Iniectio Natrii hlorati isotonica Polpharma

Package Leaflet: Information for the User

Injectio Natrii Chlorati Isotonica Polpharma, 9 mg/ml,

Solvent for the preparation of parenteral drugs
Sodium chloride

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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 possible side effects not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Injectio Natrii Chlorati Isotonica Polpharma and what is it used for

Injectio Natrii Chlorati Isotonica Polpharma is a sterile solution used as a solvent or carrier for parenteral drugs, including: intravenous, intramuscular, subcutaneous, epidural, and subarachnoid administration.

2. Important information before using Injectio Natrii Chlorati Isotonica Polpharma

When not to use Injectio Natrii Chlorati Isotonica Polpharma

Due to the type of indications for use, contraindications depend on the drug to be diluted or dissolved.
The medicine should not be used to dissolve silver, mercury, or lead salts.

Warnings and precautions

Before starting to use Injectio Natrii Chlorati Isotonica Polpharma, discuss it with your doctor or nurse.
In the case of subcutaneous injections, it should be taken into account that drugs added to the isotonic sodium chloride solution may change the isotonic solution to a hypertonic solution, which may cause pain at the injection site or redness (especially if the solution is administered too quickly).
Do not use the medicine if the ampoule is damaged and the solution is not clear.
Caution should be exercised when administering sodium chloride to patients with uncontrolled heart failure, liver cirrhosis, pre-eclampsia, peripheral or pulmonary edema, and kidney function disorders.
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 levels in the blood), and in patients with diabetes.

Children

In newborns, there may be too high a concentration of sodium due to kidney immaturity.
Therefore, repeated injections of sodium chloride should be performed after determining the sodium concentration in the blood.

Injectio Natrii Chlorati Isotonica Polpharma and other medicines

Tell your 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.
The solution is compatible with many different medicines. In case of doubts about the physicochemical compatibility of preparations with the physiological saline solution, a test should be performed before mixing.
The solution is incompatible with silver, mercury, and lead salts.
Sodium chloride should not be used to dilute vincristine, etoposide, or mannitol solutions due to the possibility of precipitate formation.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
There are no contraindications to the use of isotonic sodium chloride solution during pregnancy and breastfeeding.

Driving and using machines

The medicine does not affect the ability to drive and use machines.

3. How to use Injectio Natrii Chlorati Isotonica Polpharma

The medicine should only be administered by qualified medical personnel.

Use in children and adults

Injectio Natrii Chlorati Isotonica Polpharma should be used according to the recommendations given in the leaflet of the medicine to be diluted or dissolved.
The medicine does not contain preservatives and can therefore be used to prepare medicines for administration into the epidural or subarachnoid space.

Using more than the recommended dose of Injectio Natrii Chlorati Isotonica Polpharma

Inappropriate and excessive intravenous administration of physiological saline (e.g., after surgery, 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).
Side effects related to 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, convulsions, coma, and death.
In case of the above symptoms, the doctor or nurse should be informed.
The doctor will decide on the use of symptomatic treatment.
In case of any further doubts related to the use of this medicine, consult a doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Local reactions from the vessels are pain and redness, if the solution is administered too quickly or not sufficiently diluted.

Reporting side effects

If any side effects occur, including any possible side effects not listed in this leaflet, the doctor or pharmacist should be consulted. 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
Phone: +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 to gather more information on the safety of the medicine.

5. How to store Injectio Natrii Chlorati Isotonica Polpharma

Store the medicine out of sight and reach of children.
Do not store above 25°C. Protect the medicine in polyethylene ampoules from the effects of steam and chemically active gases or those with a strong odor.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Injectio Natrii Chlorati Isotonica Polpharma contains

• The active substance of the medicine is sodium chloride. Each ml of solution contains 9 mg of sodium chloride (Sodium chloride). One 5 ml ampoule contains 45 mg of sodium chloride (Sodium chloride). One 10 ml ampoule contains 90 mg of sodium chloride (Sodium chloride).
• The other ingredient of the medicine is water for injections.

Ion content:
Na: 154 mmol/l, Cl: 154 mmol/l.
pH of the solution: 5.5-7.5.

What Injectio Natrii Chlorati Isotonica Polpharma looks like and contents of the pack

The pack contains:
50 glass ampoules of 5 ml,
10 or 50 glass ampoules of 10 ml,
100 polyethylene ampoules of 5 ml,
100 polyethylene ampoules of 10 ml.

Marketing authorization holder and manufacturer

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

Date of last revision of the leaflet: