Patient leaflet - Sodium Bicarbonate 8.4% w/v solution for infusion
1. WHAT SODIUM BICARBONATE 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 dis-order 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
2. BEFORE YOU USE SODIUM BICARBONATE
You should not receive Sodium Bicarbonate
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.
Take special care with Sodium Bicarbonate
in presence of the following conditions:
- certain types of breathing problems
- abnormally low levels of calcium
when intake of sodium should be limited as may be the case with
- some kinds of heart disease
- fluid retention with swelling
- high blood pressure
eclampsia (a condition causing convulsions during preg-
nancy)
- severe kidney disease.
PACKAGE LEAFLET: INFORMATION FOR THE USER
B. Braun Melsungen AG · 34209 Melsungen, Germany
8.4 % w/v Sodium Bicarbonate Intravenous Infusion BP
Sodium bicarbonate
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.
3. HOW TO USE SODIUM BICARBONATE
You will be given Sodium Bicarbonate by infusion into a vein (intravenous drip).
Your doctor will decide how much 8.4 % w/v Sodium Bicar-bonate and for how long the infusion should be given. This will depend upon your clinical condition.
You will normally receive up to 60 ml of 8.4 % w/v Sodium Bicarbonate Intravenous Infusion per hour.
New-born babies and children below 2 years of age should receive Sodium Bicarbonate only at a lower dose level and a particular low infusion (drip) rate.
If you received more medicine than you should
It is unlikely that this happens because Sodium Bicarbonate is given to you by a doctor or a nurse. Yet if you received an overdose your blood may become too alkaline or too concen-trated with respect to dissolved salts.
If you received Sodium Bicarbonate too rapidly, more carbon dioxide may be released, which may adversely affect your brain.
If overdose occurs, your infusion will be stopped. Your doc-tor 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, 8.4 % w/v Sodium Bicarbonate Intrave-nous Infusion BP can cause side effects, although not eve-rybody gets them.
It is unlikely that 8.4 % 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 phar-macist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more infor-mation on the safety of this medicine.
5. HOW TO STORE SODIUM BICARBONATE
Keep out of the reach and sight of children.
Do not use 8.4 % w/v Sodium Bicarbonate Intravenous Infu-sion 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 8.4 % w/v Sodium Bicarbonate Intravenous Infu-sion 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 8.4 % w/v Sodium Bicarbonate Intravenous Infusion BP contains
The active substance is:
sodium bicarbonate
1000 ml of the solution contain 84.0 g of sodium bicarbo-nate.
The other ingredients are:
disodium edetate and water for injections
What Sodium Bicarbonate looks like and contents of the pack
8.4 % w/v Sodium Bicarbonate Intravenous Infusion is a so-lution 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 and 250 ml glass bottles, sealed with rubber stop-pers.
Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Str. 1
34212 Melsungen,
Germany
Postal address:
34209 Melsungen, Germany
This leaflet was last approved in October 2014.
B. Braun Melsungen AG
34209 Melsungen
Germany
B|BRAUN
201/12223875/1114