Pharmaceutical particulars : מידע רוקחי

6       PHARMACEUTICAL PARTICULARS
6.1     List of excipients

Mannitol
Polysorbate 80
Fructose
Tartaric acid
Sodium hydroxide (for pH-adjustment)
Hydrochloric acid (for pH-adjustment)

6.2     Incompatibilities
This medicinal product must not be mixed with other medicinal products or electrolytes except those mentioned in section 6.6.

6.3     Shelf life


The expiry date of the product is indicated on the packaging materials.

Reconstituted solution:
The reconstituted solution may be stored at up to 25°C for up to 24 hours.

Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 24 hours at 25ºC.

From a microbiological point of view, following good aseptic practices, the reconstituted solution can be utilized for up to 24 hours when stored at 25ºC.

Infusion solution:

The infusion solution may be stored at 25ºC for 48 hours. Do not freeze.
Chemical and physical in-use stability of the infusion solution has been demonstrated for 48 hours at 25ºC.

From a microbiological point of view, following good aseptic practices, the infusion solution can be utilized for up to 48 hours from preparation when stored at 25ºC.

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

Type 1 glass vial with an elastomeric stopper and aluminum seal with flip-off cap.
Pack size of single Use Vial.

6.6     Special precautions for disposal and other handling

There are no special requirements for disposal.
ERAXIS® must be reconstituted with water for injections and subsequently diluted with ONLY sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) glucose for infusion. The compatibility of reconstituted ERAXIS® with intravenous substances, additives, or medicines other than 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion has not been established.

Reconstitution 100 mg/vial
Aseptically reconstitute each 100 mg vial with 30 mL of sterile Water for Injection to provide a concentration of 3.33 mg/mL. The reconstituted solution may be stored at up to 25ºC for 24 hours.

Dilution and infusion

Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit. If particulate matter or discolouration is identified, discard the solution.

Adult Patients


Aseptically transfer the contents of the reconstituted vial(s) into an intravenous bag (or bottle) containing either 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion to obtain the appropriate ERAXIS® concentration. The table below provides the dilution to a concentration of 0.77 mg/mL for the final infusion solution and infusion instructions for each dose.

Dilution requirements for ERAXIS® administration

Dose       Number            Total          Infusion        Total         Rate of      Minimum of vials of    reconstituted      volume A      infusion       infusion      duration of powder           volume                        volumeB                       infusion 
100 mg         1              30 mL           100 mL        130 mL        1.4 mL/         90 min min or 84 mL/hour)
200 mg         2              60 mL           200 mL        260 mL        1.4 mL          180 min
/min or
84 mL/hour)
A
Either 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion.
B
Infusion solution concentration is 0.77 mg/mL

The rate of infusion should not exceed 1.1 mg/min (equivalent to 1.4 mL/min or 84 mL/hour when reconstituted and diluted per instructions) (see sections 4.2, 4.4 and 4.8).

Paediatric Patients

For paediatric patients aged 1 month to < 18 years, the volume of infusion solution required to deliver the dose will vary depending on the weight of the patient. The reconstituted solution must be further diluted to a concentration of 0.77 mg/mL for the final infusion solution. A programmable syringe or infusion pump is recommended. The rate of infusion should not exceed 1.1 mg/minute (equivalent to 1.4 mL/minute or 84 mL/hour when reconstituted and diluted per instructions) (see sections 4.2 and 4.4).

1. Calculate patient dose and reconstitute vial(s) required according to reconstitution instructions to provide a concentration of 3.33 mg/mL (see sections 2 and 4.2)

2. Calculate the volume (mL) of reconstituted anidulafungin required:

• Volume of anidulafungin (mL) = Dose of anidulafungin (mg)  3.33 mg/mL 
3. Calculate the total volume of dosing solution (mL) required to provide a final concentration of 0.77 mg/mL:

• Total volume of dosing solution (mL) = Dose of anidulafungin (mg) ÷ 0.77 mg/mL 

4. Calculate the volume of diluent [5% Dextrose Injection, USP or 0.9% Sodium Chloride
Injection, USP (normal saline)] required to prepare the dosing solution: 
• Volume of diluent (mL) = Total volume of dosing solution (mL) – Volume of anidulafungin (mL)


5. Aseptically transfer the required volumes (mL) of anidulafungin and 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (normal saline) into an infusion syringe or IV infusion bag needed for administration.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.