Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1. List of excipients
Water for Injections.

6.2. Incompatibilities
Ceftriaxone must not be mixed with calcium-containing solutions including Ringer Lactate S.A.L.F. See also sections 4.3 and 4.4.
As with all parenteral solutions additives may be incompatible. Compatibility of the additives with Ringer Lactate S.A.L.F 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 Lactate S.A.L.F is appropriate (pH 5.5 to 7.0).
When making additions to Ringer Lactate S.A.L.F, 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 Lactate S.A.L.F (non- exhaustive listing):
Aminocaproic acid
Amphotericin B
Metaraminol tartrate
Cefamandole
Ceftriaxone
Cortisone acetate
Diethylstilbestrol
Etamivan
Ethyl alcohol
Phosphate and carbonate solutions
Oxytetracycline
Thiopental sodium
Versenate disodium

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.

6.4. Special precautions for storage
Store below 25°C.
Do not refrigerate or freeze.

6.5. Nature and contents of container
500 ml PP bottle.
6.6. Special precautions for disposal and other handling
After opening the container, the contents should be used immediately and should not be stored for a subsequent infusion.
Shake well before administration. Do not use this medicine if the solution is not clear and colourless or if it contains particles.
Take all usual precautions to maintain sterility before and during intravenous infusion. Any unused product or waste material should be disposed of in accordance with local requirements.