Asparaginase medac

Страна: Армения

Език: английски

Източник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активна съставка:

l-asparaginase

Предлага се от:

Medac GmbH

INN (Международно Name):

l-asparaginase

дозиране:

10000U

Лекарствена форма:

powder lyophilized for solution for injection

Вид предписание :

Prescription

Данни за продукта

SPC (RUS-Version) Asparaginase 5000/10000 U medac
Date of latest revision: 03/2015
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Asparaginase 5000 U medac
Asparaginase 10000 U medac
Powder for solution for injection
Active substance: L-Asparaginase
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial of Asparaginase 5000 (10000) U medac with 21.6 - 24.5 (43.2 –
49.0) mg of powder for solution
for injection contains:
L-Asparaginase (E. C. 3.5.1.1) 83 (167) µkat, corresponding to 5000
(10000) U.
(1 U L-asparaginase releases 1 µmol ammonia from L-asparagine in 1
Minute at 37° C.)
3.
PHARMACEUTICAL FORM
Powder for solution for injection
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Asparaginase 5000 (10000) U medac is indicated as a component of an
anti-neoplastic combination
therapy of acute lymphatic leukaemia (ALL) in children and adults as
well as in cases of non-Hodgkin’s
lymphomas in childhood.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
To reduce the risk of a possible IgE-mediated hypersensitivity
reaction, a prick test (place 1 drop of
the ready-to-use solution on the volar side of the forearm using a
tube-like instrument and inject into
the epidermis through the drop using a sterile syringe. Avoid
bleeding. Wipe away the drop of the
preparation after 3 minutes. After a further 20 minutes, observe the
reaction: if redness and weals
develop, refrain from L-asparaginase treatment) or an intracutaneous
injection (increasing
concentrations in an appropriate dilution) should be carried out
before treatment is started or resumed.
Since not just IgE-mediated allergic reactions that are detectable by
skin testing but also IgG and IgM-
mediated sensitisation has been described in the literature, the use
of an intravenous test dose before
intravenous administration is recommended (1000 U i.v. as a short
infusion 1 hour before the
beginning of treatment).
Unless otherwise prescribed, the mean intravenous daily dose in
children and adults in the
monotherapy is 200 U per kg body weight (B