ABIRATERONE MEDOMIE 250 MG

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

ABIRATERONE ACETATE

Tilgængelig fra:

MEDOMIE PHARMA LTD, ISRAEL

ATC-kode:

L02BX03

Lægemiddelform:

TABLETS

Sammensætning:

ABIRATERONE ACETATE 250 MG

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

MSN LABORATORIES PRIVATE LIMITED, INDIA

Terapeutisk område:

ABIRATERONE

Terapeutiske indikationer:

a CYP17 inhibitor indicated:- in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer.- for the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT)

Autorisation dato:

2023-08-31

Indlægsseddel

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS)
- 1986
This medicine is dispensed with a doctor’s prescription only
ABIRATERONE MEDOMIE 250 MG
TABLETS
ACTIVE INGREDIENT AND ITS QUANTITY
Abiraterone acetate 250 mg, equivalent to 223 mg of abiraterone
.
Inactive ingredients and allergens in the preparation
–
see section 2 “Important information
about some of the medicine’s ingredients” and section 6 “Further
Information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains
concise information about the medicine. If you have further questions,
consult your doctor or
pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them even if it seems to you that their illness is similar.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Abiraterone Medomie 250 mg is a prescription medicine containing an
active ingredient called
abiraterone acetate. Abiraterone Medomie 250 mg is a CYP17 enzyme
inhibitor, given in
combination with prednisone for the treatment of:
•
metastatic castration-resistant prostate cancer.
•
adult males with newly diagnosed high risk metastatic
hormone-sensitive prostate cancer
(mHSPC) in combination with androgen deprivation therapy (ADT).
THERAPEUTIC GROUP:
Specific inhibitor of the enzyme CYP17.
2. BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE:
•
If you are sensitive (allergic) to abiraterone acetate or to any of
the additional ingredients
contained in the
medicine. For a list of the additional ingredients, see section 6
“Further
Information”.
•
If you are a woman, especially a pregnant woman. Abiraterone Medomie
250 mg is
intended for use in males only.
•
If you suffer from severe liver damage.
•
In combination with Ra-223 (used to treat prostate cancer).
Do not take the medicine if any of the above applies to your
condition. If you are not sure,
consult with your doctor or pharmacist before taking the medicine.
SPECIAL WARNINGS REGARDING THE