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STERIFLEX NO. 2 OR FREEFLEX SODIUM CHLORIDE 0.45% IV INFUSION BP

Active substance(s): SODIUM CHLORIDE INJECTION / SODIUM CHLORIDE INJECTION / SODIUM CHLORIDE INJECTION

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Sodium Chloride Infusion BP 0.45% as Steriflex No. 2 or freeflex

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Steriflex No. 2 has the following composition:
Name
Sodium Chloride for Injections

3.

Specification
Reference
EP

%w/v
0.45

PHARMACEUTICAL FORM

Intravenous infusion.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

This product is used in the treatment of dehydration associated with hyperosmolarity
(hypernatraemia).

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 the judgement of the physician.
Elderly
Care should be taken to avoid circulatory overload, particularly in patients with
cardiac and renal insufficiency.

Intravenous infusion.

4.3

Contraindications

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
unwanted sodium.

4.4

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.

4.5

Interaction with other medicinal products and other forms of interaction

No clinically significant interactions.

4.6

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.

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. If
infusion is protracted then another vein should be selected after 12 – 24 hours.

4.9

Overdose

Overdosage may lead to fluid overload and electrolyte imbalance. Treatment should
consist of discontinuing the infusion and if necessary administering a diuretic.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Sodium chloride provides a source of sodium and chloride ions to maintain the
osmotic tension of the extracellular fluid and tissues.

5.2

Pharmacokinetic properties

Not applicable

5.3

Preclinical safety data
Not Applicable

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

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

6.2

Specification
Reference
EP
EP
BP

%w/v
To 100
QS
QS

Incompatibilities

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.

6.3

Shelf life

500ml PVC Bags - 24 months
500ml Polyolefin Bags – 36 months

6.4

Special precautions for storage

Store between 2 and 25oC

6.5

Nature and contents of container

The container is a 500ml flexible 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 500ml polyolefine bag sealed in a polyolefine overwrap.

6.6

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.

7.

MARKETING AUTHORISATION HOLDER

Fresenius Kabi Limited
Cestrian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT
UK

8.

MARKETING AUTHORISATION NUMBER

PL 08828/0036.

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
23/02/2011

10

DATE OF REVISION OF THE TEXT
23/02/2011

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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.

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