Document: spc-doc_PL 08828-0019 change

• spc-doc_PL 08828-0019
• spc-doc_PL 12580-0007

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SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Sodium Chloride 0.18% and Glucose 10% Intravenous Infusion

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Steriflex No. 19 has the following composition:

Name    Specification Reference %w/v

Sodium Chloride for Injections    EP    0.18

Glucose Monohydrate for Parenteral Use EP    11.0

(Equivalent to Anhydrous Glucose 10.0)

3.    Pharmaceutical Form

Intravenous fluid

Clinical Particulars

4.1. Therapeutic Indications

For maintenance treatment of dehydration with carbohydrate loss.

4.2. Posology and Method of Administration

Adults and Children

The volume and rate of infusion will depend upon the requirements of the individual patient and the judgement of the physician.

Elderly

A reduced volume and rate of infusion may be necessary to avoid circulatory overload, particularly in patients with cardiac or renal insufficiency.

For intravenous infusion.

Contra-indications

Patients with impaired renal or cardiac function. The intravenous infusion of glucose containing solutions may be hazardous in patients with impaired liver function. This solution is not suitable for the treatment of insulin coma.

4.4. Special Warnings and Precautions for Use

Glucose-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 label states: Do not use unless solution is free from particles.

4.5. Interactions with other Medicaments and other forms of Interaction

No clinically significant drug interactions.

4.6 Pregnancy and Lactation

The safety of this solution during pregnancy and lactation has not been assessed, but their use during these periods is not considered 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 to24 hours.

4.9. Overdose

Overdosage may lead to fluid overload and electrolyte imbalance and possibly hyperglycaemia.

Hyperglycaemia may need to be treated with insulin and fluid overload with a diuretic. Electrolyte disturbances may need to be treated with either sodium-free or sodium containing intravenous fluids.

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.

Glucose is a monosaccharide which provides a source of energy.

5.2.    Pharmacokinetic Properties

Glucose is metabolised via pyruvic or lactic acid to carbon dioxide and water with the release of energy. All body cells are capable of oxidising glucose and it forms the principal source of energy in cellular metabolism.

5.3.    Preclinical Safety Data

None

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Water for Injection in Bulk Hydrochloric Acid Sodium Hydroxide

6.2. Incompatibilities

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 to the surface of the bag to varying and significant degrees.

Shelf Life

500 ml & 1000 ml PVC Bags:    24 months

500 ml & 1000 ml Polyolefin Bags:    36 months

6.4. Special Precautions for Storage

Store between 2°C and 25°C.

6.5. Nature and Contents of Container

The container is a flexible bag (500ml and l000ml ) 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 500ml & 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