Sodium chloride aptapharma

Package leaflet: Information for the user

Sodium Chloride AptaPharma, 9 mg/mL, infusion solution
Natrii chloridum
Please read all of this leaflet carefully before the medicine is administered, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or nurse.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor or nurse. See section 4.

Table of contents :

1. What Sodium Chloride AptaPharma is and what it is used for
2. Important information before using Sodium Chloride AptaPharma
3. How to use Sodium Chloride AptaPharma
4. Possible side effects
5. How to store Sodium Chloride AptaPharma
6. Contents of the pack and other information

1. What Sodium Chloride AptaPharma is and what it is used for

Sodium Chloride AptaPharma is a solution of sodium chloride in water. Sodium chloride is
a chemical substance (commonly known as "salt") which is a component of blood. This medicine contains sodium
chloride at a concentration similar to the salt concentration in human blood. It is intended for intravenous
administration via an infusion set.
Sodium Chloride AptaPharma helps to replace losses of salt and fluids that may occur in the body and to maintain proper fluid balance inside cells and tissues as well as in the extracellular fluid.
The Sodium Chloride AptaPharma solution is used in the treatment of:

• loss of water from the body (dehydration)
• loss of sodium from the body (excessive sodium loss from the body).

Loss of sodium chloride and water may occur if the patient has:

• inability to eat or drink due to illness or surgical procedure
• excessive sweating caused by fever (e.g. due to infection)
• extensive skin loss, which may occur as a result of severe burns.

Sodium Chloride AptaPharma may also be used for delivering or dissolving other infusion medicines.
Sodium Chloride AptaPharma can be used in adults, children and adolescents.

2. Important information before using Sodium Chloride AptaPharma

Do NOT use Sodium Chloride AptaPharma, 9 mg/mL infusion solution, if the
patient has any of the following conditions:

• excessive fluid content in the body (fluid overload)
• elevated blood chloride levels compared to normal (hyperchloremia)
• elevated blood sodium levels compared to normal (hypernatremia)

If another medicine has been added to Sodium Chloride AptaPharma, it is necessary to read
the package leaflet of the added medicine to assess whether the solution can be administered to
the patient.
Warnings and precautions
The patient should inform the doctor if they currently have or have ever had any of the
following conditions:

• any type of heart disease or impaired heart function
• impaired kidney function or liver disease (e.g. cirrhosis)
• blood acidification (acidosis)
• higher than normal blood volume in blood vessels (hypervolemia)
• high blood pressure (hypertension)
• fluid accumulation under the skin, especially around the ankles (peripheral edema)
• fluid accumulation in the lungs (pulmonary edema)
• high blood pressure during pregnancy (pre-eclampsia – a condition that may occur during pregnancy, characterized by edema, proteinuria, and convulsions)
• increased production of the hormone called aldosterone (aldosteronism)
• any other conditions associated with sodium retention in the body (hypernatraemia – a condition in which the body retains excessive amounts of sodium), such as treatment with corticosteroids or steroids (see also section “Sodium Chloride AptaPharma and other medicines”)

Talk to a doctor or nurse before administering this medicine if the patient has a condition that may cause high levels of vasopressin, a hormone regulating fluid balance in the body. Excessively high vasopressin levels in the body may be caused, for example, by:

• acute and serious illness;
• pain;
• surgery;
• infection, burns, or brain disease;
• diseases affecting the heart, liver, kidneys, or central nervous system;
• taking certain medicines (see also section “Sodium Chloride AptaPharma and other medicines”). This may increase the risk of low blood sodium levels (hyponatremia) and may cause headache, nausea, seizures, drowsiness, coma, brain edema, and death. Brain edema increases the risk of brain damage and death. Patients at higher risk of brain edema include:
• children
• women (especially of childbearing age)
• patients with problems related to cerebrospinal fluid levels, for example due to meningitis, intracranial hemorrhage, or brain injury.

During infusion of the solution, the doctor will take blood and urine samples to monitor:

• fluid levels in the body
• vital signs
• levels of chemical substances such as sodium and potassium in the blood (serum electrolytes). This is particularly important in children and newborns (preterm infants), as they may retain excessive amounts of sodium due to immature kidney function.

When rapid infusion of Sodium Chloride AptaPharma is required, cardiovascular and respiratory function should be closely monitored.
To prevent brain damage (osmotic demyelination syndrome), the doctor will ensure that blood sodium concentration does not rise too rapidly.
If Sodium Chloride AptaPharma is used as a solvent to prepare solutions for administration of other electrolytes or medicines, follow the safety information provided by the manufacturer of the medicine to be added.
Children
Because the kidneys of preterm infants and infants are not fully developed, these patients may retain excessive amounts of sodium. Therefore, serum sodium concentration should be determined before re-administering sodium chloride to preterm infants and infants.
Sodium Chloride AptaPharma and other medicines
Tell your doctor or nurse about all medicines the patient is currently taking, has recently taken, or plans to take.
It is especially important to inform the doctor about the use of:

• corticosteroids (anti-inflammatory medicines), corticosteroids, or carbenoxolone (used in the treatment of gastrointestinal ulcers), or salt-retaining medicines such as NSAIDs. These medicines may cause retention of sodium and water in the body, leading to tissue swelling due to fluid accumulation under the skin (edema) and high blood pressure (hypertension).
• lithium (used in the treatment of psychiatric disorders)
• certain medicines that may affect the level of the hormone vasopressin, which may lead to reduced serum sodium concentration (hyponatremia). These include:
• antidiabetic medicines (chlorpropamide)
• cholesterol-lowering medicines (clofibrate)
• certain anticancer medicines (vincristine, ifosfamide, cyclophosphamide)
• selective serotonin reuptake inhibitors (used in the treatment of depression)
• antipsychotic medicines (used in the treatment of psychiatric disorders)
• opioids used to relieve severe pain (narcotics) or the illicit substance – methamphetamine (known as ecstasy)
• painkillers and/or anti-inflammatory medicines (also known as NSAIDs)
• medicines that mimic or enhance the action of vasopressin, such as desmopressin (used to treat excessive thirst and urine output), terlipressin (used to treat esophageal bleeding), and oxytocin (used to induce labor)
• antiepileptic medicines (carbamazepine and oxcarbazepine)
• diuretics (water pills).

Note: When this medicine is used as a solvent for another medicine, follow the safety information provided by the manufacturer of the medicine to be added.
Potential interactions are described in the leaflet of the added medicine.
Sodium Chloride AptaPharma with food and drink
Ask the doctor what the patient may eat or drink.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Sodium Chloride AptaPharma may be administered to pregnant patients as indicated.
Caution should be exercised if specific disorders occur during pregnancy (called pre-eclampsia), characterized by high blood pressure, convulsions, and edema. Caution should also be exercised in patients who are to receive oxytocin during labor.
Breastfeeding
Since the concentrations of sodium and chloride in the medicine are similar to those naturally present in the human body, harmful effects of the medicine are not expected, provided it is used as indicated. Sodium Chloride AptaPharma may be used during breastfeeding if required.
Before adding any medicine to the Sodium Chloride AptaPharma solution used during
pregnancy or breastfeeding, the following should be done:

• consult a doctor
• read the leaflet included in the package of the medicine to be added.

Driving and operating machinery
Sodium Chloride AptaPharma has no or negligible effect on the ability to drive and operate machinery.

3. How to use Sodium Chloride AptaPharma

Sodium Chloride AptaPharma is administered by a doctor or nurse intravenously. The dose and duration of administration are determined by the doctor and depend on the patient's age, body weight, condition, reason for treatment, and whether the infusion is used to deliver or dilute another medicine or not.
Other medicines the patient is taking may also influence the dose.

Recommended dosing in conditions of water loss from the body (dehydration) and sodium loss:

• Adults: the usual dose is 500 mL to 3000 mL per day. The maximum dose for an adult is 40 mL per kg of body weight per day. Elderly patients should be monitored particularly closely.
• Children and adolescents: the usual dose is 20 mL to 100 mL per kg of body weight per day. The doctor will determine the dose individually for each pediatric patient.

If rapid replacement of sudden blood volume loss is required, higher doses may be used, for example administered under pressure in an infusion. In such cases, particular care must be taken to ensure that all air is removed from the bag and the entire infusion system.
Sodium Chloride AptaPharma 9 mg/mL infusion solution is usually administered through a plastic tube connected to a needle placed in a vein. Typically, the solution is infused into a vein in the arm; however, the doctor may choose another route of administration for the patient.

Before and during the infusion, the doctor will monitor:

• fluid levels in the body
• blood and urine acidity
• electrolyte concentrations in the body (especially sodium), particularly in patients with high levels of vasopressin hormone or those taking other medicines that enhance the effect of vasopressin.

Solvent use
When Sodium Chloride AptaPharma is used as a solvent, the dosing and infusion rate should primarily follow the dosing regimen of the added medicine.

Use of a higher than recommended dose of Sodium Chloride AptaPharma
If the patient suspects they may have received too high a dose of Sodium Chloride AptaPharma, they should immediately inform the doctor, nurse, or other medical personnel.
Overdose may lead to overhydration, elevated blood levels of sodium and chloride, edema, and/or increased levels of acidic substances in the blood (blood becomes acidic).
Early signs of overdose may include thirst, restlessness, sweating, fever, headache, dizziness, weakness, or tachycardia. A rapid increase in serum sodium concentration may lead to brain damage (onset of osmotic demyelination syndrome).
If another medicine has been added to the Sodium Chloride AptaPharma infusion solution, it may also cause symptoms. Please read the package leaflet of the added medicine to become familiar with possible adverse effects.

Missed dose of Sodium Chloride AptaPharma
If the patient suspects they may have missed a dose of Sodium Chloride AptaPharma, they should immediately inform the doctor, nurse, or other medical personnel.

Discontinuation of Sodium Chloride AptaPharma
The decision to discontinue Sodium Chloride AptaPharma will be made by the doctor.

If you have any further questions about the use of this medicine, please consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The frequency of occurrence of the listed adverse reactions is unknown (frequency cannot be
determined from the available data):

• tremor
• low blood pressure
• fever, chills
• urticaria, itching (pruritus), skin rash

Adverse reactions associated with the administration of sodium chloride:

• brain damage caused by too rapid an increase in sodium concentration, leading to the development of osmotic demyelination syndrome;
• low sodium levels in the blood, which may be associated with hospital treatment (hospital-acquired hyponatremia) and related neurological disorders (acute hyponatremic encephalopathy), potentially leading to irreversible brain damage and death due to brain swelling/edema. Signs of brain edema include headache, nausea, vomiting, seizures, drowsiness, lack of energy;

Adverse reactions that may occur as a result of the administration technique used include:

• itching (urticaria), redness, pain or burning sensation at the site of administration
• infection at the site of administration
• irritation and inflammation of the vein into which the solution is administered (phlebitis). This may cause redness, pain or burning, and swelling along the vein
• formation of blood clots in veins (venous thrombosis) at the infusion site, causing pain, swelling or redness in the area of the clot
• leakage of solution into the surrounding tissue (extravasation). This may damage tissues and lead to scarring
• increased fluid volume in the blood vessels (hypervolemia)

Other adverse reactions reported with similar medicines (other sodium-containing solutions) include:

• higher than normal sodium levels in the blood (hypernatremia), leading to tissue swelling due to fluid retention under the skin (edema) and elevated blood pressure (hypertension)
• lower than normal sodium levels in the blood (hyponatremia)
• blood acidification associated with higher than normal chloride levels in the blood (hyperchloremic metabolic acidosis)

If another medicine has been added to the Sodium Chloride AptaPharma infusion solution, it may also cause adverse reactions. Please read the Package Leaflet of the added medicine to become familiar with possible adverse reactions.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or nurse. 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 responsible entity.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Sodium Chloride AptaPharma

Keep this medicine out of the sight and reach of children.
Store the medicine at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the specified month.
Do not use this medicine if it contains visible particles, or if the container is damaged in any way, or if it has been previously opened or partially used.
From a microbiological standpoint, the medicine should be used immediately after opening. If not used immediately, the user is responsible for the storage duration and conditions prior to use.
Any unused solution remaining after treatment should be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the pack and other information

What Sodium Chloride AptaPharma contains
The active substance is sodium chloride. 1 mL of solution contains 9 mg (0.9%) of sodium chloride.
The other ingredient is water for injections.
Each 100 mL bag contains 0.9 g (900 mg) of sodium chloride.
Each 250 mL bag contains 2.25 g of sodium chloride.
Each 500 mL bag contains 4.5 g of sodium chloride.
Each 1000 mL bag contains 9 g of sodium chloride.

What Sodium Chloride AptaPharma looks like and contents of the pack
Sodium Chloride AptaPharma 9 mg/mL infusion solution is a clear, colourless solution free from visible particles.
Sodium Chloride AptaPharma is available in bags made of polyolefin/styrene, equipped with two SFC (Single Function Connector) ports made of polypropylene (PP), closed with a stopper made of bromobutyl rubber and a closure made of polypropylene (PP). Each bag may be wrapped in a protective plastic overwrap (a mixture of HDPE/LDPE/PP) or not.
Sodium Chloride AptaPharma is available in packs containing 40 bags of 100 mL, 20 bags of 250 mL, 20 bags of 500 mL, or 10 bags of 1000 mL. The bags are packed in cardboard outer containers.
Two types of packaging are available: with or without protective overwrap.
Not all pack types may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Apta Medica Internacional d.o.o.
Likozarjeva ulica 6
1000 Ljubljana
Slovenia
Tel.: 00386 51 615 015
e-mail: [email protected]

Manufacturer:
Eurolife Healthcare Hungary Kft.
Táncsics Mihály út 15
2100 Gödöllő
Hungary

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

The following information is intended exclusively for physicians or medical professionals:
For complete information on dosage, warnings,
indications, interactions, management of overdose, etc., the
Product Information Leaflet must be consulted.
Administration and preparation instructions
The medicinal product is for single use only.
Use only if the solution is clear and free from visible particles, and if the container is
undamaged. Discard any damaged or partially used bags. Do not re-connect
partially used bags. Administer immediately after connecting the infusion set.
Use under aseptic conditions.
Precautions during use of plastic bags
Plastic containers must not be connected in series. Such use could result in an air embolism caused by residual air drawn from the first container before the infusion from the second container is completed. Applying additional pressure to intravenous solutions contained in flexible plastic containers to increase the flow rate may cause an air embolism if residual air has not been completely removed from the container prior to administration.
Dosage and route of administration – see section 4.2 of the Product Information Leaflet.
1. Opening
a. For bags with a protective pouch, remove the bag from the plastic protective packaging immediately before use.
b. Firmly squeeze the inner bag for 60 seconds to check for leakage. If leakage is detected, discard the bag, as the contents may no longer be sterile.
c. Check whether the solution is clear and free from insoluble particles. If the solution is not clear or contains insoluble particles, discard it.
2. Preparation for administration
a. Use sterile materials and follow aseptic techniques during preparation and administration.
b. Hang the bag on an IV stand.
c. Remove the plastic cover from the administration port located at the bottom of the bag.
d. Connect the infusion set to the SFC port.
e. After use, dispose of any unused solution and infusion set components. Do not store or re-connect partially used bags.
3. Methods of adding additional medicinal products
Additional medicinal products may be added before or during infusion via the second self-sealing port. When adding additional medicinal products, isotonicity of the solution for parenteral administration must be verified prior to use. Addition of other medicinal products must be performed under aseptic conditions.
Each bag has two identical SFC ports (Single Function Connector – single-use ports).
One is intended for connecting the infusion set, the other may be used if necessary for injecting additional medicinal products.
Note: Added medicinal products may exhibit incompatibilities. Do not store bags containing added medicinal products.
Adding medicinal products prior to administration
a. Disinfect the medication addition port.
b. Using a syringe with an appropriate 21–23 gauge needle, insert the needle into the self-sealing medication addition port and inject the medicinal product. Do not leave the needle in the port after adding the medicinal product.
c. Mix the solution thoroughly after adding the medicinal product. For highly viscous medicinal products, such as potassium chloride, gently squeeze the ports while holding the bag with ports facing upwards, and mix by shaking and squeezing the bag while turning it several times.
Adding medicinal products during administration
a. Close the roller clamp of the infusion set.
b. Disinfect the medication addition port.
c. Using a syringe with an appropriate 21–23 gauge needle, insert the needle into the self-sealing medication addition port and inject the medicinal product. Larger needles are not permitted due to the risk of leakage.
d. The needle must be inserted into the center of the rubber stopper. The angle of insertion must not exceed 30 degrees.
e. Remove the bag from the stand and (or) invert it with ports facing upwards.
f. Empty both ports by gently tapping them while holding the bag with ports facing upwards.
g. Mix the solution thoroughly after adding the medicinal product.
h. Hang the bag in the infusion position, reopen the roller clamp, and continue administration.
4. Stability during administration
After opening, the medicinal product should be used immediately.
For each added medicinal product, its chemical and physical stability in the pH range of Sodium Chloride AptaPharma must be determined prior to use.
For information on the shelf-life and storage conditions of the medicinal product to be added to Sodium Chloride AptaPharma, refer to the Product Information Leaflet and Patient Information Leaflet of the added medicinal product.
From a microbiological standpoint, the diluted medicinal product should be used immediately. If not used immediately, the user is responsible for the duration and conditions of storage.
5. Incompatibilities of added medicinal products
Before adding any additional substances or medicinal products, their solubility and stability in water within the pH range of Sodium Chloride AptaPharma must be verified.
Medicinal products known to be incompatible must not be used.
It is the physician’s responsibility to assess the compatibility of the added medicinal product with Sodium Chloride AptaPharma by checking for potential changes in color and (or) the formation of precipitate, insoluble complexes, or crystals.