Pharmaceutical particulars : מידע רוקחי

PHARMACEUTICAL PARTICULARS
6.1     List of excipients

Sodium carbonate (anhydrous sterile)

6.2.    Incompatibilities
Fortum is less stable in Sodium Bicarbonate Injection than in other intravenous fluids. It is not recommended as a diluent.

Fortum and aminoglycosides should not be mixed in the same giving set or syringe.
Precipitation has been reported with vancomycin added to ceftazidime in solution. Therefore, it would be prudent to flush giving sets and intravenous lines between administration of these two agents.

6.3.    Shelf life

The expiry date of the product is indicated on the label and packaging.
After reconstitution:
Chemical and physical in-use stability has been demonstrated for 6 days at 4°C and 9 hours at 25°C.

From a microbiological point of view, the reconstituted solution 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 normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

After dilution:
Chemical and physical in-use stability has been demonstrated for 6 days at 4°C and 9 hours at 25°C.

From a microbiological point of view, the reconstituted and diluted solution 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 normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

6.4.    Special precautions for storage

Store below 25°C.
Keep vials in the outer carton to protect from light.

For storage conditions after reconstitution see section 6.3
.

6.5.     Nature and contents of container
Fortum 1 g powder for solution for injection or infusion is packaged in clear Ph.Eur.Type III glass 17 ml, 26 ml, 60 ml or 77 ml vial with a bromobutyl rubber plug and a flip-off type aluminium overseal.
Packs of 1 or 5 vials

Fortum 2 g powder for solution for injection or infusion is packaged in clear Ph.Eur.Type III glass 60 ml or 77 ml vial with a bromobutyl rubber plug and a flip-off type aluminium overseal.
Pack of 1 vial.
Not all pack sizes may be marketed.

6.6.     Special precautions for disposal and other handling

All sizes of vials of Fortum 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 7 and table 8 for addition volumes and solution concentrations, which may be useful when fractional doses are required.

Table 7: Powder for Solution for Injection
Presentation                                Amount of diluent to         Approximate be added (ml)          concentration (mg/ml)
1g
Intramuscular           3 ml                   260
Intravenous bolus       10 ml                  90
2g
Intravenous bolus       10 ml                  170


Note:
• The resulting volume of the solution of ceftazidime in reconstitution medium is increased due to the displacement factor of the drug product resulting in the listed concentrations in mg/ml presented in the above table.

Table 8: Powder for Solution for Infusion
Presentation                                   Amount of diluent to Approximate be added (ml)        concentration
(mg/ml)
1g
Intravenous infusion           50 ml*                20
2g
Intravenous infusion             50 ml*                40
* Addition should be in two stages.

Note:
• The resulting volume of the solution of ceftazidime in reconstitution medium is increased due to the displacement factor of the drug product resulting in the listed concentrations in mg/ml presented in the above table.



Solutions range in colour 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 colour variations.

Ceftazidime at concentrations between 1 mg/ml and 40 mg/ml is compatible with: 
•   sodium chloride 9 mg/ml (0.9%) solution for injection
•   M/6 sodium lactate injection
•   compound sodium lactate injection (Hartmann's solution)
•   5% dextrose injection
•   0.225% sodium chloride and 5% dextrose injection
•   0.45% sodium chloride and 5% dextrose injection
•   0.9% sodium chloride and 5% dextrose injection
•   0.18% sodium chloride and 4% dextrose injection
•   10% dextrose injection
•   Dextran 40 injection 10% in 0.9% sodium chloride injection
•   Dextran 40 injection 10% in 5% dextrose injection
•   Dextran 70 injection 6% in 0.9% sodium chloride injection
•   Dextran 70 injection 6% in 5% dextrose injection 
Ceftazidime at concentrations between 0.05 mg/ml and 0.25 mg/ml is compatible with Intra- peritoneal Dialysis Fluid (Lactate).

Fortum 1 g: Ceftazidime at concentrations detailed in Table 7 may be constituted for intramuscular use with 0.5% or 1% Lidocaine Hydrochloride Injection.

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 the intravenous fluids listed above.

Preparation of solutions for IV infusion from ceftazidime injection in standard vial presentation (mini-bag or burette-type set):

Prepare using a total of 50 ml of compatible diluents (listed above), added in TWO stages as below.

1. Introduce the syringe needle through the vial closure and inject 10 ml of diluent.
2. Withdraw the needle and shake the vial 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 vial 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 the gas relief needle is not inserted through the vial closure before the product has dissolved.
Any residual antibiotic solution should be discarded.

For single use only.

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