POTASSIUM GRIFOLS 0.04 mEq/mL in 0.9% SODIUM CHLORIDE SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Potassium Grifols 0.04 mEq/ml in Sodium Chloride 0.9% Solution for Infusion

Potassium chloride, Sodium chloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What Potassium Grifols 0.04 mEq/ml in Sodium Chloride 0.9% is and what it is used for
2. What you need to know before you use Potassium Grifols 0.04 mEq/ml in Sodium Chloride 0.9%
3. How to use Potassium Grifols 0.04 mEq/ml in Sodium Chloride 0.9%
4. Possible side effects
5. Storage of Potassium Grifols 0.04 mEq/ml in Sodium Chloride 0.9%

Contents of the pack and other information

1. What Potassium Grifols 0.04 mEq/ml in Sodium Chloride 0.9% is and what it is used for

Potassium Grifols 0.04 mEq/ml in Sodium Chloride 0.9% is an intravenous solution for restoring electrolyte balance containing electrolytes.

Potassium Grifols 0.04 mEq/ml in Sodium Chloride 0.9% is indicated in the following situations:

• Hypokalemia (low potassium levels in the blood).
• Potassium depletion due to vomiting, diarrhea, gastrointestinal aspiration, or fistulas.
• Nutritional deficits without potassium.
• Prolonged treatment with potassium-depleting diuretics and corticosteroids.
• Primary or secondary hyperaldosteronism (increased production and secretion of aldosterone hormone).
• Tubular disorders with potassium elimination.
• Cardiac arrhythmias due to digitalis intoxication.
• Hypochloremic alkalosis (increase in blood pH due to low chloride ion concentration in the blood).
• Familial periodic hypokalemic paralysis (hereditary disorder that produces occasional episodes of muscle weakness, during which the potassium level in the blood is low).

2. What you need to know before you use Potassium Grifols 0.04 mEq/ml in Sodium Chloride 0.9%

Do not use Potassium Grifols 0.04 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 potassium levels in the blood) or hyperchloremia (high chloride levels in the blood)
• if you have acute renal failure (kidney failure) or suppression or decreased urine production
• if you have adrenal insufficiency (adrenal gland failure): Addison's disease or hypoaldosteronism (decreased secretion of aldosterone hormone)
• if you have extensive burns (initial phase)
• if you have hemolytic crises (destruction of red blood cells)
• if you have metabolic or respiratory acidosis
• if you are being treated with potassium-sparing diuretics or aldosterone inhibitors
• if you have familial periodic hyperkalemic paralysis (hereditary disorder that produces occasional episodes of muscle weakness, with potentially higher than normal potassium levels in the blood)
• if you are a digitalized patient with severe cardiac block, as the use of potassium salts is not recommended in this case

Warnings and precautions

Consult your doctor or nurse before starting to use Potassium Grifols 0.04 mEq/ml in Sodium Chloride 0.9%.

• It is recommended to perform frequent checks of diuresis (urine production), ionic balance, and acid-base balance before and during treatment, with special attention to serum sodium if you have an increase in non-osmotic vasopressin release (SIADH) and if you are receiving simultaneous medication with vasopressin agonists, due to the risk of hospital hyponatremia (see sections 2 and 4).

• The administration of large volumes will require special monitoring if you are a patient with heart or lung failure and if you are a patient with non-osmotic vasopressin release (including SIADH), due to the risk of hospital hyponatremia (see previous subsection and sections 3 and 4).

Hyponatremia:

If you have non-osmotic vasopressin release (e.g., in the presence of critical states, pain, postoperative stress, infections, burns, and central nervous system diseases), if you have heart, liver, and kidney diseases, and if you are exposed to vasopressin agonists (see next subsection), you have a special risk of suffering from acute hyponatremia after the administration of hypotonic and even isotonic/isonatremic solutions.

Acute hyponatremia can cause acute hyponatremic encephalopathy (brain edema) characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with brain edema have a special risk of suffering from severe, irreversible, and potentially fatal brain damage.

Children, women of childbearing age, and patients with reduced cerebral distensibility (e.g., in cases of meningitis, intracranial hemorrhage, and cerebral contusion) have a special risk of suffering from severe and potentially fatal brain edema caused by acute hyponatremia.

Other medicines and Potassium Grifols 0.04 mEq/ml in Sodium Chloride 0.9%

Tell your doctor if you are using, have recently used, or may need to use any other medicine.

• Do not administer with medicines that decrease kidney function.
• The concomitant administration of potassium salts with captopril may cause hyperkalemia.
• The concomitant administration with salt substitutes or potassium-sparing diuretics (spironolactone, triamterene, amiloride) may produce hyperkalemia, which can be severe, especially in patients with renal insufficiency.
• The intravenous administration of this type of solution with medicines that increase the effect of antidiuretic hormone (such as chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxymethamphetamine, ifosfamide, antipsychotics, narcotics, non-steroidal anti-inflammatory drugs, cyclophosphamide, desmopressin, oxytocin, vasopressin, terlipressin), which reduce water excretion in urine, increases the risk of hospital hyponatremia (see previous subsection and sections 3 and 4).

• Diuretics in general and antiepileptics 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 baby.

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

Driving and using machines

Since this medicine is administered only to hospitalized patients, no studies have been conducted on such effects.

3. How to use Potassium Grifols 0.04 mEq/ml in Sodium Chloride 0.9%

The dosage will be established according to medical criteria depending on the degree of hypokalemia and the patient's clinical situation. Generally, 500-1000 ml per day at a rate of 20-30 drops/min by intravenous route is recommended. The maximum daily dose is 2000 ml at a rate of 60-80 drops/min.

You may need to monitor fluid balance, serum electrolytes, and acid-base balance before and during administration, with special attention to serum sodium if you have an increase in non-osmotic vasopressin release (SIADH) and if you receive simultaneous medication with vasopressin agonists, due to the risk of hospital hyponatremia (see sections 2 and 4).

Your doctor will decide on the need for simultaneous treatment (see sections 2 and 4).

If you receive more Potassium Grifols 0.04 mEq/ml in Sodium Chloride 0.9% than you should

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

In case of hyperkalemia, administration should be discontinued and symptomatic treatment should be initiated, mainly aimed at counteracting the effects of potassium and stimulating its elimination.

To do this, it is suitable to administer intravenous 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) along with 30 units of crystalline insulin.

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

If there are electrocardiographic alterations due to excess potassium, it can be eliminated by administering an ion exchange resin (sodium polystyrene sulfonate) orally or by enema.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects can occur if an excessive dose of potassium chloride is administered. If there are high levels of potassium in the blood (hyperkalemia), the following side effects may occur:

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

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

In patients with non-osmotic vasopressin release, in patients with heart, liver, and kidney diseases, and in patients treated with vasopressin agonists, the risk of suffering from acute hyponatremia after the administration of hypotonic and even isotonic/isonatremic solutions is increased. Hospital hyponatremia can cause irreversible brain damage and death due to the occurrence of brain edema (see sections 2 and 3).

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Potassium Grifols 0.04 mEq/ml in Sodium Chloride 0.9%

No special storage conditions are required.

Once the container is opened, the solution should be used immediately.

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

Do not use this medicine after the expiration date stated on the container. The expiration date is the last day of the month indicated.

Do not use this medicine if you notice that the solution is not transparent or contains particles or precipitates.

6. Contents of the pack and other information

Composition of Potassium Grifols 0.04 mEq/ml in Sodium Chloride 0.9%

• The active ingredients are potassium chloride and sodium chloride. Each 100 ml of solution contains 0.30 g of potassium chloride and 0.9 g of sodium chloride.

• The other ingredients (excipients) are hydrochloric acid (for pH adjustment) and water for injectable preparations.

Appearance of the product and contents of the pack

Potassium Grifols 0.04 mEq/ml in Sodium Chloride 0.9% is a solution for infusion, colorless and transparent, presented in flexible polypropylene bags (Fleboflex) of 500 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 last revision of this leaflet: June 2018

Other sources of information

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/)

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This information is intended only for healthcare professionals:

Potassium Grifols 0.04 mEq/ml in Sodium Chloride 0.9% will be administered by infusion. The medicine is presented ready for administration.

The solution must be transparent and not contain particles or precipitates. Do not administer otherwise.

Once the container is opened, the solution should be used immediately. Discard the unused content.

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

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

The Fleboflex bags are designed for air-free administration. If you need to use an infusion device with air entry, make sure it is always closed.

To connect the infusion device, separate the protective tab from the infusion port, exposing the access membrane to the bag.

In case of adding medicines to the solution, disinfect the injection point of the bag. Prepare a syringe with the medication, using a 20-22 G needle.

Use an aseptic technique to administer the solution, as well as to add medicines to the solution, if necessary.

Like other parenteral solutions, before adding medicines, incompatibility tables should be consulted.

Generally, 500-1000 ml per day at a rate of 20-30 drops/min by intravenous route is recommended, although the dose should be adjusted according to medical criteria. The maximum daily dose is 2000 ml at a rate of 60-80 drops/min.