SODIUM CHLORIDE 2.7% INTRAVENOUS INFUSION - summary of medicine 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                            S­pecification     %w/v

Reference

Sodium Chloride                        EP          2.7

3. 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.

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

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 THEAUTHORISATION

Date of First Authorisation: 20th April 1989

Date of Renewal of Authorisation: 17th February 2009