FrancophonIA/ELRC3.0 huggingface dataset:
English: In the adrenal gland, there was an increased incidence of adrenal subcapsular cell and adrenal cortical tumours in animals dosed at high dose.
Croatian: U nadbubrežnoj žlijezdi incidencija tumora adrenalnih subkapsularnih stanica i adrenalnih kortikalnih tumora bila je povećana u životinja koje su primale visoke doze.
English: If necessary, because of impaired tolerance, ospemifene should be stopped as long as treatment with fluconazole lasts.
Croatian: Ako je potrebno zbog neodgovarajuće podnošljivosti, primjenu ospemifena potrebno je prekinuti sve dok traje liječenje flukonazolom.
English: The pharmacokinetics of ospemifene is only mildly affected by mild and moderate hepatic impairment (Child Pugh scores 5-9) when compared to healthy matched controls.
Croatian: Na farmakokinetiku ospemifena samo blago utječe blago do umjereno oštećenje jetre (Child-Pugh rezultat 5-9) u usporedbi sa zdravim podudarnim osobama iz kontrolne skupine.
English: No dose adjustment is necessary in elderly patients.
Croatian: U starijih bolesnica prilagodba doze nije potrebna.
English: In the mammary gland, they have a predominantly oestrogen antagonist effect.
Croatian: Njihov učinak na mliječnu žlijezdu je prevladavajuće estrogen-antagonistički.
English: In CYP2C9 poor metabolizers, co-administration of CYP3A4 inhibitors may increase systemic concentration of ospemifene to a larger extent.
Croatian: Kod slabih metabolizatora CYP2C9 istodobna primjena inhibitora CYP3A4 može povećati sistemsku koncentraciju ospemifena u većoj mjeri.
English: Uncommon side effects (may affect up to 1 in 100 people): - Thickening of the womb lining (endometrium) as seen on ultrasound scan (endometrial hypertrophy).
Croatian: Manje česte nuspojave (mogu se javiti u do 1 od 100 osoba): - zadebljanje sluznice maternice (endometrija) vidljivo ultrazvučnim pregledom (hipertrofija endometrija) - alergijska reakcija.
English: The most bothersome symptom (MBS) was assessed at baseline, 4 and 12 weeks with the severity scored as follows: None=0, Mild=1, Moderate=2, Severe=3.
Croatian: Simptom koji najviše smeta procijenjen je na početku ispitivanja i u 4. i 12. tjednu, a težina simptoma je bodovana kako slijedi: bez simptoma=0, blagi=1, umjereni=2, teški=3.
English: Film coating: Hypromellose (E 464), lactose monohydrate, titanium dioxide (E 171), triacetin (E 1518), polyethylene glycol (E 1521).
Croatian: Film-ovojnica: hipromeloza (E 464), laktoza hidrat, titanijev dioksid (E 171), triacetin (E 1518), polietilenglikol (E 1521).
English: Following oral administration of [3-H]-ospemifene in the fasted state, approximately 75% and 7% of the dose was excreted in faeces and urine respectively.
Croatian: Nakon peroralne primjene [3-H]-ospemifena natašte, približno 75% doze izlučuje se fecesom, odnosno 7% urinom.
English: In the ovary, there was an increase in sex-cord stromal tumours, tubulostromal tumours, granulosa cell tumours and luteomas in all treatment groups.
Croatian: U jajniku incidencija tumora specijalizirane strome jajnika, tubulostromalnih tumora, tumora granuloza stanica i luteoma bila je povećana u svim skupinama.
English: In the uterus ospemifene and its major metabolite have weak partial agonist/antagonist effects.
Croatian: Učinci ospemifena i njegovog glavnog metabolita na uterus su slabi djelomično agonistički, djelomično antagonistički.
English: No clinically important pharmacokinetic differences between subjects with severe renal impairment and healthy subjects were observed.
Croatian: Nisu primijećene bitne razlike u farmakokinetici između ispitanica s teškim oštećenjem bubrega i zdravih ispitanica.
English: If you stop using Senshio
Croatian: Ako prestanete uzimati Senshio
English: Ospemifene and its major metabolite, 4-hydroxyospemifene, are metabolised by multiple metabolic pathways, the main enzymes involved are UGT1A3, UGT2B7, UGT1A1 and UGT1A8, and CYP2C9,
Croatian: Ospemifen i njegov glavni metabolit 4-hidroksiospemifen metaboliziraju se putem višestrukih metaboličkih putova, a glavni enzimi koji sudjeluju su UGT1A3, UGT2B7, UGT1A1 i UGT1A8 te CYP2C9, CYP3A4 i CYP2C19.
English: No dose adjustment is necessary for patients with mild, moderate or severe renal impairment (see section 5.2).
Croatian: U bolesnica s blagim, umjerenim ili teškim oštećenjem bubrega prilagodba doze nije potrebna (vidjeti dio 5.2).
English: The pharmacokinetics of medicinal products that are mainly metabolised by UGT1A3 and UGT1A9 could be affected when administered concomitantly with ospemifene and co-administration should be made with caution.
Croatian: Na farmakokinetiku lijekova koji se uglavnom metaboliziraju preko enzima UGT1A3 i UGT1A9 može se utjecati kada se daju istodobno s ospemifenom te je pri istodobnoj primjeni potreban oprez.
English: How to take Senshio
Croatian: Kako uzimati Senshio
English: Senshio has no known or very little influence on the ability to drive and use machines.
Croatian: Upravljanje vozilima i strojevima Senshio nema poznatih učinaka na sposobnost upravljanja vozilima ili strojevima, ili su oni vrlo mali.
English: Table 1 shows the mean change in severity score in MBS after 12 weeks with the associated statistical testing for the difference vs. placebo for trials 1 and 2.
Croatian: Tablica 1 prikazuje srednju promjenu rezultata bodovanja težine simptoma koji najviše smeta bolesnicama nakon 12 tjedana, s pripadajućim statističkim testiranjem razlike u usporedbi s placebom u ispitivanju 1 i 2.
English: Ketoconazole, a strong CYP3A4 inhibitor and moderate P-glycoprotein inhibitor, increased the AUC of ospemifene by 1.4-fold.
Croatian: Ketokonazol, snažni inhibitor CYP3A4 i umjereni inhibitor P-glikoproteina, povećao je AUC ospemifena 1,4 puta.
English: There were four co-primary endpoints for which change from baseline was assessed: percentage parabasal cells and superficial cells in the vaginal smear, vaginal pH, and MBS of VVA (dryness or dyspareunia).
Croatian: Procjenjivane su promjene četiri koprimarnih mjera ishoda u odnosu na početak ispitivanja: postotak parabazalnih i površinskih stanica u vaginalnom razmazu, vaginalni pH i simptom VVA koji najviše smeta (suhoća ili dispareunija).
English: What you need to know before you take Senshio Do not take Senshio
Croatian: Što morate znati prije nego počnete uzimati Senshio
English: Fluconazole, a moderate CYP3A / moderate CYP2C9 / strong CYP2C19 inhibitor, increased the AUC of ospemifene by 2.7-fold.
Croatian: Flukonazol, umjereni CYP3A / umjereni CYP2C9 / jaki CYP2C19 inhibitor, povećao je AUC ospemifena 2,7 puta.
English: Senshio is only for use in postmenopausal women and should not be used in women of child-bearing potential.
Croatian: Senshio je namijenjen samo za primjenu u žena u postmenopauzi i ne smije se koristiti u žena reproduktivne dobi.
English: - The other ingredients are: Tablet core: Colloidal silicon dioxide (E 551), magnesium stearate (E 578), mannitol (E 421), microcrystalline cellulose (E 460), povidone (E 1201), pregelatinised starch (maize), sodium starch glycolate (type A).
Croatian: Drugi sastojci su: Jezgra tablete: koloidni silicijev dioksid (E 551), magnezijev stearat (E 578), manitol (E 421), mikrokristalična celuloza (E 460), povidon (E 1201), prethodno geliran škrob (kukuruzni), natrijev škroboglikolat (vrsta A).
English: Therefore, co-administration of ospemifene with strong/moderate CYP3A4 inhibitors should be avoided in patients who are known, or suspected to be CYP2C9 poor metabolizers based on genotyping or previous history/experience with other CYP2C9 substrates.
Croatian: Stoga je istodobnu primjenu ospemifena sa snažnim/umjerenim inhibitorima CYP3A4 potrebno izbjegavati u bolesnika za koje se, na temelju genotipizacije ili ranijih podataka u anamnezi/iskustava s drugim supstratima CYP2C9, zna ili sumnja da su slabi metabolizatori CYP2C9.
English: If pregnancy occurs during treatment with ospemifene, ospemifene should be withdrawn immediately.
Croatian: Ako tijekom liječenja ospemifenom žena zatrudni, liječenje se smjesta mora prekinuti.
English: St John's wort, a herbal medicine sometimes used to treat depression.
Croatian: (antikonvulzivnim lijekovima) o gospinom travom, biljnim lijekom koji se ponekad koristi za liječenje depresije o orlistatom koji se ponekad koristi za liječenje pretilosti.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Senshio sadrži laktozu Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije uzimanja ovog lijeka.
English: Co-administration of ketoconazole, a strong CYP3A4 inhibitor, increased the AUC of ospemifene by 1.4-fold.
Croatian: Istodobna primjena ketokonazola, snažnog inhibitora CYP3A4, povećao je AUC ospemifena 1,4 puta.
English: In case of impaired tolerance of ospemifene, the latter should be stopped as long as treatment with fluconazole lasts.
Croatian: U slučaju neodgovarajuće podnošljivosti ospemifena, primjenu ospemifena potrebno je prekinuti dok traje liječenje flukonazolom.
English: Senshio contains the active substance ospemifene.
Croatian: Senshio sadrži djelatnu tvar ospemifen.
English: Fri.
Croatian: Peroralno.
English: Therefore, caution is recommended when co-administering ospemifene with fluconazole.
Croatian: Stoga se preporučuje oprez pri istodobnoj primjeni ospemifena s flukonazolom.
English: 23-24 Tafarnaubach Industrial Estate Tredegar, Gwent, South Wales
Croatian: 23-24 Tafarnaubach Industrial Estate
English: Ospemifene and its major metabolite, 4-hydroxyospemifene, inhibited organic cation transporter (OCT)1 in vitro at clinically relevant concentrations.
Croatian: Ospemifen i njegov glavni metabolit 4-hidroksiospemifen inhibiraju organski kationski prijenosnik (OCT)1 in vitro u klinički relevantnim koncentracijama.
English: Coadministration of ospemifene with strong/moderate CYP3A4 inhibitors should be avoided in patients who are known or suspected to be CYP2C9 poor metabolizers based on genotyping or previous history/experience with other CYP2C9 substrates.
Croatian: Istodobnu primjenu ospemifena s jakim/umjerenim inhibitorima CYP3A4 potrebno je izbjegavati u bolesnica za koje se, na temelju genotipizacije ili ranijih podataka u anamnezi/iskustava s drugim supstratima CYP2C9, zna ili sumnja da slabo metaboliziraju CYP2C9.
English: Trial 2 Dryness
Croatian: Ispitivanje 2 Suhoća
English: Percentage of patients with improvement, relief or substantial improvement of MBS after 12 weeks on ospemifene vs. placebo (ITT, LOCF)
Croatian: Tablica 2. Postotak bolesnica s poboljšanjem, olakšanjem ili značajnim poboljšanjem simptoma koji ih najviše smeta nakon 12 tjedna primjene ospemifena u usporedbi s placebom (ITT,
English: - If you are suffering from any gynaecological illness other than vulvar and vaginal atrophy.
Croatian: Vas postoji visoki rizik od moždanog udara - ako patite od bilo kakve ginekološke bolesti osim vulvarne i vaginalne atrofije - ako ste imali rak dojke.
English: Effects of ospemifene on other medicinal products
Croatian: Učinci ospemifena na druge lijekove
English: - Headache - Vaginal bleeding
Croatian: - mišićni grčevi - vaginalni ili genitalni iscjedak - osip - glavobolja - vaginalno krvarenje
English: Colloidal silicon dioxide (E 551) Magnesium stearate (E 578) Mannitol (E 421) Microcrystalline cellulose (E 460) Povidone (E 1201) Pregelatinised starch (maize) Sodium starch glycolate (type A)
Croatian: silicijev dioksid, koloidni (E 551) magnezijev stearat (E 578) manitol (E 421) mikrokristalična celuloza (E 460) povidon (E 1201) prethodno geliran škrob (kukuruzni) natrijev škroboglikolat (vrsta A)
English: Trial 1 Dryness
Croatian: Ispitivanje 1 Suhoća
English: Senshio 60 mg film-coated tablets ospemifene
Croatian: Senshio 60 mg filmom obložene tablete ospemifen
English: Senshio has no or negligible influence on the ability to drive and use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Senshio ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Adverse reactions are listed below by MedDRA preferred term system organ class and by frequency.
Croatian: Nuspojave su navedene prema MedDRA preporučenom pojmu klasifikacije organskih sustava i prema učestalosti.
English: Hot flushes
Croatian: Navale vrućine
English: BN
Croatian: Dob
English: Tel: +39 06 94 805 118 contattaci@shionogi.eu
Croatian: Shionogi Srl Tel: +39 06 94 805 118 contattaci@shionogi.eu
English: Gender Senshio is indicated for use only in postmenopausal women.
Croatian: Senshio je indiciran za primjenu samo u žena u postmenopauzi.
English: In vitro, ospemifene and 4-hydroxyospemifene inhibited glucuronidation mainly via UGT1A3 and UGT1A9 at clinically relevant concentrations.
Croatian: In vitro, ospemifen i 4-hidroksiospemifen inhibiraju glukuronidaciju uglavnom preko enzima UGT1A3 i UGT1A9 u klinički relevantnim koncentracijama.
English: Pre-existing gynaecological pathology other than signs of vaginal atrophy There are limited clinical trial data on the use of ospemifene in patients with other gynaecological conditions.
Croatian: Podaci kliničkih ispitivanja primjene ospemifena u bolesnica s drugim ginekološkim stanjima su ograničeni.
English: Senshio is for use only in postmenopausal women.
Croatian: Senshio je namijenjen samo za primjenu u žena u postmenopauzi.
English: How to store Senshio
Croatian: Kako čuvati Senshio
English: Ospemifene is not indicated for fertile women.
Croatian: Ospemifen nije indiciran za primjenu u žena reproduktivne dobi.
English: The risk of cerebrovascular events is possibly increased with other SERMs.
Croatian: Rizik od cerebrovaskularnih događaja vjerojatno je povećan s drugim selektivnim modulatorima estrogenskih receptora.
English: In vitro, ospemifene and 4-hydroxyospemifene inhibited glucuronidation via UGT1A3 and UGT1A9 at clinically relevant concentrations.
Croatian: In vitro, ospemifen i 4-hidroksiospemifen inhibiraju glukuronidaciju preko enzima UGT1A3 i UGT1A9 u klinički relevantnim koncentracijama.
English: 5.0% superficial cells in the vaginal smear, a vaginal pH >5.0 and were required to have at least one moderate or severe VVA symptom, where patients had to choose the symptom that was the most bothersome (MBS).
Croatian: Populacija u ispitivanju sastojala se općenito od zdravih žena u postmenopauzi u dobi između 41 i 80 godina (srednja dob = 59 godina), koje su na početku ispitivanja u vaginalnom razmazu imale ≤5,0% površinskih stanica, vaginalni pH >5,0 i koje su imale najmanje jedan umjereni ili teški simptom VVA, a od kojih su bolesnice morale izabrati onaj simptom koji ih najviše smeta.
English: Common side effects (may affect up to 1 in 10 people): - An infection of the genitals caused by a fungus (thrush) - Hot flushes - Muscle cramps - Vaginal or genital discharge - Rash
Croatian: Česte nuspojave (mogu se javiti u do 1 od 10 osoba): - infekcija spolovila uzrokovana gljivicama (kandidijaza)
English: Tel +44 (0)20 3053 4190 contact@shionogi.eu
Croatian: Tel +44 (0)20 3053 4190 contact@shionogi.eu Ova uputa je zadnji puta revidirana u
English: A low fat meal resulted in approximately a two-fold increase in exposure of ospemifene and a high fat meal resulted in approximately a three-fold increase in exposure of ospemifene in two food effect studies with tablet formulations different from the commercial formulation.
Croatian: U dva ispitivanja učinka hrane primjenom lijeka u obliku tablete koja se razlikuje od komercijalno dostupnog pripravka, uzimanje s obrokom s niskim udjelom masnoće rezultiralo je dvostrukim porastom izloženosti ospemifenu, a uzimanje s obrokom s visokim udjelom masnoća rezultiralo je s trostrukim povećanjem izloženosti ospemifenu.
English: “Substantial improvement” was restricted to patients who had moderate or severe MBS at baseline and changed from severe to mild or severe or moderate to none.
Croatian: „Olakšanje“ je definirano kao bez ili samo s blagim simptomima u 12. tjednu. „Značajno poboljšanje“ bilo je ograničeno na bolesnice kod kojih se umjereni ili teški simptom koji ih je najviše smetao na početku ispitivanja promijenio od teškog na blagi ili od teškog ili umjerenog na bez simptoma.
English: Senshio 60 mg tablets ospemifene
Croatian: NAZIV LIJEKA Senshio 60 mg tablete ospemifen
English: Hypromellose (E 464) Lactose monohydrate Titanium dioxide (E 171) Triacetin (E 1518) Macrogols (E 1521)
Croatian: hipromeloza (E 464) laktoza hidrat titanijev dioksid (E 171)
English: The major metabolite, 4-hydroxyospemifene, was seen to undergo formation rate-limited elimination (with t1/2 similar to the parent compound) in a human mass balance study.
Croatian: U ispitivanjima masene bilance u ljudi primijećeno je da brzina eliminacije glavnog metabolita, 4-hidroksiospemifena, ovisi o brzini njegovog stvaranja (s t1/2 sličnim ishodnom spoju).
English: Senshio contains lactose
Croatian: Senshio sadrži natrij
English: Hepatic impairment
Croatian: Poremećaji živčanog sustava glavoboljac
English: ANNEX II
Croatian: Appelhof 13
English: Dryness
Croatian: Dojenje
English: Senshio 60 mg film-coated tablets
Croatian: NAZIV LIJEKA Senshio 60 mg filmom obložene tablete
English: In bone, ospemifene has agonist-like activity.
Croatian: Učinak ospemifema na kosti je nalik agonističkom.
English: No changes in blood biochemical parameters such as ALT or ALP were determined in postmenopausal women treated with Ospemifene in clinical studies.
Croatian: U kliničkim ispitivanjima žena u postmenopauzi liječenih ospemifenom nisu utvrđene promjene krvnih biokemijskih parametara poput ALT ili ALP.
English: Oestrogens.
Croatian: • estrogenima
English: No dose adjustment is necessary for patients with mild to moderate hepatic impairment.
Croatian: U bolesnica s blagim do umjerenim oštećenjem jetre prilagodba doze nije potrebna.
English: Trial 2 Dyspareunia
Croatian: Ispitivanje 2 Dispareunija
English: See leaflet for further information.
Croatian: Za više informacija pogledati uputu o lijeku.
English: Age
Croatian: Ned
English: Trial 1 Dyspareunia
Croatian: Ispitivanje 1 Dispareunija
English: This leaflet was last revised in Other sources of information
Croatian: Ostali izvori informacija
English: INFORMATION IN BRAILLE
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Senshio
English: GENERAL CLASSIFICATION FOR SUPPLY
Croatian: MedDRA klasifikacija organskih sustava
English: Any of the following medicines, as their concentrations may be increased while taking Senshio: Metformin used to treat Type II diabetes.
Croatian: • Bilo kojim od sljedećih lijekova, jer njihova koncentracija može biti poviše na za vrijeme uzimanja Senshia: o metforminom koji se koristi za liječenje šećerne bolesti tipa II o aciklovirom koji se koristi za liječenje herpesa simpleks i genitalnog herpesa o ganciklovirom koji se koristi za liječenje infekcija uzrokovanih virusom naziva citomegalovirusom o oksaliplatinom, lijekom protiv raka za liječenje uznapredovalog (metastatskog) raka debelog crijeva (kolona) ili stražnjeg crijeva (rektuma).
English: - If you have or have ever had a blood clot in a vein (thrombosis), for example, in your legs (deep vein thrombosis), lungs (pulmonary embolism), or eyes (retinal thrombosis).
Croatian: Nemojte uzimati Senshio - ako ste alergični na ospemifen ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) - ako imate ili ste ikad imali krvni ugrušak u veni (trombozu), npr. u nogama (duboka venska tromboza), plućima (plućna embolija) ili očima (tromboza mrežnice) - ako imate neobjašnjivo krvarenje iz rodnice - ako Vaš liječnik smatra da biste mogli imati rak dojke ili se liječite zbog raka dojke - ako Vaš liječnik smata da biste mogli imati ili se liječite od raka osjetljivog na estrogene, poput raka maternice
English: It may harm them even if their signs of illnesses are the same as yours.
Croatian: Može im naškoditi, čak i ako su njihovi znakovi bolesti jednaki Vašima.
English: 2, cold hands and feet
Croatian: 2, hladne ruke i stopala
English: Cartons containing 1 or 3 bottles.
Croatian: Kutija sadrži 1 ili 3 bočice.
English: You can usually carry on taking the drops, unless the effects are serious.
Croatian: Obično možete nastaviti s primjenom kapi, osim ako su nuspojave ozbiljne.
English: Do not drive or use machines until your vision is clear.
Croatian: Nemojte upravljati vozilima ni strojevima sve dok Vam se vid ne razbistri.
English: B-2870 Puurs Belgium or
Croatian: B-2870 Puurs Belgija ili
English: However, a risk to the suckling child cannot be excluded.
Croatian: Ipak, rizik za dojenče ne može se isključiti.
English: Do not use a double dose to make up for the forgotten dose.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili onu zaboravljenu.
English: The response of these patients should be closely observed.
Croatian: Odgovor ovih bolesnika se mora pomno pratiti.
English: White to off-white uniform suspension, pH 7.2 (approximately).
Croatian: Bijela do bjelkasta jednolična suspenzija, pH 7,2 (približno).
English: • Get the AZARGA bottle and a mirror.
Croatian: • Uzmite AZARGA bočicu i ogledalo.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Croatian: Interakcije s drugim lijekovima i drugi oblici interakcija
English: They are classified according to 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 <1/1000), very rare (<1/10,000), or not known (cannot be estimated from the available data).
Croatian: Razvrstane su prema učestalosti na sljedeći način: vrlo česte (≥1/10), česte (≥1/100 do <1/10), manje česte (≥1/1000 do <1/100), rijetke (≥1/10 000 do <1/1000), vrlo rijetke (<1/10 000), ili nepoznato (ne može se procijeniti iz dostupnih podataka).
English: These could be the signs of an allergic reaction (frequency is not known).
Croatian: Ovo mogu biti znakovi alergijske reakcije (učestalost nije poznata).
English: Contact with soft contact lenses should be avoided.
Croatian: Kontakt s mekim kontaktnim lećama mora se izbjegavati.
English: Ask your doctor for advice before taking any medicine during breastfeeding.
Croatian: Obratite se svom liječniku za savjet prije nego uzmete bilo koji lijek tijekom dojenja.
English: Raynaud's phenomenon
Croatian: Raynaudov fenomen
English: • Hypersensitivity to other beta-blockers.
Croatian: • Preosjetljivost na ostale beta-blokatore.
English: • Tilt your head back.
Croatian: • Zabacite glavu.
English: • If you have severe hay fever
Croatian: • Ako imate tešku peludnu groznicu
English: How to use
Croatian: Kako primijeniti
English: Do not put in any more drops until it is time for your next regular dose.
Croatian: Ne ukapavajte dalje lijek sve dok ne dođe vrijeme za primjenu iduće uobičajene doze.
English: 6 OTHER
Croatian: 6 DRUGO
English: You should not use AZARGA if you are pregnant or might get pregnant, unless your doctor considers it necessary.
Croatian: Ne smijete koristiti AZARGU ako ste trudni ili postoji mogućnost da zatrudnite, osim u slučaju da to Vaš liječnik smatra potrebnim.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primjenjivati ovaj lijek jer sadrži Vama važne podatke - Sačuvajte ovu uputu.
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: • prilikom 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 izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: UNIQUE IDENTIFIER-2D BARCODE
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD
English: Clinical effects:
Croatian: Klinički učinci:
English: Date of first Authorisation: 25 November 2008 Date of latest renewal: 26 August 2013
Croatian: Datum posljednje obnove odobrenja: 26. kolovoza 2013.
English: It could infect the drops.
Croatian: To bi moglo kontaminirati kapi.