FORTEO

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

TERIPARATIDE

Commercializzato da:

ELI LILLY ISRAEL LTD, ISRAEL

Codice ATC:

H05AA02

Forma farmaceutica:

SOLUTION FOR INJECTION

Composizione:

TERIPARATIDE 250 MCG/ML

Via di somministrazione:

S.C

Tipo di ricetta:

Required

Prodotto da:

LILLY FRANCE S.A.S., FRANCE

Gruppo terapeutico:

TERIPARATIDE

Area terapeutica:

TERIPARATIDE

Indicazioni terapeutiche:

Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture:Forteo is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Forteo increases BMD reduces the risk of vertebral and nonvertebral fractures . Increase of Bone Mass in Men with Primary or Hypogonadal Osteoporosis at High Risk for Fracture :Forteo is indicated to increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy . Treatment of Men and Women with Glucocorticoid-Induced Osteoporosis at High Risk for Fracture:Forteo is indicated for the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy .

Data dell'autorizzazione:

2013-10-31

Foglio illustrativo

I FORTPN F 09
Page 1 of 6
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
This medicine is dispensed with a physician’s prescription only
FORTEO
Solution for subcutaneous injection
ACTIVE INGREDIENT AND ITS QUANTITY: teriparatide 250 mcg/ml
Each injected dose contains:
teriparatide 20 mcg
INACTIVE INGREDIENTS: see Section 6 “Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise
information about this medicine. If you have any further questions,
contact your doctor or
pharmacist.
Also read the User Manual of the FORTEO pen.
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 illness seems to be the same as yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
•
Treatment of men and postmenopausal women who are suffering from
osteoporosis and
are at high risk of developing fractures.
•
Treatment of osteoporosis associated with corticosteroid therapy in
men and women at
increased risk for fractures.
•
FORTEO increases bone mineral density (BMD), strengthens the bone and
reduces the
risk for fractures.
THERAPEUTIC GROUP
: Parathyroid hormones.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS PREPARATION IF:
•
you are sensitive (allergic) to the active ingredient or to any of the
other ingredients of
this medicine (see section 6). Reactions include angioedema and
anaphylactic reaction.
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:
•
Bone cancer (osteosarcoma) has been reported rarely in patients who
had been taking
FORTEO. In people, osteosarcoma is a serious but rare cancer. It is
not known if people
who take FORTEO have a higher chance of getting osteosarcoma.
•
The duration of treatment is limited to two years over your lifetime.
BEFORE STARTING TREATMENT WITH FORTEO, TELL YOUR DOCTOR IF:
•
you are sensitive (allergic) to the active ingredient or to any of the
other ingredients of
this medicine.
•
y
suffer
ou
or have s

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