FrancophonIA/ELRC3.0 huggingface dataset:
English: 1.75 m 85.75 kg 5 ' 8 ''
Slovenian: 1,75 m 85,75 kg 1,80 m 90,75 kg 1,85 m 95,75 kg 1,90 m 101 kg
English: 1.65 m 76.25 kg 5' 4''
Slovenian: 1,55 m 67,25 kg 1,60 m 71,75 kg 1,65 m 76,25 kg 1,70 m 81 kg
English: GlaxoSmithKline Consumer Healthcare s.a./n.v.
Slovenian: GlaxoSmithKline Consumer Healthcare S.p.A.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each chewable tablet contains 27 mg orlistat.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena žvečljiva tableta vsebuje 27 mg orlistata.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON SLEEVE
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA KARTONSKA ZGIBANKA
English: Marketing Authorisation Holder:
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Uporabno do:
English: Hepatobiliary disorders Not known
Slovenian: Bolezni imunskega sistema neznana
English: Oily spotting Flatus with discharge Faecal urgency Fatty oily stool Oily evacuation Flatulence
Slovenian: Neznana oljni madeži flatus z izcedkom nujno odvajanje blata mastno/oljnato blato oljnat izcedek flatulenca mehko blato bolečina v trebuhu inkontinenca blata tekoče blato povečana pogostnost odvajanja blata divertikulitis pankreatitis blaga krvavitev v predelu danke (glejte poglavje 4.4)
English: 6.4 Special precautions for storage
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Gastrointestinalni simptomi
English: Tell your doctor that you are taking alli when you have a blood test.
Slovenian: kot je varfarin Ob krvni preiskavi povejte zdravniku, da jemljete zdravilo alli.
English: - Anxiety.
Slovenian: - srčne bolezni
English: Adverse reaction
Slovenian: Hude alergijske reakcije
English: sodium laurilsulfate, talc.
Slovenian: (E1201), natrijev lavrilsulfat, smukec.
English: - Severe stomach pain caused by gallstones.
Slovenian: - bolečine v trebuhu
English: Cholelithiasis
Slovenian: Levotiroksin
English: Weight loss aid
Slovenian: SEZNAM POMOŽNIH SNOVI
English: You can also visit your country specific alli website for further information about the alli weight loss programme.
Slovenian: Za vse morebitne nadaljnje inforamcije o tem zdravilu ali o programu za izgubo telesne mase se lahko obrnete na spletno stran v vašem lokalnem jeziku.
English: The fat gram target chart follows the information below on setting your calorie target.
Slovenian: Preglednica Določitev ciljnih vrednosti števila gramov maščob sledi v nadaljevanju tega poglavja
English: Pancreatitis
Slovenian: Dojenje
English: These may affect more than 1 in 10 people - Wind (flatulence), with or without oily spotting.
Slovenian: - vetrovi (napenjanje) z ali brez oljnih madežev
English: Talk to your doctor or pharmacist when taking alli - If you are taking a medicine for high blood pressure as it may be necessary to adjust your dose.
Slovenian: Pogovorite se s svojim zdravnikom, ki bo morda moral prilagoditi odmerek vaših zdravil za zdravjenje sladkorne bolezni.
English: These final reports should be provided by April 2018 and November 2019, for the ongoing 300 L and 2000 L stability studies, respectively.
Slovenian: Ta končna poročila je treba predložiti do aprila 2018 in novembra 2019, za 300 l in 2000 l stabilnostne študije, ki so v teku.
English: ATC vet code: QD11AH91
Slovenian: Oznaka ATC vet: QD11AH91
English: In such cases appropriate treatment should be administered immediately.
Slovenian: V takih primerih je nemudoma potrebno ustrezno zdravljenje.
English: In those cases, withdraw the appropriate content from each required vial into the same syringe.
Slovenian: V teh primerih izvlecite ustrezno vsebino iz vsake viale v isto brizgo.
English: The recommended minimum dose is 1 mg/kg bodyweight, once a month.
Slovenian: Priporočen najmanjši odmerek je 1 mg / kg telesne mase, enkrat na mesec.
English: This is likely due to the highly targeted mechanism of action of lokivetmab in the context of a complex disease and heterogeneous pathogenesis.
Slovenian: To je verjetno posledica visoko ciljno usmerjenega mehanizma delovanja lokivetmaba v smislu kompleksnosti bolezni in heterogene patogeneze.
English: Do not use in dogs less than 3 kg bodyweight.
Slovenian: Ne uporabite pri psih, lažjih od 3 kg.
English: Treatment should be administered as needed.
Slovenian: Zdraviti je treba po potrebi.
English: It is not expected for this to cause any adverse effects, however, repeated self-administration may increase the risk of hypersensitivity reactions.
Slovenian: Ni pričakovati, da bi to povzročilo kakršne koli neželene učinke, vendar ponavljajoče samoinjiciranje lahko poveča tveganje za preobčutljivostne reakcije.
English: To allow for mixing of the solution, gently invert the syringe three or four times before administering.
Slovenian: Da bi omogočili mešanje raztopine, previdno obrnite brizgo trikrat ali štirikrat pred dajanjem.
English: A small number of dogs showed a low or an absence of clinical response to lokivetmab.
Slovenian: Manjše število psov je pokazalo nizek klinični odziv oziroma odsotnost kliničnega odziva na lokivetmab.
English: Secondary packaging: cardboard box.
Slovenian: Sekundarna ovojnina: kartonska škatla.
English: For dogs above 40 kg, the contents of more than one vial are required to administer a single dose.
Slovenian: Za pse nad 40 kg je za en odmerek potrebna vsebina več kot ene viale.
English: Accidental self-injection may result in an immune response to lokivetmab.
Slovenian: Nenamerno samoinjiciranje lahko povzroči imunski odziv na lokivetmab.
English: 601 Cornhusker Highway 68521 Lincoln, Nebraska UNITED STATES
Slovenian: 68521 Lincoln, Nebraska
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, vendar manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 žival od 10.000 zdravljenih živali, vključno s posameznimi primeri).
English: For the full list of excipients, see section 6.1.
Slovenian: Pomožne snovi: Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: The blocking of IL-31 by lokivetmab prevents IL-31 from binding to its co-receptor and thereby inhibits IL-31 mediated cell signalling, providing relief from Atopic Dermatitis-related pruritus and anti-inflammatory activity.
Slovenian: Blokiranje IL-31, ki ga izvaja lokivetmab, preprečuje vezavo IL-31 s svojimi koreceptorji in s tem zavira celično signalizacijo IL-31, ki zagotavlja olajšanje pri atopijskem dermatitisu, povezanim s srbenjem in protivnetnim delovanjem.
English: Agents for dermatitis, excluding corticosteroids.
Slovenian: Učinkovine za zdravljenje dermatitisa, razen kortikosteroidov.
English: In case of adverse clinical signs after an overdose the dog should be treated symptomatically.
Slovenian: V primeru neželenih kliničnih znakov po prevelikem odmerjanju je treba psa zdraviti simptomatsko.
English: Each vial of 1 ml contains:
Slovenian: Vsaka 1 ml viala vsebuje:
English: Do not use this veterinary medicinal product after the expiry date which stated on the label after EXP Shelf life after first opening the container: use immediately.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po EXP. Rok uporabnosti po prvem odpiranju vsebnika: uporabite takoj.
English: In field studies up to 9 months, treatment of dogs with atopic dermatitis was demonstrated to have a favourable effect on the reduction of pruritus and on the reduction of disease severity as evaluated by Canine Atopic Dermatitis Extent and Severity Index (CADESI) 03 scores.
Slovenian: V terenskih študijah do 9 mesecev se je pri zdravljenju psov z atopijskim dermatitisom pokazalo, da ima ugoden učinek na zmanjšanje srbenja in na zmanjšanje resnosti bolezni, kot jih ocenjuje indeks obsega in resnosti atopijskega dermatitisa pri psih (CADESI) 03.
English: Administer the entire contents (1 ml) of the vial.
Slovenian: Uporabite celotno vsebino (1 ml) viale.
English: The induction of such antibodies is uncommon and may have no effect (transient anti-drug antibodies) or may result in a noticeable decrease in efficacy (persistent anti-drug antibodies) in animals that responded to treatment previously.
Slovenian: Nastanek takih protiteles je redek in lahko nima nobenega učinka (prehodna protitelesa proti zdravilom) oziroma lahko povzroči opazno zmanjšanje učinkovitosti (obstojna protitelesa proti zdravilom) pri živalih, ki so se prej odzvale na zdravljenje.
English: The product should appear clear to opalescent without any visible particle.
Slovenian: Zdravilo je bistra do opalescentna raztopina brez vidnih delcev.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/17/205/001-012
Slovenian: ŠTEVILKA (E) DOVOLJENJ(A) ZA PROMET EU/2/17/205/001-012
English: Avoid excessive shaking.
Slovenian: Izogibajte se prekomernemu stresanju.
English: If the animal does not show a better response after a second dose, the veterinary surgeon should consider alternative treatments.
Slovenian: V primeru, da žival ne pokaže boljšega odziva po drugem odmerku, se mora veterinar odločiti za alternativna zdravljenja.
English: If no or limited response is obtained within one month after initial dosing, a second dose one month later may increase effectiveness.
Slovenian: Če v roku enega meseca po začetnem odmerjanju ni odziva na zdravljenje ali je le-ta omejen, bo do boljšega odziva prišlo po drugem odmerku, en mesec kasneje.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary No adverse reactions other than those mentioned in section 4.6 were observed in laboratory overdose studies.
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) V laboratorijskih študijah prevelikega odmerjanja zdravila niso opazili nobenih neželenih reakcij, razen tistih, ki so omenjene v poglavju 4.6.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25/04/2017
Slovenian: Datum pridobitve dovoljenja za promet: 25/04/2017.
English: EU/2/17/205/009 10 mg/ml 1 vial EU/2/17/205/001 10 mg/ml 2 vials EU/2/17/205/002 10 mg/ml 6 vials EU/2/17/205/010 20 mg/ml 1 vial EU/2/17/205/003 20 mg/ml 2 vials EU/2/17/205/004 20 mg/ml 6 vials EU/2/17/205/011 30 mg/ml 1 vial EU/2/17/205/005 30 mg/ml 2 vials EU/2/17/205/006 30 mg/ml 6 vials
Slovenian: EU/2/17/205/009 10 mg/ml 1 vial EU/2/17/205/001 10 mg/ml 2 viali EU/2/17/205/002 10 mg/ml 6 vial EU/2/17/205/010 20 mg/ml 1 vial EU/2/17/205/003 20 mg/ml 2 viali EU/2/17/205/004 20 mg/ml 6 vial EU/2/17/205/011 30 mg/ml 1 vial EU/2/17/205/005 30 mg/ml 2 viali EU/2/17/205/006 30 mg/ml 6 vial
English: Special warnings for each target species
Slovenian: Posebna opozorila za vsako ciljno živalsko vrsto:
English: EU/2/17/205/012 40 mg/ml 1 vial EU/2/17/205/007 40 mg/ml 2 vials EU/2/17/205/008 40 mg/ml 6 vials
Slovenian: EU/2/17/205/012 40 mg/ml 1 vial EU/2/17/205/007 40 mg/ml 2 viali EU/2/17/205/008 40 mg/ml 6 vial
English: Shelf life after first opening the immediate packaging: use immediately
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: uporabite takoj.
English: In a laboratory model study lokivetmab demonstrated an onset of efficacy for pruritus by the first time point at 8 hours post administration.
Slovenian: Laboratorijska modelska študija lokivetmaba je pokazala začetek učinkovitosti proti srbečici v prvi časovni točki 8 ur po dajanju.
English: It is recommended to monitor dogs for bacterial infections associated with atopic dermatitis, especially during the first weeks of treatment.
Slovenian: Priporočljivo je spremljati pse zaradi bakterijskih okužb, povezanih z atopijskim dermatitisom, zlasti v prvih tednih zdravljenja.
English: CYTOPOINT strength (mg) to be administered
Slovenian: Količina zdravila CYTOPOINT (mg) za odmerjanje
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Slovenian: V primeru nenamernega samoinjiciranja takoj poiščite zdravniško pomoč in zdravniku pokažite navodila za uporabo ali ovojnino.
English: Active substance stability: The applicant should complete the ongoing lokivetmab stability evaluation up to 36 months at the different batch sizes.
Slovenian: D. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM Stabilnost aktivne učinkovine: Predlagatelj mora zaključiti oceno stabilnosti lokivetmaba, ki je v teku, do 36 mesecev na različnih serijah.
English: Special precautions for use in animals
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih:
English: INDICATION(S) Treatment of clinical manifestations of atopic dermatitis in dogs.
Slovenian: INDIKACIJA(E) Zdravljenje klinično izraženega atopijskega dermatitisa pri psih.
English: Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Slovenian: Ne uporabite v primeru preobčutljivosti na učinkovino ali na katerokoli pomožno snov.
English: In cases of atopic dermatitis, it is recommended to investigate and treat complicating factors, such as bacterial, fungal or parasitic infections/infestations (e.g. flea and mange).
Slovenian: V primeru atopijskega dermatitisa je priporočljivo, da se razišče in zdravi dejavnike, ki povzročajo zaplete, kot so bakterijske, glivične ali parazitske okužbe/infestacije (npr. bolhe in garje).
English: 1348 Louvain-la-Neuve BELGIUM
Slovenian: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIJA
English: *Lokivetmab is a caninised monoclonal antibody expressed through recombinant techniques in Chinese hamster ovary (CHO) cells
Slovenian: *lokivetmab je pasje monoklonsko protitelo, izraženo z rekombinantnimi tehnikami pri celicah jajčnika kitajskega hrčka (CHO)
English: 4.2 Indications for use, specifying the target species Treatment of clinical manifestations of atopic dermatitis in dogs.
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Zdravljenje klinično izraženega atopijskega dermatitisa pri psih.
English: MANUFACTURER'S BATCH NUMBER
Slovenian: PROIZVAJALČEVA ŠTEVILKA SERIJE Lot {številka}
English: Lokivetmab is a caninised monoclonal antibody (mAb) specifically targeting canine interleukin-31.
Slovenian: Lokivetmab je pasje monoklonsko protitelo (mAb), ki izrecno deluje na pasji interlevkin-31.
English: If a vaccine(s) is to be administered at the same time as treatment with lokivetmab, the vaccine(s) should be administered at a different site to that of lokivetmab administration.
Slovenian: Če dajete cepivo(-a) istočasno kot poteka zdravljenje z lokivetmabom, ga (jih) morate dati na drugo mesto od tistega, kjer ste dali lokivetmab.
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Slovenian: NAVEDBA UČINKOVIN(E) IN DRUGEIH SESTAVIN
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Učinkovina(e):
English: Refer also to section 4.5 of the SPC.
Slovenian: Glejte tudi poglavje 4.5 povzetka glavnih značilnosti zdravila.
English: Avoid excessive shaking or foaming of the solution.
Slovenian: Izogibajte se pretiranemu tresenju in penjenju raztopine.
English: It is recommended to monitor dogs for bacterial infections, especially during the first weeks of treatment.
Slovenian: Priporočljivo je spremljati pse zaradi bakterijskih okužb povezanih z atopijskim dermatitisom, zlasti v prvih tednih zdravljenja.
English: Methionine
Slovenian: KARENCA
English: No adverse reactions other than those mentioned in section 6 were observed in laboratory overdose studies.
Slovenian: V laboratorijskih študijah prevelikega odmerjanja zdravila niso opazili nobenih neželenih reakcij, razen tistih, ki so omenjene v poglavju 6.
English: Vomiting and/or diarrhoea have been reported to occur in rare cases from spontaneous reports and may occur in connection with hypersensitivity reactions.
Slovenian: Na podlagi spontanih poročil so v redkih primerih poročali tudi o bruhanju in/ali driski, ki se lahko pojavijo v povezavi s preobčutljivostno reakcijo.
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
English: Name and address of the manufacturer of the biological active substance
Slovenian: Ime in naslov proizvajalca (proizvajalcev) biološke (bioloških) učinkovine ( učinkovin) Zoetis Inc.
English: Dosage and treatment schedule:
Slovenian: Odmerjanje in potek zdravljenja
English: Dog.
Slovenian: Pes.
English: Primary packaging: Single dose clear glass Type I vials with chlorobutyl rubber stopper.
Slovenian: Primarna ovojnina: en odmerek v prozorni viali iz stekla tipa I, z zamaškom iz klorobutilne gume.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Subcutaneous use.
Slovenian: ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE ZDRAVILA
English: Neurological signs (seizure, convulsion or ataxia) have been rarely observed in spontaneous reports following use of the veterinary medicinal product.
Slovenian: Na podlagi spontanih poročil so redko poročali o nevroloških znakih (epileptičnem napadu, konvulziji ali ataksiji) po uporabi zdravila.
English: 2 vials 1 vial
Slovenian: 1 viala 1 viala
English: No drug interactions were observed in field studies where lokivetmab was administered concomitantly with veterinary medicinal products such as endo- and ectoparasiticides, antimicrobials antiinflammatories and vaccines.
Slovenian: V terenskih študijah pri sočasni uporabi lokivetmaba in zdravili za uporabo v veterinarski medicini kot so endo- in ektoparaziti, protimikrobna in protivnetna zdravila ter cepiva, niso opazili nobenih medsebojnih interakcij.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE ( UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: Marketing authorisation holder and Manufacturer responsible for batch release:
Slovenian: Imetnik dovoljenja za promet z zdravilom in proizvajalec odgovoren za sproščanje serij:
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation; therefore its use is not recommended during pregnancy, lactation or in breeding dogs.
Slovenian: Varnost zdravila v obdobju brejosti in laktacije ni bila ugotovljena, zato uporaba v obdobju brejosti,
English: CARDBOARD BOX
Slovenian: PODATKI NA ZUNANJI OVOJNINI Kartonska škatla
English: Pharmacotherapeutic group: Other dermatological preparations.
Slovenian: IMUNOLOŠKE LASTNOSTI Farmakoterapevtska skupina: Druga zdravila za bolezni kože in podkožnega tkiva.
English: Histidine hydrochloride monohydrate Trehalose dihydrate Disodium edetate
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi histidin histidinijev klorid monohidrat trehaloza dihidrat dinatrijev edetat metionin polisorbat 80 voda za injekcije
English: Bodyweight (kg) of dog
Slovenian: Telesna masa (kg) psa 10 1 viala
English: Dose according to the dosing chart below.
Slovenian: Odmerjanje na podlagi spodnje tabele.
English: PACKAGE LEAFLET:
Slovenian: Odmerjanje na podlagi spodnje tabele:
English: 2 x 1 ml
Slovenian: 1 x 1 ml 2 x 1 ml
English: Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Slovenian: 4.3 Kontraindikacije Ne uporabite v primerih preobčutljivosti na učinkovino ali na katerokoli pomožno snov.
English: CYTOPOINT 10 mg solution for injection for dogs CYTOPOINT 20 mg solution for injection for dogs CYTOPOINT 30 mg solution for injection for dogs CYTOPOINT 40 mg solution for injection for dogs lokivetmab
Slovenian: CYTOPOINT 10 mg raztopina za injiciranje za pse CYTOPOINT 20 mg raztopina za injiciranje za pse CYTOPOINT 30 mg raztopina za injiciranje za pse CYTOPOINT 40 mg raztopina za injiciranje za pse lokivetmab
English: 1 vial 2 vials
Slovenian: 2 viali
English: CYTOPOINT 10 mg solution for injection for dogs CYTOPOINT 20 mg solution for injection for dogs CYTOPOINT 30 mg solution for injection for dogs CYTOPOINT 40 mg solution for injection for dogs
Slovenian: CYTOPOINT 10 mg raztopina za injiciranje za pse CYTOPOINT 20 mg raztopina za injiciranje za pse CYTOPOINT 30 mg raztopina za injiciranje za pse CYTOPOINT 40 mg raztopina za injiciranje za pse
English: Hypersensitivity reactions, including anaphylaxis, could potentially occur in the case of accidental self-injection.
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Preobčutljivostne reakcije, vključno z anafilakso, se lahko pojavijo v primeru nenamernega samoinjiciranja.
English: Active substance:
Slovenian: Subkutana uporaba.
English: Hypersensitivity reactions (anaphylaxis, facial oedema, urticaria) have been reported to occur in rare cases from spontaneous reports.
Slovenian: Na podlagi spontanih poročil so v redkih primerih poročali o preobčutljivostnih reakcijah (anafilaksiji, obraznem edemu, urtikariji).
English: Lokivetmab may induce transient or persistent anti-drug antibodies.
Slovenian: Zdravilo lahko povzroči nastanek prehodnih ali obstojnih protiteles proti zdravilom.
English: Name and address of the manufacturer responsible for batch release
Slovenian: ZDRUŽENE DRŽAVE AMERIKE Ime in naslov proizvajalca (proizvajalcev) zdravila, odgovornega (odgovornih) za sproščanje serij
English: 4.6 Adverse reactions (frequency and seriousness)
Slovenian: 4.6 Neželeni učinki (pogostost in resnost) Na podlagi spontanih poročil so v redkih primerih poročali o preobčutljivostnih reakcijah
English: WITHDRAWAL PERIOD(S)
Slovenian: INDIKACIJA(E)
English: 4.9 Amounts to be administered and administration route Subcutaneous use.
Slovenian: 4.9 Odmerjanje in pot uporabe
English: CYTOPOINT 30 mg solution for injection for dogs: Cardboard box with 1 vial of 1 ml Cardboard box with 2 vials of 1 ml Cardboard box with 6 vials of 1 ml
Slovenian: CYTOPOINT 30 mg raztopina za injiciranje za pse: Kartonska škatla z 1 vialo po 1 ml Kartonska škatla z 2 vialama po 1 ml Kartonska škatla s 6 vialami po 1 ml
English: CYTOPOINT 20 mg solution for injection for dogs: Cardboard box with 1 vial of 1 ml Cardboard box with 2 vials of 1 ml Cardboard box with 6 vials of 1 ml
Slovenian: CYTOPOINT 20 mg raztopina za injiciranje za pse: Kartonska škatla z 1 vialo po 1 ml Kartonska škatla z 2 vialama po 1 ml
English: Zoetis Inc.
Slovenian: Rp-Vet.
English: CYTOPOINT 40 mg solution for injection for dogs: Cardboard box with 1 vial of 1 ml Cardboard box with 2 vials of 1 ml Cardboard box with 6 vials of 1 ml
Slovenian: CYTOPOINT 40 mg raztopina za injiciranje za pse: Kartonska škatla z 1 vialo po 1 ml Kartonska škatla z 2 vialama po 1 ml
English: CYTOPOINT 10 mg solution for injection for dogs: Cardboard box with 1 vial of 1 ml Cardboard box with 2 vials of 1 ml Cardboard box with 6 vials of 1 ml
Slovenian: CYTOPOINT 10 mg raztopina za injiciranje za pse: Kartonska škatla z 1 vialo po 1 ml Kartonska škatla z 2 vialama po 1 ml
English: The relevance of these findings to humans is unknown.
Slovenian: Pomen teh ugotovitev za človeka ni znan.
English: Date of first authorisation: 05 July 2010 Date of latest renewal: 24 April 2015
Slovenian: Datum prve odobritve: 05. julij 2010 Datum zadnjega podaljšanja: 24. april 2015
English: None of these changes were considered to be clinically meaningful.
Slovenian: Nobena od teh sprememb ni bila prepoznana kot klinično pomembna.
English: The majority of these adverse reactions were mild or moderate.
Slovenian: Večina teh neželenih učinkov je bila blagih ali zmernih.
English: Swallow the tablet with some water.
Slovenian: Tableto pogoltnite z nekaj vode.