PROSPECTO: INFORMATION FOR THE USER

KabiPac Sodium Chloride 9 mg/ml Infusion Solution
Sodium Chloride

KabiPacSodium Chloride 9 mg/ml is an intravenous infusion solution that is presented 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 known as electrolyte solutions.

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

• 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 been diagnosed or detected with high blood pressure, edemas, kidney or liver diseases, or have any heart disorder.
• If you present hypernatremia (elevated sodium blood concentration), hyperchloremia (elevated chloride blood concentration), hypokalemia (decreased potassium blood level), or acidosis (pH below the normal range).
• In states of hyperhydration (overload of liquid).

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 blood analytical controls of electrolytes should be performed in prolonged therapies and particularly if you have: acid-base imbalance, cardiac, hepatic, and/or renal alterations, as well as if you are being treated with corticosteroids or adrenocorticotropic hormone.

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

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

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

Use of 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 acquired without a prescription, as it may be necessary to interrupt treatment or adjust the dose of one of them.

Before mixing with other medications, check the compatibility tables, take into account the pH, and control the ions.

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 lactation

Consult your doctor or pharmacist before using any medication.

As long as administration is correct and controlled, no adverse effects are expected during the period of pregnancy and lactation.

There are no relevant epidemiological data available at this time, so it is recommended that if used during these periods, it be done with caution.

Driving and operating machines

It is not advisable, due to its characteristics of use.

Follow exactly the administration instructions for KabiPac Sodium Chloride 9 mg/ml 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 administration drop by drop 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 babies and children: 20 ml to 100 ml per kg of body weight every 24 hours

Generally, administration drop by drop is recommended at a rate of 120- 180 ml/hour, 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, you may experience overhydration, hypernatremia, hyperchloremia, and related manifestations such as metabolic acidosis (blood pH lower than normal), heart overload, and edema formation. Administration will be suspended and symptomatic treatment will be sought.

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

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

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

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

Discontinue infusion in case of adverse reactions.

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

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

Do not use this medication after the expiration date that appears 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 drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Sodium Chloride 9 mg/ml Composition of KabiPac

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

- The only excipient is water for injection preparations.

Ionic Composition:

Sodium154 mmol/l(154 meq/l)

Chloride154 mmol/l(154 meq/l)

Theoretical Osmolarity: 308 mosm/l.

pH: 4.5 - 7

Appearance of the Product and Contents of the Container

KabiPac Sodium Chloride 9 mg/ml is a transparent and colorless solution, without visible particles, sterile and apyrogenic. It is presented 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

Only some sizes of containers may be commercially marketed.

Holder of the Marketing Authorization and Responsible for Manufacturing

Holder

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

08005-Barcelona (Spain)

Manufacturing Responsible:

Labesfal – Laboratorios Almiro, S.A.

Zona Industrial do Lagedo,

3465-157 Santiago de Besteiros (Portugal)

Fresenius Kabi Deutschland GmbH Werk Friedberg Freseniusstraβe 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 Medical Devices (AEMPS)http://www.aemps.gob.es/”

Last Review Date of this Leaflet: April 2021.

This information is intended solely for doctors or healthcare professionals:

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

The solution must be transparent without particles and not contain precipitates. Do not administer otherwise.

The contents of each container are for a single infusion, discard any unused portion.

Use an aseptic method to administer the solution and in case of preparation of mixtures.

Before adding medications to the solution or administering simultaneously with other medications, check for any incompatibilities.

Discard after single use.

Discard partially used containers.

Do not reconnect partially used containers.