Cloruro de metiltioninio proveblue 5 mg/ml solucion inyectable

Prospecto: information for the user

Cloruro de metiltioninio Proveblue 5 mg/ml injectable solution

Cloruro de metiltioninio

Read this prospect carefully before receiving this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or nurse.
• If you experience adverse effects, consult your doctor or nurse, even if they are not listed in this prospect. See section 4.

Content of the prospect:

1. What Cloruro de metiltioninio Proveblue is and for what it is used
2. What you need to know before receiving Cloruro de metiltioninio Proveblue
3. How to administer Cloruro de metiltioninio Proveblue
4. Possible adverse effects
5. Storage of Cloruro de metiltioninio Proveblue
6. Contents of the package and additional information

Methylene Blue Chloride (also known as methylene blue) belongs to a group of medications called antidotes.

Methylene Blue Chloride Proveblue will be administered to you or your child (0-17 years) to treat blood problems caused by exposure to certain medications or chemical substances that can cause a disease called methemoglobinemia.

In methemoglobinemia, the blood contains an excessive amount of methemoglobin (an abnormal form of hemoglobin that is not able to transport oxygen effectively through the body).

This medication will help normalize hemoglobin and restore oxygen transport in the blood.

Do not receive Methylthioninium Chloride Proveblue:

• if you are allergic to methylthioninium chloride or other thiazine-derived dyes
• if your body does not produce a sufficient amount of the enzyme G6PD (glucose-6-phosphate dehydrogenase)
• if your body does not produce a sufficient amount of the enzyme NADPH (nicotinamide adenine dinucleotide phosphate) reductase
• if the blood disorder was caused by nitrite during cyanide poisoning treatment
• if the blood disorder was caused by a chlorate overdose.

Warnings and Precautions

Consult your doctor or nurse before receiving Methylthioninium Chloride Proveblue

• if you have moderate or severe kidney disease; may need to reduce the dose (<1>
• if your blood disorder was caused by a chemical substance called aniline, contained in dyes; may need to reduce the dose, and the total accumulated dose should not exceed 4 mg/kg (see section 3 of this leaflet)
• if your blood disorder was caused by a medication called dapsone (used to treat leprosy and other skin diseases); may need to reduce the dose, and the total accumulated dose should not exceed 4 mg/kg (see section 3)
• if you have hyperglycemia or diabetes mellitus, as these conditions may worsen due to the glucose solution used for diluting the medication

-The urine and feces may turn blue-green in color, and it is possible that the skin may turn blue during treatment with Methylthioninium Chloride Proveblue. This color change is predictable and will disappear when treatment is completed.

If any of the above situations apply to you, consult your doctor.

Sensitivity to Light

Methylthioninium chloride may cause a photosensitivity reaction in the skin (a reaction similar to sunburn) when exposed to intense light sources such as phototherapy, operating room lights, and pulse oximeters.

Protective measures against light exposure should be taken.

Control Tests

You will undergo control tests during and after treatment with Methylthioninium Chloride Proveblue.

Children

Special care should be taken with Methylthioninium Chloride Proveblue:

-In newborns and infants under 3 months, lower doses are recommended (see section 3 of this leaflet).

Other Medications and Methylthioninium Chloride Proveblue

Inform your doctor, pharmacist, or nurse if you are using or have used recently or may need to use any other medication.

Do not receive Methylthionium Chloride if you are taking certain medications for depression or anxiety that affect a brain chemical called serotonin. If used in combination with these medications, methylthioninium chloride may cause serotonin syndrome, which can be potentially fatal. These medications are:

• selective serotonin reuptake inhibitors (SSRIs) such as citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, and zimeldine
• bupropion
• buspirone
• clomipramine
• mirtazapine
• venlafaxine
• monoamine oxidase inhibitors.

However, if it cannot be avoided, administer the lowest possible dose and monitor for 4 hours after administration.

If you have any doubts about whether you should receive this medication, consult your doctor.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor before receiving this medication.

The use of Methylthioninium Chloride Proveblue during pregnancy is not recommended unless clearly necessary, for example, in a potentially life-threatening situation.

Due to the lack of data on whether methylthioninium chloride passes into human milk, breastfeeding should be interrupted for 8 days after treatment with this medication.

Driving and Operating Machines

Do not drive or operate tools or machines because methylthioninium chloride has a moderate effect on the ability to drive and use machines.

The doctor will inject this medication into a vein (intravenously) slowly over a period of 5 minutes.

Adults, children over 3 months, and the elderly

The usual dose is 1 to 2 mg per kilogram of body weight, that is, 0.20 to 0.4 ml per kilogram, administered over a period of 5 minutes. A second dose may be administered after 1 hour if necessary.

The maximum recommended cumulative dose throughout treatment is 7 mg/kg.

If the blood disorder has been caused by aniline or dapsone, the total cumulative dose should not exceed 4 mg/kg (see section 2).

Generally, treatment should not last more than 1 day.

Infants under 3 months

The recommended dose is 0.3 to 0.5 mg/kg of body weight, that is, 0.06 to 0.1 ml/kg, administered over a period of 5 minutes.

A repeated dose (0.3 to 0.5 mg/kg of body weight, that is, 0.06-0.1 ml/kg) may be administered after 1 hour if symptoms persist or recur. Generally, treatment should not last more than 1 day.

This medication may be diluted in 50 ml of 5% glucose injectable solution (50 mg/ml) to avoid local pain, especially in children.

If you receive more Cloruro de metiltioninio Proveblue than you should

Since this medication will be administered to you while you are in the hospital, it is unlikely that you will receive an excessive or insufficient amount; however, inform your doctor if you observe any of the following adverse reactions:

• nausea
• stomach pain
• chest pain
• dizziness
• headache
• sweating
• confusion
• increased methemoglobin (an abnormal form of hemoglobin in the blood)
• high blood pressure
• difficulty breathing
• abnormally rapid heart rate
• trembling
• skin discoloration (it is possible that the skin may turn blue)
• reduction in the number of red blood cells, which may cause pallor, shortness of breath, and weakness
• jaundice (yellowing of the skin and eyes); only reported in infants

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Methylthioninium Chloride Proveblue can cause side effects, although not everyone will experience them.

These side effects are identical in adults and children, except for jaundice, which has only been described in infants.

• Very common side effects(may affect more than 1 in 10 people)

• limb pain
• dizziness

-sweating

-skin color changes. The skin may turn blue

-blue or green urine

• numbness and tingling
• abnormal taste in the mouth
• nausea

• Common side effects(may affect up to 1 in 10 people):

• stomach pain
• chest pain
• headache
• anxiety
• pain at the injection site
• vomiting

• Unknown frequency(the frequency cannot be estimated from the available data):

• serotonin syndrome when Methylthioninium Chloride Proveblue is taken with certain medications for depression or anxiety, see section 2
• reduction of hemoglobin levels (protein in red blood cells that carries oxygen in the blood) in blood tests
• reduction in the number of red blood cells, which can cause paleness, shortness of breath, and weakness
• tissue damage at the injection site
• jaundice (yellowing of the skin and eyes); only reported in infants
• difficulty speaking
• increase or decrease in blood pressure
• agitation
• lack of oxygen
• irregular heartbeats, including an abnormally slow or fast heart rate
• severe allergic reactions (anaphylaxis, which can cause swelling of the throat or face, difficulty breathing, or intense rash)
• increase in methemoglobin (an abnormal form of hemoglobin in the blood)
• difficulty breathing
• confusion
• tremors
• hallucinations
• fever
• rapid breathing
• pupil dilation
• change in stool color. They may appear green or blue
• increased skin sensitivity to light (photosensitivity).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

This medication should not be used after the expiration date that appears on the box, and the labels on the ampule after CAD. The expiration date is the last day of the month indicated. The doctor or nurse will check that the expiration date on the label has not passed before administering the injection.

Do not refrigerate or freeze.Store the ampule in the original packaging to protect it from light.

The medication must be used immediately after opening or dilution.

Do not use Methionine Chloride Proveblue if the solution shows color changes, is cloudy or

contains precipitates or particles.

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

Composition of Methionine Chloride Proveblue

• The active ingredient is methionine chloride.

Each milliliter of solution contains 5 mg of methionine chloride. Each ampoule of 10 ml contains 50 mg of

methionine chloride.Each ampoule of 2 ml contains 10 mg of methionine chloride.

• The other component is water for injection preparations.

Appearance of the product and contents of the package

Methionine Chloride Proveblue is a clear, dark blue injectable solution that is supplied in transparent glass ampoules.

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.

Marketing Authorization Holder

Provepharm SAS

22 rue Marc Donadille, 13013 Marseille, France

Responsible for manufacturing

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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

België/Belgique/Belgien

Lamepro B.V.

Tél/Tel: + 31 (0) 76-5600030

Lietuva

Provepharm SAS

Tel: +33 (0)4 91 08 69 30

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Provepharm SAS

Te?.: + 33 (0)4 91 08 69 30

Luxembourg/Luxemburg

Lamepro B.V.

Tél/Tel: + 31 (0) 76-5600030

Ceskárepublika

LERAM pharmaceuticals s.r.o

Tel: +420 737 657 454

Magyarország

Mediwings Pharma Kft.

Tel.: + 36 28 410 463

Danmark

Pharmanovia A/S

Tlf: + 45 33 33 76 33

Malta

Provepharm SAS

Tel: + 33 (0)4 91 08 69 30

Deutschland

Dr. Franz Köhler Chemie GmbH

Tel: + 49 (0) 6251-1083-0

Nederland

Lamepro B.V

Tel: + 31 (0) 76-5600030

Eesti

Provepharm SAS

Tel: + 33 (0)4 91 08 69 30

Norge

Pharmanovia A/S

Tlf: + 45 33 33 76 33

Ελλ?δα

a VIPharma International AE

Τηλ: +30-210-6194170

Österreich

Dr. Franz Köhler Chemie GmbH

Tel: + 49 (0) 6251-1083-0

España

Fresenius Kabi España, S.A.U.

Tel: + 34 93 225 65 65

Polska

AB Pharm Sp. z o.o.

Tel: + 48 694 775 205

France

Provepharm SAS

Tél: + 33 (0)4 91 08 69 30

Portugal

Labesfal - Laboratórios Almiro

Tel: + 351 232 831100

Hrvatska

Provepharm SAS

Tel: + 33 (0)4 91 08 69 30

Ireland

Laboratoires ETHYPHARM

Tel: + 33 1 41 12 65 63

România

Dynamic Medical Solutions

Tel: + 40 (0)725596648

Slovenija

Provepharm SAS

Tel: + 33 (0)4 91 08 69 30

Ísland

Pharmanovia A/S

Sími: + 45 33 33 76 33

Slovenská republika

LERAM pharmaceuticals s.r.o

Tel: +420 737 657 454

Italia

Medac Pharma S.r.l.

Tel: + 39 06 51 59 121

Suomi/Finland

Pharmanovia A/S

Puh/Tel: + 4533 33 76 33

Κ?προς

Isangen Pharma Cyprus Ltd

Τηλ: + 357-24-638833

Sverige

Pharmanovia A/S

Tel: + 45 33 33 76 33

Latvija

Provepharm SAS

Tel: + 33 (0)4 91 08 69 30

United Kingdom

Martindale Pharmaceuticals Ltd

Tel: + 44 (0)1277 266600

Last revision date of this leaflet:

The detailed information about this medication is available on the website of the European Medicines Agency:http://www.ema.europa.eu/.

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This information is intended solely for healthcare professionals:

Preparation for intravenous administration

Use the product immediately after opening. Inject it very slowly over 5 minutes.

Methionine Chloride Proveblue is hypotonic and can be diluted in 50 ml of 5% glucose injectable solution (50 mg/ml) to avoid local pain, especially in pediatric populations. Do not dilute it in 0.9% sodium chloride injectable solution (9 mg/ml), as it has been shown that sodium chloride reduces the solubility of methionine chloride.

Additional information on the administration of Methionine Chloride Proveblue is provided in Section 3 of the leaflet.

The elimination of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.