Methylthioninium chloride Proveblue
methylthioninium chloride
methylthioninium chloride
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 Methylthioninium chloride Proveblue is and what it is used for
What you need to know before you are given Methylthioninium chloride Proveblue
How Methylthioninium chloride Proveblue is given
Possible side effects
How to store Methylthioninium chloride Proveblue
Contents of the pack and other information
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.
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 by nitrite during treatment of cyanide poisoning
if your blood disorder has been caused by chlorate poisoning.
Talk to your doctor or nurse before you are given Methylthioninium chloride Proveblue
if you have moderate or severe renal disease; lower doses (< 1 mg/kg) may be needed
if your blood disorder has been caused by a chemical called aniline, which is contained in dyes; lower doses may be needed and total cumulative dose should not exceed 4 mg/kg (see section 3
of this package leaflet)
if your blood disorder has been caused by a medicine called dapsone (used to treat leprosy and other skin conditions); lower doses may be needed and total cumulative dose should not exceed
4 mg/kg (see section 3)
if you suffer from hyperglycaemia or diabetes mellitus, as these conditions may be worsened by the glucose solution used for the dilution of the medicine
your urine and stools may turn a blue-green colour; and skin may possibly turn a blue colour when you are treated with Methylthioninium chloride Proveblue. This discolouration is
expected and will disappear after the treatment has ended
If any of the above applies to you, please consult your doctor.
Methylthioninium chloride may cause a photosensitivity reaction in the skin (sunburn-like reaction) when exposed to strong light sources, such as light therapy, lights in operating rooms and pulse oximeters.
Protective measures against exposure to light should be taken.
You will undergo monitoring tests during and after treatment with Methylthioninium chloride Proveblue.
in newborns and infants 3 months old or younger, lower doses are recommended (see section 3 of this package leaflet).
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
You should not be given methylthioninium chloride at the same time you are taking certain medicines to treat depression or anxiety which affect a brain chemical called serotonin. When used in combination with these medicines methylthioninium chloride may cause serotonin syndrome, which can be potentially life-threatening. Such medicines include:
Selective serotonin reuptake inhibitors (SSRIs) such as citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline and zimelidine
bupropion
buspirone
clomipramine
mirtazapine
venlafaxine
Monoamine oxidase inhibitors
However, if the intravenous use of methylthioninium chloride cannot be avoided, you should be administered the lowest possible dose and observed closely for up to 4 hours after administration.
If you have any doubts about whether this medicine should be given to you, consult your doctor.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
The use of Methylthioninium chloride Proveblue during pregnancy is not recommended unless it is clearly necessary, for example in a life-threatening situation.
Due to a lack of available data on whether methylthioninium chloride passes into human breast milk, breast-feeding should be discontinued for up to 8 days after treatment with this medicine.
Do not drive or use any tools or machines as methylthioninium chloride has moderate influence on the ability to drive and use machines.
Your doctor will inject this medicine into a vein (intravenously) slowly over a period of 5 minutes.
The usual dose is 1 to 2 mg per kilogram of your body weight, i.e. 0.2 to 0.4 ml per kilogram given over a period of 5 minutes. A second dose may be given after one hour if required.
The maximum recommended cumulative dose for the course of treatment is 7 mg/kg.
If your blood disorder has been caused by aniline or dapsone, total cumulative dose should not exceed 4 mg/kg (see section 2).
Usually, treatment should not exceed one day.
The recommended dose is 0.3 to 0.5 mg/kg body weight, i.e. 0.06 to 0.1 ml/kg, over a period of 5 minutes.
A repeat dose (0.3 to 0.5 mg/kg body weight, i.e. 0.06-0.1 ml/kg) may be given after one hour in case
of persistence or recurrence of symptoms. Usually, treatment should not exceed one day.
This medicine may be diluted in 50 ml glucose 50 mg/ml (5%) solution for injection to avoid local pain, in particular in children.
As this medicine will be given to you whilst you are in hospital, it is unlikely that you will be given too much or too little, however, tell your doctor if you notice one of the following adverse reactions:
feeling sick,
stomach pain,
chest pain,
dizziness,
headache,
sweating,
confusion,
an increase in methaemoglobin (an abnormal form of haemoglobin in the blood),
high blood pressure,
shortness of breath,
abnormally fast beating of the heart,
tremor,
skin discolouration. Your skin may turn blue
reduction in red blood cells which may turn your skin pale and make you breathless and weak,
jaundice (yellowing of the skin and eyes), this has only been reported in infants.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, Methylthioninium chloride Proveblue can cause side effects, although not everybody gets them.
These effects are the same in adults and children except jaundice which has only been reported in infants.
pain in extremity
dizziness
- sweating
- blue or green urine
numbness and tingling
abnormal taste in mouth
nausea
stomach pain
chest pain
headache
anxiety
injection site pain
vomiting
serotonin syndrome when Methylthioninium chloride Proveblue has been taken with certain medicines to treat depression or anxiety, see section 2
decreased haemoglobin (protein in red blood cells that carry oxygen in the blood) levels may be reported during blood tests
reduction in red blood cells which may turn your skin pale and make you breathless and weak
local tissue damage at the injection site
jaundice (yellowing of the skin and eyes) – this has only been reported in infants
problems with speech
high or low blood pressure
agitation
lack of oxygen
irregular heartbeat, including an abnormally slow or fast beating of the heart
severe allergic reactions (so called anaphylactic reaction which may cause your throat or face to swell, difficulty breathing or a severe rash)
an increase in methaemoglobin (an abnormal form of haemoglobin in the blood)
shortness of breath
confusion
shaking
hives
fever
rapid breathing
dilated pupils
discoloured stools. They may appear green or blue
increased sensitivity of your skin to light (photosensitivity)
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting
system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
You should not be given this medicine after the expiry date which is printed on the carton and the ampoule labels after EXP. The expiry date refers to the last day of that month. The doctor or nurse will check that the expiry date on the label has not been passed before administering the injection to you.
Do not refrigerate or freeze. Keep the ampoule in the original package in order to protect from light. The medicine must be used immediately after opening or dilution.
Do not use Methylthioninium chloride Proveblue if the solution is discoloured, cloudy, turbid, or a precipitate or particles are present.
Any unused product or waste material should be disposed of in accordance with local requirements.
The active substance is methylthioninium chloride. 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.
The other ingredient is water for injections.
Each box contains a tray with 5 ampoules of 10 ml. Each box contains a tray with 5 ampoules of 2 ml.
Each box contains a tray with 20 ampoules of 2 ml.
Provepharm SAS
22 rue Marc Donadille, 13013 Marseille, France
Pierrel S.p.A.
s.s. Appia 7 bis, 46/48 - 81043 Capua, Italy
Cenexi
52, Rue Marcel et Jacques Gaucher, 94120 Fontenay-sous-Bois, France
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Lamepro B.V.
Tél/Tel: + 31 (0) 76-5600030
Provepharm SAS
Tel: +33 (0)4 91 08 69 30
Provepharm SAS
Teл.: + 33 (0)4 91 08 69 30
Lamepro B.V.
Tél/Tel: + 31 (0) 76-5600030
LERAM pharmaceuticals s.r.o Tel: +420 737 657 454
Provepharm SAS
Tel: + 33 (0)4 91 08 69 30
Dr. Franz Köhler Chemie GmbH Tel: + 49 (0) 6251-1083-0
Lamepro B.V
Tel: + 31 (0) 76-5600030
Provepharm SAS
Tel: + 33 (0)4 91 08 69 30
Pharmanovia A/S Tlf: + 45 33 33 76 33
a VIPharma International AE Τηλ: + 30-210-6194170
Dr. Franz Köhler Chemie GmbH Tel: +49 (0) 6251-1083-0
Fresenius Kabi España, S.A.U. Tel: + 34 93 225 65 65
Apfel Pharm Sp. z o.o. Tel: + 48 694 775 205
Provepharm SAS
Tél: + 33 (0)4 91 08 69 30
Labesfal - Laboratórios Almiro Tel: + 351 232 831100
Provepharm SAS
Tel: + 33 (0)4 91 08 69 30
Laboratoires ETHYPHARM Tel: + 33 1 41 12 65 63
Dynamic Medical Solutions Tel: + 40 (0)725596648
Provepharm SAS
Tel: + 33 (0)4 91 08 69 30
Pharmanovia A/S Sími: + 45 33 33 76 33
Medac Pharma S.r.l. Tel: + 39 06 51 59 121
Isangen Pharma Cyprus Ltd Τηλ: + 357-24-638833
Provepharm SAS
Tel: + 33 (0)4 91 08 69 30
Laboratoires ETHYPHARM Tel: + 33 1 41 12 65 63
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The following information is intended for healthcare professionals only:
Preparation for intravenous administration
Use immediately on opening. Inject very slowly over a period of 5 minutes.
Methylthioninium chloride Proveblue is hypotonic and may be diluted in 50 ml glucose 50 mg/ml (5%) solution for injection to avoid local pain, in particular in paediatric population.
It must not be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection because it has been demonstrated that chloride reduces the solubility of methylthioninium chloride.
Additional information on how Methylthioninium chloride Proveblue can be given is provided in section 3 of the Package Leaflet.
Any unused product or waste material should be disposed of in accordance with local requirements.