FrancophonIA/ELRC3.0 huggingface dataset:
English: Fluenz Tetra should not be used in infants and toddlers below 24 months of age because of safety concerns regarding increased rates of hospitalisation and wheezing in this population (see section 4.8).
Danish: Fluenz Tetra bør ikke anvendes til spædbørn og små børn i alderen under 24 måneder på grund af problemstillinger vedrørende sikkerheden i forhold til forhøjede tal for indlæggelser og hvæsen hos denne population (se pkt.
English: Fluenz demonstrated 64.4% (1.4, 88.8) fewer cases than injectable influenza vaccine in 476 infants and toddlers 6-23 months of age and 48.2% (12.7, 70.0) fewer cases in 1,609 children 24-71 months of age.
Danish: Fluenz havde 64,4 % (1,4; 88,8) færre tilfælde end injicerbar influenzavaccine hos 476 spædbørn og små børn i alderen 6-23 måneder og 48,2 % (12,7; 70,0) færre tilfælde hos 1.609 børn i alderen 24-71 måneder.
English: In previously unvaccinated study participants who received one dose in year 1, efficacy was 57.7% (95% CI: 44.7, 67.9) and 56.3% (95% CI: 43.1, 66.7), respectively, thus supporting the need for two doses of vaccine in previously unvaccinated children.
Danish: Hos tidligere ikke-vaccinerede deltagere i studiet, som fik en dosis i år 1, var virkningen hhv. 57,7 % (95 % CI: 44,7; 67,9) og 56,3 % (95 % CI: 43,1; 66,7), hvilket støtter behovet for to doser af vaccinen hos tidligere ikke-vaccinerede børn.
English: The concurrent use of Fluenz Tetra with antiviral agents that are active against influenza A and/or B viruses has not been evaluated.
Danish: Samtidig anvendelse af Fluenz Tetra og antivirale stoffer aktivet mod influenza A- og/eller B-vira er ikke blevet evalueret.
English: After administering half of the dose in one nostril, administer the other half of the dose in the other nostril immediately or shortly thereafter.
Danish: Efter indgivelse af halvdelen af dosen i et næsebor, skal den anden halvdel af dosen straks eller kort tid efter indgives i det andet næsebor.
English: Fluenz Tetra nasal spray suspension Influenza vaccine (live attenuated, nasal) 2019/2020 season
Danish: Fluenz Tetra næsespray, suspension Influenzavaccine (levende svækket, nasal) Sæson 2019/2020
English: In a study of children and adolescents 9 to 17 years of age with moderate to severe asthma (trivalent Fluenz: n=24, placebo: n=24), the primary safety criterion, change in percent predicted forced expiratory volume in 1 second (FEV1) measured before and after vaccination, did not differ between treatment arms.
Danish: I et studie med børn og unge i alderen 9 til 17 år med moderat til svær astma (trivalent Fluenz: n=24, placebo: n=24) var der ingen forskel i de to behandlingsgrupper for så vidt angår det primære sikkerhedskriterium, ændring i procent af forventet værdi af forceret eksspiration på 1 sekund (FEV1), målt før og efter vaccinationen.
English: Reduction in culture-confirmed influenza illness relative to injectable influenza vaccine.
Danish: Reduktion i influenzasygdom bekræftet ved dyrkning i forhold til injicerbar influenzavaccine.
English: B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, MEDI 254977)
Danish: B/Phuket/3073/2013 - lignende stamme (B/Phuket/3073/2013, MEDI 254977)
English: The patient can breathe normally while the vaccine is being administered - there is no need to actively inhale or sniff.
Danish: Patienten kan trække vejret normalt, mens vaccinen indgives - der er ikke grund til aktivt at inhalere eller snøfte.
English: Study Number
Danish: Undersøgel sesnummer
English: 5 single-use nasal applicators (0.2 ml each)
Danish: 5 nasale applikatorer til engangsbrug (0,2 ml applikator)
English: This vaccine complies with the WHO (World Health Organisation) recommendations (Northern Hemisphere) and EU decision for the 2019/2020 season.
Danish: Denne vaccine følger WHO's (World Health Organisation) anbefalinger (nordlige halvkugle) og EU's beslutning for sæson 2019/2020.
English: • The patient can breathe normally while the vaccine is being administered - there is no need to actively inhale or sniff.
Danish: • Patienten kan trække vejret normalt mens vaccinen indgives - der er ikke grund til at aktivt at inhalere eller snøfte.
English: In study participants who received 2 doses in year 1 and placebo in year 2, efficacy in year 2 was 56.2% (95% CI: 30.5, 72.7) and 44.8% (95% CI: 18.2, 62.9), respectively, in D153-P501, thus supporting the need for second-season revaccination.
Danish: Hos deltagere i studiet, som fik 2 doser i år 1 og placebo i år 2, var virkningen i år 2 hhv. 56,2 % (95 % CI: 30,5; 72,7) og 44,8 % (95% CI: 18,2; 62,9) i D153-P501, hvilket støtter behovet for en gentagen vaccination i 2. sæson.
English: .................................................................................................................per 0.2 ml dose
Danish: .......................................................................................................pr. 0,2 ml dosis
English: Fluenz demonstrated 55.7% (39.9, 67.6) fewer cases than injectable influenza vaccine in 3,686 infants and toddlers 6-23 months of age and 54.4% (41.8, 64.5) fewer cases in 4,166 children 24-59 months of age.
Danish: Fluenz havde 55,7 % (39,9; 67,6) færre tilfælde end injicerbar influenzavaccine hos 3.686 spædbørn og små børn i alderen 6-23 måneder og 54,4 % (41,8; 64,5) færre tilfælde hos 4.166 børn i alderen 24-59 måneder.
English: Fluenz Tetra should under no circumstances be injected.
Danish: Fluenz Tetra må under ingen omstændigheder injiceres.
English: This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for the 2019/2020 season.
Danish: Denne vaccine følger WHO's anbefalinger (nordlige halvkugle) og EU's beslutning for sæson 2019/2020.
English: Spray in other nostril Place the tip just inside the other nostril and with a single motion, depress plunger as rapidly as possible to deliver remaining vaccine.
Danish: Placer spidsen lige indenfor det andet næsebor og tryk stemplet ned så hurtigt som muligt med en enkelt bevægelse, for at indgive den resterende vaccine.
English: SINGLE-USE NASAL APPLICATOR
Danish: NASAL APPLIKATOR TIL ENGANGSBRUG
English: Skin and subcutaneous tissue disorders Uncommon: Rash
Danish: Hud og subkutane væv Ikke almindelig: Udslæt
English: A/Brisbane/02/2018 (H1N1)pdm09 - like strain (A/Switzerland/3330/2017, MEDI 307134)
Danish: A/Brisbane/02/2018 (H1N1)pdm09 - lignende stamme (A/Switzerland/3330/2017, MEDI 307134)
English: Paediatric studies
Danish: Pædiatriske studier
English: This observation with trivalent Fluenz is relevant to the use of Fluenz Tetra because Fluenz Tetra (influenza vaccine-liveattenuated, nasal) is identical to Fluenz with the only difference being the addition of a fourth strain (a second B strain) to Fluenz Tetra.
Danish: Denne observation med trivalent Fluenz er relevant for brugen af Fluenz Tetra, fordi Fluenz Tetra (influenzavaccine, levende svækket, nasal) er identisk med Fluenz, den eneste forskel er tilføjelsen af en fjerde stamme (den anden B-stamme) i Fluenz Tetra.
English: B/Colorado/06/2017 - like strain (B/Colorado/06/2017, MEDI 293454)
Danish: B/Colorado/06/2017 - lignende stamme (B/Colorado/06/2017, MEDI 293454)
English: The co-administration of Fluenz Tetra with inactivated vaccines has not been studied.
Danish: Samtidig indgivelse af Fluenz Tetra og inaktiverede vacciner er ikke blevet undersøgt.
English: A/Kansas/14/2017 (H3N2) - like strain (A/Kansas/14/2017, MEDI 308763)
Danish: A/Kansas/14/2017 (H3N2) - lignende stamme (A/Kansas/14/2017, MEDI 308763)
English: Fluenz Tetra will be given as a spray in each nostril.
Danish: Fluenz Tetra gives som spray i hvert næsebor.
English: General disorders and administration site conditions Very common: Malaise
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig: Utilpashed Almindelig: Feber
English: If any of these apply, tell your doctor, nurse or pharmacist before vaccination.
Danish: Hvis noget af dette gælder for dig, skal du fortælle det til lægen, sundhedspersonalet eller på apoteket før vaccinationen.
English: The safety experience with trivalent Fluenz is relevant to the use of Fluenz Tetra because Fluenz Tetra (influenza vaccine-live attenuated, nasal) is identical to Fluenz with the only difference being the addition of a fourth strain (a second B strain) to Fluenz Tetra.
Danish: Erfaringen med sikkerheden ved trivalent Fluenz er relevant for brugen af Fluenz Tetra, fordi Fluenz Tetra (influenzavaccine, levende svækket, nasal) er identisk med Fluenz, den eneste forskel er tilføjelsen af en fjerde stamme (den anden B-stamme) i Fluenz Tetra.
English: Other possible side effects of Fluenz Tetra
Danish: Andre bivirkninger ved Fluenz Tetra
English: Figure 1 Fluenz Tetra Administration
Danish: Figur 1 Indgivelse af Fluenz Tetra
English: Efficacy (95% CI) All strains regardless of match
Danish: Virkning (95% CI) Alle stammer uanset match
English: Dipotassium phosphate Potassium dihydrogen phosphate Gelatin (porcine, Type A) Arginine hydrochloride Monosodium glutamate monohydrate Water for injections
Danish: Dikaliumphosphat Kaliumdihydrogenphosphat Gelatine (svin, Type A) Argininhydrochlorid Mononatriumglutamatmonohydrat Vand til injektionsvæsker
English: What you need to know before you are given Fluenz Tetra
Danish: Det skal du vide, før du får Fluenz Tetra
English: Fluenz Tetra must not be injected.
Danish: Fluenz Tetra må ikke injiceres.
English: The suspension should be colourless to pale yellow, clear to opalescent.
Danish: Suspensionen skal være farveløs til lysegul, klar til opaliserende.
English: - Hypersensitivity to the active substances, to any of the excipients listed in section 6.1 (e.g. gelatin), or to gentamicin (a possible trace residue).
Danish: 6.1 (f.eks. gelatine), eller over for gentamicin (et muligt reststof).
English: PACK SIZE OF 1 SINGLE-USE NASAL APPLICATOR PACK SIZE OF 1 SINGLE-USE NASAL APPLICATOR (IN A TRI-FOLD CARTON) PACK SIZE OF 10 SINGLE-USE NASAL APPLICATORS (IN TRAYS) PACK SIZE OF 10 SINGLE-USE NASAL APPLICATORS
Danish: PAKNINGSSTØRRELSE PÅ 1 NASAL APPLIKATOR TIL ENGANGSBRUG PAKNINGSSTØRRELSE PÅ 1 NASAL APPLIKATOR TIL ENGANGSBRUG (I FOLDEKARTON)
English: • Fluenz Tetra is administered as a divided dose in both nostrils as described below.
Danish: • Fluenz Tetra indgives som en delt dosis i begge næsebor, som beskrevet nedenfor.
English: What Fluenz Tetra is and what it is used for What you need to know before you are given Fluenz Tetra How Fluenz Tetra is given
Danish: Virkning og anvendelse Det skal du vide, før du får Fluenz Tetra Sådan gives Fluenz Tetra Bivirkninger
English: This vaccine is presented as a nasal spray suspension in a single-use nasal applicator (0.2 ml) in a pack size of 1 and 10.
Danish: Denne vaccine foreligger som en næsespray-suspension, i en nasal applikator til engangsbrug (0,2 ml) i en pakningsstørrelse på 1 og 10. Ikke alle pakningsstørrelser er nødvendigvis tilgængelige i dit land.
English: PACK SIZE OF 5 SINGLE-USE NASAL APPLICATORS
Danish: PAKNINGSSTØRRELSE PÅ 5 NASALE APPLIKATORER TIL ENGANGSBRUG
English: Do not administer Fluenz Tetra to children and adolescents receiving salicylate therapy (see section 4.3).
Danish: Fluenz Tetra må ikke administreres til børn og unge, som er i behandling med salicylater (se pkt.
English: The rate of hospitalisations was not increased in Fluenz recipients 12 months and older.
Danish: Hyppigheden af indlæggelser var ikke forøget hos modtagere af Fluenz Tetra i alderen 12 måneder og derover.
English: The suspension is colourless to pale yellow, clear to slightly cloudy.
Danish: Suspensionen er farveløs til let gullig, klar til let uigennemsigtig.
English: Efficacy (95% CI) Matched strains
Danish: Virkning (95% CI) Matchede stammer
English: Musculoskeletal and connective tissue disorders Common: Myalgia
Danish: Knogler, led, muskler og bindevæv Almindelig: Myalgi
English: You will not be given Fluenz Tetra:
Danish: Du vil ikke få Fluenz Tetra
English: Contains also: sucrose, dipotassium phosphate, potassium dihydrogen phosphate, gelatin (porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate, water for injections.
Danish: Indeholder også: sakkarose, dikaliumphosphat, kaliumdihydrogenphosphat, gelatine (svin, type A), argininhydrochlorid, mononatriumglutamatmonohydrat, vand til injektionsvæsker.
English: Nasal spray, suspension 1 single-use nasal applicator (0.2 ml) 10 single-use nasal applicators (0.2 ml each)
Danish: 1 nasal applikator til engangsbrug (0,2 ml) 10 nasale applikatorer til engangsbrug (0,2 ml)
English: Peak incidence of vaccine virus recovery occurred 2-3 days post-vaccination in Fluenz clinical studies.
Danish: I kliniske studier med Fluenz forekom den højeste udskillelse af vaccine-virus 2-3 dage efter vaccinationen.
English: Tell your doctor, nurse or pharmacist if the person being vaccinated is taking, has recently taken or might take any other medicines, including medicines that do not require a prescription.
Danish: Fortæl altid lægen, sundhedspersonalet eller apotekspersonalet, hvis du eller dit barn bruger anden medicin eller har gjort det for nylig.
English: The other ingredients are sucrose, dipotassium phosphate, potassium dihydrogen phosphate, gelatin (porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate and water for injections.
Danish: Øvrige indholdsstoffer: Sakkarose, dikaliumphosphat, kaliumdihydrogenphosphat, gelatine (svin, type A), argininhydrochlorid, mononatriumglutamatmonohydrat og vand til injektionsvæsker.
English: Fluenz Tetra immunogenicity
Danish: Immunogenicitet for Fluenz Tetra
English: Fluenz Tetra IS FOR NASAL USE ONLY.
Danish: Fluenz Tetra er kun til nasal anvendelse.
English: Fluenz Tetra is for nasal use only.
Danish: Fluenz Tetra ER KUN TIL NASAL ANVENDELSE.
English: Very rare (may affect up to 1 in 10,000 people):
Danish: Meget sjælden (kan forekomme hos op til 1 ud af 10.000):
English: Fluenz Tetra must only be used as a nasal spray.
Danish: Fluenz Tetra må kun anvendes som en næsespray.
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10):
English: • Fluenz Tetra is administered as a divided dose in both nostrils.
Danish: • Fluenz Tetra indgives som en delt dosis i begge næsebor.
English: Fluenz Tetra is administered as a divided dose in both nostrils.
Danish: Fluenz Tetra indgives som en delt dosis i begge næsebor.
English: How Fluenz Tetra is given
Danish: Sådan gives Fluenz Tetra
English: If any of these apply, tell your doctor, nurse or pharmacist.
Danish: Hvis noget af dette gælder for dig, skal du fortælle det til lægen, sundhedspersonalet eller på apoteket.
English: D153-P514 Europe
Danish: D153-P514 Europa
English: • weakness
Danish: • træthed
English: What Fluenz Tetra contains
Danish: Fluenz Tetra indeholder:
English: D153-P515 Europe
Danish: D153-P515 Europa
English: Common (may affect up to 1 in 10 people):
Danish: Almindelig (kan forekomme hos op til 1 ud af 10):
English: Uncommon (may affect up to 1 in 100 people):
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100):
English: For administration in the other nostril, pinch and remove the dose-divider clip from plunger.
Danish: Fjern klipsen til dosisfordeling Klem klipsen til dosisfordeling sammen og fjern den fra stemplet, så vaccinen kan indgives i det andet næsebor.
English: Fluenz has demonstrated superiority in 3 active-controlled studies with injectable influenza vaccine.
Danish: I 3 kontrollerede studier med aktiv injicerbar influenzavaccine som kontrol var profylakse med Fluenz forbundet med statistisk forbedret beskyttelse mod influenza.
English: How Fluenz Tetra works
Danish: Sådan virker Fluenz Tetra
English: Respiratory, thoracic and mediastinal disorders Very common: Nasal congestion/rhinorrhoea
Danish: Meget almindelig: Tilstoppet næse/rhinorré Ikke almindelig: Epistakse
English: AstraZeneca S.p.A. Tel: +39 02 98011
Danish: Tel: +39 02 98011
English: 6 to 17 Y 2,211 2002-2003
Danish: 11 til 24
English: • muscle aches
Danish: • muskelsmerter
English: Posology
Danish: Stempelstang
English: Södertälje Sweden
Danish: SE-151 85 Södertälje, Sverige
English: Breast-feeding
Danish: Aldersinterval
English: Prozac and associated names
Danish: Prozac og tilknyttede navne
English: The final opinion was converted into a Decision by the European Commission on 21 August 2006.
Danish: Den endelige udtalelse blev omdannet til en afgørelse truffet af Europa-Kommissionen den 21. august 2006.
English: International Non-Proprietary Name (INN): Fluoxetine
Danish: Internationalt fællesnavn ( INN): Fluoxetin
English: The Member States competent authorities will continue to keep the product under regular review.
Danish: Medlemsstaternes kompetente myndigheder skal fortsat føre regelmæssigt tilsyn med lægemidlet.
English: The review was initiated on the basis of unresolved safety and efficacy concerns.
Danish: Der blev på grundlag af de problemer med hensyn til sikkerhed og virkning, som endnu ikke er løst, indledt en undersøgelse.
English: Fluoxetine is a selective inhibitor of serotonin reuptake.
Danish: Fluoxetin er en selektiv hæmmer af serotoningenoptagelse.
English: The Rapporteur and Co-Rapporteur appointed were: Dr Barbara van Zwieten-Boot and Dr Tomas Salmonson, respectively.
Danish: Som rapportør og medrapportør udpegedes: henholdsvis dr. Barbara van Zwieten-Boot og dr. Tomas Salmonson.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 6(12) REFERRAL
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 6, STK. 12,
English: * Notes: The information given in this document and Annexes reflect only the CHMP Opinion dated 1 June 2006.
Danish: * Bemærkninger: Oplysningerne i dette dokument og bilagene afspejler udelukkende CHMP's udtalelse af 1. juni 2006.
English: The referral procedure started on 26 May 2005.
Danish: Proceduren for indbragte sager indledtes den 26. maj 2005.
English: Based on evaluation of the currently available data and the Rapporteurs' assessment reports, the CHMP considered that the benefits of Prozac are greater than its potential risks in this population and therefore adopted an opinion on 1 June 2006 recommending the following extension of the indication:
Danish: På grundlag af vurderingen af de aktuelt foreliggende oplysninger og evalueringsrapporterne fra rapportørerne var CHMP af den opfattelse, at fordelene ved Prozac er større end dets potentielle risici for denne befolkningsgruppe, og vedtog en udtalelse den 1. juni 2006, hvori det anbefaledes at udvide indikationen således:
English: The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II, together with the amended product information in the Annex III and the conditions of the marketing authorisations in the Annex IV.
Danish: Listen over de pågældende lægemiddelnavne fremgår af bilag I. De faglige konklusioner findes i bilag II, det ændrede produktresumé findes i bilag III, og betingelserne for markedsføringstilladelserne findes i bilag IV.
English: Written explanations were provided by the Marketing Authorisation Holders on 29 August 2005, 6 January 2006, 3 April 2006 and 11 May 2006.
Danish: Indehaverne af markedsføringstilladelsen fremsendte skriftlige redegørelser den 29. august 2005, den 6. januar 2006, den 3. april 2006 og den 11. maj 2006.
English: Prozac is authorised in most EU Member States for the treatment of major depressive episodes, obsessive-compulsive disorder and bulimia nervosa in adults.
Danish: Prozac er i de fleste EU-medlemsstater godkendt til behandling af svære depressive episoder, obsessiv-kompulsiv tilstand og bulimia nervosa hos voksne.
English: Children and adolescents aged 8 years and above: Moderate to severe major depressive episode, if depression is unresponsive to psychological therapy after 4-6 sessions.
Danish: Børn og unge fra 8-årsalderen og derover: Moderat til svær depressiv episode, hvis depressionen ikke reagerer på psykoterapi efter 4-6 seancer.
English: The CHMP began an arbitration review for Prozac, following an application by the marketing authorisation holder to extend the indication to include the treatment of major depressive episodes in children and adolescents.
Danish: CHMP indledte en voldgiftsundersøgelse for Prozac efter en ansøgning indgivet af indehaveren af markedsføringstilladelsen om at udvide indikationen til at omfatte behandling af svære depressive episoder hos børn og voksne.
English: Oral explanations were given by the Marketing Authorisation Holders on 26 April 2006.
Danish: Indehaverne af markedsføringstilladelsen afgav mundtlige redegørelser den 26. april 2006.
English: Antidepressant medication should be offered to a child or young person with moderate to severe depression only in combination with a concurrent psychological therapy.
Danish: Antidepressiv medikamentel behandling bør kun tilbydes børn eller unge med moderat til svær depression, når den kombineres med sideløbende psykoterapi.
English: On 2 May 2005, France referred the matter to the EMEA under Article 6(12) of Commission Regulation EC No 1084/2003.
Danish: Frankrig indbragte i henhold til artikel 6, stk. 12, i Kommissionens forordning (EF) nr. 1084/2003 en sag for EMEA den 2. maj 2005.
English: The European Commission issued a decision on 7 January 2016.
Danish: Europa-Kommissionen traf en afgørelse den 7. januar 2016.
English: What are the conclusions of the CVMP?
Danish: Hvilke konklusioner traf CHMP?
English: 7 January 2016
Danish: Den 7. januar 2016
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the United Kingdom) assesses a veterinary medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Poland, Portugal, Slovakia, Spain and The Netherlands).
Danish: Ved denne procedure vurderer én medlemsstat ("referencemedlemsstaten", her Det Forenede Kongerige) et veterinærlægemiddel med henblik på udstedelse af en markedsføringstilladelse, der er gyldig i det pågældende land foruden i andre medlemsstater (de "berørte medlemsstater", her Østrig, Belgien, Tjekkiet, Danmark, Frankrig, Tyskland, Grækenland, Ungarn, Irland, Italien, Luxembourg, Polen, Portugal, Slovakiet, Spanien og Nederlandene).
English: However, the Member States were not able to reach an agreement and the Veterinary Medicines Directorate of the United Kingdom referred the matter to the CVMP for arbitration on 28 May 2015.
Danish: Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og Det Forenede Kongeriges kompetente myndighed, Veterinary Medicines Directorate, indbragte den 28. maj 2015 sagen for CHMP til voldgift.
English: Thus the CVMP concluded that the concerns expressed by Denmark should not prevent the granting of marketing authorisations and recommended marketing authorisation be granted in the concerned Member States.
Danish: CVMP konkluderede således, at de af Danmark udtrykte betænkeligheder ikke burde forhindre udstedelse af markedsføringstilladelser, og anbefalede, at der udstedes markedsføringstilladelse i de berørte medlemsstater.
English: The grounds for the referral were concerns raised by Denmark that the marketing authorisation of Solamocta may present a potential serious risk to human and animal health.
Danish: Begrundelsen for indbringelsen var betænkelighed rejst af Danmark om, at markedsføringstilladelsen for Solamocta kan udgøre en potentiel alvorlig risiko for menneskers og dyrs helbred.
English: In addition, Denmark raised a concern that the advice for prudent use in the product information is insufficient.
Danish: Desuden rejste Danmark betænkelighed ved, at anvisningerne om forsvarlig brug i produktinformationen er utilstrækkelige.
English: Amoxicillin is a bactericidal antibiotic belonging to the semisynthetic penicillin group.
Danish: Amoxicillin er et baktericidt antibiotikum i gruppen af halvsyntetiske penicilliner.
English: The CVMP also recommended that the product information for Solamocta be amended.
Danish: CVMP anbefalede desuden, at produktoplysningerne for Solamocta rettes.