FrancophonIA/ELRC3.0 huggingface dataset:
English: The effects of repeat dosing of cyclosporine A (100 - 150 mg twice daily) on the steady-state pharmacokinetics of ambrisentan (5 mg once daily), and the effects of repeat dosing of ambrisentan (5 mg once daily) on the steady-state pharmacokinetics of cyclosporine A (100 - 150 mg twice daily) were studied in healthy volunteers.
Croatian: U zdravih dobrovoljaca je ispitivan učinak ponavljajućeg doziranja ciklosporina A (100 - 150 mg dva puta dnevno) na farmakokinetiku ambrisentana (5 mg jednom dnevno) u stanju dinamičke ravnoteže, i učinke ponavljajućeg doziranja ambrisentana (5 mg jednom dnevno) na farmakokinetiku ciklosporina A (100 - 150 mg dva puta dnevno) u stanju dinamičke ravnoteže.
English: Ambrisentan has not been studied in individuals with hepatic impairment (with or without cirrhosis).
Croatian: Primjena ambrisentana nije ispitivana u bolesnika s oštećenjem jetre (sa ili bez ciroze).
English: Women of child-bearing potential
Croatian: Žene reproduktivne dobi
English: The effects of repeat dosing of ketoconazole (400 mg once daily) on the pharmacokinetics of a single dose of 10 mg ambrisentan were investigated in 16 healthy volunteers.
Croatian: Učinak ponavljanih doza ketokonazola (400 mg jednom dnevno) na farmakokinetiku pojedinačne doze od 10 mg ambrisentana, ispitivan je na 16 zdravih dobrovoljaca.
English: If patients have pre-existing fluid overload, this should be managed as clinically appropriate prior to starting ambrisentan.
Croatian: Prethodno volumno preopterećenje potrebno je adekvatno klinički liječiti prije početka terapije ambrisentanom.
English: Adverse reactions identified from 12 week placebo controlled clinical trial data are included below by system organ class and frequency.
Croatian: Nuspojave identificirane u placebom kontroliranim kliničkim ispitivanjima u trajanju od 12 tjedana navedene su prema organskim sustavima i učestalosti u tablici ispod.
English: The development of testicular tubular atrophy in male animals has been linked to the chronic administration of ERAs, including ambrisentan (see section 5.3).
Croatian: U životinja je kronična primjena ERA, uključujući i ambrisentan, povezana s razvojem tubularne atrofije testisa (vidjeti dio 5.3).
English: Ambrisentan did not have any clinically relevant effects on the pharmacokinetics of tadalafil.
Croatian: Ambrisentan nije pokazao klinički značajan učinak na farmakokinetiku tadalafila.
English: The Cmax and AUC(0-∞) were slightly decreased for ethinyl estradiol (8% and 4%, respectively), and slightly increased for norethindrone (13% and 14%, respectively).
Croatian: Uočeno je blago smanjenje Cmax za 8% te AUC(0-∞) za 4% kod etinilestradiola i blago povećanje Cmax za 13% te AUC(0-∞) za 14% kod noretindrona.
English: Ambrisentan did not have any clinically relevant effects on the pharmacokinetics or pharmacodynamics of warfarin.
Croatian: Ambrisentan nije imao klinički značajan učinak na farmakokinetiku i farmakodinamiku varfarina.
English: Ambrisentan Mylan contains the active substance ambrisentan.
Croatian: Ambrisentan Mylan sadrži djelatnu tvar ambrisentan.
English: No specific drug-drug interactions with soluble guanylate cyclase stimulators or prostanoids are anticipated based on the known biotransformation data (see section 5.2).
Croatian: S obzirom na poznate podatke o biotransformaciji, ne očekuju se specifične interakcije sa stimulatorima topljive gvanilat ciklaze ni prostanoidima (vidjeti dio 5.2).
English: Nasal bone hyperplasia of the ethmoid turbinates has been observed in the nasal cavity of rats treated with ambrisentan, at exposure levels 3-fold the clinical AUC.
Croatian: Hiperplazija nosne kosti i etmoida je zamijećena u nosnoj šupljini štakora koji su primali ambrisentan pri izloženosti razinama 3 puta većim od kliničkog AUC.
English: Patients with significant anaemia, fluid retention or rare retinal diseases were excluded according to the investigators' criteria.
Croatian: Sukladno kriterijima ispitivača, u ispitivanje nisu bili uključeni bolesnici sa značajnom anemijom, retencijom tekućine ili rijetkim bolestima mrežnice.
English: The placebo-adjusted improvement in mean 6MWD at week 12 compared to baseline was 30.6 m (95% CI: 2.9 to 58.3; p=0.008) and 59.4 m (95% CI: 29.6 to 89.3; p<0.001) for the 5 mg group, in ARIES-1 and 2 respectively.
Croatian: Placebom prilagođeno poboljšanje srednjeg 6MWD u 12-tom tjednu, u usporedbi s početnim je iznosilo 30,6 m (95% CI: 2,9 do 58,3; p=0,008) u ispitivanju ARIES-1, i 59,4 m (95% CI: 29,6 do 89,3; p<0,001) u ARIES-2, za grupe ispitanika na 5 mg ispitivanog lijeka.
English: There was no evidence of carcinogenic potential in 2 year oral studies in rats and mice.
Croatian: U dvogodišnjim oralnim ispitivanjima na štakorima i miševima nije nađen dokaz kancerogenog potencijala.
English: • That pregnant women must not take Ambrisentan Mylan
Croatian: • da se Ambrisentan Mylan ne smije primjenjivati tijekom trudnoće
English: In addition to the above, except abnormal blood test results for liver function:
Croatian: U kombinaciji s tadalafilom, dodatno uz gore navedene nuspojave (izuzev poremećenih nalaza krvnih pretraga za funkciju jetre):
English: Abnormalities of the lower jaw, tongue, and/or palate were seen at all doses tested.
Croatian: Pri svim testiranim dozama su zabilježene abnormalnosti donje čeljusti, jezika i/ili nepca.
English: Patients WHO FC at baseline was II (31%) and FC III (69%).
Croatian: Bolesnici su na početku ispitivanja imali bolest funkcionalnog razreda II (31%) i III (69%) prema SZO-u.
English: Ambrisentan Mylan 5 mg film-coated tablet (tablet) is a pink round biconvex tablet engraved with ‘M' on one side and ‘AN' on the other side.
Croatian: Kako Ambrisentan Mylan izgleda i sadržaj pakiranja Ambrisentan Mylan 5 mg filmom obložena tableta (tableta) je ružičasta, okrugla, bikonveksna tableta s utisnutom oznakom „M” na jednoj i „AN” na drugoj strani tablete.
English: Ambrisentan Mylan 5 mg film-coated tablets contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'
Croatian: Ambrisentan Mylan 5 mg filmom obložene tablete sadrže manje od 1 mmol natrija (23 mg) po tableti, tj. zanemarive količine natrija.
English: Do not take Ambrisentan Mylan: - if you are allergic to ambrisentan or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Ambrisentan Mylan: - ako ste alergični na ambrisentan ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako ste trudni, ako planirate trudnoću ili ako biste mogli zatrudnjeti jer ne koristite pouzdane metode zaštite od začeća (kontracepciju).
English: No clinically meaningful effects on the pharmacokinetics of ambrisentan or sildenafil were seen during a drug-drug interaction study in healthy volunteers, and the combination was well tolerated.
Croatian: Tijekom ispitivanja interakcija lijekova na zdravim dobrovoljcima nije utvrđen klinički značajan učinak na farmakokinetiku ambrisentana ili sildenafila, a kombinacija je bila dobro podnošena.
English: Ambrisentan Mylan 10 mg film-coated tablets contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'
Croatian: Ambrisentan Mylan 10 mg filmom obložene tablete sadrže manje od 1 mmol natrija (23 mg) po tableti, tj. zanemarive količine natrija.
English: Supportive comparisons of combination therapy group vs. the individual monotherapy groups were also made.
Croatian: Provedene su i potporne usporedbe između skupine koja je primala kombiniranu terapiju i pojedinih skupina liječenih monoterapijom.
English: Inflammation and changes in the nasal cavity epithelium have been seen in rodents after chronic administration at exposures below the therapeutic levels in humans.
Croatian: Tijekom kronične primjene ambrisentana zamijećene su upala i promjene epitela sluznice nosne šupljine u glodavaca, pri izloženosti koje su bile ispod terapijskih razina u ljudi.
English: Teratogenicity is a suspected class effect of ERAs.
Croatian: Teratogenost je pretpostavljeni učinak skupine antagonista endotelinskih receptora.
English: Talk to your doctor, who will decide whether this medicine is suitable for you - if you have scarring of the lungs, of unknown cause (idiopathic pulmonary fibrosis).
Croatian: Vam se na plućima stvaraju ožiljci nepoznatog uzroka (idiopatska plućna fibroza).
English: The effect of 7-day dosing of sildenafil (20 mg three times daily) on the pharmacokinetics of a single dose of ambrisentan, and the effects of 7-day dosing of ambrisentan (10 mg once daily) on the pharmacokinetics of a single dose of sildenafil were investigated in 19 healthy volunteers.
Croatian: Učinak sedmodnevne primjene sildenafila (20 mg triput dnevno) na farmakokinetiku pojedinačne doze ambrisentana, kao i učinak sedmodnevne primjene ambrisentana (10 mg dnevno) na farmakokinetiku sildenafila, ispitivan je na 19 zdravih dobrovoljaca.
English: Ambrisentan is a non-sulphonamide (propanoic acid) ERA.
Croatian: Ambrisentan je nesulfonamidski ERA (derivat propionatne kiseline).
English: Tadalafil monotherapy
Croatian: Monoterapija tadalafilom
English: Hepatobiliary disorders Hepatic injury (see section 4.4)
Croatian: Poremećaji jetre i žuči oštećenje jetre (vidjeti dio 4.4)
English: Initiation of ambrisentan is not recommended for patients with clinically significant anaemia.
Croatian: U bolesnika s klinički značajnom anemijom ne preporučuje se započinjanje liječenja ambrisentanom.
English: Ambrisentan Mylan 5 mg film-coated tablets contain the azo-colouring agent Allura red AC Aluminium Lake (E129), which may cause allergic reactions.
Croatian: Ambrisentan Mylan 5 mg filmom obložene tablete sadrže azo-boju Allura red AC Aluminium Lake (E129), koja može uzrokovati alergijske reakcije.
English: Peripheral oedema, fluid retention and headache (including sinus headache, migraine) were the most common adverse reactions observed with ambrisentan.
Croatian: Najčešće primijećene nuspojave kod primjene ambrisentana bile su periferni edem, retencija tekućine i glavobolja (uključujući sinusnu glavobolju i migrenu).
English: • chest pain or discomfort
Croatian: • bol ili nelagoda u prsnom košu
English: Ambrisentan Mylan 10 mg film-coated tablets contain the azo-colouring agent Allura red AC Aluminium Lake (E129), which may cause allergic reactions.
Croatian: Ambrisentan Mylan 10 mg filmom obložene tablete sadrže azo-boju Allura red AC Aluminium Lake (E129), koja može uzrokovati alergijske reakcije.
English: Swallow the tablet whole, with a glass of water, do not split, crush or chew the tablet.
Croatian: Tablete nemojte lomiti, drobiti ni žvakati.
English: 47% to 92%).
Croatian: 2 godine: 79,7%
English: Warfarin also had no clinically significant effects on the pharmacokinetics of ambrisentan.
Croatian: Također nije utvrđen klinički značajan učinak varfarina na farmakokinetiku ambrisentana.
English: No previously unknown adverse reactions were identified with long-term treatment or for ambrisentan in combination with tadalafil.
Croatian: Pri dugoročnom liječenju i primjeni ambrisentana u kombinaciji s tadalafilom nisu identificirane nikakve prethodno nepoznate nuspojave.
English: A statistically significant increase (3.41 ± 6.96) was observed for the combined dose group in the physical functioning scale of the SF-36 Health Survey compared with placebo (-0.20 ± 8.14, p=0.005).
Croatian: Statistički značajan porast (3,41 ± 6,96) za skupinu s kombiniranim dozama, u ljestvici tjelesne sposobnosti u ‚SF-36
English: • flushing (redness of the skin)
Croatian: • navale crvenila (crvenilo kože)
English: Similarly, co-administration with tadalafil did not affect the pharmacokinetics of ambrisentan (see section 4.5).
Croatian: Slično tome, niti tadalafil nije pokazao klinički značajan učinak na farmakokinetiku ambrisentana (vidjeti dio 4.5).
English: The primary analysis was combination group vs. pooled monotherapy groups.
Croatian: Primarna analiza uspoređivala je podatke iz skupine liječene kombiniranom terapijom s objedinjenim podacima iz skupina liječenih monoterapijom.
English: Secondary endpoints
Croatian: Sekundarne mjere ishoda
English: Ambrisentan Mylan 10 mg film-coated tablets contain lactose.
Croatian: Ambrisentan Mylan 10 mg filmom obložene tablete sadrže laktozu.
English: Patients on ambrisentan therapy should be closely monitored when starting treatment with rifampicin (see sections 4.5 and 5.2).
Croatian: Bolesnike na terapiji ambrisentanom potrebno je pažljivo pratiti na početku terapije rifampicinom (vidjeti dijelove 4.5 i 5.2).
English: Patients on ambrisentan therapy should be closely monitored when starting treatment with rifampicin (see sections 4.4 and 4.5).
Croatian: Bolesnike na terapiji ambrisentanom potrebno je pažljivo pratiti na početku terapije rifampicinom (vidjeti dijelove 4.4 i 4.5).
English: The effects of steady-state ambrisentan (10 mg once daily) on the pharmacokinetics of a single dose of tadalafil, and the effects of steady-state tadalafil (40 mg once daily) on the pharmacokinetics of a single dose of ambrisentan were studied in 23 healthy volunteers.
Croatian: Učinak stanja dinamičke ravnoteže ambrisentana (10 mg jednom dnevno) na farmakokinetiku pojedinačne doze tadalafila, kao i učinak stanja dinamičke ravnoteže tadalafila (40 mg jednom dnevno) na farmakokinetiku pojedinačne doze ambrisentana, ispitivan je na 23 zdrava dobrovoljca.
English: Ambrisentan Mylan 5 mg film-coated tablets contain lactose.
Croatian: Ambrisentan Mylan 5 mg filmom obložene tablete sadrže laktozu.
English: Ambrisentan Mylan tablets contain a colouring agent called Allura red AC Aluminium Lake (E129) which may cause allergic reactions.
Croatian: Ambrisentan Mylan tablete sadrže boju Allura red AC Aluminium Lake (E129), koja može uzrokovati alergijske reakcije.
English: Pack sizes of 30 film-coated tablets and unit dose blisters of 30x1 film-coated tablets Not all pack sizes may be marketed.
Croatian: Pakiranja od 30 filmom obloženih tableta i 30x1 filmom obložena tableta u blisterima djeljivima na jedinične doze.
English: Patients on ambrisentan therapy should be closely monitored when starting treatment with rifampicin (see sections 4.4 and 5.2).
Croatian: Bolesnike na terapiji ambrisentanom potrebno je pažljivo pratiti na početku terapije rifampicinom (vidjeti dijelove 4.4 i 5.2).
English: The effects of steady-state ambrisentan (10 mg once daily) on the pharmacokinetics and pharmacodynamics of a single dose of warfarin (25 mg), as measured by PT and INR, were investigated in 20 healthy volunteers.
Croatian: Ispitivan je učinak stanja dinamičke ravnoteže ambrisentana (10 mg jednom dnevno) na farmakokinetiku i farmakodinamiku pojedinačne doze varfarina (25 mg), mjerenu PV-om i INR-om, na 20 zdravih dobrovoljaca.
English: Ambrisentan Mylan 5 mg film-coated tablets Ambrisentan Mylan 10 mg film-coated tablets ambrisentan
Croatian: Ambrisentan Mylan 5 mg filmom obložene tablete Ambrisentan Mylan 10 mg filmom obložene tablete ambrisentan
English: Talk to your doctor if you have any questions or concerns about this.
Croatian: Ako imate bilo kakvih pitanja ili ste zabrinuti oko toga, razgovarajte sa svojim liječnikom.
English: Ambrisentan monotherapy
Croatian: Monoterapija ambrisentanom
English: Since the main routes of metabolism of ambrisentan are glucuronidation and oxidation with subsequent elimination in the bile, hepatic impairment might be expected to increase exposure (Cmax and AUC) to ambrisentan.
Croatian: Za očekivati je da bi oštećenje jetre moglo povećati izloženost ambrisentanu (Cmax i AUC) jer su glavni putevi metaboliziranja ambrisentana glukuronidacija i oksidacija s naknadnom eliminacijom putem žuči.
English: The main routes of metabolism of ambrisentan are glucuronidation and oxidation with subsequent elimination in the bile and therefore hepatic impairment might be expected to increase exposure (Cmax and AUC) of ambrisentan.
Croatian: Glavni putevi metaboliziranja ambrisentana su glukuronidacija i oksidacija, te poslije eliminacija putem žuči.
English: The effects of acute and repeat dosing of rifampicin (600 mg once daily) on the steady-state pharmacokinetics of ambrisentan (10 mg once daily) were studied in healthy volunteers.
Croatian: Na zdravim dobrovoljcima istraživani su učinci jedne i ponovljenih doza rifampicina (600 mg jednom dnevno) na farmakokinetiku ambrisentana (10 mg jednom dnevno) u stanju dinamičke ravnoteže.
English: CI: -44.8, -20.7
Croatian: % razlike -33,8; 95% CI: -44,8;
English: Each tablet contains 5 mg ambrisentan
Croatian: Jedna tableta sadrži 5 mg ambrisentana
English: → Tell your doctor immediately.
Croatian: Ako primijetite bilo koji od ovih simptoma: → Odmah obavijestite svog liječnika.
English: Cases of pulmonary oedema have been reported with vasodilating medicinal products, such as ERAs, when used in patients with pulmonary veno-occlusive disease.
Croatian: Tijekom primjene vazodilatirajućih lijekova, kao što su antagonisti endotelinskih receptora, kod bolesnika sa plućnom venookluzivnom bolesti zabilježeni su slučajevi plućnog edema.
English: Each tablet contains 10 mg ambrisentan
Croatian: Jedna tableta sadrži 10 mg ambrisentana
English: Patients should be aware of how they might be affected by ambrisentan before driving or using machines.
Croatian: Prije upravljanja vozilom ili rada sa strojevima, bolesnici moraju znati kako ambrisentan može djelovati na njih.
English: Upper respiratory (e.g. nasal, sinus) congestion, sinusitis, nasopharyngitis, rhinitis
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja epistaksa dispneja vrlo često vrlo često kongestija gornjih dišnih putova (npr. nosa, sinusa), sinusitis, nazofaringitis, rinitis nazofaringitis vrlo često vrlo često sinusitis, rinitis kongestija nosa vrlo često vrlo često
English: Each tablet contains 5 mg of ambrisentan.
Croatian: Jedna tableta sadrži 5 mg ambrisentana.
English: Each tablet contains 10 mg of ambrisentan.
Croatian: Jedna tableta sadrži 10 mg ambrisentana.
English: Your doctor may need to adjust your dose of Ambrisentan Mylan if you start taking cyclosporine A (a medicine used after transplant or to treat psoriasis).
Croatian: Ako započinjete terapiju ciklosporinom A (lijek koji se koristi nakon transplantacije organa ili za liječenje psorijaze), liječnik će možda trebati prilagoditi dozu lijeka Ambrisentan Mylan.
English: Ambrisentan Mylan 10 mg film-coated tablets ambrisentan
Croatian: Ambrisentan Mylan 10 mg filmom obložene tablete ambrisentan
English: Cardiac disorders Cardiac failure
Croatian: Srčani poremećaji zatajenje srca palpitacije vrlo često vrlo često
English: Ambrisentan Mylan 5 mg film-coated tablets ambrisentan
Croatian: Ambrisentan Mylan 5 mg filmom obložene tablete ambrisentan
English: However, there was no clinically relevant effect on ambrisentan exposure by day 8, following administration of multiple doses of rifampicin.
Croatian: Međutim, nakon višekratne primjene doza rifampicina nije bilo klinički značajnog utjecaja na izloženost ambrisentanu do dana 8.
English: Ambrisentan Mylan 10 mg film-coated tablets
Croatian: Ambrisentan Mylan 10 mg filmom obložene tablete
English: Ambrisentan Mylan 5 mg film-coated tablets
Croatian: Ambrisentan Mylan 5 mg filmom obložene tablete
English: Monotherapy Pooled
Croatian: Objedinjene monoterapije
English: In the rat, hyperplasia of nasal turbinate bone is a recognised response to nasal inflammation, based on experience with other compounds.
Croatian: Prema dosadašnjim iskustvima s drugim tvarima, promjene kosti nosne školjke su uobičajeni odgovor na upalu nosne sluznice u štakora.
English: Ambrisentan Mylan tablets contain small amounts of a sugar called lactose.
Croatian: Ambrisentan Mylan sadrži laktozu i boju Allura red (E129) Ambrisentan Mylan tablete sadrže male količine šećera koji se zove laktoza.
English: Multiple doses of ambrisentan had no effect on cyclosporine A exposure, and no dose adjustment of cyclosporine A is warranted.
Croatian: Višekratne doze ambrisentana nemaju učinak na izloženost ciklosporinu
English: • constipation
Croatian: • slabost
English: → Don't take two doses at the same time to make up for a forgotten dose Don't stop taking Ambrisentan Mylan without your doctor's advice Ambrisentan Mylan is a treatment that you will need to keep on taking to control your PAH.
Croatian: → Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: Data derived from routine pharmacovigilance surveillance Most of the reported cases of cardiac failure were associated with fluid retention.
Croatian: NP - nije prijavljeno vidjeti dio „Opis odabranih nuspojava” učestalost glavobolja je veća pri primjeni 10 mg ambrisentana. podaci dobiveni tijekom rutinskog farmakovigilancijskog praćenja i učestalost temeljena na iskustvu iz placebom kontroliranog kliničkog ispitivanja. podaci dobiveni tijekom rutinskog farmakovigilancijskog praćenja većina prijavljenih slučajeva zatajenja srca bila je povezana s retencijom tekućine.
English: Syncope
Croatian: NP
English: Uncommon side effects:
Croatian: Manje česte nuspojave:
English: Please read the information under ‘Pregnancy' - if you are breast feeding.
Croatian: „Trudnoća“. - ako dojite.
English: • dizziness
Croatian: • mučninu
English: → Contact your doctor before taking this medicinal product.
Croatian: Razgovarajte sa svojim liječnikom prije nego počnete uzimati Ambrisentan Mylan.
English: Tel: + 386 1 236 31 80
Croatian: Mylan Healthcare d.o.o. Tel: + 386 1 236 31 80
English: Ambrisentan was clastogenic when tested at high concentrations in mammalian cells in vitro.
Croatian: U in vitro ispitivanjima na kulturi stanica sisavaca, visoke doze ambrisentana su se pokazale klastogene.
English: Dyspnoea
Croatian: Ambrisentan
English: Elderly (≥65 years of age)
Croatian: Starija populacija (≥65 godina)
English: The disease can also affect other organs in your body.
Croatian: Bolest također može pogoditi i druge organe u Vašem organizmu.
English: See also section 4, ‘Possible side effects'.
Croatian: Također pogledajte dio 4, „Moguće nuspojave”.
English: • if you have had heart problems,
Croatian: • ako ste imali problema sa srcem,
English: t½ (days)
Croatian: t½ (dani)
English: 10 to 12
Croatian: 10. do 12.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego što dobijete ovaj lijek jer sadrži Vama važne podatke.
English: Your response to the vaccine may be weakened and you may not be fully protected.
Croatian: Vaš odgovor na cjepivo bi mogao biti slabiji te možda nećete biti u potpunosti zaštićeni.
English: Each cycle lasts 28 days and is counted from day 1 of the cycle.
Croatian: Svaki ciklus traje 28 dana i broji se od 1. dana ciklusa.
English: • producing less urine than normal
Croatian: • stvaranje manje mokraće nego što je to uobičajeno
English: Best response is a clinical response that did not improve with 3 additional cycles of treatment.
Croatian: Najbolji odgovor je klinički odgovor koji se nije poboljšao nakon 3 dodatna ciklusa liječenja.
English: You will be checked closely and if you do have any reactions these will be treated.
Croatian: Pažljivo će Vas se promatrati i u slučaju da imate bilo kakve reakcije, one će se liječiti.
English: The safety and efficacy of Arzerra in children aged below 18 years have not been established.
Croatian: Sigurnost i djelotvornost Arzerre u djece mlađe od 18 godina nisu ustanovljene.
English: • high temperature
Croatian: • visoka temperatura
English: This is followed by a four- to five-week gap.
Croatian: Nakon toga slijedi pauza od četiri do pet tjedana.
English: What Arzerra is and what it is used for
Croatian: Što je Arzerra i za što se koristi
English: In rare cases, these reactions may lead to death.
Croatian: U rijetkim slučajevima te reakcije mogu imati smrtni ishod.
English: 101 International Drive Portsmouth, NH 03801-2815 United States
Croatian: 101 International Drive Portsmouth, NH 03801-2815 Sjedinjene Američke Države
English: Ask your doctor for advice if you are planning to become pregnant after this period.
Croatian: Obratite se svom liječniku za savjet ako planirate zatrudnjeti nakon tog razdoblja.