SODIUM CHLORIDE INTRAVENOUS INFUSION BP 0.9% [SIN09600P]

Product Info

SODIUM CHLORIDE INTRAVENOUS INFUSION BP 0.9%

[SIN09600P]

4.1 THERAPEUTIC INDICATIONS

Baxter Sodium Chloride 0.9% IV Infusion is indicated for extracellular fluid replacement and in the management of metabolic alkalosis in the presence of fluid loss, and for restoring or maintaining the concentration of sodium and chloride ions.

4.2 DOSE AND METHOD OF ADMINISTRATION

General directive

Baxter Sodium Chloride IV Infusion is for intravenous infusion.

To be used as directed by the doctor.

Dosage, rate, and duration of administration are to be individualised and depend upon the indication for use, the patient’s age, weight, clinical condition, and concomitant treatment, and on the patient’s clinical and laboratory response to treatment.

Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration whenever solution and container permit. The solution should be clear and free from particles. Do not administer unless solution is clear and seal is intact.

Additives may be incompatible. Suitability of potential additives has not been demonstrated. Complete information is not available. Those additives known to be incompatible should not be used. Before adding a substance or medication, verify that it is soluble and/or stable in water and that the pH range of Baxter Sodium Chloride IV Infusion is appropriate. The instructions for use of the medication to be added and other relevant literature must be consulted. Consult with a pharmacist, if available.

If in the informed judgment of the doctor, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. After addition, check for a possible colour change and/or the appearance of precipitates, insoluble complexes or crystals. Do not store solutions containing additives. The stability of this product when mixed with additive has not been demonstrated (see section 4.4 Special Warnings and Precautions for Use and section 4.5 Interactions with Other Medicines and Other Forms of Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

When other electrolytes or medicines are added to this solution, the dosage and the infusion rate will also be dictated by the dose regimen of the additions.

The product should be used for one patient on one occasion only. Any unused portion should be discarded.

Direction for use of VIAFLEX plastic container

Warning: Do not use flexible plastic containers in series connections. Such use could result in embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.

Pressurising intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration.

Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.

To open: Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilisation process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard the product as sterility may be impaired. If supplemental medication is desired, follow directions below.

Preparation for administration: Baxter Sodium Chloride IV Infusion is a sterile preparation. Thus, aseptic technique must be applied throughout the administration.

1. Suspend container from eyelet support.

2. Remove plastic protector from outlet port at the bottom of container.

3. Attach administration set.

To add Medications:

Warning: Additives may be incompatible (see section 4.4 Special Warnings and Precautions for Use and section 4.5 Interactions with Other Medicines and Other Forms of Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• To add medication before solution administration: Supplemental medication may be added with needle through the medication injection port. To proceed, swab medication site (port) with alcohol swab. Using syringe with 0.63 to 0.80 mm needle, puncture resealable medication port and inject. Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.

• To add medication during solution administration: Close clamp on the set. Prepare medication port. Using syringe with 0.63 to 0.80 mm needle, puncture resealable medication port and inject. Remove container from IV pole and/or turn to upright position. Evaluate both ports by squeezing them while container is in the upright position. Mix solution and medication thoroughly. Return container to in use position and continue administration.

4.3 CONTRAINDICATIONS

The use of Baxter Sodium Chloride IV Infusion requires careful evaluation of risks and benefits by the attending physician. It must not be used in the following conditions unless the physician has determined that potential benefits outweigh risks:

• congestive heart failure,

• severe impairment of renal function,

• clinical states in which there exists oedema with sodium retention (see section 4.4 Special Warnings and Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).