FrancophonIA/ELRC3.0 huggingface dataset:
English: The application was submitted to the Netherlands as reference Member State and Austria, Belgium, Czech Republic, Denmark, France, Germany, Hungary, Ireland, Italy, Poland, Spain and the United Kingdom as concerned Member States.
Slovenian: Vloga je bila predložena Nizozemski kot referenčni državi članici ter Avstriji, Belgiji, Češki republiki, Danski, Franciji, Nemčiji, Madžarski, Irski, Italiji, Poljski, Španiji in Združenem kraljestvu kot zadevnim državam članicam.
English: The referral procedure started on 11 July 2012.
Slovenian: Napotitveni postopek se je začel 11. julija 2012.
English: International non-proprietary name (INN): meloxicam
Slovenian: Mednarodno nelastniško ime (INN): meloksikam
English: Written explanations were provided by the applicant on 11 September 2012.
Slovenian: Predlagatelj je pisna pojasnila predložil 11. septembra 2012.
English: Veterinary Medicines and Product Data Management
Slovenian: Zdravila za uporabo v veterinarski medicini in upravljanje podatkov o zdravilih
English: Meloxicam is a Non-Steroidal Anti-Inflammatory Drug.
Slovenian: Meloksikam je nesteroidno protivnetno zdravilo.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amendments to the Summary of Product Characteristics, labelling and package leaflet in the Annex III.
Slovenian: Seznam zadevnih imen zdravila je na voljo v Prilogi I. Znanstveni zaključki so podani v Prilogi II, skupaj s spremembami povzetka glavnih značilnosti zdravila in navodila za uporabo v Prilogi III.
English: Potential serious risks were identified during the decentralised procedure by two concerned Member States, Ireland and the United Kingdom, regarding the bioequivalence for the target species pigs.
Slovenian: Med decentraliziranim postopkom sta dve zadevni državi članici, Irska in Združeno kraljestvo, opozorili na morebitna resna tveganja v zvezi z bioekvivalenco za ciljno vrsto prašiči.
English: Based on the evaluation of the currently available data, the CVMP considered that the particulars concerning the target species pigs that were submitted in support of the application do not comply with Article 13 of Directive 2001/82/EC, and consequently do not satisfy the criteria for authorisation in respect of safety and efficacy for the target species pigs.
Slovenian: Odbor CVMP je na podlagi ocene trenutno razpoložljivih podatkov menil, da podatki o ciljni vrsti prašiči, ki so bili posredovani v podporo vlogi, niso skladni s členom 13 Direktive 2011/82/ES in posledično ne izpolnjujejo meril za odobritev, kar zadeva varnost in učinkovitost za ciljno vrsto prašiči.
English: The active substance is included in veterinary medicinal products currently authorised in the European Union via the centralised authorisation procedure, as well as nationally, for use in cattle, pigs, horses, dogs and cats.
Slovenian: To zdravilno učinkovino vsebujejo zdravila za uporabo v veterinarski medicini, ki so trenutno v Evropski uniji odobrena tako po centraliziranem postopku pridobitve dovoljenja za promet kot po nacionalnih postopkih, in sicer za uporabo pri govedu, prašičih, konjih, psih in mačkah.
English: On 29 June 2012 the reference Member State, the Netherlands, notified to the European Medicines Agency that the CMD(v) had failed to reach an agreement regarding the product and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Slovenian: Referenčna država članica, Nizozemska, je 29. junija 2012 Evropsko agencijo za zdravila obvestila, da CMD(v) ni dosegla soglasja o zdravilu in da je v skladu s členom 33(4) Direktive 2001/82/ES zadevo napotila na odbor CVMP.
English: Therefore, the Committee adopted a negative opinion on 8 November 2012 recommending the refusal of the granting of the marketing authorisation for Melosolute 40 mg/ml solution for injection for the target species pigs.
Slovenian: Odbor je zato 8. novembra 2012 sprejel negativno mnenje in priporočil zavrnitev vloge za izdajo dovoljenja za promet za zdravilo Melosolute 40 mg/ml raztopina za injiciranje za ciljno vrsto prašiči.
English: On day 210, these issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started on 2 May 2012.
Slovenian: Ker ti pomisleki na 210. dan postopka še vedno niso bili rešeni, je bila zadeva 2. maja 2012 v skladu s členom 33(1) Direktive 2001/82/ES napotena na Usklajevalno skupino za postopek z medsebojnim priznavanjem in decentralizirani postopek (zdravila za uporabo v veterinarski medicini) (CMD(v)).
English: Day 60 of the CMD(v) procedure was on 29 June 2012, and since the Member States concerned failed to reach an agreement regarding the product the procedure was referred to the CVMP.
Slovenian: Na šestdeseti dan postopka CMD(v) dne 29. junija 2012 zadevne države članice niso dosegle soglasja o zdravilu, zato je bil postopek napoten na odbor CVMP.
English: This is a ‘hybrid' application according to Article 13(3) Directive 2001/82/EC, as amended, referring to the centrally authorised reference product Metacam 20 mg/ml solution for injection for cattle, pigs and horses (EU/2/97/004).
Slovenian: Gre za hibridno vlogo v skladu s členom 13(3) Direktive 2001/82/ES, kakor je bila spremenjena, pri čemer je referenčno zdravilo, odobreno po centraliziranem postopku, zdravilo Metacam 20 mg/ml raztopina za injiciranje za govedo, prašiče in konje (EU/2/97/004).
English: The applicant, CP-Pharma Handelsgesellschaft mbH, submitted an application for a decentralised procedure for Melosolute 40 mg/ml solution for injection for cattle, pigs and horses.
Slovenian: Predlagatelj, družba CP-Pharma Handelsgesellschaft mbH, je predložil vlogo za decentralizirani postopek za zdravilo Melosolute 40 mg/ml raztopina za injiciranje za govedo, prašiče in konje.
English: Melosolute 40 mg/ml solution for injection for cattle, pigs and horses contains meloxicam as active ingredient.
Slovenian: Zdravilo Melosolute 40 mg/ml raztopina za injiciranje za govedo, prašiče in konje vsebuje zdravilno učinkovino meloksikam.
English: Opinion following an Article 33(4)0F referral for Melosolute 40 mg/ml solution for injection for cattle, pigs and horses
Slovenian: Mnenje v zvezi z napotitvijo v skladu s členom 33(4)0F za zdravilo Melosolute 40 mg/ml raztopina za injiciranje za govedo, prašiče in konje
English: referral for Melosolute 40 mg/ml solution for injection for cattle, pigs and horses
Slovenian: za zdravilo Melosolute 40 mg/ml raztopina za injiciranje za govedo, prašiče in konje
English: Alar Irs (Estonia)
Slovenian: Alar Irs (Estonija)
English: Pieter de Graeff (The Netherlands)
Slovenian: Pieter de Graeff (Nizozemska)
English: ‘Essential' means that the hypertension has no obvious cause.
Slovenian: „Esencialna“ pomeni, da hipertenzija nima očitnega vzroka.
English: The areas harmonised include:
Slovenian: Usklajena so bila naslednja področja:
English: The companies that market these medicines are AstraZeneca and Takeda.
Slovenian: Družbi, ki dajeta ta zdravila v promet, sta AstraZeneca in Takeda.
English: Why was Atacand Plus reviewed?
Slovenian: Zakaj je bilo zdravilo Atacand Plus pregledano?
English: Atacand Plus is authorised in the EU via national procedures.
Slovenian: Zdravilo Atacand Plus je v EU odobreno z nacionalnimi postopki.
English: Dose titration is recommended.
Slovenian: Priporoča se titracija odmerka.
English: Atacand Plus is also available in the EU under other trade names: Atacand Plus Forte, Atacand Plus Mite, Atacand Zid, Blopresid, Blopress, Blopress Comp, Blopress Forte, Blopress Plus, CoKenzen, Hytacand, Parapres Comp, Parapres Comp Forte, Parapres Plus and Ratacand Plus.
Slovenian: Zdravilo Atacand Plus je na voljo v EU tudi pod drugimi imeni: Atacand Plus Forte, Atacand Plus Mite, Atacand Zid, Blopresid, Blopress, Blopress Comp, Blopress Forte, Blopress Plus, CoKenzen, Hytacand, Parapres Comp, Parapres Comp Forte, Parapres Plus in Ratacand Plus.
English: The European Commission issued a decision on 16 September 2010.
Slovenian: Evropska komisija je odločbo izdala dne 16. septembra 2010.Poročevalec:
English: It is used to treat essential hypertension (high blood pressure).
Slovenian: Uporablja se za zdravljenje esencialne hipertenzije (visokega krvnega tlaka).
English: The European Medicines Agency has completed a review of Atacand Plus and associated names.
Slovenian: Evropska agencija za zdravila je zaključila pregled zdravila Atacand Plus in povezanih imen.
English: 19 November 2009
Slovenian: 19. novembra 2009
English: This means that the doctor should try different tablet strengths until the strength that adequately controls the patient's blood pressure is found.
Slovenian: To pomeni, da mora zdravnik preskusiti tablete različne jakosti, dokler ne najde jakosti, ki ustrezno nadzoruje bolnikov krvni tlak.
English: The Committee also harmonised other sections of the SmPC including sections on special warnings, interactions with other medicines and pregnancy and lactation.
Slovenian: Odbor je uskladil tudi druga poglavja povzetka glavnih značilnosti zdravila, vključno s poglavji o posebnih opozorilih, medsebojnem delovanju z drugimi zdravili ter nosečnostjo in dojenjem.
English: It must also not be given to women in their second or third trimesters of pregnancy or to patients with severe kidney or liver problems, cholestasis (problems with the elimination of bile), gout (a painful inflammation of the joints) and hypokalaemia (low blood potassium levels) or hypercalcaemia (high blood calcium levels).
Slovenian: Prav tako se ne sme dajati ženskam v drugem ali tretjem tromesečju nosečnosti ali bolnikom s hudimi ledvičnimi ali jetrnimi težavami, holestazo (težavami z izločanjem žolča), protinom (bolečim vnetjem sklepov) in hipokaliemijo (nizko koncentracijo kalija v krvi) ali hiperkalciemijo (visoko koncentracijo kalcija v krvi).
English: 24 June 2010
Slovenian: 24. junija 2010
English: It works by increasing urine output, reducing the amount of fluid in the blood and reducing blood pressure.
Slovenian: Deluje s povečanjem izločanja seča, zmanjšanjem količine tekočine v krvi in znižanjem krvnega tlaka.
English: The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone.
Slovenian: Kombinacija obeh zdravilnih učinkovin ima aditiven učinek, kar pomeni, da zmanjšuje krvni tlak bolj kot vsako posamezno zdravilo.
English: Candesartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Slovenian: Kandesartan je „antagonist receptorja za angiotenzin II“, kar pomeni, da zavira delovanje hormona angiotenzin II v telesu.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Atacand Plus in the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je treba v Evropski uniji (EU) uskladiti podatke o predpisovanju zdravila Atacand Plus.
English: Atacand Plus must not be used in patients who are hypersensitive (allergic) to the active substances, any of the other ingredients or to substances derived from sulfonamide.
Slovenian: Zdravilo Atacand Plus se ne sme uporabljati pri bolnikih, ki so preobčutljivi za (alergični na) zdravilni učinkovini, katero koli drugo sestavino ali snov, izpeljano iz sulfonamida.
English: Atacand Plus should be taken at a dose of one tablet once a day.
Slovenian: Odmerek zdravila Atacand Plus je ena tableta na dan.
English: Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels).
Slovenian: Angiotenzin II je močan vazokonstriktor (snov, ki oži krvne žile).
English: Atacand Plus is a medicine that contains two active substances candesartan cilexetil and hydrochlorothiazide.
Slovenian: Atacand Plus je zdravilo, ki vsebuje zdravilni učinkovini kandesartan cileksetil in hidroklorotiazid.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Slovenian: To je v različnih državah članicah, kjer je zdravilo v prometu, privedlo do razhajanj glede uporabe zdravila, kot je razvidno iz povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo.
English: By blocking the receptors to which angiotensin II normally attaches, candesartan stops the hormone having an effect, allowing the blood vessels to widen and blood pressure to fall.
Slovenian: Kandesartan blokira receptorje, na katere se angiotenzin II običajno veže, s čimer preprečuje učinek hormona ter omogoča širjenje krvnih žil in zmanjšuje krvni tlak.
English: The CHMP recommended that Atacand Plus be used to treat essential hypertension in adults whose blood pressure is not optimally controlled by candesartan cilexetil or hydrochlorothiazide alone.
Slovenian: CHMP je priporočil, da se zdravilo Atacand Plus uporablja za zdravljenje esencialne hipertenzije pri odraslih bolnikih, ko samostojno zdravljenje s kandesartan cileksetilom ali hidroklorotiazidom ne uravnava krvnega tlaka optimalno.
English: On 27 October 2009, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Atacand Plus in the EU.
Slovenian: Da bi Evropska komisija uskladila dovoljenja za promet z zdravilom Atacand Plus v EU, je dne 27. oktobra 2009 zadevo napotila na CHMP.
English: Company responses provided on: 25 February 2010 Opinion date:
Slovenian: Odgovori družbe, poslani dne:
English: Hydrochlorothiazide is a diuretic, which is another type of treatment for hypertension.
Slovenian: Hidroklorotiazid je diuretik, ki je druga oblika zdravljenja visokega krvnega tlaka.
English: What is Atacand Plus?
Slovenian: Kaj je zdravilo Atacand Plus?
English: Atacand Plus was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Slovenian: Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila v humani medicini (CMD(h)) je ugotovila, da je za zdravilo Atacand Plus potrebno usklajevanje.
English: FI-02200 Espoo FINLAND
Slovenian: FI-02200 Espoo FINSKA
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13/04/2018
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 13/04/2018
English: The volume of one drop is approximately 27 µl.
Slovenian: Volumen ene kapljice je približno 27 µl.
English: Inform your veterinarian if your dog is given other medicines.
Slovenian: Obvestite svojega veterinarja, če vaš pes dobiva druga zdravila.
English: Ropinirole is rapidly distributed and has a relatively high apparent volume of distribution.
Slovenian: Ropinirol se hitro porazdeli in ima razmeroma velik navidezni volumen porazdelitve.
English: Extended vomiting (for more than 60 minutes) which should be evaluated by the responsible veterinarian as it might need appropriate treatment.
Slovenian: Dolgotrajno bruhanje (več kot 60 minut), ki ga mora oceniti odgovorni veterinar, saj bo morda potrebno ustrezno zdravljenje.
English: Very slightly yellow to yellow clear solution.
Slovenian: Zelo rahlo rumenkasta do rumena bistra raztopina.
English: Three dogs (3%) did not vomit at all despite an additional dose.
Slovenian: Trije psi (3 %) sploh niso bruhali kljub dodatnemu odmerku.
English: Please refer to sections 4.9 and 5.1 for further information.
Slovenian: Dodatne informacije so v poglavjih 4.9 in 5.1.
English: Pharmacotherapeutic group: Dopaminergic agents, dopamine agonists ATC vet code: QN04BC04
Slovenian: Farmakoterapevtska skupina: dopaminergiki, agonisti dopamina Oznaka ATC vet: QN04BC04
English: The fraction bound to plasma proteins in dogs is low (37%).
Slovenian: Frakcija, vezana na plazemske beljakovine, je pri psih majhna (37 %).
English: The systemic bioavailability of the drug by this ocular route of administration is 23%.
Slovenian: Sistemska biološka uporabnost zdravila je pri tej očesni poti uporabe 23 %.
English: pH 3.8-4.5 and osmolality 300-400 mOsm/kg.
Slovenian: Vrednost pH 3,8-4,5 in osmolalnost 300-400 mOsm/kg.
English: Each eye drop contains 810 µg of ropinirole.
Slovenian: Vsaka kapljica za oko vsebuje 810 µg ropinirola.
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 veterinarian.
Slovenian: Če opazite kakršne koli stranske učinke, tudi tiste, ki niso navedeni v tem navodilu za uporabo ali mislite, da zdravilo ni delovalo, obvestite svojega veterinarja.
English: See the detailed instructions for administration at the end of this leaflet.
Slovenian: Glejte podrobna navodila za dajanje zdravila na koncu tega navodila za uporabo.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label or carton after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na oznaki ali kartonasti škatli po „EXP“.
English: Based on the clinical trial results, most dogs are expected to respond to a single dose of the veterinary medicinal product; however, a small proportion of dogs will require a second dose to induce vomiting.
Slovenian: Na podlagi rezultatov kliničnih preskušanj se pričakuje, da se bo večina psov odzvala na posamezen odmerek zdravila za uporabo v veterinarski medicini; vendar bo pri majhnem deležu psov za sprožitev bruhanja potreben še drugi odmerek.
English: The efficacy of the veterinary medicinal product has not been established in dogs weighing less than 1.8 kg, or in dogs under 4.5 months of age or in elderly dogs.
Slovenian: Učinkovitost zdravila za uporabo v veterinarski medicini ni ugotovljena pri psih, lažjih od 1,8 kg, mlajših od 4,5 meseca, ali pri ostarelih psih.
English: Body surface area (m2)
Slovenian: Telesna površina (m2)
English: Ropinirole is a full dopamine agonist with high selectivity for the dopamine D2-like receptor family (D2, D3 and D4 receptors).
Slovenian: Ropinirol je polni dopaminski agonist z visoko selektivnostjo za receptorsko družino dopamina D2 (receptorji D2, D3 in D4).
English: The tolerance of this veterinary medicinal product has been tested in dogs up to 5 times the recommended dose.
Slovenian: Toleranco tega zdravila za uporabo v veterinarski medicini je bilo preskušeno pri psih do 5-kratnega priporočenega odmerka.
English: The time between the first to the last vomit was 0-108 minutes (0 if the dog vomited only once) with a mean duration of 23 minutes and a median duration of 16 minutes.
Slovenian: Čas med prvim in zadnjim bruhanjem je bil 0-108 minut (0, če je pes bruhal samo enkrat), s povprečnim trajanjem 23 minut in medianim trajanjem 16 minut.
English: Maropitant does not reverse the clinical signs related to the pharmacological action of ropinirole.
Slovenian: Maropitant ne odpravi kliničnih znakov, povezanih s farmakološkim delovanjem ropinirola.
English: Pack sizes: 1, 2, 3, 4, 5, 6, 8 and 10 single-dose containers.
Slovenian: Velikosti pakiranj: 1, 2, 3, 4, 5, 6, 8 in 10 enoodmernih vsebnikov.
English: This veterinary medicinal product may cause the following adverse reactions:
Slovenian: To zdravilo za uporabo v veterinarski medicini lahko povzroči naslednje neželene učinke:
English: The additional dose should be the same as the initial dose.
Slovenian: Dodatni odmerek mora biti enak začetnemu.
English: Biotransformation occurs by dealkylation, hydroxylation and subsequent conjugation with glucuronic acid or oxidation to carboxylic acid.
Slovenian: Biotransformacija poteka z dealkilacijo, hidroksilacijo in nadaljnjo konjugacijo z glukuronsko kislino ali oksidacijo v karboksilno kislino.
English: Number of eye drops
Slovenian: Število kapljic za oko
English: It is not recommended to administer further doses to these dogs.
Slovenian: Tem psom ni priporočljivo dajati nadaljnjih odmerkov.
English: Do not use in dogs with depression of the central nervous system, seizures or other marked neurologic impairments that could lead to aspiration pneumonia.
Slovenian: Ne uporabite pri psih z depresijo osrednjega živčevja, konvulzivnimi napadi ali drugimi izrazitimi nevrološkimi okvarami, ki bi lahko povzročile aspiracijsko pljučnico.
English: The portion recovered as unchanged ropinirole in the urine is below 3% within the first 24 hours.
Slovenian: Delež nespremenjenega ropinirola, izmerjen v prvih 24 urah v urinu, je manjši od 3 %.
English: Increased mean heart rate was observed one hour after treatment with all three doses (1X, 3X, 5X) and went back to normal levels after 6 hours.
Slovenian: Eno uro po zdravljenju so pri vseh treh odmerkih (1X, 3X, 5X) opazili povišan povprečni srčni utrip, ki se je po 6 urah vrnil na normalne ravni.
English: Do not use in dogs which are hypoxic, dyspnoeic or lacking pharyngeal reflexes.
Slovenian: Ne uporabite pri psih, ki imajo hipoksijo, dispnejo ali pomanjkanje faringealnih refleksov.
English: Symptoms of overdose consist of the same signs seen as adverse reactions.
Slovenian: Simptomi prevelikega odmerjanja zajemajo enake znake kot neželeni učinki.
English: A very small proportion of dogs may fail to respond to the treatment despite administration of a second dose.
Slovenian: Zelo majhen delež psov se ne odzove na zdravljenje niti po uporabi drugega odmerka.
English: Sodium hydroxide (to adjust pH) Hydrochloric acid (to adjust pH) Water for injections
Slovenian: Natrijev hidroksid (za uravnavanje vrednosti pH) Klorovodikova kislina (za uravnavanje vrednosti pH) Voda za injekcije
English: OPENING THE CONTAINER:
Slovenian: ODPRTJE VSEBNIKA:
English: Vomiting starts before the Cmax in plasma is reached; at 4-6 minutes in a pharmacokinetic study in dogs.
Slovenian: Bruhanje se začne, preden je dosežena koncentracija Cmax v plazmi; v študiji farmakokinetike pri psih se je začelo po 4-6 minutah.
English: 1 x 0.6 ml single-dose container 2 x 0.6 ml single-dose containers 3 x 0.6 ml single-dose containers 4 x 0.6 ml single-dose containers 5 x 0.6 ml single-dose containers 6 x 0.6 ml single-dose containers 8 x 0.6 ml single-dose containers 10 x 0.6 ml single-dose containers
Slovenian: 1 x 0,6 ml enoodmerni vsebnik 2 x 0,6 ml enoodmerna vsebnika 3 x 0,6 ml enoodmerna vsebnika 4 x 0,6 ml enoodmerni vsebniki 5 x 0,6 ml enoodmernih vsebnikov 6 x 0,6 ml enoodmernih vsebnikov 8 x 0,6 ml enoodmernih vsebnikov 10 x 0,6 ml enoodmernih vsebnikov
English: When a quantity of 2 to 4 drops is to be administered, the dose should be divided between both eyes.
Slovenian: Če je potrebna količina zdravila od 2 do 4 kapljice, je treba odmerek razdeliti med obe očesi.
English: It is recommended to record the time of first administration.
Slovenian: Priporočljivo je, da zapišete uro dajanja prvega odmerka.
English: These doses have been tested in dogs weighing between 1.8 kg and 100 kg (0.15-2.21 m2 body surface area).
Slovenian: Te odmerke so testirali pri psih, ki tehtajo med 1,8 in 100 kg (telesna površina 0,15-2,21 m2).
English: REPEATED DOSE:
Slovenian: PONOVITEV ODMERJANJA:
English: People with known hypersensitivity to ropinirole should avoid contact with the veterinary medicinal product.
Slovenian: Osebe z znano preobčutljivostjo na ropinirol naj se izogibajo stiku z zdravilom za uporabo v veterinarski medicini.
English: 5% of the dogs in the clinical study received anti-emetic treatment (metoclopramide) because their vomiting persisted for more than 60 minutes.
Slovenian: 5 % psov v klinični študiji je dobilo antiemetično zdravilo (metoklopramid), ker je bruhanje trajalo več kot 60 minut.
English: The pouch/pouches are then packed in a cardboard box together with the same number of package leaflets (intended for the animal owners) as the number of single-dose containers in the outer package.
Slovenian: Ena ali več vrečk je nato pakiranih v kartonasto škatlo skupaj s številom navodil za uporabo (namenjenih lastnikom živali), ki ustreza številu enoodmernih vsebnikov v zunanji embalaži.