Prepandrix Evropska unija - slovenščina - EMA (European Medicines Agency)

prepandrix

glaxosmithkline biologicals s.a. - a / indonesia / 05/2005 (h5n1), podoben sevu (pr8-ibcdc-rg2) - influenza, human; immunization; disease outbreaks - cepiva - aktivna imunizacija proti podtipu h5n1 virusa influence. ta navedba temelji na immunogenicity podatkov iz zdravih predmetov iz 18. leta starosti dalje po uporabi zdravila dva odmerka cepiva, pripravljene s h5n1 podtipa sevi. prepandrix je treba uporabljati v skladu z uradnimi smernice.

Pumarix Evropska unija - slovenščina - EMA (European Medicines Agency)

pumarix

glaxosmithkline biologicals s.a.  - pandemije cepiva proti gripi (h5n1) (split virion, inaktivirano, adjuvanted) - influenza, human; immunization; disease outbreaks - cepiva - preprečevanje gripe v uradno prijavljeni pandemični situaciji. pandemije-influence cepivo je treba uporabljati v skladu z uradnimi smernice.

Arexvy Evropska unija - slovenščina - EMA (European Medicines Agency)

arexvy

glaxosmithkline biologicals s.a.  - respiratory syncytial virus recombinant glycoprotein f stabilised in the pre-fusion conformation (rsvpref3) produced in chinese hamster ovary (cho) cells by recombinant dna technology - infekcije respiratornih sincicijskih virusov - cepiva - arexvy is indicated for active immunisation for the prevention of lower respiratory tract disease (lrtd) caused by respiratory syncytial virus in adults 60 years of age and older. uporaba tega cepiva mora biti v skladu z uradnimi priporočili.

VaxigripTetra suspenzija za injiciranje v napolnjeni injekcijski brizgi Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

vaxigriptetra suspenzija za injiciranje v napolnjeni injekcijski brizgi

sanofi pasteur - ha seva b/phuket/3073/2013, divji tip, podoben sevu b/phuket/3073/2013; ha seva a/darwin/9/2021, ivr-228, podoben sevu a/darwin/9/2021 (h3n2); ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/2021; ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p - suspenzija za injiciranje - ha seva b/phuket/3073/2013, divji tip, podoben sevu b/phuket/3073/2013 15 µg / 1 brizga  ha seva a/darwin/9/2021, ivr-228, podoben sevu a/darwin/9/2021 (h3n2)15 µg / 1 brizga  ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/202115 µg / 1 brizga  ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p15 µg / 1 brizga; ha seva a/darwin/9/2021, ivr-228, podoben sevu a/darwin/9/2021 (h3n2) 15 µg / 1 brizga  ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/202115 µg / 1 brizga  ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p15 µg / 1 brizga; ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/2021 15 µg / 1 brizga  ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p15 µg / 1 brizga; ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p - cepivo proti gripi, z delci virusov ali s površinskimi antigeni, inaktivirano

VaxigripTetra suspenzija za injiciranje v napolnjeni injekcijski brizgi Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

vaxigriptetra suspenzija za injiciranje v napolnjeni injekcijski brizgi

sanofi pasteur - ha seva b/phuket/3073/2013, divji tip, podoben sevu b/phuket/3073/2013; ha seva a/darwin/9/2021, ivr-228, podoben sevu a/darwin/9/2021 (h3n2); ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/2021; ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p - suspenzija za injiciranje - ha seva b/phuket/3073/2013, divji tip, podoben sevu b/phuket/3073/2013 15 µg / 1 brizga  ha seva a/darwin/9/2021, ivr-228, podoben sevu a/darwin/9/2021 (h3n2)15 µg / 1 brizga  ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/202115 µg / 1 brizga  ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p15 µg / 1 brizga; ha seva a/darwin/9/2021, ivr-228, podoben sevu a/darwin/9/2021 (h3n2) 15 µg / 1 brizga  ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/202115 µg / 1 brizga  ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p15 µg / 1 brizga; ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/2021 15 µg / 1 brizga  ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p15 µg / 1 brizga; ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p - cepivo proti gripi, z delci virusov ali s površinskimi antigeni, inaktivirano

Glivec Evropska unija - slovenščina - EMA (European Medicines Agency)

glivec

novartis europharm limited - imatinib - precursor cell lymphoblastic leukemia-lymphoma; gastrointestinal stromal tumors; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - antineoplastična sredstva - glivec is indicated for the treatment of , adult and paediatric patients with newly diagnosed philadelphia-chromosome (bcr-abl)-positive (ph+) chronic myeloid leukaemia (cml) for whom bone-marrow transplantation is not considered as the first line of treatment;, adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult and paediatric patients with newly diagnosed philadelphia-chromosome-positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy;, adult patients with relapsed or refractory ph+ all as monotherapy;, adult patients with myelodysplastic / myeloproliferative diseases (mds / mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements;, adult patients with advanced hypereosinophilic syndrome (hes) and / or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfra rearrangement. učinek glivec na izid kostnega mozga presaditev ni bilo določeno. glivec is indicated for: , the treatment of adult patients with kit (cd 117)-positive unresectable and / or metastatic malignant gastrointestinal stromal tumours (gist);, the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. bolniki, ki imajo nizko ali zelo nizko tveganje za ponovitev, ne bi smel imeti adjuvant treatment;, zdravljenje odraslih bolnikov z unresectable dermatofibrosarcoma protuberans (dfsp) in odraslih bolnikih s ponavljajočimi in / ali metastatskim dfsp, ki niso primerni za operacijo. v izobraževanju odraslih in pediatričnih bolnikov, učinkovitost glivec je na podlagi splošno hematoloških in postopek citogenetske stopnjo odziva in napredovanje-free survival v cml, na hematoloških in postopek citogenetske stopnjo odziva, v ph+ all, mds / mpd, na hematoloških stopnjo odziva, v hes / cel in na cilj stopnjo odziva pri odraslih bolnikih z unresectable in / ali metastatskim bistvo in dfsp in na ponovitev-free survival v adjuvant bistvo. izkušnje z glivec pri bolnikih z mds / mpd, povezanih z pdgfr gena ponovno ureditev je zelo omejeno (glej poglavje 5. razen v novo diagnozo kronične faze cml, ni kontroliranih preskušanjih, dokazujejo kliničnih koristi ali poveča preživetje pri teh bolezni.

Twinrix Paediatric Evropska unija - slovenščina - EMA (European Medicines Agency)

twinrix paediatric

glaxosmithkline biologicals s.a. - hepatitis a virus (inactivated), hepatitis b surface antigen - immunization; hepatitis b; hepatitis a - cepiva - twinrix pediatric je indiciran za uporabo pri neimunskih dojenčkih, otrocih in mladostnikih od enega leta do vključno 15 let, pri katerih obstaja tveganje za okužbo s hepatitisom a in hepatitisom b.

Twinrix Adult Evropska unija - slovenščina - EMA (European Medicines Agency)

twinrix adult

glaxosmithkline biologicals s.a. - hepatitis a virus (inaktivirano), hepatitis b površinski antigen - hepatitis b; hepatitis a; immunization - cepiva - zdravilo twinrix adult je indicirano za uporabo pri neimunskih odraslih in mladostnikih, starih 16 let ali več, ki jim grozi okužba s hepatitisom a in hepatitisom b.

COMBICLAV Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

combiclav

norbrook laboratories (ireland) limited rossmore industrial estate monaghan irska proizvajalec odgovoren za sproščanje serij: norbrook manufacturing ltd -