Consumer medicine information

B. Braun (Australia) Intravenous Replacement Fluids

Sodium chloride

BRAND INFORMATION

Brand name

B. Braun 0.9% Sodium Chloride Intravenous Infusion BP

Active ingredient

Sodium chloride

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using B. Braun (Australia) Intravenous Replacement Fluids.

What are the products used for?

Electrolyte replacement solutions are used to replace fluid and electrolytes which have been lost from the body due to illness or injury.

How do they work?

The solution chosen by your doctor is infused slowly into a vein and provides water as well as some or all of the following electrolytes: sodium, chloride, potassium and bicarbonate ions to replace those lost. The solution may also contain glucose.

Before using this product:

Please note that the solutions should not be used if the container is found to be leaking or the solution is not clear.

* Tell your doctor if you have kidney or liver problems or if you have high levels of potassium in your blood.

Directions for Use:

This product has been chosen by your doctor and will be given to you as an intravenous drip. The amount of solution and the rate at which it is given will depend on how much fluid replacement is necessary and on your age and weight.

When using the container remove the aluminium strip from the cap and attach tubing by inserting a needle through the port into the bottle. The container has been designed to empty and collapse during use. A small residual volume of solution remains at the end of infusion to prevent accidental entry of air into the tubing. Other medications can be added if necessary by injecting through the second port and gently shaking the container.

Unwanted Effects:

It is unlikely that side effects occur if the solutions are infused at the correct rate to replace lost fluid, however disturbances in fluid or electrolyte balance in the body may occur (see below at Overdosage for a description of possible side effects).

If any side-effects are noticed or if the site of injection is painful your doctor or nurse should be notified.

Overdosage:

Overdosage with the solutions may result in symptoms caused by too much fluid or electrolytes. The following symptoms should be immediately reported to your doctor:

  • shortness of breath
  • puffiness in the hands or ankles
  • nausea, vomiting and diarrhoea
  • stomach cramps
  • listlessness, weakness (general and muscular)
  • burning or prickling of the fingers or toes
  • mental confusion
  • irregular heart beat

Storage Conditions:

The solutions should be stored in a cool place, below 25°C and used before the expiry date on the container.

Presentations:

0.9% Sodium Chloride
50 mL AUST R 154967
100 mL AUST R 98311
250 mL AUST R 98312
500 mL AUST R 49335
1000 mL AUST R 49337

Glucose 5%
100 mL AUST R 98318
250 mL AUST R 98343
500 mL AUST R 49331
1000 mL AUST R 49332

Sodium Chloride 0.9% and Glucose 5%
500 mL AUST R 49333
1000 mL AUST R 49334

Compound Sodium Lactate:
500 mL AUST R 99547
1000 mL AUST R 49330

For further information:

This leaflet provides a summary of some of the important things you need to know about this medicine. Only your doctor and pharmacist are able to weigh up all the relevant facts about the use of this medicine in your condition and you should consult them for further details.

Sponsor:

B. Braun Australia Pty Ltd
Level 5, 7-9 Irvine Place
Bella Vista, NSW 2153
Australia

Toll free number: 1800 251 705

This leaflet was prepared in August 2022

Published by MIMS October 2022

BRAND INFORMATION

Brand name

B. Braun 0.9% Sodium Chloride Intravenous Infusion BP

Active ingredient

Sodium chloride

Schedule

Unscheduled

 

1 Name of Medicine

Sodium chloride, glucose, sodium lactate.

2 Qualitative and Quantitative Composition

The solutions have the following formulations (g/L) (see Table 1).
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/BBIVRF01.gif The solutions have the following content of electrolytes (mmol/L), total osmolality and pH (see Table 2).
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/BBIVRF02.gif

3 Pharmaceutical Form

B. Braun intravenous replacement solutions are clear to colourless solutions intended for intravenous infusion.

4 Clinical Particulars

4.9 Overdose

Symptoms of overdosage with intravenous solutions are related to excessive electrolyte levels and fluid imbalance. The following symptoms are indicative of overdosage and indicate the need for immediate measurement of serum electrolyte levels and blood glucose, calculation of fluid balance, ECG monitoring and commencement of appropriate supportive symptomatic treatment: shortness of breath, peripheral oedema; nausea, vomiting and diarrhoea; abdominal cramps; listlessness, weakness (general and muscular); paraesthesia of the extremities, paralysis; mental confusion; cardiac complications.
Hyperkalaemia should be treated by eliminating the intake of potassium and potassium sparing diuretics and infusion of 50 - 125 g of dextrose over one hour with insulin. Severe cardiac toxicity resulting from hyperkalaemia requires immediate attention and may be treated by intravenous injection over 1-5 minutes of 10 - 20 mL Calcium Gluconate Injection 10%.
Severe cases of hypernatremia and hyperkalaemia may benefit from dialysis.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Sodium chloride. Na-Cl.
Sodium lactate.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSSODLAC.gif Glucose.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSGLUCOS.gif CAS number. Sodium chloride. 7647-14-5.
Sodium lactate. 867-56-1.
Glucose. 50-99-7.

7 Medicine Schedule (Poisons Standard)

Not scheduled.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/BBIVRFST.gif