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Freeflex

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Document: spc-doc_PL 08828-0037 change

SUMMARY OF PRODUCT CHARACTERISTICS


1


NAME OF THE MEDICINAL PRODUCT


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


2.


QUALITATIVE AND QUANTITATIVE COMPOSITION

Steriflex No. 28 has the following composition:

Name    Specification Reference

%w/v

Potassium Chloride    EP

0.2

Sodium Chloride for Injections    EP

0.9


3.


PHARMACEUTICAL FORM

Intravenous Infusion.


4.

4.1.

4.2.


CLINICAL PARTICULARS Therapeutic Indications

Potassium replacement therapy


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 mmol of potassium per hour. The total daily dosage of potassium should not exceed 200 mmol 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 real insufficiency.

For intravenous infusion.

4.3. Contra-Indications

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

Intravenous infusion must be carried out slowly. Caution should be used with administration to patients receiving digitalistherapy, patients with renal or adrenal insufficiency, cardiac disease acute dehydration or heat cramp, those recieving potassium sparing diurectics and patients with sickle cell haemoglobinopathy.

Caution should be exercised in the volume and rate of infusion since fluid overload and hyperkalaemia may comprise cardiac function. Before administering potassium by the intravenous route a non potassium containing hydrating solution should be administered to ensure adequate renal function.

Repeated measurements of plasma potassium are necessary to determine whether further infusions are necessary and to avoid the development of hyperkalaemia this is especially liable to occur in renal failure. Continuous ECG monitoring is desirable.

The label states: Rapid infusion may be harmful.

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

Contains 13.5 mmol potassium (500ml)

Contains 27 mmol potassium (1000ml)

4.5. Interactions 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.

4.6. Pregnancy and Lactation

The use of potassium containing solutions during pregnancy and lactation has not been assessed but its use during these periods is not considered a hazard.

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.

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. 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. Pre-clinical Safety Data

None stated.

6. PHARMACEUTICAL PARTICULARS

6.1. List of Excipients

Name

Specification

Reference

%w/v

Water for Injections in bulk

EP

TO 100

Hydrochloric Acid

EP

QS

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 of the plastic material of the sterifiex 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

500ml & 1000ml PVC bags - 24 months. 500ml & 1000ml 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 1000ml 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 500ml or 1000ml polyolefine bag sealed in a polyolefine overwrap.

6.6. Instruction for Use, Handling and 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

PL 08828/0037

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 20/04/1989 / 23/02/2009

10


DATE OF REVISION OF THE TEXT

23/02/2009