POLYFUSOR BC SODIUM BICARBONATE INTRAVENOUS INFUSIONBP 1.26%

Active substance: SODIUM BICARBONATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Sodium Bicarbonate Infusion 1.26% Polyfusor BC.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Polyfusor BC has the following composition:
Name
Sodium Bicarbonate BP

3.

Specification
Reference
EP

%w/v
1.26

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 and Children
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 less urgent forms of metabolic acidosis,
an average dose 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 patients’ 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.
Elderly

Care should be taken to avoid circulatory overload, particularly in patients
with cardiac and renal insufficiency.
For intravenous infusion.

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.

4.5.

Interactions 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 Polyfusor Sodium Bicarbonate infusions during pregnancy and
lactation has not been assessed, but their 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
Overdose 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% w/v 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
Water for Injections in bulk
Disodium Edetate
Carbon Dioxide

6.2.

Specification Reference
EP
EP
EP

%w/v
To 100
0.01
QS

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 2° to 25°C.

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.

Instructions for use and handling, (and 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(S)
PL: 8828/0013.

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
21/01/2009

10

DATE OF REVISION OF THE TEXT
20/11/2013

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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.

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