FrancophonIA/ELRC3.0 huggingface dataset:
English: Annex I of Directive 2001/82/EC as amended by directive 2004/28/EC notes that post-marketing experience with other products containing the same constituents is of particular importance and applicants should put a special emphasis on this issue.
Danish: I Bilag I til direktiv 2001/82/EF, som ændret ved direktiv 2004/28/EF, er anført, at erfaringer efter markedsføring med andre produkter, som indeholder samme indholdsstoffer, er af særlig betydning, og at ansøgere bør lægge særlig vægt på dette punkt.
English: The Marketing Authorisation Holder (MAH) was requested to substantiate the efficacy of the product.
Danish: Indehaveren af markedsføringstilladelsen (MAH) blev anmodet om at underbygge produktets virkning.
English: The applicant provided a justification for submission of this application on a “well-established use” basis.
Danish: Ansøgeren fremsatte en begrundelse for den indgivne ansøgning på basis af “almindelig anerkendt anvendelse”.
English: London, June 2008 EMEA/532206/2007- Rev.1
Danish: London, juni 2008 EMEA/532206/2007- Rev.1
English: These are all references provided with the original submission.
Danish: Disse referencer medfølger alle i den oprindelige ansøgning.
English: Germany considered that the product could represent a potential serious risk to animal health on the grounds that the efficacy had not been sufficiently substantiated.
Danish: Tyskland mente, at produktet kunne udgøre en potentiel alvorlig risiko for dyrs sundhed, fordi dets virkning ikke var tilstrækkeligt velunderbygget.
English: Germany could not agree to the granting a marketing authorisation and the matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures, CMD(v), and subsequently to the Committee for Medicinal Products for Veterinary Use (CVMP).
Danish: Tyskland kunne ikke tilslutte sig udstedelse af en markedsføringstilladelse, og sagen blev indbragt for koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede godkendelsesprocedurer, CMD(v), og efterfølgende for Udvalget for Veterinærlægemidler (CVMP).
English: The applicant submitted a scientific report on Porcine Respiratory Disease Complex (PRDC).
Danish: Ansøgeren fremlagde en videnskabelig rapport om Porcine Respiratory Disease Complex (PRDC).
English: EMEA/532206/2007- Rev.1
Danish: EMEA/532206/2007- Rev.1-DA
English: Therefore, the CVMP considered that the reports mentioned above give favourable evidence for the safety and efficacy of doxycycline in general, but also for the specific final formulation as marketed in Spain.
Danish: Derfor fandt CVMP, at ovennævnte rapporter taler tydeligt til fordel for doxycyclins sikkerhed og virkning generelt, men også for den specifikke endelige formulering, som den markedsføres i Spanien.
English: The applicant justifies that the presence of M. hyopneumoniae was not determined by bacteriological methods because it was difficult to isolate at that time.
Danish: Ansøgeren fremfører som begrundelse, at tilstedeværelse af M. hyopneumoniae ikke blev bestemt ved bakteriologiske metoder, da denne var vanskelig at isolere på daværende tidspunkt.
English: The CVMP recommended the granting of the marketing authorisation to Doxyprex 100 mg/g Premix for medicated feeding stuff for pigs for the following indication because a positive benefit/risk analysis has been demonstrated and no potential serious risk has been identified.
Danish: CVMP anbefalede udstedelse af markedsføringstilladelse for Doxyprex 100 mg/g Premix til medicineret foder til svin til følgende indikation på baggrund af, at der er fremlagt en positiv benefit/risk-analyse, og at der ikke er fundet nogen potentielt alvorlig risiko.
English: Within the EU doxycycline-based premix products for pigs at recommended dose rates of 10mg/kg once daily for 5 days are stated as having been authorised since 1985.
Danish: Inden for EU angives doxycyclin-baserede færdigblandede produkter til svin ved anbefalede doseringer på 10 mg/kg en gang dagligt i 5 dage som værende godkendt siden 1985.
English: The CVMP during its meeting of 21-22 June 2006 started a referral procedure under Article 33(4) of Directive 2001/82/EC, as amended, for Doxyprex 100 mg premix.
Danish: CVMP indledte på sit møde den 21.-22. juni 2006 en indbringelsesprocedure i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF, med senere ændringer, for Doxyprex 100 mg premix.
English: Doxyprex 100 mg premix presented in 5 kg, 20 kg and 25 kg bags containing 100 mg/g doxycycline base as hyclate.
Danish: Doxyprex 100 mg premix findes i 5 kg, 20 kg og 25 kg sække indeholdende 100 mg/g doxycyclinbase som hyclat.
English: A benefit-risk analysis could not be conducted due to the lack of pivotal evidence on clinical efficacy for the indication M. hyopneumoniae.
Danish: Der kunne ikke gennemføres en benefit/risk-analyse på grund af manglende hoveddokumentation for klinisk effekt til indikationen M. hyopneumoniae.
English: However, the CVMP considered that the fact that no post treatment bacteriological samples were taken mean that bacteriological cure cannot be assumed or claimed.
Danish: CVMP anså dog, at den manglende bakteriologiske prøvetagning efter behandlingen indebærer, at bakteriologisk helbredelse ikke kan antages eller påberåbes.
English: OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR DOXYPREX 100mg PREMIX
Danish: UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 33, STK. 4 VEDRØRENDE DOXYPREX 100 mg PREMIX
English: In the pivotal clinical trial, the presence of P. multocida and B. bronchiseptica was clearly demonstrated in sick pigs, however, no post treatment sampling was done to show bacteriological cure.
Danish: I den pivotale kliniske undersøgelse påvistes tilstedeværelsen af P. multocida og B. bronchiseptica tydeligt hos syge svin, men der blev ikke udtaget prøver efter behandlingen til påvisning af bakteriologisk helbredelse.
English: “For the treatment and prevention of porcine respiratory disease, caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to doxycycline, when the disease has been diagnosed in the herd.”
Danish: “Til behandling og forebyggelse af luftvejssygdomme hos svin forårsaget af Pasteurella multocida og Bordetella bronchiseptica, som er følsomme over for doxycyclin, når sygdommen er blevet diagnosticeret i besætningen.”
English: The product is authorised with the indication the treatment of swine respiratory disease caused by Pasteurella multocida, Bordetella bronchiseptica and Mycoplasma hyopneumoniae.
Danish: Produktet er godkendt med indikationen behandling af luftvejslidelser hos svin forårsaget af Pasteurella multocida, Bordetella bronchiseptica og Mycoplasma hyopneumoniae.
English: The applicant provided evidence of efficacy of the active substance, doxycycline, against M. hyopneumoniae in pigs from published literature and from MIC studies.
Danish: Ansøgeren forelagde dokumentation for virkningen af det aktive indholdsstof, doxycyclin, mod M. hyopneumoniae hos svin baseret på den offentliggjorte faglitteratur og MIC-bestemmelser.
English: 1 pre-filled syringe pre-filled syringe (glass) with needle guard
Danish: 1 fyldt injektionssprøjte fyldt injektionssprøjte (glas) med kanylebeskyttelse
English: Pack size pre-filled syringe (glass)
Danish: Pakningsstørrelse fyldt injektionssprøjte (glas)
English: 1 pre-filled syringe with needle guard
Danish: 1 fyldt injektionssprøjte med kanylebeskyttelse
English: • you regularly drink alcohol.
Danish: • Du regelmæssigt drikker alkohol.
English: Date of first authorisation: 28th April 2014 Date of latest renewal:
Danish: Dato for første markedsføringstilladelse: 28. april 2014.
English: The use of DuoResp Spiromax follows three steps: open, breathe and close which are outlined below.
Danish: Brugen af DuoResp Spiromax følger tre trin: åbning, indånding og lukning, som beskrevet nedenfor.
English: • It is important to use DuoResp Spiromax every day, even if you have no asthma or COPD symptoms at the time.
Danish: • Det er vigtigt, at du bruger DuoResp Spiromax hver dag, også selvom du ikke har nogen astmaeller KOL-symptomer på det pågældende tidspunkt.
English: Before using your DuoResp Spiromax for the first time, you need to prepare it for use as follows:
Danish: Inden du bruger DuoResp Spiromax første gang, skal du gøre den klar til brug på følgende måde:
English: Mogilska 80 Str. 31-546 Kraków Poland
Danish: Mogilska 80 Str. 31-546 Kraków Polen
English: DuoResp Spiromax should be used correctly in order to achieve effective treatment.
Danish: DuoResp Spiromax skal anvendes korrekt for at opnå en effektiv behandling.
English: Some medicines may increase the effects of DuoResp Spiromax and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
Danish: Nogle lægemidler kan øge virkningen af DuoResp Spiromax, og din læge vil overvåge dig omhyggeligt, hvis du tager sådanne lægemidler (inklusive visse former for HIV-medicin, herunder ritonavir og cobicistat).
English: The amount of DuoResp Spiromax to use and when to use it depends on how it has been prescribed for you.
Danish: Den mængde DuoResp Spiromax, du skal bruge, og hvornår du skal bruge den, afhænger af, hvordan den er ordineret til dig.
English: • If you are using DuoResp Spiromax for asthma, your doctor will want to regularly check your symptoms.
Danish: • Hvis du bruger DuoResp Spiromax mod astma, vil din læge ønske at kontrollere dine symptomer med jævne mellemrum.
English: The prophylactic use of DuoResp Spiromax, e.g. before exercise, has not been studied.
Danish: Profylaktisk brug af DuoResp Spiromax, f.eks. før motion, er ikke blevet undersøgt.
English: - The other ingredient is lactose monohydrate (see section 2 under ‘DuoResp Spiromax contains lactose')
Danish: - Øvrige indholdsstoffer: lactosemonohydrat (se punkt 2 under 'DuoResp Spiromax indeholder lactose')
English: The dosage of DuoResp Spiromax is individual and should be adjusted to the severity of the disease.
Danish: Doseringen af DuoResp Spiromax er individuel og skal justeres i henhold til sygdommens sværhedsgrad.
English: If you are doing exercise and you get asthma symptoms, use DuoResp Spiromax as described here.
Danish: Hvis du dyrker motion, og du får astmasymptomer, skal du bruge DuoResp Spiromax som beskrevet her.
English: The reliever inhalations of DuoResp Spiromax should be taken in response to symptoms but are not intended for regular prophylactic use, e.g. before exercise.
Danish: Inhalation af DuoResp Spiromax efter behov bør ske i forbindelse med symptomer, men er ikke beregnet til regelmæssig profylaktisk brug, f.eks. før motion.
English: For DuoResp Spiromax there are two treatment approaches:
Danish: For DuoResp Spiromax findes der to behandlingsmetoder:
English: You should speak to your doctor if you are concerned as to whether you should continue to use DuoResp Spiromax.
Danish: Tal med din læge, hvis du er i tvivl om, hvorvidt du skal fortsætte med at bruge DuoResp Spiromax.
English: If you have been taking steroid tablets for your asthma or COPD, your doctor may reduce the number of tablets that you take, once you start to use DuoResp Spiromax.
Danish: Hvis du har taget steroidtabletter for din astma eller KOL, kan lægen reducere det antal tabletter, du tager, når du begynder at bruge DuoResp Spiromax.
English: • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking DuoResp Spiromax - do NOT use this medicine unless your doctor tells you to.
Danish: • Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge, apotekspersonalet eller sundhedspersonalet til råds, før du tager DuoResp Spiromax - brug IKKE denne medicin, medmindre din læge beder dig om det.
English: If these effects occur, they are usually mild and usually disappear as you continue to use DuoResp Spiromax.
Danish: Hvis disse virkninger forekommer, er de som regel lette og forsvinder normalt, når du fortsætter med at bruge
English: DuoResp Spiromax maintenance and reliever therapy should especially be considered for patients with:
Danish: DuoResp Spiromax vedligeholdelses- og behovsbehandling bør specielt overvejes til patienter med:
English: DuoResp Spiromax can be prescribed for asthma in two different ways.
Danish: DuoResp Spiromax kan ordineres for astma på to måder.
English: DuoResp Spiromax can also be used to treat the symptoms of severe COPD in adults.
Danish: DuoResp Spiromax kan også anvendes til at behandle symptomer på svær KOL hos voksne.
English: You do not need a separate ‘reliever inhaler' for this.
Danish: Du behøver ikke en særskilt inhalator med anfaldsmedicin hertil.
English: Patients should be reassessed regularly by their prescriber/healthcare provider so that the dose of DuoResp Spiromax remains optimal.
Danish: Patienterne bør revurderes med jævne mellemrum af deres læge/sundhedsperson, således at dosis af DuoResp Spiromax forbliver optimal.
English: Close monitoring for dose-related adverse reactions is needed in patients who frequently take high numbers of DuoResp Spiromax as-needed inhalations.
Danish: Nøje overvågning for dosisrelaterede bivirkninger er nødvendig hos patienter, der ofte tager et stort antal DuoResp Spiromax inhalationer efter behov.
English: Since DuoResp Spiromax contains both budesonide and formoterol, the same pattern of adverse reactions as reported for these substances may occur.
Danish: Da DuoResp Spiromax indeholder både budesonid og formoterol, kan det samme bivirkningsmønster, som er indberettet for disse stoffer, forekomme.
English: The most common symptoms that may occur after when you use more DuoResp Spiromax than you should are trembling, headache or a rapid heartbeat.
Danish: De hyppigste symptomer, der kan opstå efter, du har taget for meget DuoResp Spiromax, er rysten, hovedpine eller hurtig hjerterytme (puls).
English: If you feel you are getting breathless or wheezy while using DuoResp Spiromax, you should continue to use DuoResp Spiromax but go to see your doctor as soon as possible, as you may need additional treatment.
Danish: Hvis du føler, at du bliver forpustet eller trækker vejret med en hvæsende lyd, mens du bruger DuoResp Spiromax, skal du fortsætte med at bruge DuoResp Spiromax, men søge læge så hurtigt som muligt, da du måske har brug for yderligere behandling.
English: Do not use DuoResp Spiromax to treat these asthma symptoms.
Danish: Brug ikke DuoResp Spiromax til at behandle disse astmasymptomer.
English: DuoResp Spiromax contains formoterol and budesonide, which have different modes of action and show additive effects in terms of reduction of asthma exacerbations.
Danish: DuoResp Spiromax indeholder formoterol og budesonid, som har forskellige virkningsmekanismer og udviser additiv virkning med hensyn til reduktion af astmaeksacerbationer.
English: If your doctor feels that you need a lower dose than is available from your DuoResp Spiromax, your doctor may prescribe an alternative inhaler containing the same active substances as your DuoResp Spiromax but with a lower dose of the corticosteroid.
Danish: Hvis din læge mener, at du har brug for en lavere dosis, end der er tilgængelig med din DuoResp Spiromax, kan din læge ordinere en anden inhalator, som indeholder de samme aktive stoffer som DuoResp Spiromax, men med en lavere dosis kortikosteroid.
English: Patients should be advised to have their rescue inhaler available at all times, either DuoResp Spiromax (for asthma patients using DuoResp Spiromax as maintenance and reliever therapy) or a separate rapid-acting bronchodilator (for asthma patients using DuoResp Spiromax as maintenance therapy only).
Danish: Patienterne skal informeres om altid at have deres anfaldsmedicin på sig, enten DuoResp Spiromax (til astmapatienter, der bruger DuoResp Spiromax som vedligeholdelses- og behovsbehandling) eller en separat hurtigtvirkende bronkodilator (til astmapatienter, der kun bruger DuoResp Spiromax som vedligeholdelsesbehandling).
English: DuoResp Spiromax contains two different active substances: budesonide and formoterol fumarate dihydrate.
Danish: DuoResp Spiromax indeholder to aktive stoffer: budesonid og formoterolfumaratdihydrat.
English: DuoResp Spiromax is an inhalation powder.
Danish: DuoResp Spiromax er et inhalationspulver.
English: • Disturbance of the heart's electrical system which does not cause symptoms (prolongation of the QTcinterval).
Danish: • Forstyrrelse i hjertets elektriske system, som ikke giver symptomer (forlængelse af QTcinterval).
English: Always keep your DuoResp Spiromax with you and use it to relieve sudden attacks of breathlessness and wheezing.
Danish: Hav altid din DuoResp Spiromax på dig og brug den til at afhjælpe pludselige anfald af åndenød og hvæsen.
English: If DuoResp Spiromax therapy has to be withdrawn due to overdose of the formoterol component of the medicinal product, provision of appropriate inhaled corticosteroid therapy must be considered.
Danish: Hvis det er nødvendigt at seponere DuoResp Spiromax på grund af overdosering med lægemidlets formoterol-komponent, skal det overvejes at give passende behandling med inhaleret kortikosteroid.
English: DuoResp Spiromax is not likely to affect your ability to drive or to use tools or machines.
Danish: Det er ikke sandsynligt, at DuoResp Spiromax vil påvirke din evne til at køre motorkøretøj eller betjene maskiner.
English: Patients take a daily maintenance dose of DuoResp Spiromax and in addition take DuoResp Spiromax as needed in response to symptoms.
Danish: Patienterne tager en daglig vedligeholdelsesdosis af DuoResp Spiromax og tager desuden DuoResp Spiromax efter behov ved forekomst af symptomer.
English: • Use DuoResp Spiromax when you need to take extra inhalations or puffs to relieve asthma symptoms andto make it easier to breathe again.
Danish: • Brug også DuoResp Spiromax, når du har brug for ekstra inhalationer eller pust til lindring af astmasymptomer og for at gøre det lettere at trække vejret igen.
English: Talk to your doctor,pharmacist or nurse before taking DuoResp Spiromax if
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger DuoResp Spiromax, hvis
English: If any of the above applies to you, or if you are not sure, talk to your doctor,pharmacist or nurse before using DuoResp Spiromax.
Danish: Hvis noget af ovenstående gælder for dig, eller hvis du ikke er sikker, så tal med din læge, apotekspersonalet eller sundhedspersonalet, før du bruger DuoResp Spiromax.
English: If any of the following happen to you, stop using DuoResp Spiromax and talk to your doctor immediately:
Danish: Hvis noget af følgende sker for dig, skal du holde op med at bruge DuoResp Spiromax og straks tale med din læge:
English: DuoResp Spiromax is not intended for the initial management of asthma.
Danish: DuoResp Spiromax er ikke beregnet til indledende behandling af astma.
English: A lower strength of DuoResp Spiromax is available for the maintenance and reliever therapy regimen.
Danish: En lavere styrke af DuoResp Spiromax er tilgængelig til vedligeholdelses- og behovsbehandling.
English: DuoResp Spiromax has no or negligible influence on the ability to drive and use machines.
Danish: DuoResp Spiromax påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: If the patient experiences paradoxical bronchopasm DuoResp Spiromax should be discontinued immediately, the patient should be assessed and an alternative therapy instituted, if necessary.
Danish: Hvis patienten oplever paradoks bronkospasme, skal DuoResp Spiromax straks seponeres, patienten udredes og alternativ behandling iværksættes, hvis det er nødvendigt.
English: Patients should be reminded to take their DuoResp Spiromax maintenance dose as prescribed, even when asymptomatic.
Danish: Patienterne bør mindes om at tage deres DuoResp Spiromax vedligeholdelsesdosis som ordineret, også når de er symptomfri.
English: • Use DuoResp Spiromax every day.
Danish: • Brug DuoResp Spiromax hver dag.
English: a) You may be prescribed two asthma inhalers: DuoResp Spiromax together with a separate ‘reliever inhaler' such as salbutamol.
Danish: a) Du kan få ordineret to astma-inhalatorer: DuoResp Spiromax sammen med en separat inhalator med anfaldsmedicin, såsom salbutamol.
English: Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation with DuoResp Spiromax.
Danish: Patienterne skal informeres om at fortsætte behandlingen og søge læge, hvis astmasymptomerne forbliver ukontrollerede eller forværres efter påbegyndelse af DuoResp Spiromaxbehandling.
English: You are allergic to budesonide, formoterol fumarate dihydrate, or the other ingredient in this medicine (listed in section 6).
Danish: Hvis du er allergisk over for budesonid, formoterolfumaratdihydrat eller det øvrige indholdsstof i DuoResp Spiromax (angivet i punkt 6).
English: • Medicines for a fast or uneven heartbeat (such as quinidine, disopyramide, procinamide and terfenadine).
Danish: • Lægemidler til behandling af hurtig eller uregelmæssig hjerterytme (såsom quinidin, disopyramid, procainamid og terfenadin).
English: DuoResp Spiromax should be discontinued immediately, the patient should be assessed and an alternative therapy is instituted if necessary (see section
Danish: DuoResp Spiromax skal straks seponeres, patienten skal udredes og alternativ behandling iværksættes, hvis det er nødvendigt (se pkt.
English: DuoResp Spiromax contains lactose
Danish: DuoResp Spiromax indeholder lactose
English: DuoResp Spiromax pharmacokinetic profile
Danish: DuoResp Spiromax farmakokinetisk profil
English: There are no clinical study data on DuoResp Spiromax available in COPD patients with a pre-bronchodilator FEV1 >50% predicted normal and with a post-bronchodilator FEV1 <70% predicted normal (see section
Danish: Der er ingen tilgængelige kliniske studiedata for DuoResp Spiromax for patienter med KOL med en præ-bronkodilator FEV1 på > 50 % af forventet normalværdi, og med en post-bronkodilator FEV1 på < 70 % af forventet normalværdi (se pkt.
English: • If you get pregnant while using DuoResp Spiromax, do NOT stop using DuoResp Spiromax but talk to your doctor immediately.
Danish: • Hvis du bliver gravid, mens du bruger DuoResp Spiromax, skal du IKKE holde op med at bruge DuoResp Spiromax, men straks tale med din læge.
English: When used for asthma, your doctor will prescribe DuoResp Spiromax together with a separate ‘reliever inhaler' such as salbutamol.
Danish: Ved brug til astma vil din læge ordinere DuoResp Spiromax sammen med en separat inhalator med anfaldsmedicin, såsom salbutamol.
English: DuoResp Spiromax maintenance therapy: DuoResp Spiromax is taken as regular maintenance treatment with a separate rapid-acting bronchodilator reliever inhaler.
Danish: DuoResp Spiromax vedligeholdelsesbehandling: DuoResp Spiromax tages regelmæssigt som vedligeholdelsesbehandling med en særskilt hurtigtvirkende bronkodilator til anfaldsbrug.
English: When it is appropriate to titrate down to a lower strength than is available for DuoResp Spiromax, a change to an alternative fixed-dose combination of budesonide and formoterol fumarate containing a lower dose of the inhaled corticosteroid is required.
Danish: Når det er hensigtsmæssigt at titrere ned til en lavere styrke, end der er tilgængeligt for DuoResp Spiromax, er det nødvendigt at skifte til en alternativ fastdosiskombination af budesonid og formoterolfumarat, som indeholder en lavere dosis af inhaleret kortikosteroid.
English: Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of DuoResp Spiromax.
Danish: Når din astma er velkontrolleret, kan din læge finde det hensigtsmæssigt gradvist at reducere DuoResp Spiromax-dosen.
English: Patients should be advised to always have DuoResp Spiromax available for rescue use.
Danish: Patienterne skal informeres om altid at have DuoResp Spiromax tilgængelig til brug ved anfald.