natgillin/translations-raw huggingface dataset:
- colitis, - diarrhoea, - nausea, vomiting, - inflammation of the mouth or mouth ulcers, - abdominal pain, - an increase in some liver test results, - increased hair loss, - eczema, dry skin, rash, itching, - tendonitis (pain caused by inflammation in the membrane surrounding the tendons usually in the feet or hands), - an increase of certain enzymes in the blood (creatine phosphokinase), - problems in the nerves of the arms or legs (peripheral neuropathy).
- nenormalne kožne zaznave, npr. mravljinčenje (parestezije), - blago zvišanje krvnega tlaka, - kolitis, - driska, - slabost, bruhanje, - vnetje v ustih ali razjede v ustih, - bolečine v trebuhu, - zvišanje nekaterih vrednosti jetrnih testov, - zvečano izpadanje las, - ekcem, suha koža, izpuščaj, srbenje, - tendonitis (bolečina, običajno v rokah in nogah, ki jo povzroči vnetje membrane, ki obdaja tetive), - zvišanje določenih encimov v krvi (kreatin-fosfokinaza), - težave z živci rok ali nog (periferna nevropatija).
Hepatic impairment
pretrganje tetive
Leflunomide Zentiva 100 mg film-coated tablets leflunomide
Leflunomid Zentiva 100 mg filmsko obložene tablete leflunomid
Leflunomide Zentiva 20 mg film-coated tablets leflunomide
Leflunomid Zentiva 20 mg filmsko obložene tablete leflunomid
The following pharmacokinetic and pharmacodynamic interaction studies were conducted with A771726 (principal active metabolite of leflunomide).
Z A771726 (glavnim aktivnim presnovkom leflunomida) so opravili naslednje študije farmakokinetičnega in farmakodinamičnega medsebojnega delovanja.
Binding of A771726 appeared slightly reduced and more variable in plasma from patients with rheumatoid arthritis or chronic renal insufficiency.
V plazmi bolnikov z revmatoidnim artritisom ali kronično ledvično insuficienco je vezava A771726 rahlo zmanjšana in bolj variabilna.
Leflunomide Zentiva 10 mg film-coated tablets leflunomide
Leflunomid Zentiva 10 mg filmsko obložene tablete leflunomid
Also contains lactose.
SEZNAM POMOŽNIH SNOVI Vsebuje tudi laktozo.
A pharmacodynamics interaction with warfarin was observed with A771726 in a clinical pharmacology study (see below).
V klinični farmakološki študiji (glejte spodaj) so ugotovili farmakodinamično medsebojno delovanje varfarina in A771726.
There was an increase in mean rosuvastatin Cmax and AUC (2.65- and 2.51-fold, respectively), following repeated doses of A771726.
Po večkratnih odmerkih A771726 se je povprečna Cmax rosuvastatina povečala za 2,65-krat in njegova povprečna AUC za 2,51-krat.
One film-coated tablet contains 20 mg of leflunomide - The other ingredients are: maize starch, povidone (E1201), crospovidone (E1202), silica colloidal anhydrous, magnesium stearate (E470b), and lactose monohydrate in the tablet core, as well as talc (E553b), hypromellose (E464), titanium dioxide (E171), macrogol 8000 and yellow ferric oxide (E172) in the film-coating.
- Pomožne snovi so: koruzni škrob, povidon (E1201), krospovidon (E1202), brezvodni koloidni silicijev dioksid, magnezijev stearat (E470b) in laktoza monohidrat v jedru tablete, ter smukec (E553b), hipromeloza (E464), titanov dioksid (E171), makrogol 8000 in rumeni železov oksid (E172) v filmski oblogi.
3 film-coated tablets
FARMACEVTSKA OBLIKA IN VSEBINA 3 filmsko obložene tablete
Treatment withdrawal may be considered taking into account patient's disease and past history.
Glede na bolnikovo bolezen in njeno anamnezo je treba premisliti o prekinitvi zdravljenja z zdravilom.
- if you are male and wish to father a child. As it can not be excluded that Leflunomide Zentiva passes into semen, reliable contraception should be used during treatment with Leflunomide Zentiva.
Obstaja možnost, da se zdravilo Leflunomid Zentiva izloča v semensko tekočino, zato mora bolnik med zdravljenjem z zdravilom Leflunomid Zentiva uporablajti zanesljivo kontracepcijo.
INSTRUCTIONS ON USE 16.
- Navodilo shranite.
Leflunomide Zentiva 20 mg film-coated tablets
IME ZDRAVILA Leflunomid Zentiva 20 mg filmsko obložene tablete
Leflunomide Zentiva 100 mg film-coated tablets
IME ZDRAVILA Leflunomid Zentiva 100 mg filmsko obložene tablete
EU/1/09/604/010 3 tablets
EU/1/09/604/002 100 tablet
EU/1/09/604/008 30 tablets EU/1/09/604/009 100 tablets
EU/1/09/604/009 100 tablet
Renal impairment
Okvara jeter
Tablet core:
Navodilo vsebuje:
Leflunomide Zentiva 10 mg film-coated tablets
IME ZDRAVILA Leflunomid Zentiva 10 mg filmsko obložene tablete
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI NALEPKA NA PLASTENKI
EU/1/09/604/003 30 tablets EU/1/09/604/004 100 tablets
EU/1/09/604/004 100 tablet
Uncommon side effects (may affect up to 1 in 100 people)
Občasni neželeni učinki (prizadenejo lahko največ 1 od 100 bolnikov) - zmanjšanje števila rdečih krvnih celic (anemija) in zmanjšanje števila krvnih ploščic
This summary was last updated in 10-2009.
Povzetek je bil nazadnje posodobljen 10-2009.
Doc.
Sklic dok.
If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Če želite več informacij o podlagi za priporočila CHMP, preberite znanstveno razpravo (ki je prav tako del EPAR).
Other information about Biopoin:
Druge informacije o zdravilu Biopoin:
Because of the risk of high blood pressure, special care should be taken to monitor and control the patient's blood pressure to avoid complications such as a hypertensive crisis.
Zaradi nevarnosti visokega krvnega tlaka je potrebna posebna previdnost pri spremljanju in nadzoru bolnikovega krvnega tlaka, da se preprečijo zapleti, kot je hipertenzivna kriza.
The European Commission granted a marketing authorisation valid throughout the European Union for Biopoin to CT Arzneimittel GmbH on 23 October 2009.
Evropska komisija je dovoljenje za promet z zdravilom Biopoin, veljavno po vsej Evropski uniji, odobrila družbi CT Arzneimittel GmbH dne 23. oktobra 2009.
The effects of Biopoin were first tested in experimental models before being studied in humans.
Učinki zdravila Biopoin so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
It is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce epoetin theta.
Proizvajajo ga z metodo, znano kot “tehnologija rekombinantne DNK”: izdela ga celica, ki je prejela gen (DNK), s katerim lahko tvori epoetin theta.
For patients with cancer, injections should be given under the skin.
Pri bolnikih z rakom morajo biti injekcije dane pod kožo.
It must not be used in patients with uncontrolled hypertension.
Zdravila ne smejo uporabljati osebe z nenadzorovano hipertenzijo.
It is available in pre-filled syringes containing between 1,000 and 30,000 international units (IU) of the active substance, epoetin theta.
Na voljo je v napolnjenih injekcijskih brizgah, ki vsebujejo med 1 000 in 30 000 mednarodnih enot (i.e.) zdravilne učinkovine epoetina theta.
What benefit has Biopoin shown during the studies?
Kakšne koristi je zdravilo Biopoin izkazalo med študijami?
The Committee recommended that Biopoin be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Biopoin odobri dovoljenje za promet.
Biopoin is a solution for injection.
Zdravilo Biopoin je raztopina za injiciranje.
The most common side effects with Biopoin (seen in between 1 and 10 patients in 100) are shunt thrombosis (clots that can form in blood vessels of patients on dialysis, a blood clearance technique), headache, hypertension (high blood pressure), hypertensive crisis (sudden, dangerously high blood pressure), skin reactions, arthralgia (joint pain) and influenza (flu)-like illness.
Najpogostejši neželeni učinki zdravila Biopoin (opaženi pri 1 do 10 bolnikih izmed 100) so tromboza spoja (strdki, ki lahko nastanejo v krvnih žilah pri bolnikih na dializi, tj. tehnika čiščenja krvi), glavobol, hipertenzija (visok krvni tlak), hipertenzivna kriza (nenaden, nevarno visok krvni tlak), kožne reakcije, artralgija (bolečine v sklepih) in gripi podobna bolezen.
These doses may be doubled after four weeks if the improvement is not enough and may be increased further at monthly intervals by a quarter of the previous dose until the right level of haemoglobin (the protein found in red blood cells that carries oxygen around the body) is achieved.
Če po štirih tednih izboljšanje ni zadostno, lahko te odmerke podvojimo, v mesečnih presledkih pa jih lahko dodatno povečujemo za četrtino predhodnega odmerka, dokler se ne doseže ustrezna raven hemoglobina (beljakovine v rdečih krvničkah, ki prenaša kisik po telesu).
Biopoin should not be used in people who may be hypersensitive (allergic) to epoetin theta, to any other epoetins or substances derived from them, or to any of the other ingredients of Biopoin.
Zdravila Biopoin ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) epoetin theta, na katere koli druge epoetine ali iz njih izpeljane snovi ali na katero koli drugo sestavino zdravila Biopoin.
The main measure of effectiveness was the average change in haemoglobin levels from 15 to 26 weeks after treatment.
Glavno merilo učinkovitosti je bila povprečna sprememba ravni hemoglobina od 15. do 26. tedna po zdravljenju.
Patients who receive Biopoin by injection under the skin may inject themselves once they have been trained appropriately.
Bolniki, ki prejemajo zdravilo Biopoin s podkožnim injiciranjem, si lahko zdravilo po ustreznem usposabljanju injicirajo sami.
There were four main studies in 842 chronic renal failure patients and three main studies in 586 nonmyeloid cancer patients receiving chemotherapy.
Izvedli so štiri glavne študije na 842 bolnikih s kronično ledvično odpovedjo in tri glavne študije na 586 bolnikih z nemielodnim rakom, ki so prejemali kemoterapijo.
This dose may be doubled after four weeks if the haemoglobin has not increased by at least 1 g/dl and can, if needed, be increased further to 60,000 IU after four additional weeks.
Če se po štirih tednih hemoglobin ni povišal za vsaj 1 g/dl, se lahko ta odmerek podvoji ter po potrebi po naslednjih štirih tednih poveča na 60 000 i.e.
In the four renal failure studies, patients were given either Biopoin (under the skin or into a vein) or epoetin beta (another erythropoietin-like medicine used for anaemia).
V štirih študijah ledvične odpovedi so bolnikom dali zdravilo Biopoin (pod kožo ali v veno) ali pa epoetin beta (drugo eritropoetinu podobno zdravilo, uporabljeno pri anemiji).
The main measure of effectiveness in two of these studies was based on whether increasing the dose of Biopoin from 20 or 40 IU per kg body weight to 120 IU per kg body weight led to improvements in haemoglobin levels during the correction phase.
Glavno merilo učinkovitosti v dveh od teh študij je temeljilo na tem, ali je povišanje odmerka zdravila Biopoin z 20 ali 40 i.e. na kilogram telesne mase na 120 i.e. na kilogram telesne mase povzročilo izboljšanje ravni hemoglobina v korekcijski fazi.
For patients with kidney failure, in the ‘correction phase', the initial recommended dose, given three times a week, is 20 IU per kilogram body weight for injections under the skin or 40 IU per kg body weight for injections into a vein.
Za bolnike z odpovedjo ledvic se v „korekcijski fazi“ začetni priporočeni odmerek daje trikrat na teden po 20 i.e. na kilogram telesne mase za injiciranje pod kožo ali 40 i.e. na kilogram telesne mase za injiciranje v veno.
Biopoin is used to treat anaemia (low levels of red blood cells or haemoglobin) that is causing symptoms.
Zdravilo Biopoin se uporablja za zdravljenje anemije (nizke koncentracije rdečih krvničk ali hemoglobina), ki povzroča simptome.
What is the risk associated with Biopoin?
Kakšna tveganja so povezana z zdravilom Biopoin?
In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin it has naturally.
Pri bolnikih, ki prejemajo kemoterapijo ali imajo težave z ledvicami, je lahko vzrok anemije pomanjkanje eritropoetina ali pa nezadostna odzivnost telesa na naravni eritropoetin.
In chronic renal failure patients, the correction phase showed that increasing the starting dose of Biopoin leads to improvements in haemoglobin levels.
Pri bolnikih s kronično ledvično odpovedjo je korekcijska faza pokazala, da povišanje začetnega odmerka zdravila Biopoin povzroči izboljšanje ravni hemoglobina.
For the full list of all side effects reported with Biopoin, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Biopoin, glejte navodilo za uporabo.
The weekly dose of Biopoin should not at any time be more than 700 IU per kg body weight.
Tedenski odmerek zdravila Biopoin ne sme nikoli preseči 700 i.e. na kilogram telesne mase.
It is used in adults with chronic renal failure (long-term, progressive decrease in the ability of the kidneys to work properly) and in adults with non-myeloid cancer (cancer not originating in the bone marrow) who are receiving chemotherapy (medicines to treat cancer).
Uporablja se pri odraslih s kronično ledvično odpovedjo (dolgotrajnim, postopnim zmanjševanjem sposobnosti ledvic za normalno delovanje) in pri odraslih z nemieloidnim rakom (rakom, ki ne izvira v kostnem mozgu), ki prejemajo kemoterapijo (zdravila za zdravljenje raka).
The initial recommended dose is 20,000 IU once a week for all patients irrespective of their body weight.
Začetni priporočeni odmerek za vse bolnike je ne glede na telesno maso 20 000 i.e. enkrat na teden.
The epoetin theta in Biopoin works in the body in the same way as the natural hormone to stimulate red blood cell production.
Epoetin theta v zdravilu Biopoin deluje v telesu enako kot naravni hormon in vzpodbuja tvorbo rdečih krvničk.
Average weekly increases in haemoglobin were 0.73 and 0.58 g/dl in patients receiving the higher dose of Biopoin compared with 0.20 and 0.26 g/dl in patients receiving the lower dose of Biopoin.
Povprečna tedenska zvišanja hemoglobina so bila 0,73 in 0,58 g/dl pri bolnikih, ki so prejemali višji odmerek zdravila Biopoin, v primerjavi z 0,20 in 0,26 g/dl pri bolnikih, ki so prejemali nižji odmerek zdravila Biopoin.
The other two renal failure studies showed that during the maintenance stage the change in haemoglobin levels was similar in patients receiving Biopoin and patients receiving epoetin beta.
Drugi dve študiji ledvične odpovedi sta pokazali, da je bila v vzdrževalni fazi sprememba ravni hemoglobina pri bolnikih, ki so prejemali zdravilo Biopoin, in pri bolnikih, ki so prejemali epoetin beta, podobna.
When the anaemia has been corrected, the dose in the ‘maintenance phase' should be adjusted to maintain the right level of haemoglobin.
Ko je anemija odpravljena, moramo prilagoditi odmerek vzdrževalne faze, da se obdrži ustrezna raven hemoglobina.
In the cancer studies, between 64 and 73% of patients who received Biopoin had an increase in haemoglobin of 2 g/dl compared with between 20 and 26% of patients who were given placebo.
V študijah raka se je pri 64 do 73 % bolnikov, ki so prejemali zdravilo Biopoin, raven hemoglobina povišala za 2 g/dl, v primerjavi z 20 do 26 % bolnikov, ki so prejemali placebo.
The active substance in Biopoin, epoetin theta, is a copy of a human hormone called erythropoietin that stimulates the production of red blood cells from the bone marrow.
Zdravilna učinkovina v zdravilu Biopoin, epoetin theta, je kopija človeškega hormona, imenovanega eritropoetin, ki spodbuja tvorbo rdečih krvničk v kostnem mozgu.
Why has Biopoin been approved?
Zakaj je bilo zdravilo Biopoin odobreno?
The other two studies compared Biopoin with epoetin beta during the maintenance phase.
V drugih dveh študijah so v vzdrževalni fazi zdravilo Biopoin primerjali z epoetinom beta.
In the cancer studies, the main measure of effectiveness was the number of patients receiving either Biopoin or placebo (a dummy treatment) with an increase in haemoglobin of 2 g/dl over 12 or 16 weeks.
V študijah raka je bilo glavno merilo učinkovitosti število bolnikov, ki so prejemali zdravilo Biopoin ali placebo (zdravilo brez zdravilne učinkovine), ki se jim je po 12 ali 16 tednih hemoglobin povišal za 2 g/dl.
For full details, see the Package Leaflet.
Za podrobnejše informacije glejte navodilo za uporabo.
The full EPAR for Biopoin can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Biopoin je na voljo tukaj.
Biopoin was effective at treating anaemia in patients with chronic renal failure and patients with nonmyeloid cancer who were receiving chemotherapy.
Zdravilo Biopoin je bilo učinkovito za zdravljenje anemije pri bolnikih s kronično ledvično odpovedjo in pri bolnikih z nemielodnim rakom, ki so prejemali kemoterapijo.
The Committee for Medicinal Products for Human Use (CHMP) decided that Biopoin's benefits are greater than its risks for the treatment of symptomatic anaemia in adults with chronic renal failure and adults with non-myeloid cancers who are receiving chemotherapy.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Biopoin za zdravljenje simptomatske anemije pri odraslih s kronično ledvično odpovedjo in pri odraslih z nemieloidnim rakom, ki prejemajo kemoterapijo, večje od z njim povezanih tveganj.
Biopoin treatment should be started by a doctor experienced in treating symptomatic anaemia in patients with chronic renal failure and non-myeloid cancer.
Zdravljenje z zdravilom Biopoin sme uvesti zdravnik, ki ima izkušnje z zdravljenjem simptomatske anemije pri bolnikih s kronično odpovedjo ledvic in nemieloidnim rakom.
Erythropoietin is produced by the kidneys.
Eritropoetin nastaja v ledvicah.
Patients with cancer should continue to receive treatment for up to four weeks after they stop receiving chemotherapy.
Tedenski odmerek zdravila Biopoin ne sme biti višji od 60 000 i.e. Bolniki z rakom naj zdravljenje nadaljujejo do štiri tedne po prenehanju zdravljenja s kemoterapijo.
What is Biopoin used for?
Za kaj se zdravilo Biopoin uporablja?
How does Biopoin work?
Kako zdravilo Biopoin deluje?
How has Biopoin been studied?
Kako je bilo zdravilo Biopoin raziskano?
What is Biopoin?
Kaj je zdravilo Biopoin?
How is Biopoin used?
Kako se zdravilo Biopoin uporablja?
Elderly patients (≥ 65 years)
Starejši bolniki (≥ 65 let)
• Risk Management Plan (RMP)
• Načrt za obvladovanje tveganj (RMP)
Based on a Log-rank test.
Na podlagi testa log-rank.
Do not take two capsules together if you have forgotten to take your earlier dose.
Ne vzemite dveh kapsul skupaj, če ste pozabili vzeti prejšnji odmerek.
A risk to the newborns/infants cannot be excluded.
Tveganja za novorojenca/dojenčka ne moremo izključiti.
95% CI
95 % IZ
It is important to take this medicine every day, as long as your doctor prescribes it for you.
Pomembno je, da zdravilo jemljete vsak dan tako dolgo, dokler vam ga je zdravnik predpisal.
Based on a logistic regression.
Na podlagi logistične regresije.
CI: confidence interval
IZ: interval zaupanja
Systemic blood pressure should be measured periodically and as clinically indicated.
Sistemski krvni tlak je treba meriti periodično in kot je klinično indicirano.
Based on this information your doctor may do some blood tests, for example to check your liver function.
Na podlagi teh podatkov lahko zdravnik opravi nekatere krvne preiskave, na primer preveri delovanje vaših jeter.
Survival analysis
Analiza preživetja
The treatment effect was consistent in both trials.
Učinek zdravljenja je bil v obeh preskušanjih skladen.
Studies in paediatric populations have not been performed.
Študij pri pediatrični populaciji niso izvedli.
Data from Black individuals were very limited but in the same range as for Caucasians.
Podatki za črnce so bili zelo omejeni, vendar v enakem razponu kot za belce.
Similar results were observed in analyses using a conservative threshold of 10%.
Podobne rezultate so opazili v analizah z bolj konservativnim pragom 10 %.
Based on data collected up to 372 days (52 weeks + 7 day margin).
Na podlagi podatkov, zbranih v do 372 dneh (52 tednov + meja 7 dni).
Your doctor will discuss the results of these tests with you and decide whether you may receive Ofev.
Zdravnik se bo z vami pogovoril o izvidih teh preiskav in se odločil, ali lahko prejemate zdravilo Ofev.
No overall differences in safety and efficacy were observed for elderly patients.
Pri starejših bolnikih na splošno niso opazili razlike glede varnosti in učinkovitosti.
Patients should then be monitored at regular intervals during the subsequent two months of treatment and periodically thereafter, e.g. at each patient visit or as clinically indicated.
Bolnike je treba v naslednjih dveh mesecih zdravljenja spremljati v rednih intervalih, nato pa periodično, npr. ob vsakem obisku bolnika ali kot je klinično indicirano.
Ofev can interact with certain other medicines.
Zdravilo Ofev lahko medsebojno deluje z nekaterimi drugimi zdravili.
Close monitoring is recommended in patients with these risk factors.
Priporočljivo je skrbno spremljanje bolnikov s temi dejavniki tveganja.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
Time to first acute IPF exacerbation
Čas do prvega akutnega poslabšanja IPF
The major route of elimination of drug related radioactivity after oral administration of [
Glavna pot izločanja z zdravilom povezane radioaktivnosti po zaužitju [
The age range covered by the analysis was 29 to 85 years; approximately 5% of the population were older than 75 years.
Obravnavani razpon starosti v analizi je bil 29 do 85 let; približno 5 % populacije je bilo starejše od 75 let.
Therefore these patients should only be treated with Ofev if the anticipated benefit outweighs the potential risk.
Zato se lahko ti bolniki z zdravilom Ofev zdravijo le, če so pričakovane koristi večje od možnih tveganj.
You should not drive or use machines if you feel sick.
Ne vozite in ne upravljajte strojev, če vam postane slabo.
In case of overdose, treatment should be interrupted and general supportive measures initiated as appropriate.
V primeru prevelikega odmerjanja je treba zdravljenje prekiniti in takoj uvesti ustrezne splošne podporne ukrepe.
Both patients recovered from these adverse reactions.
Oba bolnika sta po teh neželenih učinkih okrevala.
Patients with low body weight (< 65 kg), Asian and female patients have a higher risk of elevations of liver enzymes.
Pri bolnikih z majhno telesno maso (< 65 kg), bolnikih azijske rase in ženskah obstaja večje tveganje za povečanje ravni jetrnih encimov.
The robustness of the effect of nintedanib in reducing the annual rate of decline in FVC was confirmed in all pre-specified sensitivity analyses.
Robustnost učinka nintedaniba pri zmanjšanju letne stopnje upada FVC je bila potrjena v vseh predhodno specificiranih analizah občutljivosti.
The overall recovery was considered complete (above 90%) within 4 days after dosing.
Skupno izločanje je veljalo za končano (nad 90 %) v 4 dneh po odmerjanju.
Effect on QT interval
Učinek na interval QT
Your doctor will decide when to resume your treatment with this medicine.
Zdravnik se bo odločil, kdaj boste lahko zdravljenje s tem zdravilom nadaljevali.
The primary endpoint was the annual rate of decline in Forced Vital Capacity (FVC).
Primarni opazovani dogodek je bila letna stopnja upada forsirane vitalne kapacitete (FVC-Forced Vital Capacity).
It is recommended that you take the capsules with food, i.e. during or immediately before or after a meal.
Priporočamo vam, da kapsule jemljete s hrano, torej med obrokom, tik pred njim ali takoj po njem.
The difference between the treatment groups reached nominal statistical significance (p=0.0136).
Razlika med skupinama zdravljenja je dosegla nominalno statistično značilnost (p=0,0136).