FrancophonIA/ELRC3.0 huggingface dataset:
English: What Senshio looks like and contents of the pack
Croatian: Kako Senshio izgleda i sadržaj pakiranja
English: Name and address of the manufacturer(s) responsible for batch release Penn Pharmaceutical Services Ltd
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet Penn Pharmaceutical Services Ltd
English: The incidence of endometrial hyperplasia was 0.3% (1 case out of 317 biopsies) after 1 year of treatment with an upper 95% confidence limit of 1.74% (see section 5.1).
Croatian: Incidencija hiperplazije endometrija iznosila je 0,3% (1 slučaj na 317 biopsija) nakon 1 godine liječenja s gornjom 95% granicom pouzdanosti od 1,74% (vidjeti dio 5.1).
English: Ospemifene was not teratogenic in rats or rabbits.
Croatian: Ospemifen nije imao teratogena svojstva u štakora ili kunića.
English: This improvement in objective measures (superficial and parabasal cells and pH) were sustained in ospemifene treated women in a long-term study of up to 52 weeks.
Croatian: To poboljšanje objektivnih mjerenja (površinske i parabazalne stanice i pH) održana su u ospemifenom liječenih žena tijekom ispitivanja dugotrajne primjene u trajanju do 52 tjedna.
English: EU/1/14/978/001 7 film-coated tablets EU/1/14/978/002 28 film-coated tablets EU/1/14/978/003 84 film-coated tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/978/001 7 filmom obloženih tableta EU/1/14/978/002 28 filmom obloženih tableta EU/1/14/978/003 84 filmom obloženih tableta
English: If bleeding or spotting occurs on therapy, or continues after treatment has been discontinued, this should always be investigated, which may include an endometrial biopsy to exclude endometrial malignancy.
Croatian: Ako se krvarenje ili točkasto krvarenje pojavi tijekom terapije ili se nastavi nakon prekida liječenja, potrebno je uvijek učiniti odgovarajuće pretrage, što može uključivati i biopsiju endomerija, kako bi se isključila maligna bolest endometrija.
English: The apparent terminal half-life of ospemifene in post-menopausal women is approximately 25 hours.
Croatian: Prividni terminalni poluvijek ospemifena u žena u postmenopauzi je oko 25 sati.
English: Generally recognised risk factors for VTE include advanced age, a family history, severe obesity (BMI>30 kg/m2) and systemic lupus erythematosus (SLE).
Croatian: Općenito priznati rizici za pojavu VTE-a uključuju uznapredovalu životnu dob, pozitivnu obiteljsku anamnezu, tešku pretilost (BMI>30 kg/m2) i sistemski eritemski lupus (SLE).
English: Less than 0.2% of the ospemifene dose was excreted unchanged in urine.
Croatian: Manje od 0,2% doze ospemifena izlučuje se nepromijenjeno urinom.
English: Senshio should be taken with food.
Croatian: Lijek Senshio potrebno je uzeti s hranom.
English: Ospemifene has not been studied in patients with severe hepatic impairment, therefore Senshio is not recommended for use in such patients (see section 5.2).
Croatian: Primjena ospemifena u bolesnika s teškim oštećenjem jetre nije ispitana, stoga se lijek Senshio ne preporučuje za primjenu u takvih bolesnica (vidjeti dio 5.2).
English: No subjects in either group developed endometrial cancer or breast cancer during the trials.
Croatian: U niti jedne ispitanice u obje skupine nije zabilježen razvoj raka endometrija ili raka dojke tijekom tih ispitivanja.
English: Patients should be advised to contact their doctors immediately when they experience a potential thromboembolic symptom (e.g. painful swelling of a leg, sudden pain in the chest, dyspnoea).
Croatian: Bolesnicama se mora savjetovati da se odmah obrate svom liječniku ako primijete simptome moguće tromboembolije (npr. bolno oticanje noge, iznenadnu bol u prsištu, dispneju).
English: Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „EXP”.
English: Trial 1 Trial 2
Croatian: Ispitivanje 1 Ispitivanje 2
English: Ospemifene may increase the incidence of hot flushes and is not effective in reducing hot flushes associated with oestrogen deficiency.
Croatian: Ospemifen može povećati incidenciju pojave navala vrućine i nije učinkovit u smanjivanju navala vrućine povezanih s nedostatkom estrogena.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for ospemifene, the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za ospemifen, znanstveni zaključci CHMP-a su sljedeći:
English: It may harm them,
Croatian: Učinci drugih lijekova na ospemifen
English: Ospemifene should be discontinued at least 4 to 6 weeks prior to and during prolonged immobilisation (e.g., post-surgical recovery, prolonged bed rest).
Croatian: Primjenu ospemifena potrebno je prekinuti najmanje 4 do 6 tjedana prije i tijekom razdoblja produžene imobilizacije (npr. tijekom oporavka nakon kirurškog zahvata, produženog mirovanja u krevetu).
English: There is therefore no reason to expect that strong CYP3A4 inhibitors would cause a clinically meaningful change in ospemifene exposure.
Croatian: Stoga nema razloga očekivati da bi snažni inhibitori CYP3A4 mogli uzrokovati klinički značajne promjene u izloženosti ospemifenu.
English: Overall, these findings are characteristic for an induction of CYP isoenzymes and are regarded as adaptive responses without any histopathological signs of liver injury.
Croatian: Sveukupno, ovi nalazi karakteristični su za indukciju izoenzima CYP i smatraju se adaptivnim odgovorom bez ikakvih histopatoloških znakova oštećenja jetre.
English: This is known as vulvar and vaginal atrophy.
Croatian: To je stanje poznato kao vulvarna i vaginalna atrofija.
English: Therefore, ospemifene may increase concentrations of medicinal products which are substrates of OCT1 (e.g. metformin, acyclovir, ganciclovir and oxaliplatin).
Croatian: Stoga ospemifen može povećati koncentracije lijekova koji su supstrati za OCT1 (npr. metformin, aciklovir, ganciklovir i oksaliplatin).
English: Ospemifene has been administered to subjects in single doses for up to 800 mg day and repeat doses up to 240 mg/day for 7 days and up to 200 mg/day for 12 weeks.
Croatian: Ospemifen je primjenjivan na ispitanicama u pojedinačnim dozama do 800 mg na dan i ponavljanim dozama do 240 mg/dan tijekom 7 dana i do 200 mg/dan tijekom 12 tjedana.
English: Talk to your doctor before taking Senshio with:
Croatian: Obratite se svom liječniku prije nego uzmete Senshio s:
English: Symptoms of an allergic reaction may include rash, itchy skin, raised patches on your skin (urticaria), swelling of the tongue and throat that may cause difficulty in breathing or swallowing.
Croatian: Simptomi alergijske reakcije mogu uključivati osip, svrbež kože, uzdignute mrlje na koži (urtikarija), oticanje jezika i grla koje može uzrokovati otežano disanje i gutanje.
English: Senshio works in a similar way to some of the helpful effects of oestrogen, helping to improve these symptoms and the underlying causes of vulvar and vaginal atrophy.
Croatian: Senshio djeluje slično nekim korisnim učincima estrogena, tako da pomaže ublažiti ove simptome i s njima povezane uzroke vulvarne i vaginalne atrofije.
English: - If any vaginal bleeding occurs while taking Senshio or soon after you have stopped taking it, you should speak to your doctor.
Croatian: - Ako nastupi krvarenje iz rodnice dok uzimate lijek Senshio ili ubrzo nakon što ste ga prestali uzimati, morate se obratiti svom liječniku.
English: Fertility studies were not conducted.
Croatian: Ispitivanja utjecaja na plodnost nisu provedena.
English: Ospemifene and 4-hydroxyospemifene are highly (both >99%) bound to serum proteins.
Croatian: Ospemifen i 4-hidroksiospemifen u velikoj se mjeri (oba >99%) vežu na proteine seruma.
English: Overall, tumour development in these studies is believed to be the result of rodent specific hormonal mechanisms when treated during their reproductive lives; these findings are unlikely to have any clinical relevance in postmenopausal women.
Croatian: Sveukupno, vjeruje se da je razvoj tumora u ovim ispitivanjima rezultat specifičnih hormonskih mehanizama u glodavaca kada su liječeni tijekom reproduktivne faze života; ovi nalazi vjerojatno nemaju kliničkog značaja za žene u postmenopauzi.
English: Patients with suspected breast cancer or patients undergoing active treatment (including adjuvant therapy) for breast cancer (see section 4.4).
Croatian: Bolesnice kod kojih postoji sumnja na postojanje raka dojke ili bolesnice koje se aktivno liječe (uključujući i adjuvantnu terapiju) zbog raka dojke (vidjeti dio 4.4).
English: Therefore, caution is recommended when ospemifene is combined with orlistat.
Croatian: Stoga, preporučuje se oprez kada se ospemifen primjenjuje u kombinaciji s orlistatom.
English: Each film-coated tablet contains 1.82 mg lactose as monohydrate.
Croatian: Jedna filmom obložena tableta sadrži 1,82 mg laktoze u obliku hidrata.
English: In patients with moderate hepatic impairment the exposure of ospemifene and 4-hydroxyospemifene was approximately 30% and 70% higher.
Croatian: U bolesnica s umjerenim oštećenjem jetre izloženost ospemifenu i 4-hidroksiospemifenu bila je približno 30% i 70% viša.
English: Plasma/blood cell partitioning of [14C]-Ospemifene (< 3%) and [14C]-4-hydroxyospemifene (< 2%) is low.
Croatian: Razdioba [14C]-ospemifena (<3%) i [14C]-4-hidroksiospemifena (<2%) između plazme/krvnih stanica je niska.
English: In contrast, abnormal, not clinically significant, findings on mammography increased in the placebo population from 6.5% to 8.3%.
Croatian: Nasuprot tomu, abnormalni, klinički ne i značajni nalazi na mamografiji bili su u porastu u populaciji koja je primala placebo od 6,5% do 8,3%.
English: For the treatment of vulvar and vaginal atrophy, ospemifene should only be initiated for symptoms that adversely affect quality of life e.g. dyspareunia and vaginal dryness.
Croatian: Za liječenje vulvarne i vaginalne atrofije, liječenje ospemifenom potrebno je započeti samo za one simptome koji negativno utječu na kvalitetu života, poput dispareunije i vaginalne suhoće.
English: They are packed in blisters and are available in pack sizes of 7, 28 or 84 film-coated tablets.
Croatian: Pakirane su u blisterima i dostupne su u veličinama pakiranja od 7, 28 ili 84 filmom obloženih tableta.
English: The biological activity profile in humans is predominantly due to the parent compound.
Croatian: Za profil biološke aktivnosti u ljudi odgovoran je prvenstveno ishodni spoj.
English: Substantial improvement 60 mg OSP Placebo 60 mg OSP Placebo 60 mg OSP Placebo
Croatian: Značajno poboljšanje 60 mg OSP Placebo 60 mg OSP Placebo 60 mg OSP Placebo
English: One tablet should be swallowed whole once daily with food and should be taken at the same time each day.
Croatian: Jednu tabletu treba progutati cijelu jedanput dnevno s hranom i mora se uzimati svakoga dana u isto vrijeme.
English: Treatment with Senshio can be restarted as soon as you regain your mobility and in consultation with your doctor.
Croatian: Liječenje lijekom Senshio može se ponovo nastaviti čim ponovno postanete pokretni i prema savjetu Vašeg liječnika.
English: Renal clearance of unchanged active substance is a minor pathway of elimination, less than 0.2% of the ospemifene dose is excreted unchanged in urine.
Croatian: Bubrežni klirens nepromijenjene djelatne tvari manje je značajan put eliminacije, manje od 0,2% doze ospemifena izlučuje se nepromijenjeno urinom.
English: This is because there are no data on the use of Senshio in pregnant or pre-menopausal women or those who are breast-feeding.
Croatian: To je zato što nema podataka o primjeni lijeka Senshio u trudnica ili žena u premenopauzi ili dojilja.
English: In repeat dose toxicity studies in mouse, rat, dog and the cynomolgus monkey main target organs of toxicity were the ovary, uterus and the liver.
Croatian: U ispitivanjima toksičnosti ponovljenih doza na miševima, štakorima, psima i makaki majmunima, glavni ciljni organi toksičnosti bili su jajnik, maternica i jetra.
English: When ospemifene is administered with a high fat meal, the Cmax and AUC are 2.5-fold and 1.9-fold higher, respectively, with lower variability relative to the fasting state.
Croatian: Kada se ospemifen uzima s obrokom s visokim udjelom masnoće, Cmax i AUC su 2,5 odnosno 1,9 puta viši, uz nižu varijabilnost u odnosu kada se uzima natašte.
English: The recommended dose is one 60 mg tablet once daily with food taken at the same time each day.
Croatian: Preporučena doza je jedna tableta od 60 mg jedanput dnevno s hranom, uzeta svakog dana u isto vrijeme.
English: Table 2 shows the percentage of subjects who reported a change in their MBS at week 12.
Croatian: Tablica 2 prikazuje postotak ispitanica koje su prijavile promjene simptoma koji ih najviše smeta u 12. tjednu.
English: Suspected or active sex-hormone dependent malignancy (e.g. endometrial cancer).
Croatian: Postojanje sumnje na ili aktivna maligna bolest ovisnu o spolnim hormonima (npr. rak endometrija).
English: - If you experience signs of a blood clot, such as painful swelling and redness of the legs, sudden chest pain, difficulty in breathing or a stroke while taking Senshio, stop taking Senshio and see a doctor immediately.
Croatian: - Ako primijetite znakove nastanka krvnog ugruška, poput bolnog oticanja i crvenila nogu, iznenadne boli u prsištu, otežanog disanja ili moždanog udara dok uzimate Senshio, prestanite uzimati Senshio i odmah se obratite svom liječniku.
English: No dose adjustment is necessary in patients above the age of 65 years (see section 5.2).
Croatian: U bolesnica starijih od 65 godina prilagodba doze nije potrebna (vidjeti dio 5.2).
English: Pharmacokinetic differences due to race have been studied in 1,091 postmenopausal women, including 93.1% White, 3.9% Black, 1.8% Asian and 1.1% other in VVA trials.
Croatian: Razlike u farmakokinetici ovisne o rasi ispitane su u ispitivanjima VVA na 1091 ženi u postmenopauzi, uključujući 93,1% žena bjelačke, 3,9% crnačke, 1,8% azijatske i 1,1% ostalih rasa.
English: - If you are unable to walk for a long time or are sitting for a long time in the same position because of major surgery, injury or illness, it may prevent good blood circulation and may temporarily increase your risk of blood clots.
Croatian: Dok uzimate lijek Senshio: - Ako dugotrajno niste sposobni kretati se ili morate dugo vremena sjediti u istom položaju zbog velikog kirurškog zahvata, ozljede ili bolesti, to može sprečavati dobru cirkulaciju krvi i privremeno povećati rizik za nastanak krvnih ugrušaka.
English: Taken together, the liver changes observed in experimental animals in repeat dose toxicity studies are regarded as adaptive changes due to enzyme induction and given the lack of any clinical signs are unlikely to represent a safety concern for humans.
Croatian: U cjelini, promjene na jetri primijećene u eksperimentalnim životinjama u ispitivanjima toksičnosti ponovljenih doza, smatraju se adaptivnim promjenama uslijed indukcije enzima, a zbog pomanjkanja kliničkih znakova nije vjerojatno da predstavljaju sigurnosni problem u ljudi.
English: It is unknown if ospemifene is a substrate for BCRP in the intestine.
Croatian: Nije poznato je li ospemifen supstrat za BCRP u crijevu.
English: There was a single subject (0.3%) who developed endometrial hyperplasia in the ospemifene group (simple hyperplasia without atypia) 88 days after the last dose of study drug.
Croatian: U jedne ispitanice (0,3%) u skupini ospemifena zabilježen je razvoj hiperplazije endometrija (jednostavna hiperplazija bez atipije) 88 dana nakon posljednje doze ispitivanog lijeka.
English: The principal radioactive component in both plasma and faeces was ospemifene and the main metabolite 4hydroxyospemifene.
Croatian: Glavna radioaktivna komponenta u plazmi i u fecesu bio je ospemifen, a glavni metabolit 4-hidroksiospemifen.
English: The glycogen content of vaginal epithelial cells also decreases, resulting in reduced colonisation by lactobacilli and increased vaginal pH.
Croatian: Sadržaj glikogena u stanicama vaginalnog epitela također opada, posljedica čega je smanjena kolonizacija laktobacila i povišeni vaginalni pH.
English: In patients with severe renal impairment the ospemifene exposure was increased by approximately 20%, when compared to healthy matched subjects.
Croatian: U bolesnica s teškim oštećenjem bubrega izloženost ospemifenu bila je povećana za približno 20% u usporedbi sa zdravim podudarnim ispitanicama.
English: EU/1/14/978/001 EU/1/14/978/002 EU/1/14/978/003
Croatian: EU/1/14/978/002
English: Co-administration with fluconazole
Croatian: Istodobna primjena s flukonazolom
English: Ospemifene belongs to a group of medicines that do not contain hormones called Selective Estrogen Receptor Modulators (SERMs).
Croatian: Ospemifen pripada skupini lijekova koji ne sadrže hormone i nazivaju se selektivni modulatori estrogenskih receptora (engl. selective oestrogen receptor modulator, SERM).
English: On the basis of the scientific conclusions for ospemifene the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing ospemifene is unchanged subject to the proposed changes to the product information
Croatian: Na temelju znanstvenih zaključaka za ospemifen, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) ospemifen nepromijenjen, uz predložene izmjene informacija o lijeku.
English: Therefore ospemifene should be used for the treatment of VVA only after the treatment of breast cancer, including adjuvant therapy, has been completed.
Croatian: Stoga je ospemifen za liječenje VVA potrebno koristiti samo nakon što je liječenje raka dojke, uključujući i adjuvantnu terapiju, dovršeno.
English: In addition, these changes can result in chronic symptoms associated with VVA, the most common of which are vaginal dryness and dyspareunia.
Croatian: Nadalje, ove promjene mogu imati za posljedicu pojavu kroničnih simptoma povezanih s VVA, od kojih su najčešći suhoća vagine i dispareunija.
English: If you take more Senshio than you should
Croatian: Ako uzmete više lijeka Senshio nego što ste trebali
English: This effect was likely due to the anti-oestrogenic effect of ospemifene in this target tissue, which was attenuating the physiological thymic involution (atrophy) process induced by oestrogens starting during puberty.
Croatian: Taj učinak je vjerojatno posljedica antiestrogenog učinka ospemifena na ovo ciljno tkivo, koji je oslabljivao proces fiziološke involucije (atrofije) timusa koji je induciran djelovanjem estrogena u pubertetu.
English: In a two-generation reproductive study on pre-and postnatal development ospemifene induced an increased post-implantation loss, an increased number of dead pups at birth as well as an increased incidence of postnatal loss of pups in the F1 generation.
Croatian: U reproduktivnom ispitivanju prenatalnog i postnatalnog razvoja u dvije generacije, ospemifen je inducirao porast postimplantacijskih gubitaka, porast broja mrtvookoćene mladunčadi, kao i porast incidencije postnatalnog gubitka mladunčadi u F1 generaciji.
English: In the liver hepatocyte hypertrophy or increased glycogen storage, increase in alanine aminotransferase (ALT) and alkaline phosphatase (ALP) were observed.
Croatian: U jetri su primijećeni hipertrofija hepatocita ili pojačana pohrana glikogena, porast alanin aminotransferaze (ALT) i alkalne fosfataze (ALP).
English: These results suggest that co-administration of ospemifene with any medicinal product that inhibits both CYP3A4 and CYP2C9 activity (e.g. fluconazole) would be expected to increase the exposure of ospemifene in a similar way.
Croatian: Ovi rezultati sugeriraju da se istodobnom primjenom ospemifena s bilo kojim lijekom koji inhibira aktivnost i CYP3A4 i CYP2C9 (npr. flukonazol) može očekivati povećana izloženost ospemifenu na sličan način.
English: Across all placebo-controlled clinical trials of ospemifene, deep vein thrombosis occurred at a frequency of approximately 3.65 cases per 1,000 patient years on 60 mg ospemifene (95% confidence interval of 0.44 to 13.19) versus 3.66 cases per 1,000 patient years for placebo (95% confidence interval of 0.09 to 20.41; relative risk is 1.0).
Croatian: U svim placebom kontroliranim kliničkim ispitivanjima ospemifena, duboka venska tromboza javljala se s učestalošću od oko 3,65 slučajeva na 1000 bolesnik godina na 60 mg ospemifena (95% interval pouzdanosti od 0,44 do 13,19) naspram 3,66 slučajeva na 1000 bolesnik godina za placebo (95% interval pouzdanosti od 0,09 do 20,41; relativni rizik je 1,0).
English: It is recommended that ospemifene should be taken with food at the same time each day.
Croatian: Preporučuje se ospemifen uzimati s hranom svakog dana u isto vrijeme.
English: The risk of cerebrovascular events associated with ospemifene cannot be excluded.
Croatian: Rizik od cerebrovaskularnih događaja povezanih s ospemifenom ne može se isključiti.
English: In the two 12 weeks studies (trials 1 and 2), 739 patients received ospemifene and 724 patients received placebo.
Croatian: U dva ispitivanja u trajanju od 12 tjedana (ispitivanje 1 i 2), 739 bolesnica primalo je ospemifen a 724 je primalo placebo.
English: Based on a review of data from clinical trials and post-marketing reporting, the PRAC considers that a causal relationship between ospemifene and the adverse reaction vaginal bleeding cannot be ruled out and therefore recommends an updated to section 4.8 of the SmPC.
Croatian: Na temelju pregledanih podataka iz kliničkih ispitivanja i izvješća nakon stavljanja lijeka u promet, PRAC smatra da se uzročno-posljedična povezanost između ospemifena i nuspojave vaginalnog krvarenja ne može isključiti i stoga preporučuje ažuriranje dijela 4.8 sažetka opisa svojstava lijeka.
English: If you take more tablets than you should, tell your doctor or pharmacist.
Croatian: Ako ste uzeli više tableta nego što ste trebali, obratite se svom liječniku ili ljekarniku.
English: A clinical monitoring of a decrease in the efficacy of ospemifene should be made.
Croatian: U tom slučaju potreban je klinički nadzor smanjenja djelotvornosti ospemifena.
English: Mean ospemifene Cmax and AUC0-24hr were 785 ng/mL and 5,448 ng•hr/mL, respectively, after repeat doses of 60 mg ospemifene once daily in the fed state.
Croatian: Srednji Cmax i AUC0-24hr za ospemifen bili su 785 ng/mL odnosno 5448 ng•h/mL, nakon ponovljenih doza od 60 mg ospemifena jedanput na dan nakon jela.
English: These non-clinical findings are consistent with findings from clinical trials, in which ospemifene demonstrated benefits on vaginal physiology without apparent oestrogen-like effects on breast tissue (see subheading Clinical safety).
Croatian: Ovi neklinički nalazi u skladu su s nalazima iz kliničkih ispitivanja u kojima je ospemifen pokazao pozitivno djelovanje na vaginalnu fiziologiju bez očitih učinaka nalik estrogenu na tkivo dojke (vidjeti podnaslov Klinička sigurnost).
English: Senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women who are not candidates for local vaginal oestrogen therapy.
Croatian: Senshio je indiciran za liječenje umjerene do teške simptomatske vulvarne i vaginalne atrofije (VVA) u žena u postmenopauzi koje nisu kandidati za lokalnu vaginalnu estrogensku terapiju.
English: This should be considered when prescribing ospemifene for postmenopausal women with a history of stroke or other significant stroke risk factors.
Croatian: Ovo je potrebno uzeti u obzir pri propisivanju ospemifena ženama u postmenopauzi kod kojih u anamnezi postoji podatak o moždanom udaru ili drugi značajni čimbenici rizika za moždani udar.
English: Endometrial findings
Croatian: Nalazi na endometriju
English: This difference is not considered clinically relevant and no dose adjustment is necessary in patients with renal impairment.
Croatian: Ta razlika se ne smatra klinički relevantnom i nije potrebna prilagodba doze u bolesnica s oštećenjem bubrega.
English: 28 Feb 2021
Croatian: 28. veljače