Xagrid
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
19-05-2018
Karatteristiċi tal-prodott
(SPC)
19-05-2018
Rapport ta 'Valutazzjoni Pubblika
(PAR)
01-03-2017
Ingredjent attiv:
anagrelide
Disponibbli minn:
Shire Pharmaceutical Contracts Limited
Kodiċi ATC:
L01XX35
INN (Isem Internazzjonali):
anagrelide
Grupp terapewtiku:
Antineoplastic agents
Żona terapewtika:
Thrombocythemia, Essential
Indikazzjonijiet terapewtiċi:
Xagrid is indicated for the reduction of elevated platelet counts in at-risk essential-thrombocythaemia (ET) patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy.
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2004-11-16
Fuljett ta 'informazzjoni
19
B. PACKAGE LEAFLET
20
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
XAGRID 0.5 MG HARD CAPSULES
anagrelide
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 further questions, ask your doctor or pharmacist.
•
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Xagrid is and what it is used for
2.
What you need to know before you take Xagrid
3.
How to take Xagrid
4.
Possible side effects
5.
How to store Xagrid
6.
Contents of the pack and other information
1.
WHAT XAGRID IS AND WHAT IT IS USED FOR
Xagrid contains the active substance, anagrelide. Xagrid is a medicine
which interferes with the
development of platelets. It reduces the number of platelets produced
by the bone marrow, which
results in a decrease in the platelet count in the blood towards a
more normal level. For this reason it is
used to treat patients with essential thrombocythaemia.
Essential thrombocythaemia is a condition which occurs when the bone
marrow produces too many of
the blood cells known as platelets. Large numbers of platelets in the
blood can cause serious problems
with blood circulation and clotting.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE XAGRID
DO NOT TAKE XAGRID
•
If you are allergic to anagrelide or any of the other ingredients of
this medicine (listed in section
6). An allergic reaction may be recognised as a rash, itching, swollen
face or lips, or shortness
of breath;
•
If you have
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Xagrid 0.5 mg hard capsules.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 0.5 mg anagrelide (as anagrelide
hydrochloride).
Excipient(s) with known effect
Each hard capsule contains lactose monohydrate (53.7 mg) and anhydrous
lactose (65.8 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
An opaque white hard capsule imprinted with S 063.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xagrid is indicated for the reduction of elevated platelet counts in
at risk essential thrombocythaemia
(ET) patients who are intolerant to their current therapy or whose
elevated platelet counts are not
reduced to an acceptable level by their current therapy.
An at risk patient
An at risk essential thrombocythaemia patient is defined by one or
more of the following features:
•
> 60 years of age or
•
a platelet count > 1000 x 10
9
/l or
•
a history of thrombo-haemorrhagic events.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Xagrid should be initiated by a clinician with
experience in the management of
essential thrombocythaemia.
Posology
The recommended starting dose of anagrelide is 1 mg/day, which should
be administered orally in two
divided doses (0.5 mg/dose).
The starting dose should be maintained for at least one week. After
one week the dose may be titrated,
on an individual basis, to achieve the lowest effective dose required
to reduce and/or maintain a
platelet count below 600 x 10
9
/l and ideally at levels between 150 x 10
9
/l and 400 x 10
9
/l. The dose
increment must not exceed more than 0.5 mg/day in any one-week and the
recommended maximum
single dose should not exceed 2.5 mg (see section 4.9). Durin
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