POTASSIUM CHLORIDE 0.3% SODIUM CHLORIDE 0.9% IV INFUSION BP AS STERIFLEX NO. 15 OR FREEFLEX - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Potassium Chloride 0.3%, Sodium Chloride 0.9% IV Infusion BP, as Steriflex

No. 15 or freeflex

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Steriflex No. 15 has the following composition:

Name                            S­pecification Reference %w/v

Potassium Chloride                 EP              0.3

Sodium Chloride for Injections      EP             0.9

3 PHARMACEUTICAL FORM

Intravenous fluid

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Potassium replacement therapy.

4.2 Posology and method of administration

Adults and Children

The volume and rate of infusion will depend upon the requirements 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 of potassium.

Children

The volume and rate of infusion will depend upon the requirements 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 be necessary to avoid circulatory overload, particularly in patients with cardiac or renal insufficiency.

For intravenous infusion.

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 sections 4.4, 4.5 and 4.8).

Monitoring of serum sodium is particularly important for hypotonic fluids.

Potassium Chloride 0.2% Sodium Chloride 0.9% IV Infusion BP, as Steriflex No. 28 and freeflex

Tonicity : hypertonic

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).

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

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)

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 life-threatening brain swelling caused by acute hyponatraemia.

4.5 Interaction with other medicinal products and other forms of interaction

Care should be exercised in the concurrent administration of potassium containing intravenous solutions and potassium sparing diuretics.

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

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.

Potassium Chloride 0.3%, Sodium Chloride 0.9% IV Infusion BP as Steriflex No 15 or freeflex 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).

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, hypertension, arrhythmias and sometimes cardiac arrest. Thrombosis of the selected vein may occasionally occur.

– 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).

Reporting of side effects :

If you get any side effects,talk to your doctor or pharmacist or nurse.

This includes any possible side effects not listed in this leaflet. You can

also report side effects directly via the Yellow Card Scheme at

www.mhra.gov.uk/y­ellow card or search for MHRA Yellow card in the

Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine

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 bicarbonate. Hyperkalaemia may be reversed by the administration of calcium gluconate injection 10% with ECG monitoring.

5.1 Pharmacodynamic properties

Potassium chloride and sodium chloride provides essential ions to maintain the intracellular/ex­tracellular milieu.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data None stated.

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.