SODIO LATTATO MONIKO 2 MEQ/ML Concentrate for infusion solution

Зміст інструкції

1. SODIO LATTATO MONICO
2. Sodio lattato
   1. What is SODIO LATTATO MONICO and what is it used for
   2. What you need to know before you use 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
3. SODIO LATTATO MONICO
   1. What is SODIO LATTATO MONICO and what is it used for
   2. What you need to know before using SODIO LATTATO MONICO
   3. How to use SODIO LATTATO MONICO
4. SODIO LATTATO MONICO must be administered intravenously (intravenous infusion)
   1. Possible side effects
   2. How to store SODIO LATTATO MONICO
   3. Contents of the pack and other information

SODIO LATTATO MONICO

1.87% infusion solution

Sodio lattato

Equivalent medicinal product
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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, 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 you use 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 is SODIO LATTATO MONICO and what is it used for

SODIO LATTATO MONICO contains the active ingredient sodium lactate, which belongs to a
group of medicines used to provide the body with the right intake of salts (electrolytes).
This medicine is indicated when there is a modest increase in acidic substances in the
blood (mild or moderate, non-severe, states of metabolic acidosis).

2. What you need to know before you use 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 acidity level higher than normal, due to an accumulation of lactic acid (lactic acidosis);
• if you suffer from serious circulatory problems (alteration of oxidative processes that prevent the utilization of sodium lactate such as shock or hypoxemia);
• 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 an increase in glucose deposits (in the form of glycogen);
• if you suffer from liver problems (hepatic insufficiency);
• if you suffer from problems associated with a decrease in blood and oxygen supply to the tissues;
• if you are to undergo heart surgery, during which a mechanical device must be used to replace the functions 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 suffer from serious heart problems (heart failure, congestive heart failure) or kidneys (severe renal insufficiency, 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 (hydrosaline retention);
• if you are taking medicines used for the treatment of heart problems (cardiac inotropic drugs), inflammation and allergies (corticosteroids) or medicines that stimulate the production of steroid hormones (corticotropic) (See section “Other medicines and SODIO LATTATO MONICO”);
• if you suffer from 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 the presence of protein in the urine;
• if you experience poor elimination of sodium from the body (sodium retention) (See section “Other medicines and SODIO LATTATO MONICO”).

Children
In children, the safety and efficacy of this medicine 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 for the treatment of
inflammation and allergies (corticosteroids), because they cause poor elimination of
sodium and fluids with consequent edema and increased blood pressure (hypertension).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you 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 absolutely necessary and under the strict supervision of your doctor.

Driving and using machines
This medicine does not impair the ability to drive vehicles or use machines.

3. How to use SODIO LATTATO MONICO

Use this medicine following exactly the instructions of your doctor, pharmacist or
nurse. If you have any doubts, consult your doctor, pharmacist or nurse.
SODIO LATTATO MONICO must be administered intravenously (endovenous infusion)
with caution, carefully monitoring the flow rate.
The dose will be established by the doctor based on your age, weight, health conditions
(clinical conditions) and the values of specific blood tests (electrolyte balance,
acid-base balance, osmolarity).
Generally the recommended doseis 60-90 mEq at a time up to 180 mEq per day, with
the possibility of increasing this dosage in relation to your response to treatment.

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

• increased levels of sodium (hypernatremia) or lactic acid in the blood (hyperlactacidemia);
• increased blood volume (hypervolemia);
• decreased levels of potassium in the blood (hypokalemia).

If you suffer from kidney problems, increased levels of sodium in the blood (hypernatremia) and its
reduced elimination can cause dehydration of some organs, especially the brain,
and an accumulation of fluid that determines swelling (edema) at the level of: brain, lungs,
legs and ankles.
In case of ingestion/assumption of an excessive amount of this medicine, stop the
treatment and immediately contact your doctor or the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, SODIO LATTATO MONICO can cause side effects
although not everybody gets them.
The side effects that may occur are listed below.

Frequency not known(the 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 levels of potassium in the blood (hypokalaemia);
• headache, dizziness, restlessness, irritability, weakness, muscle stiffness, convulsions, coma, death;
• drowsiness, confusion (confusional states);
• difficulty breathing (dyspnoea), respiratory arrest;
• thirst, reduced salivation, nausea, vomiting, diarrhoea, abdominal pain;
• increased heart rate (tachycardia);
• reduced lacrimation;
• kidney problems (renal failure);
• low or high blood pressure (hypotension or hypertension), swelling due to fluid accumulation around the lungs (pulmonary oedema) or legs and ankles (peripheral oedema);
• fever (febrile episodes), infection at the infusion site, pain or allergic reactions in the area near the injection site, irritation of the veins, 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 get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can 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 SODIO LATTATO MONICO

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is 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 in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What SODIO LATTATO MONICO contains

• The active ingredient is sodium lactate 60%. 1000 ml of solution contain 31.17 g of sodium lactate 60%. One liter 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 contents of the pack
SODIO LATTATO MONICO 1.87% is an infusion solution.
SODIO LATTATO MONICO 1.87% is available in glass bottles of 50, 100, 250, 500 ml
and bags made of plastic material of 100, 250, 500, 1000 ml.

Marketing authorisation holder and manufacturer
MONICO SPA – Via Ponte di Pietra 7, 30173 – VENEZIA/MESTRE – Italy

SODIO LATTATO MONICO

2 mEq/ml concentrate for infusion solution
3 mEq/ml concentrate for infusion solution
Sodium lactate

Equivalent medicinal product
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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, 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 you use 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 is SODIO LATTATO MONICO and what is it used for

SODIO LATTATO MONICO contains the active ingredient sodium lactate, which belongs to a
group of medicines used to provide the body with the right supply of salts (electrolytes).
This medicine is indicated when there is a modest increase in acidic substances in the
blood (mild or moderate, non-severe, states of 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 is more acidic than normal, due to an accumulation of lactic acid (lactic acidosis);
• if you suffer from severe circulatory problems (alteration of oxidative processes that prevent the utilization of sodium lactate such as shock or hypoxemia, 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 an increase in glucose deposits in the form of glycogen;
• if you suffer from liver problems (hepatic insufficiency);
• if you suffer from problems associated with a decrease in blood and oxygen supply to the tissues;
• if you are to undergo heart surgery, during which a mechanical device must be used to replace the functions of your heart (extracorporeal circulation).

Warnings and precautions
Consult 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 suffer from severe heart problems (heart failure, congestive heart failure) or kidneys (severe renal insufficiency, reduced renal function);
• if you experience swelling due to an accumulation of fluid around the lungs (pulmonary edema), or in the ankles and legs (peripheral edema), with poor elimination of fluids and salts (hydrosaline retention);
• if you are taking medicines used for the treatment of heart problems (cardiac inotropic drugs), inflammation and allergies (corticosteroids), or medicines that stimulate the production of steroid hormones (corticotropic) (See section “Other medicines and SODIO LATTATO MONICO”);
• if you suffer from high blood pressure (hypertension);
• if you are pregnant and suffer from a condition called pre-eclampsia, characterized by high blood pressure, swelling due to an accumulation of fluid and the presence of protein in the urine;
• if you experience poor elimination of sodium from the body (sodium retention) (See section “Other medicines and SODIO LATTATO MONICO”).

Children
The use of this medicine is not recommended in children.

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 for the treatment of
infections and allergies (corticosteroids), because they cause poor elimination of sodium and
fluids resulting in swelling (edema) and increased blood pressure
(hypertension).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding
with breast milk, ask your doctor, pharmacist or nurse for advice before using
this medicine.
If you are pregnant or breastfeeding, use this medicine only if
absolutely necessary and under strict medical supervision.

Driving and operating machinery
This medicine does not impair the ability to drive vehicles or operate machinery.

3. How to use SODIO LATTATO MONICO

Use this medicine only as administered to you following the instructions exactly
given 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 diluting it with compatible solutions, carefully controlling the
flow rate.
Dilute the solution immediately after opening the container; the diluted solution must be
used immediately through a single and uninterrupted administration and only if the
solution appears clear, colorless and free of visible particles. Any remaining solution must not
be used.
The dose will be established by the doctor based on your age, weight, health conditions
(clinical conditions) and the values of specific blood tests (electrolyte levels,
acid-base balance, osmolarity).
Generally the recommended doseis 60-90 mEq at a time up to 180 mEq per day, with
the possibility of increasing this dosage in relation to your response to treatment.

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

• increased levels of sodium (hypernatremia) or lactic acid in the blood (hyperlactacidemia);
• increased blood volume (hypervolemia);
• decreased levels of potassium in the blood (hypokalemia).

If you suffer from kidney problems, increased levels of sodium in the blood (hypernatremia) and its
reduced elimination can cause dehydration of some organs, especially the brain,
and an accumulation of fluid that causes swelling (edema) at the level of: brain, lungs,
legs and ankles.
In case of ingestion/administration of an excessive amount of this medicine, stop the
treatment and immediately consult your doctor or the nearest hospital. It will be necessary to
start a therapy to lower the amounts of substances in excess in the blood and restore
the correct balance of acidic and alkaline substances (acid-base balance).
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, SODIO LATTATO MONICO can cause side effects
although not everybody gets them.
The side effects that may occur are listed below.

Frequency not known(the frequency of which 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 levels of potassium in the blood (hypokalaemia);
• headache, dizziness, restlessness, irritability, weakness, muscle stiffness, convulsions, coma, death;
• drowsiness, confusion (confusional states);
• difficulty breathing (dyspnoea), respiratory arrest;
• thirst, reduced salivation, nausea, vomiting, diarrhoea, abdominal pain;
• increased heart rate (tachycardia);
• reduced lacrimation;
• kidney problems (renal failure);
• low or high blood pressure (hypotension or hypertension), swelling due to fluid accumulation around the lungs (pulmonary edema) or legs and ankles (peripheral edema);
• fever (febrile episodes), infection at the infusion site, pain or allergic reactions in the area near the injection site, irritation of the veins, 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 get any side effects, even those not listed in this leaflet, please
tell your doctor or pharmacist. You can 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 SODIO LATTATO MONICO

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is 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 in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What SODIO LATTATO MONICO 2 mEq/ml concentrate for solution for
infusion contains

• The active ingredient 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 ingredient 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 pack containing 5 or 10 glass vials of 10 ml.
SODIO LATTATO 3 mEq/ml is a concentrate for solution for infusion and is available in
a pack containing 5 or 10 glass vials of 10 ml or in glass bottles of 30 ml.

Marketing authorisation holder and manufacturer
MONICO SPA – Via Ponte di Pietra 7, 30173 – VENEZIA/MESTRE – Italy