FrancophonIA/ELRC3.0 huggingface dataset:
English: Gastrointesti nal disorders nausea, vomiting, abdominal pain
Danish: Mave-tarmkanalen kvalme, opkastning, mavesmerter
English: Kigabeq 100 mg is supplied in packs of 100 soluble tablets.
Danish: Kigabeq 100 mg leveres i pakninger med 100 opløselige tabletter.
English: Oral and gastric use.
Danish: Oral anvendelse og til anvendelse i mavesækken
English: Visual field testing should continue at 6 month intervals for the whole duration of treatment.
Danish: Undersøgelsen bør fortsættes hver 6. måned, så længe behandlingen varer.
English: Kigabeq 500 mg is supplied in packs of 50 soluble tablets
Danish: Kigabeq 500 mg leveres i pakninger med 50 opløselige tabletter.
English: 500 mg tablet size: 16.0 mm x 9.0 mm
Danish: 500 mg-tablettens størrelse: 16,0 mm x 9,0 mm 100 mg-tablettens størrelse: 9,4 mm x 5,3 mm
English: What Kigabeq looks like and contents of the pack Kigabeq are white oval scored soluble tablets.
Danish: Kigabeq er hvide, ovale, opløselige tabletter med delekærv.
English: HDPE bottle closed with a child resistant tamper evident PP screw cap.
Danish: HDPE-beholder med et børnesikret skruelåg af polypropylen og sikkerhedsforsegling.
English: Half a tablet (500 mg) or two and a half tablets (100 mg)
Danish: (500 mg) eller 2½ tabl.
English: Syste m organ class
Danish: Systemorga nklasse
English: One tablet (500 mg) and two tablets (100 mg)
Danish: (500 mg) og 2 tabl.
English: optic atrophy
Danish: optisk atrofi
English: Kigabeq 100 mg soluble tablets Kigabeq 500 mg soluble tablets
Danish: Kigabeq 100 mg opløselige tabletter Kigabeq 500 mg opløselige tabletter
English: Kigabeq 100 mg soluble tablets EU/1/18/1302/001
Danish: EU/1/18/1302/001 100 opløselige tabletter - 100 mg EU/1/18/1302/002 50 opløselige tabletter - 500 mg
English: INFORMATION IN BRAILLE Kigabeq 500 mg
Danish: Kigabeq 500 mg
English: One tablet (500 mg) and one tablet (100 mg)
Danish: (500 mg) og 1 tabl.
English: PHARMACEUTICAL FORM AND CONTENTS 50 soluble tablets
Danish: 50 opløselige tabletter
English: Pregnancy and breast-feeding This medicine is not intended for use in women of child-bearing potential or in breast-feeding women.
Danish: Dette lægemiddel er ikke beregnet til kvinder, der kan blive gravide, eller som ammer.
English: Kigabeq 500 mg soluble tablets
Danish: Kigabeq 500 mg opløselige tabletter
English: One tablet (100 mg)
Danish: (100 mg)
English: Kigabeq 100 mg soluble tablets
Danish: Kigabeq 100 mg opløselige tabletter
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING 1 BOTTLE OF 50 SOLUBLE TABLETS OF KIGABEQ 500 MG
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE INDEHOLDENDE 1 BEHOLDER MED 50 OPLØSELIGE TABLETTER KIGABEQ 500 MG
English: NAME OF THE MEDICINAL PRODUCT Kigabeq 500 mg soluble tablets vigabatrin
Danish: Kigabeq 500 mg opløselige tabletter vigabatrin
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING 1 BOTTLE OF 100 SOLUBLE TABLETS OF KIGABEQ 100 MG
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE INDEHOLDENDE 1 BEHOLDER MED 100 OPLØSELIGE TABLETTER KIGABEQ 100 MG
English: NAME OF THE MEDICINAL PRODUCT Kigabeq 100 mg soluble tablets vigabatrin
Danish: Kigabeq 100 mg opløselige tabletter vigabatrin
English: PHARMACEUTICAL FORM AND CONTENTS 100 soluble tablets
Danish: 100 opløselige tabletter
English: How to give Kigabeq
Danish: Sådan skal du give dit barn Kigabeq
English: Musculoskel etal and connective tissue disorders arthralgia
Danish: Knogler, led, muskler og bindevæv artralgi
English: Suomi/Finland ORPHELIA Pharma SAS Puh/Tel: + 33 1 42 77 08 18
Danish: ORPHELIA Pharma SAS Puh/Tel: + 33 1 42 77 08 18
English: This medicine has been prescribed for your child. Do not pass it on to others.
Danish: Lad derfor være med at give medicinen til andre.
English: PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING LABEL FOR BOTTLE CONTAINING 50 SOLUBLE TABLETS OF KIGABEQ 500 MG
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE ETIKET TIL BEHOLDER INDEHOLDENDE 50 OPLØSELIGE TABLETTER KIGABEQ 500 MG
English: 1 x 500 mg tablet morning 1 x 500 mg and 1 x 100 mg tablet evening
Danish: 1 x 500 mg-tablet (morgen) 1 x 500 mg- og 1 x 100 mgtablet (aften)
English: movement disorders, including dystonia, dyskinesia and hypertonia, either alone or in association with abnormalities in MRI
Danish: encefalop ati optisk neuritis anomalier på MR-billeder af hjernen, bevægeforstyr relser, herunder dystoni, dyskinesi og hypertoni, enten alene eller i forbindelse med anomalier på MRbilleder
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL FOR BOTTLE CONTAINING 100 SOLUBLE TABLETS OF KIGABEQ 100 MG
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE ETIKET TIL BEHOLDER INDEHOLDENDE 100 OPLØSELIGE TABLETTER KIGABEQ 100 MG
English: 1 x 500 mg and 3 x 100 mg tablet morning 1 x 500 mg and 3 x 100 mg tablet evening
Danish: 1 x 500 mg- og 3 x 100 mgtablet (morgen) 1 x 500 mg- og 3 x 100 mgtablet (aften)
English: 1 x 500 mg and 2 x 100 mg tablet morning 1 x 500 mg and 2 x 100 mg tablet evening
Danish: 1 x 500 mg- og 2 x 100 mgtablet (morgen) 1 x 500 mg- og 2 x 100 mgtablet (aften)
English: 1 x 500 mg and 1 x 100 mg tablet morning 1 x 500 mg and 1 x 100 mg tablet evening
Danish: 1 x 500 mg- og 1 x 100 mgtablet (morgen) 1 x 500 mg- og 1 x 100 mgtablet (aften)
English: 1 x 500 mg and 1 x 100 mg tablet morning 1 x 500 mg and 2 x 100 mg tablet evening
Danish: 1 x 500 mg- og 1 x 100 mgtablet (morgen) 1 x 500 mg- og 2 x 100 mgtablet (aften)
English: What Kigabeq contains
Danish: Pakningsstørrelser og yderligere oplysninger Kigabeq indeholder:
English: Luxe mbourg/Luxemburg ORPHELIA Pharma SAS Tél/Tel: + 33 1 42 77 08 18
Danish: ORPHELIA Pharma SAS Tél/Tel: + 33 1 42 77 08 18
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each soluble tablet contains 100 mg vigabatrin.
Danish: Kigabeq 100 mg opløselige tabletter Hver opløselig tablet indeholder 100 mg vigabatrin.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Dificlir on 5 December 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Dificlir den 5. december 2011.
English: The recommended dose is one tablet twice a day (every 12 hours) for 10 days.
Danish: Den anbefalede dosis er en tablet to gange dagligt (hver 12. time) i 10 dage.
English: It is available as tablets (200 mg).
Danish: Det fås som tabletter (200 mg).
English: The full EPAR for Dificlir can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Dificlir findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Dificlir.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Dificlir.
English: The effects of Dificlir were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Dificlir blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The main measure of effectiveness was the number of patients that were cured after 10 days of treatment.
Danish: Det primære mål for virkningen var antallet af patienter, som blev helbredt efter 1o dages behandling.
English: For more information about treatment with Dificlir, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Dificlir, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: EPAR summary for the public fidaxomicin
Danish: EPAR - sammendrag for offentligheden fidaxomicin
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Dificlir.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Dificlir.
English: When looking at the results of the two studies, 92 % of patients on Dificlir were cured compared with 90% of patients on vancomycin.
Danish: Af resultaterne af de to undersøgelser fremgår, at 92 % af patienterne, der blev behandlet med Dificlir, blev helbredt sammenlignet med 90 % af patienter, der fik vancomycin.
English: C. difficile are bacteria that are present naturally in the gut and do not cause any problems in healthy people.
Danish: C. difficile er en bakterie, som er naturligt forekommende i tarmen, og som ingen problemer giver hos raske personer.
English: When this happens, C. difficile bacteria can multiply and produce toxins (poisons), which cause illness such as diarrhoea and fever.
Danish: Når dette sker, kan C. difficile formere sig og danne toksiner (giftstoffer), hvilket fremkalder sygdomme såsom diarré og feber.
English: Why has Dificlir been approved?
Danish: Hvorfor blev Dificlir godkendt?
English: When it is swallowed most of the active substance does not get absorbed into the blood stream but acts locally on C. difficile bacteria in the gut.
Danish: Når det sluges, bliver det meste af det aktive stof ikke optaget i blodet, men virker lokalt mod C. difficile-bakterien i tarmen.
English: Dificlir must not be used in people who are hypersensitive (allergic) to fidaxomicin or any of the other ingredients.
Danish: Dificlir bør ikke anvendes til personer, som kan være overfølsomme (allergiske) over for fidaxomicin eller andre af indholdsstofferne.
English: Dificlir is a medicine that contains the active substance fidaxomicin.
Danish: Dificlir er et lægemiddel, der indeholder det aktive stof fidaxomicin.
English: What is the risk associated with Dificlir?
Danish: Hvilken risiko er der forbundet med Dificlirz?
English: The most common side effects with Dificlir (seen in between 1 and 10 patients in 100) are nausea (feeling sick), vomiting and constipation.
Danish: De hyppigste bivirkninger ved Dificlir (som kunne observeres hos mellem 1 og 10 patienter ud af 100) er kvalme, opkastning og forstoppelse.
English: This stops the C. difficile bacteria from growing and multiplying.
Danish: Dette forhindrer C. Difficile-bakterien i at vokse og formere sig.
English: The active substance in Dificlir, fidaxomicin, is an antibiotic that belongs to the class of macrocylic antibiotics.
Danish: Det aktive stof i Dificlir, fidaxomicin, er et antibiotikum, som tilhører den nye gruppe af makrocykliske antibakterielle midler.
English: The CHMP considered the severity of C. difficile infections and the drawbacks of current treatments and concluded that benefits of Dificlir are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP vurderede sværhedsgraden af C. difficile-infektioner og ulemperne ved de nuværende behandlinger og konkluderede, at fordelene ved Dificlir er større end risiciene og anbefalede udstedelse af en markedsføringstilladelse.
English: Dificlir has been compared with vancomycin (another antibiotic for C. difficile infections) in two main studies involving a total of 1,147 adult patients with mild to moderately severe C. difficile infection.
Danish: Dificlir blev sammenlignet med vancomycin (et andet antibiotikum mod C. Difficile-infektioner) i to hovedundersøgelser af i alt 1 147 voksne patienter med mild til moderat svær C. difficile-infektion.
English: Dificlir is used to treat adults with infections of the gut caused by bacteria called Clostridium difficile.
Danish: Dificlir anvendes til behandling af voksne med infektioner i tarmen, som forårsages af en bakterie kaldet Clostridium difficile.
English: What is Dificlir?
Danish: Hvad er Dificlir?
English: The CHMP noted however, that there are uncertainties about the effects of Dificlir in certain groups of patients such as those with liver and kidney problems and recommended that further studies in this group should be carried out.
Danish: CHMP bemærkede dog, at der hos visse grupper af patienter med lever- og nyreproblemer hersker usikkerhed om Dificlirs virkning og anbefalede, at der blev udført yderligere undersøgelser i denne gruppe.
English: Other information about Dificlir
Danish: Andre oplysninger om
English: For the full list of all side effects reported with Dificlir, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Dificlir fremgår af indlægssedlen.
English: Dificlir was at least as effective as vancomycin in curing C. difficile infection.
Danish: Dificlir var mindst lige så effektivt som vancomycin til at helbrede C. difficile-infektion.
English: What is Dificlir used for?
Danish: Hvad anvendes Dificlir til?
English: polymerase, which is used to produce the RNA that the bacteria need to make proteins.
Danish: Det virker ved at blokere bakterieenzymet RNApolymerase, som producerer RNA, som bakterierne skal bruge til at danne proteiner.
English: How has Dificlir been studied?
Danish: Hvordan blev Dificlir undersøgt?
English: What benefit has Dificlir shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Dificlir?
English: However, some antibiotics that are used to treat infections can interfere with the balance of 'good' bacteria in the gut.
Danish: Visse antibiotika, som anvendes til behandling af infektioner, kan imidlertid forstyrre tarmfloraen.
English: At this point, a person is said to be infected with C. difficile.
Danish: Så er der tale om en C. difficile-infektion.
English: How is Dificlir used?
Danish: Hvordan anvendes Dificlir?
English: The CHMP considered that Dificlir was effective in curing C. difficile infections and was generally well tolerated with side effects that are similar to vancomycin.
Danish: CHMP var af den opfattelse, at Dificlir var effektivt til behandling af C. difficile-infektioner, og at det overvejende tåltes godt.
English: How does Dificlir work?
Danish: Hvordan virker Dificlir?
English: 6 February 2012
Danish: Den 6. februar 2012
English: Opinion following an Article 34
Danish: Udtalelse efter en artikel 34
English: Article 34 of Directive 2001/82/EC
Danish: Artikel 34 i direktiv 2001/82/EF
English: The final opinion was converted into a Decision by the European Commission on 6 February 2012.
Danish: Den endelige udtalelse blev omarbejdet til en beslutning af Europa-Kommissionen den 6. februar 2012.
English: The referral procedure started on 11 November 2009.
Danish: Henvisningsproceduren blev indledt den 11. november 2009.
English: Fortekor and associated names
Danish: 1-henvisning for Fortekor og relaterede navne
English: The Committee adopted a positive opinion by majority on 10 November 2011.
Danish: Udvalget vedtog en positiv udtalelse den 10. november 2011.
English: Written explanations were provided by the marketing authorisation holders on 24 May 2010 and 6 January 2011.
Danish: Indehaverne af markedsføringstilladelserne indsendte skriftlige redegørelser den 24. maj 2010 og den 6. januar 2011.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended product information in Annex III.
Danish: Listen over de omfattede produktnavne findes i bilag I. De videnskabelige konklusioner fremgår af bilag II, det ændrede produktresumé af bilag III.
English: In line with the principles of referrals under Article 34(1) of Directive 2001/82/EC, on 16 September 2010 Sweden sent a revised referral notification under Article 34(1) of Directive 2001/82/EC and extended the scope of the referral procedure to all Fortekor and associated names tablet strengths and formulations.
Danish: I overensstemmelse med principperne fra henvisninger i artikel 34, stk. 1, i direktiv 2001/82/EF indsendte Sverige den 16. september 2010 en revideret indbringelsesanmeldelse i henhold til artikel 34, stk. 1, i direktiv 2001/82/EF og udvidede henvisningsproceduren til at omfatte alle tabletstyrker og -formuleringer af Fortekor og relaterede navne.
English: International non-proprietary name (inn): benazepril hydrochloride
Danish: Internationalt fællesnavn (INN): benezaprilhydroklorid
English: Opinion following an Article 34 referral for Fortekor and associated names EMA/965903/2011
Danish: Udtalelse efter en artikel 34 -henvisning for Fortekor og relaterede navne EMA/965903/2011
English: Oral explanations were given on 4 May 2011.
Danish: Mundtlige redegørelser blev afgivet den 4. maj 2011.
English: Benazeprilat is a highly potent and selective inhibitor of angiotensin converting enzyme, thus preventing the conversion of inactive angiotensin I to active angiotensin II and thereby also reducing synthesis of aldosterone.
Danish: Benazeprilat er en højpotent og selektiv ACE-hæmmer og forhindrer således omdannelse af det inaktive angiotensin I til det aktive angiotensin II, hvorved også syntesen af aldosteron nedsættes.
English: An ad-hoc expert group meeting was held on 10 October 2011 and the marketing authorisation holders attended the meeting for an oral explanation.
Danish: Den 10. oktober 2011 trådte ad hoc-ekspertgruppen sammen, og indehaverne af markedsføringstilladelserne deltog i mødet for at afgive mundtlig redegørelse.
English: The product is intended for the treatment of heart failure in dogs and/or the treatment of chronic kidney disease in cats and dogs, and the approved indications and target species varied between the Member States.
Danish: Produktet er godkendt til behandling af hjerteinsufficiens hos hunde og/eller til behandling af kronisk nyreinsufficiens hos katte og hunde, idet de godkendte indikationer og måldyrearter varierer mellem medlemsstaterne.
English: Benazepril hydrochloride is a prodrug hydrolysed in vivo to its active metabolite, benazeprilat.
Danish: Benezaprilhydroklorid er et prodrug, der in vivo hydrolyseres til sin aktive metabolit, benazeprilat.
English: Based on the assessment of the currently available data and further to a consultation with the ad-hoc expert group, the CVMP considered that the benefit-risk balance for Fortekor and associated names remains positive, except for the chronic kidney disease in dogs, subject to variation of the marketing authorisations in accordance with the recommended product information.
Danish: På grundlag af vurderingen af de aktuelt tilgængelige data og efter samråd med ad hocekspertgruppen var CVMP af den opfattelse, at benefit/risk-forholdet for Fortekor og relaterede navne fortsat er positivt bortset fra kronisk nyresygdom hos hunde, forudsat at markedsføringstilladelserne ændres i overensstemmelse med den anbefalede produktinformation.
English: Due to the divergent decisions taken by Member States concerning the authorisation of Fortekor and associated names (5 mg benazepril hydrochloride film-coated tablet) and differences between the summary of product characteristics of the product as authorised in the Member States, the issue was referred on 16 October 2009 by Sweden to the CVMP under Article 34(1) of Directive 2001/82/EC.
Danish: På grund af medlemsstaternes divergerende nationale afgørelser vedrørende godkendelsen af Fortekor og relaterede navne (filmovertrukne tabletter indeholdende 5 mg benezaprilhydroklorid) indledte Sverige den 16. oktober 2009 en henvisning til CVMP i henhold til artikel 34, stk. 1, i direktiv 2001/82/EF.
English: holders' oral explanations to the Committee, the CVMP, at its May 2011 meeting, agreed that an ad-hoc expert group should be consulted regarding the scientific evidence base for angiotensin converting enzyme inhibitor in the treatment of chronic kidney disease in dogs.
Danish: redegørelser fra indehaverne af markedsføringstilladelserne til udvalget vedtog CVMP på sit møde i maj 2011 at konsultere en ad hoc-ekspertgruppe vedrørende den videnskabelige dokumentation for anvendelsen af ACE-hæmmere til behandling af kronisk nyresygdom hos hunde.
English: Fortekor and associated names is a veterinary medicinal product containing benazepril hydrochloride presented in 2.5 mg, 5 mg and 20 mg flavoured tablets and 5 mg and 20 mg film-coated tablets intended for use in dogs and cats.
Danish: Det dispenseres som aromatiserede tabletter på 2,5 mg, 5 mg og 20 mg samt som filmovertrukne tabletter på 5 mg og 20 mg og er bestemt til anvendelse hos hunde og katte.
English: The Committee appointed Dr Karolina Törneke as rapporteur and Dr Michael Holzhauser-Alberti as co-rapporteur.
Danish: Som rapportør og medrapportør udpegede udvalget henholdsvis dr. Karolina Törneke og dr. Claire Chauvin.
English: Further to the marketing authorisation
Danish: Som opfølgning af de mundtlige
English: The four remaining studies are summarised below.
Danish: De fire tilbageværende undersøgelser er sammenfattet nedenfor.
English: The Reference Member State was Ireland and the Concerned Member States were Austria, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Greece, Spain, Finland, France, Hungary, Iceland, Latvia, Lithuania, Malta, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia and Sweden.
Danish: Referencemedlemsstaten var Irland, og de berørte medlemsstater var Østrig, Bulgarien, Cypern, Tjekkiet, Danmark, Estland, Grækenland, Spanien, Finland, Frankrig, Ungarn, Island, Letland, Litauen, Malta, Nederlandene, Norge, Polen, Portugal, Rumænien, Slovakiet, Slovenien og Sverige.
English: Special warnings, if necessary
Danish: SÆRLIG(E) ADVARSEL/ADVARSLER, OM NØDVENDIGT
English: Although this study was well conducted other studies cannot be disregarded unless there is a sound reason for doing so (e.g. evidence of mistakes).
Danish: Skønt undersøgelsen var veludført, kan der ikke ses bort fra andre undersøgelser, medmindre der er gyldig grund til det (f.eks. tegn på fejl).
English: Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom
Danish: Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ Storbritannien
English: CATTLE:
Danish: KVÆG:
English: The applicant provided a targeted Phase II environmental risk assessment.
Danish: Ansøgeren forelagde en målrettet fase II-miljørisikovurdering.
English: It is noted that the study (2002) predates the introduction of that guideline (2005).
Danish: Det bemærkes, at undersøgelsen er fra 2002, altså før indførelsen af retningslinjerne (2005).
English: Add the following text in the relevant sections of the product information:
Danish: Tilføj følgende tekst til relevante afsnit i produktinformationen:
English: Based on the data from the last study a withdrawal period of 54 days could be calculated.
Danish: På grundlag af data fra den seneste undersøgelse kunne der beregnes en tilbageholdelsestid på 54 dage.
English: During the decentralised procedure it was agreed that the authorisation of the generic product under the name "Dectomax" will not be issued until the reference product under the name "Dectomax" has either been withdrawn or renamed.
Danish: Under den decentrale procedure blev det aftalt, at godkendelsen for det generiske produkt under navnet "Dectomax" ikke vil blive udstedt, før referenceproduktet under navnet "Dectomax" enten er trukket tilbage eller har fået ændret navnet.
English: The product has claims for persistent efficacy ranging from 18 to 42 days.
Danish: Produktet påberåbes at virke i en tidsrum af 18 til 42 dage.
English: It cannot be excluded that actual injection sites were missed in this study.
Danish: Det kan ikke udelukkes, at faktisk anvendte injektionssteder blev udeladt i denne undersøgelse.
English: This method is however not considered suitable for substances with a log Pow above 4.
Danish: Denne metode anses imidlertid ikke for velegnet til stoffer med log Pow over 4.
English: It is a macrocyclic lactone and is closely related to ivermectin.
Danish: Det er en makrocyklisk lacton, der er nært beslægtet med ivermectin.
English: The product is applied by a single subcutaneous or intramuscular injection.
Danish: Produktet gives som en enkelt subkutan eller intramuskulær injektion.
English: The product has the same indications as the reference product.
Danish: Produktet har samme indikationer som referenceproduktet.