FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Biopoin is used to treat anaemia (low levels of red blood cells or haemoglobin) that is causing symptoms.
Slovenian: Zdravilo Biopoin se uporablja za zdravljenje anemije (nizke koncentracije rdečih krvničk ali hemoglobina), ki povzroča simptome.
English: What is the risk associated with Biopoin?
Slovenian: Kakšna tveganja so povezana z zdravilom Biopoin?
English: 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.
Slovenian: Pri bolnikih, ki prejemajo kemoterapijo ali imajo težave z ledvicami, je lahko vzrok anemije pomanjkanje eritropoetina ali pa nezadostna odzivnost telesa na naravni eritropoetin.
English: In chronic renal failure patients, the correction phase showed that increasing the starting dose of Biopoin leads to improvements in haemoglobin levels.
Slovenian: Pri bolnikih s kronično ledvično odpovedjo je korekcijska faza pokazala, da povišanje začetnega odmerka zdravila Biopoin povzroči izboljšanje ravni hemoglobina.
English: For the full list of all side effects reported with Biopoin, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Biopoin, glejte navodilo za uporabo.
English: The weekly dose of Biopoin should not at any time be more than 700 IU per kg body weight.
Slovenian: Tedenski odmerek zdravila Biopoin ne sme nikoli preseči 700 i.e. na kilogram telesne mase.
English: 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).
Slovenian: 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).
English: The initial recommended dose is 20,000 IU once a week for all patients irrespective of their body weight.
Slovenian: Začetni priporočeni odmerek za vse bolnike je ne glede na telesno maso 20 000 i.e. enkrat na teden.
English: The epoetin theta in Biopoin works in the body in the same way as the natural hormone to stimulate red blood cell production.
Slovenian: Epoetin theta v zdravilu Biopoin deluje v telesu enako kot naravni hormon in vzpodbuja tvorbo rdečih krvničk.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: When the anaemia has been corrected, the dose in the ‘maintenance phase' should be adjusted to maintain the right level of haemoglobin.
Slovenian: Ko je anemija odpravljena, moramo prilagoditi odmerek vzdrževalne faze, da se obdrži ustrezna raven hemoglobina.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Zdravilna učinkovina v zdravilu Biopoin, epoetin theta, je kopija človeškega hormona, imenovanega eritropoetin, ki spodbuja tvorbo rdečih krvničk v kostnem mozgu.
English: Why has Biopoin been approved?
Slovenian: Zakaj je bilo zdravilo Biopoin odobreno?
English: The other two studies compared Biopoin with epoetin beta during the maintenance phase.
Slovenian: V drugih dveh študijah so v vzdrževalni fazi zdravilo Biopoin primerjali z epoetinom beta.
English: 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.
Slovenian: 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.
English: For full details, see the Package Leaflet.
Slovenian: Za podrobnejše informacije glejte navodilo za uporabo.
English: The full EPAR for Biopoin can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Biopoin je na voljo tukaj.
English: Biopoin was effective at treating anaemia in patients with chronic renal failure and patients with nonmyeloid cancer who were receiving chemotherapy.
Slovenian: Zdravilo Biopoin je bilo učinkovito za zdravljenje anemije pri bolnikih s kronično ledvično odpovedjo in pri bolnikih z nemielodnim rakom, ki so prejemali kemoterapijo.
English: 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.
Slovenian: 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.
English: Biopoin treatment should be started by a doctor experienced in treating symptomatic anaemia in patients with chronic renal failure and non-myeloid cancer.
Slovenian: Zdravljenje z zdravilom Biopoin sme uvesti zdravnik, ki ima izkušnje z zdravljenjem simptomatske anemije pri bolnikih s kronično odpovedjo ledvic in nemieloidnim rakom.
English: Erythropoietin is produced by the kidneys.
Slovenian: Eritropoetin nastaja v ledvicah.
English: Patients with cancer should continue to receive treatment for up to four weeks after they stop receiving chemotherapy.
Slovenian: 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.
English: What is Biopoin used for?
Slovenian: Za kaj se zdravilo Biopoin uporablja?
English: How does Biopoin work?
Slovenian: Kako zdravilo Biopoin deluje?
English: How has Biopoin been studied?
Slovenian: Kako je bilo zdravilo Biopoin raziskano?
English: What is Biopoin?
Slovenian: Kaj je zdravilo Biopoin?
English: How is Biopoin used?
Slovenian: Kako se zdravilo Biopoin uporablja?
English: 3 years
Slovenian: 3 leta
English: Elderly patients (≥ 65 years)
Slovenian: Starejši bolniki (≥ 65 let)
English: • Risk Management Plan (RMP)
Slovenian: • Načrt za obvladovanje tveganj (RMP)
English: Based on a Log-rank test.
Slovenian: Na podlagi testa log-rank.
English: Do not take two capsules together if you have forgotten to take your earlier dose.
Slovenian: Ne vzemite dveh kapsul skupaj, če ste pozabili vzeti prejšnji odmerek.
English: A risk to the newborns/infants cannot be excluded.
Slovenian: Tveganja za novorojenca/dojenčka ne moremo izključiti.
English: 95% CI
Slovenian: 95 % IZ
English: It is important to take this medicine every day, as long as your doctor prescribes it for you.
Slovenian: Pomembno je, da zdravilo jemljete vsak dan tako dolgo, dokler vam ga je zdravnik predpisal.
English: Based on a logistic regression.
Slovenian: Na podlagi logistične regresije.
English: CI: confidence interval
Slovenian: IZ: interval zaupanja
English: Systemic blood pressure should be measured periodically and as clinically indicated.
Slovenian: Sistemski krvni tlak je treba meriti periodično in kot je klinično indicirano.
English: Based on this information your doctor may do some blood tests, for example to check your liver function.
Slovenian: Na podlagi teh podatkov lahko zdravnik opravi nekatere krvne preiskave, na primer preveri delovanje vaših jeter.
English: Survival analysis
Slovenian: Analiza preživetja
English: The treatment effect was consistent in both trials.
Slovenian: Učinek zdravljenja je bil v obeh preskušanjih skladen.
English: Studies in paediatric populations have not been performed.
Slovenian: Študij pri pediatrični populaciji niso izvedli.
English: Data from Black individuals were very limited but in the same range as for Caucasians.
Slovenian: Podatki za črnce so bili zelo omejeni, vendar v enakem razponu kot za belce.
English: Similar results were observed in analyses using a conservative threshold of 10%.
Slovenian: Podobne rezultate so opazili v analizah z bolj konservativnim pragom 10 %.
English: Based on data collected up to 372 days (52 weeks + 7 day margin).
Slovenian: Na podlagi podatkov, zbranih v do 372 dneh (52 tednov + meja 7 dni).
English: Your doctor will discuss the results of these tests with you and decide whether you may receive Ofev.
Slovenian: Zdravnik se bo z vami pogovoril o izvidih teh preiskav in se odločil, ali lahko prejemate zdravilo Ofev.
English: No overall differences in safety and efficacy were observed for elderly patients.
Slovenian: Pri starejših bolnikih na splošno niso opazili razlike glede varnosti in učinkovitosti.
English: 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.
Slovenian: 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.
English: Ofev can interact with certain other medicines.
Slovenian: Zdravilo Ofev lahko medsebojno deluje z nekaterimi drugimi zdravili.
English: Close monitoring is recommended in patients with these risk factors.
Slovenian: Priporočljivo je skrbno spremljanje bolnikov s temi dejavniki tveganja.
English: 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.
Slovenian: 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.
English: Time to first acute IPF exacerbation
Slovenian: Čas do prvega akutnega poslabšanja IPF
English: The major route of elimination of drug related radioactivity after oral administration of [
Slovenian: Glavna pot izločanja z zdravilom povezane radioaktivnosti po zaužitju [
English: The age range covered by the analysis was 29 to 85 years; approximately 5% of the population were older than 75 years.
Slovenian: Obravnavani razpon starosti v analizi je bil 29 do 85 let; približno 5 % populacije je bilo starejše od 75 let.
English: Therefore these patients should only be treated with Ofev if the anticipated benefit outweighs the potential risk.
Slovenian: Zato se lahko ti bolniki z zdravilom Ofev zdravijo le, če so pričakovane koristi večje od možnih tveganj.
English: You should not drive or use machines if you feel sick.
Slovenian: Ne vozite in ne upravljajte strojev, če vam postane slabo.
English: In case of overdose, treatment should be interrupted and general supportive measures initiated as appropriate.
Slovenian: V primeru prevelikega odmerjanja je treba zdravljenje prekiniti in takoj uvesti ustrezne splošne podporne ukrepe.
English: Both patients recovered from these adverse reactions.
Slovenian: Oba bolnika sta po teh neželenih učinkih okrevala.
English: Patients with low body weight (< 65 kg), Asian and female patients have a higher risk of elevations of liver enzymes.
Slovenian: Pri bolnikih z majhno telesno maso (< 65 kg), bolnikih azijske rase in ženskah obstaja večje tveganje za povečanje ravni jetrnih encimov.
English: The robustness of the effect of nintedanib in reducing the annual rate of decline in FVC was confirmed in all pre-specified sensitivity analyses.
Slovenian: Robustnost učinka nintedaniba pri zmanjšanju letne stopnje upada FVC je bila potrjena v vseh predhodno specificiranih analizah občutljivosti.
English: The overall recovery was considered complete (above 90%) within 4 days after dosing.
Slovenian: Skupno izločanje je veljalo za končano (nad 90 %) v 4 dneh po odmerjanju.
English: Effect on QT interval
Slovenian: Učinek na interval QT
English: Your doctor will decide when to resume your treatment with this medicine.
Slovenian: Zdravnik se bo odločil, kdaj boste lahko zdravljenje s tem zdravilom nadaljevali.
English: The primary endpoint was the annual rate of decline in Forced Vital Capacity (FVC).
Slovenian: Primarni opazovani dogodek je bila letna stopnja upada forsirane vitalne kapacitete (FVC-Forced Vital Capacity).
English: It is recommended that you take the capsules with food, i.e. during or immediately before or after a meal.
Slovenian: Priporočamo vam, da kapsule jemljete s hrano, torej med obrokom, tik pred njim ali takoj po njem.
English: The difference between the treatment groups reached nominal statistical significance (p=0.0136).
Slovenian: Razlika med skupinama zdravljenja je dosegla nominalno statistično značilnost (p=0,0136).
English: As a result, scarring reduces the ability to transfer oxygen from the lungs into the bloodstream and it becomes difficult to breathe deeply.
Slovenian: Brazgotine posledično zmanjšajo sposobnost prenosa kisika iz pljuč v krvni obtok, zato postane globoko dihanje težavno.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Slovenian: Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: Serum albumin is considered to be the major binding protein.
Slovenian: Smatra se, da je albumin v serumu najpomembnejša vezavna beljakovina.
English: P-glycoprotein (P-gp)
Slovenian: P-glikoprotein (P-gp)
English: Ofev should only be initiated at least 4 weeks after abdominal surgery.
Slovenian: Zdravilo Ofev se lahko uvede najmanj 4 tedne po abdominalni operaciji.
English: As nintedanib may cause foetal harm also in humans, it must not be used during pregnancy.
Slovenian: Ker lahko nintedanib tudi pri ljudeh poškoduje plod, se ga med nosečnostjo ne sme uporabljati.
English: These changes are known from other VEGFR-2 inhibitors and can be considered class effects.
Slovenian: Te spremembe so poznane pri drugih zaviralcih VEGFR-2 in jih smatrajo kot učinek skupine zdravil.
English: Other medicines and Ofev
Slovenian: Druga zdravila in zdravilo Ofev
English: Linearity/non-linearity
Slovenian: Linearnost/nelinearnost
English: This leaflet was last revised in
Slovenian: Navodilo je bilo nazadnje revidirano dne
English: At the first signs of diarrhoea drink plenty of fluids and contact your doctor immediately.
Slovenian: Pri prvih znakih driske spijte veliko tekočine in se takoj posvetujte z zdravnikom.
English: Based on a Cox's regression model.
Slovenian: Na podlagi Coxovega regresijskega modela.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Ofev in all subsets of the paediatric population in IPF (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Ofev za vse podskupine pediatrične populacije z IPF (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Frequency categories are defined using 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: 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 pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: OTHER Do not open before use.
Slovenian: DRUGI PODATKI Pred uporabo ne odpirajte.
English: Do not use this medicine if you notice that the blister containing the capsules is opened or a capsule is broken.
Slovenian: Ne uporabljajte tega zdravila, če opazite, da je pretisni omot, ki vsebuje kapsule odprt, ali če je kapsula zlomljena.
English: ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
English: The recommended maximum daily dose of 300 mg should not be exceeded.
Slovenian: Ne sme se prekoračiti največjega priporočenega dnevnega odmerka 300 mg.
English: Women of childbearing potential / Contraception
Slovenian: Ženske v rodni dobi/kontracepcija
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
English: The use of VEGF pathway inhibitors in patients with or without hypertension may promote the formation of aneurysms and/or artery dissections.
Slovenian: Uporaba zaviralcev poti VEGF pri bolnikih s hipertenzijo ali brez nje lahko spodbudi nastanek anevrizem in/ali disekcij arterij.
English: 4.1 Therapeutic indications
Slovenian: 4.1 Terapevtske indikacije
English: The safety and efficacy of Ofev in children aged 0-18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila Ofev pri otrocih, starih 0 do 18 let, nista bili dokazani.
English: What Ofev is and what it is used for
Slovenian: Kaj je zdravilo Ofev in za kaj ga uporabljamo
English: Alternative causes of the liver enzyme elevations should be investigated.
Slovenian: Raziskati je treba alternativne vzroke za zvečane jetrnih encimov.
English: In patients with missing data, the primary analysis assumes that the decline in FVC after the last observed value would be similar to the decline in other patients in the same treatment group.
Slovenian: Za bolnike z manjkajočimi podatki so v primarni analizi domnevali, da bo upad FVC po zadnji opaženi vrednosti podoben upadu pri drugih bolnikih v isti zdravljeni skupini.
English: There is no specific antidote or treatment for Ofev overdose.
Slovenian: Specifičnega antidota ali zdravljenja za preveliko odmerjanje zdravila Ofev ni.
English: Very common
Slovenian: Zelo pogosti
English: Do not take this medicine during pregnancy, as it can harm your unborn baby and cause birth defects.
Slovenian: Tega zdravila ne jemljite med nosečnostjo, ker lahko škoduje še nerojenemu otroku in povzroči prirojene okvare.
English: Do not reduce the dose or stop the treatment by yourself without consulting your doctor first.
Slovenian: Sami pa ne zmanjšajte odmerka in ne opustite zdravljenja, ne da bi se prej posvetovali z zdravnikom.
English: In view of the limited number of patients, this study detected only the most frequent adverse events and showed an increase in gastrointestinal adverse events and a trend toward increased hepatic adverse events.
Slovenian: Zaradi omejenega števila bolnikov je ta študija odkrila le najpogostejše neželene učinke in pokazala povečano število neželenih učinkov prebavil in trend povečanja števila jetrnih neželenih učinkov.
English: Before initiating Ofev, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Slovenian: Pred uvedbo zdravila Ofev je treba to tveganje skrbno preučiti pri bolnikih z dejavniki tveganja, kot sta hipertenzija ali anamneza anevrizme.
English: Administration of Ofev may increase blood pressure.
Slovenian: Dajanje zdravila Ofev lahko zviša krvni tlak.
English: The results of all survival endpoints (such as on-treatment mortality and respiratory mortality) showed a consistent numerical difference in favour of nintedanib.
Slovenian: Rezultati vseh opazovanih dogodkov preživetja (kot so smrtnost med zdravljenjem in smrtnost zaradi dihal) je pokazala dosledno številčno razliko v korist nintedaniba.
English: Exposure to nintedanib increased linearly with age.
Slovenian: Izpostavljenost nintedanibu se je večala linearno s starostjo.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Slovenian: EDINSTVENA OZNAKA - V BERLJIVI OBLIKI PC:
English: Children and adolescents Ofev should not be taken by children and adolescents under 18 years of age.
Slovenian: Otroci in mladostniki Otroci in mladostniki, stari manj kot 18 let, ne smejo jemati zdravila Ofev.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 January 2015
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 15. januar 2015 Datum zadnjega podaljšanja: 23. september 2019
English: You should discuss the most appropriate methods of contraception for you with your doctor.
Slovenian: O kontracepcijskih metodah, ki so za vas najustreznejše, se morate pogovoriti z zdravnikom.
English: Based on the high inter-individual variability of exposure observed moderate effects are considered not clinically relevant (see section 4.4).
Slovenian: Na podlagi velike variabilnosti izpostavljenosti med posamezniki opaženi zmerni učinki ne veljajo za klinično pomembne (glejte poglavje 4.4).