Xromi

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

hydroxycarbamide

Saadav alates:

Nova Laboratories Ireland Limited

ATC kood:

L01XX05

INN (Rahvusvaheline Nimetus):

hydroxycarbamide

Terapeutiline rühm:

Antineoplastic agents

Terapeutiline ala:

Anemia, Sickle Cell

Näidustused:

Prevention of vaso-occlusive complications of sickle cell disease in patients over 2 years of age

Toote kokkuvõte:

Revision: 6

Volitamisolek:

Authorised

Loa andmise kuupäev:

2019-07-01

Infovoldik

27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET: INFORMATION FOR THE USER
XROMI 100 MG/ML ORAL SOLUTION
hydroxycarbamide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Xromi is and what it is used for
2.
What you need to know before you take Xromi
3.
How to take Xromi
4.
Possible side effects
5.
How to store Xromi
6.
Contents of the pack and other information
1.
WHAT XROMI IS AND WHAT IT IS USED FOR
Xromi contains hydroxycarbamide, a substance which reduces the growth
and multiplication of some
cells in the bone marrow. These effects lead to a reduction of
circulating red, white and coagulation
blood cells. In Sickle Cell Disease, hydroxycarbamide also helps to
prevent red blood cells from
taking the abnormal sickle shape.
Sickle Cell disease is an inherited blood disorder that affects the
disc shaped red cells of the blood.
Some cells become abnormal, rigid and take a crescent or sickle shape
which leads to anaemia.
The sickle cells also get stuck in blood vessels, blocking blood flow.
This can cause acute pain crises
and organ damage.
Xromi is used to prevent the complications of blocked blood vessels
caused by Sickle Cell Disease in
patients over 9 months of age. Xromi will decrease the number of
painful crises as well as the need for
hospitalisation as a result of the disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE XROMI
_ _
DO NOT TAKE XROMI
-
if you are allergic to hydroxycarbamide or any of the other
ingredients of Xromi (listed in
section 6).
-
if you suffer from severe liver disease
-
if you suffe

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Xromi 100 mg/ml oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of solution contains 100 mg hydroxycarbamide.
Excipients with known effect
One ml of solution contains 0.5 mg methyl hydroxybenzoate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
Clear, colourless to pale yellow viscous liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xromi is indicated for the prevention of vaso-occlusive complications
of Sickle Cell Disease in
patients over 9 months of age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Hydroxycarbamide treatment should be supervised by a physician or
other healthcare professionals
experienced in the management of patients with Sickle Cell Disease.
Posology
The posology should be based on the patient’s body weight (kg).
The usual starting dose of hydroxycarbamide is 15 mg/kg/day and the
usual maintenance dose is
between 20-25 mg/kg/day. The maximum dose is 35 mg/kg/day. Full blood
cell count with white cell
differential and reticulocyte count should be monitored once a month
for the first 2 months following
treatment initiation.
A target absolute neutrophil count 1,500 – 4,000/ μL should be
aimed for, whilst maintaining platelet
count > 80,000/ μL. If neutropenia or thrombocytopenia occurs,
hydroxycarbamide dosing should be
temporarily withheld and full blood cell count with white cell
differential should be monitored weekly.
When blood counts have recovered, hydroxycarbamide should be
reinstated at a dose 5 mg/kg/day
lower than the dose given before onset of cytopenias.
If dose escalation is warranted based on clinical and laboratory
findings, the following steps should be
taken:
•
Dose to be increased by 5 mg/kg/day increments every 8 weeks.
•
Increases in dose to be continued until mild myelosuppression
(absolute neutrophil count
1,500/ μL to 4,000/ μL) is achieved, up to a maximum of 35
mg/kg/day.
•
Full blood cell count with white cell