Sodium acetate Monico

ANNEX
Changes to the medicinal product Sodio Acetato Monico, with application code
N1B/2015/3508, referred to in this notification, are reported below.
The current PACKAGE LEAFLET is to be amended as follows:
Package leaflet: Information for the user

SODIUM ACETATE MONICO

3 mEq/ml concentrate for solution for infusion
Sodium acetate trihydrate
Generic medicine
Please read all of this leaflet carefully before you are given 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 side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

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

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

SODIO ACETATO MONICO is a saline (electrolyte) solution for intravenous injection that contains the active substance sodium acetate.
This medicinal product is indicated to supply sodium and acetate to the body, thereby restoring the correct salt concentration in body fluids and re-establishing normal blood pH when a significant increase in acid levels occurs (moderate metabolic acidosis).

2. What you need to know before you are given SODIO ACETATO MONICO

Do not use SODIO ACETATO MONICO

• if you are allergic to sodium acetate, to other similar substances, or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver problems (severe hepatic insufficiency, with inability to metabolize the acetate ion);
• if you have low levels of calcium in your blood (hypocalcemia).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given SODIO ACETATO MONICO.
This medicine must be administered with great care and under close medical supervision in the following cases:

• if you have heart problems (congestive heart failure, cardiac insufficiency);
• if you have severe kidney problems (severe renal insufficiency, reduced kidney function);
• if you experience swelling due to fluid retention with salt reabsorption (salt retention). Swelling may affect the legs, ankles (peripheral edema), or lungs (pulmonary edema);
• if you are taking medicines:
• that increase or decrease the force of heart contraction (cardiac inotropic agents),
• used to treat inflammation and allergies (corticosteroids),
• that stimulate the production of steroid hormones (corticotropics) (See section “Other medicines and SODIO ACETATO 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 proteins in the urine;
• if you have other conditions occurring when the body retains excessive sodium (sodium retention);
• if you have an increased amount of basic substances in the blood (increased pH, metabolic and respiratory alkalosis);
• if you have mild or moderate liver problems (mild or moderate hepatic insufficiency).

During treatment, your doctor will monitor your body fluid levels,
the levels of salts (electrolytes) in your blood (plasma osmolarity), and the regulation of acid-base balance in the blood (acid-base equilibrium).
Other medicines and SODIO ACETATO MONICO
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicine.
This medicine must be administered with caution if you are taking medicines for inflammation (corticosteroids) or medicines containing sodium (sodium salts), because they prevent the body from eliminating sodium and water, causing fluid accumulation (edema) and increased blood pressure (hypertension).
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or nurse before you are given this medicine.
If you are pregnant or breastfeeding, use this medicine only when strictly necessary and under direct medical supervision.
Driving and using machines
This medicine does not impair the ability to drive vehicles or operate machinery.

3. How to use SODIUM ACETATE MONICO

This medicine will be administered to you by specialized healthcare personnel. If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine will be administered by intravenous infusion (into a vein), after appropriate dilution.
Your doctor will adjust the dose and infusion rate according to: age, body weight, health status, fluid levels in the body, blood electrolyte levels (plasma osmolarity), and acid-base balance in the blood.

If you use more SODIUM ACETATE MONICO than you should
Since this medicine will be administered by specialized personnel, it is unlikely that you will receive an excessive dose.
However, if an excessive dose of this medicine is administered, the following may occur:

• increased levels of sodium in the blood (hypernatremia);
• increased blood volume in circulation (hypervolemia). If sodium levels in the blood rise too much, fluid loss from internal organs (dehydration) may occur, particularly affecting the brain, as well as accumulation of extracellular fluid that may affect cerebral, pulmonary, and peripheral circulation, leading to fluid buildup around the lungs (pulmonary edema) or swelling in the legs and ankles (peripheral edema).

If you think you have been given too much of this medicine, contact your doctor or nurse immediately.
If you have any doubts about how to use this medicine, ask your doctor, pharmacist, or nurse for advice.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Not known (frequency cannot be estimated from the available data)

• increased sodium levels in the blood (hypernatraemia);
• increased blood volume circulating in the body (hypervolaemia);
• disturbance in fluid and substance levels in the blood (hypo-osmolality);
• headache (cephalalgia);
• dizziness;
• restlessness;
• fever, weakness;
• irritability;
• muscle stiffness;
• seizures;
• coma and death;
• drowsiness, confusion;
• difficulty breathing (dyspnoea);
• respiratory arrest;
• swelling due to fluid accumulation around the lungs (pulmonary oedema) or in the legs and ankles (peripheral oedema);
• thirst, reduced salivation and tear production;
• nausea, vomiting, diarrhoea;
• abdominal pain (abdominal pain);
• increased heart rate (tachycardia);
• kidney problems (renal failure);
• increased (hypertension) or decreased (hypotension) blood pressure;
• infection, pain and irritation at the injection site;
• circulation problems due to blood clot formation (thrombosis);
• inflammation of the vein at the injection site (phlebitis);
• tissue damage and death at the site of administration (tissue necrosis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
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 SODIUM ACETATE MONICO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP.".
The expiry date refers to the last day of that month.
Store in the original packaging and in the original container tightly closed. Do not refrigerate or
freeze.
Medical and nursing staff are aware of the appropriate storage conditions for this medicine.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What SODIO ACETATO MONICO contains

• The active substance is sodium acetate trihydrate.
• 10 ml of solution contain 4.08 g of sodium acetate trihydrate.
• 30 ml of solution contain 12.25 g of sodium acetate trihydrate. (each ml contains 3 mEq of sodium and acetate)
• The other components (excipients) are: water for injections (pH: 7.1 - 7.7).

Description of the appearance of SODIO ACETATO MONICO and contents of the pack
Pack containing 5 or 10 vials of 10 ml of concentrate for infusion solution.
Pack containing 10 glass bottles of 30 ml of concentrate for infusion solution.

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

The following information is intended exclusively for healthcare professionals

Dosage and administration
Adults
Initial dose of 2 to 5 mEq/kg body weight administered over 4–8 hours, depending on the severity of acidosis. The dose should then be adjusted according to blood bicarbonate concentrations or blood gas analysis results (increase of 20–22 mmol/L).
Children
Initial dose of 1 mEq/kg administered by slow intravenous infusion, diluted to a concentration of 0.5 mEq/mL, up to a maximum dosage of 8 mEq/kg body weight per day to avoid excessive reduction in cerebrospinal pressure and possible intracranial hemorrhage.
In children, the safety and efficacy of sodium acetate have not been established.
Elderly
In elderly patients over 60 years of age, the maximum daily dose is 90–100 mEq of acetate.
It is advisable NOT to achieve full correction of acidosis within the first 24 hours to avoid alkalosis due to excessive respiratory overcompensation.

Overdose
Treatment
Immediately discontinue the infusion and initiate corrective therapy to reduce plasma levels of excess ions and restore, if necessary, acid-base balance.
The patient should be closely monitored for the appearance of any signs and symptoms related to the administered drug, providing appropriate symptomatic and supportive measures as required.
In such cases, intravenous administration of 5% glucose or hypotonic or isotonic sodium chloride solutions (which are hypotonic in hypernatremic patients) is recommended.
Loop diuretics may be used in cases of marked hypernatremia.
A serum sodium concentration exceeding 200 mmol/L may require dialysis.

Incompatibilities
Solutions suitable for dilution of MONICO sodium acetate: 0.9% Sodium Chloride (physiological saline) or 5% Glucose.

Special precautions for disposal and handling
For single, uninterrupted use; any residual solution must not be reused.
Dilute the solution immediately after opening the container; the diluted solution must be used immediately.
Shake well during preparation of the dilution and before administration. Do not use the medicinal product if the solution is not clear, colorless, or contains particles.
Observe all standard precautions to maintain sterility before and during intravenous infusion.
Unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.