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NACL 0.45% W/V KCL 0.15% W/V & GLUCOSE 5% W/V IV INFUSION

Active substance(s): ANHYDROUS GLUCOSE / POTASSIUM CHLORIDE / SODIUM CHLORIDE / ANHYDROUS GLUCOSE / POTASSIUM CHLORIDE / SODIUM CHLORIDE / ANHYDROUS GLUCOSE / POTASSIUM CHLORIDE / SODIUM CHLORIDE

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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 Glucose anhydrous BP Potassium chloride BP 0.45% w/v 5.00% w/v 0.15% w/v

3.

PHARMACEUTICAL FORM Sterile, apyrogenic solution for infusion.

4.
4.1.

CLINICAL PARTICULARS
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 Addisons 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 potassiumcontaining 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.

4.8.

Undesirable Effects 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.
5.1.

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic Properties None stated.

5.2.

Pharmacokinetic Properties None stated.

5.3.

Preclinical Safety Data None stated.

6
6.1.

PHARMACEUTICAL PARTICULARS
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 25C.

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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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