Rituzena (previously Tuxella) Den Europæiske Union - dansk - EMA (European Medicines Agency)

rituzena (previously tuxella)

celltrion healthcare hungary kft. - rituximab - lymphoma, non-hodgkin; microscopic polyangiitis; leukemia, lymphocytic, chronic, b-cell; wegener granulomatosis - antineoplastiske midler - rituzena er angivet i voksne til følgende indikationer:non-hodgkin ' s lymfom (nhl)rituzena er indiceret til behandling af tidligere ubehandlede patienter med stadium iii-iv, follikulært lymfom i kombination med kemoterapi. rituzena monoterapi er indiceret til behandling af patienter med stadie iii-iv follikulært lymfom, der er kemo resistente eller er i deres andet eller efterfølgende tilbagefald efter kemoterapi. rituzena er indiceret til behandling af patienter med cd20-positive diffuse store b-celle non hodgkin ' s lymfom i kombination med chop (cyclofosfamid, doxorubicin, vincristin, prednisolon) kemoterapi. kronisk lymfatisk leukæmi (cll)rituzena i kombination med kemoterapi er indiceret til behandling af patienter med tidligere ubehandlet og recidiverende/refraktær cll. foreligger kun begrænsede oplysninger om effekt og sikkerhed for patienter, der tidligere er behandlet med monoklonale antistoffer, herunder rituzenaor patienter ildfaste materialer til tidligere rituzena plus kemoterapi. granulomatosis med polyangiitis og mikroskopiske polyangiitisrituzena, i kombination med glukokortikoider er indiceret til induktion af remission hos voksne patienter med svær, aktive granulomatosis med polyangiitis (wegeners) (gpa) og mikroskopisk polyangiitis (mpa).

Hexacima Den Europæiske Union - dansk - EMA (European Medicines Agency)

hexacima

sanofi pasteur - hepatitis b surface antigen, diphtheria toxoid, tetanus toxoid, bordetella pertussis antigens pertussis toxoid filamentous haemagglutinin, poliovirus (inactivated) type 1 (mahoney) type 2 (mef-1) type 3 (saukett), haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to tetanus protein - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; poliomyelitis; diphtheria - vaccines, bacterial and viral vaccines, combined - hexacima (dtap-ipv-hb-hib) er angivet til primær og booster nødvaccination, som spædbørn og småbørn fra seks uger mod difteri, stivkrampe, kighoste, hepatitis b, polio og invasive sygdomme forårsaget af haemophilus influenzae type b (hib). brug af denne vaccine bør være i overensstemmelse med de officielle anbefalinger.

Hexyon Den Europæiske Union - dansk - EMA (European Medicines Agency)

hexyon

sanofi pasteur europe - filamentous haemagglutinin, haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate), hepatitis b surface antigen, pertussis toxoid, poliovirus (inactivated) type 1 (mahoney strain) produced on vero cells, poliovirus (inactivated) type 2 (mef-1 strain) produced on vero cells, poliovirus (inactivated) type 3 (saukett strain) produced on vero cells, tetanus protein, tetanus toxoid adsorbed on aluminium hydroxide, hydrated, diphtheria toxoid - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; poliomyelitis; diphtheria - vacciner - hexyon (dtap-ipv-hb-hib) er angivet til primær og booster nødvaccination, som spædbørn og småbørn fra seks uger mod difteri, stivkrampe, kighoste, hepatitis b, polio og invasive sygdomme forårsaget af haemophilus influenzae type b (hib). brug af denne vaccine bør være i overensstemmelse med de officielle anbefalinger.

Zavicefta Den Europæiske Union - dansk - EMA (European Medicines Agency)

zavicefta

pfizer ireland pharmaceuticals - avibactam sodium, ceftazidime pentahydrate - pneumonia, bacterial; soft tissue infections; pneumonia; urinary tract infections; gram-negative bacterial infections - antibakterielle midler til systemisk brug, - zavicefta is indicated in adults and paediatric patients aged 3 months and older for the treatment of the following infections:complicated intra-abdominal infection (ciai)complicated urinary tract infection (cuti), including pyelonephritishospital-acquired pneumonia (hap), including ventilator associated pneumonia (vap)treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. zavicefta is also indicated for the treatment of infections due to aerobic gram-negative organisms in adults and paediatric patients aged 3 months and older with limited treatment options. det bør overvejes at officielle vejledning om hensigtsmæssig brug af antibakterielle midler..

Vectormune FP ILT + AE Den Europæiske Union - dansk - EMA (European Medicines Agency)

vectormune fp ilt + ae

ceva-phylaxia co. ltd. - live recombinant fowlpox virus expressing the membrane fusion protein and the encapsidation protein of avian infectious laryngotracheitis virus (rfp-lt) and avian encephalomyelitis virus, strain calnek 1143 (ae) - immunologicals for aves, live viral vaccines, domestic fowl - kylling - for active immunisation of chickens of 8 to 13 weeks of age in order to reduce the skin lesions due to fowlpox, to reduce the clinical signs and tracheal lesions due to avian infectious laryngotracheitis and to prevent egg production losses due to avian encephalomyelitis.

Kigabeq Den Europæiske Union - dansk - EMA (European Medicines Agency)

kigabeq

orphelia pharma sas - vigabatrin - spasms, infantile; epilepsies, partial - antiepileptika, - kigabeq er angivet i spædbørn og børn fra 1 måned til mindre end 7 år:behandling i monoterapi af infantile spasmer (west ' s syndrom). behandling i kombination med andre antiepileptiske lægemidler til patienter med resistent partiel epilepsi (fokale anfald) med eller uden sekundær generalisering, det er der, hvor alle andre relevante lægemiddel kombinationer har vist sig utilstrækkelig eller ikke tolereres.

Yescarta Den Europæiske Union - dansk - EMA (European Medicines Agency)

yescarta

kite pharma eu b.v. - axicabtagene ciloleucel - lymphoma, follicular; lymphoma, large b-cell, diffuse - antineoplastiske midler - yescarta is indicated for the treatment of adult patients with diffuse large b cell lymphoma (dlbcl) and high-grade b-cell lymphoma (hgbl) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy. yescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) dlbcl and primary mediastinal large b cell lymphoma (pmbcl), after two or more lines of systemic therapy. yescarta is indicated for the treatment of adult patients with r/r follicular lymphoma (fl) after three or more lines of systemic therapy.

Dimethyl fumarate Neuraxpharm Den Europæiske Union - dansk - EMA (European Medicines Agency)

dimethyl fumarate neuraxpharm

laboratorios lesvi s.l. - dimethylfumarat - multipel sklerose, recidiverende-remitterende - immunosuppressiva - dimethyl fumarate neuraxpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Tecfidera Den Europæiske Union - dansk - EMA (European Medicines Agency)

tecfidera

biogen netherlands b.v. - dimethylfumarat - multipel sclerose - immunosuppressiva - tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).

Tysabri Den Europæiske Union - dansk - EMA (European Medicines Agency)

tysabri

biogen netherlands b.v. - natalizumab - multipel sclerose - selektive immunosuppressiva - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 og 5. 1), , or, patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.