natgillin/translations-raw huggingface dataset:
Infliximab
infliksimab
Infliximab + AZA Combination therapy
infliksimab + AZA v kombinirani terapiji
Infliximab crosses the placenta and has been detected in the serum of infants up to 6 months following birth.
Infliksimab prehaja skozi posteljico in so ga vse do 6 mesecev po rojstvu določili v serumu dojenčkov.
Infliximab has been associated with acute infusion-related reactions, including anaphylactic shock, and delayed hypersensitivity reactions (see section 4.8).
Zdravljenje z infliksimabom je bilo povezano z akutnimi infuzijskimi reakcijami, vključno z anafilaktičnim šokom in poznimi preobčutljivostnimi reakcijami (glejte poglavje 4.8 ).
Infliximab inhibits the functional activity of TNFα in a wide variety of in vitro bioassays.
Številni različni biološki testi in vitro so pokazali, da infliksimab zavira delovanje TNFα.
Infliximab inhibits the functional activity of TNF in a wide variety of in vitro bioassays.
Številni različni biološki testi in vitro so pokazali, da infliksimab zavira delovanje TNF.
Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in murine hybridoma cells by recombinant DNA technology.
Infliksimab je himerno človeško–glodalsko monoklonsko protitelo IG1, pridobljeno iz celic glodalskega hibridoma s tehnologijo rekombinantne DNK.
Infliximab is a type of protein of human and mouse origin.
Infliksimab je vrsta beljakovine človeško-glodalskega izvora.
Infliximab is a type of protein of human and mouse origin.
Infliksimab je vrsta beljakovine človeško-glodavskega izvora.
Infliximab Maintenance
Vzdrževalno zdravljenje z infliksimabom
Infliximab Maintenance 5 mg/kg (n=113) (p value)
vzdrževalno zdravljenje z infliksimabom 5 mg/kg
Infliximab Monotherapy
infliksimab v monoterapiji
Infliximab Monotherapy
monoterapiji
Infliximab treatment of Crohn’s disease patients was also associated with a substantial reduction of the commonly elevated serum inflammatory marker, CRP.
Pri bolnikih s Crohnovo boleznijo je bilo zdravljenje z infliksimabom tudi povezano z znatnim zmanjšanjem običajno zvišane serumske koncentracije vnetnega pokazatelja CRP.
Infliximab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment at the week 24 primary endpoint as measured by change from baseline in total modified vdH-S score (mean ± SD score was 0.82 ± 2.62 in the placebo group compared with -0.70 ± 2.53 in the infliximab group; p < 0.001).
Zdravljenje z infliksimabom je zmanjšalo hitrost napredovanja okvare perifernih sklepov v primerjavi s placebom v 24. tednu kot primarni končni rezultat, merjeno kot sprememba celotne vrednosti modificiranega rezultata vdH-S glede na stanje na začetku študije (v skupini za placebo je znašala srednja vrednost ± SD 0,82 ± 2,62, v primerjavi z - 0,70 ± 2,53 za skupino, ki je prejemala infliksimab; p < 0,001).
Infliximab with or without AZA was assessed in a randomised, double-blind, active comparator study (SONIC) of 508 adult patients with moderate to severe Crohn’s disease (CDAI ≥ 220 ≤ 450) who were naive to biologics and immunosuppressants and had a median disease duration of 2.3 years.
Uporabo infliksimaba z ali brez AZA so ovrednotili v randomizirani, dvojno slepi študiji s kontrolno zdravilno učinkovino (SONIC) pri 508 odraslih bolnikih z zmerno do hudo bliko Crohnove bolezni (CDAI ≥ 220 ≤ 450), ki pred tem niso še nikoli prejemali bioloških zdravil ali imunosupresivov in je bila pri njih mediana vrednost trajanja bolezni 2,3 leta.
Infliximab with or without AZA was assessed in a randomised, double-blind, active comparator study (SONIC) of 508 adult patients with moderate to severe Crohn’s disease (CDAI ≥220 ≤450) who were naive to biologics and immunosuppressants and had a median disease duration of 2.3 years.
Uporabo infliksimaba z ali brez AZA so ovrednotili v randomizirani, dvojno slepi študiji s kontrolno zdravilno učinkovino (SONIC) pri 508 odraslih bolnikih z zmerno do hudo obliko Crohnove bolezni (CDAI ≥ 220 ≤ 450), ki pred tem niso še nikoli prejemali bioloških zdravil ali imunosupresivov in je bila pri njih mediana vrednost trajanja bolezni 2,3 leta.
infliximab)*.
pogosti:
Influence of AED on brivaracetam plasma concentration
Učinek antiepileptikov na plazemsko koncentracijo brivaracetama
Influence of brivaracetam on AED plasma concentration
Učinek brivaracetama na plazemsko koncentracijo antiepileptikov
Influenza
gripa okužba s
influenza (“swine flu”) was almost uniformly susceptible to oseltamivir, with only sporadic reports of resistance in connection with both therapeutic and prophylactic regimens.
Leta 2009 je bila gripa H1N1 (''prašičja gripa'') skoraj konstantno občutljiva na oseltamivir, poročali so samo o posameznih primerih odpornosti v povezavi s terapevtskim in profilaktičnim režimom.
Influenza A/eq/Ohio/03 [H3N8] (vCP2242) ...............................................................≥ 5.3 log10 FAID50
Influenza A/eq/ Ohio/03 [H3N8] (vCP2242) ............................................................ ≥ 5,3 log10 FAID50
Influenza A/eq/Ohio/03 [H3N8] recombinant canarypox virus (vCP2242) ............ ≥ 5.3 log10 FAID50* Influenza A/eq/Richmond/1/07 [H3N8] recombinant canarypox virus (vCP3011) . ≥ 5.3 log10 FAID50*
Influenza A/eq/ Ohio/03 [H3N8] rekombinantni canarypox virus (vCP2242)............≥ 5,3 log10 FAID50* Influenza A/eq/Richmond/1/07 [H3N8] rekombinantni canarypox virus (vCP1533).≥ 5,3 log10 FAID50
Influenza A/eq/Ohio/03 [H3N8] recombinant canarypox virus (vCP2242) ............ ≥ 5.3 log10 FAID50* Influenza A/eq/Richmond/1/07 [H3N8] recombinant canarypox virus (vCP3011). ≥ 5.3 log10 FAID50*
Influenza A/eq/ Ohio/03 [H3N8] rekombinantni canarypox virus (vCP2242)............≥ 5,3 log10 FAID50* Influenza A/eq/Richmond/1/07 [H3N8] rekombinantni canarypox virus (vCP1533).≥ 5,3 log10 FAID50
Influenza A/eq/Ohio/03 [H3N8] recombinant canarypox virus (vCP2242) ...........≥ 5.3 log10 FAID50* Influenza A/eq/Richmond/1/07 [H3N8] recombinant canarypox virus (vCP3011) ≥ 5.3 log10 FAID50* Clostridium tetani toxoid ......................................................................................................... ≥ 30 IU**
Influenza A/eq/Ohio/03 [H3N8] rekombinantni Canarypox virus (vCP2242)......... ≥ 5,3 log10 FAID50* Influenza A/eq/Richmond/1/07 rekombinantni Canarypox virus (vCP3011).......... ≥ 5,3 log10 FAID50* Clostridium tetani toksoid. ....................................................................................................... ≥ 30 IU
Influenza can be associated with a variety of neurologic and behavioural symptoms which can include events such as hallucinations, delirium, and abnormal behaviour, in some cases resulting in fatal outcomes.
Gripa je lahko povezana s številnimi nevrološkimi in vedenjskimi simptomi, ki lahko vključujejo dogodke kot so halucinacije, delirij, nenavadno vedenje, in so v nekaterih primerih lahko tudi smrtni.
Influenza can be associated with a variety of neurologic and behavioural symptoms which can include events such as hallucinations, delirium, and abnormal behaviour, in some cases resulting in fatal outcomes.
Gripa je lahko povezana s številnimi nevrološkimi in vedenjskimi simptomi, ki lahko vključujejo dogodke, kot so halucinacije, delirij, nenavadno vedenje, in so v nekaterih primerih lahko tudi smrtni.
Influenza cases were identified by active and passive surveillance of influenza-like illness (ILI).
Primeri gripe so bili odkriti z aktivnim in pasivnim spremljanjem gripi podobnih bolezni (ILI – influenza-like illness).
Influenza Gastrointestinal infection Gastroenteritis Folliculitis
gripa, okužba prebavil, gastroenteritis, folikulitis,
Influenza Infection Pharyngitis Rhinitis
gripa okužba faringitis rinitis
Influenza like
bolezen, podobna
influenza like illness
bolezen, podobna gripi
Influenza like illness Fatigue2
gripi podobna bolezen utrujenost2
Influenza like illness Injection site reaction, malaise, irritation, anaesthesia, desquamation, nodule or discoloration
bolezen, podobna gripi reakcija na mestu injiciranja, splošno slabo počutje, draženje, anestezija, luščenje, vozlič ali obarvanje
Influenza like illness Oedema
gripi podobna bolezen edem
influenza like illness restlessness
gripi podobna bolezen nemirnost
Influenza like illness*
bolezen, podobna gripi
Influenza like illness*, chills*
gripi podobna bolezen*, mrzlica
Influenza like illness*, Fatigue
bolezen, podobna gripi*, utrujenost
Influenza like illness, chills
gripi podobna bolezen, mrzlica
Influenza like illness, Pyrexia, Chills, Fatigue, Pain, Injection site reactions§
gripi podobna bolezen, zvišana telesna temperatura, mrzlica, utrujenost, bolečina, reakcije na mestu injiciranja§
influenza like illness, pyrexia, chills, feeling hot
gripi podobna bolezen, pireksija, mrzlica, občutek vročine
Influenza Localised infection Nasopharyngitis
gripa lokalizirana okužba nazofaringitis
Influenza Sinusitis
gripa sinusitis
Influenza vaccine (split virion, inactivated)
Cepivo proti gripi z delci virionov, inaktivirano
Influenza vaccine (whole virion, inactivated) containing antigen of*:
Cepivo proti gripi (celi virioni, inaktivirano), ki vsebuje antigen*:
Influenza vaccine (whole virion, inactivated) containing antigen*
Cepivo proti gripi (celi virioni, inaktivirano), ki vsebuje antigen*:
Influenza vaccine (whole virion, inactivated) containing antigen* of: A/Vietnam/1203/2004 (H5N1) 7.5 micrograms**per
Cepivo proti gripi (celi virioni, inaktivirano), ki vsebuje antigen*:
Influenza vaccine 2013/2014 season
cepivo proti gripi Sezona 2013/2014
Influenza vaccine, ATC Code: J07BB02 Clinical efficacy and safety
Cepiva proti gripi, oznaka ATC: J07BB02 Klinična učinkovitost in varnost
Influenza vaccine, ATC Code: J07BB02 Clinical efficacy and safety
Cepivo proti gripi, oznaka ATC: J07BB02 Klinična učinkovitost in varnost
Influenza virus (inactivated, split) of the following strains:
Virusi influence (inaktivirani, razcepljeni) naslednjih sevov: A/California/7/2009 (H1N1)pdm09 - podoben sev
Influenza virus (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1) 7.5 micrograms per 0.5 ml dose
Virus gripe (celotni virioni, inaktiviran), ki vsebuje antigen: A/Vietnam/1203/2004 (H5N1) 7,5 mikrogramov na odmerek 0,5 ml
Influenza virus (whole virion, inactivated), containing antigen of*: A/Vietnam/1203/2004 (H5N1) 7.5 micrograms** per 0.5 ml dose produced in Vero cells
Virus gripe (celotni virioni, inaktiviran), ki vsebuje antigen*: A/Vietnam/1203/2004 (H5N1) 7,5 mikrogramov** na odmerek 0,5 ml pripravljen v celicah Vero
Influenza virus (whole virion, inactivated), containing antigen* of: A/Vietnam/1203/2004 (H5N1) 7.5 micrograms** per 0.5 ml dose
Virus gripe (celi virioni, inaktiviran), ki vsebuje antigen*: A/Vietnam/1203/2004 (H5N1) 7,5 mikrogramov** v enem odmerku 0,5 ml
Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain:
Površinski antigeni (hemaglutinin in nevraminidaza) seva virusa influence*:
Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain:
Površinski antigeni (hemaglutinin in nevraminidaza) seva virusa influence*: NYMC X-181 pridobljenega iz seva
Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain:
Površinski antigeni (hemaglutinin in nevraminidaza)* naslednjega seva virusa influence:
Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain:
Površinski virusni antigeni (hemaglutinin in nevraminidaza) * seva: NYMC X-181 pridobljenega iz seva
Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14) 7.5 micrograms** per 0.5 ml dose
Sev* virusa influence s površinskimi antigeni (hemaglutinin in nevraminidaza): sevu A/Vietnam/1194/2004 (H5N1) podobnega seva (NIBRG-14) 7,5 mikrogramov** na 0,5 ml odmerek
Influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following strains:
Površinski antigeni virusa gripe (hemaglutinin in nevraminidaza)*, inaktivirani, naslednjih sevov:
Influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following strains:
Sevi virusa influence s površinskimi antigeni (hemaglutinin in nevraminidaza)*, inaktivirani:
Influenza, nasopharyngitis
gripa, nazofagitis
Influenza, nasopharyngitis
gripa, nazofaringitis
Influenza, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and discomfort when swallowing, cystitis, gastroenteritis viral, oral herpes, tooth infection, laryngitis, fungal infection of the foot
gripa, okužba zgornjih dihal, okužba sečil, bronhitis, sinusitis, boleče žrelo in nelagoden občutek pri požiranju, cistitis, virusni gastroenteritis, herpes v ustih, zobna okužba, laringitis, glivična okužba stopala,
Influenza, urinary tract infection
gripa, okužba sečil
Influenza-like
akutni holecistitis
influenza-like
gripi podobna
Influenza-like
gripi podobni simptomi
influenza-like
zastajanje seča, ledvična cista
Influenza-like illness Chest discomfort
gripi podobna bolezen stiskanje v prsih
Influenza-like illness*
bolezen, podobna gripi
Influenza-like illness, chills, fatigue,
gripi podobna bolezen, mrzlica,
Influenza-like illness, injection site reaction, irritability, fatigue
bolezen, podobna gripi, reakcija na mestu injiciranja, razdražljivost, utrujenost
Influenza-like illness, Injection-site desquamation, Injection-site discoloration, Injection-site pruritus, Injection-site rash non-specific, Injection-site reaction, Injection-site scar, Hyperthermia, Pain, Pain/Tenderness/Soreness
gripi podobna bolezen, luščenje kože na mestu injiciranja, sprememba barve na mestu injiciranja, srbečica na mestu injiciranja, nespecifični izpuščaj na mestu injiciranja, reakcija na mestu injiciranja, brazgotina na mestu injiciranja, hipertermija, bolečina, bolečina/občutljivost/bolečnost
Influenza-like illness, pain
Redki: gripi podobna bolezen, bolečina
Influenza-like illness, swelling arms, weight increase, fatigue
gripi podobna bolezen, otekanje zgornjih udov, zvečanje telesne mase, utrujenost
Influenza-like symptoms
gripi podobni simptomi
influenza-like symptoms
gripi podobni simptomi,
influenza-like symptoms,
gripi podobni simptomi,
Influenza-like syndrome.
gripi podobni znaki bolezni
influenza.
gripa,
influenza; localised infection; inflammation of the passages in the nose and throat (nasopharyngitis);
gripa, lokalizirana okužba, vnetje nosnih prehodov in žrela (nazofaringitis),
Influenza†
gripa
INFO RMATIO N IN BRAILLE
PODATKI V BRAILLOVI PISAVI
Inform patients that they should not donate blood during treatment with Erivedge and for 24 months after their final dose
Bolnike je treba obvestiti, da med zdravljenjem z zdravilom Erivedge in 24 mesecev po končanem zdravljenju z zdravilom Erivedge ne smejo darovati krvi.
Inform the doctor if you begin to limp during treatment.
Obvestite svojega zdravnika, če začnete med zdravljenjem šepati.
Inform the patient about the potential for an interaction with other prescribed medicinal products and to contact his/her doctor in case of dizziness, nausea or vomiting.
Bolnika je treba obvestiti o možnosti interakcij z drugimi predpisanimi zdravili in mu naročiti, naj obvesti svojega zdravnika, če se pojavijo omotica, navzeja ali bruhanje.
Inform the veterinary surgeon if the animal is taking, or has recently taken, any other medicines.
Obvestite veterinarja, če žival dobiva ali je pred kratkim dobivala katero koli drugo zdravilo.
Inform your child’s doctor as soon as possible if they take more than the prescribed dose of Aptivus.
Če je vaš otrok vzel večji odmerek zdravila Aptivus od predpisanega, čim prej obvestite njegovega zdravnika.
Inform your doctor about all medicines you are currently taking.
Obvestite svojega zdravnika o vseh zdravilih, ki jih trenutno jemljete.
Inform your doctor about all other medicines you are taking before you start taking Viramune.
Zdravnika obvestite o vseh zdravilih, ki jih jemljete vi ali vaš otrok, preden boste začeli jemati zdravilo Viramune.
Inform your doctor also: if you have any illnesses other than Parkinson’s disease,
Prav tako obvestite svojega zdravnika: če imate katero drugo bolezen poleg Parkinsonove bolezni,
Inform your doctor as soon as possible if you develop symptoms suggesting a problem with your liver (like feeling sick without explanations, vomiting, stomach ache, tiredness, loss of appetite and/or dark urine) as your liver function should be checked. if you have cysts on your ovaries (polycystic ovary syndrome).
Obvestite svojega zdravnika kakor hitro je mogoče, če se pojavijo simptomi, ki kažejo na težave z jetri (npr. nepojasnjeno siljenje na bruhanje, bruhanje, bolečine v trebuhu, utrujenost, izguba apetita in/ali temen urin), ker je treba preveriti delovanje jeter. če imate ciste na jajčnikih (sindrom policističnih jajčnikov).
Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema). if you retain water (fluid retention) or have heart failure problems in particular if you are over 75 years old.
Obvestite svojega zdravnika kakor hitro je mogoče, če imate znake srčnega popuščanja, kot so nenavadno težko dihanje ali hitro povečanje telesne mase ali lokalizirana oteklina (edem). če zadržujete vodo (zastajanje tekočine v telesu) ali imate težave s srčnim popuščanjem, zlasti če ste starejši od 75 let.
Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema). if you retain water (fluid retention) or have heart failure problems in particular if you are over 75 years old.
Obvestite svojega zdravnika kakor hitro je mogoče, če imate znake srčnega popuščanja, kot so nenavadno težko dihanje ali hitro povečanje telesne mase ali lokalizirano oteklino (edem). če zadržujete vodo (zastajanje tekočine) ali imate težave s srčnim popuščanjem, zlasti če ste starejši od 75 let.
Inform your doctor as soon as possible if you take more than the prescribed dose of Aptivus.
Če ste vzeli večji odmerek zdravila Aptivus od predpisanega, čim prej obvestite zdravnika.
Inform your doctor before you take Soliris if you have any infections.
Pred pričetkom jemanja zdravila Soliris povejte svojemu zdravniku, če imate katerokoli okužbo.
Inform your doctor if you are breast-feeding or intending to breast-feed.
Če dojite ali nameravate dojiti, o tem obvestite zdravnika.
Inform your doctor if you are pregnant or planning to become pregnant soon.
Če ste noseči ali načrtujete nosečnost v bližnji prihodnosti, o tem obvestite svojega zdravnika.
Inform your doctor if you have a disease of
Obvestite svojega zdravnika, če imate bolezen
Inform your doctor if you have a history of liver or kidney disease.
Obvestite svojega zdravnika, če ste v preteklosti imeli jetrno ali ledvično bolezen
Inform your doctor if you have a prior history of eye conditions or eye treatments, or if you have had a stroke or experienced transient signs of stroke (weakness or paralysis of limbs or face, difficulty speaking or understanding).
Zdravniku povejte, če ste imeli že kdaj prej katero od očesnih bolezni ali ste si zdravili oči oziroma ste imeli kdaj možgansko kap ali prehodne znake možganske kapi (šibkost ali ohromelost okončin ali obraza, oteženo govorjenje ali razumevanje).
Inform your doctor if you have been or are using similar medicines for breathing problems, e.g. medicines containing tiotropium, ipratropium.
Če ste uporabljali ali uporabljate podobna zdravila za težave z dihanjem, npr. zdravila, ki vsebujejo tiotropij, ipratropij, obvestite svojega zdravnika.
Inform your doctor if you have difficulty taking the oral solution.
Povejte zdravniku, če imate težave pri jemanju peroralne raztopine.
Inform your doctor if you have difficulty taking the tablet.
Povejte zdravniku, če imate težave pri jemanju tablet.
Inform your doctor if you notice any of these symptoms.
Obvestite svojega zdravnika, če opazite katerega od teh simptomov.
Inform your doctor if you use medicines that increase allergic or other harmful reactions after light exposure, such as
Obvestite svojega zdravnika, če uporabljate zdravila, ki povečujejo alergijske ali druge škodljive reakcije po izpostavljanju svetlobi, kot so
Inform your doctor immediately if you experience any of the following possible symptoms of a liver problem: jaundice (yellowing of the skin or of the whites of the eyes), widespread itching, loss of appetite accompanied by nausea and vomiting and easy bruising of the skin.
Takoj obvestite svojega zdravnika, če ste opazili katerega od sledečih možnih znakov, ki kažejo na težave z jetri: zlatenica (porumenelost kože ali beločnic), splošno srbenje, izguba apetita, ki jo spremljajo siljenje na bruhanje in bruhanje ter pojav manjših podplutb na koži.
Inform your doctor immediately if you experience signs of heart failure such as unusual shortness of breath, rapid increase in weight or localised swelling (oedema).
Če občutite znake srčnega popuščanja, npr. nenavadno kratka sapa, hitro pridobivanje telesne mase ali lokalizirano otekanje (edem), nemudoma obvestite svojega zdravnika.
Inform your doctor immediately while taking this medicine if you get diarrhoea.
Zdravnika takoj obvestite, če boste med jemanjem tega zdravila: dobili drisko.
Inform your doctor immediately while taking this medicine, if you get diarrhoea.
Zdravnika takoj obvestite, če boste med jemanjem tega zdravila: dobili drisko.
Inform your doctor immediately while taking this medicine: if you develop diarrhoea.
Zdravnika med zdravljenjem s tem zdravilom nemudoma obvestite: če se pojavi driska.
Inform your doctor immediately, if you take more than the prescribed dose of Pradaxa.
Če ste vzeli večji odmerek zdravila Pradaxa, kot je predpisano, o tem nemudoma obvestite svojega zdravnika.
Inform your doctor immediately, if you take more than the prescribed dose of Pradaxa.
Če ste vzeli večji odmerek zdravila Pradaxa, kot je predpisano, o tem nemudoma obvestite vašega zdravnika.
Inform your doctor of any change in the medications you are taking.
Zdravnika obvestite o vseh spremembah zdravil, ki jih jemljete.
Inform your doctor or surgeon if you have a history of heart problems or are prone to frequent infections so that they can closely monitor you.
Zdravnika ali kirurga obvestite, če ste v preteklosti imeli težave s srcem ali če ste nagnjeni k pogostim okužbam, da vas bo lahko skrbno spremljal.
Inform your doctor or surgeon if you have been administered this medicine in the past.
Zdravnika ali kirurga obvestite, če ste že kdaj v preteklosti prejeli to zdravilo.
Inform your healthcare professional if you have a history of blood cancer including multiple myeloma.
Obvestite zdravstvenega delavca, če ste kdaj imeli krvnega raka, vključno z diseminiranim plazmocitomom.
Information about any registry or other monitoring system set up in the Member State and how to enter patients
Informacije o kakršnemkoli registru ali drugem sistemu spremljanja, ki je bil uveden v državi članici in o načinu vključevanja bolnikov.
Information about clinical findings (i.e., hepatic enzyme increases and steatosis) in subjects treated with Lojuxta during the developmental phase;
Podatki o kliničnih ugotovitvah (tj. povišanih ravneh jetrnih encimov in steatozi) pri preskušancih, zdravljenih z zdravilom Lojuxta med razvojno fazo;
Information about contraindication in patients with moderate or severe pre-existing hepatic impairment/disease, including those with unexplained persistent abnormal liver function tests;
Podatki o kontraindikacijah pri bolnikih z zmerno ali hudo potrjeno jetrno okvaro/boleznijo, vključno z bolniki z nepojasnjenimi stalno nenormalnimi rezultati preiskav jetrnega delovanja;
Information about dose counting scheme included in the labelling and the educational material for the multi-dose nasal spray
Informacije o shemi štetja odmerkov, ki so vključene v označevanje in izobraževalna gradiva za večodmerno pršilo za nos.
Information about drug interactions with ONIVYDE is referenced from the published scientific literature for nonliposomal irinotecan.
Podatki o medsebojnem delovanju zdravila ONIVYDE z drugimi zdravili izhajajo iz objavljene znanstvene literature za neliposomski irinotekan.