Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
NA
6.2 Incompatibilities
Based on literature reports, ceftriaxone is not compatible with amsacrine, vancomycin, fluconazole and aminoglycosides.
Solutions containing ceftriaxone should not be mixed with or added to other agents except those mentioned in section 4.2. In particular diluents containing calcium, (e.g. Ringer’s solution, Hartmann’s solution) should not be used to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for intravenous administration because a precipitate can form.
Ceftriaxone must not be mixed or administered simultaneously with calcium containing solutions including total parenteral nutrition (see section 4.2, 4.3, 4.4 and 4.8).
6.3 Shelf life
The expiry date of the product is indicated on the packaging materials.
6.4 Special precautions for storage
Do not store above 25°C.
Keep in the outer carton in order to protect from light. Storage conditions after reconstitution 24 hours at 2-8°C.
6 hours below 25°C.
From a microbiological point of view the 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 not normally be longer than 24 hours at 2-8°C, unless reconstitution/ dilution has taken place in controlled and validated aseptic conditions.
7. MARKETING AUTHORISATION HOLDER
Vitamed Phramceutical Industries Ltd., 6 Hatachana St., P.O.Box 114, Binyamina 30550020.
8. MARKETING AUTHORISATION NUMBER
159 42 34699 00