KABIPAC SODIUM CHLORIDE 9 mg/mL SOLUTION FOR INFUSION

Introduction

PROSPECT: INFORMATION FOR THE USER

KabiPac Sodium Chloride 9 mg/ml solution for infusion Sodium Chloride

Contents of the prospectus:

1. What KabiPac Sodium Chloride 9 mg/ml is and what it is used for
2. What you need to know before starting to use KabiPac Sodium Chloride 9 mg/ml
3. How to use KabiPac Sodium Chloride 9 mg/ml
4. Possible adverse effects
5. Storage of KabiPac Sodium Chloride 9 mg/ml
6. Package contents and additional information

1. What is KABIPAC SODIUM CHLORIDE 9 MG/ML and what is it used for

KabiPac Sodium Chloride 9 mg/ml is a solution for intravenous infusion that comes in 100 ml bottles containing 50 ml or 100 ml of solution, 250 ml bottles containing 100 ml or 250 ml of solution, 500 ml and 1000 ml bottles.

It belongs to the group of medications called electrolyte solutions.

It is used as an electrolyte supplement in cases of dehydration with salt loss. In states of hypovolemia (decreased blood volume). Mild alkalosis. As a vehicle for the administration of medications and electrolytes.

2. WHAT YOU NEED TO KNOW BEFORE STARTING TO USE KABIPAC SODIUM CHLORIDE 9 MG/ML

• Do not use KabiPac Sodium Chloride 9 mg/mlif you are allergic to the active ingredient or any of the other components of KabiPac Sodium Chloride 9 mg/ml
• If you have ever been diagnosed with or detected high blood pressure, edema, kidney or liver disease, or have any heart disorder.
• If you have hypernatremia (increased sodium levels in the blood), hyperchloremia (increased chloride levels in the blood), hypokalemia (decreased potassium levels in the blood), or acidosis (pH below the normal range).
• In states of hyperhydration (fluid overload).

Warnings and precautions

Your doctor may request that blood tests be performed to monitor your condition, as it is necessary to control the balance of water and salts in the body.

Regular analytical controls should be performed on your blood electrolytes, especially during prolonged therapy and if you have acid-base imbalance, cardiac, hepatic, and/or renal disorders, as well as if you are being treated with corticosteroids or adrenocorticotropic hormone.

This medication should be administered with caution if you have hypertension, pre-eclampsia (symptoms preceding convulsions and blood pressure drop in pregnant women) or aldosteronism (morbid state due to excessive aldosterone formation) or other conditions associated with sodium retention.

KabiPac Sodium Chloride 9 mg/ml will be administered with caution to premature and full-term infants.

If administered continuously in the same infusion site, pain, fever, infection, and phlebitis (inflammation of the veins) may occur.

Using KabiPac Sodium Chloride 9 mg/ml with other medications

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription, as it may be necessary to interrupt treatment or adjust the dose of one of them.

Before mixing with other medications, compatibility tables should be checked, pH should be taken into account, and ions should be controlled.

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

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Provided that administration is correct and controlled, no adverse effects are expected during pregnancy and breastfeeding.

To date, there are no relevant epidemiological data available, so it is recommended that if used during these periods, it should be done with caution.

Driving and using machines

This is not applicable due to the characteristics of its use.

3. HOW TO USE KABIPAC SODIUM CHLORIDE 9 MG/ML

Follow the administration instructions for KabiPac Sodium Chloride 9 mg/ml exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will indicate the most suitable dose for your needs. Generally, intravenous drip administration is recommended according to your age, body weight, clinical condition, fluid balance, electrolyte balance, and acid-base balance.

Recommended dosage:

For adults, elderly, and adolescents: 500 ml to 3000 ml every 24 hours

For infants and children: 20 ml to 100 ml per kg of body weight every 24 hours

Generally, drip administration of 120-180 ml/hour is recommended at a speed of 40-60 drops/minute.

It should be administered intravenously.

If you use more KabiPac Sodium Chloride 9 mg/ml than you should

In case of overdose, hyperhydration (excess water), hypernatremia (excess sodium), hyperchloremia (excess chloride), and related manifestations such as metabolic acidosis (low blood pH), heart overload, and edema formation may occur. Administration will be discontinued and symptomatic treatment will be initiated.

If you are not hospitalized, go to the nearest hospital or consult the Toxicology Information Service. Phone: 91 562 04 20.

4. Possible adverse effects

Like all medications, KabiPac Sodium Chloride 9 mg/ml can cause adverse effects, although not everyone will experience them.

If administered continuously in the same infusion site, pain, fever, infection, and phlebitis that extends 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 medications will determine the likelihood of other adverse reactions.

In case of adverse reactions, the infusion should be discontinued.

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

5. Storage of KABIPAC SODIUM CHLORIDE 9 MG/ML

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

Do not use this medication after the expiration date shown on the packaging.

No special storage conditions are required.

Do not use KabiPac Sodium Chloride 9 mg/ml if the solution is not transparent and contains precipitates.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. PACKAGE CONTENTS AND ADDITIONAL INFORMATION

Composition of KabiPac Sodium Chloride 9 mg/ml

The active ingredient is sodium chloride. Each 100 ml of solution contains 0.9 g of sodium chloride.

• The only excipient is water for injectable preparations.

Ionic composition:

Sodium 154 mmol/l (154 meq/l)

Chloride 154 mmol/l (154 meq/l)

Theoretical osmolality: 308 mosm/l.

pH: 4.5 - 7

Appearance of the product and package contents

KabiPac Sodium Chloride 9 mg/ml is a clear, colorless solution without visible particles, sterile, and apyrogenic. It comes in polyethylene bottles of the following capacities and formats:

1 bottle of 50 ml

1 bottle of 100 ml

1 bottle of 100/250 ml

1 bottle of 250 ml

1 bottle of 500 ml

1 bottle of 1000 ml

40 bottles of 100 ml

10 bottles of 500 ml

20 bottles of 50 ml

20 bottles of 250 ml

20 bottles of 100/250 ml

10 bottles of 1000 ml

40 bottles of 50 ml

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Holder

Fresenius Kabi España S.A.U. C/ Marina 16-18,

08005-Barcelona (Spain)

Manufacturers:

Labesfal – Laboratorios Almiro, S.A.

Zona Industrial do Lagedo,

3465-157 Santiago de Besteiros (Portugal)

Fresenius Kabi Deutschland GmbH Werk Friedberg Freseniusstraße 1

D-61169 Friedberg

Fresenius Kabi Polska SP Z.O.O. Sienkiewicza, 25 (Kutno)

P-99-300 Poland

Fresenius Kabi Italy S.r.l.

Via Camagre, 41

I – 37063 Isola della Scala – Verona

Fresenius Kabi España S.A.U.

C/ Dr. Ferran, 4

08339 Vilassar de Dalt (Barcelona)

“Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)http://www.aemps.gob.es/”

Date of the last revision of this prospectus: April 2021.

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This information is intended only for doctors or healthcare professionals:

This medication will always be administered by specialized personnel. It will be administered by perfusion, through a central or peripheral vein.

The solution must be transparent and particle-free, and not contain precipitates. Do not administer otherwise.

The contents of each package are for a single perfusion; the unused fraction must be discarded.

An aseptic method should be used to administer the solution and in the preparation of mixtures.

Before adding medications to the solution or administering them simultaneously with other medications, compatibility should be checked, pH should be taken into account, and ions should be controlled.

Discard after a single use.

Discard partially used packages.

Do not reconnect partially used packages.