FrancophonIA/ELRC3.0 huggingface dataset:
English: Marketing authorisation holder and manufacturer responsible for batch release:
Slovenian: Imetnik dovoljenja za promet z zdravilom in proizvajalec, odgovoren za sproščanje serij:
English: PACKAGE LEAFLET: Porcilis PCV M Hyo emulsion for injection for pigs
Slovenian: NAVODILO ZA UPORABO: Porcilis PCV M Hyo emulzija za injiciranje za prašiče
English: Porcine circovirus type 2 (PCV2) ORF2 subunit antigen ≥ 2,828 AU1 Mycoplasma hyopneumoniae J strain inactivated
Slovenian: Učinkovine: cirkovirus prašičev, tip 2 (PCV2), antigenska podenota ORF2 ≥ 2,828 AU1
English: Onset of immunity with two dose vaccination:
Slovenian: Nastop imunosti po shemi cepljenja z dvema odmerkoma:
English: M. hyopneumoniae: 3 weeks after the second vaccination.
Slovenian: M. hyopneumoniae: 3 tedne po drugem cepljenju.
English: The product literature of Porcilis PRRS should be consulted.
Slovenian: Ob sočasni uporabi upoštevajte tudi navodilo za uporabo Porcilis PRRS.
English: In individual pigs the temperature increase after associated use may commonly exceed 2°C.
Slovenian: Pri posameznih prašičih se lahko telesna temperatura po običajni uporabi poviša za več kot 2 ° C. Temperatura se normalizira v 1 do 2 dneh po opaženi najvišji temperaturi.
English: IM
Slovenian: i.m.
English: 4.4 Special warnings for each target species
Slovenian: 4.4 Posebna opozorila za vsako ciljno živalsko vrsto Cepite samo zdrave živali.
English: PCV2 ORF2 subunit antigen ≥ 2,828 AU M. hyopneumoniae inac.
Slovenian: KOLIČINA UČINKOVIN(E) PCV2, antigenska podenota ORF2 ≥ 2828 AU,
English: Single dose vaccination schedule:
Slovenian: Shema cepljenja z enim odmerkom:
English: SPAIN
Slovenian: NIZOZEMSKA
English: Duration of immunity (both vaccination schedules): PCV2: 22 weeks after (the last) vaccination.
Slovenian: PCV2: 22 tednov po (zadnjem) cepljenju.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: Further information on Nerlynx can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije o zdravilu Nerlynx so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The recommended dose is 6 tablets (240 mg) once a day with food, preferably in the morning.
Slovenian: Priporočeni odmerek je šest tablet (240 mg) enkrat na dan s hrano, najbolje zjutraj.
English: It is given following treatment with trastuzumab (another medicine used for the same purpose).
Slovenian: Daje se po zdravljenju s trastuzumabom (drugim zdravilom, ki se uporablja za enak namen).
English: The medicine is available as tablets (40 mg).
Slovenian: Zdravilo je na voljo v obliki tablet (40 mg).
English: Treatment should be started within a year of finishing treatment with trastuzumab, and is given for 1 year.
Slovenian: Zdravljenje je treba začeti v enem letu po koncu zdravljenja s trastuzumabom in traja eno leto.
English: What measures are being taken to ensure the safe and effective use of Nerlynx?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Nerlynx?
English: The Agency therefore decided that Nerlynx's benefits are greater than its risks in this group and it can be authorised for use in the EU.
Slovenian: Agencija je zato zaključila, da so koristi zdravila Nerlynx večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Other information about Nerlynx
Slovenian: Druge informacije o zdravilu Nerlynx
English: As for all medicines, data on the use of Nerlynx are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Nerlynx stalno spremljajo.
English: Other common side effects (which may affect more than 1 in 10 people) are nausea (feeling sick), vomiting, tiredness, belly pain, rash, decreased appetite, stomatitis (sore, inflamed mouth), and muscle spasms.
Slovenian: Drugi pogosti neželeni učinki (ki se lahko pojavijo pri več kot 1 bolnici od 10) so navzeja (slabost), bruhanje, utrujenost, bolečine v trebuhu, izpuščaj, zmanjšan tek, stomatitis (boleča, vneta usta) in mišični krči.
English: An overview of Nerlynx and why it is authorised in the EU
Slovenian: Pregled zdravila Nerlynx in zakaj je odobreno v EU
English: The doctor may also modify the dose if Nerlynx is given with certain other medicines.
Slovenian: Zdravnik lahko odmerek spremeni tudi, če se zdravilo Nerlynx daje skupaj z nekaterimi drugimi zdravili.
English: What benefits of Nerlynx have been shown in studies?
Slovenian: Kakšne koristi zdravila Nerlynx so se pokazale v študijah?
English: It is intended for use only in breast cancers that produce high levels of a protein called HER2, which helps cells to divide and grow (HER2-positive breast cancer), and that also have receptors (targets) for the female sex hormones (hormone-receptor positive breast cancer).
Slovenian: Namenjeno je samo za zdravljenje raka dojke, ki tvori visoko raven beljakovine, imenovane HER2, ki pomaga celicam pri delitvi in rasti (HER2-pozitiven rak dojke), in ima tudi receptorje (tarče) za ženske spolne hormone (za hormonske receptorje pozitiven rak dojke).
English: Because HER2 helps cancer cells to grow and divide, blocking it helps to stop these cells growing and prevents the cancer from coming back.
Slovenian: Ker HER2 rakavim celicam pomaga pri rasti in delitvi, njeno zaviranje ustavi rast teh celic in prepreči ponovitev raka.
English: Side effects reported with Nerlynx are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Nerlynx, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Why is Nerlynx authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Nerlynx odobreno v EU?
English: The most common serious side effects are diarrhoea and vomiting.
Slovenian: Najpogostejša resna neželena učinka sta driska in bruhanje.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nerlynx have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Nerlynx upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Nerlynx has been shown to be more effective than placebo (a dummy treatment) at preventing the cancer from coming back in one main study involving 2,840 women with HER2-positive early breast cancer who had already received trastuzumab.
Slovenian: Zdravilo Nerlynx se je pokazalo kot učinkovitejše od placeba (zdravila brez učinkovine) pri preprečevanju ponovitve raka v eni glavni študiji, v katero je bilo vključenih 2 840 žensk s HER2-pozitivnim zgodnjim rakom dojke, ki so že prejemale trastuzumab.
English: It attaches to the HER2 protein on the cancer cells, and so blocks its action.
Slovenian: Veže se na beljakovino HER2 na rakavih celicah in tako zavira njeno delovanje.
English: Although the side effects, particularly diarrhoea, can be severe and lead to treatment being stopped, there would be patients with HER2-positive, hormone-receptor positive early breast cancer for whom treatment with Nerlynx after surgery and trastuzumab would be a reasonable option.
Slovenian: Čeprav so lahko neželeni učinki, zlasti driska, hudi in zahtevajo ustavitev zdravljenja, bi bilo pri nekaterih bolnicah s HER2-pozitivnim, za hormonske receptorje pozitivnim zgodnjim rakom dojke zdravljenje z zdravilom Nerlynx po kirurškem posegu in zdravljenju s trastuzumabom smiselno.
English: When only women with hormone-receptor positive cancer were considered, about 95% of those given Nerlynx lived another year without the cancer coming back versus 91% of those given placebo.
Slovenian: Če bi upoštevali samo ženske z rakom, pozitivnim za hormonske receptorje, jih je 95 % tistih, ki so prejemale zdravilo Nerlynx, brez ponovitve raka živelo še eno leto, v primerjavi z 91 % tistih, ki so prejemale placebo.
English: What are the risks associated with Nerlynx?
Slovenian: Kakšna tveganja so povezana z zdravilom Nerlynx?
English: The European Medicines Agency considered that Nerlynx had been shown to be of benefit in women with HER2-positive early breast cancer, and that this benefit seemed to be mainly in women with hormone-receptor positive disease.
Slovenian: Evropska agencija za zdravila je presodila, da je zdravilo Nerlynx dokazano koristno pri ženskah s HER2-pozitivnim zgodnjim rakom dojke, to korist pa je bilo opaziti predvsem pri ženskah z boleznijo, pozitivno za hormonske receptorje.
English: For more information about using Nerlynx, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Nerlynx glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: What is Nerlynx and what is it used for?
Slovenian: Kaj je zdravilo Nerlynx in za kaj se uporablja?
English: It must also not be used with certain medicines that affect the way Nerlynx is broken down in the body.
Slovenian: Prav tako se ne sme uporabljati skupaj z nekaterimi drugimi zdravili, ki vplivajo na presnovo zdravila Nerlynx v telesu.
English: The company that markets Nerlynx will provide a guide for healthcare professionals who prescribe or dispense the medicine, and educational material for patients and carers.
Slovenian: Podjetje, ki trži zdravilo Nerlynx, bo zagotovilo vodnik za zdravstvene delavce, ki predpisujejo ali razdeljujejo to zdravilo, ter izobraževalno gradivo za bolnike in negovalce.
English: The active substance in Nerlynx, neratinib, is a type of cancer medicine called a tyrosine kinase inhibitor.
Slovenian: Učinkovina zdravila Nerlynx, neratinib, je vrsta zdravila za zdravljenje raka, imenovana zaviralec tirozin-kinaze.
English: Around 94% of the women given a year's treatment with Nerlynx lived for 1 further year after stopping Nerlynx without their cancer coming back versus 92% of those given placebo.
Slovenian: Približno 94 % žensk, ki so zdravilo Nerlynx prejemale eno leto, je po prenehanju zdravljenja s tem zdravilom brez ponovitve raka živelo še eno leto, v primerjavi z 92 % žensk, ki so prejemale placebo.
English: These materials will explain the effects of Nerlynx on the gut, such as diarrhoea, and how to manage them, and will give advice on the need for patients to tell their healthcare professionals of side effects.
Slovenian: V tem gradivu bodo razloženi učinki zdravila Nerlynx na črevo, kot je na primer driska, ter napotki za njihovo obvladovanje, gradivo pa bo vsebovalo tudi navodilo, da naj bolniki o neželenih učinkih obvestijo zdravstvene delavce.
English: Nerlynx is a breast cancer medicine used to reduce the risk of the disease coming back in patients with early breast cancer who have had surgery.
Slovenian: Nerlynx je zdravilo za zdravljenje raka dojke, ki se uporablja za zmanjševanje tveganja ponovitve bolezni pri bolnicah z zgodnjim rakom dojke po kirurškem posegu.
English: The most common side effect with Nerlynx is diarrhoea, which affects nearly all patients.
Slovenian: Najpogostejši neželeni učinek zdravila Nerlynx je driska; pojavi se pri skoraj vseh bolnicah.
English: Nerlynx must not be used in patients with severely reduced liver function.
Slovenian: Zdravila Nerlynx ne smejo uporabljati bolnice s hudo okvaro delovanja jeter.
English: Nerlynx treatment should be started and supervised by a doctor experienced in giving cancer medicines and can only be obtained with a prescription.
Slovenian: Zdravljenje mora uvesti in nadzorovati zdravnik, ki ima izkušnje z dajanjem zdravil za zdravljenje raka, predpisovanje in izdaja zdravila pa je le na recept.
English: How is Nerlynx used?
Slovenian: Kako se zdravilo Nerlynx uporablja?
English: For the full list of side effects of Nerlynx, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Nerlynx, glejte navodilo za uporabo.
English: The doctor may reduce the dose or stop treatment if a patient has severe side effects, including diarrhoea.
Slovenian: Če ima bolnica hude neželene učinke, vključno z drisko, lahko zdravnik zmanjša odmerek ali ustavi zdravljenje.
English: Patients are given treatment to prevent diarrhoea when starting Nerlynx.
Slovenian: Bolnice ob začetku jemanja zdravila Nerlynx prejmejo zdravljenje za preprečevanje driske.
English: How does Nerlynx work?
Slovenian: Kako zdravilo Nerlynx deluje?
English: Target species
Slovenian: Ciljna živalsk a vrsta
English: Package size Withdrawal period
Slovenian: Vsebina Velikost pakiranja
English: Lyophilisate: vial (glass); Solvent: vial (PET)
Slovenian: Liofilizat: viala (steklena) Topilo: viala (PET)
English: Content
Slovenian: Jakost
English: EU (MA) number Invented name
Slovenian: Izmišljeno ime
English: Lyophilisate: 5 vials; Solvent: 5 vials
Slovenian: Liofilizat: 50 odmerkov + Solvent: 10 ml
English: Annex A
Slovenian: EMEA številka
English: --1 Live myxoma vectored RHD virus strain 009: ≥103.0 and ≤106.1 FFU* *Focus Forming Units
Slovenian: Liofilizat:50 odmerkov + topilo: 50 ml
English: 56 tablets (multipack)
Slovenian: 56 tablet (večkratno pakiranje)
English: MA(EU) Number
Slovenian: Številka (EU) dovoljenja za promet
English: Blister (PVC/PE/PCTFE/ALU)
Slovenian: 250 mg filmsko obložena tableta peroralna uporaba pretisni omot (PVC/PE/PCTFE/ALU)
English: Strength Pharmaceutical Form
Slovenian: (Izmišljeno) ime Jakost Farmacevtska oblika
English: The application was withdrawn after ‘day 181'.
Slovenian: Vlogo je bila umaknjena po „181.
English: FEV1 is the most air a person can breathe out in one second.
Slovenian: FEV1 je največja količina zraka, ki jo lahko posameznik izdiha v eni sekundi.
English: The main measures of effectiveness in the studies were based on the change in FEV1 after 12 weeks.
Slovenian: Glavno merilo učinkovitosti v teh študijah je bila sprememba FEV1 po 12 tednih.
English: Formoterol is a long-acting beta-2 agonist.
Slovenian: Formoterol je dolgo delujoči beta-2-agonist.
English: The letter from the company notifying the Agency of the withdrawal of the application is available under the tab ‘All documents'.
Slovenian: Dopis, s katerim družba agencijo obvešča o umiku vloge, je na voljo v rubriki „All documents“.
English: This means that the CHMP had evaluated the documentation provided by the company and formulated a list of questions.
Slovenian: To pomeni, da je CHMP ocenil dokumentacijo, ki jo je predložila družba, in pripravil seznam vprašanj.
English: Both formoterol and mometasone have been available in the European Union for the maintenance treatment of asthma for a number of years.
Slovenian: Formoterol in mometazon sta v Evropski uniji za vzdrževalno zdravljenje astme na voljo že vrsto let.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Slovenian: Kakšne so posledice tega umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe?
English: The effects of Zenhale were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Zenhale so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: Two studies also looked at the how long it took before the patients had their first severe exacerbation.
Slovenian: V dveh študijah so pri bolnikih opazovali tudi časovno obdobje do prvega hujšega poslabšanja.
English: Mometasone is a corticosteroid with anti-inflammatory effects.
Slovenian: Mometazon je kortikosteroid s protivnetnimi učinki.
English: On 5 November, Schering-Plough Europe officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zenhale, for the maintenance treatment of asthma.
Slovenian: Družba Schering-Plough Europe je dne 5. novembra 2010 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Zenhale, ki je namenjeno vzdrževalnemu zdravljenju astme.
English: Following a routine inspection of study sites, the CHMP had concerns over the way the studies were conducted in some sites, which cast doubt on the reliability of the results.
Slovenian: Po rednem inšpekcijskem pregledu mest študij je CHMP izrazil zadržke glede načina izvajanja študij na nekaterih mestih, zaradi česar bi bila lahko zanesljivost rezultatov dvomljiva.
English: The company informed the CHMP that this withdrawal does not have any consequences for patients in ongoing trials or on compassionate use programmes.
Slovenian: Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v preskušanjih ali v programih sočutne uporabe.
English: After the CHMP had assessed the company's responses to the last round of questions, there were still unresolved issues.
Slovenian: Potem ko je CHMP ocenil odgovore družbe na zadnja vprašanja, so nekatera vprašanja še vedno ostala nerešena.
English: The CHMP also had concerns with one of the comparator medicines, mometasone furoate, which was not in an approved formulation.
Slovenian: CHMP je prav tako izrazil zadržke glede primerjalnega zdravila, mometazon furoata, ki ni bilo v odobreni formulaciji.
English: The company was asked to provide further data to justify the use of that comparator, specifically to show how mometasone furoate in the comparator was released in the body compared with the approved mometasone furoate.
Slovenian: Družbo so prosili, da zagotovi dodatne podatke, ki bi utemeljili uporabo tega primerjalnega zdravila, in predvsem prikaže, kako se v telesu sprošča mometazon furoat v primerjalnem zdravilu v primerjavi z odobrenim mometazon furoatom.
English: What is Zenhale?
Slovenian: Kaj je zdravilo Zenhale?
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Zenhale could not have been approved for the maintenance treatment of asthma.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da zdravila Zenhale ni mogoče odobriti za vzdrževalno zdravljenje astme.
English: It works by attaching to beta-2 receptors that are found in the muscle cells of many organs and that cause the muscles to relax.
Slovenian: Deluje tako, da se veže na receptorje beta 2, ki so prisotni v mišičnih celicah več organov in povzročajo sproščanje mišic.
English: Zenhale was expected to be used in adults and adolescents aged 12 years and older as a maintenance treatment for asthma, including for reducing exacerbations (where asthma gets worse, requiring rescue treatment with other medicines).
Slovenian: Zdravilo Zenhale naj bi se uporabljalo pri odraslih in mladostnikih, starih 12 let in več, za vzdrževalno zdravljenje astme, vključno z zmanjševanjem možnosti poslabšanja (kadar se astma tako poslabša, da je potrebno reševalno zdravljenje z drugimi zdravili).
English: It was to be available as a suspension for inhalation in a metered-dose inhaler.
Slovenian: Na voljo naj bi bilo kot suspenzija za vdihavanje z inhalatorjem z odmernim ventilom.
English: When inhaled, it causes the muscles of the airways to relax, helping to keep the airways open and allowing the patient to breathe more easily.
Slovenian: Pri inhaliranju povzroča sproščanje mišic dihalnih poti, s čimer pomaga, da dihalne poti ostanejo odprte, kar bolnikom omogoča lažje dihanje.
English: There were four main studies involving a total of 2,977 adults and adolescents who had been receiving treatment with inhaled corticosteroids or a combination of inhaled corticosteroid and a long-acting beta-2 agonist.
Slovenian: Izvedene so bile štiri glavne študije, v katerih je sodelovalo 2 977 odraslih in mladostnikov, ki so se zdravili z inhalacijskimi kortikosteroidi ali s kombinacijo inhalacijskega kortikosteroida in dolgo delujočega beta-2-agonista.
English: When inhaled, it relieves the symptoms of asthma by blocking the release from white blood cells of substances that are involved in inflammatory reactions in the airways.
Slovenian: Pri vdihavanju blaži simptome astme, tako da zavira sproščanje snovi iz belih krvnih celic, ki vplivajo na vnetne reakcije v dihalnih poteh.
English: The patients were treated with one of the following: Zenhale, mometasone furoate alone, formoterol fumarate alone, an asthma medicine containing fluticasone propionate and salmeterol (another combination of a steroid and a long-acting bronchodilator used in asthma), or placebo (a dummy treatment).
Slovenian: Bolniki so prejemali eno izmed naslednjih terapij: zdravilo Zenhale, samostojno zdravljenje z mometazon furoatom, samostojno zdravljenje s formoterol fumaratom, zdravilo za astmo, ki vsebuje flutikazon propionat in salmeterol (drugačna kombinacija steroida in dolgo delujočega bronhodilatorja, ki se uporablja pri astmi) ali placebo (zdravilo brez zdravilne učinkovine).
English: It was developed for use in patients whose asthma was not adequately controlled by an inhaled corticosteroid used, when needed, with an inhaled short-acting ‘beta-2 agonist' (a bronchodilator, a medicine that widens the airways in the lungs).
Slovenian: Razvito je bilo za uporabo pri bolnikih, pri katerih ni mogoče doseči zadostnega nadzora astme z inhalacijskim kortikosteroidom, ki se po potrebi uporablja z inhalacijskim kratko delujočim „beta-2agonistom“ (bronhodilator, zdravilo, ki širi dihalne poti v pljučih).
English: Zenhale is a medicine that contains the active substances mometasone furoate and formoterol fumarate.
Slovenian: Zenhale je zdravilo, ki vsebuje zdravilni učinkovini mometazon furoat in formoterol fumarat.
English: It was also expected to be used in patients whose asthma was already controlled with both an inhaled corticosteroid and a long-acting beta-2 agonist.
Slovenian: Zdravilo naj bi se uporabljalo tudi pri bolnikih, pri katerih je astma že nadzorovana z inhalacijskim kortikosteroidom in dolgo delujočim beta2-agonistom.
English: What was Zenhale expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Zenhale uporabljalo?
English: How is Zenhale expected to work?
Slovenian: Kako naj bi zdravilo Zenhale delovalo?
English: Use within 24 hours.
Slovenian: Uporabite v 24 urah.
English: It is eliminated from the plasma in 5-7 days.
Slovenian: Iz plazme se izloči po 5-7 dneh.
English: DATE OF REVISION OF THE TEXT
Slovenian: 10 DATUM REVIZIJE BESEDILA
English: Do not store above 30 °C.
Slovenian: Ne shranjujte pri temperaturi nad 30 °C.
English: 125 ml - 5years
Slovenian: 125 ml - 5 leta
English: <EXP {month/year}>
Slovenian: <EXP {mesec/leto}>
English: Date of first authorisation: 29/11/1999 Date of last renewal: 01/10/2009
Slovenian: Datum pridobitve dovoljenja za promet: 29/11/1999 Datum zadnjega podaljšanja dovoljenja za promet: 01/10/2009
English: Do not overheat.
Slovenian: Ne pregrevajte ga.
English: Haematology: No interference.
Slovenian: Hematologija: Ni vpliva.
English: For a full list of excipients, see section 6.1.
Slovenian: Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
English: (Contact the distributor for specific data.)
Slovenian: (Kar zadeva posebne podatke, se obrnite na distributerja.)
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 so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/
English: If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Slovenian: Če opazite kakršne koli resne stranske učinke ali druge učinke, ki niso omenjeni v teh navodilih za uporabo, obvestite svojega veterinarja.
English: (See Table A Pharmacokinetic Parameters)
Slovenian: (Glej Preglednico A Farmakokinetični parametri.)
English: None known.
Slovenian: Niso znane