Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Anhydrous sodium carbonate, sterile

6.2 Incompatibilities

Ceftazidime should not be mixed with solutions with a pH above 7.5 for example sodium bicarbonate solution for injection. Ceftazidime and aminoglycosides should not be mixed in the solution for injection because of the risk for precipitation.
Cannulae and catheters for intravenous use should be flushed with physiological salt-solution between administrations of ceftazidime and vancomycin to avoid precipitation.

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6 
6.3 Shelf-life

The expiry date of the product is indicated on the packaging materials.
Reconstituted solution: Chemical and physical in use stability has been demonstrated up to 6 h at 25ºC and 12 h at 5ºC after reconstitution of the product with water for injection, 1 % lidocain solution, 0.9 % sodium chloride solution, ringer lactate and 10 % glucose solution.
From a microbiological point of view, the product should be used immediately 
6.4 Special precautions for storage

Keep the vial/bottle in the outer carton in order to protect from light.
Do not store above 25ºC.
For storage conditions after reconstitution of the medicinal product, see section 6.3.
6.5 Nature and contents of container

Ceftazidime Fresenius 1000 mg powder for solution for injection
Nature: Colourless type II glass vials closed with type I rubber stoppers covered with aluminium caps and plastic flip off caps.Contents: Each pack contains:
1 x 10 ml vial
10 x 10 ml vials

Ceftazidime Fresenius 2000 mg powder for solution for injection or infusion Nature: Colourless type II glass bottles closed with type I rubber stoppers covered with aluminium caps and plastic flip off caps.
Contents: Each pack contains:
10 x 50 ml bottles


Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling

All sizes of vials of Ceftazidime are supplied under reduced pressure. As the product dissolves, carbon dioxide is released and a positive pressure develops. Small bubbles of carbon dioxide in the constituted solution may be ignored.

Instructions for constitution
See table for addition volumes and solution concentrations, which may be useful when fractional doses are required.

Vial/Bottle size                             Amount of diluent to           Approximate concentration be added (ml)                  (mg/ml)
1 g powder for solution for injection

1g           Intramuscular                    3 ml                          260 Intravenous bolus                10 ml                         90
2 g powder for solution for injection or infusion

2g            Intravenous bolus              10 ml                          170
Intravenous infusion           50 ml*                         40
* Addition should be in 2 stages

Compatible intravenous fluids:
At ceftazidime concentrations between 40mg/ml and 260 mg/ml, the Ceftazidime Fresenius powders for injection may be mixed in commonly used solutions for infusion:
- sodium chloride 9 mg/ml (0.9%) solution (physiological saline solution), - Ringer Lactate Solution
- Glucose 100 mg/ml (10%) solution


When reconstituted for intramuscular use, the Ceftazidime Fresenius powder for injection can also be diluted with lidocaine 10 mg/ml (1%) solutions.

When ceftazidime is dissolved, carbon dioxide is released and a positive pressure develops. For ease of use, the recommended techniques of reconstitution described below should be followed.

Instructions for reconstitution:

1g IM/IV:
Preparation of solutions for bolus injection
1. Insert the syringe needle through the vial closure and inject the recommended volume of diluent. The vacuum may assist entry of the diluent. Remove the syringe needle.
2. Shake to dissolve: carbon dioxide is released and a clear solution will be obtained in about 1 to 2 minutes.
3. Invert the vial. With the syringe plunger fully depressed, insert the needle through the vial closure and withdraw the total volume of solution into the syringe (the pressure in the vial may aid withdrawal). Ensure that the needle 
remains within the solution and does not enter the head space. The withdrawn solution may contain small bubbles of carbon dioxide; they may be disregarded.

These solutions may be given directly into the vein or introduced into the tubing of a giving set if the patient is receiving parenteral fluids. Ceftazidime is compatible with above mentioned intravenous fluids.

For 2g infusion bottles
Preparation of solutions for iv infusion from ceftazidime injection in standard bottle presentation (minibag or burette-type set):

1. Introduce the syringe needle through the bottle closure and inject 10 ml of diluent.
2. Withdraw the needle and shake the bottle to give a clear solution.
3. Do not insert a gas relief needle until the product has dissolved. Insert a gas relief needle through the bottle closure to relieve the internal pressure.
4. Transfer the reconstituted solution to final delivery vehicle (e.g. mini-bag or burette-type set) making up a total volume of at least 50 ml and administer by intravenous infusion over 15 to 30 min.

NOTE: To preserve product sterility, it is important that a gas relief needle is not inserted through the vial/bottle closure before the product has dissolved.

The dilution is to be made under aseptic conditions.
Single use only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Only clear solutions practically free from particles should be used.
Free from bacterial endotoxins.

Solutions range from light yellow to amber depending on concentration, diluent and storage conditions used.
Within the stated recommendations, product potency is not adversely affected by such color variations.