FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 2: Recommended dose modifications for ONIVYDE pegylated liposomal +5-FU/LV for Grade 3-4 toxicities in patients homozygous for UGT1A1*28
Danish: Tabel 2: Anbefalede dosisændringer for ONIVYDE pegyleret liposomal + 5-FU/LV ved grad 3-4 toksicitet hos patienter, der er homozygote for UGT1A1*28
English: ONIVYDE is supplied as a sterile liposomal dispersion at a concentration of 4.3 mg/ml and must be diluted prior to administration.
Danish: ONIVYDE pegyleret liposomal leveres som en steril liposomal dispersion i en koncentration på 4,3 mg/ml, som skal fortyndes før administration.
English: ONIVYDE pegylated liposomal /5-FU adjustment (for patients not homozygous for UGT1A1*28)
Danish: Justering af ONIVYDE pegyleret liposomal/5-FU (for patienter, der ikke er homozygote for UGT1A1*28)
English: You must not be given ONIVYDE if you are breast-feeding as this may be harmful to your baby.
Danish: Du må ikke få ONIVYDE pegyleret liposomal, hvis du ammer, da det kan skade barnet.
English: If the solution contacts mucous membranes, they should be flushed thoroughly with water.
Danish: Ved kontakt med slimhinder skylles grundigt med rigelige mængder vand.
English: Gastrointestinal disorders Very common: Diarrhoea, Vomiting, Nausea, Abdominal pain, Stomatitis
Danish: Meget almindelig: Diarré, opkastning, kvalme, abdominalsmerter, stomatitis
English: No dose adjustment is recommended in patients with mild to moderate renal impairment (see sections 4.4 and 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter med let til moderat nedsat nyrefunktion (se pkt.
English: A new cycle of therapy should not begin until the platelet count is ≥ 100,000 platelets/mm
Danish: En ny behandlingscyklus bør ikke påbegyndes, før trombocyttallet er ≥ 100.000 trombocytter/mm
English: Servier Italia S.p.A. Tel: + 39 (06) 669081
Danish: Tel: + 39 (06) 669081
English: Talk to your doctor or nurse immediately during treatment with ONIVYDE pegylated liposomal - if you feel sudden shortness of breath, flushing, headache, skin rash or hives (itchy rash with swollen red bumps on the skin that appear suddenly), itching, swelling around the eyes,
Danish: Kontakt straks lægen eller sundhedspersonalet under behandlingen med ONIVYDE pegyleret liposomal - Hvis du pludseligt får åndedrætsbesvær, ansigtsrødme, hovedpine, hududslæt eller nældefeber (pludseligt får kløende udslæt med hævede røde buler på huden), kløe, hævelse omkring øjnene, trykken for brystet eller en snørende fornemmelse omkring halsen under eller kort efter infusionen.
English: Hazard Ratio (95% CI) p-value
Danish: Risikorate (95 % CI) p-værdi
English: No reproductive and developmental toxicity studies have been performed with ONIVYDE pegylated liposomal.
Danish: Der er ikke udført studier af reproduktions- og udviklingstoksicitet med ONIVYDE pegyleret liposomal.
English: The rates of adverse reactions leading to permanent treatment discontinuation were 11% for the ONIVYDE pegylated liposomal +5-FU/LV arm and 12% for the monotherapy arm.
Danish: Andelen af patienter, der seponerede behandlingen permanent pga. bivirkninger, var 11 % i ONIVYDE pegyleret liposomal + 5-FU/LV-gruppen og 12 % i monoterapigruppen.
English: Renal impairment and acute renal failure have been identified, usually in patients who became volume depleted from severe vomiting and/or diarrhoea.
Danish: Nedsat nyrefunktion og akut nyresvigt er især set hos patienter med hypovolæmi som følge af svær opkastning og/eller diarré.
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).
Danish: I alt 417 patienter blev randomiseret, 117 til ONIVYDE pegyleret liposomal + 5-FU/LV-gruppen, 151 til ONIVYDE pegyleret liposomal-monoterapigruppen og 149 til 5-FU/LV-gruppen.
English: No carcinogenicity studies have been performed with ONIVYDE pegylated liposomal.
Danish: Der er ikke udført karcinogenicitetsstudier med ONIVYDE pegyleret liposomal.
English: Reduce 5-FU dose by 25% (1,800 mg/m
Danish: Reducer ONIVYDE pegyleret liposomal-dosis til 50 mg/m Reducer 5-FU-dosis med 25 % (1.800 mg/m
English: Grade 3 or higher neutropenia occurred more frequently in patients treated with ONIVYDE pegylated liposomal +5-FU/LV (27.4%) compared to patients treated with 5-FU/LV (1.5%).
Danish: Neutropeni af grad 3 eller højere forekom hyppigere hos patienter i ONIVYDE pegyleret liposomal + 5-FU/LVgruppen (27,4 %) end i 5-FU/LV-gruppen (1,5 %).
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).
Danish: I det kliniske studie, der evaluerede ONIVYDE pegyleret liposomal + 5-FU/LV, oplevede 5 ud af 8 undervægtige patienter en bivirkning af grad 3 eller 4, især myelosuppression, dosisændring, f.eks. udskydelse af dosis, dosisreduktion eller seponering var nødvendig hos 7 ud af 8 patienter (se pkt.
English: ONIVYDE pegylated liposomal 4.3 mg/ml concentrate for solution for infusion Irinotecan
Danish: ONIVYDE pegyleret liposomal 4,3 mg/ml koncentrat til infusionsvæske, opløsning Irinotecan
English: No dedicated pharmacokinetic study has been conducted in patients with renal impairment.
Danish: Der er ikke udført specifikke farmakokinetiske studier hos patienter med nedsat nyrefunktion.
English: No dedicated pharmacokinetic study has been conducted in patients with hepatic impairment.
Danish: Der er ikke udført specifikke farmakokinetiske studier af patienter med nedsat leverfunktion.
English: Interactions with strong CYP3A4 inhibitors or strong UGT1A1 inhibitors
Danish: Interaktion med potente CYP3A4-hæmmere og potente UGT1A1-hæmmere
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).
Danish: - Hvis du er svært overfølsom over for irinotecan eller et af de øvrige indholdsstoffer i
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
Danish: Tabel 1: Anbefalede dosisændringer for ONIVYDE pegyleret liposomal + 5-FU/LV ved grad 3-4 toksicitet hos patienter, der ikke er homozygote for UGT1A1*28
English: In case of a dose increase of ONIVYDE pegylated liposomal to 70 mg/m if tolerated in subsequent cycles, recommended dose modifications should follow Table 1.
Danish: Asteni og anoreksi af grad 3 nødvendiggør ikke dosisjustering I tilfælde af en forhøjelse af ONIVYDE pegyleret liposomal-dosis til 70 mg/m i efterfølgende cyklusser, hvis det tolereres, bør anbefalede dosisændringer følge tabel 1
English: A new cycle of therapy should not begin until the adverse reaction resolves to ≤ Grade 1
Danish: En ny behandlingscyklus bør ikke påbegyndes, før bivirkningen er reduceret til ≤ grad 1.
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.
Danish: - Hvis du får diarré med hyppig flydende afføring, og det ikke er under kontrol 12-24 timer efter behandlingen (se nedenfor).
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.
Danish: Trombocytopeni af grad 3 eller højere forekom hos 2,6 % af patienterne i ONIVYDE pegyleret liposomal + 5-FU/LV-gruppen og hos 0 % i 5-FU/LV-gruppen.
English: Breast-feeding
Danish: HEPES-buffer
English: Grade 3 or higher anaemia occurred in 10.3% of patients treated with ONIVYDE pegylated liposomal +5-FU/LV and in 6.7% of patients treated with 5-FU/LV.
Danish: Anæmi af grad 3 eller højere forekom hos 10,3 % af patienterne i ONIVYDE pegyleret liposomal + 5-FU/LV-gruppen og hos 6,7 % i 5-FU/LV-gruppen.
English: water, soda water, fizzy drinks, soup) to avoid losing too much liquid and salts from your body.
Danish: Så snart du får den første flydende afføring, skal du begynde af drikke store mængder væske for at genoprette væskebalancen (f.eks. vand, danskvand, kulsyreholdige drikke, suppe), så kroppen ikke mister for meget væske og salte.
English: - if you are breastfeeding
Danish: - Hvis du ammer.
English: Strong CYP3A4 inhibitors and UGT1A1 inhibitors
Danish: Potente CYP3A4-hæmmere og UGT1A1-hæmmere
English: Reduce ONIVYDE pegylated liposomal dose to 35 mg/m
Danish: Reducer ONIVYDE pegyleret liposomal-dosis til 35 mg/m
English: ONIVYDE pegylated liposomal contains sodium, if you are on a controlled sodium diet, see section 2.
Danish: Se punkt 2, hvis du er på en natriumkontrolleret diæt.
English: Preparation of the solution and administration
Danish: Klargøring af infusionsvæske og administration
English: Nervous system disorders Very common: Dizziness Common: Cholinergic syndrome, Dysgeusia
Danish: Almindelig: Kolinergt syndrom, dysgeusi
English: In the population pharmacokinetic analysis in patients with ONIVYDE pegylated liposomal using the results of a subset with UGT1A1*28 genotypic testing, in which the analysis adjusted for the lower dose administered to patients homozygous for the UGT1A1*28 allele, patients homozygous (N=14) and non-homozygous (N=244) for this allele had total SN-38 average steady-state concentrations of 1.06 and 0.95 ng/ml, respectively.
Danish: I en populationsfarmakokinetisk analyse af ONIVYDE pegyleret liposomal med anvendelse af resultater fra en undergruppe af patienter med UGT1A1*28-genotypetestning, hvor analysen justerede for den lavere dosis, der blev givet til patienter, som var homozygote for UGT1A1*28-allelen, havde patienter, som var homozygote
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ONIVYDE pegylated liposomal 4.3 mg/ml concentrate for solution for infusion Irinotecan
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) ONIVYDE pegyleret liposomal 4,3 mg/ml koncentrat til infusionsvæske, opløsning Irinotecan i.v.-administration efter fortynding
English: h×ng/ml
Danish: l/m²
English: Other medicines and ONIVYDE pegylated liposomal
Danish: Brug af anden medicin sammen med ONIVYDE pegyleret liposomal
English: Common: Pulmonary embolism, Embolism, Deep vein thrombosis Uncommon: Thrombosis
Danish: Almindelig: Lungeemboli, emboli, dyb venetrombose
English: ONIVYDE pegylated liposomal is given as a drip (infusion) into a vein, which should take at least 90 minutes and should be given as a single dose.
Danish: Infusionen tager mindst 90 minutter og gives som en enkeltdosis.
English: ONIVYDE pegylated liposomal geomean (95% CI)
Danish: b, geometrisk gennemsnit (95 % CI)
English: What to do in case of diarrhoea
Danish: Hvis du får diarré
English: NAME OF THE MEDICINAL PRODUCT ONIVYDE pegylated liposomal 4.3 mg/ml concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN ONIVYDE pegyleret liposomal 4,3 mg/ml koncentrat til infusionsvæske, opløsning
English: Reduce ONIVYDE pegylated liposomal dose to 43 mg/m
Danish: Reducer ONIVYDE pegyleret liposomal-dosis til 43 mg/m
English: Optimise antiemetic therapy Reduce ONIVYDE pegylated liposomal dose to 50 mg/m
Danish: Optimer den antiemetiske behandling Reducer ONIVYDE pegyleret liposomal-dosis til 50 mg/m
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%)].
Danish: ONIVYDE pegyleret liposomal + 5-FU/LV-gruppen (4 patienter (3,4 %)) end i 5-FU/LV-kontrolgruppen (1 patient (0,7 %)).
English: Other excipients
Danish: Andre hjælpestoffer
English: No genotoxicity studies have been performed with ONIVYDE pegylated liposomal.
Danish: Der er ikke foretaget genotoksicitetsstudier med ONIVYDE pegyleret liposomal.
English: Special populations Hepatic impairment
Danish: Særlige populationer Nedsat leverfunktion
English: One ml of concentrate contains 4.3 mg irinotecan anhydrous free base (as irinotecan sucrosofate salt in a pegylated liposomal formulation).
Danish: 1 ml koncentrat indeholder 4,3 mg irinotecan vandfri fri base (som irinotecansucrosofatsalt i en pegyleret liposomal formulering).
English: (maculo-papular rash) - Change in the colour of the nail plates
Danish: (makulopapuløst udslæt) - Misfarvning af neglene
English: How to handle and dispose of ONIVYDE pegylated liposomal
Danish: Håndtering og bortskaffelse af ONIVYDE pegyleret liposomal
English: Dose adjustments, as summarised in Table 1 and Table 2, are recommended to manage Grade 3 or 4 toxicities related to ONIVYDE pegylated liposomal.
Danish: Ved toksicitet af grad 3 eller 4 i forbindelse med ONIVYDE pegyleret liposomal anbefales dosisjustering i henhold til tabel 1 og 2.
English: In the limited number of patients with prior exposure to non-liposomal irinotecan, no benefit of ONIVYDE pegylated liposomal has been demonstrated.
Danish: Der blev ikke påvist nogen fordele ved ONIVYDE pegyleret liposomal hos det begrænsede antal patienter, som tidligere havde været eksponeret for nonliposomal irinotecan.
English: Optimise antiemetic therapy Reduce ONIVYDE pegylated liposomal dose to 43 mg/m
Danish: Optimer den antiemetiske behandling Reducer ONIVYDE pegyleret liposomal-dosis til 43 mg/m
English: What ONIVYDE pegylated liposomal contains
Danish: ONIVYDE pegyleret liposomal indeholder:
English: ONIVYDE pegylated liposomal should not be administered as a single agent.
Danish: ONIVYDE pegyleret liposomal bør ikke gives alene.
English: In patients who experienced severe haematological events, a dose reduction or treatment discontinuation is recommended (see section 4.2).
Danish: Dosisreduktion eller behandlingsophør anbefales til patienter, som har oplevet svære hæmatologiske bivirkninger (se pkt.
English: What ONIVYDE pegylated liposomal is and what it is used for What you need to know before you use ONIVYDE pegylated liposomal How ONIVYDE pegylated liposomal is used Possible side effects
Danish: Det skal du vide, før du begynder at bruge ONIVYDE pegyleret liposomal Sådan bruges ONIVYDE pegyleret liposomal Bivirkninger
English: Mix the diluted solution by gentle inversion.
Danish: Bland den fortyndede opløsning ved at vende den forsigtigt op og ned.
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
Danish: Patienter, som var randomiseret til ONIVYDE pegyleret liposomal + 5-FU/LV, fik 70 mg/m
English: Very common: Pyrexia, Peripheral oedema, Mucosal inflammation, Fatigue, Asthenia
Danish: Meget almindelig: Pyreksi, perifert ødem, slimhindeinflammation, træthed, asteni Almindelig: Infusionsrelateret reaktion, ødem
English: [30 of 110 (27.3%)] (see section 5.1).
Danish: ONIVYDE pegyleret liposomal (30 ud af 110 (27,3 %)) (se pkt.
English: Clearance (CL)
Danish: c, gennemsnit (SD)
English: The use of ONIVYDE pegylated liposomal in patients with significant renal impairment has not been established (see section 5.2).
Danish: ONIVYDE pegyleret liposomal er ikke blevet undersøgt hos patienter med signifikant nedsat nyrefunktion (se pkt.
English: Immune system disorders Uncommon: Hypersensitivity
Danish: Ikke almindelig: Overfølsomhed
English: How to prepare and administer ONIVYDE pegylated liposomal
Danish: Klargøring og administration af ONIVYDE pegyleret liposomal
English: One 10 ml vial of concentrate contains 43 mg irinotecan anhydrous free base (as sucrosofate salt in a pegylated liposomal formulation).
Danish: Et 10 ml hætteglas med koncentrat indeholder 43 mg irinotecan vandfri fri base (som sucrosofatsalt i en pegyleret liposomal formulering).
English: What ONIVYDE pegylated liposomal is used for
Danish: Hvad bruges ONIVYDE pegyleret liposomal til?
English: Overall Survival Number of deaths, n (%) Median OS (months) (95% CI)
Danish: Median SO (måneder) (95 % CI)
English: Uncommon: Oesophagitis, Proctitis
Danish: Almindelig: Kolitis, hæmorroider Ikke almindelig: Øsofagitis, proktitis
English: How ONIVYDE pegylated liposomal is used
Danish: Sådan bruges ONIVYDE pegyleret liposomal
English: One 10 ml vial of concentrate contains 43 mg irinotecan anhydrous free base (as irinotecan sucrosofate salt in a pegylated liposomal formulation).
Danish: Et 10 ml hætteglas med koncentrat indeholder 43 mg irinotecan vandfri fri base (som irinotecansucrosofatsalt i en pegyleret liposomal formulering).
English: Breast-feeding (see section 4.6).
Danish: ONIVYDE pegyleret liposomal (angivet i punkt 6).
English: Servier Nederland Farma B.V. Tel: + 31 (0)71 5246700
Danish: Tel: + 31 (0)71 5246700
English: Pregnant staff should not handle ONIVYDE pegylated liposomal.
Danish: ONIVYDE pegyleret liposomal må ikke håndteres af gravide.
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).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Et 10 ml hætteglas med koncentrat indeholder 43 mg irinotecan vandfri fri base (som irinotecansucrosofatsalt i en pegyleret liposomal formulering).
English: MPEG-2000-DSPE Sucrose octasulphate HEPES buffer
Danish: MPEG-2000-DSPE
English: Discontinue treatment Anaphylactic reaction First occurrence Discontinue treatment NCI CTCAE v 4.0 = National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 Excludes asthenia and anorexia; Asthenia and Grade 3 anorexia do not require dose adjustment.
Danish: NCI CTCAE v 4.0 = National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
English: - If you have any further questions, ask your doctor or nurse.
Danish: - Spørg lægen eller sundhedspersonalet, hvis der er mere, du vil vide.
English: ONIVYDE pegylated liposomal is largely confined to vascular fluid.
Danish: ONIVYDE pegyleret liposomal var 2,6 l/m 2, hvilket tyder på, at ONIVYDE pegyleret liposomal stort set er begrænset til vaskulær væske.
English: Neutropenic fever
Danish: celler/mm3) eller neutropen feber
English: If loose stools persist, contact your doctor.
Danish: Kontakt lægen, hvis den løse afføring fortsætter.
English: 280 capsules + 2 inhalers
Danish: 280 kapsler + 2 inhalatorer
English: Packaging Package size
Danish: Emballage Pakningsstørrelse
English: Initiation Pack:10 capsules + 1 inhaler
Danish: 10 kapsler + 1 inhalator
English: This overview was last updated in May 2019.
Danish: Denne oversigt blev sidst ajourført i maj 2019.
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).
Danish: Lægemidlet fås som en spot-on-opløsning i to forskellige koncentrationer (6 % og 12 %) og i tuber med forskellige størrelser (15, 30, 45, 60, 120, 240 og 360 mg).
English: Evicto received a marketing authorisation valid throughout the EU on 19 July 2019.
Danish: Evicto modtog en markedsføringstilladelse med gyldighed i hele EU den 19/07/2019.
English: Other information about Evicto
Danish: Andre oplysninger om Evicto
English: Further information on Evicto can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/evicto.
Danish: Yderligere oplysninger om Evicto findes på agenturets websted under: ema.europa.eu/medicines/veterinary/EPAR/evicto.
English: As for every medicine, the company provided studies on the quality of Evicto.
Danish: Som for alle lægemidler fremlagde virksomheden studier af kvaliteten af Evicto.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Evicto has been shown to be comparable to Stronghold.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Evicto er sammenligneligt med Stronghold.
English: What are the benefits and risks of Evicto?
Danish: Hvilke fordele og risici er der forbundet med Evicto?
English: An overview of Evicto and why it is authorised in the EU
Danish: Oversigt over Evicto, og hvorfor det er godkendt i EU
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.
Danish: Selamectin aktiverer særlige proteiner, som kaldes "chloridkanaler", på overfladen af parasittens nerve- og muskelceller, hvilket gør det muligt for ladede chloridpartikler at trænge ind i nervecellerne og afbryde deres normale elektriske aktivitet.
English: What is Evicto and what is it used for?
Danish: Hvad er Evicto, og hvad anvendes det til?
English: This causes the paralysis or death of the parasites.
Danish: Dette medfører, at parasitterne lammes eller dør.
English: The active substance is absorbed through the skin and has an effect throughout the animal's body.
Danish: Det aktive stof absorberes gennem huden og virker i hele dyrets krop.
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.
Danish: Der er allerede gennemført studier af fordelene og risiciene ved det aktive stof i de godkendte anvendelser med referencelægemidlet, Stronghold, og det er ikke nødvendigt at gentage disse for Evicto.
English: Because Evicto is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Evicto er et generisk lægemiddel, anses dets fordele og risici for at være de samme som for referencelægemidlet.
English: Why is Evicto authorised in the EU?
Danish: Hvorfor blev Evicto godkendt i EU?
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.
Danish: Det betyder, at Evicto indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Stronghold.
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.
Danish: Dette skyldes, at sammensætningen af Evicto er sammenlignelig med referencelægemidlets, og når det påføres huden, forventes det aktive stof i begge lægemidler at blive optaget på samme måde.
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.
Danish: Der var ikke behov for "bioækvivalensstudier" af, om Evicto optages på samme måde som referencelægemidlet for at producere den samme mængde af det aktive stof i blodet.
English: The strength and the amount to use depend on the weight and species of the animal being treated, and the type of parasite.
Danish: Den nødvendige styrke og mængde afhænger af det behandlede dyrs vægt og art og af parasittypen.
English: The precautions are the same as for the reference medicine since Evicto is a generic medicine.
Danish: Disse forholdsregler er de samme som for referencelægemidlet, eftersom Evicto er et generisk lægemiddel.
English: Evicto contains selamectin, which is an antiparasitic medicine that belongs to the ‘avermectin' class.
Danish: Evicto indeholder selamectin, som er et lægemiddel mod parasitter, der tilhører klassen "avermectin".
English: Evicto contains the active substance selamectin and is a ‘generic medicine'.
Danish: Evicto indeholder det aktive stof selamectin og er et "generisk lægemiddel".
English: Therefore, the Agency's view was that, as for Stronghold, the benefit of Evicto outweighs the identified risk and it can be authorised for use in the EU.
Danish: Agenturet var derfor af den opfattelse, at fordelene ved Evicto opvejer de identificerede risici som for Stronghold, og at det kan godkendes til anvendelse i EU.