Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS

6.1. List of excipients
Water for Injection.
6.2. Incompatibilities

Ceftriaxone must not be mixed with calcium-containing solutions including Compound Sodium Lactate solution. See also sections 4.3 and 4.4.
As with all parenteral solutions additives may be incompatible. Compatibility of the additives with the Compound Sodium Lactate solution and Viaflo container must be assessed before addition. After addition of the additive, incompatibility may become visible by a possible colour change and/or the appearance of precipitates, insoluble complexes or crystals.
The Instructions for Use of the medication to be added and other relevant literature must be consulted.
Before adding a substance or medication, verify that it is soluble and/or stable in water and that the pH range of Compound Sodium Lactate solution is appropriate (pH 5.0 to 7.0).
When making additions to Compound Sodium Lactate solution, aseptic technique must be used.
Mix the solution thoroughly when additives have been introduced. Do not store solutions containing additives.
As a guidance the following medications are incompatible with the Compound Sodium Lactate solution (non-exhaustive listing):
•    Medications incompatible with Compound Sodium Lactate solution: Aminocaproic acid
Amphotericin B
Metaraminol tartrate
Cefamandole
Ceftriaxone
Cortisone acetate
Diethylstilbestrol
Etamivan
Ethyl alcohol
Phosphate and carbonate solutions
Oxytetracycline
Thiopental sodium
Versenate disodium
•    Medications with partial incompatibility with Compound Sodium Lactate solution: Tetracycline stable for 12 hours
Ampicillin sodium concentration of 2%-3% stable for 4 hours concentration >3% must be given within 1 hour
Minocycline stable for 12 hours
Doxycycline stable for 6 hours.
Additives known or determined to be incompatible should not be used.

6.3. Shelf life

Shelf life (Unopened): The expiry date of the product is indicated on the packaging materials.
In-use shelf-life: Additives
Chemical and physical stability of any additive at the pH of Compound Sodium Lactate solution in the Viaflo container should be established prior to use.
From a microbiological point of view, the diluted product must be used immediately unless dilution has taken place in controlled and validated aseptic conditions. If not used immediately, in-use storage times and conditions are the responsibility of the user.

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.
Bag sizes: 250ml, 500ml and 1000ml.
The bags are overwrapped with a protective plastic pouch composed of polyamide/polypropylene.
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.

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

Preparation for administration
Use sterile material for preparation and administration.
• Suspend container from eyelet support.
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.
• Use an aseptic method to set up the infusion.
• Attach administration set. Refer to directions accompanying set for connection, priming of the set and administration of the solution.

Techniques for injection of additive medications
Warning: Some additives may be incompatible.
Check additive compatibility with both the solution and container prior to use. 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
•    Disinfect medication site.
•    Using syringe with 19 gauge (1.10 mm) to 22 gauge (0.70 mm) needle, puncture resealable medication port and inject.
•    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
•    Close clamp on the set.
•    Disinfect medication site.
•    Using syringe with 19 gauge (1.10 mm) to 22 gauge (0.70 mm) needle, puncture resealable medication port and inject.
•    Remove container from IV pole and/or turn to an upright position.
•    Evacuate both ports by tapping gently while the container is in an upright position.
•    Mix solution and medication thoroughly.
•    Return container to in-use position, re-open the clamp and continue administration.

7.     LICENCE HOLDER AND MANUFACTURER

Licence holder:
Teva Israel Ltd, 124 Dvora HaNevi'a St, Tel Aviv 6944020 Israel
Manufacturer:
Baxter Healthcare Ltd.
Thetford,
United Kingdom