FrancophonIA/ELRC3.0 huggingface dataset:
English: No specific side effects have been reported when Seebri Breezhaler has been used together with other medicines used to treat COPD such as reliever inhalers (e.g. salbutamol), methylxanthines (e.g. theophylline) and/or oral and inhaled steroids (e.g. prednisolone).
Slovenian: Pri uporabi zdravila Seebri Breezhaler skupaj z drugimi zdravili, ki se uporabljajo pri zdravljenju KOPB, kot so inhalacijski olajševalci (npr. salbutamol), metilksantini (npr. teofilin) in/ali peroralni ali inhalacijski kortikosteroidi (npr. prednizolon), niso poročali o posebnih neželenih učinkih.
English: Seebri Breezhaler 44 micrograms inhalation powder, hard capsules glycopyrronium (as glycopyrronium bromide)
Slovenian: Seebri Breezhaler 44 mikrogramov prašek za inhaliranje, trde kapsule glikopironij (v obliki glikopironijevega bromida)
English: The pooled analysis also showed fewer patients treated with Seebri Breezhaler than with placebo experienced an exacerbation requiring hospitalisation (1.7% versus 4.2%, p=0.003).
Slovenian: Rezultati analize združenih podatkov poleg tega kažejo, da je bil delež bolnikov, pri katerih je prišlo do akutnega poslabšanja, zaradi katerega je bila potrebna hospitalizacija, manjši med bolniki, ki so prejemali zdravilo Seebri Breezhaler, v primerjavi s tovrstnim deležem pri tistih, ki so prejemali placebo (1,7 % v primerjavi s 4,2 %, p=0,003).
English: If you forget to inhale a dose, take one as soon as possible.
Slovenian: Če ste pozabili uporabiti zdravilo Seebri Breezhaler Če pozabite inhalirati odmerek, ga inhalirajte čimprej, vendar ne vzemite dveh odmerkov na isti dan.
English: During treatment with Seebri Breezhaler, stop taking this medicine and tell your doctor immediately: - if you experience tightness of the chest, coughing, wheezing or breathlessness immediately after using Seebri Breezhaler (signs of bronchospasm).
Slovenian: Med zdravljenjem z zdravilom Seebri Breezhaler, takoj prenehajte uporabljati to zdravilo in obvestite zdravnika: - če vas začne takoj po uporabi zdravila Seebri Breezhaler stiskati v prsih, če začnete kašljati, če vam v pljučih piska ali vam zmanjkuje sape (to so znaki bronhospazma), - če težko dihate ali požirate, če vam otekajo jezik, ustnice ali obraz, če se pojavi izpuščaj, srbenje in koprivnica (to so znaki alergijske reakcije), - če vas začne boleti ali ščemeti v očeh, če se vam začasno zamegli vid, če opažate svetlobne ali živobarvne kolobarje okrog luči, pri tem pa so vaše oči pordele.
English: Talk to your doctor before using Seebri Breezhaler, if any of the following applies to you: - you have kidney problems.
Slovenian: Pred začetkom uporabe zdravila Seebri Breezhaler se posvetujte z zdravnikom, če kaj od navedenega velja za vas: - če imate težave z ledvicami, - če imate očesno bolezen, ki se imenuje glavkom zaprtega zakotja, - če imate težave pri uriniranju.
English: This medicine is used to make breathing easier for adult patients who have breathing difficulties due to a lung disease called chronic obstructive pulmonary disease (COPD).
Slovenian: Za kaj uporabljamo zdravilo Seebri Breezhaler To zdravilo uporabljamo za lajšanje dihanja pri odraslih bolnikih, ki imajo težave z dihanjem zaradi bolezni, ki se imenuje kronična obstruktivna pljučna bolezen (KOPB).
English: Your Seebri Breezhaler Inhaler pack contains:
Slovenian: Vaše pakiranje zdravila Seebri Breezhaler vsebuje:
English: 6 or 10 Seebri Breezhaler capsules to be used in the inhaler
Slovenian: 10 kapsul zdravila Seebri Breezhaler, ki jih vstavljate v inhalator.
English: Other medicines and Seebri Breezhaler
Slovenian: Druga zdravila in zdravilo Seebri Breezhaler
English: Seebri Breezhaler contains lactose
Slovenian: Zdravilo Seebri Breezhaler vsebuje laktozo
English: Seebri Breezhaler also reduced dyspnoea at rest measured using the Transitional Dyspnoea Index.
Slovenian: Poleg tega je zdravilo Seebri Breezhaler zmanjšalo dispnejo v mirovanju po oceni z indeksom spreminjanja dispneje v času (angl. Transitional Dyspnoea Index).
English: In patients with severe renal impairment (eGFR <30 ml/min/1.73 m2), including those with end-stage renal disease requiring dialysis, Seebri Breezhaler should only be used if the expected benefit outweighs the potential risk (see section 4.4).
Slovenian: Pri bolnikih s hudo okvaro ledvic (z ocenjeno hitrostjo glomerulne filtracije <30 ml/min/1,73 m vključno s tistimi s končno ledvično odpovedjo, ki potrebujejo dializo, je zdravilo Seebri Breezhaler mogoče uporabljati samo v primeru, da pričakovana korist presega potencialno tveganje (glejte poglavje 4.4).
English: No change in mean heart rate or QTc interval was observed with Seebri Breezhaler in doses up to 176 micrograms in COPD patients.
Slovenian: Pri odmerjanju zdravila Seebri Breezhaler v odmerkih do 176 mikrogramov bolnikom s KOPB niso opažali nobenih sprememb srčne frekvence ali trajanja intervala QTc.
English: Breezhaler inhaler).
Slovenian: Seebri Breezhaler).
English: Seebri Breezhaler was found to decrease dyspnoea and leg discomfort when exercising as measured using Borg scales.
Slovenian: Ugotovili so, da zdravilo Seebri Breezhaler zmanjša dispnejo in bolečine v nogah pri naporu po Borgovi lestvici zaznavanja napora.
English: Show the pack of Seebri Breezhaler.
Slovenian: Tam pokažite škatlo z zdravilom Seebri Breezhaler.
English: Seebri Breezhaler 44 mcg inhalation powder glycopyrronium
Slovenian: Seebri Breezhaler 44 μg prašek za inhaliranje glikopironij
English: • One Seebri Breezhaler inhaler
Slovenian: • en inhalator Seebri Breezhaler,
English: A pooled analysis of the 6- and 12-month pivotal studies found a statistically significantly higher percentage of patients receiving Seebri Breezhaler responded with a 4 point or greater improvement in SGRQ compared to placebo at week 26 (57.8% and 47.6% respectively, p<0.001).
Slovenian: Po rezultatih analize združenih podatkov iz ključnih študij (6-mesečne in 12-mesečne) je bil po 26 tednih delež bolnikov, ki so dosegli izboljšanje ocene SGRQ za 4 točke ali več, statistično značilno večji med bolniki, ki so prejemali zdravilo Seebri Breezhaler, v primerjavi s tistimi, ki so prejemali placebo (57,8 % v primerjavi s 47,6 %, p<0,001).
English: The usual dose is to inhale the content of one capsule each day.
Slovenian: Koliko zdravila Seebri Breezhaler je treba uporabljati Običajni odmerek je inhaliranje vsebine ene kapsule vsak dan.
English: In a pooled analysis of the 6and 12-month pivotal studies a statistically significantly higher percentage of patients receiving Seebri Breezhaler responded with a 1 point or greater improvement in the TDI focal score at week 26 compared to placebo (58.4% and 46.4% respectively, p<0.001).
Slovenian: Po rezultatih analize združenih podatkov iz ključnih študij (6-mesečne in 12-mesečne) je bil po 26 tednih delež bolnikov, ki so dosegli izboljšanje skupne ocene indeksa TDI za 1 točko ali več, statistično značilno večji med bolniki, ki so prejemali zdravilo Seebri Breezhaler, v primerjavi s tistimi, ki so prejemali placebo (58,4 % v primerjavi s 46,4 %, p<0,001).
English: How to use Seebri Breezhaler
Slovenian: Kako uporabljati zdravilo Seebri Breezhaler
English: In the 6-month study, the percentage of patients experiencing a moderate or severe exacerbation was 17.5% for Seebri Breezhaler and 24.2% for placebo (Hazard ratio: 0.69, p=0.023), and in the 12-month study it was 32.8% for Seebri Breezhaler and 40.2% for placebo (Hazard ratio: 0.66, p=0.001).
Slovenian: (razmerje ogroženosti: 0,69, p=0,023), medtem ko je bil v 12-mesečni študiji odstotek takih bolnikov pri uporabi zdravila Seebri Breezhaler 32,8 %, pri uporabi placeba pa 40,2 % (razmerje ogroženosti: 0,66, p=0,001).
English: Peak plasma levels and total systemic exposure following intravenous administration of 150 micrograms glycopyrronium bromide (equivalent to 120 micrograms glycopyrronium) in healthy volunteers were respectively about 50-fold and 6-fold higher than the peak and total exposure at steady-state achieved with the recommended dose (44 micrograms once daily) of Seebri Breezhaler and were well tolerated.
Slovenian: Pri tem je najvišja koncentracija v plazmi 50-krat, celotna izpostavljenost pa 6-krat presegala vrednost v stanju dinamičnega ravnovesja po priporočenem odmerjanju zdravila Seebri Breezhaler (44 mikrogramov na dan).
English: Seebri Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment.
Slovenian: Bolniki z blago do zmerno okvaro ledvic lahko uporabljajo zdravilo Seebri Breezhaler v priporočenem odmerku.
English: What Seebri Breezhaler is
Slovenian: Kaj je zdravilo Seebri Breezhaler
English: See package leaflet for further information.
Slovenian: Za več podatkov glejte Navodilo za uporabo.
English: Empty remaining
Slovenian: PRETISNI OMOTI
English: How to store Seebri Breezhaler
Slovenian: Shranjevanje zdravila Seebri Breezhaler
English: They also presented data from the published literature.
Slovenian: Družba je predstavila tudi podatke iz objavljene literature.
English: This damages the bacteria and eventually kills them.
Slovenian: To poškoduje bakterije in jih sčasoma uniči.
English: The trials lasted 24 weeks (three treatment cycles).
Slovenian: Preskušanji sta trajali 24 tednov (trije cikli zdravljenja).
English: The capsules are only to be inserted into the Podhaler and must never be swallowed.
Slovenian: Kapsule so namenjene le za vstavljanje v inhalator Podhaler in se ne smejo nikoli pogoltniti.
English: The recommended dose is four capsules twice a day (as close as possible to 12 hour intervals) for four weeks, followed by four weeks without treatment.
Slovenian: Priporočeni odmerek so štiri kapsule dvakrat na dan (v časovnem razmiku, ki mora biti čim bližje 12 uram), ki se jemljejo štiri tedne, temu pa sledijo štirje tedni brez zdravljenja.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tobi Podhaler on 20 July 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Tobi Podhaler, veljavno po vsej Evropski uniji, izdala 20. julija 2011.
English: It is available as capsules (28 mg) containing a dry powder for inhalation using a portable inhaler device.
Slovenian: Na voljo je v obliki kapsul (28 mg), ki vsebujejo suh prašek za inhaliranje z uporabo prenosnega inhalatorja.
English: The main measure of effectiveness was the change in FEV1 at the end of the treatment period of cycle 1 in the first study and at the end of the treatment period of cycle 3 in the second study.
Slovenian: Glavno merilo učinkovitosti v prvi študiji je bila sprememba FEV1 ob koncu prvega cikla zdravljenja, v drugi študiji pa ob koncu tretjega cikla zdravljenja.
English: This is a summary of the European public assessment report (EPAR) for Tobi Podhaler.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Tobi Podhaler.
English: What measures are being taken to ensure the safe and effective use of Tobi Podhaler?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila ?
English: It works by disrupting the production of proteins that P. aeruginosa needs to build its cell walls.
Slovenian: Deluje tako, da ovira tvorjenje beljakovin, ki jih bakterija P. aeruginosa potrebuje za gradnjo celičnih sten.
English: If the patient's lung infection gets worse, the doctor should consider replacing or adding another treatment to Tobi Podhaler.
Slovenian: Če se okužba pljuč poslabša, mora zdravnik razmisliti o zamenjavi zdravila ali zdravljenju z zdravilom Tobi Podhaler dodati drugo zdravilo.
English: For more information about treatment with Tobi Podhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Tobi Podhaler preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Because the number of patients with cystic fibrosis and P. aeruginosa bacterial lung infection is low, the disease is considered ‘rare' and Tobi Podhaler was designated an ‘orphan medicine' (a medicine used in rare diseases) on 17 March 2003.
Slovenian: Ker je bolnikov s cistično fibrozo in bakterijsko okužbo pljuč z bakterijo P. aeruginosa malo, velja bolezen za redko, zato je bilo zdravilo Tobi Podhaler 17. marca 2003 določeno kot „zdravilo sirota“ (zdravilo, ki se uporablja pri redkih boleznih).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Tobi Podhaler.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z zdravilom in priporočila glede pogojev njegove uporabe.
English: The applicant presented data on an existing nebuliser solution containing tobramycin called Tobi.
Slovenian: Predlagatelj je predstavil podatke o obstoječi raztopini za nebulator, ki vsebuje tobramicin in se imenuje Tobi.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Tobi Podhaler can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Tobi Podhaler je na voljo na spletni strani Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: A risk management plan has been developed to ensure that Tobi Podhaler is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Tobi Podhaler je bil pripravljen načrt obvladovanja tveganj.
English: Tobi Podhaler tobramycin
Slovenian: Tobi Podhaler tobramicin
English: The most common side effects with Tobi Podhaler (seen in more than 1 patient in 10) are haemoptysis (coughing up blood), dyspnoea (difficulty breathing), dysphonia (hoarseness), cough and productive cough (producing mucus), oropharyngeal pain (affecting the mouth and throat) and pyrexia (fever).
Slovenian: Najpogostejši neželeni učinki zdravila Tobi Podhaler (opaženi pri več kot 1 bolniku od 10) so hemoptiza (izkašljevanje krvi), dispneja (težave z dihanjem), disfonija (hripavost), kašelj in produktiven kašelj (izkašljevanje sluzi), orofaringealne bolečine (prizadenejo usta in grlo) in pireksija (povišana telesna temperatura).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tobi Podhaler, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: After four weeks of treatment, the patients taking Tobi Podhaler had an improvement in FEV1 of 13.2%, while patients taking placebo had a reduction in FEV1 of around 0.6%.
Slovenian: Po štirih tednih zdravljenja se je FEV1 pri bolnikih, ki so jemali zdravilo Tobi Podhaler izboljšal za 13,2 %, pri bolnikih, ki so jemali placebo, pa se je FEV1 poslabšal za okoli 0,6 %.
English: The full EPAR for Tobi Podhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Tobi Podhaler je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Tobi Podhaler must not be used in people who are hypersensitive (allergic) to tobramycin, any aminoglycoside or any of the other ingredients.
Slovenian: Zdravila Tobi Podhaler ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) tobramicin, kateri koli aminoglikozid ali katero koli drugo sestavino zdravila.
English: The first trial, which involved 102 patients aged 6 to 21 years, compared Tobi Podhaler with placebo (a dummy treatment), while the second, involving 553 mostly adult patients, compared it with Tobi.
Slovenian: V prvem preskušanju, v katerem sta sodelovala 102 bolnika starosti od šest do 21 let, so zdravilo Tobi Podhaler primerjali s placebom (zdravilom brez zdravilne učinkovine), v drugem preskušanju, v katerem je sodelovalo 553 večinoma odraslih bolnikov, pa so zdravilo Tobi Podhaler primerjali z zdravilom Tobi.
English: What benefit has Tobi Podhaler shown during the studies?
Slovenian: Kakšne koristi je zdravilo Tobi Podhaler izkazalo med študijami?
English: Cystic fibrosis is an inherited disease in which there is accumulation of thick mucus in the lungs that allows bacteria to grow more easily causing infections.
Slovenian: Cistična fibroza je dedna bolezen, pri kateri se v pljučih kopiči gosta sluz, ki omogoča lažjo rast bakterij, kar povzroča okužbe.
English: Tobramycin is a well-known antibiotic that has been used to treat lung infection in cystic fibrosis patients, available in the form of a solution used with a nebuliser (a machine that changes a solution into an aerosol that the patient can breathe in).
Slovenian: Tobramicin je dobro znan antibiotik, ki se uporablja za zdravljenje okužb pljuč pri bolnikih s cistično fibrozo in je na voljo v obliki raztopine za uporabo z nebulatorjem (napravo, ki raztopino spremeni v razpršilo, ki ga bolnik lahko vdihne).
English: Other information about Tobi Podhaler
Slovenian: Druge informacije o zdravilu Tobi Podhaler
English: When the patients in the placebo group were switched to Tobi Podhaler for the second and third cycles they also experienced a similar improvement in FEV1.
Slovenian: Ko so bolnike, ki so najprej prejemali placebo, v drugem in tretjem ciklu začeli zdraviti z zdravilom Tobi Podhaler, se je tudi pri njih pokazalo podobno izboljšanje FEV1.
English: The effect of Tobi Podhaler was similar to that of Tobi after three cycles of treatment.
Slovenian: Učinek zdravila Tobi Podhaler je bil po treh ciklih zdravljenja podoben učinku zdravila Tobi.
English: Tobi Podhaler is used to suppress chronic lung infection caused by bacteria called Pseudomonas aeruginosa in adults and children aged 6 years and over who have cystic fibrosis.
Slovenian: Zdravilo Tobi Podhaler se uporablja za supresivno zdravljenje kronične okužbe pljuč, ki jo povzroča bakterija Pseudomonas aeruginosa, pri odraslih in otrocih, starih šest let in več, ki imajo cistično fibrozo.
English: What is the risk associated with Tobi Podhaler?
Slovenian: Kakšna tveganja so povezana z zdravilom Tobi Podhaler?
English: The active substance in Tobi Podhaler, tobramycin, is an antibiotic that belongs to the group ‘aminoglycosides'.
Slovenian: Zdravilna učinkovina v zdravilu Tobi Podhaler, tobramicin, je antibiotik, ki sodi v skupino „aminoglikozidov“.
English: Tobi Podhaler is a medicine that contains the active substance tobramycin.
Slovenian: Tobi Podhaler je zdravilo, ki vsebuje zdravilno učinkovino tobramicin.
English: Tobi Podhaler was more effective than placebo in treating P. aeruginosa infection in patients with cystic fibrosis.
Slovenian: Zdravilo Tobi Podhaler je bilo učinkovitejše od placeba pri zdravljenju okužbe z bakterijo P. aeruginosa pri bolnikih s cistično fibrozo.
English: The CHMP decided that Tobi Podhaler's benefits are greater than its risks, since it is effective at treating lung infection in cystic fibrosis patients and given its added convenience for patients.
Slovenian: CHMP je zaključil, da so koristi zdravila Tobi Podhaler večje od z njim povezanih tveganj, saj je učinkovito pri zdravljenju okužb pljuč pri bolnikih s cistično fibrozo in priročno za jemanje, zato je priporočil, da se za zanj izda dovoljenje za promet.
English: Tobi Podhaler was studied in two main trials in patients who had cystic fibrosis with P. aeruginosa lung infection.
Slovenian: Zdravilo Tobi Podhaler so proučevali v dveh glavnih preskušanjih, ki sta vključevali bolnike s cistično fibrozo in okužbo pljuč z bakterijo P. aeruginosa.
English: For the full list of all side effects reported with Tobi Podhaler, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Tobi Podhaler, glejte navodilo za uporabo.
English: treatment for as long as the doctor believes the patient is benefiting from it.
Slovenian: Bolniki morajo nadaljevati s ciklom štiritedenskega zdravljenja, ki mu sledijo štirje tedni brez zdravljenja, vse dokler je zdravnik prepričan, da zdravljenje bolniku koristi.
English: Why has Tobi Podhaler been approved?
Slovenian: Zakaj je bilo zdravilo Tobi Podhaler odobreno?
English: For more information on how to use Tobi Podhaler, see the instructions in the package leaflet.
Slovenian: Za podrobnejše informacije o uporabi zdravila Tobi Podhaler glejte navodilo za uporabo.
English: Tobi Podhaler is intended to increase the convenience of taking tobramycin for patients.
Slovenian: Zdravilo Tobi Podhaler je namenjeno lažjemu jemanju tobramicina.
English: How has Tobi Podhaler been studied?
Slovenian: Kako je bilo zdravilo Tobi Podhaler raziskano?
English: Tobi Podhaler is inhaled using a hand-held device called Podhaler.
Slovenian: Zdravilo Tobi Podhaler se inhalira z uporabo ročnega inhalatorja, imenovanega Podhaler.
English: What is Tobi Podhaler?
Slovenian: Kaj je zdravilo Tobi Podhaler?
English: What is Tobi Podhaler used for?
Slovenian: Za kaj se zdravilo Tobi Podhaler uporablja?
English: How is Tobi Podhaler used?
Slovenian: Kako se zdravilo Tobi Podhaler uporablja?
English: How does Tobi Podhaler work?
Slovenian: Kako zdravilo Tobi Podhaler deluje?
English: Emtricitabine/Tenofovir disoproxil Mylan received a marketing authorisation valid throughout the EU on 16 December 2016.
Slovenian: Za zdravilo Emtricitabin/dizoproksiltenofovirat Mylan je bilo 16. decembra 2016 izdano dovoljenje za promet, veljavno po vsej EU.
English: This means that it contains the same active substances and works in the same way as a ‘reference medicine' already authorised in the EU called Truvada.
Slovenian: To pomeni, da vsebuje enaki učinkovini in ima enak način delovanja kot referenčno zdravilo Truvada, ki je že odobreno v EU.
English: Further information on Emtricitabine/Tenofovir disoproxil Mylan can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/emtricitabinetenofovir-disoproxil-mylan.
Slovenian: Nadaljnje informacije o zdravilu Emtricitabin/dizoproksiltenofovirat Mylan so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/emtricitabinetenofovir-disoproxil-mylan.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Emtricitabine/Tenofovir disoproxil Mylan has been shown to have comparable quality and to be bioequivalent to Truvada.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Emtricitabin/dizoproksiltenofovirat Mylan primerljivo raven kakovosti kot referenčno zdravilo Truvada ter da mu je biološko enakovredno.
English: Because Emtricitabine/Tenofovir disoproxil Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Emtricitabin/dizoproksiltenofovirat Mylan generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Studies on the benefits and risks of the active substances in the authorised uses have already been carried out with the reference medicine, Truvada, and do not need to be repeated for Emtricitabine/Tenofovir disoproxil Mylan.
Slovenian: Študije o koristih in tveganjih obeh učinkovin pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Truvada, zato jih ni treba ponoviti za zdravilo Emtricitabin/dizoproksiltenofovirat Mylan.
English: Side effects reported with Emtricitabine/Tenofovir disoproxil Mylan are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Emtricitabin/dizoproksiltenofovirat Mylan, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.