Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1 List of excipients
None.

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
Store below 25ºC and keep the vial in original package in order to protect from light.
Storage conditions after reconstitution:
Chemical and physical in-use stability has been demonstrated for 12 hours at 25°C and for 2 days at 2°C to 8°C.
From a microbiological point of view, the product should be used immediately. If not used immediately. If not used immediately, in-use storage times and conditions are in the responsibility of the user and would normally be no longer than 24 hours at 2- 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

6.5 Nature and contents of container
15 ml glass vial of hydrolytic class 2 or 3 (Ph. Eur.), stopper made of butyl rubber with aluminium cap.
Pack sizes: 1, 5, 10, 50 vials.


6.6 Special precautions for disposal and other handling
Ceftriaxone should not be mixed in the same syringe with any drug other than 1% lidocaine hydrochloride solution (for intramuscular injection only).

The reconstituted solution should be shaken up to 60 seconds to ensure complete dissolution of ceftriaxone.

Compatibility with the following solutions has been demonstrated: - 0.9% NaCl solution (9 mg/ml)
- 1% Lidocaine hydrochloride solution (10 mg/ml)
- 5% Glucose (50 mg/ml)
- Water for Injection

Only the diluents mentioned in the tables below should be used for reconstitution for the relevant route of administration.

Intramuscular injection:
Diluent         Ceftriaxone Volume      Approximate powder      of          concentration of diluent     ceftriaxone in the final solution
1%               1g           3.5 ml    285.7 mg/ml
Lidocaine hydrochloride solution
The solution should be administered by deep intragluteal injection.
Solutions of lidocaine should not be administered intravenously.

Intravenous injection:
Diluent       Ceftriaxone Volume       Approximate powder      of           concentration of diluent      ceftriaxone in the final solution
Water for     1g             10 ml     100 mg/ml injections
The injection should be administered over 5 minutes, directly into the vein or via the tubing of an intravenous infusion.

The reconstituted solutions for injection show a pale yellow colouration which does not impair the efficacy or tolerability of Ceftriaxone – Fresenius.

Intravenous infusion:
Diluent       Ceftriaxone Volume       Approximate powder      of           concentration of diluent      ceftriaxone in the final solution
0.9% NaCl  1g                20 ml       50 mg/ml solution
5% Glucose 1 g               20 ml       50 mg/ml solution

The reconstitution of the ready to use solution for infusion has to take place in two steps in order to allow the reconstitution of the necessary volume of solution for infusion:

1. Ceftriaxone - Fresenius 1 g Powder for solution for infusion is reconstituted with 10 ml of one of the compatible intravenous fluids in its vial. This solution has to be transferred into a suitable infusion bag. Controlled and validated aseptic conditions have to be observed.

2. This solution should be diluted with 9.5 ml more of diluent giving a final volume of 20 ml and a concentration of 50 mg/ml.

The infusion should be administered over at least 30 minutes.
It is recommended to rinse the infusion line with one of the diluents at the end of the infusion to assure that the total volume with Ceftriaxone - Fresenius was administered.

(Please refer to section 4.2 for more information).

Reconstituted solutions should be inspected visually. Only clear solutions free of visible particles should be used. The reconstituted product is for single use only and any unused solution must be discarded.

Any unused product or waste material should be disposed of in accordance with local requirements.


7.   Registration Holder
Neopharm (Israel) 1996 LTD
Hashiloach 6, POB 7063 Petach Tiqva 4917001