Mannitol Eurospital
ItalyTable of Contents
Package leaflet: Information for the user
Mannitol Eurospital 5% solution for infusion
Generic medicine
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 pass it on to other people, even if they have the same symptoms as you, because it could 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:
- What Mannitol Eurospital is and what it is used for
- What you need to know before you use Mannitol Eurospital
- How to use Mannitol Eurospital
- Possible side effects
- How to store Mannitol Eurospital
- Contents of the pack and other information
1. What Mannitolo Eurospital is and what it is used for
Mannitolo Eurospital contains the active substance mannitol and belongs to the group of osmotic diuretics, which facilitate the elimination of excess water from the body. Mannitol distributes exclusively in the extracellular space, causing fluid to move out of cells and increasing the volume of circulating blood; it is rapidly eliminated by the kidneys, resulting in the production of a significant amount of urine.
Mannitolo Eurospital is indicated:
- In the prevention and/or treatment of the oliguric phase in acute renal failure (characterized by low urine output), before it becomes irreversible and established;
- In the treatment of increased intracranial and intraspinal pressure and cerebral masses;
- To reduce intraocular pressure;
- To increase renal excretion of toxic substances;
- For the measurement of glomerular filtration rate (assessment of kidney function).
2. What you need to know before using Mannitolo Eurospital
Do not use Mannitolo Eurospital
- if you are allergic to mannitol or to any of the other ingredients of this medicine (listed in section 6).
- if you have anuria (lack of urine production) due to severe kidney impairment
- if you have pulmonary congestion and pulmonary edema (accumulation of fluid in the lungs)
- in case of active cerebral or intracranial hemorrhage
- in case of severe dehydration
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Mannitolo Eurospital.
This medicine must be administered to you with great caution:
- if you have severe heart problems (congestive heart failure)
- if you have severe renal failure and clinical conditions associated with edema and fluid and salt retention. In cases of severe renal failure, an initial test dose should be administered to assess patient tolerance.
- if you are being treated with corticosteroid or corticotropin medications.
This medicine must not be administered:
- simultaneously with blood transfusion through the same intravenous infusion line, due to the risk of pseudo-agglutination. If concomitant administration with blood transfusion is necessary, add 20 mEq of sodium chloride per liter of mannitol solution.
During treatment with Mannitolo Eurospital, the following should be monitored:
- renal function, to prevent irreversible osmotic nephrosis (kidney cell damage);
- urine output, to avoid accumulation of mannitol, which could lead to heart failure.
- fluid balance, electrolytes, and plasma osmolarity (levels of fluids, salts, and substances in the blood).
Children
The safety and efficacy in children have not been established.
Other medicines and Mannitolo Eurospital
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
This medicine must not be used as a vehicle for other medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor, pharmacist, or nurse before using this medicine.
This medicine may be administered during pregnancy and while breastfeeding only if clearly needed and under strict medical supervision.
Driving and using machines
Consult your doctor for any information regarding your ability to drive or operate machinery.
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
3. How to use Mannitolo Eurospital
This medicine must be administered to you exactly as directed by your doctor, nurse, or pharmacist.
If you have any doubts, consult your doctor, nurse, or pharmacist.
For intravenous use only.
The recommended dose will be determined by your doctor based on your age, body weight, and health condition.
However, the total dose must be between 50 and 200 g of mannitol in 24 hours. The infusion rate should be adjusted to maintain a urine output of at least 30–50 ml/hour.
If you use more Mannitolo Eurospital than you should
If you accidentally take or receive too much of this medicine, stop the treatment immediately and contact your doctor or go to the nearest hospital without delay.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur with the use of Mannitol Eurospital:
- Hydroelectrolytic and acid-base balance disorders (alterations in body fluids, salts, and blood acidity);
- Congestive heart failure;
- Urinary retention;
- Headache;
- Blurred vision;
- Seizures;
- Nausea and vomiting;
- Feeling faint;
- Low blood pressure;
- Tachycardia;
- Fever and angina-like pain (chest pain);
- Infection at the injection site;
- Venous thrombosis or phlebitis (inflammation of the veins or blood clot formation);
- Tissue necrosis (tissue death).
If a side effect occurs, stop administration and keep the unused portion for possible testing.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse. You may also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Mannitolo Eurospital
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. The expiry date applies to the product in its original, unopened packaging, correctly stored.
Store in tightly closed containers.
Protect from freezing.
Store at a temperature between 15°C and 30°C.
Do not use this medicine if you notice any visible signs of deterioration.
Use immediately after opening the container.
The solution must be clear, colourless, free from visible particles, and under vacuum. To check for vacuum, insert the vial adapter while holding the vial upside down: bubbling should be observed. Do not administer if crystals are present; any precipitate that may be present can be redissolved by brief exposure to a temperature not exceeding 40–70°C; allow to cool before use.
This preparation is intended for single, uninterrupted administration; any remaining solution must not be used.
Do not dispose of any medicine 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 Eurospital contains
The active substance is mannitol. 1000 ml contain 50.0 g of mannitol. [mmol/l: (C H O ) 274] -
[Theoretical osmolarity: mOsm/l 274] pH between 4.5 and 7.0.
The other component is water for injections.
Description of the appearance of Mannitolo Eurospital and contents of the pack
Sterile, pyrogen-free intravenous infusion solution, isotonic with blood.
1 glass bottle of 500 ml.
Marketing Authorization Holder
Eurospital S.p.A., Via Flavia, 122 – Trieste
Manufacturers
Laboratorios Grifols S.A., Pol. Ind. Autopista, Passeig Fluvial 24 - 08150 Parets del Vallès (Barcelona –
Spain)
Bieffe Medital S.p.A., Via Nuova Provinciale s/n – 23034 Grosotto, Italy
Package leaflet: Information for the user
Mannitol Eurospital 10% infusion solution
Equivalent medicine
Please read this leaflet carefully before 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 others, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet:
- What Mannitol Eurospital is and what it is used for
- What you need to know before using Mannitol Eurospital
- How to use Mannitol Eurospital
- Possible side effects
- How to store Mannitol Eurospital
- Package contents and other information
1. What Mannitolo Eurospital is and what it is used for
Mannitolo Eurospital contains the active substance mannitol and belongs to the group of osmotic diuretics, which facilitate the elimination of excess water from the body. Mannitol distributes exclusively in the extracellular space, causing fluid to move out of the cells and increasing the volume of circulating blood; it is rapidly eliminated by the kidneys, resulting in the production of a significant amount of urine.
Mannitolo Eurospital is indicated:
- In the prevention and/or treatment of the oliguric phase in acute renal failure (a condition characterized by low urine output), before it becomes irreversible and established;
- In the treatment of increased intracranial and spinal pressure and cerebral masses;
- To reduce intraocular pressure;
- To increase renal excretion of toxic substances;
- For the measurement of glomerular filtration rate (assessment of kidney function).
2. What you need to know before using Mannitolo Eurospital
Do not use Mannitolo Eurospital
- if you are allergic to mannitol or to any of the other ingredients of this medicine (listed in section 6).
- if you have anuria (lack of urine production) due to severe kidney impairment.
- if you have pulmonary congestion and pulmonary edema (excess fluid in the lungs).
- in case of active cerebral or intracranial hemorrhage.
- in case of severe dehydration.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Mannitolo Eurospital.
This medicine must be administered to you with great caution:
- if you have serious heart problems (congestive heart failure).
- if you have severe renal insufficiency or clinical conditions associated with edema and fluid and salt retention. In cases of severe renal insufficiency, an initial test dose should be administered to assess patient tolerance.
- if you are being treated with corticosteroid or corticotropin medications.
This medicine must not be administered:
- simultaneously with blood transfusion in the same intravenous infusion, due to the risk of pseudo-agglutination. If concomitant administration with blood transfusion is necessary, add 20 mEq of sodium chloride per liter of mannitol solution.
During treatment with Mannitolo Eurospital, the following should be monitored:
- renal function to prevent irreversible osmotic nephrosis (kidney cell damage);
- urine output to avoid mannitol accumulation, which may lead to cardiac decompensation;
- fluid balance, electrolytes, and plasma osmolarity (amounts of fluids, salts, and substances in the blood).
Children
In children, safety and efficacy have not been established.
Other medicines and Mannitolo Eurospital
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
This medicine must not be used as a vehicle for other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
This medicine may be administered during pregnancy and while breastfeeding only if clearly needed and under strict medical supervision.
Driving and using machines
Consult your doctor for any information regarding your ability to drive vehicles or operate machinery.
“For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.”
3. How to use Mannitol Eurospital
This medicine must be administered to you exactly as instructed by your doctor,
nurse, or pharmacist. If you have any doubts, consult your doctor, nurse, or pharmacist.
For intravenous use only.
Mannitol Eurospital 10% is a hypertonic intravenous solution (with a higher salt concentration than that of
blood) that must be administered with caution and at a controlled infusion rate.
Do not use this concentration unless specifically prescribed.
The recommended dose will be determined by your doctor based on your age, body weight, and health
condition. The total daily dose should be between 50 and 200 g of mannitol within 24 hours. The infusion
rate should be adjusted to maintain a urine output of at least 30–50 ml/hour.
If you use more Mannitol Eurospital than you should
In case of accidental ingestion or administration of an excessive amount of this medicine, stop treatment
immediately and contact your doctor or go to the nearest hospital without delay.
If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects may occur with the use of Mannitol Eurospital:
- Electrolyte and acid-base balance disorders (alterations in fluids, salts, and blood acidity);
- Congestive heart failure;
- Urinary retention;
- Headache;
- Blurred vision;
- Seizures;
- Nausea and vomiting;
- Feeling faint;
- Low blood pressure;
- Tachycardia;
- Fever and angina-like pain (chest pain);
- Infections at the injection site;
- Venous thrombosis or phlebitis (inflammation of veins or blood clot formation);
- Tissue necrosis (tissue death).
If a side effect occurs, stop administration and keep the unused portion for possible testing.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse. You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Mannitolo Eurospital
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. The expiry date applies to the product in its original, undamaged packaging, properly stored.
Store in tightly closed containers.
Protect from cooling.
Store at a temperature between 15°C and 30°C.
Do not use this medicine if you notice any visible signs of deterioration.
Use immediately after opening the container.
The solution must be clear, colourless, free from visible particles, and under vacuum. To check for vacuum, insert the vial adapter with the vial inverted: bubbling should be observed. Do not administer if crystals are present; any precipitate that may occur can be redissolved by brief exposure to a temperature not exceeding 40–70°C; allow to cool before use.
This medicine is intended for single and uninterrupted administration; any remaining solution must not be used.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Pack contents and other information
What Mannitolo Eurospital contains
The active substance is mannitol. 1000 ml contain 100.0 g of mannitol. [mmol/l: (C H O 549] -
[Theoretical osmolarity mOsm/l 549] – pH between 4.5 and 7.0.
The other component is water for injections.
Description of the appearance of Mannitolo Eurospital and contents of the pack
Sterile, apyrogenic, hypertonic intravenous infusion solution.
1 glass bottle of 500 ml.
Marketing Authorization Holder
Eurospital S.p.A., Via Flavia, 122 – Trieste
Manufacturers
Laboratorios Grifols S.A., Pol. Ind. Autopista, Passeig Fluvial 24 - 08150 Parets del Vallès (Barcelona –
Spain)
Bieffe Medital S.p.A., Via Nuova Provinciale s/n – 23034 Grosotto, Italy
Package leaflet: information for the user
Mannitolo Eurospital 18% solution for intravenous infusion
Equivalent medicine
Please read this leaflet carefully before 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 could be harmful.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- What Mannitolo Eurospital is and what it is used for
- What you need to know before using Mannitolo Eurospital
- How to use Mannitolo Eurospital
- Possible side effects
- How to store Mannitolo Eurospital
- Package contents and other information
1. What Mannitolo Eurospital is and what it is used for
Mannitolo Eurospital contains the active substance mannitol and belongs to the group of osmotic diuretics, which facilitate the elimination of excess water from the body. Mannitol distributes exclusively in the extracellular space, causing fluid to move out of cells and increasing the volume of circulating blood; it is rapidly eliminated by the kidneys, resulting in the production of a significant amount of urine.
Mannitolo Eurospital is indicated:
- In the prevention and/or treatment of the oliguric phase of acute renal failure (a condition characterized by low urine output), before it becomes irreversible and established;
- In the treatment of increased intracranial and spinal pressure and cerebral masses;
- To reduce intraocular pressure;
- To enhance renal elimination of toxic substances;
- For the measurement of glomerular filtration rate (assessment of kidney function).
2. What you need to know before using Mannitolo Eurospital
Do not use Mannitolo Eurospital
- if you are allergic to mannitol or to any of the other ingredients of this medicine (listed in section 6).
- if you have anuria (lack of urine production) due to severe kidney impairment
- if you have pulmonary congestion and pulmonary edema (accumulation of fluid in the lungs)
- in case of active cerebral or intracranial hemorrhage
- in case of severe dehydration
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Mannitolo Eurospital.
This medicine must be administered with great caution
- if you have severe heart problems (congestive heart failure)
- if you have severe renal insufficiency and clinical conditions associated with edema and fluid and salt retention. In cases of severe renal insufficiency, an initial test dose should be administered to assess patient tolerance.
- if you are being treated with corticosteroid or corticotropin medications.
This medicine must not be administered:
- simultaneously with blood transfusion through the same intravenous infusion line, due to the risk of pseudo-agglutination. If concomitant administration with blood transfusion is necessary, add 20 mEq of sodium chloride per liter of mannitol solution.
During treatment with Mannitolo Eurospital, the following should be monitored:
- renal function, to prevent irreversible osmotic nephrosis (kidney cell damage);
- urine output, to avoid mannitol accumulation, which could lead to heart failure.
- fluid balance, electrolytes, and plasma osmolarity (levels of fluids, salts, and substances in the blood).
Children
The safety and efficacy in children have not been established.
Other medicines and Mannitolo Eurospital
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
This medicine must not be used as a vehicle for other medicinal products.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
This medicine may be administered during pregnancy and breastfeeding only if clearly necessary and under strict medical supervision.
Driving and using machines
Consult your doctor for any information regarding your ability to drive or operate machinery.
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
3. How to use Mannitol Eurospital
This medicine must be administered to you exactly as prescribed by your doctor,
nurse, or pharmacist. If you have any doubts, consult your doctor, nurse, or pharmacist.
For intravenous use only.
Mannitol Eurospital 18% is a hypertonic intravenous solution (with a higher salt concentration than that of
blood) which must be administered with caution and at a controlled infusion rate.
Do not use this concentration unless specifically prescribed.
The recommended dose will be determined by your doctor according to your age, body weight, and medical
condition. The total daily dose should be between 50 and 200 g of mannitol in 24 hours. The infusion rate
should be adjusted to maintain a urine output of at least 30–50 ml/hour.
If you use more Mannitol Eurospital than you should
In case of accidental ingestion/overdose of this medicine, stop treatment immediately and seek medical
advice without delay from your doctor or at the nearest hospital.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with the use of Mannitol Eurospital:
- Electrolyte and acid-base balance disorders (alterations in body fluids, salts, and blood acidity);
- Congestive heart failure;
- Urinary retention;
- Headache;
- Blurred vision;
- Seizures;
- Nausea and vomiting;
- Feeling faint;
- Low blood pressure;
- Tachycardia;
- Fever and angina-like pain (chest pain);
- Infections at the injection site;
- Venous thrombosis or phlebitis (inflammation of veins or blood clot formation);
- Tissue necrosis (tissue death).
If a side effect occurs, stop administration and keep the unused portion for possible testing.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Mannitolo Eurospital
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. The expiry date applies to the product in its original, unopened packaging, correctly stored.
Store in tightly closed containers.
Protect from freezing.
Store at a temperature between 15°C and 30°C.
Do not use this medicine if you notice any visible signs of deterioration.
Use immediately after opening the container.
The solution must be clear, colourless, free from visible particles, and must contain a vacuum. To check for vacuum, insert the vial adapter into the inverted vial: bubbling should be observed. Do not administer if crystals are present; any precipitate may be redissolved by brief exposure to a temperature not exceeding 40–70°C; allow to cool before use.
This product is intended for single and uninterrupted administration; any remaining solution must not be reused.
Do not dispose of any medicine 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 Eurospital contains
- The active substance is mannitol. 1000 ml contain 180 g of mannitol [mmol/l: (C H O 988] - [Theoretical osmolarity mOsm/l 988] - pH between 4.5 and 7.0. The other component is water for injections.
Description of the appearance of Mannitolo Eurospital and package contents
Sterile, pyrogen-free, hypertonic intravenous infusion solution.
1 glass bottle of 500 ml.
Marketing Authorization Holder
Eurospital S.p.A., Via Flavia, 122 – Trieste
Manufacturers
Laboratorios Grifols S.A., Pol. Ind. Autopista, Passeig Fluvial 24 - 08150 Parets del Vallès (Barcelona –
Spain)
Bieffe Medital S.p.A., Via Nuova Provinciale s/n – 23034 Grosotto, Italy