Anagrelide Zentiva 0,5 mg harde capsules

Երկիր: Նիդերլանդեր

Լեզու: հոլանդերեն

Աղբյուրը: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Ակտիվ բաղադրիչ:

ANAGRELIDEHYDROCHLORIDE 1-WATER 0,61 mg/stuk SAMENSTELLING overeenkomend met ; ANAGRELIDE 0,5 mg/stuk

Հասանելի է:

Zentiva k.s. U kabelovny 130 102 37 PRAGUE 10 (TSJECHIË)

ATC կոդը:

L01XX35

INN (Միջազգային անվանումը):

ANAGRELIDEHYDROCHLORIDE 1-WATER 0,61 mg/stuk SAMENSTELLING overeenkomend met ; ANAGRELIDE 0,5 mg/stuk

Դեղագործական ձեւ:

Capsule, hard

Կազմը:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; LACTOSE 0-WATER ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; LACTOSE 0-WATER ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171),

Կառավարման երթուղին:

Oraal gebruik

Թերապեւտիկ տարածք:

Anagrelide

Ապրանքի ամփոփագիր:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); GELATINE (E 441); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); POVIDON K 30 (E 1201); TITAANDIOXIDE (E 171);

Հաստատման ամսաթիվը:

1900-01-01

Տեղեկատվական թերթիկ

ANAGRELIDE HYDROCHLORIDE_0.5 mg_hard capsule_NL_NL-H-3935-001
03/2022 RR + 04/2022 EPAR Consolidated
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ANAGRELIDE ZENTIVA 0,5 MG HARDE 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 any 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 Zentiva is and what it is used for
2.
What you need to know before you take Anagrelide Zentiva
3.
How to take Anagrelide Zentiva
4.
Possible side effects
5.
How to store Anagrelide Zentiva
6.
Contents of the pack and other information
1.
WHAT ANAGRELIDE ZENTIVA IS AND WHAT IT IS USED FOR
Anagrelide Zentiva 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 ZENTIVA
DO NOT TAKE ANAGRELIDE ZENTIVA
−
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
.

Ապրանքի հատկությունները

ANAGRELIDE HYDROCHLORIDE_0.5 mg_hard capsule_NL_NL-H-3935-001
03/2022 RR + 04/2022 EPAR Consolidated
SAMENVATTING VAN DE PRODUCTKENMERKEN
1.
NAAM VAN HET GENEESMIDDEL
Anagrelide Zentiva 0,5 mg harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 0.5 mg anagrelide (as anagrelide
hydrochloride monohydrate).
Excipient with known effect:
Each hard capsule contains 59.5 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
A hard capsule (size 4, 14.3×5.3 mm) with an opaque white body and
cap.
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 essential thrombocythaemia patient is defined by one or
more of the following
features:
−
> 60 years of age or
−
a platelet count > 1,000×10
9
/l or
−
a history of thrombo-haemorrhagic events.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with anagrelide 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).
ANAGRELIDE HYDROCHLORIDE_0.5 mg_hard capsule_NL_NL-H-3935-001
03/2022 RR + 04/2022 EPAR Consolidated
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 600×10
9
/l and ideally at levels between 150×10
9
/l and
400×10
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). During
clinical development doses of 10 mg/day have been used.
Th