Inj. sodium chloride 10% polpharma

Package leaflet: Information for the user

INJ. NATRII CHLORATI 10% POLPHARMA
100 mg/ml, concentrate for solution for infusion
Natrii chloridum
Please read all of this leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or nurse.
• This medicine has been prescribed for a specific individual. 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 adverse reactions, including any not listed in this leaflet, inform your doctor or nurse immediately. See section 4.

Contents of the leaflet

1. What Inj. Natrii Chlorati 10% Polpharma is and what it is used for
2. Important information before use of 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 pack and other information

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

Inj. Natrii Chlorati 10% Polpharma is a hypertonic sodium chloride solution (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 normal body function.
Deficiency of these ions often occurs in hypotonic dehydration (dehydration with salt loss), following excessive loss in body fluids. The Inj. Natrii Chlorati 10% Polpharma concentrate is usually used as an additive to other pharmacologically and chemically compatible infusion fluids, to increase the amount of ions administered without excessive fluid load on the body. As a hypertonic solution, it must not be used without prior dilution.
Indications for Inj. Natrii Chlorati 10% Polpharma:

• Hyponatremia (reduced serum sodium concentration).
• Hypotonic overhydration (water intoxication).
• Adjunctive treatment in metabolic alkalosis.

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

When not to use Inj. Natrii Chlorati 10% Polpharma
Do not use the medicine Inj. Natrii Chlorati 10% Polpharma in the following cases:

• hypernatraemia (increased serum sodium concentration),
• hyperchloraemia (increased serum chloride concentration),
• metabolic acidosis (increased acidic metabolites in blood),
• oedema.

Warnings and precautions
Before starting treatment with Inj. Natrii Chlorati 10% Polpharma, discuss it with your doctor or nurse.
Exercise caution when administering sodium chloride to patients with uncompensated heart failure, liver cirrhosis, pre-eclampsia, peripheral and pulmonary oedema, or impaired kidney function.
Exercise caution when administering sodium chloride to very young patients and elderly patients.
During treatment, the doctor will monitor serum concentrations of sodium, potassium, and chlorides, and will control fluid balance.
When measuring blood sodium levels, results may be falsely low in patients with hyperlipidaemia (elevated LDL cholesterol and triglyceride levels in blood), hyperproteinaemia (increased blood protein concentration), and in patients with diabetes.
Do not use the solution if the ampoule is damaged or if the solution is not clear.

Inj. Natrii Chlorati 10% Polpharma and other medicines
Inform the doctor about all medicines currently taken or recently taken by the patient, as well as any medicines the patient plans to take.
Do not use simultaneously with other medicines that cause sodium retention in the body due to the risk of developing hypernatraemia.
The solution is incompatible with silver, mercury, and lead salts.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.

Pregnancy
There are no contraindications regarding the use of diluted sodium chloride solution during pregnancy. However, administration of Inj. Natrii Chlorati 10% Polpharma should be performed under medical supervision, as the hypertonic solution may have harmful effects on the foetus.

Breastfeeding
There are no contraindications to using diluted sodium chloride solution during breastfeeding.

Driving and operating machinery
The medicine does not affect the ability to drive, operate machinery, or psychophysical performance.

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

The medicinal product may be administered only by qualified medical personnel.
The dose is determined individually by a physician for each patient, depending on the clinical picture and results of laboratory tests assessing water and electrolyte balance.
The concentrate is administered via intravenous infusion after prior dilution or as an additive to infusion solutions.

Hyponatremia
In every case, the physician will identify the underlying cause of hyponatremia and aim to eliminate it.
In acute symptomatic hyponatremia lasting less than 24 hours, serum sodium ion concentration should be increased to 120–125 mmol/L within 24 hours or a shorter period.
In patients with symptomatic chronic hyponatremia or hyponatremia of unknown duration, serum sodium ion concentration should be increased at a rate of 0.5 mmol/L per hour until reaching a concentration of 120–125 mmol/L. This approach helps avoid complications involving the central nervous system or pulmonary edema.
The increase in serum sodium ion concentration over 24 hours should not exceed 12 mmol/L.

Water intoxication
3% or 5% sodium chloride solution is usually administered. The infusion rate should not exceed 100 mL per hour.
1 mL of 3% NaCl solution contains 0.51 mmol of sodium ions, while 1 mL of 5% NaCl solution contains 0.86 mmol of sodium ions.

Use of a higher than recommended dose of Inj. Natrii Chlorati 10% Polpharma
Inappropriate and excessive intravenous administration of saline (e.g., after surgical procedures, in patients with impaired cardiac or renal function, etc.) may lead to increased blood sodium concentration, resulting in dehydration of internal organs (e.g., brain—potentially leading to thrombosis and hemorrhage).
Adverse effects associated with excess sodium chloride include: nausea, vomiting, diarrhea, abdominal cramps, excessive thirst, reduced salivation and lacrimation, sweating, fever, tachycardia, renal failure, peripheral and pulmonary edema, respiratory arrest, headache, dizziness, restlessness, irritability, weakness, muscle tremors and stiffness, seizures, coma, and death.
If any of the above symptoms occur, inform the physician or nurse immediately.
The physician will decide on implementing symptomatic treatment.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions may occur if the water-electrolyte balance is incorrectly assessed.
The most commonly observed reactions were hypernatraemia and hyperchloraemia.
Local vascular reactions include pain and redness, especially if the solution is administered too rapidly or is insufficiently diluted.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: mz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

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

Keep the medicine out of sight and reach of children.
Store below 25°C. Protect the concentrate in polyethylene ampoules from exposure to vapours and gases that are chemically reactive or have strong odours.
Do not use this medicine after the expiry date stated on the carton and label. The expiry date refers to the last day of the stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and the abbreviation Lot indicates the batch number.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Inj. Natrii Chlorati 10% Polpharma contains

• The active substance is natrii chloridum. 1 ml of concentrate contains 100 mg of sodium chloride.
• The other component is: water for injections.

What Inj. Natrii Chlorati 10% Polpharma looks like and contents of the pack
A colourless or almost colourless clear solution.
The pack contains:

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

Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01