US regulatory Authority yakazivisa kubviswa pamusika we angangoita 141.984 mabhodhoro e atorvastatin calcium, statin inoshandiswa zvakanyanya pakudzora LDL cholesterol. Chiyero chakagamuchirwa mushure mekuona kutsauka mukuyedzwa kwekunyungudika, parameter yakakosha inoita kuti chinhu chinoshanda chiburitswe mumuviri.
Chiziviso, chakarongwa ne FDA seKirasi II inorangarira, zvinoreva kuti mukana wekukuvadzwa kwakakomba uri kure, kunyangwe mhedzisiro yenguva pfupi kana yekurapa inogona kuitika nekuda kwekushomeka-kupfuura-kunotarisirwa kushanda. Vakuru vanokurudzira varwere kuti vasaregedze kurapwa kwavo voga uye kubvunzana nenyanzvi dzavo dzezvehutano.
Chii chave pamudyandigere uye nei?
Mijenya yakakanganiswa inowirirana atorvastatin calcium (generic yeLipitor), inowanikwa mu 10 mg, 20 mg, 40 mg, uye 80 mg formulations. Miedzo yekudzora mhando yakawana kusateerana nezvinonzi dissolution yakatarwa, izvo zvinogona kukonzera kusakwana kunyudzwa kwemushonga uye, nekudaro, hurombo hunodzora huwandu hwecholesterol.
Kubviswa kwakaziviswa panguva ye vhiki yechitatu yaGumiguru uye inogumira kumusika weUS. Nyanzvi midhiya uye webhusaiti yesangano rinotonga yakaratidza kuti ichi ndicho chimwe chezvakakosha kuyeuka zvegore mumajenariki anodyiwa zvakanyanya nekuda kwehuwandu hwezvikamu zvinobatanidzwa.
Yakakanganiswa mijenya uye mharidzo
Zvinoenderana nechiziviso chepamutemo, chiyero chinovhara mabheji masere anogadzirwa neAlkem Laboratories uye yakagoverwa neAscend Laboratories LLC. Mabhodhoro akabatwa ane 90, 500, uye 1.000 mapiritsi, uye zvigadzirwa zvakarangarirwa zvinosanganisira masimba akasiyana-siyana (10-80 mg).
Mazuva ekupera kwemabhechi anobatanidzwa ari pakati Chikunguru 2026 uye Kukadzi 2027Roti makodhi uye saizi chaiyo/simba musanganiswa anogona kuwanikwa muFDA yekurangarira dhatabhesi (fda.gov), iyo inonyora mareferensi akadhindwa pamazita ekutengesa.
Njodzi dzinogona kuitika kune varwere
Njodzi huru inoonekwa ndeye kusakwana kusunungurwa kwechinhu chinoshanda iyo isingasviki painoda kurapwa. Muvanhu vane njodzi yakakwira yemoyo, izvi zvinogona kuita kuti kudzora cholesterol kuve kwakaoma uye, munguva yepakati, kukanganisa zvinangwa zvekudzivirira.
Parizvino, iyo FDA inoratidza izvozvo hapana zviitiko zvakakomba zvakashata zvakashumwa zvakabatana nemabhati aya. Zvisinei, kuongororwa kwekliniki kunokurudzirwa, uye kuchinja kamwe kamwe mukurapa pasina mazano ekurapa kunodziviswa, kunyanya muvarwere vanotora mishonga yakawanda kana vane nhoroondo yechirwere chemwoyo.
Chii chinofanira kuitwa nevarwere?
Tarisa chinyorwa pamudziyo wako uye enzanisa iyo nhamba yakawanda paFDA portal (fda.gov)Kana mushonga wako ukabuda pachirongwa chekuyeuka, usarega kuutora uri wega: bvunza chiremba wako kana wemishonga kuti akupe mazano ekuti ungautsiva sei zvakachengeteka.
Pamibvunzo nezve maitiro, iyo agency inochengetedza inoshanda yeruzivo mutsara. 1-888-INFO-FDA (1-888-463-6332)IAmerican Heart Association inoyeuchidza kuti chero shanduko ye statin inofanira kuitwa pasi pekutariswa nenyanzvi kudzivirira kubhadharwa.
Context yeSpain neEurope
Chiziviso chakaburitswa chinoenderana nemusika we United StatesMuSpain neEuropean Union, kuongororwa kwezvinodhaka uye chero zviziviso zvinorongwa neAEMPS (Spanish Agency for International Medicines and Pesticides) uye EMA (Spanish Association of Medical Devices). Kana iwe uine mibvunzo nezve kurongedza kwakatengwa kubva kuSpanish pharmacy, bvunza wezvemishonga wako uye tarisa zviri pamutemo AEMPS chiteshi kuti uone kana paine chaiyo kutaurirana.
Kazhinji, kusati kwambobviswa kune imwe nyika, zviremera zveEurope zvinoongorora kana zviripo mabheji akaenzana pamusika weCommunity uye, kana zvichidikanwa, topa matanho akakodzera. Kusvikira pave nechenjedzo yemunharaunda, zvinokurudzirwa kuenderera mberi nekurapa uye kugadzirisa chero mibvunzo nenyanzvi yako yekunongedza.
Mirayiridzo kune ma pharmacy uye nyanzvi
Pharmacy uye kugovera masevhisi anofanira tarisa stock by lot number uye isa parutivi chero mareferensi anopindirana nechiziviso chepamutemo. Zvakakosha kuzivisa varwere zvakajeka uye kuronga shanduko nemupi pazvinenge zvakakodzera.
Iyo FDA nemakambani anobatanidzwa akakumbira kuti chero chigadzirwa chitaurirwe nekukurumidza. chiitiko kana fungidziro yeadverse reaction kuburikidza nematanho ane mvumo. Kudyidzana navanachiremba vemhuri uye nyanzvi dzezvemwoyo kunofambisa gadziridzo dzekurapa kana dzimwe nzira dzichidikanwa.
Mukudzokera kubva Kirasi IIChinonyanya kukosha ndechekuderedza njodzi dzinogona kuitika pasina kukonzera kukanganisa kusingakoshi kwekurapa. Naizvozvo, kutaurirana kwakananga nevarwere uye kusimbisa kutumira pane yepamutemo runyorwa matanho akakosha.
Kuyeuka kweUS kweanopfuura 140.000 mabhodhoro eatorvastatin nekuda kwekutadza kuparara kunoda. Batch cheki, zano rehunyanzvi uye kuenderera kwekutarisira kuve nechokwadi chekuti avo vanovimba nema statins vanochengeta yakachengeteka cholesterol kudzora.