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POLYFUSOR BE SODIUM BICARBONATE I.V. INFUSION BP 4.2%

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Sodium Bicarbonate Infusion BP 4.2% Polyfusor BE

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Polyfusor BE has the following composition: Name Sodium Bicarbonate Specification Reference EP 4.2

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PHARMACEUTICAL FORM
Intravenous fluid

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4.1

CLINICAL PARTICULARS
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 the individual patients as perceived by the physician. Administration should be effected cautiously and gradually. In the less urgent forms of metabolic acidosis, an average dose for adults and older children is 2 - 5 ml 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 cardio-pulmonary 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

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% w/v sodium chloride intravenous infusion BP.

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5.1

PHARMACOLOGICAL PROPERTIES
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 Preclinical safety data None Stated

5.3

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6.1

PHARMACEUTICAL PARTICULARS
List of excipients Name Water for Injections in bulk Disodium Edetate Carbon Dioxide Specification Reference EP EP 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 12 months.

6.4

Special precautions for storage Store at 20 to 25C.

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.

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

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MARKETING AUTHORISATION NUMBER(S)
PL 0828/0042

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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
25/04/1989 / 12/04/2005

10

DATE OF REVISION OF THE TEXT
05/11/2008

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Source: Medicines and Healthcare Products Regulatory Agency

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