Potassium acetate Monico

Package leaflet: Information for the user

POTASSIUM ACETATE MONICO

3 mEq/ml concentrate for solution for infusion
Potassium acetate
Generic medicine
Please read this leaflet carefully before using this medicine because 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.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet:

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

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

POTASSIO ACETATO MONICO is a saline solution for direct intravenous injection, containing the active substance potassium acetate.
This medicinal product is indicated:

• to supply potassium and acetate to the body when oral (by mouth) administration of mineral salts is not possible;
• as an addition to solutions for artificial nutrition when standard electrolyte solutions or nutrient solutions are not sufficient;
• for the treatment of moderate acidosis (conditions in which there is a significant increase in the amount of acid in the blood).

2. What you need to know before using POTASSIO ACETATO MONICO

Do not use POTASSIO ACETATO MONICO

• if you are allergic to potassium acetate or to any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of potassium in the blood (hyperkalaemia, potassium retention);
• if you suffer from severe liver, kidney, or adrenal gland problems (hepatic, renal, or adrenal insufficiency);
• if you have an untreated adrenal gland disorder (Addison's disease);
• if you are experiencing severe fluid loss from the body (acute dehydration);
• if you have severe muscle pain (heat cramps);
• if you suffer from an inherited disease causing muscle paralysis (episodic adynamy);

Warnings and precautions
Talk to your doctor or nurse before being administered POTASSIO ACETATO MONICO.
This medicine must be administered as a very slow intravenous infusion,
as potassium intoxication may occur, which could lead to death due to loss of heart function (cardiac depression) and irregular heartbeat (arrhythmias), up to complete cessation of heart activity (cardiac arrest) (See section 3).
This medicine must be administered with great caution and under strict medical supervision in the following cases:

• if you have heart problems (cardiopathy) and are taking other heart medications (digitalis);
• if you have kidney problems (renal insufficiency), as it may cause potassium retention and thus increase potassium concentration in the blood (hyperkalaemia);
• if you have adrenal gland problems (adrenal insufficiency);
• if you have liver problems (hepatic insufficiency);
• if you have an increased blood pH (metabolic and respiratory alkalosis);
• in the presence of familial periodic paralysis (a disorder characterized by sudden attacks of muscle weakness);
• if you have congenital myotonia, a disease characterized by muscle stiffness;
• if you have recently undergone surgery.

During treatment with this medicine, your doctor must periodically monitor your blood potassium levels and heart function through serial electrocardiograms.
During treatment, you must be monitored for body fluid levels, blood electrolyte levels, and regulation of acid-base balance in the blood.
Children
In children, the safety and efficacy of potassium acetate have not been established; therefore, this medicine should be administered only if absolutely necessary.
Other medicines and POTASSIO ACETATO MONICO
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
This medicine must be administered with caution if you are taking medicines used to lower blood pressure, such as potassium-sparing diuretics, especially in case of kidney problems, ACE inhibitors, or other medicines that cause a decrease in aldosterone hormone levels, as they may lead to increased potassium levels in the blood (hyperkalaemia); in such cases, serum potassium levels must be closely monitored.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or nurse before this medicine is administered, as it should only be used if your doctor considers it truly necessary.
POTASSIO ACETATO MONICO must not be used during pregnancy or while breastfeeding unless clearly necessary.
Driving and using machines
Not applicable.

3. How to use POTASSIUM ACETATE MONICO

This medicinal product will be administered to you by trained healthcare personnel. If you have any doubts, consult your doctor or nurse.
This medicinal product will be administered by direct intravenous injection (intravenous infusion), after appropriate dilution and at a controlled rate, only if your kidney function is normal. Infusing too rapidly may cause local pain.
Your doctor will adjust the dosage and infusion rate according to your age, body weight, clinical condition, and blood potassium levels.
The recommended dose in adults should provide 40–80 mEq per day. The total daily dose must not exceed 200 mEq per day.
In emergency situations (when blood potassium levels are very low), the infusion rate and dose may be increased by the doctor under close electrocardiographic monitoring.

Use in children:
In children, this medicinal product should be administered only if absolutely necessary, as the safety and efficacy of potassium acetate have not been established. The recommended dose is 2–3 mEq per kg of body weight per day.

Preparation of the medicinal product: Dilute the solution immediately after opening the container; the diluted solution must be used immediately. The solution must be clear, colourless, and free from visible particles. It is intended for single and uninterrupted administration; any remaining solution must not be reused.
Shake well during preparation of the dilution and before administration. Do not use the medicinal product if the solution is not clear and colourless or if it contains particles. This medicinal product must not be injected undiluted. It may cause death if administered without dilution.
This medicinal product must be diluted with 5% glucose solution or 0.9% sodium chloride solution (physiological saline) and must not be mixed with other medicinal products.
Ensure that all precautions are taken to maintain sterility before and during intravenous infusion.

If you use more POTASSIUM ACETATE MONICO than you should
This medicinal product will be administered by trained healthcare personnel, so it is unlikely that you will receive an excessive dose. However, if you think that you have been given too much of this medicinal product, inform your doctor or another healthcare professional immediately. They will stop the infusion and initiate appropriate therapies.
If you have any doubts about how to use this medicinal product, ask your doctor or nurse.

4. Possible side effects

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

• gastrointestinal disorders;
• neuromuscular disorders, altered limb sensation (paresthesia), flaccid paralysis, weakness;
• confusion;
• changes in heart rhythm (arrhythmias), conduction disorders, disappearance of the P wave, widening of the QRS complex on the electrocardiogram;
• reduction in blood pressure (hypotension), cardiac arrest;
• fever, infection at the infusion site, inflammation of veins at the injection site (phlebitis);
• circulation problems due to formation of blood clots (thrombosis);
• leakage of the medicine into surrounding tissues at the injection site (extravasation);
• increase in blood volume (hypervolemia).

If side effects occur, administration must be stopped and the unused portion should be kept for possible testing.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. 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 POTASSIUM ACETATE MONICO

Keep this medicine out of the sight and reach of children.
Medical and nursing staff are aware of the appropriate storage conditions for this medicine.
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.
The solution should be clear, colourless, and free from visible particles. The diluted solution must be used
immediately, and any unused medicinal solution remaining must be discarded.
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 POTASSIO ACETATO MONICO contains
POTASSIO ACETATO MONICO 10 ml vials

• The active substance is potassium acetate. Each vial contains 2.94 g of potassium acetate (equivalent to 30 mEq/10 ml of potassium and 30 mEq/10 ml of acetate), pH 7.10 ÷ 7.70.
• The other component is water for injections.

POTASSIO ACETATO MONICO 30 ml vials

• The active substance is potassium acetate. Each vial contains 8.83 g of potassium acetate (equivalent to 90 mEq/30 ml of potassium and 90 mEq/30 ml of acetate), pH 7.10 ÷ 7.70.
• The other component is water for injections.

Description of the appearance of POTASSIO ACETATO MONICO and contents of the pack
Pack containing 5 or 10 glass vials of 10 ml concentrate for infusion solution.
Pack containing 10 glass vials of 30 ml 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 method of administration
The dose depends on the patient's age, weight, and clinical condition, taking into account the following normal daily potassium requirements.
Adults: 40–80 mEq per day. The total daily dose must not exceed 200 mEq.
Children: 2–3 mEq/kg per day.
In children, the safety and efficacy of potassium acetate use have not been established.
The medicine must not be injected undiluted. It is fatal if administered without dilution.
The medicine must be administered intravenously only after dilution in 5% glucose solution or 0.9% sodium chloride solution (physiological saline).
The medicine must be administered intravenously only after dilution with compatible solutions and at a controlled infusion rate.
The medicine must be administered only in the presence of normal renal function and at a rate not exceeding 10 mEq of potassium per hour.
Too rapid infusions may cause local pain, and the infusion rate should be adjusted according to patient tolerance.
Dilute the solution immediately after opening the container; the diluted solution must be used immediately. The solution must be clear, colorless, and free from visible particles. It is intended for single, uninterrupted administration, and any unused portion must not be retained.
Shake well during dilution preparation and before administration.
Emergency conditions
In emergency conditions (serum potassium levels ≤ 2 mEq/l with electrocardiographic changes and muscle paralysis), do not exceed an infusion rate of 40 mEq/hour, under continuous electrocardiographic monitoring, and do not exceed a total dose of 400 mEq within 24 hours.
OVERDOSE
In case of overdose, immediately discontinue the potassium-containing infusion and initiate corrective therapy to reduce elevated plasma potassium levels and, if necessary, restore acid-base balance.
Incompatibilities
Unless otherwise indicated, and except for the solutions mentioned in the section "Dosage and method of administration," it is not recommended to mix potassium acetate solution with other medicinal products.
Special precautions for disposal and handling
Do not use the medicine 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.
Unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.
For further information, consult the Summary of Product Characteristics.