FrancophonIA/ELRC3.0 huggingface dataset:
English: Antibiotics may be continued during treatment with SOLYMBIC if necessary.
Croatian: Ako je potrebno, primjena antibiotika može se nastaviti i tijekom liječenja lijekom SOLYMBIC.
English: A. Remove the number of SOLYMBIC pre-filled syringes you need from the package.
Croatian: Izvadite onoliko SOLYMBIC napunjenih štrcaljki koliko vam je potrebno iz pakiranja.
English: Among all randomised patients b Among patients with baseline HS-related skin pain assessment ≥ 3, based on Numeric Rating Scale 0 - 10; 0 = no skin pain, 10 = skin pain as bad as you can imagine
Croatian: Među bolesnicima s procijenjenom početnom kožnom boli uzrokovanom gnojnim hidradenitisom ≥ 3 prema brojčanoj ocjenskoj ljestvici od 0 - 10; 0 = bez kožne boli, 10 = nezamislivo jaka kožna bol
English: Concomitant administration of SOLYMBIC with other biologic DMARDS (e.g. anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions (see section
Croatian: Istodobna primjena lijeka SOLYMBIC i drugih bioloških antireumatika koji modificiraju tijek bolesti (npr. anakinra i abatacept) ili drugih antagonista TNF-a se ne preporučuje zbog mogućeg povećanog rizika od razvoja infekcija, uključujući ozbiljne infekcije, i drugih potencijalnih farmakoloških interakcija (vidjeti dio 4.5).
English: SOLYMBIC is administered by subcutaneous injection.
Croatian: SOLYMBIC se primjenjuje supkutanom injekcijom.
English: With the needle cap off, insert the syringe into your skin at 45 to 90 degrees.
Croatian: Uvedite iglu, s koje je uklonjen zatvarač, u kožu pod kutom od 45 do 90 stupnjeva.
English: Both studies demonstrated an early and sustained effect of adalimumab on the treatment failure rate versus placebo (see figure 1).
Croatian: Oba su ispitivanja pokazala rani i održan učinak adalimumaba na stopu neuspjeha liječenja u odnosu na placebo (vidjeti Sliku 1).
English: If you have or develop demyelinating disease such as multiple sclerosis, your doctor will decide if you should receive or continue to receive SOLYMBIC.
Croatian: • Ako bolujete ili obolite od demijelinizirajuće bolesti, poput multiple skleroze, odluku o tome smijete li početi ili nastaviti primati lijek SOLYMBIC donijet će Vaš liječnik.
English: A risk for the development of hepatosplenic T-cell lymphoma in patients treated with SOLYMBIC cannot be excluded (see section 4.8).
Croatian: Rizik od pojave hepatospleničnog T-staničnog limfoma u bolesnika liječenih lijekom SOLYMBIC ne može se isključiti (vidjeti dio 4.8).
English: Glacial acetic acid
Croatian: Ledena acetatna kiselina Saharoza
English: Table 21 Paediatric CD study discontinuation of corticosteroids or immunomodulators and fistula remission
Croatian: Tablica 21 Ispitivanje kod Crohnove bolesti u djece prestanak uzimanja kortikosteroida ili imunomodulatora i remisija fistula
English: Hidradenitis Suppurativa Clinical Response (HiSCR)
Croatian: Klinički odgovor gnojnog hidradenitisa (HiSCR)
English: Table 12 Ps study II (CHAMPION) efficacy results at 16 weeks
Croatian: Tablica 12 Ispitivanje Ps II (CHAMPION) rezultati djelotvornosti nakon 16 tjedana
English: It is important that you tell your baby's doctors and other health care professionals about your SOLYMBIC use during your pregnancy before the baby receives any vaccine (for more information see section on vaccination).
Croatian: Važno je da prije bilo kakvog cijepljenja djeteta obavijestite liječnika svog djeteta i druge zdravstvene radnike o tome da ste u trudnoći primali lijek SOLYMBIC (za više informacija pogledajte dio o cijepljenju).
English: ***, ** Statistically significant at p < 0.001, < 0.01 for all comparisons between adalimumab and placebo at weeks 2, 12 and 24
Croatian: ***, **Statistički značajno uz p < 0,001, p < 0,01 za sve usporedbe adalimumaba s placebom u 2., 12. i 24. tjednu a
English: For adalimumab, limited clinical data on exposed pregnancies are available.
Croatian: Dostupni su ograničeni klinički podaci o izloženosti adalimumabu za vrijeme trudnoće.
English: SOLYMBIC reduces the rate of progression of joint damage as measured by x-ray and improves physical function, when given in combination with methotrexate.
Croatian: SOLYMBIC smanjuje brzinu progresije oštećenja zglobova mjerene radiološki i poboljšava fizičku funkciju kada se uzima u kombinaciji s metotreksatom.
English: SOLYMBIC can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).
Croatian: SOLYMBIC se može primjenjivati istodobno s metotreksatom ili nekim antireumaticima koji mijenjaju tijek bolesti (sulfasalazinom, hidroksiklorokinom, leflunomidom i injekcijskim pripravcima zlata), steroidima ili analgeticima, uključujući i nesteroidne protuupalne lijekove (NSAIL).
English: If adequate response is achieved with an increased dosing frequency, the dose may subsequently be reduced to 40 mg every other week.
Croatian: Ako se s povećanjem učestalosti doziranja postigne zadovoljavajući odgovor, doza se potom može smanjiti na 40 mg svaka dva tjedna.
English: Table 17 Induction of clinical remission and response (percent of patients)
Croatian: Tablica 17 Indukcija kliničke remisije i kliničkog odgovora (postotak bolesnika)
English: Maintenance of remission and response rates are presented in table 18.
Croatian: Održavanje remisije i stope kliničkog odgovora nalaze se u Tablici 18.
English: Some of those patients were also treated with azathioprine or 6-mercaptopurine.
Croatian: Neki od tih bolesnika su također uzimali i azatioprin ili 6-merkaptopurin.
English: Not known Hepatosplenic T-cell lymphoma Merkel cell carcinoma (neuroendocrine carcinoma of the skin)
Croatian: rijetko leukemija nepoznato hepatosplenični T-stanični limfom karcinom Merkelovih stanica (neuroendokrini karcinom kože)
English: The benefits and risks of continued weekly therapy should be carefully reconsidered in a patient with an inadequate response after the increase in dosing frequency (see section 5.1).
Croatian: Potrebno je vrlo pažljivo procijeniti koristi i rizike kontinuiranog liječenja jednom tjedno u bolesnika u kojih nije postignut zadovoljavajući odgovor nakon povećanja učestalosti doziranja (vidjeti dio 5.1).
English: P = 0.083, adalimumab 0.8 mg/kg versus MTX
Croatian: P = 0,083, adalimumab 0,8 mg/kg naspram MTX-a
English: Do not use the 40 mg pre-filled pen if doses other than 40 mg are recommended.
Croatian: • Ne primjenjujte napunjenu brizgalicu od 40 mg ako su preporučene doze različite od 40 mg.
English: SOLYMBIC is injected under the skin (subcutaneous use).
Croatian: SOLYMBIC se ubrizgava pod kožu (supkutana primjena).
English: For patients who develop the signs and symptoms such as fever, malaise, weight loss, sweats, cough, dyspnoea, and/or pulmonary infiltrates or other serious systemic illness with or without concomitant shock an invasive fungal infection should be suspected and administration of SOLYMBIC should be promptly discontinued.
Croatian: Ako se u bolesnika pojave znakovi i simptomi kao što su vrućica, malaksalost, gubitak težine, znojenje, kašalj, dispneja i/ili plućni infiltrati ili druge ozbiljne sistemske bolesti s istodobnim šokom ili bez njega, treba posumnjati na invazivnu gljivičnu infekciju te odmah prekinuti primjenu lijeka
English: In psoriasis studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at week 16 (see tables 11 and 12).
Croatian: U ispitivanjima Psoriasis Study I i II primarni ishod bio je udio bolesnika u kojih je od početka ispitivanja do 16. tjedna postignut odgovor PASI 75 (vidjeti Tablice 11 i 12).
English: a p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test b p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test c p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Croatian: a p-vrijednost dobivena sparenom usporedbom monoterapije metotreksatom i kombinirane terapije adalimumabom i metotreksatom uz primjenu Mann-Whitney U testa b p-vrijednost dobivena sparenom usporedbom monoterapije adalimumabom i kombinirane terapije adalimumabom i metotreksatom uz primjenu Mann-Whitney U testa c p-vrijednost dobivena sparenom usporedbom monoterapije adalimumabom i monoterapije metotreksatom uz primjenu Mann-Whitney U testa
English: Children with enthesitis-related arthritis
Croatian: Djeca s artritisom povezanim s entezitisom
English: SOLYMBIC is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Croatian: SOLYMBIC je indiciran za liječenje umjerene do teške kronične plak psorijaze u odraslih bolesnika koji su kandidati za sistemsko liječenje.
English: Table 18 Maintenance of clinical remission and response (percent of patients)
Croatian: Tablica 18 Održavanje kliničke remisije i kliničkog odgovora (postotak bolesnika)
English: Spondyloarthritis Research Consortium of Canada i n = 84 placebo and adalimumab j n = 82 placebo and n = 85 adalimumab ***, **, * Statistically significant at p < 0.001, < 0.01, and < 0.05, respectively, for all comparisons between adalimumab and placebo
Croatian: i n = 84 za placebo i adalimumab j n = 82 za placebo i n = 85 za adalimumab ***, **, * Statistički značajno kod p < 0,001, p < 0,01 odnosno p < 0,05 za sve usporedbe adalimumaba s placebom
English: Each pack contains 1, 2, 4, or 6 single use SureClick pre-filled pens.
Croatian: Svako pakiranje sadrži 1, 2, 4 ili 6 SureClick napunjenih brizgalica za jednokratnu primjenu.
English: Week 12 results showed statistically significant improvement of the signs and symptoms of active non-radiographic axial spondyloarthritis in patients treated with adalimumab compared to placebo (table 9).
Croatian: Rezultati u 12. tjednu pokazali su značajno poboljšanje znakova i simptoma aktivnog aksijalnog spondiloartritisa bez radiološkog dokaza AS-a u bolesnika koji su liječeni adalimumabom u odnosu na placebo (Tablica 9).
English: SOLYMBIC 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).
Croatian: SOLYMBIC je indiciran za liječenje aktivnog artritisa povezanog s entezitisom u bolesnika u dobi od 6 godina i starijih u kojih nije postignut zadovoljavajući odgovor ili koji ne podnose konvencionalnu terapiju (vidjeti dio 5.1).
English: During treatment with SOLYMBIC, other concomitant therapies (e.g. corticosteroids and/or immunomodulatory agents) should be optimised.
Croatian: Tijekom liječenja lijekom SOLYMBIC potrebno je prilagoditi ostalu istodobno primijenjenu terapiju (npr. kortikosteroide i/ili imunomodulirajuće lijekove).
English: PGA: Clear/minimal a, b a p < 0.001 adalimumab versus placebo b p < 0.001 adalimumab versus methotrexate c p < 0.01 adalimumab versus placebo d p < 0.05 adalimumab versus methotrexate
Croatian: PGA: bez bolesti/minimalno a, b a p < 0,001 adalimumab naspram placeba b p < 0,001 adalimumab naspram metotreksata c p < 0,01 adalimumab naspram placeba d p < 0,05 adalimumab naspram metotreksata
English: Physicians should exercise caution when considering the use of SOLYMBIC in patients with a history of recurring infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.
Croatian: Liječnici trebaju oprezno razmotriti liječenje lijekom SOLYMBIC u bolesnika s ponavljajućim infekcijama u anamnezi ili podležećim stanjima koja pogoduju razvoju infekcija u bolesnika, uključujući istodobnu primjenu imunosupresivnih lijekova.
English: Reactivation of hepatitis B1), Autoimmune hepatitis Not known Liver failure
Croatian: Hepatitis, reaktivacija hepatitisa B autoimuni hepatitis nepoznato zatajenje jetre
English: ● Do not put the needle cap back onto the syringe.
Croatian: Nemojte vraćati zatvarač igle natrag na štrcaljku.
English: Uncommon Neurological infections (including viral meningitis), Opportunistic infections and tuberculosis (including coccidioidomycosis, histoplasmosis and mycobacterium avium complex infection),
Croatian: manje često neurološke infekcije (uključujući virusni meningitis), oportunističke infekcije i tuberkuloza (uključujući kokcidioidomikozu, histoplazmozu i infekciju kompleksom mycobacterium avium),
English: As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check you for signs and symptoms of tuberculosis before starting SOLYMBIC.
Croatian: • Budući da su u bolesnika liječenih adalimumabom prijavljeni slučajevi tuberkuloze, prije nego počnete s liječenjem lijekom SOLYMBIC, liječnik će provjeriti imate li znakove i simptome tuberkuloze.
English: H. Using slow and constant pressure, push the plunger rod all the way down until it stops moving.
Croatian: Potisnite klip polaganim i postojanim pritiskom, sve do kraja dok se klip ne zaustavi.
English: SOLYMBIC is a clear and colourless to slightly yellow solution.
Croatian: SOLYMBIC je bistra i bezbojna do blago žuta otopina.
English: Patients should be tested for HBV infection before initiating treatment with SOLYMBIC.
Croatian: Bolesnike je potrebno prije početka terapije lijekom SOLYMBIC testirati na HBV infekciju.
English: SOLYMBIC contains sodium
Croatian: SOLYMBIC sadrži natrij
English: If you do not respond well enough to these medicines, you will be given SOLYMBIC to reduce the signs and symptoms of your disease.
Croatian: Ako na njih ne odgovorite dovoljno dobro, dobit ćete lijek SOLYMBIC kako bi se smanjili simptomi i znakovi Vaše bolesti.
English: SOLYMBIC dose in milligrams (mg) by height and weight of patients for enthesitis-related arthritis
Croatian: Tablica 1 Doza lijeka SOLYMBIC u miligramima (mg) prema visini i težini bolesnika za artritis povezan s entezitisom
English: 1 p value for standard dose versus low dose comparison Immunosuppressant therapy could only be discontinued at or after week 26 at the investigator's discretion if the subject met the clinical response criterion defined as a closure of all fistulas that were draining at baseline for at least 2 consecutive post-baseline visits
Croatian: Imunosupresivna terapija mogla se obustaviti samo u 26. tjednu ili kasnije, prema slobodnoj procjeni ispitivača ako je ispitanik ispunio kriterije kliničkog odgovora definirano kao zatvaranje svih fistula iz kojih se na početku cijedio sadržaj, održano kroz barem 2 uzastopna posjeta nakon početka liječenja
English: The safety and efficacy of adalimumab in children aged 2-17 years have not yet been established.
Croatian: Sigurnost i djelotvornost adalimumaba u djece u dobi od 2 do 17 godina još nisu ustanovljene.
English: Neurologic evaluation should be performed in patients with non-infectious intermediate uveitis prior to the initiation of SOLYMBIC therapy and regularly during treatment to assess for pre-existing or developing central demyelinating disorders.
Croatian: U bolesnika s neinfektivnim intermedijarnim uveitisom treba provesti neurološku procjenu prije početka liječenja lijekom SOLYMBIC i redovito tijekom liječenja kako bi se utvrdili otprije postojeći ili novorazvijeni demijelinizirajući poremećaji središnjeg živčanog sustava.
English: SOLYMBIC is used to treat enthesitis-related arthritis in children and adolescents aged 6 to 17 years.
Croatian: SOLYMBIC je namijenjen liječenju artritisa povezanog s entezitisom u djece i adolescenata u dobi od 6 do 17 godina.
English: Very common Elevated liver enzymes Uncommon Cholecystitis and cholelithiasis, Hepatic steatosis, Bilirubin increased
Croatian: vrlo često povišeni jetreni enzimi manje često kolecistitis i kolelitijaza, steatoza jetre, povišen bilirubin rijetko
English: SOLYMBIC is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.
Croatian: SOLYMBIC je indiciran za liječenje teške kronične plak psorijaze u djece i adolescenata u dobi od 4 ili više godina u kojih nije postignut zadovoljavajući odgovor ili koji nisu prikladni kandidati za topikalnu terapiju i fototerapije.
English: (up to a maximum of 40 mg) subcutaneously every other week to patients with enthesitis-related arthritis who were 6 to 17 years, the mean trough steady-state (values measured at week 24) serum adalimumab concentrations were 8.8 ± 6.6 µg/mL for adalimumab without concomitant methotrexate and 11.8 ± 4.3 µg/mL with concomitant methotrexate.
Croatian: (do maksimalno 40 mg) supkutano svaki drugi tjedan u bolesnika s artritisom povezanim s entezitisom u dobi od 6 do 17 godina, srednja vrijednost najniže koncentracije adalimumaba u serumu u stanju dinamičke ravnoteže (vrijednosti mjerene u 24. tjednu) bila je 8,8 ± 6,6 µg/ml za adalimumab bez istodobne primjene metotreksata i 11,8 ± 4,3 µg/ml uz istodobnu primjenu metotreksata.
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 adalimumab versus placebo pairwise comparison of proportions ** p < 0.001 for adalimumab versus placebo pairwise comparison of proportions a
Croatian: Klinički odgovor je postignut ako je ostvareno smanjenje Mayo rezultata u odnosu na početne vrijednosti od ≥ 3 boda i ≥ 30%, uz smanjenje podrezultata rektalnog krvarenja [engl. rectal bleeding subscore, RBS] od ≥ 1 ili apsolutni RBS od 0 ili 1; * p < 0,05 za adalimumab naspram placeba, sparena usporedba udjela ** p < 0,001 za adalimumab naspram placeba, sparena usporedba udjela a onih koji su na početku uzimali kortikosteroide
English: However, because human immunoglobulins are excreted in milk, women must not breast-feed for at least five months after the last SOLYMBIC treatment.
Croatian: Budući da se ljudski imunoglobulini izlučuju u majčino mlijeko, ne smije se dojiti najmanje pet mjeseci nakon posljednje doze lijeka SOLYMBIC.
English: Non-infectious uveitis affecting the back of the eye
Croatian: Nezarazni uveitis koji zahvaća stražnji dio oka
English: If you are a breast-feeding mother, you should stop breast-feeding during SOLYMBIC treatment and for at least 5 months after the last SOLYMBIC treatment.
Croatian: Ako ste dojilja, morate prestati dojiti za vrijeme liječenja lijekom SOLYMBIC i barem 5 mjeseci od zadnje doze lijeka SOLYMBIC.
English: Table 4 ACR responses in placebo-controlled trials (percent of patients)
Croatian: Tablica 4 ACR odgovori u ispitivanjima kontroliranim placebom (postotak bolesnika)
English: The recommended dose of SOLYMBIC for patients with enthesitis-related arthritis 6 years of age and older is 24 mg/m² body surface area up to a maximum single dose of 40 mg adalimumab administered every other week via subcutaneous injection.
Croatian: Preporučena doza lijeka SOLYMBIC za bolesnike s artritisom povezanim s entezitisom u dobi od 6 godina i starije je 24 mg/m2 tjelesne površine do maksimalne pojedinačne doze od 40 mg adalimumaba primijenjene svaki drugi tjedan supkutanom injekcijom.
English: Table 10 ACR response in placebo-controlled psoriatic arthritis studies (percent of patients)
Croatian: Tablica 10 ACR odgovor u placebom kontroliranim ispitivanjima kod psorijatičnog artritisa (postotak bolesnika)
English: Thirty-three (18%) of patients were treated concomitantly with disease-modifying anti-rheumatic drugs, and 146 (79%) patients with NSAIDs at baseline.
Croatian: Na početku je 33 bolesnika (18%) istodobno bilo liječeno antireumatskim lijekovima koji modificiraju tijek bolesti, a 146 (79%) NSAIL-ovima.
English: At week 52, 42.9% of patients who received adalimumab/methotrexate combination therapy achieved clinical remission (DAS28 < 2.6) compared to 20.6% of patients receiving methotrexate monotherapy and 23.4% of patients receiving adalimumab monotherapy.
Croatian: Nakon 52 tjedna liječenja, klinička remisija postignuta je u 42,9% bolesnika liječenih kombinacijom adalimumaba i metotreksata (DAS28 < 2,6) u usporedbi s 20,6% bolesnika koji su dobivali monoterapiju metotreksatom, odnosno 23,4% bolesnika koji su dobivali monoterapiju adalimumabom.
English: The 20 mg solution for injection in pre-filled syringe can be used for the 20 mg dose.
Croatian: Otopina za injekciju u napunjenoj štrcaljki od 20 mg se može koristiti za dozu od 20 mg.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČI ODGOVORANI ZA
English: Do not use the 20 mg or 40 mg pre-filled syringe if doses other than 20 mg or 40 mg are recommended.
Croatian: • Ne primjenjujte napunjene štrcaljke od 20 mg ili 40 mg ako su preporučene doze različite od 20 mg ili 40 mg.
English: SOLYMBIC slows down the damage to the cartilage and bone of the joints caused by the disease and to improve physical function.
Croatian: SOLYMBIC usporava oštećenja hrskavičnih i koštanih zglobnih struktura uzrokovana bolešću i da poboljšava fizičku funkciju.
English: Paediatric Crohn's disease patients ≥ 40 kg:
Croatian: Crohnova bolest u djece tjelesne težine ≥ 40 kg:
English: Discontinuation of Immunomodulators
Croatian: Prekinuti imunomodulatori
English: CD study I and CD study II induction of remission and response rates are presented in table 17
Croatian: Indukcija remisije i stopa kliničkog odgovora u ispitivanjima CD I i II nalaze se u Tablici 17.
English: In patients with at least a partial response to adalimumab 40 mg weekly at week 12, the HiSCR rate at week 36 was higher in patients who continued weekly adalimumab than in patients in whom dosing frequency was reduced to every other week, or in whom treatment was withdrawn (see table 16).
Croatian: Među bolesnicima koji su u 12. tjednu ostvarili barem djelomičan odgovor na liječenje adalimumabom u dozi od 40 mg svaki tjedan, stopa HiSCR-a zabilježena u 36. tjednu bila je veća u onih bolesnika koji su nastavili primati adalimumab svaki tjedan nego u bolesnika kojima je učestalost doziranja smanjena na jednom svaki drugi tjedan ili onih kojima je liječenje ukinuto (vidjeti Tablicu 16).
English: SOLYMBIC is contraindicated in moderate to severe heart failure (see section 4.3).
Croatian: Primjena lijeka SOLYMBIC je kontraindiciran u bolesnika s umjerenim do teškim zatajenjem srca (vidjeti dio 4.3).
English: bruise or bleed very easily or look very pale, call your doctor right away.
Croatian: Ako imate povišenu temperaturu koju ne možete smanjiti, modrice ili ako lako krvarite ili izgledate jako blijedo, odmah nazovite liječnika.
English: The recommended SOLYMBIC dose is 0.8 mg per kg body weight (up to a maximum of 40 mg per dose) administered subcutaneously weekly for the first two doses and every other week thereafter.
Croatian: Preporučena doza lijeka SOLYMBIC je 0,8 mg po kg tjelesne težine (do maksimalno 40 mg po dozi), a primjenjuje se supkutano, jednom tjedno za prve dvije doze, a zatim svaki drugi tjedan.
English: Women of childbearing potential are strongly recommended to use adequate contraception to prevent pregnancy and continue its use for at least five months after the last SOLYMBIC treatment.
Croatian: Žene reproduktivne dobi/Kontracepcija u muškaraca i žena Ženama reproduktivne dobi izričito se preporučuje da koriste odgovarajuću kontracepciju kako bi spriječile trudnoću te da je nastave koristiti još najmanje pet mjeseci nakon posljednje doze lijeka SOLYMBIC.
English: It is recommended that paediatric patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating SOLYMBIC therapy.
Croatian: Preporučuje se da se pedijatrijske bolesnike, ako je moguće, cijepi u skladu sa svim važećim smjernicama za cijepljenje prije započinjanja liječenja lijekom SOLYMBIC.