KOCHSALZLÖSUNG

KOCHSALZLÖSUNG 0,9% Glasfl.

Important notes (mandatory information)

Isotonic sodium chloride solution 0.9% Braun injection solution. Areas of application: for replacing fluids and salt in the event of fluid deficiency (isotonic dehydration) or simultaneous sodium and fluid deficiency (hypotonic dehydration); increased pH value and simultaneously reduced chloride level (hypochloraemic alkalosis) and in the event of chloride loss. It is also used: for short-term replenishment of the vascular system (intravascular volume replacement); as a carrier solution for electrolyte concentrates and compatible medications and for wound treatment and for moistening cloths and dressings.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Isotonic saline solution 0.9% Braun infusion solution
Active ingredient: sodium chloride

Read the entire package leaflet carefully before you start using this medicine.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice
• If any of the listed side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

This package leaflet contains

1. WHAT IS ISOTONIC SALINE SOLUTION 0.9% BRAUN AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO CONSIDER BEFORE USING ISOTONIC SALINE SOLUTION 0.9% BRAUN?
3. HOW IS ISOTONIC SALINE SOLUTION 0.9% BRAUN USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD ISOTONIC SALINE SOLUTION 0.9% BRAUN BE STORED?
6. FURTHER INFORMATION

1. WHAT IS ISOTONIC SALINE SOLUTION 0.9% BRAUN AND WHAT IS IT USED FOR?

Isotonic saline solution 0.9% Braun is a saline solution that is administered to you via a venous drip. The solution contains sodium chloride in a concentration that corresponds to the salt concentration in the blood.

It is used to replace fluids and salt in the event of:

• Fluid deficiency (isotonic dehydration) or simultaneous sodium and fluid deficiency (hypotonic dehydration),
• increased pH value and simultaneously reduced chloride level (hypochloraemic alkalosis) and in the event of chloride loss.

It is also used:

• for short-term replenishment of the vascular system (intravascular volume replacement),
• as a carrier solution for electrolyte concentrates and compatible medications and
• for wound treatment and for moistening cloths and dressings.

2. WHAT DO YOU NEED TO CONSIDER BEFORE USING ISOTONIC SALINE SOLUTION 0.9% BRAUN?

Isotonic saline solution 0.9% Braun must not be used if you suffer from overhydration.

Special care must be taken when using isotonic saline solution 0.9% Braun in the event of:

• reduced potassium level in the blood (hypokalaemia)
• increased sodium level in the blood (hypernatraemia)
• increased chloride level in the blood (hyperchloraemia)
• diseases that require a restrictive sodium intake, such as heart failure (cardiac insufficiency), fluid retention in the tissue (generalised oedema), fluid retention in the lungs (pulmonary oedema), high blood pressure (hypertension), pregnancy-related

If you suffer from water deficiency and simultaneously a high salt content in the blood (hypertonic dehydration), the solution must be infused very slowly in order to avoid a further increase in the salt content and in particular the sodium level. During the infusion, your water balance, acid-base balance and serum electrolyte levels will be monitored.

When using isotonic saline solution 0.9%

Braun with other medicines

Please tell your doctor or pharmacist if you are taking or using, or have recently taken or used other medicines, even if they are non-prescription medicines.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. Isotonic saline solution 0.9% Braun should be used with caution in the event of pregnancy-related conditions with high blood pressure, cramps and fluid retention in the tissue (eclampsia).

3. HOW IS ISOTONIC SALINE SOLUTION 0.9% BRAUN USED?

For intravenous use or for rinsing and moistening.

Dosage

The amount of solution that you receive depends on the fluid and electrolyte requirement.

Maximum dose

The maximum is 40 ml per kg body weight and day; this corresponds to 6 mmol sodium per kg body weight and day. The solution is usually administered to you at up to 5 ml per kg body weight and hour. This corresponds to approx. 1.7 drops per kg body weight and minute. In exceptional cases, e.g. after major blood loss, the solution can also be administered to you at a considerably higher speed, as a pressure infusion. In this case, it is carefully ensured that all air is removed from the container and tube before the start of the infusion in order to eliminate the risk of an air embolism. The amount required for wound treatment or moistening depends on the specific requirement.

If you have received a larger amount of isotonic saline solution 0.9%

Braun than you should have (overdose)

An overdose can lead to an increased sodium and chloride level in the blood (hypernatraemia, hyperchloraemia), overhydration and increased acidity of the blood (acidosis). In such a case, the infusion is stopped immediately and you may be given a diuretic, whereby your serum electrolyte levels are constantly monitored. Your doctor will decide on the administration of further medications or other measures to normalise your serum electrolyte levels, water balance and acid-base balance.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, isotonic saline solution 0.9% Braun can have side effects, although not everybody gets them. The following side effects are possible: When used, it can lead to an increased sodium and chloride level in the blood (hypernatraemia and hyperchloraemia).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly via Federal Institute for Drugs and Medical Devices Dept. of Pharmacovigilance Kurt-Georg-Kiesinger Allee 3 D-53175 Bonn Website: http://www.bfarm.de by reporting side effects, you can help to ensure that more information on the safety of this medicine is available.

5. HOW SHOULD ISOTONIC SALINE SOLUTION 0.9% BRAUN BE STORED?

Keep out of the reach of children. No special storage conditions are required for this medicine. Do not use the medicine after the expiry date which is stated on the container and the outer carton. The expiry date refers to the last day of the month. Do not use isotonic saline solution 0.9% Braun if you notice the following: clouding of the solution, suspended particles in the solution, damage to the container or closure. After first opening: From a microbiological point of view, the preparation should be used immediately. If it is not used immediately, the storage times and conditions between first opening and use are the responsibility of the user and should not normally exceed 24 hours at 2 to 8 °C. Any unused infusion solution after use should be discarded.

6. FURTHER INFORMATION

What isotonic saline solution 0.9%

Braun contains

The active ingredient is sodium chloride. 1000 ml of infusion solution contain 9.0 g of sodium chloride. The other ingredient is water for injections. Electrolytes: sodium ion 154 mmol/l, chloride ion 154 mmol/l.

What isotonic saline solution 0.9%

Braun looks like and contents of the pack

Isotonic saline solution 0.9% Braun is an infusion solution (solution for administration as a venous drip). It is a clear, colourless, aqueous solution. Theoretical osmolarity 308 mOsm/l, titration acidity (pH 7.4) < 0.3 mmol/l, pH value 4.5 - 7.0. Isotonic saline solution 0.9% Braun is available in: Glass bottles: 1 x 100 ml, 10 x 100 ml, 20 x 100 ml, 1 x 250 ml, 10 x 250 ml, 1 x 500 ml, 10 x 500 ml, 1 x 1000 ml, 6 x 1000 ml. Plastic bottles: 1 x 50 ml, 20 x 50 ml, 1 x 100 ml, 10 x 100 ml, 20 x 100 ml, 1 x 250 ml, 10 x 250 ml, 1 x 500 ml, 10 x 500 ml, 1 x 1000 ml, 10 x 1000 ml. Plastic bags: 1 x 100 ml, 20 x 100 ml, 1 x 250 ml, 20 x 250 ml, 1 x 500 ml, 20 x 500 ml, 1 x 1000 ml, 10 x 1000 ml 1 x 3000 ml, 4 x 3000 ml as well as a set consisting of 1 x 500 ml plastic bottle, infusion device and venipuncture set.

Pharmaceutical entrepreneur

B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen

Postal address

B. Braun Melsungen AG
34209 Melsungen
Tel.: 05661/71-0
Fax: 05661/71-4567

Manufacturer

B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen

or

B. Braun Medical S. A.
Carretera de Terrassa 121
08191 Rubí (Barcelona), Spain

or

B. Braun Pharmaceuticals S.A.
Louis Pasteur Street no. 2,
300264 Timisoara, Romania

This package leaflet was last revised in June 2014.

Source: Information from the package leaflet
Status: 06/2016
Areas of application: for replacing fluids and salt in the event of fluid deficiency (isotonic dehydration) or simultaneous sodium and fluid deficiency (hypotonic dehydration); increased pH value and simultaneously reduced chloride level (hypochloraemic alkalosis) and in the event of chloride loss. It is also used: for short-term replenishment of the vascular system (intravascular volume replacement); as a carrier solution for electrolyte concentrates and compatible medications and for wound treatment and for moistening cloths and dressings.