ENew Delhi: Ukuphendula kwisiphakamiso seFresenius Medical Care, iKomiti yeeNgcali eziKhethekileyo (i-SEC) yeCentral Drugs Standard Control Organisation (i-CDSCO) icebise inkampani ukuba ingenise isizathu sokuvunywa kunye nedatha yesilingo seklinikhi yesigaba sesi-3 se-calcium chloride dihydrate kunye nedatha yokujonga emva kokuthengisa evela kumazwe avunyiweyo ukuze iqwalaselwe ngakumbi.
Le nkampani ngaphambili yayifake isicelo sokwenza nokuthengisa isisombululo se-calcium chloride dihydrate kwi-concentration ye-100 mmol/L, esetyenziselwa "unyango lokutshintshwa kwe-calcium kwi-continuous renal replacement therapy (CRRT), i-continuous low-efficiency (yemihla ngemihla) dialysis (CLED) kunye ne-therapeutic plasma exchange (TPE) ene-citrate anticoagulation. Le mveliso ifanelekile kubantu abadala kunye nabantwana" kwaye ichaze izizathu zokukhutshwa kwizilingo zeklinikhi zesigaba sesithathu nesigaba sesine.
Ikomiti iqaphele ukuba imveliso ivunyiwe kumazwe aseYurophu afana nePortugal, iUnited Kingdom, iBrazil, iSwitzerland, iFrance kunye neDenmark.
I-compound calcium chloride dihydrate yiCaCl2 2H2O, eyi-calcium chloride equlethe iimolekyuli ezimbini zamanzi ngeyunithi nganye ye-calcium chloride. Yinto emhlophe ekristale, enyibilikayo emanzini kwaye i-hygroscopic, oko kukuthi, ekwaziyo ukufunxa umswakama ovela emoyeni.
I-calcium chloride dihydrate yikhompawundi engasetyenziswa njengenkqubo yesinyibilikisi yokunyibilikisa i-chitin xa inyibilikiswa kwi-methanol. Idlala indima ebalulekileyo ekuphuleni isakhiwo sekristale se-chitin kwaye ineendlela ezahlukeneyo zokusebenza kwicandelo lekhemistri.
Kwintlanganiso ye-SEC Nephrology ebibanjwe ngoMeyi 20, 2025, iphaneli ihlolisise isindululo sokuvuma ukwenziwa kunye nokuthengiswa kwesisombululo sokufakwa kwe-calcium chloride dihydrate esiyi-100 mmol/L ukuze sisetyenziswe “kwi-calcium replacement therapy kwi-continuous renal replacement therapy (CRRT), i-continuous low-efficiency (yemihla ngemihla) dialysis (SLEDD), kunye ne-therapeutic plasma exchange (TPE) ene-citrate anticoagulation. Le mveliso iboniswa kubantu abadala kunye nabantwana” kwaye yanika izizathu zokungabandakanywa kwizilingo zeklinikhi zesigaba sesi-3 nesesi-IV.
Emva kwengxoxo eneenkcukacha, ikomiti icebise ukuba isiseko sokuvunywa, kunye nedatha yesigaba sesiThathu sovavanyo lwezonyango kunye nedatha yokujonga emva kokuthengisa evela kumazwe avumile eli yeza, zingeniswe kwikomiti ukuze ziqwalaselwe ngakumbi.
Funda kwakhona: Iqela le-CDSCO Livumile Ukuhlaziywa Kweelebheli ze-Sanofi's Myozyme, Licela Uphononongo Lwemithetho
UDkt. Divya Kolin ungumfundi ophumelele kwiPharmD onamava amaninzi ezonyango nasesibhedlele kunye nezakhono ezibalaseleyo zokuxilonga kunye nokunyanga. Ukwasebenze njengengcali yezonyango kwisebe le-oncology kwiMysore Medical College and Research Institute. Okwangoku uqhubeka nomsebenzi wakhe kuphando lwezonyango kunye nolawulo lwedatha yezonyango. Usebenze neMedical Dialogue ukusukela ngoJanuwari 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
Uphononongo lwe-ABYSS lufumanise ukuba ukuyeka i-beta-blockers emva kokuhlaselwa yintliziyo kubangele ukunyuka koxinzelelo lwegazi, izinga lentliziyo, kunye neziganeko ezimbi zentliziyo: …