Sodium chloride 0.9% with potassium chloride 0.3% Baxter

Italy
Brand name Sodium chloride 0.9% with potassium chloride 0.3% Baxter
Form solution for infusion
Active substance / Dosage
SODIUM CHLORIDE
POTASSIUM CHLORIDE
Prescription type Restricted prescription – hospital or equivalent facility use only
ATC code
B05BB01
Registration number 035841
Manufacturer BAXTER S.P.A.

Table of Contents

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Sodium Chloride 0.9% with Potassium Chloride 0.3% Baxter, solution for infusion

Active substances: potassium chloride and sodium chloride
Please read this leaflet carefully before you start using this medicine

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you personally. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
  • If any of the side effects worsen, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist. This medicine is called “Sodium Chloride 0.9% with Potassium Chloride 0.3% Baxter solution for infusion”, but will be referred to as “Sodium 0.9 & Potassium 0.3 for infusion” throughout the remainder of this leaflet.

Contents of this leaflet:

  1. What Sodium 0.9 & Potassium 0.3 for infusion is and what it is used for
  2. What you need to know before using Sodium 0.9 & Potassium 0.3 for infusion
  3. How to use Sodium 0.9 & Potassium 0.3 for infusion
  4. Possible side effects
  5. How to store Sodium 0.9 & Potassium 0.3 for infusion
  6. Contents of the pack and other information

1. WHAT SODIO 0,9 & POTASSIO 0,3 FOR INFUSION IS AND WHAT IT IS USED FOR

Sodio 0,9 & Potassio 0,3 for infusion is a solution of potassium chloride and sodium chloride in water.
Potassium chloride and sodium chloride are chemical substances (often called "salts") found in the blood.

The infusion of Sodio 0,9 & Potassio 0,3 for infusion is used to prevent and treat:

  • loss of potassium from the body (potassium depletion, for example after treatment with certain diuretics [water tablets])
  • low blood potassium levels (hypokalemia) in conditions that may cause loss of sodium chloride and water, including:
  • when unable to eat or drink, due to illness or after surgery
  • excessive sweating due to high fever
  • extensive skin loss, as may occur in severe burns

2. BEFORE USING SODIUM 0.9% & POTASSIUM CHLORIDE 0.3% FOR INFUSION

DO NOT receive the infusion of Sodium 0.9% & Potassium 0.3% for infusion if
you have any of the following conditions:

  • elevated potassium levels in the blood (hyperkalemia)
  • elevated chloride levels in the blood (hyperchloremia) 1 of 10
  • elevated sodium levels in the blood (hypernatremia)
  • severe renal failure (when your kidneys do not function properly and you require dialysis)
  • decompensated heart failure. This is heart failure that is not adequately treated and causes symptoms such as:
    • shortness of breath
    • swelling of the ankles
  • Addison’s disease (impaired function of the adrenal gland. The adrenal gland produces hormones that help regulate the concentrations of chemicals in the body)

Take special care when receiving Sodium 0.9% & Potassium 0.3% for infusion
Sodium 0.9% & Potassium 0.3% for infusion is a hypertonic (concentrated) solution. Your doctor will take this into account when calculating the amount of solution to administer to you.
Inform your doctor if you have or have had any of the following medical conditions:

  • any heart disease or weakened cardiac function
  • reduced kidney function
  • adrenocortical insufficiency (this disease of the adrenal gland affects hormones that regulate chemical concentrations in the body)
  • loss of body fluids (acute dehydration, for example due to vomiting or diarrhea)
  • extensive tissue damage (such as may occur in severe burns)
  • if you are being treated with cardiac glycosides (also known as cardiotonics), such as digitalis or digoxin. These medicines are used to treat heart conditions. Regular monitoring of potassium levels in the blood must be performed.
  • high blood pressure (hypertension)
  • fluid accumulation under the skin, particularly in the ankles (peripheral edema)
  • fluid accumulation in the lungs (pulmonary edema)
  • high blood pressure during pregnancy (pre-eclampsia)
  • any condition associated with sodium retention (when the body retains too much sodium), such as during treatment with steroids (also read “Use of other medicines”)
  • if you are in a condition that may cause high levels of vasopressin, a hormone that regulates fluids in your body. You may have excessive vasopressin in your body, for example, if:
    • you have a sudden and serious illness
    • you have pain
    • you have undergone surgery
    • you have infections, burns, or brain diseases
    • you have diseases affecting your heart, liver, kidneys, or central nervous system
    • you are taking certain medications (see also below “Use of other medicines”) This may increase the risk of low sodium levels in your blood and may lead to headache, seizures, lethargy, coma, cerebral edema, and death. Cerebral edema increases the risk of death and brain damage. People at higher risk of cerebral edema include:
      • children
      • women (especially if of childbearing age)

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  • individuals who have problems with their brain fluid levels, for example due to meningitis, intracranial hemorrhage, or brain injury

While you are receiving the infusion, your doctor will take blood and urine samples to monitor:

  • the amount of fluid in your body
  • your vital signs
  • the levels of chemical compounds such as sodium and potassium in your blood (your plasma electrolytes)
  • the blood concentration of a substance called creatinine (your plasma creatinine)
  • the blood concentration of a substance called urea (your BUN levels)
  • the acidity of your blood and urine (your acid-base balance)
  • your heart tracing (ECG)

Your doctor will consider whether you are receiving parenteral nutrition (nutrition administered via intravenous infusion).
During long-term treatment with Sodium Chloride 0.9% with Potassium Chloride 0.3% for infusion, you may require additional nutritional support.

Use of other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
It is especially important that you inform your doctor if you are taking:

  • cardiac glycosides (cardiotonics) used to treat heart dysfunction, such as digitalis or digoxin
  • medicines that increase potassium concentration in the blood, such as:
    • potassium-sparing diuretics (certain water tablets, e.g., amiloride, spironolactone, triamterene)
    • angiotensin-converting enzyme (ACE) inhibitors (used to treat high blood pressure)
    • angiotensin II receptor antagonists (used to treat high blood pressure)
    • cyclosporine (used to prevent transplant rejection)
    • tacrolimus (used to prevent transplant rejection and to treat certain skin diseases)
    • medicines containing potassium (e.g., potassium supplements, potassium-containing salt substitutes)
    • corticosteroids (anti-inflammatory drugs)

Some medicines affect the vasopressin hormone. These may include:

  • antidiabetic drugs (chlorpropamide)
  • cholesterol-lowering drugs (clofibrate)
  • certain anticancer drugs (vincristine, ifosfamide, cyclophosphamide)
  • selective serotonin reuptake inhibitors (used to treat depression)
  • antipsychotics
  • opioids, for relief of severe pain
  • painkillers and/or anti-inflammatory drugs (also known as NSAIDs)

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  • medicines that mimic or enhance the effect of vasopressin, such as desmopressin (used to treat increased thirst and urination), terlipressin (to treat esophageal bleeding), and oxytocin (used to induce labor)
  • antiepileptic drugs (carbamazepine and oxcarbazepine)
  • diuretics (tablets to promote urination)
  • .

Use of Sodium 0.9% & Potassium 0.3% for infusion with food and drink
Ask your doctor what you may eat or drink.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
Inform your doctor if you are pregnant or breastfeeding.
Changes in potassium levels in your blood may affect the heart function of both you and your unborn baby. Therefore, your doctor will closely monitor the levels of chemicals in your blood.
Sodium 0.9% & Potassium 0.3% for infusion may be used during pregnancy. The amount administered must be carefully controlled by your doctor.
However, if you are pregnant or breastfeeding and any medicine needs to be added to your infusion solution, you must:

  • consult your doctor
  • carefully read the package leaflet of the medicine being added

Driving and using machines
Sodium Chloride 0.9% with Potassium Chloride 0.3% Baxter has no effect on your ability to drive or operate machinery.

3. HOW TO USE SODIUM CHLORIDE 0.9% & POTASSIUM CHLORIDE 0.3% FOR INFUSION

INFUSION
Sodium 0.9 & Potassium 0.3 for infusion will be administered to you by a doctor or nurse.
Your doctor will decide how much medicine you need and when it will be given. This will depend on
your age, body weight, clinical and biological condition, and hydration status (amount of water in your
body). The amount you receive may also depend on other treatments you are undergoing.
Sodium 0.9 & Potassium 0.3 for infusion must NOT be administered to you if the solution contains
suspended particles or if the container is damaged in any way.
The infusion rate will be determined by your doctor.
If you require a large volume or rapid infusion of Sodium Chloride 0.9% with Potassium Chloride 0.3%
Baxter, your doctor may monitor your ECG (heart tracing).
Sodium 0.9 & Potassium 0.3 for infusion is usually administered intravenously through a plastic tube
connected to a needle. Typically, a vein in your arm is used for administration of the solution. However,
your doctor may choose a different route of administration.
Before and during the infusion, your doctor will monitor:

  • potassium levels
  • fluid volume in your body
  • acidity of blood and urine
  • electrolyte levels (especially sodium, in patients with elevated levels of vasopressin hormone, or in those taking medications that enhance the effect of vasopressin).

If you have impaired kidney function, you may receive a lower dose.
Any unused solution must be discarded. NEVER administer an infusion of Sodium 0.9 & Potassium 0.3
from a partially used bag.

If you are given more Sodium 0.9 & Potassium 0.3 for infusion than you should receive
If you receive too much Sodium 0.9 & Potassium 0.3 for infusion (over-infusion), this may lead to the
following symptoms:

  • tingling in arms and legs (paresthesia)
  • muscle weakness
  • inability to move (paralysis)
  • irregular heartbeat (cardiac arrhythmias)
  • heart block (a very slow heartbeat)
  • cardiac arrest (heart stops beating; a life-threatening condition)
  • confusion
  • fluid accumulation in the lungs causing breathing difficulties (pulmonary edema)
  • fluid accumulation under the skin, especially in the ankles (peripheral edema)
  • acidification of the blood (acidosis), leading to fatigue, confusion, lethargy, and increased respiratory rate.

If you develop any of these symptoms, you must inform your doctor immediately. Your infusion will be
stopped and you will be given appropriate treatment depending on your symptoms. If a medication was
added to the Sodium 0.9 & Potassium 0.3 for infusion solution before the over-infusion occurred, that
medication may also cause symptoms. You should read the package leaflet of the added medicine for a
list of all possible side effects.

Discontinuation of Sodium 0.9 & Potassium 0.3 for infusion
Your doctor will decide when to stop administering the infusion.
If you have further questions about the use of this product, you may ask your doctor.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, the infusion of Sodio 0.9 & Potassio 0.3 for infusion can cause adverse reactions, although not everyone experiences them.

  • Low levels of sodium in the blood that may develop during hospitalization (hospital-acquired hyponatremia) and related neurological disorders (acute hyponatremic encephalopathy). Hyponatremia may cause irreversible brain damage and death due to the
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    development of cerebral edema/swelling (see also section “What you need to know before you use Sodio 0.9 & Potassio 0.3 for infusion”)

Adverse reactions that may occur due to the administration technique include:

  • Fever (febrile response)
  • Infection at the infusion site
  • Pain or local reaction (redness or swelling at the infusion site)
  • Irritation and inflammation of the vein used for infusion (phlebitis). This may cause redness, pain, burning, and swelling along the course of the vein where the solution was infused
  • Formation of a blood clot (venous thrombosis) at the infusion site, causing pain, swelling, or redness in the area of the clot
  • Leakage of the infused solution into the surrounding tissues (extravasation). This may damage tissues and lead to scarring
  • Excess fluid in the blood vessels (hypervolemia)

If a drug has been added to the infusion solution, the added drug may also cause adverse reactions. You should read the package leaflet of the added medicine for a list of all possible symptoms.
If any of the adverse reactions worsen, or if you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.
If any adverse reaction occurs, the infusion must be stopped.

5. HOW TO STORE SODIUM 0.9 & POTASSIUM 0.3 BAXTER

Keep the medicine out of the reach and sight of children.
Sodium 0.9 & Potassium 0.3 for infusion does not require any special storage conditions.
DO NOT administer Sodium 0.9 & Potassium 0.3 for infusion after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
DO NOT administer Sodium 0.9 & Potassium 0.3 for infusion if particles are present in the solution or if the packaging is in any way damaged.

6. OTHER INFORMATION

What Sodio 0.9 & Potassio 0.3 for infusion contains
The active substances are:

  • potassium chloride: 3 g per litre
  • sodium chloride: 9 g per litre

The only excipient is water for injections.
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Description of the appearance of Sodio cloruro Sodio 0.9 & Potassio 0.3 for infusion and contents of the pack
Sodio 0.9 & Potassio 0.3 for infusion is a clear solution, free from visible particles. It is supplied in plastic bags made of polyolefin/polyamide (Viaflo).
Each bag is enclosed in a sealed protective plastic overwrap.
The bag sizes are:

  • 500 ml
  • 1000 ml

The bags are packed in cardboard boxes. Each box contains one of the following quantities:

  • 20 bags of 500 ml
  • 10 bags of 1000 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder:
Baxter S.p.A., Piazzale dell’Industria 20, 00144 Roma, Italy

Manufacturers:
Baxter S.A.
Boulevard Rene Branquart, 80
B–7860 Lessines, Belgium
Baxter Healthcare Ltd.
Caxton Way,
Thetford Norfolk IP24 3SE
United Kingdom
Bieffe Medital Sabiñanigo
Ctra de Biescas, Senegüé
22666 Sabiñanigo (Huesca)
Spain

This summary of product characteristics was last approved on: ……………………..

The following information is intended exclusively for physicians and healthcare professionals:
Handling and Preparation
Use the product only if the solution is clear, free from visible particles, and the container is intact. Administer immediately after inserting the infusion set.
Do not remove the bag from its overwrap until immediately before use.
The inner bag maintains the sterility of the product.
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Do not use plastic containers in series connection. Such use may result in gas embolism due to aspiration of residual air from the primary container before completion of fluid administration from the secondary container.

The solution must be administered using sterile equipment and aseptic technique. The administration set must be primed with the solution to prevent air from entering the system.

Medicinal additives may be introduced before or during infusion through the resealable access port.

When adding medicinal products, verify isotonicity prior to parenteral administration.

Thorough and aseptic mixing of any additive is mandatory.

Solutions containing additives must be administered immediately and must not be stored.

The addition of medicinal products or incorrect administration techniques may lead to febrile reactions due to possible introduction of pyrogens. In the event of adverse reactions, the infusion must be immediately discontinued.

Discard the product after single use.
Dispose of any unused portion of the product.
Do not reconnect partially used bags.

1. Opening

a. Remove the Viaflo container from the outer wrapper immediately before use.
b. Check for any small leaks by firmly compressing the inner bag. If any leaks are detected, discard the solution as sterility may be compromised.
c. Check that the solution is clear and that no foreign particles are visible. Discard the solution if foreign material and/or cloudiness is observed.

2. Preparation for Administration

Use sterile equipment for both preparation and administration.
a. Hang the container by the support hole.
b. Remove the plastic cap from the outlet port located at the bottom of the container:

  • firmly hold with one hand the small tab on the neck of the outlet port,
  • with the other hand grasp the large tab on the cap and twist,
  • the cap will open.
    c. Use an aseptic technique to prepare the infusion.

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d. Connect the infusion set. Refer to the instructions provided with the infusion set for connection, priming the device, and administering the solution.

3. Techniques for Adding Medication Additions

The solution must not be administered into the atrium or ventricle to avoid localized hyperkalemia, but rather into a large peripheral or central vein to reduce the risk of causing sclerosis.
Warning: additives may be incompatible (see the following section 5 "Incompatibility of Additives").
Adding Medications Prior to Administration
a. Disinfect the medication injection site
b. Using a syringe with a 19 gauge (1.10 mm) to 22 gauge (0.70 mm) needle, puncture the resealable medication injection site and inject the drug.
c. Mix the solution and medication thoroughly. For high-density medications, such as potassium chloride, gently tap the injection sites while keeping the container in an upright position to ensure mixing.
Caution: Do not store bags containing added medications.
Adding Medications During Administration
a. Close a clamp on the infusion set
b. Disinfect the medication injection site
c. Using a syringe with a 19 gauge (1.10 mm) to 22 gauge (0.70 mm) needle, puncture the resealable medication injection site and inject the drug.
d. Remove the container from the infusion device pole and invert it
e. Eliminate any residual medication and solution from both injection sites by gently tapping while the container is in an upright position
f. Mix the solution and added medication thoroughly
g. Return the container to its correct upright position, reopen the clamp, and continue administration

4 In-Use Stability (Additives)
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The chemical and physical stability of each medication added to the pH of Sodio 0.9 & Potassio 0.3 for infusion solution in the Viaflo container must be evaluated before use. From a microbiological standpoint, the diluted product should be used immediately unless dilution has occurred under controlled and validated aseptic conditions.
If the solution is not used immediately, the storage times and conditions are the responsibility of the user.

5 Incompatibility of Medication Additives
As with all parenteral solutions, incompatibility of medication additives with the solution in the Viaflo container must be assessed before addition.
In the absence of compatibility studies, this solution must not be mixed with other medicinal products.
It is the physician's responsibility to assess the incompatibility of a medication additive with Sodio 0.9 & Potassio 0.3 for infusion solution by checking for any change in color and/or formation of precipitate, insoluble complexes, or crystals. The instructions for use of the medication to be added must be consulted.
Before adding a drug, verify whether it is soluble and/or stable in water at the same pH as the Sodio 0.9 & Potassio 0.3 for infusion solution (pH: 4.5–7.0).
Medications known to be incompatible must not be used.
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