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SODIUM CHLORIDE 0.45% INTRAVENOUS INFUSION

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 0.45% Intravenous Infusion

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Chloride 0.45% Intravenous Infusion has the following composition:
Name
Sodium Chloride

3

Specification
Reference
EP

%w/v
0.45

PHARMACEUTICAL FORM
Intravenous fluid

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Sodium Chloride 0.45% Intravenous Infusion 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.
The effect of saline therapy on dehydration can often be assessed from relief
of symptoms, observation of blood pressure and measurement of the volume
and concentration of urine output.
Elderly
Care should be taken to avoid circulatory overload, particularly in patients
with cardiac and renal insufficiency.

For intravenous infusion.

4.3.

Contra-indications
Intravenous saline solutions may be contra-indicated in patients with impaired
renal or cardiac function.

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 saline will increase potassium loss, so that if it is given,
potassium supplements should also be given. The solution is hypotonic.
The label states: Do not use unless solution is clear and free from particles.

4.5.

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

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
None

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Water for Injections in bulk
Hydrochloric Acid
Sodium Hydroxide

6.2.

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.
Pack size: 500ml

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 AUTHORISATION NUMBER(S)
PL 08828/0018

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of First Authorisation: 20th April 1989
Date of Renewal of Authorisation: November 1999

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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