VIMIZIM

국가: 이스라엘

언어: 영어

출처: Ministry of Health

유효 성분:

ELOSULFASE ALFA

제공처:

MEDISON PHARMA LTD

ATC 코드:

A16AB12

약제 형태:

CONCENTRATE FOR SOLUTION FOR INFUSION

구성:

ELOSULFASE ALFA 1 MG/ML

관리 경로:

I.V

처방전 유형:

Required

Manufactured by:

BIOMARIN INTERNATIONAL LIMITED, IRELAND

치료 영역:

ELOSULFASE ALFA

치료 징후:

Vimizim is indicated for the treatment of mucopolysaccharidosis, type IVA (Morquio A Syndrome ,MPS IVA) in patients of all ages.

승인 날짜:

2020-06-30

환자 정보 전단

,םידבכנ ת/חקור ,ה/אפור
ולעה יכ םכעידוהל ינירה
ן
רישכתה לש
ןכדוע
:
VIMIZIM
םיזימיו
CONCENTRATE FOR SOLUTION FOR INFUSION
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
:
Each ml of solution contains 1 mg elosulfase alfa*. Each vial of 5 ml
contains 5 mg elosulfase alfa.
*Elosulfase alfa is a recombinant form of human
N-acetylgalactosamine-6-sulfatase (rhGALNS) and is
produced in Chinese Hamster Ovary cell culture by recombinant DNA
technology.
תרשואמ היוותה
-
Vimizim is indicated for the treatment of mucopolysaccharidosis, type
IVA (Morquio A Syndrome,
MPS IVA) in patients of all ages.
ןוכדע השענ
אפורל ןולעב
:אבה ףיעסב
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Sodium restricted diet
This medicinal product contains 8 mg sodium per vial, equivalent to
0.4% of the WHO recommended
maximum daily intake of 2 g sodium for an adult, and is administered
in sodium chloride 9 mg/ml (0.9%)
solution for infusion (see section 6.6).
Sorbitol
This medicinal product contains 100 mg sorbitol in each vial which is
equivalent to 40 mg/kg. Patients
with hereditary fructose intolerance (HFI) must not be given this
medicinal product unless strictly
necessary.
Babies and young children (below 2 years of age) may not yet be
diagnosed with hereditary fructose
intolerance (HFI). Medicinal products (containing sorbitol/fructose)
given intravenously may be life-
threatening. The treatment benefit to the child compared to the
associated risks must be fully evaluated
prior to treatment.
A detailed history with regard to HFI symptoms has to be taken for
each patient prior to being given this
medicinal product.
ןולעה
אצמנ אפורל
ןכו רושיקב
לעבל הינפ ידי לע ספדומ ולבקל ןתינו
תואירבה דרשמ רתאב תופורתה רגאמב
םסרופמ
.םושירה
,הכרבב
וילש היח 'רגמ
הנוממ תחקור

제품 특성 요약

1
פ
רשואו קדבנ ונכותו תואירבה דרשמ י"ע
עבקנ הז ןולע טמרו
ראתב תואירבה דרשמ י"ע
ךי
07/2015 ןכדועו
ראתב תואירבה דרשמ תוארוהל םאתהב
ךי
9
201
/
5
0
1.
NAME OF THE MEDICINAL PRODUCT
Vimizim
concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 1 mg elosulfase alfa*. Each vial of 5 ml
contains 5 mg elosulfase alfa.
*Elosulfase alfa is a recombinant form of human
N-acetylgalactosamine-6-sulfatase (rhGALNS) and
is produced in Chinese Hamster Ovary cell culture by recombinant DNA
technology.
Excipients with known effect:
Each 5 ml vial contains 8 mg sodium and 100 mg sorbitol (E420).
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
Vimizim is indicated for the treatment of mucopolysaccharidosis, type
IVA (Morquio A Syndrome,
MPS IVA) in patients of all ages.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be supervised by a physician experienced in the
management of patients with
MPS IVA or other inherited metabolic diseases. Administration of
Vimizim should be carried out by
an appropriately trained healthcare professional with the ability to
manage medical emergencies.
Home administration under the supervision of an appropriately trained
healthcare professional may be
considered for patients who are tolerating their infusions well.
_ _
Posology
The recommended dose of elosulfase alfa is 2 mg/kg of body weight
administered once a week. The
total volume of the infusion should be delivered over approximately 4
hours (see Table 1).
Because of the potential for hypersensitivity reactions with
elosulfase alfa, patients should receive
antihistamines with or without antipyretics 30 to 60 minutes prior to
start of infusion (see section 4.4).
2
_Special populations _
_ _
_Elderly patien