Sodium lactate Monico

PACKAGE LEAFLET: INFORMATION FOR THE USER

SODIO LATTATO MONICO

1.87% solution for infusion
Sodium lactate
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, consult 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 side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What SODIO LATTATO MONICO is and what it is used for

SODIO LATTATO MONICO contains the active substance sodium lactate, which belongs to a
group of medicines used to provide the body with the correct balance of salts (electrolytes).
This medicine is indicated when there is a mild increase in acidic substances in the
blood (mild or moderate, not severe, metabolic acidosis).

2. What you need to know before using SODIO LATTATO MONICO

Do not use SODIO LATTATO MONICO

• if you are allergic to sodium lactate or to any of the other ingredients of this medicine (listed in section 6);
• if your blood has an abnormally high acidity level due to lactic acid buildup (lactic acidosis);
• if you have severe circulatory problems (alterations in oxidative processes that prevent the utilization of sodium lactate, such as shock or hypoxemias);
• if you have an accumulation of basic substances in the blood (metabolic and respiratory alkalosis);
• if your body temperature is very low (hypothermia);
• if you suffer from diseases characterized by increased glucose storage (in the form of glycogen);
• if you have liver problems (hepatic insufficiency);
• if you have conditions associated with reduced blood and oxygen supply to tissues;
• if you are undergoing heart surgery requiring the use of a mechanical device to replace the function of your heart (extracorporeal circulation).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using SODIO LATTATO MONICO.
This medicine should be administered to you with caution in the following cases:

• if you have severe heart problems (heart failure, congestive cardiac decompensation) or kidney problems (severe renal failure, reduced renal function);
• if you experience swelling due to fluid accumulation around the lungs (pulmonary edema), or in the ankles and legs (peripheral edema), with poor elimination of fluids and salts (hydro-saline retention);
• if you are taking medicines used to treat heart conditions (cardiotonic inotropic drugs), inflammatory conditions or allergies (corticosteroids), or drugs that stimulate steroid hormone production (corticotropins) (See section “Other medicines and SODIO LATTATO MONICO”);
• if you have high blood pressure (hypertension);
• if you are pregnant and have a condition called pre-eclampsia, characterized by high blood pressure, swelling due to fluid accumulation, and presence of protein in the urine;
• if you have poor sodium elimination from the body (sodium retention) (See section “Other medicines and SODIO LATTATO MONICO”).

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

Other medicines and SODIO LATTATO MONICO
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Use caution and inform your doctor if you are taking medicines used to treat inflammation and allergies (corticosteroids), as they may cause reduced excretion of sodium and fluids, leading to edema and increased blood pressure (hypertension).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor, pharmacist, or nurse before using this medicine.
If you are pregnant or breastfeeding, use this medicine only when strictly necessary and under close medical supervision.

Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

3. How to use SODIO LATTATO MONICO

Use this medicine exactly as directed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
SODIO LATTATO MONICO must be administered intravenously (by intravenous infusion) with caution, carefully controlling the flow rate.
The dose will be determined by your doctor based on your age, body weight, clinical condition, and specific blood test results (electrolyte profile, acid-base balance, osmolarity).
Generally, the recommended dose is 60–90 mEq at a time, up to a maximum of 180 mEq per day, with the possibility of increasing this dose depending on your response to treatment.

If you use more SODIO LATTATO MONICO than you should
Following administration of an excessive dose of this medicine, the following symptoms may occur:

• increased levels of sodium (hypernatraemia) or lactic acid in the blood (hyperlactatacidemia);
• increased blood volume in circulation (hypervolaemia);
• decreased levels of potassium in the blood (hypokalaemia).

If you suffer from kidney problems, increased levels of sodium in the blood (hypernatraemia) and its reduced elimination may cause dehydration of certain organs, especially the brain, and fluid accumulation leading to swelling (oedema) in the brain, lungs, legs, and ankles.
In case of accidental ingestion/overdose of this medicine, stop treatment immediately and contact your doctor or go to 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, SODIO LATTATO MONICO may 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 available data):

• increased levels of sodium (hypernatremia) and lactic acid (hyperlactacidemia) in the blood, increased blood volume (hypervolemia), decreased levels of solutes in the blood (hypoosmolarity), reduced potassium levels in the blood (hypokalemia);
• headache (cephalalgia), dizziness, restlessness, irritability, weakness, muscle stiffness, seizures, coma, death;
• drowsiness, confusion (confusional states);
• difficulty breathing (dyspnea), breathing stoppage (respiratory arrest);
• thirst, reduced salivation, nausea, vomiting, diarrhea, abdominal pain (abdominal pains);
• increased heart rate (tachycardia);
• reduced tear production;
• kidney problems (renal failure);
• low or high blood pressure (hypotension or hypertension), swelling due to fluid accumulation around the lungs (pulmonary edema) or in the legs and ankles (peripheral edema);
• fever (febrile episodes), infection at the infusion site, pain or allergic reactions near the injection site, vein irritation, formation of blood clots in the veins (venous thrombosis), inflammation of the veins (venous phlebitis), 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 or pharmacist. You may also report side effects directly through the national reporting system at the website
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 SODIO LATTATO MONICO

Keep this medicine out of the reach and sight 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.
Do not refrigerate or freeze.
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 SODIO LATTATO MONICO contains

• The active substance is sodium lactate 60%. 1000 ml of solution contain 31.17 g of sodium lactate 60%. One litre of solution contains 167 mEq of sodium and 167 mEq of lactate ions. pH: 6.0 ÷ 7.3.
• The other component is water for injections.

Description of the appearance of SODIO LATTATO MONICO and pack contents
SODIO LATTATO MONICO 1.87% is an infusion solution.
SODIO LATTATO MONICO 1.87% is available in glass vials of 50, 100, 250, 500 ml
and in plastic bags of 100, 250, 500, 1000 ml.
Marketing Authorization Holder and Manufacturer
MONICO SPA – Via Ponte di Pietra 7, 30173 – VENEZIA/MESTRE – Italy

PACKAGE LEAFLET: INFORMATION FOR THE USER

SODIUM LACTATE MONICO

2 mEq/ml concentrate for solution for infusion
3 mEq/ml concentrate for solution for infusion
Sodium lactate
Generic 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 may 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:

1. What SODIUM LACTATE MONICO is and what it is used for
2. What you need to know before using SODIUM LACTATE MONICO
3. How to use SODIUM LACTATE MONICO
4. Possible side effects
5. How to store SODIUM LACTATE MONICO
6. Package contents and other information

1. What SODIO LATTATO MONICO is and what it is used for

SODIO LATTATO MONICO contains the active substance sodium lactate, which belongs to a
group of medicines used to provide the body with the correct balance of salts (electrolytes).
This medicine is indicated in cases of mild increase in acidic substances in the blood (mild or moderate, not severe, metabolic acidosis).

2. What you need to know before using SODIUM LACTATE MONICO

Do not use SODIUM LACTATE MONICO

• if you are allergic to sodium lactate or to any of the other ingredients of this medicine (listed in section 6);
• if your blood is more acidic than normal due to an accumulation of lactic acid (lactic acidosis);
• if you have severe circulatory problems (alterations in oxidative processes that prevent the utilization of sodium lactate, such as shock or hypoxemias, conditions associated with reduced tissue perfusion);
• if you have an accumulation of basic substances in the blood (metabolic and respiratory alkalosis);
• if your body temperature is very low (hypothermia);
• if you suffer from diseases characterized by increased deposits of glucose in the form of glycogen;
• if you have liver problems (hepatic insufficiency);
• if you have conditions associated with reduced blood and oxygen supply to tissues;
• if you are about to undergo heart surgery requiring the use of a mechanical device to replace the function of your heart (extracorporeal circulation).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using SODIUM LACTATE MONICO.
This medicine should be administered with caution in the following cases:

• if you have severe heart problems (heart failure, congestive cardiac decompensation) or kidney problems (severe renal failure, reduced renal function);
• if you experience swelling due to fluid accumulation around the lungs (pulmonary edema), or in the ankles and legs (peripheral edema), with poor elimination of fluids and salts (hydro-saline retention);
• if you are taking medicines used to treat heart conditions (cardiac inotropic agents), inflammatory conditions or allergies (corticosteroids), or medicines that stimulate the production of steroid hormones (corticotropinics) (See section “Other medicines and SODIUM LACTATE MONICO”);
• if you have high blood pressure (hypertension);
• if you are pregnant and suffer from a condition called pre-eclampsia, characterized by high blood pressure, swelling due to fluid accumulation, and presence of protein in the urine;
• if you have poor elimination of sodium from the body (sodium retention) (See section “Other medicines and SODIUM LACTATE MONICO”).

Children
The use of this medicine is not recommended in children.
Other medicines and SODIUM LACTATE MONICO
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Use caution and inform your doctor if you are taking medicines used to treat infections and allergies (corticosteroids), as they may cause reduced elimination of sodium and fluids, resulting in swelling (edema) and increased blood pressure (hypertension).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor, pharmacist, or nurse for advice before using this medicine.
If you are pregnant or breastfeeding, use this medicine only if clearly needed and under strict medical supervision.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery.

3. How to use SODIO LATTATO MONICO

Use this medicine exactly as directed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.

SODIO LATTATO MONICO must be administered intravenously (intravenous infusion) with caution, only after dilution with compatible solutions, and the infusion rate must be carefully controlled.

Dilute the solution immediately after opening the container; the diluted solution must be used immediately, through a single, uninterrupted administration, and only if the solution is clear, colourless, and free from visible particles. Any unused portion must not be kept for later use.

The dose will be determined by your doctor according to your age, body weight, clinical condition, and blood test results (electrolyte levels, acid-base balance, osmolarity).

The recommended dose is generally 60–90 mEq at a time, up to 180 mEq per day, with the possibility of increasing this dose depending on your response to treatment.

If you use more SODIO LATTATO MONICO than you should

Following administration of an excessive dose of this medicine, the following symptoms may occur:

• increased levels of sodium (hypernatraemia) or lactic acid in the blood (hyperlactataemia);
• increased blood volume (hypervolaemia);
• decreased levels of potassium in the blood (hypokalaemia).

If you have kidney problems, increased sodium levels in the blood (hypernatraemia) and reduced elimination may lead to dehydration of certain organs, especially the brain, and fluid accumulation causing swelling (oedema) in the brain, lungs, legs, and ankles.

In case of accidental ingestion or overdose of this medicine, stop treatment immediately and contact your doctor or go to the nearest hospital. Therapy will be required to reduce the excess substances in the blood and restore the correct balance of acidic and alkaline substances (acid-base balance).

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, SODIO LATTATO MONICO may cause adverse reactions,
although not everyone experiences them.
The adverse reactions that may occur are listed below.
Frequency not known (frequency cannot be estimated from available data):

• increased levels of sodium (hypernatraemia) and lactic acid (hyperlactataemia) in the blood, increased blood volume (hypervolaemia), decreased levels of solutes in the blood (hypo-osmolality), reduced potassium levels in the blood (hypokalaemia);
• headache (cephalalgia), dizziness, restlessness, irritability, weakness, muscle rigidity, convulsions, coma, death;
• drowsiness, confusion (confusional states);
• difficulty breathing (dyspnoea), respiratory arrest (respiratory failure);
• thirst, reduced salivation, nausea, vomiting, diarrhoea, abdominal pain (abdominal pain);
• increased heart rate (tachycardia);
• reduced tear production;
• kidney problems (renal failure);
• low or high blood pressure (hypotension or hypertension), swelling due to fluid accumulation around the lungs (pulmonary oedema) or in the legs and ankles (peripheral oedema);
• fever (febrile episodes), infection at the infusion site, pain or allergic reactions near the injection site, vein irritation, formation of blood clots in the veins (venous thrombosis), inflammation of the veins (venous phlebitis), tissue damage and tissue death (tissue necrosis).

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please contact your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide further information on the safety of this medicine.

5. How to store SODIUM LACTATE MONICO

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the pack 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.
Do not refrigerate or freeze.
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 SODIO LATTATO MONICO 2 mEq/ml concentrate for solution for infusion contains

• The active substance is sodium lactate 60%. 10 ml of solution contain 3.74 g of sodium lactate 60% (each ml contains 2 mEq of sodium and 2 mEq of lactate ion). pH: 6.5 ÷ 8.0.
• The other component is water for injections.

What SODIO LATTATO MONICO 3 mEq/ml concentrate for solution for infusion contains

• The active substance is sodium lactate 60%. 10 ml of solution contain 5.61 g of sodium lactate 60% (each ml contains 3 mEq of sodium and 3 mEq of lactate ion). pH: 6.5 ÷ 8.0.
• The other component is water for injections.

Description of the appearance of SODIO LATTATO MONICO and contents of the pack
SODIO LATTATO MONICO 2 mEq/ml is a concentrate for solution for infusion and is available in a carton containing 5 or 10 glass vials of 10 ml.
SODIO LATTATO MONICO 3 mEq/ml is a concentrate for solution for infusion and is available in a carton containing 5 or 10 glass vials of 10 ml or in 30 ml glass vials.

Marketing Authorisation Holder and Manufacturer
MONICO SPA – Via Ponte di Pietra 7, 30173 – VENEZIA/MESTRE – Italy