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 RINGER LACTATED SOLUTION/VIOSER. See also sections 4.3 and 4.4.
As with all parenteral solutions additives may be incompatible. Compatibility of the additives with the RINGER LACTATED SOLUTION/VIOSER 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 RINGER LACTATED SOLUTION/VIOSER is appropriate (pH 5.0 to 7.0).
When making additions to RINGER LACTATED SOLUTION/VIOSER, 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 RINGER LACTATED SOLUTION (non-exhaustive listing):
•   Medications incompatible with RINGER LACTATED 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 RINGER LACTATED 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 RINGER LACTATED SOLUTION/VIOSER 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
Plastic polyethylene bottles: 500 ml and 1000 ml in a package of 10 pieces.
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 containers.

Use only if the solution is clear and the container undamaged.
Do not use if bottle is leaking, solution is cloudy or contains particles.