FrancophonIA/ELRC3.0 huggingface dataset:
English: In ALTA, visual disturbance adverse reactions were reported in 18% of patients treated with Alunbrig at the 180 mg regimen.
Slovenian: V študiji ALTA so se pri 18% bolnikov, ki so prejemali zdravilo Alunbrig pri režimu z odmerkom 180 mg, pojavile motnje vida kot neželeni učinki.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTER
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PRETISNI OMOT
English: No dose adjustment is required for Alunbrig during coadministration with P-gp and BCRP inhibitors.
Slovenian: Pri sočasni uporabi z zaviralci P-gp in BCRP prilagajanje odmerka zdravila Alunbrig ni potrebno.
English: Takeda Pharma A/S.
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Takeda Pharma A/S
English: Uncommon Pancreatitis
Slovenian: Občasni mialgijan
English: • If the Grade 3 event recurs, Alunbrig should be withheld until recovery to baseline, then resumed at the next lower dose level as per Table 1 or permanently discontinued.
Slovenian: • Če se ponovi neželeni učinek stopnje 3, je treba zdravljenje z zdravilom Alunbrig do okrevanja na izhodiščno vrednost začasno prekiniti, ter nato nadaljevati z naslednjim nižjim odmerkom v skladu s preglednico 1 ali trajno ukiniti.
English: If concomitant use of strong CYP3A inhibitors cannot be avoided, the dose of Alunbrig should be reduced from 180 mg to 90 mg, or from 90 mg to 60 mg. After discontinuation of a strong CYP3A inhibitor, Alunbrig should be resumed at the dose that was tolerated prior to the initiation of the strong CYP3A inhibitor.
Slovenian: Če se sočasni uporabi močnih zaviralcev CYP3A ni mogoče izogniti, je treba odmerek zdravila Alunbrig zmanjšati s 180 mg na 90 mg ali z 90 mg na 60 mg.
English: Hypomagnesaemia Hyponatraemia
Slovenian: Zelo pogosti hipertenzija hipertenzija
English: Agents that may have their plasma concentrations altered by brigatinib
Slovenian: Učinkovine, katerim lahko brigatinib spremeni koncentracijo v plazmi
English: • Alunbrig should be permanently discontinued in case of recurrence.
Slovenian: • V primeru ponovitve je treba zdravljenje z zdravilom Alunbrig trajno ukiniti.
English: Film-coated tablets 28 film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA filmsko obložene tablete 28 filmsko obloženih tablet
English: • Alunbrig should be withheld until recovery to baseline or less than or equal to 3 × ULN, then resumed at next lower dose per Table 1.
Slovenian: • Uporabo zdravila Alunbrig je treba, do okrevanja na izhodiščno vrednost ali ≤3 × ULN, začasno prekiniti, nato se nadaljuje z naslednjim nižjim odmerkom v skladu s preglednico 1.
English: • Alunbrig should be withheld until recovery to Grade ≤ 1 (≤ 2.5 × ULN) or to baseline, then resumed at the next lower dose level per Table 1.
Slovenian: • Uporabo zdravila Alunbrig je treba do okrevanja na stopnjo ≤1 (≤2,5 × ULN) začasno prekiniti, nato se nadaljuje z naslednjim nižjim odmerkom v skladu s preglednico 1.
English: APTT increased Anaemia
Slovenian: Pogosti zvišan APTT anemia znižano število nevtrofilcev
English: • dizziness
Slovenian: • napenjanje
English: Outer carton: Do not swallow the desiccant canister found in the bottle.
Slovenian: Ne pogoltnite sušilnega sredstva, ki se nahaja v plastenki.
English: No dose adjustment is required for Alunbrig in combination with moderate CYP3A inhibitors.
Slovenian: Pri kombinaciji z zmernimi zaviralci CYP3A prilagajanje odmerka ni potrebno.
English: Tell your doctor if you have upper abdominal pain, including abdominal pain that gets worse with eating and may spread to the back, weight loss or nausea.
Slovenian: • zvišane koncentracije amilaze ali lipaze v krvi pri preiskavah - lahko kažejo na vnetje trebušne slinavke Obvestite svojega zdravnika, če imate bolečine v zgornjem delu trebuha, vključno z bolečino v trebuhu, ki se poslabša po jedi in se lahko razširi na hrbet, izgubljate telesno maso ali vas sili na bruhanje.
English: • tissue swelling caused by excess fluid
Slovenian: • otekanje tkiva zaradi odvečne tekočine • zvišana telesna temperatura
English: • muscle problems
Slovenian: • težave s trebušno slinavko
English: • reduced blood level of potassium
Slovenian: • zmanjšana koncentracija kalija v krvi
English: Visual disturbance adverse reactions have occurred in patients treated with Alunbrig (see section 4.8).
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom Alunbrig, so se kot neželeni učinek pojavile motnje vida (glejte poglavje 4.8).
English: However, the study had weaknesses.
Slovenian: Vendar je imela ta študija tudi slabosti.
English: It was first made available in Germany in the 1950s and subsequently in Austria and Hungary.
Slovenian: Prvič je bilo na voljo v Nemčiji v 50. letih 20. stoletja, nato pa v Avstriji in na Madžarskem.
English: • An observational study involving adolescents and children aged over 4 years did not provide sufficient evidence of efficacy and safety in children and adolescents.
Slovenian: • Z opazovalno študijo, ki je vključevala mladostnike in otroke, starejše od štirih let, niso pridobili dovolj dokazov o učinkovitosti in varnosti pri otrocih in mladostnikih.
English: The review of Symbioflor 2 (and associated names) was initiated on 30 March 2016 at the request of Germany, under Article 31 of Directive 2001/83/EC.
Slovenian: Pregled zdravila Symbioflor 2 (in povezanih imen) se je začel 30. marca 2016 na zahtevo Nemčije v skladu s členom 31 Direktive 2001/83/ES.
English: • The safety profile of Symbioflor 2 is acceptable.
Slovenian: • Varnostni profil zdravila Symbioflor 2 je sprejemljiv.
English: • If you have any questions or concerns, speak with a pharmacist or your doctor.
Slovenian: • Če imate dodatna vprašanja ali pomisleke, se posvetujte z zdravnikom ali farmacevtom.
English: Escherichia coli bacteria form part of the normal gut flora.
Slovenian: Bakterije Escherichia coli tvorijo del normalne črevesne flore.
English: The CHMP recommendation was sent to the European Commission which issued a legally binding decision valid throughout the EU.
Slovenian: Priporočilo odbora CHMP je bilo predloženo Evropski komisiji, ki je izdala pravno zavezujoč sklep, veljaven v vsej EU.
English: The data included clinical studies, scientific publications, post-marketing experience, as well as information provided by the company and the views of an expert group formed for evaluating Symbioflor 2.
Slovenian: Podatki so vključevali klinične študije, znanstvene objave, izkušnje iz obdobja trženja zdravila ter informacije, ki jih je predložila družba, in stališča strokovne skupine, ustanovljene za ovrednotenje zdravila Symbioflor 2.
English: Submission of the study report to national authorities will be a condition for maintaining Symbioflor 2's marketing authorisation.
Slovenian: Predložitev poročila o študiji nacionalnim organom bo pogoj za ohranitev dovoljenja za promet z zdravilom Symbioflor 2.
English: • Speak with a pharmacist or your doctor if you have any problems affecting your stomach or gut.
Slovenian: • Pogovorite se z zdravnikom ali farmacevtom, če imate težave z želodcem ali črevesjem.
English: • The product information will be updated in line with this review of Symbioflor 2.
Slovenian: • Informacije o zdravilu bodo posodobljene v skladu s tem pregledom zdravila Symbioflor 2.
English: Medicine should no longer be used for other disorders of the gut
Slovenian: Zdravilo se ne sme več uporabljati za druge prebavne motnje
English: The way it works in irritable bowel syndrome is not fully understood.
Slovenian: Način delovanja pri sindromu razdražljivega črevesa ni v celoti znan.
English: Medicines containing Escherichia coli are available as oral drops in Austria, Germany and Hungary under the following invented names: Symbioflor 2, Symbioflor E. Coli and Symbioflor Escherichia.
Slovenian: Zdravila, ki vsebujejo bakterije Escherichia coli, so na voljo kot peroralne kapljice v Avstriji, Nemčiji in na Madžarskem po naslednjimi lastniškimi imeni: Symbioflor 2, Symbioflor E. Coli in Symbioflor Escherichia.
English: However, the medicine should no longer be used more widely to treat so-called functional gastrointestinal disorders, a group of disorders with a variety of causes that may require different treatment approaches.
Slovenian: Zdravilo pa se ne sme več uporabljati širše, in sicer za zdravljenje t. i. funkcionalnih bolezni prebavil, skupine motenj, ki so posledica različnih vzrokov in lahko zahtevajo različne pristope zdravljenja.
English: It is marketed in some European Union countries for treating irritable bowel syndrome, functional gastrointestinal diseases and some other gastrointestinal disorders and for regulating the immune system.
Slovenian: Trži se v nekaterih državah Evropske unije, in sicer za zdravljenje sindroma razdražljivega črevesa, funkcionalnih bolezni prebavil in nekaterih drugih prebavnih motenj ter za uravnavanje imunskega sistema.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 28/08/2017.
Slovenian: Mnenje odbora CHMP je bilo predloženo Evropski komisiji, ki je 28. avgusta 2017 izdala končni pravno zavezujoči sklep, ki velja za vse države članice EU.
English: On 22 June 2017 a review by European Medicines Agency (EMA) concluded that Symbioflor 2 and associated names can continue to be used for treatment of irritable bowel syndrome (IBS) in adults.
Slovenian: Evropska agencija za zdravila (EMA) je 22. junija 2017 po pregledu zaključila, da se zdravilo Symbioflor 2 in povezana imena lahko še naprej uporablja za zdravljenje sindroma razdražljivega črevesa pri odraslih.
English: The company that markets Symbioflor 2 did not submit data to support its use in ‘functional gastrointestinal disorders' and agreed to remove this use from the medicine's authorisation.
Slovenian: Družba, ki trži zdravilo Symbioflor 2, ni predložila podatkov v podporo njegovi uporabi pri „funkcionalnih boleznih prebavil“ in se je strinjala, da se uporaba pri tej bolezni odstrani iz dovoljenja za promet z zdravilom.
English: Since the available data were not sufficiently robust for the CHMP to draw conclusions on how well Symbioflor 2 works and whether it is effective for any particular type of IBS, the CHMP has asked the company to carry out a well-designed study on effectiveness and safety among patients with different features of IBS (e.g. those with diarrhoea or with constipation as an important feature).
Slovenian: Ker razpoložljivi podatki niso bili dovolj trdni, da bi odbor CHMP lahko sprejel zaključke o delovanju zdravila Symbioflor 2 in njegovi učinkovitosti pri posameznih vrstah sindroma razdražljivega črevesa, je odbor CHMP družbi naročil, naj izvede dobro zasnovano študijo o učinkovitosti in varnosti zdravila pri bolnikih z različnimi manifestacijami sindroma razdražljivega črevesa (npr. bolnikih, pri katerih se bolezen kaže z drisko ali pa zaprtostjo).
English: Available evidence suggests that the risk of harm from Symbioflor 2 is low.
Slovenian: Razpoložljivi dokazi kažejo, da je tveganje za škodljive učinke zdravila Symbioflor 2 nizko.
English: Symbioflor 2 and associated names contains Escherichia coli bacteria some of which have been broken down (autolysed) while others are living.
Slovenian: Zdravilo Symbioflor 2 in povezana imena vsebuje bakterije Escherichia coli, med katerimi so nekatere razgrajene (avtolizirane), druge pa žive.
English: In reaching its conclusions, EMA's Committee for Medicinal Products for Human Use (CHMP) reviewed all available evidence on the effectiveness and safety of Symbioflor 2.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je do svojih zaključkov prišel po pregledu vseh razpoložljivih dokazov o učinkovitosti in varnosti zdravila Symbioflor 2.
English: The medicine has been described as probiotic, which means that it encourages the growth of beneficial organisms (‘flora') in the gut.
Slovenian: Zdravilo so opisali kot probiotik, kar pomeni, da spodbuja rast koristnih organizmov („flore“) v črevesju.
English: The review did not find any new evidence on the effectiveness of Symbioflor 2 since the product was last approved.
Slovenian: S pregledom niso našli novih dokazov o učinkovitosti zdravila Symbioflor 2 od zadnje odobritve.
English: A randomised study involving around 300 adults suggested that Symbioflor 2 was effective for treating IBS.
Slovenian: Randomizirana študija, ki je vključevala približno 300 odraslih, je pokazala, da je zdravilo Symbioflor 2 učinkovito pri zdravljenju sindroma razdražljivega črevesa.
English: Symbioflor 2, which contains Escherichia coli bacteria, has been described as a probiotic, which means that it encourages the growth of beneficial organisms (‘flora') in the gut.
Slovenian: Zdravilo Symbioflor 2, ki vsebuje bakterije Escherichia coli, so opisali kot probiotik, kar pomeni, da spodbuja rast koristnih organizmov („flore“) v črevesju.
English: • You can continue to take Symbioflor 2 for treating symptoms of irritable bowel syndrome by following the information in the medicine's revised package leaflet.
Slovenian: • Zdravilo Symbioflor 2 lahko še naprej jemljete za zdravljenje simptomov sindroma razdražljivega črevesa, z upoštevanjem informacij v popravljenem in dopolnjenem navodilu za uporabo zdravila.
English: However, the study had some weaknesses and it did not provide evidence on how well Symbioflor 2 works in different types of IBS.
Slovenian: Vendar pa je imela študija nekaj pomanjkljivosti in z njo niso dokazali učinkovitosti zdravila Symbioflor 2 pri posameznih vrstah sindroma razdražljivega črevesa.
English: • Symbioflor 2 should be used for the treatment of irritable bowel syndrome (IBS) only, and it should no longer be used for treating ‘functional gastrointestinal disorders' or other conditions of the gastrointestinal tract.
Slovenian: • Zdravilo Symbioflor 2 se sme uporabljati samo za zdravljenje sindroma razdražljivega črevesa in se ne sme več uporabljati za zdravljenje „funkcionalnih bolezni prebavil“ ali drugih prebavnih motenj.
English: • A study comparing Symbioflor 2 with placebo suggested that it was effective at treating IBS in adults.
Slovenian: • Študija, v kateri so zdravilo Symbioflor 2 primerjali s placebom, je pokazala, da je zdravilo učinkovito pri zdravljenju sindroma razdražljivega črevesa pri odraslih.
English: • The company will need to carry out a well-designed study to demonstrate the efficacy and safety of Symbioflor 2 for treating different variants of IBS, as a condition for continuing to market it.
Slovenian: • Družba bo morala kot pogoj za nadaljnje trženje zdravila Symbioflor 2 izvesti dobro zasnovano študijo za dokaz njegove učinkovitosti in varnosti pri zdravljenju različnih različic sindroma razdražljivega črevesa.
English: • Speak with a pharmacist or your doctor if your symptoms of irritable bowel syndrome do not improve with Symbioflor 2 or if they get worse.
Slovenian: • Če se simptomi sidroma razdražljivega črevesa ob jemanju zdravila Symbioflor 2 ne izboljšajo ali se poslabšajo, se pogovorite z zdravnikom ali farmacevtom.
English: You should not use Symbioflor 2 for conditions affecting the gut other than irritable bowel syndrome.
Slovenian: Zdravila Symbioflor 2 ne smete uporabljati za druge črevesne bolezni, pač pa samo za sindrom razdražljivega črevesa.
English: Benefit has not yet been established in children with IBS.
Slovenian: Koristi pri otrocih s sindromom razdražljivega črevesa niso ugotovili.
English: GmbH can be started between a few days and 35 days after the attack;
Slovenian: GmbH se lahko začne jemati od nekaj dni po napadu do 35 dni po njem;
English: This is then followed by the standard 75 mg dose once a day for at least four weeks (in ST segment elevation myocardial infarction) or for up to 12 months (in non-ST segment elevation syndrome).
Slovenian: Temu sledi običajni 75-miligramski odmerek enkrat na dan najmanj štiri tedne (pri miokardnem infarktu z dvigom spojnice ST) ali največ 12 mesecev (pri sindromu brez dviga spojnice ST).
English: The full EPAR for Clopidogrel ratiopharm GmbH 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 Clopidogrel ratiopharm GmbH je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Clopidogrel ratiopharm GmbH.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Clopidogrel ratiopharm GmbH.
English: In acute coronary syndrome, Clopidogrel ratiopharm GmbH is used together with aspirin and treatment generally starts with a loading dose of four 75 mg tablets.
Slovenian: Pri akutnem koronarnem sindromu se zdravilo Clopidogrel ratiopharm GmbH uporablja skupaj z aspirinom, zdravljenje pa se na splošno začne z udarnim odmerkom štirih 75-miligramskih tablet.
English: This means that Clopidogrel ratiopharm GmbH is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Plavix.
English: For more information about treatment with Clopidogrel ratiopharm GmbH, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Clopidogrel ratiopharm GmbH preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Clopidogrel ratiopharm GmbH is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Slovenian: Zdravilo Clopidogrel ratiopharm GmbH se uporablja pri odraslih za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročajo krvni strdki in otrdelost krvnih žil).
English: It can also be used in patients who do not have this abnormal reading on the ECG, if they have unstable angina (a severe type of chest pain) or have had a ‘non-Q-wave' myocardial infarction.
Slovenian: Lahko se uporablja tudi pri bolnikih, pri katerih ni tega nenormalnega zapisa na EKG, če imajo nestabilno angino (hudo obliko bolečine v prsih) ali so imeli miokardni infarkt brez zobca Q. Izdaja zdravila je le na recept.
English: Clopidogrel ratiopharm GmbH can be used in patients who are having myocardial infarction with ‘ST segment elevation' (an abnormal reading on the electrocardiogram or ECG) when the doctor thinks that they would benefit from the treatment.
Slovenian: Zdravilo Clopidogrel ratiopharm GmbH se lahko uporablja pri bolnikih, ki so imeli srčni napad z „dvigom spojnice ST“ (nenormalni zapis na elektrokardiogramu ali EKG), če zdravnik meni, da bi jim zdravilo lahko pomagalo.
English: The CHMP concluded that, in accordance with EU requirements, Clopidogrel ratiopharm GmbH has been shown to have comparable quality and to be bioequivalent to Plavix.
Slovenian: CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Clopidogrel ratiopharm GmbH primerljivo raven kakovosti kot zdravilo Plavix ter da mu je biološko enakovredno.
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel ratiopharm GmbH on 28 July 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Clopidogrel ratiopharm GmbH, veljavno po vsej Evropski uniji, odobrila dne 28. julija 2009.
English: Clopidogrel ratiopharm GmbH can be started between seven days and six months after the stroke;
Slovenian: Zdravilo Clopidogrel ratiopharm GmbH se lahko začne jemati od sedem dni po napadu do šest mesecev po njem;
English: The standard dose of Clopidogrel ratiopharm GmbH is one 75 mg tablet once a day.
Slovenian: Običajni odmerek zdravila Clopidogrel ratiopharm GmbH je ena 75-miligramska tableta enkrat dnevno.
English: Because Clopidogrel ratiopharm GmbH is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Clopidogrel ratiopharm GmbH generično zdravilo in je biološko enakovredno referenčnemu zdravilu, se šteje, da so koristi in tveganja enaki kot pri referenčnem zdravilu.
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 Clopidogrel ratiopharm GmbH.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Clopidogrel ratiopharm GmbH, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Because Clopidogrel ratiopharm GmbH is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Slovenian: Ker je zdravilo Clopidogrel ratiopharm GmbH generično zdravilo, so bile študije z bolniki omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Plavix.
English: The Committee recommended that Clopidogrel ratiopharm GmbH be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Clopidogrel ratiopharm GmbH odobri dovoljenje za promet.
English: Clopidogrel ratiopharm GmbH is a ‘generic medicine'.
Slovenian: Clopidogrel ratiopharm GmbH je „generično zdravilo“.
English: Clopidogrel ratiopharm GmbH is a medicine that contains the active substance clopidogrel.
Slovenian: Clopidogrel ratiopharm GmbH je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
English: What are the benefits and risks of Clopidogrel ratiopharm GmbH?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Clopidogrel ratiopharm GmbH?
English: The active substance in Clopidogrel ratiopharm GmbH, clopidogrel, is an inhibitor of platelet aggregation.
Slovenian: Zdravilna učinkovina v zdravilu Clopidogrel ratiopharm GmbH, klopidogrel, je zaviralec agregacije trombocitov.
English: Other information about Clopidogrel ratiopharm GmbH
Slovenian: Druge informacije o zdravilu Clopidogrel ratiopharm GmbH
English: Clopidogrel ratiopharm
Slovenian: Zdravilo Clopidogrel ratiopharm
English: Why has Clopidogrel ratiopharm GmbH been approved?
Slovenian: Zakaj je bilo zdravilo Clopidogrel ratiopharm GmbH odobreno?
English: How has Clopidogrel ratiopharm GmbH been studied?
Slovenian: Kako je bilo zdravilo Clopidogrel ratiopharm GmbH raziskano?
English: What is Clopidogrel ratiopharm GmbH?
Slovenian: Kaj je zdravilo Clopidogrel ratiopharm GmbH?
English: What is Clopidogrel ratiopharm GmbH used for?
Slovenian: Za kaj se zdravilo Clopidogrel ratiopharm GmbH uporablja?
English: How is Clopidogrel ratiopharm GmbH used?
Slovenian: Kako se zdravilo Clopidogrel ratiopharm GmbH uporablja?
English: How does Clopidogrel ratiopharm GmbH work?
Slovenian: Kako zdravilo Clopidogrel ratiopharm GmbH deluje?
English: Do not use prophylactically.
Slovenian: Ne uporabljajte profilaktično.
English: Consideration should be given to the eradication of infection from the farm.
Slovenian: Treba je biti pozoren na eradikacijo okužbe iz območja kmetij.
English: 21 days
Slovenian: 21 dni.
English: However, the aetiology of ERE still remains unclear.
Slovenian: Etiologija ERE ostaja nejasna.
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required, or considered as not falling within the scope of Regulation (EC) No. 470/2009 when used as in this veterinary medicinal product.
Slovenian: Pomožne snovi, navedene v poglavju 6.1 SPC, so bodisi dovoljene snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben, ali pa ne spadajo v področje uporabe Uredbe (ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
English: Rabbits: See section 4.4
Slovenian: Kunci: Glejte poglavje 4.4.