POTASSIUM CHLORIDE 0.15% SODIUM CHLORIDE 0.9% IV INFUSION BP AS STERIFLEX NO. 12 OR FREEFLEX - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Potassium Chloride 0.15%, Sodium Chloride 0.9% IV Infusion BP, as Steriflex No. 12 or freeflex

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Polyfusor SD has the following composition:_________­______________

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 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 0.15%, Sodium Chloride 0.9% IV Infusion BP, as Steriflex No. 12 or 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.

4.4 Special warnings and precautions for use

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:      Special care in renal failure rapid infusion may be harmful.

Do not use unless solution is clear and free from particles.

Contains 10 mmol Potassium (500 ml)

Contains 20 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.

ACE-inhibitors; Cyclosporin; care should be taken when administering to patients with digitalis therapy

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 safety of this product during pregnancy and lactation has not been established, but its use during these periods is not considered to constitute a hazard.

Potassium Chloride 0.15%, Sodium Chloride 0.9% IV Infusion BP, as Steriflex No. 12 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

There is no effect on ability to drive and use machinery.

4.8 Undesirable effects

Adverse effects are usually due to hyperkalamia and include listlessness, mental confusion, parasthesiae, weakness, hypotension, 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 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 bicarbonate or sodium lactate. Hyperkalaemia may be reversed by the administration of calcium gluconate injection 10% with ECG monitoring.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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

5.2 Pharmacokinetic properties

Not applicable

5.3 Preclinical safety data N/A

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium Hydroxide

BP

QS

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 if 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

24 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 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 polyolefine bag sealed in a polyolefine overwrap.

6.6 Special precautions for disposal

Opening 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

8 MARKETING AUTHORISATION NUMBER(S)

PL 08828/0065

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

6th June 1989