Freeflex
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glucose Infusion BP 5% Steriflex No. 6 or freeflex
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Steriflex No. 6 has the following composition:
|
Name |
Specification Reference |
%w/v |
|
Glucose Monohydrate for Parenteral Use BP |
EP |
5.5 |
|
(Equivalent to Anhydrous Glucose BP |
EP |
5.0) |
3 PHARMACEUTICAL FORM
Intravenous infusion.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
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.
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 judgement of the physician.
Elderly
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 used.
For intravenous infusion.
4.3. Contraindications
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.
4.4. 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 consulted.
The label states:
Do not use unless solution is clear and free from particles.
4.5. Interactions with other medicinal products and other forms of interaction
No clinically significant drug interactions known.
4.6. 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
4.7.
Not applicable.
4.8. Undesirable effects
Thrombosis of the chosen vein is always a possibility with intravenous infusion.
4.9. Overdose
Overdosage may lead to fluid overload and hyperglycaemia. Fluid overload may need to be treated with a diuretic and hyperglycaemia with insulin.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Glucose is a monosaccharide, which provides a source of energy.
5.2. Pharmacokinetic properties
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.
5.3. Preclinical safety data
None stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
|
Name |
Specification Reference |
%w/v |
|
Water for Injection in bulk |
EP |
to 100 |
|
Hydrochloric Acid |
EP |
QS |
|
Sodium Hydroxide |
BP |
QS |
6.2. Incompatibilities
Incompatible with blood, frusemide, hydralazine, cyancobalamin, kanamycin sulphate, novobiocin or warfarin sodium.
6.3. Shelf life
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
6.4. Special Precautions for Storage
Store at 2° to 25 °C
6.5. 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 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 50, 100, 150, 250, 500 or 1000 ml polyolefine bag sealed in a polyolefine overwrap.
6.6. 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
close.
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.
7 MARKETING AUTHORISATION HOLDER
Fresenius Kabi Limited
Cestrian Court
Eastgate Way
Runcorn
Cheshire
WA7 1NT
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 08828/0095
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
12/04/2005
10 DATE OF REVISION OF THE TEXT
03/11/2008