Impilo, Amalungiselelo
"Octagam": yokusetshenziswa, izinkomba, side effects
Libhekisela izidakamizwa ezikhulisa izivikeli mzimba, "Octagam". Regulations liyakushunyayelwa wakhumbula ukuthi lena izidakamizwa sina, futhi yethulwa kuphela isibhedlela, ngokuqinile on kadokotela. Isetshenziswa njengesici esikhundleni kanye nokwelashwa immunomodulatory.
Yakha ukukhulula izidakamizwa futhi ngezithako zawo
It ikhiqizwa kuphela ngesimo isixazululo ukumnika ukulungiselela "Octagam". Imiyalelo elikulo futhi kuncike cwaningo saziso ngaphambi kokufaka isicelo. Isisombululo esobala, ephethe tinge aphuzi. Umuthi ikhiqizwa ingilazi izitsha eziyisikhombisa 20, 50, 100, 200 ml, avalwa ngesivalo zenjoloba kanye burnishing aluminium phama ebhokisini amakhadibhodi, lapho ngaphezu imiyalelo sokusebenzisa umnikazi plastic-anezikhala.
I nomuthi iqukethe e 1 ml okungenani 95% immunoglobulin G. Inkomba okulingana inani amaprotheni eziqukethwe womuntu plasma yegazi. izinto engeziwe lichaza ekwakheni izidakamizwa yilezi:
- maltose;
- octoxynol;
- tributyl phosphate;
- amanzi imijovo.
Umuthi akufanele iqhwa noma adalule uma sithola ilanga. Lilondolozwe ezingeni lokushisa 2-8 ° C, kude nezingane.
Kwemithi kanye pharmacokinetics
Izidakamizwa "Octagam" (ngesandla esixwayisa contraindications nangemiphumela engaba khona ukusetshenziswa kwezidakamizwa) kuthinta omzimba omuntu futhi libhekisela immunoglobulin, ayisiza.
Imithi siyingxenye ye ekilasini immunoglobulin G, okuyinto ukukhiqiza amasosha izinqubo ezihlukahlukene ezithathelwanayo emzimbeni. Umuthi iqukethe subclasses we immunoglobulin G, nsé plasma womuntu, ukuphinda yonke impahla yayo futhi izici. Ukwethulwa kwe izidakamizwa emzimbeni, elikhishiwe kwezinye izinguqulo amazinga esincishisiwe IgG, umenza isimo evamile. IgG molecule ngenxa enzymatic futhi kumakhemikhali okungenakugwenywa akukashintshi. Umsebenzi amasosha omzimba akwazi ukusindisa ngokuphelele.
Lapho belungela ukuya khona "Octagam" akuyona ezingaphezu kuka-3% polymer, okusele ufunyenwe ngu monomers futhi dimers imayelana 90%.
Uma udala ithuluzi wasebenzisa igazi 3500 abanikeli engumqemane. Amasosha Omzimba ababekhona plasma balaba bantu bahlala kule nokulungiselela ingashintshiwe futhi ahlale ngokugcwele asebenzayo.
Ngemva izidakamizwa ekuphathweni ibe immunoglobulin umthambo G ngokushesha ingena kwegazi, elithengiswa phakathi isikhala semithambo kanye plasma. Lapho ebonisa indlela lo "Oktagama" isimo lesiguli ngcono zingakapheli izinsuku 3-5. Etholakale imithi ku 24-36 usuku th. Ingxenye-ukuphila ihlukile wonke umuntu futhi incike yobudala lesiguli, degree of immunodeficiency. Immunoglobulin G noma ezinye izakhiwo mzimba equkethe ingxenye esebenzayo, libhujiswa uhlelo reticuloendothelial.
Uma usebenzisa "Octagam"?
Zifakwe "Octagam" replacement therapy, lapho kukhona immunodeficiency eyinhloko syndromes, okokuqala kunakho konke, a hypogammaglobulinemia azalwa naso, agammaglobulinemia futhi Wiskott-Aldrich syndrome. Lokhu kuhlanganisa variable unclassifiable uhlobo immunodeficiency futhi immunodeficiencies kuhlanganiswe.
Inkomba ye-izidakamizwa senzelwe myeloma amaningi, ifomu lymphocytic ezingamahlalakhona. imithi letibekiwe iziguli izifo yansukuzonke, futhi sitholakele HIV ezinganeni.
Umuthi ithole elisetshenziswa zokwelapha. Okungukuthi, isetshenziswa idiopathic purpura thrombocytopenic (ITP), ephelezelwa kwengozi ebangela ukopha. Futhi, izidakamizwa isetshenziswa ngaphambi kokuhlinzwa ukuze kulesetayelekile platelet count. imithi ezinqunyiwe Guillain-Barre syndrome. It ukhonza njengelungu inkomba Kawasaki isifo ezinganeni nakubantu abadala.
Sebenzisa "Octagam" (isicelo Umsebenzisi likuchaza ngokuningiliziwe indlela yokuphathwa umthamo zomuthi) e allogeneic umnkantsha transplantation.
Izimo for infusions
Ixwayisa ngokuthi kubalulekile acabangele Izimo ngaphambi kokusebenzisa "Octagam" imiyalelo nokulungiselela. Ungayisebenzisi imithi ebukhoneni hypersensitivity ukuze izinto zayo abamelwe noma immunoglobulin, ayisiza homologous.
Ngokukhulu ukucophelela ukhombe iziguli izidakamizwa abakhuluphele. Sinenkosi nezici ezithile ukuthuthukisa thrombosis. Kusho is contraindicated uma kukhona "ukuxilongwa umfutho wegazi ophakeme," isifo sikashukela, izifo kohlelo eziphathelene nenhliziyo, ukuhlala enwetshiwe ngaphandle womgwaqo, anda viscosity igazi.
Lapho viscosity eliphezulu plasma immunoglobulin, lingene egazini, ingqondo ingozi isilethikusebenza, embolism yamaphaphu, unhlangothi, thrombosis emithambo yegazi.
Okumele kuqashelwe Kumelwe usebenzise leli izidakamizwa, iziguli ezinemishini ukwehluleka kwezinso neziguli ukwelashwa hypovolemia ubhekene ejenti nephrotoxic. Uma kukhona abaphathi okukhulu immunoglobulin-esiteji isifo so-renal, i- "Oktagamom" Ukwelapha imisiwe.
Iziguli ukwehluleka oyingozi kwezinso isesimweni kanye nabantu yezinkinga thromboembolic ukuvuza emthanjeni noma umjovo, umuthi iqondiswa kancane futhi amanani omncane.
Ithonya izidakamizwa kwabesifazane abakhulelwe kanye lactating ezingazange wafunda, ngakho nezikhathi wabonisa imithi kumele kusetshenziswe ngokuqapha okukhulu. Naphezu kwakho konke lokhu, lo mkhuba ubonisa ukuthi ukusetshenziswa immunoglobulin, ayisiza lingenzeki noma iyiphi imiphumela emibi ngesikhathi sokukhulelwa. Umuthi akunamthelela-fetus futhi akuphazamisi ingane ngokuphuphunyelwa obisini lukamama. Immunoglobulin, ayisiza, eba ubisi lwebele, musa zibangele noma iyiphi umonakalo owayesanda kuzalwa, futhi amasosha omzimba ezikuyo, kuphela nomthelela ekwakhekeni amasosha omzimba enamandla.
Isikali
"Octagam" isidakamizwa iqondiswa ngemithambo yegazi kuphela. Ngaphambi kokuqala induduzo egumbini lokushisa, inqubo isixazululo. Lolu ketshezi kumele kube sobala ngokuphelele futhi abanalo kwenze futhi turbidity.
ekuphathweni ngamunye izidakamizwa silotshwe umlando lesi sifo. Kukhona futhi ukwenza inombolo izidakamizwa batch negama. Lokhu kwenziwa ukuthuthukisa nokuqapha isimo lesiguli. Umuthi ezisele ngemuva ukumnika, awukwazi ukugcinwa kanye wobulawa nokubulawa.
Izinga kokuqala isingeniso sostvlyaet 0.01 ukuze 0.02 ml / esisindo kg ngomzuzu owodwa, njalo njalo kuze kuphele isigamu sehora. Nge tolerability ezinhle nomuthi izinga kancane kancane zingandiswa ukuze 0.12 ml / kg esisindo ngomzuzu.
Inani izidakamizwa kanye nesikhathi yokwelapha zinqunywa ngamunye isiguli ngasinye. Konke kuncike impendulo ngeziguli isiguli esithile, isimo sakhe futhi sitholakele isifo.
Ukushintshwa yokwelapha immunomodulating e immunodeficiency eyinhloko kuhilela okwandisa imali immunoglobulin G 4.0-6.0 g / l, ke sasibalwa ngaphambi ukumnika ngamunye. Ukuze kuzuzwe onethonya kuzodinga izinyanga 3-6 yokwelashwa. Kokuqala umthamo abaphathi kuyinto 0.4-0.8 g / kg. Ngemva kwalokho izidakamizwa iqondiswa iziguli njalo emavikini amathathu ngesikhathi 0.2 g / kg. Ukuze kuzuzwe target immunoglobulin 6.0 g / L, isiguli kumele ibekwe nyangazonke 0.2-0.8 g / kg izidakamizwa. Uma sibuyela isiguli esimeni esejwayelekile, umuthi uyaqhubeka ukuba iphathwe njalo emavikini 2-4, ngemva yokulinganisa lokuhlushwa immunoglobulin G egazini. Lokhu kuzokusiza ukhethe imithamo ephezulu.
Ukushintshwa yokwelapha imithi iqhutshwa ezingamahlalakhona wegazi lymphocytic, oludlula kuya hypogammaglobulinemia yesibili ngefomu ezinzima, e myeloma amaningi, kanye sitholakele "abane-HIV 'nezingane yansukuzonke nezinqubo ezithathelwanayo. ngaleyo ndlela Isikali liyashintshashintsha emhlabeni 0.2-0.4 g / kg. Kaningi isingeniso - njalo emavikini 3-4.
Phakathi ekwelapheni iziqephu okukhulu idiopathic purpura thrombocytopenic (ITP) isetshenziswa umthamo izidakamizwa 0.8-1.0 g / kg uma iqondiswa ngosuku lokuqala. Uma kudingekile, ukusetshenziswa kabusha nomuthi ekhiqizwa at 2-5 usuku isamba 0.4 g / kg. Uma amacala exacerbation lesi sifo ziyabuya, izidakamizwa iqondiswa futhi.
Guillain-Barre ukwelashwa syndrome kuhilela 0.4 g / kg zomuthi ngelilanga emalanga 3-7. Kulokhu, ukusetshenziswa kwezidakamizwa izingane sincane kakhulu.
Kawasaki isifo ezinganeni nakubantu abadala ziphathwe umthamo 1.6-2.0 g / kg. Umuthi iqondiswa ku umthamo ofanayo phezu izinsuku 2-5. Ivunyelwe umuthi owodwa ekwakhiweni e isamba 2.0 g / kg. Phakathi ukwelashwa okuqhubekayo isiguli kanyekanye lapho umuntu eba "Oktagama" kudingekile ukusebenzisa aspirin.
Immunoglobulin isetshenziswa ngemva ithambo allogeneic umnkantsha transplantation ukwelashwa wokulungiselela. Administration isidakamizwa kuvimbela nesenzakalo ukutheleleka kanye nokuthuthukiswa sifo of "ihlumela kuqhathaniswa aphethe". Isilinganiso esithathwa esigulini ngasinye ikhethwa ngamunye. Kunconywa ukuba uqale kusukela umthamo 0.5 g / kg ngeliviki. inqubo umjovo kumele kuqale isonto ngaphambi oluzayo isitho ukufakelwa. Ukwelashwa baqhubeka izinyanga ezintathu ngemuva kokuhlinzwa. Uma kukhona ukuntuleka njalo immunoglobulin, ayisiza, umuthi esetshenziswa 0.5 g / kg njalo ngenyanga uma nje okuqukethwe kwabo engabuyi ukuba amazinga evamile.
side effects
Ngokweyame cwaningo saziso ngaphambi kokufaka imithi "Octagam" imfundo manual. Ukuthuthukiswa amathuba okuba nemiphumela engemihle uma usebenzisa izidakamizwa kuncike umthamo kanye izinga zokuphatha.
umjovo i-intravenous ne izidakamizwa kungabangela leukopenia, hemolysis futhi esethola anaemia hemolytic. Ekwelapheni okunokwenzeka ekusabeleni okungekuhle izivikeli mzimba, okuyinto obonakaliswe ukubonakaliswa hypersensitivity. Ezimweni ezingavamile kuphakama anaphylactoid futhi ukusabela anaphylactic, puffiness ebusweni, angioedema.
yokwelapha i-HIV ezinganeni ukwelashwa ezinye izifo ngokuvamile kubangela ubuhlungu bekhanda. Akuvamile isifo sobuchopho waquleka kwegazi, injabulo ngokweqile, aseptic meningitis. Umuthi kungabangela ubuhlungu bekhanda, paresthesia futhi inzululwane.
Phakathi ukwelashwa, kukhona amathuba okuvela isilethikusebenza. Kungase kube nesinye ukushaya kwenhliziyo anda tahikradiya. Ngezinye izikhathi ayinandaba cyanosis, hypotension futhi thrombosis. Akuve ezingavamile esingamahlalakhona kwegazi, deep vein thrombosis, umfutho wegazi ophakeme.
Umuthi kungabangela ukusabela phezu ingxenye umgudu wokuphefumula. Lokhu nokuvaleka kwemigudu yokuphefumula, edema yamaphaphu, iphika. Imiphumela engemihle eshiwo umuntu eqhuma ukukhwehlela, bronchospasm, embolism yamaphaphu.
Ukwelapha kungabangela ukucanuzela kwenhliziyo, ukuhlanza reflex, ubuhlungu besisu, uhudo. Ezimweni ezingavamile, kukhona eczema, urticaria futhi ukulunywa. Kwezinye iziguli, ngemva kokusebenzisa indlu izidakamizwa kwaphakama dermatitis, Alopecia, futhi pruritus.
It is kuyaqabukela bephawula ukusabela ezifana ubuhlungu emuva endaweni, myalgia futhi arthralgia. Okuningi ekwelashweni angagcina esingamahlalakhona kwezinso, kukhuphuke serum creatinine, ukuphazamisa imfiva, ukukhathala kakhulu, ukungakhululeki ukuphendula kwenzeke isayithi umjovo. Phakathi izenzakalo ukungasebenzisi enqabayo waphawula Ukugodola, ubuhlungu esifubeni, siwasebenzise, ukucobeka ukuqubuka futhi pyrexia. Ezimweni ezingavamile, iziguli umfutho ophansi wegazi, ukushaqeka anaphylactic.
Ukubukeka imiphumela engemihle engase ezigulini, nokuphathwa izidakamizwa ibekezelelwe kahle ngaphambili. "Octagam" kubangela ukwenyuka enzyme isibindi kanye glucose lokuhlala ezifundweni igazi laboratory.
Lapho akhethiwe kahle umthamo kungenzeka overdosing izimpawu. Kuvamise nokugcinwa uketshezi emzimbeni, umfutho viscosity, okuyinto okubonakale abantu nge isifo sezinso, futhi ezigulini esezikhulile.
Kuzo zonke izimo ngenhla, impatho lingaze Kunconywa.
Izixwayiso
Umuthi uyakwazi ukunciphisa imithelela bukhoma attenuated igciwane yokugoma isikhathi emavikini ayisithupha kuya ezinyangeni ezintathu. Ukuze ugweme lokhu, kufanele ulinde emva ukusetshenziswa 'Octagam "izinyanga ezintathu ukulungiselela. Imithi kunciphisa ukusebenza yomgomo isimungumungwane ngonyaka, ngakho ngaphambi isiteji lokhu yokugoma kumele ihlolwe titer isimungumungwane amasosha omzimba.
Ukwelashwa nale izidakamizwa kungabangela inombolo yemiphumela emibi, ngakho-ke kubalulekile ukulandela ngokucophelela iziyalezo for umthamo kanye nokuphathwa izinga. Ngokuhamba yokwelapha kuyadingeka ngaso sonke isikhathi ukuze kuqashwe impilo iziguli.
Iziguli iphathwa immunoglobulin emthanjeni, kumele zithole hydration eyanele ngaphambi inqubo, ukuqhuba ukuqapha umchamo okukhipha negazi creatinine. Kuyadingeka ukuba asuse ngokuphelele isicelo "loop" isisu.
Uma kukhona abantu basabele ngendlela embi ezidingekayo sinciphise izinga lokutholakala kwengculazi izidakamizwa abaphathi noma ngokuphelele uyeka ukuyisebenzisa. Yokwelapha kuxhomeke ngokuphelele kobukhulu kanye nemvelo izigigaba ezingezinhle. Uma kukhona ukushaqeka, kubalulekile iphendukele imishanguzo-ukushaqeka, okumele abe ngokuhlanganiswa ukwelashwa.
Isikhathi esining impela kubangela ukusabela ezingezinhle elishesha yokuphathwa, ikakhulukazi hypo- futhi agammaglobulinemia nokusebenzisa immunoglobulin eyinhloko. Imiphumela engemihle kungenzeka uma udlulisa isiguli immunoglobulin nomkhiqizi eyodwa kuya kwenye izidakamizwa, futhi uma isikhathi esiningi isidlulile kusukela ukumnika odlule.
Control salezi ziguli (futhi lokhu kuhlanganisa iziguli ezinesifo se-HIV-positive) kumele kwenziwe njalo phakathi naso sonke isikhathi i-ukumnika lokuqala isinyathelo, ikakhulu, ngemizuzu yokuqala kuqale ngemva kokuhlinzwa. Iziguli abangenalo imiphumela emibi, kufanele ibe ngaphansi kokuqondisa kukadokotela ngemva ukumnika "Oktagamom" owokuqala 20 imizuzu.
Phakathi ukwelashwa kufanele bathathe izinyathelo standard ukuze avimbele izifo ukuthi kungenzeka uma usebenzisa imithi zalo kuvela egazini labantu noma uketshezi olungenambala olusegazini. Lezi zihlanganisa ukukhethwa abanikele efanelekayo, ukuqapha of servings ngabanye kanye plasma amachibi ngoba nakomaka ethize ukutheleleka. Le nqubo kumele zihlanganisa izinyathelo ukuze inactivation / nokuqedwa amagciwane.
Naphezu kwakho konke izinyathelo ekwelapheni izidakamizwa ezinjalo, asikwazi ukuvala amathuba nokudluliswa eziningi ejenti yokungenwa yizifo ezithathelwanayo, amagciwane kanye nezinye amagciwane. Zonke zezinto ezingenhla ukusebenza ekutholweni amagciwane wasibekela HIV, i-hepatitis B no-C I okungenani zinikeza abathwali parvovirus B19 futhi gipatita A. isipiliyoni Clinical yokwelashwa ejenti equkethe immunoglobulin womuntu kusikisela ukuthi parvovirus B19 kanye ne-hepatitis A ekwelapheni izidakamizwa ayihambi idatha. Lokubaluleke kakhulu ekuphepheni namagciwane kuyinto khona umkhiqizo okwelapha elihambisana amasosha omzimba.
Phakathi ukudlula Yiqiniso zokwelapha amasosha omzimba zibukele adlulisiwe umthamo wegazi lesiguli angase akhiphe imiphumela eyiphutha uma enifeza serologic ukuhlolwa. Maltose eziqukethwe ukulungiselela uyakwazi amanga phendulela ezingeni igazi glucose.
Ukusebenza okuthuthukisiwe e igazi glucose lokuhlushwa waphawula phakathi ekususweni izidakamizwa kusukela umzimba noma amahora ayishumi nanhlanu emva Ukuvalwa yayo. Kulokhu, kukhona kungenzeka olungalungile injongo insulini umthamo ezingaba avuse kahle kungakhuphula izinga likashukela. Ngakho-ke, izindlela kuphela glyukozospetsificheskie sokunquma ezingeni glucose egazini ukuze isetshenziswe ekwelapheni "0ktagamom". kits yokuhlola nokuqapha kashukela kufanele ukwazi ukunquma lokhu ipharamitha iziguli ukuthatha imithi nge maltose.
Uma kungenjalo yisikhathi, wabe esenikwa ithuba ukugcina izidakamizwa "Octagam" (50 ml kanye 100 ml) at lokushisa kuze kufinyelele + 25 ° C izinyanga ezintathu ngaphandle yesibili uyibeka ku esiqandisini. Ubuningi isikhathi esibekiwe, izidakamizwa wobulawa nokubulawa.
Imithi akuphazamisi ikhono ukushayela futhi ukwenza izenzo ezidinga ukunakekelwa okukhethekile nezipani futhi ngokushesha lengqondo ukusabela.
Izidakamizwa "Octagam": nozakwabo
Lokhu imithi inezici ezinhle eziningana analogue ezingaba esikhundleni sakhe uma isidingo, kuba:
- "Biaven VI."
- "Veegum-zezimali."
- "Venoglobulin".
- "Gabriglobin".
- "Gabriglobin-IgG».
- "Veegum-C."
- "Gamunex."
- "I-gamma globulin Hooman".
- "IG Vienna N.I.V. ".
- "Imbioglobulin".
- "Immunoglobulin".
- "Imbiogam".
- "Immunovenin".
- "Intratekt".
- "Sandoglobulin".
- "Endobulin".
- "Flebogamma 5%."
- "Humaglobin".
esikhundleni Russian ishibhile kuka nozakwabo zabo zakwamanye amazwe. Kunoma ikuphi, zonke lezi izidakamizwa zinzima ngokwanele ukuba sithathe futhi kumelwe ithathelwe kuphela udokotela, esekelwe isimo lesiguli.
"Octagam" Medicine: Intengo
Izindleko zomuthi impela high. It angathengwa ruble ayizigidi 9,5-12 kanye 50 ml we izidakamizwa "Octagam". 100 ml Intengo emhlabeni izinkulungwane 20-24 ruble.
Imibono iziguli nodokotela
Izidakamizwa "Octagam" has Izibuyekezo ikakhulukazi omuhle. Ikakhulukazi bayakwazisa izinga yayo abantu, abasiza ukuba alulame nge immunodeficiency futhi Guillain-Barre syndrome. Livame ukusetshenziswa kubantu abane-AIDS banakekele impilo yabo. Wazibonakalisa aphumelele ezingamahlalakhona wegazi lymphocytic, myasthenia gravis. Abesifazane ukusebenzisa lolu izidakamizwa ukukhulelwa kanye nomntwana.
Iningi iziguli awanelisekile nge izindleko zomuthi, babe uqaphele ukuthi kunzima ukuthenga Pharmacy. Abanye okuthiwa kuwukuba buthakathaka, ikhanda, futhi umkhuhlane jikelele.
Odokotela bathi ukulungiswa okumsulwa, it is kahle amuncwa wumzimba, futhi ngokungafani immunoglobulin, ayisiza yasekhaya kancane engabangela komzimba.
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