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SODIUM CHLORIDE INFUSION BP 0.9% AS STERIFLEX NO. 1 OR FREEFLEX

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

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Sodium Chloride Infusion BP 0.9%, as Steriflex No. 1 or freeflex

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Steriflex No. 1 has the following composition:
Sodium Chloride for Injections 0.9% w/v

3

PHARMACEUTICAL FORM
Intravenous infusion.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Steriflex No 1 is used in the treatment of dehydration to correct water and
electrolyte depletion.
The smaller volume containers may be used as a diluent and delivery system
when administering compatible additives so as to avoid the risk of any over
dilution of the additive drug.
For intravenous infusion.

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.
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.

4.3

Contraindications
Patients with sodium overload. It is well known that this 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
This product is not suitable for protracted use unless there is heavy continued
loss of electrolyte, even then it should be used with care. 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 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 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 this 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
duiretic.

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 Specification
Water for Injections in bulk BP
Hydrochloric Acid BP
Sodium Hydroxide BP

6.2

%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
50, 100, 150 & 250ml PVC Bags - 18 months.
330, 500 & 1000ml PVC Bags – 24 months.
50, 100 & 150ml Polyolefin Bags – 24 months
250, 330, 500 & 1000ml 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 50, 100, 150, 250, 330, 500 or 1000ml flexible 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, 330, 500 or 1000ml polyolefine bag
sealed in a polyolefine overwrap.

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
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 08828/0084.

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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