Nacl 0.45% W/V Kcl 0.15% W/V & Glucose 5% W/V Iv Infusion
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS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
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
Administration by intravenous infusion.
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 10-20 mmols of potassium per hour. The total daily dosage of potassium should not exceed 200 mmols.
Children:
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.
4.3. Contra-indications
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 Medications and other forms of Interaction
Care should be exercised in the concurrent administration of potassium-containing intravenous solutions and potassium sparing diuretics.
4.6. 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
Does not affect the ability to drive or operate machinery.
Undesirable Effects
4.8.
Adverse effects are usually due to hyperkalaemia and include listlessness, mental confusion, parasthesia, weakness, hypotension, arrhythmias and sometimes cardiac arrest.
Thrombosis of the selected vein may occasionally occur.
4.9 Overdose
Symptoms of overdosage include hypotension, 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.
Hyperkalaemia may be reversed by the administration of calcium gluconate injection 10% with E.C.G. monitoring.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
None stated.
5.2. Pharmacokinetic Properties
None stated.
5.3. Preclinical Safety Data
None stated.
6 PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Water for Injections BP to 100.0% w/v
6.2. Incompatibilities
Incompatibilities have been demonstrated in potassium-containing intravenous infusions with for example amikacin, amphotericin, benzyl-penicillin and dobutamine.
6.3. Shelf Life
2 years from the date of manufacture.
6.4. Special Precautions for Storage
Store below 25°C.
6.5. Nature and Contents of Container
PVC which complies with EP VI 2.2.3 1990 (Containers for Intravenous Infusion).
Closures
(a) : radiofrequency weld
(b) : polycarbonate plug
(c) : PVC plug
Pack sizes: 500ml and 1000ml.
6.6. Instructions for Use/Handling Discard any unused portion.
Do not reconnect partially used bags.
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
07/01/2013