FrancophonIA/ELRC3.0 huggingface dataset:
English: As generally recommended in such situations, if vomiting occurs less than 30 minutes following administration of AMGLIDIA, a new dose can be given.
Croatian: U takvim se situacijama općenito preporučuje primjena nove doze lijeka AMGLIDIA ako do povraćanja dođe nakon manje od 30 minuta od primjene lijeka AMGLIDIA.
English: Open the bottle by unscrewing the child-resistant closure while pressing downwards.
Croatian: Otvorite bočicu tako što ćete zatvarač siguran za djecu odvrtati uz istovremeno pritiskanje prema dolje.
English: For severe renal impairment see section 4.3.
Croatian: Za teško oštećenje funkcije jetre vidjeti dio 4.3.
English: AMGLIDIA is indicated for the treatment of neonatal diabetes in newborns, infants and children.
Croatian: AMGLIDIA je indicirana za liječenje neonatalnog diabetes mellitusa u novorođenčadi, dojenčadi i djece.
English: If capillary blood glucose is < 7 mmol/L reduce insulin.
Croatian: Ako je glukoza u kapilarnoj krvi < 7 mmol/l potrebno je smanjiti dozu inzulina.
English: Anabolic steroids and male sex hormones (such as testosterone enanthate) (used to treat testosterone deficiency)
Croatian: (kao što je testosteronenantat) (upotrebljava se za liječenje nedostatka testosterona)
English: - if your child is treated with bosentan, e.g. a medicine used to treat problems of blood circulation.
Croatian: - ako Vaše dijete boluje od porfirije (nemogućnost razlaganja molekula porfirina u tijelu). - ako Vaše dijete prima bosentan, npr. lijek koji se koristi za liječenje problema s cirkulacijom krvi. - ako Vaše dijete boluje od teškog poremećaja funkcije bubrega.
English: Severe hypoglycaemic reactions, with coma, convulsions or other neurological disorders are possible and are medical emergencies requiring immediate treatment as soon as the cause is diagnosed or suspected before immediately admitting the patient to hospital.
Croatian: To su hitna stanja koja zahtijevaju liječenje odmah po dijagnosticiranju uzroka ili postavljanju sumnje na njega, i prije samog hitnog primanja bolesnika u bolnicu.
English: Give basal and bolus insulin as usual on Day 1.
Croatian: Na dan 1 primijenite uobičajenu bazalnu i bolusnu inzulinsku terapiju.
English: How to give AMGLIDIA
Croatian: Kako davati lijek AMGLIDIA
English: - The other ingredients are: xanthan gum, hydroxyethylcellulose, lactic acid, purified water sodium citrate and sodium benzoate (E211) (see section 2 “AMGLIDIA contains sodium and benzoate”).
Croatian: natrijev citrat i natrijev benzoat (E211) (vidjeti dio 2. „AMGLIDIA sadrži natrij i benzoat“).
English: Increased blood-glucose levels
Croatian: Povećane razine glukoze u krvi
English: To avoid exceeding sodium benzoate acceptable daily dose, AMGLIDIA daily dose should not exceed 1 mL/kg/day.
Croatian: Kako bi se izbjeglo prekoračenje prihvatljive dnevne doze natrijeva benzoata, dnevna doza lijeka
English: One bottle of 30 ml suspension and one oral syringe of 1 mL packed in an individual bag and one syringe adaptor.
Croatian: Jedna bočica suspenzije od 30 ml i jedna štrcaljka od 1 ml za usta u jednoj vrećici te jedan nastavak za bočicu.
English: Sulfamethoxazole with trimethoprim (Cotrimoxazole)
Croatian: Sulfametoksazol s trimetoprimom (kotrimoksazol)
English: It may be necessary to adjust the dosage of AMGLIDIA in patients suffering from intercurrent infections, trauma, shock or anaesthesia:
Croatian: Možda će trebati prilagoditi dozu lijeka AMGLIDIA u bolesnika koji imaju interkurentnu infekciju,
English: These values were approx. 40% greater than those obtained for the crushed tablet (148.34 ± 46.74 ng/mL).
Croatian: Te su vrijednosti bile približno 40 % veće od onih dobivenih nakon primjene zdrobljene tablete (148,34 ± 46,74 ng/ml).Izloženost je bila slična za obje oralne suspenzije glibenklamida te veća od one primijećene nakon primjene zdrobljenih tableta
English: One bottle of 30 ml suspension and one oral syringe of 5 mL packed in an individual bag and one syringe adaptor.
Croatian: Jedna bočica suspenzije od 30 ml i jedna štrcaljka od 5 ml za usta u jednoj vrećici te jedan nastavak za bočicu.
English: The dose in mL per administration and the number of administrations per day have to carefully follow the medical prescription.
Croatian: Doza u ml po primjeni i broj primjena na dan ne smiju odstupati od propisanog.
English: Both acute and chronic alcohol intake may attenuate the hypoglycaemic effect of glibenclamide or dangerously potentiate it by delaying its metabolic inactivation.
Croatian: Akutni i kronični unos alkohola može umanjiti učinak glibenklamida na snižavanje razine šećera u krvi ili ga opasno pojačati odgađanjem metaboličke deaktivacije.
English: Miconazole used to treat fungal infection Blood sugar levels too low Nicotinic acid (in high doses) used to decrease high levels of cholesterol and triglycerides which are fat-like substances in the blood
Croatian: Nikotinatna kiselina (u velikim dozama) koja se upotrebljava za smanjenje visokih razina kolesterola i triglicerida, koji su masnoće u krvi
English: In those patients, treatment should be started at the lowest dose and dosage levels strictly followed, to avoid hypoglycaemic reactions (see section 4.4).
Croatian: Treba se strogo pridržavati propisanih razina u doziranju radi izbjegavanja hipoglikemijskih reakcija (vidjeti dio 4.4).
English: Ifosfamide
Croatian: Ifosfamid
English: Fibrates
Croatian: Fibrati
English: Insert the adaptor firmly into the bottle while holding the bottle the right way up.
Croatian: Čvrsto umetnite nastavak u bočicu dok je držite u uspravnom položaju.
English: Each mL contains 6 mg glibenclamide.
Croatian: Svaki ml sadrži 6 mg glibenklamida.
English: The educational material is aimed at increasing awareness about the four presentations available (two strengths of the product, each containing either a 1mL or a 5mL syringe) and at minimising the risk of hypoglycaemia in case of mix-ups of the different presentations.
Croatian: (dvije jačine lijeka, pri čemu svaka sadrži štrcaljku od 1 ml ili 5 ml) i na smanjenje opasnosti od hipoglikemije u slučaju zamjene različitih pakiranja.
English: In case of minor vomiting, an antivomiting medicine will be prescribed by your doctor and AMGLIDIA can be continued.
Croatian: Vaš će Vam liječnik propisati lijek protiv povraćanja te možete nastaviti s primjenom lijeka AMGLIDIA.
English: If capillary blood glucose is < 7 mmol/L, do not increase AMGLIDIA and reduce pre-meal insulin boluses by 50%.
Croatian: Ako je glukoza u kapilarnoj krvi <7 mmol/l, nemojte povećavati dozu lijeka AMGLIDIA,
English: H2-receptor antagonists Potentiation or weakening of the bloodglucose lowering effect
Croatian: Antagonisti H2-receptora koji se upotrebljava za smanjenje želučane kiseline
English: Tritoqualine
Croatian: Tritokvalin
English: From Day 2 until the end of the titration phase, if capillary blood glucose is ≥7 mmol/L, increase AMGLIDIA by 0.2 mg/kg/day.
Croatian: Od dana 2 do završetka faze titracije povećavajte dozu lijeka AMGLIDIA za 0,2 mg/kg/dan ako je glukoza u kapilarnoj krvi
English: Diazoxide
Croatian: Diazoksid
English: Each carton contains: - 1 bottle containing 30 mL oral suspension - one 1 mL oral syringe (thin and small) or one 5 mL oral syringe (thick and long) depending on the prescribed dose and the volume to be given.
Croatian: - jednu štrcaljku za usta od 1 ml (tanka i mala) ili jednu štrcaljku za usta od 5 ml (debela i dugačka), ovisno o propisanoj dozi i volumenu koju treba primijeniti.
English: Thyroid hormones (such as L-thyroxin) used for hormonal treatment
Croatian: Hormoni štitnjače (na primjer L-tiroksin)
English: Start AMGLIDIA at a dose of 0.2 mg/kg/day, in two administration.
Croatian: Liječenje lijekom AMGLIDIA počnite dozom od 0,2 mg/kg/dan podijeljenom u dvije primjene.
English: Progestogens
Croatian: Progestogeni
English: This medicinal product is administered orally as a “ready for-use” oral suspension using a graduated oral syringe.
Croatian: Ovaj se lijek primjenjuje peroralno kao gotova oralna suspenzija pomoću graduirane štrcaljke za usta.
English: Each mL contains 0.6 mg glibenclamide.
Croatian: Svaki ml sadrži 0,6 mg glibenklamida.
English: AMGLIDIA 0.6 mg/mL oral suspension AMGLIDIA 6 mg/mL oral suspension
Croatian: AMGLIDIA 0,6 mg/ml oralna suspenzija AMGLIDIA 6 mg/ml oralna suspenzija
English: Adverse reactions (diarrhoea/nausea/reduced appetite/abdominal pain) were reported in 10/81(12%); these were transient, and no patients discontinued sulphonylurea as a result.
Croatian: (proljev, mučnina, smanjeni apetit, bol u trbuhu) zabilježene su u 10 od 81 bolesnika (12 %).
English: The screw cap should be retightened in order to push the adaptor well into the bottle.
Croatian: Navojni zatvarač se treba ponovno zategnuti kako biste nastavak gurnuli duboko u bočicu.
English: Glibenclamide suspension therapy should be initiated by a physician experienced in the treatment of patients with very early onset diabetes.
Croatian: 4.2 Doziranje i način primjene Liječenje suspenzijom glibenklamida treba uvesti liječnik s iskustvom u liječenju bolesnika s vrlo ranim pojavljivanjem dijabetesa.
English: Each syringe is included in a specific presentation.
Croatian: Svaka štrcaljka je priložena u njoj odgovarajuće pakiranje lijeka.
English: Blood-glucose should be monitored periodically throughout treatment with glibenclamide.
Croatian: Tijekom liječenja glibenklamidom treba povremeno provjeravati razinu glukoze u krvi.
English: How to store AMGLIDIA
Croatian: Kako čuvati lijek AMGLIDIA
English: AMGLIDIA 6 mg/mL oral suspension Each mL contains 6 mg glibenclamide.
Croatian: AMGLIDIA 6 mg/ml oralna suspenzija Jedan ml sadrži 6 mg glibenklamida.
English: Symptomatic measures were taken and the medicinal product continued and the situation resolved in the two cases.
Croatian: Poduzete su simptomatske mjere, nastavljena primjena lijeka te su se u oba slučaja poremećaji povukli . U jednog se djeteta pojavila dispepsija povezana s lijekom.
English: Blood sugar levels too low Increased blood sugar levels Incorrect control of plasma sugar
Croatian: Preniske razine šećera u krvi Povišene razine šećera u krvi Nepravilna kontrola šećera u plazmi
English: Phosphamides
Croatian: Fosfamidi
English: Your child's blood sugar levels may become too low (hypoglycaemia) after taking AMGLIDIA.
Croatian: Nakon primjene lijeka AMGLIDIA razina šećera u krvi Vašeg djeteta može biti preniska (hipoglikemija).
English: AMGLIDIA 0.6 mg/mL oral suspension AMGLIDIA 6 mg/mL oral suspension glibenclamide
Croatian: AMGLIDIA 0,6 mg/ml oralna suspenzija AMGLIDIA 6 mg/ml oralna suspenzija glibenklamid
English: AMGLIDIA 0.6 mg/mL oral suspension Each mL contains 0.6 mg glibenclamide.
Croatian: AMGLIDIA 0,6 mg/ml oralna suspenzija Jedan ml sadrži 0,6 mg glibenklamida.
English: This may be done as an outpatient.
Croatian: Stoga se ne smije propisivati za takve bolesnike.
English: This medicine is a ready-for-use oral suspension to be given with a marked oral syringe.
Croatian: Ovaj je lijek gotova suspenzija za oralnu primjenu koja se primjenjuje pomoću označene štrcaljke za usta.
English: Package leaflet: Information for the user AMGLIDIA 6 mg/mL oral suspension
Croatian: Uputa o lijeku: Informacije za korisnika AMGLIDIA 6 mg/ml oralna suspenzija glibenklamid
English: Oestrogens
Croatian: Estrogeni
English: Thyroid hormones
Croatian: Hormoni štitnjače
English: Weakening of the blood-glucose-lowering effect and, thus, raised blood-glucose levels may occur when taking other medicinal products.
Croatian: Pri primjeni drugih lijekova može se pojaviti slabljenje učinka smanjenja razine glukoze u krvi i posljedično povećanje razine glukoze u krvi.
English: Fluoxetine
Croatian: Fluoksetin
English: Hypoglycaemia may occur when taking other medicinal products.
Croatian: Pri primjeni drugih lijekova može se pojaviti hipoglikemija.
English: - one syringe adaptor.
Croatian: - promjena boje zubiju.
English: Package leaflet: Information for the user AMGLIDIA 0.6 mg/mL oral suspension
Croatian: Uputa o lijeku: Informacije za korisnika AMGLIDIA 0,6 mg/ml oralna suspenzija glibenklamid
English: The signs of too low blood sugar may include: - shaking, sweating, feeling very anxious or confused, fast heart beat
Croatian: - tresenje, znojenje, osjećaj velike tjeskobe ili zbunjenosti, brze otkucaje srca
English: Dose adjustment is required in patients with mild to moderate hepatic impairment.
Croatian: Prilagodba doze potrebna je u bolesnika s blagim do umjerenim oštećenjem jetre.
English: Biguanides
Croatian: Nuspojave
English: Tooth discoloration
Croatian: Promjena boje zubiju
English: Replace the screw cap on the bottle with the adaptor.
Croatian: 3. Vratite zatvarač na bočicu s nastavkom.
English: Close the bottle by tightening the screw cap well on top of the adaptor.
Croatian: Zatvorite bočicu tako što ćete čvrsto zavrnuti zatvarača na nastavak.
English: Blood sugar levels too low Incorrect control of plasma sugar
Croatian: Preniske razine šećera u krvi Nepravilna kontrola šećera u plazmi
English: Colesevelam used to lower cholesterol
Croatian: Kolesevelam koji se upotrebljava za smanjenje razine kolesterola
English: The Prescriber's Guide shall contain the following key messages:
Croatian: • Vodič za propisivača, uključujući priloženi sažetak opisa svojstava lijeka Amglidia Vodič za propisivača mora sadržavati sljedeće ključne informacije:
English: The 5 mL syringe is thick and long and graduated in steps of 0.1 mL.
Croatian: Štrcaljka od 1 ml tanka je i mala te na sebi ima oznake u koracima od 0,05 ml. Štrcaljka od 5 ml debela je i dugačka te na sebi ima oznake u koracima od 0,1 ml.
English: Oxypentifylline
Croatian: Oksipentifilin
English: Weakening of the blood-glucoselowering effect
Croatian: Slabljenje učinka smanjenja razine glukoze u krvi
English: Insulin reduction should be done using the pre-meal glucose.
Croatian: Smanjenje doze inzulina potrebno je odrediti prema razini glukoze prije obroka.
English: Potentiation of the blood-glucose lowering
Croatian: Potenciranje snižavanja razine glukoze u krvi
English: Dose adjustment is required in patients with mild to moderate renal impairment.
Croatian: Prilagodba doze potrebna je u bolesnika s blagim do umjerenim oštećenjem bubrega
English: Cyclophosphamides
Croatian: Ciklofosfamidi
English: - The other ingredients are: xanthan gum, hydroxyethylcellulose, lactic acid, purified water, sodium citrate and sodium benzoate (E211) (see section 2 “AMGLIDIA contains sodium and benzoate).
Croatian: - Drugi sastojci su: ksantanska guma, hidroksietilceluloza, laktatna kiselina, pročišćena voda,
English: Beta-receptor blockers Potentiation of the blood-glucose lowering
Croatian: Blokatori beta receptora
English: SN:
Croatian: Tel:.
English: Retighten the screw cap to push the adaptor well into the bottle.
Croatian: Ponovno zategnite zatvarač da biste nastavak gurnuli duboko u bočicu.
English: Dose adjustment is required in patients with mild to moderate renal impairment (refer to section 4.2).
Croatian: Treba se strogo pridržavati propisanih razina pri doziranju radi izbjegavanja hipoglikemijskih reakcija (vidjeti dio 4.4).
English: Guanethidine
Croatian: Gvanetidin
English: Chloramphenicol
Croatian: Kloramfenikol
English: Symptomatic measures were taken and the situation resolved.
Croatian: Poduzete su simptomatske mjere te poremećaj povukao.
English: Probenecid used to treat gout, gouty arthritis Blood sugar levels too low Progestogens (such as desogestrel, dydrogesterone) used for hormonal treatment
Croatian: Progestageni (na primjer dezogestrel, didrogesteron) koji se upotrebljavaju za hormonsko liječenje
English: EXPIRY DATE
Croatian: EXP {MM/GGGG}
English: Children and adolescents Don't give this medicine to children or adolescents below the age of 18 years.
Croatian: Ovaj lijek se ne smije davati djeci ni adolescentima mlađima od 18 godina.
English: “Click”
Croatian: “Klik”
English: Hold this breath in for as long as possible (at least 3-4 seconds).
Croatian: Zadržite dah koliko god dugo možete (najmanje 3 - 4 sekunde).
English: Other side effects have occurred but their exact frequency is not known (frequency cannot be estimated from the available data):
Croatian: Pojavile su se i druge nuspojave, ali njihova točna učestalost nije poznata (učestalost se ne može procijeniti iz dostupnih podataka):
English: Health-Related Quality of Life
Croatian: Kvaliteta života vezana uz zdravlje
English: Not for acute use
Croatian: Nije za akutnu primjenu
English: You only need to inhale once a day because the effect of this medicine lasts for 24 hours.
Croatian: Dovoljno je da lijek inhalirate jedanput na dan jer njegov učinak traje 24 sata.
English: Your inhaler is now empty.
Croatian: Vaš je inhalator sada prazan.
English: The pre-specified non-inferiority margin was 50 mL.
Croatian: Unaprijed specificirana granična vrijednost za neinferiornost iznosila je 50 ml.
English: • weakening of the bones, leading to fractures.
Croatian: • slabljenje kostiju, koje dovodi do prijeloma
English: Contents of the pack and other information Step-by-step instructions
Croatian: Sadržaj pakiranja i druge informacije Upute za primjenu korak po korak
English: It is very important that you use Trelegy Ellipta every day, as instructed by your doctor.
Croatian: Vrlo je važno da Trelegy Ellipta primjenjujete svakoga dana prema uputama liječnika.
English: There is some evidence of an increased risk of pneumonia with increasing steroid dose but this has not been demonstrated conclusively across all studies.
Croatian: Postoje neki pokazatelji povećanog rizika od pneumonije s povećanjem doze steroida, ali to nije uvjerljivo dokazano u svim ispitivanjima.
English: After this date the inhaler should no longer be used.
Croatian: Nakon tog datuma inhalator se više ne smije koristiti.
English: If a dose is missed the next dose should be taken at the usual time the next day.
Croatian: Ako bolesnik propusti dozu, sljedeću dozu treba uzeti idući dan u uobičajeno vrijeme.
English: • pain in the back of the mouth and throat
Croatian: • bol u stražnjem dijelu usta i grlu
English: This shows how many doses of medicine are left in the inhaler.
Croatian: Pokazuje koliko je doza ostalo u inhalatoru.
English: You may notice that your heart is beating faster than usual, you feel shaky, you have visual disturbances, have a dry mouth, or have a headache.
Croatian: Možda ćete primijetiti da Vam srce kuca brže nego inače, da drhtite, imate smetnje vida, suha usta ili glavobolju.
English: See section 4 ‘Possible side effects' for information on symptoms to look out for while you are using this medicine.
Croatian: Pogledajte dio 4. ‘Moguće nuspojave' za informacije o simptomima na koje trebate obratiti pozornost dok primjenjujete ovaj lijek.
English: It is unlikely that this medicine will affect your ability to drive or use machines.
Croatian: Nije vjerojatno da će ovaj lijek utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: Increasing use of short-acting bronchodilators to relieve symptoms may indicate deterioration of disease control.
Croatian: Pojačano korištenje kratkodjelujućih bronhodilatatora za ublažavanje simptoma može ukazivati na slabiju kontrolu bolesti.
English: At this dose, no effects on systemic exposure were observed.
Croatian: Pri toj dozi nisu opaženi učinci na sistemsku izloženost.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego primijenite ovaj lijek.
English: Don't stop unless your doctor advises you to, even if you feel better, as your symptoms may get worse.
Croatian: Nemojte prestati primjenjivati lijek osim ako Vam to ne kaže liječnik, čak i ako se osjećate bolje, jer se simptomi mogu pogoršati.
English: For further instructions for use and handling, see section 4.2.
Croatian: Za dodatne upute za uporabu i rukovanje vidjeti dio 4.2.
English: The first time you use Trelegy Ellipta you do not need to check that the inhaler is working properly; it contains previously measured doses and is ready to use straight away.
Croatian: Kada koristite Trelegy Ellipta po prvi puta, ne morate provjeravati radi li inhalator ispravno; on sadrži prethodno odmjerene doze i odmah je spreman za uporabu.
English: Your doctor may wish to monitor you carefully if you are taking any of these medicines as they may increase the side effects of Trelegy Ellipta.
Croatian: Liječnik će Vas možda htjeti pažljivo nadzirati ako uzimate neki od tih lijekova jer oni mogu pojačati nuspojave lijeka Trelegy Ellipta.
English: What is the inhaler?
Croatian: Što je inhalator?
English: It is not known whether the ingredients of this medicine can pass into breast milk.
Croatian: Nije poznato mogu li se sastojci ovog lijeka izlučiti u majčino mlijeko.
English: COPD is a longterm condition characterised by breathing difficulties that slowly get worse.
Croatian: KOPB je dugotrajna bolest koju karakteriziraju tegobe s disanjem koje se polako pogoršavaju.
English: 1) Read this before you start
Croatian: 1) Prije primjene pročitajte ovaj tekst
English: If you use too much of this medicine, contact your doctor or pharmacist for advice immediately as you may need medical attention.
Croatian: Ako primijenite previše ovog lijeka, odmah se obratite svom liječniku ili ljekarniku za savjet jer ćete možda trebati liječničku pomoć.
English: • painful and frequent urination (may be signs of a urinary tract infection)
Croatian: • bolno i učestalo mokrenje (može biti znak infekcije mokraćnih putova)
English: It counts down by 1 each time you open the cover.
Croatian: Smanjuje se za 1 dozu svaki put kada otvorite poklopac.
English: • inflammation of the lungs (bronchitis)
Croatian: • upala u plućima (bronhitis)
English: Administration of Trelegy Ellipta to pregnant women should only be considered if the expected benefit to the mother justifies the potential risk to the foetus.
Croatian: Primjenu lijeka Trelegy Ellipta u trudnica treba razmotriti samo ako očekivana korist za majku opravdava mogući rizik za plod.
English: If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
Croatian: Ako dođe do predoziranja, bolesnika treba liječiti suportivno te po potrebi uvesti odgovarajuće praćenje.
English: tiotropium, indacaterol.
Croatian: tiotropij, indaketerol.
English: Tell your doctor as soon as possible if you develop any of these symptoms.
Croatian: Obavijestite svog liječnika što je prije moguće ako primijetite bilo koji od navedenih simptoma.
English: Stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm.
Croatian: Odmah prestanite primjenjivati ovaj lijek i zatražite liječničku pomoć jer možda imate ozbiljno stanje koje se zove paradoksalni bronhospazam.
English: If your breathing or wheezing gets worse straight after using this medicine, stop using it and get medical help immediately.
Croatian: Ako Vam se disanje ili piskanje u plućima pogoršaju neposredno nakon primjene ovog lijeka, odmah ga prestanite primjenjivati i zatražite liječničku pomoć.
English: It may harm them, even if their signs of illness are the same as yours.
Croatian: Veći postotak bolesnika liječenih lijekom Trelegy Ellipta odgovorio je klinički značajnim poboljšanjem SGRQ rezultata u 24. tjednu ispitivanja FULFIL u usporedbi s bolesnicima koji su primjenjivali BUD/FOR (50% odnosno 41%; omjeri izgleda [engl. odds ratio, OR] za odgovor u odnosu na izostanak odgovora [1,41; 95% CI: 1,16; 1,70]), kao i u 52. tjednu ispitivanja IMPACT u usporedbi s bolesnicima koji su primjenjivali FF/VI i UMEK/VI (42%, 34% odnosno 34%; OR u odnosu na FF/VI [1,41; 95% CI: 1,29; 1,55]; OR u odnosu na UMEK/VI [1,41; 95% CI: 1,26; 1,57]).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 November 2017
Croatian: Datum prvog odobrenja: 15.studeni 2017.
English: Studies in animals have shown reproductive toxicity at exposures which are not clinically relevant (see section 5.3).
Croatian: Ispitivanja na životinjama ukazala su na reproduktivnu toksičnost pri razinama izloženosti koje nisu klinički značajne (vidjeti dio 5.3).