FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/09/603/001 1 film-coated tablet EU/1/09/603/002 4 film-coated tablets EU/1/09/603/003 8 film-coated tablets EU/1/09/603/004 12 film-coated tablets EU/1/09/603/013 2 film-coated tablets
Croatian: EU/1/09/603/001 1 filmom obložena tableta EU/1/09/603/002 4 filmom obložene tablete EU/1/09/603/003 8 filmom obloženih tableta EU/1/09/603/004 12 filmom obloženih tableta EU/1/09/603/013 2 filmom obložene tablete
English: Throat tightness, Nasal oedema, Nasal dryness
Croatian: Stezanje u grlu, nazalni edem, suhoća nosne sluznice
English: The mean AUC and Cmax of the N-desmethyl metabolite increased up to 126% and up to 73% respectively,
Croatian: Srednja AUC i Cmax N-dezmetil metabolita porasla je do 126% odnosno do 73%, u usporedbi s dobrovoljcima odgovarajućim po dobi, bez oštećenja bubrega.
English: 1 film-coated tablet 2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 12 film-coated tablets 24 film-coated tablets 48 film-coated tablets
Croatian: 1 filmom obložena tableta 2 filmom obložene tablete 4 filmom obložene tablete 8 filmom obloženih tableta 12 filmom obloženih tableta 24 filmom obloženih tableta 48 filmom obloženih tableta
English: What Sildenafil ratiopharm is
Croatian: Što je Sildenafil ratiopharm
English: Marketing Authorisation Holder ratiopharm GmbH Graf-Arco-Straße 3
Croatian: Nositelj odobrenja za stavljanje lijeka u promet ratiopharm GmbH
English: Sildenafil ratiopharm 25 mg film-coated tablets White to off-white, oblong film-coated tablet with edge.
Croatian: Sildenafil ratiopharm 25 mg filmom obložene tablete Bijela do skoro bijela, duguljasta filmom obložena tableta s rubom.
English: NAME OF THE MEDICINAL PRODUCT Sildenafil ratiopharm 25 mg film-coated tablets Sildenafil ratiopharm 50 mg film-coated tablets Sildenafil ratiopharm 100 mg film-coated tablets
Croatian: Sildenafil ratiopharm 25 mg filmom obložene tablete Sildenafil ratiopharm 50 mg filmom obložene tablete Sildenafil ratiopharm 100 mg filmom obložene tablete
English: Pharmacotherapeutic group: Urologicals; Drugs used in erectile dysfunction, ATC code: G04BE03
Croatian: Farmakoterapijska skupina: urološki preparati; lijekovi koji se primjenjuju kod erektilne disfunkcije.
English: - if you suffer from any of the following disorders, please tell your doctor who will check carefully whether this medicine is suitable for you: if you currently have a stomach ulcer; if you have a blood-clotting disorder (e.g. haemophilia).
Croatian: - ako patite od nekog od sljedećih poremećaja, o tome obavijestite svojeg liječnika koji će pažljivo provjeriti odgovara li Vam ovaj lijek:
English: No relevant adverse effects were found in reproduction studies in rats and rabbits following oral administration of sildenafil.
Croatian: Nakon peroralne primjene sildenafila u ispitivanjima reprodukcije u štakora i kunića nisu opažene značajne nuspojave.
English: resulted in a 49.8% increase in bosentan AUC and a 42% increase in bosentan Cmax (125 mg b.i.d.
Croatian: U zdravih muških dobrovoljaca, sildenafil je u stanju dinamičke ravnoteže (80 mg tri puta dnevno) rezultirao sa 49,8%-tnim povećanjem AUC bosentana i 42%-tnim povećanjem Cmax bosentana (125 mg dva puta dnevno).
English: 1 film-coated tablet 2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 12 film-coated tablets 24 film-coated tablets
Croatian: 1 filmom obložena tableta 2 filmom obložene tablete 4 filmom obložene tablete 8 filmom obloženih tableta 12 filmom obloženih tableta 24 filmom obložen tablete
English: 1 film-coated tablet 2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 12 film-coated tablets
Croatian: 1 filmom obložena tableta 2 filmom obložene tablete 4 filmom obložene tablete 8 filmom obloženih tableta 12 filmom obloženih tableta
English: NAME OF THE MARKETING AUTHORISATION HOLDER ratiopharm
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET ratiopharm
English: INFORMATION IN BRAILLE Sildenafil ratiopharm 100 mg
Croatian: PODACI NA BRAILLEOVOM PISMU Sildenafil ratiopharm 100 mg
English: There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil in healthy volunteers (see section 4.6).
Croatian: Nakon jednokratnih oralnih doza sildenafila od 100 mg u zdravih dobrovoljaca nije bilo učinka na motilitet ili morfologiju spermija (vidjeti dio 4.6).
English: INFORMATION IN BRAILLE Sildenafil ratiopharm 25 mg
Croatian: PODACI NA BRAILLEOVOM PISMU Sildenafil ratiopharm 25 mg
English: How to take Sildenafil ratiopharm
Croatian: Kako uzimati Sildenafil ratiopharm
English: How to store Sildenafil ratiopharm
Croatian: Kako čuvati Sildenafil ratiopharm
English: What Sildenafil ratiopharm is used for
Croatian: Za što se Sildenafil ratiopharm koristi
English: Sildenafil ratiopharm 25 mg film-coated tablets Pack sizes of 1, 2, 4, 8, or 12 film-coated tablets.
Croatian: Sildenafil ratiopharm 25 mg filmom obložene tablete Veličine pakiranja od 1, 2, 4, 8, ili 12 filmom obloženih tableta.
English: Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance, stuffy nose and dizziness.
Croatian: Često (mogu se javiti kod najviše 1 na 10 osoba): mučnina, naleti crvenila u licu, navala vrućine (simptomi uključuju iznenadan osjećaj vrućine u gornjem dijelu tijela), probavne tegobe, obojeni vid, zamagljen vid, poremećaj vida, začepljenost nosa i omaglica.
English: INFORMATION IN BRAILLE Sildenafil ratiopharm 50 mg
Croatian: PODACI NA BRAILLEOVOM PISMU Sildenafil ratiopharm 50 mg
English: Sildenafil ratiopharm 50 mg film-coated tablets Pack sizes of 1, 2, 4, 8, 12 or 24 film-coated tablets.
Croatian: Sildenafil ratiopharm 50 mg filmom obložene tablete Veličine pakiranja od 1, 2, 4, 8, 12 ili 24 filmom obložene tablete.
English: In particular, sildenafil has greater than 4,000-fold selectivity for PDE5 over PDE3, the cAMP-specific phosphodiesterase isoform involved in the control of cardiac contractility.
Croatian: Kod maksimalnih preporučenih doza, prisutna je 80 puta veća selektivnost u usporedbi s PDE1 te preko 700 puta u usporedbi s PDE2, 3, 4, 7, 8, 9, 10 i 11. Posebno, sildenafil ima preko 4000 puta veću selektivnost za PDE5 u usporedbi s PDE3, cAMP-specifičnoj izoformi fosfodiesteraze uključenoj u kontrolu kontraktilnosti srca.
English: Effects of sildenafil on other medicinal products In vitro studies
Croatian: Učinci sildenafila na druge lijekove
English: Sildenafil ratiopharm 100 mg film-coated tablets Each film-coated tablet contains sildenafil citrate equivalent to 100 mg of sildenafil.
Croatian: Sildenafil ratiopharm 100 mg filmom obložene tablete Svaka filmom obložena tableta sadrži sildenafilcitrat, što odgovara 100 mg sildenafila.
English: Sildenafil ratiopharm 25 mg film-coated tablets Each film-coated tablet contains sildenafil citrate equivalent to 25 mg of sildenafil.
Croatian: Sildenafil ratiopharm 25 mg filmom obložene tablete Svaka filmom obložena tableta sadrži sildenafilcitrat, što odgovara 25 mg sildenafila.
English: Flushing, Hot flush
Croatian: Naleti crvenila, navala vrućine
English: Sildenafil ratiopharm 100 mg film-coated tablets
Croatian: Sildenafil ratiopharm 100 mg filmom obložene tablete sildenafil
English: Sildenafil ratiopharm 25 mg film-coated tablets
Croatian: Sildenafil ratiopharm 25 mg filmom obložene tablete sildenafil
English: Sildenafil ratiopharm 50 mg film-coated tablets Each film-coated tablet contains sildenafil citrate equivalent to 50 mg of sildenafil.
Croatian: Sildenafil ratiopharm 50 mg filmom obložene tablete Svaka filmom obložena tableta sadrži sildenafilcitrat, što odgovara 50 mg sildenafila.
English: (≥ 1/10,000 and eye,
Croatian: (≥1/10 000 i mokraćnog sustava
English: Sildenafil ratiopharm are supplied in packs of 1, 2, 4, 8, 12, 24 or 48 film-coated tablets in blisters.
Croatian: Sildenafil ratiopharm je dostupan u pakiranjima od 1, 2, 4, 8, 12, 24 ili 48 filmom obloženih tableta u blisterima
English: Haematuria
Croatian: Doziranje
English: Sildenafil ratiopharm are supplied in packs of 1, 2, 4, 8 or 12 film-coated tablets in blisters.
Croatian: Sildenafil ratiopharm je dostupan u pakiranjima od 1, 2, 4, 8 ili 12 filmom obloženih tableta u blisterima.
English: Deafness
Croatian: Hematurija
English: Sildenafil ratiopharm 50 mg film-coated tablets
Croatian: Sildenafil ratiopharm 50 mg filmom obložene tablete sildenafil
English: The most commonly reported adverse reactions in clinical studies among sildenafil treated patients were headache, flushing, dyspepsia nasal congestion, dizziness, nausea, hot flush, visual disturbance, cyanopsia and vision blurred.
Croatian: dispepsija, nazalna kongestija, omaglica, mučnina, navale vrućine, poremećaji vida, cijanopsija i zamagljen vid.
English: Each film-coated tablet contains sildenafil citrate equivalent to 25 mg of sildenafil.
Croatian: - Svaka filmom obložena tableta sadrži sildenafilcitrat, što odgovara 25 mg sildenafila.
English: - Chest pains - this occurs uncommonly.
Croatian: - Bolovi u prsnom košu - javljaju se manje često.
English: Sildenafil ratiopharm are supplied in packs of 1, 2, 4, 8, 12 or 24 film-coated tablets in blisters.
Croatian: Sildenafil ratiopharm je dostupan u pakiranjima od 1, 2, 4, 8, 12 ili 24 filmom obložene tablete u blisterima.
English: Each film-coated tablet contains sildenafil citrate equivalent to 100 mg of sildenafil.
Croatian: - Svaka filmom obložena tableta sadrži sildenafilcitrat, što odgovara 100 mg sildenafila.
English: Each film-coated tablet contains sildenafil citrate equivalent to 50 mg of sildenafil.
Croatian: - Svaka filmom obložena tableta sadrži sildenafilcitrat, što odgovara 50 mg sildenafila.
English: Halo vision, Eye oedema, Eye swelling, Eye disorder, Conjunctival hyperaemia, Eye irritation, Abnormal sensation in
Croatian: (≥1/10 000 i midrijaza, svjetlosne aureole, edem oka, oticanje oka, poremećaj oka, konjuktivalna hiperemija, iritacija oka, neuobičajena osjetljivost oka, edem vjeđe, diskoloracija bjeloočnice
English: Heart rate increased
Croatian: Ubrzan rad srca
English: Tabulated list of adverse reactions
Croatian: Opći poremećaji i reakcije na mjestu primjene
English: Transient ischaemic attack,
Croatian: Cerebrovaskularni inzult, tranzitorna ishemijska ataka, napadaji,* ponavljanje napadaja,* sinkopa
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Croatian: DODATAK II A. PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains sildenafil citrate equivalent to 100 mg of sildenafil.
Croatian: TVARI Svaka filmom obložena tableta sadrži sildenafilcitrat, što odgovara 100 mg sildenafila.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains sildenafil citrate equivalent to 25 mg of sildenafil.
Croatian: TVARI Svaka filmom obložena tableta sadrži sildenafilcitrat, što odgovara 25 mg sildenafila.
English: Sildenafil ratiopharm with food, drink and alcohol When this medicine is taken with food, it may take a little longer for Sildenafil ratiopharm to work.
Croatian: Sildenafil ratiopharm s hranom, pićem i alkoholom
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains sildenafil citrate equivalent to 50 mg of sildenafil.
Croatian: TVARI Svaka filmom obložena tableta sadrži sildenafilcitrat, što odgovara 50 mg sildenafila.
English: There are also links to other websites about rare diseases and treatments.
Croatian: Tamo se također nalaze poveznice na druge internetske stranice o rijetkim bolestima i liječenjima istih.
English: D-82319 Starnberg Germany
Croatian: D-82319 Starnberg
English: FEV1 should be measured before and after nebulisation.
Croatian: FEV1 je potrebno mjeriti prije i nakon raspršivanja.
English: 4.5 Interaction with other medicinal products and other forms of interaction No interaction studies have been performed.
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Nisu provedena ispitivanja interakcija.
English: The medicine is not intended for use in children under 6 years of age.
Croatian: Lijek nije namijenjen za primjenu u djece mlađe od 6 godina.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može izazvati nuspojave iako se one neće javiti kod svakoga.
English: • blood in your sputum (the substance you cough up);
Croatian: • krv u sputumu (sadržaj koji iskašljavate);
English: If you use more Vantobra than you should
Croatian: Ako primijenite više Vantobre nego što ste trebali
English: • Keep the rest of the medicine refrigerated in the original carton.
Croatian: • Ostatak lijeka čuvajte u hladnjaku u originalnoj kutiji.
English: Stability after opening of the pouch: 4 weeks when stored below 25 °C 6.4 Special precautions for storage
Croatian: Stabilnost nakon otvaranja vrećice: 4 tjedna ako se čuva na temperaturi ispod 25°C 6.4 Posebne mjere pri čuvanju lijeka
English: If the product has been stored at room temperature for longer than 4 weeks, it has to be disposed according to local requirements.
Croatian: U slučaju da je lijek čuvan na sobnoj temperaturi duže od 4 tjedna potrebno ga je zbrinuti u skladu s lokalnim propisima.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • Uoči svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja
English: • Lay out all the pieces of your Tolero nebuliser handset on a clean, dry paper or cloth towel.
Croatian: • Položite sve dijelove svog ručnog atomizatora Tolero na čisti, suhi papir ili ručnik.
English: Make sure the nebuliser handset is on a flat, stable surface.
Croatian: Osigurajte da je ručni atomizator na ravnoj, stabilnoj površini.
English: The contents of a single-dose ampoule should be used immediately after opening (see section 6.6).
Croatian: Sadržaj jednodozne ampule mora se upotrijebiti odmah nakon otvaranja (vidjeti dio 6.6)
English: If you inhale too much Vantobra you may get a very hoarse voice.
Croatian: Ako inhalirate previše Vantobre glas Vam može postati jako hrapav.
English: Hold the nebuliser handset horizontally and breath normally through your mouth.
Croatian: Držite ručni atomizator u vodoravnom položaju i normalno dišite kroz usta.
English: Distribution Less than 10% of tobramycin is bound to plasma proteins.
Croatian: Manje od 10 % tobramicina veže se na proteine plazme.
English: Outer carton contains:
Croatian: Vanjsko pakiranje sadrži:
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within 12 months following authorisation.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet će prvo periodičko izvješće o neškodljivosti za ovaj lijek dostaviti unutar 12 mjeseci nakon dobivanja odobrenja.
English: If you don't have a refrigerator available (such as when you are transporting your medicine) you can store the carton with the medicine (pouches opened or unopened) below 25°C for up to 4 weeks.
Croatian: Ako nemate dostupan hladnjak (u slučaju da prenosite Vaš lijek) kutiju s lijekom (vrećice, otvorene ili zatvorene) možete čuvati na temperaturi ispod 25°C najduže 4 tjedna.
English: Sputum concentrations were higher and more variable with Cmax of 1,951 + 2,187 µg/g.
Croatian: Koncentracije u sputumu su bile još veće i promjenjivije s Cmax 1,951 + 2,187 µg/g.
English: See also information on clinical benefit and tolerability in sections 4.4, 4.8 and
Croatian: Pogledajte informacije o kliničkoj koristi i podnošljivosti u dijelovima 4.4., 4.8. i 5.1.
English: However, aminoglycosides can cause foetal harm (e.g., congenital deafness and nephrotoxicity) when high systemic concentrations are achieved in a pregnant woman.
Croatian: Međutim, aminoglikozidi mogu uzrokovati oštećenje ploda (npr. kongenitalnu gluhoću i nefrotoksičnost) kad se u trudnice postigne visoka sustavna koncentracija lijeka.
English: • Inhale by mouth the full content of one ampoule in the morning, and one ampoule in the evening using
Croatian: • Inhalirajte na usta ukupni sadržaj jedne ampule ujutro i jedne ampule navečer koristeći ručni
English: When you inhale Vantobra, the antibiotic can enter directly into your lungs to fight the bacteria causing the infection.
Croatian: Kada inhalirate Vantobru, antibiotik može ući izravno u Vaša pluća kako bi se borio protiv bakterija koje uzrokuju infekciju.
English: Any unused medicinal product or waste material should be disposed off in accordance with local
Croatian: Neiskorišteni lijek ili otpadni materijal valja zbrinuti sukladno lokalnim propisima.
English: Non-clinical data reveal that the main hazard for humans, based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction and development, consists of renal toxicity and ototoxicity.
Croatian: Neklinički podaci ukazuju da glavnu opasnost za ljude, na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenosti, reproduktivne i razvojne toksičnosti, predstavljaju bubrežna toksičnost i ototoksičnost.
English: As a result of study 12012.101, lung function improvement FEV1% predicted relative to baseline increased by 8.2 ± 9.4% under Vantobra and by 4.8 ± 9.6% under the reference therapy in the first treatment cycle showing non-inferior (p=0.0005) efficacy.
Croatian: Kao rezultat ispitivanja 12012.101, predviđeno poboljšanje plućne funkcije FEV1 % u odnosu na osnovnu vrijednost povećano je za 8,2 ± 9,4 % uslijed uzimanja lijeka Vantobra i za 4,8 ± 9,6 % uslijed referentne terapije u prvom ciklusu liječenja pokazujući neinferiornost djelotvornosti (p = 0,0005).
English: In addition, the corresponding frequency category is provided using the following convention: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare
Croatian: Uz to, za svaku je nuspojavu navedena i odgovarajuća kategorija učestalosti prema sljedećem načelu: vrlo često (≥ 1/10); često (≥ 1/100 do < 1/10); manje često (≥
English: Limited data from one controlled clinical study over one treatment cycle indicate that the improvement in lung function was maintained above baseline during the 28-day off-treatment period.
Croatian: Ograničeni podaci prikupljeni u jednom kontroliranom kliničkom ispitivanju tijekom jednog ciklusa liječenja ukazuju da je poboljšanje plućne funkcije održano iznad početne tijekom 28-dnevnog razdoblja neuzimanja lijeka.
English: Based upon in-vitro data and/or clinical trial experience, the organisms associated with pulmonary infections in CF may be expected to respond to Vantobra therapy as follows:
Croatian: Na temelju in-vitro podataka i/ili iskustava kliničkih ispitivanja, za organizme vezane za plućne infekcije kod CF može se očekivati sljedeći odgovor na terapiju lijekom Vantobra:
English: If clinical deterioration of pulmonary status is evident, additional or alternative anti-pseudomonal therapy should be considered.
Croatian: Ako je uočljivo kliničko pogoršanje stanja pluća, potrebno je razmisliti o dodatnoj ili nekoj drugoj antipseudomonasnoj terapiji.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent
Croatian: Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim nadopunama Plana.
English: Do not use an alternative untested nebuliser system because it may alter the amount of medicine reaching the lungs.
Croatian: Nemojte koristiti neki drugi neprovjereni atomizatorski sustav jer bi moglo doći do promjene količine lijeka koja dolazi do pluća.
English: Do not use the Tolero nebuliser handset for any other medicine.
Croatian: Nemojte koristiti ručni atomizator Tolero ni za koji drugi lijek.
English: When all of the medicine has been delivered, you will hear the “treatment complete” tone.
Croatian: Nakon što je sav lijek isporučen čut ćete
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
Croatian: Zbog nedostatka ispitivanja kompatibilnosti ovaj lijek se ne smije miješati s drugim lijekovima u atomizatoru.
English: Urea and creatinine levels should be reassessed after every 6 complete cycles of Vantobra therapy (180 days of nebulised aminoglycoside therapy).
Croatian: Vrijednosti uree i kreatinina moraju se ponovno provjeriti nakon svakih 6 dovršenih ciklusa terapije lijekom Vantobra (180 dana terapije atomiziranim aminoglikozidom).
English: The first dose of Vantobra should be used under supervision of a physician, after taking a bronchodilator if this is part of the current regimen for the patient.
Croatian: Prva doza lijeka Vantobra mora se dati pod nadzorom liječnika i to nakon uzimanja bronhodilatatora, ako su oni dio trenutnog terapijskog režima u bolesnika.
English: There is no evidence that patients treated with up to 18 months with tobramycin nebuliser solution were at a greater risk for acquiring B. cepacia, S. maltophilia or A. xylosoxidans, than would be expected in untreated patients.
Croatian: Nema dokaza da su bolesnici liječeni atomiziranom otopinom tobramicina do najviše 18 mjeseci bili izloženi većem riziku od zaraze bakterijama B. cepacia, S. maltophilia ili A. xylosoxidans nego što se očekuje u neliječenih bolesnika.
English: • other medicines which may harm your kidneys or hearing:
Croatian: • drugi lijekovi koji mogu naštetiti Vašim bubrezima ili sluhu:
English: If you forget to use Vantobra and there are at least 6 hours to your next dose, use your dose as soon as you can.
Croatian: Ako zaboravite primijeniti Vantobru, a imate najmanje 6 sati vremena prije iduće doze, primijenite lijek što je prije moguće.
English: Systemic exposure following inhalation of Vantobra is very low (see section 5.2).
Croatian: Sustavna izloženost nakon inhalacije lijeka Vantobra vrlo je niska (vidjeti dio 5.2).
English: Do not stop using Vantobra unless your doctor tells you to do so, as your lung infection may not be controlled sufficiently and may become worse.
Croatian: Nemojte prestati primjenjivati Vantobru ako Vam Vaš liječnik nije tako savjetovao, jer Vaša plućna infekcija možda nije dovoljno kontrolirana te se može pogoršati
English: • voice alteration (hoarseness)
Croatian: • promjena glasa (promuklost)
English: In the case of any overdose, the possibility of drug interactions with alterations in the elimination of Vantobra or other medicinal products should be considered.
Croatian: U slučaju bilo kakvog predoziranja, mora se uzeti u obzir mogućnost interakcije lijeka s promjenama u eliminaciji lijeka Vantobra ili drugog lijeka.
English: Ampoules are packed in pouches, one pouch contains 8 ampoules which correspond with 4 days of
Croatian: Ampule su zapakirane u vrećice, s time da jedna vrećica sadrži 8 ampula, što odgovara količini potrebnoj za 4 dana liječenja
English: tacrolimus (used to reduce the activity of immune system).
Croatian: (za smanjenje aktivnosti imunološkog sustava).
English: • Read the Instructions for Use provided with the handset device before use.
Croatian: • Prije uporabe pročitajte Upute za uporabu priložene uz ručni uređaj.
English: What you need to know before you use Vantobra
Croatian: Što morate znati prije nego počnete primjenjivati Vantobru