FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/13/841/008 4 tablets EU/1/13/841/009 8 tablets EU/1/13/841/010 12 tablets EU/1/13/841/011 2 tablets
Croatian: EU/1/13/841/008 4 tablete EU/1/13/841/009 8 tableta EU/1/13/841/010 12 tableta EU/1/13/841/011 2 tablete
English: EU/1/13/841/004 2 tablets EU/1/13/841/005 4 tablets EU/1/13/841/006 8 tablets EU/1/13/841/007 12 tablets
Croatian: EU/1/13/841/004 2 tablete EU/1/13/841/005 4 tablete EU/1/13/841/006 8 tableta EU/1/13/841/007 12 tableta
English: • If you have a physical condition that affects the shape of your penis (such as angulation,
Croatian: • ako imate tjelesno stanje koje utječe na oblik penisa (kao što su angulacija, Peyroniejeva bolest ili kavernozna fibroza)
English: Priapism has been reported in a small number of post-marketing and clinical trial cases with other PDE5 inhibitors.
Croatian: Prijapizam je prijavljen u malom broju slučajeva nakon stavljanja lijeka u promet i u kliničkim ispitivanjima s drugim inhibitorima PDE5.
English: • swelling in the feet or ankles
Croatian: • oticanje stopala ili gležnjeva
English: EU/1/13/841/003 12 tablets
Croatian: EU/1/13/841/003 12 tableta
English: CYP3A4 substrate
Croatian: Supstrati CYP3A4
English: Medicinal products reducing systemic blood pressure As a vasodilator, avanafil may reduce systemic blood pressure.
Croatian: Kao vazolidatator, avanafil može sniziti sistemski krvni tlak.
English: • fast heart beat
Croatian: • ubrzani srčani otkucaji
English: EU/1/13/841/002 8 tablets
Croatian: EU/1/13/841/002 8 tableta
English: In men with either Type 1 or Type 2 diabetes mellitus, the mean percentage of attempts resulting in successful intercourse was approximately 34% and 40% for the 100 mg and 200 mg avanafil groups, respectively, compared to approximately 21% for the placebo group.
Croatian: U muškaraca s dijabetes melitusom tipa 1 ili tipa 2, srednja vrijednost postotka pokušaja koja je rezultirala uspješnim spolnim odnosom bila je približno 34% odnosno 40% za skupinu koja je primala 100 mg odnosno 200 mg avanafila, u usporedbi s približno 21% za placebo skupinu.
English: inhibitors') including amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil.
Croatian: CYP3A4“) uključujući amprenavir, aprepitant, diltiazem, flukonazol, fosamprenavir i verapamil
English: Ketoconazole (400 mg daily), a selective and highly potent inhibitor of CYP3A4, increased avanafil 50 mg single-dose Cmax and exposure (AUC) equal to 3-fold and 14-fold respectively and prolonged the half-life of avanafil to approximately 9 hours.
Croatian: Ketokonazol (400 mg dnevno), selektivni i visoko potentni inhibitor CYP3A4, povećao je Cmax jednokratne doze avanafila od 50 mg i izloženost (AUC) jednaku 3 puta odnosno 14 puta i produljio poluvijek avanafila na približno 9 sati.
English: Ritonavir (600 mg twice daily), a highly potent CYP3A4 inhibitor, which also inhibits CYP2C9, increased avanafil 50 mg single-dose Cmax and AUC equal to approximately 2-fold and 13-fold, and prolonged the half-life of avanafil to approximately 9 hours.
Croatian: Ritonavir (600 mg dvaput dnevno), visoko potentni inhibitor CYP3A4 koji također inhibira CYP2C9, povećao je Cmax i AUC jednokratne doze avanafila od 50 mg približno 2 puta odnosno 13 puta i produljio poluvijek avanafila na približno 9 sati.
English: How to store Spedra
Croatian: Kako čuvati lijek Spedra
English: • medicines for an irregular heartbeat (“arrhythmia”) such as quinidine, procainamide,
Croatian: • lijekove za nepravilni srčani ritam („aritmija“) kao što su kinidin, prokainamid, amiodaron ili sotalol
English: Co-administration of avanafil with potent inhibitors of CYP3A4, such as ketoconazole or ritonavir is contraindicated (see sections 4.2, 4.3 and 4.5).
Croatian: Kontraindicirana je istodobna primjena avanafila s potentnim inhibitorima CYP3A4, kao što su ketokonazol ili ritonavir (vidjeti dijelove 4.2, 4.3 i 4.5).
English: INFORMATION IN BRAILLE Spedra 200 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Spedra 200 mg
English: • If you are taking medicines for HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir
Croatian: • ako uzimate lijekove protiv HIV-a ili AIDS-a kao što su ritonavir, indinavir, sakinavir, nelfinavir ili atazanavir
English: In men with ED following bilateral nerve-sparing radical prostatectomy, the mean percentage of attempts resulting in successful intercourse was approximately 23% and 26% for the 100 mg and 200 mg avanafil groups, respectively, compared to approximately 9% for placebo.
Croatian: U muškaraca sa ED nakon bilateralne radikalne prostatektomije s očuvanjem neurovaskularnog snopa, srednja vrijednost postotka pokušaja koja je rezultirala uspješnim spolnim odnosom bila je približno 23% odnosno 26% za skupinu koja je primala 100 mg odnosno 200 mg avanafila, u usporedbi s približno 9% za placebo skupinu.
English: MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A., 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg
Croatian: MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A., 1, Avenue de la Gare, L1611 Luxembourg, Luksemburg
English: INFORMATION IN BRAILLE Spedra 50 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Spedra 50 mg
English: PDE5 inhibitors have been shown to increase the hypotensive effects of this medicine.
Croatian: Pokazalo se da inhibitori PDE5 pojačavaju učinak tog lijeka na sniženje krvnog tlaka.
English: The exposure 4 hours post-dose was lower in subjects with moderate hepatic impairment (Child-Pugh B) compared to subject with normal hepatic function after 200 mg of avanafil.
Croatian: Nakon avanafila u dozi od 200 mg izloženost 4 sata poslije doze bila je niža u ispitanika s umjerenim oštećenjem jetre (Child-Pugh B) u usporedbi s ispitanikom s normalnom funkcijom jetre.
English: There was no effect on sperm movement or structure after single 200 mg oral doses of avanafil in healthy volunteers.
Croatian: U zdravih dobrovoljaca nije bilo učinka na pokretljivost ili strukturu sperme nakon jednokratne doze avanafila od 200 mg uzete kroz usta.
English: INFORMATION IN BRAILLE Spedra 100 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Spedra 100 mg
English: Premature ejaculation Inappropriate affect
Croatian: Psihijatrijski poremećaji nesanica preuranjena ejakulacija neprikladni afekt
English: How to take Spedra
Croatian: Kako uzimati lijek Spedra
English: Blood urine present Cardiac murmur Prostate specific antigen increased Weight increased Blood bilirubin increased
Croatian: Pretrage povišen jetreni enzim poremećaj u elektrokardiogramu povećana brzina srčanih otkucaja povišen krvni tlak prisutna krv u urinu šum na srcu povišen antigen specifičan za prostatu povećana tjelesna težina povišen bilirubin u krvi povišen kreatinin u krvi povišena tjelesna temperatura
English: Cytochrome P450 Inhibition
Croatian: Inhibicija citokroma P450
English: Patients who are using potent CYP3A4 inhibitors (including ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin) (see sections 4.2, 4.4 and 4.5).
Croatian: Bolesnici liječeni potentnim inhibitorima CYP3A4 (uključujući ketokonazol, ritonavir, atazanavir, klaritromicin, indinavir, itrakonazol, nefazodon, nelfinavir, sakvinavir i telitromicin) (vidjeti dijelove 4.2, 4.4 i 4.5).
English: Description of selected adverse reactions observed with other PDE5 inhibitors Non-arteritic anterior ischaemic optic neuropathy (NAION) and sudden loss of hearing have been reported in a small number of postmarketing and clinical trial cases with other PDE5 inhibitors.
Croatian: Nearterijska anteriorna ishemijska optička neuropatija (NAION) i iznenadni gubitak sluha prijavljeni su u malom broju slučajeva nakon stavljanja lijeka u promet i u kliničkim ispitivanjima s drugim inhibitorima PDE5.
English: Chest pain Influenza like illness Oedema peripheral
Croatian: Opći poremećaji i reakcije na mjestu primjene umor astenija bol u prsima bolest nalik gripi periferni edem
English: • itching in the genital area
Croatian: • svrbež u području spolovila
English: • feeling weak or tired all the time
Croatian: • stalno prisutan osjećaj slabosti ili umora
English: Erythromycin (500 mg twice daily), a moderate CYP3A4 inhibitor, increased avanafil 200 mg singledose Cmax and AUC equal to approximately 2-fold and 3-fold, respectively, and prolonged the half-life of avanafil to approximately 8 hours.
Croatian: Eritromicin (500 mg dvaput dnevno), umjereni inhibitor CYP3A4, povećao je Cmax i AUC jednokratne doze avanafila od 200 mg približno 2 puta odnosno 3 puta i produljio poluvijek avanafila na približno 8 sati.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. 1, Avenue de la Gare, L-1611 Luxembourg
Croatian: 11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. 1, Avenue de la Gare, L-1611 Luxembourg
English: Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease before prescribing Spedra.
Croatian: U bolesnika s već postojećom kardiovaskularnom bolešću, prije propisivanja Spedre liječnici trebaju uzeti u obzir mogući rizik koji spolna aktivnost predstavlja za srce.
English: • dry mouth
Croatian: • začepljen nos
English: Co-administration of avanafil with potent CYP3A4 inhibitors (including ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin) is contraindicated (see sections 4.3, 4.4 and 4.5).
Croatian: Kontraindicirana je istodobna primjena avanafila s potentnim inhibitora CYP3A4 (uključujući ketokonazol, ritonavir, atazanavir, klaritromicin, indinavir, itrakonazol, nefazodon, nelfinavir, sakvinavir i telitromicin) (vidjeti dijelove 4.3, 4.4 i 4.5).
English: • Patients should be stable on alpha-blocker therapy prior to initiating Spedra.
Croatian: • Prije nego što započnu uzimati Spedru, bolesnici moraju biti stabilni na terapiji alfa blokatorima.
English: No cases were reported during clinical trials of avanafil (see section 4.4).
Croatian: Tijekom kliničkih ispitivanja avanafila nije bilo prijavljenih slučajeva (vidjeti dio
English: There was no effect on sperm motility or morphology after single 200 mg oral doses of avanafil in healthy volunteers.
Croatian: Nakon jednokratnih peroralnih doza avanafila od 200 mg nije bilo učinka na pokretljivost ili morfologiju spermija u zdravih dobrovoljaca.
English: Each tablet contains 50 mg of avanafil.
Croatian: Svaka tableta sadrži 50 mg avanafila.
English: PVC/PCTFE/Aluminium perforated unit dose blisters in cartons of 4x1, 8x1 and 12x1 tablets.
Croatian: PVC/PCTFE/aluminijski perforirani blisteri s jediničnim dozama u kutijama od 4x1, 8x1 i 12x1 tableta.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg of avanafil.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka tableta sadrži 50 mg avanafila.
English: PVC/PCTFE/Aluminium perforated unit dose blisters in cartons of 2x1, 4x1, 8x1 and 12x1 tablets.
Croatian: PVC/PCTFE/aluminijski perforirani blisteri s jediničnim dozama u kutijama od 2x1, 4x1, 8x1 i 12x1 tableta.
English: Each tablet contains 200 mg of avanafil.
Croatian: Svaka tableta sadrži 200 mg avanafila.
English: Other strong inhibitors of CYP3A4 (e.g. itraconazole, voriconazole, clarithromycin, nefazodone, saquinavir, nelfinavir, indinavir, atazanavir, and telithromycin) would be expected to have similar effects.
Croatian: Slični učinci očekuju se i za druge snažne inhibitore CYP3A4 (npr. itrakonazol, vorikonazol, klaritromicin, nefazodon, sakvinavir, nelfinavir, indinavir, atazanavir i telitromicin).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg of avanafil.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka tableta sadrži 200 mg avanafila.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/841/001 4 tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/841/001 4 tablete
English: MARKETING AUTHORISATION HOLDER MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. 1, Avenue de la Gare, L-1611 Luxembourg Luxembourg
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. 1, Avenue de la Gare, L-1611 Luxembourg Luksemburg
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg of avanafil.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka tableta sadrži 100 mg avanafila.
English: NAME OF THE MEDICINAL PRODUCT Spedra 50 mg tablets
Croatian: NAZIV LIJEKA Spedra 50 mg tablete
English: Each tablet contains 100 mg of avanafil.
Croatian: Svaka tableta sadrži 100 mg avanafila.
English: Spedra is a pale yellow oval tablet, marked “50”on one side.
Croatian: Spedra je blijedožuta ovalna tableta, s oznakom „50“ na jednoj strani.
English: Package leaflet: Information for the patient Spedra 200 mg tablets avanafil
Croatian: Uputa o lijeku: Informacija za bolesnika Spedra 200 mg tablete avanafil
English: Spedra is a pale yellow oval tablet, marked “100” on one side.
Croatian: Spedra je blijedožuta ovalna tableta, s oznakom „100“ na jednoj strani.
English: Spedra is a pale yellow oval tablet, marked “200” on one side.
Croatian: Spedra je blijedožuta ovalna tableta, s oznakom „200“ na jednoj strani.
English: NAME OF THE MEDICINAL PRODUCT Spedra 200 mg tablets
Croatian: NAZIV LIJEKA Spedra 200 mg tablete
English: NAME OF THE MEDICINAL PRODUCT Spedra 100 mg tablets
Croatian: NAZIV LIJEKA Spedra 100 mg tablete
English: Package leaflet: Information for the patient Spedra 50 mg tablets avanafil
Croatian: Uputa o lijeku: Informacija za bolesnika Spedra 50 mg tablete avanafil
English: Decreased or sudden loss of hearing
Croatian: Smanjenje ili iznenadni gubitak sluha
English: Package leaflet: Information for the patient Spedra 100 mg tablets avanafil
Croatian: Uputa o lijeku: Informacija za bolesnika Spedra 100 mg tablete avanafil
English: The tablets are provided in perforated unit dose blister packs containing 2x1, 4x1, 8x1, or 12x1 tablets.
Croatian: Tablete se nalaze u perforiranim blister pakiranjima s jediničnim dozama koja sadrže 2x1, 4x1, 8x1, ili 12x1 tableta.
English: • If you are taking “nitrate” medicines for chest pain (angina), such as amyl nitrite or glyceryl trinitrate.
Croatian: • ako uzimate „nitratne“ lijekove za bolove u prsima (angina), kao što su amilnitrit ili gliceril trinitrat; Spedra može povećati učinke tih lijekova i jako sniziti Vaš krvni tlak
English: The tablets are provided in perforated unit dose blister packs containing 4x1, 8x1, or 12x1 tablets.
Croatian: Tablete se nalaze u perforiranim blister pakiranjima s jediničnim dozama koja sadrže 4x1, 8x1, ili 12x1 tableta.
English: NAME OF THE MEDICINAL PRODUCT Spedra 50 mg tablets avanafil
Croatian: NAZIV LIJEKA Spedra 50 mg tablete avanafil
English: NAME OF THE MEDICINAL PRODUCT Spedra 200 mg tablets avanafil
Croatian: NAZIV LIJEKA Spedra 200 mg tablete avanafil
English: • If you suffer from priapism, that is a persistent erection lasting 4 hours or more.
Croatian: • erekcija koja ne prestaje („prijapizam“); ako dobijete erekciju koja traje dulje od 4 sata, to je potrebno liječiti što prije jer bi moglo dovesti do trajnog oštećenja penisa (uključujući i to da više ne biste mogli postići erekciju).
English: Pale yellow oval tablets, debossed with “50” on one side.
Croatian: Blijedožute ovalne tablete s oznakom „50“ na jednoj strani.
English: NAME OF THE MEDICINAL PRODUCT Spedra 100 mg tablets avanafil
Croatian: NAZIV LIJEKA Spedra 100 mg tablete avanafil
English: Pale yellow oval tablets, debossed with “100” on one side.
Croatian: Blijedožute ovalne tablete s oznakom „100“ na jednoj strani.
English: Yellow iron oxide (E172)
Croatian: nisko supstituirana, kalcijev karbonat, magnezijev stearat i željezov oksid, žuti (E172).
English: In patients receiving stable tamsulosin treatment, the placebo-subtracted mean maximum decreases in standing and supine systolic blood pressure following avanafil dosing were 3.6 mmHg and 3.1 mmHg,
Croatian: U bolesnika koji su primali stabilno liječenje tamsulozinom, za placebo oduzeta srednja vrijednost maksimalnih smanjenja sistoličkog krvnog tlaka u stojećem i ležećem položaju na leđima, bila je nakon doziranja avanafila 3,6 mmHg odnosno 3,1 mmHg, a 5/24 ispitanika imalo je nakon doziranja avanafila vrijednosti ili smanjenja krvnog tlaka u odnosu na početne vrijednosti koja su bile od potencijalnog kliničkog značaja (vidjeti dio 4.4).
English: Cytochrome P450 Induction
Croatian: Indukcija citokroma P450
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/841/004-007
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/841/004-007
English: Pale yellow oval tablets, debossed with “200” on one side.
Croatian: Blijedožute ovalne tablete s oznakom „200“ na jednoj strani.
English: • sinus congestion
Croatian: • začepljeni sinusi
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/841/008-011
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/841/008-011
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/841/001-003
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/841/001-003
English: Fumaric acid
Croatian: Oštećenje jetre
English: • muscle aches or pains
Croatian: • grčevi u mišićima
English: Dyspepsia Nausea
Croatian: Prijavljivanje nuspojava
English: This can happen in men with conditions like sickle cell disease, multiple myeloma or leukaemia.
Croatian: • ako patite od prijapizma, odnosno, to je erekcija koja traje 4 sata ili dulje; to se može dogoditi muškarcima sa stanjem poput bolesti srpastih stanica, multiplog mijeloma ili leukemije
English: Reproductive system and breast disorders
Croatian: Poremećaji bubrega i mokraćnog sustava polakizurija
English: • indigestion, feeling or being sick to your stomach
Croatian: • tupa bol u želucu ili žgaravica
English: Visual defects and cases of non-arteritic anterior ischaemic optic neuropathy (NAION) have been reported in connection with the intake of other PDE5 inhibitors.
Croatian: Povezano s unosom drugih inhibitora PDE5 prijavljena su oštećenja vida i slučajevi nearterijske anteriorne ishemične optičke neuropatije (NAION).
English: Rhinorrhoea Upper respiratory tract congestion
Croatian: Krvožilni poremećaji crvenilo uz osjećaj vrućine navala vrućine hipertenzija
English: • stuffy or runny nose
Croatian: • pun nos ili curenje nosa
English: Visual problems
Croatian: • zamućen vid
English: • hayfever
Croatian: • proljev
English: What is Longrange?
Croatian: Što je Longrange?
English: The animals were monitored for 4 months and the main measure of effectiveness was the percentage of animals that were cured of worms over 4 months.
Croatian: Životinje su praćene u razdoblju od 4 mjeseca, a glavna mjera djelotvornosti bio je postotak životinja koje su izliječene od crva kroz 4 mjeseca.
English: Although the company proposed measures to reduce the environmental risk, the CVMP did not consider them to be sufficient.
Croatian: Tvrtka je predložila mjere za smanjenje rizika za okoliš, no CVMP ih nije smatrao dovoljnima.
English: 12 December 2018 EMA/778491/2018 EMEA/H/V/004291
Croatian: EMA/15591/2019 EMEA/H/C/004291
English: Longrange is a veterinary medicine that contains the active substance eprinomectin.
Croatian: Longrange je veterinarsko-medicinski proizvod koji sadrži aktivnu tvar eprinomektin.
English: Prolonged-release means that the solution releases eprinomectin slowly over an extended time period - four months in the case of Longrange.
Croatian: Produljeno oslobađanje znači da otopina oslobađa eprinomektin polako tijekom duljeg vremenskog razdoblja - u slučaju Longrangea, tijekom četiri mjeseca.
English: It was also expected to prevent reinfections with gut roundworms and lungworm for 100 to 120 days.
Croatian: Također se očekivalo da će spriječiti ponovne infekcije želučano-crijevnim oblićima i plućnim vlascima tijekom 100 do 120 dana.
English: After considering the grounds for this request, the CVMP re-examined the opinion and confirmed the refusal of the marketing authorisation on 11 October 2018.
Croatian: Nakon razmatranja osnovanosti ovog zahtjeva, CVMP je preispitao prvotno mišljenje te potvrdio odbijanje izdavanja odobrenja za stavljanje lijeka u promet 11. listopada 2018.
English: On 21 June 2018, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Longrange, intended for the treatment and prevention of parasitic infections in cattle.
Croatian: Dana 21. lipnja 2018., Odbor za veterinarsko-medicinske proizvode (Committee for Medicinal Products for Veterinary Use - CVMP) donio je negativno mišljenje i preporučio odbijanje odobrenja za stavljanje u promet lijeka Longrange, koji je namijenjen liječenju i prevenciji parazitskih infekcija kod goveda.
English: What was Longrange expected to be used for?
Croatian: Za što se Longrange trebao primjenjivati?
English: The company presented data from a main field study of 156 young cattle with natural roundworm and/or lungworm infections that were treated with Longrange.
Croatian: Tvrtka je predstavila podatke iz glavnog terenskog istraživanja na 156 mladih goveda s prirodnim infekcijama želučano-crijevnim oblićima i/ili plućnim vlascima koje su liječene Longrangeom.
English: The active substance in Longrange, eprinomectin, is a well-known antiparasitic substance that works by attaching to tiny pores on the surface of parasitic nerve or muscle cells called glutamate-gated chloride ion channels.
Croatian: Eprinomektin, aktivna tvar u Longrangeu, dobro je poznata antiparazitska tvar koja djeluje tako da se veže na sitne pore na površini parazitskog živca ili mišićnih stanica nazvanih glutamatom regulirani kloridni ionski kanali.
English: This leads to an increase in the amount of chloride ions that enter the cells, resulting in paralysis and death of the parasite.
Croatian: To dovodi do povećanja propusnosti stanične membrane za kloridne ione, rezultirajući paralizom i uginućem parazita.
English: Refusal of the marketing authorisation for Longrange (eprinomectin)
Croatian: Odbijanje odobrenja za stavljanje u promet lijeka Longrange (eprinomektin)
English: Therefore, the CVMP was of the opinion that the benefits of Longrange did not outweigh its risks and recommended that it be refused marketing authorisation.
Croatian: Stoga je CVMP smatrao da koristi lijeka Longrange ne nadmašuju s njim povezane rizike te je preporučio odbijanje odobrenja za stavljanje lijeka u promet.
English: Longrange was expected to be used to treat infections with the following parasites: gut roundworms, lungworm, warbles, mange mites, lice and horn flies.
Croatian: Očekivalo se da će se Longrange primjenjivati za liječenje infekcija sljedećim parazitima: želučanocrijevnim oblićima, plućnim vlascima, goveđim štrkovima, grinjama, ušima i muhama pecavkama.
English: The company also presented data on the effectiveness of Longrange against ectoparasites - those parasites such as lice and warble flies that live on the outside of the animal's body.
Croatian: Tvrtka je predstavila i podatke o djelotvornosti Longrangea u slučaju ektoparazita - parazita kao što su uši i goveđi štrkovi koje žive izvan tijela životinje.
English: The CVMP was concerned mainly about the possible effects of Longrange on the environment, specifically its effects on organisms in cattle dung.
Croatian: Razlozi CVMP-ove glavne zabrinutosti bili su mogući učinci Longrangea na okoliš, posebice njegovi učinci na organizme u izmetu goveda.
English: Refusal of the marketing authorisation for Longrange (eprinomectin) EMA/778491/2018
Croatian: Odbijanje odobrenja za stavljanje u promet lijeka Longrange (eprinomektin) EMA/15591/2019
English: The company that applied for authorisation is Merial.
Croatian: Zahtjev za izdavanje odobrenja podnijela je tvrtka Merial.
English: It was to be available as a prolonged-release solution for injection under the skin in cattle.
Croatian: Trebao je biti dostupan kao otopina za potkožnu injekciju za goveda, s produljenim oslobađanjem.
English: How does Longrange work?
Croatian: Kako djeluje Longrange?
English: • hair loss: in most cases normal hair growth should return.
Croatian: • gubitak kose (u većini slučajeva trebao bi se vratiti normalan rast kose).