TERROSA

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

TERIPARATIDE

Tilgængelig fra:

DEXCEL LTD, ISRAEL

ATC-kode:

H05AA02

Lægemiddelform:

SOLUTION FOR INJECTION

Sammensætning:

TERIPARATIDE 250 MCG/ML

Indgivelsesvej:

S.C

Recept type:

Required

Fremstillet af:

GEDEON RICHTER PLC, HUNGARY

Terapeutisk område:

TERIPARATIDE

Terapeutiske indikationer:

Treatment of postmenopausal women with osteoporosis at high risk for fracture: Terrosa 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,Terrosa 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: Terrosa 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: Terrosa 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.

Autorisation dato:

2020-02-24

Indlægsseddel

ACTIVE INGREDIENT AND ITS QUANTITY: Teriparatide 250 mcg/ml
Each injected dose contains Teriparatide 20 mcg.
Inactive ingredients and allergens in the medicine - see section 6
“Additional information” and in section 2 “Important information
about
some of the ingredients of this medicine”
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise information about the medicine. If you have
any further questions, ask the doctor or pharmacist.
Also read the User’s Manual for TERROSA PEN.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them, even if you think that their
illness is
the same as yours.
TERROSA
is
a
biosimilar
medicine.
For
more
detailed
information
regarding biosimilar medicines, see the Ministry of Health website:
https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/Registration/
Pages/Biosimilars.aspx . WHAT IS THE 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.
TERROSA increases bone mineral density (BMD), strengthens the
bone and reduces the risk for fractures
THERAPEUTIC GROUP: Parathyroid hormones
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
You are hypersensitive (allergic) to the active ingredient or to any
of the other ingredients this medicine contains (see section 6).
Reactions include angioedema and anaphylactic reaction
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE
There have been rare reports of osteosarcoma among patients who
had been taking teriparatide. In humans, osteosarcoma is a serious
but rare cancer. Whether the risk of developing this condition is
higher among patients who take TERROSA is unknown.
Duration of treatment is limited to 2 years during a lifetime.
BEFORE THE TREATMENT WITH TERROSA, TELL THE DOCTOR IF:
You are hypersensitive (allergic) to the active in

Produktets egenskaber

1
TERROSA
®
TERIPARATIDE 250 MCG/ML SOLUTION FOR SUBCUTANEOUS INJECTION
FULL PRESCRIBING INFORMATION
WARNING: POTENTIAL RISK OF OSTEOSARCOMA
IN MALE AND FEMALE RATS, TERIPARATIDE CAUSED AN INCREASE IN THE
INCIDENCE OF OSTEOSARCOMA (A MALIGNANT BONE TUMOR) THAT WAS
DEPENDENT ON DOSE AND TREATMENT DURATION. THE EFFECT WAS OBSERVED AT
SYSTEMIC EXPOSURES TO TERIPARATIDE RANGING FROM 3 TO 60
TIMES THE EXPOSURE IN HUMANS GIVEN A 20
MCG DOSE. BECAUSE OF THE UNCERTAIN RELEVANCE OF THE RAT OSTEOSARCOMA
FINDING TO
HUMANS, PRESCRIBE TERROSA
ONLY FOR PATIENTS FOR WHOM THE POTENTIAL BENEFITS ARE CONSIDERED TO
OUTWEIGH THE POTENTIAL RISK.
TERROSA SHOULD NOT BE PRESCRIBED FOR PATIENTS WHO ARE AT INCREASED
BASELINE RISK FOR OSTEOSARCOMA (INCLUDING THOSE WITH
PAGET’S DISEASE OF BONE OR UNEXPLAINED ELEVATIONS OF ALKALINE
PHOSPHATASE, PEDIATRIC AND YOUNG ADULT PATIENTS WITH OPEN
EPIPHYSES, OR PRIOR EXTERNAL BEAM OR IMPLANT RADIATION THERAPY
INVOLVING THE SKELETON)
_[SEE WARNINGS AND PRECAUTIONS (5.1), _
_ADVERSE REACTIONS (6.2), AND NONCLINICAL TOXICOLOGY (12.1)]_
.
TERROSA
is a biosimilar medicinal product that has been demonstrated to be
similar in quality, safety and efficacy to the reference
medicinal product Forteo. Please be aware of any differences in the
indications between the biosimilar medicinal product and the
reference medicinal product. The biosimilar is not to be switched with
the reference medicinal product unless specifically stated
otherwise. More detailed information regarding biosimilar medicinal
products is available on the website of the Ministry of Health:
https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/Registration/Pages/Biosimilars.aspx
1
INDICATIONS AND USAGE
1.1
TREATMENT OF POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS AT HIGH RISK FOR
FRACTURE
Terrosa 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 osteoporo