Mannitol FKI

Package leaflet: Information for the user

MANNITOL FRESENIUS KABI ITALIA 10% infusion solution

MANNITOL FRESENIUS KABI ITALIA 18% infusion solution
Please read all of this leaflet carefully before you start using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What MANNITOL FRESENIUS KABI ITALIA is and what it is used for
2. What you need to know before using MANNITOL FRESENIUS KABI ITALIA
3. How to use MANNITOL FRESENIUS KABI ITALIA
4. Possible side effects
5. How to store MANNITOL FRESENIUS KABI ITALIA
6. Contents of the pack and other information

1. What MANNITOLO FRESENIUS KABI ITALIA is and what it is used for

MANNITOLO FRESENIUS KABI ITALIA contains the active substance mannitol, which belongs to a group of medicines called osmotic diuretics, which increase the amount of urine produced by the kidneys, thereby facilitating the elimination of excess water from the body.

This medicine is indicated for:

• the prevention and/or treatment of low urine output in the presence of severe kidney problems (oliguric phase of acute renal failure);
• reducing elevated pressure within the skull, spinal cord, and due to cerebral masses (intracranial and spinal hypertension and cerebral masses);
• reducing pressure within the eyes (intraocular pressure);
• increasing the elimination of toxic substances through the kidneys.

2. What you need to know before using MANNITOL FRESENIUS KABI ITALIA

Do not use MANNITOL FRESENIUS KABI ITALIA

• if you are allergic to mannitol or to any of the other ingredients of this medicine (listed in section 6);
• if you are not producing urine (anuria) due to severe kidney problems (severe renal impairment);
• if you have increased blood in the lungs (pulmonary congestion) or fluid accumulation around the lungs (pulmonary edema);
• if you have active bleeding in the brain (active cerebral or intracranial hemorrhage);
• if you suffer from severe fluid loss (severe dehydration).

If you require blood transfusions, healthcare professionals must not administer this medicine through the same catheter as blood, as this may damage the blood (pseudoagglutination). This medicine must not be used to carry other medicines.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using MANNITOL FRESENIUS KABI ITALIA
This medicine should be administered with caution in the following cases:

• if you suffer from severe heart (congestive heart failure) or kidney problems (severe renal failure);
• if you experience swelling due to fluid accumulation (edema), poor fluid and salt elimination (hydro-saline retention), increased acid levels in the blood (acidosis), or severe fluid loss (marked dehydration);
• if you are taking medicines used to treat inflammation and allergies (corticosteroids) or medicines that stimulate steroid hormone production (corticotropins);
• if you are scheduled to receive blood transfusions. In this case, the doctor must add 20 mEq of sodium chloride to each liter of the medicine.

During treatment with MANNITOL FRESENIUS KABI ITALIA, your doctor should monitor:

• fluid, electrolyte, and substance levels in the blood (plasma osmolarity);
• your kidney function to prevent serious complications (irreversible osmotic nephrosis);
• urine output (diuresis) to avoid mannitol accumulation, which could cause serious heart problems (heart failure);
• brain blood pressure (cerebral perfusion pressure), which must be maintained above 70 mm Hg.

For athletes: Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Children
There are no available data on the use of this medicine in children.
Other medicines and MANNITOL FRESENIUS KABI ITALIA
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking the following medicines, as mannitol may increase their toxicity:

• aminoglycoside antibiotics, used to treat infections;
• curare-type muscle relaxants, used to relax muscles during surgical procedures;
• digoxin, used for heart problems, particularly if low potassium levels in the blood (hypokalemia) occur.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor, pharmacist, or nurse before using this medicine.
If you are pregnant or breastfeeding, your doctor will evaluate the risk/benefit ratio and will administer this medicine only if clearly necessary and under strict medical supervision.
Driving and using machines
This medicine does not impair the ability to drive or use machinery.

3. How to use MANNITOL FRESENIUS KABI ITALIA

Use this medicine exactly as directed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
The recommended dose will be determined by your doctor based on your age, body weight, and general health condition.

Use in adults
Treatment of low urine output due to severe kidney problems (oliguric renal failure)
The recommended dose ranges from 50 to 100 g of mannitol, administered at a rate sufficient to promote adequate urine output (30–50 mL/hour).

Treatment of increased blood pressure in the brain (intracranial) and within the eyes (intraocular)
The recommended dose is 0.5–2 g of mannitol per kg of body weight, administered by infusion over 30–60 minutes.

Increased elimination of toxic substances through the kidneys
In this case, the 5% mannitol solution is recommended, administered at a rate sufficient to achieve higher urine output (150–500 mL/hour).

Use in children
Treatment of low urine output due to severe kidney problems (oliguric renal failure)
The recommended dose is 0.25–2 g of mannitol per kg of body weight (or 60 g/m² of body surface area), administered by infusion over 2–6 hours.

• Treatment of increased blood pressure in the brain (intracranial) and within the eye (intraocular) The recommended dose is 1–2 g of mannitol per kg of body weight (or 30–60 g/m² of body surface area).

Use in debilitated patients
In debilitated patients, a reduced dose may be required (500 mg/kg).

If you use more MANNITOL FRESENIUS KABI ITALIA than you should
In case of accidental overdose by excessive infusion, treatment will be stopped and you will be closely monitored for any signs or symptoms related to the administered medicine, with appropriate supportive care and symptomatic treatment provided as needed.
If you ingest or take an excessive amount of this medicine, stop treatment immediately and seek medical advice right away from your doctor or go to the nearest hospital.

If you forget to use MANNITOL FRESENIUS KABI ITALIA
Do not use a double dose to make up for the missed dose.

If you stop using MANNITOL FRESENIUS KABI ITALIA
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The side effects that may occur are listed below:
Frequency not known (frequency cannot be estimated from the available data)

• allergic reactions (hypersensitivity), skin rash (urticaria);
• headache (cephalalgia), seizures, feeling faint;
• blurred vision;
• serious heart problems (congestive heart failure), increased heart rate (tachycardia), chest pain (anginal pain);
• nausea, vomiting, diarrhoea;
• inability of the bladder to empty (urinary retention);
• low blood pressure (hypotension);
• swelling due to fluid accumulation around the lungs (pulmonary oedema);
• changes in levels of water, salts and other substances in the blood (electrolyte and acid-base imbalances), reduced levels of sodium in the blood (hyponatraemia), dehydration;
• febrile reactions, chills, pain and infection at the infusion site, formation of blood clots in veins (venous thrombosis), inflammation of the veins (venous phlebitis) also in areas near the infusion site, tissue damage and death (tissue necrosis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. You may also report side effects directly through the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MANNITOLO FRESENIUS KABI ITALIA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Store this medicine in its original packaging and in a tightly closed container.
Store at a temperature above 15°C. Do not refrigerate or freeze.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MANNITOLO FRESENIUS KABI ITALIA 10% infusion solution contains

• The active substance is mannitol. Each litre of solution (1000 ml) contains 100 g of mannitol.
• The other component is water for injections.

What MANNITOLO FRESENIUS KABI ITALIA 18% infusion solution contains

• The active substance is mannitol. Each litre of solution (1000 ml) contains 180 g of mannitol.
• The other component is water for injections.

Description of the appearance of MANNITOLO FRESENIUS KABI ITALIA and contents of the pack
MANNITOLO FRESENIUS KABI ITALIA 10% infusion solution, sterile and pyrogen-free
Bottle of 50 ml, 100 ml, 250 ml, 24x250 ml, 500 ml, 20x500 ml and 1000 ml.
MANNITOLO FRESENIUS KABI ITALIA 18% infusion solution, sterile and pyrogen-free
Bottle of 50 ml, 100 ml, 49x100 ml, 250 ml, 24x250 ml, 500 ml, 20x500 ml and 1000 ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Fresenius Kabi Italia S.r.l.
Via Camagre, 41
37063 Isola della Scala (Verona) - Italy

Manufacturer:
Fresenius Kabi Italia S.r.l. – Via Camagre, 41 – 37063 Isola della Scala (VR)
S.M. Farmaceutici S.r.l. – Zona Industriale – 85050 Tito (PZ)

The following information is intended exclusively for physicians or healthcare professionals

Dosage and method of administration
The 5% mannitol solution is isotonic with blood. The 10% and 18% mannitol solutions are hypertonic with blood and must be administered by intravenous infusion with caution and at a controlled infusion rate; these solutions should not be used unless specifically prescribed. The dose depends on the patient's age, weight, and clinical condition.

Adults
Treatment of oliguric renal failure: After possible correction of plasma volume, administer a test dose of approximately 200 mg/kg body weight by infusion over 3–5 minutes to achieve a diuresis of 30–50 mL/hour for the following 2–3 hours. A second test dose may be administered if the response is inadequate. Usual doses of mannitol range from 50 to 100 g, with an infusion rate adjusted to maintain a urinary flow of 30–50 mL/hour.

Reduction of intracranial or intraocular pressure: Administer 0.5–2 g of mannitol/kg body weight over 30–60 minutes.

Increased renal excretion of toxic substances: Administer 5% mannitol at an infusion rate sufficient to maintain a urinary flow of 150–500 mL/hour.

Children
The safety and efficacy of mannitol in children have not been established.

Treatment of oliguric renal failure: Administer 0.25–2 g of mannitol/kg body weight or 60 g/m² of body surface area over 2–6 hours.

Reduction of intracranial or intraocular pressure: Administer 1–2 g of mannitol/kg body weight or 30–60 g/m² of body surface area.

Use in debilitated patients
In debilitated patients, 500 mg of mannitol/kg body weight may be sufficient.

Incompatibilities
Avoid adding adrenocorticotropic hormones, barbiturates, noradrenaline, metaraminol, suxamethonium, etoposide, aztreonam, or filgrastim to the mannitol solution.
The prescribing physician should refer to the scientific literature.

Special warnings and precautions for use
The medicinal product must be used with caution in patients with congestive heart failure, severe renal failure, conditions associated with edema and water-sodium retention, acidosis, and marked dehydration, as well as in patients receiving corticosteroid or corticotropin therapy.

If it is necessary to administer the medicinal product simultaneously with blood transfusion, add 20 mEq of sodium chloride to the medicinal product for each liter of mannitol solution.

During mannitol administration, the following parameters must be monitored:

• Fluid balance, electrolytes, and plasma osmolarity;
• Renal function to prevent irreversible osmotic nephrosis;
• Urine output to avoid mannitol accumulation, which may lead to cardiac decompensation;
• Cerebral perfusion pressure, which must always be maintained above 70 mmHg.

In patients with severe renal failure, a first and second test dose should be used to assess patient tolerance.

Use immediately after opening the container. The container is intended for single, uninterrupted administration; any remaining solution must not be used. The solution must be clear, colorless, and free from visible particles. Do not infuse if crystals are present; any precipitate may be dissolved by brief exposure to a temperature of 40–70°C (using a water bath), then allowed to cool before use.

Special handling precautions
Shake well before administration.
Do not use the medicinal product if the solution is not clear and colorless or if it contains particles.
Observe all standard precautions to maintain sterility before and during intravenous infusion.

Overdose
In case of accidental excessive infusion, treatment should be discontinued and the patient should be closely observed for any signs and symptoms related to the administered drug. Provide appropriate symptomatic and supportive measures as needed.

For further information, consult the Summary of Product Characteristics.