FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended Hyrimoz dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (table 3).
Slovenian: Priporočeni odmerek zdravila Hyrimoz pri bolnikih s psoriazo v plakih, starih od 4 do 17 let, temelji na telesni masi (preglednica 3).
English: If you do not respond well enough to these medicines, you will be given Hyrimoz to reduce the signs and symptoms of your Crohn's disease.
Slovenian: Če se nanje ne boste odzvali dovolj dobro, boste za zmanjšanje znakov in simptomov Crohnove bolezni dobili zdravilo Hyrimoz.
English: In these trials, 11.9 % of patients treated with adalimumab and 8.1 % of placebo and active control-treated patients that had negative baseline anti-nuclear antibody titres reported positive titres at week 24.
Slovenian: prejemnikov adalimumaba in 8,1 % prejemnikov placeba in kontrolne učinkovine, ki so imeli izhodiščno negativne titre teh protiteles.
English: Hyrimoz is supplied in a single-use pre-filled syringe assembled into a triangular-shaped pen (SensoReady) with transparent window and label.
Slovenian: Zdravilo Hyrimoz je na voljo v injekcijski brizgi za enkratno uporabo, v injekcijskem peresniku trikotne oblike (SensoReady), s prozornim okencem in oznako.
English: Hyrimoz is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age.
Slovenian: Zdravilo Hyrimoz se uporablja za zdravljenje hidradenitis suppurativa pri odraslih in mladostnikih,
English: Hyrimoz is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Slovenian: Ankilozirajoči spondilitis (AS) Zdravilo Hyrimoz je indicirano za zdravljenje hudega aktivnega ankilozirajočega spondilitisa pri odraslih, ki se na konvencionalno terapijo ne odzovejo ustrezno.
English: Serious allergic reactions associated with adalimumab were rare during clinical trials.
Slovenian: V kliničnih študijah so bile redke resne alergijske reakcije, povezane z adalimumabom.
English: Hyrimoz 40 mg / 0.8 ml injection adalimumab
Slovenian: Hyrimoz 40 mg / 0,8 ml injekcija adalimumab
English: Patients should be instructed to seek medical advice if signs / symptoms suggestive of a tuberculosis infection (e.g., persistent cough, wasting/weight loss, low grade fever, listlessness) occur during or after therapy with Hyrimoz.
Slovenian: Bolnikom je treba naročiti, naj poiščejo zdravniško pomoč, če med zdravljenjem z zdravilom Hyrimoz ali po njem doživijo znake ali simptome, ki nakazujejo tuberkulozno okužbo (npr. trdovraten kašelj, hujšanje/izgubljanje teže, nekoliko zvišano telesno temperaturo).
English: Hyrimoz is administered by subcutaneous injection.
Slovenian: Zdravilo Hyrimoz se uporablja kot subkutana injekcija.
English: Carriers of HBV who require treatment with Hyrimoz should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Slovenian: Nosilce HBV, ki potrebujejo zdravljenje z zdravilom Hyrimoz, je treba ves čas zdravljenja in več mesecev po koncu zdravljenja natančno spremljati glede znakov in simptomov aktivne okužbe s HBV. O zdravljenju nosilcev HBV s protivirusno terapijo v kombinaciji z antagonistom TNF za preprečitev reaktivacije HBV ni zadostnih podatkov.
English: It is important to tell your doctor if you get symptoms such as fever, wounds, feeling tired or dental problems.
Slovenian: Pomembno je, da zdravniku poveste, če doživite simptome, kot so npr. zvišana telesna temperatura, rane, občutek utrujenosti ali težave z zobmi.
English: Hyrimoz is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.
Slovenian: Uveitis pri pediatričnih bolnikih Zdravilo Hyrimoz je indicirano za zdravljenje kroničnega, neinfekcijskega, anteriornega uveitisa pri bolnikih, ki so starejši od 2 let in se niso ustrezno odzvali na konvencionalno zdravljenje, ga ne prenašajo ali pri katerih konvencionalno zdravljenje ni primerno.
English: Be sure that you read, understand, and follow these Instructions for use before injecting Hyrimoz.
Slovenian: Preden injicirate zdravilo Hyrimoz, morate ta navodila za uporabo prebrati, razumeti in jih upoštevati.
English: • inflammation of the eye lid and eye swelling;
Slovenian: • vnetje očesne veke in otekanje oči;
English: Hyrimoz dose for patients with enthesitis-related arthritis Patient weight
Slovenian: Odmerjanje zdravila Hyrimoz pri bolnikih z artritisom, povezanim z entezitisom
English: EU/1/18/1286/001 1 pre-filled syringe EU/1/18/1286/002 2 pre-filled syringes
Slovenian: EU/1/18/1286/001 1 napolnjena injekcijska brizga EU/1/18/1286/002 2 napolnjeni injekcijski brizgi
English: Hyrimoz is used to treat psoriatic arthritis in adults.
Slovenian: Zdravilo Hyrimoz se uporablja za zdravljenje psoriatičnega artritisa pri odraslih.
English: Polyarticular juvenile idiopathic arthritis from 2 years of age The recommended dose of Hyrimoz for patients with polyarticular juvenile idiopathic arthritis from 2 years of age is based on body weight (table 1).
Slovenian: Priporočeni odmerek zdravila Hyrimoz pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom od 2. leta starosti, temelji na telesni masi (preglednica 1).
English: Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Hyrimoz.
Slovenian: salicilatov, nesteroidnih protivnetnih zdravil ali analgetikov.
English: Talk to your doctor or pharmacist before using Hyrimoz.
Slovenian: Pred začetkom uporabe zdravila Hyrimoz se posvetujte z zdravnikom ali farmacevtom.
English: • In some patients the body may fail to produce enough of the blood cells that fight off infections or help you to stop bleeding.
Slovenian: Zvišana telesna temperatura, podplutbe, krvavitve, bledica • Pri nekaterih bolnikih telo ne ustvari dovolj krvnih celic, ki premagujejo okužbo ali pomagajo pri ustavitvi krvavitve.
English: Hyrimoz dose for paediatric patients with plaque psoriasis Patient weight
Slovenian: Odmerjanje zdravila Hyrimoz pri pediatričnih bolnikih s psoriazo v plakih
English: Each syringe contains 40 mg/0.8 ml of Hyrimoz.
Slovenian: Ena injekcijska brizga vsebuje 40 mg/0,8 ml zdravila Hyrimoz.
English: You should record the date when your pre-filled syringe is first removed from the refrigerator, and the date after which it should be discarded.
Slovenian: Zapisati si morate datum, ko je bila napolnjena injekcijska brizga vzeta iz hladilnika, in datum, po katerem jo je treba zavreči.
English: Hyrimoz contains sodium
Slovenian: Zdravilo Hyrimoz vsebuje natrij
English: Hyrimoz is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and / or an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Slovenian: Zdravilo Hyrimoz je indicirano za zdravljenje zmerno do hudo aktivne Crohnove bolezni pri pediatričnih bolnikih (od 6. leta starosti), ki se ne odzovejo zadovoljivo na konvencionalno zdravljenje, vključno s primarno prehransko terapijo in kortikosteroidom in/ali imunomodulatorjem,
English: Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift away from the nail bed which can be painful.
Slovenian: Luskavica v plakih lahko prizadene tudi nohte, ki postanejo krušljivi,
English: EU/1/18/1286/006 6 pre-filled pens (3 packs of 2)
Slovenian: EU/1/18/1286/006 6 napolnjenih injekcijskih peresnikov (3 pakiranja po 2)
English: Your Hyrimoz single-use pre-filled syringe with needle guard and add-on finger flange
Slovenian: Vaša napolnjena injekcijska brizga zdravila Hyrimoz z varovalnim pokrovčkom in držalom
English: The recommended Hyrimoz dose is 80 mg at week 0 followed by 40 mg every other week starting at week 1 via subcutaneous injection.
Slovenian: Priporočeni odmerek zdravila Hyrimoz je 80 mg v 0. tednu, ki mu sledi 40 mg vsak drugi teden z začetkom v 1. tednu, v obliki subkutane injekcije.
English: Multipack cartons contain 6 (3 packs of 2) pre-filled syringes of Hyrimoz.
Slovenian: Škatle za večkratno pakiranje vsebujejo 6 (3 pakiranja po 2) napolnjenih injekcijskih brizg zdravila Hyrimoz.
English: Hyrimoz 40 mg solution for injection in pre-filled syringe Hyrimoz 40 mg solution for injection in pre-filled pen
Slovenian: Hyrimoz 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Hyrimoz 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: All patients, and in particular patients with a medical history of extensive immunosuppressant therapy or psoriasis patients with a history of PUVA treatment should be examined for the presence of nonmelanoma skin cancer prior to and during treatment with Hyrimoz.
Slovenian: Pred zdravljenjem z zdravilom Hyrimoz in med zdravljenjem z njim je treba za nemelanomskega kožnega raka pregledati vse bolnike, še zlasti pa bolnike z anamnezo intenzivne imunosupresivne terapije in bolnike s psoriazo, ki so kdaj prejemali PUVA.
English: EU/1/18/1286/004 1 pre-filled pen EU/1/18/1286/005 2 pre-filled pens
Slovenian: EU/1/18/1286/004 1 napolnjen injekcijski peresnik EU/1/18/1286/005 2 napolnjena injekcijska peresnika
English: The recommended dose of Hyrimoz for patients with enthesitis-related arthritis from 6 years of age is based on body weight (table 2).
Slovenian: Priporočeni odmerek zdravila Hyrimoz pri bolnikih z artritisom, povezanim z entezitisom, starih 6 let in več, temelji na telesni masi (preglednica 2).
English: Children and adolescents from 6 to 17 years of age weighing 40 kg or more
Slovenian: Otroci in mladostniki, stari od 4 do 17 let, ki tehtajo 30 kg ali več
English: Opportunistic infections, including invasive fungal infections have been observed in patients receiving adalimumab.
Slovenian: Pri bolnikih, ki so dobivali adalimumab, so opažali oportunistične okužbe, vključno z invazivnimi glivičnimi okužbami.
English: Room spinning sensation (vertigo) and vision disturbances may occur after taking Hyrimoz.
Slovenian: Po dajanju zdravila Hyrimoz se lahko pojavita vrtoglavica (občutek vrtenja prostora) in poslabšanje vida.
English: Hyrimoz is used to treat ulcerative colitis in adults.
Slovenian: Zdravilo Hyrimoz se uporablja za zdravljenje ulceroznega kolitisa pri odraslih.
English: In adolescent patients with inadequate response to Hyrimoz 40 mg every other week, an increase in dosage to 40 mg every week or 80 mg every other week may be considered.
Slovenian: Pri mladostnikih z nezadostnim odzivom na zdravilo Hyrimoz 40 mg vsak drugi teden je možno razmisliti o povečanju odmerka na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: Hyrimoz is only available as 40 mg pre-filled syringe and 40 mg pre-filled pen.
Slovenian: Zdravilo Hyrimoz je na voljo samo v 40 mg napolnjeni injekcijski brizgi in 40 mg napolnjenem injekcijskem peresniku.
English: Your doctor may also prescribe an initial dose of 80 mg which may be administered one week prior to the start of the usual dose.
Slovenian: Zdravnik lahko predpiše začetni odmerek 80 mg, ki se ga uporabi en teden pred začetkom zdravljenja z običajnim odmerkom.
English: Discontinuation of Hyrimoz therapy should be considered in patients with confirmed significant haematologic abnormalities.
Slovenian: Pri bolnikih s potrjenimi pomembnimi hematološkimi nepravilnostmi je treba razmisliti o prekinitvi terapije z zdravilom Hyrimoz.
English: Your healthcare provider should show you how to prepare and inject Hyrimoz properly using the prefilled syringe before you use it for the first time.
Slovenian: Preden zdravilo Hyrimoz prvič uporabite, vam mora zdravstveni delavec pokazati, kako ga pravilno pripraviti in injicirati z napolnjeno injekcijsko brizgo.
English: Hyrimoz is used to treat moderate to severe plaque psoriasis in adults.
Slovenian: Zdravilo Hyrimoz se uporablja za zdravljenje zmerne do hude luskavice (psoriaze) v plakih pri odraslih.
English: Beyond 16 weeks, patients with inadequate response to Hyrimoz 40 mg every other week may benefit from an increase in dosage to 40 mg every week or 80 mg every other week.
Slovenian: Od 16. tedna dalje lahko bolnikom z nezadostnim odzivom na zdravilo Hyrimoz 40 mg vsak drugi teden koristi povečanje odmerka na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: Hyrimoz 40 mg / 0.8 ml injection adalimumab SC
Slovenian: Hyrimoz 40 mg / 0,8 ml injekcija adalimumab s.c.
English: In monotherapy, some patients who experience a decrease in their response to Hyrimoz 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week.
Slovenian: Med monoterapijo lahko nekaterim bolnikom, ki se jim zmanjša odziv na zdravilo Hyrimoz 40 mg vsak drugi teden, koristi povečanje odmerka adalimumaba na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: How to store Hyrimoz
Slovenian: Shranjevanje zdravila Hyrimoz
English: Hyrimoz is available as a pre-filled syringe and a pre-filled pen (SensoReady).
Slovenian: Zdravilo Hyrimoz je lahko na voljo v napolnjeni injekcijski brizgi in napolnjenem injekcijskem peresniku (SensoReady).
English: Hyrimoz 40 mg injection adalimumab
Slovenian: Hyrimoz 40 mg injekcija adalimumab s.c.
English: • Hyrimoz pre-filled syringe/s (see Figure A).
Slovenian: • napolnjen(a) injekcijski(a) peresnik(a) (glejte sliko A).
English: The usual dose regimen for Crohn's disease is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg every other week starting two weeks later.
Slovenian: Običajna shema odmerjanja pri Crohnovi bolezni je 80 mg (kot dve 40 mg injekciji v enem dnevu) na začetku, čemur sledi 40 mg vsak drugi teden dva tedna kasneje.
English: The usual Hyrimoz dose for adults with ulcerative colitis is 160 mg initially (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), then 80 mg (as two 40 mg injections) two weeks later, and then 40 mg every other week.
Slovenian: Običajni začetni odmerek zdravila Hyrimoz pri odraslih z ulceroznim kolitisom je 160 mg (kot štiri 40 mg injekcije v enem dnevu ali po dve 40 mg injekciji na dan dva zaporedna dneva), nato 80 mg (kot dve 40 mg injekciji) dva tedna pozneje in nato 40 mg vsaka dva tedna.
English: Hyrimoz is only available as 40 mg pre-filled syringe / pre-filled pen.
Slovenian: Zdravilo Hyrimoz je na voljo samo v 40 mg napolnjeni injekcijski brizgi/napolnjenem injekcijskem peresniku.
English: Hyrimoz is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1).
Slovenian: Zdravilo Hyrimoz je indicirano za zdravljenje aktivnega artritisa, povezanega z entezitisom pri bolnikih, starih 6 let in več, ki so se neustrezno odzvali ali so intolerantni za običajno zdravljenje
English: paleness.
Slovenian: Hyrimoz.
English: Hyrimoz 40 mg solution for injection in pre-filled syringe adalimumab
Slovenian: Hyrimoz 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku adalimumab
English: The recommended Hyrimoz induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) and 80 mg at week 2 (given as two 40 mg injections in one day).
Slovenian: Priporočena shema odmerjanja zdravila Hyrimoz med indukcijo je pri odraslih bolnikih z zmerno do hudo aktivnim ulceroznim kolitisom 160 mg 0. teden (aplicirano kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan dva dni zapored) in 80 mg 2. teden (aplicirano kot dve 40 mg injekciji v enem dnevu).
English: Hyrimoz 40 mg solution for injection in single-use pre-filled SensoReady pen Hyrimoz is supplied in a single-use pre-filled syringe assembled into a triangular-shaped pen with transparent window and label (SensoReady).
Slovenian: Zdravilo Hyrimoz je na voljo v napolnjeni injekcijski brizgi za enkratno uporabo, v peresniku trikotne oblike s prozornim okencem in oznako (peresnik SensoReady®).
English: Some patients who experience decrease in their response to Hyrimoz 40 mg every other week may benefit from an increase in dosage to 40 mg Hyrimoz every week or 80 mg every other week.
Slovenian: Nekaterim bolnikom, ki se jim zmanjša odziv na zdravilo Hyrimoz 40 mg vsak drugi teden, lahko koristi povečanje odmerka zdravila Hyrimoz na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: Your Hyrimoz single-use pre-filled SensoReady pen
Slovenian: Vaš napolnjeni injekcijski peresnik SensoReady zdravila Hyrimoz za enkratno uporabo
English: 6.8 (4.4, 10.5) per 1,000 patient years among 5,291 adalimumab-treated patients versus a rate of 6.3 (3.4, 11.8) per 1,000 patient years among 3,444 control patients (median duration of treatment was 4.0 months for adalimumab and 3.8 months for control-treated patients).
Slovenian: AS, psoriatičnim artritisom, psoriazo, hidradenitis suppurativa, Crohnovo boleznijo, ulceroznim kolitisom in uveitisom so malignome (razen limfoma in nemelanomskega kožnega raka) opažali z deležem (95 % interval zaupanja) 6,8 (4,4; 10,5) na 1000 bolnikov let med 5291 bolniki, ki so dobivali adalimumab, in 6,3 (3,4; 11,8) na 1000 bolnikov let med 3444 kontrolnimi bolniki (pri prvih je zdravljenje z adalimumabom mediano trajalo 4,0 mesece in pri drugih 3,8 meseca).
English: The recommended Hyrimoz dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at Day 15 (given as two 40 mg injections in one day).
Slovenian: Priporočena shema odmerjanja zdravila Hyrimoz pri odraslih bolnikih s hidradenitis suppurativa (HS) je 160 mg na 1. dan (apliciranov obliki štirih 40 mg injiciranj na dan ali z dvema 40 mg injiciranjema na dan dva dni zapored), ki mu sledi 80 mg dva tedna kasneje na 15. dan (apliciranov obliki dveh 40 mg injiciranj v enem dnevu).
English: The recommended dose of Hyrimoz for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose.
Slovenian: Priporočeno odmerjanje zdravila Hyrimoz za odrasle bolnike je začetni odmerek 80 mg subkutano in nato 40 mg subkutano vsak drugi teden, začenši en teden po začetnem odmerku.
English: Hyrimoz 40 mg solution for injection (injection) in pre-filled syringe is supplied as a 0.8 ml clear to slightly opalescent, colourless to slightly yellowish solution.
Slovenian: Zdravilo Hyrimoz 40 mg raztopina za injiciranje (injekcija) v napolnjeni injekcijski brizgi je na voljo kot bistra do rahlo opalescentna, brezbarvna do rahlo rumenkasta raztopina.
English: Hyrimoz is supplied in a single-use clear type I glass syringe with a stainless steel needle with a needle guard with finger flange, rubber needle cap and plastic plunger rod, containing 0.8 ml of solution.
Slovenian: Zdravilo Hyrimoz je na voljo v injekcijski brizgi za enkratno uporabo iz prozornega stekla tipa I z iglo iz nerjavečega jekla s ščitnikom za iglo z držalom, z gumijastim pokrovčkom za iglo in s plastičnim batom, ki vsebuje 0,8 ml raztopine.
English: Hyrimoz can reduce the number of nodules and abscesses you have, and the pain that is often associated with the disease.
Slovenian: Zdravilo Hyrimoz lahko zmanjša število vozličev in ognojkov, ki jih imate.
English: There is no relevant use of Hyrimoz in children aged less than 2 years in this indication.
Slovenian: Uporaba zdravila Hyrimoz pri otrocih, mlajših od 2 let, za to indikacijo ni primerna.
English: Hyrimoz 40 mg solution for injection (injection) in pre-filled pen is supplied as a 0.8 ml clear to slightly opalescent, colourless to slightly yellowish solution.
Slovenian: Zdravilo Hyrimoz 40 mg raztopina za injiciranje (injekcija) v napolnjenem injekcijskem peresniku je na voljo kot bistra do rahlo opalescentna, brezbarvna do rahlo rumenkasta raztopina.
English: Check with your doctor before you receive any vaccines.
Slovenian: Preden opravite kakršnokoli cepljenje, se posvetujte z zdravnikom.
English: Vertigo and visual impairment may occur following administration of Hyrimoz (see section 4.8).
Slovenian: Po dajanju zdravila Hyrimoz se lahko pojavita vrtoglavica in poslabšanje vida (glejte poglavje 4.8).
English: The recommended dose of Hyrimoz for adult patients with uveitis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose.
Slovenian: Priporočeni začetni odmerek zdravila Hyrimoz za odrasle bolnike z uveitisom je 80 mg, čemur sledi 40 mg odmerek vsak drugi teden, ki se ga začne dajati en teden po začetnem odmerku.
English: Hyrimoz is administered via subcutaneous injection.
Slovenian: Zdravilo Hyrimoz se odmerja v obliki subkutane injekcije.
English: Hyrimoz dose for paediatric patients with uveitis Patient weight
Slovenian: Odmerjanje zdravila Hyrimoz pri pediatričnih bolnikih z uveitisom
English: • You might get infections more easily while you are receiving Hyrimoz treatment.
Slovenian: • Med zdravljenjem z zdravilom Hyrimoz se lahko poveča dovzetnost za okužbe.
English: Hyrimoz 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 Hyrimoz uporabljati previdno.
English: Treatment with Hyrimoz must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Slovenian: Pri bolnikih, ki se jim na novo pojavijo simptomi kongestivnega srčnega popuščanja ali se jim takšni simptomi poslabšajo, je treba zdravljenje z zdravilom Hyrimoz prekiniti.
English: During the controlled portions of pivotal adalimumab trials in adults of at least 12 weeks in duration in patients with moderately to severely active rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis, malignancies, other than lymphoma and non-melanoma skin cancer, were observed at a rate (95% confidence interval) of
Slovenian: V kontroliranih delih preskušanj, ki podpirajo vlogo za pridobitev dovoljenja za promet adalimumaba pri odraslih, ki so trajala vsaj 12 tednov, pri bolnikih z zmerno do hudo aktivnim revmatoidnim artritisom, ankilozirajočim spondilitisom, aksialnim spondiloartritisom brez radiografskega dokaza za
English: The recommended dose of Hyrimoz 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 Hyrimoz je začetni odmerek 8 mg (kot dve 40-mg injekciji v enem dnevu), čemur sledi 40 mg vsak drugi teden z začetkom en teden po začetnem odmerku.
English: Hyrimoz is contraindicated in moderate to severe heart failure (see section 4.3).
Slovenian: Pri bolnikih z zmernim ali hudim srčnim popuščanjem je zdravilo Hyrimoz kontraindicirano (glejte poglavje 4.3).
English: • low blood measurements for platelets;
Slovenian: • nizke krvne vrednosti za trombocite;
English: Hyrimoz therapy should not be continued in patients failing to respond within this time period.
Slovenian: Pri bolnikih, ki se v tem času ne odzovejo, zdravljenja z zdravilom Hyrimoz ni priporočljivo nadaljevati.
English: When needed (for example when you are travelling), Hyrimoz 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 zdravilo Hyrimoz hranite pri sobni temperaturi
English: Available data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Slovenian: 40 mg vsak drugi teden Podatki, ki so na voljo, kažejo, da je klinični odziv ponavadi dosežen v 12 tednih zdravljenja.