PACKAGE LEAFLET:

INFORMATION FOR THE USER

B. Braun Melsungen AG ■ 34209 Melsungen ■ Germany

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

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    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.

In this leaflet:

1.    What 4.2 % w/v Sodium Bicarbonate Intravenous Infusion BP is and what it is used for

2.    Before you use 4.2 % w/v Sodium Bicarbonate Intravenous Infusion BP

3.    How to use 4.2 % w/v Sodium Bicarbonate Intravenous Infusion BP

4.    Possible side effects

5.    How to store 4.2 % w/v Sodium Bicarbonate Intravenous Infusion BP

6.    Further information

1.    WHAT 4.2 % W/V SODIUM BICARBONATE INTRAVENOUS INFUSION BP IS AND WHAT IT IS USED FOR

This medicine contains sodium bicarbonate (bicarbonate of soda) which is used to correct the acid-base balance (a disorder of metabolism) in the body.

The situations in which you may receive this product include:

•    when you have too much acid in your body fluids or

•    when your urine has to be made more alkaline e.g. in order to promote the excretion of certain drugs

•    to correct your blood potassium level before reaching abnormally high values.

2.    BEFORE YOU USE 4.2 % W/V SODIUM BICARBONATE INTRAVENOUS INFUSION BP

YOU SHOULD NOT RECEIVE 4.2 % W/V SODIUM BICARBONATE INTRAVENOUS INFUSION BP

if you suffer from any of the following conditions:

•    too much alkali in your body fluids

•    abnormally high level of sodium in your blood

•    abnormally low level of potassium in your blood.

4.2    % w/v Sodium Bicarbonate Intravenous Infusion BP

Sodium bicarbonate

TAKE SPECIAL CARE WITH 4.2 % W/V SODIUM BICARBONATE INTRAVENOUS INFUSION BP

in presence of the following conditions:

•    certain types of breathing problems

•    abnormally low levels of calcium

•    high concentration of salts in the blood (hyperosmolarity)

•    when intake of sodium should be limited such as

-    some kinds of heart disease

-    fluid retention with swelling

-    high blood pressure

-    eclampsia (a condition causing convulsions during pregnancy)

-    severe kidney disease.

4.2    % w/v Sodium Bicarbonate should only be given to you as an intravenous infusion (as a drip into a vein).

Special care will be taken while you are receiving the medicine to ensure that the correct potassium and sodium levels are maintained in your blood.

TAKING OR USING OTHER MEDICINES

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

Sodium Bicarbonate may interact with other medicines, in particular

•    lithium (used to treat mental disease)

•    some steroid products, e.g. cortisones

•    androgens (a male hormone)

•    diuretics (medicine increasing the urine flow).

PREGNANCY AND BREAST-FEEDING

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

Bicarbonate also readily crosses the placenta. No unwanted effects, however, are expected to occur if 4.2 % w/v Sodium Bicarbonate Intravenous Infusion is used as prescribed when given during pregnancy.

You should not normally receive this product if you have eclampsia.

Breast-feeding

Your doctor will advise whether it should be used if you are breast-feeding.

DRIVING AND USING MACHINES

This medicine has no influence on the ability to drive and use machines.

3.    HOW TO USE 4.2 % W/V SODIUM BICARBONATE INTRAVENOUS INFUSION BP

You will be given this medicine by infusion into a vein (intravenous drip).

Your doctor will decide how much 4.2 % w/v Sodium Bicarbonate and for how long the infusion should be given. This will depend upon your clinical condition.

You will normally receive 60 - 120 ml of 4.2 % w/v Sodium Bicarbonate Intravenous Infusion per hour.

IF YOU RECEIVED MORE 4.2 % W/V SODIUM BICARBONATE INTRAVENOUS INFUSION BP THAN YOU SHOULD

It is unlikely that this happens because this medicine is given to you by a doctor or a nurse. Yet if you received an overdose your blood may become too alkaline or too concentrated with respect to dissolved salts.

If you received this medicine too rapidly, more carbon dioxide may be released, which may adversely affect your brain.

If overdose occurs, your infusion will be stopped. Your doctor will decide on further treatment and medication that you may need.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, 4.2 % w/v Sodium Bicarbonate Intravenous Infusion BP can cause side effects, although not everybody gets them.

It is unlikely that 4.2 % w/v Sodium Bicarbonate Intravenous Infusion would cause any unwanted effects when used as directed.

If you notice any side effects, please tell your doctor or pharmacist.

201/12223875R/R608

5.    HOW TO STORE 4.2 % W/V SODIUM BICARBONATE INTRAVENOUS INFUSION BP

Keep out of the reach and sight of children.

Do not use 4.2 % w/v Sodium Bicarbonate Intravenous Infusion BP after the expiry date which is stated on the bottle and the outer carton. The expiry date refers to the last day of that month.

Do not store above 25 °C.

Do not use 4.2 % w/v Sodium Bicarbonate Intravenous Infusion BP if you notice

•    cloudiness of solution,

•    particles in the solution,

•    leaking of the bottle.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION

What 4.2 % w/v Sodium Bicarbonate Intravenous Infusion BP contains

•    The active substance is sodium bicarbonate.

1000 ml of the solution contain 42.0 g of sodium bicarbonate.

•    The other ingredients are

disodium edetate and water for injections.

What 4.2 % w/v Sodium Bicarbonate Intravenous Infusion BP looks like and contents of the pack

4.2 % w/v Sodium Bicarbonate Intravenous Infusion is a solution for infusion (a solution for administration by a vein drip).

It is a clear, colourless sterile solution of sodium bicarbonate in water.

It is available in the following presentations: 100 ml, 250 ml and 500 ml glass bottles, sealed with rubber stoppers.

Marketing Authorisation Holder and Manufacturer

B. Braun Melsungen AG

Carl-Braun-Str. 1    Postal address

34212 Melsungen, Germany 34209 Melsungen, Germany.

This leaflet was last approved in October 2008

|    _ lhj Braun Melsungen AG

13 | bllAUN 34209 Melsungen, Germany

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