País: Israel
Língua: inglês
Origem: Ministry of Health
ASPARAGINASE
CTS LTD
L01XX02
POWDER FOR SOLUTION FOR INJECTION
ASPARAGINASE 10000 IU/VIAL
I.M, I.V
Required
JAZZ PHARMACEUTICALS FRANCE S.A.S., FRANCE
ASPARAGINASE
ASPARAGINASE
Acute lymphoblastic leukemia, acute myeloblastic leukemia.
2011-03-31
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 Leia o documento completo