Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Edetate disodium
Polysorbate 80
Lactose anhydrous
Sodium hydroxide (for pH adjustment) and/or
Hydrochloric acid diluted (for pH adjustment)

6.2   Incompatibilities
EMEND IV is incompatible with any solutions containing divalent cations (e.g., Ca2+, Mg2+), including Hartman’s and lactated Ringer’s solutions. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3   Shelf-life

2 years.
After reconstitution and dilution, chemical and physical in-use stability has been demonstrated for 24 hours at 25°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 and would normally not be longer than 24 hours at 2 to 8°C.

6.4   Special precautions for storage

Store in a refrigerator (2°C - 8°C).
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.

6.5   Nature and contents of container

10 ml Type I clear glass vial with a chlorobutyl or bromobutyl rubber stopper and an aluminum seal with a grey plastic flip off cap.

Each vial contains 150 mg of fosaprepitant. Pack sizes: 1 vial.
6.6   Special precautions for disposal and other handling

EMEND IV must be reconstituted and then diluted prior to administration.
Preparation of EMEND IV 150 mg for intravenous administration:

1.    Inject 5 ml sodium chloride 9 mg/ml (0.9 %) solution for injection into the vial. Assure that sodium chloride 9 mg/ml (0.9 %) solution for injection is added to the vial along the vial wall in order to prevent foaming. Swirl the vial gently. Avoid shaking and jetting sodium chloride 9 mg/ml (0.9 %) solution for injection into the vial.

2.    Prepare an infusion bag filled with 145 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection (for example, by removing 105 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection from a 250 ml sodium chloride 9 mg/ml (0.9 %) solution for injection infusion bag).

3.    Withdraw the entire volume from the vial and transfer it into an infusion bag containing 145 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection to yield a total volume of 150 ml. Gently invert the bag 2-3 times.

The medicinal product must not be reconstituted or mixed with solutions for which physical and chemical compatibility has not been established (see section 6.2).

The appearance of the reconstituted solution is the same as the appearance of the diluent.

The reconstituted and diluted medicinal product should be inspected visually for particulate matter and discoloration before administration.

No special requirements for disposal.