Hydroxycarbamide medac capsules

Država: Armenija

Jezik: engleski

Izvor: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivni sastojci:

hydroxycarbamide

Dostupno od:

Medac GmbH

ATC koda:

L01XX05

INN (International ime):

hydroxycarbamide

Doziranje:

500mg

Farmaceutski oblik:

capsules

Jedinice u paketu:

(50/5x10/) in blister, (100/10x10/) in blister

Tip recepta:

Prescription

Status autorizacije:

Registered

Datum autorizacije:

2019-04-15

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Hydroxycarbamide medac 500 mg capsule, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains 500 mg hydroxycarbamide.
Excipient with known effect
One capsule contains 25 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard (capsule)
White capsules.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of patients with chronic myeloid leukaemia (CML) in the
chronic or accelerated phase of
the disease.
Treatment of patients with essential thrombocythaemia or polycythaemia
vera with a high risk for
thromboembolic complications.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Therapy should only be conducted by a physician experienced in
oncology or haematology. Doses are
based on real or ideal bodyweight of the patient, whichever is the
less.
In CML hydroxycarbamide is usually given at an initial dose of 40
mg/kg daily dependent on the
white cell count. The dose is reduced by 50 % (20 mg/kg daily) when
the white cell count has dropped
below 20 x 10
9
/l. The dose is then adjusted individually to keep the white cell
count at 5 – 10 x 10
9
/l.
The hydroxycarbamide dose should be reduced if white cell counts fall
below 5 x 10
9
/l, and increased
if white cell counts
>
10 x 10
9
/l are observed.
If the white cell count falls below 2.5 x 10
9
/l, or the platelet count below 100 x 10
9
/l, therapy should be
interrupted until the counts rise significantly towards normal.
An adequate trial period for determining the antineoplastic effect of
Hydroxyurea medac is six weeks.
Therapy should be interrupted indefinitely if there is significant
progress of the disease. If there is
significant clinical response therapy may be continued indefinitely.
In essential thrombocythaemia, hydroxycarbamide is usually given at
starting doses of 15 mg/kg/day
with dose adjustment to maintain a platelet count below 600 x 10
9
/l without lowering the white blood
cell count below 4 x 10
9
/l.
In