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POLYFUSOR B SODIUM BICARBONATE IV INFUSION 8.4%

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Sodium Bicarbonate BP 8.4% Polyfusor B.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Polyfusor B has the following composition:
Name

Specification Reference

Sodium Bicarbonate BP EP

3

%w/v
8.4

PHARMACEUTICAL FORM
Intravenous infusion.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the treatment of metabolic acidosis and rapid urine alkalinisation.

4.2

Posology and method of administration
Adults
The volume, strength and rate of infusion will depend upon the requirements
of individual patients as perceived by the physician. Administration should be
effected cautiously and gradually. In cardiac arrest an adult dose of 1 mmol of
bicarbonate per kg of bodyweight of the 8.4% solution may be given initially,
followed by repeat doses of 0.5 mmol per kg at 10 minute intervals during the
cardiac arrest, according to blood gas analysis. In the less urgent forms of
metabolic acidosis, an average dosage for adults and older children is 2-5
mmol of bicarbonate per kg bodyweight, given over 4-8 hours. Subsequent
doses of sodium bicarbonate should be adjusted to the individual patient’s
requirements. It is generally recommended that administration should be
initiated with half the calculated dose, which may be adjusted subject to
satisfactory blood gas analysis.
Children

A reduced volume, strength and rate of infusion will be necessary, depending
upon the requirements of the patient as determined by the physician. In cardiac
arrest the 8.4% solution should be used in an initial dose of 2 mmol of
bicarbonate per kilogram slowly, at a rate not exceeding 1-2 mmol per
kilogram per minute. Subsequent doses should be determined according to
blood gas analysis.
Elderly
Care should be taken to avoid circulatory overload, particularly in, patients
with cardiac and renal insufficiency.

4.3

Contraindications
Intravenous infusions of sodium bicarbonate may be contraindicated in,
patients with hypertension, impaired renal and cardiac function, pulmonary
oedema, respiratory and metabolic alkalosis, hyperventilation, hypernatraemia
and eclampsia.

4.4

Special warnings and precautions for use
Infusion of sodium bicarbonate solutions must be strictly intravenous, since
extravasation may lead to tissue necrosis. Administration to patients receiving
cardiopulmonary resuscitation may induce pulmonary oedema. Careful
attention should be given to avoid possible hypokalaemia.
The label states: Do not use unless solution is clear and free from particles
Because of the nature of the enclosed solution, this Polyfusor is supplied only
partially filled (200 ml in a 500 ml container). This means that, unlike a
standard Polyfusor, the flow of liquid will not terminate automatically when
used without an air inlet. Therefore, to avoid the possibility of air entering the
system, this Polyfusor should not be allowed to drain completely.

4.5

Interaction with other medicinal products and other forms of interaction
Sodium bicarbonate will alkalinise the urine and reduce the urinary excretion
of amphetamines, methadone, quinidine and quinine. Sodium bicarbonate will
reduce the effectiveness of hexamine compounds, which are only effective as
urinary antiseptics in acid urine. The renal excretion of lithium appears to be
increased by sodium bicarbonate and this could lead to reduced plasma levels
of lithium and impairment of the therapeutic response.

4.6

Pregnancy and lactation
The safety of sodium bicarbonate infusion during pregnancy and lactation has
not been assessed, but its use during these periods is not considered to
constitute a hazard.

4.7

Effects on ability to drive and use machines
Not applicable.

4.8

Undesirable effects
Thrombosis of the chosen vein is always a possibility with intravenous
infusion.

4.9

Overdose
Overdoses may cause hyperpnoea, nausea and convulsions. Particular care
should be paid to administration in the elderly and infants. Over-rapid infusion
may lead to hyperosmolarity. In cases of overdosage the infusion of sodium
bicarbonate should be discontinued immediately and metabolic alkalosis
corrected by means of administration of 0.9% wlv sodium chloride
intravenous infusion BP.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Sodium bicarbonate provides a source of bicarbonate ions, which will
neutralise the relative excess of hydrogen ions present in acidotic conditions.

5.2

Pharmacokinetic properties
No data available.

5.3

Preclinical safety data
None Stated

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Name
Specification Reference
Water for Injections in EP
bulk
Disodium Edetate
EP
Carbon Dioxide
EP

%w/v
To 100
0.01
QS

6.2

Incompatibilities
A number of drugs are incompatible with sodium bicarbonate infusions
including:
Ascorbic acid, adrenaline, benzyl penicillin, calcium chloride, calcium
gluconate, calcium salts of drugs, carmustine, cisplatin, codeine phosphate,
corticotrophin, dobutamine, insulin, labetalol, levorphanol, magnesium salts,
methadone, morphine sulphate, noradrenaline, oxytetracycline, pethidine,
pentobarbitone, procaine, streptomycin, suxamethonium, tetracycline,
vancomycin and vitamin B complex with C.

6.3

Shelf life
3 months

6.4

Special precautions for storage
Store at 10º to 25ºC.

6.5

Nature and contents of container
Sealed semi-rigid, cylindrical neutral polythene container with a ‘Twist-off
seal at one end and a ring tab at the opposite end.

6.6

Special precautions for disposal
Do not dilute before use.
Use standard sterile peritoneal dialysis equipment.

7

MARKETING AUTHORISATION HOLDER
Fresenius Kabi Limited
Cestrian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT

8

MARKETING AUTHORISATION NUMBER
PL 08828/0043.

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
17/04/1989 / 20/01/2009

10

DATE OF REVISION OF THE TEXT
20/11/2013

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Source: Medicines and Healthcare Products Regulatory Agency

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