ALDURAZYME

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

LARONIDASE

Dostopno od:

SANOFI ISRAEL LTD

Koda artikla:

A16AB05

Farmacevtska oblika:

CONCENTRATE FOR SOLUTION FOR INFUSION

Sestava:

LARONIDASE 500 UNITS / 5 ML

Pot uporabe:

I.V

Tip zastaranja:

Required

Izdeluje:

GENZYME LTD, UK

Terapevtska skupina:

LARONIDASE

Terapevtsko območje:

LARONIDASE

Terapevtske indikacije:

Aldurazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of mucopolysaccharidosis I (MPS I alfa-l-iduronidase deficiency) to treat the non-neurological manifestations of the disease.

Datum dovoljenje:

2014-02-28

Navodilo za uporabo

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ )תוחיטב )תוחיטב
ןולעב
ןולעב
אפורל
אפורל
:ךיראת
___
8/1/2014
___
םש
רישכת
:תילגנאב
ALDURAZYME
רפסמ :םושיר
130-4230779-00
םש
לעב
:םושירה
SANOFI AVENTIS ISRAEL LTD
.
ספוט
הז
דעוימ
טוריפל
תורמחה
!דבלב
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
4.8
-
UNDESIRABLE
EFFECTS
_______
Laryngeal edema, edema peripheral
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.
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יתוהמ
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םייוניש
םוקימב
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.
רבעוה
ראודב
ינורטקלא
ךיראתב
8/1/2014
.
1

Lastnosti izdelka

1
_ALDU-PI-2.0 _
1.
NAME OF THE MEDICINAL PRODUCT
Aldurazyme
concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 100 U (approximately 0.58 mg) of laronidase.
Each vial of 5 ml contains 500 U of laronidase.
The activity unit (U) is defined as the hydrolysis of one micromole of
substrate (4-MUI) per minute.
Laronidase is a recombinant form of human
α
-L-iduronidase and is produced by recombinant DNA
technology using mammalian Chinese Hamster Ovary (CHO) cell culture.
Excipient(s) with known effect:
Each vial of 5 ml contains 1.29 mmol sodium.
For the 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
Aldurazyme is indicated for long-term enzyme replacement therapy in
patients with a confirmed
diagnosis of Mucopolysaccharidosis I (MPS I; α-L-iduronidase
deficiency) to treat the non-
neurological manifestations of the disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Aldurazyme treatment should be supervised by a physician experienced
in the management of patients
with MPS I or other inherited metabolic diseases. Administration of
Aldurazyme should be carried out
in an appropriate clinical setting where resuscitation equipment to
manage medical emergencies would
be readily available.
Posology
The recommended dosage regimen of Aldurazyme is 100 U/kg body weight
administered once every
week.
_Paediatric population _
No dose adjustment is necessary for the paediatric population.
_ _
_Elderly _
The safety and efficacy of Aldurazyme in patients older than 65 years
have not been established and
no dosage regimen can be recommended in these patients.
2
_Renal and hepatic impairment _
The safety and efficacy of Aldurazyme in patients with renal or
hepatic insufficiency have not been
evaluated and no dosage regimen can be recommended in these patients.
Method of administration
Aldurazyme is to be administe