FrancophonIA/ELRC3.0 huggingface dataset:
English: Luxembourg/Luxemburg Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Croatian: Luxembourg/Luxemburg Chanelle Pharmaceuticals Manufacturing Ltd.
English: Selamectin 120 mg
Croatian: 120 mg
English: Chanhold 45 mg for cats
Croatian: Chanhold 45 mg za mačke
English: Through a reduction in the flea population, monthly treatment of pregnant and lactating animals will aid prevention of flea infestation in the litter up to seven weeks of age.
Croatian: Primjena otopine jednom mjesečno kod skotnih životinja ili životinja u laktaciji može kroz smanjenje populacije buha pomoći u prevenciji infestacije buhama u leglu do sedam tjedana starosti.
English: Chanelle Pharmaceuticals Manufacturing Ltd, Loughrea,
Croatian: Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co.
English: • Treatment and prevention of flea infestations caused by Ctenocephalides spp.
Croatian: • Liječenje i prevencija infestacija buhama uzrokovanih s Ctenocephalides spp. tijekom mjesec dana nakon jednokratne primjene.
English: CARTON, 30 mg, 60 mg, 120 mg, 240 mg, 360 mg for dogs
Croatian: KARTONSKA KUTIJA, 30 mg, 60 mg, 120 mg, 240 mg, 360 mg za pse
English: 15 mg selamectin 30 mg selamectin 45 mg selamectin 60 mg selamectin 120 mg selamectin 240 mg selamectin 360 mg selamectin
Croatian: 15 mg selamektina 30 mg selamektina 45 mg selamektina 60 mg selamektina 120 mg selamektina 240 mg selamektina 360 mg selamektina
English: Chanhold 15 mg spot-on solution for cats and dogs ≤ 2.5 kg selamectin
Croatian: Chanhold 15 mg otopina za nakapavanje na kožu za mačke i pse ≤ 2,5 kg selamektin
English: Selamectin 360 mg
Croatian: 360 mg
English: Flea treatment and prevention (cats and dogs)
Croatian: Terapija protiv buha i prevencija buha (kod mačaka i pasa)
English: Following spot on administration selamectin is absorbed from the skin reaching maximum plasma concentrations approximately 1 and 3 days after administration in cats and dogs respectively.
Croatian: Nakon topikalne primjene selamektin se transdermalno resorbira i postiže vršnu koncentraciju u plazmi približno jedan dan nakon primjene na mačkama i približno tri dana nakon primjene na psima.
English: Selamectin 60 mg
Croatian: 60 mg
English: FOIL LABEL/SACHET FOIL, 15 mg, 30 mg, 45 mg, 60 mg, 120 mg, 240 mg, 360 mg
Croatian: NALJEPNICA ZA FOLIJU / VREĆICU, 15 mg, 30 mg, 45 mg, 60 mg, 120 mg, 240 mg, 360 mg
English: Selamectin 240 mg
Croatian: 240 mg
English: ≤ 2.5 1 pipette of Chanhold 15 mg for cats and dogs ≤ 2.5 kg
Croatian: 1 pipeta Chanholda 15 mg za mačke i pse ≤ 2,5 kg
English: Selamectin was administered at 3 times the recommended dose to cats and dogs infected with adult heartworms and no undesirable effects were observed.
Croatian: Veterinarsko- medicinski proizvod je primijenjen u trostrukoj preporučenoj dozi kod mačaka i pasa koji su invadirani odraslim srčanim dirofilarijama bez opažanja štetnih reakcija.
English: Lactation: Can be used in lactating cats and dogs.
Croatian: Laktacija: Može se koristiti za mačke i pse u laktaciji.
English: Република България Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Croatian: Република България Chanelle Pharmaceuticals Manufacturing Ltd.
English: Chanhold 45 mg spot-on solution for cats 2.6-7.5 kg Chanhold 60 mg spot-on solution for cats 7.6-10.0 kg selamectin
Croatian: Chanhold 45 mg otopina za nakapavanje na kožu za mačke 2,6 - 7,5kg Chanhold 60 mg otopina za nakapavanje na kožu za mačke 7,6 - 10,0 kg selamektin
English: Chanhold 240 mg for dogs
Croatian: Chanhold 240 mg za pse
English: Prevention of heartworm disease (cats and dogs)
Croatian: Prevencija bolesti dilofilarioze (kod mačaka i pasa)
English: EU/2/19/236/001 EU/2/19/236/002
Croatian: EU/2/19/236/001
English: Chanhold 120 mg for dogs
Croatian: Chanhold 120 mg za pse
English: Chanhold 360 mg for dogs
Croatian: Chanhold 360 mg za pse
English: Chanhold 30 mg for dogs
Croatian: Chanhold 30 mg za pse
English: Chanhold 60 mg for cats
Croatian: Chanhold 60 mg za mačke
English: • Treatment of adult intestinal roundworms (Toxocara canis).
Croatian: • Liječenje invazije odraslim crijevnim oblićima (Toxocara canis).
English: 6% w/v solution
Croatian: 6% w/v otopina selamektin
English: Selamectin 30 mg
Croatian: 30 mg
English: Treatment of hookworm infections (cats)
Croatian: Liječenje invazije ankilostomima (kod mačaka)
English: 12% w/v solution
Croatian: 12 % w/v otopina selamektin
English: Name and address of the manufacturer responsible for batch release
Croatian: PROIZVOĐAČ BIOLOŠKI DJELATNE TVAR I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
English: Treatment of biting lice (cats and dogs)
Croatian: Liječenje infekcije crijevnim oblićima (kod mačaka i pasa)
English: • Treatment of biting lice infestations (Trichodectes canis)
Croatian: • Liječenje infestacije paušima (Trichodectes canis).
English: Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Croatian: Chanelle Pharmaceuticals Manufacturing Ltd.
English: • Treatment of adult roundworms (Toxocara cati)
Croatian: • Liječenje infestacije odraslim crijevnim oblićima (Toxocara cati)
English: Dogs weighing 2.6-5.0 kg.
Croatian: Psi tjelesne mase 2,6 - 5,0 kg.
English: Selamectin 45 mg
Croatian: 45 mg
English: Treatment of roundworm infections (cats and dogs)
Croatian: Liječenje infestacije paušima (kod mačaka i pasa)
English: 10.1-20.0 1 pipette of Chanhold 120 mg for dogs 10.1-20.0 kg
Croatian: Psi tjelesne mase 10,1 kg - 20,0 kg (Chanhold 120 mg: otopina za nakapavanje na kožu za pse 10,1 kg - 20,0 kg)
English: Dogs weighing 5.1-10.0 kg.
Croatian: Psi tjelesne mase 5,1 - 10,0 kg.
English: Dogs weighing 40.1-60.0 kg.
Croatian: Psi tjelesne mase 40,1 - 60,0 kg.
English: 20.1-40.0 1 pipette of Chanhold 240 mg for dogs 20.1-40.0 kg
Croatian: Psi tjelesne mase 20,1 kg - 40,0 kg (Chanhold 240 mg: otopina za nakapavanje na kožu za pse 20,1 kg - 40,0 kg)
English: Chanhold 60 mg for dogs
Croatian: Chanhold 60 mg za pse
English: Dogs weighing 20.1-40.0 kg.
Croatian: Psi tjelesne mase 20,1 - 40,0 kg.
English: Chanhold 30 mg spot-on solution for dogs 2.6-5.0 kg Chanhold 60 mg spot-on solution for dogs 5.1-10.0 kg Chanhold 120 mg spot-on solution for dogs 10.1-20.0 kg Chanhold 240 mg spot-on solution for dogs 20.1-40.0 kg Chanhold 360 mg spot-on solution for dogs 40.1-60.0 kg selamectin
Croatian: Chanhold 30 mg otopina za nakapavanje na kožu za pse 2,6 - 5,0 kg Chanhold 60 mg otopina za nakapavanje na kožu za pse 5,1 - 10,0 kg Chanhold 120 mg otopina za nakapavanje na kožu za pse 10,1 - 20,0 kg Chanhold 240 mg otopina za nakapavanje na kožu za pse 20,1 - 40,0 kg Chanhold 360 mg otopina za nakapavanje na kožu za pse 40,1 - 60,0 kg selamektin
English: Dogs weighing 10.1-20.0 kg.
Croatian: Psi tjelesne mase 10,1 - 20,0 kg.
English: 7.6-10.0 1 pipette of Chanhold 60 mg for cats 7.6-10 kg
Croatian: 7,6 - 10,0 1 pipeta Chanholda 60 mg za mačke 7,6-10,0 kg odgovarajuća kombinacija pipeta odgovarajuća kombinacija pipeta
English: 5.1-10.0 1 pipette of Chanhold 60 mg for dogs 5.1-10.0 kg
Croatian: Psi tjelesne mase 5,1 kg - 10,0 kg (Chanhold 60 mg: otopina za nakapavanje na kožu za pse 5,1 kg - 10,0 kg)
English: Cats weighing 2.6-7.5 kg. Cats weighing 7.6-10.0 kg.
Croatian: Mačke tjelesne mase 2,6 - 7,5 kg.
English: The product should be administered topically as a single application of a single-dose delivering a minimum of 6 mg/kg selamectin.
Croatian: Proizvod treba primijeniti jednokratno na kožu u pojedinačnoj dozi koja osigurava min.
English: 40.1-60.0 1 pipette of Chanhold 360 mg for dogs 40.1-60.0 kg
Croatian: Psi tjelesne mase 40,1 kg - 60,0 kg (Chanhold 240 mg: otopina za nakapavanje na kožu za pse 40,1 kg - 60,0 kg)
English: The product can be used as part of a treatment strategy for flea allergy dermatitis and through its ovicidal and larvicidal action may aid in the control of existing environmental flea infestations in areas to which the animal has access.
Croatian: Svojim ovicidnim i larvicidnim djelovanjem može pomoći u kontroli postojeće infestacije buhama u okolišu životinja.
English: Chanhold 15 mg spot-on solution for cats and dogs ≤ 2.5 kg Chanhold 30 mg spot-on solution for dogs 2.6-5.0 kg Chanhold 45 mg spot-on solution for cats 2.6-7.5 kg Chanhold 60 mg spot-on solution for cats 7.6-10.0 kg Chanhold 60 mg spot-on solution for dogs 5.1-10.0 kg Chanhold 120 mg spot-on solution for dogs 10.1-20.0 kg Chanhold 240 mg spot-on solution for dogs 20.1-40.0 kg Chanhold 360 mg spot-on solution for dogs 40.1-60.0 kg
Croatian: Chanhold 15 mg otopina za nakapavanje na kožu za mačke i pse ≤ 2,5 kg Chanhold 30 mg otopina za nakapavanje na kožu za pse 2,6 - 5,0 kg Chanhold 45 mg otopina za nakapavanje na kožu za mačke 2,6 - 7,5kg Chanhold 60 mg otopina za nakapavanje na kožu za mačke 7,6 - 10,0 kg Chanhold 60 mg otopina za nakapavanje na kožu za pse 5,1 - 10,0 kg Chanhold 120 mg otopina za nakapavanje na kožu za pse 10,1 - 20,0 kg Chanhold 240 mg otopina za nakapavanje na kožu za pse 20,1 - 40,0 kg Chanhold 360 mg otopina za nakapavanje na kožu za pse 40,1 - 60,0 kg
English: Chanhold 15 mg spot-on solution for cats and dogs ≤ 2.5 kg Chanhold 30 mg spot-on solution for dogs 2.6-5.0 kg Chanhold 45 mg spot-on solution for cats 2.6-7.5 kg Chanhold 60 mg spot-on solution for cats 7.6-10.0 kg Chanhold 60 mg spot-on solution for dogs 5.1-10.0 kg Chanhold 120 mg spot-on solution for dogs 10.1-20.0 kg Chanhold 240 mg spot-on solution for dogs 20.1-40.0 kg Chanhold 360 mg spot-on solution for dogs 40.1-60.0 kg selamectin
Croatian: Chanhold 15 mg otopina za nakapavanje na kožu za mačke i pse ≤ 2,5 kg Chanhold 30 mg otopina za nakapavanje na kožu za pse 2,6 - 5,0 kg Chanhold 45 mg otopina za nakapavanje na kožu za mačke 2,6 - 7,5kg Chanhold 60 mg otopina za nakapavanje na kožu za mačke 7,6 - 10,0 kg Chanhold 60 mg otopina za nakapavanje na kožu za pse 5,1 - 10,0 kg Chanhold 120 mg otopina za nakapavanje na kožu za pse 10,1 - 20,0 kg Chanhold 240 mg otopina za nakapavanje na kožu za pse 20,1 - 40,0 kg Chanhold 360 mg otopina za nakapavanje na kožu za pse 40,1 - 60,0 kg selamektin
English: Cats and dogs weighing 2.5 kg or less (Chanhold 15 mg spot-on solution for cats and dogs ≤ 2.5 kg) Dogs weighing 2.6 kg-5.0 kg (Chanhold 30 mg spot-on solution for dogs 2.6-5.0 kg) Cats weighing 2.6 kg-7.5 kg (Chanhold 45 mg spot-on solution for cats 2.6-7.5 kg) Cats weighing 7.6 kg-10.0 kg (Chanhold 60 mg spot-on solution for cats 7.6-10.0 kg) Dogs weighing 5.1 kg-10.0 kg (Chanhold 60 mg spot-on solution for dogs 5.1-10.0 kg) Dogs weighing 10.1 kg-20.0 kg (Chanhold 120 mg spot-on solution for dogs 10.1-20.0 kg) Dogs weighing 20.1 kg-40.0kg (Chanhold 240 mg spot-on solution for dogs 20.1-40.0 kg) Dogs weighing 40.1 kg-60.0 kg (Chanhold 360 mg spot-on solution for dogs 40.1-60.0 kg)
Croatian: Psi tjelesne mase 2,6 kg - 5,0 kg (Chanhold 30 mg: otopina za nakapavanje na kožu za pse 2,6 - 5,0 kg) Mačke tjelesne mase 2,6 kg - 7,5 kg (Chanhold 45 mg: otopina za nakapavanje na kožu za mačke 2,6 - 7,5 kg) Mačke tjelesne mase 7,6 kg - 10,0 kg (Chanhold 60 mg: otopina za nakapavanje na kožu za mačke 7,6 - 10,0 kg)
English: EMEA Number
Croatian: Broj (EU) odobrenja
English: Other changes
Croatian: Druge promjene
English: The areas harmonised include:
Croatian: Područje usklađivanja uključuje:
English: The medicine is currently marketed in the following Member States of the EU: Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Latvia, Luxembourg, Malta, Netherlands, Poland, Portugal, Spain, Sweden and United Kingdom, as well as in Iceland and Norway.
Croatian: Lijek je trenutno u prometu u sljedećim državama članicama EU-a: Austriji, Belgiji, Cipru, Češkoj Republici, Danskoj, Finskoj, Francuskoj, Njemačkoj, Grčkoj, Irskoj, Italiji, Latviji, Luksemburgu, Malti, Nizozemskoj, Poljskoj, Portugalu, Španjolskoj, Švedskoj i Ujedinjenoj Kraljevini te također na Islandu i u Norveškoj.
English: The European Commission issued an EU-wide legally binding decision on 28 November 2014.
Croatian: Europska komisija izdala je pravno obavezujuću odluku na razini EU-a dana 28.studenog 2014.
English: The company that markets these medicines is Astra Zeneca.
Croatian: Tvrtka koja stavlja ovaj lijek u promet je Astra Zeneca.
English: What is EMLA cream?
Croatian: Što je EMLA krema?
English: It is used as a local anaesthetic to prevent pain during medical or superficial surgical procedures.
Croatian: Koristi se kao lokalni anestetik za sprječavanje boli tijekom medicinskih ili površinskih kirurških postupaka.
English: The CHMP also harmonised other sections of the SmPC including sections 4.4 (special warning and precautions for use), 4.6 (fertility, pregnancy and lactation) and 4.8 (side effects).
Croatian: CHMP je također uskladio druge dijelove SPC-a uključujući dijelove 4.4 (posebna upozorenja i mjere opreza pri uporabi), 4.6 (plodnost, trudnoća i dojenje) i 4.8 (nuspojave).
English: Why was EMLA cream reviewed?
Croatian: Zašto je pregledana EMLA krema?
English: EMLA cream has been nationally authorised in EU Member States since 1984.
Croatian: EMLA krema je nacionalno odobrena u državama članicama EU-a od 1984.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom28 November 2014
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom28. studenog 2014. EMA/749922/2014 EMEA/H/A-30/1388
English: After reviewing the available data supporting the medicine's use, the CHMP agreed that EMLA cream can be used for the following:
Croatian: Nakon pregleda dostupnih podataka koji podržavaju primjenu lijeka, CHMP je suglasan da se EMLA krema može koristiti za sljedeće:
English: The CHMP agreed that hypersensitivity (allergy) to lidocaine and/or prilocaine or similar local anaesthetics or to any other ingredients in EMLA cream should be the only contraindication.
Croatian: CHMP je suglasan da preosjetljivost (alergija) na lidokain i/ili prilokain ili slične lokalne anestetike ili bilo koju drugu pomoćnu tvar EMLA kreme treba biti jedina kontraindikacija.
English: EMLA cream is authorised in the EU via national procedures.
Croatian: EMLA krema je odobrena u EU-u putem nacionalnih postupaka.
English: EMLA cream is a topical (skin) cream that contains the active substances lidocaine and prilocaine.
Croatian: EMLA krema je topikalna (kožna) krema koja sadrži djelatne tvari lidokain i prilokain.
English: Having harmonised the indications, the CHMP also harmonised recommendations on the doses and the duration of application of EMLA cream before different medical or surgical procedures in children, adolescents or adults.
Croatian: Nakon što je uskladio indikacije, CHMP je također uskladio preporuke za doziranje i trajanje primjene EMLA kreme prije različitih liječničkih i kirurških postupaka u djece, adolescenata ili odraslih.
English: On 25 September 2014, the European Medicines Agency completed a review of EMLA cream.
Croatian: Dana 25. rujna 2014., Europska agencija za lijekove završila je pregled EMLA kreme.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in differences in the SmPCs (Summary of Product Characteristics), labelling and package leaflets in the countries where the medicine is marketed.
Croatian: Ovo je rezultiralo razlikama diljem država članica u načinu primjene lijeka, što je uočeno u razlikama između sažetaka opisa svojstava lijeka, etiketi i uputama o lijeku u državama u kojima je lijek stavljen u promet.
English: In addition, information has been included to explain that studies did not show that EMLA cream is effective at providing adequate pain relief for circumcision (surgical removal of the foreskin).
Croatian: Nadalje, uključene su informacije kako bi se pojasnilo da ispitivanjima nije utvrđeno da je EMLA krema djelotvorna u pružanju odgovarajućeg ublažavanja boli za obrezivanje (kirurško uklanjanje prepucija).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for EMLA cream in the European Union (EU).
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je da postoji potreba za usklađivanjem informacija o propisivanju EMLA kreme u Europskoj uniji (EU).
English: • topical anaesthesia of leg ulcers in adults only.
Croatian: • topikalnu anesteziju ulceracija nogu samo u odraslih.
English: • topical anaesthesia of the skin in adults and children;
Croatian: • topikalnu anesteziju kože u odraslih i djece;
English: In view of this, on 11 October 2013 the German medicines regulatory agency referred the matter to the CHMP in order to harmonise the marketing authorisations for EMLA cream in the EU.
Croatian: U svjetlu ovoga, dana 11. listopada 2013. njemačka regulatorna agencija za lijekove uputila je predmet CHMP-u kako bi uskladila odobrenja za stavljanje lijeka u promet za EMLA kremu u EU-u.
English: The labelling and package leaflet were also revised in line with the changes to the SmPC.
Croatian: Etiketa i uputa za uporabu lijeka trebaju biti također revidirani kako bi bili u skladu sa SPC-om.
English: EMEA/H/A-30/1388
Croatian: EMA/749922/2014
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Croatian: U svijetlu dostavljenih podataka i znanstvenih rasprava u sklopu Odbora, mišljenje je CHMP-a kako je potrebno usklađivanje sažetaka opisa svojstava lijeka, etiketa i uputa o lijeku diljem EU-a.
English: • topical anaesthesia of the genital mucosa in adults and adolescents;
Croatian: • topikalnu anesteziju sluznice spolnih organa u odraslih i djece;
English: Refer also to section 4.8
Croatian: Također vidi odjeljak 4.8.
English: Treatment duration:
Croatian: Trajanje liječenja:
English: EU/2/10/119/001 EU/2/10/119/002 EU/2/10/119/003 EU/2/10/119/004 EU/2/10/119/005 EU/2/10/119/006 EU/2/10/119/007 EU/2/10/119/008 EU/2/10/119/009 EU/2/10/119/010 EU/2/10/119/011
Croatian: EU/2/10/119/001 EU/2/10/119/002 EU/2/10/119/003 EU/2/10/119/004 EU/2/10/119/005 EU/2/10/119/006 EU/2/10/119/007 EU/2/10/119/008 EU/2/10/119/009 EU/2/10/119/010
English: There is no specific antidote to this product.
Croatian: Ne postoji specifičan antidot za ovaj proizvod.
English: The elimination half-life (t1/2) is 1.38 (± 0.24) hours.
Croatian: Vrijeme polueliminacije (t1/2) iznosi 1,38 (± 0,24) sati.
English: Do not use in breeding, pregnant or lactating animals (see Section 12 “Special precautions for dogs”).
Croatian: Ne primjenjivati kod životinja u rasplodu, graviditetu ili laktaciji (vidi odjeljak 12 “Posebna upozorenja za pse”).
English: EU/2/10/119/012
Croatian: EU/2/10/119/011 EU/2/10/119/012
English: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Croatian: Proizvođač odgovoran za puštanje u promet mora obavijestiti Europsku komisiju o planovima za puštanje u promet medicinskog proizvoda za koji je ovom odlukom ovlašten.
English: Lactose monohydrate Povidone K25
Croatian: Monohidrat laktoze Povidon K25
English: Pharmacotherapeutic group: non-steroidal anti-inflammatory drug, ATCvet code: QM01AH93
Croatian: Farmakoterapijska grupa: nesteroidni protuupalni lijekovi , ATCvet kod: QM01AH93
English: The following table is presented as an example of how the tablets and tablet parts could be used in order to reach the recommended dose.
Croatian: Sljedeća tablica predstavlja primjer kako se tablete i dijelovi tableta mogu upotrijebiti da se dostigne preporučena doza.
English: 8 tablets 32 tablets 144 tablets 45 tablets
Croatian: 8 tableta 32 tablete 144 tablete 45 tableta
English: Medicines should not be disposed of via wastewater or household waste.
Croatian: Proizvodi se ne smiju odlagati u otpadne vode ili kućni otpad.
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 3 godine.
English: • Aluminium blisters (each strip containing 8 tablets) packaged into an outer cardboard box.
Croatian: • Aluminijski blisteri (svaka traka sadržava 8 tableta) pakirani u vanjsku kartonsku kutiju.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Croatian: Učestalost nuspojava definira se s pomoću sljedeće konvencije: - vrlo često (nuspojave se tijekom jednog liječenja javljaju kod više od 1 na 10 životinja) - često (više od 1 no manje od 10 na 100 životinja) - manje često (više od 1 no manje od 10 na 1.000 životinja) - rijetko (više od 1 no manje od 10 na 10.000 životinja) - vrlo rijetko (manje od 1 na 10.000 životinja, uključujući izolirane slučajeve).
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu/
English: The tablets are flavoured and studies (in healthy Beagle dogs) show they are likely to be taken voluntarily by most dogs.
Croatian: Ove su tablete aromatizirane, a istraživanja (na zdravim psima pasmine bigl) pokazuju kako će ih većina pasa vjerojatno rado uzimati.
English: • Relief of pain and inflammation associated with osteoarthritis: 6 months.
Croatian: • Ublažavanje bolova i upale povezane s osteoartritisom: 6 mjeseci.
English: STATEMENT OF MRLs
Croatian: IZVJEŠĆE O MRL
English: Do not use in dogs less than 10 weeks of age.
Croatian: Ne primjenjivati kod pasa mlađih od 10 tjedana.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Croatian: Nemojte ovaj veterinarsko-medicinski proizvod primjenjivati nakon isteka roka valjanosti koji je naznačen na etiketi.
English: The peak concentration (Cmax) is 0.3918 (± 0.09021) µg/ml, area under the curve (AUC) is 1.676 (± 0.4735) µg.hr/ml, and oral bioavailability is 44.53 (± 10.26) percent.
Croatian: Vršna koncentracija (Cmax) je 0,3918 (± 0,09021) µg/ml, površina pod krivuljom (AUC) iznosi 1,676 (± 0,4735) µg.h/ml, a peroralna biološka dostupnost je 44,53 (± 10,26) posto.
English: The metabolising enzymes have not been fully investigated and slower metabolism (up to four-fold increased exposure) has been noted in some individuals.
Croatian: Metabolizirajući enzimi nisu potpuno istraženi, a kod nekih je pojedinaca zabilježeno usporavanje metabolizma (sve do četverostruko povećane ekspozicije).
English: The oral administration of cimicoxib with food did not significantly influence the bioavailability but decreased significantly the observed Tmax.
Croatian: Peroralno davanje hrane uz cimikoksib nije značajno utjecalo na biološku dostupnost, ali je značajno smanjilo zabilježeni Tmax.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 45 tablets
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU DOZA 45 tableta
English: If such use cannot be avoided, these animals require careful veterinary monitoring.
Croatian: Ne može li se takva primjena izbjeći, ove životinje treba pozorno nadzirati veterinar.
English: After oral administration in dogs at the recommended dose of 2 mg/kg without food, cimicoxib is rapidly absorbed and the time to maximal concentration (Tmax) is 2.25 (± 1.24) hours.
Croatian: Nakon peroralnog davanja psima, u preporučenoj dozi od 2 mg/kg bez hrane, cimikoksib se brzo apsorbira, a vrijeme potrebno za dostizanje maksimalne koncentracije (Tmax) je 2,25 (± 1,24) sati.
English: If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Croatian: Ako zamijetite bilo koju ozbiljnu nuspojavu ili druge nuspojave koje nisu opisane u ovoj uputi, molimo obavijestite svojega veterinara.
English: All strengths are available in the following pack sizes and types:
Croatian: Sve jačine su dostupne u sljedećim veličinama i vrstama pakovanja: