Sulperazon 1 g

5. How to store Sulperazon

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
The prepared solution can be stored for 24 hours after reconstitution.
Do not use this medicine after the expiry date stated on the carton after "Expiry Date (EXP)". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Sulperazon contains

Sulperazon 1 g
The active substances of the medicine are cefoperazone and sulbactam.
Each vial contains 500 mg of cefoperazone in the form of cefoperazone sodium (517 mg) and 500 mg of sulbactam in the form of sulbactam sodium (547 mg).
Sulperazon 2 g

• The active substances of the medicine are cefoperazone and sulbactam. Each vial contains 1000 mg of cefoperazone in the form of cefoperazone sodium (1034 mg) and 1000 mg of sulbactam in the form of sulbactam sodium (1094 mg).

The medicine does not contain any other ingredients.

What Sulperazon looks like and what the pack contains

A vial made of colorless glass, sealed with a silicone, gray, bromobutyl, teflon-coated or EFTE plug, closed with an aluminum cap with a plastic flip-off lid.
A cardboard box containing 1 vial with 500 mg of cefoperazone and 500 mg of sulbactam (Sulperazon 1 g) or 1000 mg of cefoperazone and 1000 mg of sulbactam (Sulperazon 2 g).

Marketing authorization holder:

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Manufacturer:

Haupt Pharma Latina S.r.l., Latina (LT), Strada Statale 156 Km 47,600, 04100 Borgo San Michele, Italy

For more information about this medicine, you should contact the marketing authorization holder:

Pfizer Polska Sp. z o.o.
phone: 22 335 61 00

Date of last revision of the leaflet:

Information intended for healthcare professionals only

Incompatibilities

Aminoglycosides
Due to physical incompatibility, the solution of Sulperazon should not be mixed with aminoglycosides. If combination therapy is considered, it can be performed in consecutive, short-term intravenous infusions using two intravenous catheters, which should be flushed with a suitable diluent between the administration of the medicines (Sulperazon and aminoglycosides). It is also recommended that the doses of Sulperazon administered during the day be spaced out as much as possible between the administration of Sulperazon and aminoglycosides.
Ringer's lactate solution
Due to the possibility of incompatibility, Ringer's lactate solution should not be used for initial dissolution of the medicine. However, in a two-stage dissolution process, after initial dissolution of the powder in water for injection (as described above), the solution can be diluted with Ringer's lactate solution to achieve a sulbactam concentration of 5 mg/ml (2 ml of solution after initial dissolution in water for injection in 50 ml or 4 ml of solution after initial dissolution in water for injection in 100 ml of Ringer's lactate solution).
Lidocaine
Due to the possibility of incompatibility, 2% lidocaine hydrochloride solution should not be used for initial dissolution of the medicine. However, in a two-stage dissolution process, after initial dissolution of the powder in water for injection (as described above), the solution can be diluted with 2% lidocaine hydrochloride solution to achieve concentrations of up to 250 mg of cefoperazone and 125 mg of sulbactam per 1 ml of lidocaine hydrochloride solution at a concentration of approximately 0.5%.

Preparation of the medicine for administration

The medicine containing cefoperazone and sulbactam is available in vials containing 1.0 g or 2.0 g of the medicine.
It has been shown that Sulperazon, which contains cefoperazone and sulbactam, is compatible with the following solvents: water for injection, 5% glucose solution, 0.9% sodium chloride solution, 5% glucose solution in 0.225% sodium chloride solution, and 5% glucose solution in 0.9% sodium chloride solution.
Cefoperazone is compatible at concentrations in the range of 10-250 mg/ml of solvent. Sulbactam is compatible at concentrations in the range of 5-125 mg/ml of solvent.
Ringer's lactate solution
For initial dissolution of the medicine, water for injection should be used. In a two-stage dissolution process, after dissolving the medicine in water for injection (as described above), the solution can be diluted with Ringer's lactate solution to achieve a sulbactam concentration of 5 mg/ml (2 ml of solution after initial dissolution in water for injection in 50 ml or 4 ml of solution after initial dissolution in water for injection in 100 ml of Ringer's lactate solution).
Lidocaine
For initial dissolution of the medicine, water for injection should be used. To achieve a cefoperazone concentration of 250 mg/ml or higher in a two-stage dissolution process, after dissolving the medicine in water for injection (as described above), the solution can be diluted with 2% lidocaine hydrochloride solution to achieve solutions containing up to 250 mg of cefoperazone and 125 mg of sulbactam per 1 ml of lidocaine hydrochloride solution at a concentration of approximately 0.5%.

Method of administration

Intravenous administration
For short-term intravenous infusions, the contents of each vial of Sulperazon should be dissolved in an appropriate volume of 5% glucose solution, 0.9% sodium chloride solution, or sterile water for injection, and then diluted with the same solution to a volume of 20 ml. The infusion should last from 15 to 60 minutes.
Ringer's lactate solution can be used for intravenous administration, but it should not be used for initial dissolution of the medicine. However, it can be used for intravenous infusion as a diluent for the previously dissolved Sulperazon powder.
For intravenous injections, the contents of each vial should be dissolved as described above. The medicine should be administered over at least 3 minutes.
Intramuscular administration
For intramuscular injections, 2% lidocaine hydrochloride solution can be used as a diluent, but it should not be used for initial dissolution of the medicine.