FrancophonIA/ELRC3.0 huggingface dataset:
English: Standard and reduced dose calculations according to body surface area for starting doses of Xeloda of 1250 mg/m2 and 1000 mg/m2 are provided in tables 1 and 2, respectively.
Slovenian: Standardni in zmanjšani odmerki so za začetni odmerek zdravila Xeloda 1.250 mg/m2 glede na telesno površino izračunani v preglednici 1, za 1.000 mg/m2 pa v preglednici 2.
English: • skin ulcer and blister, reaction of the skin with sunlight, reddening of palms, swelling or pain of the face joint swelling or stiffness, bone pain, muscle weakness or stiffness
Slovenian: • razjedo in mehurčke na koži, reakcijo kože s svetlobo, pordevanje dlani, otekanje ali bolečino obraza,
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Xeloda Vsebina pakiranja in dodatne informacije
English: Very rare side effects (may affect up to 1 in 10,000 people) include: severe skin reaction such as skin rash, ulceration and blistering which may involve ulcers of the mouth, nose, genitalia, hands, feet and eyes (red and swollen eyes)
Slovenian: • hude kožne reakcije, kot so kožni izpuščaj, razjede in mehurji, ki lahko vključujejo razjede v ustih, nosu, na spolovilih, rokah, nogah in v očeh (rdeče in zatekle oči).
English: Reduced dose 625 mg/m2
Slovenian: Zmanjšani odmerek (50 %) 625 mg/m2
English: Febrile neutropenia, Pancytopenia, Granulocytopenia, Thrombocytopenia, Leukopenia, Haemolytic anaemia, International Normalised Ratio (INR) increased/Prothrombin time prolonged
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenija, anemija febrilna nevtropenija, pancitopenija, granulocitopenija, trombocitopenija, levkopenija, hemolitična anemija, zvišano internacionalno normalizirano razmerje/podaljšan protrombinski čas
English: How to store Xeloda
Slovenian: Shranjevanje zdravila Xeloda
English: In this trial, 255 patients were randomised to treatment with capecitabine (1250 mg/m2 twice daily for 2 weeks followed by 1-week rest period and docetaxel 75 mg/m2 as a 1 hour intravenous infusion every 3 weeks).
Slovenian: 255 bolnikov, randomizirano vključenih v preskušanje, je prejemalo zdravljenje s kapecitabinom (1.250 mg/m2 dvakrat na dan 2 tedna, sledil je enotedenski premor, in docetaksel 75 mg/m2 v obliki enourne intravenske infuzije vsake 3 tedne).
English: •h/ml were 7.75, 7.24,
Slovenian: Vrednosti AUC0-∞ v μg•h/ml so znašale 7,75; 7,24; 24,6; 2,03 in 36,3.
English: Full dose 1250 mg/m2
Slovenian: Polni odmerek 1.250 mg/m2
English: Herpes zoster, Urinary tract infection, Oral candidiasis, Upper respiratory tract infection , Rhinitis, Influenza, +Infection, Oral herpes
Slovenian: Infekcijske in parazitske bolezni herpes zoster, okužba sečil, oralna kandidoza, okužba zgornjih dihal, rinitis, gripa,
English: 120 Patients were randomised to a modified XELIRI regimen with capecitabine 800 mg/m2 twice daily for two weeks followed by a 7-day rest period), irinotecan (200 mg/m2 as a 30 minute infusion on day 1 every
Slovenian: Randomizirali so 120 bolnikov v spremenjeno shemo XELIRI: kapecitabin (800 mg/m2 dvakrat na dan dva tedna, čemur je sledil 7-dnevni premor), irinotekan (200 mg/m2 v 30-minutni infuziji 1. dan vsake 3 tedne) in bevacizumab (7,5 mg/kg v 30 do 90-minutni infuziji 1. dan vsake 3 tedne).
English: In the absence of safety and efficacy data in patients with hepatic impairment, Capecitabine use should be carefully monitored in patients with mild to moderate liver dysfunction, regardless of the presence or absence of liver metastasis.
Slovenian: Zato moramo uporabo kapecitabina pri bolnikih z blago do zmerno motnjo delovanja jeter, ne glede na to, ali imajo zasevek v jetrih ali ne, pazljivo spremljati.
English: Dehydration, Weight decreased
Slovenian: • dehidracijo, zmanjšanje telesne mase,
English: 256 patients were randomised to treatment with docetaxel alone (100 mg/m2 as a
Slovenian: 256 bolnikov, randomizirano vključenih v preskušanje, je prejemalo le docetaksel (100 mg/m2 v obliki enourne intravenske infuzije vsake 3 tedne).
English: Xeloda 150 mg film-coated tablets Each 150 mg film-coated tablet contains 15.6 mg anhydrous lactose.
Slovenian: Xeloda 150 mg filmsko obložene tablete Ena 150-mg filmsko obložena tableta vsebuje 15,6 mg brezvodne laktoze.
English: Xeloda 150 mg film-coated tablets Xeloda 500 mg film-coated tablets capecitabine
Slovenian: Xeloda 150 mg filmsko obložene tablete Xeloda 500 mg filmsko obložene tablete kapecitabin
English: Xeloda belongs to the group of medicines called "cytostatic medicines", which stop the growth of cancer cells.
Slovenian: Zdravilo Xeloda spada v skupino zdravil, ki jih imenujemo citostatiki.
English: Pharyngitis, Oral candidiasis, Influenza, Gastroenteritis, Fungal infection, Infection, Tooth abscess
Slovenian: nazofaringitis, okužba spodnjih dihal sepsa, okužba sečil, celulitis, tonzilitis, faringitis, oralna kandidoza, gripa, gastroenteritis, glivična okužba, okužba, zobni absces
English: Breast cancer:
Slovenian: • mišične krče,
English: 3 weeks), and bevacizumab (7.5 mg/kg as a 30 to 90 minute infusion on day 1 every 3 weeks ; 127 patients were randomised to treatment with capecitabine (1000 mg/m2 twice daily for two weeks followed by a 7-day rest period), oxaliplatin (130 mg/m as a 2 hour infusion on day 1 every 3 weeks), and bevacizumab (7.5 mg/kg as a 30 to 90 minute infusion on day 1 every 3 weeks).
Slovenian: V zdravljenje s kapecitabinom (1.000 mg/m2 dvakrat na dan dva tedna, čemur je sledil 7-dnevni premor), oksaliplatinom (130 mg/m2 v 2-urni infuziji 1. dan vsake 3 tedne) in bevacizumabom (7,5 mg/kg v 30 do 90-minutni infuziji 1. dan vsake 3 tedne) pa so randomizirali 127 bolnikov.
English: During capecitabine monotherapy, no adjustment of the starting dose is needed.
Slovenian: Starejši bolniki Zanje prilagajanje začetnega odmerka pri samostojnem zdravljenju s kapecitabinom ni potrebno.
English: Xeloda 500 mg film-coated tablets Each 500 mg film-coated tablet contains 52 mg anhydrous lactose.
Slovenian: Xeloda 500 mg filmsko obložene tablete Ena 500-mg filmsko obložena tableta vsebuje 52 mg brezvodne laktoze.
English: 10.0 and 8.9 months; p=0.64, overall survival 25.7 and 27.5 months; p=0.55 and response rates 45.5 and 39.8%; p=0.32 for FOLFIRI-Bev and XELIRI-Bev, respectively.
Slovenian: Pri skupini B so v shemi XELIRI uporabili kapecitabin 1000 mg/m2 dvakrat na dan 14 dni in irinotekan 250 mg/m2 1. dan. Mediana preživetja brez napredovanja bolezni je bila za FOLFIRIbevacizumab 10,0 in za XELIRI-bevacizumab 8,9 meseca; p = 0,64, celokupno preživetje za FOLFIRI-bevacizumab je bilo 25,7 in za XELIRI-bevacizumab 27,5 meseca; p = 0,55, odgovor je bil 45,5 % za FOLFIRI-bevacizumab in 39,8 % za XELIRI-bevacizumab; p = 0,32.
English: Diabetes,
Slovenian: • alergijo,
English: Reduced dose 500 mg/m2
Slovenian: 500 mg/m2
English: Gender, presence or absence of liver metastasis at baseline, Karnofsky Performance Status, total bilirubin, serum albumin, ASAT and ALAT had no statistically significant effect on the pharmacokinetics of 5'-DFUR, 5-FU and FBAL.
Slovenian: Populacijsko farmakokinetično študijo so opravili po zdravljenju 505 bolnikov s kolorektalnim rakom, ki so prejemali 1.250 mg/m2 kapecitabina dvakrat na dan. Spol, prisotnost ali odsotnost zasevkov v jetrih, splošno bolnikovo stanje, celokupni bilirubin, serumski albumin, AST in ALT niso statistično značilno vplivali na farmakokinetiko 5´-DFUR, 5-FU in FBAL.
English: Oxaliplatin on Day 1, every 3 weeks Capecitabine oral twice daily for 2 weeks (followed by 1 week offtreatment)
Slovenian: XELOX + bevacizumab oksaliplatin 130 mg/m2 intravensko 2 h oksaliplatin 1. dan, vsake 3 tedne kapecitabin peroralno dvakrat na dan 2 tedna (sledi 1-tedenski premor)
English: Reduced dose 750 mg/m2
Slovenian: Zmanjšani odmerek (75 %) 750 mg/m2
English: Xeloda 150 mg film-coated tablets Each film-coated tablet contains 150 mg capecitabine.
Slovenian: Xeloda 150 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 150 mg kapecitabina.
English: A.
Slovenian: ali
English: • fluid collection in the kidneys, increased frequency of urination during the night, incontinence, blood in the urine, increase in blood creatinine (sign of kidney dysfunction) unusual bleeding from the vagina swelling (oedema), chills and rigors
Slovenian: • zadrževanje tekočine v ledvicah, pogostejše uriniranje ponoči, inkontinenco, kri v urinu,
English: Xeloda 150 mg film-coated tablets
Slovenian: Xeloda 150 mg filmsko obložene tablete
English: Table 5 Summary of related ADRs reported in patients treated with capecitabine in combination treatment in addition to those seen with capecitabine monotherapy or seen at a higher frequency grouping compared to capecitabine monotherapy Body System
Slovenian: Povzetek neželenih učinkov, povezanih z uporabo kapecitabina v kombinaciji z drugimi zdravili, o katerih so poročali poleg neželenih učinkov, opaženih pri samostojnem zdravljenju s kapecitabinom ali pa so jih opazili pogosteje (spadajo v višjo skupino po pogostnosti) kot pri samostojnem zdravljenju s kapecitabinom
English: Radiotherapy: the MTD of capecitabine alone using the intermittent regimen is 3000 mg/m2 per day, whereas, when combined with radiotherapy for rectal cancer, the MTD of capecitabine is 2000 mg/m2
Slovenian: Radioterapija: Največji prenosljivi odmerek kapecitabina samega pri intermitentnem dajanju je 3.000 mg/m2 na dan, v kombinaciji z radioterapijo za rak danke pa je največji prenosljivi odmerek kapecitabina 2.000 mg/m2 na dan z uporabo neprekinjene sheme ali dnevnim dajanjem od ponedeljka do petka med 6-tedensko radioterapijo.
English: Xeloda 500 mg film-coated tablets Each film-coated tablet contains 500 mg capecitabine
Slovenian: Xeloda 500 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 500 mg kapecitabina.
English: Reduced dose 950 mg/m2
Slovenian: Zmanjšani odmerek (75 %) 950 mg/m2
English: In combination with other medicines the usual dose for adults may be less than 1250 mg/m2 of body surface area, and you may need to take the tablets over a different time period (e.g. every day, with no rest period).
Slovenian: V kombinaciji z drugimi zdravili je lahko običajni odmerek za odrasle manjši od 1250 mg/m2 telesne površine.
English: Do not take Xeloda:
Slovenian: Zdravilo Xeloda je indicirano:
English: • skin rash, hair loss (alopecia), skin reddening, dry skin, itching (pruritus), skin discolouration, skin loss, skin inflammation, nail disorder pain in the joints, or in the limbs (extremities), chest or back fever, swelling in the limbs, feeling ill
Slovenian: • kožni izpuščaj, izpadanje las (alopecijo), pordevanje kože, suho kožo, srbenje (pruritus), razbarvanje kože, izgubo kože, vnetje kože, spremembe na nohtih,
English: Hepatic failure (rare), Cholestatic hepatitis (rare)
Slovenian: Bolezni jeter, žolčnika in žolčevodov hiperbilirubinem ija, nenormalni testi jetrne funkcije zlatenica odpoved jeter (redki), holestatični hepatitis (redki)
English: Hepatic impairment.
Slovenian: Bolniki z ledvično okvaro.
English: A total of 156 patients were randomised to treatment with 5-FU (800 mg/m2 per day, continuous infusion on days 1 to 5 every 3 weeks) and cisplatin (80 mg/m2 as a 2-hour infusion on day
Slovenian: V zdravljenje s 5-FU (800 mg/m2 na dan, v kontinuirani infuziji od 1. do 5. dne vsake 3 tedne) in cisplatinom (80 mg/m2, v 2-urni infuziji 1. dan, vsake 3 tedne) pa so skupno randomizirali 156 bolnikov.
English: Hepatobiliary disorders
Slovenian: oralni herpes
English: 600 mg/ m intravenous 22 hr
Slovenian: sledi 600 mg/m intravensko 22 h placebo ali bevacizumab
English: +Neutropenia, +Leucopenia, Anaemia, +Neutropenic fever, Thrombocytopenia
Slovenian: +anemija, zvišana telesna temperatura z nevtropenijo, trombocitopenija depresija kostnega mozga,
English: • Xeloda 500 mg film-coatedtablets: Each tablet contains 500 mg capecitabine
Slovenian: • Xeloda 500 mg filmsko obložene tablete Ena tableta vsebuje 500 mg kapecitabina.
English: Lacrimation increased, Conjunctivitis, Eye irritation
Slovenian: • vnetje oči, povečano solzenje, rdeče oči (konjunktivitis),
English: • Xeloda 150 mg film-coated tablets: Each tablet contains 150 mg capecitabine
Slovenian: • Xeloda 150 mg filmsko obložene tablete Ena tableta vsebuje 150 mg kapecitabina.
English: PRIMARY ANALYSI S XELOX/XELOX+P/ XELOX+BV (EPP*: N=967; ITT**: N=1017)
Slovenian: XELOX/XELOX + P/
English: Xeloda 500 mg film-caoted tablets
Slovenian: Xeloda 500 mg filmsko obložene tablete kapecitabin
English: You must not take Xeloda if you are pregnant or think you might be.
Slovenian: Če ste noseči ali če obstaja sum na nosečnost, zdravila Xeloda ne smete jemati.
English: You must inform your doctor if you know that you have an allergy or over-reaction to this medicine,
Slovenian: Če imate preobčutljivostno reakcijo na to zdravilo, obvestite zdravnika;
English: The film-coated tablets are light peach tablets of biconvex, oblong shape with the marking ‘150' on the one side and ‘Xeloda' on the other side
Slovenian: Filmsko obložene 150-mg tablete Xeloda so svetlo breskove barve, bikonveksne in podolgovate oblike z oznako “150” na eni strani in “Xeloda” na drugi strani.
English: Light peach film-coated tablet of biconvex, oblong shape with the marking ‘150' on the one side and ‘Xeloda' on the other side.
Slovenian: Svetlo breskove barve, bikonveksne in podolgovate oblike z oznako “150” na eni strani in “Xeloda” na drugi strani.
English: The film-coated tablets are peach tablets of biconvex, oblong shape with the marking ‘500' on the one side and ‘Xeloda' on the other side.
Slovenian: Filmsko obložene 500-mg tablete Xeloda so breskove barve, bikonveksne in podolgovate oblike z oznako “500” na eni strani in “Xeloda” na drugi strani.
English: • headache, sleepiness, dizziness, abnormal sensation in the skin (numbness or tingling sensation), taste changes eye irritation, increased tears, eye redness (conjunctivitis) inflammation of the veins (thrombophlebitis), shortness of breath, nose bleeds, cough, runny nose cold sores or other herpes infections infections of the lungs or respiratory system (e.g. pneumonia or bronchitis)
Slovenian: Bolezni kože in podkožja palmarnoplantarna eritrodisestezija kožni izpuščaj, alopecija, eritem, suha koža, pruritus, hiperpigmentaci ja kože, makulozni izpuščaj, luščenje kože, dermatitis, motnje pigmentacije, spremembe na nohtih žulj, razjede na koži, kožni izpuščaj, urtikarija, fotosenzitivne reakcije, palmarni eritem, oteklost obraza, purpura, kožna reakcija po obsevanju eritematozni lupus s spremembami na koži (redki), hude kožne reakcije, kot sta StevensJohnsonov sindrom in toksična epidermalna nekroliza (zelo redki) (glejte poglavje 4.4)
English: 150 mg 500 mg
Slovenian: Enkratni odmerek (mg) 150 mg 500 mg
English: Peach film-coated tablet of biconvex, oblong shape with the marking ‘500' on the one side and ‘Xeloda' on the other side.
Slovenian: Breskove barve, bikonveksne in podolgovate oblike z oznako “500” na eni strani in “Xeloda” na drugi strani.
English: Mucosal inflammation, Pain in limb, Pain, Chills, Chest pain, Influenza-like illness, +Fever, Infusion related reaction, Injection site reaction, Infusion site pain, Injection site pain
Slovenian: +zvišana telesna temperatura, z infuzijo povezana reakcija, reakcija na mestu injiciranja, bolečina na mestu infundiranja, bolečina na mestu injiciranja
English: Hypokalaemia, Appetite disorder, Malnutrition, Hypertriglyceridaemia,
Slovenian: Presnovne in prehranske motnje anoreksija dehidracija, zmanjšanje telesne mase sladkorna bolezen, hipokaliemija, motnje apetita, podhranjenost, hipertrigliceridemija
English: Pulmonary embolism, Pneumothorax, Haemoptysis, Asthma, Dyspnoea exertional
Slovenian: Bolezni dihal, prsnega koša in mediastinalne ga prostora dispneja, epistaksa, kašelj, rinoreja pljučna embolija, pnevmotoraks, hemoptiza, astma, dispneja ob naporu
English: 604 patients were randomised to treatment with 5-FU and leucovorin (Mayo regimen: 20 mg/m2 leucovorin intravenous followed by 425 mg/m2 intravenous bolus 5-FU, on days 1 to 5, every 28 days).
Slovenian: V teh študijah so 603 randomizirane bolnike zdravili s kapecitabinom v tritedenskem ciklu jemanja 1.250 mg/m2/dvakrat na dan 14 dni, čemur je sledil enotedenski premor, 604 randomizirane bolnike pa s 5-FU in levkovorinom (shema Mayo: 20 mg/m2 levkovorina intravensko, sledilo je 425 mg/m2 5-FU v obliki intravenskega bolusa vsakih 28 dni - na prvi do peti dan).
English: Contusion
Slovenian: Zdravljenje
English: There are no side effects caused by stopping treatment with capecitabine.
Slovenian: Če ste prenehali jemati zdravilo Xeloda Po prenehanju zdravljenja s kapecitabinom se ne pojavijo neželeni učinki.
English: During pregnancy and lactation,
Slovenian: • če ste noseči ali dojite,
English: Xeloda 500 mg film-coated tablets.
Slovenian: Xeloda 500 mg filmsko obložene tablete
English: In patients with severe renal impairment (creatinine clearance below 30 ml/min), Recent or concomitant treatment with brivudine (see section 4.4 and 4.5 for drug-drug interaction),
Slovenian: • Nedavno ali sočasno zdravljenje z brivudinom (glede medsebojnega delovanja med zdravili glejte poglavji 4.4 in 4.5).
English: - ECF: epirubicin (50 mg/ m2 as a bolus on day 1 every 3 weeks), cisplatin (60 mg/m2 as a two hour infusion on day 1 every 3 weeks) and 5-FU (200 mg/m2 daily given by continuous infusion via a central line).
Slovenian: - ECF: epirubicin (50 mg/m2 kot bolus 1. dan vsake 3 tedne), cisplatin (60 mg/m2 v 2-urni infuziji 1. dan vsake 3 tedne) in 5-FU (200 mg/m2 na dan v kontinuirani infuziji skozi centralni venski kateter); - ECX: epirubicin (50 mg/m2 kot bolus 1. dan vsake 3 tedne), cisplatin (60 mg/m2 v 2-urni infuziji 1. dan vsake 3 tedne) in kapecitabin (625 mg/m dvakrat na dan neprekinjeno); - EOF: epirubicin (50 mg/m2 kot bolus 1. dan vsake 3 tedne), oksaliplatin (130 mg/m2 v 2-urni infuziji 1. dan vsake tri tedne) in 5-FU (200 mg/m2 na dan v kontinuirani infuziji skozi centralni venski kateter); - EOX: epirubicin (50 mg/m2 kot bolus 1. dan vsake 3 tedne), oksaliplatin (130 mg/m2 v 2-urni infuziji 1. dan vsake tri tedne) in kapecitabin (625 mg/m2 dvakrat na dan neprekinjeno).
English: • tiredness
Slovenian: XELOX
English: Ventricular fibrillation (rare), QT prolongation (rare), Torsade de pointes (rare), Bradycardia (rare), Vasospasm (rare)
Slovenian: • določene tipe aritmije (vključno z ventrikularno fibrilacijo, torsade de pointes in bradikardijo),
English: PC:
Slovenian: PPP ITT
English: Roche (Hellas) A.E.
Slovenian: Roche Norge AS
English: • Repeat steps 8, 9, 10 and 11.
Slovenian: • Ponovite 8., 9., 10. in 11. korak.
English: Tell your doctor immediately
Slovenian: Takoj obvestite zdravnika:
English: If this happens, you may be able to feel these pieces on your tongue.
Slovenian: Če pride do tega, jih boste morda začutili na jeziku.
English: Approximately 41% of patients had severe COPD.
Slovenian: Približno 41 % bolnikov je imelo hudo KOPB.
English: This ensures that there is always enough medicine in your body to help you breathe more easily throughout the day and night.
Slovenian: Tako zagotovite, da je v telesu vedno dovolj zdravila, da vam olajša dihanje preko dneva in noči.
English: If this happens:
Slovenian: Če pride do tega:
English: • Inhale the medicine again by repeating steps 8 and 9.
Slovenian: • Ponovno poskusite inhalirati zdravilo, tako da ponovite 8. in 9. korak.
English: If the capsule is empty, there is no need for concern.
Slovenian: Če je kapsula prazna, ni nobenega razloga za zaskrbljenost.
English: Keep it dry.
Slovenian: Pazite, da ostane suh.
English: Clean your inhaler once a week.
Slovenian: Inhalator očistite enkrat na teden.
English: • cold-like symptoms.
Slovenian: • prehladu podobni simptomi.
English: The bronchodilator effect did not depend on the time of dosing, morning or evening.
Slovenian: Bronhodilatatorno delovanje ni bilo odvisno od časa odmerjanja, t.j zjutraj ali zvečer.
English: Not all pack sizes or strengths may be available in your country.
Slovenian: V vaši državi morda niso na voljo vse jakosti oziroma velikosti pakiranj.
English: The chances of the capsule shattering will be increased if the capsule is accidentally pierced more than once (step 6).
Slovenian: Možnost, da se kapsula tako zdrobi, je večja, če kapsulo nehote predrete več kot enkrat (6. korak).
English: The maximum dose is 300 microgram once daily.
Slovenian: Najvišji odmerek je 300 mikrogramov enkrat dnevno.
English: These may be signs of a condition called bronchospasm.
Slovenian: To so lahko znaki stanja, ki ga imenujemo bronhospazem.
English: Patients should be instructed on how to administer the product correctly.
Slovenian: Bolnike je treba poučiti, kako naj si pravilno aplicirajo zdravilo.
English: • Hold your breath for at least 5-10 seconds or as long as you comfortably can while taking the inhaler out of your mouth.
Slovenian: • Zadržite dih vsaj za 5-10 sekund oziroma tako dolgo, kolikor zmorete, in medtem vzemite ustnik iz ust.
English: Steady state was achieved within 12 to 14 days.
Slovenian: Do stanja dinamičnega ravnovesja je prišlo v 12 do 14 dneh.
English: • Breathe in rapidly but steadily and as deeply as you can.
Slovenian: • Hitro in enakomerno vdihnite, kolikor globoko morete.
English: This medicine contains lactose (milk sugar).
Slovenian: To zdravilo vsebuje laktozo (mlečni sladkor).
English: Date of first authorisation: 30 November 2009 Date of latest renewal: 18 September 2014
Slovenian: Datum zadnjega podaljšanja: 18. september 2014
English: These were in the vast majority mild or moderate and became less frequent if treatment was continued.
Slovenian: V veliki večini so bili ti učinki blagi ali zmerni, njihova pogostnost pa se je z nadaljevanjem zdravljenja zmanjšala.
English: An additional adverse reaction was tremor (common).
Slovenian: Pojavil se je dodatni neželeni učinek, in sicer tremor (pogosto).
English: Within each system organ class, adverse reactions are ranked by frequency in descending order 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 <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: Znotraj vsakega organskega sistema so neželeni učinki razvrščeni po padajoči pogostnosti v skladu z naslednjim dogovorom: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Therefore the frequency was calculated from clinical trial experience.
Slovenian: Iz tega razloga je pogostnost izračunana na podlagi izkušenj v kliničnih študijah.
English: You will feel tired, very thirsty and hungry (without gaining weight) and will pass more urine than usual (common).
Slovenian: Čutili boste utrujenost, hudo žejo in lakoto (brez povečanja telesne mase), poleg tega pa boste odvajali več urina kot običajno
English: Patients who do not experience improvement in breathing should be asked if they are swallowing the medicine rather than inhaling it.
Slovenian: Bolnike, pri katerih ne pride do izboljšanja dihanja, je treba vprašati, ali zdravilo morda pogoltnejo namesto da bi ga inhalirali.
English: The mean age of patients was 64 years, with 48% of patients aged 65 years or older, and the majority (80%) was Caucasian.
Slovenian: Povprečna starost bolnikov je znašala 64 let, pri čemer je bilo 48 % bolnikov starih 65 let ali več in je bila večina (80 %) belcev.
English: After intravenous infusion the volume of distribution of indacaterol during the terminal elimination phase was 2557 litres indicating an extensive distribution.
Slovenian: Po intravenski infuziji je bil volumen porazdelitve indakaterola v obdobju končne faze izločanja 2557 litrov, kar kaže na obsežno porazdelitev.
English: Do this only once.
Slovenian: Pritisnite samo enkrat.
English: The magnitude of response was generally greater than seen with active comparators (Table 2).
Slovenian: Obseg odziva je bil večinoma večji kot pri aktivnih primerjalnih zdravilih (preglednica 2).
English: In case such effects occur, treatment may need to be discontinued.
Slovenian: Če pride do takega vpliva, je včasih treba zdravljenje prekiniti.