FrancophonIA/ELRC3.0 huggingface dataset:
English: The population pharmacokinetic analysis suggest that Asians have 56% lower total irinotecan average steady state concentration (3.93 [95%CI: 3.68-4.2] and 1.74 [95%CI: 1.58-1.93] mg/l, respectively) and 8% higher total SN-38 average steady state concentration (0.97 [95%CI: 0.92-1.03] and 1.05 [95%CI: 0.98-1.11] ng/ml, respectively) than Caucasians.
Croatian: odnosno 1,74 [95%CI: 1,58-1,93] mg/l) i 8% višu prosječnu koncentraciju ukupnog SN-38 u stanju dinamičke ravnoteže (0,97 [95%CI: 0,92-1,03] odnosno 1,05 [95%CI: 0,98-1,11] ng/ml) od bijelaca.
English: Patients with severe bone marrow failure should not be treated with ONIVYDE pegylated liposomal.
Croatian: Bolesnici s teškim zatajenjem koštane srži ne smiju se liječiti lijekom
English: The population pharmacokinetic analysis in patients aged 28 to 87 years, of whom 11% were ≥75 years suggests that age had no clinically meaningful effect on the exposure to irinotecan and SN-38.
Croatian: Populacijska farmakokinetička analiza u bolesnika u dobi od 28 do 87 godina, od kojih je 11% bilo
English: What ONIVYDE pegylated liposomal contains
Croatian: Što ONIVYDE pegilirani liposomalni sadrži
English: Grade 3 or higher thrombocytopenia occurred in 2.6% of patients treated with ONIVYDE pegylated liposomal +5-FU/LV and 0% in patients treated with 5-FU/LV.
Croatian: Trombocitopenija stupnja 3 ili višeg javila se u 2,6% bolesnika koji su primali ONIVYDE pegilirani liposomalni +5-FU/LV i u 0% bolesnika koji su primali samo 5-FU/LV.
English: The volume of distribution of ONIVYDE pegylated liposomal 70 mg/m was 2.6 l/m 2, which suggests that
Croatian: Volumen distribucije lijeka ONIVYDE pegilirani liposomalni 70 mg/m2 bio je 2,6 l/m2, što upućuje na to da je ONIVYDE pegilirani liposomalni u velikoj mjeri ograničen na vaskularnu tekućinu.
English: No carcinogenicity studies have been performed with ONIVYDE pegylated liposomal.
Croatian: Nisu provedena ispitivanja kancerogenosti s lijekom ONIVYDE pegilirani liposomalni.
English: Regular monitoring of complete blood counts should be conducted in patients with total bilirubin of 1.0-2.0 mg/dl.
Croatian: U bolesnika s ukupnim bilirubinom od 1,0-2,0 mg/dl potrebno je provesti redovito praćenje kompletne krvne slike.
English: A new cycle of therapy should not begin until nausea/vomiting resolves to ≤ Grade 1 or baseline
Croatian: Novi ciklus liječenja ne smije se započinjati sve dok se mučnina/povraćanje ne povuče na ≤ stupanj 1 ili na prvobitno stanje
English: Complete blood cell count monitoring is recommended during ONIVYDE pegylated liposomal treatment.
Croatian: Tijekom liječenja lijekom ONIVYDE pegilirani liposomalni preporučuje se praćenje kompletne krvne slike.
English: ONIVYDE pegylated liposomal 4.3 mg/ml concentrate for solution for infusion Irinotecan
Croatian: ONIVYDE pegilirani liposomalni 4,3 mg/ml koncentrat za otopinu za infuziju Irinotekan
English: Gastrointestinal disorders Very common: Diarrhoea, Vomiting, Nausea, Abdominal pain, Stomatitis
Croatian: Vrlo često: proljev, povraćanje, mučnina, bol u abdomenu, stomatitis
English: Based on the drug interaction of non-liposomal irinotecan and ketoconazole, co-administration of ONIVYDE pegylated liposomal with other inhibitors of UGT1A1 (e.g. atazanavir, gemfibrozil, indinavir) may also increase systemic exposure of ONIVYDE pegylated liposomal.
Croatian: pegilirani liposomalni s drugim inhibitorima UGT1A1 (npr. atazanavir, gemfibrozil, indinavir) može također povećati sustavnu izloženost lijeku ONIVYDE pegilirani liposomalni.
English: Diarrhoea and related adverse reactions
Croatian: Proljev i povezane nuspojave
English: No dedicated pharmacokinetic study has been conducted in patients with hepatic impairment.
Croatian: Nije provedeno posebno farmakokinetičko ispitivanje u bolesnika s oštećenjem jetre.
English: Servier Pharma, d. o. o. Tel: + 385 (0)1 3016 222
Croatian: Tel: + 385 (0)1 3016 222
English: Optimise antiemetic therapy Reduce ONIVYDE pegylated liposomal dose to 50 mg/m
Croatian: Optimizirati antiemetsku terapiju Smanjiti dozu lijeka ONIVYDE pegilirani liposomalni na 50 mg/m2
English: One ml of concentrate contains 4.3 mg irinotecan anhydrous free base (as irinotecan sucrosofate salt in a pegylated liposomal formulation).
Croatian: Jedan ml koncentrata sadrži 4,3 mg bezvodne slobodne baze irinotekana (u obliku irinotekansaharozasulfata u pegiliranoj liposomskoj formulaciji).
English: Suomi/Finland Servier Finland Oy P. /Tel: +358 (0)9 279 80 80
Croatian: P. /Tel: +358 (0)9 279 80 80
English: A reduced starting dose of ONIVYDE pegylated liposomal (irinotecan) of 50 mg/m should be considered for patients known to be homozygous for the UGT1A1*28 allele (see sections 4.8 and 5.1).
Croatian: Za bolesnike za koje je poznato da su homozigoti za alel UGT1A1*28 potrebno je razmotriti smanjenu početnu dozu lijeka ONIVYDE pegilirani liposomalni (irinotekan) od 50 mg/m2 (vidjeti dijelove 4.8 i 5.1).
English: How to store ONIVYDE pegylated liposomal
Croatian: Kako čuvati ONIVYDE pegilirani liposomalni
English: United Kingdom Servier Laboratories Ltd Tel: +44 (0)1753 666409
Croatian: Tel: +44 (0)1753 666409
English: 70 mg/m
Croatian: ≥ 3,0 g/dl.
English: ONIVYDE pegylated liposomal is a cytotoxic medicinal product, and caution should be exercised in handling it.
Croatian: ONIVYDE pegilirani liposomalni je citotoksični lijek s kojim je potrebno oprezno rukovati.
English: What ONIVYDE pegylated liposomal is used for
Croatian: Za što se ONIVYDE pegilirani liposomalni koristi
English: (anaemia) - Low level of blood platelets (thrombocytopenia) - Diarrhoea (loose or watery and frequent stools) - Nausea and vomiting - Pain in the stomach or in the gut area - Sore mouth - Loss of weight - Loss of appetite - Loss of body fluid (dehydration) - Low level of salts (electrolytes) in the body (e.g. of potassium, magnesium) - Unusual hair loss - Tiredness - Dizziness - Swelling and fluid retention in the soft tissues (peripheral oedema)
Croatian: - Niske razine bijelih krvnih stanica (neutropenija i leukopenija), niske razine crvenih krvnih stanica (anemija) - Niska razina trombocita (trombocitopenija) - Proljev (mekane ili vodenaste i česte stolice)
English: Name and address of the manufacturer(s) responsible for batch release Les Laboratoires Servier Industrie
Croatian: A PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet
English: Store in a refrigerator (2°C-8°C).
Croatian: 6.4 Posebne mjere pri čuvanju lijeka Čuvati u hladnjaku (2°C-8°C).
English: Servier Laboratories (Ireland) Ltd. Tel: + 353 (0)1 663 8110
Croatian: Tel: + 353 (0)1 663 8110
English: Acute renal failure
Croatian: - Opća slabost
English: AUC= area under the plasma concentration curve (extrapolated to infinity for ONIVYDE pegylated liposomal and AUC24h for non-liposomal irinotecan) Cmax= maximum plasma concentration t1/2 effective= effective half-lives
Croatian: AUC= površina ispod krivulje koncentracije u plazmi (ekstrapolirano do beskonačnosti za ONIVYDE
English: No dedicated pharmacokinetic study has been conducted in patients with renal impairment.
Croatian: Nije provedeno posebno farmakokinetičko ispitivanje u bolesnika s oštećenjem bubrega.
English: Tabulated list of adverse reactions
Croatian: Opis odabranih nuspojava
English: Optimise antiemetic therapy Reduce ONIVYDE pegylated liposomal dose to 43 mg/m
Croatian: Optimizirati antiemetsku terapiju Smanjiti dozu lijeka ONIVYDE pegilirani liposomalni na 43 mg/m2
English: Water for injections
Croatian: Infekcije i infestacije
English: Česká republika Servier s.r.o.
Croatian: Servier Slovensko spol. s r.o.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Onivyde pegylated liposomal (irinotecan) is not equivalent to non-liposomal formulations.
Croatian: Onivyde pegilirani liposomalni (irinotekan) nije ekvivalentan neliposomalnim formulacijama.
English: A dose increase of ONIVYDE pegylated liposomal to 70 mg/m should be considered if tolerated in subsequent cycles.
Croatian: pegilirani liposomalni može se povećati do ukupne doze od 70 mg/m2 u narednim ciklusima temeljeno na podnošljivosti pojedinog bolesnika.
English: A reticulo-nodular pattern on chest X-ray was observed in a small percentage of patients enrolled in a clinical study with irinotecan.
Croatian: Kod malog postotka bolesnika uključenih u kliničko ispitivanje s irinotekanom na rendgenu prsnog koša uočen je retikulonodularni oblik.
English: tightness in the chest or throat during or shortly after your infusion - if you experience fever, chills or other symptoms of infection - if you get diarrhoea with frequent liquid stools and cannot control this after 12 to 24 hours of treatment (see below) - if you get breathlessness or cough.
Croatian: - ako osjetite vrućicu, zimicu ili druge simptome infekcije - ako dobijete proljev s čestim tekućim stolicama i ne možete to kontrolirati nakon 12 do 24 sata liječenja (vidjeti u nastavku) - ako osjetite nedostatak zraka ili kašljete - ako primijetite znakove ili simptome krvnog ugruška, poput iznenadne boli i oticanja noge ili ruke, iznenadnog napada kašlja, iznenadne boli u prsnom košu ili otežanog disanja.
English: Overall, no major clinical differences in safety or efficacy were reported between patients ≥ 65 years and patients < 65 years, although a higher frequency of discontinuation (14.8% vs 7.9%) was noted in the former group treated with ONIVYDE pegylated liposomal +5-FU/LV in the NAPOLI-1 study and in some cases the adverse reactions did not resolve.
Croatian: Sveukupno, nisu prijavljene velike kliničke razlike u sigurnosti i djelotvornosti lijeka između bolesnika ≥ 65 godina i bolesnika < 65 godina, iako je veća učestalost prekida liječenja (14,8%
English: The safety and efficacy of ONIVYDE pegylated liposomal in children and adolescents aged ≤ 18 years have not yet been established.
Croatian: Pedijatrijska populacija Sigurnost i djelotvornost lijeka ONIVYDE pegilirani liposomalni u djece i adolescenata u dobi
English: No genotoxicity studies have been performed with ONIVYDE pegylated liposomal.
Croatian: Nisu provedena ispitivanja genotoksičnosti s lijekom ONIVYDE pegilirani liposomalni.
English: Neutropenic fever/sepsis appeared more frequently in the ONIVYDE pegylated liposomal +5-FU/LV combination arm [in 4 patients (3.4%)] compared to 5-FU/LV control arm [in 1 patient (0.7%)].
Croatian: Neutropenijska vrućica/sepsa javila se učestalije u skupini bolesnika koji su primali kombinaciju ONIVYDE pegilirani liposomalni +5-FU/LV [u 4 bolesnika (3,4%)] u usporedbi s kontrolnom skupinom koja je primala samo 5-FU/LV
English: A total of 417 patients were randomised to the ONIVYDE pegylated liposomal +5-FU/LV arm (N=117), ONIVYDE pegylated liposomal monotherapy arm (N=151) and 5-FU/LV arm (N=149).
Croatian: Ukupno 417 bolesnika randomizirano je za skupinu koja je primala ONIVYDE pegilirani liposomalni +5-FU/LV (N=117), za skupinu koja je primala ONIVYDE pegilirani liposomalni u monoterapiji
English: Cholesterol
Croatian: DSPC kolesterol
English: Nervous system disorders Very common: Dizziness Common: Cholinergic syndrome, Dysgeusia
Croatian: Često: kolinergički sindrom, disgeuzija
English: How ONIVYDE pegylated liposomal is used
Croatian: Kako se ONIVYDE pegilirani liposomalni primjenjuje
English: Reduce ONIVYDE pegylated liposomal dose to 50 mg/m
Croatian: Smanjiti dozu lijeka ONIVYDE pegilirani liposomalni na 50 mg/m2
English: Reduce ONIVYDE pegylated liposomal dose to 43 mg/m
Croatian: Smanjiti dozu ONIVYDE pegilirani liposomalni na 43 mg/m2
English: Servier Nederland Farma B.V. Tel: + 31 (0)71 5246700
Croatian: Tel: + 31 (0)71 5246700
English: Servier Pharma d. o. o. Tel: + 386 (0)1 563 48 11
Croatian: Tel: + 386 (0)1 563 48 11
English: headache, tightness in the chest or throat - Abnormal fluid retention in the body causing swelling in the affected tissues (oedema)
Croatian: - Upala želuca i crijeva (gastroenteritis) - Sustavna upala tijela uzrokovana infekcijom (sepsa)
English: Thrombocytopenia
Croatian: topoizomeraze I.
English: (maculo-papular rash) - Change in the colour of the nail plates
Croatian: Manje često: makulopapularni osip, promjene boje noktiju
English: Adverse reaction frequency** Infections and infestations Common: Septic shock, Sepsis, Pneumonia, Febrile neutropenia, Gastroenteritis, Oral candidiasis Uncommon: Biliary sepsis
Croatian: Često: septički šok, sepsa, upala pluća, febrilna neutropenija,
English: Servier Deutschland GmbH Tel: +49 (0)89 57095 01
Croatian: Tel: +49 (0)89 57095 01
English: Lot:
Croatian: Serija:
English: STATEMENT OF ACTIVE SUBSTANCE One 10 ml vial of concentrate contains 43 mg irinotecan anhydrous free base (as irinotecan sucrosofate salt in a pegylated liposomal formulation).
Croatian: NAVOĐENJE DJELATNE TVARI Jedna bočica sa 10 ml koncentrata sadrži 43 mg bezvodne slobodne baze irinotekana (u obliku irinotekansaharozasulfata u pegiliranoj liposomskoj formulaciji).
English: Acute infusion reactions were reported in 8 of 117 patients (6.8%) in the ONIVYDE pegylated liposomal +5-FU/LV arm, 3 of 147 patients (2.0%) in the ONIVYDE pegylated liposomal monotherapy arm, and 8 of 134 patients (6.0%) in the 5-FU/LV arm.
Croatian: ONIVYDE pegilirani liposomalni +5-FU/LV, u 3 od 147 bolesnika (2,0%) u skupini koja je primala ONIVYDE pegilirani liposomalni kao monoterapiju i u 8 od 134 bolesnika (6,0%) u skupini koja je primala samo 5-FU/LV.
English: In the clinical study evaluating ONIVYDE pegylated liposomal +5-FU/LV, the frequency of ≥ Grade 3 neutropenia in these patients [2 of 7 (28.6%)] was similar to the frequency in patients not homozygous for the UGT1A1*28 allele who received a starting dose of ONIVYDE pegylated liposomal of 70 mg/m
Croatian: U kliničkom ispitivanju koje je procjenjivalo ONIVYDE pegilirani liposomalni +5-FU/LV, učestalost neutropenije stupnja ≥3 u tih bolesnika [2 od 7 (28,6%)]
English: ONIVYDE pegylated liposomal should not be administered as a single agent.
Croatian: ONIVYDE pegilirani liposomalni se ne smije primjenjivati kao monoterapija.
English: stomatitis and pyrexia.
Croatian: CA Papaellinas Ltd.
English: Magyarország Servier Hungaria Kft. Tel: +36 1 238 7799
Croatian: Tel: +36 1 238 7799
English: Vascular disorders
Croatian: Trombocitopenija
English: Reduce ONIVYDE pegylated liposomal dose to 35 mg/m
Croatian: Smanjiti dozu lijeka ONIVYDE pegilirani liposomalni na 35 mg/m2
English: Patients randomised to ONIVYDE pegylated liposomal +5-FU/LV received ONIVYDE pegylated liposomal at 70 mg/m as an intravenous infusion over 90 minutes, followed by
Croatian: Bolesnici randomizirani za ONIVYDE pegilirani liposomalni +5-FU/LV primali su 70 mg/m2 lijeka ONIVYDE pegilirani liposomalni putem intravenske infuzije tijekom 90 minuta, nakon čega je slijedio LV 400 mg/m2 intravenski tijekom 30 minuta te potom 5-FU 2400 mg/m2 intravenski tijekom 46 sati, primijenjeno svaka 2 tjedna.
English: Close monitoring of blood counts is recommended, and the use of myeloid growth factors should be considered for patients with a history of abdominal radiation.
Croatian: Kod bolesnika s anamnezom zračenja abdomena preporučuje se pomno praćenje krvne slike, a potrebno je razmotriti i primjenu mijeloidnih faktora rasta.
English: Uncommon (may affect up to 1 in 100 people) - Systemic body inflammation, caused by infection of the gall bladder and bile ducts (biliary sepsis) - Allergic reaction to ONIVYDE pegylated liposomal (the active substance or the excipients) - Diminished availability of oxygen to the body tissues - Inflammation of the oesophagus (food pipe) - Formation or presence of a blood clot within a blood vessel - vein or artery (thrombosis) - Inflammation of the lining of the rectum (the end of the large intestine) - Type of rash, characterised by appearance of a flat, red area on the skin covered with bumps
Croatian: - Smanjena raspoloživost kisika u tjelesnim tkivima - Upala jednjaka (cijevi kroz koju prolazi hrana do želuca) - Stvaranje ili prisutnost krvnog ugruška u krvnoj žili - veni ili arteriji (tromboza)
English: The use of gloves, goggles and protective clothing when handling or administering ONIVYDE pegylated liposomal is recommended.
Croatian: pegilirani liposomalni preporučuje se uporaba rukavica, naočala i zaštitne odjeće.
English: ONIVYDE pegylated liposomal is a cancer medicine that contains the active substance irinotecan.
Croatian: Što je ONIVYDE pegilirani liposomalni i za što se koristi Što je ONIVYDE pegilirani liposomalni i kako djeluje ONIVYDE pegilirani liposomalni je lijek protiv raka koji sadrži djelatnu tvar irinotekan.
English: - If you get any side effects, talk to your doctor or nurse.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili medicinsku sestru.
English: Excipients
Croatian: Proljev
English: Non haematological toxicities
Croatian: Nehematološke toksičnosti2
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ONIVYDE pegylated liposomal 4.3 mg/ml concentrate for solution for infusion Irinotecan
Croatian: Uputa o lijeku: Informacije za korisnika ONIVYDE pegilirani liposomalni 4,3 mg/ml koncentrat za otopinu za infuziju
English: One 10 ml vial of concentrate contains 43 mg irinotecan anhydrous free base (as irinotecan sucrosofate salt in a pegylated liposomal formulation).
Croatian: Jedna bočica sa 10 ml koncentrata sadrži 43 mg bezvodne slobodne baze irinotekana (u obliku irinotekansaharozasulfata u pegiliranoj liposomskoj formulaciji).
English: Servier Laboratories c/o Icepharma hf Sími: + 354 540 8000
Croatian: Servier Laboratories c/o Icepharma hf
English: NAME OF THE MEDICINAL PRODUCT ONIVYDE pegylated liposomal 4.3 mg/ml concentrate for solution for infusion
Croatian: ONIVYDE pegilirani liposomalni 4,3 mg/ml koncentrat za otopinu za infuziju
English: Common: Colitis, Haemorrhoids
Croatian: - Umor - Omaglica
English: Сервие Медикал ЕООД Тел.
Croatian: Stoga, istodobna primjena lijeka ONIVYDE
English: Immune system disorders Uncommon: Hypersensitivity
Croatian: Poremećaji živčanog sustava Vrlo često: omaglica
English: - Soreness and swelling of the digestive tract lining (mucosal inflammation) - Fever - Generalised weakness
Croatian: - Potencijalno opasne po život komplikacije upale cijelog tijela (septički šok) - Infekcija pluća (pneumonija)
English: Servier Pharma SRL Tel: + 4 021 528 52 80
Croatian: Tel: + 4 021 528 52 80
English: Camptothecins act as specific inhibitors of the enzyme DNA topoisomerase I. Irinotecan and its active metabolite SN-38 bind reversibly to the topoisomerase I-DNA complex and induce single-strand DNA lesions which block the DNA replication fork and are responsible for the cytotoxicity.
Croatian: Irinotekan i njegov aktivni metabolit SN-38 reverzibilno se vežu za kompleks topoizomeraze
English: ONIVYDE pegylated liposomal +5-FU/LV (N= 117)
Croatian: (N=151) te za skupinu koja je primala 5-FU/LV (N=149).
English: Slovenská republika Servier Slovensko spol.
Croatian: Servier Hungaria Kft.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Croatian: OBLIK I SADRŽAJ
English: No cases of ILD-like events have been reported with ONIVYDE pegylated liposomal therapy in clinical studies.
Croatian: U kliničkim ispitivanjima nije zabilježen niti jedan događaj nalik na IBP.
English: Sucrose octasulphate
Croatian: Ostale pomoćne tvari saharozaoktasulfat
English: Very common: Pyrexia, Peripheral oedema, Mucosal inflammation, Fatigue, Asthenia
Croatian: Vrlo često: vrućica, periferni edem, upala sluznice, umor, astenija Često: reakcija povezana s infuzijom, edem
English: 280 capsules + 2 inhalers
Croatian: 280 kapsula + 2 inhalatora
English: Initiation Pack:10 capsules + 1 inhaler
Croatian: Paket za pokretanje: 10 kapsula + 1 inhalator
English: Packaging Package size
Croatian: Veličina pakovanja
English: The medicine is available as a spot-on solution in 2 different concentrations (6% and 12%) and in tubes of various sizes (15, 30, 45, 60, 120, 240 and 360 mg).
Croatian: VMP je dostupan u obliku otopine za nakapavanje u dvije različite koncentracije (6 % i 12 %) i u kapaljkama različitih jačina (15, 30, 45, 60, 120, 240 i 360 mg).
English: Evicto (selamectin)
Croatian: Evicto (selamektin)
English: This causes the paralysis or death of the parasites.
Croatian: To uzrokuje paralizu ili uginuće parazita.
English: Further information on Evicto can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/evicto.
Croatian: Više informacija o VMP-u Evicto nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/veterinary/EPAR/evicto.
English: This overview was last updated in May 2019.
Croatian: Pregled informacija posljednji je put ažuriran u 5. 2019.
English: Selamectin activates special proteins called ‘chloride channels' on the surface of nerve and muscle cells of the parasite, allowing charged chloride particles to enter nerve cells and disrupting their normal electrical activity.
Croatian: Selamektin aktivira posebne bjelančevine pod nazivom „kloridni kanali” na površini živčanih i mišićnih stanica parazita, pri čemu omogućuje nabijenim česticama klorida da uđu u živčane stanice i ometaju njihovu normalnu električnu aktivnost.
English: What is Evicto and what is it used for?
Croatian: Što je Evicto i za što se koristi?
English: What are the benefits and risks of Evicto?
Croatian: Koje su koristi i rizici od VMP-a Evicto?
English: As for every medicine, the company provided studies on the quality of Evicto.
Croatian: Kao i za svaki VMP, tvrtka je dostavila ispitivanja o kvaliteti VMP-a Evicto.
English: The active substance is absorbed through the skin and has an effect throughout the animal's body.
Croatian: Djelatna se tvar upija kroz kožu i djeluje na cijeloj površini tijela životinje.
English: Evicto contains selamectin, which is an antiparasitic medicine that belongs to the ‘avermectin' class.
Croatian: Evicto sadrži selamektin, antiparazitik koji pripada skupini „avermektina”.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Evicto has been shown to be comparable to Stronghold.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, utvrđeno da je VMP Evicto usporediv s VMP-om Stronghold.
English: The strength and the amount to use depend on the weight and species of the animal being treated, and the type of parasite.
Croatian: Jačina i količina doze za primjenu ovise o težini i vrsti životinje koja se liječi te o vrsti parazita.
English: Evicto (selamectin) EMA/287671/2019
Croatian: EMA/287671/2019
English: Other information about Evicto
Croatian: Ostale informacije o VMP-u Evicto
English: This is because the composition of Evicto is comparable to the reference medicine and when applied to the skin the active substance in both products is expected to be absorbed in the same way.
Croatian: Razlog tome je činjenica da je sastav VMP-a Evicto sličan sastavu referentnog lijeka i kada se primjenjuje na koži, očekuje se da se djelatna tvar kod obaju lijekova apsorbira na isti način.
English: This means that Evicto contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Stronghold.
Croatian: To znači da Evicto sadrži istu djelatnu tvar i djeluje na isti način kao i „referentni VMP” koji je već odobren u Europskoj uniji (EU) pod nazivom Stronghold.
English: The contents of the tube are squeezed onto the skin after parting the fur at the base of the neck between the shoulder blades.
Croatian: Sadržaj kapaljke istisne se na kožu nakon što se razdvoji dlaka na bazi vrata između lopatica.
English: An overview of Evicto and why it is authorised in the EU
Croatian: Pregled informacija o VMP-u Evicto i zašto je odobren u EU-u
English: There was no need for ‘bioequivalence' studies to investigate whether Evicto is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Croatian: Nije bilo potrebe za ispitivanjima bioekvivalencije kako bi se istražilo apsorbira li se VMP Evicto na sličan način kao referentni VMP radi proizvodnje jednake razine djelatne tvari u krvi.