FrancophonIA/ELRC3.0 huggingface dataset:
English: Humira should be used with caution in patients with mild heart failure (NYHA class I/II).
Slovenian: Pri bolnikih z blagim srčnim popuščanjem (razred I/II po NYHA) je treba zdravilo Humira uporabljati previdno.
English: Table 18 Response, Remission and Mucosal Healing in Study UC-II (Percent of Patients)
Slovenian: Preglednica 18 Odziv, remisija in celjenje sluznice v študiji UC-II (odstotek bolnikov) Placebo Humira 40 mg vsak drugi teden
English: • ≥ 40 kg: 40 mg every week or 80 mg every other week
Slovenian: 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: The recommended dose of Humira is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg every other week starting one week later.
Slovenian: Priporočeno odmerjanje zdravila Humira je začetni odmerek 80 mg (dve 40 mg injekciji v enem dnevu), čemur sledi 40 mg vsak drugi teden z začetkom en teden po začetnem odmerku.
English: Humira 80 mg solution for injection in pre-filled syringe adalimumab
Slovenian: Humira 80 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku adalimumab
English: Humira 40 mg solution for injection in pre-filled syringe adalimumab
Slovenian: Humira 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku adalimumab
English: Children and adolescents from 2 years of age weighing 10 kg to less than 30 kg
Slovenian: Otroci in mladostniki od 2. leta starosti, ki tehtajo od 10 kg do manj kot 30 kg
English: • Tell your doctor if your child is a carrier of the hepatitis B virus (HBV), if he/she has active HBV or if you think he/she might be at risk of getting HBV.
Slovenian: • Zdravniku morate povedati, če je vaš otrok nosilec virusa hepatitisa B (HBV), če ima aktiven HBV ali če mislite, da bi lahko dobil HBV.
English: Adalimumab significantly delayed the time to treatment failure, as compared to placebo (See Figure 3, P < 0.0001 from log rank test).The median time to treatment failure was 24.1 weeks for subjects treated with placebo, whereas the median time to treatment failure was not estimable for subjects treated with adalimumab because less than one-half of these subjects experienced treatment failure.
Slovenian: Mediani čas do neuspeha zdravljenja je bil 24,1 tedna za bolnike, ki so se zdravili s placebom, medtem ko medianega časa do neuspeha zdravljenja pri bolnikih, ki so bili zdravljeni z adalimumabom, ni bilo mogoče oceniti, ker je bilo zdravljenje neuspešno pri manj kot polovici teh bolnikov.
English: Check the appearance of the Humira solution through the window on the sides of the pre-filled pen.
Slovenian: Skozi okenci ob strani napolnjenega peresnika preglejte raztopino zdravila Humira.
English: • 2 pre-filled syringes with automatic needle guard (0.4 ml sterile solution), each with 1 alcohol pad, in a blister.
Slovenian: • 2 napolnjeni injekcijski brizgi z avtomatskim ščitnikom za iglo (0,4 ml sterilne raztopine), vsaka z 1 alkoholnim zložencem, v pretisnem omotu.
English: 2 pre-filled syringes 2 alcohol pads
Slovenian: 2 napolnjena injekcijska peresnika 2 alkoholna zloženca
English: Table 8 ACR Responses in RA Study V (percent of patients)
Slovenian: Preglednica 8: Odzivi ACR v študiji revmatoidnega artritisa V (odstotek bolnikov)
English: Talk to your child's doctor or pharmacist before using Humira
Slovenian: Pred začetkom uporabe zdravila Humira se posvetujte z otrokovim zdravnikom ali farmacevtom.
English: Table 5 ACR Responses in RA Study V (percent of patients)
Slovenian: Preglednica 5: Odzivi ACR v študiji revmatoidnega artritisa V (odstotek bolnikov)
English: • 3 pre-filled pens (0.8 ml sterile solution), with 4 alcohol pads in a blister.
Slovenian: • 3 napolnjeni injekcijski peresniki (0,8 ml sterilne raztopine) s 4 alkoholnimi zloženci v pretisnem omotu.
English: The recommended dose of Humira for paediatric patients with uveitis from 2 years of age is based on body weight (Table 2).
Slovenian: Uveitis pri pediatričnih bolnikih Priporočeni odmerek zdravila Humira pri pediatričnih bolnikih z uveitisom, starih 2 leti ali več, temelji na telesni masi (preglednica 2).
English: If a faster response is required your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or two 40mg injections per day for two consecutive days), followed by 80 mg (as two 40 mg injections in one day) two weeks later and thereafter as 40 mg every other week.
Slovenian: Če je potreben hitrejši odziv, vam zdravnik lahko predpiše začetni odmerek 160 mg (kot štiri 40 mg injekcije na dan ali kot dve 40 mg injekciji na dan dva dni zapored), ki mu sledi 80 mg (kot dve 40 mg injekciji v enem dnevu) dva tedna kasneje in potem 40 mg vsak drugi teden.
English: First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg every other week starting one week after the first dose.
Slovenian: Prvi odmerek je 80 mg (dve 40 mg injekciji v enem dnevu), čemur sledi 40 mg vsak drugi teden z začetkom en teden po začetnem odmerku.
English: If a faster response is required, the doctor may prescribe a first dose of 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (two 40 mg injections in one day) two weeks later.
Slovenian: Če je potreben hitrejši odziv, vam zdravnik lahko predpiše prvi odmerek 160 mg (štiri 40 mg injekcije v enem dnevu ali dve 40 mg injekciji na dan dva dni zapored), čemur sledi 80 mg (dve 40 mg injekciji v enem dnevu) dva tedna kasneje.
English: • It is very important that you tell your doctor if your child has ever had tuberculosis, or if your child has been in close contact with someone who has had tuberculosis.
Slovenian: • Zelo pomembno je, da zdravniku poveste, če je vaš otrok kadarkoli imel tuberkulozo ali je bil v tesnem stiku s kom, ki jo je imel.
English: • If you receive Humira during your pregnancy, your baby may have a higher risk for getting an infection.
Slovenian: • Če prejemate zdravilo Humira med nosečnostjo, obstaja večje tveganje, da bo vaš dojenček dobil okužbo.
English: Humira may have a minor influence on the ability to drive, cycle or use machines.
Slovenian: Zdravilo Humira ima lahko majhen vpliv na sposobnost vožnje, kolesarjenja ali upravljanja strojev.
English: • pulmonary fibrosis (scarring of the lung);
Slovenian: • pljučna fibroza (zabrazgotinjenje pljuč);
English: Adalimumab significantly delayed the time to treatment failure, as compared to placebo (See Figure 1, P < 0.0001 from log rank test).The median time to treatment failure was 24.1 weeks for subjects treated with placebo, whereas the median time to treatment failure was not estimable for subjects treated with adalimumab because less than one-half of these subjects experienced treatment failure.
Slovenian: Mediani čas do neuspeha zdravljenja je bil 24,1 tedna za bolnike, ki so se zdravili s placebom, medtem ko mediani čas do neuspeha zdravljenja pri bolnikih, ki so bili zdravljeni z adalimumabom, ni bilo mogoče oceniti, ker je bilo zdravljenje neuspešno pri manj kot polovici teh bolnikov.
English: • bruising
Slovenian: • vnetja
English: Depending on your child's response, your child's doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Slovenian: Glede na odziv vašega otroka mu lahko njegov zdravnik odmerek poveča na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: Children, adolescents and adults from 2 years of age weighing 30 kg or more
Slovenian: Otroci, mladostniki in odrasli, od 2. leta starosti, ki tehtajo 30 kg ali več
English: Humira 40 mg solution for injection in pre-filled syringe with automatic needle guard is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.4 ml solution.
Slovenian: Zdravilo Humira 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi z avtomatskim ščitnikom za iglo je na voljo kot sterilna raztopina 40 mg adalimumaba, raztopljenega v 0,4 ml raztopine.
English: • cancer;
Slovenian: • rak;
English: Clinical remission and clinical response (defined as reduction in PCDAI score of at least 15 points from Baseline) rates are presented in Table 26.
Slovenian: Stopnja klinične remisije in kliničnega odziva (definiran kot zmanjšanje vrednosti PCDAI vsaj za 15
English: • certain disease-modifying anti-rheumatic agents (for example, sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations)
Slovenian: • nekaterimi imunomodulirajočimi antirevmatičnimi zdravili (na primer sulfasalazinom,
English: • Paediatric plaque psoriasis
Slovenian: • luskavica (psoriaza) v plakih pri pediatričnih bolnikih
English: If you have an inadequate response, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Slovenian: Če odziv ne bo ustrezen, vam bo zdravnik lahko odmerek povečal na 40 mg vsak teden ali 80 mg vsak drugi teden.
English: Clinical response is decrease from baseline in Mayo score ≥ 3 points and ≥ 30% plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS of 0 or 1; p < 0.05 for Humira vs. placebo pairwise comparison of proportions **p < 0.001 for Humira vs. placebo pairwise comparison of proportions a Of those receiving corticosteroids at baseline
Slovenian: Klinični odgovor pomeni znižanje ocene Mayo od začetka za ≥ 3 in ≥ 30 % ter znižanje podocene rektalne krvavitve [RBS] ≥ 1 ali absolutna RBS 0 ali 1;
English: • dyspepsia (indigestion, bloating, heart burn)
Slovenian: • dispepsija (slaba prebava, napihnjenost, zgaga)
English: • 6 pre-filled syringes with automatic needle guard (0.4 ml sterile solution), each with 1 alcohol pad, in a blister.
Slovenian: • 6 napolnjenih injekcijskih brizg z avtomatskim ščitnikom za iglo (0,4 ml sterilne raztopine), vsaka z 1 alkoholnim zložencem, v pretisnem omotu.
English: The safety and efficacy of Humira were studied in adult patients with chronic plaque psoriasis ( 10% BSA involvement and PASI  12 or  10) who were candidates for systemic therapy or phototherapy in randomised, double-blind studies.
Slovenian: Varnost in učinkovitost zdravila Humira so raziskali v randomiziranih, dvojno slepih študijah pri odraslih bolnikih s kronično psoriazo v plakih (zajete ≥ 10 % telesne površine ter indeksom obsežnosti in izrazitosti psoriaze PASI ≥ 12 ali ≥ 10), ki so bili kandidati za sistemsko zdravljenje ali fototerapijo.
English: Humira is used to treat moderate to severe Crohn's disease in children and adolescents aged 6 to 17 years.
Slovenian: Zdravilo Humira je namenjeno za zdravljenje Crohnove bolezni pri otrocih in mladostnikih, starih 6 do 17 let.
English: • If you have an infection, including long-term or localized infection (for example, leg ulcer) consult your doctor before starting Humira.
Slovenian: • Če imate kakšno okužbo, vključno z dolgotrajno ali omejeno okužbo (npr. razjedo na nogi), se pred uporabo zdravila Humira posvetujte s svojim zdravnikom.
English: Humira is also used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years for whom topical therapy and phototherapies have either not worked very well or are not suitable.
Slovenian: Zdravilo Humira se uporablja tudi za zdravljenje hude luskavice v plakih pri otrocih in mladostnikih, starih od 4 do 17 let, pri katerih lokalno zdravljenje in fototerapija nista dovolj dobro delovala ali pa nista primerna.
English: • The following instructions explain how to give yourself a subcutaneous injection of Humira using the pre-filled syringe.
Slovenian: • Naslednja navodila pojasnjujejo, kako si subkutano injicirate zdravilo Humira z napolnjeno injekcijsko brizgo.
English: PGA: Clear/minimal a, b p < 0.001 Humira vs. placebo p < 0.001 Humira vs. methotrexate p < 0.01 Humira vs. placebo p < 0.05 Humira vs. methotrexate
Slovenian: 79 (73,1) a, b a p < 0,001 zdravilo Humira v primerjavi s placebom b p < 0,001 zdravilo Humira v primerjavi z metotreksatom c p < 0,01 zdravilo Humira v primerjavi s placebom d p < 0,05 zdravilo Humira v primerjavi z metotreksatom
English: Humira 40 mg solution for injection in pre-filled syringe EU/1/03/256/012
Slovenian: Humira 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/03/256/012
English: Therefore, the combination of adalimumab and anakinra is not recommended.
Slovenian: Zato kombinacija adalimumaba in anakinre ni priporočena (glejte poglavje 4.5).
English: Humira has not been studied in these patient populations.
Slovenian: Zdravilo Humira pri teh populacijah bolnikov še ni bilo preskušeno, zato priporočil za odmerjanje ni mogoče dati.
English: Humira is used to treat severe chronic plaque psoriasis in children and adolescents aged 4 to 17 years for whom topical therapy and phototherapies have either not worked very well or are not suitable.
Slovenian: Zdravilo Humira se uporablja za zdravljenje hude kronične luskavice v plakih pri otrocih in mladostnikih, starih od 4 do 17 let, pri katerih lokalno zdravljenje in fototerapija nista dovolj dobro delovala ali pa nista primerna.
English: • 1 pre-filled syringe (0.8 ml sterile solution) with 1 alcohol pad in a blister.
Slovenian: • 1 napolnjena injekcijska brizga (0,8 ml sterilne raztopine) z 1 alkoholnim zložencem v pretisnem omotu.
English: Figure 3: Kaplan-Meier Curves Summarizing Time to Treatment Failure in the Paediatric Uveitis Study
Slovenian: Slika 3: Kaplan-Meier-jeve krivulje povzemajo čas do neuspeha zdravljenja v študiji uveitisa pri pediatričnih bolnikih
English: • arm or leg weakness
Slovenian: • šibkost rok ali nog
English: First dose of 160 mg (two 80 mg injections in one day or one 80 mg injection per day for two consecutive days), followed by 80 mg (one 80 mg injection) two weeks later.
Slovenian: Prvi odmerek je 160 mg (dve 80 mg injekciji v enem dnevu ali ena 80 mg injekcija na dan dva zaporedna dneva), čemur sledi 80 mg (ena 80 mg injekcija) dva tedna kasneje.
English: 3 pre-filled pens 4 alcohol pads
Slovenian: 3 napolnjeni injekcijski peresniki 4 alkoholni zloženci
English: Humira 40 mg solution for injection in pre-filled syringe EU/1/03/256/002
Slovenian: Humira 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/03/256/002
English: • 1 pre-filled syringe (0.4 ml sterile solution) with 1 alcohol pad in a blister.
Slovenian: • 1 napolnjena injekcijska brizga (0,4 ml sterilne raztopine) z 1 alkoholnim zložencem v pretisnem omotu.
English: • Advise your doctor if your child has a history of recurrent infections or other conditions that increase the risk of infections.
Slovenian: • Zdravniku povejte, če je vaš otrok imel v preteklosti ponavljajoče se okužbe ali druge bolezni, ki zvečujejo tveganje za okužbe.
English: Humira is used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years in whom topical therapy and phototherapies have either not worked very well or are not suitable.
Slovenian: Zdravilo Humira se uporablja za zdravljenje hude luskavice v plakih pri otrocih in mladostnikih, starih od 4 do 17 let, pri katerih lokalno zdravljenje in fototerapija nista dovolj dobro delovala ali pa nista primerna.
English: If a faster response is required, your child's doctor may prescribe a first dose of 160 mg, followed by 80 mg two weeks later.
Slovenian: Če je potreben hitrejši odziv, lahko zdravnik vašemu otroku predpiše začetni odmerek 160 mg
English: Elevated liver enzymes
Slovenian: zelo pogosti zvišani jetrni encimi
English: • Advise your doctor if your child resides or travels in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are endemic.
Slovenian: • Zdravniku morate povedati, če vaš otrok živi na območju ali potujete v predele, kjer so endemične glivične okužbe, npr. histoplazmoza, kokcidioidomikoza ali blastomikoza.
English: RA Study III a**
Slovenian: Študija revmatoidnega artritisa Ia**
English: One 0.8 ml pre-filled syringe contains 80 mg adalimumab.
Slovenian: En 0,8 ml napolnjen injekcijski peresnik vsebuje 80 mg adalimumaba.
English: The syringe inside the pen is made from type 1 glass with a plunger stopper (bromobutyl rubber) and a needle with a needle shield (thermoplastic elastomer).
Slovenian: Injekcijska igla znotraj peresnika je narejena iz stekla tipa I z batno zaporko (bromobutilni kavčuk) in igle z varovalnim pokrovčkom (termoplastični elastomer).
English: Hepatosplenic T-cell lymphoma Merkel cell carcinoma (neuroendocrine
Slovenian: hepatosplenični T-celični limfom1)
English: Check the expiry date on the pre-filled pen label (EXP:) Do not use the product if the date has passed the month and year shown.
Slovenian: Preverite datum izteka roka uporabnosti na peresniku (Uporabno do).
English: Children, adolescents and adults from 6 years of age weighing 30 kg or more
Slovenian: Otroci, mladostniki in odrasli od 6. leta starosti, ki tehtajo 30 kg ali več
English: In study UC-I, 390 TNF-antagonist naïve patients were randomised to receive either placebo at Weeks 0 and 2, 160 mg Humira at Week 0 followed by 80 mg at Week 2, or 80 mg Humira at Week 0 followed by 40 mg at Week 2.
Slovenian: V študiji UC-I so 390 bolnikov, ki še niso prejemali antagonista TNF, randomizirali bodisi na placebo 0. in 2. teden, na zdravilo Humira 0. teden in 80 mg 2. teden, ali na 80 mg 0. teden in 40 mg 2. teden.
English: • pulmonary fibrosis (scarring of the lung)
Slovenian: • pljučna fibroza (brazgotinjenje pljuč)
English: If you accidentally inject Humira more frequently than told to by your doctor or pharmacist, call your doctor or pharmacist and tell them that your child has taken more.
Slovenian: Če pomotoma injicirate zdravilo Humira pogosteje, kot vam je naročil zdravnik, se morate posvetovati z zdravnikom ali farmacevtom in jima povedati, da je vaš otrok uporabil večji odmerek.
English: Table 12 Radiographic Mean Changes at Week 52 in RA Study V
Slovenian: Preglednica 12: Povprečne rentgenografske spremembe po 52 tednih študije revmatoidnega artritisa V
English: CD study I and CD study II induction of remission and response rates are presented in Table 20.
Slovenian: Indukcijo remisije in deleže odziva v študiji pri Crohnovi bolezni I in študiji pri Crohnovi bolezni II prikazuje preglednica 20.
English: Table 10 ACR Responses in RA Study V (percent of patients)
Slovenian: Pregledica 10: Odzivi ACR v študiji revmatoidnega artritisa V (odstotek bolnikov)
English: First dose of 160 mg (two 80 mg injections in one day or one 80 mg injection per day for two consecutive days), followed by an 80 mg dose (one 80 mg injection) two weeks later.
Slovenian: Prvi odmerek je 160 mg (dve 80 mg injekciji v enem dnevu ali ena 80 mg injekcija na dan dva zaporedna dneva), čemur sledi 80 mg odmerek (ena 80 mg injekcija) dva tedna kasneje.
English: Humira 80 mg solution for injection in pre-filled syringe Each 0.8 ml single dose pre-filled syringe contains 80 mg of adalimumab.
Slovenian: Humira 80 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena 0,8 ml napolnjena injekcijska brizga z enim odmerkom vsebuje 80 mg adalimumaba.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Slovenian: PODATKI NA ZUNANJI OVOJNINI NOTRANJA ŠKATLA
English: When needed (for example when you are travelling), a single Humira pre-filled syringe may be stored at room temperature (up to 25°C) for a maximum period of 14 days - be sure to protect it from light.
Slovenian: Če je potrebno (na primer kadar potujete), lahko posamezno napolnjeno injekcijsko brizgo zdravila Humira hranite pri sobni temperaturi (do 25 ºC) za največ 14 dni - zagotovite, da bo zaščitena pred svetlobo.
English: In the pivotal controlled trials in adults and children, 12.9% of patients treated with Humira developed injection site reactions (erythema and/or itching, haemorrhage, pain or swelling), compared to 7.2% of patients receiving placebo or active control.
Slovenian: 12,9 % bolnikov, ki so dobivali zdravilo Humira, in 7,2 % bolnikov, ki so dobivali placebo ali kontrolno učinkovino.
English: • Tell your doctor if you have had infections which keep coming back or other conditions that increase the risk of infections.
Slovenian: • Zdravniku povejte, če ste imeli v preteklosti ponavljajoče se okužbe ali druga stanja, ki povečajo tveganje za okužbe.
English: Enrolled patients were either current users of Humira 40 mg/0.8 ml and rated their average injection site pain as at least 3 cm (on a 0-10 cm VAS) or were biologic-naïve subjects who were starting Humira 40 mg/0.8 ml.
Slovenian: Humira 40 mg/0,8 ml in so ocenili njihovo povprečno bolečino na mestu injiciranja kot vsaj 3 cm (na vizualni analogni lestvici od 0 do 10 cm VAS - Visual Analog Scale) ali pa še niso prejemali terapije z biološkimi zdravili in so začeli z zdravljenjem z zdravilom Humira 40 mg/0,8 ml. Bolniki so bili randomizirani tako, da so prejeli enkraten odmerek zdravila Humira 40 mg/0,8 ml ali Humira 40 mg/0,4 ml, ki mu je pri naslednjem odmerku sledila ena injekcija nasprotnega zdravljenja.
English: In patients who develop HBV
Slovenian: Bolniki, ki so že dobivali infliksimab
English: Clinical Response Clinical Remission Mucosal Healing
Slovenian: Klinična remisija Klinični odziv
English: If you accidentally inject Humira more frequently than told to by your doctor or pharmacist, call your doctor or pharmacist and tell them that you have taken more.
Slovenian: Če pomotoma injicirate zdravilo Humira pogosteje, kot vam je naročil zdravnik ali farmacevt, se morate posvetovati z zdravnikom ali farmacevtom in jima povedati, da ste uporabili večji odmerek.
English: Children, adolescents and adults from 6 years of age weighing 40 kg or more
Slovenian: Otroci, mladostniki in odrasli od 6. leta starosti, ki tehtajo 40 kg ali več
English: • Advise your doctor if you reside or travel in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are endemic.
Slovenian: • Zdravniku morate povedati, če živite na območju ali potujete v predele, kjer so endemične glivične okužbe, npr. histoplazmoza, kokcidioidomikoza ali blastomikoza.
English: The syringe or pen must be protected from light, and discarded if not used within the 14-day period.
Slovenian: Brizga ali peresnik morata biti zaščitena pred svetlobo.
English: GI haemorrhage, dyspepsia, gastroesophageal reflux disease, sicca syndrome
Slovenian: navzeja in bruhanje pogosti gastrointestinalna krvavitev, dispepsija, bolezen gastroezofagealnega refluksa Sjögrenov sindrom občasni redki pankreatitis, disfagija, edem obraza intestinalna perforacija1)
English: There is no relevant use of Humira in the paediatric population for the indications of ankylosing spondylitis and psoriatic arthritis.
Slovenian: Psoriatični artritis in aksialni spondiloartritis, vključno z ankiloznim spondilitisom Uporaba zdravila Humira pri pediatrični populaciji za indikaciji ankilozni spodilitis in psoriatični artritis ni primerna.
English: Figure 2: Kaplan-Meier Curves Summarizing Time to Treatment Failure in the Paediatric Uveitis Study
Slovenian: Slika 2: Kaplan-Meier-jeve krivulje povzemajo čas do neuspeha zdravljenja v študiji uveitisa pri pediatričnih bolnikih
English: urinary tract infections (including pyelonephritis),
Slovenian: okužbe reproduktivnega trakta (vključno z vulvovaginalno mikotično okužbo), okužbe urinarnega trakta (vključno s pielonefritisom),
English: First dose of 80 mg (one 80 mg injection), followed by 40 mg two weeks later.
Slovenian: 80 mg (ena 80 mg injekcija) dva tedna kasneje.
English: • neurological infections (including viral meningitis);
Slovenian: • nevrološke okužbe (vključno z virusnim meningitisom); • okužbe oči;
English: Humira 80 mg solution for injection in pre-filled syringe is supplied as a sterile solution of 80 mg adalimumab dissolved in 0.8 ml solution.
Slovenian: Zdravilo Humira 80 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku je na voljo kot sterilna raztopina 80 mg adalimumaba, raztopljenega v 0,8 ml raztopine.
English: Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with Humira versus patients receiving placebo (See Table 22).
Slovenian: Klinični odziv Rezultati iz obeh študij kažejo statistično značilno zmanjšanje tveganja za neuspeh zdravljenja pri bolnikih, ki so prejemali zdravilo Humira, v primerjavi z bolniki, ki so prejemali placebo (glejte preglednico 22).