BKEMV REMS Package Insert
Litlhaloso
- Lebitso la Sehlahiswa: BKEMV
- Moetsi: Amgen Inc.
- Nomoro ea Kopo: 761333Orig1s000
Litaelo tsa Tšebeliso ea Sehlahisoa
- Bakeng sa Bakuli ba Laetsoeng BKEMV:
- Pele o Qala Kalafo:
- Get meningococcal vaccines for serogroups A, C, W, Y, and B as directed by your prescriber.
- Take antibiotics as directed by your prescriber if you have to start BKEMV right away.
- Receive counseling from the prescriber using the Patient Safety Card and Patient Guide.
- Get the Patient Safety Card and Patient Guide from your prescriber.
- Pele o Qala Kalafo:
- Nakong ea Kalafo:
- Get additional meningococcal vaccines as directed by your prescriber.
- Ka linako tsohle nakong ea kalafo le likhoeli tse 3 kamora lethal dose la ho qetela:
- E-ba le Karete ea Tšireletso ea Mokuli le uena.
- Inform your prescriber or get emergency medical care right away if you experience any of the following symptoms: fever; fever and a rash; fever with high heart rate; headache with nausea or vomiting; headache and fever; headache with stiff neck or stiff back; confusion; eyes sensitive to light; muscle aches with flu-like symptoms.
- Bakeng sa Litlhophiso tsa Bophelo bo Botle le Litlhare tse Fanang ka BKEMV:
- Ho ba le Setifikeiti sa ho Fana:
- Designate an Authorized Representative to carry out the certification process and oversee implementation and compliance with the REMS on behalf of the healthcare setting or pharmacy.
- E-ba le Moemeli ea Fetoletsoeng Review Bukana ea Tšireletseho ea Bafani ba Bophelo bo Botle.
- Enroll by completing and submitting the Healthcare Setting and Pharmacy Enrollment Form to the REMS.
- Train all relevant staff involved in dispensing BKEMV using the Healthcare Provider Safety Brochure.
- Ho ba le Setifikeiti sa ho Fana:
- Pele o fana, lethal dose ea pele:
- Fumana tumello ea ho fana ka lengolo le leng le le leng la ngaka ka ho ikopanya le REMS ho netefatsa hore ngaka e tiisitsoe.
FAQs
- P: Ke lokela ho etsa eng haeba ke lebala ho nka Karete ea Tšireletso ea Mokuli nakong ea phekolo?
- A: It is essential to have the Patient Safety Card with you at all times during treatment. If you forget to carry it, contact your prescriber immediately for guidance on obtaining a replacement.
- P: Nka netefatsa joang haeba ngaka ea ka e tiisitsoe ho fana ka BKEMV?
- A: Before dispensing each prescription, contact the REMS to verify that the prescriber is certified to prescribe BKEMV. This step ensures compliance with safety protocols.
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SEBAKA SA TLHAKISO EA LITHETHEFATSI LE PATLISISO
Nomoro ea Kopo:
761333Orig1s000
REMS
Nakong ea phekolo Ka linako tsohle
8. Ho eletsa mokuli ho sebelisa Karete ea Tšireletso ea Mokuli le Tataiso ea Mokuli. Fana ka kopi ea lisebelisoa ho mokuli.
9. Eletsa mokuli ka tlhokahalo ea ho nka Karete ea Tšireletso ea Mokuli.
10. Lekola mokuli bakeng sa matšoao a pele le matšoao a tšoaetso ea meningococcal 'me u hlahlobe hang-hang haeba ho belaelloa tšoaetso.
11. Ente bakuli ha ho hlokahala ho latela litlhahiso tsa hona joale tsa ACIP bakeng sa liente tsa meningococcal bakeng sa bakuli ba fumanang inhibitor e tlatsetsang.
12. Tlaleha liketsahalo tse mpe tse fanang ka maikutlo a tšoaetso ea meningococcal, ho kenyeletsa le liphello tsa mokuli, ho Amgen Inc.
2. Bakuli ba laetsoeng BKEMV:
Pele ho qala kalafo
1. Fumana liente tsa meningococcal bakeng sa li-serogroups A, C, W, Y, le B joalokaha ho laetsoe ke ngaka ea hau.
2. Nka lithibela-mafu joalokaha u laetsoe ke ngaka ea hau haeba u tlameha ho qala BKEMV hang-hang.
3. Fumana tlhabollo ho tsoa ho ngaka e sebelisang Karete ea Tšireletseho ea Mokuli le Tataiso ea Mokuli.
4. Fumana Karete ea Tšireletso ea Mokuli le Tataiso ea Mokuli ho tsoa ho ngaka ea hau.
Nakong ea kalafo
5. Fumana liente tse eketsehileng tsa meningococcal joalokaha ho laetsoe ke ngaka ea hau.
Ka linako tsohle nakong ea phekolo 6. E-ba le Karete ea Polokeho ea Mokuli ho uena.
le bakeng sa likhoeli tse 3 ka mor'a tekanyo ea ho qetela
7. Tsebisa ngaka ea hao kapa u fumane tlhokomelo ea meriana ea tšohanyetso hang-hang haeba u ba le e ’ngoe ea tse latelang: feberu; feberu le lekhopho; feberu e nang le
lebelo la pelo le phahameng; hlooho ka ho nyekeloa ke pelo kapa ho hlatsa; hlooho le
feberu; hlooho e opang ka molala o sataletseng kapa mokokotlo o thata; pherekano; mahlo a utloang bohloko
ho khantša; ho opeloa ke mesifa ka matšoao a kang a ntaramane.
3. Litlhophiso tsa tlhokomelo ea bophelo le likhemisi tse fanang ka BKEMV li tlameha ho:
Ho ba setifikeiti sa ho fana
1. Khetha Moemeli ea Fetoletsoeng ho phethahatsa ts'ebetso ea setifikeiti le ho hlokomela ts'ebetsong le ho lumellana le REMS lebitsong la boemo ba tlhokomelo ea bophelo kapa khemisi.
2. E-ba le Moemeli ea Fetoletsoeng hapeview Bukana ea Tšireletseho ea Bafani ba Bophelo bo Botle.
3. Etsa hore Moemeli ea Lumetsoeng a ingolise ka ho tlatsa le ho romela Foromo ea Ngoliso ea Pharmacy Setting le Pharmacy ho REMS.
4. Koetlisa basebetsi bohle ba amehang ba amehang ho aba BKEMV ho sebelisoa Bukana ea Polokeho ea Bafani ba Bophelo bo Botle.
5. Theha mekhoa le mekhoa ea ho ikopanya le ngaka ea ngaka ho hlahloba boemo ba ente ea mokuli bakeng sa liente tsa morao-rao tsa meningococcal bakeng sa serogroups A, C, W, Y, le B ho ea ka Komiti ea Boeletsi ea Hona joale ea Mekhoa ea ho Entoa (ACIP) ho kenyeletsa le antibacterial drug prophylaxis, haeba ho hlokahala, pele ho qaleha ho fumana phekolo.
ID ea boitsebiso: 5388039
6. Bakeng sa bakuli ba seng ba ntse ba e-na le liente tsa meningococcal ha ba qala phekolo: Theha mekhoa le mekhoa ea ho hlahloba boemo ba ho entoa ha mokuli bakeng sa liente tsa morao-rao tsa meningococcal ho akarelletsa le antibacterial drug prophylaxis, haeba ho hlokahala, ka ho ikopanya le ngaka pele u fana ka litaelo ho fihlela likhoeli tse 6 ka mor'a ho fumana tekanyo ea pele le ho ngola lengolo la pele.
Pele o fana, tekanyo ea pele ea 7. Fumana tumello ea ho fana ka lengolo le leng le le leng la ngaka ka ho ikopanya le REMS ho netefatsa hore ngaka e tiisitsoe.
8. Hlahloba boemo ba ente ea mokuli bakeng sa liente tsa morao-rao tsa meningococcal bakeng sa serogroups A, C, W, Y, le B ho kenyelletsa le antibacterial drug prophylaxis, ha ho hlokahala, ka ho ikopanya le ngaka le ho ngola liphuputso ka mekhoa le mekhoa e thehiloeng e le tlhokahalo ea REMS.
Pele o fana ka, ho fihlela
9. Fumana tumello ea ho fana ka lengolo le leng le le leng la ngaka ka ho iteanya le
Likhoeli tse 6 ka mor'a tekanyo ea pele
REMS ho netefatsa hore ngaka e netefalitsoe.
10. Bakeng sa bakuli ba seng ba ntse ba e-na le liente tsa meningococcal ha ba qala kalafo: Hlahloba boemo ba mokuli bakeng sa liente tsa meningococcal bakeng sa li-serogroups A, C, W, Y, le B ho kenyeletsa antibacterial drug prophylaxis, ha ho hlokahala, ka ho ikopanya le ngaka le ho ngola liphuputso tse thehiloeng ka mokhoa oa REMS.
Pele o fana ka, likhoeli tse 6 11. Fumana tumello ea ho fana ka lengolo le leng le le leng ka ho ikopanya le
ka mor'a tekanyo ea pele le
REMS ho netefatsa hore ngaka e netefalitsoe.
kamora moo
Ho boloka setifikeiti hore se fane
12. Haeba Moemeli ea Fetoletsoeng a fetoha, e-ba le Moemeli e mocha ea Fetotsoeng ea ngolisitseng ka ho tlatsa le ho romela Foromo ea Ngoliso ea Bophelo bo Botle le Pharmacy ho REMS.
Ka dinako tsohle
13. Tlaleha liketsahalo tse mpe tse fanang ka maikutlo a tšoaetso ea meningococcal ho Amgen Inc.
14. Se ke oa aba, oa fetisetsa, oa alima, kapa oa rekisa BKEMV, ntle le ho litlhophiso tse ling tse netefalitsoeng tsa tlhokomelo ea bophelo kapa likhemisi tse netefalitsoeng.
15. Boloka lirekoto tsa ho qetela ha basebetsi thupelong ea REMS.
16. Boloka lirekoto tsa hore lits'ebetso le lits'ebetso tsohle li teng 'me li ntse li lateloa.
17. Ikamahanye le liphuputso tse entsoeng ke Amgen Inc. kapa motho e mong ea sebetsang lebitsong la Amgen Inc. ho netefatsa hore lits'ebetso le mekhoa eohle e teng le hore e ntse e lateloa.
4. Barekisi-bahoeletsi ba abang BKEMV ba tlameha ho:
Ho kgona ho aba
1. Theha mekhoa le mekhoa ea ho etsa bonnete ba hore lithethefatsi li ajoa feela ho litlhophiso tsa tlhokomelo ea bophelo bo botle le li-pharmacy.
2. Koetlisa basebeletsi ba amehang ba amehang kabong ea BKEMV mabapi le litlhoko tsa REMS.
Ka dinako tsohle
3. Abela feela litlhophisong tsa tlhokomelo ea bophelo bo botle le likhemisi tse netefalitsoeng. 4. Boloka lirekoto tsa kabo eohle ea lithethefatsi.
ID ea boitsebiso: 5388039
5. Ikamahanye le liphuputso tse entsoeng ke Amgen Inc. kapa motho e mong ea sebetsang lebitsong la Amgen Inc. ho netefatsa hore lits'ebetso le mekhoa eohle e teng le hore e ntse e lateloa.
Amgen Inc. e tlameha ho fana ka koetliso ho bafani ba tlhokomelo ea bophelo ba fanang ka BKEMV. Koetliso e kenyelletsa lisebelisoa tse latelang tsa thuto: Bukana ea Tšireletso ea Bafani ba Bophelo bo Botle, Karete ea Tšireletso ea Mokuli, le Tataiso ea Mokuli. Koetliso e tlameha ho ba teng inthaneteng le ka mokhoa oa hardcopy ka poso.
Amgen Inc. e tlameha ho fana ka koetliso ho litlhophiso tsa tlhokomelo ea bophelo bo botle le likhemisi tse fanang ka BKEMV. Koetliso e kenyelletsa lisebelisoa tse latelang tsa thuto: Bukana ea Tšireletso ea Bafani ba Bophelo bo Botle. Koetliso e tlameha ho ba teng inthaneteng le ka mokhoa oa hardcopy ka poso.
Ho tšehetsa tšebetso ea REMS, Amgen Inc. e tlameha ho:
1.
Theha le ho hlokomela REMS Websebaka, www.BKEMVREMS.com. Setšoantšo sa REMS Websebaka se tlameha ho kenyelletsa
bokhoni ba ho tlatsa lengolo la setifikeiti le ho ingolisa ka fax, imeile le inthaneteng,
boemo ba tlhokomelo ea bophelo bo botle le setifikeiti sa pharmacy le ho ngolisoa ka fekse le imeile, le khetho ea ho
hatisa Tlhahisoleseding ea Litlhahiso, Tataiso ea Meriana, le thepa ea REMS. Lihlahisoa tsohle weblibaka tsa
bareki le bafani ba tlhokomelo ea bophelo ba tlameha ho kenyelletsa likhokahano tse ikhethileng tsa REMS ho REMS
Websebaka. Setšoantšo sa REMS Websebaka sa marang-rang ha sea tlameha ho hokahana morao le sehlahisoa sa papatso weblibaka.
2.
Etsa REMS WebSebaka sa marang-rang se sebetsa ka botlalo le lisebelisoa tsohle tsa REMS tse fumanehang ka REMS
Websebaka le Setsi sa Khokahanyo ka letsatsi leo BKEMV e qalang ho ajoa ka eona khoebong.
3.
Theha le ho hlokomela Setsi sa Mehala sa REMS ho 1-866-718-6927.
4.
Theha le ho boloka polokelo ea litaba e netefalitsoeng, e sireletsehileng ea bangoli bohle ba netefalitsoeng, 'me ba netefalitsoe
litlhophiso tsa tlhokomelo ea bophelo le likhemisi ho BKEMV REMS.
5.
Etsa bonnete ba hore litlhophiso tsa tlhokomelo ea bophelo le li-pharmacy li khona ho fumana tumello ea ho fana ka
fono le inthaneteng.
6.
Netefatsa hore barekisi ba khona ho ingolisa ka fax, imeile le inthaneteng.
7.
Netefatsa hore litlhophiso tsa tlhokomelo ea bophelo le likhemisi li khona ho ingolisa ka fax le lengolo-tsoibila.
8.
Etsa bonnete ba hore li-prescribers, 'me litlhophiso tsa tlhokomelo ea bophelo le li-pharmacy li khona ho tlaleha liketsahalo tse mpe
maikutlo a tšoaetso ea meningococcal ka mohala.
9.
Netefatsa hore hang ha tlaleho e fanang ka maikutlo a tšoaetso ea meningococcal e amoheloa, Amgen Inc. e tla
latela le bafani ba tlhokomelo ea bophelo ho fumana lintlha tsohle tse hlokahalang. Tlhokahalo ena ha e joalo
e ama litlhoko tse ling tsa tlaleho le ho latela tsa Amgen Inc. tlasa melaoana ea FDA.
10. Fana ka Foromo ea Ngoliso ea Prescriber, Bukana ea Tšireletso ea Mofani oa Bophelo bo Botle, Karete ea Tšireletso ea Mokuli, Tataiso ea Mokuli, Tataiso ea Meriana, le BKEMV Prescribing Information ho bafani ba tlhokomelo ea bophelo (1) ba lekang ho laela BKEMV 'me ha ba e-s'o tiisetsoe kapa (2) ba botse hore na ba ka netefatsoa joang.
11. Fana ka Foromo ea Ngoliso ea Bophelo bo Botle le Pharmacy le Bukana ea Tšireletseho ea Bafani ba Bophelo bo Botle ho litlhophiso tsa tlhokomelo ea bophelo le li-pharmacy tseo (1) li lekang ho odara / ho fana ka tsona 'me ha li e-s'o tiisetsoe kapa (2) li botse mabapi le mokhoa oa ho fumana setifikeiti.
12. Tsebisa ba ngaka, le litlhophiso tsa tlhokomelo ea bophelo le likhemisi nakong ea matsatsi a khoebo a 2 ka mor'a hore ba netefatsoe ho REMS.
13. Fana ka bangoli ba netefalitsoeng ho fihlella polokelong ea litaba tsa litlhophiso tsa tlhokomelo ea bophelo bo botle le likhemisi.
14. Fana ka litlhophiso tsa tlhokomelo ea bophelo bo botle le li-pharmacy phihlello ho database ea lingaka tse netefalitsoeng.
15. Fana ka barekisi ba nang le tumello ba lumelletsoeng ho fumana sebaka sa polokelo ea litaba tsa litlhophiso tsa tlhokomelo ea bophelo bo botle le likhemisi.
Ho netefatsa hore bankakarolo ba REMS ba latela melao ya REMS, Amgen Inc. e tlameha ho:
16. Boloka direkoto tse lekaneng ho bontsha hore ditlhoko tsa REMS di fihletswe, ho kenyeletswa, empa ho sa felle feela ho direkoto tsa: Kabo le kabo ya BKEMV; setifikeiti sa lingaka, le
ID ea boitsebiso: 5388039
Lisebelisoa tse ling 7. REMS Websebaka
VI.
Lintlha tsa Molao
REMS ena e hlokahala tlasa Karolo ea 505-1 ea Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 USC 355-1) mme e na le lintlha tse latelang:
1.
Lintlha tsa ho netefatsa Tšebeliso e Sireletsehileng:
Bafani ba tsa bophelo bo botle ba fanang ka BKEMV ba netefalitsoe ka ho khetheha tlasa 505-1 (f) (3) (A)
Litlhophiso tsa tlhokomelo ea bophelo le li-pharmacy tse fanang ka BKEMV li netefalitsoe ka ho khetheha tlasa
505-1(f) (3)(B)
BKEMV e abeloa bakuli ba nang le bopaki kapa litokomane tse ling tsa maemo a ts'ebeliso e sireletsehileng
tlasa 505-1(f)(3)(D)
2.
Sistimi ea Ts'ebetso
3.
Lethathamo la Nako ea Tlhahiso ea Litlhahlobo
ID ea boitsebiso: 5388039
BKEMV ke eng?
BKEMV e bontšoa bakeng sa phekolo ea:
· Bakuli ba nang le paroxysmal nocturnal hemoglobinuria (PNH) ho fokotsa hemolysis. · Bakuli ba nang le atypical hemolytic uremic syndrome (aHUS) ho thibela thrombotic e tlatsetsang.
Microangiopathy.
Moeli oa Tšebeliso
BKEMV ha e bontšoa bakeng sa phekolo ea bakuli ba nang le chefo ea Shiga E. coli e amanang le hemolytic uremic syndrome (STEC-HUS).
Kotsi ea mafu a tebileng a Meningococcal
· BKEMV, e tlatsetsang inhibitor, e eketsa monyetla oa ho ba le tšoaetso ea mokuli ho mafu a tebileng, a kotsi, kapa a bolaeang a bakoang ke baktheria ea meningococcal (septicemia le/kapa meningitis) ho serogroup leha e le efe, ho kenyelletsa le mefuta e sa kopaneng.
· Mafu a kotsi a bophelo le a bolaeang a meningococcal a etsahetse ho bakuli ba entetsoeng le ba sa entoa ba phekoloang ka li-complement inhibitors tse kang BKEMV.
· Ho qalisoa ha phekolo ea BKEMV ho hanyetsanoa ho bakuli ba nang le tšoaetso e tebileng ea Neisseria meningitidis e sa rarolloang.
· Bonyane libeke tse 2 pele ho tsamaiso ea tekanyo ea pele ea BKEMV, ho tlatsa kapa ho ntlafatsa ente ea meningococcal (bakeng sa li-serogroups A, C, W, Y le B) ho ea ka litlhahiso tsa Komiti ea Boeletsi ea Mekhoa ea Boipheliso (ACIP) ea hona joale bakeng sa bakuli ba fumanang inhibitor e tlatsetsang.
· Haeba phekolo e potlakileng ea BKEMV e bontšoa ho mokuli ea seng a ntse a e-na le liente tsa meningococcal ho latela litlhahiso tsa ACIP, fana ka mokuli ka antibacterial drug prophylaxis le ho fana ka liente tsa meningococcal kapele kamoo ho ka khonehang.
• Ho entoa ha ho felise kotsi ea tšoaetso ea meningococcal, ho sa tsotellehe tsoelo-pele ea li-antibodies ka mor'a ho entoa.
• Lekola bakuli ka hloko bakeng sa matšoao a pele a tšoaetso ea meningococcal le ho hlahloba bakuli hang-hang haeba ho belaelloa hore ba tšoaelitsoe. Kapele-pele ho phekola mafu a tsejoang.
• Tšoaetso ea meningococcal e ka beha bophelo kotsing ka potlako kapa ea bolaea haeba e sa lemohuoe le ho phekoloa kapele. · Tsebisa bakuli ka matšoao le matšoao a tšoaetso e tebileng ea meningococcal le ho laela bakuli ho
batla thuso ea bongaka hang-hang haeba matšoao ana a hlaha. · Nahana ka tšitiso ea BKEMV ho bakuli ba ntseng ba phekoloa bakeng sa meningococcal e tebileng
tšoaetso, ho itšetlehile ka likotsi tsa ho sitisa phekolo lefung le phekoloang.
BKEMV REMS ke eng?
A REMS (Risk Evaluation and Mitigation Strategy) ke lenaneo le hlokoang ke Tsamaiso ea Lijo le Lithethefatsi (FDA) ho thusa ho netefatsa hore melemo ea moriana e feta likotsi tsa eona. Ka lebaka la kotsi ea tšoaetso e tebileng ea meningococcal, BKEMV e fumaneha feela ka BKEMV REMS, lenaneo le thibetsoeng la kabo.
Mohala: 1-866-718-6927 | www.BKEMVREMS.com | Fax: 1-866-718-8244
ID ea boitsebiso: 5388039
LEQEPHE LA 2 LA 5
Litlhokahalo tsa Bangoli
Lingaka li Lokela ho Etsa'ng Ha li Hlakisa BKEMV?
Bafani ba tlhokomelo ea bophelo ba fanang ka BKEMV ba tlameha ho netefatsoa ka ho khetheha. Ho netefatsoa ho BKEMV REMS le ho fana ka taelo ea BKEMV, bangoli ba tlameha ho:
1. Review The BKEMV Prescribing Information, Healthcare Provider Safety Brochure (tokomane ena), Karete ea Tšireletseho ea Mokuli, le Tataiso ea Mokuli.
2. Tlatsa le ho romela Foromo ea Ngoliso ea Bangoli ho REMS: · inthaneteng ho www.BKEMVREMS.com · ka fekse ho 1-866-718-8244 · ka ho skena le ho romella lengolo-tsoibila ho Amgen@BKEMVREMS.com
Pele o qala kalafo ea BKEMV ea mokuli, lingaka li tlameha ho:
· Hlahloba mokuli bakeng sa tšoaetso ea meningococcal e sa rarolloang 'me u se ke ua qala BKEMV ho mokuli leha e le ofe ea nang le tšoaetso ena.
· Hlahloba boemo ba ente ea mokuli bakeng sa li-serogroups tsa meningococcal A, C, W, Y le B le ho enta ha ho hlokahala ho ea ka litlhahiso tsa Komiti ea Boeletsi ea Mekhoa ea Boipheliso (ACIP) bakeng sa liente tsa meningococcal ho bakuli ba fumanang inhibitor e tlatsetsang.
· Bakeng sa bakuli ba seng ba ntse ba fumana liente tsa meningococcal bonyane libeke tse peli pele ho qala kalafo le ba lokelang ho qala BKEMV ka potlako: Fana ka lengolo la ngaka bakeng sa antibacterial drug prophylaxis.
· Ho eletsa mokuli ho sebelisa Karete ea Tšireletso ea Mokuli le Tataiso ea Mokuli. Fana ka kopi ea lisebelisoa ho mokuli.
o Tataiso ea Bakuli e fana ka leseli ho bakuli ba hau mabapi le kotsi ea tšoaetso e matla ea meningococcal ho kenyelletsa:
Tlhokahalo ea ho tlatsa kapa ho ntlafatsa liente tsa bona tsa meningococcal bakeng sa serotypes A, C, W, Y, le B bonyane libeke tse 2 pele ba fumana tekanyo ea pele ea BKEMV kapa ho fumana antibacterial drug prophylaxis haeba BKEMV e tlameha ho qalisoa hang-hang, 'me ha ba e-s'o entoe pele.
Liente tse ling li ka hlokahala nakong ea kalafo le BKEMV.
Liente tsa meningococcal ha li thibele mafu 'ohle a meningococcal.
o Karete ea Tšireletso ea Mokuli e na le lintlha tsa bohlokoa tsa polokeho bakeng sa bakuli ka bobeli le basebeletsi leha e le bafe ba tlhokomelo ea bophelo ba ka bonang kapa ba phekola mokuli oa hau. E hlalosa matšoao le matšoao a latelang ao, haeba a le teng, a lokelang ho susumelletsa mokuli ho batla thuso ea bongaka hang-hang:
fever fever and a rash fever with high heart rate headache with nausea or vomiting headache and fever
headache with stiff neck or stiff back confusion eyes sensitive to light muscle aches with flu-like symptoms
· Eletsa mokuli ka tlhoko ea ho nka Karete ea Tšireletso ea Mokuli. Laela mokuli oa hau ho bontša karete ho mofani ofe kapa ofe oa tlhokomelo ea bophelo ea amehang tlhokomelong ea bona.
o Laela mokuli ho nka Karete ea Tšireletso ea Mokuli ka linako tsohle le likhoeli tse 3 ka mor'a tekanyo ea bona ea ho qetela.
Mohala: 1-866-718-6927 | www.BKEMVREMS.com | Fax: 1-866-718-8244
ID ea boitsebiso: 5388039
LEQEPHE LA 3 LA 5
Nakong ea kalafo ea BKEMV, lingaka li tlameha ho:
• Hlahloba mokuli bakeng sa matšoao a pele a tšoaetso ea meningococcal 'me u hlahlobe hang-hang haeba ho belaelloa tšoaetso.
· Enta bakuli ka moo ho hlokahalang ho ea ka likhothaletso tsa hajoale tsa ACIP bakeng sa liente tsa meningococcal bakeng sa bakuli ba fumanang li-complement inhibitor.
Ka linako tsohle, bakopi ba tlameha ho:
· Tlaleha liketsahalo tse mpe tse fanang ka maikutlo a tšoaetso ea meningococcal, ho kenyeletsoa le liphello tsa mokuli, ho Amgen Inc. ka 1-800-772-6436 (1-800-77-AMGEN).
· Ikamahanye le litlhoko tsa BKEMV REMS ho boloka setifikeiti ho fana ka taelo. Pele ho fana ka, litlhophiso tsa tlhokomelo ea bophelo bo botle le li-pharmacy li tlameha ho hlahloba boemo ba mokuli bakeng sa liente tsa meningococcal bakeng sa li-serogroups A, C, W, Y, le B ho latela litlhahiso tsa hona joale tsa ACIP tse kenyeletsang antibacterial drug prophylaxis, ha ho hlokahala. Haeba ha o so fane ka tlhahisoleseling ena, o ka fumana mohala o tsoang setsing sa tlhokomelo ea bophelo le khemisi ho bokella tlhahisoleseling e netefatsang hore mokuli o fumane liente tse nepahetseng kapa antibacterial drug prophylaxis.
Litlhoko tsa Tlhokomelo ea Bophelo le Litlhoko tsa Pharmacy
Litlhophiso tsa tlhokomelo ea bophelo bo botle le likhemisi li hloka ho etsa eng ho fana ka BKEMV?
BKEMV e ka fanoa feela ke litlhophiso tsa tlhokomelo ea bophelo le likhemisi tse netefalitsoeng hore li tla fana ka tsona. E le hore e be setifikeiti, setsi sa tlhokomelo ea bophelo kapa k'hemisteng e tlameha ho khetha Moemeli ea Fetoletsoeng ho phethahatsa ts'ebetso ea setifikeiti le ho hlokomela ts'ebetsong le ho latela melao ea REMS lebitsong la boemo ba tlhokomelo ea bophelo kapa khemisi. Ho fumana setifikeiti, Moemeli ea Fetoletsoeng o tlameha ho:
· Review Bukana ea Polokeho ea Bafani ba Bophelo bo Botle (tokomane ena) · Tlatsa 'me u romele Foromo ea Boingoliso ea Bophelo bo Botle le Pharmacy ho REMS:
o ka fax ho 1-866-718-8244 o ka ho skena le ho romella lengolo-tsoibila ho Amgen@BKEMVREMS.com
Ka ho tlatsa Foromo ea Ngoliso ea Tlhokomelo ea Bophelo le Pharmacy, Moemeli ea Fetoletsoeng o lumela ho:
· Koetlisa basebetsi bohle ba amehang ho aba BKEMV ho sebelisoa Bukana ea Polokeho ea Bafani ba Bophelo bo Botle. • Theha mekhoa le mekhoa ea ho ikopanya le ngaka ea ngaka ho hlahloba boemo ba mokuli oa ente
bakeng sa liente tsa morao-rao tsa meningococcal bakeng sa li-serogroups A, C, W, Y, le B ho ea ka litlhahiso tsa Komiti ea Boeletsi ea Mekhoa ea Boipheliso (ACIP) e kenyeletsang antibacterial drug prophylaxis, haeba ho hlokahala, pele ho qala kalafo le ho ngola liphuputso. · Bakeng sa bakuli ba seng ba ntse ba e-na le liente tsa meningococcal ha ba qala phekolo: Theha mekhoa le mekhoa ea ho ikopanya le ngaka ea ngaka ho hlahloba boemo ba ho entoa ha mokuli bakeng sa liente tsa meningococcal tsa morao-rao tse kenyeletsang antibacterial drug prophylaxis, haeba ho hlokahala, pele o fana ka litaelo ho fihlela likhoeling tsa 6 ka mor'a tekanyo ea pele le ho ngola liphuputso.
Pele o fana ka tekanyetso ea pele, basebetsi bohle ba tlhokomelo ea bophelo bo botle le likhemisi ba tlameha ho:
· Fumana tumello ea ho fana ka lengolo le leng le le leng la ngaka ka ho ikopanya le REMS ho netefatsa hore ngaka e tiisitsoe.
· Hlahloba boemo ba ente ea mokuli bakeng sa liente tsa morao-rao tsa meningococcal bakeng sa li-serogroups A, C, W, Y, le B ho kenyelletsa le antibacterial drug prophylaxis, ha ho hlokahala, ka ho ikopanya le ngaka le ho ngola liphuputso ka mekhoa le mekhoa e thehiloeng e le tlhokahalo ea REMS.
Mohala: 1-866-718-6927 | www.BKEMVREMS.com | Fax: 1-866-718-8244
ID ea boitsebiso: 5388039
LEQEPHE LA 4 LA 5
Pele o fana ka, ho fihlela likhoeling tse 6 ka mor'a tekanyo ea pele, basebetsi bohle ba tlhokomelo ea bophelo bo botle le litlhare tsa meriana ba tlameha ho:
· Fumana tumello ea ho fana ka lengolo le leng le le leng la ngaka ka ho ikopanya le REMS ho netefatsa hore ngaka e tiisitsoe.
Bakeng sa bakuli ba sa tsebeng ho fumana liente tsa meningococcal ha ba qala kalafo: Lekola boemo ba mokuli bakeng sa liente tsa meningococcal bakeng sa li-serogroups A, C, W, Y, le B ho kenyelletsa le antibacterial drug prophylaxis, ha ho hlokahala, ka ho ikopanya le ngaka le ho ngola liphuputso ka mekhoa le mekhoa ea REMS e thehiloeng.
Pele o fana ka, likhoeli tse 6 ka mor'a tekanyo ea pele le ka mor'a moo, basebetsi bohle ba tlhokomelo ea bophelo le basebetsi ba litlhare ba tlameha ho:
· Fumana tumello ea ho fana ka lengolo le leng le le leng la ngaka ka ho ikopanya le REMS ho netefatsa hore ngaka e tiisitsoe.
Ka linako tsohle, basebetsi bohle ba tlhokomelo ea bophelo bo botle le likhemisi ba tlameha ho:
· Tlaleha liketsahalo tse mpe tse fanang ka maikutlo a tšoaetso ea meningococcal ho Amgen Inc. ka mohala ho 1-800-772-6436 (1-800-77-AMGEN).
· Se ke oa aba, oa fetisa, oa alima, kapa oa rekisa BKEMV, ntle le ho litlhophiso tsa tlhokomelo ea bophelo tse netefalitsoeng kapa likhemisi tse netefalitsoeng. · Boloka lirekoto tsa ho qetela ha basebetsi thupelong ea REMS. · Boloka lirekoto tsa hore lits'ebetso le lits'ebetso li teng 'me lia lateloa. · Ikamahanye le liphuputso tse entsoeng ke Amgen Inc. kapa motho e mong ea emelang Amgen Inc. ho netefatsa.
hore lits'ebetso le lits'ebetso tsohle li teng 'me li ntse li lateloa.
Ho boloka setifikeiti hore se felisoe, Moemeli ofe kapa ofe e mocha ea Amoheletsoeng o tlameha ho:
· Ingolise ka ho tlatsa le ho romela Foromo ea Ngoliso ea Bophelo bo Botle le Pharmacy ho REMS.
Lisebelisoa tsa BKEMV REMS
Etela www.BKEMVREMS.com kapa letsetsa 1-866-718-6927 ho ithuta haholoanyane ka BKEMV REMS.
Tlaleho ea Ketsahalo e mpe
Tlaleha liketsahalo tse mpe tse fanang ka maikutlo a tšoaetso ea meningococcal, ho kenyelletsa le liphello tsa mokuli, hang-hang ho Amgen Inc. ka 1-800-772-6436 (1-800-77-AMGEN). U khothaletsoa ho tlaleha maikutlo a mang a mabe a BKEMV ho Amgen Inc. ka mohala ho 1-800-772-6436 (1-800-77-AMGEN) kapa FDA ho www.fda.gov/medwatch kapa letsetsa 1-800-FDA-1088.
Bukana ena ha e fane ka lintlha tsohle tsa kotsi bakeng sa BKEMV. Ka kopo, bona Tlhahisoleseding ea Prescribing bakeng sa BKEMV, ho kenyeletsa TEMOSO EA BOXED mabapi le tšoaetso e tebileng ea meningococcal bakeng sa boitsebiso bo eketsehileng ba tšireletso.
BKEMVTM ke letshwao la kgwebo la Amgen Inc. Copyright© 2024, Amgen Inc. Litokelo tsohle li sirelelitsoe.
Mohala: 1-866-718-6927 | www.BKEMVREMS.com | Fax: 1-866-718-8244
ID ea boitsebiso: 5388039
LEQEPHE LA 5 LA 5
ID ea boitsebiso: 5388039
ID ea boitsebiso: 5388039
ID ea boitsebiso: 5388039
ID ea boitsebiso: 5388039
ID ea boitsebiso: 5388039
ID ea boitsebiso: 5388039
ID ea boitsebiso: 5388039
Tshaeno Leqephe la 1 la 1
——————————————————————————————————————————————————————————————————————————————————————Se ke seswantšho sa rekhoto ya elektroniki yeo e saennwego ka mokgwa wa elektroniki. Ka mor'a sena ke lipontšo tsa li-signature tsohle tsa elektroniki bakeng sa rekoto ena ea elektroniki. ————————————————————————————————
/s/ ———————————————————–TANYA M WROBLEWSKI 05/28/2024 04:09:41 PM
ID ea boitsebiso: 5388039
Litokomane / Lisebelisoa
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BKEMV REMS Package Insert [pdf] Buka ea Mong'a Kenya Pakete ea REMS, REMS, Kenya Pakete, Kenya |