Label: information for the user

Vitulia Physiological Serum 0.9% solution for perfusion

Sodium chloride

Read this label carefully before starting to use this medicationmedication

• Keep this label as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this label, inform your doctor or pharmacist.

1.What is Vitulia Physiological Serum and how it is used

2.Before using Vitulia Physiological Serum

3.How to use Vitulia Physiological Serum

4.Possible adverse effects

5.Storage of Vitulia Physiological Serum

6.Additional information

Vitulia Physiological Solution belongs to the group of intravenous medication solutions.

Vitulia Physiological Solution is used to replace water and sodium and chloride salts that may be low as a result of different alterations or disorders. It is also used as a transport solution for other compatible medications.

No usePhysiological Solution Vitulia

• If you are allergic (hypersensitive) to the active principle of Physiological Solution Vitulia.

Present the following symptoms:

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

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

Be especially careful withPhysiological Solution Vitulia

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

Regularly monitor serum electrolytes, water balance, and acid-base equilibrium.

In prolonged therapies and in patients with acid-base imbalance, cardiac, hepatic, and/or renal alterations, as well as those undergoing treatment with corticosteroids or adrenocorticotropic hormone, frequent blood electrolyte controls should be performed.

In cases of hypertonic dehydration (loss of water with excess of salts), avoid high perfusion rates as it may cause an increase in plasma osmolarity (concentration of salts in the plasma) and, specifically, plasma sodium concentration (amount of sodium in the blood).

In premature and lactating infants, the administration of sodium chloride should only be given after determining serum sodium levels.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

The administration of sodium chloride accelerates renal excretion of lithium, leading to a decrease in its therapeutic effect.

Administer with caution in patients treated with corticosteroids or adrenocorticotropic hormone as they may retain water and sodium.

Before mixing with other medications, check compatibility tables, consider pH, and control ions.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

Physiological Solution Vitulia can be used when indicated during pregnancy and lactation.

There is currently no relevant epidemiological data available, so it is recommended to use it with caution during these periods.

Driving and operating machines

This section does not apply due to the characteristics of the medication.

Follow exactly the administration instructions for Physiological Solution Vitulia 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, which corresponds to 1.7 drops per kg of body weight per minute.

Your doctor will decide the dose and frequency at which the solution will be administered to you, and it will depend on your age, weight, and clinical condition.

A greater amount of solution should be administered at a higher rate in patients who exhibit a plasma volume deficit (hypovolemic shock).

If you use morePhysiological Solution Vituliathan you should

This is unlikely to happen since your doctor will determine your daily doses. However, if you receive an overdose, it may cause an excess of sodium, chloride, and electrolyte concentration in the blood, or excessive hydration and related manifestations such as metabolic acidosis (blood pH below normal), heart overload, and edema formation. In this case, discontinue the infusion, administer diuretic medications to eliminate excess fluid, along with blood electrolyte control and acid-base balance monitoring.

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

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

Like all medications, Physiological Solution Vitulia may cause adverse effects, although not everyone will experience them.

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

Continuous administration in the same site of infusion may cause pain, fever, infection, and phlebitis extending from the injection site, extravasation, and hypervolemia.

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

In case of adverse reactions, infusion should be interrupted.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Physiological Saline Solution after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Do not use Physiological Saline Solution if the solution shows turbidity or sedimentation (presence of particles at the bottom of the packaging) or if the packaging shows visible signs of deterioration.

Medicines should not be disposed of through drains or in the trash. Dispose of empty packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of empty packaging and unused medicines.This will help protect the environment.

Composition of Physiological Solution Vitulia

The active principle is:

Active PrinciplePer 100 ml

Sodium Chloride0.9 g

Electrolytesmmol/lmEq/l

Sodium154154

Chlorides154154

Theoretical Osmolarity308 mOsm/l

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

pH4.5 – 7.0

The other components are: water for injection.

Appearance of the product and contents of the packaging

Physiological Solution Vitulia is a perfusion solution, transparent and colorless, which is packaged in plastic bottles.

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

Clinical packaging: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 packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

LABORATORIOS ERN, S.A.

C/ Perú, 228

08020 Barcelona, Spain.

Responsible for manufacturing:

LABORATORIOS ERN, S.A.

C/ GorcsiLladó, 188

Polígono Industrial Can Salvatella

08210 Barberá del Vallés – Barcelona

Spain

O

Parenteral Solution Industry Vioser S.A.

9th km Trikala-Larisa Nt.Rd.

42100 Trikala

Greece

This leaflet has been revised inAugust 2017.

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This information is intended solely for doctors or healthcare professionals:

Single-use containers. Dispose of any remaining unused content after completing the perfusion.

Only use the solution if the packaging seal is not damaged and the solution is clear.

Use the sterile administration set for administration.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/