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SODIUM CHLORIDE 2.7% INTRAVENOUS INFUSION

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 2.7% Intravenous Infusion

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Chloride 2.7% Intravenous Infusion has the following composition:
Name
Sodium Chloride

3.

Specification
Reference

%w/v

EP

2.7

PHARMACEUTICAL FORM
Intravenous fluid

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Sodium Chloride 2.7% Intravenous Infusion is used in the treatment of acute sodium
deficiency and water intoxication.

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.
For intravenous infusion.

4.3.

Contra-Indications
Patients with sodium overload. This may occur with myocardial and renal
damage, but it should also be appreciated 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 Special Precautions for Use
Sodium Chloride 2.7% Intravenous Infusion is not suitable for protracted use

unless there is heavy continued loss of electrolytes; 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. A too rapid injection
of hypertonic saline may cause sudden cardiac arrest or circulatory
overloading. In potassium deficient patients administration of saline will
increase potassium loss, so that if it is given, potassium supplements should
also be given. The solution is hypertonic.
The label states: Do not use unless the solution is clear and free from particles.

4.5. Interactions with other Medicinal Products and other Forms of
Interaction
No clinically significant interactions known.

4.6.

Pregnancy and Lactation
The safety of the Sodium Chloride 2.7% Intravenous Infusion 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, electrolyte imbalance, in particular
hypematraemia.
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
No data available.

5.3.

Pre-clinical Safety Data

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients
Name
Water for Injections in bulk
Hydrochloric Acid
Sodium Hydroxide

6.2.

Incompatibilities

Specification Reference
EP
EP
BP

%w/v
TO 100
QS
QS

Incompatible with amiodarone, amphotericin B, amsacrine and sodium
nitroprusside.

6.3.

Shelf-Life
36 months.

6.4.

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

6.5.

Nature and Contents of Container
Sealed semi-rigid, cylindrical neutral polythene container with a ‘Twist-off’
seal at one end and a ring tab at the opposite end
Or
A flexible polyolefine bag sealed in a polyolefine overwrap.

6.6.

Instruction for Use, Handling and Disposal
Do not dilute before use.
Use standard sterile peritoneal dialysis equipment.
OR
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 AUTHORIZATION NUMBER
PL 08828/0052

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of First Authorisation: 20th April 1989
Date of Renewal of Authorisation: 17th February 2009

10

DATE OF REVISION OF THE TEXT
22/02/2010

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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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