PRASUGREL - TRIMA 10 MG

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

PRASUGREL

Tilgængelig fra:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD

ATC-kode:

B01AC22

Lægemiddelform:

FILM COATED TABLETS

Sammensætning:

PRASUGREL 10 MG

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

GEDEON RICHTER ROMÂNIA S.A., ROMANIA

Terapeutisk område:

PRASUGREL

Terapeutiske indikationer:

Prasugrel - Trima 10 mg, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in 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). The increased efficacy should be balanced with the increased risk in patients with bleeding tendencyin those who had TIA/CVA in the past and in those above the age of 75 or weight below 60 kg.

Autorisation dato:

2023-06-04

Indlægsseddel

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
Prasugrel - Trima 10 mg
Film-coated tablets
Active ingredient
Each film-coated tablet contains: prasugrel 10 mg
For information regarding inactive ingredients and allergens, see
section
2 under “Important information about some of the ingredients of the
medicine” and section 6 - “Additional information”.
Read the entire leaflet carefully before using the medicine. This
leaflet
contains concise information about the medicine. If you have
additional
questions, refer to the doctor or the pharmacist.
This medicine has been prescribed for your treatment. Do not pass it
on to
others. It may harm them even if it seems to you that their medical
condition is similar.
Prasugrel - Trima 10 mg is not intended for children and adolescents
under the age of 18, since no information is available regarding the
efficacy and safety of this medicine in this age group.
1. What is the medicine intended for?
Prasugrel - Trima 10 mg in combination with acetylsalicylic acid is
intended
for prevention of atherothrombotic events in patients with acute
coronary
syndrome (unstable angina pectoris, acute myocardial infarction) who
are
undergoing primary or planned catheterization with or without a stent.
Therapeutic class: platelet aggregation inhibitors.
2. Before using the medicine
Do not use this medicine if:
You are sensitive (allergic) to the active ingredient or to any of the
additional
ingredients
the
medicine
contains
(see
section
6).
An allergic reaction may occur as a rash, itch, swelling of the face
and
lips or shortness of breath. If you experience any of these effects,
inform your doctor immediately.
You have active bleeding (such as bleeding from an ulcer in your
digestive system).
You have previously had a stroke or a transient ischemic attack (TIA).
You have severe liver disease.
Special warnings regarding the use of the medicine
Before treatment with Prasugrel - Trima,