KOCHSALZLÖSUNG

Saline solution 0.9% Miniplasco connect

Important notes (mandatory information)

Isotonic sodium chloride solution 0.9% Braun injection solution. Areas of application: for dissolving or diluting medicines that you receive as an injection (syringe).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Isotonic sodium chloride solution 0.9% Braun injection solution
Active ingredient: sodium chloride

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

• Keep the package leaflet. You may need to read it again later.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others.
• If you notice any side effects, please inform your doctor or pharmacist.

This package leaflet contains

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

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

Isotonic sodium chloride solution 0.9% Braun is a saline solution for dissolving or diluting medicines that you receive as an injection (syringe). The finished solutions are administered to you by a doctor or medical professional.

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

Conditions or illnesses for which you should not receive isotonic sodium chloride solution 0.9% Braun under any circumstances are not known. Special care should be taken when using isotonic sodium chloride solution 0.9% Braun if you have elevated blood levels of sodium and/or chloride.

When taking/using isotonic sodium chloride solution 0.9%

Braun with other medicines

Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if they are non-prescription medicines. However, interactions of other medicines with isotonic sodium chloride solution 0.9% Braun are not known.

Pregnancy and breast-feeding

Please inform your doctor before treatment with isotonic sodium chloride solution 0.9% Braun about a possible pregnancy or if you are breast-feeding. However, no specific risks are known for the use of isotonic sodium chloride solution 0.9% Braun during pregnancy and breast-feeding.

Driving and operating machinery

This medicine has no influence on the ability to drive and operate machinery.

3. HOW IS ISOTONIC SODIUM CHLORIDE SOLUTION 0.9% BRAUN USED?

This medicine will be used on you by a doctor or medical professional. The amount you receive depends on how much of the solution is needed to prepare the finished preparation. You will receive the finished solution as an injection (as a syringe) either into a vein or under the skin, according to the instructions for use for the finished preparation.

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

Braun than you should

Overdoses of sodium chloride (table salt) can lead to excessive salt concentration in the blood or excessive blood levels of sodium and chloride, resulting in tissue swelling due to water retention (edema) and acidosis of the blood. Should this occur, administration of the solution will be stopped immediately. The doctor will decide on any further necessary treatment measures.

If you have any further questions about the use of the medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, isotonic sodium chloride solution 0.9% Braun can have side effects, although not everybody gets them. However, when isotonic sodium chloride solution 0.9% Braun is used according to the instructions, side effects are not to be expected.

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 to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

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

Keep medicines out of the reach of children. Do not use the medicine after the expiry date which is stated on the carton and the container after "Use by" or "Exp" or "EXP". The expiry date refers to the last day of the month. Storage conditions: No special storage conditions are required for this medicine. Do not use isotonic sodium chloride solution 0.9% Braun if you notice the following: cloudiness or particles in the solution, damage to the container.

6. FURTHER INFORMATION

What isotonic sodium chloride solution 0.9%

Braun contains

The active ingredient is sodium chloride (table salt). 100 ml of the injection solution contains 0.9 g of sodium chloride. The other ingredient is water for injections. Electrolyte concentrations: Na+ 154 mmol/l, Cl- 154 mmol/l. Theor. Osmolarity: 308 mOsm/l. Titration acidity (pH 7.4): < 0.3 mmol/l. pH value: 4.5 - 7.0.

What isotonic sodium chloride solution 0.9%

Braun looks like and contents of the pack

Isotonic sodium chloride solution 0.9% Braun is an injection solution, i.e. a solution for administration by syringe.
It is available in:

• Ampoules made of colourless glass, contents: 2 ml, 5 ml, 10 ml, pack sizes: 10 × 2 ml, 10 × 5 ml, 10 × 10 ml.
• Ampoules made of polyethylene, contents: 5 ml, 10 ml, 20 ml, pack sizes: 10 × 5 ml, 20 x 5 ml, 10 × 10 ml, 20 × 10 ml, 100 x 10 ml, 10 × 20 ml, 20 × 20 ml, 100 x 20 ml.
• Ampoules made of polypropylene, contents: 10 ml, 20 ml, pack sizes: 10 x 10 ml, 20 x 10 ml, 100 x 10 ml, 10 x 10 ml, 20x 10 ml, 100 x 20 ml.
• Vials made of colourless glass, contents: 50 ml, 100 ml, pack sizes: 1 × 50 ml, 20 × 50 ml, 1 × 100 ml, 20 × 100 ml.

Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

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

Postal address

34209 Melsungen
Tel.: 05661-71-0
Fax: 05661-71-4567

Manufacturer

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

or

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

or

hameln pharmaceuticals gmbh
Langes Feld 13
31789 Hameln
Germany

or

Industria Farmaceutica Galenica Senese S.r.l.
Via Cassia Nord, 351
53014 Monteroni d'Arbia (Siena), Italy

This package leaflet was last revised in July 2014.

Source: Information from the package leaflet
Status: 01/2018
Areas of application: for dissolving or diluting medicines that you receive as an injection (syringe).