Nacl 0.45% W/V Kcl 0.15% W/V & Glucose 5% W/V Iv Infusion
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Chloride 0.45% w/v, Potassium Chloride 0.15% w/v and Glucose 5% Intravenous Infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Chloride BP 0.45% w/v
Glucose Anhydrous BP 5.00% w/v
Potassium Chloride BP 0.15% w/v
For the full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Sterile, apyrogenic solution for infusion.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Sodium Chloride, Potassium Chloride and Glucose Intravenous Infusion is administered in patients post-operatively for electrolyte balance maintenance.
Repeated measurements of plasma potassium are necessary to determine whether further infusions are required and to avoid the development of hyperkalaemia; this is especially liable to occur in renal failure.
4.2 Posology and method of administration
Adults:
The volume and rate of infusion will depend on the condition of the individual patient and the judgement of the physician. The rate of infusion should not exceed 10-20mmols of potassium per hour. The total daily dosage of potassium should not exceed 200mmols.
Paediatric population:
The volume and rate of infusion will depend on the condition of the individual patient and the judgement of the physician. Correspondingly reduced volumes and rates of infusion may be required.
Elderly:
The volume and rate of infusion may need to be reduced in the elderly to avoid circulatory overload, particularly in patients with cardiac or renal insufficiency.
For intravenous infusion.
4.3 Contraindications
Addison's disease, adrenal insufficiency, acute or chronic renal disease, oliguria, anuria and patients with hyperkalaemia. The intravenous infusion of dextrose solutions may also be hazardous in patients with impaired hepatic function.
4.4 Special warnings and precautions for use
Caution should be exercised in the volume and rate of infusion since fluid overload and hyperkalaemia may compromise cardiac function. Before administering potassium by the intravenous-route a non-potassium containing hydrating solution should be administered to ensure adequate renal function.
4.5 Interaction with other medicinal products and other forms of interaction
Solutions containing potassium should be used with caution in patients receiving drugs that increase serum potassium concentrations (potassiumsparing diuretics, ACE inhibitors, cyclosporin, and drugs that contain potassium such as potassium salts of penicillin).
Corticosteroids are associated with the retention of sodium and water, with oedema and hypertension.
Glucose should not be administered through the same infusion equipment as whole blood as haemolysis and clumping can occur.
4.6 Fertility, pregnancy and lactation
The use of potassium-containing solutions 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
Sodium Chloride, Potassium Chloride and Glucose Intravenous Infusion has no or negligible influence on the ability to drive or operate machinery.
4.8 Undesirable effects
Tabulated list of adverse reactions
|
System Organ Class |
Symptoms (LLT terms MedDRA) |
Frequency |
|
Metabolism and nutrition disorders |
Hyperkalaemia |
Not known |
|
General disorders and administration site conditions |
Listlessness Weakness | |
|
Cardiac disorders |
Arrhythmias Cardiac arrest. | |
|
Nervous system disorders |
Parasthesia Confusion | |
|
Vascular disorders |
Hypertension Thrombosis |
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.
Website: www.mhra.gov.uk/yellowcard
4.9 Overdose
Symptoms of overdosage include hypertension, cardiac arrhythmias, heart block and cardiac arrest. Treatment is to stop infusion immediately and if there is persistent acidosis, administer an intravenous infusion of sodium lactate or sodium bicarbonate. Excessive administration of potassium may lead to the development of hyperkalaemia. Hyperkalaemia may be reversed by the administration of calcium gluconate injection 10% with electrocardiogram monitoring.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Electrolytes with Carbohydrates, ATC code: B05BB02.
The pharmacodynamic properties of this solution are those of its components (glucose, sodium, potassium, and chloride) in maintaining fluid, electrolyte and energy balance.
Potassium is essential for numerous metabolic and physiological processes including nerve conduction, muscle contraction, and acid-base regulation. A normal concentration of potassium in plasma is about 3.5 to 5.0 mmoles per litre. Potassium is predominantly an intracellular action.
The passage of potassium into the cells and retention against the concentration gradient requires active transport via the Na+/K+ ATPase enzyme.
Ions, such as sodium, circulate through the cell membrane, using various mechanisms of transport, among which is the sodium pump (Na-K-ATPase). Sodium plays an important role in neurotransmission and cardiac electrophysiology, and also in its renal metabolism.
Chloride is mainly an extracellular anion. Intracellular chloride is in high concentration in red blood cells and gastric mucosa. Reabsorption of chloride follows reabsorption of sodium.
Glucose is the principal source of energy in cellular metabolism.
5.2 Pharmacokinetic properties
The pharmacokinetic properties of this solution are those of its components (glucose, sodium, potassium, and chloride).
Intravenous administration of the solution provides an immediate supply of electrolytes and glucose to blood.
Factors influencing potassium transfer between intracellular and extracellular fluid such as acid base disturbances can distort the relationship between plasma concentrations and total body stores. Potassium is excreted mainly by the kidneys; it is secreted in the distal tubules in exchange of sodium or hydrogen ions. The capacity of the kidneys to conserve potassium is poor and some urinary excretion of potassium continues even when there is severe depletion. Some potassium is excreted in the faeces and small amounts may also be excreted in sweat.
After injection of radiosodium (24Na), the half-life is 11 to 13 days for 99% of the injected Na and one year for the remaining 1%. The distribution varies according to tissues: it is fast in muscles, liver, kidney, cartilage and skin; it is slow in erythrocytes and neurones; it is very slow in the bone. Sodium is predominantly excreted by the kidney, but (as described earlier) there is extensive renal reabsorption. Small amounts of sodium are lost in the faeces and sweat.
The two main metabolic pathways of glucose are gluconeogenesis (energy storage) and glycogenolysis (energy release). Glucose metabolism is regulated by insulin. Glucose is metabolised via pyruvic or lactic acid to carbon dioxide and water with the release of energy. All body cells are capable of oxidising glucose and it forms the principal source of energy in cellular metabolism.
5.3 Preclinical safety data
The preclinical safety assessment of Potassium Chloride 0.15%, Sodium Chloride 0.45% and Glucose 5% solution for infusion in animals is not relevant as electrolytes and glucose are physiological constituents of the body and are covered by appropriate pharmacopoeial references.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for Injections BP
6.2 Incompatibilities
Incompatibilities have been demonstrated in potassium-containing intravenous infusions with for example amikacin, amphotericin, benzyl-penicillin and dobutamine.
Before adding a drug, verify it is soluble and stable in water at the pH of Potassium Chloride 0.15%, Sodium Chloride 0.18% and Glucose 4%.
Glucose should not be administered through the same infusion equipment as whole blood as haemolysis and clumping can occur.
Those additives known to be incompatible should not be used.
6.3 Shelf life
2 years from the date of manufacture.
6.4 Special precautions for storage
Store below 25oC.
Nature and contents of container
6.5
The container is a flexible bag made of medical grade PVC.
Closures:
|
(a) |
radiofrequency weld |
|
(b) |
polycarbonate plug |
|
(c) |
PVC plug |
|
Pack Sizes: 500ml |
and 1000ml |
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Discard after single use. Do not reconnect partially used bags. Discard any unused portion. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Terumo BCT Ltd.
Old Belfast Road
Millbrook
Larne
Northern Ireland BT40 2SH United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 21538/0014
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
18/03/2009
10 DATE OF REVISION OF THE TEXT
13/09/2016