POTASSIUM GRIFOLS 0.02 MEQ/ML IN SODIUM CHLORIDE 0.9% SOLUTION FOR INFUSION

Patient Information Leaflet

Introduction

Patient Information Leaflet

Potassium Grifols 0.02 mEq/ml in Sodium Chloride 0.9% Solution for infusion

Potassium Chloride, Sodium Chloride

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, talk to your doctor or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Potassium Grifols 0.02 mEq/ml in Sodium Chloride 0.9% is and what it is used for
2. What you need to know before using Potassium Grifols 0.02 mEq/ml in Sodium Chloride 0.9%
3. How to use Potassium Grifols 0.02 mEq/ml in Sodium Chloride 0.9%
4. Possible side effects
5. How to store Potassium Grifols 0.02 mEq/ml in Sodium Chloride 0.9%
6. Contents of the pack and other information

1. What Potassium Grifols 0.02 mEq/mL in 0.9% Sodium Chloride is and what it is used for

Potassium Grifols 0.02 mEq/mL in 0.9% Sodium Chloride is an intravenous electrolyte-replenishing solution containing electrolytes.

Potassium Grifols 0.02 mEq/mL in 0.9% Sodium Chloride is indicated in the following conditions:

• Hypokalemia (low blood potassium levels).
• Potassium depletion due to vomiting, diarrhea, gastrointestinal suction, or fistulas.
• Nutritional deficiencies lacking potassium.
• Prolonged treatment with potassium-depleting diuretics and corticosteroids.
• Primary or secondary hyperaldosteronism (increased production and secretion of the hormone aldosterone).
• Tubular disorders with potassium loss.
• Cardiac arrhythmias due to digitalis intoxication.
• Hypochloremic alkalosis (increased blood pH due to low blood chloride ion concentration).
• Familial hypokalemic periodic paralysis (an inherited disorder causing occasional episodes of muscle weakness, during which blood potassium levels are low).

2. What you need to know before using Potassium Grifols 0.02 mEq/mL in Sodium Chloride 0.9%

Do not use Potassium Grifols 0.02 mEq/mL in Sodium Chloride 0.9%

• if you are allergic to potassium chloride, sodium chloride, or any of the other components of this medicine (listed in section 6)
• if you have hyperkalemia (high levels of potassium in the blood) or hyperchloremia (high levels of chloride in the blood)
• if you have acute renal failure (impaired kidney function) or suppression or decreased urine production
• if you have adrenal insufficiency (impaired function of the adrenal glands): Addison's disease or hypoaldosteronism (reduced secretion of the hormone aldosterone)
• if you have extensive burns (initial phase)
• if you are experiencing hemolytic crises (destruction of red blood cells)
• if you have metabolic or respiratory acidosis
• if you are receiving treatment with potassium-sparing diuretics or aldosterone-inhibiting agents
• if you have familial hyperkalemic periodic paralysis (an inherited disorder causing occasional episodes of muscle weakness, possibly with elevated blood potassium levels)
• if you are a digitalized patient with severe cardiac block, as potassium salts are not recommended in this case

Warnings and precautions

Consult your doctor or nurse before starting treatment with Potassium Grifols 0.02 mEq/mL in Sodium Chloride 0.9%.

• Frequent monitoring of diuresis (urine output), electrolyte balance, and blood glucose levels is recommended during treatment. Special monitoring of serum potassium levels (potassemia) and electrocardiogram is required during potassium-containing solution administration.

• Special monitoring is necessary when administering large volumes to patients with cardiac or pulmonary failure, or to patients with non-osmotic release of vasopressin (antidiuretic hormone), including the syndrome of inappropriate antidiuretic hormone secretion (SIADH), due to the risk of hospital-acquired hyponatremia (low sodium levels in blood during hospitalization).

Hyponatremia:

Patients with non-osmotic release of vasopressin (e.g., in critical conditions, pain, postoperative stress, infections, burns, and central nervous system disorders), those with heart, liver, or kidney diseases, and those exposed to vasopressin agonists (see next subsection) are at special risk of developing acute hyponatremia following administration of hypotonic, and even isotonic/isosodic solutions.

Acute hyponatremia may cause acute hyponatremic encephalopathy (cerebral edema), characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with cerebral edema are at particular risk of severe, irreversible, and potentially fatal brain damage.

Children, women of childbearing age, and patients with reduced cerebral compliance (e.g., in cases of meningitis, intracranial hemorrhage, and cerebral contusion) are at special risk of developing severe and potentially fatal cerebral edema due to acute hyponatremia.

Other medicines and Potassium Grifols 0.02 mEq/mL in Sodium Chloride 0.9%

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

• Do not administer with drugs that reduce kidney functional capacity.
• Concomitant administration of potassium salts with captopril may cause hyperkalemia.
• Administration together with salt substitutes or potassium-sparing diuretics (spironolactone, triamterene, amiloride) may lead to hyperkalemia, which can be severe, especially in patients with renal failure.
• Intravenous administration of such solutions together with drugs that enhance the effect of antidiuretic hormone (such as chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics, NSAIDs (non-steroidal anti-inflammatory drugs), cyclophosphamide, desmopressin, oxytocin, vasopressin, terlipressin), which reduce water excretion in urine, increases the risk of hospital-acquired hyponatremia (see previous subsection and sections 3 and 4).
• Diuretics in general and antiepileptic drugs such as oxcarbazepine increase the risk of hyponatremia.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

The safety of its use during pregnancy and breastfeeding has not been established. Therefore, it should only be used when clearly necessary and when the beneficial effects outweigh the potential risks to the fetus or infant.

This medicine should be administered with special caution in pregnant women during labor, and special monitoring of serum sodium is required if administered in combination with oxytocin (see previous subsections and section 4).

Driving and use of machines

As this medicine is administered only to hospitalized patients, studies on such effects have not been conducted.

3. How to use Potassium Grifels 0.02 mEq/ml in Sodium Chloride 0.9%

The dosage will be determined at the physician's discretion, depending on the degree of hypokalemia and the patient's clinical condition. Generally, 500–1000 ml per day at a rate of 20–30 drops/min intravenously is recommended. The maximum daily dose is 2000 ml at a rate of 60–80 drops/min.

You may need to be monitored for fluid balance, serum electrolytes, and acid-base balance before and during administration, with special attention to serum sodium levels if there is increased non-osmotic release of vasopressin (SIADH) or if you are simultaneously receiving medications with vasopressin agonists, due to the risk of hospital-acquired hyponatremia (see sections 2 and 4).

Your doctor will decide whether concomitant treatment is necessary (see sections 2 and 4).

If you receive more Potassium Grifels 0.02 mEq/ml in Sodium Chloride 0.9% than you should

In case of overdose or administration too rapid, hyperkalemia may occur.

If hyperkalemia occurs, administration should be discontinued and symptomatic treatment initiated, aimed primarily at antagonizing the effects of potassium and stimulating its elimination.

For this purpose, intravenous infusion of sodium bicarbonate 1.4%, calcium chloride or calcium gluconate (10 or 20 ml of 10% solution), or glucose (100 ml of 50% solution or 1000 ml of 10% solution) together with 30 units of crystalline insulin is appropriate.

In severe cases with renal failure, hemodialysis or peritoneal dialysis should be performed to remove body potassium and correct hyperkalemia.

If electrocardiographic abnormalities due to excess potassium are present, potassium may be removed by oral administration or enema of an ion-exchange resin (sodium polystyrene sulfonate).

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 915 620 420.

If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse effects may occur if an excessive dose of potassium chloride is administered. If there are high levels of potassium in the blood (hyperkalaemia), the following adverse effects may occur:

• Mental depression
• Confusion
• Paresthesia (abnormal sensation of senses or general sensitivity)
• Muscle weakness and flaccid paralysis (loss of strength and muscle tone) of the limbs and respiratory muscles
• Bradycardia (slowed heart rate)
• Hypotension (reduced blood pressure)
• Electrocardiographic abnormalities
• Cardiac arrest
• Death

Hyperkalaemia also causes a series of hormonal effects, as it stimulates the secretion of aldosterone, insulin, and glucagon, and inhibits renin production.

In patients with non-osmotic release of vasopressin, in patients with heart, liver, or kidney disease, and in patients treated with vasopressin agonists, there is an increased risk of developing acute hyponatraemia after administration of hypotonic and even isotonic/isonatraemic solutions. Hospital-acquired hyponatraemia may cause irreversible brain damage and death due to cerebral oedema (see sections 2 and 3).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Potassium Grifols 0.02 mEq/mL in 0.9% Sodium Chloride

No special storage conditions are required.

After opening the container, the solution must be used immediately.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Do not use this medicine if the solution is not clear or contains any precipitate.

6. Contents of the container and other information

Composition of Potassium Grifols 0.02 mEq/mL in Sodium Chloride 0.9%

• The active substances are potassium chloride and sodium chloride. Each 100 mL of solution contains 0.149 g of potassium chloride and 0.9 g of sodium chloride.

• The other components (excipients) are hydrochloric acid (for pH adjustment) and water for injections.

Appearance of the product and contents of the container

Potassium Grifols 0.02 mEq/mL in Sodium Chloride 0.9% is an infusion solution, colorless and clear, supplied in flexible polypropylene bags (Fleboflex) of 500 mL and 1000 mL.

Marketing Authorization Holder

LABORATORIOS GRIFOLS, S.A.
Can Guasch, 2
08150 Parets del Vallès, Barcelona (SPAIN)

Manufacturer

LABORATORIOS GRIFOLS, S.A.
Polígono Industrial Los Llanos. C/ Marte, 4
30565 Las Torres de Cotillas, Murcia (SPAIN)

Date of the most recent revision of this leaflet: June 2018

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

This information is intended exclusively for healthcare professionals:

Potassium Grifols 0.02 mEq/mL in Sodium Chloride 0.9% is administered by infusion. The medicine is supplied ready for administration.

The solution must be clear and free from particles or precipitates. Do not administer if this is not the case.

Once the container has been opened, the solution must be used immediately. Discard any unused portion.

Do not remove the Fleboflex bag from its protective overwrap until immediately before use.

Check for small leaks by firmly pressing the bag. If leaks are detected, discard the product.

Fleboflex bags are designed for air-free administration. If an infusion set with an air inlet must be used, ensure that it remains closed at all times.

To connect the infusion set, separate the protective tab from the infusion port, thereby exposing the access membrane of the bag.

If adding medications to the solution, disinfect the injection site on the bag. Prepare a syringe with the medication using a 20–22 G needle.

Use an aseptic technique when administering the solution and when adding medications to the solution, if necessary.

As with other parenteral solutions, compatibility tables should be consulted before adding medications.

In general, 500–1000 mL daily at a rate of 20–30 drops/minute intravenously is recommended, although dosage should be adjusted according to medical judgment. The maximum daily dose is 2000 mL at a rate of 60–80 drops/minute.