Summary of medicine characteristics - POTASSIUM CHLORIDE 0.3% AND GLUCOSE 5% INTRAVENOUS INFUSION BP
1 NAME OF THE MEDICINAL PRODUCT
Potassium Chloride 0.3% and Glucose 5% Intravenous Infusion BP as Steriflex No. 16 or freeflex
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Steriflex No. 16 has the following composition:
Name Specification Reference %w/v
Potassium Chloride EP
Glucose Monohydrate for Parenteral EP
Use
(Equivalent to Anhydrous Glucose
3 PHARMACEUTICAL FORM
Intravenous fluid
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Potassium replacement therapy.
4.2 Posology and method of administration
The volume and rate of infusion will depend upon the requirements of the individual patient and the judgement of the physician.
Adults
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 of potassium.
Children
Correspondingly reduced volumes and rates of infusion may be required.
Elderly
A reduced volume and rate of infusion may be necessary to avoid circulatory overload, particularly in patients with cardiac or renal insufficiency.
For intravenous infusion.
Fluid balance, serum glucose, serum sodium and other electrolytes may need to be monitored before and during administration, especially 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 hyponatraemia. Monitoring of serum sodium is particularly important for physiologically hypotonic fluids. Potassium Chloride 0.3% and Glucose 5% Infusion BP, as Steriflex No. 16 or freeflex may become extremely hypotonic after administration due to glucose metabolization in the body (see sections 4.4, 4.5 and 4.8).
4.3 Contraindications
Addison’s disease, adrenal insufficiency, acute or chronic renal disease, oliguria, anuria and patients with hyperkalaemia. The intravenous infusion of glucose solutions may also be hazardous in patients with impaired hepatic function.
4.4 Special warnings and precautions for use
Glucose intravenous infusions are usually isotonic solutions. In the body, however, glucose containing fluids can become extremely physiologically hypotonic due to rapid glucose metabolization (see section 4.2).
Depending on the tonicity of the solution, the volume and rate of infusion and depending on a patient's underlying clinical condition and capability to metabolize glucose, intravenous administration of glucose can cause electrolyte disturbances most importantly hypo- or hyperosmotic hyponatraemia.
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 (brain oedema) characterized by headache, nausea, seizures, lethargy and vomiting. Patients with brain 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, and cerebral contusion) are at particular risk of the severe and life-threatening brain swelling caused by acute hyponatraemia.
Intravenous infusion must be carried out slowly. Caution should be used with administration to patients receiving digitalis therapy, patients with renal or adrenal insufficiency, cardiac disease, acute dehydration or heat cramp, those receiving potassium sparing diuretics and patients with sickle cell haemoglobinopathy.
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.
The label states: Do not use unless the solution is clear and free from particles.
Rapid infusion may be harmful.
Contains 20 mmol Potassium (500 ml)
Contains 40 mmol Potassium (1000 ml)
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 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, e.g.: Chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3.4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics
Drugs potentiating vasopressin action, e.g.: Chlorpropamide, NSAIDs, cyclophosphamide
Vasopressin analogues, e.g.: Desmopressin, oxytocin, vasopressin, terlipressin
Other medicinal products increasing the risk of hyponatraemia also include diuretics in general and antiepileptics such as oxcarbazepine.
Care should be exercised in the concurrent administration of potassium containing intravenous solutions and potassium sparing diuretics.
ACE-inhibitors; Cyclosporin; care should be taken when administering to patients with digitalis therapy
4.6 Fertility, pregnancy and lactation
The safety of potassium containing solutions during pregnancy and lactation has not been assessed, but its use during these periods is not considered to constitute a hazard.
Potassium Chloride 0.3% and Glucose 5% Infusion BP, as Steriflex No. 16 or freeflex should be administrated with special caution for pregnant women during labour particularly if administered in combination with oxytocin due to the risk of hyponatraemia (see section 4.4,4.5 and 4.8)
4.7 Effects on ability to drive and use machines Not applicable.
4.8 Undesirable effects
Adverse effects are usually due to hyperkalaemia and include listlessness, mental confusion, parasthesiae, weakness, hypotension, arrhythmias and sometimes cardiac arrest. Thrombosis of the selected vein may occasionally occur.
| Tabulated list of adverse reactions | ||
| System Organ Class | Adverse reaction (MedDRA term) | Frequency |
| Metabolism and nutrition disorders | Hospital Acquired Hyponatraemia | Not known |
| Nervous system disorders | Hyponatraemic encephalopathy | Not known |
** Hospital acquired hyponatraemia may cause irreversible brain injury and death due to development
of acute hyponatraemic encephalopathy (see sections 4.2 and 4.4).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medical product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
4.9 OverdoseSymptoms 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 bicarbonate. Hyperkalaemia may be reversed by the administration of calcium gluconate injection 10% with ECG monitoring.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Potassium chloride provides essential ions to maintain the intracellular/extracellular milieu.
Glucose is a monosaccharide which provides a source of energy.
5.2 Pharmacokinetic properties
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
5.3 Preclinical safety dataNone Stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for Injections in bulk
Hydrochloric Acid
Sodium Hydroxide
6.2 Incompatibilities
Incompatibilities have been demonstrated in potassium containing intravenous infusions with for example; amikacin, amphotericin, benzyl-penicillin and dobutamine.
Because of the nature of the plastic material of the steriflex bag (PVC), this solution should not be used as a vehicle for the administration of drugs which may be sorbed to the surface of the bag to varying and significant degrees.
6.3 Shelf life
500 & 1000 ml PVC Bags 24 months
500 & 1000 ml Polyolefin Bags 36 months
6.4 Special precautions for storage
Store at 2° to 25°C.
6.5 Nature and contents of container
The container is a flexible 500 or 1000 ml bag made of medical grade PVC.
a) A hermetically sealed polythene bag
b) A rectangular pouch consisting of polyamide/polythene composite
c) Polyamide/Polyethylene-Propylene composite laminate welded to polypropylene ethylene propylene composite, plugged with a polycarbonate plug with either a bromobutyl (West 4481/45) or gum (West 7006/45) stopper.
Or a flexible 500 or 1000 ml polyolefin bag sealed in a polyolefin overwrap.
6.6 Special precautions for disposal
6.6 Special precautions for disposalOpening the overwrap:
Locate the corner tabs at the end of the bag. Grip the two tabs and pull the two halves of the overwrap apart, releasing the bag onto a clean surface.
Setting up the solution:
Position the roller clamp of the giving-set to just below the drip chamber and close. Hold the base of the giving set port firmly and grip the wings of the twist of tab. Twist to remove the protective cover.
Still holding the base of the giving-set port push the set spike fully into the port to ensure a leak proof connection.
Prime the set in accordance with the manufacturer’s instructions.
7 MARKETING AUTHORISATION HOLDER
Fresenius Kabi Limited
Cestrian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT