Label: information for the user

Potassium Grifols 0.04 mEq/mL in Glucose 3.3% and Sodium Chloride 0.3% Solution for infusion

Potassium chloride, Glucose, Sodium chloride

Read this label carefully before starting to use this medication, as it contains important information for you.

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

1.What is Potassium Grifols 0.04 mEq/mL in Glucose 3.3% and Sodium Chloride 0.3% Solution for infusion and how it is used

2.What you need to know before starting to use Potassium Grifols 0.04 mEq/mL in Glucose 3.3% and Sodium Chloride 0.3% Solution for infusion

3.How to use Potassium Grifols 0.04 mEq/mL in Glucose 3.3% and Sodium Chloride 0.3% Solution for infusion

4.Possible adverse effects

1. Storage of Potassium Grifols 0.04 mEq/mL in Glucose 3.3% and Sodium Chloride 0.3% Solution for infusion
2. Contents of the package and additional information

This medication contains the following active principles: potassium chloride, glucose (as monohydrate) and sodium chloride. This medication is a solution for infusion and will be administered through a vein via a thin tube.

This medication belongs to the group of medications called intravenous solutions that affect electrolyte balance – electrolytes with carbohydrates (used to maintain bodily fluids in correct balance).

This medication is indicated for the prevention or treatment of potassium deficiency (an electrolyte) in your body, when you require a supply of water, electrolytes and carbohydrates because dietary measures or oral medication are inadequate.

No usePotassium Grifols 0.04 mEq/mL in Glucose 3.3% and Sodium Chloride 0.3% Solution for InfusionSolution for Infusion

• If you are allergic to potassium chloride, glucose, or sodium chloride or to any of the other components of this medication (listed in section 6)
• If your blood potassium levels are elevated (hyperkalemia)
• If you have a severe kidney disease with oliguria (reduced urine excretion), anuria (absence of urine production), or azotemia (presence of excess nitrogen waste in the blood due to kidney failure)
• If your blood chloride levels are elevated (hyperchloremia)
• If your blood sodium levels are elevated (hypernatremia)
• If you are experiencing states of hyperhydration (excess water in the body)

-If you are experiencing states of hyperglycemia (high blood glucose levels) such as in cases of hyperosmolar coma, decompensated diabetes, or other glucose intolerances such as in situations of metabolic stress

• If you are experiencing tubular renal acidosis (alteration of kidney function)
• If you have an acute ischemic stroke (sudden loss of brain function due to a blockage in blood flow)
• During the first 24 hours after a head trauma.

Warnings and Precautions

Consult your doctor or nurse before starting to use Potassium Grifols 0.04 mEq/mL in Glucose 3.3% and Sodium Chloride 0.3% Solution for Infusion.

-Potassium administration should always be carried out under strict medical supervision. During the administration of this medication, and in order to detect early signs of excessive potassium levels (hyperkalemia), your doctor will monitor your heart with electrocardiograms and perform periodic blood tests to determine your blood potassium levels, especially:

-If you have a heart or kidney disease, or other conditions that may favor the development of hyperkalemia

-If you are taking other medications that may increase your blood potassium levels (see subheading below).

-Your doctor should exercise extreme caution if you are receiving digitalis, especially when stopping potassium administration, as a sudden decrease in potassium levels can cause digitalis toxicity. In these cases, potassium treatment should not be stopped abruptly.

-The potassium solution should only be administered if you have a normal urine flow. If not, you may need to receive a solution that does not contain potassium.

-Your doctor will perform frequent medical and laboratory tests to monitor changes in fluid balance and acid-base balance, and to check your blood electrolyte and glucose levels.

• This medication may become physiologically hypotonic in the body due to the rapid metabolism of glucose (see section 3).

-Depending on the volume and rate of infusion, your initial clinical condition, and your ability to metabolize glucose, the intravenous administration of this type of solution may cause electrolyte imbalances such as hyponatremia (low blood sodium levels).

Hyponatremia:

If you are a patient with non-osmotic vasopressin release (antidiuretic hormone) (e.g., in cases of critical illness, pain, postoperative stress, infections, burns, and central nervous system diseases), if you have heart, liver, or kidney disease, and if you are exposed to vasopressin agonists (see next subheading), you have a special risk of developing acute hyponatremia after receiving hypotonic solutions.

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

Children, pregnant women, and patients with reduced cerebral compliance (e.g., in cases of meningitis, intracranial hemorrhage, and cerebral contusion) have a special risk of developing severe and potentially fatal cerebral edema caused by acute hyponatremia.

-If you are in an emergency situation and your blood potassium levels are very low, or if you are taking digitalis medications, it is not recommended to administer glucose solutions as the presence of glucose prevents potassium levels from increasing as quickly as they should.

-If you are experiencing episodes of intracranial hypertension, your doctor will closely monitor your blood glucose levels.

-Since this medication contains glucose, it should be administered with caution if you have vitamin B1 deficiency or diabetes. Your doctor can give you this medication as long as you have previously been started on an appropriate treatment.

-Since this medication contains sodium, it should be administered with caution if you have hypertension, congestive heart failure, pulmonary or peripheral edema, kidney insufficiency, preeclampsia (development of hypertension during pregnancy), or other conditions associated with sodium retention, as well as if you are taking corticosteroids or corticotropin (see subheading below).

-This medication should be administered with special caution if you are elderly, as you may be taking other medications (see subheading below) or may have impaired kidney or heart function, or other conditions that may affect your blood potassium levels.

-With prolonged administration, extravasation (escape of the solution from the vein into the surrounding tissue) or thrombophlebitis (inflammation of the vein associated with the formation of blood clots) may occur.

Other Medications and Potassium Grifols 0.04 mEq/mL in Glucose 3.3% and Sodium Chloride 0.3% Solution for Infusion

It is very important to inform your doctor if you are taking or have taken recently any of the following medications:

?Medications that may cause potassium levels in the blood to be too high due to additive effects, particularly if the kidneys do not function correctly:

-Potassium-sparing diuretics (amiloride, triamterene, spironolactone, eplerenone)

-Angiotensin-converting enzyme inhibitors (ACE inhibitors) (such as captopril, enalapril, lisinopril)

-Angiotensin II receptor antagonists (candesartan, telmisartan, eprosartan, irbesartan, losartan, valsartan)

-Potassium-containing medications such as penicillin salts

-Nonsteroidal anti-inflammatory drugs (NSAIDs) (diclofenac, indomethacin, piroxicam, mefenamic acid, celecoxib)

-Heparin

-Pentamidine, trimethoprim

-Ciclosporin, tacrolimus

-β-Adrenergic blockers (propranolol, nadolol, atenolol)

-Succinylcholine (suxamethonium)

?Medications that may reduce potassium levels in the blood, so you may need higher doses of potassium:

-Corticosteroids

-Diuretics (thiazide diuretics, potassium-wasting diuretics, osmotic diuretics, carbonic anhydrase inhibitors)

-High doses of penicillins

-Aminoglycosides

-Cisplatin

-Foscarnet

-Amphotericin B

-Theophylline

-Insulin

-Folic acid and vitamin B12

-β2-adrenergic agonists

?Digitalis glycosides (digoxin and methyldigoxin) (high potassium levels can reduce their effect and a sudden decrease in potassium levels can cause digitalis toxicity)

?Antiarrhythmic medications (such as quinidine, hydroquinidine, procainamide) (high potassium levels increase their activity and low potassium levels reduce their efficacy)

?Lithium carbonate (sodium can accelerate renal excretion of lithium, leading to a decrease in its therapeutic effect)

?Corticosteroids with mineralocorticoid activity (such as fludrocortisone) or ACTH (corticotropin) (these medications promote water and sodium retention)

?Corticosteroids with glucocorticoid activity (such as hydrocortisone) (these medications can cause high blood glucose levels)

?Insulin and oral antidiabetic medications (biguanides, sulfonylureas) (glucose can reduce their effect)

• Medications that increase the effect of antidiuretic hormone (such as chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxymethamphetamine, ifosfamide, antipsychotics, narcotics, NSAIDs, cyclophosphamide, desmopressin, oxytocin, vasopressin, terlipressin). These medications reduce water excretion in urine and increase the risk of hospital-acquired hyponatremia after receiving an insufficiently balanced intravenous infusion treatment (see previous subheading and sections 3 and 4)
• Diuretics in general and antiepileptic medications such as oxcarbazepine, which may increase the risk of hyponatremia.

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

Pregnancy and Lactation

If you are pregnant or breastfeeding, consult your doctor before using this medication.

The safety of its use during pregnancy and lactation has not been established. Therefore, it should only be used when the benefits clearly outweigh the potential risks for the fetus or infant.

The maternal administration of large amounts of glucose-containing solutions during delivery, especially in complicated deliveries, may cause hyperglycemia, hyperinsulinemia, and acidosis in the fetus and may be harmful to the newborn.

This medication should be administered with special caution in pregnant women during delivery, especially if it is administered in combination with oxytocin, due to the risk of hyponatremia (see previous subheadings and section 4).

Due to the presence of sodium chloride in this medication, caution should be exercised in cases of preeclampsia during pregnancy.

If you are pregnant or breastfeeding, your doctor should closely monitor your heart and blood potassium levels, as incorrect levels may cause severe cardiac complications for both the mother and the fetus or newborn.

Driving and Operating Machinery

Not relevant.

This medication will be administered by a doctor or nurse in a hospital through a vein using a drip (slow intravenous infusion).

Your doctor will decide on the dose you should receive, taking into account the severity of hypokalemia, your age, weight, and clinical condition (especially if you have any heart or kidney disease), and how long you need to receive it.

You may need to be monitored for fluid balance, serum glucose, serum sodium, and other electrolytes before and during administration, especially if you have an increased non-osmotic release of vasopressin (SIADH syndrome) and if you are receiving medication with vasopressin agonists simultaneously, due to the risk of hyponatremia. Monitoring of serum sodium is especially important when administering hypotonic solutions. This medication can become hypotonic after administration due to the rapid metabolism of glucose in the body (see sections 2 and 4).

The recommended maximum dose of potassium is 2-3 mEq/kg/day. In adults, the potassium dose should not exceed 200 mEq per day. The recommended dose to meet maintenance needs is 40-80 mEq per day.

Your doctor will decide on the amount of fluid you should receive. However, in general, you should not receive more than 40 ml/kg/day (maximum 3000 ml per day).

The amount of glucose administered with the solution should not exceed 4-5 mg/kg/min.

If your kidneys do not function correctly, you should receive a lower dose.

As a general rule, the infusion rate should never exceed 20 mEq of potassium per hour when administered through a peripheral vein.

Oral potassium supplements or the ingestion of potassium-rich foods should replace intravenous administration of this medication as soon as possible.

Use in children

In children, the potassium dose should not exceed 3 mEq/kg/day, and daily maintenance needs are 2-2.5 mEq/kg.

The recommended daily fluid dose in these patients is as follows:

- less than 10 kg of weight: 100 ml/kg

- between 10 and 20 kg of weight: 1000 ml + 50 ml/kg that exceeds 10 kg

- more than 20 kg of weight: 1500 ml + 20 ml/kg that exceeds 20 kg

If you receive morePotassium Grifols 0.04 mEq/ml in Glucose 3.3% and Sodium Chloride 0.3%Solution for infusion than you should

Excessive administration of potassium solutions can cause hyperkalemia, which can be potentially fatal, especially if your kidneys do not function correctly. In case of overdose, alterations in fluid balance and serum electrolytes, swelling, and circulatory and cardiac alterations may also occur (see symptoms in section 4. Possible adverse effects).

In case of hyperkalemia, your doctor should suspend administration and take the necessary measures to reduce blood potassium levels.

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

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

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

After administration of this medicine, hyperhydration (fluid retention), hyperglycemia, hyperchloremic acidosis(high chloride content in blood), and hyperkalemia may occur, especially if the solution is administered too quickly or in excess, or if your kidneys do not function properly. The symptoms of hyperkalemia mainly affect nerves, muscles, and the heart, and include itching or tingling in the extremities, muscle weakness, paralysis in which the muscles are flaccid, respiratory paralysis, intestinal paralysis, mental confusion, loss of reflexes, apathy, cold skin, pallor (grayish tone of the skin), weakness, and heaviness in the legs, hypotension (low blood pressure), electrocardiogram abnormalities, cardiac arrhythmias, cardiac block, and cardiac arrest. It is very important that your doctor monitor your heart to assess the severity of possible hyperkalemia.

Patients with non-osmotic vasopressin release, patients with heart, liver, and kidney diseases, and patients treated with vasopressin agonists have a special risk of suffering acute hyponatremia after administration of hypotonic solutions. Hospital-acquired hyponatremia can cause irreversible brain damage and death due to the appearance of cerebral edema (see sections 2 and 3).

Other side effects may occur due to intravenous administration. These effects include fever, injection site infection, local pain, venous irritation, venous thrombosis (formation of a clot), inflammation, hardening or contraction of the vein, extravasation, and necrosis (tissue death).

The following side effects may appear in some people:

-Elevated potassium and/or glucose levels in blood, fluid retention, hyperchloremic acidosis

-Mental confusion, apathy

-Muscle weakness, itching or tingling in the extremities, loss of voluntary muscle movement (paralysis), loss of reflexes, feeling ofweakness and heaviness

-Severe or total weakness of respiratory muscles

-Intestinal obstruction due to lack of intestinal muscle movement

-Cardiac arrhythmias, cardiac block, cardiac arrest

-Low sodium levels in blood(acquired during hospitalization)

-Cerebral edema

-Injection site infection

-Fever

-Inflammation, hardening or contraction of the vein in which the medicine is administered, venous thrombosis, cold skin, pallor (grayish tone of the skin), hypotension

-Pain, irritation, extravasation, and necrosis at the injection site

-Electrocardiogram abnormalities.

Reporting of side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label. The expiration date is the last day of the month indicated.

This medication does not require special conditions of conservation.

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

This medication is for single use. Discard unused solution.

Do not use this medication if you observe that the solution is not transparent or contains particles, or if the container is damaged.

Composition of Potasio Grifols 0.04 mEq/ml in Glucose 3.3% and Sodium Chloride 0.3%Solution for Infusion

-The active principles are potassium chloride, glucose, and sodium chloride. Each 100 ml of this medication contains 0.298 g of potassium chloride, 3.3 g of glucose (as monohydrate) and 0.3 g of sodium chloride.

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

Aspect of the product andcontent of the package

Potasio Grifols 0.04 mEq/ml in Glucose 3.3% and Sodium Chloride 0.3% is a solution for infusion. It is a transparent and colorless aqueous solution.

This medication is available inflexible polypropylene bags (Fleboflex) (in boxes containing 20 bags of 500 ml or 10 bags of 1000 ml).

Holder of the marketing authorization

LABORATORIOS GRIFOLS, S.A.

Can Guasch, 2

08150 Parets del Vallès, Barcelona (SPAIN)

Responsible for manufacturing

LABORATORIOS GRIFOLS, S.A.

Polígono Los Llanos. C/Marte 4

30565 Las Torres de Cotillas, Murcia (SPAIN)

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:July 2018

Other sources of information

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

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This information is intended solely for healthcare professionals:

Potasio Grifols 0.04 mEq/ml in Glucose 3.3% and Sodium Chloride 0.3%Solution for Infusion is a ready-to-use solution that mustbe administered by slow infusion.

The theoretical osmolarity of the solution is 366 mOsm/l.

Given the concentration of potassium in the solution (40 mEq/l), this medication is suitable for administration via peripheral vein. If administered via central vein, it is recommended to use the femoral vein and avoid the jugular and subclavian veins.

It is generally recommended not to exceed 40 mEq/l via peripheral vein.

Dosage:

The dose and duration of treatment should be individualized for each patient, depending on the severity of hypokalemia, age, weight, and clinical condition, especially in cases of heart or renal insufficiency.

It may be necessary to monitor fluid balance, serum glucose, serum sodium, and other electrolytes before and during administration, especially in patients with increased non-osmotic vasopressin release (SIADH) and patients receiving concomitant medication with vasopressin agonists, due to the risk of hyponatremia. Monitoring of serum sodium is particularly important when administering hypotonic solutions. Potasio Grifols 0.04 mEq/ml in Glucose 3.3% and Sodium Chloride 0.3% may become hypotonic after administration due to rapid glucose metabolism in the body.

The dose and infusion rate should be determined by monitoring electrocardiogram and potassium plasma determinations.

In adults, the maximum recommended dose of potassium is 2-3 mEq/kg/day, without exceeding 200 mEq/day, with a recommended dose of 40-80 mEq/day for maintenance therapy.

The infusion of fluid should be calculated for each patient based on the requirements forreplacement ormaintenance. However, in general, it should not be administered more than 40 ml/kg/day (max. 3000 ml per day).

The amount of glucose administered with the solution should not exceed 4-5 mg/kg/min.

In children, the dose of potassium should not exceed 3 mEq/kg/day, and the daily maintenance requirements are 2-2.5 mEq/kg.

The recommended daily dose of fluid in these patients is as follows:

- <10 kg

- between 10 and 20 kg of weight: 1000 ml + 50 ml/kg that exceeds 10 kg

- > 20 kg of weight: 1500 ml + 20 ml/kg that exceeds 20 kg

Patients with renal insufficiency should receive lower doses due to the risk of hyperkalemia.

The administration of intravenous potassium at a rate of 10 mEq/h is considered safe. When the infusion rate exceeds 10 mEq/h, the patient should be closely monitored by ECG and periodic determinations of plasma potassium concentrations. As a general rule, the infusion rate via peripheral vein should not exceed 20 mEq/h. Via central vein, higher infusion rates can be achieved.

General recommendations for the administration of intravenous potassium solutions:

Precautions for preparation and handling:

The contents of each package are for single use only. The unused contents should be discarded.

The solution should be transparent and free of particles. Do not administer if otherwise.

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

To connect the infusion equipment, separate the protective tab from the infusion port, leaving the access membrane to the bag exposed.

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

As with all parenteral solutions, before adding medications to the solution or administering simultaneously with other medications, check for incompatibilities of the added medications with the solution or the container. Also, consult the technical data sheet of the added medication.

It is the user's responsibility to evaluate the incompatibility of the added medication withPotasio Grifols 0.04 mEq/ml in Glucose 3.3% and Sodium Chloride 0.3%Solution for Infusion, monitoring for possible changes in color and/or the formation of precipitates, insoluble complexes, or crystals.

Before administering the mixture, verify the stability and osmolarity of the final solution.

When adding compatible medication to this formulation, the solution should be administered immediately, unless the dilution has been carried out in controlled and validated aseptic conditions.

Incompatibilities:

No studies have been found that describe incompatibilities related to this medication, but they have been found with the active principles of the solution.

Potassium chloride in intravenous mixtures has been shown to be incompatible with amoxicillin sodium, amphotericin B, hydrochloride of dobutamine, and penicillin G sodium. Additionally, it is not recommended to administer in "Y" the following drugs when administering potassium mixtures: azithromycin, hydrochloride of prometazina, diazepam, sodium phenytoin, succinate of metilprednisolona or ergotamine tartrate.

It has been described that the glucose-saline solution with a glucose content of 3.3% and sodium chloride content of 0.3% is incompatible with mitomicin, due to the low pH of this solution. Additionally, incompatibility has been observed for different glucose-saline solutions with: sodium phenytoin, sodium heparin, lactate of haloperidol, imipenem-cilastatina sodium, and meropenem. However, some of these drugs may be compatible with glucose-saline solutions depending on different factors such as the concentration of the drug in the solution (sodium heparin) or the time elapsed between dissolution and administration of the solution (imipenem-cilastatina sodium and meropenem).

On the other hand, signs of incompatibility have been described when some medications are diluted in solutions containing glucose, including: amoxicillin sodium/acid clavulanic, ampicillin sodium, interferon alfa-2b, and hydrochloride of procainamide. However, we should note that some of these drugs, such as amoxicillin sodium/acid clavulanic, can be injected directly into the injection site while these infusion solutions are being administered.

Also, signs of incompatibility have been described when some medications are diluted in solutions containing chloride, including: amsacrina and trimetrexate glucuronate.

Emergency treatment for hyperkalemia:

The treatment of hyperkalemia depends on its severity. Different regimens have been established, consisting of the administration of calcium to counteract the negative effects of hyperkalemia on the heart, the use of insulin and glucose or bicarbonate sodium to promote the passage of extracellular potassium into the cell, and/or the use of diuretics, cation exchange resins, or dialysis to increase its excretion:

-If cardiac manifestations exist: administration of intravenous calcium salts (10-20 ml of gluconate calcium at 10%). In some cases, a second administration may be necessary.

-To rapidly decrease plasma potassium: intravenous administration of insulin and glucose (e.g., 5-15 units of insulin together with 50 ml of glucose at 50%). Alternatively or additionally, in acidotic patients, bicarbonate sodium can be administered intravenously (40-160 mEq administered in 5 minutes).

-To eliminate excess potassium from the body: use of diuretics, especially loop diuretics (furosemide), cation exchange resins (polystyrene sulfonate or calcium) by rectal or oral route, or hemodialysis or peritoneal dialysis in severe cases of renal insufficiency and hypercatabolism.

A rapid decrease in plasma potassium levels in digitalized patients can cause digitalis toxicity.

Preventive measures to avoid thrombophlebitis:

If administration is prolonged, extravasation or thrombophlebitis may occur. To avoid thrombophlebitis, it is recommended to change the site of catheter insertion every 24-48 hours.