ELAPRASE

Kraj: Izrael

Język: angielski

Źródło: Ministry of Health

Składnik aktywny:

IDURSULFASE

Dostępny od:

TAKEDA ISRAEL LTD

Kod ATC:

A16AB09

Forma farmaceutyczna:

CONCENTRATE FOR SOLUTION FOR INFUSION

Skład:

IDURSULFASE 2 MG/ML

Droga podania:

I.V

Typ recepty:

Required

Wyprodukowano przez:

TAKEDA PHARMACEUTICALS INTERNATIONAL AG IRELAND BRANCH, IRELAND

Grupa terapeutyczna:

IDURSULFASE

Dziedzina terapeutyczna:

IDURSULFASE

Wskazania:

Long term treatment of patients with Hunter syndrome (MPS II).

Data autoryzacji:

2023-07-31

Ulotka dla pacjenta

רשוא
–
61
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2
ךיראת
:
61
02.
2
0.
22
תילגנאב רישכת םש
םושירה רפסמו ELAPRASE
138 94 31772 00
םושירה לעב םש
:
מ"עב המראפ ןוסידמ
ה טורפל דעוימ הז ספוט
דבלב תורמחה
! לע העדוה לע העדוה לע העדוה
( הרמחה
( הרמחה
( הרמחה עדימ עדימ עדימ
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב אפור אפור אפור
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
5.PHARMACO
LOGICAL
PROPERTIES
5.1
PHARMACODYNAM
IC PROPERTIES
5.1 PHARMACODYNAMIC PROPERTIES
Among all patients, statistically
significant mean increases from
treatment baseline (TKT024 baseline for
TKT024 idursulfase patients and Week
53 baseline for TKT024 placebo patients)
were seen in the distance walked 6MWT
at the majority of time points tested, with
significant mean and percent increases
ranging from 13.7m to 41.5m and from
6.4% to 11.7% (maximum at Month 20).
At most time points tested, patients who
were from the original TKT024 weekly
treatment group improved their walking
distance to a greater extent that patients
in the other 2 treatment groups.
Among all patients, mean % predicted
FVC was significantly increased at Month
16, although by Month 36, it was similar
to the baseline. Patients with the most
severe pulmonary impairment at baseline
(as measured by % predicted FVC)
tended to show the least improvement.
Statistically significant increases from
treatment baseline in absolute FVC
volume were seen at most visits for each
of the prior TKT024 treatment groups.
Mean changes from 0.07 l to 0.31 l and
percent ranged from 6.3% to 25.1%
(maximum at Month 30). The mean and
percent changes from treatment baseline
were greatest in the group of patients
from the TKT024 study who had received
the weekly dosing, across all time points.
5.1 PHARMACODYNAMIC PROPERTIES
Among all patients, statistically
significant mean increases from
treatment baseline (TKT024 bas

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Elaprase
Concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each vial contains 6 mg of idursulfase. Each ml contains 2 mg of
idursulfase*.
Excipient with known effect
Each vial contains 0.482 mmol of sodium.
For the full list of excipients, see section 6.1.
* idursulfase is produced by recombinant DNA technology in a
continuous human cell line.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
A clear to slightly opalescent, colourless solution.
4.
CLINICAL
PARTICULARS
4.1
Therapeutic indications
Elaprase is indicated for the long-term treatment of patients with
Hunter syndrome
(Mucopolysaccharidosis II, MPS II).
Heterozygous females were not studied in the clinical trials.
4.2
Posology and method of administration
This treatment should be supervised by a physician or other healthcare
professional experienced
in the management of patients with MPS II disease or other inherited
metabolic disorders.
Posology
Elaprase is administered at a dose of 0.5 mg/kg body weight every week
by intravenous infusion
over a 3 hour period, which may be gradually reduced to 1 hour if no
infusion-associated
reactions are observed (see section 4.4).
For instructions for use, see section
6.6.
Infusion
at home may be considered for patients who have received several
months of treatment
in the clinic and who are tolerating their infusions well. Home
infusions should be performed
under the surveillance of a physician or other healthcare
professional.
Special populations
_Elderly patients _
There is no clinical experience in patients over 65 years of age.
_Patients with renal or hepatic impairment_
_ _
There is no clinical experience in patients with renal or hepatic
insufficiency (
s
ee section 5.2).
_Paediatric population _
The dose for children and adolescents is the same as for adults, 0.5
mg/kg body weight weekly.
Method of administration
For instructions on dilution of the medicinal product before
a