SODIUM BICARBONATE 1.4% SOLUTION FOR INFUSION - summary of medicine characteristics

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

Fluid balance, serum electrolytes and acid-base balance may need to be monitored before and during administration, with particular attention to serum sodium in patients with increased non-osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients co-medicated with vasopressin agonist drugs, due to the risk of hospital acquired hyponatraemia (see section 4.4, 4.5 and 4.8).

Monitoring of serum sodium is particularly important for hypotonic fluids.

The infusion rate and volume depend on the age, weight, clinical condition (e.g. burns, surgery, head-injury, infections), and concomitant therapy should be determined by the consulting physician experienced in paediatric intravenous fluid therapy (see sections 4.4 and 4.8)

Posology

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.

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

High volume infusion must be used under specific monitoring in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including SIADH), due to the risk of hospital-acquired hyponatraemia (see below).

Hyponatraemia

Patients with non-osmotic vasopressin release (e.g. in acute illness, pain, postoperative stress, infections, burns, and CNS diseases), patients with heart-, liver- and kidney diseases and patients exposed to vasopressin agonists (see section 4.5) are at particular risk of acute hyponatraemia upon infusion of hypotonic fluids.

Acute hyponatraemia can lead to acute hyponatraemic encephalopathy (cerebral oedema) characterized by headache, nausea, seizures, lethargy and vomiting. Patients with cerebral oedema are at particular risk of severe, irreversible and life-threatening brain injury.

Children, women in the fertile age and patients with reduced cerebral compliance (e.g. meningitis, intracranial bleeding, cerebral contusion and brain oedema) are at particular risk of the severe and lifethreatening brain swelling caused by acute hyponatraemia. 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.

4.5 Interaction with other medicinal products and other forms of interaction

Drugs leading to an increased vasopressin effect

The below listed drugs increase the vasopressin effect, leading to reduced renal electrolyte free water excretion and may increase the risk of hospital acquired hyponatraemia following inappropriately balanced treatment with i.v. fluids (see sections 4.2, 4.4 and 4.8).

Drugs stimulating vasopressin release include:

Chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3.4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics

Drugs potentiating vasopressin action include: Chlorpropamide, NSAIDs, cyclophosphamide

Vasopressin analogues include:

Desmopressin, oxytocin, vasopressin, terlipressin

Other medicinal products increasing the risk of hyponatraemia also include diuretics in general and antiepileptics such as oxcarbazepine.

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

Sodium Bicarbonate 1.4% solution for infusion should be administrated with special caution for pregnant women during labour particularly as to serum-sodium if administered in combination with oxytocin (see section 4.4, 4.5 and 4.8).

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

– Hospital acquired hyponatraemia*

– Acute hyponatraemic encephalopathy

Hospital acquired hyponatraemia may cause irreversible brain injury and death, due to development of acute hyponatraemic encephalopathy, frequency unknown (see sections 4.2. 4.4, 4.5).

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

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