FrancophonIA/ELRC3.0 huggingface dataset:
English: Single subcutaneous or intravenous injection at a dose of 0.5 mg meloxicam/kg body weight (i.e. 1.25 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Danish: Enkelt subkutan eller intravenøs injektion på 0,5 mg meloxicam/kg legemsvægt (d.v.s. 1,25 ml/100 kg legemsvægt), om nødvendigt i kombination med antibiotika-behandling eller med oral tilførsel af passende mængder vand.
English: Metacam 40 mg/ml solution for injection for cattle and horses
Danish: Metacam 40 mg/ml injektionsvæske, opløsning til kvæg og heste.
English: Vial, 20 ml and 50 ml
Danish: Hætteglas, 20 ml og 50 ml
English: IV
Danish: Lot
English: In very rare cases, haemorrhagic diarrhoea, haematemesis and gastrointestinal ulceration have been reported.
Danish: Der i meget sjældne tilfælde set hæmoragisk diarré, opkastning af blod samt mavesår.
English: Do not use in horses suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Danish: Må ikke anvendes til heste med gastro-intestinale lidelser som f.eks. irritation og tegn på blødning, svækket lever-, hjerte- eller nyrefunktion og hæmoragiske lidelser.
English: Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Danish: Må ikke anvendes til hunde med gastro-intestinale lidelser som f.eks. irritation og tegn på blødning, svækket lever-, hjerte- eller nyrefunktion og hæmoragiske lidelser.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated)
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelige (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger) - Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr)
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelige (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger) - Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjældne (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter).
English: Single subcutaneous or intravenous injection at a dose of 0.5 mg meloxicam/kg body weight (i.e. 10.0 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Danish: Enkelt subkutan eller intravenøs injektion på 0,5 mg meloxicam/kg legemsvægt (d.v.s. 10,0 ml/100 kg legemsvægt), om nødvendigt i kombination med antibiotika-behandling eller med oral tilførsel af passende mængder vand.
English: Do not use in cats suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Danish: Må ikke anvendes til katte med gastro-intestinale lidelser som f.eks. irritation og tegn på blødning, svækket lever-, hjerte- eller nyrefunktion og hæmoragiske lidelser.
English: EXP {month/year} Once broached use within 28 days.
Danish: EXP {måned/år} Efter åbning: anvendes indenfor 28 dage..
English: Marketing authorisation holder and manufacturer responsible for batch realease Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Danish: Indehaveren af markedsføringstilladelsen Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein TYSKLAND
English: Vial, 10 ml and 20 ml
Danish: Hætteglas, 10 ml og 20 ml
English: These side effects usually disappear within one to two days without treatment.
Danish: Disse bivirkninger forsvinder normalt uden behandling i løbet af en til to dage.
English: The full EPAR for Optaflu can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Optaflu findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Optaflu is a vaccine.
Danish: Optaflu er en vaccine.
English: This is a summary of the European public assessment report (EPAR) for Optaflu.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Optaflu.
English: The vaccine's effectiveness was assessed in one main study involving 2,654 adults, around half of whom were elderly (over 60 years of age).
Danish: Vaccinens virkning blev vurderet i én hovedundersøgelse, der omfattede 2 654 voksne, hvoraf ca. halvdelen var ældre personer (over 60 år).
English: Other information about Optaflu
Danish: Andre oplysninger om Optaflu
English: A risk management plan has been developed to ensure that Optaflu is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Optaflu anvendes så sikkert som muligt.
English: The use of the vaccine should be based on official
Danish: Anvendelsen af vaccinen bør ske i overensstemmelse med officielle
English: influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
Danish: influenzavaccine (overfladeantigen, inaktiveret, fremstillet i cellekulturer)
English: What measures are being taken to ensure the safe and effective use of Optaflu?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Optaflu?
English: What is the risk associated with Optaflu?
Danish: Hvilken risiko er der forbundet med Optaflu?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Optaflu, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Optaflu, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Optaflu is used to vaccinate adults against flu, especially those who are at an increased risk of developing complications from the disease.
Danish: Optaflu anvendes til vaccination af voksne mod influenza, navnlig personer med særlig risiko for at få komplikationer af sygdommen.
English: Each year, the World Health Organization (WHO) makes recommendations on which flu strains should be included in vaccines for the upcoming flu season.
Danish: Verdenssundhedsorganisationen (WHO) udsender hvert år anbefalinger til, hvilke influenzastammer der bør være indeholdt i vacciner til den efterfølgende influenzasæson.
English: The CHMP decided that Optaflu's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Optaflu opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Optaflu.
English: The most common side effects with Optaflu (seen in more than 1 patient in 10) are headache, reddening of the skin, muscle pain, pain at the site of injection, malaise (feeling unwell) and fatigue (tiredness).
Danish: De hyppigste bivirkninger ved Optaflu (som optræder hos flere end 1 ud af 10 patienter) er hovedpine, erytem (rødmen), myalgi (muskelsmerter), smerter på injektionsstedet, utilpashed og træthed.
English: Optaflu contains fragments from the surface of three different strains of flu virus.
Danish: Optaflu indeholder fragmenter fra overfladen af tre forskellige stammer af influenzavirus.
English: The antibodies will then help to protect against the disease caused by these strains of the flu virus.
Danish: Antistofferne medvirker til at beskytte mod sygdom forårsaget af disse stammer af influenzavirus.
English: Optaflu is given as one injection of 0.5 ml into the muscle at the top of the arm.
Danish: Optaflu gives som en injektion på 0,5 ml i overarmsmusklen.
English: The ability of Optaflu to trigger the production of antibodies (immunogenicity) was first assessed using a formulation of the vaccine that included the virus strains expected to cause flu in the 2004/2005 season.
Danish: Optaflus evne til at fremkalde antistofdannelse (immunogenicitet) blev først vurderet ved hjælp af en formulering af vaccinen, der indeholdt de virusstammer, som forventedes at forårsage influenza i sæsonen 2004/2005.
English: A/California/7/2009 (H1N1)pdm09-like strain; A/Switzerland/9715293/2013 (H3N2)-like strain; and
Danish: Vaccinen indeholder "overfladeantigen" fra tre forskellige stammer (typer) af influenzavirus: A/California/7/2009 (H1N1)pdm09-lignende stamme, A/Switzerland/9715293/2013 (H3N2)-lignende stamme og
English: The two vaccines were similar in triggering the production of antibodies, both in adults 60 years of age and below, and in the elderly.
Danish: De to vacciner havde samme egenskaber med hensyn til at udløse antistofdannelse både hos voksne under 60 år og hos ældre.
English: For more information about treatment with Optaflu, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Optaflu, kan du læse indlægssedlen (også en del af denne EPAR) eller
English: Optaflu contains fragments (surface antigens) of the virus strains that are expected to cause flu in the upcoming season, according to the recommendations from the WHO for the northern hemisphere and from the European Union (EU), need to be included in Optaflu before the vaccine can be used.
Danish: Optaflu indeholder fragmenter af de virusstammer, der ifølge anbefalingerne fra WHO for den nordlige halvkugle og fra Den Europæiske Union (EU) forventes at forårsage influenza i den kommende sæson.
English: In the original main study, both Optaflu and the comparator vaccine brought about adequate levels of antibodies for protection against all three flu strains, as defined in criteria laid down by the CHMP for flu vaccines.
Danish: I den oprindelige hovedundersøgelse bevirkede både Optaflu og sammenligningsvaccinen dannelsen af tilstrækkelige mængder beskyttende antistoffer mod alle tre influenzastammer svarende til de kriterier, der er fastlagt af CHMP for influenzavacciner produceret i cellekulturer.
English: Later seasonal formulations of Optaflu have been shown to bring about similar antibody responses against the three flu strains included in the vaccine to those seen in the main study.
Danish: Senere sæsoners formuleringer af Optaflu har vist sig at fremkalde lignende antistofreaktioner mod de tre influenzastammer, som er indeholdt i vaccinen, svarende til reaktionerne i hovedundersøgelsen.
English: The study compared the ability of the two vaccines to trigger the production of antibodies (immunogenicity), by comparing antibody levels before injection
Danish: I undersøgelsen sammenlignedes de to vacciners evne til at fremkalde antistofdannelse (immunogenicitet) ved sammenholdelse af antistofindholdet før injektionen og tre uger senere.
English: The effects of Optaflu were compared to those of a similar flu vaccine that was made in eggs.
Danish: Virkningerne af Optaflu blev sammenlignet med virkningerne af tilsvarende influenzavacciner fremstillet i æg.
English: What benefit has Optaflu shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Optaflu?
English: The viruses used to obtain the surface antigen that are included in Optaflu are grown in mammalian cells, unlike those used for other flu vaccines, which are grown in hen's eggs.
Danish: De vira, der anvendes til at opnå de overfladefragmenter, som indgår i Optaflu, dyrkes i pattedyrceller i modsætning til dem, der anvendes i andre influenzavacciner, som dyrkes i hønseæg.
English: Optaflu is a vaccine, which is available as a suspension for injection in a pre-filled syringe.
Danish: Optaflu er en vaccine, der fås som injektionsvæske, suspension, i en fyldt injektionssprøjte.
English: For the full list of all side effects reported with Optaflu, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Optaflu fremgår af indlægssedlen.
English: The vaccine can only be obtained with a prescription.
Danish: Disse fragmenter skal indgå i Optaflu, inden vaccinen kan anvendes.
English: This authorisation was based on the authorisation granted to Competat on 28 July 2006 (‘informed consent').
Danish: Denne tilladelse er baseret på den tilladelse, der blev udstedt for Competact den 28. juli 2006 ("informeret samtykke").
English: The studies lasted from four months to two years and involved 1,305 patients who took the combination.
Danish: Undersøgelserne varede fra fire måneder til to år og omfattede 1 305 patienter, som tog denne kombination.
English: Elderly patients should have their kidney function monitored regularly.
Danish: Ældre patienter skal have deres nyrefunktion kontrolleret regelmæssigt.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Glubrava on 11 December 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Glubrava den 11. december 2007.
English: Pioglitazone / metformin hydrochloride
Danish: Pioglitazon/metforminhydrochlorid
English: The full EPAR for Glubrava can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Glubrava findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: These side effects are very common but disappear on their own in most cases.
Danish: Disse bivirkninger optræder hyppigt, men går som oftest væk af sig selv.
English: This is a summary of the European public assessment report (EPAR) for Glubrava.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Glubrava.
English: Other information about Glubrava
Danish: Andre oplysninger om Glubrava
English: Glubrava contains two active substances which each have a different mode of action.
Danish: Glubrava indeholder to aktive stoffer, som hver især virker forskelligt.
English: What measures are being taken to ensure the safe and effective use of Glubrava?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Glubrava?
English: Treatment with Glubrava should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit.
Danish: Behandlingen med Glubrava skal tages op til fornyet vurdering efter tre til seks måneder og afbrydes hos patienter, der ikke får tilstrækkelig gavn af behandlingen.
English: The usual dose of Glubrava is one tablet taken twice a day.
Danish: Den normale dosis af Glubrava er en tablet to gange dagligt.
English: It is possible to change to Glubrava directly from metformin if appropriate.
Danish: Det er muligt at skifte til Glubrava direkte fra metformin, når det er hensigtsmæssigt.
English: For more information about treatment with Glubrava, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Glubrava, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Glubrava is a medicine that is available as tablets containing two active substances, pioglitazone (15 mg) and metformin hydrochloride (850 mg).
Danish: Glubrava er et lægemiddel, der fås som tabletter, der indeholder to aktive stoffer, pioglitazon (15 mg) og metforminhydrochlorid (850 mg).
English: Pioglitazone makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Danish: Pioglitazon gør (fedt-, muskel- og lever)cellerne mere følsomme over for insulin, hvilket betyder, at kroppen bedre udnytter den insulin, den selv danner.
English: Other side effects such as bone fracture, increased weight and oedema (swelling) may occur in less than 1 in 10 patients.
Danish: Andre bivirkninger såsom knoglebrud, vægtforøgelse og ødem (hævelser) optræder hos færre end 1 ud af 10 patienter.
English: Three studies of Actos used with metformin as separate tablets were used to support the use of Glubrava in the same indication.
Danish: Tre undersøgelser med Actos, anvendt sammen med metformin som separate tabletter, blev anvendt til at understøtte brugen af Glubrava til samme indikation.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Glubrava.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Glubrava skal anvendes.
English: Lactic acidosis (a build-up of lactic acid in the body) is a side effect which may occur in less than 1 in 10,000 patients.
Danish: Laktacidose (ophobning af mælkesyre i kroppen) er en bivirkning, som optræder hos færre end 1 ud af 10 000 patienter.
English: They measured the level in the blood of a substance (HbA1c), which gives an indication of how well the blood glucose is controlled.
Danish: I undersøgelserne målte man blodets indhold af et stof (HbA1c), der viser, hvor godt blodets sukkerindhold reguleres.
English: Patients changing from metformin only to Glubrava may need to introduce pioglitazone slowly until a dose of 30 mg per day is reached.
Danish: Patienter, der skifter fra udelukkende at have taget metformin til Glubrava, kan blive nødt til gradvist at øge dosen af pioglitazon, indtil der opnås en dosis på 30 mg pr. dag.
English: What is the risk associated with Glubrava?
Danish: Hvilken risiko er der forbundet med Glubrava?
English: Taking Glubrava with or just after food may reduce any stomach problems caused by metformin.
Danish: Hvis Glubrava tages sammen med mad eller lige efter et måltid, kan dette reducere eventuelle maveproblemer forårsaget af metformin.
English: The CHMP concluded that the effectiveness of pioglitazone and metformin in type 2 diabetes had been shown, and that Glubrava simplifies treatment and improves compliance when a combination of the active substances is required.
Danish: CHMP konkluderede, at der var påvist tilstrækkelig effekt af pioglitazon og metformin hos type 2diabetes, og at Glubrava forenkler behandlingen og forbedrer overholdelsen af anvendelsesbestemmelserne, når der kræves en kombination af de aktive indholdsstoffer.
English: Glubrava is used in adults (particularly those who are overweight) who have type 2 diabetes.
Danish: Glubrava anvendes til voksne (navnlig overvægtige patienter) med type 2-diabetes.
English: Pioglitazone on its own has been approved in the EU under the name Actos and can be used with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Danish: Pioglitazon alene er blevet godkendt i EU under navnet Actos til anvendelse sammen med metformin hos patienter med type 2- diabetes, som ikke er tilfredsstillende kontrolleret med metformin alene.
English: At the start of treatment, abdominal pain (stomach ache), diarrhoea, loss of appetite, nausea (feeling sick) and vomiting may occur.
Danish: Når behandlingen påbegyndes, kan der forekomme mavesmerter, diarré, appetitløshed, kvalme og opkastning.
English: At subsequent reviews, prescribers should confirm that benefits to patients are maintained.
Danish: Lægen skal ved efterfølgende kontroller bekræfte, at patienten stadig har gavn af behandlingen.
English: The Committee decided that Glubrava's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget konkluderede, at fordelene ved Glubrava opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Glubrava.
English: Why has Glubrava been approved?
Danish: Hvorfor blev Glubrava godkendt?
English: What is Glubrava?
Danish: Hvad er Glubrava?
English: Glubrava must not be used where there is alcohol intoxication, diabetic ketoacidosis (high levels of ketones), conditions that may affect the kidneys, and during breast-feeding.
Danish: Glubrava må ikke anvendes i tilfælde af alkoholforgiftning, diabetisk ketoacidose (højt ketonindhold), sygdomme, der kan påvirke nyrerne, og under amning.
English: For the full list of all side effects reported with Glubrava, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Glubrava fremgår af indlægssedlen.
English: As a result of the action of both active substances, the blood glucose is reduced and this helps to control type 2 diabetes.
Danish: Tilsammen nedsætter de to aktive stoffer blodsukkeret og forbedrer derved reguleringen af type 2-sukkersyge.
English: The company that markets Glubrava will produce educational material for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.
Danish: Materialet skal redegøre for den mulige risiko for hjertesvigt og blærekræft ved lægemidler, der indeholder pioglitazon, kriterier for udvælgelse af patienterne og behovet for regelmæssig gennemgang og indstilling af behandlingen, hvis patienten ikke længere har gavn af den.
English: Glubrava is used in patients who are not satisfactorily controlled on metformin (a diabetes medicine) used on its own and at the maximum possible dose.
Danish: Glubrava anvendes til patienter, som ikke er tilfredsstillende kontrolleret udelukkende med metformin (et lægemiddel mod sukkersyge) ved den højest mulige dosis.
English: Glubrava must not be used in patients who have heart failure, or problems with their liver or their kidneys.
Danish: Glubrava må ikke anvendes til patienter, som har hjerteinsufficiens eller problemer med deres lever eller nyrer.
English: Glubrava must not be used in patients who have a disease that causes lack of oxygen to the tissues such as a recent heart attack or shock.
Danish: Glubrava må ikke anvendes til patienter med sygdomme, der medfører mangelfuld ilttilførsel til vævet, f.eks. som følge af et nyligt hjertetilfælde eller chok.
English: In all studies, adding pioglitazone 30 mg to metformin led to an improvement in the control of blood glucose, with levels of HbA1c which further decreasing by 0.64 to 0.89% compared with the levels on metformin alone.
Danish: HbA1c-niveauerne faldt yderligere med 0,64 til 0,89 % i forhold til niveauerne, når der kun anvendtes metformin.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Glubrava have also been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der desuden indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Glubrava.
English: What is Glubrava used for?
Danish: Hvad anvendes Glubrava til?
English: How has Glubrava been studied?
Danish: Hvordan blev Glubrava undersøgt?
English: What benefit has Glubrava shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Glubrava?
English: How is Glubrava used?
Danish: Hvordan anvendes Glubrava?
English: How does Glubrava work?
Danish: Hvordan virker Glubrava?