Natrium hloratum 0,9% Fresenius

Leaflet attached to the packaging: information for the user

SODIUM CHLORIDE 0.9% FRESENIUS, 9 mg/ml, solution for infusion

Sodium chloride

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

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Keep this leaflet, you may need to read it again.
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In case of any doubts, consult a doctor, pharmacist, or nurse.
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This medicine has been prescribed specifically for one person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
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If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse.
See section 4.

Table of contents of the leaflet

• 1. What is SODIUM CHLORIDE 0.9% FRESENIUS and what is it used for
• 2. Important information before using SODIUM CHLORIDE 0.9% FRESENIUS
• 3. How to use SODIUM CHLORIDE 0.9% FRESENIUS
• 4. Possible side effects
• 5. How to store SODIUM CHLORIDE 0.9% FRESENIUS
• 6. Contents of the packaging and other information

1. What is SODIUM CHLORIDE 0.9% FRESENIUS and what is it used for

SODIUM CHLORIDE 0.9% FRESENIUS is a physiological saline solution, a source of water and electrolytes (sodium and chloride). The medicine is administered intravenously.
In adults, the average water requirement is 2 to 3 liters per day.
Sodium is responsible for water management in the body, regulates muscle contractions and relaxations, including the heart muscle. It is essential for the functioning of various enzymes.
Chloride is a component of digestive juices in the digestive tract (gastric juice and saliva), participates in the regulation of water management in the body, and acid-base balance.
Sodium, in combination with chloride, is responsible for proper fluid management in the body and helps maintain proper acid-base balance.
Indications for use:

• extraintestinal fluid and electrolyte supplementation (sodium and chloride);
• dilution and dissolution of electrolyte and drug concentrates;
• a volume of 1000 ml can be used as an infusion solution in surgical procedures or as a test solution for dialysis equipment.

2. Important information before using SODIUM CHLORIDE 0.9% FRESENIUS

When not to use SODIUM CHLORIDE 0.9% FRESENIUS

Before administering this medicine, consider the contraindications for the substance being dissolved or diluted in the patient.
Do not use the medicine:

• if the patient is allergic to the substance being dissolved or diluted in SODIUM CHLORIDE 0.9% FRESENIUS;
• if the patient has hyperhydration (excess fluid in the body).

The use of the medicine may be contraindicated:

• if the patient has too high a concentration of sodium and chloride in the blood;
• if the patient has too low a concentration of potassium in the blood;
• if the patient has acidosis (accumulation of excessive amounts of acidic substances in the blood);
• in situations where the patient should limit sodium intake (limiting salt in the diet) due to: heart failure, generalized edema, pulmonary edema, hypertension, preeclampsia (a cardiovascular disease that occurs in pregnant women) or severe renal failure, inform the doctor;
• in newborns for the purpose of supplementing water deficiency (use only to correct ionic disorders).

Warnings and precautions

The medicine should be used with caution if the patient:

• has congestive heart failure;
• has severe renal failure; in patients with renal function disorders, the medicine may cause sodium retention in the body;
• has edema (caused by sodium retention in the body);
• is being treated with corticosteroids or corticotropin (see section: SODIUM CHLORIDE 0.9% FRESENIUS and other medicines).

During prolonged administration of SODIUM CHLORIDE 0.9% FRESENIUS, the doctor will monitor the patient's condition and order blood tests (to check for fluid balance disorders, electrolyte concentration, and acid-base balance).

SODIUM CHLORIDE 0.9% FRESENIUS and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
It is not recommended to use the following medicines simultaneously with SODIUM CHLORIDE 0.9% FRESENIUS, as they may increase the concentration of sodium in the body:

• non-steroidal anti-inflammatory drugs (e.g., ibuprofen, diclofenac);
• carbenoxolone (a medicine used to treat oral ulcers);
• corticosteroids (also known as steroids, medicines used to treat, among other things, rheumatic diseases);
• corticotropin (a hormone of the pituitary gland).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
SODIUM CHLORIDE 0.9% FRESENIUS may be administered to pregnant women and during breastfeeding.

Driving and operating machinery

Not applicable.

3. How to use SODIUM CHLORIDE 0.9% FRESENIUS

This medicine is administered only by medical personnel. The medicine should not be used by itself. In case of doubts, consult a doctor.
The dosage is determined by the doctor individually for each patient, depending on the patient's age, weight, and clinical condition.

Using a higher dose of SODIUM CHLORIDE 0.9% FRESENIUS than recommended

In case of using a higher dose of the medicine, inform the doctor or nurse immediately.
This may cause side effects (see section 4: Possible side effects).
In case of any further doubts related to the use of this medicine, consult a doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Frequency not known(frequency cannot be estimated from the available data):

• Administration of too large a volume of SODIUM CHLORIDE 0.9% FRESENIUS may cause:
• increased concentration of sodium and chloride in the blood,
• acidosis (accumulation of excessive amounts of acidic substances in the blood),
• exacerbation of heart failure symptoms and pulmonary edema (especially in patients with cardiovascular diseases) such as shortness of breath, fatigue, swelling of the lower limbs, irregular heartbeat.
• At the injection site, the following may occur:
• vein irritation,
• thrombophlebitis (inflammation and small blood clots in the vein, manifested by palpable hardening of the vein, redness around it, pain, and tenderness).

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, inform the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store SODIUM CHLORIDE 0.9% FRESENIUS

Store the medicine out of sight and reach of children.
Polyethylene container KabiPac with cap:
Do not freeze.
Polypropylene container KabiClear with cap, polypropylene bag of " freeflex" type, " freeflex+" or
" freeflexProDapt", glass bottle:
Store at a temperature below 25°C. Do not freeze.
After opening, the packaging cannot be stored and used again. Unused medicine is not suitable for further use.
Do not use this medicine after the expiry date stated on the packaging. The expiry date is the last day of the specified month.
Do not use this medicine in case of contamination, color change, or if the packaging is damaged.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What SODIUM CHLORIDE 0.9% FRESENIUS contains

• The active substance of the medicine is sodium chloride.

1000 ml of the solution contains 9 g of sodium chloride.

• Other ingredients are: water for injections, sodium hydroxide (to adjust pH), and hydrochloric acid (to adjust pH).

The osmolality of the solution is 308 mOsmol/l, pH: 4.5 – 7.0.

What SODIUM CHLORIDE 0.9% FRESENIUS looks like and what the packaging contains

The medicine is a colorless and transparent solution.
Packaging of the medicine:

• polyethylene container KabiPac with cap - 100 ml, 250 ml, 500 ml, 1000 ml;
• polyethylene container KabiPac with cap - 40 x 100 ml, 20 x 250 ml, 10 x 500 ml, 20 x 500 ml, 10 x 1000 ml, in a cardboard box;
• polypropylene container KabiClear with cap - 100 ml, 250 ml, 500 ml, 1000 ml;
• polypropylene container KabiClear with cap - 40 x 100 ml, 20 x 250 ml, 10 x 500 ml, 20 x 500 ml, 10 x 1000 ml, in a cardboard box;
• polypropylene bag of " freeflex" type or " freeflex+" (with a needle-free port) - 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml;
• polypropylene bag of " freeflex" type or " freeflex+" (with a needle-free port) - 60 x 50 ml, 50 x 100 ml, 30 x 250 ml, 20 x 500 ml, 10 x 1000 ml, in a cardboard box;
• polypropylene bag of " freeflexProDapt" type (with a needle-free port) - 60 x 50 ml, 50 x 100 ml, 30 x 250 ml, in a cardboard box;
• glass bottle - 250 ml, 500 ml;
• glass bottle - 12 x 250 ml, 12 x 500 ml, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer

Fresenius Kabi Polska Sp. z o.o.
Infusion Fluids Factory
ul. Sienkiewicza 25
99-300 Kutno
Fresenius Kabi Italia S.r.l.
Via Camagre 41
37063 Isola della Scala - Verona
Italy
Fresenius Kabi France
6, Rue du Rempart
B.P. 611
27400 Louviers Cedex
France
Fresenius Kabi Deutschland GmbH
Freseniusstraße 1
D-61169 Friedberg
Germany
To obtain more detailed information, contact the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

Date of last update of the leaflet:

Information intended for healthcare professionals only:

Dosage and administration

The dosage is determined by the doctor individually, depending on the patient's age, weight, and clinical condition.
In cases of severe sodium deficiency, 2 to 3 liters of SODIUM CHLORIDE 0.9% FRESENIUS can be administered over 2-3 hours, and then the administration rate can be reduced.
Excessive administration of solutions without potassium may cause significant hypokalemia.
Intravenous administration of these solutions may cause fluid overload and a decrease in the concentration of some electrolytes in the serum, leading to signs of heart failure or pulmonary edema.
The risk of fluid overload causing signs of heart failure is directly proportional to the electrolyte concentration in these solutions.

Overdose

In case of hyperhydration or overload of dissolved substances, assess the patient's clinical condition and provide appropriate treatment.

Interactions with other medicines and other types of interactions

As with all parenterally administered medicines, check the compatibility of other medicines added to the SODIUM CHLORIDE 0.9% FRESENIUS solution.
Concomitant administration of sodium-retaining medicines, such as non-steroidal anti-inflammatory drugs, carbenoxolone, corticosteroids, and corticotropin, may increase the risk of sodium excess.
When adding other medicines to SODIUM CHLORIDE 0.9% FRESENIUS, the resulting solution should be administered immediately.
Pay attention to possible color changes.

Preparation of the medicine for use

Use only a clear solution.
Unused medicine is not suitable for further use.
Do not use the medicine in case of contamination, color change, or if the packaging is damaged.
Follow aseptic procedures.
Instructions for using the " freeflex" and " freeflex+" polypropylene bags:

• 1. Before use, check the appearance of the bag and the solution – the solution should be clear and free of contaminants (do not use damaged or previously used bags).
• 2. Preparation of the infusion: a) Remove the bag from the outer packaging. b) Remove the plastic cover/plug from the larger dark blue port (infusion port) with the arrow pointing outward. c) Connect the infusion set.
• 3. Adding medicine to the packaging: a) Remove the bag from the outer packaging. b) Remove the plastic cover/plug from the smaller port for injections (white for " freeflex" bags, light blue for " freeflex+" bags) with the arrow pointing inward, and then add the medicine:
• to the " freeflex" bag using a syringe with a needle.
• to the " freeflex+" bag using a luer lock syringe by screwing it directly into the injection port or using a standard syringe with a needle.
• using the freeflex+ transfer adapter designed for direct addition of medicine from a vial to the packaging.

Note: The ports are sterile, do not require disinfection before first use.

Medical devices intended for administration and addition of medicine should be used in accordance with their instructions for use. The solution resulting from the addition of medicine should be carefully mixed and checked for precipitation.
Instructions for using the KabiPac and KabiClear containers:

• 1. Before use, check the appearance of the container and the solution – the solution should be clear and free of contaminants (do not use damaged or previously used containers).
• 2. Preparation of the infusion: a) Place the KabiPac/KabiClear container on a stable and even surface. b) Remove the plastic cover/plug from the larger port (infusion port) with the arrow pointing outward. c) Insert the infusion set needle into the infusion port, gently rotating the set with one hand while holding the container neck with the other.
• 3. Adding medicine to the packaging: a) Place the KabiPac/KabiClear container on a stable and even surface. b) Remove the plastic cover/plug from the smaller port (injection port) with the arrow pointing inward, and then insert the needle into the center of the injection port and add the medicine to the KabiPac/KabiClear container.

Note: The ports are sterile, do not require disinfection before first use.

Medical devices intended for administration and addition of medicine should be used in accordance with their instructions for use. The solution resulting from the addition of medicine should be carefully mixed and checked for precipitation.

Pharmaceutical incompatibilities

Check the compatibility of other medicines added to the SODIUM CHLORIDE 0.9% FRESENIUS solution.

Storage conditions

After opening, the packaging cannot be stored and used again. From a microbiological point of view, the medicine should be used immediately. Otherwise, the user is responsible for the storage conditions and time of the remaining medicine in the packaging.
Polyethylene container KabiPac with cap: Do not freeze.
Polypropylene container KabiClear with cap, polypropylene bag of " freeflex" type, " freeflex+" or
" freeflexProDapt", glass bottle: Store at a temperature below 25°C. Do not freeze.

Disposal of unused medicine

Any unused medicine or waste should be disposed of in accordance with local regulations.