Ringer lactate Physan solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ringer Lactate Physan infusion solution

Sodium Chloride, Potassium Chloride, Calcium Chloride, Sodium Lactate

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, consult your doctor, pharmacist or nurse.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

Ringer Lactate PHYSAN belongs to a group of medicines called Intravenous Solutions affecting the Electrolyte Balance – Electrolytes.

Ringer Lactate PHYSAN is indicated in the following situations:

• Hydroelectrolytic repletion of extracellular fluid, such as in states of dehydration with electrolyte loss or in surgical procedures.

• Short-term repletion of plasma volume in states of hypovolemic shock (hemorrhage, burns, and other conditions causing loss of circulating volume) or hypotension (decreased blood pressure).

• Mild to moderate metabolic acidosis (except lactic acidosis).

As a vehicle for the intravenous administration of compatible medicines.

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

Monitoring of fluid and electrolyte balance is recommended.

Do not use Ringer Lactate PHYSAN:

If you are allergic to Sodium Chloride, Potassium Chloride, Calcium Chloride, Sodium Lactate, or any of the other components of this medicine (listed in section 6).

In case of:

• Extracellular hyperhydration or hypervolemia.
• Severe renal insufficiency with oliguria or anuria (kidney failure characterized by very little or no urine production).
• Uncompensated cardiac failure (heart failure).
• Hyperkalemia (excess potassium).
• Hypernatremia (excess sodium).
• Hypercalcemia (excess calcium).
• Hyperchloremia (excess chloride).
• Metabolic alkalosis.
• Severe metabolic acidosis.
• Lactic acidosis.
• Severe hepatocellular insufficiency or impaired lactate metabolism.
• Generalized edema (fluid retention) or ascitic cirrhosis.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Ringer Lactate Physan.

• If your kidneys, heart, or lungs do not function properly. In such cases, administration of large volumes of this solution must be performed under strict clinical monitoring.

• Regular clinical monitoring and laboratory tests (blood and urine electrolytes, acid-base balance, hematocrit) are recommended during administration of this solution. Particular care should be taken to monitor serum potassium levels if you are at risk of hyperkalemia.

• If you suffer from hypertension (high blood pressure), heart failure, peripheral or pulmonary edema (generalized or lung fluid retention), preeclampsia, aldosteronism, impaired renal function, or other conditions associated with sodium retention. In these situations, administration of the solution should be performed with caution as it contains sodium chloride.

• If you suffer from heart diseases or conditions predisposing to hyperkalemia, such as renal or adrenocortical insufficiency, acute dehydration, or massive tissue destruction (e.g., in severe burns). In these situations, administration of the solution should be performed with caution as it contains potassium salts.

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

• If you have impaired renal function or suffer from or have previously suffered from calcium kidney stones or diseases associated with high vitamin D levels, such as sarcoidosis. In these situations, administration of the solution should be performed with caution as it contains calcium salts.

• Metabolic alkalosis may occur if Ringer Lactate solution is administered in large quantities, due to the presence of lactate ions in the solution.

• Special caution is required if your liver does not function properly, as the metabolism of lactate may be impaired, reducing the effectiveness of Ringer Lactate solution.

• Particular attention should be paid to elderly patients, as they may have impaired liver, kidney, or heart function.

• 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 (ACTH), or digitalis medications, administration of Ringer Lactate solution should be performed with caution (see section "Use with other medicines").

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

Use of Ringer Lactate Physan with other medicines:

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

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

In general, concomitant administration of Ringer Lactate solution with any medicine that has or may have nephrotoxic effects 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:

• Corticosteroids/steroids or adrenocorticotropic hormone (ACTH).

• 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 nephrotoxic effects).

• Cardiac 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 potentiate the effect of vasopressin. The following medicines increase the effect of vasopressin, reducing renal excretion of electrolyte-free water and increasing the risk of hospital-acquired hyponatremia after inadequately balanced intravenous infusion therapy:

• Medicines that stimulate vasopressin release include, among others: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine (MDMA), ifosfamide, antipsychotics, narcotics.
• Medicines that enhance the action of vasopressin include, among others: chlorpropamide, NSAIDs, cyclophosphamide.
• Vasopressin analogues include, among others: desmopressin, oxytocin, vasopresin, terlipressin.

Other medicines known to increase the risk of hyponatremia include diuretics in general and antiepileptic medicines such as oxcarbazepine.

Pregnancy and breastfeeding:

Ringer Lactate Physan should be administered with special caution in pregnant women during labor, especially if administered in combination with oxytocin, due to the risk of hyponatremia.

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

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

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 suggesting that Ringer Lactate PHYSAN may affect the ability to drive or operate machinery.

3. How to use Ringer Lactate Physan

Ringer Lactate Physan is supplied as a solution for intravenous administration and will be used in a hospital setting by qualified healthcare personnel (see section 6).

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

The dose may vary according to medical judgment.

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 body weight per day.

• between 10 and 20 kg body weight: 1000 ml + an additional 50 ml for each kg exceeding 10 kg body weight, per day.

• above 20 kg body weight: 1500 ml + an additional 20 ml for each kg exceeding 20 kg body weight, per day.

The infusion rate should be adjusted according to the patient's clinical needs, taking into account age, weight, clinical condition, fluid balance, electrolyte balance, and acid-base equilibrium.

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

If you are given more Ringer Lactate Physan than you should have:

Contact your doctor or pharmacist immediately.

In case of overdose or excessively rapid administration, the following symptoms may occur: hyperhydration (edema, hypervolemia), disturbances in electrolyte balance, and/or induction of metabolic alkalosis, especially 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 necessary.

Overdose or excessively rapid administration may lead to water and sodium overload, with risk of edema, particularly when renal sodium excretion is impaired.

Excessive administration of potassium salts may lead to hyperkalemia, especially in patients with impaired renal function. Symptoms include paresthesia of the extremities, muscle weakness, paralysis, cardiac arrhythmias, cardiac 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, polyuria, nephrocalcinosis, kidney stones, and, in severe cases, cardiac arrhythmias and coma. Very rapid intravenous injection of calcium salts may cause many of the symptoms of hypercalcemia, as well as a sensation of calcium taste, burning sensation, and peripheral vasodilation. Mild, asymptomatic hypercalcemia usually resolves by discontinuing calcium administration and withholding contributing agents such as vitamin D. In cases of severe hypercalcemia, urgent treatment is required (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 mental status, fatigue, respiratory insufficiency, muscle weakness, and irregular heartbeat. Muscle hypertonicity, muscle spasms, and tetany may develop, especially in patients with hypocalcemia. Treatment of metabolic alkalosis associated with bicarbonate overdose consists primarily of appropriate correction of fluid and electrolyte balance. Replacement of calcium, chloride, and potassium may be particularly important.

When overdose is related to medication added to the infused solution, signs and symptoms of over-infusion may be related to the nature of the added medication. In case of accidental overdose, treatment should be discontinued and the patient observed for symptoms and signs related to the administered medication. 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.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

After administration of a large volume of Ringer Lactate solution, there may be a risk of hyperhydration (mainly edema) and electrolyte disturbances.

Allergic reactions have been reported during administration of Ringer Lactate solution, such as urticaria, skin rashes, skin redness, itching, swelling, chest pain, altered heart rhythm, nasal congestion, cough, sneezing, and difficulty breathing.

Adverse effects related to the administration technique may occur, including fever, injection site infection, local reaction or pain, venous thrombosis, or phlebitis.

When Ringer Lactate 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.

If you notice any other reaction not described in this leaflet, consult your doctor or pharmacist.

Adverse reactions:

• Hospital-acquired hyponatremia*
• Acute hyponatremic encephalopathy*

*Hospital-acquired hyponatremia may lead to irreversible brain damage and death due to the development of acute hyponatremic encephalopathy, frequency not known

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through 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 Physan

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

No special storage conditions are required.

Once the container has been opened, the solution must be used immediately (see section 6).

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

Do not use this medicine if there are any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the container and other information

Composition of Ringer Lactate Physan

• 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, 27 mg of calcium chloride (as dihydrate), and 329 mg of sodium lactate.
• 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

The solution should be clear and free from precipitates. Do not administer if otherwise.

Ringer Lactate PHYSAN is an infusion solution supplied in Type II glass vials, polypropylene (PP) bottles, polypropylene (PP) bags, and polyvinyl chloride (PVC) bags containing 250 ml or 500 ml, available in the following presentations:

1 vial of 250 ml
1 vial of 500 ml
1 bag (PP and PVC) of 250 ml
1 bag (PP and PVC) of 500 ml
1 bottle (PP) of 250 ml
1 bottle (PP) of 500 ml

Also available in clinical pack presentations:

1. Glass vials:
   24 vials of 250 ml
   10 vials of 500 ml

2. PP vials:
   24 bottles (PP) of 250 ml
   10 bottles (PP) of 500 ml
   20 bottles (PP) of 500 ml

3. PVC bags:
   30 bags (PP and PVC) of 250 ml
   20 bags (PP and PVC) of 500 ml

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

LAPHYSAN, S.A.U.
Anabel Segura, 11, Building A, 4th Floor, Door D
28108 Alcobendas – Madrid, Spain

Manufacturer:

LABORATORIOS BASI – INDUSTRIA FARMACÉUTICA, S.A.
Manuel Lourenço Ferreira Industrial Park,
Nos. 8, 15 and 16
3450-232 Mortágua - Portugal

or

S.M. FARMACEUTICI SRL
Industrial Zone
85050 TITO – POTENZA, Italy

or

SALF SPA LABORATORIO FARMACOLOGICO
Via Marconi 2
24069 Cenate Sotto (Bergamo), Italy

Date of the most recent revision of this leaflet: April 2019

This information is intended exclusively for healthcare professionals:

Ringer Lactate Physan is administered by intravenous infusion.

The contents of each Ringer Lactate Physan container are intended for single use only. Once the container is opened, the solution must be administered immediately, and any unused portion must be discarded.

To administer the solution, and especially when adding medications, strict aseptic technique must be maintained. From a microbiological standpoint, when the solution is used as a vehicle for other drugs, it should be used immediately unless dilution has been performed under controlled, validated aseptic conditions. If not used immediately, the conditions and duration of storage during use are the responsibility of the user.

Before adding medications to Ringer Lactate solution or administering it simultaneously with other drugs, potential incompatibilities must be checked. It is recommended to consult the package leaflet of the added medications and verify their solubility and stability in aqueous solution at the pH of Ringer Lactate solution (pH 5.0–7.0).

When compatible medication is added to Ringer Lactate Physan, the solution should be administered immediately.

Ringer Lactate solution should not be used as a vehicle for drugs containing ions capable of forming insoluble calcium salts.

It is recommended not to mix or co-administer Ringer Lactate solution with whole blood or blood components preserved with a citrate-containing anticoagulant (such as CPD) in 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.

Fluid balance, serum electrolytes, and acid-base balance should be monitored before and during administration, with particular attention to serum sodium levels in patients exhibiting non-osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients receiving concomitant treatment with vasopressin agonists, due to the risk of hospital-acquired hyponatremia. Monitoring of serum sodium is especially important when using hypotonic solutions.

Tonicity of Ringer Lactate Physan: isotonic.

The infusion rate and infused volume depend on age, weight, and clinical condition (e.g., burns, surgery, head injury, infections). The responsible physician, experienced in pediatric intravenous infusion therapy, must determine the need for concomitant treatment.