I-Apo-Acyclovir Ikhunjulwa Ngenxa Ye-Nitrosamine i-iImpurity

Isifinyezo

• Imikhiqizo: Apo-Acyclovir (acyclovir) 200 mg kanye namaphilisi angu-800 mg

• Inkinga: Inkatho ethile iyabuyiselwa ngenxa yokuba khona kokungcola kwe-nitrosamine ngaphezu kwezinga elamukelekayo.

• Okufanele ukwenze: Qhubeka uphuza imithi yakho ngaphandle uma uceliwe ukuthi uyeke umhlinzeki wakho wezempilo. Awudingi ukubuyisela imithi yakho ekhemisi lakho. Ukungaselaphi isimo sakho kungase kube yingozi enkulu empilweni.

Issue

I-Akatex Inc. ikhumbula inqwaba yamaphilisi e-Apo-Acyclovir (acyclovir), ku-200 mg kanye namandla angu-800 mg, ngenxa yokuba khona kokungcola kwe-nitrosamine (N-nitrosodimethylamine [NDMA]) ngaphezu kwezinga elamukelekayo.

I-Apo-Acyclovir iyisidakamizwa esilwa namagciwane esetshenziswa kadokotela esetshenziselwa ukwelapha i-shingles, kanye nokwelapha noma ukunciphisa ukubuya kwe-herpes ezithweni zangasese.

I-NDMA ihlukaniswa njenge-carcinogen yomuntu okungenzeka. Lokhu kusho ukuthi ukuchayeka isikhathi eside ezingeni elingaphezu kwalokho okubhekwa njengokwamukelekayo kungase kwenyuse ingozi yomdlavuza. Sonke sichayeka emazingeni aphansi e-nitrosamine ngokudla okunhlobonhlobo (njengenyama ebhenywayo nelashiwe, imikhiqizo yobisi nemifino), amanzi okuphuza kanye nokungcoliswa komoya. Lokhu kungcola akulindelekile ukuthi kubangele ukulimala lapho kudliwe ezingeni elivumelekile noma ngaphansi. Umuntu odla isidakamizwa esiqukethe lokhu kungcola ezingeni elamukelekayo noma elingaphansi kwazo zonke izinsuku iminyaka engu-70 akulindelekile ukuthi abe sengozini enkulu yokuba nomdlavuza.

Iziguli zingaqhubeka nokuphuza imithi yazo njengoba ziyalelwe umhlinzeki wazo wezempilo futhi akudingekile ukuba zibuyisele imithi yazo ekhemisi, kodwa kufanele zithinte umhlinzeki wazo wezempilo uma ziwuphuze umkhiqizo obuyiselwe emuva futhi zikhathazekile ngempilo yazo.

Ayikho ingozi esheshayo yokuqhubeka nokuthatha imithi ebuyisiwe, njengoba ukwanda kwengozi yomdlavuza ngokuvamile kuhilela ukuchayeka isikhathi eside ekungcoleni kwe-nitrosamine ngaphezu kwezinga elamukelekayo.

I-Health Canada iqapha ukusebenza kahle kokukhumbula kanye nokusebenzisa kwenkampani noma yiziphi izinyathelo ezidingekayo zokulungisa nokuvimbela. Uma kwenzeka noma yikuphi ukukhumbula okwengeziwe kudingekile, i-Health Canada izobuyekeza ithebula futhi yazise abantu baseCanada.

Imikhiqizo ethintekile

Ukuphelelwa yisikhathi koMkhiqizo weNkampani we-DIN

Apotex Inc. Apo-Acyclovir 200 mg 02207621 RH9368 08/2022

Apotex Inc. Apo-Acyclovir 200 mg 02207621 RH9370 08/2022

Apotex Inc. Apo-Acyclovir 800 mg 02207656 RP8516 07/2022

Apotex Inc. Apo-Acyclovir 800 mg 02207656 RP8517 07/2022

Apotex Inc. Apo-Acyclovir 800 mg 02207656 RT8943 07/2022

Okufanele ukwenze

• Qhubeka uphuza imithi yakho ngaphandle uma uceliwe ukuthi uyeke umhlinzeki wakho wezempilo. Awudingi ukubuyisela imithi yakho ekhemisi lakho. Ukungaselaphi isimo sakho kungase kube yingozi enkulu empilweni.

• Khuluma nomhlinzeki wakho wezempilo uma uthatha umkhiqizo obuyiselwe emuva futhi ukhathazekile ngempilo yakho.

• Uma unemibuzo mayelana nokukhumbula, xhumana ne-Apotex Inc. kokuthi 1-888-628-0732 noma nge-imeyili kokuthi [i-imeyili ivikelwe].

• Bika noma yimiphi imiphumela emibi ehlobene nomkhiqizo wezempilo noma izikhalazo kwa-Health Canada.

Background

I-Health Canada ibilokhu isebenzela ukubhekana nenkinga yokungcola kwe-nitrosamine okutholakala emithini ethile kusukela ehlobo lika-2018. Izinkampani zaziqondiswe ukuthi ziqedele ukuhlola okuningiliziwe kwezinqubo zabo zokukhiqiza kanye nokuhlola imikhiqizo uma ukubuyekezwa kwabo kuhlonze ukuthi kungenzeka yini ukwakheka kwe-nitrosamine. Njengoba lo msebenzi uqhubeka, imikhiqizo eyengeziwe ingase ikhonjwe futhi ikhunjulwe ngokufanelekile. I-Health Canada iyaqhubeka nokusebenzisana eduze nabalingani bezomthetho bamazwe ngamazwe kanye nezinkampani ukubhekana nalolu daba futhi izoqhubeka nokwazisa abantu baseCanada. Ulwazi olwengeziwe ngomsebenzi we-Health Canada wokubhekana nama-nitrosamine emithini iyatholakala ku-Canada.ca.