natgillin/translations-raw huggingface dataset:
•h/ml were 7.75, 7.24,
Vrednosti AUC0-∞ v μg•h/ml so znašale 7,75; 7,24; 24,6; 2,03 in 36,3.
Full dose 1250 mg/m2
Polni odmerek 1.250 mg/m2
Herpes zoster, Urinary tract infection, Oral candidiasis, Upper respiratory tract infection , Rhinitis, Influenza, +Infection, Oral herpes
Infekcijske in parazitske bolezni herpes zoster, okužba sečil, oralna kandidoza, okužba zgornjih dihal, rinitis, gripa,
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
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).
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.
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.
Dehydration, Weight decreased
• dehidracijo, zmanjšanje telesne mase,
256 patients were randomised to treatment with docetaxel alone (100 mg/m2 as a
256 bolnikov, randomizirano vključenih v preskušanje, je prejemalo le docetaksel (100 mg/m2 v obliki enourne intravenske infuzije vsake 3 tedne).
Xeloda 150 mg film-coated tablets Each 150 mg film-coated tablet contains 15.6 mg anhydrous lactose.
Xeloda 150 mg filmsko obložene tablete Ena 150-mg filmsko obložena tableta vsebuje 15,6 mg brezvodne laktoze.
Xeloda 150 mg film-coated tablets Xeloda 500 mg film-coated tablets capecitabine
Xeloda 150 mg filmsko obložene tablete Xeloda 500 mg filmsko obložene tablete kapecitabin
Xeloda belongs to the group of medicines called "cytostatic medicines", which stop the growth of cancer cells.
Zdravilo Xeloda spada v skupino zdravil, ki jih imenujemo citostatiki.
Pharyngitis, Oral candidiasis, Influenza, Gastroenteritis, Fungal infection, Infection, Tooth abscess
nazofaringitis, okužba spodnjih dihal sepsa, okužba sečil, celulitis, tonzilitis, faringitis, oralna kandidoza, gripa, gastroenteritis, glivična okužba, okužba, zobni absces
Breast cancer:
• mišične krče,
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).
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.
During capecitabine monotherapy, no adjustment of the starting dose is needed.
Starejši bolniki Zanje prilagajanje začetnega odmerka pri samostojnem zdravljenju s kapecitabinom ni potrebno.
Xeloda 500 mg film-coated tablets Each 500 mg film-coated tablet contains 52 mg anhydrous lactose.
Xeloda 500 mg filmsko obložene tablete Ena 500-mg filmsko obložena tableta vsebuje 52 mg brezvodne laktoze.
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.
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.
Diabetes,
• alergijo,
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.
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.
Oxaliplatin on Day 1, every 3 weeks Capecitabine oral twice daily for 2 weeks (followed by 1 week offtreatment)
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)
Reduced dose 750 mg/m2
Zmanjšani odmerek (75 %) 750 mg/m2
Xeloda 150 mg film-coated tablets Each film-coated tablet contains 150 mg capecitabine.
Xeloda 150 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 150 mg kapecitabina.
A.
ali
• 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
• zadrževanje tekočine v ledvicah, pogostejše uriniranje ponoči, inkontinenco, kri v urinu,
Xeloda 150 mg film-coated tablets
Xeloda 150 mg filmsko obložene tablete
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
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
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
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.
Xeloda 500 mg film-coated tablets Each film-coated tablet contains 500 mg capecitabine
Xeloda 500 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 500 mg kapecitabina.
Reduced dose 950 mg/m2
Zmanjšani odmerek (75 %) 950 mg/m2
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).
V kombinaciji z drugimi zdravili je lahko običajni odmerek za odrasle manjši od 1250 mg/m2 telesne površine.
Do not take Xeloda:
Zdravilo Xeloda je indicirano:
• 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
• kožni izpuščaj, izpadanje las (alopecijo), pordevanje kože, suho kožo, srbenje (pruritus), razbarvanje kože, izgubo kože, vnetje kože, spremembe na nohtih,
Hepatic failure (rare), Cholestatic hepatitis (rare)
Bolezni jeter, žolčnika in žolčevodov hiperbilirubinem ija, nenormalni testi jetrne funkcije zlatenica odpoved jeter (redki), holestatični hepatitis (redki)
Hepatic impairment.
Bolniki z ledvično okvaro.
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
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.
Hepatobiliary disorders
oralni herpes
600 mg/ m intravenous 22 hr
sledi 600 mg/m intravensko 22 h placebo ali bevacizumab
+Neutropenia, +Leucopenia, Anaemia, +Neutropenic fever, Thrombocytopenia
+anemija, zvišana telesna temperatura z nevtropenijo, trombocitopenija depresija kostnega mozga,
• Xeloda 500 mg film-coatedtablets: Each tablet contains 500 mg capecitabine
• Xeloda 500 mg filmsko obložene tablete Ena tableta vsebuje 500 mg kapecitabina.
Lacrimation increased, Conjunctivitis, Eye irritation
• vnetje oči, povečano solzenje, rdeče oči (konjunktivitis),
• Xeloda 150 mg film-coated tablets: Each tablet contains 150 mg capecitabine
• Xeloda 150 mg filmsko obložene tablete Ena tableta vsebuje 150 mg kapecitabina.
PRIMARY ANALYSI S XELOX/XELOX+P/ XELOX+BV (EPP*: N=967; ITT**: N=1017)
XELOX/XELOX + P/
Xeloda 500 mg film-caoted tablets
Xeloda 500 mg filmsko obložene tablete kapecitabin
You must not take Xeloda if you are pregnant or think you might be.
Če ste noseči ali če obstaja sum na nosečnost, zdravila Xeloda ne smete jemati.
You must inform your doctor if you know that you have an allergy or over-reaction to this medicine,
Če imate preobčutljivostno reakcijo na to zdravilo, obvestite zdravnika;
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
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.
Light peach film-coated tablet of biconvex, oblong shape with the marking ‘150' on the one side and ‘Xeloda' on the other side.
Svetlo breskove barve, bikonveksne in podolgovate oblike z oznako “150” na eni strani in “Xeloda” na drugi strani.
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.
Filmsko obložene 500-mg tablete Xeloda so breskove barve, bikonveksne in podolgovate oblike z oznako “500” na eni strani in “Xeloda” na drugi strani.
• 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)
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)
150 mg 500 mg
Enkratni odmerek (mg) 150 mg 500 mg
Peach film-coated tablet of biconvex, oblong shape with the marking ‘500' on the one side and ‘Xeloda' on the other side.
Breskove barve, bikonveksne in podolgovate oblike z oznako “500” na eni strani in “Xeloda” na drugi strani.
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
+zvišana telesna temperatura, z infuzijo povezana reakcija, reakcija na mestu injiciranja, bolečina na mestu infundiranja, bolečina na mestu injiciranja
Hypokalaemia, Appetite disorder, Malnutrition, Hypertriglyceridaemia,
Presnovne in prehranske motnje anoreksija dehidracija, zmanjšanje telesne mase sladkorna bolezen, hipokaliemija, motnje apetita, podhranjenost, hipertrigliceridemija
Pulmonary embolism, Pneumothorax, Haemoptysis, Asthma, Dyspnoea exertional
Bolezni dihal, prsnega koša in mediastinalne ga prostora dispneja, epistaksa, kašelj, rinoreja pljučna embolija, pnevmotoraks, hemoptiza, astma, dispneja ob naporu
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).
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).
Contusion
Zdravljenje
There are no side effects caused by stopping treatment with capecitabine.
Če ste prenehali jemati zdravilo Xeloda Po prenehanju zdravljenja s kapecitabinom se ne pojavijo neželeni učinki.
During pregnancy and lactation,
• če ste noseči ali dojite,
Xeloda 500 mg film-coated tablets.
Xeloda 500 mg filmsko obložene tablete
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),
• Nedavno ali sočasno zdravljenje z brivudinom (glede medsebojnega delovanja med zdravili glejte poglavji 4.4 in 4.5).
- 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).
- 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).
• tiredness
XELOX
Ventricular fibrillation (rare), QT prolongation (rare), Torsade de pointes (rare), Bradycardia (rare), Vasospasm (rare)
• določene tipe aritmije (vključno z ventrikularno fibrilacijo, torsade de pointes in bradikardijo),
PC:
PPP ITT
Roche (Hellas) A.E.
Roche Norge AS
• Repeat steps 8, 9, 10 and 11.
• Ponovite 8., 9., 10. in 11. korak.
Tell your doctor immediately
Takoj obvestite zdravnika:
If this happens, you may be able to feel these pieces on your tongue.
Če pride do tega, jih boste morda začutili na jeziku.
Approximately 41% of patients had severe COPD.
Približno 41 % bolnikov je imelo hudo KOPB.
This ensures that there is always enough medicine in your body to help you breathe more easily throughout the day and night.
Tako zagotovite, da je v telesu vedno dovolj zdravila, da vam olajša dihanje preko dneva in noči.
If this happens:
Če pride do tega:
• Inhale the medicine again by repeating steps 8 and 9.
• Ponovno poskusite inhalirati zdravilo, tako da ponovite 8. in 9. korak.
If the capsule is empty, there is no need for concern.
Če je kapsula prazna, ni nobenega razloga za zaskrbljenost.
Keep it dry.
Pazite, da ostane suh.
Clean your inhaler once a week.
Inhalator očistite enkrat na teden.
• cold-like symptoms.
• prehladu podobni simptomi.
The bronchodilator effect did not depend on the time of dosing, morning or evening.
Bronhodilatatorno delovanje ni bilo odvisno od časa odmerjanja, t.j zjutraj ali zvečer.
Not all pack sizes or strengths may be available in your country.
V vaši državi morda niso na voljo vse jakosti oziroma velikosti pakiranj.
The chances of the capsule shattering will be increased if the capsule is accidentally pierced more than once (step 6).
Možnost, da se kapsula tako zdrobi, je večja, če kapsulo nehote predrete več kot enkrat (6. korak).
The maximum dose is 300 microgram once daily.
Najvišji odmerek je 300 mikrogramov enkrat dnevno.
These may be signs of a condition called bronchospasm.
To so lahko znaki stanja, ki ga imenujemo bronhospazem.
Patients should be instructed on how to administer the product correctly.
Bolnike je treba poučiti, kako naj si pravilno aplicirajo zdravilo.
• Hold your breath for at least 5-10 seconds or as long as you comfortably can while taking the inhaler out of your mouth.
• Zadržite dih vsaj za 5-10 sekund oziroma tako dolgo, kolikor zmorete, in medtem vzemite ustnik iz ust.
Steady state was achieved within 12 to 14 days.
Do stanja dinamičnega ravnovesja je prišlo v 12 do 14 dneh.
• Breathe in rapidly but steadily and as deeply as you can.
• Hitro in enakomerno vdihnite, kolikor globoko morete.
This medicine contains lactose (milk sugar).
To zdravilo vsebuje laktozo (mlečni sladkor).
Date of first authorisation: 30 November 2009 Date of latest renewal: 18 September 2014
Datum zadnjega podaljšanja: 18. september 2014
These were in the vast majority mild or moderate and became less frequent if treatment was continued.
V veliki večini so bili ti učinki blagi ali zmerni, njihova pogostnost pa se je z nadaljevanjem zdravljenja zmanjšala.
An additional adverse reaction was tremor (common).
Pojavil se je dodatni neželeni učinek, in sicer tremor (pogosto).
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).
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).
Therefore the frequency was calculated from clinical trial experience.
Iz tega razloga je pogostnost izračunana na podlagi izkušenj v kliničnih študijah.
You will feel tired, very thirsty and hungry (without gaining weight) and will pass more urine than usual (common).
Čutili boste utrujenost, hudo žejo in lakoto (brez povečanja telesne mase), poleg tega pa boste odvajali več urina kot običajno
Patients who do not experience improvement in breathing should be asked if they are swallowing the medicine rather than inhaling it.
Bolnike, pri katerih ne pride do izboljšanja dihanja, je treba vprašati, ali zdravilo morda pogoltnejo namesto da bi ga inhalirali.
The mean age of patients was 64 years, with 48% of patients aged 65 years or older, and the majority (80%) was Caucasian.
Povprečna starost bolnikov je znašala 64 let, pri čemer je bilo 48 % bolnikov starih 65 let ali več in je bila večina (80 %) belcev.
After intravenous infusion the volume of distribution of indacaterol during the terminal elimination phase was 2557 litres indicating an extensive distribution.
Po intravenski infuziji je bil volumen porazdelitve indakaterola v obdobju končne faze izločanja 2557 litrov, kar kaže na obsežno porazdelitev.
Do this only once.
Pritisnite samo enkrat.
The magnitude of response was generally greater than seen with active comparators (Table 2).
Obseg odziva je bil večinoma večji kot pri aktivnih primerjalnih zdravilih (preglednica 2).
In case such effects occur, treatment may need to be discontinued.
Če pride do takega vpliva, je včasih treba zdravljenje prekiniti.
4,764 patients were exposed to indacaterol up to one year at doses up to twice the maximum recommended dose.
4.764 bolnikov je bilo izpostavljenih indakaterolu v trajanju do enega leta z uporabo odmerkov, ki so dosegali do dvakratno vrednost najvišjega priporočenega odmerka.
Use your inhaler at the same time each day, the effects last for 24 hours.
Inhalator uporabljajte vsak dan ob istem času, saj učinek zdravila traja 24 ur.
Most people are able to empty the capsule with one or two inhalations.
Večina ljudi lahko izprazni kapsulo z eno ali z dvema vdihoma.
Do not press the side buttons more than once.
Stranskih gumbov ne pritiskajte več kot enkrat.
Pharmacokinetic data were obtained from a number of clinical studies, from healthy volunteers and COPD patients.
Farmakokinetični podatki izvirajo iz številnih kliničnih študij, v katere so bili vključeni zdravi prostovoljci in bolniki s KOPB.
• Then breathe out.
• Nato izdihnite.
Hold breath:
Zadržite dih:
Oslif Breezhaler should only be used during pregnancy if the expected benefits outweigh the potential risks.
Uporaba zdravila Oslif Breezhaler je v času nosečnosti upravičena le v primeru, da pričakovane koristi presegajo možna tveganja.
If a dose is missed the next dose should be taken at the usual time the next day.
V primeru izpuščenega odmerka je treba naslednji odmerek vzeti naslednji dan ob običajnem času.
The dose should only be increased on medical advice.
Odmerek je mogoče zvišati samo po nasvetu zdravnika.
The clinical development programme included one 12-week, two six-month (one of which was extended to one year to evaluate safety and tolerability) and one one-year randomised controlled studies in patients with a clinical diagnosis of COPD.
Klinični razvojni program je obsegal eno 12-tedensko, dve 6-mesečni (od katerih so eno podaljšali na eno leto, da bi ocenili varnost in prenosljivost zdravila) in eno enoletno randomizirano kontrolirano študijo pri bolnikih s klinično diagnozo KOPB.
Absolute bioavailability of indacaterol after an inhaled dose was on average 43% to 45%.
Absolutna biološka uporabnost indakaterola po inhaliranju odmerka je bila povprečno od 43 do 45 %.
Always release the push buttons before inhalation.
Pred inhaliranjem vedno izpustite potisne gumbe.
Your doctor may tell you to use the 150 microgram capsule or the 300 microgram capsule depending on your condition and on how you respond to the treatment.
Zdravnik vam lahko naroči, da uporabljate kapsule s 150 mikrogrami ali s 300 mikrogrami, kar je odvisno od vaše bolezni in odziva na zdravljenje.
There are no data from the use of indacaterol in pregnant women available.
Ni podatkov o uporabi indakaterola pri nosečnicah.
If you do, don't worry.
Če tudi vi kašljate, naj vas to ne skrbi.
All these findings occurred at exposures sufficiently in excess of those anticipated in humans.
Do vseh teh izsledkov je prišlo pri izpostavljenosti zdravilu, ki je v zadostni meri presegla izpostavljenost, predvideno pri ljudeh.
1.0 b a n/e a
1,0 b a n/o a
Limited treatment experience is available in individuals of African descent.
Izkušenj z zdravljenjem posameznikov afriškega rodu je malo.
Renal clearance of indacaterol was, on average, between 0.46 and 1.20 litres/hour.
Ledvični očistek indakaterola je bil v povprečju med 0,46 in 1,20 litra/uro.
The capsules contain lactose.
Kapsule vsebujejo laktozo.
• if you get high levels of sugar in your blood (diabetes).
• če se vam zviša raven glukoze v krvi (sladkorna bolezen).
• Pierce the capsule by firmly pressing together both side buttons at the same time.
• Kapsulo predrete tako, da oba stranska gumba istočasno močno stisnete skupaj.
Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake "EXP".
Percentage of patients who achieved MCID SGRQ†
41 c odstotek bolnikov, ki so dosegli MCID SGRQ†
You may notice that your heart is beating faster than usual, or you may have a headache, feel drowsy, feel nauseous or have to vomit.
Morda boste opazili, da vam srce bije hitreje kot običajno, morda vas bo bolela glava ali boste zaspani ali pa vam bo slabo in morda boste bruhali.