ULTOMIRIS 100MGML

Šalis: Izraelis

kalba: anglų

Šaltinis: Ministry of Health

Veiklioji medžiaga:

RAVULIZUMAB

Prieinama:

ALEXION PHARMA ISRAEL LTD

ATC kodas:

L04AA43

Vaisto forma:

CONCENTRATE FOR SOLUTION FOR INFUSION

Sudėtis:

RAVULIZUMAB 100 MG/ML

Vartojimo būdas:

I.V

Recepto tipas:

Required

Pagaminta:

ALEXION PHARMA INTERNATIONAL OPERATIONS LIMITED, IRELAND.

Gydymo sritis:

RAVULIZUMAB

Terapinės indikacijos:

Ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with paroxysmal nocturnal haemoglobinuria (PNH): * In patients with haemolysis with clinical symptom(s) indicative of high disease activity. * In patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. Ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with atypical haemolytic uremic syndrome aHUS who are complement inhibitor treatment naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab. Ultomiris is indicated in the treatment of adult patients with generalized myasthenia gravis (gMG) who are antiacetylcholine receptor (AChR) antibody-positive.

Leidimo data:

2023-05-30

Prekės savybės

Page 1 of 31
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ultomiris 10 mg/ml
Ultomiris 100 mg/ml
Concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ultomiris is a formulation of ravulizumab, produced in Chinese hamster
ovary (CHO) cell
culture by recombinant DNA technology.
Ultomiris 300 mg/3 mL concentrate for solution for infusion
Each vial of 3 mL contains 300 mg of ravulizumab (100 mg/mL).
After dilution, the final concentration of the solution to be infused
is 50 mg/mL.
_Excipient(s) with known effect: _
Sodium (4.6 mg per 3 mL vial)
Ultomiris 1,100 mg/11 mL concentrate for solution for infusion
Each vial of 11 mL contains 1,100 mg of ravulizumab (100 mg/mL).
After dilution, the final concentration of the solution to be infused
is 50 mg/mL.
_Excipient(s) with known effect: _
Sodium (16.8 mg per 11 mL vial)
Ultomiris 300 mg/30 mL concentrate for solution for infusion
Each vial of 30 mL contains 300 mg of ravulizumab (10 mg/mL).
After dilution, the final concentration of the solution to be infused
is 5 mg/mL.
_Excipient(s) with known effect: _
Sodium (115 mg per 30 mL vial)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Ultomiris 300 mg/3 mL and 1,100 mg/11 mL concentrates for solution for
infusion
Translucent, clear to yellowish colour, pH 7.4 solution.
Ultomiris 300 mg/30 mL concentrate for solution for infusion
Clear to translucent, slight whitish colour, pH 7.0 solution.
Page 2 of 31
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Paroxysmal nocturnal haemoglobinuria (PNH) _
Ultomiris is indicated in the treatment of adult and paediatric
patients with a body weight of
10 kg or above with PNH:
-
in patients with haemolysis with clinical symptom(s) indicative of
high disease activity
-
in patients who are clinically stable after having been treated with
eculizumab for at
least the past 6 months
_Atypical haemolytic uremic syndrome (aHUS) _
Ultomiris is indicated in