STERIFLEX NO. 2 OR FREEFLEX SODIUM CHLORIDE 0.45% IV INFUSION BP
Active substance(s): SODIUM CHLORIDE INJECTION
NAME OF THE MEDICINAL PRODUCT
Sodium Chloride Infusion BP 0.45% as Steriflex No. 2 or freeflex
QUALITATIVE AND QUANTITATIVE COMPOSITION
Steriflex No. 2 has the following composition:
Sodium Chloride for Injections
This product is used in the treatment of dehydration associated with hyperosmolarity
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.
Care should be taken to avoid circulatory overload, particularly in patients with
cardiac and renal insufficiency.
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
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.
Interaction with other medicinal products and other forms of interaction
No clinically significant interactions.
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.
Effects on ability to drive and use machines
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.
Overdosage may lead to fluid overload and electrolyte imbalance. Treatment should
consist of discontinuing the infusion and if necessary administering a diuretic.
Sodium chloride provides a source of sodium and chloride ions to maintain the
osmotic tension of the extracellular fluid and tissues.
Preclinical safety data
List of excipients
Water for Injection in Bulk BP
Hydrochloric Acid BP
Sodium Hydroxide BP
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.
500ml PVC Bags - 24 months
500ml Polyolefin Bags – 36 months
Special precautions for storage
Store between 2 and 25oC
Nature and contents of container
The container is a 500ml flexible bag made of medical grade PVC.
A hermetically sealed polythene bag.
A rectangular pouch consisting of polyamide/polythene composite
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.
A flexible 500ml polyolefine bag sealed in a polyolefine overwrap.
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.
MARKETING AUTHORISATION HOLDER
Fresenius Kabi Limited
MARKETING AUTHORISATION NUMBER
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT