SALINE SOLUTION 0.9% glass bottle

Important Information (Mandatory Information)

Isotonic Sodium Chloride Solution 0.9% Braun solution for infusion. Fields of application: for the replacement of fluids and salt in case of fluid deficiency (isotonic dehydration) or simultaneous sodium and fluid deficiency (hypotonic dehydration); increased pH value and simultaneous decreased chloride level (hypochloraemic alkalosis) and in case of chloride losses. 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 moistening of wipes and dressings.

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


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Isotonic Saline Solution 0.9% Braun solution for infusion
Active substance: Sodium chloride

Read all of this leaflet carefully before you start using this medicine.

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

This leaflet contains

1. WHAT IS ISOTONIC SALINE SOLUTION 0.9% BRAUN AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE YOU USE ISOTONIC SALINE SOLUTION 0.9% BRAUN?
3. HOW TO USE ISOTONIC SALINE SOLUTION 0.9% BRAUN?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE ISOTONIC SALINE SOLUTION 0.9% BRAUN?
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 given to you via an intravenous 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 case of:

• fluid deficiency (isotonic dehydration) or simultaneous sodium and fluid deficiency (hypotonic dehydration),
• increased pH value and simultaneous decreased chloride level (hypochloraemic alkalosis) and in case of chloride losses.

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 moistening of wipes and dressings.

2. WHAT DO YOU NEED TO KNOW BEFORE YOU USE ISOTONIC SALINE SOLUTION 0.9% BRAUN?

Isotonic Saline Solution 0.9% Braun must not be used if you suffer from overhydration.

Take special care with Isotonic Saline Solution 0.9% Braun if you have:

• decreased potassium level in the blood (hypokalaemia)
• increased sodium level in the blood (hypernatraemia)
• increased chloride level in the blood (hyperchloraemia)
• diseases that require a cautious sodium intake, such as heart failure, fluid accumulation in tissues (generalised oedema), fluid accumulation in the lungs (pulmonary oedema), high blood pressure (hypertension), pregnancy-related conditions with high blood pressure, convulsions and fluid accumulation in tissues (eclampsia), severe kidney dysfunction (renal impairment)

If you suffer from water deficiency and at the same time a high content of salts in the blood (hypertonic dehydration), the solution must be infused sufficiently slowly to avoid a further increase in the salt content and especially the sodium level. During the infusion, your fluid balance, acid-base balance and serum electrolyte levels will be monitored.

Using Isotonic Saline Solution 0.9%

Braun with other medicines

Please tell your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. In pregnancy-related conditions with high blood pressure, convulsions and fluid accumulation in tissues (eclampsia), Isotonic Saline Solution 0.9% Braun should be used with caution.

3. HOW TO USE ISOTONIC SALINE SOLUTION 0.9% BRAUN?

For intravenous use or for rinsing and moistening.

Dosage

The amount of solution you receive depends on your fluid and electrolyte requirements.

Maximum dose

The maximum dose is 40 ml per kg of body weight per day; this corresponds to 6 mmol of sodium per kg of body weight per day. The solution is usually given to you at up to 5 ml per kg of body weight per hour. This corresponds to approx. 1.7 drops per kg of body weight per minute. In exceptional cases, e.g. after major blood loss, the solution can also be given to you at a much higher rate as a pressure infusion. In this case, care is taken to ensure that all air is removed from the container and tubing before the infusion begins to eliminate the risk of air embolism. The amount required for wound treatment or moistening depends on the respective requirement.

If you have received more Isotonic Saline Solution 0.9% Braun

than you should (overdose)

An overdose can lead to increased sodium and chloride levels 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 medicine that increases urine flow (a diuretic), while your serum electrolyte levels are constantly monitored. Your doctor will decide on the administration of further medicines or other measures to normalise your serum electrolyte levels, fluid balance and acid-base balance.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, Isotonic Saline Solution 0.9% Braun can cause side effects, although not everybody gets them. The following side effects are possible: Use may lead to increased sodium and chloride levels in the blood (hypernatraemia and hyperchloraemia).

Reporting of side effects

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

5. HOW TO STORE ISOTONIC SALINE SOLUTION 0.9% BRAUN?

Keep out of the reach and sight of children. This medicine does not require any special storage conditions. 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 that month. Do not use Isotonic Saline Solution 0.9% Braun if you notice: turbidity of the solution, suspended particles in the solution, damage to the container or closure. After first opening: From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C. Any unused infusion solution after a course of treatment must be discarded.

6. FURTHER INFORMATION

What Isotonic Saline Solution 0.9%

Braun contains

The active substance is sodium chloride. 1000 ml of solution for infusion contains 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 a solution for infusion (solution for administration as an intravenous 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 and as a set consisting of 1 x 500 ml plastic bottle, infusion set and venipuncture set.

Marketing Authorisation Holder

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

Postal Address

B. Braun Melsungen AG
34209 Melsungen
Germany
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

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

This leaflet was last revised in June 2014.

Source: Information from the package leaflet
Status: 07/2016
Fields of application: for the replacement of fluids and salt in case of fluid deficiency (isotonic dehydration) or simultaneous sodium and fluid deficiency (hypotonic dehydration); increased pH value and simultaneous decreased chloride level (hypochloraemic alkalosis) and in case of chloride losses. 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 moistening of wipes and dressings.