Valsts: Izraēla
Valoda: angļu
Klimata pārmaiņas: Ministry of Health
TERIPARATIDE
DEXCEL LTD, ISRAEL
H05AA02
SOLUTION FOR INJECTION
TERIPARATIDE 250 MCG/ML
S.C
Required
GEDEON RICHTER PLC, HUNGARY
TERIPARATIDE
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.
2020-02-24
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 Izlasiet visu dokumentu
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 Izlasiet visu dokumentu