Injection sodium chlorate isotonic polpharma

Package leaflet: Information for the user

Injectio Natrii chlorati isotonica Polpharma, 9 mg/ml,
solvent for the preparation of parenteral medicines
Natrii chloridum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any not listed in this leaflet, inform your doctor or nurse. See section 4.

Leaflet contents

1. What Injectio Natrii chlorati isotonica Polpharma is and what it is 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 Injectio Natrii chlorati isotonica Polpharma is and what it is used for

Injectio Natrii chlorati isotonica Polpharma is a sterile solution used as a solvent or carrier for parenteral medicines, including: intravenous, intramuscular, subcutaneous, epidural, intrathecal, and intra-arterial administration.

2. Important information before using Injectio Natrii chlorati isotonica Polpharma

When not to use Injectio Natrii chlorati isotonica Polpharma
Due to the nature of its indications, contraindications depend on the medicine to be diluted or dissolved.
This medicine should not be used to dissolve silver, mercury, or lead salts.

Warnings and precautions
Before using Injectio Natrii chlorati isotonica Polpharma, discuss it with your doctor or nurse.
For subcutaneous injections, note that medicines added to isotonic sodium chloride solution may change the isotonic solution into a hypertonic one, 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 or if the solution is not clear.
Exercise caution when administering sodium chloride to patients with uncompensated heart failure, liver cirrhosis, pre-eclampsia, peripheral or pulmonary edema, or impaired kidney function.
When measuring serum sodium levels, falsely low results may occur in patients with hyperlipidemia (elevated LDL cholesterol and triglycerides), hyperproteinemia (increased blood protein levels), or in patients with diabetes.

Children
In newborns, elevated sodium levels may occur due to immature kidney function. Therefore, repeated sodium chloride injections should be performed only after measuring serum sodium levels.

Injectio Natrii chlorati isotonica Polpharma and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
The solution is compatible with many different medicines. If in doubt about the physicochemical compatibility of a preparation with normal saline, perform a compatibility test 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 risk of precipitate formation.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
There are no contraindications to the use of isotonic sodium chloride solution during pregnancy or breastfeeding.

Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

3. How to use the medicine Injectio Natrii chlorati isotonica Polpharma

The medicine should be administered only by qualified medical personnel.
Use in children and adults
Injectio Natrii chlorati isotonica Polpharma should be used according to the recommendations provided in the leaflet of the medicine which is to be diluted or dissolved.
The medicine does not contain preservatives and therefore may be used for the preparation of medicines administered into the intrathecal or subarachnoid space.
Administration of a higher than recommended dose of Injectio Natrii chlorati isotonica Polpharma
Inappropriate and excessive intravenous administration of physiological saline (e.g. after procedures, in patients with impaired heart or kidney function, etc.) may lead to increased sodium concentration in the blood, resulting in dehydration of internal organs (e.g. brain – which may lead to thrombosis and haemorrhage).
Adverse effects associated with excess sodium chloride include: nausea, vomiting, diarrhoea, abdominal cramps, excessive thirst, decreased salivation and lacrimation, sweating, fever, tachycardia, renal failure, peripheral and pulmonary oedema, respiratory arrest, headache, dizziness, restlessness, irritability, weakness, tremor and muscle rigidity, convulsions, coma and death.
If any of the above symptoms occur, inform the doctor or nurse immediately.
The doctor will decide on implementing symptomatic treatment.
If you have any further doubts regarding the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Local vascular reactions include pain and redness, especially if the solution is administered too quickly or is insufficiently diluted.
Reporting of adverse reactions
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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: https://smz.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 the medicinal product Injectio Natrii chlorati isotonica Polpharma

Keep the medicinal product out of the sight and reach of children.
Do not store above 25°C. Protect the solution in polyethylene ampoules from exposure to vapours and chemically active gases or gases with strong odours.
Do not use this medicinal product after the expiry date stated on the packaging. 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 following the abbreviation Lot indicates the batch number.
Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What the medicinal product contains Injectio Natrii Chlorati Isotonica Polpharma

• The active substance is sodium chloride. Each ml of solution contains 9 mg of sodium chloride ( Natrii chloridum ). A 5 ml ampoule contains 45 mg of sodium chloride ( Natrii chloridum ). A 10 ml ampoule contains 90 mg of sodium chloride ( Natrii chloridum ).
• The other ingredient 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 with a capacity of 5 ml,
10 or 50 glass ampoules with a capacity of 10 ml,
100 polyethylene ampoules with a capacity of 5 ml,
100 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