Pharmaceutical particulars : מידע רוקחי

6.   PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for Injections

6.2 Incompatibilities
Incompatibility of the medicinal product to be added with the solution in the Viaflo container must be assessed before addition. In the absence of compatibility studies, this solution must not be mixed with other medicinal products.

The instructions for use of the medicinal product to be added must be consulted.
Before adding a drug, verify it is soluble and stable in water at the pH of Sodium Chloride 0.9% w/v and Glucose 5% w/v solution (see section 3).

As guidance, the following medications are incompatible with the Sodium Chloride 0.9 % w/v & Glucose 5% w/v solution (non-exhaustive listing):
- Ampicillin sodium
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- Mitomycin
- Amphotericin B
- Erythromycin lactobionate
Those additives known to be incompatible should not be used.

Because of the presence of glucose, Sodium chloride 0.9% w/v and Glucose 5% w/v solution should not be administered simultaneously with blood through the same administration set because of the possibility of pseudoagglutination or haemolysis

6.3   Shelf life

Unopened:          The expiry date of the product is indicated on the packaging materials 

In-use shelf life: Additives
From a physico-chemical viewpoint, solution containing additives should be used immediately unless chemical and physical in-use stability has been established.

From a microbiological point of view, solutions containing additives 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 25°C.
6.5 Nature and contents of container
The bags known as Viaflo are composed of polyolefin/polyamide co-extruded plastic. (PL 2442). The bags are overwrapped with a protective plastic pouch composed of polyamide/polypropylene.

The bag size is 500 or 1000 ml.

Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
Discard after single use.
Discard any unused portion.
Do not reconnect partially used bags.

For method of administration and precautions to be taken before handling or administering the medicinal product, please see also section 4.2.

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 impaired.
c. Check the solution for limpidity and absence of foreign matters. If solution is not clear or contains foreign matters, discard the solution.

2. Preparation for administration
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a. Use sterile material for preparation and administration.
b. Suspend container from eyelet support.
c. 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.
d. Use an aseptic method to set up the infusion e. 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: Additives may be incompatible.
To add medication before administration.
a. Disinfect medication site.
b. Using syringe with 19 to 22 gauge 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. See section 6.3.

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


7. REGISTRATION HOLDER
Teva Israel Ltd. 124 Dvora HaNevi'a St.,
Tel Aviv 6944020 Israel

8. REGISTRATION NUMBER

164-06-35835