FrancophonIA/ELRC3.0 huggingface dataset:
English: If you stop using Brimica Genuair
Danish: Hvis du har brugt for meget Brimica Genuair
English: Each delivered dose (the dose leaving the mouthpiece) contains 396 micrograms of aclidinium bromide (equivalent to 340 micrograms of aclidinium) and 11.8 micrograms of formoterol fumarate dihydrate.
Danish: Hver afgivet dosis (dosen, der kommer ud af mundstykket) indeholder 396 mikrogram aclidiniumbromid (svarende til 340 mikrogram aclidinium) og 11,8 mikrogram formoterolfumaratdihydrat.
English: Each delivered dose contains 396 micrograms aclidinium bromide (equivalent to 340 micrograms of aclidinium) and 11.8 micrograms of formoterol fumarate dihydrate.
Danish: Hver leveret dosis indeholder 396 mikrogram aclidiniumbromid (svarende til 340 mikrogram aclidinium) og 11,8 mikrogram formoterolfumaratdihydrat.
English: The MAH shall complete, within the stated timeframe, the below measure: Description
Danish: Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: Each delivered dose (the dose leaving the mouthpiece) contains 396 micrograms aclidinium bromide equivalent to 340 micrograms of aclidinium and 11.8 micrograms of formoterol fumarate dihydrate.
Danish: Hver leveret dosis (den dosis, der kommer ud af mundstykket) indeholder 396 mikrogram aclidiniumbromid, svarende til 340 mikrogram aclidinium, og 11,8 mikrogram formoterolfumaratdihydrat.
English: These include: o corticosteroids that you take by mouth (such as prednisolone), o diuretics (such as furosemide or hydrochlorothiazide), o certain medicines used to treat breathing conditions (such as theophylline).
Danish: Disse omfatter: o kortikosteroider, som tages gennem munden (såsom prednisolon).
English: Brimica Genuair 340 mcg/12 mcg inhalation powder aclidinium/formoterol fumarate dihydrate
Danish: Brimica Genuair 340 mikrog/12 mikrog inhalationspulver aclidinium/formoterolfumaratdihydrat
English: What you need to know before you use Brimica Genuair 3.
Danish: Det skal du vide, før du begynder at bruge Brimica Genuair Sådan skal du bruge Brimica Genuair Bivirkninger
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Brimica Genuair Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Renally and hepatically impaired patients
Danish: Patienter med nedsat nyre- eller leverfunktion
English: Do not tilt.
Danish: Se pkt.
English: Also contains: Lactose See leaflet for further information
Danish: Se indlægssedlen for yderligere oplysninger.
English: No dose adjustments are necessary in these patients.
Danish: Det er ikke nødvendigt at justere dosen.
English: - If you get sudden tightness of the chest, coughing, wheezing or breathlessness immediately after using the medicine.
Danish: Stop med at tage Brimica Genuair og søg lægehjælp omgående, hvis du oplever noget af følgende: - Hvis du oplever pludselig trykken for brystet, hoste, hvæsende vejrtrækning eller kortåndethed umiddelbart efter brug af lægemidlet.
English: If you have any questions about how to use your inhaler, please ask your doctor, pharmacist or nurse for assistance.
Danish: Spørg din læge, apotekspersonalet eller sygeplejersken om hjælp, hvis du har nogen spørgsmål om, hvordan du skal bruge din inhalator.
English: Myalgia Muscle spasms
Danish: Myalgi Muskelspasmer
English: How to store Brimica Genuair 6.
Danish: - Virkningen af Brimica Genuair varer i 12 timer.
English: Mouthpiece
Danish: Amning
English: België/Belgique/Belgien AstraZeneca S.A./N.V.
Danish: België/Belgique/Belgien AstraZeneca S.A./N.V Tél/Tel: + 32 2 370 48 11
English: Ifirmasta 75 mg Film-coated tablet
Danish: 75 mg
English: MA (EU) Number Name Strength Pharmaceutical Form Route of Administration
Danish: Styrke Lægemiddelform Administration Emballage
English: EU/1/08/480/001
Danish: MF (EU)-nummer
English: Date of first authorisation: 8 December 2017
Danish: Dato for første markedsføringstilladelse: 8. december 2017
English: Your doctor will tell you exactly how many capsules to take.
Danish: Lægen vil oplyse dig om præcis, hvor mange kapsler du skal tage.
English: You should keep in regular contact with your doctor.
Danish: Du bør jævnligt være i kontakt med din læge.
English: This may cause allergic reactions.
Danish: Dette kan medføre allergiske reaktioner.
English: If you have forgotten to take your capsules in the morning, take them as soon as possible on the same day.
Danish: Hvis du har glemt at tage dine kapsler om morgenen, skal du tage dem så hurtigt som muligt den samme dag.
English: The course of preexisting infections may be aggravated.
Danish: Forløbet af eksisterende infektionssygdomme kan forværres.
English: Once daily.
Danish: En gang daglig.
English: Tacforius with food and drink
Danish: Brug af Tacforius sammen med mad og drikke
English: Tacforius is used in adults.
Danish: Tacforius anvendes til voksne.
English: EU/1/17/1244/001 30 capsules EU/1/17/1244/002 30x1 capsules EU/1/17/1244/003 50 capsules EU/1/17/1244/004 50x1 capsules EU/1/17/1244/005 100 capsules EU/1/17/1244/006 100x1 capsules EU/1/17/1244/007 30 capsules EU/1/17/1244/008 30x1 capsules EU/1/17/1244/009 50 capsules EU/1/17/1244/010 50x1 capsules EU/1/17/1244/011 60 capsules EU/1/17/1244/012 60x1 capsules EU/1/17/1244/013 100 capsules EU/1/17/1244/014 100x1 capsules EU/1/17/1244/015 30 capsules EU/1/17/1244/016 30x1 capsules EU/1/17/1244/017 50 capsules EU/1/17/1244/018 50x1 capsules EU/1/17/1244/019 100 capsules EU/1/17/1244/020 100x1 capsules EU/1/17/1244/021 30 capsules EU/1/17/1244/022 30x1 capsules EU/1/17/1244/023 50 capsules EU/1/17/1244/024 50x1 capsules
Danish: EU/1/17/1244/001 30 kapsler EU/1/17/1244/002 30 x 1 kapsler EU/1/17/1244/003 50 kapsler EU/1/17/1244/004 50 x 1 kapsler EU/1/17/1244/005 100 kapsler EU/1/17/1244/006 100 x 1 kapsler EU/1/17/1244/007 30 kapsler EU/1/17/1244/008 30 x 1 kapsler EU/1/17/1244/009 50 kapsler EU/1/17/1244/010 50 x 1 kapsler EU/1/17/1244/011 60 kapsler EU/1/17/1244/012 60 x 1 kapsler EU/1/17/1244/013 100 kapsler EU/1/17/1244/014 100 x 1 kapsler EU/1/17/1244/015 30 kapsler EU/1/17/1244/016 30 x 1 kapsler EU/1/17/1244/017 50 kapsler EU/1/17/1244/018 50 x 1 kapsler EU/1/17/1244/019 100 kapsler EU/1/17/1244/020 100 x 1 kapsler EU/1/17/1244/021 30 kapsler EU/1/17/1244/022 30 x 1 kapsler EU/1/17/1244/023 50 kapsler EU/1/17/1244/024 50 x 1 kapsler EU/1/17/1244/025 100 kapsler EU/1/17/1244/026 100 x 1 kapsler
English: Prilaz baruna Filipovica 25 10 000 Zagreb Croatia
Danish: Prilaz baruna Filipovica 25 10 000 Zagreb Kroatien
English: Take Tacforius on an empty stomach or 2 to 3 hours after a meal.
Danish: Tag Tacforius på tom mave eller 2 til 3 timer efter et måltid.
English: Limited data are available but no recommendation on a posology can be made.
Danish: Der foreligger begrænsede data, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: Your dose depends on your general condition and on which other immunosuppressive medication you are taking.
Danish: Dosis afhænger af din generelle tilstand, og af hvilken anden immundæmpende medicin du tager.
English: After opening the aluminium wrapper: 1 year
Danish: Efter åbning af aluminiumsposen: 1 år
English: Elderly There is no evidence currently available to indicate that dosing should be adjusted in the elderly.
Danish: Ældre På nuværende tidspunkt er der intet, der tyder på, at doseringen skal justeres hos ældre.
English: Do not drive or use any tools or machines if you feel dizzy or sleepy, or have problems seeing clearly after taking Tacforius.
Danish: Kør ikke bil, og lad være med at bruge værktøj eller maskiner, hvis du føler dig svimmel eller søvnig eller har problemer med at se klart, efter du har taget Tacforius.
English: This medicine should only be prescribed to you by a doctor with experience in the treatment of transplant patients.
Danish: Denne medicin bør kun udskrives til dig af en læge med erfaring i behandling af transplanterede patienter.
English: You should limit your exposure to the sun and UV (ultraviolet) light whilst taking Tacforius.
Danish: Du bør begrænse din udsættelse for sollys og UV (ultraviolet) lys, mens du tager Tacforius.
English: Other interactions leading to clinically detrimental effects
Danish: Andre interaktioner som har klinisk skadelig effekt
English: If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du bruger dette lægemiddel.
English: Administration should commence approximately 12 - 18 hours after the completion of surgery.
Danish: Administrationen bør indledes cirka 12 - 18 timer efter afslutningen af operationen.
English: C/C, n. 4, Poligono Industrial Malpica ES-50016 Zaragoza Spain
Danish: C/C, n. 4, Poligono Industrial Malpica ES-50016 Zaragoza Spanien
English: Effect of tacrolimus on the metabolism of other medicinal products
Danish: Effekt af tacrolimus på andre lægemidlers metabolisme
English: Tacforius should generally be administered on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal, to achieve maximal absorption (see section 5.2).
Danish: Tacforius bør som regel indtages på tom mave eller mindst 1 time før eller 2-3 timer efter et måltid for at opnå maksimal absorption (se pkt 5.2).
English: If the appearance of this medicine is not the same as usual, or if dosage instructions have changed, speak to your doctor or pharmacist as soon as possible to make sure that you have the right medicine.
Danish: Hvis medicinen ikke ser ud, som den plejer, eller hvis doseringsanvisningerne er ændret, så kontakt lægen eller apotekspersonalet hurtigst muligt for at sikre, at du har fået den rigtige medicin.
English: 0.10 - 0.30 mg per kg body weight per day depending on the transplanted organ.
Danish: 0,10 - 0,30 mg/kg legemsvægt pr. døgn afhængigt af, hvilket organ der er transplanteret.
English: If you need to have any vaccinations, please tell your doctor before.
Danish: Hvis du har brug for at blive vaccineret, så fortæl din læge det på forhånd.
English: Tacforius is routinely administered in conjunction with other immunosuppressive agents in the initial postoperative period.
Danish: Tacforius administreres rutinemæssigt sammen med andre immunsuppressive stoffer i den initiale, postoperative periode.
English: Do not take a double dose the next morning.
Danish: Du må ikke tage en dobbeltdosis den næste morgen.
English: Following your organ transplant (liver, kidney), your body's immune system will try to reject the new organ.
Danish: Efter en organtransplantation (lever, nyre), vil kroppens immunsystem forsøge at afstøde det nye organ.
English: Take the capsules immediately following removal from the blister.
Danish: Tag kapslerne umiddelbart efter, at de er fjernet fra blisteren.
English: Tell your doctor if any of the following apply to you: - if you are taking any medicines mentioned below under “Other medicines and Tacforius”.
Danish: Fortæl din læge, hvis et eller flere af følgende punkter gælder for dig: hvis du tager noget af den medicin, som er nævnt under ”Brug af anden medicin sammen med Tacforius”.
English: EXP Use all the capsules within 1 year of opening the aluminium wrapping and before the expiry date.
Danish: EXP: Brug alle kapslerne inden for 1 år efter åbning af aluminiumsposen og før udløbsdatoen.
English: Make sure that you receive the same tacrolimus medicine every time you collect your prescription, unless your transplant specialist has agreed to change to a different tacrolimus medicine.
Danish: Sørg for, at du får den samme tacrolimusmedicin hver gang, du henter din medicin, medmindre din transplantationslæge har godkendt at skifte til en anden tacrolimusmedicin.
English: Tell your doctor immediately if during treatment you suffer from: - problems with your vision such as blurred vision, changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted.
Danish: Fortæl straks din læge, hvis du under behandlingen lider af: problemer med dit syn, såsom sløret syn, ændringer i farvesynet, problemer med at se detaljer eller hvis dit synsfelt bliver begrænset.
English: Tacforius doses are usually reduced in the post-transplant period.
Danish: Doseringen af Tacforius reduceres sædvanligvis i perioden efter transplantationen.
English: No studies on the effects of tacrolimus on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af tacrolimus' virkning på evnen til at føre motorkøretøj eller betjene maskiner.
English: Your doctor will usually reduce your Tacforius dose once your condition has stabilised.
Danish: Lægen vil sædvanligvis reducere dosis af Tacforius, når din tilstand er stabiliseret.
English: Administration should commence within 24 hours after the completion of surgery.
Danish: Administrationen bør indledes inden for 24 timer efter afslutningen af oprerationen.
English: Not known (frequency cannot be estimated from the available data) - Abnormality of the optic nerve (optic neuropathy)
Danish: Ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data): Forandring i synsnerven (optisk neuropati)
English: Tacforius is not recommended for use in children below 18 years due to limited data on safety and/or efficacy.
Danish: Tacforius anbefales ikke til børn under 18 år på grund af begrænsede sikkerheds- og virkningsdata.
English: If you have accidentally taken too many capsules, contact your doctor or nearest hospital emergency department immediately.
Danish: Hvis du ved en fejl har taget for mange kapsler, skal du straks kontakte lægen eller den nærmeste skadestue.
English: These may worsen kidney or nervous system problems when taken together with Tacforius.
Danish: Disse kan forværre problemer med nyrerne eller centralnervesystemet, hvis de tages sammen med Tacforius.
English: Avoid grapefruit (also as juice) while on treatment with Tacforius, since it can affect its levels in the blood.
Danish: Undgå grapefrugt (også som juice) under behandling med Tacforius, da det kan påvirke indholdet af Tacforius i blodet.
English: Tubing, syringes and other equipment used to prepare a suspension of Tacforius capsule contents must not contain PVC.
Danish: Slanger, sprøjter og andet udstyr, som anvendes til at fremstille en suspension af Tacforius kapsler, må ikke indeholde PVC.
English: Your doctor may need to adjust your dose of Tacforius.
Danish: Din læge skal måske justere din Tacforius dosis.
English: There is a risk for premature delivery (<37 week) (incidence of 66 of 123 births, i.e. 53.7%; however, data showed that the majority of the newborns had normal birth weight for their gestational age) as well as for hyperkalaemia in the newborn (incidence 8 of 111 neonates, i.e. 7.2%) which, however normalises spontaneously.
Danish: Der er risiko for præmatur fødsel (<37 uger) (forekom ved 66 ud af 123 fødsler, dvs. 53,7 %; dog viste data, at størstedelen af de nyfødte havde normal fødselsvægt for deres gestationsalder) såvel som hyperkaliæmi hos den nyfødte (forekomst hos 8 ud af 111 nyfødte, dvs. 7,2 %), hvilket dog normaliseres spontant.
English: You will need to take Tacforius every day as long as you need immunosuppression to prevent rejection of your transplanted organ.
Danish: Du skal tage Tacforius hver dag så længe, du har behov for immundæmpende medicin, for at forebygge afstødning af dit transplanterede organ.
English: Tacforius therapy requires careful monitoring by adequately qualified and equipped personnel.
Danish: Behandling med Tacforius kræver, at patienter omhyggeligt monitoresaf velkvalificeret og specielt uddannet personale.
English: Animal data have shown that tacrolimus could potentially decrease the clearance and increase the halflife of pentobarbital and antipyrine.
Danish: Data fra dyreundersøgelser har vist, at tacrolimus kunne nedsætte clearance og forøge halveringstiden af pentobarbital og antipyrin.
English: It is recommended that the oral daily dose of Tacforius be administered once daily in the morning.
Danish: Det anbefales, at den daglige orale dosis af Tacforius administreres én gang daglig om morgenen.
English: Patients treated with tacrolimus have been reported to develop posterior reversible encephalopathy syndrome (PRES).
Danish: Det er rapporteret, at patienter, der får behandling med tacrolimus, udvikler posterior reversibel encefalopati-syndrom (PRES).
English: Ponceau 4R (E124)
Danish: Penceau 4R (E 124)
English: It is an immunosuppressant.
Danish: Det er et immundæmpende lægemiddel.
English: Tacforius reduces your body's defence mechanism (immune system), which will not be as good at fighting infections.
Danish: Tacforius nedsætter kroppens egen forsvarsmekanisme (immunsystemet), som så ikke vil kunne bekæmpe infektioner så godt som normalt.
English: Tacforius is a prolonged-release formulation of tacrolimus resulting in an extended oral absorption profile with an average time to maximum blood concentration (Cmax) of approximately 2 hours (tmax).
Danish: Tacforius er en formulering med forlænget frigivelse af tacrolimus, hvilket medfører en forlænget oral absorptionsprofil med en gennemsnitstid til maksimal blodkoncentration (Cmax) på ca. 2 timer.
English: Stopping your treatment with Tacforius may increase the risk of rejection of your transplanted organ.
Danish: Afbrydelse af behandlingen med Tacforius kan øge risikoen for afstødning af det transplanterede organ.
English: Bile flow does not influence the absorption of tacrolimus and therefore treatment with Tacforius may commence orally.
Danish: Galdeflow påvirker ikke absorptionen af tacrolimus, og derfor kan behandling med Tacforius påbegyndes oralt.
English: From time to time, your doctor may need to do blood, urine, heart, eye tests, to set the right dose of Tacforius.
Danish: Fra tid til anden kan det være nødvendigt for lægen at tage blod- eller urinprøver eller undersøge dit hjerte eller dine øjne for at bestemme den rette Tacforius dosis.
English: In case of in utero exposure, monitoring of the newborn for the potential adverse reactions of tacrolimus is recommended (in particular effects on the kidneys).
Danish: I tilfælde af eksponering in utero anbefales det at overvåge den nyfødte for tacrolimusbivirkninger (især effekt på nyrerne).
English: The safety and efficacy of Tacforius in children under 18 years of age have not yet been established.
Danish: Tacforius' sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: Therefore, in this patient group, EBV-VCA serology should be ascertained before starting treatment with Tacforius.
Danish: Derfor bør EBV-VCA-serologien for denne patientgruppe være klarlagt inden behandling med Tacforius.
English: It is not recommended that Tacforius is taken with ciclosporin (another medicine used for the prevention of transplant organ rejection).
Danish: Tacforius må ikke tages sammen med ciclosporin (anden medicin der anvendes til at undgå afstødning af transplanteret organ).
English: You may also be given Tacforius for an ongoing rejection of your transplanted liver, kidney, heart or other organ when any previous treatment you were taking was unable to control this immune response after your transplantation.
Danish: Du kan også få ordineret Tacforius ved en igangværende afstødning af den transplanterede lever, nyre, hjerte eller andet organ, hvis din tidligere behandling ikke kunne kontrollere immunreaktionen efter transplantationen.
English: Tacforius should be administered in the morning.
Danish: Tacforius bør gives om morgenen.
English: Tacforius is used to control your body's immune response, enabling your body to accept the transplanted organ.
Danish: Tacforius benyttes til at kontrollere din krops immunreaktion, således at kroppen kan acceptere det nye transplanterede organ.
English: Use all the prolonged-release hard capsules within 1 year of opening the aluminium wrapping.
Danish: Brug alle de hårde depotkapsler inden for 1 år efter, at aluminiumsposen er åbnet.
English: If patients taking tacrolimus present with symptoms indicating PRES such as headache, altered mental status, seizures, and visual disturbances, a radiological procedure (e.g. MRI) should be performed.
Danish: Hvis patienter, der tager tacrolimus, får symptomer, der indikerer PRES, som for eksempel hovedpine, forandret mentaltilstand, krampeanfald og synsforstyrrelser, bør der udføres en radiologisk undersøgelse (f.eks. MRI).
English: This is because Tacforius capsules allow for a prolonged-release (more slow release over a longer period) of tacrolimus.
Danish: Dette skyldes, at Tacforius depotkapsler har en langvarig frigivelse af tacrolimus (langsommere frigivelse over en længere periode).
English: Tacforius is taken orally once daily in the morning.
Danish: Tacforius tages oralt én gang daglig om morgenen.
English: Significantly more ciclosporin-treated patients (n = 13) required a switch to tacrolimus than tacrolimus-treated patients to ciclosporin (n = 2) (p = 0.02) (Keenan et al., Ann Thoracic Surg 1995;60:580).
Danish: Der var signifikant flere patienter i ciclosporingruppen (n=13), som måtte overføres til tacrolimus end tacrolimusbehandlede patienter, der måtte overføres til ciclosporin (n=2) (p=0,02) (Keenan et al.; Ann Thoracic Surg 1995; 60:580).
English: If PRES is diagnosed, adequate blood pressure and seizure control and immediate discontinuation of systemic tacrolimus is advised.
Danish: Hvis PRES diagnosticeres, tilrådes det, at der udføres passende blodtryks- og anfaldskontrol, samt at systemisk tacrolimus omgående afbrydes.
English: - if you are allergic to sirolimus or to any macrolide-antibiotic (e.g. erythromycin, clarithromycin, josamycin).
Danish: hvis du er allergisk over for sirolimus eller over for makrolidantibiotika (f.eks. erythomycin, clarithromycin, josamycin).
English: Teva Denmark A/S Tlf: +45 44985511
Danish: Danmark Teva Denmark A/S Tlf: +45 44985511
English: Following the initiation of your treatment with Tacforius, frequent blood tests will be taken by your doctor to define the correct dose.
Danish: Efter behandlingen med Tacforius er påbegyndt, vil lægen ofte tage blodprøver for at bestemme den korrekte dosis.
English: Peak blood concentrations achieved with these doses were above 150 ng/ml which is more than 6 - fold higher than mean peak concentrations observed with tacrolimus prolonged-release capsules in clinical transplantation.
Danish: Peak-blodkoncentrationer opnået med disse doser var over 150 ng/ml, hvilket er mere end 6 gange højere end gennemsnitlige peakkoncentrationer observeret med tacrolimus depotkapsler i forbindelse med transplantation.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der star på kartonen og blisteren efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Tacforius contains the active substance tacrolimus.
Danish: Tacforius indeholder det aktive stof tacrolimus.
English: Cases of pure red cell aplasia (a very severe reduction in red blood cell counts), agranulocytosis (a severely lowered number of white blood cells) and haemolytic anaemia (decreased number of red blood cells due to abnormal breakdown) have been reported.
Danish: Tilfælde af pure red cell aplasia (udtalt mangel på røde blodlegemer), agranulocytose (alvorligt nedsat antal hvide blodlegemer) og hæmolytisk anæmi (nedsat antal røde blodlegemer på grund af unormal nedbrydning) er blevet indberettet.
English: Pharmacotherapeutic group: Immunosuppressants, calcineurin inhibitors, ATC code: L04AD02
Danish: Farmakoterapeutisk klassifikation: Immunsuppressiva, calcineurinhæmmere, ATC-kode: L04AD02 Virkningsmekanisme
English: It is possible in some cases to withdraw concomitant immunosuppressive therapy, leading to Tacforius monotherapy.
Danish: Det er i visse tilfælde muligt at seponere anden samtidig immunsuppressiv behandling, hvilket resulterer i Tacforius-monoterapi.