ODOMZO 200 MG

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

SONIDEGIB AS DIPHOSPHATE

Disponível em:

TARO INTERNATIONAL LTD, ISRAEL

Código ATC:

L01XX48

Forma farmacêutica:

HARD CAPSULE

Composição:

SONIDEGIB AS DIPHOSPHATE 200 MG

Via de administração:

PER OS

Tipo de prescrição:

Required

Fabricado por:

PATHEON INC., CANADA

Área terapêutica:

SONIDEGIB

Indicações terapêuticas:

Odomzo 200 mg is indicated for the treatment of adult patients with locally advanced basal cell carcinoma which cannot be treated with curative surgery or radiation therapy

Data de autorização:

2021-06-30

Folheto informativo - Bula

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS)
- 1986
This medicine is dispensed with a doctor’s prescription only
ODOMZO
® 200 MG
HARD CAPSULES
ACTIVE INGREDIENT:
Each capsule contains: sonidegib diphosphate 280.80 mg (equivalent to
sonidegib 200 mg)
See list of inactive ingredients and allergens in this medicine in
section 6 “Additional
information” and in section 2 under “Important information about
some of this medicine’s
ingredients”.
READ THE ENTIRE PATIENT LEAFLET CAREFULLY BEFORE USING THIS MEDICINE.
This leaflet contains
concise information about this medicine. If you have any further
questions, ask 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 to
yours.
THIS MEDICINE IS NOT INTENDED FOR CHILDREN AND ADOLESCENTS UNDER 18
YEARS OLD.
PATIENT SAFETY INFORMATION CARD
In addition to the patient leaflet, Odomzo has a patient safety
information card about possible
harm to your unborn baby. This card contains important safety
information that you need to
know before starting treatment and during treatment with Odomzo.
Carefully read the patient
safety information card and package insert before using this medicine.
Keep the card and
package insert in case you need to read them again.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Odomzo is intended to treat adults with a type of skin cancer called
basal cell carcinoma
(BCC). It is used when the cancer has spread locally and cannot be
treated with surgery or
radiation.
The normal growth of cells is controlled by various chemical signals.
In patients with basal
cell carcinoma, changes occur in genes that control a part of this
process known as the
“hedgehog pathway”. This pathway switches on signals that make the
cancer cells grow out
of control. Odomzo works by blocking this pathway, blocking the
signals, and thereby
stopping cancer cells from growing and making new cells.
THERAPE

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