Prasugrel Teva 10 mg, filmomhulde tabletten

Страна: Нидерландия

Език: нидерландски

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

Активна съставка:

PRASUGRELHYDROBROMIDE 12,2 mg/stuk SAMENSTELLING overeenkomend met ; PRASUGREL 10 mg/stuk

Предлага се от:

Teva Nederland B.V. Swensweg 5 2031 GA HAARLEM

АТС код:

B01AC22

INN (Международно Name):

PRASUGRELHYDROBROMIDE 12,2 mg/stuk SAMENSTELLING overeenkomend met ; PRASUGREL 10 mg/stuk

Лекарствена форма:

Filmomhulde tablet

Композиция:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; GLYCEROLDIBEHENAAT ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463a) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 3350 ; MANNITOL (D-) (E 421) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SUCROSESTEARAAT (E 473) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; GLYCEROLDIBEHENAAT ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 3350 ; MANNITOL (D-) (E 421) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SUCROSESTEARAAT (E 473) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Начин на приложение:

Oraal gebruik

Терапевтична област:

Prasugrel

Каталог на резюме:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); GLYCEROLDIBEHENAAT; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); MACROGOL 3350; MANNITOL (D-) (E 421); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); SUCROSESTEARAAT (E 473); TALK (E 553 B); TITAANDIOXIDE (E 171);

Дата Оторизация:

1900-01-01

Листовка

Prasugrel, film-coated tablets, NL/H/4112/001-002
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Prasugrel Teva 5 mg, filmomhulde tabletten
Prasugrel Teva 10 mg, filmomhulde tabletten
prasugrel
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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
, which contains the active substance prasugrel, belongs
to a group of medicines
called anti-platelet agents. Platelets are very small cell particles
that circulate in the blood. When a
blood vessel is damaged, for example if it is cut, platelets clump
together to help form a blood clot
(thrombus). Therefore, platelets are essential to help stop bleeding.
If clots form within a hardened
blood vessel such as an artery they can be very dangerous as they can
cut off the blood supply, causing
a heart attack (myocardial infarction), stroke or death. Clots in
arteries supplying blood to the heart
may also reduce the blood supply, causing unstable angina (a severe
chest pain).
inhibits the clumping of platelets and so reduces the
chance of a blood clot forming.
You have been prescribed because you have already had a
heart attack or unstable
angina and you have been treated with a procedure to open blocked
arteries in the heart. You may also
have had

Данни за продукта

Prasugrel, film-coated tablets, NL/H/4112/001-002, 31.10.2019
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Prasugrel Teva 5 mg, filmomhulde tabletten
Prasugrel Teva 10 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_5 mg:_
Each film-coated tablet contains 5 mg prasugrel (as hydrobromide).
Excipient with known effect: Each film-coated tablet contains 2.75 mg
sucrose stearate which contains
0.11 mg sucrose.
_10 mg:_
Each film-coated tablet contains 10 mg prasugrel (as hydrobromide).
Excipient with known effect: Each film-coated tablet contains 5.5 mg
sucrose stearate which contains
0.22 mg sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_5 mg:_
Yellow, oval film-coated tablets, debossed with "P5" on one side and
plain on the other side of
the tablet. Dimensions: approx. 9 x 4 mm.
_10 mg:_
Beige, oval film-coated tablets, debossed with "P10" on one side and a
score line on the other
side of the tablet. Dimensions: approx. 11 x 6 mm.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
, co-administered with acetylsalicylic acid (ASA), is
indicated for the prevention of
atherothrombotic events in adult patients with acute coronary syndrome
(i.e. unstable angina, non-ST
segment elevation myocardial infarction [UA/NSTEMI] or ST segment
elevation myocardial
infarction [STEMI]) undergoing primary or delayed percutaneous
coronary intervention (PCI).
For further information please refer to section 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
should be initiated with a single 60 mg loading dose
and then continued at 10 mg
once a day. In UA/NSTEMI patients, where coronary angiography is
performed within 48 hours after
admission, the loading dose should only be given at the time of PCI
(see sections 4.4, 4.8 and 5.1).
Patients taking should also take ASA daily (75 mg to
325 mg).
2
rvg 121357-8 R-001 EU SPC met NL info-c