FrancophonIA/ELRC3.0 huggingface dataset:
English: 3 inhalers each containing 60 doses.
Danish: 3 inhalatorer, der hver indeholder 60 doser.
English: What you need to know before you use Vylaer Spiromax
Danish: Det skal du vide, før du begynder at bruge Vylaer Spiromax
English: The safety and efficacy of Vylaer Spiromax in children, 12 years and younger and adolescents, 13 to 17 years of age has not yet been established.
Danish: Vylaer Spiromaxs sikkerhed og virkning hos børn i alderen 12 år og derunder og unge i alderen 13-17 år er endnu ikke klarlagt.
English: Prolongation of QTc-interval
Danish: Angina pectoris, forlænget QTc-interval
English: To treat your asthma your doctor will prescribe two asthma inhalers: Vylaer Spiromax together with a separate ‘reliever inhaler' such as salbutamol.
Danish: Når Vylaer Spiromax ordineres til behandling af astma, vil din læge ordinere to astmainhalatorer: Vylaer Spiromax sammen med en separat inhalator med anfaldsmedicin, såsom salbutamol.
English: Keep the mouthpiece cover closed after removal of the foil wrap.
Danish: Hold mundstykkets låg lukket, når folien er fjernet.
English: 3 inhalers each containing 120 doses.
Danish: 3 inhalatorer, der hver indeholder 120 doser.
English: Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Vylaer Spiromax .
Danish: Når astmasymptomerne er under kontrol, kan det overvejes gradvist at reducere dosis af Vylaer Spiromax.
English: When used for asthma, your doctor will prescribe Vylaer Spiromax together with a separate ‘reliever inhaler' such as salbutamol.
Danish: Når Vylaer Spiromax ordineres for astma, vil din læge ordinere lægemidlet sammen med en separat inhalator med anfaldsmedicin, såsom salbutamol.
English: Vylaer Spiromax 320 mcg/9 mcg
Danish: Vylaer Spiromax 320 mikrogram/9 mikrogram
English: Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Vylaer Spiromax.
Danish: Når astmasymptomerne er under kontrol, bør det overvejes gradvist at reducere dosis af Vylaer Spiromax.
English: Asthma Using Vylaer Spiromax and a separate ‘reliever inhaler'
Danish: Brug af Vylaer Spiromax og en separat inhalator med anfaldsmedicin
English: Vylaer Spiromax is indicated for use in adults 18 years of age and older only.
Danish: Vylaer Spiromax er udelukkende beregnet til brug hos voksne i alderen 18 år og derover.
English: Vylaer Spiromax is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:
Danish: Vylaer Spiromax er indiceret til behandling af astma, hvor det er hensigtsmæssigt at anvende en kombination (inhaleret kortikosteroid og langtidsvirkende β2-agonist): - hos patienter, der ikke er tilstrækkeligt velkontrollerede med inhaleret kortikosteroid og inhaleret korttidsvirkende β2-agonister ved behov.
English: What you need to know before you use Vylaer Spiromax (page 5) 3.
Danish: Det skal du vide, før du begynder at bruge Vylaer Spiromax (side 5) Sådan skal du bruge Vylaer Spiromax (side 9) Bivirkninger (side 18)
English: Preparing your new Vylaer Spiromax
Danish: Sådan klargør du din nye Vylaer Spiromax
English: Vylaer Spiromax is indicated in adults 18 years of age and older only.
Danish: Vylaer Spiromax er kun indiceret til voksne fra og med 18 år.
English: Vylaer Spiromax is NOT indicated for use in children 12 years of age and younger or adolescents 13 to 17 years of age.
Danish: Vylaer Spiromax er ikke indiceret til brug hos børn under 12 år eller unge mellem 13 og 17 år.
English: Teva Pharma B.V., Swensweg 5, 2031GA Haarlem,The Netherlands
Danish: Teva Pharma B.V., Swensweg 5, 2031GA Haarlem, Holland.
English: Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Ireland Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Netherlands Teva Operations Sp. Z o.o ul, Mogilska 80; 31-546 Krakow, Poland.
Danish: Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Irland
English: Vylaer Spiromax 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate
Danish: Vylaer Spiromax 320 mikrogram/9 mikrogram inhalationspulver budesonid/formoterolfumaratdihydrat
English: Do not use Vylaer Spiromax if:
Danish: Vylaer Spiromax indeholder:
English: Vylaer Spiromax 160 micrograms / 4.5 micrograms inhalation powder
Danish: LÆGEMIDLETS NAVN Vylaer Spiromax 160 mikrogram/4,5 mikrogram inhalationspulver
English: If patients find the treatment ineffective, or exceed the highest recommended dose of Vylaer Spiromax, medical attention must be sought (see section 4.2).
Danish: Patienten skal informeres om at søge læge, hvis patienten finder, at behandlingen ikke er effektiv, eller hvis den højeste anbefalede dosis Vylaer Spiromax overskrides (se pkt.
English: Vylaer Spiromax 160 micrograms / 4.5 micrograms inhalation powder budesonide/ formoterol fumarate dihydrate
Danish: Vylaer Spiromax 160 mikrogram/4,5 mikrogram inhalationspulver budesonid/formoterolfumaratdihydrat
English: How to use Vylaer Spiromax
Danish: Sådan skal du bruge Vylaer Spiromax
English: Vylaer Spiromax 320 micrograms/9 micrograms inhalation powder
Danish: LÆGEMIDLETS NAVN Vylaer Spiromax 320 mikrogram/9 mikrogram inhalationspulver
English: Each delivered dose (the dose that leaves the mouthpiece of the Spiromax) contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver afgivet dosis (den dosis, som forlader mundstykket på Spiromax) indeholder 160 mikrogram budesonid og 4,5 mikrogram formoterolfumaratdihydrat.
English: Patients should also be advised to rinse their mouth with water after inhaling (see section 4.4) The patient may notice a taste when using Vylaer Spiromax due to the lactose excipient.
Danish: Patienterne bør informeres om at skylle munden med vand efter inhalation (se pkt.
English: Serious asthma-related adverse reactions and exacerbations may occur during treatment with Vylaer Spiromax .
Danish: Under behandling med Vylaer Spiromax kan der forekomme alvorlige astmarelaterede reaktioner og eksacerbationer.
English: Each delivered dose (the dose that leaves the mouthpiece of the Spiromax) contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver afgivet dosis (den dosis, som forlader mundstykket på Spiromax) indeholder 320 mikrogram budesonid og 9 mikrogram formoterolfumaratdihydrat.
English: Tell your doctor if you have any of the following while taking Vylaer Spiromax they could be symptoms of a lung infection:
Danish: Kontakt lægen, hvis du oplever nogle af følgende symptomer, mens du tager Vylaer Spiromax.
English: MARKETING AUTHORISATION HOLDER
Danish: Indehaver af markedsføringstilladelsen og fremstiller
English: Vylaer Spiromax 160 mcg/4.5 mcg
Danish: INFORMATION I BRAILLESKRIFT Vylaer Spiromax 160 mikrogram/4,5 mikrogram
English: Inhalation powder 1 inhaler containing 60 doses.
Danish: 1 inhalator indeholdende 60 doser.
English: If you stop using Vylaer Spiromax
Danish: Hvis du har taget for meget Vylaer Spiromax
English: Side panel: Each delivered dose contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Kartonside: Hver afgivet dosis indeholder 160 mikrogram budesonid og 4,5 mikrogram formoterolfumaratdihydrat.
English: EU/1/15/1050/001 IONSYS 40 µg/dose
Danish: EU/1/15/1050/001 IONSYS 40 µg/dosis
English: Transdermal use sachet (nylon/alu/copoly mer of polyethylene and polymethacrylic acid)
Danish: Transdermal anvendelse pose (nylon/alu/ copolymer af polyethylen og polymethacrylsyre)
English: 80 doses per transdermal system
Danish: 80 doser pr. transdermalt system
English: 6 transdermal systems
Danish: 6 transdermale systemer
English: The advice of a hepatologist is recommended.
Danish: Det anbefales, at konsultere en hepatolog.
English: The Member States shall ensure that the following key elements are included in the appropriate material and that the material is not promotional.
Danish: Medlemslandene skal sikre, at de følgende centrale elementer er inkluderet i det relevante materiale og at materialet ikke er reklame.
English: • Information about the post marketing surveillance study
Danish: • Information om post-marketingovervågningsstudiet
English: • That the patient should not give Volibris to any other person.
Danish: • At patienten ikke må give Volibris til andre.
English: • Liver function tests.
Danish: • Leverfunktionstest.
English: The Member States shall ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Danish: Medlemslandene skal sikre, at alle betingelser eller begrænsninger med hensyn til en sikker og virkningsfuld anvendelse af lægemidlet, der er beskrevet nedenfor, bliver implementeret:
English: o Definition of reliable contraception and the need to seek expert advice if unsure what is suitable for an individual patient.
Danish: o Definition af sikker prævention og nødvendigheden af at søge eksperthjælp, hvis der er usikkerhed om hvad der er bedst for den enkelte patient.
English: o The need to provide comprehensive advice and counselling to patients.
Danish: o Give udførlig vejledning og rådgivning til patienterne.
English: The effect of Volibris on human testicular function and male fertility is not known.
Danish: Volibris' virkning på testikelfunktionen og den mandlige fertilitet hos mennesker kendes ikke.
English: o The need to refer patients who become pregnant to a physician specialised or experienced in teratology and its diagnosis for evaluation and advice.
Danish: o Nødvendigheden af at henvise patienten, som er blevet gravid, til en læge som er specialist eller har erfaring med teratologi og dets diagnostik for evaluering og vejledning.
English: o The need to advise women (even if a woman has amenorrhoea) on the use of reliable contraception during treatment and for one month following permanent discontinuation of treatment.
Danish: o Nødvendigheden af at vejlede kvinder (selv hvis kvinden har amenorré) i brugen af sikker prævention under behandling og i en måned efter permanent ophør med behandlingen.
English: • That Volibris may cause liver injury.
Danish: • At Volibris kan forårsage leverskader.
English: Patient information The information for patients should include the following information:
Danish: Informationen til patienterne skal indeholde information om:
English: − The physician prescribing her contraception that she is taking Volibris
Danish: − lægen, som ordinerer hendes prævention, om at hun tager Volibris
English: • Obligations of health care professionals in relation to the prescribing of Volibris: o That patients should be capable of complying with the requirements for the safe use of Volibris.
Danish: • Sundhedspersonalets forpligtigelser i forbindelse med ordination af Volibris: o Sikre at patienterne er i stand til at efterleve kravene til en sikker brug af Volibris.
English: • Information booklets for patients
Danish: • Informationsbrochure til patienter
English: • That Volibris may cause serious birth defects in unborn babies conceived before, during, or within a month after stopping treatment.
Danish: • At Volibris kan forårsage alvorlige skader hos ufødte babyer, der er undfanget før, under eller inden for en måned efter ophør med behandlingen.
English: The healthcare professional information regarding Volibris should contain the following key elements:
Danish: Informationen om Volibris til sundhedspersonalet skal indeholde følgende centrale elementer:
English: Physician checklist
Danish: Lægens tjekliste
English: o That the safety database of Volibris is limited and physicians are encouraged to enrol patients in a post marketing surveillance study.
Danish: o Bivirkningsdatabasen for Volibris er begrænset, og læger opfordres til at involvere patienterne i et post-marketingovervågningsstudie.
English: The Member States shall agree details of the implementation of the post-marketing surveillance study in each member state with the MAH and ensure that it is put in place prior to marketing of the product.
Danish: Medlemslandene skal sammen med indehaveren af markedsføringstilladelsen aftale detaljerne omkring implementering af post-marketingovervågningsstudiet i hvert medlemsland og sikre at studiet er klart inden markedsføring af produktet.
English: o That if a women of childbearing potential needs to change or stop her method of contraception she should inform:
Danish: o At hvis en kvinde i den fødedygtige alder har brug for at ændre eller stoppe brugen af prævention, så skal hun informere:
English: • The need for the patient to discuss with her doctor if she is planning to become pregnant.
Danish: • Nødvendigheden af at patienten diskuterer det med sin læge, hvis hun planlægger at blive gravid.
English: • That because of the potential for liver injury and anaemia, patients should have regular blood tests and also tell their doctor if experiencing any symptoms of liver injury.
Danish: • At patienterne, pga. risikoen for leverskader og anæmi, skal have foretaget regelmæssige blodprøver og skal fortælle deres læge, hvis de får symptomer på leverskade.
English: o Patients taking Volibris should have their haemoglobin and/or haematocrit levels measured regularly.
Danish: o Patienter, der tager Volibris, skal have målt deres hæmoglobin og/eller hæmatokrit regelmæssigt.
English: • Product information (Summary of Product Characteristics (SPC) and Package Leaflet)
Danish: • Produktinformation (produktresume og indlægsseddel)
English: • The need to ensure that women of child bearing potential are using reliable contraception and that patients should inform their doctors of any possibility of pregnancy before a new prescription is issued.
Danish: • Nødvendigheden af at sikre, at kvinder i den fødedygtige alder bruger sikker prævention, og at patienterne informerer deres læge om en enhver mulighed for gravidtet inden en ny ordination udskrives.
English: For women with childbearing potential o Exclusion of pregnancy prior to treatment initiation and monthly pregnancy testing during treatment.
Danish: Til kvinder i den fødedygtige alder o Udelukkelse af graviditet ved påbegyndelse af behandling og månedlig graviditetstest under behandling.
English: o To report all cases of pregnancy occurring during therapy.
Danish: o At indrapportere alle tilfælde af graviditet forekommende under behandling.
English: • That if a women of childbearing potential needs to change or stop her method of contraception she should inform: o The physician prescribing her contraception that she is taking Volibris o The physician prescribing Volibris that she has changed or stopped her method of contraception
Danish: • At hvis en kvinde i den fødedygtige alder har brug for at ændre eller stoppe brugen af prævention, så skal hun informere: o Lægen, som ordinerer hendes prævention, om at hun tager Volibris o Lægen, som ordinerer Volibris, om at hun har ændret eller stoppet brugen af prævention
English: • That Volibris is potentially hepatotoxic o Contraindication in patients with severe hepatic impairment (with or without cirrhosis) and in patients with baseline values of hepatic aminotransferases (AST and/or ALT) > 3X ULN.
Danish: • At Volibris muligvis er levertoksisk o Kontraindiceret til patienter med svært nedsat leverfunktion (med eller uden cirrose) og til patienter med baselineværdier for leveraminotransferaser (ASAT og/eller ALAT) > 3 x ULN.
English: The physician pre-prescription checklist will highlight the contraindications to the use of ambrisentan and important pre-prescription assessments including:
Danish: Lægens tjekliste, der skal anvendes inden ordination, fremhæver ambrisentans kontraindikationer samt vigtige vurderinger, der skal foretages inden ordintaion, herunder:
English: • That Volibris cannot be initiated if patient is pregnant.
Danish: • At Volibris ikke må påbegyndes, hvis patienten er gravid.
English: o That women receiving Volibris should be advised of the risk of foetal harm.
Danish: o Kvinder, der behandles med Volibris, skal informeres om risikoen for forsterskader.
English: Health care Professional information
Danish: Information til sundhedspersonale
English: • Healthcare professional information regarding Volibris
Danish: • Information om Volibris til sundhedspersonale
English: • That Volibris is teratogenic o Volibris is contraindicated in pregnancy and in women of child bearing potential who are not using reliable contraception.
Danish: • Information om at Volibris er teratogent o Volibris er kontraindiceret ved graviditet og til kvinder i den fødedygtige alder som ikke bruger sikker prævention.
English: • That treatment with Volibris causes peripheral oedema and fluid retention o If a patient develops clinically significant peripheral oedema, with or without associated weight gain, carry out further evaluation to determine the cause and if appropriate consider discontinuation of Volibris.
Danish: • At behandling Volibris medfører perifere ødemer og væskeophobning o Hvis en patient udvikler klinisk signifikant perifert ødem, med eller uden vægtøgning, skal der foretages en yderligere evaluering for at afgøre årsagen, og hvis det er relevant, skal det overvejes at afbryde behandlingen med Volibris.
English: o Guidance for identifying women of child bearing potential and the actions the physician should take if unsure.
Danish: o Vejledning i at identificere kvinder i den fødedygtige alder, og hvad lægen skal gøre hvis der er usikkerhed.
English: • This should include key messages regarding the need for regular blood and pregnancy tests and provide spaces for the dates of appointments and the results of tests.
Danish: • Dette skal indeholde nøglebudskaber vedrørende kravet om regelsmæssige blodprøver og graviditetstest.
English: • That chronic administration of Volibris in animals has been linked to testicular tubular atrophy and impaired fertility.
Danish: • At kronisk administration af Volibris til dyr er blevet forbundet med udvikling af testikeltubulæratrofi og nedsat fertilitet.
English: • That hypersensitivity reactions, although uncommon, have been reported with Volibris.
Danish: • At der er rapporteret overfølsomhedsreaktioner i forbindelse med Volibris (dog ikke almindeligt forekommende).
English: • That Volibris should be initiated with caution in patients with severe renal impairment.
Danish: • At Volibris skal indledes med forsigtighed hos patienter med svært nedsat nyrefunktion.
English: • Women with childbearing potential must have a pregnancy test immediately prior to the first prescription and at monthly intervals whilst taking Volibris.
Danish: • At kvinder i den fødedygtige alder skal have taget en graviditetstest umiddelbart før første ordination og efterfølgende en hver måned, så længe de er i behandling med Volibris.
English: o If tests show a clinically significant decrease in haemoglobin or haematocrit, and other causes have been excluded, consider reducing the dose of Volibris, or stopping treatment.
Danish: o Hvis der ses et klinisk signifikant fald i hæmoglobin eller hæmatokrit, og andre årsager er udelukket, skal det overvejes at reducere dosis eller afbryde behandlingen.
English: • That Volibris cannot be taken if a woman is or might become pregnant.
Danish: • At Volibris ikke må anvendes, hvis en kvinde er gravid eller har mulighed for at blive gravid.
English: The Member States shall agree the details of a controlled distribution system with the MAH according to national regulations and healthcare systems and ensure that it is implemented nationally so that prior to prescribing (and at the discretion of the Member State, dispensing) all health care professionals who intend to prescribe (and where appropriate, dispense) Volibris have been provided with the following:
Danish: Det skal sikres, at systemet er implementeret nationalt, således at alt sundhedspersonale, som har til hensigt at ordinere (og hvor relevant, og efter aftale med medlemslandet, udlevere) Volibris, forinden har fået udleveret følgende:
English: • The need for female patients to contact their treating doctor immediately if they suspect that they might be pregnant.
Danish: • Nødvendigheden af at kvindelige patienter straks kontakter deres læge, hvis de tror, at de gravide.
English: • That treatment with Volibris often causes a decrease in haemoglobin and haematocrit o Initiation of Volibris is not recommended for patients with clinically significant anaemia.
Danish: • At behandling med Volibris ofte medfører et fald i hæmoglobin og hæmatokrit o Påbegyndelse af behandling med Volibris frarådes hos patienter med klinisk signifikant anæmi.
English: • Information booklets for male partners of female patients with childbearing potential
Danish: • Informationsbrochure til mandlige partnere til kvinder i den fødedygtige alder
English: • That the patient should tell their doctor about any adverse event.
Danish: • At patienten skal informere lægen om bivirkninger.
English: • Pregnancy reporting forms
Danish: • Graviditetsindberetningsskemaer
English: • The need to ensure that women of child bearing potential are using reliable contraception.
Danish: • Nødvendigheden af at sikre, at kvinder i den fødedygtige alder bruger sikker prævention.
English: Booklet for male partners of women with childbearing potential The information for male partners of women with childbearing potential should include the following information:
Danish: Denne brochure til mandlige partnere til kvinder i den fødedygtige alder indeholder information om:
English: o To report suspected adverse reactions and pregnancy.
Danish: o Indrapportere formodede bivirkninger og graviditeter.
English: • Pre-prescription checklist for physicians
Danish: • Tjekliste, der skal anvendes forud for lægens ordination
English: o Discontinuation of ambrisentan therapy if patients develop sustained, unexplained clinically significant ALT and/or AST elevation or if ALT and/or AST elevation is accompanied by signs or symptoms of hepatic injury (e.g. jaundice).
Danish: o Behandlingen med ambrisentan skal ophøre i tilfælde af vedvarende, uforklarlige klinisk signifikante stigninger af ALAT og/eller ASAT eller hvis stigningerne af ALAT og/eller ASAT ses samtidig med symptomer på leverskade (f.eks. gulsot).
English: o In subjects without clinical symptoms of hepatic injury or jaundice, reinitiation of ambrisentan may be considered following resolution of hepatic enzyme abnormalities.
Danish: o Hos personer uden kliniske tegn på leverskade eller gulsot, kan det overvejes at genoptage behandlingen, hvis leverenzymerne normaliseres.
English: o The need to provide patients with the appropriate information booklet(s) and patient reminder card. o Should consider monthly prescription of 30 day supply to ensure that patients and key test results are reviewed prior to further prescription.
Danish: o Overveje behov for månedlig ordination for således at kunne sikre at patienter og testresultater bliver vurderet inden næste ordination.
English: • Pregnancy test if female patient with childbearing potential.
Danish: • Graviditetstest; hvis det er en kvinde, der er i den fødedygtige alder.
English: o Hepatic aminotransferases (ALT and/or AST) should be evaluated prior to initiation of ambrisentan.
Danish: o Inden påbegyndelse af behandling med ambrisentan skal leveraminotransferaserne ASAT og/eller ALAT vurderes.
English: o During therapy, monthly monitoring of ALT and AST is recommended.
Danish: o Det anbefales, at monitorere ALAT og ASAT under behandlingsperioden.
English: • Determination of child bearing potential in female patients.
Danish: • Kvindelige patienters mulighed for at blive gravid.
English: Patient reminder card
Danish: Patientinformation
English: o That the patient should contact her doctor immediately if pregnancy is suspected and that alternative therapy should be initiated if pregnancy confirmed.
Danish: − lægen, som ordinerer Volibris, om at hun har ændret eller stoppet brugen af prævention o At patienten straks skal kontakte hendes læge, hvis hun tror hun er gravid, og at anden behandling skal igangsættes hvis kvinden er gravid.