Pharmaceutical particulars : מידע רוקחי

6        PHARMACEUTICAL PARTICULARS
6.1      List of excipients

Water for Injections
Sodium hydroxide (1N)

6.2     Incompatibilities
Additives
When introducing additives to Plasma-Lyte 148 (pH 7.4), aseptic technique must be used.
Mix the solution thoroughly when additives have been introduced. Do not store solutions containing additives.

Incompatibility of the medicinal product to be added with the solution in Viaflo container must be assessed before addition.

The Instructions for Use of the medicinal product to be added must be consulted.

Before adding a substance or medication, verify it is soluble and/or stable in water and that the pH range of Plasma-Lyte 148 (pH 7.4) is appropriate (pH 6.5 - 8.0). After addition, check for a possible colour change and/or the appearance of precipitates, insoluble complexes or crystals.

Those additives known to be incompatible should not be used.

6.3      Shelf life
The expiry date of the product is indicated on the packaging materials.
Shelf life after first opening: The product should be used immediately after opening.
In-use shelf-life after reconstitution with additives:
From a microbiological point of view, the diluted product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C unless reconstitution has taken place in controlled and validated aseptic conditions.


6.4      Special precautions for storage
Store below 250C.

For storage conditions after reconstitution of additives with the medicinal product, see section 6.3.

6.5       Nature and contents of container

The bags are composed of polypropylene/ polyamide/polyethylene\. The bags are overwrapped with a protective plastic pouch which serves only to provide physical protection to the bags.

The bag size is either 500 or 1000ml.

Not all pack sizes may be marketed.
6.6       Special precautions for disposal

After opening the container, the contents should be used immediately and should not be stored for a subsequent infusion.

Discard after single use.
Discard any unused portion.
Do not reconnect partially used bags.

1.    Opening a. Remove the Viaflo container from the overpouch just before use.
b. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution, as sterility may be broken.
c. Check the solution for clarity and absence of foreign matters. If solution is not clear or contains foreign matters, discard the solution.

2.    Preparation for administration
Use sterile material for preparation and administration.
a. Suspend container from eyelet support.
b. Remove plastic protector from outlet port at bottom of container: -               grip the small wing on the neck of the port with one hand, -              grip the large wing on the cap with the other hand and twist, -              the cap will pop off.
c. Use an aseptic method to set up the infusion.
d. Attach administration set. Refer to complete directions accompanying set for connection, priming of the set and administration of the solution.

3.   Techniques for injection of additive medications
Warning: Some additives may be incompatible
When additive is used, verify isotonicity prior to parenteral administration.
Thorough and careful aseptic mixing of any additive is mandatory. Solutions containing additives should be used immediately and not stored.

To add medication before administration a. Disinfect the medication site.
b. Using a syringe with 19 gauge (1.10 mm) to 22 gauge (0.70 mm) needle, puncture resealable medication port and inject.
c. Mix solution and medication thoroughly. For high-density medication such as potassium chloride, tap the ports gently while ports are upright and mix.

Caution: Do not store bags containing added medications.

To add medication during administration a. Close clamp on the set.
b. Disinfect medication site.
c. Using syringe with 19 gauge (1.10 mm) to 22 gauge (0.70 mm) needle, puncture resealable medication port and inject.
d. Remove container from IV pole and/or turn to an upright position.
e. Evacuate both ports by tapping gently while the container is in an upright position.
f. Mix solution and medication thoroughly.
g. Return container to in use position, re-open the clamp and continue administration.

7.       REGISTRATION NUMBER

163-51-35362