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Iimveliso ezigqityiweyo ze-Varicella Vaccine PFS

Ulwazi oluSiseko

Umzekelo No.: Pre-filled Syringe

Type: Vaccine

Application: for Prevention

Form: Powder

Additional Info

Zothutho: Air

Port: Beijing,Shanghai

Ingcaciso yeMveliso

Iimveliso ezigqityiweyo ze-Varicella Vaccine, Live, I-Syringe yangaphambili

Iimveliso ezigqityiweyo zokugonya kwe-varicella. Unempawu ezintathu, ukhuseleko lwe-gelatin , ixesha lokuqinisekisa ngokuzinzileyo, ukukhuselwa kwe- b etter kunye ne-high titer kunye nokusebenza komzimba. Ezi mphuculo zithuthukise ukhuseleko lokugonya kunye nobunjani, kwaye i-BCHT isungulwe isikhundla esiphezulu kwi-vaccine ye-varicella. Kwaye ithunyelwa kwamanye amazwe, njengamaNdiya, ePhilippines.

Kwaye xa kuthelekiswa neenguqulelo zepenicillin, i-syringe ezaliswe ngaphambili ikulungele ukusetyenziswa.

[ Amaqhinga kunye neF F ]

Isitofu senziwa sisasazo se-varicella-zoster virus (i-Oka strain) kwisityalo se-diploid yeseli (MRC-5), emva kokulima kunye nokuvuna, ukunyuswa kwegciwane lesifo sengculaza kulungiswe ukukhutshwa kwegciwane emva kokungqiniswa kwesimo sokuzinzisa esifanelekileyo. Le mveliso ibomhlophe i-pellet iplatey in glass glass. Isigodlo sokugonywa emva kokupheliswa kwendlululo isisombululo esicacileyo ngaphandle kobukho obubonakalayo beengqungquthela zangaphandle.

Isithako esisebenzayo: I-viral varicella-zoster virus (i-Oka strain): engekho ngaphantsi kwe-3.3 lgPFU (2000 PFU)

Izithako ezingasebenzi: I-Trehalose, i-Human Albumin, i-Sodium Glutamate, i- Sucrose, i-Glucose, i- Carbamide,

Arginine.

I-Diluent: Amanzi angamaNtsholongwane

[I zi boniso]

Isitofu sokugonya siboniswe ukugonywa ngokuthe ngqo kwi-varicella yezilwanyana ezinempilo, izilwanyana ezithintekayo ezivela kwiinyanga ezili-12.

[Umsebenzi kunye nokusetyenziswa]

Emva kokugonywa, umzimba we-immuno-umsebenzi we-varicella-zoster virus unokuveliswa ukukhusela umntu e-varicella.

[Inkcazo]

I-vial iqukethe i-0.5 ml yamanzi ngokuchithwa kwesitofu sokugonywa nge-lyophilized with diluent. Isigodlo sokugonywa esinezixhobo eziqukethe i-PF ye-varicella-zoster virus kwaye isetyenziswe kwisifundo esisodwa kwisilinganiso esisodwa.

[Inkqubo ye-immune kunye neeritha]

(1) Umthamo omnye wokugonywa okuyisiseko kubantwana abaneminyaka eyi-1-12 ubudala; Amanyathelo amabini okugonywa okuyisiseko kubantu abaneminyaka engama-13 ubudala nangaphezulu kunye neiveki ezi-4-8 zexesha.

(2) Dlulisa i-diluent ngesirinji kwi-vial ene-vaccine ephilileyo. Gubungela kakuhle ukuqinisekisa ukuchithwa okupheleleyo kweplate ukuze kusetshenziswe kunye nokutshintshela zonke i-liquid back to syringe.

(3) Faka isicelo sokumiswa kwe-0.5 ml ye-injection subcutaneous kwindawo yecala.

Ngokubhekiselele kwingxelo yesifo seengxaki kunye nokubhala kwee-klinikhi zonyango ekhaya nakwamanye amazwe, i-Health Authorities kumgangatho wephondo okanye ngasentla inokwenza i-foster dose eyodwa kubantu abaneminyaka engaphantsi kwe-12 ubudala ngokubhekisele ekubhekeleni kwindyikitya yomhlaba xa kuyimfuneko.

[Iimiphumo ezingathandekiyo]

1. Uphando lwekliniki lwasekhaya

(1) Kwilingo lekliniki elibandakanya abantwana abangama-600 kunye nabantwana abaneminyaka engama-1 ukuya ku-12 ubudala abagonywe ngumkhiqizo, iimpembelelo eziphambili ze-systemic zazingumkhuhlane kunye nomlinganiselo we-12%, nceda ubone i-table 1, ngelixa i-systemic reaction reaction, ukhwehlela , ukukhawuleza, ukukhala, ukungazinzi kunye ne-anorexia yenzeka kwi-1-5 yobudala kunye ne-1-10%; Impendulo ephakamileyo yendawo yayiyi-pruritus, ubomvu, ukuvuvukala kunye nentlungu kunye nenani le-5.25%, nceda khangela itafile 2.

Itheyibhile 1 Umkhuhlane kwiminyaka eyi-1-12 ubudala

Age /years

Group

Cases (n)

Mild (%)

Moderate (%)

Severe (%)

Total (%)

1~5

The product

200

16 (8.00)

10 (5.00)

1 (0.50)

27 (13.5)

Control

100

3 (3.00)

4 (4.00)

0 (0.00)

7 (7.00)

6~12

The product

200

14 (7.00)

7 (3.50)

0 (0.00)

21 (10.50)

Control

100

5 (5.00)

1 (1.00)

1 (1.00)

7 (7.00)

Total

The product

400

30 (7.50)

17 (4.25)

1 (0.25)

48 (12.00)

Control

200

8 (4.00)

5 (2.50)

1 (0.50)

14 (7.00)

Itheyibhile 2 Ukusabela kwendawo kwi-1-12 ubudala ubudala

Age /years

Group

Cases (n)

Mild (%)

Moderate (%)

Severe (%)

Total (%)

1~5

The product

200

9 (4.50)

1 (0.50)

0

10 (5.00)

Control

100

4 (4.00)

0 (0.00)

0

4 (4.00)

6~12

The product

200

11 (5.50)

0 (0.00)

0

11 (5.50)

Control

100

8 (8.00)

0 (0.00)

0

8 (8.00)

Total

The product

400

20 (5.00)

1 (0.25)

0

21 (5.25)

Control

200

12 (6.00)

0 (0.00)

0

12 (6.00)

Akukho mfahluko omkhulu phakathi kweqela lokugonya kunye neqela lolawulo kwiThebula 1 no-2.

(2) Kwilingo lekliniki elibandakanya abantu abayi-928 abaneminyaka engama-13 ubudala nangaphezulu ngaphezu kokugonywa ngumkhiqizo, ukulingana kwenani lezinto ezihamba ngayo kwingu-28.76% eyona nto yayingumkhuhlane. I-8.24% eyayibomvu, ukuvuvukala nentlungu, nceda khangela itafile 4.

Itheyibhile 3 Ukuphendulela kwendlela yokusebenza kwiminyaka eyi-13 ubudala nangaphezulu

Dose

Age/ years

Group

Cases (n)

Mild (%)

Moderate (%)

Severe (%)

Total (%)

First dose

13~16

The product

299

69 (23.08)

14 (4.68)

0 (0.00)

83 (27.76)

Control

149

53 (35.57)

4 (2.68)

0 (0.00)

57 (38.26)

17~50

The product

320

49 (15.31)

3 (0.94)

1 (0.31)

53 (16.56)

Control

160

21 (13.13)

6 (3.75)

0 (0.00)

27 (16.88)

Total

The product

619

118 (19.06)

17 (2.75)

1 (0.16)

136 (21.97)

Control

309

74 (23.95)

10 (3.24)

0 (0.00)

84 (27.18)

Second dose

13~16

The product

293

41 (13.99)

4 (1.37)

1 (0.34)

46 (15.70)

Control

146

19 (13.01)

4 (2.74)

0 (0.00)

23 (15.75)

17~50

The product

307

21 (6.84)

0 (0.00)

0 (0.00)

21 (6.84)

Control

154

15 (9.74)

1 (0.65)

1 (0.65)

17 (11.04)

Total

The product

600

62 (10.33)

4 (0.67)

1 (0.17)

67 (11.17)

Control

300

34 (11.33)

5 (1.67)

1 (0.33)

40 (13.33)

Total

13~50

The product

619

155 (25.04)

21 (3.39)

2 (0.32)

178 (28.76)

Control

309

88 (28.48)

14 (4.53)

1 (0.32)

103 (33.33)

Itheyibhile 4 Ukusabela kwendawo kwiminyaka eyi-13 ubudala nangaphezulu

Dose

Age/years

Group

Cases (n)

Mild (%)

Moderate (%)

Severe (%)

Total (%)

First dose

13~16

The product

299

10 (3.34)

5 (1.67)

1 (0.33)

16 (5.35)

Control

149

10 (6.71)

4 (2.68)

0 (0.00)

14 (9.40)

17~50

The product

320

21 (6.56)

8 (2.50)

2 (0.63)

31 (9.69)

Control

160

22 (13.75)

11 (6.88)

4 (2.50)

37 (23.13)

Total

The product

619

31 (5.01)

13 (2.10)

3 (0.48)

47 (7.59)

Control

309

32 (10.36)

15 (4.85)

4 (1.29)

51 (16.50)

Second dose

13~16

The product

293

4 (1.37)

1 (0.34)

0 (0.00)

5 (1.71)

Control

146

1 (0.68)

0 (0.00)

0 (0.00)

1 (0.68)

17~50

The product

307

1 (0.33)

1(0.33)

0 (0.00)

2 (0.65)

Control

154

1 (0.65)

0 (0.00)

0 (0.00)

1 (0.65)

Total

The product

600

5 (0.83)

2 (0.33)

0 (0.00)

7 (1.17)

Control

300

2 (0.67)

0 (0.00)

0 (0.00)

2 (0.67)

Total

13~50

The product

619

35 (5.65)

13 (2.10)

3 (0.48)

51 (8.24)

Control

309

32 (10.36)

15 (4.85)

4 (1.29)

51 (16.50)

Akukho mfahluko omkhulu phakathi kweqela lokugonya kunye neqela lolawulo kwiThebula 3 no-4.

Iziphumo ezingathandekiyo zingacwangciswa ngolu hlobo lulandelayo ngokwemilinganiselo ye-occurence: eziqhelekileyo (≥10%); eziqhelekileyo ( 1% kunye <10%) ; ngamanye amaxesha ( 0.1% kunye <1%) ; inqabile ( 0.01% kunye <0.1%) ; inqabile kakhulu (<0.01%).

Kuhlolisiso lwezonyango lwe-2-dose yokugonywa kwabantu abaneminyaka engama-13 ubudala nangaphezulu kunye nexesha leeveki ezingama-6 ngale mveliso, izigqibo zengingqi kunye nendlela yokusebenza ngayo ebanjwe ngomhla we-42 zilandelayo:

C ommon ukusabela okubi:

(1) Ngokuqhelekileyo kwisithuba seeyure ezingama-24 emva kokugonywa, intlungu kunye ne-haphalgesia zenzeka kwindawo yokuxela, kwiimeko ezininzi, ziya kuphelisa ngokuzenzekelayo.

(2) Ngokuqhelekileyo kwiiveki ezi-1-2 emva kokugonywa, ukuphendulwa komkhuhlane wesikhashana kungenzeka, ngokukhululeka, kwaye kunokukhutshwa ngokuzenzekelayo emva kokugqibela kweentsuku ezingama-1-2 ngaphandle kweyonyango, izigulana zifuna ukuphumla xa ziyimfuneko kwaye zininzi amanzi, zihlala zifudumele xa usulelo lwesibini; ukuba ufikelele kumfiva okanye ixesha lomkhuhlane ngaphezu kweeyure ezingama-48, unokuphathwa ngeendlela eziphathekayo okanye kwiyeza.

(3) I-Rash: ngokuqhelekileyo kwiiyure ezingama-72 emva kokugonywa, i-rashes encinci inokwenzeka, kwimeko apho

unyango olungumqondiso lunganikwa ngokufanelekileyo, kwaye ubude buya kuba ngaphantsi kweentsuku ezimbini.

Impendulo engavamile kakhulu:

(1) Ukuqhaqhazela okuvuthayo: ngokuqhelekileyo kungakapheli iiyure ezingama-72 emva kokugonywa, i-urticaria iyenzeka, xa kwenzeka ukuphendula, ubone ugqirha ngexesha elifanelekileyo kwaye uthathe unyango olwenziwe lukhuseleko.

(2) Ukutshatyalaliswa kwamanzi: ngokuqhelekileyo kwenzeke ngeyure eli-1 emva kokugonywa. Ukujova kwe-epinephrine kunye nezinye iindlela zokongxamiseko ziya kwenziwa njengonyango ngexesha elifanelekileyo.

(3) I-purpura ye-allergic: xa kwenzeka ukutshatyalaliswa kwe-purpura ye-allergen, kufuneka ubone udokotela ngexesha elifanelekileyo kwaye i-cortical steroids iya kulawulwa njengonyango oluchasayo, ukuba lugcinwe ngokufanelekileyo okanye ngexesha elifanelekileyo, i-purpura nephritis ingaqhuma ngexesha elinye.

[Inkcazo]

(1) Iigxina ezine-hypersensitivity ezaziwayo kunoma yimuphi umbandela walo mveliso kuquka neomycin.

(2) Abafazi ngexesha lokukhulelwa.

(3) Izifundo ezijongene nezifo ezinzima, izifo ezingapheliyo, iziqhamo ezinzima zezifo ezingapheliyo, umkhuhlane kunye naziphi na izifo ezikhuselweyo ze-immune.

(4) Izifundo ezinokukhubazeka kwe-immune, immunocompromise okanye ukufumana unyango lwe-immunosuppression.

(5) Izifundo ezinomdla owaziwayo wesifo sokugonywa ngumzimba okanye ukuba uthinteke kakhulu nelungu lentsapho elinomlando wesi sifo.

(6) Izifundo ezijongene ne-cerebropathy kunye nokuhluthwa okungalawulwayo kunye nezinye izifo zesifo segazi

(7) Gweba ukusebenzisa i-salicylate kwiiveki ezingama-6 emva kokugonywa kwalo mveliso.

[Amanyathelo okuqaphela]

(1) Izigulane kwezi zilandelayo zimele zisebenzise ngokuzenzekelayo: umntu okanye intsapho yomntu unomlando wokuxubha, izigulane eziphethwe zizifo ezingapheliyo, imbali yokuhluthwa, izigulane ezinomdla wokuqhaqhaqhaqhaqha, abafazi abaselwandle.

(2) Iigxina ezifakwe ngeemveliso kufuneka zigcinwe ubuncinane imizuzu engama-30 kwindawo. U-Epinephrine kunye nezinye iziyobisi kufuneka zilungiselelwe ukusetyenziswa ngokukhawulezileyo xa kwenzeka ukuphazamiseka okuthe xaxa.

(3) Ukutshatyalaliswa kwegciwane lesigonyo kuphela kuvela kwiimeko ezinqabileyo kakhulu. Zonke izigulana ezinokuhlakulela i-varicella, ngokukodwa izigulane ezijongene nokuxhatshazwa kwemizimba emibini ukuya kwiiveki ezintathu emva kokugonywa, kufuneka ziphephe ukudibanisa nezigulane ezinobomi be-leukemia okanye abafumana unyango olungakhuselekanga, okanye abafazi abakhulelweyo ngokukodwa kwiinyanga ezintathu zokuqala zokukhulelwa.

(4) Ukulawulwa ngaphantsi, kungekho ngaphakathi kwe-intradermally kwaye akuzange nanini, phantsi kwayo nayiphi na imeko, nge-intravenously.

(5) Gweba nayiphina i-disinfectant ukuba uqhagamshelane nesitofu sokukhusela le mveliso ngexesha lokuvula izigulane zokugonya kunye nokuthwala i-injection. Utywala kunye naliphi na i-disinfectants inokuthi ingasebenzi kwisifo sengcinezelo esichengileyo, ngoko kufuneka ugonyelwe ukusetyenziswa emva kokuqinisekisa ukukhupha okupheleleyo kwe-disinfectant kude nekhumba.

(6) Ukuba kukho iimeko eziqhelekanga zokubonakala, ezifana nesibhakabhaka esiqhekezayo, i-label yeblasi okanye ukulahlekelwa ngempumelelo, ukuphazamiseka okwenzeka emva kokuchithwa, njl, i-injection ayiyi kulawulwa.

(7) I-vaccine yale mveliso kufuneka ilawulwe ngokukhawuleza xa ivula izitya zokugonya; kwiimeko ezizodwa, isitofu sokugonya singafakwa kwi-2-8 ℃, kwaye kufuneka isetyenziswe kwisithuba semaminithi engama-30, isitofu sokugonywa kwesigxina kufuneka sigxothwe.

(8) Abasetyhini abaneminyaka yobudala abanokuzala abantwana banokugonywa kuphela ukuba amanyathelo athathwe ngokufanelekileyo athatyathwa ubuncinane kwiinyanga ezintathu emva kokugonywa.

(9) Ulawulo lwezinye izitofu zokugonywa kufuneka zigcine ubuncinci bexesha elilodwa emva kokugonywa kwesi sigxina semveliso; Nangona kunjalo, esi sigxina semveliso sinokulawulwa ngexesha elifanayo kunye neentsholongwane ezithintekayo zokugonywa kwemaselisi, i-rubella kunye nama-mumps.

(10) Ukukhutshwa kwefriji akuvumelekile.

[Isitoreji]

Ukugcinwa kunye nokuthuthwa ngekhendi ebandayo ebumnyameni phakathi ko-2-8 ℃.

[Ukupakisha]

I-white fluey pellet ye-vaccine ye-lyophilized is in one 2ml flagrant made of glass borosilicate.

1 isibalo / umthamo womntu × 1 idosi yomntu / ibhokisi (kunye nesitya esisodwa okanye esinye sirityu ekhethiweyo yamanzi oyinyumba).

[Ixesha lokuqinisekisa] 36 iinyanga.

[Umgangatho wokuvelisa] I-Pharmacopoeia yeRiphabhliki Yabantu baseChina (2015 Volume III), kunye neMigangatho yokuBhaliswa kwemveliso.


Pre-filled Syringe of Varicella Vaccine

Iikhathalo zomkhiqizo : I-Varicella Vaccine (Live) > Iimveliso ezigqityiweyo

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