5 mg / ml solution for injection
What Methylthioninium chloride Proveblue is and what it is used for
Pharmaceutical group
Methylthionine chloride (also called methylene blue) belongs to a group of drugs called antidotes.
Methylthioninium chloride Proveblue will be given to you or your child (0-17 years) to treat blood problems due to exposure to certain medicines or chemicals that can cause a disease called methemoglobinemia.
In methemoglobinemia, the blood contains too much methemoglobin (an abnormal form of hemoglobin that can not transport oxygen efficiently in the body). This medicine helps the hemoglobin to return to normal and restores the transport of oxygen in the blood.
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 methylthionine chloride or any of the other thiazine dyes
- if your body does not produce enough enzyme G6PD ( glucose -6-phosphate dehydrogenase)
- if your body does not produce enough enzyme NADPH ( nicotinamide -adenine dinucleotide phosphate) -reductase
- if your blood disease is caused by nitrite during treatment of cyanide poisoning
- if your blood disease is caused by chlorate poisoning.
Warnings and cautions
Talk to your doctor or nurse before using Methylthioninium chloride Proveblue
- if you have moderate or severe kidney disease; lower doses (<1 mg / kg) may be needed
- if your blood disease has been caused by a chemical called aniline, which is found in dyes; lower dose may be required and the total added dose should not exceed 4 mg / kg (see section 3 of this leaflet)
- if your blood disease has been caused by a medicine called dapsone (used to treat leprosy and other skin conditions); lower dose may be required and the total added dose should not exceed 4 mg / kg (see section 3)
- if you have hyperglycaemia or diabetes mellitus , as these conditions may be aggravated by the glucose solution used to dilute the medicine
- your urine and feces may turn blue-green, and your skin may turn blue when you are treated with Methylthioninium chloride Proveblue. This discoloration is expected and disappears when the treatment is completed.
If any of the above apply to you, talk to your doctor.
Light sensitivity
Methyl thionine chloride can cause a photosensitivity reaction in the skin (sunburn-like reaction) when exposed to strong light sources, such as light therapy, operating room lamps, and pulse oximeters. Protective measures against light exposure should be taken.
Monitoring tests
You will undergo monitoring tests during and after treatment with Methylthioninium chloride Proveblue.
Children
Particular care must be taken with Methylthioninium chloride Proveblue
- in newborns and infants 3 months of age or younger; lower dose is recommended (see section 3 of this leaflet).
Other medicines and Methylthioninium chloride Proveblue
Tell your doctor, pharmacist, or nurse if you are taking or have recently taken or might take any other medicines.
You should not be given Methylthioninium chloride while taking certain medicines for the treatment of depression or anxiety that affect a chemical in the brain called serotonin. When used in combination with these drugs, methylthionine chloride can cause serotonin syndrome, which can be potentially life-threatening. Such drugs include:
- selective serotonin reuptake inhibitors ( SSRIs ) such as citalopram , escitalopram, fluoxetine , fluvoxamine, paroxetine , sertraline and zimelidine
- bupropion
- buspiron
- clomipramine
- mirtazapine
- venlafaxine
- monoamine oxidase inhibitors
If intravenous use of Methylthioninium chloride is unavoidable, you should be given the lowest possible dose and carefully observed for up to 4 hours after receiving the medicine.
If you are not sure if this medicine should be given to you, talk to your doctor
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
The use of Methylthioninium chloride Proveblue during pregnancy is not recommended unless necessary, for example in a life-threatening situation.
Due to a lack of information on whether methylthionine chloride is excreted in human milk, breastfeeding should be discontinued for up to 8 days after treatment with this medicine.
Driving and using machines
Do not drive or use any tools or machines as methylthionine chloride has a moderate effect on the ability to drive and use machines.
How to give Methylthioninium chloride Proveblue
Dosage instructions
Your doctor will inject this medicine slowly into a vein ( intravenously ) for 5 minutes.
Adults, children over 3 months and older
The usual dose is 1 to 2 mg per kg body weight, ie. 0.2 to 0.4 ml per kg body weight, and given for 5 minutes. A second dose can be given after one hour if necessary.
The highest recommended combined dose for treatment is 7 mg/kg. If your blood disease has been caused by aniline or dapsone, the total pooled dose should not exceed 4 mg/kg (see section 2).
The treatment should usually not exceed one day.
Infants 3 months or younger
The recommended dose is 0.3 to 0.5 mg / kg per kg body weight, ie. 0.06 to 0.1 ml / kg per kg body weight, and given for 5 minutes.
Repeated dose (0.3 to 0.5 mg / kg body weight, ie 0.06-0.1 ml / kg) may be given after one hour in case of persistent or recurrent symptoms. The treatment should usually not exceed one day.
This medicine can be diluted in 50 ml of glucose 50 mg/ml (5 percent) solution for injection to avoid local pain, especially in children.
If you take more Methylthioninium chloride Proveblue than you should
Because this medicine is given to you while you are in hospital, you are unlikely to get too much or too little, but tell your doctor if you notice any of the following side effects:
- nausea
- abdominal pain
- chest pain
- dizziness
- headache
- sweating
- confusion
- an increase in methemoglobin (an abnormal form of hemoglobin in the blood)
- high blood pressure
- shortness of breath
- abnormally fast heartbeat
- shaking ( tremor )
- discoloration of the skin. Your skin may turn blue
- decreased number of red blood cells , which can make your skin pale and make you short of breath 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 product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
These side effects are the same in adults and children, except for jaundice which has only been reported in infants.
- Very common side effects ( may affect more than 1 user in 10)
– pain in the extremity
– dizziness
– sweating
– discoloration of the skin; your skin may turn blue
blue or green urine
numbness and tingling
– abnormal taste in the mouth
– nausea
- Common side effects are (may affect up to 1 in 10):
– abdominal pain
– chest pain
– headache
– anxiety
injection site pain
vomiting
- Has been reported (occurs in an unknown number of users):
– serotonin syndrome when Methylthioninium chloride Proveblue has been taken with certain medicines for the treatment of depression or anxiety, see section 2
Decreased levels of hemoglobin ( protein in red blood cells that carry oxygen in the blood) can be reported from blood tests
– reduced number of red blood cells, which can make your skin pale and make you short of breath and weak
– local tissue damage at the injection site
jaundice (yellowing of the skin and eyes) – this has only been reported in infants
speech difficulties
high or low blood pressure
– agitation
– acid deficiency
irregular heartbeats, including abnormally slow or fast heartbeats
– severe allergic reactions (a so-called anaphylactic reaction which may cause your throat or face to swell, cause difficulty breathing, or severe rash)
– an increase in methemoglobin (an abnormal form of hemoglobin in the blood)
– shortness of breath
– confusion
shaking
hives
– fever
– rapid breathing
– enlarged pupil er
– discolored stools; it can be green or blue
– increased sensitivity to light in your skin (light sensitivity)
How to store Methylthioninium chloride Proveblue
Keep this medicine out of the sight and reach of children.
You must be given this medicine before the expiry date which is stated on the carton, blister, and ampoule label after EXP. The expiration date is the last day of the specified month. Your doctor or nurse will check that the expiry date on the label has not passed before you receive an injection.
Store in a cold place. Do not freeze. Store ampoule one in the original package. Sensitive to light.
It must be used immediately after opening or diluting.
Do not use Methylthioninium chloride Proveblue if the solution is discolored, cloudy, cloudy, or contains precipitates or particles. Any unused product or waste material should be disposed of by local requirements.
Contents of the pack and other information
Content declaration
The active substance is methyl thionine chloride.
One ml of solution contains 5 mg of methyl thionine chloride.
Each 10 ml ampoule contains 50 mg of methyl thionine chloride.
Each 2 ml ampoule contains 10 mg of methyl thionine chloride.
The other ingredient is water for injections.
What the medicine looks like and the contents of the pack
Methylthioninium chloride Proveblue is a clear, dark blue solution for injection ( injection ) and is supplied in clear glass ampoules.
Each carton contains a tray with 5 ampoules of 10 ml.
Each carton contains a tray with 5 ampoules of 2 ml.
Each carton contains a tray with 20 ampoules of 2 ml.
Marketing Authorisation Holder
Provepharm SAS
22 rue Marc Donadille, 13013 Marseille, France
Manufacturer
Pierrel SpA
ss Appia 7 bis, 46/48, 81043 Capua, Italy
Cenex
52, Rue Marcel and Jacques Gaucher, 94120 Fontenay-sous-Bois, France
Contact the representative of the marketing authorization holder to find out more about this medicine:
Sweden
Pharmanovia A / S
Tel: + 45 33 33 76 33