Package leaflet: information for the user
D02437
Sodium Bicarbonate Injection BP 8.4% w/v
Sodium Bicarbonate 8.4% w/v
Read all of this leaflet carefully before you are given this
medicine. It contains important information.
•Keep this leaflet. You may need to read it again.
•If you have any further questions, ask your doctor or nurse.
•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 nurse.
In this leaflet:
1. What Sodium Bicarbonate Injection is and what it is used for
2. Before you are given Sodium Bicarbonate Injection
3. How Sodium Bicarbonate Injection is given
4. Possible side effects
5. How to store Sodium Bicarbonate Injection
6. Further information
3. How Sodium Bicarbonate Injection is given
Your doctor will give you Sodium Bicarbonate Injection by slow
injection into the vein (intravenous injection).
Adults, the elderly and children over 12 years
The usual dose is 1ml per kilogram of bodyweight followed by
0.5ml per kg given every 10 minutes.
Children under 12 years
The usual dose is 1ml per kilogram of bodyweight. In premature
babies and newborns the solution should be diluted 1:1 with 5%
dextrose solution.
If you think you have been given too much Sodium Bicarbonate
Injection
As this medicine will be given to you whilst you are in hospital, it is
unlikely that you will be given too little or too much, however, tell
your doctor if you have any concerns.
4. Possible side effects
Sodium Bicarbonate is one of a group of medicines known as
alkalinising agents. It is used to correct the acid-alkaline balance in
the body.
Like all medicines, Sodium Bicarbonate Injection can cause side
effects, although not everybody gets them.
Possible side effects include:
•lower blood acidity than usual
•lower levels of potassium in the blood than usual
•very sensitive skin
•involuntary jerky movements
This medicine is used to control blood acidity following a heart
attack.
If any of the side effects get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or nurse.
2.Before you are given Sodium Bicarbonate Injection
5. How to store Sodium Bicarbonate Injection
1.What Sodium Bicarbonate Injection is and what it is used for
You should not be given Sodium Bicarbonate Injection if:
•you are allergic (hypersensitive) to Sodium Bicarbonate or any of the other ingredients of this medicine, listed in section 6 of this leaflet
•your breathing is faster or deeper than usual (hyperventilation), or slower or more shallow than usual (hypoventilation)
•you have any blood abnormalities such as high levels of sodium, low levels of calcium, potassium or chloride, or your blood is less
acidic than usual (your doctor will need to check this)
•you are having stomach pains or pain whilst passing urine
•you are dehydrated
•you have high blood pressure
•you have problems with your kidneys
•you have heart problems
•you are suffering from eclampsia (a serious complication of pregnancy)
•you are suffering from swelling caused by excess water retention
(oedema)
If any of the above apply to you or your child please tell your doctor
or nurse before you are given Sodium Bicarbonate Injection.
Taking 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, including:
•corticosteroids or corticotropin (medicines used to reduce swelling or to treat hormone problems)
•medicines used to treat infections (tetracyclines) such as doxycycline
•quinidine (a medicine used to treat heart problems)
•medicines used to treat certain mental disorders and drowsiness
•ephedrine and pseudoephedrine (medicines used to treat colds
and asthma)
•potassium supplements
•medicines used to treat water retention and problems with passing urine such as ethacrynic acid, bumetanide or frusemide
•thiazides (a type of medicine used to treat high blood pressure)
•lithium (a medicine used to treat a type of depression)
Keep all medicines out of the reach and sight of children.
This Sodium Bicarbonate Injection should not be used after the
expiry date which is printed on the carton and syringe label. The
doctor or nurse will check that the expiry date on the label has not
been passed before administering the injection to you. The expiry
date refers to the last day of that month.
Do not use if the packaging has been damaged.
Store below 25°C. Store in the original container.
6. Further Information
What Sodium Bicarbonate Injection contains
The active substance is Sodium Bicarbonate BP 8.4%w/v
The other ingredients are nitrogen and water for injections.
What Sodium Bicarbonate Injection looks like and contents of
the pack
Sodium Bicarbonate Injection is a clear, colourless solution supplied
in a prefilled syringe containing 10ml of the solution.
Marketing Authorisation Holder:
Aurum Pharmaceuticals Ltd
Bampton Road, Harold Hill, Romford, Essex, RM3 8UG, England
Manufacturer:
Federa SC
71 Avenue Jean Jaures Laan, B-1030 Brussels, Belgium
If you would like any more information, or would like the leaflet in
a different format, please contact Medical Information at the above
address
Product licence number: PL 12064/0052
Date of revision: January 2013
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, or think you may be pregnant
or if you are breast-feeding, before being given Sodium Bicarbonate
Injection.
Driving and using machines
There are no known effects of having Sodium Bicarbonate Injection
on driving or using machines.
D00251
Continued overleaf
TECHNICAL LEAFLET
D00251
Sodium Bicarbonate Injection BP 8.4% w/v
Trade Name of the Medicinal Product
Sodium Bicarbonate 8.4% w/v Injection
Qualitative and Quantitative Composition
Sodium Bicarbonate 8.4% w/v
Pharmaceutical Form
Solution for Injection
CLINICAL PARTICULARS
Therapeutic Indications
For the correction of metabolic acidosis associated with cardiac
arrest after other resuscitative measures, such as cardiac
compression, ventilation, adrenaline and anti arrhythmic agents
have been used.
Undesirable Effects
Alkalosis and/or hypokalaemia may ensue as a result of prolonged
use or over-correction of the bicarbonate deficit. Hyperirritability or
tetany may occur caused by rapid shifts of free ionised calcium or
due to serum protein alterations arising from pH changes.
Overdose
Symptoms; metabolic alkalosis accompanied by compensatory
hyperventilation, paradoxical acidosis of the cerebrospinal fluid,
severe hypokalaemia, hyperirritability and tetany. Treatment;
discontinue the administration of sodium bicarbonate, rebreathe
expired air or, if more severe administer calcium gluconate
especially if tetany is present. In severe alkalosis, an infusion of
2.14% ammonium chloride is recommended, except in patients
with pre-existing hepatic disease. If hypokalaemia is present
administer potassium chloride.
Posology and Method of Administration
For intravenous administration only.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic Properties
Sodium Bicarbonate therapy increases plasma bicarbonate, buffers
excess hydrogen ion concentration, raises blood pH and reverses
clinical manifestations of metabolic acidosis.
Adults and children over 12 years
The usual dose is 1mmol/kg (1ml/kg 8.4% solution). Followed by
0.5mmol/kg (0.5ml/kg 8.4% solution) given at 10 minute intervals.
Pharmacokinetic Properties
Sodium Bicarbonate is eliminated principally in the urine and
effectively alkalises it.
Children under 12 years
The usual dose is 1mmol/kg (1ml/kg 8.4% solution) by slow iv
injection
Preclinical Safety Data
Not applicable since sodium bicarbonate has been used in clinical
practice for many years and its effects are well known.
In premature infants and neonates, a 4.2% solution should be used
or the 8.4% solution should be diluted 1:1 with 5% dextrose.
Elderly
As for adults
PHARMACEUTICAL PARTICULARS
List of Excipients
Water for Injections
Nitrogen
Contra-indications
Sodium Bicarbonate intravenous infusion is contra-indicated in
cases of respiratory and metabolic alkalosis, hypoventilation,
hypernatraemia, urinary calculi, potassium and chloride depletion,
hypocalcaemia and in situations where supply of sodium is contraindicated such as cardiac insufficiency, oedema, hypertension,
eclampsia, renal impairment.
Incompatibilities
Sodium Bicarbonate Injection must not be administered
simultaneously with solutions containing Calcium, Magnesium or
Phosphate.
Special Warnings and Precautions for Use
Whenever sodium bicarbonate is used intravenously, arterial blood
gas analysis, in particular arterial/venous blood pH and carbon
dioxide levels, should be performed before and during the course
of treatment to minimise the possibility of overdosage and resultant
alkalosis. Accidental extravascular injection of hypertonic solutions
may cause vascular irritation or sloughing. The use of scalp veins
should be avoided. Whenever respiratory acidosis is concomitant
with metabolic acidosis, both pulmonary ventilation and perfusion
must be adequately supported to get rid of excess CO2.
Special Precautions for Storage
Do not store above 25oC. Store in the original container.
Interactions with other Medicaments and other forms of
Interaction
Caution should be used when administering sodium ions to patients
receiving corticosteroids and corticotrophin. Urinary alkalisation will
increase the renal clearance of tetracyclines, especially doxycycline,
but it will increase the half life and duration of action of basic drugs
such as quinidine, amphetamines, ephedrine and pseudoephedrine.
Hypochloraemic alkalosis may occur if sodium bicarbonate is
used in conjunction with potassium depleting diuretics such as
bumetanide, ethacrynic acid, frusemide and thiazides. Concurrent
use in patients taking potassium supplements may reduce serum
potassium concentration by promoting an intracellular ion
shift. Lithium excretion increased with reduced plasma lithium
concentration.
Pregnancy and Lactation
Safe use in pregnancy has not been established. The use of any drug
in pregnant or lactating women requires that the expected benefit
be carefully weighed against the possible risk to mother and child.
Shelf Life
2 years
Nature and Contents of Container
Type 1 clear glass prefilled syringes 10ml stopper rubber PH
50/701C with tip cap rubber W1883, containing 8.4%w/v Sodium
Bicarbonate BP in Water for Injections
Instruction for Use/Handling
No needle is provided with this syringe. Discard any unused
solution at the end of the session in the appropriate manner. Don’t
use the product if the packaging is damaged.
ADMINISTRATIVE DATA
Marketing Authorisation Holder
Aurum Pharmaceuticals Ltd
Bampton Road
Harold Hill
Romford
Essex
RM3 8UG
Marketing Authorisation Number
PL 12064/0052
Date of revision: January 2013
D02437
Effects on Ability to Drive and Use Machines
Not applicable; this preparation is intended for use only in
emergencies.
2437-B
100mm Measurement Verification Bar