Anagrelide Mylan
Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Листовка
(PIL)
17-01-2024
Данни за продукта
(SPC)
17-01-2024
Доклад обществена оценка
(PAR)
27-02-2018
Активна съставка:
Anagrelide hydrochloride
Предлага се от:
Mylan Pharmaceuticals Limited
АТС код:
L01XX35
INN (Международно Name):
anagrelide
Терапевтична група:
Antineoplastic agents
Терапевтична област:
Thrombocythemia, Essential
Терапевтични показания:
Anagrelide 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 patientAn at-risk essential thrombocythaemia patient is defined by one or more of the following features:>60 years of age ora platelet count >1,000 x 10⁹/l ora history of thrombo-haemorrhagic events.
Каталог на резюме:
Revision: 8
Статус Оторизация:
Authorised
Дата Оторизация:
2018-02-15
Листовка
23
B.
PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ANAGRELIDE VIATRIS 0.5 MG HARD CAPSULES
anagrelide
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 Anagrelide Viatris is and what it is used for
2.
What you need to know before you take Anagrelide Viatris
3.
How to take Anagrelide Viatris
4.
Possible side effects
5.
How to store Anagrelide Viatris
6.
Contents of the pack and other information
1.
WHAT ANAGRELIDE VIATRIS IS AND WHAT IT IS USED FOR
Anagrelide Viatris contains the active substance, anagrelide.
Anagrelide 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 ANAGRELIDE VIATRIS
DO NOT TAKE ANAGRELIDE VIATRIS
•
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 moderate or severe liver problems;
•
If you have moderate or severe kidney problems.
WARNINGS AND PRECAUTIONS
Talk to yo
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Данни за продукта
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Anagrelide Viatris 0.5 mg hard capsules
Anagrelide Viatris 1 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Anagrelide Viatris 0.5 mg hard capsules
Each hard capsule contains anagrelide hydrochloride monohydrate
equivalent to 0.5 mg anagrelide.
_Excipients with known effect _
Each hard capsule contains approximately 59.5 mg lactose.
Anagrelide Viatris 1 mg hard capsules
Each hard capsule contains anagrelide hydrochloride monohydrate
equivalent to 1 mg anagrelide.
_Excipients with known effect _
Each hard capsule contains approximately 119 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule).
Anagrelide Viatris 0.5 mg hard capsules
A capsule size 4 (approximately 14.3 x 5.3 mm)
with an opaque white body and cap. The capsule is
filled with white to off-white powder.
Anagrelide Viatris 1 mg hard capsules
A capsule size 4
(approximately 14.3 x 5.3 mm) with a grey body and cap. The capsule is
filled with
white to off-white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Anagrelide 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 ET patient is defined by one or more of the following
features:
•
> 60 years of age or
•
a platelet count >1,000 x 10
9
/l or
•
a history of thrombo-haemorrhagic events.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
3
Treatment with anagrelide should be initiated by a clinician with
experience in the management of ET.
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 eff
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