FrancophonIA/ELRC3.0 huggingface dataset:
English: In a combined female mouse fertility and embryo-foetal developmental toxicity study with oral dosages of 10, 20, 40, and 80 mg/kg/day, a prolongation of oestrous cycles and increased time to mating were observed at 20 mg/kg/day and above; despite this, all mice mated and pregnancy rates were unaffected.
Croatian: U kombiniranom ispitivanju plodnosti ženke miša i embriofetalne razvojne toksičnosti pri peroralnim dozama od 10, 20, 40 i 80 mg/kg na dan, produljenje ciklusa estrusa i dulje vrijeme do parenja opaženo je pri dozi od 20 mg/kg na dan i višoj; unatoč tome, svi su se miševi parili i stope skotnosti nisu se promijenile.
English: 30 mg (beige)
Croatian: 30 mg (bež)
English: • hives (urticaria)
Croatian: • koprivnjača (urtikarija)
English: In Study ESTEEM 2, approximately 80.3% of patients re-randomised to apremilast at week 32 had a PASI50 response at week 52.
Croatian: U ispitivanju ESTEEM 2, približno 80,3% bolesnika ponovno randomiziranih na apremilast u 32. tjednu imalo je odgovor PASI-50 u 52. tjednu.
English: 4 film-coated tablets of 20 mg
Croatian: 4 filmom obložene tablete od 20 mg
English: In PALACE 1, PALACE 2 and PALACE 3, improvements in Disease Activity Scale (DAS) 28 C-reactive protein (CRP) and in the proportion of patients achieving a modified PsA response criteria (PsARC) were greater in the apremilast group, compared to placebo at week 16 (nominal p-value p< 0.0004, p-value ≤0.0017, respectively).
Croatian: Disease Activity Scale, DAS) u 28 zglobova na temelju razine C-reaktivnog proteina (CRP) te poboljšanja u udjelu bolesnika koji su postigli odgovor prema modificiranim kriterijima za procjenu odgovora u psorijatičnom artritisu (PsARC) bila su veća u skupini koja je primala apremilast u usporedbi s placebom u 16. tjednu (nominalna p-vrijednost p ≤ 0,0004 odnosno p ≤ 0,0017).
English: Change in Pruritus VASf (mm), mean± SD Change in DLQIg, mean± SD
Croatian: Postotak promjene u BSAe (%) srednja vrijednost ± SD Promjena u pruritusu VASf (mm), srednja vrijednost ± SD
English: The adverse reactions observed in patients treated with apremilast are listed below by system organ class (SOC) and frequency for all adverse reactions.
Croatian: Nuspojave opažene u bolesnika liječenih apremilastom navedene su u nastavku prema klasifikaciji organskih sustava i učestalosti svih nuspojava.
English: Each film-coated tablet contains 171 mg of lactose (as lactose monohydrate).
Croatian: Jedna filmom obložena tableta sadrži 171 mg laktoze (u obliku laktoze hidrata).
English: Each film-coated tablet contains 57 mg of lactose (as lactose monohydrate).
Croatian: Jedna filmom obložena tableta sadrži 57 mg laktoze (u obliku laktoze hidrata).
English: The improvements were generally maintained in subjects who were re-randomised to apremilast at week 32 through week 52 (Table 5).
Croatian: Poboljšanja su se obično održala u ispitanika koji su od 32. do 52. tjedna ponovno randomizirani na apremilast (tablica 5).
English: Summary of adverse reactions in psoriatic arthritis (PsA) and/or psoriasis (PSOR)
Croatian: Tablica 2. Sažeti prikaz nuspojava kod psorijatičnog artritisa (PsA) i/ili psorijaze (PSOR) Klasifikacija organskih sustava
English: Each film-coated tablet contains 114 mg of lactose (as lactose monohydrate).
Croatian: Jedna filmom obložena tableta sadrži 114 mg laktoze (u obliku laktoze hidrata).
English: Otezla is for oral use.
Croatian: Otezla je za peroralnu primjenu.
English: 4.4 Special warnings and precautions for use
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Proljev, mučnina i povraćanje
English: The 30 mg tablets also contain iron oxide yellow (E172) and iron oxide black (E172).
Croatian: Tablete od 30 mg sadrže također žuti željezov oksid (E172) i crni željezov oksid (E172).
English: No dose adjustment is needed in patients with mild and moderate renal impairment.
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim i umjerenim oštećenjem funkcije bubrega.
English: DMARDs N=496
Croatian: DMARD terapija N=496
English: Of the patients with at least a PASI-75 response who were re-randomised to placebo at week 32 during a Randomised Treatment Withdrawal Phase, 11.7% were PASI-75 responders at week 52.
Croatian: Od bolesnika s odgovorom najmanje PASI-75, koji su u fazi obustave randomiziranog liječenja u 32. tjednu ponovno randomizirani na placebo, 11,7% imalo je odgovor PASI-75 u 52. tjednu.
English: Time Point
Croatian: Vremenska točka procjene
English: • Otezla 20 mg film-coated tablets: each film-coated tablet contains 20 mg of apremilast.
Croatian: • Otezla 20 mg filmom obložena tableta: jedna filmom obložena tableta sadrži 20 mg apremilasta.
English: One qualifying psoriatic skin lesion (at least 2 cm in diameter) was also required in PALACE 3.
Croatian: Za uključivanje u ispitivanje PALACE 3, kriterij je bilo i postojanje jedne psorijatične lezije na koži (promjera najmanje 2 cm).
English: Patients who were re-randomised to placebo and who lost PASI-75 response (ESTEEM 1) or lost 50% of the PASI improvement at week 32 compared to baseline (ESTEEM 2) were retreated with apremilast 30 mg twice daily.
Croatian: Bolesnici koji su prema toj ponovnoj randomizaciji primali placebo, a koji su u usporedbi s početnim vrijednostima u 32. tjednu izgubili odgovor PASI-75 (ESTEEM 1) ili su izgubili 50%-tno poboljšanje u rezultatu PASI (ESTEEM 2), vraćeni su na terapiju apremilastom od 30 mg dvaput na dan.
English: The safety and efficacy of apremilast were evaluated in two multicentre, randomised, double-blind, placebocontrolled studies (Studies ESTEEM 1 and ESTEEM 2) which enrolled a total of 1,257 patients with moderate to severe plaque psoriasis who had a body surface area (BSA) involvement of ≥ 10%, Psoriasis Area and Severity Index (PASI) score ≥ 12, static Physician Global Assessment (sPGA) of ≥ 3 (moderate or severe), and who were candidates for phototherapy or systemic therapy.
Croatian: Sigurnost i djelotvornost apremilasta bile su procijenjene u dva multicentrična, randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja (ispitivanja ESTEEM 1 i ESTEEM 2), u koja je bilo uključeno ukupno 1257 bolesnika s umjerenom do teškom plak psorijazom koja je zahvaćala ≥ 10% tjelesne površine (engl.
English: Otezla contains lactose
Croatian: Otezla sadrži laktozu
English: Improved physical function as assessed by the HAQ-DI and the SF36v2PF domain, and the FACIT-fatigue scores were maintained in the open-label extension studies for up to 5 years of treatment.
Croatian: U otvorenim nastavcima ispitivanja, poboljšanje fizičkog funkcioniranja procijenjeno na temelju upitnika HAQ-DI i domene PF upitnika SF-36v2 te rezultata za FACIT-umor održalo se do 5 godina liječenja.
English: • Otezla 30 mg film-coated tablets: each film-coated tablet contains 30 mg of apremilast.
Croatian: • Otezla 30 mg filmom obložena tableta: jedna filmom obložena tableta sadrži 30 mg apremilasta.
English: • Otezla 10 mg film-coated tablets: each film-coated tablet contains 10 mg of apremilast.
Croatian: • Otezla 10 mg filmom obložena tableta: jedna filmom obložena tableta sadrži 10 mg apremilasta.
English: In addition, in Study ESTEEM 1, significant improvement in the Work Limitations Questionnaire (WLQ-25) Index was achieved in patients receiving apremilast compared to placebo.
Croatian: Work Limitations Questionnaire, WLQ-25) postigli su bolesnici koji su primali apremilast u usporedbi s onima koji su primali placebo.
English: The 20 mg tablets also contain iron oxide yellow (E172).
Croatian: Tablete od 20 mg sadrže također žuti željezov oksid (E172).
English: Very Common
Croatian: Često kašalj
English: The dose of apremilast should be reduced to 30 mg once daily in patients with severe renal impairment (creatinine clearance of less than 30 mL per minute estimated by the Cockcroft-Gault equation).
Croatian: U bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina manji od 30 ml u minuti, procijenjeno CockcroftGaultovom jednadžbom), dozu apremilasta treba smanjiti na 30 mg jedanput na dan.
English: Each film-coated tablet contains 20 mg of apremilast.
Croatian: Jedna filmom obložena tableta sadrži 20 mg apremilasta.
English: Treatment with apremilast resulted in significant improvements in the signs and symptoms of PsA, as assessed by the ACR 20 response criteria compared to placebo at weeks 16.
Croatian: Prema kriterijima za odgovor ACR 20, liječenje apremilastom rezultiralo je značajnim poboljšanjima u znakovima i simptomima psorijatičnog artritisa u usporedbi s placebom u 16. tjednu.
English: • The 20 mg film-coated tablet also contains iron oxide yellow (E172).
Croatian: • Filmom obložena tableta od 20 mg sadrži također željezov oksid, žuti (E172).
English: Percent Change in PASI from baseline, mean (%) ± SDa
Croatian: Postotak promjene u rezultatu PASI od početnih vrijednosti, srednja vrijednost (%) ± SDa
English: You may also experience sleeplessness (common), or depressive mood (common).
Croatian: Također možete patiti od nesanice (često) ili depresivnog raspoloženja (često).
English: • The 30 mg film-coated tablet also contains iron oxide yellow (E172) and iron oxide black (E172).
Croatian: • Filmom obložena tableta od 30 mg sadrži također željezov oksid, žuti (E172) i željezov oksid, crni (E172).
English: Each film-coated tablet contains 10 mg of apremilast.
Croatian: Jedna filmom obložena tableta sadrži 10 mg apremilasta.
English: In studies PALACE 1, PALACE 2 and PALACE 3, significant improvements were demonstrated in healthrelated quality of life, as measured by the changes from baseline in the physical functioning (PF) domain of the Short Form Health Survey version 2 (SF-36v2), and in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-fatigue) scores in patients treated with apremilast compared to placebo at weeks 16 and 24.
Croatian: U ispitivanjima PALACE 1, PALACE 2 i PALACE 3, u 16. i 24. tjednu pokazala su se značajna poboljšanja u bolesnika liječenih apremilastom u usporedbi s onima liječenim placebom u kvaliteti života povezanoj sa zdravljem, mjerenoj kao promjena u odnosu na početne vrijednosti u domeni tjelesnog funkcioniranja (PF) u kratkom upitniku o zdravstvenom stanju, 2. verzija (engl.
English: • The treatment initiation pack is a folding wallet containing 27 film-coated tablets: 4 x 10 mg tablets, 4
Croatian: • Pakiranje za početak liječenja je kartonski presavinuti ovitak koji sadrži 27 filmom obloženih tableta:
English: Each film-coated tablet contains 30 mg of apremilast.
Croatian: Jedna filmom obložena tableta sadrži 30 mg apremilasta.
English: a Includes subjects re-randomised to APR 30 twice daily at week 32 with a baseline value and a post-baseline value at the evaluated study week.
Croatian: 52. tjedan a Uključuje bolesnike koji su ponovno randomizirani na APR 30 dvaput na dan u 32. tjednu, s tim da je u ispitivanom tjednu procijenjena vrijednost prije i poslije početka liječenja.
English: NAME OF THE MEDICINAL PRODUCT Otezla 30 mg tablets apremilast
Croatian: NAZIV LIJEKA Otezla 30 mg tablete apremilast
English: You should not use Otezla while breast-feeding.
Croatian: Ne smijete uzimati lijek Otezla u razdoblju dojenja.
English: There was no pharmacokinetic interaction between apremilast and methotrexate in psoriatic arthritis patients.
Croatian: U bolesnika s psorijatičnim artritisom nije bilo farmakokinetičke interakcije između apremilasta i metotreksata.
English: • This is a total daily dose of 60 mg. By the end of day 6 you will have reached this recommended dose.
Croatian: Vi ćete tu preporučenu dozu dosegnuti do kraja 6. dana.
English: The safety of apremilast was not evaluated in PsA or PSOR patients with moderate or severe renal impairment in the clinical studies.
Croatian: U kliničkim ispitivanjima sigurnost primjene apremilasta nije procijenjena u bolesnika s psorijatičnim artritisom ili psorijazom i umjerenim ili teškim oštećenjem funkcije bubrega.
English: Otezla 10 mg film-coated tablets
Croatian: Otezla 10 mg filmom obložene tablete
English: Otezla 20 mg film-coated tablets
Croatian: Otezla 20 mg filmom obložene tablete
English: Bronchitis
Croatian: FARMACEUTSKI
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 30 mg of apremilast.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 30 mg apremilasta.
English: Otezla 30 mg film-coated tablets
Croatian: Otezla 30 mg filmom obložene tablete
English: Diarrhoea* Nausea*
Croatian: Vrlo često proljev* mučnina*
English: The Otezla 10 mg film-coated tablet is a pink, diamond shaped film-coated tablet with “APR” engraved on one side and “10” on the opposite side.
Croatian: Otezla 10 mg filmom obložena tableta ružičasta je filmom obložena tableta u obliku romba, s oznakom „APR” utisnutom na jednoj strani i „10” na drugoj strani.
English: DMARDs N=168
Croatian: DMARD terapija N=168
English: Patients with hepatic impairment The safety of apremilast was not evaluated in PsA or PSOR patients with hepatic impairment.
Croatian: Sigurnost primjene apremilasta nije procijenjena u bolesnika s psorijatičnim artritisom ili psorijazom i oštećenjem funkcije jetre.
English: croscarmellose sodium and magnesium stearate.
Croatian: Jezgra tablete celuloza, mikrokristalična laktoza hidrat karmelozanatrij, umrežena magnezijev stearat
English: DMARDs N=169
Croatian: DMARD terapija N=169
English: DMARDs N=167
Croatian: DMARD terapija N=167
English: Hypersensitivity
Croatian: Manje često preosjetljivost
English: The Otezla 20 mg film-coated tablet is a brown, diamond shaped film-coated tablet with “APR” engraved on one side and “20” on the opposite side.
Croatian: Otezla 20 mg filmom obložena tableta smeđa je filmom obložena tableta u obliku romba, s oznakom „APR” utisnutom na jednoj strani i „20” na drugoj strani.
English: NAME OF THE MEDICINAL PRODUCT Otezla 10 mg tablets
Croatian: NAZIV LIJEKA Otezla 10 mg tablete Otezla 20 mg tablete
English: Gastrointestinal haemorrhage
Croatian: Manje često gastrointestinalno krvarenje
English: The Otezla 30 mg film-coated tablet is a beige, diamond shaped film-coated tablet with “APR” engraved on one side and “30” on the opposite side.
Croatian: Otezla 30 mg filmom obložena tableta bež je filmom obložena tableta u obliku romba, s oznakom „APR” utisnutom na jednoj strani i „30” na drugoj strani.
English: Pink, diamond shaped 10 mg film-coated tablet of 8 mm length with “APR” engraved on one side and “10” on the opposite side.
Croatian: Ružičasta, filmom obložena tableta od 10 mg u obliku romba, duljine 8 mm, s utisnutom oznakom „APR” na jednoj strani te „10” na drugoj strani.
English: For pre-clinical fertility data, see section 5.3.
Croatian: Za podatke o plodnosti u nekliničkim ispitivanjima vidjeti dio 5.3. 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima
English: Fatigue
Croatian: Nuspojava
English: DMARDs N=162
Croatian: DMARD terapija N=162
English: In
Croatian: A.
English: Brown, diamond shaped 20 mg film-coated tablet of 10 mm length with “APR” engraved on one side and “20” on the opposite side.
Croatian: Smeđa, filmom obložena tableta od 20 mg u obliku romba, duljine 10 mm, s utisnutom oznakom „APR” na jednoj strani te „20” na drugoj strani.
English: Beige, diamond shaped 30 mg film-coated tablet of 12 mm length with “APR” engraved on one side and “30” on the opposite side.
Croatian: Bež, filmom obložena tableta od 30 mg u obliku romba, duljine 12 mm, s utisnutom oznakom „APR” na jednoj strani te „30” na drugoj strani.
English: 168 film-coated tablets
Croatian: OBLIK I SADRŽAJ Filmom obložena tableta 56 filmom obloženih tableta 168 filmom obloženih tableta
English: The pharmacokinetics of apremilast and its major metabolite M12 are not affected by moderate or severe hepatic impairment.
Croatian: M12 ne utječe umjereno ili teško oštećenje funkcije jetre.
English: Cyclic AMP also modulates levels of anti-inflammatory cytokines such as IL-10.These pro- and anti-inflammatory mediators have been implicated in psoriatic arthritis and psoriasis.
Croatian: Ti proupalni i protuupalni medijatori uključeni su u psorijatični artritis i psorijazu.
English: What Otezla is
Croatian: Što je Otezla
English: Among patients who were initially randomised to apremilast 30 mg twice daily treatment, ACR 20/50/70 response rates were maintained through week 52 in the pooled studies PALACE 1, PALACE 2 and PALACE 3 (Figure 1).
Croatian: U objedinjenim ispitivanjima PALACE 1, PALACE 2 i PALACE 3, među bolesnicima koji su na početku ispitivanja randomizirani na terapiju apremilastom od 30 mg dvaput na dan, stope odgovora ACR 20/50/70 održale su se do 52. tjedna (slika 1).
English: The proportion of patients achieving PASI-50, -75 and -90 responses, and sPGA score of clear (0) or almost clear (1), are presented in Table 4 below.
Croatian: Udio bolesnika koji su postigli odgovore PASI-50, -75 i -90 te rezultat sPGA 'bez znakova' (0) ili 'gotovo bez znakova' (1) prikazani su ispod u tablici 4. Liječenje apremilastom rezultiralo je značajnim poboljšanjem umjerene do teške plak psorijaze, kako je pokazao udio bolesnika s odgovorom PASI-75 u 16. tjednu u usporedbi s onima koji su primali placebo.
English: In Studies ESTEEM 1 and ESTEEM 2, significant improvements in scalp psoriasis of at least moderate severity (≥3), measured by the proportion of patients achieving Scalp Psoriasis Physician's Global Assessment (ScPGA) of clear (0) or minimal (1) at week 16, were observed in patients receiving apremilast compared to placebo-treated patients (p< 0.0001 for both studies).
Croatian: Općoj procjeni liječnika (ScPGA) u 16. tjednu postigli rezultat 'bez znakova' (0) ili 'gotovo bez znakova' (1), opažena su u bolesnika koji su primali apremilast u usporedbi s onima koji su primali placebo (p < 0,0001 u oba ispitivanja).
English: • feeling tired
Croatian: • osjećaj umora
English: Do not take Otezla:
Croatian: Nemojte uzimati lijek Otezla:
English: Titanium dioxide (E171)
Croatian: Film-ovojnica poli(vinilni alkohol) titanijev dioksid (E171) makrogol (3350) talk željezov oksid, crveni (E172)
English: How to store Otezla
Croatian: Kako uzimati lijek Otezla
English: Severe renal impairment
Croatian: • česta pražnjenja crijeva
English: In Studies ESTEEM 1 and ESTEEM 2, significant improvements (reductions) in nail psoriasis, as measured by the mean percent change in Nail Psoriasis Severity Index (NAPSI) from baseline, were observed in patients receiving apremilast compared to placebo-treated patients at week 16 (p< 0.0001 and p=0.0052, respectively).
Croatian: U ispitivanjima ESTEEM 1 i ESTEEM 2, u bolesnika koji su primali apremilast u usporedbi s onima koji su primali placebo ustanovljena su u 16. tjednu značajna poboljšanja (smanjenja) psorijaze noktiju mjerena kao srednja vrijednost postotka promjene pokazatelja stupnja težine psorijaze noktiju (engl.
English: Protect other people
Croatian: Zaštitite druge osobe
English: • if they drink alcohol
Croatian: • ako piju alkohol
English: Such changes may in part be linked to disease control and life style.
Croatian: Takve promjene mogu biti djelomično povezane s kontrolom bolesti i načinom života.
English: Do not take Dovato:
Croatian: Nemojte uzimati Dovato:
English: If possible, show them the Dovato pack.
Croatian: Ako je moguće, pokažite im pakiranje lijeka Dovato.
English: N = Number of subjects in each treatment group
Croatian: N = broj ispitanika u svakoj liječenoj skupini
English: Like all medicines, this medicine can cause side effects, although not everybody gets them, so it is very important to talk to your doctor about any changes in your health.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga, stoga je vrlo važno da sa svojim liječnikom razgovarate o bilo kojoj promjeni svog zdravstvenog stanja.
English: These reactions have often been transitory.
Croatian: Te su nuspojave često bile prolazne.
English: • if their immune systems are very weak
Croatian: • ako im je imunosni sustav jako oslabljen
English: Tell your doctor immediately if you become pregnant or are planning to become pregnant.
Croatian: Odmah recite liječniku ako zatrudnite ili planirate trudnoću.
English: →Do not take a double dose to make up for a forgotten dose.
Croatian: →Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: A similar effect was not seen in rats even at very high systemic exposure.
Croatian: Sličan učinak nije primijećen u štakora, čak ni pri izuzetno visokoj razini sistemske izloženosti.
English: If you miss a dose, take it as soon as you remember.
Croatian: Ako propustite uzeti dozu, uzmite je čim se sjetite.
English: See section 4 for more information.
Croatian: Pogledajte dio 4. za više informacija.
English: You need to be aware of the extra risks:
Croatian: Morate biti svjesni da je taj rizik povećan:
English: Reasons
Croatian: Razlozi
English: This medicine is not for use in children under 12 years of age, because it has not been studied in these patients.
Croatian: Ovaj lijek nije namijenjen za primjenu u djece mlađe od 12 godina jer se u tih bolesnika nije ispitivao.
English: Assessed using a non-inferiority margin of 10%.
Croatian: Za ocjenu je korištena granična vrijednost neinferiornosti od 10%.
English: What Dovato is and what it is used for
Croatian: Što je Dovato i za što se koristi
English: What you need to know before you take Dovato
Croatian: Što morate znati prije nego počnete uzimati Dovato
English: The safety and efficacy of a dual regimen has not been studied in pregnancy.
Croatian: Nisu se ispitivale sigurnost i djelotvornost ovog dvojnog režima u trudnica.
English: ATC code: J05AR25
Croatian: ATK oznaka: J05AR25
English: Pharmacokinetic parameters are comparable to those reported in adults.
Croatian: Farmakokinetički parametri slični su onima prijavljenima u odraslih osoba.
English: • if they have been taking combination therapy for a long time
Croatian: • ako dugotrajno uzimaju kombiniranu terapiju
English: Dovato does not cure HIV infection; it keeps the amount of virus in your body at a low level.
Croatian: Dovato ne može izliječiti HIV infekciju; on održava količinu virusa u tijelu na niskoj razini.
English: This helps maintain the number of CD4 cells in your blood.
Croatian: Tako pomaže održati broj CD4 stanica u Vašem tijelu.
English: Your doctor will monitor the effectiveness of your treatment.
Croatian: Vaš će liječnik nadzirati učinkovitost liječenja.
English: • if they are also taking anti-inflammatory medicines called corticosteroids
Croatian: • ako uzimaju i protuupalne lijekove koji se zovu kortikosteroidi
English: The absolute bioavailability of oral lamivudine in adults is approximately 80-85%.
Croatian: Apsolutna bioraspoloživost peroralno primijenjenog lamivudina u odraslih iznosi približno 80 - 85%.
English: If you forget to take Dovato
Croatian: Ako ste zaboravili uzeti Dovato
English: CD4 cells are a type of white blood cells that are important in helping your body to fight infection.
Croatian: CD4 stanice su jedna vrsta bijelih krvnih stanica koje su važne jer pomažu organizmu u borbi protiv infekcija.
English: • weakness beginning in the hands and feet and moving up towards the trunk of the body.
Croatian: • slabost koja počinje u šakama i stopalima i širi se prema trupu
English: → Tell your doctor immediately.
Croatian: Odmah razgovarajte sa svojim liječnikom.
English: Effect of human serum
Croatian: Utjecaj ljudskog seruma
English: • difficulty sleeping (insomnia)
Croatian: • poteškoće sa spavanjem (nesanica)
English: Symptoms may include:
Croatian: Simptomi mogu uključivati:
English: • swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
Croatian: • oticanje, ponekad lica ili usta (angioedem), koje otežava disanje
English: Do not stop taking Dovato without consulting your doctor, as this may harm you and your unborn child.
Croatian: Nemojte prestati uzimati Dovato bez prethodnog savjetovanja s liječnikom jer bi to moglo naškoditi Vama i Vašem nerođenom djetetu.
English: Tell your doctor if you are taking any of the medicines in the following list:
Croatian: Obavijestite svog liječnika ako uzimate neki od lijekova sa sljedećeg popisa:
English: Swallow the tablet with some liquid.
Croatian: Tabletu progutajte s malo tekućine.