Hydroxycarbamide 500mg capsules

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Hydroxycarbamide

可用日期:

medac UK

ATC代码:

L01XX05

INN（国际名称）:

Hydroxycarbamide

剂量:

500mg

药物剂型:

Oral capsule

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 08010500; GTIN: 4037353444430

产品特点

OBJECT 1
HYDROXYCARBAMIDE MEDAC 500 MG CAPSULE, HARD
Summary of Product Characteristics Updated 01-Aug-2016 | medac GmbH
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 thrombocythemia or polycythemia
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
Hydroxycarbamide 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 thrombocythemia hydroxycarbamide is usually given at
starting doses of 15 mg/kg/day with
dose adjustment to maintain a platelet count