Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Ultomiris 300 mg/3 mL and 1,100 mg/11 mL concentrates for solution for infusion Sucrose
Sodium phosphate monobasic
Sodium phosphate dibasic
L-Arginine
Polysorbate 80
Water for injection

Ultomiris 300 mg/30 mL concentrate for solution for infusion
Sodium chloride
Dibasic sodium phosphate
Monobasic sodium phosphate
Polysorbate 80
Water for injection

6.2   Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Dilution should only use sodium chloride 9 mg/mL (0.9 %) solution for injection as diluent.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
Ultomiris 300 mg/3 mL and 1,100 mg/11 mL concentrates for solution for infusion After dilution, the medicinal product should be used immediately. However, chemical and physical stability of the diluted product have been demonstrated for up to 24 hours at 2 °C-8 °C and up to 4 hours at room temperature

Ultomiris 300 mg/30 mL concentrate for solution for infusion
After dilution with sodium chloride 9 mg/ml (0.9%) solution, the medicinal product should be used immediately. However, chemical and physical stability of the diluted product have been demonstrated for up to 24 hours at 2°C-8°C and up to 6 hours at room temperature.

6.4   Special precautions for storage

Store in a refrigerator (2°C–8°C)
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
For storage conditions after dilution of the medicinal product, see section 6.3.
6.5   Nature and contents of container

Pack size of one vial.

Ultomiris 300 mg/3 mL concentrate for solution for infusion
3 mL of sterile concentrate in a vial (Type I glass) with a stopper and a seal.

Ultomiris 1,100 mg/11 mL concentrate for solution for infusion

11 mL of sterile concentrate in a vial (Type I glass) with a stopper and a seal.
Ultomiris 300 mg/30 mL concentrate for solution for infusion

30 mL of sterile concentrate in a vial (Type I glass) with a stopper and a seal.

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

Ultomiris 300 mg/3 mL and 1,100 mg/11 mL concentrates for solution for infusion 
This medicinal product requires dilution to a final concentration of 50 mg/mL.

Aseptic technique must be used.
Prepare Ultomiris concentrate for solution for infusion as follows:
1. The number of vials to be diluted is determined based on the individual patient’s weight and the prescribed dose, see section 4.2.
2. Prior to dilution, the solution in the vials should be visually inspected; the solution should be free of any particulate matter or precipitation. Do not use if there is evidence of particulate matter or precipitation.
3. The calculated volume of medicinal product is withdrawn from the appropriate number of vials and diluted in an infusion bag using sodium chloride 9 mg/mL (0.9 %) solution for injection as diluent. Refer to the administration reference tables below.
The product should be mixed gently. It should not be shaken.
4. After dilution, the final concentration of the solution to be infused is 50 mg/mL.
5. The prepared solution should be administered immediately following preparation unless it is stored at 2 °C-8 °C. If stored at 2 °C-8 °C, allow the diluted solution to warm to room temperature prior to administration. Do not administer as an intravenous push or bolus injection. Refer to the Table 4 and Table 5 for minimum infusion duration. Infusion must be administered through a 0.2 µm filter.
6. If the medicinal product is not used immediately after dilution, storage times must not exceed 24 hours at 2 °C – 8 °C or 4 hours at room temperature taking into account the expected infusion time.


Table 24:          Loading dose administration reference table for Ultomiris 300 mg/3 mL and 1,100 mg/11 mL concentrates for solution for infusion
Body weight         Loading dose          Ultomiris          Volume of NaCl           Total volume a                                                         b range (kg)          (mg)                  volume (mL)        diluent (mL)             (mL) ≥ 10 to < 20        600                   6                  6                        12 ≥ 20 to < 30        900                   9                  9                        18 ≥ 30 to < 40        1,200                 12                 12                       24 ≥ 40 to < 60        2,400                 24                 24                       48 ≥ 60 to < 100       2,700                 27                 27                       54 ≥ 100               3,000                 30                 30                       60 a
Body weight at time of treatment.
b
Ultomiris should only be diluted using sodium chloride 9 mg/mL (0.9 %) solution for injection.

Table 25:          Maintenance dose administration reference table for Ultomiris 300 mg/3 mL and 1,100 mg/11 mL concentrates for solution for infusion
Body weight        Maintenance          Ultomiris volume Volume of NaCl              Total volume a                                                        b range (kg)         dose (mg)            (mL)                 diluent (mL)            (mL) ≥ 10 to < 20       600                  6                    6                       12 ≥ 20 to < 30       2,100                21                   21                      42 ≥ 30 to < 40       2,700                27                   27                      54 ≥ 40 to < 60       3,000                30                   30                      60 ≥ 60 to < 100      3,300                33                   33                      66 ≥ 100              3,600                36                   36                      72 a
Body weight at time of treatment.
b
Ultomiris should only be diluted using sodium chloride 9 mg/mL (0.9 %) solution for injection.

Table 26:    Supplemental dose administration reference table for Ultomiris 300 mg/3 mL and 1,100 mg/11 mL concentrates for solution for infusion
Body weight        Supplemental Ultomiris volume Volume of NaCl                      Total volume range (kg)a        dose (mg)            (mL)                 diluentb (mL)           (mL) ≥ 40 to < 60       600                  6                    6                       12 1,200                12                   12                      24
1,500                15                   15                      30
≥ 60 to < 100      600                  6                    6                       12 1,500                15                   15                      30
1,800                18                   18                      36
≥ 100              600                  6                    6                       12 1,500                15                   15                      30
1,800                18                   18                      36 a
Body weight at time of treatment.
b
Ultomiris should only be diluted using sodium chloride 9 mg/mL (0.9 %) solution for injection.

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

Ultomiris 300 mg/30 mL concentrate for solution for infusion

This medicinal product requires dilution to a final concentration of 5 mg/mL.
Aseptic technique must be used.

Prepare Ultomiris concentrate for solution for infusion as follows:
1.    The number of vials to be diluted is determined based on the individual patient’s weight and the prescribed dose, see section 4.2.


2.       Prior to dilution, the solution in the vials should be visually inspected; the solution should be free of any particulate matter or precipitation. Do not use if there is evidence of particulate matter or precipitation.
3.       The calculated volume of medicinal product is withdrawn from the appropriate number of vials and diluted in an infusion bag using sodium chloride 9 mg/mL (0.9 %) solution for injection as diluent. Refer to the administration reference tables below. The product should be mixed gently. It should not be shaken.
4.       After dilution, the final concentration of the solution to be infused is 5 mg/mL.
5.       The prepared solution should be administered immediately following preparation unless it is stored at 2-8°C. If stored at 2-8°C, allow the diluted solution to warm to room temperature prior to administration. Do not administer as an intravenous push or bolus injection. Refer to the table 6 and Table 7 for minimum infusion duration.
Infusion must be administered through a 0.2 µm filter.
6.       If the medicinal product is not used immediately after dilution, storage times must not exceed 24 hours at 2°C - 8°C or 6 hours at room temperature taking into account the expected infusion time.

Table 27:        Loading dose administration reference table for Ultomiris 300 mg/30 mL concentrate for solution for infusion
Body weight         Loading dose         Ultomiris volume      Volume of NaCl         Total volume range (kg)a         (mg)                 (mL)                  diluentb (mL)          (mL) ≥ 10 to < 20        600                   60                 60                       120 ≥ 20 to < 30        900                   90                 90                       180 ≥ 30 to < 40        1200                  120                120                      240 ≥ 40 to < 60        2,400                 240                240                      480 ≥ 60 to < 100       2,700                 270                270                      540 ≥ 100               3,000                 300                300                      600 a
Body weight at time of treatment.
b
Ultomiris should only be diluted using sodium chloride 9 mg/mL (0.9 %) solution for injection.

Table 28:          Maintenance dose administration reference table for Ultomiris 300 mg/30 mL concentrate for solution for infusion
Body weight        Maintenance         Ultomiris volume       Volume of NaCl         Total volume range (kg)a        dose (mg)           (mL)                   diluentb (mL)          (mL) ≥ 10 to < 20       600                  60                   60                      120 ≥ 20 to < 30       2100                 210                  210                     420 ≥ 30 to < 40       2700                 270                  270                     540 ≥ 40 to < 60       3,000                300                  300                     600 ≥ 60 to < 100      3,300                330                  330                     660 ≥ 100              3,600                360                  360                     720 a
Body weight at time of treatment.
b
Ultomiris should only be diluted using sodium chloride 9 mg/mL (0.9 %) solution for injection.


Table 29:           Supplemental dose administration reference table for Ultomiris 300 mg/30mL concentrate for solution for infusion
Body Weight     Supplemental        ULTOMIRIS           Volume of NaCl        Total volume Range (kg)a     dose (mg)           volume (mL)         diluentb (mL)         (mL) ≥ 40 to < 60    600                 60                  60                    120 1,200               120                 120                   240
1,500               150                 150                   300
≥ 60 to < 100     600                 60                  60                    120 1,500               150                 150                   300
1,800               180                 180                   360
≥ 100             600                 60                  60                    120 1,500               150                 150                   300
1,800               180                 180                   360 a
Body weight at time of treatment b
Ultomiris should only be diluted using sodium chloride 9 mg/mL (0.9 %) solution for injection 
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.