New Delhi: Mu gusubiza icyifuzo cya Fresenius Medical Care, Komite Ishinzwe Impuguke mu by’Ubumenyingiro (SEC) y’Ikigo Gishinzwe Kugenzura Ibiyobyabwenge (CDSCO) yasabye ko ikigo gitanga impamvu zo kwemezwa hamwe n’amakuru y’igerageza ry’icyiciro cya gatatu cya calcium chloride dihydrate n’amakuru y’igenzura nyuma yo kugurisha aturutse mu bihugu byemewe kugira ngo birusheho gusuzumwa.
Iyi sosiyete yari yarasabye mbere gukora no gucuruza umuti wa kalisiyumu chloride dihydrate ku kigero cya 100 mmol/L, ukoreshwa mu “gusimbuza kalisiyumu calcium mu kuvura impyiko mu buryo buhoraho (CRRT), dialysis idakora neza (CLED) buri munsi (cyangwa se buri munsi) no guhinduranya plasma (TPE) hamwe na citrate anticoagulation. Uyu muti ukwiriye abantu bakuru n'abana” kandi wavuze impamvu zo kutajya mu igeragezwa ry’ubuvuzi ry’icyiciro cya gatatu n’icya kane.
Komite yavuze ko iki gicuruzwa cyemejwe mu bihugu by'i Burayi nka Porutugali, Ubwongereza, Brezili, Ubusuwisi, Ubufaransa na Danemark.
Ikinyabutabire cya kalisiyumu chloride dihydrate ni CaCl2 2H2O, ari yo kalisiyumu chloride irimo molekile ebyiri z'amazi kuri buri gice cya kalisiyumu chloride. Ni ikintu cy'umweru gikozwe muri kristale, gishobora gushonga mu mazi kandi kikaba gikozwe muri hygroscopic, ni ukuvuga gishobora kwinjiza ubushuhe buva mu kirere.
Kalisiyumu chloride dihydrate ni ikintu gishobora gukoreshwa nk'uburyo bwo gushonga chitin iyo ishongeshejwe muri methanol. Igira uruhare runini mu gusenya imiterere ya chitin kandi ifite akamaro kanini mu bijyanye na chimie.
Mu nama ya SEC Nephrology yabaye ku ya 20 Gicurasi 2025, abagize akanama basuzumye icyifuzo cyo kwemeza ikorwa n'ubucuruzi bw'umuti wa calcium chloride dihydrate wa 100 mmol/L kugira ngo ukoreshwe muri "ubuvuzi bwo gusimbuza kalisiyumu mu buvuzi bukomeza gusimbuza impyiko (CRRT), dialysis idakora neza (ya buri munsi) (SLEDD), no guhinduranya plasma (TPE) hamwe na citrate anticoagulation. Uyu muti ugaragazwa ku bantu bakuru n'abana" kandi watanze impamvu zo kudashyirwa mu igeragezwa ry'ubuvuzi rya phase III na IV.
Nyuma yo kuganira ku buryo burambuye, komite yasabye ko ishingiro ryo kwemezwa, hamwe n'amakuru y'igerageza ry'icyiciro cya gatatu cy'ubuvuzi ndetse n'amakuru y'igenzura nyuma yo kugurisha aturutse mu bihugu byemeye uyu muti, byashyikirizwa komite kugira ngo birusheho gusuzumwa.
Soma kandi: Itsinda rya CDSCO ryemeye ivugururwa ry’ibirango bya Sanofi's Myozyme, risaba ko amategeko abigenzura
Dr. Divya Kolin ni umunyeshuri warangije muri PharmD ufite uburambe bwinshi mu buvuzi no mu bitaro ndetse n'ubuhanga mu gusuzuma no kuvura. Yanakoze nk'umufarumasiye w'indwara za kanseri mu ishami rya kanseri muri Mysore Medical College and Research Institute. Ubu arimo gukurikirana umwuga we mu bushakashatsi mu buvuzi no gucunga amakuru y'ubuvuzi. Yakoranye na Medical Dialogue kuva muri Mutarama 2022.
Dr Kamal Kant Kohli, MBBS, MD, CP, is a thoracic specialist with over 30 years of experience and specializes in clinical writing. He joins Medical Dialogues as the Editor-in-Chief of Medical News. Apart from writing articles, as the Editor, he is responsible for proofreading and reviewing all medical content published in Medical Dialogues, including content from journals, research papers, medical conferences, guidelines, etc. Email: drkohli@medicaldialogues.in Contact: 011-43720751
Ubushakashatsi bwa ABYSS bwagaragaje ko guhagarika beta-blockers nyuma yo kurwara indwara y’umutima bitera kwiyongera k’umuvuduko w’amaraso, umuvuduko w’umutima, n’ingaruka mbi z’umutima n’amaraso: …
Igihe cyo kohereza: Kamena-06-2025