FrancophonIA/ELRC3.0 huggingface dataset:
English: Hyperactivity disorder Libido changes
Slovenian: Psihiatrične motnje motnje razpoloženja čustvene motnje tesnoba nespečnost hiperaktivne motnje spremembe v libidu dezorientacija
English: If your next period is late after taking ellaOne
Slovenian: Če vam po zaužitju zdravila ellaOne zamuja naslednja menstruacija
English: 4.4 Special warnings and precautions for use ellaOne is for occasional use only.
Slovenian: Zdravilo ellaOne je namenjeno občasni uporabi.
English: 17 Rue de Pontoise 95520 Osny France
Slovenian: 17 Rue de Pontoise
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva mišične bolečine bolečine v hrbtu
English: MedDRA
Slovenian: Po MedDRA
English: Croscarmellose sodium Magnesium stearate
Slovenian: Jedro tablete: laktoza monohidrat povidon premreženi natrijev karmelozat magnezijev stearat
English: - The active substance is ulipristal acetate.
Slovenian: - Učinkovina je ulipristalacetat.
English: NETHERLANDS www.hra-pharma.com/PIL/NL/GS NORWAY
Slovenian: NIZOZEMSKA www.hra-pharma.com/PIL/NL/GS NORVEŠKA
English: Headache Dizziness
Slovenian: Huda okvara jeter
English: ellaOne 30 mg film-coated tablet Ulipristal acetate
Slovenian: ellaOne 30 mg filmsko obložena tableta ulipristalacetat
English: In such cases ritonavir might reduce plasma concentrations of ulipristal acetate.
Slovenian: V takih primerih lahko ritonavir zmanjša koncentracije ulipristalacetata v plazmi, zato sočasna uporaba nie priporočljiva (glejte poglavje 4.4).
English: A&D Pharma Romania Tel: + 40-(0)372 072 219
Slovenian: Tel: + 40-(0)372 072 219
English: www.hra-pharma.com/PIL/LT/GS LUXEMBOURG www.hra-pharma.com/PIL/BE/GS MALTA
Slovenian: www.hra-pharma.com/PIL/LT/GS LUKSEMBURG www.hra-pharma.com/PIL/BE/GS MALTA
English: Ask a healthcare professional for advice if you are worried about this.
Slovenian: Če vas to skrbi, se posvetujte z zdravstvenim delavcem.
English: 1 film-coated tablet.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 1 filmsko obložena tableta
English: Abdominal pain* Abdominal discomfort Vomiting*
Slovenian: Bolezni prebavil navzea* bolečine v trebuhu* nelagodje v želodcu bruhanje*
English: General disorders and administration site conditions
Slovenian: Navodilo za uporabo na spletnem mestu DRŽAVA
English: www.hra-pharma.com/PIL/LT LUXEMBOURG www.hra-pharma.com/PIL/BE MALTA
Slovenian: www.hra-pharma.com/PIL/LT LUKSEMBURG www.hra-pharma.com/PIL/BE MALTA
English: HRA Pharma Deutschland GmbH Tel: + 49-(0) 611 890777-0
Slovenian: Tel: + 49-(0) 611 890777-0
English: The active substance is ulipristal acetate.
Slovenian: • Učinkovina je ulipristalacetat.
English: Disorientation
Slovenian: Odmerjanje
English: www.hra-pharma.com/PIL/SE/GS UNITED-KINGDOM www.hra-pharma.com/PIL/UK/GS
Slovenian: www.hra-pharma.com/PIL/SE/GS VELIKA BRITANIJA www.hra-pharma.com/PIL/UK/GS
English: Ear and labyrinth disorders
Slovenian: Ušesne bolezni, vključno z motnjami labirinta vrtoglavica
English: LIST OF EXCIPIENTS
Slovenian: Izdelovalec Cenexi
English: What ellaOne is and what it is used for ellaOne is an emergency contraceptive ellaOne is a contraceptive intended to prevent pregnancy after unprotected sex or if your contraceptive method has failed.
Slovenian: Kaj je zdravilo ellaOne in za kaj ga uporabljamo Zdravilo ellaOne je nujno kontracepcijsko sredstvo
English: www.hra-pharma.com/PIL/SE UNITED-KINGDOM www.hra-pharma.com/PIL/UK
Slovenian: www.hra-pharma.com/PIL/SE VELIKA BRITANIJA www.hra-pharma.com/PIL/UK
English: Nervous system disorders
Slovenian: Organski sistemi
English: Long lasting methods
Slovenian: Metode z dolgim časom delovanja Kontracepcijski vsadek
English: ellaOne film-coated tablet
Slovenian: PODATKI V BRAILLOVI PISAVI ellaOne filmsko obložena tableta
English: Dry throat
Slovenian: Okvara jeter
English: www.hra-pharma.com/PIL/GR/GS CZECH REPUBLIC www.hra-pharma.com/PIL/CZ/GS DENMARK
Slovenian: www.hra-pharma.com/PIL/GR/GS MADŽARSKA www.hra-pharma.com/PIL/HU/GS
English: www.hra-pharma.com/PIL/RO SLOVAK REPUBLIC www.hra-pharma.com/PIL/SK SLOVENIA
Slovenian: www.hra-pharma.com/PIL/PL PORTUGALSKA www.hra-pharma.com/PIL/PT
English: www.hra-pharma.com/PIL/RO/GS SLOVAK REPUBLIC www.hra-pharma.com/PIL/SK/GS SLOVENIA
Slovenian: www.hra-pharma.com/PIL/PL/GS PORTUGALSKA www.hra-pharma.com/PIL/PT/GS
English: Appetite disorders
Slovenian: PODATKI NA ZUNANJI OVOJNINI
English: www.hra-pharma.com/PIL/PT
Slovenian: www.hra-pharma.com/PIL/SK
English: Package leaflet: Information for the user ellaOne 30 mg film-coated tablet
Slovenian: Navodilo za uporabo ellaOne 30 mg filmsko obložena tableta ulipristalacetat
English: www.hra-pharma.com/PIL/PT/GS
Slovenian: www.hra-pharma.com/PIL/SK/GS
English: www.hra-pharma.com/PIL/HU/GS
Slovenian: www.hra-pharma.com/PIL/CZ/GS
English: Menorrhagia Vaginal discharge Menstrual disorder Metrorrhagia Vaginitis
Slovenian: Bolezni živčevja glavobol omotica somnolenca migrena tremor motnje pozornosti motnje v okušanju sinkopa
English: (Two medicines are bioequivalent when they produce the same levels of the active substance in the body.)
Slovenian: (Dve zdravili sta biološko enakovredni, kadar proizvedeta enake ravni zdravilne učinkovine v telesu.)
English: With the skeleton still in place, the cells cannot divide and they eventually die.
Slovenian: Dokler je ogrodje prisotno, se celice ne morejo deliti in sčasoma odmrejo.
English: It was intended to be used on its own or in combination with other cancer medicines, depending on the type of cancer and the response to previous treatments.
Slovenian: Uporabljalo naj bi se samostojno ali v kombinaciji z drugimi zdravili za zdravljenje raka, odvisno od vrste raka in odziva na predhodna zdravljenja.
English: Withdrawal of the marketing authorisation application for Docetaxel Sun (docetaxel) EMA/396891/2016
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Docetaxel Sun (docetaksel) EMA/396891/2016
English: Docetaxel Sun was to be used to treat breast cancer, non-small-cell lung cancer, prostate cancer, gastric adenocarcinoma (a type of stomach cancer) and cancer of the head and neck.
Slovenian: Zdravilo Docetaxel Sun naj bi se uporabljalo za zdravljenje bolnikov z rakom dojke, nedrobnoceličnim pljučnim rakom, rakom prostate, adenokarcinomom želodca (vrsto želodčnega raka) in rakom glave in vratu.
English: Because Docetaxel Sun was developed as a generic medicine, the company presented the results of studies from the literature, and studies to show the quality of the medicine.
Slovenian: Ker je bilo zdravilo Docetaxel Sun razvito kot generično zdravilo, je družba predložila rezultate študij iz literature in študij, ki dokazujejo kakovost zdravila.
English: It was to be available as a concentrate to make a solution for infusion (drip) into a vein.
Slovenian: Na voljo naj bi bilo v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: The company had not carried out a study to demonstrate that Docetaxel Sun is bioequivalent to the reference medicine, because this is not required if the medicines are simple solutions that are given into a vein.
Slovenian: Družba ni izvedla študije, s katero bi dokazala, da je zdravilo Docetaxel Sun biološko enakovredno referenčnemu zdravilu, ker to ni zahtevano, kadar so zdravila preproste raztopine, ki se dajejo v veno.
English: Withdrawal of the marketing authorisation application for Docetaxel Sun (docetaxel)
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Docetaxel Sun (docetaksel)
English: On 6 June 2016, Sun Pharmaceutical Industries Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Docetaxel Sun, for the treatment of various types of cancer.
Slovenian: je 6. junija 2016 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Docetaxel Sun, namenjenim zdravljenju različnih vrst raka.
English: Docetaxel Sun was developed as a ‘generic medicine'.
Slovenian: Zdravilo Docetaxel Sun je bilo razvito kot „generično zdravilo“.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Docetaxel Sun.
Slovenian: Zato je CHMP v času umika vloge menil, da družba ni predložila zadostnih podatkov v podporo vlogi za zdravilo Docetaxel Sun.
English: This means that Docetaxel Sun was intended to be similar to a ‘reference medicine' already authorised in the European Union called Taxotere.
Slovenian: To pomeni, da naj bi bilo zdravilo Docetaxel Sun podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Taxotere.
English: However, solutions containing micelles may behave differently from one another, and the CHMP considered that more information was needed to show that the Docetaxel Sun solution was similar enough in its composition and behaviour to Taxotere solution to allow a bioequivalence study to be omitted.
Slovenian: Vendar pa se obnašanje posameznih raztopin, ki vsebujejo micele, lahko razlikuje, zato je CHMP presodil, da je potrebnih več informacij za dokaz, da je raztopina zdravila Docetaxel Sun po sestavi in obnašanju dovolj podobna raztopini zdravila Taxotere, da študija biološke enakovrednosti ni potrebna.
English: Docetaxel blocks the ability of cells to destroy the internal ‘skeleton' that allows them to divide and multiply.
Slovenian: Docetaksel zavira sposobnost celic, da uničijo notranje „ogrodje“, ki celicam
English: In particular, the CHMP noted that the docetaxel in Docetaxel Sun and in Taxotere is contained in tiny droplets (micelles) made with another substance, polysorbate 80, that helps the docetaxel to dissolve.
Slovenian: Odbor je zlasti poudaril, da je docetaksel v zdravilu Docetaxel Sun in v zdravilu Taxotere vsebovan v drobnih kapljicah (micelih), narejenih iz druge snovi, polisorbata 80, ki docetakselu pomaga pri raztapljanju.
English: The CHMP was assessing the company's responses to the questions at the time of the withdrawal.
Slovenian: V času umika je CHMP ocenjeval odgovore družbe na posredovana vprašanja.
English: What is Docetaxel Sun?
Slovenian: Kaj je zdravilo Docetaxel Sun?
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Docetaxel Sun could not have been approved for the treatment of cancer.
Slovenian: Na podlagi pregleda podatkov je Odbor v času umika vloge izrazil določene zadržke in je začasno menil, da zdravila Docetaxel Sun ni mogoče odobriti za zdravljenje raka.
English: The active substance in Docetaxel Sun and Taxotere, docetaxel, belongs to the group of cancer medicines known as taxanes.
Slovenian: Zdravilna učinkovina v zdravilu Docetaxel Sun, docetaksel, spada v skupino zdravil za zdravljenje raka, ki so znana kot taksani.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing the application for Docetaxel Sun for commercial reasons.
Slovenian: Družba je v dopisu, s katerim agencijo obvešča o umiku vloge, navedla, da se je za umik vloge za zdravilo Docetaxel Sun odločila zaradi poslovnih razlogov.
English: Docetaxel Sun is expected to work in the same way as the reference medicine, Taxotere.
Slovenian: Zdravilo Docetaxel Sun naj bi delovalo na enak način kot referenčno zdravilo Taxotere.
English: Docetaxel Sun is a medicine that contains the active substance docetaxel.
Slovenian: Docetaxel Sun je zdravilo, ki vsebuje zdravilno učinkovino docetaksel.
English: What was Docetaxel Sun expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Docetaxel Sun uporabljalo?
English: How is Docetaxel Sun expected to work?
Slovenian: Kako naj bi zdravilo Docetaxel Sun delovalo?
English: No further studies were carried out because Docetaxel Sun is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Taxotere.
Slovenian: Ker je zdravilo Docetaxel Sun generično zdravilo, ki se daje z infundiranjem in vsebuje enako zdravilno učinkovino kot referenčno zdravilo Taxotere, niso bile opravljene nobene dodatne študije.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom29 January 2016
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom29.
English: This may help to reduce psychotic and manic symptoms and prevent them from returning.
Slovenian: To lahko pripomore k zmanjšanju psihotičnih in maničnih simptomov ter prepreči, da bi se ponovili.
English: It was to be available as tablets (5, 10, 15 and 30 mg) and as 10 and 15 mg orodispersible tablets (tablets that dissolve in the mouth).
Slovenian: Na voljo naj bi bilo v obliki tablet (5, 10, 15 in 30 mg) ter 10- in 15-miligramskih orodisperzibilnih tablet (tablet, ki se raztopijo v ustih).
English: Its exact mechanism of action is unknown, but it attaches to several types of receptors on nerve cells in the brain.
Slovenian: Natančen mehanizem njegovega delovanja ni znan, znano pa je, da se veže na več različnih vrst receptorjev na živčnih celicah v možganih.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila?
English: This action disrupts signals transmitted between brain cells by ‘neurotransmitters', chemicals that nerve cells use to communicate with neighbouring cells.
Slovenian: S tem prekine signale, ki jih med možganskimi celicami prenašajo „živčni prenašalci“, tj. kemične snovi, ki jih živčne celice uporabljajo za komunikacijo z bližnjimi celicami.
English: This means that Aripiprazole Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Abilify.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Abilify.
English: The company informed the CHMP that there were no consequences for patients in clinical trials.
Slovenian: Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki sodelujejo v kliničnih preskušanjih.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that the reason for withdrawal was identification of manufacturing issues.
Slovenian: Družba je v dopisu, s katerim je Agencijo obvestila o umiku vloge, navedla, da se je za umik vloge odločila zaradi ugotovljenih težav v proizvodnji.
English: It was also expected to be used to treat moderate to severe manic episodes and to prevent new manic episodes in adults with bipolar I disorder who have responded to the medicine in the past, and for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over with bipolar I disorder.
Slovenian: Prav tako naj bi se uporabljalo za zdravljenje zmernih do hudih maničnih epizod in preprečevanje novih maničnih epizod pri odraslih z bipolarno motnjo I, ki so se v preteklosti že odzvali na zdravilo, največ 12 tednov pa tudi za zdravljenje zmernih do hudih maničnih epizod pri bolnikih z bipolarno motnjo I, starejših od 13 let.
English: Aripiprazole Mylan was expected to be used to treat schizophrenia in patients aged 15 years or over.
Slovenian: Zdravilo Aripiprazole Mylan naj bi se uporabljalo za zdravljenje shizofrenije pri bolnikih, starejših od 15 let.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Aripiprazole Mylan.
Slovenian: Zato je CHMP v času umika menil, da družba ni predložila zadostnih podatkov v podporo vlogi za zdravilo Aripiprazole Mylan.
English: Aripiprazole Mylan was developed as a ‘generic medicine'.
Slovenian: Zdravilo Aripiprazole Mylan je bilo razvito kot „generično zdravilo“.
English: This means that aripiprazole acts like dopamine and 5-hydroxytryptamine by activating these receptors, but it has a weaker effect than the natural neurotransmitters.
Slovenian: To pomeni, da aripiprazol z aktiviranjem teh receptorjev deluje kot dopamin in 5-hidroksitriptamin, vendar šibkeje kot naravni živčni prenašalci.
English: agonist' on the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin).
Slovenian: domnevno deluje kot „delni agonist“ na receptorje za živčna prenašalca dopamin in 5-hidroksitriptamin (imenovanega tudi serotonin).
English: Because Aripiprazole Mylan is a generic medicine, the company had presented results of studies in volunteers to show that Aripiprazole Mylan 10-mg tablet and the 10-mg orodispersible tablet were bioequivalent to the corresponding tablets of the reference medicine, Abilify.
Slovenian: Ker je Aripiprazole Mylan generično zdravilo, je družba predložila rezultate študij, izvedenih na prostovoljcih, da bi dokazala, da so 10-miligramske tablete in 10-miligramske orodisperzibilne tablete zdravila Aripiprazole Mylan biološko enakovredne ustreznim tabletam referenčnega zdravila Abilify.
English: The CHMP considered that the dissolution tests required for the biowaiver had not been carried out according to existing recommendations and thus, bioequivalence for all the different strengths of tablets and orodispersible tablets had not been demonstrated.
Slovenian: Prav tako je menil, da preiskave raztapljanja, potrebne za opustitev izvedbe študij biološke enakovrednosti, niso bile izvedene v skladu z obstoječimi priporočili in tako ni bila dokazana biološka enakovrednost za različne jakosti tablet in orodisperzibilnih tablet.
English: Aripiprazole's action alters dopamine and 5-hydroxytryptamine activity, which is abnormal in schizophrenia and bipolar disorder.
Slovenian: Zaradi delovanja aripiprazola se spremeni tudi aktivnost dopamina in 5-hidroksitriptamina, kar je pri shizofreniji in bipolarni motnji nenormalno.
English: What is Aripiprazole Mylan?
Slovenian: Kaj je zdravilo Aripiprazole Mylan?
English: Aripiprazole Mylan is a medicine that contains the active substance aripiprazole.
Slovenian: Aripiprazole Mylan je zdravilo, ki vsebuje zdravilno učinkovino aripiprazol.
English: Based on the review of the data, at the time of the withdrawal, the CHMP was of the provisional opinion that Aripiprazole Mylan could not have been approved for the treatment of schizophrenia and for the treatment and prevention of manic episodes in patients with bipolar I disorder.
Slovenian: Na podlagi pregleda podatkov je Odbor v času umika začasno menil, da zdravila Aripiprazole Mylan ni mogoče odobriti za zdravljenje shizofrenije ter zdravljenje in preprečevanje maničnih epizod pri bolnikih z bipolarno motnjo I.
English: On 8 January 2016, Mylan S.A.S.
Slovenian: Družba Mylan S.A.S.
English: To support an application for a ‘biowaiver', the company also presented laboratory tests to show that other strengths of Aripiprazole Mylan tablets dissolve in an identical way to the reference medicine.
Slovenian: V podporo vlogi za „opustitev izvedbe študij biološke enakovrednosti“ je družba predložila tudi laboratorijske preiskave, da bi dokazala, da se tablete zdravila Aripiprazole Mylan drugačnih jakosti raztopijo na enak način kot referenčno zdravilo.
English: The active substance in Aripiprazole Mylan, aripiprazole, is an antipsychotic medicine.
Slovenian: Zdravilna učinkovina v zdravilu Aripiprazole Mylan, aripiprazol, je antipsihotik.
English: officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Aripiprazole Mylan, for the treatment of schizophrenia and the treatment and prevention of manic episodes in patients with bipolar I disorder.
Slovenian: je dne 8. januarja 2016 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Aripiprazole Mylan, namenjenim zdravljenju shizofrenije ter zdravljenju in preprečevanju maničnih epizod pri bolnikih z bipolarno motnjo I.
English: The biowaiver removes the need to repeat bioequivalence studies for all the other strengths of Aripiprazole Mylan tablets.
Slovenian: Zaradi opustitve izvedbe študij biološke enakovrednosti teh ni več treba ponoviti za vse ostale jakosti tablet zdravila Aripiprazole Mylan.
English: The CHMP considered that the tests to support a biowaiver were not acceptable.
Slovenian: Menil je, da preiskave, predložene v podporo opustitve izvedbe študij biološke enakovrednosti, niso sprejemljive.
English: How is Aripiprazole Mylan expected to work?
Slovenian: Kako naj bi zdravilo Aripiprazole Mylan delovalo?
English: What was Aripiprazole Mylan expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Aripiprazole Mylan uporabljalo?
English: These clinical signs disappear within 7 days without any particular treatment.
Slovenian: Ti klinični znaki izginejo brez kakršne koli posebne terapije v sedmih dneh.
English: were commonly observed in safety studies.
Slovenian: so se prav tako pogosto pojavili v študijah varnosti.
English: These parameters return to normal in the week following the last injection.
Slovenian: Ti parametri se vrnejo na običajne v roku tedna dni po zadnji injekciji.
English: The use of supplementary supportive treatments improves prognosis.
Slovenian: Uporaba dodatnih podpornih zdravljenj izboljša prognozo.
English: Date of first autorisation: 06.11.2001 / Date of last renewal: 21.11.2006
Slovenian: Datum pridobitve dovoljenja za promet: 06.11.2001 / Datum zadnjega podaljšanja dovoljenja za promet: 21.11.2006.
English: Detailed information on this product is available on the website of the European Medicines Agency http://emea.europa.eu/.
Slovenian: Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.emea.europa.eu/).
English: After injection it is quickly bound to specific receptors of a large variety of cells.
Slovenian: Po injiciranju se hitro veže na specifične receptorje raznolikih celic.
English: EXP: {month/year}
Slovenian: EXP {mesec/leto}
English: *MU : Million Units
Slovenian: *ME: milijonov enot
English: a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Slovenian: a) bi uporaba zdravila za uporabo v veterinarski medicini ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali.
English: Dispose of waste material in accordance with local requirements.
Slovenian: Odpadne snovi odstranite v skladu z lokalnimi zahtevami.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, Member States prohibit or may prohibit the import, sale, supply and/or use of the veterinary medicinal product on the whole or part of their territory if it is established that:
Slovenian: Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta države članice prepovejo ali lahko prepovejo uvoz, prodajo, oskrbo in/ali uporabo zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če se ugotovi da:
English: Do not use after the expiry date stated on the label.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na nalepki.
English: Three separate 5-day treatments must be performed at day 0, day 14 and day 60.
Slovenian: Izvesti se morajo tri ločena 5-dnevna zdravljenja z začetkom na 0., 14. in 60. dan.
English: • in anaemic cats, mortality rate of about 60% at 4, 6, 9 and 12 months was reduced by approximately 30% following treatment with interferon.
Slovenian: • pri anemičnih mačkah z okrog 60 % stopnjo smrtnosti pri 4, 6, 9 in 12 mesecih je zdravljenju z interferonom sledilo zmanjšanje smrtnosti za približno 30 %.