HYDROXYUREA MEDAC 500 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

HYDROXYCARBAMIDE

متاح من:

TZAMAL BIO-PHARMA LTD

ATC رمز:

L01XX05

الشكل الصيدلاني:

CAPSULES

تركيب:

HYDROXYCARBAMIDE 500 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH, GERMANY

المجال العلاجي:

HYDROXYCARBAMIDE

الخصائص العلاجية:

Treatment of patient with chronic myeloid leukaemia (CML) in the chronic or accelerated phase of the disease.Treatment of patients with essential thrombocytaemia or polycythaemia vera with a high risk for thrmboembolic complications.

تاريخ الترخيص:

2021-12-22

نشرة المعلومات

Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations) - 1986
This medicine is dispensed with a doctor’s prescription only
Hydroxyurea medac 500 mg
Capsules
Active ingredient
Each capsule contains:
hydroxycarbamide 500 mg
Inactive ingredients and allergens: See section 2 "Important
information about some of this
medicine’s ingredients" and section 6 "Additional information".
Read the entire leaflet carefully before you start using this
medicine. This leaflet
contains concise information about this medicine. If you have any
further questions, consult
your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them, even if it seems to you that their illness is similar to
yours.
1.
What is this medicine intended for?
Hydroxyurea Medac is indicated for the treatment of patients with
chronic myeloid leukemia
(CML) in the chronic or accelerated phase of the disease.
Hydroxyurea Medac is also indicated for the treatment of patients with
essential
thrombocythemia or polycythemia vera with a high risk of
thromboembolic complications.
Therapeutic group: Hydroxyurea Medac contains the active ingredient
hydroxycarbamide,
which belongs to the group of medicines used in certain blood diseases
and interfering with
the growth of cancer cells.
2.
Before using this medicine
Do not use this medicine if:
●
You are sensitive (allergic) to the active ingredient
(hydroxycarbamide) or to any of the
other ingredients in this medicine (see section 6 "Additional
information"). Stop the
treatment if hypersensitivity to Hydroxyurea Medac occurs.
●
The blood cell count is too low.
Special warnings about using this medicine
●
Treatment with hydroxycarbamide requires comprehensive observation
(see section
"Tests and follow-up").
●
You should drink plenty of liquids during the treatment.
●
Secondary leukemia may develop due to long-term treatment with
hydroxycarbamide. It
is currently unknown to what extent this results from the underlying
dis

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Hydroxyurea medac 500 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains 500 mg hydroxycarbamide.
Excipient with known effect
This medicine contains 25 mg lactose monohydrate per capsule.
This medicine contains less than 1 mmol sodium (23 mg) per capsule.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule
White, gelatin capsules, filled with an off-white powder.
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 co