Država: Izrael
Jezik: angleščina
Source: Ministry of Health
TERIPARATIDE
KAMADA LTD, ISRAEL
H05AA02
SOLUTION FOR INJECTION
TERIPARATIDE 0.250 MG / 1 ML
S.C
Required
ALVOGEN INC., USA
TERIPARATIDE
Treatment of Postmenopausal Women with Osteoporosis at High Risk for FractureTeriparatide Kamada 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, Teriparatide Kamada 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 FractureTeriparatide Kamada 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 FractureTeriparatide Kamada 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.
2022-07-24
Kamada Teriparatide Solution for Injection User manual 355.6 x 750 mm 7.5 7 7.5 1 Heb+Eng 08/12/22 Keren 2 Heb+Eng 21/12/22 Keren 3 Heb+Eng 5-1-23 Keren 4 Heb+Eng 30-1-23 Keren 5 Heb+Eng 06-2-23 Keren 6 Heb+Eng 13-2-23 Keren 7 Heb+Eng+Arabic 13/3/23 Rima 8 Heb+Eng+Arabic 21/3/23 Rima Client C M Y K 3200004076-01 הקידב אלל ינכט - תילגנאו תירבע Lot: XXX XXXX 1 2 Lot: XXX XXXX EXP: MM / YYYY EXP: MM / YYYY EXP: MM / YYYY EXP: MM / YYYY 3 4 5 6 7 8 9 10 הקרזה טע רובע שמתשמל ןולע עדהמק דייטארפירט הקרזהל הסימת שומישל ןכומ טעב עדהמק דייטארפירט שומישל ןכומ טעב הקרזהל הסימת עדהמק דייטארפירט שומישל ןכומ טעב הקרזהל הסימת TERIPARATIDE KAMADA SOLUTION FOR INJECTION IN A PRE-FILLED PEN TERIPARATIDE KAMADA SOLUTION FOR INJECTION IN A PRE-FILLED PEN :ותומכו ליעפה רמוחה ל"מ/םרגורקימ 250 דייטארפירט :הליכמ תקרזומ הנמ לכ )teriparatide 20 mcg( םרגורקימ 20 דייטארפירט .תולולכ ןניא םיטחמ* שמתשהל ץלמומ הז טעב תרבח לש 29-31G לדוגב םיטחמב Becton, Dickinson and Company .)המוד וא( תא תוסכל שי .תע לכב )2°C-8°C( ררקמב ןסחא קזנמ תינסחמה לע ןגהל ידכ ןבלה הסכמה םע טעה רישכתב שמתשהל ןיא .איפקהל ןיא .רואמו יזיפ .אפקוהש :הנושארה החיתפה רחאל ררקמב ןסחאל שי ןושארה שומישה רחאל • ךילשהל שי .םימי 28 ךות שמתשהלו )2°C-8°C( .ןושארה שומישהמ םימי 28 רחאל טעה תא ךשמ תא רעזמל שי שומישה תפוקת ךלהמב םע דיימ הנמה קירזהל ןתינ ;ררקמל ץוחמ ןמזה .ררקמהמ האצוהה .אפקוהש רישכתב שמתשהל ןיא .איפקהל ןיא • .תרבוחמ טחמ םע טעה תא ןסחאל ןיא .שומישה ינפל םיידיה ת Preberite celoten dokument
Page 1 of 14 TERIPARATIDE KAMADA 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 TERIPARATIDE KAMADA ONLY FOR PATIENTS FOR WHOM THE POTENTIAL BENEFITS ARE CONSIDERED TO OUTWEIGH THE POTENTIAL RISK. TERIPARATIDE KAMADA 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 (13.1)]_. TERIPARATIDE KAMADA 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 Teriparatide Kamada 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 pati Preberite celoten dokument