Freeflex
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glucose Infusion BP 10% as Steriflex No. 7, freeflex or KabiPac.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Steriflex No. 7 has the following composition:
|
Name |
Specification Reference |
%w/v |
|
Glucose Monohydrate |
EP |
11.0 |
|
(Equivalent to Anhydrous Glucose BP |
EP |
10.0 |
3 PHARMACEUTICAL FORM
Intravenous infusion.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
The product in indicated in simple dehydration, carbohydrate depletion, and hypoglycaemia coma. It can also be used to provide a temporary increase in blood volume in haemorrhage and shock.
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.
For intravenous infusion via a central vein.
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 label states: Do not use unless solution is clear and free from particles.
4.5 Interaction with other medicinal products and other forms of interaction
No clinically significant drug interactions known.
4.6 Fertility, pregnancy and lactation
The safety of this product during pregnancy and lactation has not been assessed. But its use during these periods is not considered to constitute a hazard.
4.7 Effects on ability to drive and use machines
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 principal 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 BP |
EP |
To 100 |
|
Hydrochloric Acid BP |
EP |
QS |
|
Sodium HydroxideBP |
BP |
QS |
6.2 Incompatibilities
Incompatible with blood, frusemide, hydralazine cyanocobalamin, kanamycin sulphate, novobiocin sodium or warfarin sodium.
6.3 Shelf life
500 & 1000ml PVC Bags - 24 months.
500 & 1000ml Polyolefin Bags - 36 months.
500 & 1000ml Polyethylene bottle with cap and administration/addition points: 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 500 or 1000ml polyolefine bag sealed in a polyolefine overwrap.
Or
A 500 or 1000ml polyethylene bottle with a cap with an administration point and an addition point (KabiPac).
6.6 Special precautions for 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(S)
PL 08828/0096
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
05/06/1989 / 25/09/2002
10 DATE OF REVISION OF THE TEXT
23/09/2009