Summary of Product Characteristics (SmPC) - Sodium Bicarbonate 1.4% solution for infusion
1 NAME OF THE MEDICINAL PRODUCT
Sodium Bicarbonate 1.4% solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Bicarbonate 1.4% w/v
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for 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
Posology
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 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.
Method of administration
For intravenous infusion.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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 Fertility, 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 relevant
4.8 Undesirable effects
Thrombosis of the chosen vein is always a possibility with intravenous infusion.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.or search for MHRA Yellow Card in the Google Play or Apple App Store.
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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.
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
No data available.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for Injections
Disodium Edetate
Carbon Dioxide
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 between 2° - 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.
Not all pack sizes may be marketed.
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(S)
PL 08828/0011
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of first authorisation – Apr 1989
Date of renewal of authorisation – Aug 1995
10 DATE OF REVISION OF THE TEXT
19/04/2024