FrancophonIA/ELRC3.0 huggingface dataset:
English: Type-II variations relate to major changes to the marketing authorisation for a medicine, such as a change in the medicine's indication (the type of disease or condition it can be used to treat), or a substantial change to the packaging or to the information that accompanies the medicine.
Slovenian: Spremembe tipa II se nanašajo na večje spremembe dovoljenja za promet z zdravilom, kot so sprememba indikacije zdravila (vrste bolezni ali stanja, za katerega se lahko uporablja), bistvena sprememba ovojnine ali informacij, ki so priložene zdravilu.
English: Alternatively, if their medicine is not intended for paediatric use, they must apply for a waiver from the obligation to submit a PIP.
Slovenian: Kadar zdravilo ni namenjeno za uporabo v pediatriji, pa mora družba zaprositi za opustitev obveznosti predložitve načrta pediatričnih raziskav.
English: Orphan medicinal product designation procedures (2006-2008)
Slovenian: Postopki za določitev zdravila sirote (2006-2008)
English: Line-extension applications relate to changes to the active substance(s), strength, pharmaceutical form (e.g. powder, ointment or tablet) or route of administration (e.g. oral, intravenous or subcutaneous) of an authorised medicine.
Slovenian: Vloge za razširitev se nanašajo na spremembe zdravilne učinkovine (zdravilnih učinkovin), jakosti, farmacevtske oblike (npr. prašek, mazilo ali tablete) ali poti uporabe zdravila (npr. peroralno, intravensko ali podkožno) za odobreno zdravilo.
English: 1 related to a medicine for the treatment of bovine mastitis in bovines.
Slovenian: 1 mnenje za zdravilo za zdravljenje mastitisa pri govedu.
English: 1 related to a painkiller for use in dogs and cats;
Slovenian: 1 mnenje za zdravilo proti bolečinam za uporabo pri psih in mačkah;
English: Volume of post-authorisation procedures initiated for veterinary medicines remains stable
Slovenian: Delež postopkov po izdaji dovoljenja za promet, sproženih za zdravila za uporabo v veterinarski medicini, ostaja stabilen
English: Positive opinions Negative opinions Application withdrawals
Slovenian: Pozitivna mnenja Negativna mnenja Umiki
English: Applications for approval of PIPs, waivers and PUMAs are assessed by the Agency's Paediatric Committee, which also conducts compliance-checks to verify that companies applying for a marketing authorisation have developed their medicine in accordance with their approved PIP.
Slovenian: Vloge za odobritev načrta pediatričnih raziskav, opustitev in dovoljenja za promet z zdravili za uporabo v pediatriji vrednoti Odbor za pediatrijo pri Agenciji, ki tudi preverja, ali je družba, ki je predložila vlogo za odobritev, zdravilo razvila skladno z odobrenim načrtom pediatričnih raziskav.
English: Outcome of initial-evaluation applications (2006-2008)
Slovenian: Izidi vlog za začetno oceno (2006-2008)
English: 1 related to a painkiller/anti-inflammatory for use in horses;
Slovenian: 1 mnenje za zdravilo proti bolečinam/vnetju za uporabo pri konjih;
English: Volume of post-authorisation procedures finalised for human medicines increased by 13%
Slovenian: Delež postopkov po izdaji dovoljenja za promet, zaključenih za zdravila za uporabo v humani medicini, se je povečal za 13 %
English: Number of initial-evaluation applications for human medicines up by 14%
Slovenian: Za 14 % več vlog za začetno oceno zdravil za uporabo v humani medicini
English: Fees
Slovenian: Ciper
English: New medicinal products (non-orphan) Orphan medicinal products Similar biological products
Slovenian: Nova zdravila (brez sirot)
English: The volume of applications received by the Agency in 2008 for initial evaluation of new veterinary medicines was, at 16 applications, similar to the volume seen in 2007.
Slovenian: Agenciji je bilo v letu 2008 predloženih 16 vlog za začetno oceno novih zdravil za uporabo v veterinarski medicini, kar je podobno številu prejetih vlog v letu 2007.
English: 1 related to a medicine for the treatment of respiratory disease in cattle;
Slovenian: 1 mnenje za zdravilo za zdravljenje bolezni dihal pri govedu;
English: The number of initial-evaluation applications submitted to the Agency in 2008 for evaluation of new medicines for use in humans was 103 - a 14% increase on the number received in 2007.
Slovenian: Agenciji so bile v letu 2008 predložene 103 vloge za začetno oceno novih zdravil za uporabo v humani medicini, kar predstavlja 14-odstotno zvišanje glede na število prejetih vlog v letu 2007.
English: Volume of post-authorisation procedures initiated for human medicines increased by 10%
Slovenian: Delež postopkov po izdaji dovoljenja za promet, sproženih za zdravila za uporabo v humani medicini, se je povečal za 10 %
English: Type-I variations Type-II variations Extensions
Slovenian: Spremembe tipa I Spremembe tipa II
English: finalised a record number of 328 scientific-advice and protocol-assistance requests relating to medicines for human use (up 14% on the number of requests finalised in 2007);
Slovenian: zaključila rekordno število 328 zahtevkov za znanstveno svetovanje in pomoč pri protokolu v zvezi z zdravili za uporabo v humani medicini (za 14 % več kot je bilo zaključenih zahtevkov v letu prejela 320 novih ali naknadnih zahtevkov za znanstveno svetovanje ali pomoč pri protokolu v zvezi z zdravili za uporabo v humani medicini;
English: 5 The ‘Community list…' is an official list, established by the HMPC and approved by the European Commission, of herbal substances and preparations that have been in medicinal use for a sufficiently long time, and which are therefore considered not to be harmful under normal conditions of use.
Slovenian: Vsebuje rastlinske snovi in pripravke, ki so bili v medicinski rabi dovolj dolgo in štejejo kot neškodljivi v običajnih pogojih uporabe.
English: Applications for new medicinal products Generic applications
Slovenian: Vloge za generična zdravila
English: adopted 35 decisions on class waivers3;
Slovenian: (Klinične) spremembe tipa II Razširitve sprejel 35 odločitev o skupinskih opustitvah3;
English: The next few pages provide brief highlights of the Agency's activities in each of its priority areas for the year, together with key figures to demonstrate the volume and evolution of its core scientific and regulatory procedures.
Slovenian: Dodane so ključne številke za prikaz obsega in razvoja njenih osrednjih strokovnih in regulativnih postopkov.
English: Type-IA variations
Slovenian: Spremembe tipa IA
English: The number of initial-evaluation procedures finalised by the Agency in relation to veterinary medicines in 2008 was 13.
Slovenian: V letu 2008 je Agencija dokončala 13 postopkov za začetno oceno zdravil za uporabo v veterinarski medicini.
English: EEA and non-EEA ADR reports received (2006-2008)
Slovenian: Prejeta poročila o neželenih učinkih zdravil iz EGP in izven EGP (2006-2008)
English: launch of the ENCePP website11, devoted to the activities of the newly created European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), which is coordinated by the Agency; creation of a new ‘Regulatory and procedural guidelines' section12 of the Agency's public website,
Slovenian: Do takrat pa se je komunikacija Agencije prek spleta med letom stalno izboljševala, vključno z: zagonom spletne strani ENCePP11, namenjene dejavnostim novo ustanovljene Evropske mreže centrov za farmakoepidemiologijo in farmakovigilanco, ki jo usklajuje Agencija;
English: Efforts made in 2008 to further enhance the involvement of healthcare professionals, patients and consumers in the Agency's activities included: extending the scope of patients' and consumers' involvement in reviewing the quality of package leaflets (the information contained in the package of a medicine); working with patients and consumers to establish, by means of a survey, their level of satisfaction with their current involvement in the activities of the Agency; integrating input received from healthcare professionals, patients and consumers in the development of the Agency's communications strategy.
Slovenian: delo z bolniki in potrošniki, da bi z anketo ugotovili zadovoljstvo s trenutnim sodelovanjem pri dejavnostih Agencije;
English: Post-authorisation applications received (2006-2008)
Slovenian: Prejete vloge za postopke po izdaji dovoljenja za promet (2006-2008)
English: 4 A herbal monograph is a collection of all relevant information concerning a herbal medicine, including its composition, use, safety precautions, etc.
Slovenian: Monografija rastlin je zbirka vseh pomembnih informacij o zdravilu rastlinskega izvora, vključno z njegovo sestavo, uporabo, varnostnih ukrepih itn. „Seznam rastlinskih snovi Skupnosti …“ je uradni seznam, ki ga uveljavil HMPC, odobrila pa Evropska komisija.
English: Applicants are exempt from the obligation to submit a product-specific waiver application if the medicine for which they are seeking a marketing authorisation belongs to one of these classes.
Slovenian: Če zdravilo, za katerega vlagatelji želijo odobritev, spada v eno izmed teh skupin, ni treba predložiti vloge za opustitev, specifične za zdravilo.
English: The Agency is committed to maintaining a strong working relationship with these important stakeholders, and has created a number of mechanisms for their involvement in a range of its activities, including: participating in meetings of the Patients' and Consumers' Working Party or of the Healthcare Professionals' Working Group; checking the quality of information about authorised medicines; assisting in the preparation of regulatory and procedural guidance documents; providing recommendations to the Agency and its scientific committees on all matters of direct or indirect interest to them.
Slovenian: Agencija se je zavezala k ohranjanju trdnega delovnega odnosa s temi pomembnimi interesnimi skupinami je ustvarila številne mehanizme za njihovo vključitev v vrsto svojih dejavnosti, vključno s:
English: 13 related to ‘orphan' medicines, i.e. ones intended for use in the diagnosis, prevention or treatment of rare and seriously debilitating diseases or conditions;
Slovenian: Izmed 103 vlog, prejetih v letu 2008: se jih je 73 nanašalo na zdravila z novo zdravilno učinkovino, tj. kemijsko ali biološko spojino, ki se prej ni uporabila v odobrenem zdravilu; se jih je 13 nanašalo na zdravila „sirote“, tj. zdravila, ki so namenjena uporabi pri diagnostiki, preprečevanju ali zdravljenju redkih in resno izčrpavajočih bolezni ali stanj; se jih je 46 nanašalo na generična ali hibridna zdravila, tj. zdravila, katerih zdravilna učinkovina je v bistvu enaka kot pri prej odobrenem zdravilu; so se 3 nanašale na „podobna biološka zdravila“, tj. zdravila, katerih zdravilno učinkovino izdeluje živ organizem ali je pridobljena iz njega ter je podobna zdravilni učinkovini prej odobrenega zdravila.
English: If this happens, try again.
Slovenian: Če se to zgodi, poskusite znova.
English: 1.0 unit
Slovenian: 1,0 enota
English: Throw away the bag.
Slovenian: Vrečko zavrzite.
English: Percentage of Patients who achieved MCID
Slovenian: Odstotek bolnikov, ki so dosegli MCID
English: Date of first authorisation: 20 July 2012 Date of last renewal: 20 April 2017
Slovenian: Datum prve odobritve: 20. julij 2012 Datum zadnjega podaljšanja: 20. april 2017
English: A risk to newborns/infants cannot be excluded.
Slovenian: Tveganja za novorojenčke/dojenčke ni možno izključiti.
English: Some patients may not hear the ‘click'.
Slovenian: Nekateri bolniki morda ne bodo slišali zvoka ‘klik'.
English: Deterioration of disease:
Slovenian: Poslabšanje bolezni:
English: It will also help you to remember to use it.
Slovenian: Prav tako vam bo pomagalo, da se spomnite uporabiti zdravilo.
English: The upper bound of the confidence interval excluded a pre-defined risk margin of 1.8.
Slovenian: Zgornja meja intervala zaupanja je izključevala vnaprej določeno mejo tveganja 1,8.
English: Therefore, please remember to pay attention to oral hygiene.
Slovenian: Zaradi tega morate biti pozorni na ustno higieno.
English: This ensures that there is always enough medicine in your body to help you breathe more easily throughout the day and night.
Slovenian: S tem zagotovite vedno dovolj zdravila v svojem telesu, kar vam pomaga, da cel dan in noč lažje dihate.
English: What should you do if you accidently prepare a dose?
Slovenian: Kaj storiti, če po nesreči pripravite odmerek?
English: If you want to stop treatment, first talk to your doctor, as your symptoms may worsen.
Slovenian: Če želite zdravljenje prekiniti, se najprej pogovorite z zdravnikom, ker se lahko simptomi poslabšajo.
English: Allergic reactions may rarely occur (may affect up to 1 in 1,000 people).
Slovenian: Redko lahko pride do alergijskih reakcij (pojavijo se lahko pri največ 1 od 1.000 bolnikov).
English: How does the dose indicator work?
Slovenian: Kako deluje indikator odmerka?
English: 70.7% of patients completed the study per investigator assessment.
Slovenian: Po raziskovalčevi oceni je študijo dokončalo 70,7 % bolnikov.
English: Make sure the green button is on top.
Slovenian: Prepričajte se, da je zeleni gumb na vrhu.
English: 2.5 Hold your breath for as long as possible.
Slovenian: 2.5 Zadržujte dih kolikor dolgo je mogoče.
English: How do you know that your inhaler is empty?
Slovenian: Kako veste, da je inhalator prazen?
English: The study had an event-driven design and was terminated once sufficient MACE events for the primary safety analysis were observed.
Slovenian: Študija je imela z dogodki voden načrt in se je končala, ko je bilo opaženih dovolj dogodkov MACE za primarno analizo varnosti.
English: Paradoxical bronchospasm:
Slovenian: Paradoksni bronhospazem:
English: • On first use, every inhaler contains at least 60 doses, or at least 30 doses, depending on the pack size.
Slovenian: • Ob prvi uporabi vsak inhalator vsebuje najmanj 60 odmerkov ali najmanj 30 odmerkov, odvisno od velikosti pakiranja.
English: If the control window still does not change to red, you may have forgotten to release the green button before inhaling, or you may not have inhaled strongly enough.
Slovenian: Če se kontrolno okence še vedno ne obarva rdeče, ste morda pred inhaliranjem pozabili sprostiti zeleni gumb, ali pa morda niste dovolj močno inhalirali.
English: For Instructions for Use, see section 6.6.
Slovenian: Za navodila za uporabo, glejte poglavje 6.6.
English: The recommended dose is one inhalation twice a day in the morning and evening.
Slovenian: Priporočeni odmerek je en vdih dvakrat na dan zjutraj in zvečer.
English: Control window Red = confirms correct inhalation
Slovenian: Kontrolno okence Rdeča = potrdi pravilno inhalacijo
English: 30 doses 60 doses
Slovenian: 30 odmerkov 60 odmerkov
English: All patients had a history of cardiovascular or cerebrovascular disease and/or significant cardiovascular risk factors.
Slovenian: Vsi bolniki so imeli v anamnezi srčno-žilno ali cerebrovaskularno bolezen in/ali pomembne srčno-žilne dejavnike tveganja.
English: When you press the button all the way down, the control window changes from red to green.
Slovenian: Ko pritisnite gumb do konca, se kontrolno okence spremeni iz rdečega v zelenega.
English: The rate of moderate or severe COPD exacerbations per patient per year during the first year of treatment was evaluated as the primary efficacy endpoint in the study.
Slovenian: Delež zmernih ali hudih poslabšanj KOPB na bolnika na leto v prvem letu zdravljenja so ovrednotili kot primarni opazovani dogodek učinkovitosti v študiji.
English: Never breathe out into the inhaler (Figure I).
Slovenian: Nikoli ne izdihnite v inhalator (Slika I).
English: NEVER use water to clean the inhaler, as this may damage your medicine.
Slovenian: NIKOLI ne uporabljajte vode za čiščenje inhalatorja, ker lahko poškodujete zdravilo.
English: If you wish to clean your inhaler, just wipe the outside of the mouthpiece with a dry tissue or paper towel.
Slovenian: Če želite očistiti inhalator, samo obrišite zunanjost ustnika s suho krpo ali papirno brisačo.
English: Do not tilt.
Slovenian: Ne nagibajte.
English: 59.8% of patients had at least one COPD exacerbation within the past 12 months from the screening visit.
Slovenian: 59,8 % bolnikov je imelo v zadnjih 12 mesecih pred presejalnim obiskom vsaj eno poslabšanje KOPB.
English: b) Do not press the green button until you are ready to take a dose.
Slovenian: b) Ne pritisnite zelenega gumba, dokler niste pripravljeni, da vzamete odmerek.
English: Control window Green = inhaler ready to use
Slovenian: Kontrolno okence Zelena = inhalator je pripravljen za uporabo
English: These may be signs of a condition called bronchospasm.
Slovenian: To so lahko znaki stanja, imenovanega bronhospazem.
English: Dose indicator moves slowly from 60 to 0: 60, 50, 40, 30, 20, 10, 0.
Slovenian: Indikator odmerka se niža v intervalih od 60 do 0: 60, 50, 40, 30, 20, 10, 0.
English: A ‘click' will let you know that you are inhaling correctly.
Slovenian: ‘Klik', ki ga boste zaslišali vam bo dal vedeti, da inhalirate pravilno.
English: • If your inhaler appears to be damaged or if you lose the cap, or
Slovenian: • Če inhalator izgleda poškodovan ali če ste izgubili pokrovček ali
English: • Each time you load a dose by pressing the green button, the dose indicator moves by a small amount towards the next number (50, 40, 30, 20, 10, or 0).
Slovenian: • Vsakič, ko s pritiskom na zeleni gumb naložite odmerek, se indikator odmerka za malenkost premakne proti naslednji številki (50, 40, 30, 20, 10, ali 0).
English: AstraZeneca (AstraZeneca logo)
Slovenian: AstraZeneca (AstraZeneca logotip)
English: Do not hold the green button down while inhaling.
Slovenian: Ne držite zelenega gumba navzdol, medtem ko inhalirate.
English: Also contains: Lactose
Slovenian: Vsebuje tudi: laktozo
English: Read steps 2.1 to 2.7 fully before use.
Slovenian: Pred uporabo v celoti preberite korake 2.1 do 2.7.
English: These conditions may be affected by the anticholinergic mechanism of action.
Slovenian: Na ta stanja lahko vpliva antiholinergični mehanizem delovanja.
English: • The dose indicator shows the total number of doses left in the inhaler (Figure N).
Slovenian: • Indikator odmerka kaže skupno število odmerkov, ki so še preostali v inhalatorju (Slika N).
English: Green button
Slovenian: Zeleni gumb
English: c Odds ratio, increase in the likelihood of achieving the MCID compared to placebo.
Slovenian: c Razmerje verjetnosti, povečanje verjetnosti za MCID v primerjavi s placebom.
English: This medicine may cause headache, dizziness or blurred vision.
Slovenian: To zdravilo lahko povzroči glavobol, omotico ali zamegljen vid.
English: 1.68-fold c increase in likelihood
Slovenian: 1,68-kratno c povečanje verjetnosti
English: - if you have an enlarged prostate, problems passing urine, or a blockage in your bladder.
Slovenian: - če imate povečano prostato, težave z uriniranjem ali blokado v mehurju.
English: The frequency of adverse reactions is 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) and not known (cannot be estimated from the available data).
Slovenian: Pogostnost neželenih učinkov je opredeljena po naslednjem dogovoru: 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) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: The mouthpiece is covered with a removable green protective cap.
Slovenian: Ustnik je prekrit z odstranljivim zelenim zaščitnim pokrovčkom.
English: Aclidinium bromide should only be used during pregnancy if the expected benefits outweigh the potential risks.
Slovenian: Aklidinijev bromid se lahko uporablja med nosečnostjo samo, če se pričakuje, da koristi odtehtajo morebitna tveganja.
English: The use of Bretaris Genuair with these medicines is not recommended.
Slovenian: Uporaba zdravila Bretaris Genuair s temi zdravili ni priporočena.
English: Then take a strong, deep breath through the mouthpiece.
Slovenian: Nato močno in globoko vdihnite skozi ustnik.
English: 1.87-fold c increase in likelihood
Slovenian: 1,87-kratno c povečanje verjetnosti
English: The safety margins for human systemic exposure with 400 µg twice daily over the no observed adverse effect levels in these studies ranged from 7- to 73-fold.
Slovenian: Varnostna rezerva za človeško sistemsko izpostavljenost z odmerkom 400 µg dvakrat na dan nad mero brez opaženih neželenih učinkov v teh študijah je bila od 7- do 73-kratna.
English: 1.1 Look in the opening of the mouthpiece and make sure nothing is blocking it (Figure C).
Slovenian: 1.1 Poglejte v odprtino ustnika in se prepričajte, da ga nič ne ovira (Slika C).
English: c) Pull off the cap by lightly squeezing the arrows marked on each side (Figure B).
Slovenian: c) Odstranite pokrovček, tako da rahlo stisnete puščici, označeni na vsaki strani (Slika B).
English: Make sure you have released the green button, and you have breathed out completely.
Slovenian: Preverite, da ste sprostili zeleni gumb in da ste v celoti izdihnili.
English: Squeeze here and pull
Slovenian: Tukaj pritisnite in povlecite
English: The occurrence of headache, dizziness or blurred vision following administration of aclidinium bromide (see section 4.8) may influence the ability to drive or to use machinery.
Slovenian: Pojav glavobola, omotice ali zamegljenega vida po dajanju aklidinijevega bromida (glejte poglavje 4.8) lahko vpliva na sposobnost vožnje ali upravljanja strojev.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, anticholinergics; ATC Code: R03BB05.
Slovenian: Farmakoterapevtska skupina: zdravila za obstruktivne pljučne bolezni, antiholinergiki; oznaka ATC: R03BB05.
English: It is important that you read this information as the Genuair may work differently from inhalers you have used previously.
Slovenian: Pomembno je, da si preberete te informacije, saj lahko Genuair deluje drugače od inhalatorjev, ki ste jih že uporabljali.
English: Go back to ‘STEP 1 Prepare your dose' and repeat steps 1.1 to 1.6.
Slovenian: Vrnite se na ‘KORAK 1 Priprava odmerka' in ponovite korake 1.1 do 1.6.
English: How should you clean the inhaler?
Slovenian: Kako je treba čistiti inhalator?
English: Push the protective cap back onto the mouthpiece after each use (Figure M), to prevent contamination of the inhaler with dust or other materials.
Slovenian: Po vsaki uporabi pritisnite zaščitni pokrovček nazaj na ustnik (Slika M), da preprečite kontaminacijo inhalatorja s prahom ali drugimi snovmi.
English: Make sure you release the button so the inhaler can work correctly.
Slovenian: Prepričajte se, da ste sprostili gumb, da bo inhalator lahko deloval pravilno.
English: The recommended dose can be used for elderly patients and for patients with kidney or liver problems.
Slovenian: Priporočen odmerek lahko uporabljajo tudi starejši bolniki in bolniki z ledvičnimi oziroma jetrnimi težavami.
English: Even though the green button is locked, your last dose may still be inhaled.
Slovenian: Tudi če je zeleni gumb zaklenjen, lahko še vedno vdihnete zadnji odmerek.
English: Do not use this medicine after the expiry date which is stated on the inhaler label and carton after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki inhalatorja in škatli poleg oznake „EXP“.
English: After that, the inhaler cannot be used again and you should start using a new inhaler.
Slovenian: Po tem inhalatorja ne morete več uporabljati, zato začnite uporabljati nov inhalator.
English: • If your inhaler is empty (Figure O).
Slovenian: • Če je inhalator prazen (Slika O).
English: Keep breathing in for as long as possible.
Slovenian: Nadaljujte z vdihovanjem kolikor dolgo je mogoče.
English: This means you have not inhaled your medicine correctly.
Slovenian: To pomeni, da zdravila niste pravilno inhalirali.
English: It is supplied in a plastic pouch.
Slovenian: Pakiran je v plastični vrečki.
English: The dose is not prepared.
Slovenian: Odmerek ni pripravljen.
English: You can use Bretaris Genuair any time before or after food or drink.
Slovenian: Zdravilo Bretaris Genuair lahko uporabite kadar koli pred uživanjem hrane ali pijače ali po tem.