Apiroserum Normaion Restaurador

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Apiroserum Normaion Restaurador infusion solution

Active substances: sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate trihydrate, sodium citrate dihydrate, glucose monohydrate

Read the entire package 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.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Apiroserum Normaion Restaurador is and what it is used for

Apiroserum Normaion Restaurador is a polyelectrolyte solution with a chloride and sodium ion content very similar to that of extracellular fluid. It also contains potassium ion, sodium acetate, and trisodium citrate, which are precursors of bicarbonate and confer an alkalizing effect.

Therefore, Apiroserum Normaion Restaurador is indicated for the treatment of moderate electrolyte losses associated with a tendency toward acidosis. Conversely, it is contraindicated when the primary need is to replace predominantly water losses, as it does not provide free water due to its osmolarity.

Apiroserum Normaion Restaurador is indicated in extracellular hydro-electrolyte disturbances caused by:

• Fluid loss in surgical patients. Fluid deficit in the extracellular space during pre- and postoperative periods. Intestinal obstruction. Peritoneal inflammation (peritonitis). Intestinal, biliary, and pancreatic fistulas. Gastrointestinal suction (endodigestive). Blood loss (hemorrhage). Extensive burns. Postoperative collapse. Shock.
• Digestive losses. Diarrhea and vomiting. Digestive system disorders (dyspeptic) in infants (gastroenteritis, enterocolitis, etc.). Nausea and vomiting during pregnancy (hyperemesis gravidarum).
• Metabolic losses. Diabetic acidosis.
• Cutaneous losses. Excessive sweating in infectious and febrile diseases.

2. What you need to know before using Apiroserum Normaion Restaurador

Do not use Apiroserum Normaion Restaurador

• if you are allergic to the active substances or to any of the other components of this medicine (listed in section 6)
• if you have hyperkalemia (excess potassium in the blood)
• if you suffer from fluid overload (hyperhydration), such as in cases of edema (fluid retention), including pulmonary edema, congestive heart failure (or other types of cardiac decompensation), and ascitic cirrhosis
• if you have renal failure (kidney failure)
• if you have severe liver disease
• if you have hypertension (high blood pressure)
• if you have extracellular fluid loss with significant water loss
• if you have metabolic alkalosis
• if you have hypernatremia (excess sodium)
• if you have hypercalcemia (excess calcium)
• if you have hypermagnesemia (excess magnesium)
• if you have hyperchloremia (excess chloride)
• if you have hyperglycemia (excess glucose)
• during the first 24 hours after a head injury

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Apiroserum Normaion Restaurador.

Take special care with Apiroserum Normaion Restaurador:

• If you have kidney, heart, or lung disorders. In these cases, administration of large volumes of this solution must be performed under strict medical supervision.

• If you have hypertension (high blood pressure), heart failure (poor heart function), peripheral or pulmonary edema (fluid retention in general or in the lungs), preeclampsia, aldosteronism, or impaired renal function, or other conditions associated with sodium retention. In these situations, administration of the solution should be done with caution as it contains sodium chloride.

• If you have heart disease or conditions predisposing to hyperkalemia (excess potassium), 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 done with caution as it contains potassium salts.

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

• If you have severe potassium deficiency. Although the Apiroserum Normaion Restaurador solution has a potassium concentration similar to that of plasma, this is insufficient to produce a beneficial effect in such cases.

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

• Solutions containing magnesium salts should be used with caution in patients with renal failure, severe cardiac conduction disorders, or myasthenia gravis. Patients should be monitored for clinical signs of magnesium excess, especially when being treated for eclampsia. Administration in the postoperative period following neuromuscular blockade should be done with caution, as magnesium salts may lead to a re-curarization effect.

• If Apiroserum Normaion Restaurador is administered in large amounts, metabolic alkalosis may occur due to the presence of acetate and citrate ions in the solution.

• If your liver function is impaired, Apiroserum Normaion Restaurador may not produce its intended effect, as the metabolism of acetate and citrate may be compromised.

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

• Administration of Apiroserum Normaion Restaurador should be done 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 Apiroserum Normaion Restaurador should be done with caution (see section "Interaction with other medicines").

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

• Blood glucose levels should be monitored regularly, especially in diabetic patients. In such cases, insulin requirements may need to be adjusted.

• Caution is also advised in patients who have suffered acute ischemic events (reduced or absent blood flow in arteries), as hyperglycemia has been associated with increased cerebral ischemic damage and impaired recovery.

• Vitamin B1 (thiamine) is essential for glucose metabolism. Special care should be taken in patients at risk of vitamin B1 deficiency (e.g., malnourished or alcoholic patients), and if necessary, this deficiency should be corrected first.

• Due to the presence of glucose, this solution must not be administered through the same infusion set used for blood transfusions, as it may cause agglutination of blood cells.

In patients with impaired renal function or in the immediate postoperative period, the solution should not be administered without prior monitoring of potassium levels due to its potassium content.

All patients must be closely monitored.

In cases where the normal regulation of blood water content is disrupted due to increased secretion of vasopressin, also known as Antidiuretic Hormone (ADH), infusion of fluids with low sodium chloride concentration (hypotonic fluids) may result in low blood sodium levels (hyponatremia). This can cause headache, nausea, seizures, lethargy, coma, brain swelling (cerebral edema), and death; therefore, these symptoms (acute symptomatic hyponatremic encephalopathy) are considered a medical emergency. (See section 4. Possible side effects.)

Children, women of childbearing age, and patients with brain disorders such as meningitis, cerebral hemorrhage, cerebral contusion, and cerebral edema are at special risk of developing severe and potentially fatal brain swelling caused by acute hyponatremia.

Interaction of Apiroserum Normaion Restaurador with other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, especially:

• Medicines that increase the effect of vasopressin (see section "Warnings and precautions"), for example:

  • Medicines that stimulate vasopressin release (e.g., antipsychotics, narcotics)
  • Medicines that enhance the action of vasopressin (e.g., non-steroidal anti-inflammatory drugs)
  • Medicines that act like vasopressin, known as vasopressin analogs
  • Other medicines that increase the risk of hyponatremia, including diuretics in general and antiepileptic drugs.
  • Corticosteroids/steroids or ACTH (adrenocorticotropic hormone)
  • Lithium carbonate
  • Amiloride, spironolactone, triamterene (potassium-sparing diuretics), alone or in combination
  • Captopril or enalapril (angiotensin-converting enzyme inhibitors [ACE inhibitors]), candesartan, telmisartan, eprosartan, irbesartan, losartan, and valsartan (angiotensin II receptor antagonists)
  • Tacrolimus and cyclosporine (immunosuppressants), due to the risk of potentially fatal hyperkalemia
  • Digoxin and methyldigoxin (cardiotonic cardiac glycosides), as their effects may be enhanced by increased blood calcium levels, potentially leading to serious or fatal cardiac arrhythmias due to digitalis toxicity
  • Hydrochlorothiazide, altizide, mebutizide, bendroflumethiazide (thiazide diuretics), or vitamin D
  • Decamethonium, succinylcholine (depolarizing neuromuscular blockers), and atracurium, mivacurium, rocuronium, doxacurium, pancuronium, vecuronium
  • Insulin or oral antidiabetics (biguanides, sulfonylureas): may lead to reduced therapeutic efficacy of the latter (antagonistic action)
  • Systemic corticosteroids with glucocorticoid activity (such as cortisol)

The following contraindications have been reported with solutions similar to this one:

1. Sodium nitrofurantoin.
2. Sodium thiopental.
3. Sodium warfarin.

Precautions should be taken in cases of urine alkalinization with bicarbonate, as this increases the elimination of certain drugs (such as salicylates, lithium) and decreases the elimination of alkaline drugs such as sympathomimetics (amphetamine-type drugs).

Other incompatibilities may occur in cases of multiple mixtures.

Pregnancy and breastfeeding

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 Apiroserum Normaion Restaurador is administered correctly and under control, no adverse effects are expected during pregnancy or breastfeeding.

During pregnancy, your doctor will decide whether the use of Apiroserum Normaion Restaurador is appropriate, as it should be used with caution in this case.

Excessive glucose administration during pregnancy may cause hyperglycemia, fetal hyperinsulinemia, and acidosis, and may therefore be harmful to the newborn.

Apiroserum Normaion Restaurador 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.

There is no evidence suggesting that Apiroserum Normaion Restaurador may cause adverse effects in the neonate during breastfeeding. Nevertheless, caution is recommended during lactation.

Driving and using machines

There is no indication that Apiroserum Normaion Restaurador may affect the ability to drive or use machines.

Apiroserum Normaion Restaurador contains 17 mg of sodium metabisulfite per 100 ml of solution, which may rarely cause severe hypersensitivity reactions and bronchospasm in susceptible individuals, especially those with a history of asthma.

3. How to use Apiroserum Normaion Restaurador

Follow exactly the instructions for administration of this medicine as given by your doctor. If you have any doubts, consult your doctor or pharmacist.

The recommended dose is 1 to 4 liters (according to medical prescription) administered by slow intravenous infusion drop by drop, at an approximate rate of 40 to 60 drops per minute.

Use in children and adolescents

In children, the dose is 50 to 150 ml/kg, and the infusion rate should be proportionally lower.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, Apiroserum Normaion Restaurador can cause adverse effects, although not everyone experiences them.

The frequency of the possible adverse effects listed below is defined as follows:

Very common (affects more than 1 in 10 patients)
Common (affects between 1 and 10 in 100 patients)
Uncommon (affects between 1 and 10 in 1,000 patients)
Rare (affects between 1 and 10 in 10,000 patients)
Very rare (affects fewer than 1 in 10,000 patients)
Not known (cannot be estimated from available data)

Some adverse effects may be serious

Rarely, allergic reactions may occur. Signs of an allergic reaction may include:

• Rash
• Difficulty breathing
• Swelling of the face, lips, throat

Other adverse effects include:

Very common (affects more than 1 in 10 patients)

• Pain at the injection site
• Edema (swelling)
• Phlebitis at the infusion site
• Infection at the injection site
• Pyrexia (high fever accompanied by sweating)
• Local reaction
• Pruritus (itching)
• Induration (formation of hard nodules)
• Erythema (redness and inflammation of the skin)
• Swelling with painful nodules
• Vein irritation

Uncommon (affects fewer than 1 in 100 patients)

• Necrosis and ulceration at the injection site

Not known (cannot be estimated from available data)

• Electrolyte imbalance
• Hyperglycemia (excessively high blood sugar levels)
• Bradycardia (slow heart rate)
• Chest pain
• Tachycardia (rapid heart rate)
• Venous thrombosis
• Bronchospasm, nasal congestion, difficulty breathing, dyspnea, sneezing, cough
• Angioedema, facial edema, laryngeal edema, periorbital edema, erythema, rash, skin swelling, pruritus
• Glucosuria (elevated sugar in urine)
• Hospital-acquired hyponatremia*
• Acute hyponatremic encephalopathy*

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

Given the nature of the product, if its indication and administration are correct and controlled, there is no risk of intoxication. However, if symptoms related to adverse effects occur due to failure to meet these conditions, administration should be discontinued and symptomatic treatment initiated.

If you experience any adverse effects, consult your doctor or nurse, even if they are adverse effects not listed in this leaflet.

General advice

Monitoring of fluid balance, serum glucose, serum sodium, and other electrolytes may be required before and during administration, particularly in patients with increased non-osmotic release of vasopressin (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients receiving concomitant medications with vasopressin agonists, due to the risk of hyponatremia. Monitoring of serum sodium is especially important when administering products with a lower sodium concentration compared to serum sodium concentration. Following infusion of Apiroserum Normaion Restaurador, there is a rapid and active transport of glucose into the body's cells. This condition promotes an effect that may be considered equivalent to the provision of free water and may lead to severe hyponatremia.

5. Storage of Apiroserum Normaion Restaurador

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

Store below 25°C.

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

Do not use this medicine if the solution is not clear and/or if particles are present.

In case of mixtures with medicines, maximum asepsis must be maintained during the addition of medicines to intravenous fluids, and such mixtures should be used within 6 hours of preparation.

6. Contents of the pack and other information

Composition of Apiroserum Normaion Restaurador

• The active substances are,

Content per 100 ml:

Sodium chloride 0.490 g

Potassium chloride 0.075 g

Calcium chloride (2 H2O) 0.028 g

Magnesium chloride (6 H2O) 0.014 g

Sodium acetate (3 H2O) 0.385 g

Trisodium citrate 2 H2O 0.057 g

Glucose (H2O) 5.000 g

• The excipients are: Sodium metabisulfite and water for injections.

Milliequivalents/litre:

Osmolarity: 579 mOsmol/litre

Calories: 200 kcal/litre

Appearance of the product and contents of the container

Apiroserum Normaion Restorative is a clear solution free from visible particles.

It is supplied in bottles containing 250, 500 and 1,000 ml.

Clinical pack containing 12 bottles of 500 ml and 10 bottles of 1,000 ml.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Fresenius Kabi España S.A.U
Marina 16-18, 08005-Barcelona
Spain

Manufacturer

Fresenius Kabi Italia S.R.L.
Via Camagre, 41/43
37063 Isola della Scala (VR)
Italy

This summary of product characteristics was approved on [pending]

"Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.es/"

This information is intended for healthcare professionals only:

Apiroserum Normaion Restorative must be administered, either completely or partially, once the infusion set has been connected to the bottle, to prevent possible contamination.

Do not administer by intramuscular route.

In case of multiple mixtures, maximum aseptic conditions must be maintained when adding medications to intravenous fluids, and such mixtures should be used within 6 hours of preparation.