STERIFLEX NO. 6 GLUCOSE INFUSION BP 5% OR FREEFLEX
Active substance(s): GLUCOSE
NAME OF THE MEDICINAL PRODUCT
Glucose Infusion BP 5% Steriflex No. 6 or freeflex
QUALITATIVE AND QUANTITATIVE COMPOSITION
Steriflex No. 6 has the following composition:
Glucose Monohydrate for Parenteral Use BP
(Equivalent to Anhydrous Glucose BP
The product is indicated in simple dehydration, carbohydrate depletion, and
hypoglycaemic coma. It can also be used to provide a temporary increase in
blood volume in haemorrhage and shock.
The smaller volume containers may be used as a diluent and delivery system
when administering compatible drug additives so as to avoid the risk of any
over dilution of the additive drug.
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 judgement of the physician.
Care should be taken to avoid circulatory overload, particularly in patients
with cardiac and renal insufficiency.
Use as a Diluent
When using this product as a diluent or vehicle for administration of drug
additives, consult the prescribing information or data sheet of the drug to be
For intravenous infusion.
Diabetes, except as a treatment for hypoglycaemia. The intravenous infusion
of glucose solutions may also be hazardous in patients with impaired hepatic
or renal function.
Special warnings and precautions for use
The infusion of these solutions should not be rapid or very prolonged large
volumes of these solutions given too quickly may cause water intoxication;
infusion over a long period can cause dehydration.
The physician should also be alerted to the possibility of adverse reactions to
drug additives diluted and administered in this container. Prescribing
information for drug additives to be administered in this manner should be
The label states:
Do not use unless solution is clear and free from particles.
Interactions with other medicinal products and other forms of interaction
No clinically significant drug interactions known.
Pregnancy and lactation
The safety of Steriflex 6 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
Overdosage may lead to fluid overload and hyperglycaemia. Fluid overload
may need to be treated with a diuretic and hyperglycaemia with insulin.
Glucose is a monosaccharide, which provides a source of energy.
Glucose is metabolised via pyruvic or lactic acid to carbon dioxide and water
with the release of energy. All body cells are capable of oxidising glucose and
it forms the principle source of energy in cellular metabolism.
Preclinical safety data
List of excipients
Water for Injection in bulk
Incompatible with blood, frusemide, hydralazine, cyancobalamin, kanamycin
sulphate, novobiocin or warfarin sodium.
50, 100, 150 & 250 ml PVC Bags – 18 months
500 & 1000 ml PVC Bags – 24 months
50, 100 & 150 ml Polyolefin Bags – 24 months
250, 500 & 1000 ml Polyolefin Bags – 36 months
Special Precautions for Storage
Store at 2° to 25°C
Nature and Contents of Container
The container is a flexible 50, 100, 150, 250, 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
Ethylene propylene composite, plugged with a polycarbonate plug with
either a bromobutyl (West 4481/45) or gum (West 7006/45) stopper.
A flexible 50, 100, 150, 250, 500 or 1000 ml polyolefine bag sealed in a
Instruction for use/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
Hold the base of the giving set port firmly and grip the wings of the twist off
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 manufacture’s instruction.
MARKETING AUTHORISATION HOLDER
Fresenius Kabi Limited
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT