FrancophonIA/ELRC3.0 huggingface dataset:
English: Reduce ONIVYDE pegylated liposomal dose to 43 mg/m
Slovenian: Odmerek zdravila ONIVYDE pegilirani liposomski zmanjšajte na 43 mg/m2
English: In a population pharmacokinetic analysis, patients with baseline total bilirubin concentrations of 1-2 mg/dl (n=19) had average steady state concentrations for total SN-38 that were increased by 37% (0.98 [95%CI: 0.94-1.02] and 1.29 [95%CI: 1.11-1.5] ng/ml, respectively) compared to patients with baseline bilirubin concentrations of < 1 mg/dl (n=329); however, there was no effect of elevated ALT/AST concentrations on total SN-38 concentrations.
Slovenian: odstotni IZ: 0,94 -1,02] oziroma 1,29 [95-odstotni IZ: 1,11 - 1,5] ng/ml) v primerjavi z bolniki z izhodiščno koncentracijo bilirubina < 1 mg/dl (n=329), vendar pa zvišane koncentracije ALT/AST niso vplivale na skupne koncentracije SN-38.
English: What ONIVYDE pegylated liposomal looks like and contents of the pack
Slovenian: Izgled zdravila ONIVYDE pegilirani liposomski in vsebina pakiranja
English: Reduce ONIVYDE pegylated liposomal dose to 35 mg/m
Slovenian: Odmerek zdravila ONIVYDE pegilirani liposomski zmanjšajte na 35 mg/m2
English: One 10 ml vial of concentrate contains 43 mg irinotecan anhydrous free base (as sucrosofate salt in a pegylated liposomal formulation).
Slovenian: Ena viala z 10 ml koncentrata vsebuje 43 mg brezvodnega irinotekana (v obliki soli saharoznega oktasulfata v pegilirani liposomski formulaciji).
English: One ml of concentrate contains 4.3 mg irinotecan anhydrous free base (as irinotecan sucrosofate salt in a pegylated liposomal formulation).
Slovenian: En mililiter koncentrata vsebuje 4,3 mg brezvodnega irinotekana (v obliki irinotekanijeve soli saharoznega oktasulfata v pegilirani liposomski formulaciji).
English: Eλλάδα
Slovenian: Jetrna okvara
English: Interactions with strong CYP3A4 inhibitors or strong UGT1A1 inhibitors
Slovenian: Interakcije z močnimi zaviralci encima CYP3A4 ali močnimi zaviralci encima UGT1A1 Zdravila ONIVYDE pegilirani liposomski ne smemo dajati skupaj z močnimi zaviralci encima
English: Tell your doctor if you are breast-feeding.
Slovenian: Obvestite zdravnika, če dojite.
English: ONIVYDE is supplied as a sterile liposomal dispersion at a concentration of 4.3 mg/ml and must be diluted prior to administration.
Slovenian: Priprava raztopine in dajanje Zdravilo ONIVYDE pegilirani liposomski je na voljo kot sterilna liposomska disperzija v koncentraciji 4,3 mg/ml, ki jo morate pred uporabo razredčiti.
English: Nervous system disorders Very common: Dizziness Common: Cholinergic syndrome, Dysgeusia
Slovenian: Pogosti: holinergični sindrom, disgevzija
English: In the clinical study Grade 3 or Grade 4 diarrhoea occurred in 15 out of 117 patients (12.8%) receiving ONIVYDE pegylated liposomal +5-FU/LV.
Slovenian: od 117 bolnikov (12,8 %), ki so prejemali zdravilo ONIVYDE pegilirani liposomski +5-FU/LV.
English: It is especially important that you tell your doctor if you are also taking the following medicines, since they increase the availability of irinotecan in your body: - ketoconazole, itraconazole or voriconazole (medicines used to treat fungal infections) - clarithromycin (an antibiotic medicine used to treat bacterial infections) - indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, atazanavir (medicines against HIV
Slovenian: - ketokonazol, itrakonazol ali vorikonazol (zdravila za zdravljenje glivičnih okužb), - klaritromicin (antibiotik za zdravljenje bakterijskih okužb), - indinavir, lopinavir, nelfinavir, ritonavir, sakvinavir, atazanavir (zdravila proti okužbi s HIV), - telaprevir (zdravilo za zdravljenje jetrne bolezni, imenovane hepatitis C), - nefazodon (zdravilo za zdravljenje depresije in slabega razpoloženja),
English: Infusion reactions primarily consisting of rash, urticaria, periorbital oedema or pruritus were reported in patients receiving ONIVYDE pegylated liposomal treatment.
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom ONIVYDE pegilirani liposomski, so poročali o infuzijskih reakcijah, večinoma izpuščaju, urtikariji, periorbitalnem edemu in pruritusu.
English: There is no known antidote for overdose of ONIVYDE pegylated liposomal.
Slovenian: Za preveliko odmerjanje zdravila ONIVYDE pegilirani liposomski ni znanega antidota.
English: Non haematological toxicities
Slovenian: Nehematološke toksičnosti2
English: One 10 ml vial of concentrate contains 43 mg irinotecan anhydrous free base (as irinotecan sucrosofate salt in a pegylated liposomal formulation).
Slovenian: Ena viala z 10 ml koncentrata vsebuje 43 mg brezvodnega irinotekana (v obliki irinotekanijeve soli saharoznega oktasulfata v pegilirani liposomski formulaciji).
English: Unstratified log-rank test
Slovenian: Analiza s Coxovim modelom Nestratificiran test log-rank Na osnovi normalne aproksimacije Fisherjev eksaktni test
English: NAME OF THE MEDICINAL PRODUCT ONIVYDE pegylated liposomal 4.3 mg/ml concentrate for solution for infusion
Slovenian: IME ZDRAVILA ONIVYDE pegilirani liposomski 4,3 mg/ml koncentrat za raztopino za infundiranje
English: New or progressive dyspnoea, cough, and fever should prompt interruption of ONIVYDE pegylated liposomal treatment, pending diagnostic evaluation.
Slovenian: Dokler ni opravljena diagnostična ocena, je treba ob pojavu nove ali napredovale dispneje, kašlja in povišane telesne temperature zdravljenje z zdravilom ONIVYDE pegilirani liposomski začasno prekiniti.
English: Nausea/vomiting
Slovenian: Navzea/bruhanje
English: Third occurrence
Slovenian: PRILOGA III
English: How to prepare and administer ONIVYDE pegylated liposomal
Slovenian: Priprava in dajanje zdravila ONIVYDE pegilirani liposomski
English: Interstitial Lung Disease (ILD)-like events leading to fatalities have occurred in patients receiving non-liposomal irinotecan.
Slovenian: Pri bolnikih, ki so prejemali neliposomski irinotekan, so se pojavili dogodki, podobni intersticijski pljučni bolezni (IPB), ki so vodili do smrtnih primerov.
English: Diarrhoea is a very common adverse reaction leading to colitis, ileus, gastroenteritis, fatigue, dehydration, weight loss, renal toxicities, hyponatraemia, and hypokalaemia.
Slovenian: Driska je zelo pogost neželeni učinek, ki privede do kolitisa, ileusa, gastroenteritisa, utrujenosti,
English: Diarrhoea and related adverse reactions
Slovenian: Driska in povezani neželeni učinki
English: What ONIVYDE pegylated liposomal is and how it works
Slovenian: Kaj je zdravilo ONIVYDE pegilirani liposomski in za kaj ga uporabljamo Kaj je zdravilo ONIVYDE pegilirani liposomski in kako deluje
English: A dose increase of ONIVYDE pegylated liposomal to 70 mg/m should be considered if tolerated in subsequent cycles.
Slovenian: Če zdravilo ONIVYDE pegilirani liposomski bolniki dobro prenašajo, lahko v naslednjih ciklih razmislimo o odmerku 70 mg/m2.
English: Pregnant staff should not handle ONIVYDE pegylated liposomal considering the cytotoxic nature of the medicinal product.
Slovenian: Nosečnice z zdravilom ONIVYDE pegilirani liposomski zaradi njegove citotoksičnosti ne smejo delati.
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.
Slovenian: ONIVYDE pegilirani liposomski +5-FU/LV, pri 3 od 147 (2,0 %) v veji z zdravilom ONIVYDE pegilirani liposomski v monoterapiji in pri 8 od 134 bolnikov (6,0 %) v veji s 5-FU/LV.
English: Adverse reaction frequency** Infections and infestations Common: Septic shock, Sepsis, Pneumonia, Febrile neutropenia, Gastroenteritis, Oral candidiasis Uncommon: Biliary sepsis
Slovenian: Pogosti: septični šok, sepsa, pljučnica, febrilna nevtropenija,
English: In the clinical study evaluating ONIVYDE pegylated liposomal +5-FU/LV, 5 of 8 underweight patients experienced a grade 3 or 4 adverse reaction, mostly myelosuppression, while 7 of the 8 patients required dose modification such as dose delay, dose reduction or dose discontinuation (see section 4.4).
Slovenian: bolnikov s premajhno telesno maso doživelo neželeni učinek 3. ali 4. stopnje, večinoma mielosupresijo, pri 7 od 8 bolnikov pa je bila potrebna sprememba odmerjanja, na primer odložitev odmerka, zmanjšanje odmerka ali prekinitev odmerjanja (glejte poglavje 4.4).
English: Sucrose octasulphate
Slovenian: Druge pomožne snovi saharozni oktasulfat
English: ONIVYDE pegylated liposomal is a cytotoxic medicinal product, and caution should be exercised in handling it.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Zdravilo ONIVYDE pegilirani liposomski je citotoksično zdravilo, zato je pri ravnanju z njim potrebna previdnost.
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
Slovenian: Bolniki, randomizirani na zdravilo ONIVYDE pegilirani liposomski +5-FU/LV, so na 2 tedna prejemali zdravilo ONIVYDE pegilirani liposomski v odmerku 70 mg/m2 v obliki 90-minutne intravenske infuzije, ki ji je sledila 30-minutna intravenska infuzija LV v odmerku 400 mg/m2, temu pa 46-urna intravenska infuzija 5-FU v odmerku 2400 mg/m2.
English: Common (may affect up to 1 in 10 people) - Chills - Infections, for example fungal infections in the mouth (oral candidiasis), fever with low counts of white blood cells (febrile neutropenia), infections related to the administration of the product into a vein - Inflammation of the stomach and the guts (gastroenteritis) - Systemic body inflammation, caused by infection (sepsis) - Potentially life-threatening complication of whole body inflammation (septic shock) - Infection of the lungs (pneumonia) - Low level of white blood cells subtype, called lymphocytes with important function for the immune system (lymphopenia) - Decrease in some salts (electrolytes) in the body (e.g. phosphate, sodium) - Low blood sugar (hypoglycaemia) - Sleeplessness - Bad taste in the mouth - A syndrome called cholinergic syndrome with sweating, salivation and abdominal cramping - Low blood pressure (hypotension) - Formation of a blood clot in a deep vein (deep vein thrombosis) or blockage of the main artery of the lung or one of its branches (pulmonary embolism), or blockage due to a blood clot elsewhere in the blood stream (embolism) - Voice impairment, hoarse or excessively breathy voice - Shortness of breath - Inflammation in the gut - Piles(haemorrhoids) - Increases in liver enzymes (alanine aminotransferase or aspartate aminotransferase) in laboratory blood tests - Increase in bilirubin levels (an orange-yellow pigment, waste product of the normal breakdown of the red blood cells) in other laboratory measurements related to liver function - Increase in other laboratory measurements (increased international normalized ratio) related to the blood clotting system function - Abnormally low blood levels of albumin (major protein in the body) - Sudden problems with kidney function which may lead to rapid deterioration or loss of the kidney function - Abnormal reaction to the infusion causing symptoms like shortness of breath, flushing,
Slovenian: - nizek krvni tlak (hipotenzija), - nastanek krvnega strdka v globoki veni (globoka venska tromboza) ali zapora glavne pljučne arterije ali ene izmed njenih vej (pljučna embolija) ali zapora zaradi krvnega strdka drugje v krvnem obtoku (embolija), - okvara glasu, hripav ali pretirano zasopel glas, - zasoplost,
English: Very common: Alopecia
Slovenian: Zelo pogosti: omotica
English: NAME OF THE MEDICINAL PRODUCT ONIVYDE pegylated liposomal 4.3 mg/ml concentrate for solution for infusion Irinotecan
Slovenian: IME ZDRAVILA onivyde pegilirani liposomski 4,3 mg/ml koncentrat za raztopino za infundiranje irinotekan
English: ONIVYDE pegylated liposomal 4.3 mg/ml concentrate for solution for infusion Irinotecan
Slovenian: Navodilo za uporabo ONIVYDE pegilirani liposomski 4,3 mg/ml koncentrat za raztopino za infundiranje irinotekan
English: Caution should be exercised in patients receiving concurrent administration of ONIVYDE pegylated liposomal with irradiation.
Slovenian: Pri bolnikih, ki hkrati prejemajo zdravilo ONIVYDE pegilirani liposomski in so obsevani, je potrebna previdnost.
English: Dose modifications for leukopenia and thrombocytopenia are based on NCI CTCAE toxicity grading and are the same as recommended for neutropenia above.
Slovenian: Nov cikel zdravljenja se ne sme začeti, dokler število trombocitov ne doseže ≥ 100.000 trombocitov/mm3 Spreminjanje odmerka zaradi levkopenije in trombocitopenije temelji na določitvi toksičnosti po NCI CTCAE in je enako kot pri zgoraj navedenih priporočilih za nevtropenijo.
English: No genotoxicity studies have been performed with ONIVYDE pegylated liposomal.
Slovenian: Študij genotoksičnosti zdravila ONIVYDE pegilirani liposomski niso izvedli.
English: - if you experience sudden shortness of breath, flushing, nausea, headache, skin rash or hives (itchy rash with swollen red bumps on the skin that appear suddenly), itching, swelling around the eyes, tightness in the chest or throat during the infusion or shortly after it (as the infusion may need to be stopped and you may need to be treated or observed for the side effects) - if you get fever, chills and signs of an infection (as this might require immediate treatment) - if you have severe persistent diarrhoea (liquid and frequent stools)-see section 2
Slovenian: (srbeč izpuščaj z nenadnim pojavom otečenih rdečih bunkic na koži), srbečico, otekanje okrog oči, tiščanje v prsih ali grlu med infuzijo ali kmalu po njej (ker bo infuzijo morda treba prekiniti,
English: Hepatic, renal, respiratory or other toxicities
Slovenian: respiratorna ali druga2 toksičnost
English: Concentrate for solution for infusion.
Slovenian: FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje
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.
Slovenian: Skupno med bolniki, starimi ≥ 65 let, in bolniki, starimi < 65 let, niso poročali o večjih kliničnih razlikah v varnosti ali učinkovitosti, vendar so v prvi skupini, zdravljeni z zdravilom ONIVYDE
English: - Soreness and swelling of the digestive tract lining (mucosal inflammation) - Fever - Generalised weakness
Slovenian: - povišana telesna temperatura, - splošna oslabelost.
English: It is also especially important that you tell your doctor if you are also taking the following medicines, since they reduce the availability of irinotecan in your body: - phenytoin, phenobarbital or carbamazepine (medicines used to treat convulsions and falls) - rifampicin and rifabutin (medicines used to treat tuberculosis) - St. John´s wort (a plant based medicine used to treat depression and low mood) - as ONIVYDE pegylated liposomal should not be given to you together with these medicines.
Slovenian: - rifampicin in rifabutin (zdravili za zdravljenje tuberkuloze), - šentjanževka (zdravilo rastlinskega izvora za zdravljenje depresije in slabega razpoloženja), - ker se zdravilo ONIVYDE pegilirani liposomski ne sme dajati skupaj s temi zdravili.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ONIVYDE pegylated liposomal 4.3 mg/ml concentrate for solution for infusion Irinotecan
Slovenian: IME ZDRAVILA IN POT(I) UPORABE onivyde pegilirani liposomski 4,3 mg/ml koncentrat za raztopino za infundiranje irinotekan i.v.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Onivyde pegylated liposomal (irinotecan) is not equivalent to non-liposomal formulations.
Slovenian: Zdravilo onivyde pegilirani liposomski (irinotekan) ni enakovredno neliposomskim formulacijam.
English: Other excipients
Slovenian: DRUGI PODATKI
English: In patients receiving ONIVYDE pegylated liposomal +5-FU/LV, the incidence of ≥ Grade 3 neutropenia was higher among Asian patients [18 of 33 (55%)] compared to Caucasians patients [13 of 73 (18%)].
Slovenian: stopnje višja pri bolnikih azijskega porekla [18 od 33 (55 %)] kot pri kavkazijskih bolnikih
English: No cases of ILD-like events have been reported with ONIVYDE pegylated liposomal therapy in clinical studies.
Slovenian: Pri zdravljenju z zdravilom ONIVYDE pegilirani liposomski v kliničnih študijah ni bilo primerov dogodkov, podobnih IPB.
English: Gastrointestinal disorders Very common: Diarrhoea, Vomiting, Nausea, Abdominal pain, Stomatitis
Slovenian: Zelo pogosti: driska, bruhanje, navzea, bolečine v trebuhu, stomatitis Pogosti: kolitis, hemoroidi
English: The most common serious adverse reactions (≥ 2%) of ONIVYDE pegylated liposomal therapy were diarrhoea, vomiting, febrile neutropenia, nausea, pyrexia, sepsis, dehydration, septic shock, pneumonia, acute renal failure, and thrombocytopenia.
Slovenian: pegilirani liposomski so bili driska, bruhanje, febrilna nevtropenija, navzea, pireksija, sepsa,
English: Common: Dyspnoea, Dysphonia
Slovenian: Pogosti: dispneja, disfonija Občasni: hipoksija
English: Excipients
Slovenian: Driska
English: Water for injections See leaflet for further information.
Slovenian: Za več informacij glejte navodilo za uporabo.
English: How to store ONIVYDE pegylated liposomal
Slovenian: Kaj vsebuje zdravilo ONIVYDE pegilirani liposomski
English: No dedicated hepatic impairment study has been conducted with ONIVYDE pegylated liposomal.
Slovenian: Z zdravilom ONIVYDE pegilirani liposomski niso izvedli posebne študije pri ledvični okvari.
English: ONIVYDE pegylated liposomal contains sodium
Slovenian: Zdravilo ONIVYDE pegilirani liposomski vsebuje natrij.
English: Servier Nederland Farma B.V. Tel: + 31 (0)71 5246700
Slovenian: Tel: + 31 (0)71 5246700
English: Table 2: Recommended dose modifications for ONIVYDE pegylated liposomal +5-FU/LV for Grade 3-4 toxicities in patients homozygous for UGT1A1*28
Slovenian: +5-FU/LV pri toksičnosti 3.-4. stopnje pri bolnikih, ki so homozigoti za UGT1A1*28 Stopnja (vrednost)
English: Table 1: Recommended dose modifications for ONIVYDE pegylated liposomal +5-FU/LV for Grade 3-4 toxicities for patients not homozygous for UGT1A1*28
Slovenian: +5-FU/LV pri toksičnosti 3.-4. stopnje pri bolnikih, ki niso homozigoti za UGT1A1*28 Stopnja (vrednost)
English: Very common: Weight decrease
Slovenian: Pogosti: akutna ledvična odpoved
English: ONIVYDE pegylated liposomal is a cytotoxic medicinal product.
Slovenian: Zdravilo ONIVYDE pegilirani liposomski je citotoksično.
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)
Slovenian: - majhno število podvrste belih krvnih celic, imenovanih limfociti, ki imajo pomembno vlogo v imunskem sistemu (limfopenija), - znižanje ravni nekaterih soli (elektrolitov) v telesu (npr. fosfata, natrija), - nizka raven sladkorja v krvi (hipoglikemija),
English: Common: Colitis, Haemorrhoids
Slovenian: Občasni: makulopapulozni izpuščaj, obarvanje nohtov
English: How ONIVYDE pegylated liposomal is used
Slovenian: Za kaj uporabljamo zdravilo ONIVYDE pegilirani liposomski
English: DSPC
Slovenian: PK-parametri
English: ONIVYDE pegylated liposomal should not be administered with strong UGT1A inhibitors (e.g. atazanavir, gemfibrozil, indinavir) unless there are no therapeutic alternatives.
Slovenian: (npr. atazanavirjem, gemfibrozilom, indinavirjem), razen če ni drugih terapevtskih možnosti.
English: - if you have a history of a severe allergy to irinotecan, or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila ONIVYDE pegilirani liposomski: - če ste v preteklosti imeli hudo alergijo na irinotekan ali katero koli sestavino tega zdravila
English: ONIVYDE pegylated liposomal should be discontinued in patients with a confirmed diagnosis of ILD.
Slovenian: Pri bolnikih s potrjeno diagnozo IPB moramo zdravljenje z zdravilom ONIVYDE pegilirani liposomski dokončno prekiniti.
English: 280 capsules + 2 inhalers
Slovenian: 280 kapsul + 2 inhalatorja
English: Initiation Pack:10 capsules + 1 inhaler
Slovenian: Začetni paket: 10 kapsul + 1 inhalator
English: Packaging Package size
Slovenian: Velikost pakiranja
English: (Invented) name
Slovenian: (Lastniško ime) Jakost
English: This overview was last updated in May 2019.
Slovenian: Povzetek je bil nazadnje posodobljen maja 2019.
English: Evicto (selamectin)
Slovenian: Evicto (selamektin)
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).
Slovenian: Zdravilo je na voljo v obliki raztopine za kožni nanos v dveh različnih koncentracijah (6 % in 12 %) in v tubah različnih jakosti (15, 30, 45, 60, 120, 240 in 360 mg).
English: Further information on Evicto can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/evicto.
Slovenian: Nadaljnje informacije o zdravilu Evicto so na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary/EPAR/evicto.
English: Why is Evicto authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Evicto odobreno v EU?
English: This causes the paralysis or death of the parasites.
Slovenian: To povzroči paralizo in pogin parazitov.
English: As for every medicine, the company provided studies on the quality of Evicto.
Slovenian: Tako kot za vsako zdravilo je podjetje predložilo študije o kakovosti zdravila Evicto.
English: The active substance is absorbed through the skin and has an effect throughout the animal's body.
Slovenian: Učinkovina se absorbira skozi kožo in učinkuje na celotno telo živali.
English: An overview of Evicto and why it is authorised in the EU
Slovenian: Pregled zdravila Evicto in zakaj je odobreno v EU
English: The European Medicines Agency concluded that, in accordance with EU requirements, Evicto has been shown to be comparable to Stronghold.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Evicto primerljivo z zdravilom Stronghold.
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.
Slovenian: Selamektin aktivira posebne beljakovine, imenovane „kloridni kanali“, na površini živčnih in mišičnih celic parazitov, kar nabitim kloridnim delcem omogoča, da vstopijo v živčne celice in ohromijo njihovo običajno električno dejavnost.
English: Other information about Evicto
Slovenian: Druge informacije o zdravilu Evicto
English: What are the benefits and risks of Evicto?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Evicto?
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.
Slovenian: To pomeni, da vsebuje enako učinkovino in ima enak način delovanja kot referenčno zdravilo Stronghold, ki je že odobreno v Evropski uniji (EU).
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Stronghold, and do not need to be repeated for Evicto.
Slovenian: Študije o koristih in tveganjih učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Stronghold, zato jih ni treba ponoviti za zdravilo Evicto.
English: Evicto received a marketing authorisation valid throughout the EU on 19 July 2019.
Slovenian: Zdravilo Evicto je dovoljenje za promet, veljavno po vsej EU, pridobilo 19/07/2019.