ULTOMIRIS 10 MGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

RAVULIZUMAB

Available from:

ALEXION PHARMA ISRAEL LTD

ATC code:

L04AA43

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

RAVULIZUMAB 10 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

ALEXION PHARMA GMBH, SWITZERLAND

Therapeutic area:

RAVULIZUMAB

Therapeutic indications:

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 anti-acetylcholine receptor (AChR) antibody-positive.

Authorization date:

2019-12-29

Patient Information leaflet

_CERTIFICATE: VACCINATION AND/OR PROPHYLACTIC ANTIBIOTICS _
_This form must be completed and provided to Neopharm before
initiation of therapy with SOLIRIS® _
_(Eculizumab) or ULTOMIRIS® (Ravulizumab)Israeli Ministry of Health _
This is MANDATORY before any shipment can be made.
TO BE IMMEDIATELY TRANSMITTED VIA FAX OR AS A SCANNED PDF VIA E-MAIL
TO:
NEOPHARM –
PATIENT'S SAFETY
UNIT
FAX /
EMAIL:
[e-mail];
[phone]
PAGE 1 OF
NAME OF PRESCRIBER:
HOSPITAL:
PHONE NUMBER:
ADDRESS:
FAX NUMBER:
CITY:
COUNTRY:
EMAIL:
INFORMATION ON PRODUCT AND INDICATION
The patient will be treated with:
☐
SOLIRIS_® (Eculizumab) _
INDICATION
☐
PNH
☐
aHUS
☐
Refractory gMG
Other:
(specify) (optional)
☐
ULTOMIRIS_® (Ravulizumab) _
INDICATION
☐
PNH
Other:
(specify) (optional)
INFORMATION ON PATIENT
BIRTH DATE
(_dd/mmm/yyy) _
The patient is/is to be included in the disease registry:
☐
YES
☐
NO
COMMITMENT
I, the undersigned,
, hereby undertake to ensure or confirm that:
I must explain the complement inhibitor treatment to the
patient/parent(s)/legal guardian(s) and I must deliver to the
patient/parent(s)/legal guardian(s) all necessary information,
including the “Patient Safety Card” and relevant educational
materials before initiating the complement inhibitor treatment.
☐
I am requesting specified educational materials and commit to provide
these materials to this patient.
THE PATIENT _(CHECK AS APPROPRIATE) _
Received a vaccination against meningococcal infection, preferably
against serotypes A, B, C, Y, W 135:
☐
At least 2 weeks prior to administration of the 1st dose of the
complement inhibitor treatment.
☐
Less than 2 weeks prior to administration of the 1st dose of the
complement inhibitor treatment.
The patient therefore receives prophylactic antibiotics from at least
the 1st day of the complement inhibitor treatment and until 2
weeks after the vaccination against meningococcal infection.
VACCINATION DATE
(_dd/mmm/yyyy): _
_ _
VACCINE(S) (optional):
DATE OF INITIATION OF ANTIBIOTIC THER

Summary of Product characteristics

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