Ini. Natrii hlorati 10% Polpharma

Leaflet attached to the packaging: information for the user

INJ. NATRII CHLORATI 10% POLPHARMA

100 mg/ml, concentrate for solution for infusion

Sodium chloride

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Inj. Natrii Chlorati 10% Polpharma and what is it used for
• 2. Important information before using Inj. Natrii Chlorati 10% Polpharma
• 3. How to use Inj. Natrii Chlorati 10% Polpharma
• 4. Possible side effects
• 5. How to store Inj. Natrii Chlorati 10% Polpharma
• 6. Contents of the packaging and other information

1. What is Inj. Natrii Chlorati 10% Polpharma and what is it used for

Inj. Natrii Chlorati 10% Polpharma is a hypertonic solution of sodium chloride (i.e., with a concentration higher than in body fluids), used in disorders of water and electrolyte balance. Sodium and chloride ions are essential for the proper functioning of the body. A deficiency of these ions often occurs in hypotonic dehydration (dehydration with salt loss), after excessive loss with body fluids. The Inj. Natrii Chlorati 10% Polpharma concentrate is usually used as an additive to other pharmacologically and chemically compatible infusion solutions, in order to increase the amount of ions administered without overloading the body with fluids. As a hypertonic solution, it should not be used without dilution. Indications for the use of Inj. Natrii Chlorati 10% Polpharma:

• Hiponatremia (reduced sodium concentration in serum).
• Water intoxication (hypotonic hyperhydration).
• Supportively in metabolic alkalosis (alkalosis).

2. Important information before using Inj. Natrii Chlorati 10% Polpharma

When not to use Inj. Natrii Chlorati 10% Polpharma

Inj. Natrii Chlorati 10% Polpharma should not be used in the case of:

• hypernatremia (increased sodium concentration in serum),
• hyperchloremia (increased chloride concentration in serum),
• metabolic acidosis (increased acidic metabolites in the blood),
• edema.

Warnings and precautions

Before starting the use of Inj. Natrii Chlorati 10% Polpharma, you should discuss it with your doctor or nurse. Caution should be exercised when administering sodium chloride to patients with uncontrolled heart failure, liver cirrhosis, pre-eclampsia, peripheral and pulmonary edema, and kidney function disorders. Caution should be exercised when administering sodium chloride to very young patients and elderly patients. During treatment, the doctor will determine the sodium, potassium, and chloride concentrations in the serum and will monitor the water balance. In the case of sodium determination in the blood, the results may be falsely low in patients with hyperlipidemia (elevated LDL cholesterol and triglycerides in the blood), hyperproteinemia (elevated protein concentration in the blood), and in patients with diabetes. The solution should not be used if the ampoule is damaged or the solution is not clear.

Inj. Natrii Chlorati 10% Polpharma and other medicines

You should tell your doctor about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Do not use simultaneously with other medicines that retain sodium in the body, due to the risk of hypernatremia. The solution is incompatible with silver, mercury, and lead salts.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before using this medicine. Pregnancy There are no contraindications to the use of diluted sodium chloride solution during pregnancy. However, the administration of Inj. Natrii Chlorati 10% Polpharma should be carried out under medical supervision, as the hypertonic solution may have a harmful effect on the fetus. Breastfeeding There are no contraindications to the use of diluted sodium chloride solution during breastfeeding.

Driving and using machines

The medicine does not affect the ability to drive vehicles, operate machines, and psycho-physical fitness.

3. How to use Inj. Natrii Chlorati 10% Polpharma

The medicine can only be administered by qualified medical personnel. The dose is determined by the doctor individually for each patient, depending on the clinical picture and the results of water and electrolyte balance tests. The concentrate is administered in intravenous drip infusion after prior dilution or as an additive to infusion solutions. HiponatremiaIn each case, the doctor will determine the cause of hyponatremia and will strive to eliminate it. In acute symptomatic hyponatremia lasting less than 24 hours, the sodium ion concentration in the serum should be increased to 120-125 mmol/l within 24 hours or in a shorter time. In patients with symptomatic chronic hyponatremia or hyponatremia of unknown duration, the sodium ion concentration in the serum should be increased at a rate of 0.5 mmol/l to achieve a concentration of 120-125 mmol/l. This can help avoid complications from the central nervous system or pulmonary edema. The increase in sodium ion concentration in the serum within 24 hours should not exceed 12 mmol/l. Water intoxicationUsually, a 3% or 5% sodium chloride solution is administered. Do not administer more than 100 ml/hour. In 1 ml of 3% solution, there are 0.51 mmol of sodium ions, and in 1 ml of 5% solution, there are 0.86 mmol of sodium ions.

Using a higher dose of Inj. Natrii Chlorati 10% Polpharma than recommended

Inappropriate and excessive intravenous administration of physiological saline (e.g., after procedures, in patients with heart or kidney function disorders, etc.) may cause an increase in sodium concentration in the blood, resulting in dehydration of internal organs (e.g., brain - which can lead to thrombosis and hemorrhage). Adverse reactions associated with an excess of sodium chloride include: nausea, vomiting, diarrhea, abdominal cramps, increased thirst, decreased saliva and tear secretion, sweating, fever, tachycardia, kidney failure, peripheral and pulmonary edema, respiratory arrest, headaches, dizziness, feeling of anxiety, irritability, weakness, tremors and muscle stiffness, seizures, coma, and death. If the above symptoms occur, you should tell your doctor or nurse. The doctor will decide on the use of symptomatic treatment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects may occur in the event of an incorrect assessment of the water and electrolyte balance. The most common side effects were hypernatremia and hyperchloremia. Local reactions from the vessels include pain and redness if the solution is administered too quickly or is not sufficiently diluted.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration 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: mz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Inj. Natrii Chlorati 10% Polpharma

The medicine should be stored out of sight and reach of children. Store at a temperature below 25°C. The concentrate in polyethylene ampoules should be protected from the effects of vapors and chemically active gases or intense odors. Do not use this medicine after the expiry date stated on the box and label. The expiry date stated is the last day of the specified month. The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number. Medicines should not be disposed of via wastewater or household waste containers. You should 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 Inj. Natrii Chlorati 10% Polpharma contains

• The active substance of the medicine is sodium chloride. 1 ml of the concentrate contains 100 mg of sodium chloride.
• The other ingredients are: water for injections.

What Inj. Natrii Chlorati 10% Polpharma looks like and what the packaging contains

Colorless or almost colorless transparent solution. The packaging contains:

• 10 glass ampoules with a capacity of 10 ml;
• 5 polyethylene ampoules with a capacity of 10 ml.

Marketing authorization holder and manufacturer

Polpharma S.A. Pharmaceutical Works ul. Pelplińska 19, 83-200 Starogard Gdański tel. + 48 22 364 61 01

Date of the last update of the leaflet: