KIDROLASE

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

ASPARAGINASE

可用日期:

CTS LTD

ATC代码:

L01XX02

药物剂型:

POWDER FOR SOLUTION FOR INJECTION

组成:

ASPARAGINASE 10000 IU/VIAL

给药途径:

I.M, I.V

处方类型:

Required

厂商:

JAZZ PHARMACEUTICALS FRANCE S.A.S., FRANCE

治疗组:

ASPARAGINASE

治疗领域:

ASPARAGINASE

疗效迹象:

Acute lymphoblastic leukemia, acute myeloblastic leukemia.

授权日期:

2011-03-31

产品特点

אירבה דרשמ י"ע עבקנ הז ןולע טמרופ
ךיראתב תואירבה דרשמ י"ע רשואו קדבנ
ונכותו תו
01/2018
ןכדועו ,
ךיראתב תואירבה דרשמ תוארוהל םאתהב
01/2018
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT:
KIDROLASE 10,000 I.U.
POWDER FOR SOLUTION FOR INJECTION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition of the powder (for one vial):
L-asparaginase 10,000 I.U.
For one bottle.
For the complete list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection.
4.
CLINICAL DATA
4.1.THERAPEUTIC INDICATIONS
- Acute lymphoblastic leukemia
- Acute myeloblastic leukemia
4.2. POSOLOGY AND METHOD OF ADMINISTRATION:
POSOLOGY
IV route (by infusion of an isotonic glucose or an isotonic sodium
chloride
solution) or IM route:
500 to 1,000 IU per kg per day in children or 7,500 to 10,000 I.U./m
2
/day in
adults:
- initial therapy: every day for 6 to 21 days,
- maintenance therapy: 1 or 2 times per week,
- reinduction therapy: 3,000 I.U./m
2
/day IV x 5 days.
INTRADERMAL SKIN TEST
Because of the occurrence of allergic reactions, an intradermal skin
test should
be performed prior to the initial administration of KIDROLASE and when
KIDROLASE is given after an interval of a week or more has elapsed
between
doses. The skin test solution may be prepared as follows: Reconstitute
the
contents of a 10,000 I.U. vial with 5.0ml of diluent. From this
solution (2,000
I.U./ml) withdraw 0.1 ml and inject it into another vial containing
9.9ml of diluent,
yielding a skin test solution of approximately 20.0 I.U./ml. Use 0.1
ml of this
solution (about 2.0 I.U.) for the intradermal skin test. The skin test
site should be
observed for at least one hour for the appearance of a wheal or
erythema either
of which indicates a positive reaction. An allergic reaction even to
the skin test
dose in certain sensitized individuals may rarely occur. A negative
skin test
reactoion does not preclude the possibility of the devel