FrancophonIA/ELRC3.0 huggingface dataset:
English: Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.55 (0.40, 0.75) Nivolumab vs. Ipilimumab - hazard ratio: 0.54 (0.40, 0.73) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 1.02 (0.73, 1.43)
Danish: Nivolumab+Ipilimumab versus Ipilimumab - hazard ratio: 0,55 (0,40; 0,75) Nivolumab versus Ipilimumab - hazard ratio: 0,54 (0,40; 0,73) Nivolumab+Ipilimumab versus Nivolumab - hazard ratio: 1,02 (0,73; 1,43)
English: A disease causing the inflammation or enlargement of a lymph node (Kikuchi lymphadenitis) Life-threatening allergic reaction
Danish: Sjælden (kan forekomme hos op til 1 ud af 1.000 personer) En sygdom, der forårsager betændelseslignende reaktion (inflammation) i lymfeknuder eller forstørrede lymfeknuder (Kikuchi lymfadenitis) Livstruende allergisk reaktion
English: If worsening or no improvement occurs despite initiation of corticosteroids, corticosteroid dose should be increased to 2 to 4 mg/kg/day methylprednisolone equivalents and nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued.
Danish: Hvis der opstår forværring, eller der ikke sker bedring, på trods af anvendelse af kortikosteroid, skal kortikosteroiddosis øges op til en dosis ækvivalent med 2-4 mg/kg/dag methylprednisolon, og nivolumab eller nivolumab i kombination med ipilimumab skal seponeres permanent.
English: In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the incidence of nephritis or renal dysfunction was 5.1% (23/448).
Danish: Hos melanom-patienter, der blev behandlet med nivolumab 1 mg/kg i kombination med ipilimumab 3 mg/kg, var hyppigheden af nefritis eller nedsat nyrefunktion 5,1 % (23/448).
English: Probability of Recurrence-Free Survival
Danish: Sandsynlighed forprogressionsfri overlevelse
English: Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.59 (0.42, 0.82) Nivolumab vs. Ipilimumab - hazard ratio: 0.84 (0.61, 1.16) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 0.70 (0.49, 0.99)
Danish: Nivolumab+Ipilimumab versus Ipilimumab - hazard ratio: 0,59 (0,42; 0,82) Nivolumab versus Ipilimumab - hazard ratio: 0.84 (0,61; 1,16) Nivolumab+Ipilimumab versus Nivolumab - hazard ratio: 0,70 (0,49; 0,99)
English: Grade 2, Grade 3, and Grade 4 cases were reported in 1.6% (7/448), 0.9% (4/448), and 0.7% (3/448) of patients, respectively.
Danish: Grad 2, grad 3 og grad 4 tilfælde blev rapporteret hos henholdsvis 1,6 % (7/448), 0,9 % (4/448) og 0,7 % (3/448) af patienterne.
English: Uncommon uveitis, blurred vision, dry eye Not known
Danish: Ikke almindelig uveitis, sløret syn, tørre øjne Ikke kendt Vogt-Koyanagi-Harada syndromh Hjerte
English: Withhold dose(s) until symptoms resolve and management with corticosteroids is complete
Danish: Dosis/doser udsættes, indtil symptomerne forsvinder, og behandling med kortikosteroider er afsluttetc
English: Rate (95% CI) At 6 months At 12 months
Danish: Hyppighed (95 % CI) Ved 6 måneder Ved 12 måneder
English: The trial demonstrated a statistically significant improvement in RFS for patients randomised to the nivolumab arm compared with the ipilimumab 10 mg/kg arm. RFS benefit was consistently demonstrated across subgroups, including tumour PD-L1 expression, BRAF status, and stage of disease.
Danish: Den observerede RFS-fordel blev vist konsistent på tværs af undergrupperne af patienter, inklusive PD-L1-ekspression, BRAF-status og sygdomsstadie.
English: Patients with a baseline performance score ≥2, active brain metastases or leptomeningeal metastases, active autoimmune disease, or medical conditions requiring systemic immunosuppression were excluded from the clinical trials of urothelial carcinoma (see sections 4.5 and 5.1).
Danish: Patienter med performance-score ≥ 2 ved baseline, aktive hjernemetastaser eller leptomeningeale metastaser, aktiv autoimmunsygdom eller sygdomstilstande, der kræver systemisk immunsuppression blev ekskluderet fra de kliniske studier med urothelialt karcinom (se pkt.
English: After administration of the nivolumab dose, flush the line with sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) glucose solution for injection.
Danish: Efter administration af nivolumab-dosis, gennemskylles slangen med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske eller glucose 50 mg/ml (5 %) injektionsvæske.
English: For Grade 3 or 4 pneumonitis, nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 2 to 4 mg/kg/day methylprednisolone equivalents.
Danish: Ved grad 3 eller 4 pneumonitis skal nivolumab eller nivolumab i kombination med ipilimumab seponeres permanent, og kortikosteroid bør initieres med en dosis ækvivalent med 2-4 mg/kg/dag methylprednisolon.
English: If worsening or no improvement occurs despite initiation of corticosteroids, corticosteroid dose should be increased to 1 to 2 mg/kg/day methylprednisolone equivalents and nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued.
Danish: Hvis der opstår forværring, eller der ikke sker bedring, på trods af anvendelse af kortikosteroid, skal dosis øges op til en dosis ækvivalent med 1-2 mg/kg/dag methylprednisolon, og nivolumab eller nivolumab i kombination med ipilimumab skal seponeres permanent.
English: Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.42 (0.31, 0.55) Nivolumab vs. Ipilimumab - hazard ratio: 0.44 (0.34, 0.58) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 0.94 (0.69, 1.28)
Danish: Nivolumab+ipilimumab versus ipilimumab - hazard ratio: 0,42 (0,31; 0,55) Nivolumab versus ipilimumab - hazard ratio: 0,44 (0,34; 0,58) Nivolumab+ipilimumab versus nivolumab - hazard ratio: 0,94 (0,69; 1,28)
English: Patients with any history of or concurrent brain metastases, active autoimmune disease, or medical conditions requiring systemic immunosuppression were excluded from the clinical trials of nivolumab or nivolumab in combination with ipilimumab (see sections 4.5 and 5.1).
Danish: Patienter med hjernemetastaser i anamnesen, aktiv autoimmun sygdom eller sygdomstilstande, der krævede systemisk immunsuppression, blev udelukket fra de kliniske studier med nivolumab eller nivolumab i kombination med ipilimumab (se pkt.
English: The safety and efficacy of nivolumab 3 mg/kg as a single agent for the treatment of advanced or metastatic non-squamous NSCLC were evaluated in a phase 3, randomised, open-label study (CA209057).
Danish: Sikkerheden og virkningen af nivolumab 3 mg/kg som enkeltstof til behandling af fremskreden eller metastatisk ikke-planocellulær NSCLC blev undersøgt i et randomiseret, åbent fase 3-studie (CA209057).
English: Thereafter the recommended dose of OPDIVO is 240 mg given every 2 weeks or 480 mg given every 4 weeks (single-agent phase).
Danish: Den anbefalede dosis OPDIVO er enten nivolumab 240 mg hver 2. uge eller 480 mg hver 4. uge (se pkt.
English: Laboratory abnormalities
Danish: Laboratorietestabnormiteter
English: Resolution occurred in 428 patients (63.8%) with a median time to resolution of 17.1 weeks
Danish: Resolution forekom hos 428 patienter (63,8 %) med en mediantid til resolution på 17,1 uger (0,1-150,0+).
English: Immune-related skin adverse reactions
Danish: Immunrelaterede hudreaktioner
English: The primary efficacy outcome measure was OS. Key secondary efficacy outcome measures were investigator-assessed PFS and ORR.
Danish: De vigtigste sekundære effektparametre var investigatorvurderet PFS og ORR.
English: This is then followed by a second phase in which nivolumab monotherapy is administered intravenously at either 240 mg every 2 weeks or at 480 mg every 4 weeks, as presented in Table 2.
Danish: Dette efterfølges af fase 2, hvor nivolumab administreres som monoterapi intravenøst, som enten 240 mg hver 2. uge.
English: Inflammation of the nerves (causing numbness, weakness, tingling or burning pain of the arms and legs), dizziness
Danish: Betændelseslignende reaktion i nerverne (som medfører følelsesløshed, svaghed, snurrende fornemmelse eller brændende smerter i arme og ben), svimmelhed Øjenbetændelse (med rødme og smerter), sløret syn Hurtig hjerterytme (puls)
English: Range Median time to response Months (range) Median duration of follow-up Months (range) Progression-free survival Rate (95% CI) at 12 months “+” denotes a censored observation.
Danish: Progressionsfri overlevelse Rate (95 % CI) ved 12 måneder “+”markerer en censoreret observation.
English: Severe rash has been observed with nivolumab in combination with ipilimumab and, less commonly, with nivolumab as monotherapy (see section 4.8).
Danish: Der er observeret alvorligt udslæt, som kan være immunrelateret, ved behandling med nivolumab i kombination med ipilimumab og, mindre hyppigt, med nivolumab som monoterapi (se pkt.
English: CA209205 Cohort B and CA209039
Danish: CA209205 kohorte B og CA209039 (n = 95)
English: For Grade 4 diarrhoea or colitis, nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Danish: Ved grad 4 diarre eller colitis skal nivolumab eller nivolumab i kombination med ipilimumab seponeres permanent, og kortikosteroid initieres med en dosis ækvivalent med 1-2 mg/kg/dag methylprednisolon.
English: Severe nephritis and renal dysfunction have been observed with monotherapy treatment or nivolumab in combination with ipilimumab (see section 4.8).
Danish: Svær nefritis og nedsat nyrefunktion er observeret med monoterapi eller nivolumab i kombination med ipilimumab (se pkt.
English: In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the proportion of patients who experienced a worsening from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 3.0% for anaemia (all Grade 3), 0.7% for thrombocytopaenia, 0.6% for leucopoenia, 5.1% for lymphopaenia, 1.1% for neutropaenia, 2.0% for increased alkaline phosphatase, 4.8% for increased AST, 6.5% for increased ALT, 1.1% for increased total bilirubin, 2.1% for increased creatinine, 7.2% for hyperglycaemia, 1.8% for hypoglycemia, 12.2% for increased amylase, 20.1% for increased lipase, 0.4% for hypocalcaemia, 1.3% for hypercalcaemia, 2.4% for hyperkalemia, 1.1% for hypermagnesaemia, 0.4% for hypomagnesaemia 1.9% for hypokalaemia, and 9.9% for hyponatraemia.
Danish: Hos RCC-patienter, der blev behandlet med nivolumab 3 mg/kg i kombination med ipilimumab 1 mg/kg, var andelen af patienter, som oplevede en forværring fra baseline til en grad 3 eller 4 abnorm laboratorietest, følgende: 3,0 % med anæmi (alle grad 3), 0,7 % med trombocytopeni, 0,6 % med leukopeni, 5,1 % med lymfopeni, 1,1 % med neutropeni, 2,0 % med forhøjet alkalisk phosphatase, 4,8 % med forhøjet ASAT, 6,5 % med forhøjet ALAT, 1,1 % med forhøjet total-bilirubin, 2,1 % med forhøjet kreatinin, 7,2 % med hyperglykæmi, 1,8 % med hypoglykæmi, 12,2 % med forhøjet amylase,
English: For Grade 4 serum creatinine elevation, nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Danish: Ved grad 4 stigning i serumkreatinin skal nivolumab eller nivolumab i kombination med ipilimumab seponeres permanent, og kortikosteroid bør initieres med en dosis ækvivalent med 1-2 mg/kg/dag methylprednisolon.
English: Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.35 (0.22, 0.55) Nivolumab vs. Ipilimumab - hazard ratio: 0.41 (0.27, 0.62) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 0.87 (0.54, 1.41)
Danish: Nivolumab+ipilimumab versus ipilimumab - hazard ratio: 0,35 (0,22; 0,55) Nivolumab versus ipilimumab - hazard ratio: 0,41 (0,27; 0,62) Nivolumab+ipilimumab versus nivolumab - hazard ratio: 0,87 (0,54; 1,41)
English: Median (95% CI) Rate (95% CI) At 6 months At 12 months
Danish: Median (95 % CI) Hyppighed (95 % CI) Ved 6 måneder Ved 12 måneder
English: Intestinal perforation, inflammation of the stomach (gastritis), inflammation of the duodenum Skin disease with thickened patches of red skin, often with silvery scales (psoriasis), severe condition of the skin that causes red, often itchy spots, similar to the rash of measles, which starts on the limbs and sometimes on the face and the rest of the body (erythema multiforme) Severe and possibly fatal peeling of the skin (Stevens-Johnson syndrome) Chronic disease of joints (spondyloarthropathy), disease in which the immune system attacks the glands that make moisture for the body, such as tears and saliva (Sjogren's syndrome), aching muscles, muscle tenderness of weakness, not caused by exercise (myopathy), inflammation of the muscles (myositis), stiffness in muscles and joints, muscle spasm (rhabdomyolysis), inflammation of the muscles causing pain or stiffness (polymyalgia rheumatica) Inflammation of the kidney
Danish: Kronisk sygdom i leddene (spondylartropati), sygdom, hvor immunsystemet angriber de kirtler, der producerer kropsvæsker som tårer og spyt (Sjögrens syndrom), muskelsmerter, ømme eller svage muskler, som ikke skyldes fysisk aktivitet (myopati), en betændelseslignende reaktion i musklerne (myositis), stivhed i muskler og led, muskelkramper (rabdomyolyse), betændelseslignende reaktion (inflammation) i musklerne med smerter og stivhed (polymyalgia rheumatica)
English: Uncommon sarcoidosis Not known solid organ transplant rejectionh Endocrine disorders Very common hypothyroidism hypothyroidism, hyperthyroidism
Danish: Almindelig infusionsrelateret reaktionc, overfølsomhedc Sjælden anafylaktisk reaktionc Ikke kendt Afstødning af transplanterede solide organerh, sarkoidoseh
English: Treatment beyond initial investigator-assessed RECIST version 1.1-defined progression was permitted in patients receiving nivolumab, if the patient had a clinical benefit and was tolerating study drug, as determined by the investigator.
Danish: Behandling efter initial investorvurderet RECIST version 1,1-defineret progression var tilladt, hvis patienten efter investigatord vurdering oplevede kliniske fordele og tolererede studielægemidlet.
English: PD-L1 ≥ 1%, PD-L1+ TAIC abundantd
Danish: PD-L1 ≥ 1 %, PD-L1+ TAIC udbredtd
English: Odds Ratio (95% CI)
Danish: Oddsratio (95 % CI)
English: The primary efficacy outcome measure was OS. Key secondary efficacy outcome measures were investigator-assessed ORR and PFS.
Danish: De vigtigste sekundære effektparametre var investigatorvurderet ORR og PFS.
English: The safety and efficacy of nivolumab 3 mg/kg as a single agent for the treatment of advanced or metastatic squamous NSCLC were evaluated in a phase 3, randomised, open-label study (CA209017).
Danish: Sikkerheden og virkningen af nivolumab 3 mg/kg som enkeltstof til behandling af fremskreden eller metastatisk planocellulær NSCLC blev undersøgt i et randomiseret, åbent fase 3-studie (CA209017).
English: Common hypothyroidism, hyperthyroidism
Danish: Det endokrine system Meget almindelig hypotyroidisme hypotyroidisme, hypertyroidisme
English: Renal Cell Carcinoma
Danish: Renalcellekarcinom
English: from the study.
Danish: Se i pkt.
English: Inflammation of the muscles causing pain or stiffness (polymyalgia rheumatica), inflammation of the joints (arthritis)
Danish: Smerter i muskler og knogler (muskuloskeletale smerter) og led (artralgi) Feber, væskeansamlinger (hævelse)
English: PD-L1 < 1%, PD-L1+ TAIC abundantd
Danish: PD-L1 < 1 %, PD-L1+ TAIC udbredtd
English: Eye disorders Common uveitis, blurred vision blurred vision
Danish: Øjne Almindelig uveitis, sløret syn sløret syn
English: Docetaxel ──Δ─── Nivolumab 3 mg/kg (events: 190/292), median and 95% CI: 12.19 (9.66, 14.98) - - -- - - Docetaxel (events: 223/290), median and 95% CI: 9.36 (8.05, 10.68) The trial demonstrated a statistically significant improvement in OS for patients randomised to nivolumab as compared with docetaxel at the prespecified interim analysis when 413 events were observed (93% of the planned number of events for final analysis).
Danish: Samlet overlevelse (måneder) Antal forsøgspersoner i risikogruppe Nivolumab 3 mg/kg Docetaxel ──Δ─── Nivolumab 3 mg/kg (hændelser: 190/292), median-OS og 95 % CI: 12,19 (9,66; 14,98) - - -- - - Docetaxel (hændelser: 223/290), median-OS og 95 % CI: 9,36 (8,05; 10,68)
English: NAME OF THE MEDICINAL PRODUCT OPDIVO 10 mg/mL concentrate for solution for infusion.
Danish: OPDIVO 10 mg/ml koncentrat til infusionsvæske, opløsning.
English: Guillain-Barré syndrome, demyelination, myasthenic syndrome, encephalitisa,c
Danish: Polyneuropati, autoimmun neuropati (herunder facial og nervus abducens parese) Sjælden Guillain-Barré syndrom, demyelinisering, myastenisk syndrom, encephalitisa,c Øjne
English: Overall survivala Events
Danish: Samlet overlevelse Hændelser
English: Median time to onset was 2.1 months (range: 0.0-27.6).
Danish: Mediantid til indtræden var 2,1 måneder (0,027,6).
English: For Grade 3 or 4 transaminase or total bilirubin elevation, nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Danish: Ved grad 3 eller 4 forhøjelse af aminotransferase eller total-bilirubin seponeres nivolumab eller nivolumab i kombination med ipilimumab permanent, og kortikosteroid initieres med en dosis ækvivalent med 1-2 mg/kg/dag methylprednisolon.
English: Median (95% CI) (months) Rate (95% CI) at 12 months
Danish: Median (95 % CI) (måneder) Hyppighed (95 % CI) ved 12 måneder
English: Infections of the upper respiratory tract
Danish: Væskemangel, forhøjet syreindhold i blodet
English: Resolution occurred in 124 patients (93.9%) with a median time to resolution of 5.1 weeks (range: 0.1-106.9).
Danish: Resolution forekom hos 124 patienter (93,9 %) med en mediantid til resolution på 5,1 uger
English: Investigator's choice
Danish: FREMSTILLERENS BATCHNUMMER
English: CA209205 Cohort Ba CA209039
Danish: CA209205 kohorte Ba CA209205 kohorte Ca
English: Rare
Danish: Sværhedsgrad
English: Not known solid organ transplant rejectionh, sarcoidosish Endocrine disorders
Danish: Ikke almindelig sarkoidose Ikke kendt afstødning af transplanterede solide organerh
English: What OPDIVO is and what it is used for 2.
Danish: Virkning og anvendelse 2.
English: Among patients with quantifiable tumour PD-L1 expression, the distribution of patients was balanced across the treatment groups.
Danish: Fordelingen af patienter var velbalanceret på tværs behandlingsgrupperne blandt patienter med kvantificerbar PD-L1-tumorekspression.
English: Skin colour change in patches (vitiligo), dry skin, redness of the skin, unusual hair loss or thinning Pain in the muscles, bones (musculoskeletal pain) and joints (arthralgia) Fever, oedema (swelling)
Danish: Betændelseslignende reaktion i tarmene (colitis), mundsår og forkølelsessår (stomatitis), opkastning, mavesmerter, forstoppelse, mundtørhed Pletvise farveændringer af huden (vitiligo), tør hud, hudrødme, unormalt hårtab eller udtynding af håret
English: Serious lung infection (pneumonia), infections of the upper respiratory tract, inflammation of the eye (conjunctivitis)
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 personer) Alvorlig lungeinfektion (lungebetændelse), infektioner i de øvre luftveje, øjenbetændelse (konjunktivitis)
English: Damage to nerves causing numbness and weakness (polyneuropathy), inflammation of the nerves caused by the body attacking itself, causing numbness, weakness, tingling or burning pain (autoimmune neuropathy)
Danish: Nerveskade, som medfører følelsesløshed og svaghed (polyneuropati), betændelseslignende reaktion i nerverne som skyldes at kroppen angriber sig selv, som medfører følelsesløshed, svaghed, snurrende fornemmelse eller brændende smerter (autoimmun neuropati) Øjenbetændelse (med rødme og smerter), sløret syn, tørre øjne Hurtig hjerterytme (puls), betændelseslignende reaktion i sækken der ligger omkring hjertet og ophobning af væske omkring hjertet (sygdomme i perikardiet) Væske omkring lungerne
English: Duration of response in PR (months) Median (95% CI)
Danish: Responsvarighed hos PR (måneder)c
English: Decreased secretion of hormones produced by adrenal glands (glands situated above the kidneys), underactive function (hypopituitarism) or inflammation (hypophysitis) of the pituitary gland situated at the base of the brain, swelling of the thyroid gland, diabetes Dehydration, increased acid levels in the blood
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer) Alvorlig lungeinfektion (lungebetændelse), bronkitis Øget mængde af bestemte typer hvide blodlegemer Nedsat udskillelse af de hormoner, der dannes i binyrerne (kirtler placeret over nyrerne), nedsat funktion af eller betændelseslignende reaktion i hypofysen (sidder nederst i hjernen), hævelse af skjoldbruskkirtlen, diabetes
English: Very common colitisa, diarrhoea, vomiting, nausea,
Danish: Ikke almindelig pleuraeffusion Mave-tarm-kanalen Meget almindelig colitisa, diarre, opkastning, kvalme, abdominalsmerter diarre, opkastning, kvalme
English: The medicine is available as a spot-on solution in 2 different concentrations (6% and 12%) and in tubes of various strengths (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 styrker (15, 30, 45, 60, 120, 240 og 360 mg).
English: Chanhold received a marketing authorisation valid throughout the EU on 17 April 2019.
Danish: Chanhold fik en markedsføringstilladelse med gyldighed i hele EU den 17/04/2019.
English: Other information about Chanhold
Danish: Andre oplysninger om Chanhold
English: Further information on Chanhold can be found on the Agency's website: ema.europa.eu/Find medicines/veterinary/EPAR/chanhold.
Danish: Yderligere oplysninger om Chanhold findes på agenturets websted under: ema.europa.eu/Find medicines/veterinary/EPAR/chanhold.
English: The package leaflet contains detailed information on dosage and duration of treatment.
Danish: Indlægssedlen indeholder detaljerede oplysninger om dosering og behandlingens varighed.
English: What are the benefits and risks of Chanhold?
Danish: Hvilke fordele og risici er der forbundet med Chanhold?
English: As for every medicine, the company provided studies on the quality of Chanhold.
Danish: Som for alle lægemidler fremlagde virksomheden studier af kvaliteten af Chanhold.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Chanhold has been shown to be comparable to Stronghold.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Chanhold er sammenligneligt med Stronghold.
English: The strength used and the number of administrations depend on the weight and species of the animal being treated, and the type of parasite.
Danish: Den anvendte styrke og antallet af administrationer afhænger af det behandlede dyrs vægt og art og af typen af parasit.
English: An overview of Chanhold and why it is authorised in the EU
Danish: Oversigt over Chanhold, og hvorfor det er godkendt i 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 Chanhold.
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 med Chanhold.
English: This means that Chanhold 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 Chanhold 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: There was no need for ‘bioequivalence' studies to investigate whether Chanhold 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" for at undersøge, om Chanhold optages på samme måde som referencelægemidlet for at give det samme niveau af det aktive stof i blodet.