Label: information for the user

Ringer Lactate Physan solution for perfusion

Sodium Chloride, Potassium Chloride, Calcium Chloride, Sodium Lactate

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

Ringer Lactato PHYSAN belongs to the group of medications called Intravenous Solutions that affect the electrolyte balance - Electrolites.

Ringer Lactato PHYSAN is indicated in the following situations:

• Replenishment of hydroelectrolytic fluid of the extracellular liquid, such as in states of dehydration with loss of electrolites or surgical operations.

• Replenishment of the plasma volume in the short term in states of hypovolemic shock (hemorrhages, burns and other problems that cause losses of the circulatory volume) or hypotension (decrease in blood pressure).

• States of mild or moderate metabolic acidosis (except lactic acidosis).

As a vehicle for the intravenous administration of compatible medications.

It is recommended to control the hydroelectrolyte balance.

Do not use Ringer Lactato PHYSAN:

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

In case of:

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

Warnings and precautions

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

• If your kidneys, heart, or lungs do not function well. In these cases, the administration of large volumes of this solution should be carried out under strict clinical control.

• It is recommended that regular clinical and analytical controls (blood and urine electrolytes, acid-base balance, hematocrit) be performed during the administration of this solution. Particular attention should be paid to potassium serum controls if you are at risk of developing hyperkalemia.

• If you have hypertension (high blood pressure), heart failure (heart not functioning well), peripheral or pulmonary edema (general fluid retention or in the lungs), preeclampsia, aldosteronism, or have impaired renal function or other conditions associated with sodium retention. In these situations, the administration of the solution should be carried out with caution since it contains sodium chloride.

• If you have heart disease or conditions that predispose to hyperkalemia, such as renal insufficiency or adrenocortical insufficiency, acute dehydration, or massive tissue destruction, such as in severe burns. In these situations, the administration of the solution should be carried out with caution since it contains potassium salts.

• If you have severe potassium deficiency. Although the Ringer Lactato solution has a potassium concentration similar to that of plasma, it is insufficient to produce a beneficial effect in these situations.

• If you have impaired renal function or have or have had calcium oxalate kidney stones or diseases associated with high vitamin D levels, such as sarcoidosis. In these situations, the administration of the solution should be carried out with caution since it contains calcium salts.

• If large quantities of Ringer Lactato solution are administered, metabolic alkalosis may occur due to the presence of lactate ions in the solution.

• If your liver does not function well, the Ringer Lactato solution may not produce its effect, as lactate metabolism may be impaired.

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

• The solution Ringer Lactato should be administered with caution if you are at risk of developing cerebral edema or intracranial hypertension.

• If you are being treated with corticosteroids, adrenocorticotropic hormone, or cardiac glycosides, the administration of the Ringer Lactato solution should be carried out with caution (see section Use of other medications).

• Administration in the same location should be avoided due to the risk of thrombophlebitis.

Use of Ringer Lactato Physan with other medications:

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

Certain medications may interact with Ringer Lactato Physan. In this case, it may be necessary to change the dose or discontinue treatment with one of the medications.

Generally, the concurrent administration of the Ringer Lactato solution with any medication that presents or may present renal toxicity should be avoided, as it may cause fluid and electrolyte retention.

It is essential to inform your doctor if you are using any of the following medications:

• Corticosteroids/steroids or adrenocorticotropic hormone (ACTH).

• Lithium carbonate.

• Diuretics that spare potassium (amiloride, spironolactone, triamterene) alone or in combination.
• Inhibitors of the angiotensin-converting enzyme (ACE inhibitors) (captopril, enalapril) or angiotensin II receptor antagonists (candesartan, telmisartan, eprosartan, irbesartan, losartan, valsartan).
• Tacrolimus and cyclosporine (medications with renal toxicity).
• Cardiac glycosides (digoxin, metildigoxin).
• Thiazide diuretics (hydrochlorothiazide, altizide, mebutizide, bendroflumethiazide) or vitamin D.
• Acidic medications such as salicylates and/or barbiturates.
• Alkaline medications such as sympathomimetics (ephedrine, pseudoephedrine) and/or stimulants (amphetamine, dexamphetamine).

Medications that potentiate the effect of vasopressin. The following medications increase the effect of vasopressin, which reduces renal water excretion without electrolytes and increases the risk of hospital-acquired hyponatremia after receiving an insufficiently balanced treatment with intravenous perfusion solutions.

• Medications that stimulate vasopressin release, such as chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics.
• Medications that potentiate the action of vasopressin, such as chlorpropamide, nonsteroidal anti-inflammatory drugs (NSAIDs), cyclophosphamide.
• Vasopressin analogs, such as desmopressin, oxytocin, vasopressin, terlipressin.

Other medications known to increase the risk of hyponatremia are diuretics in general and antiepileptic drugs such as oxcarbazepine.

Pregnancy and lactation:

Ringer lactate Physan 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.

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using a medication.

If the administration of the Ringer Lactato solution is carried out correctly and under control, no adverse effects should be expected during pregnancy or lactation.

During pregnancy and lactation, the use of the Ringer Lactato solution as a vehicle for administering other medications should be evaluated based on the nature of these medications.

Driving and operating machinery:

There is no indication that Ringer Lactato Physan may affect the ability to drive or operate machinery.

Ringer Lactato Physan is presented in a solution form for intravenous administration and will be used in a hospital by the corresponding healthcare personnel (see section 6).

Your doctor will inform you of the duration of your treatment with Ringer Lactato Physan.

The dose may vary according to medical criteria.

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

Recommended daily dose:

• Adults:between500 and 3000 ml per day.

• Children: -up to 10 kg of weight: 100 ml per each kg of weight and day.
• between 10 and 20 kg of weight: 1000 ml + 50 ml additional per each kg that exceeds 10 kg of weight, per day.

The infusion rate should be adjusted according to the patient's clinical needs based on age, weight, clinical condition, fluid balance, electrolytes, and acid-base balance.

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

If you are administered more Ringer Lactato Physan than you should:

Consult your doctor or pharmacist immediately.

In case of overdose or too rapid administration, the following symptoms may appear: hyperhydration (edema, hypervolemia), disorders in electrolyte balance, and/or induction of metabolic alkalosis, especially in patients with impaired renal function. In these cases, the administration will be decreased or suspended, and symptomatic treatment will be sought. If renal function is compromised, dialysis may be necessary.

Overdose or too rapid administration may lead to water and sodium overload with a risk of edema, particularly when there is defective renal excretion of sodium.

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 alteration, polydipsia, polyuria, nephrocalcinosis, renal calculi, and, in severe cases, cardiac arrhythmias and coma. Rapid intravenous injection of calcium salts may cause many of the symptoms of hypercalcemia, as well as a metallic taste, burning, and peripheral vasodilation. Mild asymptomatic hypercalcemia will usually resolve by stopping calcium administration and using other contributing medications such as vitamin D. If hypercalcemia is severe, urgent treatment is required (such as diuretic cycles, hemodialysis, calcitonin, bisphosphonates, and edetate trisodium).

Excessive administration of sodium lactate may lead to hypokalemia and metabolic alkalosis. Symptoms may include change in character, fatigue, respiratory insufficiency, muscle weakness, and irregular heartbeats. Muscle hypertonicity, muscle spasms, and tetany may develop, especially in hypocalcemic patients. Treatment of metabolic alkalosis associated with bicarbonate overdose consists mainly of correcting fluid and electrolyte balance. Replacing calcium, chloride, and potassium may be especially important.

In case of overdose related to medication added to the infused solution, signs and symptoms of overinfusion may be related to the nature of the added medication used. In case of accidental overdosing, treatment should be interrupted, and the patient should be observed for symptoms and signs related to the administered medication. If necessary, symptomatic and supportive measures should be taken.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

After administration of a significant volume of Ringer Lactate solution, there may be a risk of hyperhydration (mainly edemas) and electrolyte imbalances.

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

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

When using Ringer Lactate solution as a vehicle to administer other medications, adverse effects may be associated with the added medications in the solution.

In case of adverse effect appearance, the infusion should be interrupted.

If any other reaction not described in this prospectus is observed, consult a doctor or pharmacist.

Adverse Reactions:

- Hospital-acquired hyponatremia*

- Acute hypnatremic encephalopathy*

*Hospital-acquired hyponatremia may cause irreversible brain damage and death due to acute hypnatremic encephalopathy, unknown frequency

Reporting Adverse Effects

Report any type of adverse effect to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

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

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

Do not use this medication if you observe visible signs of deterioration.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition ofRinger Lactato Physan

-The active principles 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 injection preparations.

Appearance of the product and contents of the package

The solution must be transparent and not contain precipitates. Do not administer in case otherwise.

Ringer Lactato PHYSAN is a perfusion solution, which is presented in a Type II glass bottle, polypropylene (PP) bottle, polypropylene (PP) bag and a polyvinyl chloride (PVC) bag containing 250 and 500 ml,available in the following presentations:

1 glass bottle of 250 ml

1 glass bottle of 500 ml

1 bag (PP and PVC) of 250 ml

1 bag (PP and PVC) of 500 ml

1 polypropylene (PP) bottle of 250 ml

1 polypropylene (PP) bottle of 500 ml

Also in the Clinical Pack presentation:

1. Glass bottles:

24 glass bottles of 250 ml

10 glass bottles of 500 ml

1. PP bottles:

24 polypropylene (PP) bottles of 250 ml

10 polypropylene (PP) bottles of 500 ml

20 polypropylene (PP) bottles of 500 ml

1. PVC bags:

30 bags (PP and PVC) of 250 ml

20 bags (PP and PVC) of 500 ml

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

LAPHYSAN, S.A.U.

Anabel Segura, 11 Building A, 4th Floor, Door D

28108 Alcobendas – Madrid, Spain

Responsible for manufacturing:

LABORATORIOS BASI – INDUSTRIA FARMACÉUTICA, S.A.

Parque Industrial Manuel Lourenço Ferreira,

Nº 8, Nº 15 and Nº 16

3450-232 Mortágua - Portugal

or

S.M. FARMACEUTICI SRL

Industrial Zone

85050 TITO – POTENZA, Italy

or

SALF SPA LABORATORY PHARMACEUTICAL

Via Marconi 2

24069 Cenate Sotto (Bergamo), Italy

Last review date of this leaflet: April 2019

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This information is intended solely for healthcare professionals:

Ringer Lactato Physan will be administered by perfusion.

The contents of each package of Ringer LactatoPhysanare for a single perfusion. Once the package is opened, the solution must be administered immediately and the unused portion must be discarded.

To administer the solution and in case of addition of medications, maximum asepsis must be maintained.From a microbiological point of view, when the solution is used as a vehicle for other medications, it must be used immediately unless the dilution has been performed in controlled and validated aseptic conditions. If it is not used immediately, the conditions and periods of conservation during use are the responsibility of the user.

Before adding medications to the Ringer Lactate solution or administering them simultaneously with other medications, it must be checked that there are no incompatibilities. It is recommended to consult the medication's prospectus, as well as to verify if they are soluble and stable in aqueous solution at the pH of the Ringer Lactate solution (pH 5.0-7.0).

When compatible medication is added to Ringer Lactato Physan, the solution must be administered immediately.

The Ringer Lactate solution must not be used as a vehicle for medications that contain ions capable of causing the formation of insoluble calcium salts.

It is recommended not to mix or administer simultaneously in the same perfusion equipment Ringer Lactate solution with total blood or with conserved blood components with an anticoagulant containing citrate (such as CPD), due to the fact that the calcium ions present in this solution may exceed the chelating capacity of the citrate, potentially causing the formation of clots. These clots may perfuse directly into the circulation and cause an embolism.

It will be necessary to monitor the water balance, serum electrolytes and acid-base balance before and

during administration, with special attention to serum sodium in patients who present an increase in non-osmotic vasopressin release (SIADH syndrome) and in patients who receive concomitant medication with vasopressin agonists due to the risk of hospital-acquired hyponatremia. Serum sodium monitoring is especially important with hypotonic solutions.

Ringer Lactato Physan tonicity: isotonic.

The perfusion rate and the perfused volume depend on age, weight and clinical condition (e.g. burns, surgery, head injury, infections); the responsible physician, with experience in pediatric treatments with intravenous perfusion solutions, must decide on the need for concomitant treatment.