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SODIUM CHLORIDE 1.8% INTRAVENOUS INFUSION

Active substance(s): SODIUM CHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Sodium Chloride 1.8% Intravenous Infusion

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Chloride 1.8% Intravenous Infusion has the following composition:
Name
Sodium Chloride

3

Specification
Reference
EP

%w/v
1.8

PHARMACEUTICAL FORM
Intravenous fluid

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Sodium Chloride 1.8% 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 Precautions for Use
Caution is necessary when considering the use of this solution in patients with
cardiac failure, hypertension, impaired renal function and peripheral or
pulmonary oedema and toxaemia of pregnancy
The label states: Do not use unless the solution is clear and free from particles.

4.5.

Interactions with other Medicaments and other forms of Interaction
No clinically significant interactions known.

4.6.

Pregnancy and Lactation
The safety of Sodium Chloride 1.8% 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.

Preclinical Safety Data

N/A

Pharmaceutical Particulars
6.1.

List of Excipients

Name Specification Reference
Water for Injections in bulk EP
Hydrochloric Acid EP
QS
Sodium Hydroxide BP
QS

6.2.

%w/v
TO 100

Incompatibilities
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.
The container is overwrapped in polyethylene.

6.6.

Instruction for Use/Handling
Do not dilute before use.
Use standard sterile peritoneal dialysis equipment.

7

MARKETING AUTHORISATION HOLDER
Fresenius Kabi Limited
Cestrian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT

8.

Marketing Authorization Number
PL 08828/0053

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of First Authorisation: 25th April 1989
Date of Renewal of Authorisation: 16th November 1994

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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