KIDROLASE

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

ASPARAGINASE

Tilgængelig fra:

CTS LTD

ATC-kode:

L01XX02

Lægemiddelform:

POWDER FOR SOLUTION FOR INJECTION

Sammensætning:

ASPARAGINASE 10000 IU/VIAL

Indgivelsesvej:

I.M, I.V

Recept type:

Required

Fremstillet af:

JAZZ PHARMACEUTICALS FRANCE S.A.S., FRANCE

Terapeutisk gruppe:

ASPARAGINASE

Terapeutisk område:

ASPARAGINASE

Terapeutiske indikationer:

Acute lymphoblastic leukemia, acute myeloblastic leukemia.

Autorisation dato:

2011-03-31

Produktets egenskaber

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