Pharmaceutical particulars : מידע רוקחי

6      PHARMACEUTICAL PARTICULARS

6.1 List of excipients
None

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

Dry Powder
The expiry date of the product is indicated on the packaging materials.
After reconstitution : Chemical and physical in -use stability has been demonstrated for 5 hours at 2°C to 8°C 
From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

6.4 Special precautions for storage

Store below 25 °C. Keep the vial in the outer carton in order to protect from light.
For storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5 Nature and contents of container

Cefuroxime -Fresenius 750 mg
15 ml glass vial with rubber stopper covered with aluminium seals with plastic flip -off caps.

Cefuroxime -Fresenius 1500 mg
20 ml glass vial with rubber stopper covered with aluminium seals with plastic flip -off caps.

6.6 Special precautions for disposal and other handling
Cefuroxime -Fresenius 750 mg

Instructions for reconstitution

Table 4. Addition volumes and concentrations which may be useful when fractional doses are required.
Addition volumes and solution/suspension concentrations, which may be useful when fractional doses are required
Approximate
Vial size                       Amount of water to be       cefuroxime               Resulting added (ml)                  concentration            Product
)mg/ml) **


750 mg          Intramuscular   3 mL                        216                      Suspension  intravenous     at least 6 mL               116                      Solution bolus
 intravenous     at least 6 mL*              116                      Solution infusion


* Reconstituted solution to be added to 50 or 100 mL of compatible infusion fluid (see information on compatibility, below) 
** The resulting volume of the solution of cefuroxime in reconstitution medium is increased due the displacement factor of the drug substance resulting in the listed concentrations in mg/mL

As for all parenteral medicinal products, inspect the reconstituted solution or suspension visually for particulate matter and discoloration prior to administration.

Intramuscular injection: After addition of the specified amount of diluent for intramuscular injection, a suspension is formed.

Intravenous bolus injection or intravenous infusion: The solution should only be used if the solution is clear and practically free from particles.

Solutions and suspensions range in colour from clear to yellow coloured depending on concentration, diluent and storage conditions used.
Preparation of solution for intravenous infusion
Cefuroxime 750 mg should be reconstituted following the instructions for reconstitution of intravenous injection with water for injection (see table 4 above).

Further dilution should take place in 50-100 ml of one of the following compatible infusion fluids prior to intravenous infusion administration:

Cefuroxime sodium is compatible with the following infusion fluids. It will remain potency for up to 5 hours at 2°C to 8°C in:
− water for injections
− 0.9 % sodium chloride solution

For single use only

Any unused product or waste material should be disposed of in accordance with local requirement 
Cefuroxime -Fresenius 1500 mg

Instructions for reconstitution
Table5 . Addition volumes and solution concentrations, which may be useful when fractional doses are required 
Addition volumes and concentrations, which may be useful when fractional doses are required
Vial size                                     Amount of water to be Approximate                 Resulting product added (ml)            cefuroxime concentration
(mg/mL) **
1.5 g
 intravenous                  at least 15mL            94                       Solution bolus
 intravenous infusion         15 mL*                   94                       Solution 

*Reconstituted solution to be added to 50 or 100 ml of compatible infusion fluid (see information on compatibility, below) 
* The resulting volume of the solution of cefuroxime in reconstitution medium is increased due the displacement factor of the drug substance resulting in the listed concentrations in mg/ml.

As for all parenteral medicinal products, inspect the reconstituted solution visually for particulate matter and discoloration prior to administration.

Intravenous bolus injection or intravenous infusion: The solution should only be used if the solution is clear and practically free from particles.

Solutions range in colour from clear to yellow coloured depending on concentration, diluent and storage conditions used.

Preparation of solution for intravenous infusion
Cefuroxime 1500 mg should be reconstituted following the instructions for reconstitution of intravenous injection with water for injection (see table 5 above).

Further dilution should take place in 50-100 ml of one of the following compatible infusion fluids prior to intravenous infusion administration:
Cefuroxime sodium is compatible with the following infusion fluids. It will remain potency for up to 5 hours at 2°C to 8°C in:  water for injections
0.9 % sodium chloride solution
For single use only

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

Labesfal - Laboratorios Almiro S.A Fresenius Kabi Group
Lagedo, 3465-157 Santiago De Besteiros, Portugal