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 injections

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

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   Volume of NaCl      Total volume range (kg)a       (mg)                   (mL)               diluentb (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 range (kg)a         dose (mg)        (mL)                 diluentb (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.