FrancophonIA/ELRC3.0 huggingface dataset:
English: Section 2: Take special care with Ciprofloxacin Bayer) - changes to the blood count (leukopenia, leukocytosis, neutropenia, anaemia), increased or decreased amounts of a blood clotting factor (thrombocytes) - allergic reaction, swelling (oedema), or rapid swelling of the skin and mucous membranes
Danish: (se pkt 2 Vær ekstra forsigtig med at tage Ciprofloxacin Bayer) - ændringer i blodtal (leukopeni, leukocytose, neutropeni, anæmi), øget eller nedsat mængde af en bestemt blodstørkningsfaktor (trombocytter) - allergisk reaktion, hævelser (ødemer) eller hurtig hævelse i hud og slimhinder (angioødem) - øget blodsukker (hyperglykæmi) - forvirring, desorientering, angst, mærkelige drømme, depression eller hallucinationer
English: • sucralfate
Danish: Indhold af sukrose
English: Ciprofloxacin Bayer and associated names (see Annex I) 500 mg film-coated tablets [See Annex I - To be completed nationally]
Danish: Ciprofloxacin Bayer og tilhørende navne (se bilag I) 500 mg filmovertrukne tabletter [Se bilag I - Udfyldes nationalt]
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAP (containing 1 infusion bag of 400 mg / 200 mL solution for infusion)
Danish: YDRE BESKYTTELSESPOSE (indeholder 1 infusionspose med 400 mg /200 ml infusionsvæske, opløsning)
English: • Keep this leaflet.
Danish: Bare slug det.
English: Serum sickness-like reaction
Danish: 4.4) Serumsygdomslignende reaktion
English: - a special type of reduced red blood cell count (haemolytic anaemia); a dangerous drop in a type of white blood cells (agranulocytosis ) - severe allergic reaction (anaphylactic reaction, anaphylactic shock, serum sickness) which can be fatal (see Section 2: Take special care with Ciprofloxacin Bayer) - disturbed coordination, unsteady walk (gait disturbance), pressure on the brain (intracranial pressure) - visual colour distortions - various skin eruptions or rashes (e.g. the potentially fatal Stevens-Johnson syndrome or toxic epidermal necrolysis) - muscle weakness, tendon inflammation, worsening of the symptoms of myasthenia gravis (see Section 2: Take special care with Ciprofloxacin Bayer)
Danish: 2 Vær ekstra forsigtig med at tage Ciprofloxacin Bayer) - besvær med at styre bevægelser, usikker gang, tryk på hjernen (forhøjet intrakranielt tryk) - forvrænget farvesyn - forskellige hududbrud eller udslæt (f.eks. det potentielt dødelige Stevens-Johnson syndrom eller toksisk epidermal nekrolyse) - muskelsvaghed, betændelse i en sene (inflammation), forværring af symptomer på myasthenia gravis (se pkt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAP (containing 1 infusion bag of 200 mg / 100 mL solution for infusion)
Danish: YDRE BESKYTTELSESPOSE (indeholder 1 infusionspose med 200 mg / 100 ml infusionsvæske, opløsning)
English: Ciprofloxacin Bayer and associated names (see Annex I) 100 mg / 50 mL solution for infusion [See Annex I - To be completed nationally]
Danish: Ciprofloxacin Bayer og tilhørende navne (se bilag I) 100 mg / 50 ml infusionsvæske, opløsning [Se bilag I - Udfyldes nationalt]
English: 100 mg/50 ml solution for infusion intravenous use
Danish: 100 mg/50 ml infusionsvæske, opløsning intravenøs anvendelse 2 mg/ml
English: - sensitivity to light (see Section 2: Take special care with Ciprofloxacin Bayer), small, pin-point bleeding under the skin (petechiae) - muscle pain, inflammation of the joints, increased muscle tone, cramping, tendon ruptureespecially of the large tendon at the back of the ankle (Achilles tendon) (see Section 2: Take special care with Ciprofloxacin Bayer) - blood or crystals in the urine (see Section 2: Take special care with Ciprofloxacin Bayer), urinary tract inflammation - excessive sweating - abnormal levels of a clotting factor (prothromibin) increased levels of the enzyme amylase
Danish: 2 Vær ekstra forsigtig med Ciprofloxacin Bayer), små nåleformede blødninger under huden (petekkier) - muskelsmerter, betændelse i leddene (inflammation), øget spænding i en muskel, kramper, senebrud - specielt i den store sene på bagsiden af anklen (Achilles-senen)(se pkt.
English: Ciprofloxacin Bayer and associated names (see Annex I) 400 mg/200 mL solution for infusion [See Annex I - To be completed nationally]
Danish: Ciprofloxacin Bayer og tilhørende navne (se bilag I) 400 mg / 200 ml infusionsvæske, opløsning [Se bilag I - Udfyldes nationalt]
English: Ciprofloxacin Bayer and associated names (see Annex I) 200 mg/100 mL solution for infusion [See Annex I - To be completed nationally]
Danish: Ciprofloxacin Bayer og tilhørende navne (se bilag I) 200 mg/100 ml infusionsvæske, opløsning [Se bilag I - Udfyldes nationalt]
English: Ciprofloxacin Bayer and associated names (see Annex I) 200 mg / 100 mL solution for infusion [See Annex I - To be completed nationally]
Danish: Ciprofloxacin Bayer og tilhørende navne (se bilag I) 200 mg / 100 ml infusionsvæske, opløsning [Se bilag I - Udfyldes nationalt]
English: Gonococcal uretritis and cervicitis
Danish: Urethritis og cervicitis, som skyldes gonokokker
English: • Pelvic inflammatory disease including cases due to Neisseria gonorrhoeae
Danish: • Underlivsbetændelse, herunder tilfælde forårsaget af Neisseria gonorrhoeae
English: Hepatic impairment Cholestatic icterus Hepatitis
Danish: Olfaktoriske nervesygdomme Intrakraniel hypertension neuropati (se pkt.
English: 200 mg/100 ml solution for infusion intravenous use
Danish: 200 mg/100 ml infusionsvæske, opløsning intravenøs anvendelse 2 mg/ml
English: Leukocytosis
Danish: Eosinofili
English: Package Leaflet and Labelling
Danish: Udseende og pakningstørrelser
English: [To be completed nationally] 6.3 Shelf life [To be completed nationally] 6.4 Special precautions for storage [To be completed nationally] 6.5 Nature and contents of container [To be completed nationally] 6.6 Special precautions for disposal No special requirements.
Danish: ANGIVELSE AF AKTIVT STOF [Udfyldes nationalt] LISTE OVER HJÆLPESTOFFER [Udfyldes nationalt] LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) [Udfyldes nationalt] ANVENDELSESMÅDE OG INDGIFTSVEJ Til intravenøs anvendelse.
English: Cardiac Disorders
Danish: Hjertesygdomme
English: BEFORE YOU ARE GIVEN CIPROFLOXACIN BAYER
Danish: DET SKAL DU VIDE, FØR DU FÅR CIPROFLOXACIN BAYER
English: Renal impairment
Danish: Forvrænget farvesyn
English: • bone and joint infections
Danish: • Knogle- og ledinfektioner
English: Theophylline
Danish: Agranulocytose
English: Tacrolimus has been used since the mid-1990's.
Danish: Tacrolimus er blevet anvendt siden midten af 1990'erne.
English: The European Commission granted a marketing authorisation valid throughout the EU for Advagraf on 23 April 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Advagraf den 23. april 2007.
English: The marketing authorisation holder is Astellas Pharma Europe B.V.
Danish: Indehaveren af markedsføringstilladelsen er Astellas Pharma Europe B.V.
English: Advagraf is given once a day, in the morning, at least one hour before or two to three hours after food.
Danish: Advagraf gives én gang dagligt om morgenen mindst én time før eller to-tre timer efter fødeindtagelse.
English: Other information about Advagraf:
Danish: Andre oplysninger om Advagraf:
English: This means that it reduces the activity of the immune system (the body's natural defences).
Danish: Det vil sige, at det dæmper aktiviteten af immunsystemet (kroppens naturlige forsvar).
English: Advagraf was as effective as both comparator medicines.
Danish: Advagraf var lige så effektivt som begge de lægemidler, det blev sammenlignet med.
English: In the European Union (EU), it has been available as capsules under the name Prograf or Prograft (depending on the country).
Danish: I Den Europæiske Union (EU) har det været markedsført som kapsler under navnet Prograf eller Prograft (afhængigt af land).
English: After one year, 14% of the patients receiving Advagraf had experienced organ failure.
Danish: Efter ét år havde 14 % af de patienter, der fik Advagraf, fået organsvigt.
English: The full EPAR for Advagraf can be found here.
Danish: Den fuldstændige EPAR for Advagraf findes her.
English: The Committee recommended that Advagraf be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Advagraf.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) ADVAGRAF EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) ADVAGRAF EPAR - sammendrag for offentligheden
English: It is available as prolongedreleased capsules containing tacrolimus (0.5 mg: yellow and orange; 1 mg: white and orange; 5 mg: greyish-red and orange).
Danish: Det leveres som depotkapsler indeholdende tacrolimus (0,5 mg: gule og orange, 1 mg: hvide og orange, 5 mg: rødgrå og orange).
English: Advagraf is a medicine containing the active substance tacrolimus.
Danish: Advagraf er et lægemiddel, der indeholder det aktive stof tacrolimus.
English: Because tacrolimus and Prograf/Prograft have already been used in the EU, the company presented the results of studies that had been carried out with Prograf/Prograft previously, as well as data from the published literature.
Danish: Da tacrolimus og Prograf/Prograft allerede har været anvendt i EU, fremlagde firmaet resultaterne af de undersøgelser, der tidligere var udført med Prograf/Prograft, foruden oplysninger fra den offentliggjorte litteratur.
English: This allows Advagraf to be given once a day, whereas Prograf/Prograft is given twice a day.
Danish: Derfor behøver Advagraf kun tages én gang dagligt, hvorimod Prograf/Prograft skal tages to gange dagligt.
English: Tacrolimus acts on some special cells in the immune system called T-cells that are primarily responsible for attacking the transplanted organ (organ rejection).
Danish: Tacrolimus virker på nogle særlige celler i immunsystemet, T-cellerne, som primært er ansvarlige for, at det transplanterede organ angribes (organafstødning).
English: Patients and doctors must be careful when other medicines (including some herbal remedies) are taken at the same time as Advagraf, as there may be a need to adjust the dose of Advagraf or the dose of the medicine it is taken with.
Danish: Patienter og læger bør udvise forsigtighed, når andre lægemidler (bl.a. visse naturlægemidler) anvendes sammen med Advagraf, da det kan være nødvendigt at justere dosis af Advagraf eller af det lægemiddel, det anvendes sammen med.
English: Patients also received mycophenolate mofetil (another medicine used in the prevention of rejection).
Danish: Patienterne fik desuden mycophenolatmofetil (et andet lægemiddel, der anvendes til forebyggelse af afstødning).
English: The main measure of effectiveness was the number of patients in whom the transplant failed (as measured by looking at, for example, the need for a repeat transplant or a return to dialysis) after one year's treatment.
Danish: Virkningen blev hovedsagelig bedømt ud fra antallet af patienter, hos hvem transplantationen mislykkedes (f.eks. vurderet efter, om det var nødvendigt at gentage transplantationen eller genoptage dialysen) efter et års behandling.
English: The percentages were 15% in the patients treated with Prograf/Prograft, and 17% in those treated with ciclosporin.
Danish: Den tilsvarende procentdel var 15,1 % hos de patienter, der havde fået Prograf/Prograft, og 17 % hos dem, der havde fået ciclosporin.
English: ‘Prolonged-release' means that tacrolimus is released slowly from the capsule over a few hours.
Danish: At kapslerne er depotkapsler, betyder, at tacrolimus frigives langsomt fra kapslen i løbet af få timer.
English: Treatment with Advagraf should only be prescribed by doctors who have experience in the management of transplant patients.
Danish: Advagraf bør kun ordineres af en læge med erfaring i behandling af transplantationspatienter.
English: Tacrolimus, the active substance in Advagraf, is an immunosuppressive agent.
Danish: Tacrolimus, det aktive stof i Advagraf, er et immundæmpende middel.
English: Advagraf is very similar to Prograf/Prograft, but the way the medicine is made has been changed so that the active substance is released more slowly from the capsule than it is in Prograf/Prograft.
Danish: Advagraf er næsten identisk med Prograf/Prograft, dog fremstilles kapslerne på en anden måde, så det aktive stof frigives langsommere fra kapslen end i Prograf/Prograft.
English: Advagraf can also be used to treat organ rejection in adult patients when other immunosuppressive medicines are not effective.
Danish: Advagraf kan også anvendes til at behandle afstødning af organer hos voksne patienter, når anden immundæmpende medicin ikke virker.
English: Advagraf should not be used in people who may be hypersensitive (allergic) to tacrolimus, to macrolide antibiotics (such as erythromycin) or to any of the other ingredients.
Danish: Advagraf bør ikke anvendes af patienter, der kan være overfølsomme (allergiske) over for tacrolimus, makrolidantibiotika (som f.eks. erythromycin) eller nogen af indholdsstofferne.
English: This can help the patients stick to their treatment.
Danish: Dette kan gøre det lettere for patienterne at overholde ordinationen.
English: What is the risk associated with Advagraf?
Danish: Hvilken risiko er der forbundet med Advagraf?
English: Advagraf is used in adult patients who have had a kidney or liver transplant, to prevent rejection (when the immune system attacks the transplanted organ).
Danish: Advagraf anvendes til voksne patienter, der har fået foretaget en nyre- eller levertransplantation, til at forhindre organafstødning (når immunsystemet angriber det transplanterede organ).
English: The most common side effects with Advagraf (seen in more than 1 patient in 10) are tremor (shaking), headache, nausea (feeling sick), diarrhoea, kidney problems, hyperglycaemia (raised blood glucose levels), diabetes, hyperkalaemia (raised blood potassium levels), hypertension (high blood pressure) and insomnia (difficulty sleeping).
Danish: De hyppigste bivirkninger af Advagraf (der ses hos flere end 1 ud af 10 patienter) er rysten, hovedpine, kvalme, diarré, nyreproblemer, for højt blodsukker, sukkersyge, for højt kaliumindhold i blodet, for højt blodtryk og søvnbesvær.
English: Further shorter studies were also carried out in 119 kidney transplant patients and 129 liver transplant patients, looking at how Advagraf is absorbed by the body in comparison to Prograf/Prograft.
Danish: Desuden blev der udført kortvarige undersøgelser hos 119 nyretransplantationspatienter og 129 levertransplantationspatienter, hvor det blev undersøgt, hvordan Advagraf optages af kroppen sammenlignet med Prograf/Prograft.
English: It also presented the results of a clinical study in 668 kidney transplant patients comparing the use of Advagraf with that of Prograf/Prograft or ciclosporin (another immunosuppressive medicine used in the prevention of rejection).
Danish: Firmaet fremlagde desuden resultaterne af en klinisk undersøgelse hos 668 nyretransplanterede patienter, hvor Advagraf sammenlignes med Prograf/Prograft eller ciclosporin (et andet immundæmpende lægemiddel, der anvendes til forebyggelse af afstødning).
English: In the prevention of rejection, the dose of Advagraf to use depends on the type of transplant the patient has received.
Danish: Når Advagraf anvendes til forebyggelse af afstødning, afhænger dosis af den type transplantat, patienten har fået.
English: When treating rejection, these same doses may be used in kidney and liver transplants.
Danish: Til behandling af afstødning kan disse doser anvendes ved nyre- og levertransplantationer.
English: In kidney transplant, the starting dose is 0.20 to 0.30 mg per kilogram body weight.
Danish: Ved nyretransplantation er startdosis 0,20 til 0,30 mg pr. kg legemsvægt.
English: Advagraf is for long-term use.
Danish: Behandlingen med Advagraf er langtidsbehandling.
English: For the full list of all side effects reported with Advagraf, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger for Advagraf fremgår af indlægssedlen.
English: The shorter studies in kidney and liver transplant patients showed that Advagraf and Prograf/Prograft have comparable absorption in the body.
Danish: De kortvarige undersøgelser hos nyre- og levertransplanterede patienter viste, at Advagraf og Prograf/Prograft optages i samme grad i kroppen.
English: Why has Advagraf been approved?
Danish: Hvorfor blev Advagraf godkendt?
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Advagraf's benefits are greater than its risks for the prophylaxis of transplant rejection in adult kidney and liver allograft recipients, and in the treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Advagraf opvejer risiciene ved forebyggelse af afstødning af allotransplantater af lever og nyre hos voksne patienter og til behandling af afstødning af allotransplantater hos voksne patienter, hos hvem andre immundæmpende lægemidler ikke virker.
English: What benefit has Advagraf shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, der er ved Advagraf?
English: What is Advagraf?
Danish: Hvad er Advagraf?
English: What is Advagraf used for?
Danish: Hvad anvendes Advagraf til?
English: How has Advagraf been studied?
Danish: Hvordan blev Advagraf undersøgt?
English: How is Advagraf used?
Danish: Hvordan anvendes Advagraf?
English: How does Advagraf work?
Danish: Hvordan virker Advagraf?
English: Starting doses are 0.10 to 0.30 mg/kg in other types of transplant (heart, lung, pancreas or intestine).
Danish: Ved andre typer transplantationer (hjerte, lunge, bugspytkirtel eller tarm) anvendes en startdosis på 0,10 til 0,30 mg/kg.
English: See the Package Leaflet for details.
Danish: Yderligere oplysninger herom fremgår af indlægssedlen.
English: Consequently, newborn infants should be monitored carefully.
Danish: Derfor bør nyfødte børn overvåges nøje.
English: Take the medicine pack with you.
Danish: Tag medicinpakken med dig.
English: * See subsection “Falls” below
Danish: * Se underafsnittet “Fald” nedenfor
English: You should be aware that both of these conditions may be caused by this type of medicine.
Danish: Du skal være opmærksom på at begge tilstande kan skyldes denne type medicin.
English: Date of first authorisation: 01 September 2010 Date of latest renewal: 05 May 2015
Danish: Dato for første markedsføringstilladelse: 1. september 2010 Dato for seneste fornyelse: 5. maj 2015
English: If this combination is deemed necessary, the lowest effective dose of each treatment should be prescribed.
Danish: Hvis denne kombination anses for nødvendig, bør den laveste effektive dosis af hver behandling ordineres.
English: Immediate medical treatment may be needed.
Danish: Omgående behandling kan være nødvendig.
English: B-2220 Heist-op-den-Berg, Belgium
Danish: B-2220 Heist-op-den-Berg, Belgien
English: Weight increased Increased appetite
Danish: Vægtstigning Øget appetit
English: Other side effects reported with this medicine include:
Danish: Andre bivirkninger, som er indberettet for dette lægemiddel, inkluderer:
English: The possibility of multiple medicinal product involvement should be considered.
Danish: Muligheden for at flere lægemidler er involveret bør overvejes.
English: If you are unable to take this medicine as is described below, the treatment may not be effective for you.
Danish: Hvis du ikke er i stand til at tage dette lægemiddel, som beskrevet nedenfor, er det ikke sikkert, at behandlingen er effektiv for dig.
English: The mechanism of action of asenapine is not fully understood.
Danish: Virkningsmekanismen for asenapin er ikke fuldt klarlagt.
English: One dose should be taken in the morning and one dose should be taken in the evening.
Danish: En dosis skal tages om morgenen og en dosis om aftenen.
English: Paediatric population (children and adolescents)
Danish: Pædiatrisk population (børn og unge)
English: During twice-daily dosing, steady-state is attained within 3 days.
Danish: Ved dosering to gange dagligt, opnås steady-state inden for 3 dage.
English: It is not known whether asenapine or its metabolites are excreted in human milk.
Danish: Det er ukendt, om asenapin eller dets metabolitter udskilles i human mælk.
English: Sycrest may cause low blood pressure.
Danish: Sycrest kan give lavt blodtryk.
English: Following an initial more rapid distribution phase, the terminal half-life of asenapine is approximately 24 h.
Danish: Efter en indledende hurtigere distribution fase, er den terminale halveringstid af asenapin cirka 24 timer.
English: Close medical supervision and monitoring should continue until the patient recovers.
Danish: Tæt medicinsk overvågning og monitorering bør fortsætte indtil patienten kommer sig.
English: This medicine belongs to a group of medicines called antipsychotics.
Danish: Lægemidlet tilhører en medicingruppe, som kaldes antipsykotika.
English: In elderly patients (between 65 and 85 years of age), exposure to asenapine is approximately 30 % higher than in younger adults.
Danish: Hos ældre patienter (mellem 65 og 85 år) er eksponeringen for asenapin cirka 30 % højere end hos yngre voksne.
English: Serious hypersensitivity reactions have been reported.
Danish: Alvorlige overfølsomhedsreaktioner er rapporteret.
English: There are no adequate data from the use of Sycrest in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af Sycrest til gravide kvinder.
English: Pharmacotherapeutic group: Psycholeptics, antipsychotics, ATC code: N05AH05
Danish: Farmakoterapeutisk klassifikation: Psykoleptika, antipsykotika, ATC-kode: N05AH05
English: This will usually pass on its own but if it does not, tell your doctor.
Danish: Dette vil sædvanligvis gå over af sig selv, men kontakt lægen hvis det ikke gør.
English: Drynam Road, Swords, Co. Dublin Ireland
Danish: Drynam Road, Swords, Co. Dublin Irland
English: You should not stop taking this medicine, unless your doctor tells you as your symptoms may return.
Danish: Du må ikke holde op med at tage dette lægemiddel, medmindre din læge beder dig om det, da symptomerne kan vende tilbage.
English: Sycrest should not be used during pregnancy unless the clinical condition of the woman requires treatment with asenapine and only if the potential benefit outweighs the potential risk to the foetus.
Danish: Sycrest bør ikke anvendes under graviditet, medmindre kvindens kliniske tilstand kræver behandling med asenapin, og kun hvis den potentielle fordel opvejer den potentielle risiko for fosteret.
English: Limited data on efficacy in patients 65 years of age and older are available.
Danish: Der er en begrænset mængde data til rådighed omkring virkning hos patienter i alderen 65 år og ældre.
English: Therefore, co-administration of asenapine and fluvoxamine should be approached with caution.
Danish: Samtidig administration af asenapin og fluvoxamin bør derfor håndteres med forsigtighed.
English: At this dose foetal body weight decreased.
Danish: Ved denne dosis faldt den føtale kropsvægt.
English: All ADRs are listed by system organ class and frequency; very common (≥ 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100), rare ( 1/10,000 to < 1/1,000) and not known (cannot be estimated from the available data).
Danish: Alle bivirkninger er anført efter organklasse og hyppighed; meget almindelig (≥ 1/10), almindelig ( 1/100 til < 1/10), ikke almindelig ( 1/1.000 til < 1/100), sjælden ( 1/10.000 til < 1/1.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Keep the tablet under your tongue until it dissolves.
Danish: Hold resoribletten under tungen indtil den er opløst.
English: - The exact amount is shown on your Sycrest tablet pack.
Danish: - Den præcise mængde er angivet på Sycrest pakningen.
English: Asenapine is rapidly distributed and has a large volume of distribution (approximately 20-25 L/kg), indicating extensive extravascular distribution.
Danish: Asenapin fordeles hurtigt og har et stort fordelingsvolumen (ca. 20-25 l/kg), hvilket indikerer stor ekstravaskulær fordeling.
English: Serious side effects have been reported with this medicine.
Danish: Der er indberettet alvorlige bivirkninger i forbindelse med dette lægemiddel.