FrancophonIA/ELRC3.0 huggingface dataset:
English: A clinical trial of pioglitazone vs. gliclazide as monotherapy was extended to two years in order to assess time to treatment failure (defined as appearance of HbA1c ≥ 8.0% after the first six months of
Danish: Et klinisk forsøg, hvor pioglitazon blev sammenlignet med gliclazid, begge som monoterapi, blev forlænget til en varighed af to år, for at undersøge hvornår behandlingen svigter (defineret som forekomst af HbA1c ≥ 8,0% efter de første seks måneders behandling).
English: Investigations weight increased common common common common common blood creatine phospho-kinase increased common increased lactic dehydro-genase uncommon
Danish: Undersøgelser øget vægt almindelig almindelig forhøjet kreatinphosphokinase almindelig forhøjet laktatdehydrogenase ikke almindelig forhøjet alaninaminotransferase ikke kendt ikke kendt
English: Bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients taking Paglitaz.
Danish: Blærekræft forekommer med hyppigheden "ikke almindelig" (kan påvirke op til 1 ud af 100 personer) hos patienter, der tager Paglitaz.
English: Nervous system disorders hypo-aesthesia common common common common common headache common uncommon dizziness common insomnia uncommon uncommon uncommon uncommon uncommon
Danish: Nervesystemet hypoæstesi almindelig almindelig almindelig almindelig almindelig hovedpine almindelig svimmelhed almindelig insomni ikke almindelig ikke almindelig ikke almindelig
English: A pooled analysis was conducted of adverse reactions of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8100 patients in the pioglitazone-treated groups and 7400 in the comparator-treated groups of up to 3.5 years duration.
Danish: Der blev udført en poolet analyse af bivirkninger i form af knoglefrakturer fra randomiserede, komparator-kontrollerede, dobbeltblindede kliniske forsøg med over 8.100 patienter i den pioglitazonbehandlede gruppe og 7.400 patienter i den komparatorbehandlede gruppe, der blev behandlet i op til 3,5 år.
English: Excipient with known effect: Each tablet contains 264.68 mg of lactose (see section 4.4).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 264,68 mg lactose (se pkt.
English: Your doctor will check whether Paglitaz is working 3 to 6 months after you start taking it.
Danish: Når du har taget Paglitaz i 3-6 måneder, vil din læge undersøge, om medicinen virker.
English: Also, if you already have blurred vision and the symptom gets worse, talk to your doctor as soon as possible.
Danish: Hvis du får disse symptomer for første gang, eller hvis de bliver værre, skal du kontakte lægen snarest muligt.
English: Musculoskeletal and connective tissue disorders fracture bone common common common common common arthralgia common common back pain common
Danish: Knogler, led, muskler og bindevæv knoglefraktur almindelig almindelig artralgi almindelig almindelig rygsmerter
English: 14 tablets: EU/1/11/721/001 28 tablets: EU/1/11/721/002 30 tablets: EU/1/11/721/003 56 tablets: EU/1/11/721/004 60 tablets: EU/1/11/721/005 90 tablets: EU/1/11/721/006 98 tablets: EU/1/11/721/007
Danish: 14 tabletter: EU/1/11/721/001 28 tabletter: EU/1/11/721/002 30 tabletter: EU/1/11/721/003 56 tabletter: EU/1/11/721/004 60 tabletter: EU/1/11/721/005 90 tabletter: EU/1/11/721/006 98 tabletter: EU/1/11/721/007
English: If you accidentally take too many Paglitaz tablets, or if someone else or a child takes your medicine, talk to a doctor or pharmacist immediately.
Danish: Kontakt lægen, skadestuen eller apoteket, hvis du ved en fejltagelse har taget for mange tabletter, eller hvis en anden eller et barn tager din medicin.
English: 14 tablets: EU/1/11/721/015 28 tablets: EU/1/11/721/016 30 tablets: EU/1/11/721/017 56 tablets: EU/1/11/721/018 60 tablets: EU/1/11/721/019 90 tablets: EU/1/11/721/020 98 tablets: EU/1/11/721/021
Danish: 14 tabletter: EU/1/11/721/015 28 tabletter: EU/1/11/721/016 30 tabletter: EU/1/11/721/017 56 tabletter: EU/1/11/721/018 60 tabletter: EU/1/11/721/019 90 tabletter: EU/1/11/721/020 98 tabletter: EU/1/11/721/021
English: 14 tablets: EU/1/11/721/008 28 tablets: EU/1/11/721/009 30 tablets: EU/1/11/721/010 56 tablets: EU/1/11/721/011 60 tablets: EU/1/11/721/012 90 tablets: EU/1/11/721/013 98 tablets: EU/1/11/721/014
Danish: 14 tabletter: EU/1/11/721/008 28 tabletter: EU/1/11/721/009 30 tabletter: EU/1/11/721/010 56 tabletter: EU/1/11/721/011 60 tabletter: EU/1/11/721/012 90 tabletter: EU/1/11/721/013 98 tabletter: EU/1/11/721/014
English: What Paglitaz looks like and contents of the pack White to almost white round tablets with bevelled edges (diameter 8.0 mm).
Danish: Udseende og pakningsstørrelser Hvide til næsten hvide, runde tabletter, med skrå kanter (diameter 8,0 mm)
English: Paglitaz 30 mg tablets
Danish: Paglitaz 30 mg tabletter
English: Focus Care Pharmaceuticals B.V. Tel: +31 (0)75 61 20 511
Danish: Tel: +31 (0)75 61 20 511
English: Paglitaz 45 mg tablets
Danish: Paglitaz 45 mg tabletter
English: Paglitaz tablets should be used every day to work properly.
Danish: For at opnå den ønskede virkning skal du tage Paglitaz hver dag.
English: Paglitaz 45 mg tablets Pioglitazone
Danish: Paglitaz 45 mg tabletter pioglitazon
English: How to take Paglitaz
Danish: Sådan skal du tage Paglitaz
English: Paglitaz 15 mg tablets
Danish: Paglitaz 15 mg tabletter
English: Paglitaz 30 mg tablets Pioglitazone
Danish: Paglitaz 30 mg tabletter pioglitazon
English: Immune System Disorders Hypersensitivity and allergic reactions not known not known not known not known not known
Danish: Synsforstyrrelser Makulaødem ikke kendt ikke kendt
English: Paglitaz 15 mg tablets Pioglitazone
Danish: Paglitaz 15 mg tabletter pioglitazon
English: In a two-year study of combination therapy comparing pioglitazone with gliclazide when added to metformin, glycaemic control measured as mean change from baseline in HbA1c was similar between treatment groups after one year.
Danish: Her viste glykæmiske kontrolmålinger ( målt som middelændringer i HbA1c fra baseline), at de var omtrentlig de samme to grupper imellem efter et år.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) bladder cancer uncommon uncommon uncommon uncommon uncommon Respiratory, thoracic and mediastinal disorders dyspnoea common
Danish: cyster og polypper) blærecancer ikke almindelig ikke almindelig ikke almindelig
English: Combination with metformin with sulphonylurea with metformin and sulphonylurea with insulin oedema very common fatigue uncommon
Danish: Kombinationsbehandling med metformin med sulfonylurea med metformin og sulfonylurea med insulin
English: If you take more Paglitaz than you should
Danish: Hvis du har taget for meget Paglitaz
English: CARTON FOLDING BOX
Danish: Mave-tarm-kanalen flatulens almindelig
English: If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Paglitaz.
Danish: Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: OTHER
Danish: Andre
English: Gastrointestinal disorders flatulence Skin and subcutaneous tissue disorders sweating uncommon
Danish: Hud og subkutane væv Svedudbrud ikke almindelig
English: Children and adolescents Use in children under 18 years is not recommended.
Danish: Børn og teenagere Børn under 18 år må normalt ikke få Paglitaz.
English: as triple oral therapy in combination with - metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy.
Danish: som oral kombinationsbehandling, sammen med metformin hos voksne patienter (specielt overvægtige patienter) med utilstrækkelig glykæmisk kontrol på metformin-monoterapi på trods af maksimalt tolereret metformindosis sulfonylurinstof hos voksne patienter med utilstrækkelig glykæmisk kontrol på monoterapi med sulfonylurinstof på trods af maksimalt tolereret sulfonylurinstofdosis; dog kun hos patienter, der udviser intolerans over for metformin, eller for hvem metformin er kontraindiceret som trippel oral kombinationsbehandling, sammen med metformin og sulfonylurinstof hos voksne patienter (specielt overvægtige patienter) med utilstrækkelig glykæmisk kontrol på trods af oral kombinationsbehandling med to præparater.
English: Combination with metformin with sulphonylurea with metformin and sulphonylurea with insulin visual disturbance common common uncommon macular oedema not known not known not known not known not known
Danish: Øjne synsforstyrrelser almindelig makulaødem ikke kendt ikke kendt
English: nausea or vomiting).
Danish: (lægemiddelovervågning eller risikominimering) er nået.
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret Paglitaz til dig personligt.
English: This is usually in your upper arm.
Danish: Normalt gives den i din overarm.
English: Limited data on overdose are available.
Danish: Begrænsede data om overdosering er tilgængelige.
English: Most people fully recover from the illness.
Danish: De fleste mennesker bliver fuldstændig raske efter sygdommen.
English: Their frequency is defined using the conventions listed below:
Danish: Hyppighederne er defineret ved hjælp af de nedenfor anførte konventioner:
English: These antibodies will protect you against the disease.
Danish: Disse antistoffer vil beskytte dig mod sygdommen.
English: However, solicited general symptoms were observed with similar frequencies in both groups.
Danish: Dog sås generelle symptomer med tilsvarende hyppighed i begge grupper.
English: You may feel tired or get a headache after receiving Fendrix.
Danish: Du kan føle dig træt eller få hovedpine efter at have fået Fendrix.
English: • The injections will be given within 6 months:
Danish: • Injektionerne vil blive givet over en tidsperiode på 6 måneder:
English: Your doctor will tell you if you need any extra or “booster” injections in the future.
Danish: Lægen vil fortælle dig, om du i fremtiden har behov for ekstra- eller "booster"-injektioner.
English: If this happens, take special care while driving or using any tools or machines.
Danish: Sker det, skal du være særlig forsigtig, når du kører bil eller betjener værktøj eller maskiner.
English: The vaccine must not be used if any change in the appearance of the vaccine has taken place.
Danish: Vaccinen må ikke anvendes, hvis der er sket ændringer af vaccinens udseende.
English: • The doctor or nurse will tell you when you should come back for the next injections.
Danish: • Lægen eller sygeplejersken vil informere dig om, hvornår du skal komme tilbage for efterfølgende injektioner.
English: The vaccine can be given after you have recovered.
Danish: Vaccinen kan gives, når du er blevet rask.
English: • Some people with hepatitis B do not look or feel ill - they do not have any signs of illness.
Danish: • Nogle mennesker med hepatitis B ser ikke syge ud og føler sig ikke syge - de har ingen tegn på sygdommen.
English: • allergic reactions, including anaphylactoid reactions.
Danish: • allergiske reaktioner, herunder anafylaktiske reaktioner.
English: Fendrix should not be given if any of the above apply to you.
Danish: Fendrix skal ikke gives, hvis noget af ovennævnte gælder for dig.
English: The doctor or nurse will give Fendrix as an injection into your muscle.
Danish: Lægen eller sygeplejersken vil give dig Fendrix som en injektion i en muskel.
English: • if you are allergic to the active substance, or any of the other ingredients of this vaccine (listed in section 6).
Danish: • hvis du er allergisk over for det aktive stof eller et af de øvrige indholdsstoffer i denne vaccine (angivet i punkt 6).
English: • Signs may not be seen for 6 weeks to 6 months after infection.
Danish: • Symptomerne ses ikke nødvendigvis før 6 uger til 6 måneder efter smitte.
English: Date of first authorisation: 02 February 2005 Date of latest renewal: 10 December 2009
Danish: Dato for seneste fornyelse: 10. december 2009
English: No fertility data are available.
Danish: Der er ingen tilgængelige fertilitetsdata.
English: Your doctor will make sure that the vaccines are injected into different parts of the body.
Danish: Din læge vil sørge for, at indsprøjtningerne bliver indgivet forskellige steder på kroppen.
English: As no data are available for the concomitant administration of this particular vaccine with other vaccines, an interval of 2 to 3 weeks should be respected.
Danish: Da, der ikke er data tilgængelige vedrørende samtidig administration af denne og andre vacciner, skal et interval på 2 til 3 uger respekteres.
English: These or other signs may mean the person might need treatment in hospital.
Danish: Disse samt andre symptomer kan betyde, at der er behov for hospitalsindlæggelse.
English: There are no data from the use of Fendrix in pregnant women.
Danish: Der er ingen data fra brugen af Fendrix hos gravide kvinder.
English: The following side effects may happen with this vaccine.
Danish: Følgende bivirkninger er set med denne vaccine.
English: • severe headache with a stiff neck
Danish: • kraftig hovedpine med stiv nakke
English: • You should have a gap of at least 2 to 3 weeks between having Fendrix and any other vaccine.
Danish: • Der skal være mindst 2 til 3 uger mellem vaccination med Fendrix og en anden vaccine.
English: Immunological data
Danish: Immunologiske data
English: A minor infection such as a cold should not be a problem, but talk to your doctor first.
Danish: En ubetydelig infektion såsom forkølelse bør ikke være et problem, men rådfør dig med lægen først.
English: Fendrix is for adults and young people aged 15 years and above.
Danish: Fendrix er til brug hos voksne og unge fra 15 år.
English: • If you miss an injection, talk to your doctor and arrange another visit.
Danish: • Hvis du glemmer en injektion, skal du tale med lægen og aftale en ny tid.
English: Some of the undesirable effects mentioned under section 4.8 may affect the ability to drive or use machines.
Danish: Nogle af bivirkningerne nævnt under pkt 4.8 kan have indflydelse på evnen til at føre bil eller betjene maskiner.
English: If you are pregnant or breast-feeding, think that you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this vaccine.
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 får denne vaccine.
English: • The hepatitis B virus stays in the body of some people all through their lives.
Danish: • Hepatitis B-virus kan hos nogle mennesker forblive i kroppen hele livet igennem.
English: Special posology recommendation for known or presumed exposure to HBV:
Danish: Doseringsanbefaling ved kendt eller formodet eksponering for HBV:
English: The safety and efficacy of Fendrix in children aged less than 15 years have not been established.
Danish: Fendrix sikkerhed og virkning hos børn under 15 år er ikke klarlagt.
English: The vaccine should be visually inspected both before and after re-suspension for any foreign particulate matter and/or change in physical appearance.
Danish: Vaccinen skal, både før og efter omrystning, inspiceres visuelt for fremmede partikler og/eller ændringer af det fysiske udseende.
English: 1adjuvanted by AS04C containing: - 3-O-desacyl-4'- monophosphoryl lipid A (MPL) 2
Danish: 1adjuveret med AS04C indeholdende: - 3-O-desacyl-4'- monophosphoryl-lipid A (MPL)2
English: The primary immunisation consists of 4 separate 0.5 ml doses administered at the following schedule: 1 month, 2 months and 6 months from the date of the first dose.
Danish: Den primære immunisering består af 4 separate doser á 0,5 ml, administreret efter følgende program: 1 måned, 2 måneder og 6 måneder efter første dosis.
English: The most common adverse reactions reported were local reactions at the injection site.
Danish: De hyppigst rapporterede bivirkninger var lokale reaktioner på injektionsstedet.
English: Hepatitis B is caused by a virus which makes the liver swollen.
Danish: Hepatitis B er forårsaget af et virus, som medfører, at leveren svulmer op.
English: These factors include older age, male gender, obesity, smoking, route of administration, and some chronic underlying diseases.
Danish: Disse faktorer omfatter alder, hankøn, fedme, rygning, administrationsvej, og visse kroniske sygdomme.
English: Booster dose:
Danish: Boosterdosis:
English: • Experience with hepatitis B vaccine:
Danish: • Erfaring med hepatitis B-vaccine:
English: Such reactions may occur before leaving the doctor's surgery.
Danish: Disse bivirkninger kan opstå, før du har forladt lægens praksis.
English: Fendrix has moderate influence on the ability to drive and use machine.
Danish: Fendrix har moderat indflydelse på evnen til at føre motorkøretøj eller betjene maskiner.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Danish: Dyreundersøgelser tyder ikke på direkte eller indirekte skadelig påvirkning med hensyn til graviditet, embryonisk/føtal udvikling, fødselsprocessen eller den postnatale udvikling.
English: The presence of a minor infection such as a cold, is not a contraindication for immunisation.
Danish: Tilstedeværelsen af en mindre infektion så som forkølelse er imidlertid ingen kontraindikation for immunisering.
English: It cannot protect you against other infections that can affect the liver - even though these infections might have signs similar to those caused by the hepatitis B virus.
Danish: Den kan ikke beskytte dig mod andre infektioner, som kan påvirke leveren - selvom disse infektioner giver samme symptomer som hepatitis B-virus.
English: The causal relationship to the vaccine has not been established.
Danish: Den kausale sammenhæng med vaccinen er ikke fastslået.
English: • red, raised skin rash
Danish: • rødt, hævet hududslæt
English: Additional doses may need to be considered for subjects who do not respond or have a sub-optimal response to a course of vaccinations.
Danish: Yderligere doser skal overvejes for personer som ikke responderer eller som har et sub-optimalt response på vaccinationsprogrammet.
English: • patients having “haemo-dialysis”- where a “dialysis” machine removes waste products from the blood
Danish: • hæmodialysepatienter - hvor et dialyseapparat renser blodet for affaldsstoffer
English: • Once you have had the first injection of Fendrix, the next injections need also to be Fendrix (not another sort of hepatitis B vaccine).
Danish: • Når du har fået den første injektion med Fendrix, skal de næste injektioner også være med Fendrix (brug ikke en anden type hepatitis B-vaccine).
English: • Make sure you finish the complete course of four injections.
Danish: • Sørg for, at du fuldfører hele vaccinationsprogrammet med fire injektioner.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/0299/001 - pack of 1 with separate needle EU/1/04/0299/002 - pack of 1 without needle EU/1/04/0299/003 - pack of 10 without needles
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/04/0299/001 - pakning med 1 og separat kanyle EU/1/04/0299/002 - pakning med 1 uden kanyle EU/1/04/0299/003 - pakning med 10 uden kanyler
English: Vaccination with Fendrix induced more transient local symptoms as compared to the comparator vaccine, with pain at the injection site being the most frequently reported solicited local symptom.
Danish: Vaccinationen med Fendrix gav lokale symptomer af mere forbigående karakter set i forhold til sammenlignings-vaccinen, med smerte på injektionsstedet som den hyppigst rapporterede lokale symptom.
English: Tell your doctor if you are taking, have recently taken, might take any other medicines or have recently received any other vaccine.
Danish: Fortæl altid lægen, hvis du bruger anden medicin eller har gjort det for nylig, eller du for nylig er vaccineret med en anden vaccine.
English: Since intramuscular administration into the gluteal muscle could lead to a suboptimal response to the vaccine, this route should be avoided.
Danish: Da intramuskulær administration i glutealregionen kan føre til et suboptimalt respons overfor vaccinen, skal denne administrationsvej undgås.
English: Patients with chronic liver disease or with HIV infection or hepatitis C carriers should not be precluded from vaccination against hepatitis B. The vaccine could be advised since HBV infection can be severe in these patients: the Hepatitis B vaccination should thus be considered on a case-by-case basis by the physician.
Danish: Patienter med kronisk leversygdom eller HIV infektion eller hepatitis C bærere må ikke udelukkes fra vaccination mod hepatitis B. Vaccinen kan tilrådes, eftersom HBV infektion kan være alvorlig hos disse patienter: lægen skal derfor overveje Hepatitis B-vaccination på et individuelt grundlag.
English: The vaccine will not prevent infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E or other pathogens known to infect the liver.
Danish: Vaccinen forebygger ikke infektion forårsaget af andre virus såsom hepatitis A, hepatitis C og hepatitis E eller andre patogene organismer, som vides at inficere leveren.
English: An anti-HBs antibody titre ≥ 10 mIU/ml correlates with protection to HBV infection.
Danish: Et anti-HBsantistoftiter på ≥ 10 mIE/ml korrelerer med beskyttelse mod HBV-infektion.
English: No increase in the incidence or severity of these adverse reactions was seen with subsequent doses of the primary vaccination schedule.
Danish: Der sås ingen stigning i forekomsten eller sværhedsgraden af disse bivirkninger ved efterfølgende doser i det primære vaccinationsprogram.
English: • if you have ever had an allergic reaction to any vaccine against hepatitis B
Danish: • hvis du tidligere har haft en allergisk reaktion mod andre vacciner mod hepatitis B
English: Before administration, the vaccine should be well shaken to obtain a slightly opaque, white suspension.
Danish: Før administration skal vaccinen omrystes omhyggeligt for at opnå en let uigennemsigtig, hvid suspension.
English: It is used for patients with kidney problems:
Danish: Den bruges til patienter med nedsat nyrefunktion:
English: • The other ingredients in Fendrix are: sodium chloride, water for injections.
Danish: • Øvrige indholdsstoffer i Fendrix: natriumchlorid, vand til injektionsvæsker
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Sodium chloride
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Fortegnelse over hjælpestoffer Natriumchlorid
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Danish: Som for alle injicerbare vacciner skal passende medicinsk behandling og overvågning altid være let tilgængeligt i tilfælde af sjældent forekommende anafylaktiske reaktioner efter administration af vaccinen.
English: Fendrix should under no circumstances be administered intradermally or intravenously.
Danish: Fendrix må under ingen omstændigheder indgives intradermalt eller intravenøst.
English: Because of the long incubation period of hepatitis B, it is possible that subjects could have been infected before the time of immunisation.
Danish: Som følge af den lange inkubationsperiode for hepatitis B, er der mulighed for, at nogle personer kan være inficerede på immuniseringstidspunktet.
English: A number of factors have been observed to reduce the immune response to hepatitis B vaccines.
Danish: En række faktorer reducerer immun response på hepatitis B-vacciner.
English: Following widespread use of hepatitis B vaccines, in very rare cases, syncope, paralysis, neuropathy, neuritis (including Guillain-Barré syndrome, optic neuritis and multiple sclerosis), encephalitis, encephalopathy, meningitis and convulsions have been reported.
Danish: Som følge af den udbredte anvendelse af hepatitis B-vacciner er der i meget sjældne tilfælde rapporteret besvimelse, lammelse, neuropati, neuritis (inklusive Guillain-Barré syndrom, optisk neuritis og multipel sclerose), encephalitis, encephalopathi, meningitis og kramper.