FrancophonIA/ELRC3.0 huggingface dataset:
English: Special precautions for use in animals Vaccination is recommended where RHDV2 is epidemiologically relevant.
Slovenian: Celjenje se priporoča le tam, kjer je virus RHDV2 epidemiološko relevanten.
English: A transient temperature increase slightly above 40 ºC might very commonly occur between two or three days following vaccination.
Slovenian: Dva do tri dni po cepljenju se zelo pogosto pojavi prehodno povišanje telesne temperatura rahlo nad 40 ºC.
English: Type I colourless glass vials with 0.5 ml (1 dose), 5 ml (10 doses) and 20 ml (40 doses).
Slovenian: Viale iz brezbarvnega stekla tipa I s 0,5 ml (1 odmerek), 5 ml (10 odmerki) in 20 ml (40 odmerki).
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Namenjeno uporabniku:
English: 17170 Amer (Girona) SPAIN
Slovenian: 17170- AMER (Girona) ŠPANIJA
English: Lethargy and/or inappetence may be observed very rarely in the first 48 hours after injection, based on post-authorisation pharmacovigilance reporting.
Slovenian: Na podlagi farmakovigilančnega poročanja po izdaji dovoljenja za promet z zdravilom se lahko v prvih 48 urah po cepljenju zelo redko pojavita letargija in/ali zmanjšanje apetita.
English: Mineral oil: ………………..104.125 mg
Slovenian: mineralno olje: ………………104,125 mg
English: Mineral oil…………104.125 mg
Slovenian: mineralno olje………………104,125 mg
English: Thiomersal: ………………..0.05 mg
Slovenian: tiomersal: ………………0,05 mg
English: la Selva, 135 17170 Amer (Girona) SPAIN
Slovenian: la Selva, 135 17170- AMER (Girona) ŠPANIJA
English: Cardboard box of 1 glass vial of 40 doses (20 ml).
Slovenian: Kartonska škatla z 1 stekleno vialo s 40 odmerki (20 ml).
English: 1 x 40 doses (20 ml).
Slovenian: 1 x 40 odmerki (20 ml).
English: Thiomersal…………0.05 mg
Slovenian: tiomersal………………0,05 mg
English: Laboratory studies in doe rabbits in the last third of gestation have not been produced any evidence of a teratogenic, foetotoxic and maternotoxic effects.
Slovenian: Brejost Z laboratorijskimi študijami na kunčicah v zadnji tretjini brejosti niso bili dokazani teratogeni,
English: ERAVAC emulsion for injection for rabbits
Slovenian: ERAVAC emulzija za injiciranje za kunce
English: Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strain V-1037 …..≥70% cELISA40* (*) ≥70 % of vaccinated rabbits shall give cELISA antibody titres equal to or higher than 40.
Slovenian: Virus hemoragične bolezni kuncev tipa 2(RHDV2), sev V-1037, inaktiviran……≥70 % cELISA40* (*) ≥ 70 % cepljenih kuncev bo imelo titer protiteles cELISA 40 ali več.
English: 10 x 1 dose (0.5 ml).
Slovenian: 10 x 1 odmerek (0,5 ml) 1 x 10 odmerki (5 ml).
English: Cardboard box of 10 glass vials of 1 dose (0.5 ml).
Slovenian: Kartonska škatla z 10 steklenimi vialami po 1 odmerek (0,5 ml) Kartonska škatla z 1 stekleno vialo z 10 odmerki (5 ml).
English: Rabbits.
Slovenian: Faks.
English: Inactivated RHDV2, strain V-1037: ………….≥70% cELISA40
Slovenian: RHDV2, sev V-1037, inaktiviran: ≥70% cELISA40 ≥ 70 % cepljenih kuncev bo imelo titer protiteles cELISA 40 ali več.
English: Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strain V-1037: ……≥70% cELISA40*
Slovenian: Virus hemoragične bolezni kuncev tipa 2 (RHDV2), sev V-1037, inaktivirani: ……≥70 % cELISA40* (*) ≥ 70 % cepljenih kuncev bo imelo titer protiteles cELISA 40 ali več.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI)
English: The full EPAR for Controloc Control 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 Controloc Control je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The recommended dose of Controloc Control is one tablet once a day until symptoms have stopped.
Slovenian: Priporočeni odmerek zdravila Controloc Control je ena tableta enkrat na dan, dokler simptomi ne izzvenijo.
English: Controloc Control pantoprazole
Slovenian: Controloc Control pantoprazol
English: The European Commission granted a marketing authorisation valid throughout the EU for Controloc Control on 12 June 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Controloc Control, veljavno po vsej Evropski uniji, odobrila dne 12. junija 2009.
English: It was also of the opinion that, based on the experience of the use of pantoprazole, the availability of Controloc Control without medical supervision is appropriate.
Slovenian: Menil je tudi, da je glede na izkušnje z uporabo pantoprazola dostopnost zdravila Controloc Control brez medicinskega nadzora ustrezna.
English: Controloc Control is similar to a ‘reference medicine' already authorised in the European Union (EU) called Controloc.
Slovenian: Zdravilo Controloc Control je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Controloc.
English: This is a summary of the European public assessment report (EPAR) for Controloc Control.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Controloc Control.
English: The most common side effects with Controloc Control (seen in around 1 patient in 100) are diarrhoea and headache.
Slovenian: Najpogostejša neželena učinka zdravila Controloc Control (opažena pri približno 1 bolniku od 100) sta driska in glavobol.
English: For more information about treatment with Controloc Control, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Controloc Control preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Controloc Control must not be used in people who are hypersensitive (allergic) to pantoprazole, soya or any of the other ingredients.
Slovenian: Zdravila Controloc Control ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) pantoprazol, sojo ali katero koli drugo sestavino zdravila.
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 Controloc Control.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Controloc Control, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Controloc Control's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Zato je zaključil, da so koristi zdravila Controloc Control večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: Controloc Control is used for the short-term treatment of the symptoms of acid reflux in adults.
Slovenian: Zdravilo Controloc Control se uporablja za kratkotrajno zdravljenje simptomov kislega refluksa pri odraslih.
English: It is used for long-term treatments and is also used to treat a wider range of gastrointestinal diseases (conditions affecting the gut) than Controloc Control.
Slovenian: Uporablja se za dolgotrajno zdravljenje in za zdravljenje širšega spektra bolezni prebavil (stanj, ki prizadenejo črevesje) kot zdravilo Controloc Control.
English: What benefit has Controloc Control shown during the studies?
Slovenian: Kakšne koristi je zdravilo Controloc Control izkazalo med študijami?
English: Controloc Control is a medicine that contains the active substance pantoprazole.
Slovenian: Zdravilo Controloc Control je zdravilo, ki vsebuje zdravilno učinkovino pantoprazol.
English: Other information about Controloc Control
Slovenian: Druge informacije o zdravilu Controloc Control:
English: It must not be used with atazanavir (a medicine used to treat human immunodeficiency virus [HIV] infection).
Slovenian: Zdravilo Controloc Control se ne uporabljati z atazanavirjem (zdravilom za zdravljenje okužbe z virusom človeške imunske pomanjkljivosti [HIV]).
English: The reference medicine, Controloc, is only available with a prescription.
Slovenian: Referenčno zdravilo Controloc se izdaja le na recept.
English: The active substance in Controloc Control, pantoprazole, is a proton pump inhibitor.
Slovenian: Zdravilna učinkovina zdravila Controloc Control, pantoprazol, je zaviralec protonske črpalke.
English: What is the risk associated with Controloc Control?
Slovenian: Kakšna tveganja so povezana z zdravilom Controloc Control?
English: Why has Controloc Control been approved?
Slovenian: Zakaj je bilo zdravilo Controloc Control odobreno?
English: How has Controloc Control been studied?
Slovenian: Kako je bilo zdravilo Controloc Control raziskano?
English: How is Controloc Control used?
Slovenian: Kako se zdravilo Controloc Control uporablja?
English: What is Controloc Control?
Slovenian: Kaj je zdravilo Controloc Control?
English: What is Controloc Control used for?
Slovenian: Za kaj se zdravilo Controloc Control uporablja?
English: How does Controloc Control work?
Slovenian: Kako zdravilo Controloc Control deluje?
English: The company requested a re-examination of the initial opinion.
Slovenian: Podjetje je zahtevalo ponoven pregled prvotnega mnenja.
English: The recommendation was confirmed after re-examination.
Slovenian: To priporočilo je bilo po ponovnem pregledu potrjeno.
English: Doxorubicin has been available since the 1960s.
Slovenian: Doksorubicin je na voljo od 60. let 20. stoletja.
English: EMA/295022/2019 EMEA/H/C/004110
Slovenian: 29. maja 2019 EMA/295022/2019 EMEA/H/C/004110
English: What consequences does this refusal have for patients in clinical trials?
Slovenian: Kakšne so posledice zavrnitve vloge za bolnike, ki sodelujejo v kliničnih preskušanjih?
English: After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 29 May 2019.
Slovenian: Po proučitvi razlogov za to zahtevo je odbor CHMP ponovno pregledal mnenje in 29. maja 2019 potrdil zavrnitev vloge za pridobitev dovoljenja za promet.
English: For more information on hybrid medicines, see the question-and-answer document here.
Slovenian: Za več informacij o hibridnih zdravilih si oglejte dokument z vprašanji in odgovori, ki je na voljo tukaj.
English: It works by interfering with the DNA within cells, preventing them from making more copies of DNA and making proteins.
Slovenian: Deluje tako, da ovira DNK v celicah, s čimer celicam preprečuje izdelavo nadaljnjih kopij DNK in tvorbo beljakovin.
English: This means that cancer cells cannot divide and they eventually die.
Slovenian: To pomeni, da se rakave celice ne morejo deliti in posledično odmrejo.
English: Therefore, Caelyx was used instead.
Slovenian: Zato so namesto njega uporabili zdravilo Caelyx.
English: What were the CHMP's main concerns that led to the refusal?
Slovenian: Kateri so bili glavni zadržki, zaradi katerih je odbor CHMP predlagal zavrnitev vloge?
English: They also reduce the medicine's effects on non-cancer cells, so it is less likely to cause some side effects.
Slovenian: Prav tako zmanjšajo učinke zdravila na nerakave celice, zato je pojav določenih neželenih učinkov manj verjeten.
English: Doxolipad was expected to be used to treat metastatic breast cancer in patients at risk of heart problems (‘metastatic' means the cancer has spread to other parts of the body), and cancer of the ovary in women whose previous treatment including a platinum-based cancer medicine has stopped working.
Slovenian: Zdravilo Doxolipad naj bi se uporabljalo za zdravljenje metastatskega raka dojk pri bolnikih, pri katerih obstaja tveganje za težave s srcem („metastatski“ pomeni, da se je rak razširil na druge dele telesa), in raka jajčnikov pri ženskah, pri katerih predhodno zdravljenje z zdravilom proti raku na osnovi platine ni več učinkovito.
English: The company informed the CHMP that there are no ongoing clinical trials with Doxolipad in the EU.
Slovenian: Podjetje je odbor CHMP obvestilo, da v EU trenutno ne poteka nobeno klinično preskušanje z zdravilom Doxolipad.
English: The applicant presented data from the scientific literature, and data from studies conducted in experimental models, including comparisons with another authorised doxorubicin medicine, Caelyx, which contains doxorubicin in pegylated liposomal form.
Slovenian: Predlagatelj je predložil podatke iz znanstvene literature in podatke iz študij, opravljenih na eksperimentalnih modelih, vključno s primerjavo z drugim odobrenim zdravilom z doksorubicinom, zdravilom Caelyx, ki vsebuje doksorubicin v obliki pegiliranih liposomov.
English: On 31 January 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Doxolipad, intended for the treatment of breast and ovarian cancer.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je v svojem negativnem mnenju z dne 31. januarja 2019 priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Doxolipad, namenjenim zdravljenju raka dojk in jajčnikov.
English: This means that Doxolipad was intended to be similar to a ‘reference medicine' already authorised in the European Union called Adriamycin.
Slovenian: To pomeni, da naj bi bilo podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji, in sicer zdravilu Adriamycin.
English: Doxolipad was developed as a ‘hybrid medicine'.
Slovenian: Zdravilo Doxolipad je bilo razvito kot „hibridno zdravilo“.
English: Because Doxolipad was developed as a hybrid medicine, the company also presented the results of a study carried out to investigate whether it is ‘bioequivalent' to Caelyx.
Slovenian: Ker je bilo zdravilo Doxolipad razvito kot hibridno zdravilo, je podjetje predložilo tudi rezultate študije, ki je bila opravljena za proučitev, ali je zdravilo „biološko enakovredno“ zdravilu Caelyx.
English: The liposomes reduce the rate at which the active substance is broken down, allowing it to circulate in the blood for longer.
Slovenian: Liposomi upočasnijo razgrajevanje učinkovine in podaljšajo čas njenega kroženja v krvi.
English: Although the reference medicine for Doxolipad is Adriamycin, this could not be used in the bioequivalence study because it contains doxorubicin in a different form (not enclosed in pegylated liposomes).
Slovenian: Čeprav je referenčno zdravilo za zdravilo Doxolipad zdravilo Adriamycin, tega ni bilo mogoče uporabiti v študiji biološke enakovrednosti, saj vsebuje doksorubicin v drugačni obliki (ni vključen v pegilirane liposome).
English: The results of the bioequivalence study showed that Doxolipad is comparable to Caelyx in terms of ‘liposome-encapsulated doxorubicin', but failed to show that the amount of ‘free doxorubicin' is the same for the two medicines.
Slovenian: Rezultati študije biološke enakovrednosti so pokazali, da je zdravilo Doxolipad primerljivo z zdravilom Caelyx v smislu „v liposome vključenega doksorubicina“, vendar niso dokazali, da je količina „prostega doksorubicina“ pri obeh zdravilih enaka.
English: The company that applied for authorisation is TLC Biopharmaceuticals B.V.
Slovenian: Vlogo za pridobitev dovoljenja za promet z zdravilom je predložilo podjetje TLC Biopharmaceuticals B.V.
English: On that basis, the CHMP recommended that Doxolipad be refused marketing authorisation.
Slovenian: Na tej podlagi je odbor CHMP priporočil, da se dovoljenje za promet z zdravilom Doxolipad zavrne.
English: Therefore, the CHMP was of the opinion that there was insufficient evidence to show that Doxolipad was bioequivalent to Caelyx, and it was not possible to establish that the benefits of Doxolipad outweigh its risks.
Slovenian: Zato je odbor CHMP menil, da ni dovolj dokazov, da je zdravilo Doxolipad biološko enakovredno zdravilu Caelyx, in da ni mogoče zaključiti, da koristi zdravila Doxolipad odtehtajo njegova tveganja.
English: What is Doxolipad?
Slovenian: Kaj je zdravilo Doxolipad?
English: Doxolipad is a cancer medicine that contains the active substance doxorubicin.
Slovenian: Doxolipad je zdravilo za zdravljenje raka, ki vsebuje učinkovino doksorubicin.
English: What was Doxolipad expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Doxolipad uporabljalo?
English: The difference between the products is that in Doxolipad the active substance doxorubicin is enclosed in tiny fatty spheres called liposomes (see below for more details).
Slovenian: Razlika med zdraviloma je v tem, da je učinkovina zdravila Doxolipad vključena v majhne maščobne kroglice, imenovane liposomi (za več podrobnosti glejte spodaj).
English: How does Doxolipad work?
Slovenian: Kako zdravilo Doxolipad deluje?
English: The active substance in Doxolipad, doxorubicin, is a cytotoxic medicine that belongs to the group ‘anthracyclines'.
Slovenian: Učinkovina v zdravilu Doxolipad, doksorubicin, je citotoksično zdravilo, ki spada v skupino „antraciklinov“.
English: In Doxolipad, it is enclosed in ‘pegylated liposomes' (tiny fatty spheres that are coated with a chemical called polyethylene glycol).
Slovenian: V zdravilu Doxolipad je doksorubicin vključen v „pegilirane liposome“ (majhne maščobne kroglice, prevlečene s kemično snovjo, imenovano polietilenglikol).
English: 29 May 2019
Slovenian: EMA/295022/2019
English: The recommended dose is one 150 microgram capsule, once a day at the same time each day.
Slovenian: Priporočeni odmerek je ena 150-mikrogramska kapsula, ki se jo vzame enkrat na dan ob istem času.
English: This causes the muscles of the airways to relax, helping to keep the airways open and allowing the patient to breathe more easily.
Slovenian: To povzroči, da se mišice dihalnih poti sprostijo, kar jih pomaga ohranjati odprte in omogoča bolniku, da lažje diha.
English: The main measure of effectiveness was based on changes in the patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second) after 12 weeks.
Slovenian: Glavno merilo učinkovitosti je bila sprememba forsiranega ekspiracijskega volumna (FEV1- največja količina zraka, ki jo oseba lahko izdihne v eni sekundi) pri bolnikih po 12 tednih.
English: The full EPAR for Oslif Breezhaler 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 Oslif Breezhaler je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It works by attaching to beta-2 receptors that are found in the muscle cells of many organs and that cause the muscles to relax.
Slovenian: Deluje tako, da se veže na receptorje beta-2, ki se nahajajo v mišičnih celicah številnih organov in povzročajo sprostitev mišic.
English: To receive a dose, the patient places a capsule into the inhaler and breathes the powder in through the mouth.
Slovenian: Da vzame odmerek, bolnik položi kapsulo v inhalator in skozi usta vdihne prašek.
English: European Commission granted a marketing authorisation valid throughout the European Union for Oslif Breezhaler on 30 November 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Oslif Breezhaler, veljavno po vsej Evropski uniji, izdala 30. novembra 2009.
English: COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing.
Slovenian: KOPB je dolgotrajna bolezen, pri kateri so dihalne poti in zračni mešički v pljučih poškodovani ali blokirani, zaradi česar je dihanje oteženo.
English: Therefore, the Agency decided that Oslif Breezhaler's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Zato je zaključila, da so koristi zdravila Oslif Breezhaler večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
English: This is a summary of the European public assessment report (EPAR) for Oslif Breezhaler.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Oslif Breezhaler.
English: Overall, the effects of the 150 and 300 microgram doses of Oslif Breezhaler were similar, but the results showed that the 300 microgram dose may provide better relief in patients with more severe disease.
Slovenian: V celoti so bili učinki 150- in 300-mikrogramskih odmerkov zdravila Oslif Breezhaler podobni, vendar pa rezultati kažejo, da je 300-mikrogramski odmerek pri bolnikih s hujšimi oblikami bolezni zagotovil večje olajšanje.
English: Other common side effects include chest pain, cough and muscle cramps.
Slovenian: Drugi neželeni učinki vključujejo bolečine v prsih, kašelj in mišične krče.
English: Oslif Breezhaler capsules, which contain a powder for inhalation, are only used with a Oslif Breezhaler inhaler and must not be swallowed.
Slovenian: Kapsule zdravila Oslif Breezhaler, ki vsebujejo prašek za inhaliranje, se uporabljajo samo z inhalatorjem Oslif Breezhaler in se jih ne sme pogoltniti.
English: Oslif Breezhaler is used for maintenance (regular) treatment.
Slovenian: Zdravilo Oslif Breezhaler se uporablja za vzdrževalno (redno) zdravljenje.
English: On average, the increase in FEV1 in patients who received Oslif Breezhaler was between 150 to 190 ml, while for patients who received placebo the change in FEV1 ranged from a decrease of 10 ml to an increase of 20 ml.
Slovenian: Pri bolnikih, ki so prejeli zdravilo Oslif Breezhaler, je izboljšanje FEV1 v povprečju znašalo med 150 in 190 ml, medtem ko je pri bolnikih, ki so prejeli placebo, sprememba FEV1 segala od poslabšanja za 10 ml do izboljšanja za 20 ml.
English: The most common side effects with Oslif Breezhaler (which may affect more than 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat) and upper respiratory tract infection (infection of the nose and throat).
Slovenian: Najpogostejša neželena učinka zdravila Oslif Breezhaler (ki se lahko pojavita pri več kot 1 bolniku od 10) sta nazofaringitis (vnetje nosu in žrela) in okužba zgornjih dihal (okužba nosu in grla).
English: What measures are being taken to ensure the safe and effective use of Oslif Breezhaler?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Oslif Breezhaler?
English: In three main studies involving over 4,000 patients with COPD, Oslif Breezhaler was compared with placebo (a dummy treatment), tiotropium or formoterol (other inhaled medicines used to treat COPD).
Slovenian: V treh glavnih študijah, ki so vključevale več kot 4 000 bolnikov s KOPB, so zdravilo Oslif Breezhaler primerjali s placebom (zdravilom brez zdravilne učinkovine), tiotropijem ali formoterolom (drugima inhalacijskima zdraviloma, ki se uporabljata za zdravljenje KOPB).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Oslif Breezhaler have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Oslif Breezhaler upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: For more information about treatment with Oslif Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Oslif Breezhaler preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The Agency also noted that there were no major safety concerns with Oslif Breezhaler, with side effects being manageable and similar to other beta-2 adrenergic receptor agonist medicines.
Slovenian: Ugotovila je tudi, da ni večjih pomislekov glede njegove varnosti, saj so njegovi neželeni učinki obvladljivi in podobni kot pri drugih agonistih adrenergičnih receptorjev beta-2.