FrancophonIA/ELRC3.0 huggingface dataset:
English: Eli Lilly ČR, s.r.o, Pobřežní 1A, , 186 00 Praha 8 Czech Republic
Slovenian: Eli Lilly ČR, s.r.o, Pobřežní 1A, , 186 00 Praha 8 Češka republika
English: Eli Lilly ČR, s.r.o, Pobřežní 1A, 186 00 Praha 8 Czech Republic
Slovenian: Eli Lilly ČR, s.r.o, Pobřežní 1A, 186 00 Praha 8 Češka republika
English: Each 1000 mg vial contains 17.5 mg (<1 mmol) sodium.
Slovenian: Ena 1.000 mg viala vsebuje 17,5 mg (< 1 mmol) natrija.
English: • Somnolence
Slovenian: • Zaspanost
English: The infusion will last approximately 30 minutes.
Slovenian: Zdravilo Gemzar boste vedno prejeli v eno izmed vaših ven. Infuzija bo trajala približno 30 minut.
English: Eli Lilly ČR, s.r.o., Pobřežní 1a, 186 00 Praha 8 Czech Republic
Slovenian: Eli Lilly ČR, s.r.o., Pobřežní 1a, 186 00 Praha 8 Češka republika
English: 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET <[Izpolni država članica]>
English: • breast cancer, together with paclitaxel.
Slovenian: • rak dojke, skupaj s paklitakselom
English: RG21 6XA
Slovenian: Hampshire RG21 6XA Velika Britanija
English: General disorders and administration site conditions
Slovenian: Splošne težave in spremembe na mesta aplikacije
English: Further dilution with sterile sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative can be done.
Slovenian: Lahko se nadalje redči z natrijevim kloridom 9 mg/ml (0,9 %) sterilno raztopino za injiciranje, brez konzervansa.
English: Combination use in bladder cancer
Slovenian: Kombinirana uporaba za karcinom dojke
English: Gemcitabine is indicated for the treatment of locally advanced or metastatic bladder cancer in combination with cisplatin.
Slovenian: Gemcitabin je indiciran za zdravljenje lokalno napredovalega ali metastatskega karcinoma sečnega mehurja v kombinaciji s cisplatinom.
English: Gemcitabine is mutagenic in an in vitro mutation test and an in vivo bone marrow micronucleus test. Long term animal studies evaluating the carcinogenic potential have not been performed.
Slovenian: Gemcitabin je mutagen v in vitro testu mutacije v in vivo mikrojedrnem testu kostnega mozga.
English: Weakness
Slovenian: Slabost
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET <[Izpolni država članica]>
English: A statistically significant prolongation of the time to progression of disease, from 5.8 to 8.6 months (log-rank p= 0.0038) was observed in the patients treated with GCb compared to patients treated with Cb.
Slovenian: Pri bolnikih, zdravljenih z GCb so v primerjavi z bolniki, zdravljenimi z Cb opazili statistično značilno podaljšanje časa do napredovanja bolezni od 5,8 do 8,6 mesecev (logaritemska stopnja p=0,0038).
English: “Gemcitabine is indicated for the treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas”.
Slovenian: „Gemcitabin je indiciran za zdravljenje bolnikov z lokalno napredovalim ali metastatskim adenokarcinomom trebušne slinavke.“
English: Gemzar 1000 mg contains 17.5 mg (< 1 mmol) sodium per vial.
Slovenian: Gemzar 1.000 mg vsebuje 17,5 mg (< 1 mmol) natrija na vialo.
English: • uncommon: affects 1 to 10 users in 1,000
Slovenian: • občasni: pri 1 do 10 od 1.000 bolnikov
English: • bladder cancer, together with cisplatin.
Slovenian: • rak sečnega mehurja, skupaj s cisplatinom
English: Your doctor may decide to change the dose or delay treating you depending on your general condition and if your blood cell counts are too low.
Slovenian: odvisno od vašega splošnega stanja in če je število vaših krvnic celic prenizko.
English: “Gemcitabine is indicated in the treatment of locally advance or metastatic bladder cancer in combination with cisplatin.”.
Slovenian: „Gemcitabin je indiciran za zdravljenje lokalno napredovalega ali metastatskega raka sečnega mehurja v kombinaciji s cisplantinom.“
English: The MAH agreed that the indication is redundant because the first line treatment of pancreatic treatment with gemcitabine is standard of care and agreed to remove it.
Slovenian: Imetnik dovoljenja za promet z zdravilom se je strinjal, da je indikacija odvečna in jo bo umaknil, ker je zdravljenje izbire v primeru raka trebušne slinavke zdravljenje z gemcitabinom, ki je že standardna nega.
English: A statistically significant prolongation of the time to progression, from 3.7 to 5.6 months (log-rank p<0.0012) and a statistically significant prolongation of median survival from 7.6 months to 9.1 months (log-rank p<0.004) was observed in patients treated with gemcitabine/cisplatin compared to patients treated with cisplatin.
Slovenian: Pri bolnikih, zdravljenih z gemcitabinom/cisplatinom so v primerjavi z bolniki, zdravljenimi s cisplatinom opazili statistično značilno podaljšanje časa do napredovanja bolezni od 3,7 do 5,6 mesecev (logaritemska stopnja p<0,0012) ter statistično značilno podaljšanje povprečnega preživetja od 7,6 mesecev do 9,1 mesecev (logaritemska stopnja p<0,004).
English: Gemcitabine is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas.
Slovenian: Gemcitabin je indiciran za zdravljenje bolnikov z lokalno napredovalim ali metastatskim adenokarcinomom trebušne slinavke.
English: Mean steady state volume of distribution (Vss): 150 l/m2 (range 96-228 l/m2).
Slovenian: Povprečni volumen porazdelitve v stanju dinamičnega ravnovesja) (Vss): 150 l/m površine telesa (razpon
English: • Absolute granulocyte count < 500 x 106/l for more than 5 days
Slovenian: • absolutna koncentracija granulocitov < 0,5 x 10
English: • Haematuria
Slovenian: • Hematurija
English: Sleepiness
Slovenian: Zaspanost
English: Discard unused contents appropriately.
Slovenian: Neuporabljeno zdravilo ustrezno zavrzite.
English: Gemzar 200 mg contains 3.5 mg (<1 mmol) sodium per vial.
Slovenian: Gemzar 200 mg vsebuje 3,5 mg (< 1 mmol) natrija na vialo.
English: Read all of this leaflet carefully before you start receiving this medicine.
Slovenian: Pred uporabo natančno preberite navodilo!
English: Muscle pain
Slovenian: Mišična bolečina
English: MARKETING AUTHORISATION NUMBER [To be completed nationally]
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET <[Izpolni država članica]>
English: Gemzar 200 mg contains:
Slovenian: Gemzar 200 mg vsebuje:
English: Gemcitabine, in combination with cisplatin is indicated as first line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
Slovenian: Gemcitabin je v kombinaciji s cisplatinom indiciran kot zdravljenje prvega izbora za bolnike z lokalno napredovalim ali metastatskim nedrobnoceličnim karcinomom pljuč.
English: You must discontinue breast-feeding during Gemzar treatment.
Slovenian: Med zdravljenjem z zdravilom Gemzar morate dojenje prekiniti.
English: Very Common
Slovenian: Zelo pogosto
English: Combination use in ovarian cancer
Slovenian: Kombinirana uporaba za karcinom sečnega mehurja
English: Patients should have an absolute granulocyte count of at least 1,500 (x 106/l) and platelet account of 100,000 (x 106/l) prior to the initiation of a cycle.
Slovenian: Bolniki morajo imeti pred uvedbo cilkusa absolutno koncentracijo granulocitov vsaj 1.500 (x 10
English: What Gemzar looks like and contents of the pack Gemzar is a white to off-white powder, for solution for infusion in a vial.
Slovenian: Zdravilo Gemzar je bel do belkast prašek za raztopino za infundiranje v viali.
English: Interstitial pneumonitis (scarring of the air sacs of the lung) Spasm of the airways (wheeze) Abnormal chest X ray/scan (scarring of the lungs)
Slovenian: Intersticijski pnevmonitis (brazgotinjenje pljučnih mešičkov pljuč) Spazem dihalnih poti (sopihanje)
English: Regarding breast cancer, the MAH only proposed combination use for inclusion in the harmonised SPC, although a Phase 3 study showed the activity of single-agent gemcitabine for the treatment of metastatic breast cancer (MBC).The indication was supported by a clinical expert report and efficacy data from Phase 2 and 3 single-agent studies of Gemzar in the treatment of breast cancer, including studies conducted by the MAH and results from the published literature.
Slovenian: Glede raka dojk je imetnik dovoljenja za promet z zdravilom predlagal, da se v usklajeni povzetek glavnih značilnosti zdravila vključi le kombinacijsko uporabo, čeprav je študija 3. faze dokazala učinkovitost samostojnega gemcitabina pri zdravljenju metastatskega raka pljuč (MBC).
English: Also, a statistically significant prolongation of the time to progression from 0.9 to 2.3 months (log-rank p<0.0002) and a statistically significant prolongation of median survival from 4.4 to 5.7 months (log-rank p<0.0024) was observed in patients treated with gemcitabine compared to patients treated with 5-fluorouracil.
Slovenian: Pri bolnikih, zdravljenih z gemcitabinom so v primerjavi z bolniki, zdravljenimi s 5fluorouracilom opazili tudi značilno podaljšanje časa do napredovanja bolezni od 0,9 do 2,3 mesecev (logaritemska stopnja p<0,0002) ter statistično značilno podaljšanje povprečnega preživetja od 4,4 do 5,7 mesecev (logaritemska stopnja p<0,0024).
English: The following indications are currently approved for Gemzar and were assessed by the CHMP: 1) Bladder cancer, 2) Advanced Non- small cell lung cancer, 3) Advanced pancreatic cancer, 4) Breast cancer and 5) Ovarian cancer.
Slovenian: Gemcitabin (difluoro deoksicitidin (dFdC)) je citotoksično sredstvo proti raku, ki kaže specifičnost do faze celice in v prvi vrsti uničuje celice, v katerih ravnokar poteka sinteza DNK (faza S), ter pod določenimi pogoji blokira prestop celice preko meje med fazama G1 in S. Za zdravilo Gemzar so trenutno odobrene naslednje indikacije, ki jih je ovrednotil tudi CHMP: 1) rak mehurja, 2) napredovali nedrobnocelični pljučni rak, 3) napredovali rak trebušne slinavke, 4) rak dojk in 5) rak jajčnikov.
English: Gemzar 1g powder for injection 1g
Slovenian: Gemzar 1g powder for injection 1 g prašek za injiciranje intravenska uporaba
English: Non small Cell lung cancer
Slovenian: Nedrobnocelični karcinom pljuč
English: The recommended dose of gemcitabine is 1000 mg/m2, given by 30-minute intravenous infusion.
Slovenian: Priporočeni odmerek gemcitabina je 1.000 mg/m površine telesa, dan kot 30-minutna intravenska infuzija.
English: CLASSIFICATION FOR SUPPLY [To be completed nationally]
Slovenian: NAČIN IZDAJANJA ZDRAVILA <[Izpolni država članica]>
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Slovenian: Ni zadostnih podatkov o uporabi gemcitabina pri nosečnicah.Študije na živalih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
English: • Absolute granulocyte count < 100 x 106/l for more than 3 days
Slovenian: • absolutna koncentracija granulocitov < 0,1 x 10
English: 1000 mg Powder for solution for infusion Intravenous use
Slovenian: 1000 mg prašek za raztopino za infundiranje intravenska uporaba
English: Vascular disorders
Slovenian: Ledvični sistem
English: Nervous system disorders
Slovenian: Pljučni sistem
English: The recommended dose for gemcitabine is 1000 mg/m2, given by 30-minute infusion.
Slovenian: Priporočeni odmerek gemcitabina je 1.000 mg/m površine telesa, dan kot 30-minutna infuzija.
English: • Vomiting
Slovenian: • Luščenje
English: White to off-white plug or powder.
Slovenian: Bel do belkast prašek ali usedlina.
English: Breast cancer
Slovenian: Karcinom dojke
English: Dose reduction with each cycle or within a cycle may be applied based upon the grade of toxicity experienced by the patient.
Slovenian: Odmerek lahko z vsakim ciklusom med tekočim ciklusom zdravljenja znižamo glede na stopnjo toksičnosti, izražene pri bolnici.
English: Combination use The recommended dose for gemcitabine is 1250 mg/m2 body surface area given as a 30-minute intravenous infusion on Day 1 and 8 of the treatment cycle (21 days).
Slovenian: Kombinirana uporaba Priporočeni odmerek gemcitabina je 1.250 mg/m2 površine telesa, dan kot 30-minutna intravenska infuzija
English: PACKAGE LEAFLET
Slovenian: Ledvično popuščanje
English: A statistically significant prolongation of the time to progression, from 4.3 to 6.9 months (p=0.014) was observed in patients treated with gemcitabine/cisplatin compared to patients treated with etoposide/cisplatin.
Slovenian: Pri bolnikih, zdravljenih z gemcitabinom/cisplatinom so v primerjavi z bolniki, zdravljenimi z etopozidom/cisplatinom opazili ststistično značilno podaljšanje časa do napredovanja bolezni od 4,3 do 6,9 mesecev (p=0,014).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains gemcitabine hydrochloride equivalent to 200 mg gemcitabine.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala vsebuje gemcitabinijev klorid, kar ustreza 200 mg gemcitabina.
English: BEFORE YOU ARE GIVEN GEMZAR
Slovenian: KAJ MORATE VEDETI PREDEN BOSTE UPORABILI ZDRAVILO GEMZAR
English: NAME OF THE MEDICINAL PRODUCT Gemzar 200 mg powder for solution for infusion Gemzar 1000 mg powder for solution for infusion Gemcitabine
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Gemzar 200 mg prašek za raztopino za infundiranje Gemzar 1.000 mg prašek za raztopino za infundiranje gemcitabin
English: Stroke
Slovenian: Nahodnost
English: 200 mg Powder for solution for injection Intravenous use
Slovenian: 200 mg prašek za injiciranje intravenska uporaba
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET Whereas - the scope of the referral was the harmonisation of the Summaries of Products Characteristics, labelling and package leaflet.
Slovenian: - je bil okvir napotitvenega postopka uskladitev povzetkov glavnih značilnosti zdravila, označevanja in navodila za uporabo,
English: Gemcitabine monotherapy can be considered in elderly patients or those with performance status 2.
Slovenian: Pri starejših bolnikih ali tistih z stanjem zmogljivosti 2 lahko razmislimo o monoterapiji z gemcitabinom.
English: BATCH NUMBER
Slovenian: ŠTEVILKA SERIJE Serijska št.:
English: • Asthenia
Slovenian: • Nespečnost
English: Gemzar 200 mg powder for solution for infusion Gemzar 1000 mg powder for solution for infusion Gemcitabine
Slovenian: Gemzar 200 mg prašek za raztopino za infundiranje Gemzar 1.000 mg prašek za raztopino za infundiranje gemcitabin
English: • Febrile neutropaenia Very rare
Slovenian: Pogosto • Febrilna nevtropenija.
English: Irregular heart beat (arrhythmia)
Slovenian: Nenormalna rentgenska slika prsnega koša (brazgotinjenje pljuč)
English: If particulate matter is observed, do not administer.
Slovenian: Ne dajajte, če opazite prisotnost trdnih delcev.
English: Common • Anorexia
Slovenian: Pogosto • Anoreksija
English: Recommended posology
Slovenian: Priporočeno odmerjanje
English: If you are concerned about any side effects, talk to your doctor.
Slovenian: Pogovorite se s svojim zdravnikom, če ste zaskrbljeni glede katerega neželenega učinka.
English: Intravenous use and intravesical use
Slovenian: 1 g prašek za raztopino za infundiranje in intravezikalno vstavitev intravenska uporaba and intravesical use
English: • It is important to check your feet regularly and adhere to any other advice regarding foot care and adequate hydration given by your health care professional.
Slovenian: • Pomembno je, da si redno pregledujete stopala in upoštevate ostale nasvete zdravstvenih delavcev o negi stopal in vzdrževanju zadostne količine telesnih tekočin (hidracije).
English: However, as precautionary measures, consideration should be given to carefully monitoring patients with a higher risk for amputation events and counselling patients about the importance of routine preventative foot care and maintaining adequate hydration.
Slovenian: Upoštevati je treba varnostne ukrepe, kot so skrbno spremljanje bolnikov z večjim tveganjem za amputacije ter podučitev bolnikov o pomembnosti rutinske nege stopal in vzdrževanju zadostne hidracije.
English: Children and adolescents Invokana is not recommended for children and adolescents under 18 years.
Slovenian: Pri otrocih in mladostnikih, ki so stari manj kot 18 let, uporaba zdravila Invokana ni priporočljiva.
English: When diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications.
Slovenian: Kadar samo dieta in telesna dejavnost ne zagotavljata zadostne urejenosti glikemije pri bolnikih, pri katerih uporaba metformina ni primerna zaradi neprenašanja ali kontraindikacij.
English: • Swallow the tablet whole with a half glass of water.
Slovenian: Jemanje tega zdravila • Tableto pogoltnite celo, s pol kozarca vode.
English: Some studies indicate that taking canagliflozin may have contributed to the risk of lower limb amputation (mainly toe amputations).
Slovenian: Nekatere študije kažejo, da lahko jemanje kanagliflozina prispeva k tveganju za amputacije na spodnjih okončinah (večinoma prstov na nogah).
English: Invokana has not been studied in patients with type 1 diabetes and is therefore not recommended for use in these patients.
Slovenian: Zdravila Invokana niso preučevali pri bolnikih s sladkorno boleznijo tipa 1, zato uporaba pri teh bolnikih ni priporočljiva.
English: The Leydig cell tumours are associated with an increase in luteinizing hormone (LH), which is a known mechanism of Leydig cell tumour formation in rats.
Slovenian: Tumorji Leydigovih celic so povezani z zvečanjem koncentracije luteinizirajočega hormona (LH), kar je že znan mehanizem tvorbe tumorja Leydigovih celic pri podganah.
English: Adverse reactions in table 1 are based on the pooled analysis of the four 26-week placebo-controlled studies (n = 2,313) described above.
Slovenian: Podatki o neželenih učinkih v preglednici 1 izhajajo iz zgoraj opisane analize združenih podatkov štirih 26-tedenskih, s placebom nadzorovanih študij (n = 2.313).
English: A paediatric Phase 1 study examined the pharmacokinetics and pharmacodynamics of canagliflozin in children and adolescents ≥ 10 to < 18 years of age with type 2 diabetes mellitus.
Slovenian: V pediatrični študiji faze 1 so preučevali farmakokinetiko in farmakodinamiko kanagliflozina pri otrocih in mladostnikih s sladkorno boleznijo tipa 2, starih ≥ 10 do < 18 let.
English: The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness.
Slovenian: prekomernega uživanja alkohola, dehidracije, nenadnega zmanjšanja odmerka insulina ali povečane potrebe po insulinu zaradi večjega kirurškega posega ali resne bolezni.
English: Additional safety analyses (including long-term data) from data across the entire canagliflozin programme (placebo- and active-controlled studies) were conducted to assess reported adverse reactions in order to identify adverse reactions (see table 1) (see sections 4.2 and 4.4).
Slovenian: (vključno s podatki pri dolgotrajni uporabi) v kateri so ocenili neželene učinke, poročane v celotnem programu študij s kanagliflozinom (s placebom in aktivno nadzorovanih študij) (glejte preglednico 1) (glejte poglavji 4.2 in 4.4).
English: Canagliflozin is transported by P-glycoprotein (P-gp) and Breast Cancer Resistance Protein (BCRP).
Slovenian: P-glikoprotein (P-gp) in membranski transporterski protein (ABCG2 oz. BCRP - Breast Cancer Resistance Protein).
English: Dabigatran: The effect of concomitant administration of canagliflozin (a weak P-gp inhibitor) on dabigatran etexilate (a P-gp substrate) has not been studied.
Slovenian: Dabigatran: Učinka sočasne uporabe kanagliflozina (šibek zaviralec P-gp) na dabigatran eteksilat
English: Table 1: Tabulated list of adverse reactions (MedDRA) from placebo-controlled studiesa and from postmarketing experience
Slovenian: Preglednica 1: Preglednica neželenih učinkov (po klasifikaciji MedDRA) iz s placebom nadzorovanih študija in neželenih učinkov poročanih v obdobju trženja zdravila
English: Compared to glimepiride as dual therapy with metformin (52 weeks) Canagliflozin + metformin Glimepiride (titrated) + metformin (N = 482)
Slovenian: V primerjavi z glimepiridom v okviru dvotirnega zdravljenja z metforminom (52 tednov) kanagliflozin + metformin glimepirid (s titracijo) + metformin (n = 482)
English: Excipient(s) with known effect Each tablet contains 39.2 mg lactose.
Slovenian: Ena tableta vsebuje 39,2 mg laktoze.
English: Invokana 300 mg film-coated tablets EU/1/13/884/005 (10 tablets)
Slovenian: Invokana 300 mg filmsko obložene tablete EU/1/13/884/005 (10 tablet)
English: Following co-administration of canagliflozin with rifampicin (an inducer of various active transporters and drug-metabolising enzymes), 51% and 28% decreases in canagliflozin systemic exposure (AUC)
Slovenian: Pri sočasni uporabi kanagliflozina z rifampicinom (ki je induktor številnih aktivnih prenašalcev in encimov, ki presnavljajo učinkovine) so opazili zmanjšanje sistemske izpostavljenosti (AUC) kanagliflozinu za 51% in zmanjšanje najvišje plazemske koncentracije (Cmax) za 28%.
English: In a 12-week clinical study, unstimulated LH did not increase in male patients treated with canagliflozin.
Slovenian: V 12-tedenski klinični študiji se pri bolnikih moškega spola, ki so prejemali kanagliflozin, koncentracija LH brez stimulacije ni zvečala.
English: Invokana 100 mg film-coated tablets EU/1/13/884/001 (10 tablets)
Slovenian: Invokana 100 mg filmsko obložene tablete EU/1/13/884/001 (10 tablet)
English: What Invokana contains
Slovenian: Kaj vsebuje zdravilo Invokana
English: • lower limb amputations (mainly of the toe) especially if you are at high risk of heart disease.
Slovenian: • ledvična odpoved (kot posledica prevelike izgube tekočine iz telesa) • amputacije na spodnjih okončinah (večinoma prstov na nogah), še posebej, če imate večje tveganje za bolezni srca
English: • If your doctor has prescribed canagliflozin along with any bile acid sequestrant such as cholestyramine (medicines for lowering cholesterol) you should take canagliflozin at least
Slovenian: • Če vam je zdravnik predpisal kanagliflozin skupaj z adsorbentom žolčnih kislin, kot je holestiramin (zdravilo za zniževanje holesterola v krvi), morate vzeti kanagliflozin vsaj 1 uro prej ali 4 do 6 ur po tem, ko ste vzeli adsorbent žolčnih kislin.
English: Excipient(s) with known effect Each tablet contains 117.78 mg lactose.
Slovenian: Ena tableta vsebuje 117,78 mg laktoze.
English: Use in patients at risk for adverse reactions related to volume depletion Due to its mechanism of action, canagliflozin, by increasing urinary glucose excretion (UGE) induces an osmotic diuresis, which may reduce intravascular volume and decrease blood pressure (see section 5.1).
Slovenian: Kanagliflozin zaradi svojega mehanizma delovanja povečuje izločanje glukoze z urinom in tako povzroča osmotsko diurezo, ki lahko zmanjša znotrajžilni volumen in zniža krvni tlak (glejte poglavje 5.1).
English: Based on AUC exposure, the NOEL of 30 mg/kg/day for pheochromocytomas and renal tubular tumours is approximately 4.5 times the exposure at the daily clinical dose of 300 mg. Based on preclinical and clinical mechanistic studies, Leydig cell tumours, renal tubule tumours, and pheochromocytomas are considered to be rat-specific.
Slovenian: 30 mg/kg/dan za feokromocitom in tumorje ledvičnih tubulov predstavljal približno 4,5-krat večjo izpostavljenost zdravilu kot klinični odmerek 300 mg. Na podlagi izsledkov predkliničnih in kliničnih mehanističnih študij velja, da so tumorji Leydigovih celic, tumorji ledvičnih tubulov in feokromocitomi specifični za podgane.
English: Adverse reactions related to volume depletion
Slovenian: Neželeni učinki, povezani s hipovolemijo