Skip to Content

STERIFLEX NO 34 GLUCOSE INTRAVENOUS INFUSION BP 50%

Active substance(s): GLUCOSE MONOHYDRATE / GLUCOSE MONOHYDRATE / GLUCOSE MONOHYDRATE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Glucose Infusion BP 50% as Steriflex No. 34 and freeflex

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Steriflex No. 34 has the following composition:
Name
Glucose Monohydrate for Parenteral use BP
(Equivalent to Anhydrous Glucose BP

3

Specification
Reference
EP
EP

%w/v
55
50.0)

PHARMACEUTICAL FORM
Intravenous infusion.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
The product is indicated in simple dehydration, carbohydrate depletion, and
hypoglycaemia.
It can also be used to provide a temporary increase in blood volume in
haemorrhage and shock. It may be combined with amino acid solutions in
parenteral nutrition.

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
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.
Rebound hypoglycaemia may occur following the use of concentrated
solutions of glucose.
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 this product has not been assessed but its use in this period 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

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.

Pre-clinical Safety Data

6

PHARMACEUTICAL PARTICULARS

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Name
Water for Injection in Bulk BP
Hydrochloric Acid BP
Sodium Hydroxide BP

6.2.

Incompatibilities

Specification
Reference
EP
EP
BP

%w/v
To 100
QS
QS

Incompatible with blood, frusemide, hydralazine cyanocobalamin, kanamycin
sulphate, novobiocin sodium or warfarin sodium.
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 to the surface of the bag to varying and significant degrees.

6.3.

Shelf Life
500 & 1000ml PVC Bags - 24 months.
500 & 1000ml Polyolefin Bags - 36 months.

6.4.

Special Precautions for Storage
Store at 2° to 25°C.

6.5.

Nature and Content of Container
The container is a flexible 500 or 1000ml bag made of medical grade PVC.
a)
b)
c)

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.

Or
A flexible 500 or 1000ml polyolefine bag sealed in a polyolefine overwrap.

6.6.

Instructions for Use, Handling and 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 08828/0031.

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
10/05/1989 / 19/02/2009

10

DATE OF REVISION OF THE TEXT
19/02/2009

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide