FrancophonIA/ELRC3.0 huggingface dataset:
English: - If you have any further questions, ask your doctor, nurse or pharmacist.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Tell your doctor straight away or seek urgent medical care if you experience any of the effects above.
Slovenian: Če opazite kateri koli zgoraj naštet neželeni učinek, nemudoma obvestite zdravnika ali poiščite nujno medicinsko pomoč.
English: Figure 1 Fluenz Tetra Administration
Slovenian: Slika 1 Aplikacija cepiva Fluenz Tetra
English: The suspension is colourless to pale yellow, clear to slightly cloudy.
Slovenian: Suspenzija je brezbarvna do bledorumena, bistra do nekoliko motna.
English: The co-administration of trivalent Fluenz with the live attenuated vaccines: measles, mumps, rubella, varicella and orally-administered poliovirus has been studied.
Slovenian: Preučili so sočasno uporabo trivalentnega cepiva Fluenz z živimi oslabljenimi cepivi proti ošpicam, mumpsu, rdečkam, noricam in peroralnim cepivom proti otroški paralizi.
English: a
Slovenian: e
English: • After administering half of the dose in one nostril, administer the other half of the dose in the other nostril immediately or shortly thereafter.
Slovenian: • Kmalu ali takoj po aplikaciji polovice odmerka v eno nosnico aplicirajte drugo polovico v drugo nosnico.
English: • Fluenz Tetra is administered as a divided dose in both nostrils.
Slovenian: • Cepivo Fluenz Tetra se aplicira kot razdeljen odmerek v obe nosnici.
English: Check expiry date Product must be used before date on applicator label.
Slovenian: Preverite rok uporabnosti Cepivo uporabite pred datumom na nalepki nosnika.
English: Improved Efficacy (95% CI) Matched strains
Slovenian: Izboljšana učinkovitost (95-% IZ) Ujemajoči se sevi
English: If you have any further questions on this vaccine, ask your doctor, nurse or pharmacist.
Slovenian: Če imate dodatna vprašanja o uporabi cepiva, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: For administration in the other nostril, pinch and remove the dose-divider clip from plunger.
Slovenian: Odstranite sponko za razdelitev odmerka Za vnos v drugo nosnico odščipnite in odstranite sponko za razdelitev odmerka z bata.
English: The other ingredients are sucrose, dipotassium phosphate, potassium dihydrogen phosphate, gelatin (porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate and water for injections.
Slovenian: Pomožne snovi so saharoza, kalijev hidrogenfosfat, kalijev dihidrogenfosfat, želatina (svinjska, tipa A), argininijev klorid, natrijev glutamat monohidrat in voda za injekcije.
English: You will not be given Fluenz Tetra:
Slovenian: Cepiva Fluenz Tetra ne boste prejeli
English: If any of these apply, tell your doctor, nurse or pharmacist.
Slovenian: Če karkoli od tega velja za vas, obvestite zdravnika, farmacevta ali medicinsko sestro.
English: Nasal spray, suspension 1 single-use nasal applicator (0.2 ml) 10 single-use nasal applicators (0.2 ml each)
Slovenian: 1 nosnik za enkratno uporabo (0,2 ml) 10 nosnikov za enkratno uporabo (vsak po 0,2 ml)
English: - If any of the side effects gets serious, talk to your doctor, nurse or pharmacist.
Slovenian: - Če katerikoli neželeni učinek postane resen, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Dipotassium phosphate Potassium dihydrogen phosphate Gelatin (porcine, Type A) Arginine hydrochloride Monosodium glutamate monohydrate Water for injections
Slovenian: 6.1 Seznam pomožnih snovi saharoza kalijev hidrogenfosfat kalijev dihidrogenfosfat želatina (svinjska, tip A) argininijev klorid natrijev glutamat monohidrat voda za injekcije
English: Do not inject Fluenz Tetra.
Slovenian: Cepiva Fluenz Tetra ne injicirajte.
English: No data exist regarding the safety of intranasal administration of Fluenz Tetra in children with unrepaired craniofacial malformations.
Slovenian: O intranazalnem dajanju cepiva Fluenz Tetra otrokom z nepopravljenimi kraniofacialnimi deformacijami ni podatkov.
English: Fluenz Tetra will be given as a spray in each nostril.
Slovenian: Cepivo Fluenz Tetra se daje v obliki pršila v vsako nosnico.
English: Fluenz Tetra is administered as a divided dose in both nostrils.
Slovenian: Cepivo Fluenz Tetra se daje kot razdeljen odmerek v obe nosnici.
English: Immunisation must be carried out by nasal administration.
Slovenian: Imunizacija se opravi z nazalno uporabo.
English: After administering half of the dose in one nostril, administer the other half of the dose in the other nostril immediately or shortly thereafter.
Slovenian: Kmalu ali takoj po aplikaciji polovice odmerka v eno nosnico, dajte drugo polovico v drugo nosnico.
English: Fluenz Tetra immunogenicity
Slovenian: Imunogenost cepiva Fluenz Tetra
English: Improved Efficacy (95% CI) All strains regardless of match
Slovenian: Izboljšana učinkovitost (95-% IZ) Vsi sevi neodvisno od ujemanja
English: How to store Fluenz Tetra
Slovenian: Kako uporabljati cepivo Fluenz Tetra
English: Fluenz Tetra must only be used as a nasal spray.
Slovenian: Cepivo Fluenz Tetra se lahko uporablja le v obliki pršila za nos.
English: Remove dose-divider clip
Slovenian: Sponka za razdelitev odmerka
English: How Fluenz Tetra works
Slovenian: Kako učinkuje cepivo Fluenz Tetra
English: Efficacy (95% CI) Matched strains
Slovenian: Učinkovitost (95-% IZ) Ujemajoči se sevi
English: Efficacy (95% CI) All strains regardless of match
Slovenian: Učinkovitost (95-% IZ) Vsi sevi neodvisno od ujemanja
English: Fluenz Tetra is for nasal use only.
Slovenian: Cepivo Fluenz Tetra JE SAMO ZA NAZALNO UPORABO.
English: Fluenz Tetra IS FOR NASAL USE ONLY.
Slovenian: Cepivo Fluenz Tetra je samo za nazalno uporabo.
English: Medicinal products subject to medical prescription.
Slovenian: Predpisovanje in izdaja zdravil je le na recept.
English: Age Range
Slovenian: Starostni razpon
English: Skin and subcutaneous tissue disorders Uncommon: Rash
Slovenian: Bolezni kože in podkožja Občasni: izpuščaj
English: What Fluenz Tetra contains
Slovenian: Kaj vsebuje cepivo Fluenz Tetra
English: 6 to 71 M 2,085 2002-2003
Slovenian: D153-P514 Evropa 6 do 71 m 2.085 2002 - 2003
English: AstraZeneca S.p.A. Tel: +39 02 98011
Slovenian: Tel: +39 02 98011
English: - Keep this leaflet.
Slovenian: Napršite v drugo nosnico
English: The review was initiated on the basis of unresolved safety and efficacy concerns.
Slovenian: Pregled je bil sprožen zaradi nerešenih vprašanj glede varnosti in učinkovitosti.
English: Prozac and associated names
Slovenian: Prozac in z njim povezana imena
English: The final opinion was converted into a Decision by the European Commission on 21 August 2006.
Slovenian: Končno mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 21. avgusta 2006.
English: International Non-Proprietary Name (INN): Fluoxetine
Slovenian: Mednarodno nelastniško ime (INN): Fluoksetin
English: London, 21 August 2006 EMEA/311654/2006
Slovenian: London, 21. avgusta 2006 EMEA/311654/2006
English: The referral procedure started on 26 May 2005.
Slovenian: Napotitveni postopek se je začel 26. maja 2005.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 6(12) REFERRAL
Slovenian: ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO IZ ČLENA 6(12)
English: * Notes: The information given in this document and Annexes reflect only the CHMP Opinion dated 1 June 2006.
Slovenian: * Opombe: Informacije, podane v tem dokumentu in Dodatkih, odražajo samo mnenje CHMP z dne 1. junija 2006.
English: The Rapporteur and Co-Rapporteur appointed were: Dr Barbara van Zwieten-Boot and Dr Tomas Salmonson, respectively.
Slovenian: Za poročevalca je bila imenovana dr. Barbara van Zwieten-Boot in za soporočevalca dr. Tomas Salmonson.
English: Fluoxetine is a selective inhibitor of serotonin reuptake.
Slovenian: Fluoksetin je selektivni zaviralec ponovnega prevzema serotonina.
English: Written explanations were provided by the Marketing Authorisation Holders on 29 August 2005, 6 January 2006, 3 April 2006 and 11 May 2006.
Slovenian: Imetniki dovoljenj za promet z zdravilom so pisna pojasnila predložili 29. avgusta 2005, 6. januarja 2006, 3. aprila 2006 in 11. maja 2006.
English: Based on evaluation of the currently available data and the Rapporteurs' assessment reports, the CHMP considered that the benefits of Prozac are greater than its potential risks in this population and therefore adopted an opinion on 1 June 2006 recommending the following extension of the indication:
Slovenian: Na podlagi vrednotenja trenutno razpoložljivih podatkov in poročevalčevega poročila o oceni je CHMP menil, da so pri tej populaciji koristi zdravila Prozac večje od z njim povezanih morebitnih tveganj in je zato dne 1. junija 2006 sprejel mnenje, v katerem priporoča naslednjo razširitev indikacije:
English: On 2 May 2005, France referred the matter to the EMEA under Article 6(12) of Commission Regulation EC No 1084/2003.
Slovenian: Francija je dne 2. maja 2005 Evropski agenciji za zdravila (EMEA) predložila napotitev v skladu s členom 6(12) Uredbe Komisije (ES) št. 1084/2003.
English: Prozac is authorised in most EU Member States for the treatment of major depressive episodes, obsessive-compulsive disorder and bulimia nervosa in adults.
Slovenian: Prozac je odobren v večini držav članic EU za zdravljenje hudih epizod depresije, obsesivnokompulzivnih motenj in bulimije nervoze pri odraslih.
English: Children and adolescents aged 8 years and above: Moderate to severe major depressive episode, if depression is unresponsive to psychological therapy after 4-6 sessions.
Slovenian: Otroci in mladostniki stari 8 let in več: Zmerne do močno izražene hude epizode depresije, če se depresija ne odziva na psihološko zdravljenje po 4 do 6 seansah.
English: The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II, together with the amended product information in the Annex III and the conditions of the marketing authorisations in the Annex IV.
Slovenian: Seznam zadevnih imen proizvodov je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II, skupaj s Povzetkom glavnih značilnosti zdravila v Dodatku III ter s Pogoji dovoljenja za promet z zdravilom v Dodatku IV.
English: The CHMP began an arbitration review for Prozac, following an application by the marketing authorisation holder to extend the indication to include the treatment of major depressive episodes in children and adolescents.
Slovenian: CHMP je začel arbitražni pregled zdravila Prozac po vlogi imetnika dovoljenja za promet z zdravilom za razširitev indikacije, da bi bilo vključeno tudi zdravljenje hudih epizod depresije pri otrocih in mladostnikih.
English: Antidepressant medication should be offered to a child or young person with moderate to severe depression only in combination with a concurrent psychological therapy.
Slovenian: Zdravljenje z antidepresivi je treba nuditi otroku ali mladi osebi z zmerno do hudo depresijo samo v kombinaciji s sočasnim psihološkim zdravljenjem.
English: Oral explanations were given by the Marketing Authorisation Holders on 26 April 2006.
Slovenian: Ustna pojasnila so podali 26. aprila 2006.
English: 7 January 2016
Slovenian: 7. januar 2016
English: The European Commission issued a decision on 7 January 2016.
Slovenian: Evropska komisija je sklep izdala 7. januarja 2016.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the United Kingdom) assesses a veterinary medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Poland, Portugal, Slovakia, Spain and The Netherlands).
Slovenian: To je postopek, pri katerem ena od držav članic („referenčna država članica“, v tem primeru Združeno kraljestvo) oceni zdravilo za uporabo v veterinarski medicini glede tega, ali se zanj lahko izda dovoljenje za promet, ki bo veljavno v tej državi in drugih državah članicah („zadevnih državah članicah“, v tem primeru Avstriji, Belgiji, Češki republiki, na Danskem, v Franciji, Nemčiji, Grčiji, na Madžarskem, Irskem, v Italiji, Luksemburgu, na Poljskem, Portugalskem, Slovaškem, v Španiji in na Nizozemskem).
English: However, the Member States were not able to reach an agreement and the Veterinary Medicines Directorate of the United Kingdom referred the matter to the CVMP for arbitration on 28 May 2015.
Slovenian: Vendar države članice niso uspele doseči soglasja, zato je direktorat za zdravila za uporabo v veterinarski medicini v Združenem kraljestvu 28. maja 2015 zadevo napotil na odbor CVMP v arbitražo.
English: In addition, Denmark raised a concern that the advice for prudent use in the product information is insufficient.
Slovenian: Poleg tega je Danska izrazila pomislek, da nasvet o preudarni uporabi v informacijah o zdravilu ne zadošča.
English: The grounds for the referral were concerns raised by Denmark that the marketing authorisation of Solamocta may present a potential serious risk to human and animal health.
Slovenian: Razlogi za napotitev so bili pomisleki Danske, da dovoljenje za promet z zdravilom Solamocta lahko pomeni morebitno resno tveganje za zdravje ljudi in živali.
English: Amoxicillin is a bactericidal antibiotic belonging to the semisynthetic penicillin group.
Slovenian: Amoksicilin je baktericidni antibiotik iz skupine polsintetskih penicilinov.
English: The CVMP also recommended that the product information for Solamocta be amended.
Slovenian: Priporočil je tudi, da se informacije o zdravilu Solamocta spremenijo.
English: The product is indicated for treatment of infections in chickens, turkeys and ducks caused by bacteria susceptible to amoxicillin.
Slovenian: Zdravilo je indicirano za zdravljenje okužb pri piščancih, puranih in racah, ki jih povzročajo bakterije, občutljive za amoksicilin.
English: Denmark considered that Solamocta is essentially different from the reference product Amoxinsol 100% w/w Powder for Oral Solution and that these differences could be sufficient to require a formal bioequivalence study.
Slovenian: Danska je menila, da se zdravilo Solamocta bistveno razlikuje od referenčnega zdravila Amoxinsol 100 % m/m prašek za peroralno raztopino in da lahko te razlike zadostujejo, da se zahteva izvedba uradne študije biološke enakovrednosti.
English: Thus the CVMP concluded that the concerns expressed by Denmark should not prevent the granting of marketing authorisations and recommended marketing authorisation be granted in the concerned Member States.
Slovenian: Tako je zaključil, da pomisleki, ki jih je izrazila Danska, ne bi smeli preprečiti izdaje dovoljenj za promet z zdravilom, in priporočil, da se v zadevnih državah članicah izda dovoljenje za promet z zdravilom.
English: On 4 November 2015, the European Medicines Agency (the Agency) completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the veterinary medicinal product Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys.
Slovenian: Evropska agencija za zdravila je 4. novembra 2015 zaključila arbitražni postopek po nesoglasju med državami članicami Evropske unije (EU) v zvezi z izdajo dovoljenja za promet z zdravilom za uporabo v veterinarski medicini Solamocta 697 mg/g prašek za uporabo v pitni vodi za piščance, race in purane.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that a satisfactory justification has been provided that the product, Solamocta, is eligible for a waiver from the requirement to demonstrate in vivo bioequivalence with the reference product in accordance with section 7.1.c) of the CVMP guideline on the conduct of bioequivalence studies for veterinary medicinal products (EMA/CVMP/016/00-Rev.2) and that the excipients will not impact the bioavailability or safety of this product compared to the reference product.
Slovenian: Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v odboru CVMP je ta zaključil, da je bila podana zadovoljiva utemeljitev, da je zdravilo Solamocta upravičeno do odstopanja od zahteve za dokaz biološke enakovrednosti in vivo z referenčnim zdravilom v skladu s točko 7.1.c) Smernic CVMP o izvajanju študij biološke enakovrednosti za zdravila za uporabo v veterinarski medicini (EMA/CVMP/016/00-Rev. 2) in da pomožne snovi ne bodo vplivale na biološko uporabnost ali varnost tega zdravila v primerjavi z referenčnim zdravilom.
English: Solamocta contains 800 mg amoxicillin trihydrate (equivalent to 697 mg amoxicillin) as an active substance per gram product.
Slovenian: Zdravilo Solamocta vsebuje 800 mg amoksicilin trihidrata (kar ustreza 697 mg amoksicilina) kot zdravilno učinkovino na gram zdravila.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the marketing authorisation for Solamocta can be granted provided that the recommended revised instructions on product administration and prudent use warnings are added to the product information.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da se dovoljenje za promet z zdravilom Solamocta lahko izda pod pogojem, da se v informacije o zdravilu vključijo priporočena revidirana navodila o načinu dajanja zdravila in opozorila o preudarni uporabi.
English: Eurovet Animal Health B.V. submitted a marketing authorisation application, under Article 13(3) of Directive 2001/82/EC (i.e. hybrid or mixed application), for Solamocta to the United Kingdom via the decentralised procedure referring to the reference product Amoxinsol 100% w/w Powder for Oral Solution authorised in the United Kingdom.
Slovenian: je po decentraliziranem postopku v Združenem kraljestvu predložilo vlogo za pridobitev dovoljenja za promet z zdravilom Solamocta v skladu s členom 13(3) Direktive 2001/82/ES (tj. hibridno ali mešano vlogo), ki se nanaša na referenčno zdravilo Amoxinsol 100 % m/m prašek za peroralno raztopino, odobreno v Združenem kraljestvu.
English: The Committee recommended revised instructions on product administration and advice on prudent use to address responsible use in relation to development of antimicrobial resistance.
Slovenian: Da bi spodbudil odgovorno uporabo v zvezi z razvojem protimikrobne odpornosti, je odbor priporočil revidirana navodila za dajanje zdravila in nasvet o preudarni uporabi.
English: Why was Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys reviewed?
Slovenian: Zakaj je bil opravljen pregled zdravila Solamocta 697 mg/g prašek za uporabo v pitni vodi za piščance, race in purane?
English: What is Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys?
Slovenian: Kaj je zdravilo Solamocta 697 mg/g prašek za uporabo v pitni vodi za piščance, race in purane?
English: Questions and answers on Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys (amoxicillin trihydrate)
Slovenian: Vprašanja in odgovori v zvezi z zdravilom Solamocta 697 mg/g prašek za uporabo v pitni vodi za piščance, race in purane (amoksicilin trihidrat)
English: It usually disappeared spontaneously within 1 week at most.
Slovenian: Običajno je spontano izginila v največ enem tednu.
English: After reconstitution, each dose of 1 ml contains:
Slovenian: Po rekonstituciji vsak odmerek (1 ml) vsebuje:
English: Date of first authorisation: 03/05/2013 Date of last renewal: 20/03/2018
Slovenian: Datum pridobitve dovoljenja za promet: 03/05/2013 Datum zadnjega podaljšanja dovoljenja za promet: 20/03/2018
English: Efficacy of the treatment has not been investigated beyond 2 years following treatment.
Slovenian: Učinkovitost zdravljenja ni bila raziskana po preteku 2 let od zdravljenja.
English: ATC-vet code: QL03AX90.
Slovenian: Oznaka ATC vet: QL03AX90.
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon
Slovenian: Če opazite kakršne koli resne stranske učinke ali druge učinke, tudi tiste, ki niso navedeni v tem navodilu za uporabo ali mislite da zdravilo ni delovalo, obvestite svojega veterinarja.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (http://www.ema.europa.eu/.)
English: This was demonstrated in a field trial over a period of 2 years.
Slovenian: To je bilo potrjeno s terensko študijo v trajanju 2 let.
English: The virus expresses the IL-2 gene at the inoculation site, but does not replicate in the cat.
Slovenian: Virus izraža IL-2 gen na mestu inokulacije, vendar se v mački ne replicira.
English: Efficacy has only been tested in conjunction with surgery and radiotherapy; therefore the treatment should be conducted according to treatment course described in section 4.9.
Slovenian: Učinkovitost je bila preskušena le v povezavi z operativnim zdravljenjem in radioterapijo, zato je potrebno zdraviti v skladu s potekom zdravljenja, opisanim v poglavju 4.9.
English: Start the treatment course the day before radiation therapy, preferably within one month after surgical excision.
Slovenian: Zdravljenje začnite dan pred zdravljenjem z obsevanjem, če je le mogoče v enem mesecu po kirurški odstranitvi tumorja.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Slovenian: A. IZDELOVALCI PROIZVAJALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN
English: Shelf life after first opening the immediate packaging: use immediately after reconstitution.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: Uporabite takoj po rekonstituciji.
English: Lyophilisate: whitish homogeneous pellet.
Slovenian: Liofilizat: belkasta homogena peleta.
English: Mild local and/or systemic adverse reactions related to the injection itself may be observed transitorily.
Slovenian: Občasno se lahko prehodno pojavijo blagi lokalni in/ali sistemski neželeni učinki povezani s samim injiciranjem.
English: Canarypox recombinants are known to be safe for humans.
Slovenian: Rekombinantni pox virus kanarčkov je varen za ljudi.
English: As safety and efficacy of repetition of the treatment to treat fibrosarcoma recurrence have not been investigated, repetition of the treatment should be considered by the veterinarian taking into account the benefit-risk balance.
Slovenian: Ker varnost in učinkovitost ponovnega zdravljenja za preprečevanje ponovitve fibrosarkoma ni bilo raziskano, mora o ponovnem zdravljenju odločati veterinar na osnovi ocene razmerja med koristjo in tveganjem.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
English: Treatment course: 4 administrations at 1-week intervals (day 0, day 7, day 14, day 21) followed by 2 administrations at 2-week intervals (day 35, day 49).
Slovenian: Potek zdravljenja: 4 odmerki v razmakih 1 tedna (dan 0, dan 7, dan 14 in dan 21), ki jim sledita 2 odmerka v razmaku 2 tednov (dan 35 in dan 49).