Suero Fisiologico Vitulia 0.9% solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Suero Fisiológico Vitulia 0.9% solution for infusion

Sodium chloride

Read the entire leaflet carefully before you start using this medicine

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
• If you consider that any of the adverse effects you experience is severe or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Leaflet contents

1. What Suero Fisiológico Vitulia is and what it is used for
2. Before you use Suero Fisiológico Vitulia
3. How to use Suero Fisiológico Vitulia
4. Possible side effects
5. How to store Suero Fisiológico Vitulia
6. Further information

1. What Suero Fisiológico Vitulia is and what it is used for

Suero Fisiológico Vitilia belongs to the group of intravenous solution medicines.

Suero Fisiológico Vitulia is used to replace water and the sodium and chloride salts that may become low as a result of various disturbances or disorders. It is also used as a vehicle solution for other compatible medicines.

2. Before using Suero Fisiológico Vitulia

Do not use Suero Fisiológico Vitulia

• If you are allergic (hypersensitive) to the active substance of Suero Fisiológico Vitulia.

Do not use if you have:

• excess body water (hyperhydration), excess sodium (hypernatremia), or excess chloride (hyperchloremia)
• acidosis (pH below the normal range)
• edematous conditions in patients with cardiac, hepatic, or renal disorders, or severe hypertension.

It should also not be administered to patients with low potassium levels (hypokalemia), especially in those with cardiovascular disease.

Take special care with Suero Fisiológico Vitulia

If you have disorders requiring sodium restriction, such as heart failure, generalized fluid retention (edema), fluid accumulation in the lungs (pulmonary edema), high blood pressure (hypertension), hypertension during pregnancy (eclampsia), or severe kidney insufficiency.

Serum electrolytes, water balance, and acid-base equilibrium should be monitored regularly.

Frequent blood electrolyte checks are necessary during prolonged therapy and in patients with acid-base imbalances, cardiac, hepatic, and/or renal disorders, as well as in those receiving corticosteroids or adrenocorticotropic hormone.

In cases of hypertonic dehydration (water loss with excess salts), a high infusion rate should be avoided, as it may lead to increased plasma osmolarity (salt concentration in plasma) and, specifically, elevated plasma sodium concentration.

In premature infants and neonates, administration of sodium chloride should only be performed after determining serum sodium levels.

Use of other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Administration of sodium chloride increases renal excretion of lithium, leading to reduced therapeutic effect of lithium.

It should be administered with caution in patients treated with corticosteroids or adrenocorticotropic hormone, as these may cause water and sodium retention.

Before mixing with other medicines, compatibility tables should be consulted, pH considered, and ions monitored.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Suero Fisiológico Vitulia may be used when indicated during pregnancy and breastfeeding.

To date, no relevant epidemiological data are available; therefore, it is recommended to use this product with caution during these periods.

Driving and using machines

This section is not applicable due to the characteristics of the medicine.

3. How to use Vitulia Physiological Serum

Follow exactly the administration instructions for Vitulia Physiological Serum as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The normal daily dose is up to 40 ml per kg of body weight.

The recommended infusion rate is approximately 5 ml per kg of body weight per hour, corresponding to 1.7 drops per kg of body weight per minute.

Your doctor will determine the dose and frequency of administration based on your age, weight, and clinical condition.

A larger volume of solution and a higher infusion rate should be administered in patients showing signs of plasma volume deficit (hypovolemic shock).

If you use more Vitulia Physiological Serum than you should

This is unlikely to occur, as your doctor will determine your daily doses. However, if you receive an overdose, it may cause elevated blood concentrations of sodium, chloride, and electrolytes in general, or lead to overhydration and related manifestations such as metabolic acidosis (blood pH lower than normal), cardiac overload, and edema formation. In such a case, the infusion must be stopped, diuretic medications should be administered to eliminate excess fluid, and blood electrolyte levels and acid-base balance should be monitored.

If you are not hospitalized, go immediately to the nearest hospital or contact the Toxicology Information Service. Telephone: 91 562 04 20, indicating the medication and amount used.

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

4. Possible adverse effects

Like all medicines, Suero Fisiológico Vitulia may produce adverse effects, although not everyone will experience them.

If large amounts of the solution are administered, plasma levels of sodium and chloride may increase.

If administered continuously at the same infusion site, pain, fever, infection, phlebitis extending from the injection site, extravasation, and hypervolemia may occur.

If used as a vehicle for the administration of other medications, the nature of the added drugs will determine the likelihood of other adverse reactions.

If adverse reactions occur, the infusion should be discontinued.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Vitulia Physiological Saline

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Vitulia Physiological Saline after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Do not use Vitulia Physiological Saline if the solution is cloudy or shows sedimentation (presence of particles at the bottom of the container), or if the container shows visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This helps protect the environment.

6. Information for Healthcare Professionals

Composition of Suero Fisiológico Vitulia

The active substance is:

Active SubstancePer 100 ml

Sodium chloride 0.9 g

Electrolytesmmol/lmEq/l

Sodium 154 154

Chloride 154 154

Theoretical osmolarity 308 mOsm/l

Acidity (up to pH 7.4) < 0.3 mmol/l

pH 4.5 – 7.0

The other component is: water for injection.

Appearance of the medicinal product and content of the container

Suero Fisiológico Vitulia is an infusion solution, transparent and colourless, supplied in plastic bottles.

Standard packaging: Bottles of 50, 100, 250, 500 or 1000 mL and packs of 10 bottles of 250 mL.

Hospital pack: 20 bottles of 50 mL

20 bottles of 100 mL

20 bottles of 250 mL

10 bottles of 500 mL

10 bottles of 1000 mL

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

LABORATORIOS ERN, S.A.

C/ Perú, 228

08020 Barcelona, Spain

Manufacturer:

LABORATORIOS ERN, S.A.

C/ Gorcs i Lladó, 188

Polígono Industrial Can Salvatella

08210 Barberà del Vallès – Barcelona

Spain

Or

Parenteral Solution Industry Vioser S.A.

9th km Trikala-Larisa Nt.Rd.

42100 Trikala

Greece

This patient information leaflet has been reviewed in August 2017.

This information is intended exclusively for medical or healthcare professionals:

Single-use containers. Discard any unused residual content after completion of the infusion.

The solution should only be used if the container closure is undamaged and the solution is clear.

Use sterile administration set for administration.

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.gob.es/