Macluumaadka Sharciyeed

 Waxa aad u baahan tahay inaad ka ogaato xeerarka daawaynta UVB

Aaladaha caafimaadka waxaa lagu maamulaa gudaha Kanada Hay'adda Caafimaadka Kanada ee Agaasinka Alaabada Therapeutic Product (TPD) iyo gudaha USA Maamulka Cuntada iyo Dawooyinka (US-FDA). Qalabka caafimaadka waxaa loo kala saaray mid ka mid ah Fasalada 1 ilaa 4, halkaasoo heerka 1 uu ka dhigan yahay khatarta ugu yar, iyo heerka 4 ee khatarta ugu sareysa. Dhammaan alaabooyinka daawaynta ee Solarc/SolRx UVB waxa loo kala saaray inay yihiin “Class 2” gudaha Kanada iyo Maraykanka. Fiiro gaar ah: US-FDA waxay isticmaashaa nambarada Roomaanka halkii ay ka isticmaali lahaayeen nambarada fasalladan, markaa gudaha USA, aaladaha Solarc waa "Class II".

In Canada, Aaladaha heerka 2 waxaa lagu maamulaa kontaroolo badan, oo ay ku jiraan: - U hoggaansanaanta Shuruucda Aaladda Caafimaadka Kanada (CMDR) - Oggolaanshaha suuqa iyada oo la adeegsanayo shatiga qalabka bilowga iyo sanadlaha - Waajibka ISO-13488 ama ISO-13485 Nidaamka tayada iyo laxiriirta 3rd sannadlaha ah xisaab xidhka xisbiga, iyo ka warbixinta dhibaatada khasabka ah. Liisaska shatiga aaladda ee Nidaamyada Solarc waxaa laga heli karaa bogga Liiska liisanka Aaladaha Caafimaadka ee Health Canada oo ah: www.mdall.ca. Guji "Raadinta Shatiga Firfircoon", oo isticmaal "Magaca Shirkadda" (Solarc). Haddii kale, aad bogga guriga Aaladda Caafimaadka ee Health Canada.

note1: Julaay-21-2008, Solarc's sedexda shati ee Aaladaha Caafimaadka Kanada (12783,62700,69833) waxaa lagu daray hal shati (12783). "Taariikhda Arrinta Koowaad" ee dhammaan aaladaha marka laga reebo 1000-Taxane hadda waxay u muuqataa Julaay-21-2008; in kasta oo aaladahaan markii ugu horeysay la siiyay shatiga Juun-16-2003 62700 (500-Series) iyo Dec-02-2005 ee 69833 (100-Series). Sidoo kale ogow in 1000-Taxane markii ugu horreysay ay shati siisay Feb-1993 "Caafimaadka iyo Welfare Canada" ee gelitaanka #157340, ka hor Xeerarka Qalabka Caafimaadka ee cusub ee Kanada ee Maajo 1998.

note2: Dhammaan aaladaha UVB ee Nidaamyada Solarc Systems (UVB-Narrowband iyo UVB-Broadband) waxay heleen oggolaanshaha Health Canada si ay ugu daraan "Fatamiin D-yarida" Tilmaamaha Isticmaalka (xaalad caafimaad oo si sharci ah loo xayeysiin karo) Luulyo 21, 2008 wax ka beddelka Solarc's kasta shatiga Aaladaha Kanada #12783.

note3: Janaayo 05, 2011, Solarc waxay heshay ogolaanshaha Health Canada inay ku darto qoyskayada aaladaha 4aad, taxanaha E-Series, shatiga Aaladaha Caafimaadka Kanada ee jira #12783. Shatiga Aaladda Caafimaadka Kanada ee Solarc's Health #12783 ayaa lagu muujiyey xagga hoose ee boggan.

In ka USA, Class II (Class 2) aaladaha sidoo kale waxaa hoos yimaada kontaroolo badan, oo ay ku jiraan:

- U hoggaansanaanta qaybaha lagu dabaqi karo ee Xeerka Shuruucda Federaalka (CFR)

- Oggolaanshaha suuqa iyada oo la adeegsanayo codsiga 510 (k) bilowga ah iyo xukunka wax u dhigma

- Soo-gudbinta Warbixinta Bilowga & Isbeddelka Alaabta ee Xarunta Qalabka iyo Caafimaadka Shucaaca (CDRH)

- Liiska Aaladaha (Hal kood badeeco)

- Hababka tayada wax-soo-saarka wanaagsan ee qasabka ah (GMP).

– Ka warbixinta dhibaatada qasabka ah

US-FDA ma ogola isticmaalka suuq-geynta 510 (k) ama macluumaadka kale ee sharciyeed. Si kastaba ha ahaatee, macluumaadkan waxaa laga heli karaa si sharci ah Mareegta US-FDA/CDRH. Dhinaca midig, hoos ugu dhaadhac Tools & Resources> Databases Aaladaha Caafimaadka, halkaas oo aad ka raadin karto Ogeysiinta Premarket 510 (k) iyo Liisaska Qalabka. Ku raadi adigoo isticmaalaya "Magaca Codsadaha" (Solarc) ama "Magaca Mulkiilaha/Magaca Hawl-wadeenka" (Solarc).

Isticmaal xiriirinta soo socota ee raadinta xogta FDA:

510 (k) Raadinta Keydka Xogta

Raadinta Xogta Liiska Qalabka

note1: (waxay khusaysaa Maraykanka oo keliya)

Sannadkii 2011 iyo iyadoo la adeegsanayo habka 510 (k) ee FDA, Solarc waxay ku guuldareysatay isku daygeeda inay ku hesho "Vitamin D Deficiency" oo lagu daray "Tilmaanta Isticmaalka" sababtoo ah ma jiro "saadaalin" (horey u jiray) qalab la mid ah oo jiray, iyo si loo helo ogolaansho Taas beddelkeeda waxay u baahnaan lahayd arjiga Ansixinta Premarket-ka ee qaaliga ah ee "PMA". Gudaha Mareykanka, Solarc waa sidaas darteed ma loo oggolaaday in lagu dhiirrigeliyo aaladaha "Fitamiin D-yarida"; iyo beddelkeeda oo keliya "Tilmaanta Isticmaalka" ee la ansixiyay ee cudurka psoriasis, vitiligo, iyo cambaarta. Xaaladdan oo kale, "Vitamin D Deficiency" waxaa loo arkaa isticmaalka "off-label", laakiin iyada oo aan loo eegin, dhakhtarku wali wuu codsan karaa macluumaadka ku saabsan isticmaalka ka baxsan calaamadda, dhakhtarkuna si sharci ah ayaa loo oggol yahay inuu u qoro bukaanka si aad u hesho alaabta. Fikradan waxaa loo yaqaan "ku dhaqanka daawada", taas oo macnaheedu yahay in takhtarku qori karo ama maamuli karo badeecad kasta oo si sharci ah loo suuqgeyn karo isticmaal kasta oo calaamad ka baxsan oo ay u arkaan inay dani ugu jirto bukaanka.

Qoraalada Dhakhaatiirta

Daawaynta dhakhtarku waa ikhtiyaari in loo soo raro ciwaanada Kanadiyaanka iyo kuwa caalamiga ah, laakiin waa qasab in loo soo diro ciwaannada Maraykanka. Wixii macluumaad dheeraad ah, fadlan tag: Rijeetooyinka.

Loogu Talo Galay Dadka Degan Kaliforniya

Alaabtani waxay kuu soo bandhigi kartaa oxide anemony, oo loo yaqaan Gobolka California inay keento kansar, iyo toluene, taas oo loo yaqaan Gobolka California inay keento cilladaha dhalashada ama waxyeelada kale ee taranka. Wixii macluumaad dheeraad ah gal www.P65Warnings.ca.gov

Solarc Health Canada shatiga Aaladda 12783 Beddel Xeerka Boostada 2017 08 21 bogga 001 Nidaamyada Solarc FDA