FrancophonIA/ELRC3.0 huggingface dataset:
English: Multipack: 196 (2 packs of 98) film-coated tablets
Slovenian: Skupno pakiranje: 196 (2 pakiranji po 98) filmsko obloženih tablet
English: • abnormalities in liver function tests, inflammation of the liver (hepatitis)
Slovenian: • nenormalni izvidi preiskav delovanja jeter, vnetje jeter (hepatitis)
English: Dosage in patients with renal impairment GFR mL/min
Slovenian: Odmerjanje pri bolnikih z okvaro ledvic GFR ml/min
English: Animal studies with metformin do not indicate harmful effects with respect to pregnancy, embryonic or foetal development, parturition or postnatal development (see section 5.3).
Slovenian: Študije metformina na živalih ne kažejo učinkov na nosečnost, embrionalni ali fetalni razvoj, porod ali poporodni razvoj (glejte poglavje 5.3).
English: • if you have severely reduced kidney function.
Slovenian: • če imate hudo oslabljeno delovanje ledvic.
English: Before initiating dapagliflozin, factors in the patient history that may predispose to ketoacidosis should be considered.
Slovenian: Pred uvedbo dapagliflozina je treba v bolnikovi anamnezi oceniti dejavnike, ki bi lahko povečevali nagnjenost h ketoacidozi.
English: High overdose or concomitant risks of metformin may lead to lactic acidosis.
Slovenian: Velik čezmeren odmerek ali sočasna tveganja metformina lahko povzročijo laktacidozo.
English: Special caution should be exercised in situations where renal function may become impaired, for example when initiating anti-hypertensive or diuretic therapy or when starting treatment with a NSAID.
Slovenian: Posebna previdnost je potrebna v okoliščinah, ko bi se lahko pojavila okvara delovanja ledvic, npr. na začetku zdravljenja z antihipertenzivi ali diuretiki ali ob uvedbi zdravljenja z NSAID.
English: HbA1c reductions were seen across subgroups including gender, age, race, duration of disease, and baseline body mass index (BMI).
Slovenian: Znižanje HbA1c so ugotovili tudi po podskupinah, vključno po spolu, starosti, rasi, trajanju bolezni in izhodiščnem indeksu telesne mase (ITM).
English: Dapagliflozin reduced the incidence of events of the composite of confirmed sustained eGFR decrease, end-stage renal disease, renal or cardiovascular death.
Slovenian: Dapagliflozin je zmanjšal pojavnost elementov sestavljenega dogodka potrjenega, trajnega zmanjšanja eGFR, končne odpovedi ledvic in ledvične ali srčno-žilne smrti.
English: Your doctor may decide to temporarily or permanently stop your treatment with Xigduo.
Slovenian: Zdravnik se bo morda odločil, da vam zdravljenje z zdravilom Xigduo začasno prekine ali trajno konča.
English: Of the 27 patients with DKA events in the dapagliflozin group, 22 had concomitant insulin treatment at the time of the event.
Slovenian: Od 27 bolnikov, ki se jim je DKA pojavila v skupini z dapagliflozinom, jih je v času dogodka 22 sočasno prejemalo insulin.
English: Do not take Xigduo
Slovenian: Ne jemljite zdravila Xigduo
English: At baseline, 10.0% of patients had a history of heart failure.
Slovenian: Izhodiščno je imelo 10,0 % bolnikov v anamnezi srčno popuščanje.
English: Diagnostic laboratory findings are decreased blood pH (< 7.35), increased plasma lactate levels above 5 mmol/L, and an increased anion gap and lactate/pyruvate ratio.
Slovenian: Diagnostični laboratorijski izvidi so zmanjšan pH krvi (< 7,35), zvišane ravni laktata v plazmi (> 5 mmol/l) in povečana anionska vrzel ter razmerje laktat/piruvat.
English: What Xigduo looks like and contents of the pack
Slovenian: Izgled zdravila Xigduo in vsebina pakiranja
English: Metformin may act via three mechanisms: - by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis; - by modestly increasing insulin sensitivity, improving peripheral glucose uptake and utilisation in muscle; - by delaying intestinal glucose absorption.
Slovenian: Metformin lahko deluje po treh mehanizmih: - z zmanjšanjem nastajanja glukoze v jetrih z zavrtjem glukoneogeneze in glikogenolize, - z zmernim povečanjem občutljivosti za insulin, s čimer izboljša periferni privzem glukoze in porabo v mišicah, - z upočasnitvijo absorpcije glukoze iz črevesa.
English: Xigduo may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Slovenian: Zdravilo Xigduo lahko povzroči zelo redek, a zelo resen neželeni učinek, imenovan laktacidoza, zlasti če ledvice ne delujejo pravilno.
English: Hypoglycaemia The frequency of hypoglycaemia depended on the type of background therapy used in each study.
Slovenian: Hipoglikemija Pogostnost hipoglikemij je bila odvisna od vrste osnovnega zdravljenja v posamezni študiji.
English: • in patients already being treated with the combination of dapagliflozin and metformin as separate tablets.
Slovenian: • pri bolnikih, ki že prejemajo kombinacijo dapagliflozina in metformina v ločenih tabletah.
English: Dapagliflozin Effect on Cardiovascular Events (DECLARE) was an international, multicentre, randomised, double-blind, placebo-controlled clinical study conducted to determine the effect of dapagliflozin compared with placebo on cardiovascular outcomes when added to current background therapy.
Slovenian: Študija DECLARE ("Dapagliflozin Effect on Cardiovascular Events") je bila mednarodna, multicentrična, randomizirana, dvojno slepa, s placebom nadzorovana klinična študija za ugotavljanje vpliva dapagliflozina v primerjavi s placebom na srčno-žilne izide med uporabo kot dodatka trenutnemu osnovnemu zdravljenju.
English: If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Xigduo before or at the time of the injection.
Slovenian: Če vam bodo v krvni obtok injicirali kontrastno sredstvo, ki vsebuje jod, na primer zaradi rentgenskega ali drugega slikanja, morate pred časom injiciranja ali v tem času prenehati z jemanjem zdravila Xigduo.
English: If you forget to take Xigduo
Slovenian: Če ste pozabili vzeti zdravilo Xigduo
English: In case of dehydration (severe diarrhoea or vomiting, fever or reduced fluid intake), Xigduo should be temporarily discontinued and contact with a health care professional is recommended.
Slovenian: V primeru dehidracije (huda driska ali bruhanje, zvišana telesna temperatura ali zmanjšan vnos tekočine) je treba jemanje zdravila Xigduo začasno prekiniti; priporoča se posvet z zdravstvenim delavcem.
English: Reproductive and developmental toxicity
Slovenian: Vpliv na razmnoževanje in razvoj
English: PVC/PCTFE/Alu blister.
Slovenian: Pretisni omot iz PVC/PCTFE/Alu.
English: In active- and placebo-controlled clinical trials (dapagliflozin, N=5936, All control, N=3403), the frequency of rash was similar for dapagliflozin (1.4%) and all control (1.4%), respectively.
Slovenian: V kliničnih preskušanjih, kontroliranih z učinkovino in s placebom (dapagliflozin n = 5936, vse kontrolne osebe; n = 3403) je bila pogostnost izpuščaja z dapagliflozinom (1,4 %) podobna kot pri vseh kontrolnih osebah (1,4 %).
English: In total, there were 30,623 patient-years of exposure to dapagliflozin.
Slovenian: V celoti je bila izpostavljenost dapagliflozinu 30.623 bolnik-let.
English: Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Slovenian: Gastrointestinalni simptomi, npr. navzea, bruhanje, driska, bolečine v trebuhu in izguba apetita, se najpogosteje pojavijo med uvedbo zdravljenja in večinoma spontano minejo.
English: Elderly patients are more likely to have impaired renal function, and/or to be treated with anti-hypertensive medicinal products that may cause changes in renal function such as angiotensin-converting enzyme inhibitors (ACE-I) and angiotensin II type 1 receptor blockers (ARB).
Slovenian: Pri starejših bolnikih je verjetnejša okvara ledvic in/ali zdravljenje z antihipertenzivnimi zdravili, ki lahko povzročijo spremembe v delovanju ledvic, na primer z zaviralci angiotenzinske konvertaze (ACE-I - angiotensin-converting enzyme inhibitors) in antagonisti angiotenzina II tipa I (ARBangiotensin II type 1 receptor blockers).
English: The following statements reflect the preclinical safety data of the individual active substances of Xigduo.
Slovenian: Naslednje navedbe temeljijo na predkliničnih podatkih o varnosti za posamezni učinkovini zdravila Xigduo.
English: Precipitating factors for DKA were as expected in a type 2 diabetes mellitus population (see section 4.4).
Slovenian: Sprožilni dejavniki za DKA so bili takšni, kot so pričakovani v populaciji s sladkorno boleznijo tipa 2 (glejte poglavje 4.4).
English: • if you have problems with your liver.
Slovenian: • če imate težave z jetri.
English: Each tablet contains a fixed dose of dapagliflozin and metformin (see section 2).
Slovenian: Vsaka tableta vsebuje fiksni odmerek dapagliflozina in metformina (glejte poglavje 2).
English: These subjects had detectable glucose in the urine for a dose-related period of time (at least 5 days for the 500 mg dose), with no reports of dehydration, hypotension or electrolyte imbalance, and with no clinically meaningful effect on QTc interval.
Slovenian: Ti preiskovanci so imeli v obdobju, ki je bilo odvisno od odmerka (vsaj 5 dni po odmerku 500 mg), v urinu zaznavno glukozo, brez dehidracije, hipotenzije ali neravnovesja elektrolitov in brez klinično pomembnega vpliva na interval QTc.
English: 14, 28, 56 and 60 film-coated tablets in non-perforated blisters.
Slovenian: 14, 28, 56 in 60 filmsko obloženih tablet v neperforiranih pretisnih omotih.
English: Xigduo is indicated in adults for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise:
Slovenian: Zdravilo Xigduo je indicirano pri odraslih za zdravljenje sladkorne bolezni tipa 2 kot dodatek dieti in telesni dejavnosti:
English: This medicine contains two different substances called dapagliflozin and metformin.
Slovenian: To zdravilo vsebuje dve različni učinkovini: dapagliflozin in metformin.
English: Taking it with other medicines that lower the amount of sugar in your blood, such as insulin or a “sulphonylurea” medicine, can cause too low blood sugar levels (hypoglycaemia), which may cause symptoms such as weakness, dizziness, increased sweating, fast heart beat, change in vision or difficulties concentrating, and may affect your ability to drive and use machines.
Slovenian: Jemanje tega zdravila skupaj z drugimi zdravili, ki znižujejo sladkor v krvi, kot je insulin ali zdravilo iz skupine sulfonilsečnin, lahko povzročijo prekomerno zmanjšanje količine sladkorja v krvi (hipoglikemijo), ta pa lahko povzroči simptome kot so šibkost, omotica, povečano znojenje, hiter srčni utrip, spremembe vida ali težave s koncentracijo, in lahko vpliva na vašo sposobnost vožnje in upravljanja s stroji.
English: In case of intercurrent conditions that may lead to volume depletion (e.g. gastrointestinal illness), careful monitoring of volume status (e.g. physical examination, blood pressure measurements, laboratory tests including haematocrit and electrolytes) is recommended.
Slovenian: V primeru sočasnih stanj, ki lahko povzročijo pomanjkanje volumna (npr. bolezen prebavil), je priporočljivo skrbno spremljati volumsko stanje (npr. s kliničnim pregledom, meritvami krvnega tlaka, laboratorijskimi preiskavami, vključno s hematokritom) in elektrolite.
English: At the usual metformin doses and dosing schedules, steady-state plasma concentrations are reached within 24-48 hours and are generally less than 1 μg/mL.
Slovenian: Ob običajnih odmerkih in odmernih shemah metformina je koncentracija v stanju dinamičnega ravnovesja v plazmi dosežena v 24 do 48 urah in je na splošno nižja od 1 µg/ml.
English: The results showed a similar mean reduction in HbA1c from baseline to Week 52, compared with glipizide, thus demonstrating non-inferiority (Table 3).
Slovenian: Rezultati so pokazali podobno povprečno znižanje HbA1c od izhodišča do 52. tedna kot z glipizidom, s čimer je bila dokazana neinferiornost (preglednica 3).
English: OUTER CARTON - PART OF MULTIPACK - WITH BLUE BOX
Slovenian: ZUNANJA ŠKATLA - DEL SKUPNEGA PAKIRANJA - Z MODRIM OKENCEM
English: • Necrotising fasciitis of the perineum or Fournier's gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus, seen very rarely.
Slovenian: • Nekrotizirajoči fasciitis presredka ali Fournierjeva gangrena, resna okužba mehkega tkiva spolovil ali predela med spolovili in zadnjikom, ki je zelo redka.
English: These findings were associated with dose-related increases in kidney weight and macroscopic kidney enlargement observed at all doses.
Slovenian: Ti izsledki so bili povezani s povečanjem mase ledvic, ki je bilo odvisno od odmerka, in makroskopskim povečanjem ledvic, opaznim pri vseh odmerkih.
English: The pack sizes are 14, 28, 56 and 60 film-coated tablets in non-perforated blisters, 60x1 film-coated tablets in perforated unit dose blisters and multipack containing 196 (2 packs of 98) film-coated tablets in non-perforated blisters.
Slovenian: Velikosti pakiranj so 14, 28, 56 in 60 filmsko obloženih tablet v neperforiranih pretisnih omotih, 60 x 1 filmsko obložena tableta v perforiranih pretisnih omotih za posamezni odmerek in skupno pakiranje, ki vsebuje 196 (2 pakiranji po 98) filmsko obloženih tablet v neperforiranih pretisnih omotih.
English: There were no clinically relevant differences in systemic exposures between White, Black or Asian races.
Slovenian: Rasa Sistemska izpostavljenost se med belsko, črnsko in azijsko raso ni klinično pomembno razlikovala.
English: • diarrhoea or stomach ache
Slovenian: • driska ali bolečine v trebuhu
English: If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking this medicine.
Slovenian: Če kaj od naštetega velja za vas (ali če ste negotovi), se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden vzamete to zdravilo.
English: The primary endpoints were time to first event of the composite of cardiovascular death, myocardial infarction or ischaemic stroke (MACE) and time to first event of the composite of hospitalisation for heart failure or cardiovascular death.
Slovenian: Primarna opazovana dogodka sta bila čas do prvega dogodka iz sestavljenega dogodka srčno-žilne smrti, miokardnega infarkta ali ishemične možganske kapi (MACE) in čas do prvega dogodka iz sestavljenega dogodka sprejema v bolnišnico zaradi srčnega popuščanja ali srčno-žilne smrti.
English: Risk of volume depletion with dapagliflozin should also be taken into account (see sections 4.4 and 5.2).
Slovenian: Upoštevati je treba tudi tveganje za pomanjkanje volumna med uporabo dapagliflozina (glejte poglavji 4.4 in 5.2).
English: At 1 year, mean eGFR was slightly lower, and at 4 years, mean eGFR was slightly higher in the dapagliflozin group compared with the placebo group.
Slovenian: Po 1 letu je bil eGFR v skupini z dapagliflozinom rahlo nižji, po 4 letih pa rahlo višji v primerjavi s skupino s placebom.
English: These may be medicine(s) by mouth or given by injection, such as insulin or a GLP-1 receptor agonist.
Slovenian: To so lahko zdravila, ki jih zaužijete, ali jih dobite z injekcijo, kot na primer insulin ali agonist receptorjev GLP-1.
English: Mean HbA1c was 8.3% and mean BMI was 32.1 kg/m
Slovenian: Povprečni HbA1c je bil 8,3 % in povprečni ITM 32,1 kg/m
English: Xigduo has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Xigduo nima vpliva ali ima le zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: In patients with decreased renal function (based on measured creatinine clearance), the plasma and blood half-life of metformin is prolonged and the renal clearance is decreased in proportion to the decrease in creatinine clearance, leading to increased levels of metformin in plasma.
Slovenian: Pri bolnikih z zmanjšanim delovanjem ledvic (na podlagi izmerjenega očistka kreatinina) se razpolovni čas metformina v plazmi in krvi podaljša, ledvični očistek pa se zmanjša sorazmerno zmanjšanju očistka kreatinina, tako da se koncentracija metformina v plazmi zviša.
English: Studies in rats treated with dapagliflozin have shown toxicity to the developing kidney in the time period corresponding to the second and third trimesters of human pregnancy (see section 5.3).
Slovenian: Študije na podganah, ki so prejemale dapagliflozin, so pokazale toksične učinke na razvijajoče se ledvice v obdobju, ki ustreza drugemu in tretjemu trimesečju nosečnosti pri človeku (glejte poglavje 5.3).
English: Subjects with mean daily insulin dose reduction of at least
Slovenian: Preiskovanci z znižanjem povprečnega dnevnega odmerka insulina za vsaj 10 % (%)
English: The renal pelvic and tubular dilatations observed in juvenile animals did not fully reverse within the approximate 1-month recovery period.
Slovenian: Pri mladih živalih ugotovljene razširitve ledvičnega meha in tubulov med približno 1-mesečnim obdobjem okrevanja niso povsem izginile.
English: Stop taking Xigduo and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.
Slovenian: Takoj prenehajte jemati zdravilo Xigduo in se obrnite na zdravnika ali najbližjo bolnišnico, če se pojavijo nekateri od simptomov laktacidoze, saj lahko to stanje vodi v komo.
English: • Dehydration: loss of too much fluid from your body, seen uncommonly (may affect up to 1 in 100 people).
Slovenian: • Dehidracija: čezmerna izguba tekočine iz telesa, ki je občasna (pojavi se lahko pri največ 1 od 100 bolnikov).
English: Posology Adults with normal renal function (glomerular filtration rate [GFR] ≥ 90 mL/min)
Slovenian: Odmerjanje Odrasli z normalnim delovanjem ledvic (hitrost glomerularne filtracije [GFR] ≥ 90 ml/min)
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/L (250 mg/dL).
Slovenian: V številnih primerih je bila klinična slika te motnje neznačilna in koncentracija glukoze v krvi je bila le zmerno zvišana, pod 14 mmol/l (250 mg/dl).
English: There is no clinically meaningful increase in exposure based on age alone in subjects up to 70 years old.
Slovenian: Bolniki v starosti do 70 let zgolj zaradi starosti nimajo klinično pomembno večje izpostavljenosti.
English: The treatment benefit of dapagliflozin over placebo was observed both in patients with and without established cardiovascular disease, with and without heart failure at baseline, and was consistent across key subgroups, including age, gender, renal function (eGFR) and region.
Slovenian: Terapevtsko korist dapagliflozina v primerjavi s placebom so opažali tako pri bolnikih z izhodiščno prisotno razvito srčno-žilno boleznijo in tistih brez nje kot pri bolnikih z izhodiščno prisotnim srčnim popuščanjem in brez njega ter je bila prisotna v ključnih podskupinah, vključno s starostjo, spolom, delovanjem ledvic (eGFR) in regijo.
English: In an analysis of 5 placebo-controlled dapagliflozin add-on to metformin studies, the safety results were similar to that of the pre-specified pooled analysis of 13 placebo-controlled dapagliflozin studies (see Dapagliflozin, Summary of the safety profile below).
Slovenian: V analizi 5 s placebom kontroliranih študij dapagliflozina, dodanega metforminu, so bili rezultati glede varnosti podobni kot v vnaprej opredeljeni kumulativni analizi 13 s placebom kontroliranih študij dapagliflozina (glejte Dapagliflozin, Povzetek varnostnih značilnosti, spodaj).
English: Urinary glucose excretion may be associated with an increased risk of urinary tract infection; therefore, temporary interruption of treatment should be considered when treating pyelonephritis or urosepsis.
Slovenian: Izločanje glukoze z urinom je lahko povezano z večjim tveganjem za okužbe sečil, zato je treba med zdravljenjem pielonefritisa ali urosepse razmisliti o začasni prekinitvi uporabe tega zdravila.
English: The primary assessment of safety and tolerability was conducted in a pre-specified pooled analysis of 13 short-term (up to 24 weeks) placebo-controlled studies with 2,360 subjects treated with dapagliflozin 10 mg and 2,295 treated with placebo.
Slovenian: Primarno oceno varnosti in prenašanja so izvedli v vnaprej opredeljeni kumulativni analizi 13 kratkotrajnih (do 24 tednov trajajočih) s placebom kontroliranih študij, v katere je bilo vključenih 2.360 preiskovancev, zdravljenih z 10 mg dapagliflozina, in 2.295 preiskovancev, ki so prejemali placebo.
English: Stop taking Xigduo and see a doctor as soon as possible if you notice any of the following serious or potentially serious effects:
Slovenian: Nehajte jemati zdravilo Xigduo in čim prej obiščite zdravnika, če opazite katerega od naslednjih resnih ali potencialno resnih neželenih učinkov:
English: Caution should be exercised in patients for whom a dapagliflozin-induced drop in blood pressure could pose a risk, such as patients on anti-hypertensive therapy with a history of hypotension or elderly patients.
Slovenian: Previdnost je potrebna pri bolnikih, pri katerih bi z dapagliflozinom povzročen padec krvnega tlaka lahko pomenil tveganje, npr. pri bolnikih, ki se zdravijo z antihipertenzivi in imajo hipotenzijo v anamnezi, ali pri starejših bolnikih.
English: Dapagliflozin is extensively metabolised, primarily to yield dapagliflozin 3-O-glucuronide, which is an inactive metabolite.
Slovenian: Dapagliflozin se obsežno presnovi, predvsem z nastankom dapagliflozin-3-O-glukuronida, ki je neaktiven presnovek.
English: Dapagliflozin should not be initiated.
Slovenian: Dapagliflozina se ne sme uvesti.
English: Heart failure or cardiovascular death
Slovenian: Srčno popuščanje ali srčno-žilna smrt
English: There are no data from the use of Xigduo or dapagliflozin in pregnant women.
Slovenian: O uporabi zdravila Xigduo ali dapagliflozina pri nosečnicah ni podatkov.
English: Glucocorticoids (given by systemic and local routes), beta-2 agonists, and diuretics have intrinsic hyperglycaemic activity.
Slovenian: Glukokortikoidi (uporabljeni sistemsko ali lokalno), agonisti adrenergičnih receptorjev beta-2 in diuretiki imajo intrinzično hiperglikemičen učinek.
English: They have “5/1000” on one side and “1069” on the other side.
Slovenian: Na eni strani imajo vtisnjeno oznako "5/1000" in na drugi strani "1069".
English: In the 13-study safety pool, urinary tract infections were more frequently reported for dapagliflozin compared with placebo (4.7% versus 3.5%, respectively; see section 4.4).
Slovenian: V kumulativni obravnavi 13 študij o varnosti so o okužbah sečil pogosteje poročali za dapagliflozin kot za placebo (4,7 % v primerjavi s 3,5 %; glejte poglavje 4.4).
English: In addition, dapagliflozin reduced the new onset of sustained albuminuria (hazard ratio 0.79 [95% CI 0.72, 0.87]) and led to greater regression of macroalbuminuria (hazard ratio 1.82 [95% CI 1.51, 2.20]) compared with placebo.
Slovenian: Poleg tega je dapagliflozin zmanjšal pojavljanje novonastale trajne albuminurije (razmerje ogroženosti 0,79 [95 % IZ 0,72; 0,87]) in je povzročil večje nazadovanje makroalbuminurije (razmerje ogroženosti 1,82 [95 % IZ 1,51; 2,20]) v primerjavi s placebom.
English: The no observed adverse effect level (NOAEL) for developmental toxicity, the lowest dose tested, is associated with a maternal systemic exposure multiple that is approximately 19 times the human value at the maximum recommended human dose.
Slovenian: Raven brez opaženih neželenih učinkov (NOAEL - no observed adverse effect level) za toksične učinke na razvoj - najmanjši testirani odmerek - je povezana z maternalno sistemsko izpostavljenostjo, ki je približno 19-krat tolikšna kot izpostavljenosti človeka pri največjem priporočenem odmerku za človeka.
English: At 24 weeks, reductions in serum uric acid concentrations ranged from -48.3 to -18.3 micromoles/L (-0.87 to -0.33 mg/dL).
Slovenian: Po 24 tednih je znižanje koncentracije sečne kisline v serumu segalo od -48,3 do -18,3 mikromolov/l (-0,87 do -0,33 mg/dl).