SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Sodium Chloride Infusion BP 0.45% as Steriflex No. 2 or freefex

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Steriflex No. 2 has the following composition:

Name	Specification Reference	%w/v
Sodium Chloride for Injections	EP	0.45

3. PHARMACEUTICAL FORM

Intravenous infusion.

4.    CLINICAL PARTICULARS

4.1    Therapeutic indications

This product is used in the treatment of dehydration associated with hyperosmolarity (hypernatraemia).

4.2 Posology and method of administration

Adults and children

The rate of administration and volume infused will depend upon the requirements of the individual patient and the judgement of the physician.

Elderly

Care should be taken to avoid circulatory overload, particularly in patients with cardiac and renal insufficiency.

Intravenous infusion.

4.3 Contraindications

Patients with absolute sodium overload. It is well known that former may occur with myocardial and renal damage, but it should also be appreciated that in that in the first five or six days after surgery or severe trauma, there may be an inability to excrete unwanted sodium.

4.4 Special warnings and precautions for use

Saline solutions should not be administered rapidly or for prolonged periods particularly in infants and the elderly. In potassium deficient patients administration of normal saline will increase potassium loss so that if it is given, potassium supplements should also be given.

The label states: Do not use unless the solution is clear and free from particles.

4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant interactions.

4.6 Pregnancy and lactation

The safety of the solution during pregnancy and lactation has not been assessed, but its use during these periods is not considered to constitute a hazard.

Not applicable.

4.8 Undesirable effects

Thrombosis of the chosen vein is always a possibility with intravenous infusion. If infusion is protracted then another vein should be selected after 12 - 24 hours.

4.9 Overdose

Overdosage may lead to fluid overload and electrolyte imbalance. Treatment should consist of discontinuing the infusion and if necessary administering a diuretic.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Sodium chloride provides a source of sodium and chloride ions to maintain the osmotic tension of the extracellular fluid and tissues.

5.2 Pharmacokinetic properties

Not applicable

5.3 Preclinical safety data

Not Applicable

6.    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Name	Specification Reference	%w/v
Water for Injection in Bulk BP	EP	To 100
Hydrochloric Acid BP	EP	QS
Sodium Hydroxide BP	BP	QS

6.2 Incompatibilities

Incompatible with Amiodarone, Amphotericin B, Amsacrine and sodium nitroprusside. 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 on to the bag to varying and significant degrees.

6.3 Shelf life

500ml PVC Bags - 24 months 500ml Polyolefin Bags - 36 months

6.4 Special precautions for storage

Store between 2 and 25^oC

Nature and contents of container

The container is a 500ml 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 500ml polyolefine bag sealed in a polyolefine overwrap.

6.6 Special precautions for disposal and other handling

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 UK

PL 08828/0036.

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

23/02/2011

10    DATE OF REVISION OF THE TEXT

23/02/2011