTION FOR INJECTION
methylthioninium chloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Methylthioninium chloride Proveblue is and what it is used for
2.
What you need to know before you are given Methylthioninium chloride
Proveblue
3.
How Methylthioninium chloride Proveblue is given
4.
Possible side effects
5.
How to store Methylthioninium chloride Proveblue
6.
Contents of the pack and other information
1.
WHAT METHYLTHIONINIUM CHLORIDE PROVEBLUE IS AND WHAT IT IS USED FOR
Methylthioninium chloride (also called methylene blue) belongs to a
group of medicines called
antidotes.
Methylthioninium chloride Proveblue will be given to you or your child
(0-17 years old) to treat
problems with your blood resulting from exposure to some medicines or
chemicals that can cause a
disease called methaemoglobinaemia.
In methaemoglobinaemia, your blood contains too much methaemoglobin
(an abnormal form of
haemoglobin that is not able to transport oxygen around your body
effectively). This medicine will
help your haemoglobin return to normal and restore the transport of
oxygen in the blood.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN METHYLTHIONINIUM CHLORIDE
PROVEBLUE
_ _
YOU MUST NOT BE GIVEN METHYLTHIONINIUM CHLORIDE PROVEBLUE
-
if you are allergic to methylthioninium chloride or other thiazine
dyes
-
if your body does not produce enough of the enzyme G6PD
(glucose-6-phosphate
dehydrogenase)
-
if your body does not produce enough of the enzyme NADPH (nicotinamide
adenine
dinucleotide phosphate) reductase
-
if your blood disorder has been caused b

Summary of Product characteristics

1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Methylthioninium chloride Proveblue 5 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 5 mg methylthioninium chloride.
Each 10 ml ampoule contains 50 mg methylthioninium chloride.
Each 2 ml ampoule contains 10 mg methylthioninium chloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection)
Clear dark blue solution with a pH value between 3.0 and 4.5
Osmolality is usually between 10 and 15 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acute symptomatic treatment of medicinal and chemical products-induced
methaemoglobinaemia.
Methylthioninium chloride Proveblue is indicated in adults, children
and adolescents (aged 0 to
17 years old).
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Methylthioninium chloride Proveblue
is for administration by a healthcare professional.
Posology
_ _
_Adults _
_ _
The usual dose is 1 to 2 mg per kg body weight, i.e. 0.2-0.4 ml per kg
body weight, given over a
period of 5 minutes.
A repeat dose (1 to 2 mg/kg body weight, i.e. 0.2-0.4 ml/kg body
weight) may be given one hour after
the first dose in cases of persistent or recurrent symptoms or if
methaemoglobin levels remain
significantly higher than the normal clinical range.
Treatment does not usually exceed one day.
The maximum recommended cumulative dose for the course of treatment is
7 mg/kg and should not be
exceeded, since Methylthioninium chloride administered above the
maximum dose may cause
methaemoglobinaemia in susceptible patients.
In the case of aniline- or dapsone-induced methaemaglobinaemia, the
maximum recommended
cumulative dose for the course of treatment is 4 mg/kg (see section
4.4).
Too limited data are available to support a continuous infusion dose
recommendation.
_ _
_ _
_ _
3
Special populations
_ _
_Elderly _
_ _
No dose adjustment is necessary.
_Renal impairment _
_ _
In infants above 3 months, children and