פרוליה 60 מ"ג - Prolia 60 mg
| ×§×××¦× ×¤×¨××§×××××ת (ATC4) | M05BX Other drugs affecting bone structure and mineralization | ||||||||||||||||||||||||||||||||||||||||||
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| ×ר××× ×¤×¢×× (ATC5) | Â
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| צ×רת ××ª× | תת-×¢××¨× - S.C | ||||||||||||||||||||||||||||||||||||||||||
| צ×רת ××× ×× | ת×××¡× ×××רק×, SOLUTION FOR INJECTION ××× ×עת ××× ×× ×תר ×× ×רע×× ×ש ××××× ×ת ×תר××¤× ××ת×× ×××× ×× ××××××¥ ××¤× ×©××פ××¢ ××¢××× ×צר×× | ||||||||||||||||||||||||||||||||||||||||||
| ×ת×××× | Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Prolia significantly reduces the risk of vertebral, non vertebral and hip fractures. Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, Prolia significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy of a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 3 months, in adult patients at high risk of fracture.
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| ×ת××ת ××× ×× | Posology and method of administration | ||||||||||||||||||||||||||||||||||||||||||
| ×ת××××ת × ×× | Contraindications | ||||||||||||||||||||||||||||||||||||||||||
| ת×פע×ת ××××× | Undesirable effects | ||||||||||||||||||||||||||||||||||||||||||
| ת××××ת ××× ×ª×¨×פת××ת | Interaction with other medicinal products and other forms of interaction | ||||||||||||||||||||||||||||||||||||||||||
| ש×××ש ×××ר××× ××× ×§× | Pregnancy and Lactation | ||||||||||||||||||||||||||||||||||||||||||
| פר××§×××× ×××§× | Pharmacodynamic Properties | ||||||||||||||||||||||||||||||||||||||||||
| פר××§××§×× ×××§× | Pharmacokinetic Properties | ||||||||||||||||||||||||||||||||||||||||||
| ×¢××× ×ר××¤× ××××ר×ת ××¢××× |
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| ×¢××× ×צר×× |  |
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| ער××× ×××××§×רפ××× | ער××× ×§×©×ר×× ×××××§×רפ××× |
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| פר×××× 60 ×"× ××××ר ××©×¨× ××ר×××ת |
| ××פ×ש ×××ר×× | ×××ר×× ×-PubMed |
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| ××××¢ ×רשת | RxList WebMD Drugs.com |
| ×©× ××¦×¨× | AMGEN EUROPE B.V., NETHERLANDS |
| ×©× ××¢× ×ר×ש×× | AMGEN EUROPE B.V. |
| ר×ש××× | ת×ר×× ××ש×: 06/2010. ר×ש××× ×ת×ר××: 05/2016 |
| ת×ר×× ×¢×××× ××ר×× | 15/11/2025 |
××××¢ × ×סף
- פר××××: ×תר××¤× ×× ××רת ×××פ×× ×ר××-×××× ×××ס×××פר×××ס
- × ×ª×× ×× ×ש×××× ×¢× ××פ×× ×ר××-×××× ×פר×××× ×©××צ×× ×× ×××¢ ×××פ×× ×××ס×××פ×ר×××ס ×××ר ××× ×××¢×ר
- ××קר: 10years of denosumab treatment in postmenopausal
women with osteoporosis: results from the phase 3 randomised FREEDOM trial and open-label extension
Prolia â(Denosumab)
Prolia ××× × ×××× ×××× × ×שר × ×§×©×¨ ××××¤× ×¡××§×××× ×××פ×× ××ת ××××× ×××××× RANK Ligand. ××××¤× ××, פר×××× ×××§× ×ת ×× ×× ×× ×××× × ××××¢× ×©× ××¢×¦× ×××××× ××¢×××× ××תפת××ת, תפק×× ×××שר××ת ×©× ××ס×××××§×ס×××.
×× ×ספר×ת
- Prolia × ×××§× ×××קר×× ×××¢× 10,000 × ×©×× ×××× ×××¢×ר ×ס××××ת ×××ס××××פ×ר×××ס ×× ×¦×¤×פ×ת ×¢×¦× × ××××.
- ×××קר × FREEDOM × ××¦× ×© Prolia ××§××× × ××××¤× ×ש××¢××ª× ×ת ×ס×××× ×ש×ר×× ××¢××× ×ש××¨× ×××××¦× ××, ×××× ××ר×.
- ××פ×× × Prolia ×××©× 6 ×©× ×× ×××× ××¢××× ×¤×¨××רס×××ת ×צפ×פ×ת ××¢×¦× ××× ××ª×¨× ×× ×ת ×עצ×.
- ×× ××× ×××× ×ש××¢××ª× ××¡× ×ª×פע×ת ××××××, ×ת×פע×ת ×××××× ××××ר×ת ××ש××¢×ר ×פסקת ××שתתפ×ת ×××קר×× ××× × ×©×× ×©×§×××× Prolia ×× ×©×× ×©××פ×× ×××× ××.
- ××× ×¦××¨× ××ת××ת ××× ×× × ×¤×¨×××× ××××פ××ת ×¢× ××¤×¨×¢× ×ת×פק×× ×××××ת ×× ××××פ××ת ××¢× ××× 65.
××¨× ××ת×
Prolia × ××ª× ×ª ××ר××§× ×ª×ª ×¢×ר×ת ××× ××¦× ×©× × (Denosumab 60mg/1ML) ××××¨×§× ×ª×¢×©× ×¢"× ××× ×××××× ×××, ×××רק ××××¢ ××× ××××× ×ר×ש ×××רק×.
- PERCENTAGE OF WOMEN ACHIEVING NONOSTEOPOROTIC BMD T-SCORES AT THE LUMBAR SPINE (LS) AND TOTAL HIP (TH) DURING UP TO 8 YEARS OF DENOSUMAB (DMAB) TREATMENT
- DENOSUMAB TREATMENT IN POSTMENOPAUSAL
WOMEN WITH OSTEOPOROSIS FOR UP TO 9 YEARS
×××ר××:
- Deal C. Nat Clin Prac Rheumatol. 2009;5:20-27
- Cummings SR. et. Al N Eng J Med 2009; 361: 756-766
- Miller P et al. Bone 2008; 43: 222â229
- Brown JP et al. J Bone Miner
- ResKendler DL et al. J Bone Miner Res 2010; 25: 72â81 2009; 24: 153â161
- Bone HG et al. J Clin Endocrinol Metab 2008
- Prolia PI as approved by MOH June 2011
- Kendler DL et al. Osteoporos Int 2010; 21: 837â846
השינוי האחרון נעשה בֹ־15 בנובמבר 2025 ב־12:35