NAGLAZYME

Riik: Iisrael

keel: inglise

Allikas: Ministry of Health

Toimeaine:

GALSULFASE

Saadav alates:

MEDISON PHARMA LTD

ATC kood:

A16AB08

Ravimvorm:

CONCENTRATE FOR SOLUTION FOR INFUSION

Koostis:

GALSULFASE 1 MG/ML

Manustamisviis:

I.V

Retsepti tüüp:

Required

Valmistatud:

BIOMARIN PHARMACEUTICAL INC, USA

Terapeutiline rühm:

GALSULFASE

Terapeutiline ala:

GALSULFASE

Näidustused:

Naglazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of MPSVI (N-acetylglactosamine 4 sulfatase deficiency Maroteaux-Lamy syndrome).

Loa andmise kuupäev:

2015-04-30

Infovoldik

_אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה_
_אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה_
_ ןכדועמ(_
_ ןכדועמ(_
_05.2013_
_05.2013_
_)_
_)_
________ ךיראת
_
04.2015
_____
____________ םושירה רפסמו תילגנאב רישכת םש
143-48-3176-700
_
Reg .No:
__
NAGLAZYME
____
_______________ םושירה לעב םש
MEDISON PHARMA LTD
_____________________
! דבלב תורמחהה טורפל דעוימ הז ספוט
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
EXCIPIENTS
Each 5 ml vial contains 0.8 mmol (18.4 mg) of sodium
THERAPEUTIC
INDICATIONS
Naglazyme is indicated for long-term enzyme
replacement therapy in patients with a confirmed
diagnosis of Mucopolysaccharidosis VI (MPS VI; N-
acetylgalactosamine 4-sulfatase deficiency;
Maroteaux-Lamy syndrome) (see section 5.1).
Naglazyme is indicated for long-term enzyme replacement
therapy in patients with a confirmed diagnosis of
Mucopolysaccharidosis VI (MPS VI; N-acetylgalactosamine 4-
sulfatase deficiency; Maroteaux-Lamy syndrome) (see
section 5.1).
A key issue is to treat children aged <5 years suffering from a severe
form
of the disease, even though children <5 years were not included in the
pivotal phase 3 study. Limited data are available in patients < 1 year
of age
(see section 5.1).
POSOLOGY AND
METHOD OF
ADMINISTRATION
Naglazyme treatment should be supervised by a
physician experienced in the management of
patients with MPS VI or other inherited metabolic
diseases. Administration of Naglazyme should be
carried out in an appropriate clinical setting
where resuscitation equipment to manage
medical emergencies would be readily available.
The recommended dosage regimen for galsulfase
is 1 mg/kg body weight administered once every
week as an intravenous infusion over 4 hours.
The initial infusion rate is adjusted so that
approximately 2.5% of the total solution is
infused during the first hour, with infusion of the
remaining volume (ap

Toote omadused

1.
NAME OF THE MEDICINAL PRODUCT
Naglazyme 1 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 1 mg galsulfase. One vial of 5 ml
contains 5 mg galsulfase.
Galsulfase is a recombinant form of human N-acetylgalactosamine
4-sulfatase and is produced by
recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO)
cell culture.
_Excipients _
Each 5 ml vial contains 0.8 mmol (18.4 mg) of sodium.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
A clear to slightly opalescent, and colourless to pale yellow
solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Naglazyme is indicated for long-term enzyme replacement therapy in
patients with a confirmed
diagnosis of Mucopolysaccharidosis VI (MPS VI; N-acetylgalactosamine
4-sulfatase deficiency;
Maroteaux-Lamy syndrome) (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
A key issue is to treat children aged <5 years suffering from a severe
form of the disease, even though
children <5 years were not included in the pivotal phase 3 study.
Limited data are available in patients
< 1 year of age (see section 5.1).
As for all lysosomal genetic disorders, it is of primary importance,
especially in severe forms, to
initiate treatment as early as possible, before appearance of
non-reversible clinical manifestations of
the disease.
Naglazyme treatment should be supervised by a physician experienced in
the management of patients
with MPS VI or other inherited metabolic diseases. Administration of
Naglazyme should be carried
out in an appropriate clinical setting where resuscitation equipment
to manage medical emergencies
would be readily available
_. _
_ _
Posology
The recommended dose regimen for galsulfase is 1 mg/kg body weight
administered once every week
as an intravenous infusion over 4 hours.
_Special populations _
_ _
_Elderly _
The safety and efficacy of Naglazyme in patients older than 65 years
has not been established, an