MANITOL MEIN 10% solution for infusion

Introduction

PROSPECTUS: INFORMATION FOR THE USER

MANITOL MEIN 10% solution for infusion

Manitol

Read the entire prospectus carefully before starting to use this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Contents of the prospectus:

1. What is MANITOL MEIN 10% and what is it used for
2. What you need to know before starting to use MANITOL MEIN 10%
3. How to use MANITOL MEIN 10%
4. Possible adverse effects
5. Storage of MANITOL MEIN 10%
6. Package contents and additional information

1. What is MANITOL MEIN 10% and what is it used for

Manitol Mein 10% belongs to a group of medications called osmotic diuretics, which increase the amount of urine produced by your body.

It is used to remove excess fluid from the body in different situations:

• Reducing intraocular pressure (glaucoma) when it cannot be reduced by other means.
• Reducing intracranial pressure when the blood-brain barrier is intact.
• Stimulating urine production when there are kidney problems and/or fluid accumulation, before irreversible renal failure is established.
• Intoxications (by toxins that are eliminated by the kidneys).

2. WHAT YOU NEED TO KNOW BEFORE STARTING TO USE MANITOL MEIN 10%

Do not use MANITOL MEIN 10%

• If you are allergic to manitol or any of the other components of this medication (listed in section 6).
• Hypersomolarity (high salt concentration in the blood)
• If you are unable to urinate or urinate very little due to kidney failure.
• If you have severe heart failure or severe arterial hypertension.
• If you are severely dehydrated (have lost a large amount of body fluid, for example due to severe vomiting or diarrhea).
• If you have severe pulmonary congestion or pulmonary edema.
• If you have active bleeding within the skull (except if it occurs during a skull operation).
• If you have alterations of the blood-brain barrier.

Warnings and precautions:

• Water and electrolyte balance may be affected during treatment. Your doctor will regularly check your water and electrolyte balance, serum osmolarity, and renal function.
• Manitol should not be administered with whole blood.
• Your doctor will assess your cardiovascular function before administering manitol rapidly.
• If your urine production is low or absent, precautions should be taken. Your doctor will perform a test infusion to check if urine is produced. If not, the infusion should not be continued.
• If you are exposed to low temperatures, the manitol solution may crystallize (see information for healthcare professionals).
• Your doctor will monitor your heart, kidney, and lung function and interrupt treatment in case of adverse effects.
• Be careful if you have congestive heart failure. Manitol accumulation may occur if urine production decreases during administration, which can worsen existing congestive heart failure.

Manitol may mask and exacerbate fluid deficiency in the body.

Administration of manitol should always be under strict medical control and only used for osmotherapy.

Use of other medications:

Tell your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

In particular, inform your doctor or pharmacist if you are taking:

• Ciclosporin - used to prevent rejection in transplants, as some studies indicate that it may enhance kidney toxicity.
• Digitalis glycosides - used for the heart, as manitol may enhance the toxicity of these medications.
• Lithium: manitol increases its elimination by the kidneys.
• Diuretics: the dose of manitol should be adjusted when used in combination with other medications used to eliminate fluids.

Do not administer with whole blood due to the risk of agglutination.

In the absence of compatibility studies, this medication should not be mixed with other medications.

This medication may interfere with laboratory test results, such as the determination of inorganic phosphorus or ethylene glycol in blood.

Pregnancy and lactation:

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

There are no data or limited data on the use of manitol in pregnant women.

The use of the medication during pregnancy may be considered in cases where it is clinically indicated.

Driving and using machines:

There is no indication that this medication may affect the ability to drive vehicles or operate complex machinery.

Important information about some of the components of Manitol Mein 10%

This medication contains manitol, which may result in a positive doping test.

3. HOW TO USE MANITOL MEIN 10%

Manitol Mein 10% will be administered intravenously in a hospital by healthcare professionals. The volume and rate of infusion will depend on your needs. Your doctor will decide what dose you should receive.

If you receive more MANITOL MEIN 10% than you should:

Overdose is manifested as an increase in plasma volume leading to cardiac decompensation, increased acid in the body, water/electrolyte imbalance, increased osmolarity, dehydration of cells, and acute renal failure (especially when diuretics are administered and pre-existing kidney disorders are present).

The first signs of overdose may appear as headache, nausea, and chills without temperature changes, which can progress to confusion, lethargy, convulsions, stupor, and coma.

If any of these effects occur, stop the administration of the medication immediately and initiate treatment of the symptoms. Correct the water and electrolyte balance.

In case of overdose or accidental ingestion, go to a medical center immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested.

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

4. Possible adverse effects

Like all medications, MANITOL MEIN 10% may cause adverse effects, although not all people experience them.

During treatment with manitol, the following adverse effects may appear, although their frequency has not been established:

• Water balance disorders with dehydration and loss of electrolytes (loss of fluid and salts from the body)
• Pulmonary edema (fluid accumulation in the lungs)
• Acute renal failure (kidney failure)
• Hypersensitivity reactions (allergic reactions)
• Confusional states
• Cramps
• Tachycardia
• Stomach discomfort
• Nausea and vomiting

Rapid administration of the medication may cause headache, chills, chest pain, and alterations in acid/base and water/electrolyte balance.

Administration of high doses may cause a syndrome similar to water intoxication, elimination of sodium and chloride (salts) in the urine, osmotic nephrosis (inflammation of the kidney tubules), and convulsions.

Other reactions due to the solution or administration technique, such as fever, infection at the injection site, venous thrombosis, or phlebitis (inflammation of the vein wall), extravasation (fluid passage into tissues), and hypervolemia (increased blood volume) may also occur.

If an undesirable effect appears, stop the administration of manitol and establish the necessary corrective measures.

If you experience adverse effects, consult your doctor or nurse, even if they are not listed in this prospectus.

5. Storage of MANITOL MEIN 10%

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

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if the solution is not transparent and free of visible precipitates.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Additional information

The active ingredient is manitol (DCI). Each ml of solution contains 100 mg of manitol. The other components are: water for injection.

Appearance of the product and package contents

Manitol Mein 10% is a clear and colorless solution, packaged in a glass vial. It is available in 250 ml and 500 ml vials.

Marketing authorization holder and manufacturer

FRESENIUS KABI ESPAÑA, S.A.U.

C/ Marina 16 – 18

08005 Barcelona

Fresenius Kabi Italia S.R.L.

Via Camagre, 41/43

37063 Isola della Scala (VR)

Italy

This prospectus was approved in October 2012

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

Manitol Mein 10% is administered intravenously. The administration regimen will depend on the patient's age, weight, clinical situation, and concomitant therapy. The general dose usually administered is 500-1000 ml per day, at a rate of 40-60 drops/minute.

Reduction of intracranial pressure and intraocular pressure:0.25-0.5 g manitol/kg body weight (~2.5-5 ml of MANITOL 10%/kg body weight) as a bolus over 10-30 minutes. Higher doses of manitol may be necessary.

Maximum daily dose: 1.5 g manitol/kg body weight (~15 ml of MANITOL 10%/kg body weight).

Prevention of acute renal failure (after test infusion) and stimulation of urine production (diuresis):Test infusion of 0.15-0.25 g manitol/kg body weight (~1.5-2.5 ml of MANITOL 10%/kg body weight) as a bolus over 3-5 minutes. If a diuresis of at least 40 ml/h is achieved in the following 3 hours, a continuous infusion of 0.15-0.3 g manitol/kg body weight/h (~1.5-3 ml of MANITOL 10%/kg body weight/h) may be administered.

The maximum daily dose should not be exceeded: 1.5 g manitol/kg body weight (~15 ml of MANITOL 10%/kg body weight).

If no effect is achieved with the test infusion, treatment with manitol should be discontinued and other measures considered (e.g., dialysis).

Guidelines for correct administration

Use a perfusion system with a filter.

Disinfect the rubber stopper before puncturing with the equipment. Do not use started solutions. It is recommended not to add any medication to the vial. Do not use previously used equipment, especially with blood (hemolysis).

The manitol solution may crystallize, which does not affect the product quality. In case of crystal presence in the solution, it is recommended to heat the vial in a water bath (between 50-70°C) until complete dissolution of the crystals. To avoid the passage of any small, invisible manitol crystals into the circulatory system, infusion equipment with a 12-15 micron filter can be used. The temperature of the solution to be injected should be at room temperature.

In case of excessive infusion rate or overdose, there is a risk of acute hypervolemia with cardiovascular system involvement.

Maximum infusion rate:

3 ml/kg body weight and hour, which corresponds to 0.3 g manitol/kg body weight and hour.

210 ml/70 kg body weight, which corresponds to 21 g manitol/70 kg body weight

Maximum daily dose:

Approx. 15 ml/kg body weight, which corresponds to approx. 1.5 g manitol/kg body weight

1050 ml/70 kg body weight, which corresponds to 105 g manitol/70 kg body weight

The duration of use is determined based on clinical requirements and should be decided by the doctor.

Do not administer with whole blood due to the risk of agglutination.

In the absence of compatibility studies, this medication should not be mixed with other medications.