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The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 40051/0002.
Methylthioninium chloride Proveblue 5 mg/ml solution for injection
Methylthioninium chloride Proveblue 5 mg/ml solution for injection
Methylthioninium chloride
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
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.
Talk to your doctor or nurse before you are given Methylthioninium chloride Proveblue
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.
Special care must be taken with Methylthioninium chloride Proveblue:
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:
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:
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.
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 (See details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
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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.
Methylthioninium chloride Proveblue is a clear dark blue solution for injection (injection) and is supplied in clear glass ampoules.
Each box contains a tray with 5 ampoules of 10 ml.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 12/2021
Marketing Authorisation number : PLGB 40051/0002
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