0,9% Sodium Hloride-braun

Leaflet attached to the packaging: information for the user

0.9% Sodium Chloride–Braun, 9 mg/ml, solution for infusion
Sodium chloride

You should 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.
• -You should consult a doctor, pharmacist, or nurse if you have any further doubts.
• -This medicine has been prescribed specifically for you. Do not pass it on to others.
• -The medicine may harm another person, even if their illness symptoms are the same.
• -If any of the side effects worsen or if any side effects not mentioned in the leaflet occur, you should tell your doctor, nurse, or pharmacist.

Table of contents of the leaflet:

• 1. What is 0.9% Sodium Chloride–Braun and what is it used for
• 2. Important information before using 0.9% Sodium Chloride–Braun
• 3. How to use 0.9% Sodium Chloride–Braun
• 4. Possible side effects
• 5. How to store 0.9% Sodium Chloride–Braun
• 6. Contents of the packaging and other information

1. What is 0.9% Sodium Chloride–Braun and what is it used for

0.9% Sodium Chloride–Braun is a sodium chloride solution administered intravenously through an infusion set.
The concentration of sodium chloride in the solution is similar to the concentration of salt in the human body.
This medicinal product is indicated in the following cases:

• replenishing fluids and electrolytes in hypochloremic alkalosis;
• chloride deficiency;
• short-term replenishment of intravascular volume;
• hypotonic or isotonic dehydration;
• solution for dissolving concentrated electrolytes and drugs that are not pharmacologically incompatible;
• externally for wound irrigation and moistening of dressings and tampons on wounds.

The solution is also used as a solvent for other electrolytes or medicinal products.
This product may also be used for wound irrigation and moistening of dressings and tampons on wounds.

2. Important information before using 0.9% Sodium Chloride–Braun

When not to use 0.9% Sodium Chloride–Braun:

• in case of excessive fluid content in the body (overhydration),
• in case of severe hypernatremia,
• in case of severe hyperchloremia.

Warnings and precautions

Particular caution should be exercised when using 0.9% Sodium Chloride–Braun in the following cases:

• low serum potassium levels (hypokalemia),
• high serum sodium levels (hyponatremia),
• high serum chloride levels (hyperchloremia),
• heart disease,
• severe kidney disease;
• pulmonary edema caused by excessive water in tissues (generalized edema);
• pulmonary disease or fluid accumulation in the lungs (pulmonary edema);
• high blood pressure (hypertension);
• pre-eclampsia, a condition that occurs during pregnancy, associated with high blood pressure, convulsions, and edema (edema).

To prevent the occurrence of osmotic demyelination syndrome, the sodium concentration in the serum should not exceed 9 mmol/l/day. In most cases, taking into account the patient's condition and co-existing risk factors, it is justified to correct the rate by 4 to 6 mmol/l/day.
Clinical monitoring should include serum electrolyte levels and overall assessment of fluid and acid-base balance.
In situations where rapid infusion of 0.9% Sodium Chloride–Braun is required, the cardiovascular and respiratory systems should be monitored.
Note: When this product is used as a solvent for another drug, the safety information provided by the manufacturer of the added drug should be followed.
Children
Since the kidneys of premature infants and newborns are not fully developed, these patients may experience excessive sodium retention. Therefore, before re-infusing sodium chloride in premature infants and newborns, the sodium chloride concentration in the patient's body should be determined

0.9% Sodium Chloride–Braun and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Sodium-retaining medicines
Concomitant use of sodium-retaining medicines (such as corticosteroids and non-steroidal anti-inflammatory drugs) may lead to edema

0.9% Sodium Chloride–Braun with food and drink

Not applicable

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
There are limited or no data on the use of 0.9% Sodium Chloride-Braun in pregnant women. These data do not indicate direct or indirect harmful effects of the 0.9% sodium chloride solution on reproduction.
Since the sodium and chloride concentrations are similar to those naturally occurring in the human body, no harmful effects are expected, provided that the medicine is used as indicated.
Therefore, 0.9% Sodium Chloride-Braun can be used as indicated.
However, caution should be exercised in cases of specific disorders during pregnancy (pre-eclampsia), characterized by high blood pressure, convulsions, and edema.
Breastfeeding
Since the sodium and chloride concentrations are similar to those naturally occurring in the human body, no harmful effects are expected, provided that the medicine is used as indicated
0.9% Sodium Chloride-Braun can be used during breastfeeding.
Fertility
No data available

Driving and using machines

0.9% Sodium Chloride-Braun has no or negligible influence on the ability to drive and use machines.

3. How to use 0.9% Sodium Chloride–Braun

This medicine is administered intravenously through a cannula or used externally for irrigation or moistening.
Dosing
The dose is determined based on the current need for water and electrolytes.
Maximum daily dose
The maximum dose for an adult is 40 ml/kg body weight per day. This is equivalent to 6 mmol of sodium per kg body weight per day.
Any other losses (e.g., due to fever, diarrhea, vomiting, etc.) should be replenished according to the volume and composition of the lost fluids.
In the case of acute fluid deficiency treatment, e.g., in the event of hypovolemic shock, higher doses can be used, administered, e.g., by pressure infusion.
Infusion rate
The infusion rate depends on the patient's health condition.
Elderly patients
Usually, the same dosing regimen is used as for adult patients. However, caution should be exercised when administering this medicinal product to patients with conditions such as heart or kidney failure, which are common in the elderly.

Use in children

The dose is determined individually based on the need for water and electrolytes, as well as the patient's age, weight, and clinical condition.
In the case of severe dehydration, it is recommended to administer a bolus of 20 ml/kg body weight in the first hour of treatment.
When administering this medicine, the total daily amount of fluids taken should be considered.
Solvent
When using 0.9% Sodium Chloride–Braun as a solvent, the dosing and infusion rate should be primarily adjusted to the dosing regimen of the added medicine.
Wound irrigation
The amount of solution used for wound irrigation or moistening depends on the actual need.
Method of administration
Intravenous infusion or irrigation and moistening.
In the case of pressure infusion, which may be necessary in emergency situations, it is essential to completely remove air from the container and infusion set before starting the administration of the solution.

Use of a higher than recommended dose of 0.9% Sodium Chloride–Braun

In the event of an overdose, the following may occur: hypernatremia, hyperchloremia, overhydration, acute fluid overload, edema, hyperosmolarity of serum, and metabolic acidosis.
Sudden increase in serum sodium levels in patients with chronic hypernatremia may lead to the development of osmotic demyelination syndrome.
The first symptoms of overdose may be thirst, confusion, sweating, headache, weakness, drowsiness, or tachycardia. In the case of severe hypernatremia, hypertension or hypotension, respiratory disorders, or coma may occur.
Depending on the severity of the disorder, it may be necessary to immediately stop the administration of the medicine.
Additionally, diuretics (diuretic drugs) can be administered. Serum electrolyte levels should be constantly monitored. The attending physician will decide on the administration of additional medicines or other measures to stabilize electrolyte levels, fluid balance, and acid-base balance.
In case of any further doubts regarding the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are not expected to occur when the medicine is used as recommended.

Reporting side effects

If you experience any side effects, including those not mentioned in the leaflet, you should tell your doctor, pharmacist, 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:
Aleje Jerozolimskie 181C
02-222 Warsaw
tel.: 22 49-21-301
fax: 22 49-21-309
website: https://smz.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 0.9% Sodium Chloride–Braun

The medicine should be stored in a place inaccessible and invisible to children.
The medicine should not be used after the expiry date stated on the packaging.
The medicine should not be used if it is cloudy or contains visible impurities or if the packaging is damaged.
After first opening:
From a microbiological point of view, the product should be used immediately after opening. Otherwise, the preparation can be stored for a maximum of 24 hours at a temperature between 2 and 8°C.

6. Contents of the packaging and other information

What 0.9% Sodium Chloride–Braun contains

1 ml of the solution contains 9 mg of sodium chloride and water for injection.

• The active substance is sodium chloride
• The other ingredient is water for injection

What 0.9% Sodium Chloride–Braun looks like and what the packaging contains

Clear, colorless aqueous solution
Theoretical osmolality:
308 mOsm/l
Acidity
<0,3 mmol/l
pH:
4.5 – 7.0
The packaging contains:
Glass bottles with rubber stoppers, with a capacity of: 100 ml, 500 ml, 1000 ml
available in collective packaging
10 x 100 ml
10 x 500 ml
6 x 1000 ml
Polyethylene containers (Ecoflac plus), with a capacity of: 100 ml, 250 ml, 500 ml, 1000 ml
available in collective packaging
20 x 100 ml
10 x 250 ml
10 x 500 ml
10 x 1000 ml

Marketing authorization holder

Manufacturer

• B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany B.Braun Medical SA Carretera de Terrassa, 121 08191 Rubi (Barcelona) Spain
• B. Braun Avitum AG Schwarzenberger Weg 73-79 34212 Melsungen Germany

Date of last update of the leaflet: 2023-04-12