Potassium chloride Bioindustria L.I.M.

BIOINDUSTRIA Italian Medicinal Laboratory S.p.A.

ILLUSTRATED LEAFLET

Potassium Chloride Bioindustria L.I.M. 2 mEq/ml concentrate for infusion solution, 3 mEq/ml concentrate for infusion solution

PHARMACOTHERAPEUTIC CATEGORY
Electrolyte solutions.

THERAPEUTIC INDICATIONS
Treatment of potassium deficiency in patients for whom oral repletion is not possible.

CONTRAINDICATIONS

• Hypersensitivity to the active substance or to any of the excipients;
• Hyperkalemia or conditions involving potassium retention;
• Severe renal insufficiency;
• Untreated Addison's disease;
• Acute dehydration;
• Heat cramps.

PRECAUTIONS FOR USE
High plasma potassium concentrations may cause death due to cardiac depression, arrhythmias, or arrest. To avoid potassium intoxication, the infusion must be administered slowly.
Administration should be guided by serial electrocardiograms; serum potassium levels do not necessarily reflect intracellular potassium concentrations. It is advisable to monitor fluid balance, electrolytes, and acid-base equilibrium during infusion.
The medicinal product must be administered with caution in patients:

• With renal insufficiency (administration of potassium-containing solutions in patients with impaired renal function may lead to potassium retention);
• With cardiac insufficiency, particularly if digitalized;
• With adrenal insufficiency;
• With hepatic insufficiency;
• With familial periodic paralysis;
• With congenital myotonia;
• In the early postoperative phase.

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicinal products,
including those without a prescription.
The use of potassium-sparing diuretics may increase the risk of hyperkalemia, especially in the presence of renal dysfunction. Therefore, in such cases, serum potassium levels must be closely monitored.
The use of medicinal products such as ACE inhibitors, which reduce aldosterone levels, may lead to potassium retention. Therefore, serum potassium levels must be closely monitored.

SPECIAL WARNINGS
The solution must be clear, colorless, and free from visible particles. Use immediately after opening the container. The container is intended for single, uninterrupted administration; any residual solution must not be used.
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.

Pregnancy and Lactation
Consult your doctor or pharmacist before taking any medicinal product.
No data are available on potential adverse effects of the medicinal product when administered during pregnancy or lactation, or on reproductive capacity.
Therefore, the medicinal product should not be used during pregnancy or lactation unless absolutely necessary and only after careful assessment of the risk/benefit ratio.

Effects on the ability to drive vehicles and operate machinery
The medicinal product does not impair the ability to drive vehicles or operate machinery.
Important information about certain excipients: none.

DOSAGE, ROUTE AND DURATION OF ADMINISTRATION
The medicinal product must not be injected undiluted. It is fatal if infused without dilution (see Precautions for Use).
The medicinal product must be administered intravenously only after dilution in 5% glucose solution, 0.9% sodium chloride solution (physiological saline), or other compatible solutions (see end of this section).
Shake well during dilution preparation and before administration.
Dosage depends on age, body weight, and clinical condition of the patient, considering that the usual daily potassium requirement is as follows:
Adults: 40–80 mEq per day. The total daily dose must not exceed 200 mEq.
Children: 2–3 mEq/kg per day.
The safety and efficacy of potassium chloride in children have not been established.
The medicinal product must be administered only in the presence of intact renal function and at a rate not exceeding 10 mEq of potassium per hour.
In emergency situations (serum potassium levels ≤ 2 mEq/L with electrocardiographic changes and muscle paralysis), the infusion rate must not exceed 40 mEq/hour, under continuous electrocardiographic monitoring, and the total dose must not exceed 400 mEq in 24 hours.
Too rapid infusions may cause local pain; the infusion rate should be adjusted according to patient tolerance.

Incompatibilities with Potassium Chloride Bioindustria L.I.M.
If used to dilute other medicinal products, consult a pharmacist, if available, before adding any additives; always consider the characteristics of the products to be added; use aseptic techniques.
Unless otherwise indicated, and except for the solutions listed below, mixing potassium chloride solution with other medicinal products is not recommended.

Solutions suitable for dilution of Potassium Chloride Bioindustria L.I.M.
5% Glucose – 0.9% Sodium Chloride (physiological saline).
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; any residual solution must not be used.
Shake well during dilution preparation and before administration. Do not use the medicinal product if the solution is not clear and colorless or if it contains particles.
All standard precautions to maintain sterility before and during intravenous infusion must be observed.
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.

OVERDOSAGE
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 (see Precautions for Use).
In case of accidental ingestion/overdose of Potassium Chloride Bioindustria L.I.M., contact a doctor immediately or go to the nearest hospital.
If you have any doubts about the use of Potassium Chloride Bioindustria L.I.M., consult your doctor or pharmacist.

UNDESIRABLE EFFECTS
Like all medicinal products, Potassium Chloride may cause adverse effects, although not everyone experiences them.
The following adverse effects of Potassium Chloride are reported. There are insufficient data to determine the frequency of the individual effects listed.

Gastrointestinal disorders
Gastrointestinal disturbances

Nervous system disorders
Neuromuscular disturbances, paresthesia, flaccid paralysis, weakness, mental confusion

Cardiac disorders
Hypotension, arrhythmias, conduction disturbances, disappearance of the P wave, widening of the QRS complex on the electrocardiogram, cardiac arrest

Disorders of water and electrolyte balance
Hypervolemia

General disorders and administration site conditions
Fever reactions, injection site infections, venous thrombosis or phlebitis, extravasation

Following the instructions in this leaflet reduces the risk of adverse effects.
If any of the adverse effects worsen, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

EXPIRY DATE AND STORAGE
Expiry date: see the date printed on the packaging.
The expiry date refers to the product stored in its original, unopened packaging under appropriate conditions.
Warning: do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions
Store in the original packaging and in a tightly closed container. Do not refrigerate or freeze.
Medicinal products must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicinal products. This will help protect the environment.
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.
Keep this medicinal product out of the reach and sight of children.

COMPOSITION
Potassium Chloride Bioindustria L.I.M. 2 mEq/ml concentrate for infusion solution
10 ml of solution contains:
Active substance: potassium chloride 1.49 g
(each ml contains 2 mEq of K and of Cl)
Excipients: Water for injections q.s.

Potassium Chloride Bioindustria L.I.M. 3 mEq/ml concentrate for infusion solution
10 ml of solution contains:
Active substance: potassium chloride 2.24 g
(each ml contains 3 mEq of K and of Cl)
Excipients: Water for injections q.s.

PHARMACEUTICAL FORM AND CONTENT
Potassium Chloride Bioindustria L.I.M. 2 mEq/ml
Sterile, pyrogen-free concentrate for infusion solution. Pack of 10 vials.
Potassium Chloride Bioindustria L.I.M. 3 mEq/ml
Concentrate for intravenous infusion solution after dilution.
Pack of 10 vials. Packs of 1 and 10 vials of 30 ml, and 1 bottle of 250 ml.

MARKETING AUTHORIZATION HOLDER
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A. – Via De Ambrosiis, 2 – Novi Ligure (AL).

MANUFACTURER
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A. – Via De Ambrosiis, 2 – Novi Ligure (AL).
AIFA determination of 20/02/2013.