POTASSIUM GRIFOLS 0.02 mEq/ml IN 5% GLUCOSE SOLUTION FOR INFUSION

2. What you need to know before you use Potassium Grifols 0.02 mEq/ml in Glucose 5%

Do not use Potassium Grifols 0.02 mEq/ml in Glucose 5%

• if you are allergic to potassium chloride, glucose, 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 0.02 mEq/ml in Glucose 5%.

• Due to its glucose content, this medicine should be administered with caution in diabetic patients, keeping blood glucose levels under control. Each 100 ml of this medicine contains 5 g of glucose.

• It is recommended to perform frequent checks of diuresis (urine production), ionic balance, and blood glucose levels before and during treatment, especially if you have an increased release of non-osmotic vasopressin (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and if you are receiving simultaneous medication with vasopressin agonists, due to the risk of hyponatremia. Monitoring of serum sodium is especially important when administering physiologically hypotonic solutions. This medicine may become hypotonic after administration due to the rapid metabolism of glucose in the body (see sections 2 and 4).

• This medicine may cause electrolyte disturbances, such as hyponatremia (low sodium levels in the blood), depending on the volume and rate of infusion, initial clinical condition, and ability to metabolize glucose.

Hyponatremia:

If you are a patient with non-osmotic release of vasopressin (e.g., in 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 are at special risk of suffering from acute hyponatremia after administration of hypotonic solutions.

Acute hyponatremia can cause acute hyponatremic encephalopathy (brain edema) characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with brain edema are at 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 case of meningitis, intracranial hemorrhage, and cerebral contusion) are at special risk of suffering from severe and potentially fatal brain edema caused by acute hyponatremia.

Other medicines and Potassium Grifols 0.02 mEq/ml in Glucose 5%

Tell your doctor if you are using, have recently used, or might use any other medicines.

• Do not administer with medicines that decrease kidney function.
• The concomitant administration of potassium salts with captopril may cause hyperkalemia.
• The concomitant administration with potassium-sparing diuretics (spironolactone, triamterene, amiloride) may produce hyperkalemia, which can be severe, especially in patients with renal insufficiency.
• The intravenous administration of physiologically hypotonic solutions 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 are planning to have a baby, ask your doctor for advice before taking 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 benefits outweigh the potential risks to the fetus or baby.

This medicine should be administered with special caution in pregnant women during labor, especially if administered in combination with oxytocin, due to the risk of hyponatremia (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 0.02 mEq/ml in Glucose 5%

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 is recommended at a rate of 20-30 drops/min by intravenous route. The maximum daily dose is 2000 ml at a rate of 60-80 drops/min.

You may need to monitor fluid balance, blood glucose, serum sodium, and other electrolytes before and during administration, especially if you have an increased release of non-osmotic vasopressin (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and if you receive simultaneous medication with vasopressin agonists, due to the risk of hyponatremia. Monitoring of serum sodium is especially important when administering physiologically hypotonic solutions. This medicine may become hypotonic after administration due to the rapid metabolism of glucose in the body (see sections 2 and 4).

If you receive more Potassium Grifols 0.02 mEq/ml in Glucose 5% 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 potassium from the body 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 further questions on 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 may occur in case of excessive potassium chloride administration. If there are high potassium levels 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 release of vasopressin, in patients with heart, liver, and kidney diseases, and in patients treated with vasopressin agonists, the risk of acute hyponatremia after administration of hypotonic 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Potassium Grifols 0.02 mEq/ml in Glucose 5%

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 expiry date stated on the container. The expiry 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 0.02 mEq/ml in Glucose 5%

• The active principles are potassium chloride and glucose. Each 100 ml of solution contains 0.149 g of potassium chloride and 5.00 g of glucose (as monohydrate).

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

Appearance and pack contents

Potassium Grifols 0.02 mEq/ml in Glucose 5% is a solution for infusion, colorless or slightly yellowish 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 last revision of this leaflet:June 2018

Other sources of information

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

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This information is intended only for healthcare professionals:

Potassium Grifols 0.02 mEq/ml in Glucose 5% 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 unused contents.

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

Check for 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, ensure it is always closed.

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

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 is recommended at a rate of 20-30 drops/min by intravenous route, 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.