Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

L-Arginine
Sodium chloride
Citric acid, anhydrous

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

The expiry date of the product is indicated on the packaging materials.
After reconstitution and dilution, chemical and physical in-use stability has been demonstrated for 24 hours at room temperature or 4 days at 2 to 8°C. The medicinal product is photosensitive and should be protected from light when not stored in the original carton.

From a microbiological point of view, the medicinal product should be used immediately upon reconstitution.
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/dilution has taken place in controlled and validated aseptic conditions.

6.4   Special precautions for storage

Store in a refrigerator (2°C   – 8°C).
Store in the original package in order to protect from light.

For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.

6.5   Nature and contents of container
20 mL vial (Type I clear glass) with stopper (bromobutyl rubber) and flip-off seal.

Pack size of 10 vials.

6.6   Special precautions for disposal and other handling
Each vial is for single use only.

Aseptic technique must be followed in preparing the infusion solution.

Preparation of doses
The powder for concentrate for solution for infusion for each vial is reconstituted with 10 mL of water for injections or sodium chloride 9 mg/mL (0.9%) solution for injection per vial; following reconstitution the vial should be shaken gently to dissolve the powder. The final volume is approximately 11.4 mL per vial. The resultant concentration is approximately 132 mg/mL (88 mg/mL of ceftolozane and 44 mg/mL of tazobactam) per vial.

CAUTION: THE RECONSTITUTED SOLUTION IS NOT FOR DIRECT INJECTION.

Zerbaxa solution for infusion is clear and colourless to slightly yellow.

Variations in colour within this range do not affect the potency of the product.

See section 4.2 for recommended dose regimens for Zerbaxa based on indication and renal function. The preparation for each dose is shown below.

Instructions for preparing doses in INFUSION BAG:

For preparation of the 2 g ceftolozane / 1 g tazobactam dose: Withdraw the entire contents from two reconstituted vials (approximately 11.4 mL per vial) using a syringe and add it to an infusion bag containing 100 mL of 0.9% sodium chloride for injection (normal saline) or 5% glucose injection.

For preparation of the 1 g ceftolozane / 0.5 g tazobactam dose: Withdraw the entire contents (approximately 11.4 mL) of the reconstituted vial using a syringe and add it to an infusion bag containing 100 mL of 0.9% sodium chloride for injection (normal saline) or 5% glucose injection.

For preparation of the 500 mg ceftolozane / 250 mg tazobactam dose: Withdraw 5.7 mL of the contents of the reconstituted vial and add it to an infusion bag containing 100 mL of 0.9% sodium chloride for injection (normal saline) or 5% glucose injection.

For preparation of the 250 mg ceftolozane / 125 mg tazobactam dose: Withdraw 2.9 mL of the contents of the reconstituted vial and add it to an infusion bag containing 100 mL of 0.9% sodium chloride for injection (normal saline) or 5% glucose injection.

For preparation of the 100 mg ceftolozane / 50 mg tazobactam dose: Withdraw 1.2 mL of the contents of the reconstituted vial and add it to an infusion bag containing 100 mL of 0.9% sodium chloride for injection (normal saline) or 5% glucose injection.



One of the active ingredients, ceftolozane, may have harmful effects if it reaches the aquatic environment (see section 5.3). Do not throw away any unused medicinal product or waste material via wastewater. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. These measures will help protect the environment.


7.    LICENCE HOLDER AND IMPORTER
Merck Sharp & Dohme (Israel-1996) Company Ltd.,        34 Ha’charash St., Hod-Hasharon.