SODIUM BICARBONATE 8.4% W/V SOLUTION FOR INFUSION

Active substance: SODIUM BICARBONATE

View full screen / Print PDF » Download PDF ⇩
Transcript


201/12223875/1114

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.
–  his medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the
T
same as yours.
– f any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or
I
pharmacist.

In this leaflet:
1. What Sodium Bicarbonate is and what it is used for
2. Before you use Sodium Bicarbonate
3. How to use Sodium Bicarbonate
4. Possible side effects
5. How to store Sodium Bicarbonate
6. Further information

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 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
•  hen your urine has to be made more alkaline e.g. in order
w
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
•  hen intake of sodium should be limited as may be the
w
case with
– some kinds of heart disease
– fluid retention with swelling
– high blood pressure
–  clampsia (a condition causing convulsions during prege
nancy)
– severe kidney disease.

8.4 % w/v Sodium Bicarbonate should only be given to you
as an intravenous infusion (as a drip into a vein).
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.
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 8.4 % 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
Sodium Bicarbonate has no influence on the ability to drive
and use machines

B|BRAUN
12223875_IL-GIF_A4_Sodium_Bicarbonat__GB_201.indd 1

05.11.14 09:53

201/12223875/1114

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 Bicarbonate 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 concentrated 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 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, 8.4 % w/v Sodium Bicarbonate Intravenous Infusion BP can cause side effects, although not everybody 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 pharmacist.
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.

Do not use 8.4 % 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 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 bicarbonate.
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 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 and 250 ml glass bottles, sealed with rubber stoppers.

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.

By reporting side effects you can help provide more information 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 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.

B|BRAUN B. Braun Melsungen AG
34209 Melsungen
Germany

12223875_IL-GIF_A4_Sodium_Bicarbonat__GB_201.indd 2

05.11.14 09:53

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)