EVISTA

Држава: Израел

Језик: Енглески

Извор: Ministry of Health

Активни састојак:

RALOXIFENE HYDROCHLORIDE

Доступно од:

ELI LILLY ISRAEL LTD, ISRAEL

АТЦ код:

G03XC01

Фармацеутски облик:

FILM COATED TABLETS

Састав:

RALOXIFENE HYDROCHLORIDE 60 MG

Пут администрације:

PER OS

Тип рецептора:

Required

Произведен од:

LILLY S.A., SPAIN

Терапеутска група:

RALOXIFENE

Терапеутска област:

RALOXIFENE

Терапеутске индикације:

Evista is indicated for the treatment of osteoporosis in post menopausal women. Evista is indicated for the prevention of osteoporosis in post menopausal women . Evista is indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis. Evista is indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer.

Датум одобрења:

2023-12-31

Информативни летак

I EVISTB A 04
Page 1 of 6
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed by a doctor's prescription only
EVISTA
FILM COATED TABLETS
ACTIVE INGREDIENT AND QUANTITY:
Each film coated tablet contains:
Raloxifene HCl 60 mg.
For the list of inactive ingredients and allergens, please see section
“important information
about some of the ingredients of this medicine” in chapter 2 and
chapter 6 "Additional
information".
PLEASE READ THIS PACKAGE INSERT CAREFULLY IN ITS ENTIRETY BEFORE USING
THIS MEDICINE. This
package insert contains concise information on the medicine. If you
have any further questions,
please ask your doctor or pharmacist.
This medicine has been prescribed for the treatment of your illness.
Do not pass it on to others. It
may harm them even if their condition seems similar to yours.
1.
WHAT IS THE MEDICINE INTENDED FOR?
EVISTA is used for the treatment and prevention of osteoporosis in
postmenopausal women.
EVISTA is used for the prevention of osteoporosis in postmenopausal
women when estrogen
therapy is considered unsuitable.
Prevention of breast cancer - EVISTA reduces the risk of invasive
breast cancer in
postmenopausal women with osteoporosis and in postmenopausal women at
high risk for
invasive breast cancer.
THERAPEUTIC GROUP:
EVISTA belongs to the non-hormonal drug group known as Selective
Estrogen Receptor
Modulators (SERMs). When a woman reaches menopause, the level of the
sex hormone
estrogen decreases. EVISTA simulates some of the supporting effects of
estrogen at the
postmenopausal stage.
Osteoporosis is a disease
which causes a decrease in bone mass and increases
the bones’
tendency to fracture - this disease is especially common in
postmenopausal women, although
it is possible that initially no symptoms will appear. Osteoporosis
increases the risk of bone
fractures, especially those of the spinal column, hips and wrists, and
may cause back pain,
loss of height and a curved back.
2.
BEFORE USING THIS MEDICINE
DO

Карактеристике производа

EVISTA
RALOXIFENE HYDROCHLORIDE 60MG FILM COATED TABLET
FULL PRESCRIBING INFORMATION
WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM
STROKE
• Increased risk of deep vein thrombosis and pulmonary embolism have
been reported with EVISTA
_[see Warnings and _
_Precautions (5.1)]_
.
. Women with active or past history of venous thromboembolism should
not take EVISTA
_[see _
_Contraindications (4.1)]_
..
• Increased risk of death due to stroke occurred in a trial in
postmenopausal women with documented coronary heart disease or at
increased risk for major coronary events. Consider risk-benefit
balance in women at risk for stroke
_[see Warnings and _
_Precautions (5.2) and Clinical Studies (14.5)]._
1
INDICATIONS AND USAGE
1.1
TREATMENT AND PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
EVISTA is indicated for the treatment of osteoporosis in
postmenopausal women
_[see Clinical Studies (14.1, 14.2)]_
.
Evista is
indicated for the prevention of osteoporosis in post menopausal women
for whom estrogen therapy is considered unsuitable
1.2
REDUCTION IN THE RISK OF INVASIVE BREAST CANCER IN POSTMENOPAUSAL
WOMEN WITH OSTEOPOROSIS
EVISTA is indicated for the reduction in risk of invasive breast
cancer in postmenopausal women with osteoporosis
_[see _
_Clinical Studies (14.3)]_
.
1.3
REDUCTION IN THE RISK OF INVASIVE BREAST CANCER IN POSTMENOPAUSAL
WOMEN AT HIGH RISK OF INVASIVE BREAST CANCER
EVISTA is indicated for the reduction in risk of invasive breast
cancer in postmenopausal women at high risk of invasive breast
cancer
_[see Clinical Studies (14.4)]_
.
The effect in the reduction in the incidence of breast cancer was
shown in a study of postmenopausal women at high risk for
breast cancer with a 5-year planned duration with a median follow-up
of 4.3 years
_[see Clinical Studies (14.4)]_
. Twenty-seven percent
of the participants received drug for 5 years. The long-term effects
and the recommended length of treatment are not known.
High risk of breast cancer is defined as at least one breast biopsy
s