Ringer lactate Grifols solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ringer Lactate Grifols Solution for infusion

Read all of this 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 adverse reactions, consult your doctor or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Ringer Lactate Grifols is and what it is used for
2. What you need to know before using Ringer Lactate Grifols
3. How to use Ringer Lactate Grifols
4. Possible adverse effects
5. How to store Ringer Lactate Grifols
6. Contents of the pack and other information

1. What Ringer Lactate Grifols is and what it is used for

Ringer Lactate Grifols belongs to a group of medicines called Intravenous Solutions Affecting Electrolyte Balance – Electrolytes (used to maintain body fluids in proper balance).

Ringer Lactate Grifols is indicated in the following situations:

• Hydroelectrolytic replacement of extracellular fluid, as in states of dehydration with electrolyte loss or surgical interventions.
• Short-term plasma volume replacement in states of hypovolemic shock (hemorrhages, burns, and other conditions causing circulatory volume loss) or hypotension (low blood pressure).
• Mild or moderate metabolic acidosis (except lactic acidosis).
• As a vehicle for the administration of compatible medications.

2. What you need to know before using Ringer Lactate Grifols

Do not use Ringer Lactate Grifols

• if you are allergic to the active substances or to any of the other components of this medicine (listed in section 6)

• in cases of extracellular hyperhydration or hypervolemia (excess fluid in the body)

• if you have severe renal failure with oliguria or anuria (kidney failure with reduced or absent urine output)

• in cases of uncompensated heart failure

• if your blood has high levels of potassium, sodium, calcium, or chlorides

• if you have metabolic alkalosis

• in cases of severe metabolic acidosis

• if you have lactic acidosis

• if you have severe hepatocellular insufficiency (severe liver dysfunction) or impaired lactate metabolism

• in cases of generalized edema (excessive fluid accumulation) or ascitic cirrhosis.

Warnings and precautions

Consult your doctor or nurse before starting to use Ringer Lactate Grifols.

• If your kidneys, heart, and/or lungs are not functioning properly, administration of large volumes of this solution must be carried out under strict clinical monitoring. Administration of large volumes also requires special monitoring if you have 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 blood sodium levels during hospitalization).

Hyponatremia:

If you have non-osmotic release of vasopressin (e.g., in critical conditions, pain, postoperative stress, infections, burns, and central nervous system disorders), if you have heart, liver, or kidney disease, or if you are exposed to vasopressin agonists (see next subsection), you are at special risk of developing acute hyponatremia after administration of hypotonic solutions.

Acute hyponatremia may cause acute hyponatremic encephalopathy (cerebral edema), characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with cerebral edema are at special risk of suffering 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.

• It is advisable that your clinical condition and blood and urine tests (blood and urine electrolytes, acid-base balance, hematocrit) be regularly monitored during administration of this solution. Blood potassium levels should be monitored if you are at risk of hyperkalemia (high blood potassium levels).

If you have any of the following conditions, this medicine should be administered with special caution, and you may require additional tests to determine whether you can receive the medication:

• Due to the presence of sodium: If you have high blood pressure (hypertension), heart failure, pulmonary or peripheral edema (in ankles, feet, or legs), preeclampsia (a condition occurring during pregnancy or postpartum characterized by elevated blood pressure), aldosteronism (a condition associated with increased secretion of a hormone called aldosterone), or impaired renal function or other conditions associated with sodium retention.

• Due to the presence of potassium: If you have heart disease or other conditions that may cause elevated blood potassium levels, such as renal or adrenocortical insufficiency, acute dehydration, or massive tissue destruction, as occurs in severe burns.

• Due to the presence of calcium: If you have impaired renal function or if you have or have had kidney stones due to calcium accumulation, or diseases associated with elevated vitamin D levels, such as sarcoidosis.

• Due to the presence of lactate ions: If Ringer Lactate solution is administered in large amounts, metabolic alkalosis may occur.

• If you have severe potassium deficiency. Although Ringer Lactate solution has a potassium concentration similar to plasma, this is insufficient to produce a beneficial effect in such situations.

• If your liver is not functioning properly, Ringer Lactate solution may not be effective, as lactate metabolism may be impaired.

• Ringer Lactate solution should be administered with caution if you are at risk of cerebral edema or increased intracranial pressure.

• If you are being treated with corticosteroids, adrenocorticotropic hormone, or digitalis medications, administration of Ringer Lactate solution should be done with caution (see section "Use with other medicines").

Special attention should be paid to elderly patients, as they may have impaired renal, hepatic, and/or cardiac function.

Repeated administration at the same injection site should be avoided due to the risk of thrombophlebitis.

Other medicines and Ringer Lactate Grifols

Inform your doctor if you are currently using, have recently used, or might need to use any other medicines.

Certain medicines may interact with Ringer Lactate Grifols. In such cases, it may be necessary to adjust the dose or discontinue one of the treatments.

In general, concomitant administration of Ringer Lactate solution with any medicine that has or may have renal toxicity should be avoided, as it may lead to fluid and electrolyte retention.

It is important that you inform your doctor if you are taking any of the following medicines:

• Medicines that may interact with any of the electrolytes present in Ringer Lactate solution:

• Corticosteroids/steroids or adrenocorticotropic hormone

• Lithium carbonate

• Potassium-sparing diuretics (amiloride, spironolactone, triamterene), alone or in combination

• Angiotensin-converting enzyme inhibitors (ACE inhibitors) (captopril, enalapril) or angiotensin II receptor antagonists (candesartan, telmisartan, eprosartan, irbesartan, losartan, valsartan)

• Tacrolimus and cyclosporine (medicines with renal toxicity)

• Cardiotonic digitalis glycosides (digoxin, methyldigoxin)

• Thiazide diuretics (hydrochlorothiazide, altizide, mebutizide, bendroflumethiazide) or vitamin D

• Acidic medicines such as salicylates and/or barbiturates

• Alkaline medicines such as sympathomimetics (ephedrine, pseudoephedrine) and/or stimulants (amphetamine, dexamphetamine)

• Medicines that increase 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). These medicines reduce water excretion in urine and increase the risk of hospital-acquired hyponatremia when treatment with inadequately balanced intravenous infusion solutions is administered (see previous subsection and sections 3 and 4)

• Diuretics in general and antiepileptic medicines such as oxcarbazepine, which 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.

If Ringer Lactate solution is administered correctly and under control, adverse effects during pregnancy or breastfeeding are not expected.

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

During pregnancy and breastfeeding, the use of Ringer Lactate solution as a vehicle for administering other medicines should be evaluated based on the nature of those medicines.

Driving and using machines

There is no evidence that this medicine may affect the ability to drive or operate machinery.

3. How to use Ringer Lactate Grifols

This medicine is provided as a solution for intravenous administration.

Ringer Lactate Grifols will be administered in a hospital setting by qualified healthcare personnel.

Your doctor will determine the duration of your treatment with Ringer Lactate Grifols.

The dose may be adjusted at the physician's discretion. The volume and rate of infusion should be tailored to the individual patient's clinical needs, taking into account age, weight, clinical condition (e.g., burns, surgery, head injury, infections), fluid balance, electrolyte status, and acid-base balance.

The amount of solution required to restore normal blood volume is 3–4 times the volume of blood lost.

Recommended daily dose:

• Adults: between 500 and 3000 ml per day.

• Children:

  • up to 10 kg body weight: 100 ml per kg of body weight per day.
  • between 10 and 20 kg body weight: 1000 ml + an additional 50 ml for each kg above 10 kg of body weight, per day.
  • above 20 kg body weight: 1500 ml + an additional 20 ml for each kg above 20 kg of body weight, per day.

You may require monitoring of fluid balance, serum electrolytes, and acid-base balance before and during administration, with special attention to serum sodium levels if you have increased non-osmotic release of vasopressin (SIADH) or are receiving concomitant treatment with vasopressin agonists, due to the risk of hospital-acquired hyponatremia (see sections 2 and 4). Monitoring of serum sodium is particularly important when hypotonic solutions are used (this medicine is considered slightly hypotonic).

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

When the solution is used as a vehicle for administering other medicines, the dose and infusion rate will be determined by the nature and dosage regimen of the prescribed medication.

If you receive more Ringer Lactate Grifols than you should

In case of overdose or too rapid administration, the following symptoms may occur:

• Fluid overload (edema, hypervolemia), disturbances in electrolyte balance, and/or induction of metabolic alkalosis, particularly in patients with impaired renal function. In such cases, administration should be reduced or discontinued and symptomatic treatment initiated. If renal function is compromised, dialysis may be required.

• Water and sodium overload with risk of edema, especially when renal sodium excretion is impaired.

Excessive administration of potassium salts may lead to hyperkalemia, particularly in patients with impaired renal function. Symptoms include tingling sensations, numbness, and/or burning in hands and feet, muscle weakness, paralysis, cardiac arrhythmias, heart block, cardiac arrest, and mental confusion.

Excessive administration of calcium salts may lead to hypercalcemia. Symptoms of hypercalcemia may include anorexia, nausea, vomiting, constipation, abdominal pain, muscle weakness, mental disturbances, polydipsia (excessive thirst), polyuria (excessive urine volume), kidney stones, and, in severe cases, cardiac arrhythmias and coma, as well as a sensation of calcium taste, burning, and peripheral vasodilation. Mild asymptomatic hypercalcemia usually resolves by discontinuing calcium administration and stopping contributing medications such as vitamin D. Severe hypercalcemia requires urgent treatment (e.g., diuretic cycles, hemodialysis, calcitonin, bisphosphonates, trisodium edetate).

Excessive administration of sodium lactate may lead to hypokalemia and metabolic alkalosis. Symptoms may include changes in behavior, fatigue, respiratory insufficiency, muscle weakness, and irregular heartbeat. In particular in hypocalcemic patients, increased muscle tone, muscle spasms, and tetany (neuromuscular hyperexcitability) may develop. Treatment of metabolic alkalosis associated with bicarbonate overdose primarily involves appropriate correction of fluid and electrolyte balance.

When overdose is related to medication added to the infused solution, signs and symptoms of over-infusion may reflect the nature of the added medication. In case of accidental overdose, treatment should be interrupted and the patient observed for any symptoms or signs related to the administered drug. If necessary, appropriate symptomatic and supportive measures should be taken.

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 may produce adverse effects, although not everyone will experience them.

The most commonly reported adverse effects are fluid overload (oedema) and electrolyte disturbances (mainly after administration of a large volume of Lactated Ringer's solution), as well as allergic reactions.

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 following administration of hypotonic solutions. Hospital-acquired hyponatraemia may cause irreversible brain damage and death due to cerebral oedema (see sections 2 and 3).

Possible adverse effects include:

• Electrolyte disturbances, hospital-acquired hyponatraemia
• Cerebral oedema
• Venous thrombosis (blood clots), phlebitis (vein inflammation) (associated with intravenous administration)
• Nasal congestion, cough, sneezing, breathing difficulty during infusion, chest pain with cardiac rhythm disturbances
• Allergic reactions such as urticaria, skin rashes, skin redness, itching, swelling, fluid accumulation in tissues
• Fluid overload (oedema)
• Fever, infection at injection site, local reaction or local pain (associated with intravenous administration)

When Lactated Ringer's solution is used as a vehicle to administer other medicines, adverse effects may be related to the added medicines.

If any adverse effects occur, the infusion should be discontinued.

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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ringer Lactate Grifols

No special storage conditions are required.

Once the container has been 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.

Do not use this medicine if the solution is not clear or if precipitates are observed.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point (SIGRE symbol) at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Ringer Lactate Grifols

The active substances are sodium chloride, potassium chloride, calcium chloride, and sodium lactate. Each 100 ml of solution contains 600 mg of sodium chloride, 40 mg of potassium chloride, 20.4 mg of calcium chloride (as dihydrate), and 305 mg of sodium lactate (as a 50% solution).

The other components (excipients) are: hydrochloric acid or sodium hydroxide (for pH adjustment) and water for injections.

Appearance of the product and contents of the container

Ringer Lactate Grifols is a clear, colourless infusion solution supplied in 500 ml and 1000 ml glass bottles; and 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 Autopista. Passeig Fluvial, 24

08150 Parets del Vallès, Barcelona (SPAIN)

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

This information is intended for healthcare professionals only:

Ringer Lactate Grifols is administered by infusion.

The contents of each container of this medicine are intended for single use only. Once the container has been opened, the solution must be administered immediately and any unused portion must be discarded.

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

Fleboflex bag:

• Check for small leaks by firmly squeezing the bag. If leaks are detected, discard the product.
• To connect the infusion set, remove the protective tab from the infusion port, exposing the access membrane of the bag.

When administering the solution and when adding medications, maximum aseptic conditions must be maintained. From a microbiological standpoint, when the solution is used as a vehicle for other medicines, it should be used immediately unless dilution has been carried out under controlled, validated aseptic conditions. If not used immediately, the conditions and duration of storage during use are the responsibility of the user.

Compatibility tables should be consulted before adding medications to Ringer Lactate solution or administering it simultaneously with other medicines. The package leaflet of the added medicines should also be consulted, and their solubility and stability in aqueous solution at the pH of Ringer Lactate solution (pH 5.0–7.0) should be verified.

When compatible medication is added to Ringer Lactate Grifols, the solution must be administered immediately.

Ringer Lactate solution should not be used as a vehicle for medicines containing ions capable of causing the formation of insoluble calcium salts.

It is recommended not to mix or administer Ringer Lactate solution simultaneously with whole blood or blood components preserved with a citrate-containing anticoagulant (such as CPD) using the same infusion set, because the calcium ions present in this solution may exceed the chelating capacity of citrate, potentially leading to clot formation. These clots could be infused directly into the circulation and cause embolism.