I-National Administration of Drugs, Food and Medical Technology yahlela le ukwenqatshelwa ngokushesha kokusetshenziswa, ukudayiswa nokusabalalisa yeqoqo le-antibiotic ejovayo, ngemuva kokuqinisekisa ubukhona bezinhlayiya ezimisiwe ezisho engozini empilweni yomphakathi.
Isilinganiso senziwa ngokusemthethweni ku Ukunikezwa 7695/2025, eshicilelwe kuGazethi Esemthethweni, futhi ihlanganisa umkhiqizo I-Clindamycin 600 mg/4 ml (isethulo esijovwayo) somnikazi we-KLONAL SRL, ehambisana ne Ingxenye ye-I2501, ivuthwa ngoJanuwari 2027.
Imuphi umuthi kanye nenqwaba okwafinyelelwa kuyo
Umkhiqizo othintekile clindamycin (njenge-phosphate) 600 mg/4 ml, ukusetshenziswa kwabazali ukumnika, okukhonjwe ngaphansi kwe Isitifiketi No. 43.852. Lokhu ukwakhiwa okuvamile ezibhedlela nasezikhungweni zokunakekelwa kwempilo, naku ukusetshenziswa kweziguli zangaphandle okulawulwayo.
Ngokusho kolwazi lwezobuchwepheshe, i-clindamycin isetshenziswa ku izifo ezinzima, kufaka phakathi umgudu wokuphefumula ophansi, isikhumba nezicubu ezithambile, isisu, amathambo namalunga, ama-bacterium kanye uhlelo lwe-genitourinaryIsethulo esikhonjiswe efayeleni sisho amabhodlela e-ampoule angu-4 ml, anamaphakethe okuthengisa angahlanganisa. amayunithi amaningi.
Yini abayitholile nokuthi kungani ibucayi
Ukuhlolwa kwekhwalithi kuqinisekisiwe izinhlayiya ezimisiwe ezinosayizi abahlukene kumayunithi amaningana enqwaba. Ngomjovo, lokhu kuchezuka kubalulekile: kungabangela ukusabela okubi, izenzakalo ze-thromboembolic, ukuvuvukala kwendawo noma ngisho izifo zesibili, ikakhulukazi uma ifakwa ngomthambo.
I-National Institute of Medicines (INAME) ihlukanise ukutholakala njengesigameko "OKUKHULU" ukugxeka kanye nokubalulekile kwesenzo “esimaphakathi”, njengoba kuyimithi elwa namagciwane eboniswa ezimeni ezinzima. Lokhu kuhlukaniswa idinga izinyathelo ezisheshayo ukuvimbela imiphumela ezigulini eziveziwe.
Izinyathelo eziyalwe yiziphathimandla
I-ANMAT iyalele ukuthi ukuhoxiswa ngokushesha emakethe yawo wonke amayunithi e-lot I2501 futhi wayala ifemu i-KLONAL SRL ukuthi yethule imibhalo esekelayo ye- alulame umkhiqizo ngaphambi kwendawo ye-Post-Marketing Surveillance.
Umthetho uyakwenqabela futhi ukusetshenziswa ezikhungweni zezempilo, amakhemisi kanye nabasabalalisi abavela ezweni lonke. Umbhalo osemthethweni ugcizelela ukuthi isici salolu hlobo siyakhombisa ukushiyeka okukhulu ku Uhlelo Lwekhwalithi Yezemithi nasezinhlelweni zokukhiqiza zesikhungo.
Ukusebenza kufakiwe: INAME kanye nama-ejensi alawulayo anekhono lobuchwepheshe nokuphatha, aphakamise ukwamukelwa kwalokhu izindlela zokuvimbela ngokuvumelana nezindinganiso zamazwe ngamazwe zokulawulwa kobungozi emikhiqizweni yezokwelapha esezingeni eliphansi.
Izincomo zochwepheshe kanye neziguli
Ngezinsizakalo zezempilo nezomsebenzi, kuyaphakanyiswa nqamula ngokushesha noma yikuphi ukusebenzisa kweqoqo elibonisiwe, hlola amasheya kanye hlukanisa amayunithi ize ibuyiselwe kumphakeli noma ukuhoxiswa kwayo kusetshenzwe.
Uma isiguli sinemithi ekhaya, kufanele gwema ukuphatha kwayo futhi uxhumane nendawo yokuthengisa ye buyelaUma unemibuzo noma izehlakalo ezingezinhle, kutuswa ukuthi uthintane nochwepheshe bezempilo futhi uzibike ngemigudu esemthethweni.
Isikhungo sikhumbule ukuthi izinhlelo ziyatholakala Izikhalazo Zezempilo kanye Nezicelo ku-portal yayo, lapho ungakwazi ukuxhumana okutholakele, imibuzo mayelana nenkatho kanye izehlakalo ezimbi okungenzeka ihlotshaniswe nomkhiqizo.
Lokhu kungenelela kokulawula kuyafuna vikela iziguli kuyilapho umnikazi wokubhalisa elungisa ukuchezuka kwekhwalithi, futhi egcizelela ukubaluleka kwalokho qinisekisa amaqoqo nezethulo ngaphambi kokusebenzisa imithi ejovayo kunoma iyiphi indawo yokunakekelwa kwezempilo.
