MANITOL MEIN 20% solution for infusion

2. WHAT YOU NEED TO KNOW BEFORE YOU USE MANITOL MEIN 20%

Do not use MANITOL MEIN 20%

• If you are allergic to manitol or any of the other ingredients of this medicine (listed in section 6).
• Hyperosmolarity (high concentration of salts in the blood).
• If you are unable to urinate or urinate very little due to kidney failure.
• If you have heart failure or severe high blood pressure.
• 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 inside the skull (except if it occurs during a skull operation).
• If you have alterations of the blood-brain barrier (the barrier that separates the nervous system from the blood vessels).

Warnings and precautions:

• The balance of water and electrolytes may be affected during treatment. Your doctor will perform regular checks of water and electrolyte balance, serum osmolarity, and renal function.

Your doctor will evaluate your cardiovascular function before administering manitol rapidly.

• Manitol should not be administered with whole blood.
• 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 the functioning of your heart, kidneys, and lungs and interrupt treatment in case of adverse effects.
• Be careful if you have congestive heart failure. Manitol accumulation can occur if urine production decreases during administration, which can worsen existing congestive heart failure.
• Manitol can hide and intensify fluid deficiency in the body.

The administration of manitol should always be done under strict medical control and only used for osmotherapy.

Use of other medicines:

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

In particular, tell 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 types of medicines.
• Lithium: manitol increases its elimination by the kidneys.
• Diuretics: the dose of manitol should be adjusted when used in combination with other medicines used to eliminate fluids.

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

In the absence of compatibility studies, this medicine should not be mixed with other medicines.

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

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 using this medicine.

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

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

Driving and using machines:

There is no indication that this medicine may affect the ability to drive or use machines.

Important information about some of the ingredients of Manitol Mein 20%

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

3. HOW TO USE MANITOL MEIN 20%

Manitol Mein 20% 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 20% than you should:

Overdose is manifested as an increase in plasma volume leading to cardiac decompensation, increased acid in the body, alterations in water/electrolyte balance, 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 changes in temperature, which can progress to confusion, lethargy, convulsions, stupor, and coma.

If any of these effects occur, stop the administration of the medicine immediately and initiate treatment of the symptoms. Correct the fluid and hydroelectrolytic balance.

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, MANITOL MEIN 20% can cause side effects, although not everybody gets them.

During treatment with manitol, the following side effects may occur, although the frequency cannot be established:

• Disorders of water balance 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)
• States of confusion
• Cramps
• Tachycardia
• Stomach discomfort
• Nausea and vomiting

Rapid administration of the medicine 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 chlorides (salts) in 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 (leakage of fluid into tissues), and hypervolemia (increased blood volume), may also occur.

If an undesirable effect occurs, the administration of manitol should be stopped, and corrective measures should be taken.

If you experience side effects, talk to your doctor or nurse, even if they are not listed in this leaflet.

5. Storage of MANITOL MEIN 20%

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Do not use this medicine if the solution is not clear and free from visible particles.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. FURTHER INFORMATION

The active substance is manitol (DCI). Each ml of solution contains 200 mg of manitol. The other ingredients are: water for injections.

Appearance and packaging

Manitol Mein 20% is a clear and colorless solution, packaged in glass vials. 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 leaflet was approved in October 2012

Detailed and updated information on this medicine 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 for healthcare professionals only:

Manitol Mein 20% is administered intravenously. The administration regimen will depend on the patient's age, weight, clinical situation, and concomitant therapy. The usual dose 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 20%/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 20%/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 20%/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 20%/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 20%/kg body weight).

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

Guidelines for correct administration

Use an infusion system with a filter.

Disinfect the rubber stopper before puncture 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 quality of the product. In case of crystal presence in the solution, it is recommended to heat the vial in a water bath (between 50-70°C) until the 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.

1,050 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 medicine should not be mixed with other medicines.