FrancophonIA/ELRC3.0 huggingface dataset:
English: Each pack of Esperoct contains a vial with white to off-white powder, a 4 mL pre-filled syringe with a clear colourless solvent, a plunger rod and a vial adapter.
Danish: Esperoct fås i pakninger med 500 IE, 1000 IE, 1500 IE, 2000 IE eller 3000 IE. Hver pakning med Esperoct indeholder et hætteglas med hvidt eller off-white pulver, en 4 ml fyldt sprøjte med en klar, farveløs solvens, en stempelstang og en hætteglasadapter.
English: The prophylactic effect of Esperoct was demonstrated with a dosing at 50 IU per kg body weight every 4 days or every 3-4 days (twice weekly) in 175 patients.
Danish: Virkningen af Esperoct som profylakse og behandling af blødninger er evalueret i et åbent, ikkekontrolleret studie med unge over 12 år og voksne patienter med svær hæmofili A. Den profylaktiske virkning af Esperoct blev påvist ved en dosis på 50 IE per kg legmsvægt hver 4. dag eller hver 3.4. dag (to gange ugentligt) hos 175 patienter.
English: They can easily be broken into two equal halves.
Danish: De kan nemt brækkes i to lige halvdele.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Carbaglu to Orphan Europe on 24 January 2003.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Carbaglu til Orphan Europe den 24. januar 2003.
English: The tablets should be dispersed (mixed) in a small amount of water before being given to the patient.
Danish: Tabletterne skal opløses (blandes) i en lille mængde vand, inden de gives til patienten.
English: This is a summary of the European public assessment report (EPAR) for Carbaglu.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Carbaglu.
English: The initial daily dose of Carbaglu should be 100 mg per kilogram body weight, but up to 250 mg/kg can be used if necessary.
Danish: Den indledende dosis af Carbaglu bør være 100 mg pr. kilo legemsvægt, men en dosis på op til 250 mg/kg kan anvendes om nødvendigt.
English: ‘Dispersible' means that the tablets can be dispersed (mixed) in water.
Danish: ”Opløselig” betyder, at tabletterne kan opløses (blandes) i vand.
English: The other eight patients were treated for hyperammonaemia of another cause.
Danish: De resterende otte patienter blev behandlet for hyperammonæmi af anden årsag.
English: The full EPAR for Carbaglu can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Carbaglu findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Because the number of patients with these diseases is low, they are considered ‘rare' and Carbaglu was designated an ‘orphan medicine' (a medicine used in rare diseases) on various dates (see below).
Danish: Da antallet af patienter med disse sygdomme er lavt, betragtes de som ”sjældne”, og Carbaglu blev udpeget som ”lægemiddel til sjældne sygdomme” på forskellige datoer (se nedenfor).
English: When ammonia builds up in the blood, it is toxic to the body, especially the brain.
Danish: Når ammonium ophobes i blodet, er det giftigt for kroppen og især for hjernen.
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 Carbaglu.
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 anvendelsesbetingelserne for Carbaglu.
English: It is available as dispersible tablets.
Danish: Det leveres som opløselige tabletter.
English: The summaries of opinion of the Committee for Orphan Medicinal Products for Carbaglu can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations (NAGS deficiency: 18 October 2000; isovaleric acidaemia: 7 November 2008; methylmalonic acidaemia: 7 November 2008; propionic acidaemia: 7 November 2008).
Danish: Sammendragene af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Carbaglu findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designations (NAGS-mangel: den 18. oktober 2000; isovalerianeacidæmi: den 7. november 2008; methylmalonacidæmi: den 7. november 2008; propionacidæmi: den 7. november 2008).
English: The most common side effect with Carbaglu (seen in between 1 and 10 patients in 100) is increased sweating.
Danish: Den hyppigste bivirkning ved Carbaglu (som optræder hos mellem 1 og 10 patienter ud af 100) er øget svedtendens.
English: The company also presented information from the published literature on a further four patients treated with the active substance in Carbaglu.
Danish: Virksomheden fremlagde også oplysninger fra den offentliggjorte faglitteratur om yderligere fire patienter, der blev behandlet med det aktive stof i Carbaglu.
English: Carbaglu has been studied in 20 patients, 12 of whom had NAGS deficiency and were treated for an average of about three years.
Danish: Carbaglu blev undersøgt hos 20 patienter, hvoraf 12 havde NAGS-mangel og var blevet behandlet gennemsnitligt cirka tre år.
English: For more information about treatment with Carbaglu, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Carbaglu, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The dose should then be adjusted to maintain normal blood ammonia levels.
Danish: Dosen bør derefter justeres, så der opretholdes normale ammoniumniveauer i blodet.
English: In patients with NAGS deficiency, treatment may be started as early as the first day of life and the medicine is used for the patient's whole life.
Danish: Hos patienter med NAGS-mangel kan behandlingen indledes allerede den første levedag, og lægemidlet anvendes igennem hele patientens levetid.
English: Carbaglu treatment should be started by a doctor who has experience in treating patients with metabolic diseases.
Danish: Behandling med Carbaglu bør indledes af en læge, som har erfaring i at behandle patienter med stofskiftesygdomme.
English: Other information about Carbaglu
Danish: Andre oplysninger om Carbaglu:
English: • N-acetylglutamate synthase (NAGS) deficiency.
Danish: • N-acetylglutamatsyntasemangel (NAGS).
English: Carbaglu carglumic acid
Danish: Carbaglu cargluminsyre
English: The Committee recommended that Carbaglu be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af en markedsføringstilladelse for Carbaglu.
English: Patients on Carbaglu could be kept stable without a need for restrictions to the diet or the use of other medicines.
Danish: Patienter, som fik Carbaglu, kunne holdes stabile, uden at der var behov for kostmæssige begrænsninger eller andre lægemidler.
English: In patients with NAGS deficiency, ammonia levels were brought back to normal after Carbaglu treatment.
Danish: Hos patienter med NAGS-mangel blev ammoniumniveauerne bragt tilbage til normalområdet efter Carbaglu-behandling.
English: Carbaglu is a medicine that contains the active substance carglumic acid.
Danish: Carbaglu er et lægemiddel, der indeholder det aktive stof cargluminsyre.
English: In all of the studies, the main measure of effectiveness was the change in ammonia levels in the blood.
Danish: I alle undersøgelserne blev virkningen hovedsagelig målt på ændringen i mængden af ammonium i blodet.
English: The CHMP concluded that Carbaglu was effective in reducing blood ammonia to normal levels and decided that Carbaglu's benefits are greater than its risks.
Danish: CHMP konkluderede, at Carbaglu var effektivt til at reducere ammoniumsniveauerne i blodet til normale niveauer, og besluttede, at fordelene ved Carbaglu opvejer risiciene.
English: Carbaglu should not be used in people who may be hypersensitive (allergic) to carglumic acid or any of the other ingredients.
Danish: Carbaglu bør ikke anvendes af personer, der kan være overfølsomme (allergiske) over for cargluminsyre eller et andre af indholdsstofferne.
English: What is the risk associated with Carbaglu?
Danish: Hvilken risiko er der forbundet med Carbaglu?
English: Patients with this lifelong disease lack a liver enzyme called NAGS, which normally helps to break down ammonia.
Danish: Patienter med denne kroniske sygdom mangler et leverenzym kaldet NAGS, som normalt er med til at nedbryde ammonium.
English: Carbaglu is very similar in structure to N-acetylglutamate, which activates an enzyme that breaks down ammonia.
Danish: Carbaglu har en struktur, der i høj grad ligner N-acetylglutamat, som aktiverer et enzym, der nedbryder ammonium.
English: For the full list of side effects reported with Carbaglu, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Carbaglu fremgår af indlægssedlen.
English: Carbaglu therefore helps break down ammonia, reducing ammonia blood levels and its toxic effects.
Danish: Carbaglu hjælper derfor med til at nedbryde ammonium, hvorved ammoniumniveauet i blodet og den giftige virkning reduceres.
English: Carbaglu is used for the treatment of hyperammonaemia (high blood levels of ammonia) in patients with the following metabolic diseases:
Danish: Carbaglu anvendes til behandling af hyperammonæmi (forhøjet ammoniumniveau i blodet) hos patienter med de følgende stofskiftesygdomme:
English: Carbaglu has also been studied in 57 patients (about two-thirds were newborn babies) with isovaleric acidaemia, methylmalonic acidaemia or propionic acidaemia who were treated with Carbaglu during hyperammonaemia crises.
Danish: Carbaglu blev desuden undersøgt hos 57 patienter (hvoraf cirka to tredjedele var nyfødte) med isovalerianeacidæmi, methylmalonacidæmi eller propionacidæmi, som blev behandlet med Carbaglu under kritiske tilfælde af hyperammonæmi.
English: In patients with isovaleric acidaemia, methylmalonic acidaemia or propionic acidaemia, Carbaglu also induced a decrease in ammonia levels in the blood, following an average of 5.5 days of treatment.
Danish: Hos patienter med isovalerianeacidæmi, methylmalonacidæmi eller propionacidæmi reducerede Carbaglu desuden mængden af ammonium i blodet efter en gennemsnitlig behandlingstid på 5,5 dage.
English: Carbaglu must not be used in women who are breastfeeding.
Danish: Carbaglu må ikke gives til ammende kvinder.
English: In patients with organic acidaemias, treatment is started when the patient has a hyperammonaemia crisis and continued until the crisis is finished.
Danish: Hos patienter med organisk acidæmi indledes behandlingen, når patienten oplever kritiske tilfælde af hyperammonæmi, og fortsættes, indtil tilfældene er ovre.
English: Why has Carbaglu been approved?
Danish: Hvorfor blev Carbaglu godkendt?
English: What is Carbaglu?
Danish: Hvad er Carbaglu?
English: ammonia cannot be broken down and it builds up in the blood;
Danish: Hvis enzymet ikke er til stede, kan ammonium ikke blive nedbrudt, og det hober sig op i blodet.
English: What is Carbaglu used for?
Danish: Hvad anvendes Carbaglu til?
English: How has Carbaglu been studied?
Danish: Hvordan blev Carbaglu undersøgt?
English: What benefit has Carbaglu shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Carbaglu?
English: • some organic acidaemias (isovaleric acidaemia, methylmalonic acidaemia and propionic acidaemia)
Danish: • Visse organiske acidæmier (isovalerianeacidæmi, methylmalonacidæmi og propionacidæmi), hvor patienterne mangler visse enzymer, som er involveret i proteinstofskiftet.
English: How is Carbaglu used?
Danish: Hvordan anvendes Carbaglu?
English: How does Carbaglu work?
Danish: Hvordan virker Carbaglu?
English: This summary was last updated in 01-2015.
Danish: Dette sammendrag blev sidst ajourført i 01-2015.
English: It is available as tablets (60 mg).
Danish: Det fås som tabletter (60 mg).
English: The full EPAR for Raloxifene Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Raloxifene Teva findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the EU for Raloxifene Teva on 29 April 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Raloxifene Teva den 29. april 2010.
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 Raloxifene Teva.
Danish: Det forklarer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Raloxifene Teva.
English: This is a summary of the European Public Assessment Report (EPAR) for Raloxifene Teva.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Raloxifene Teva.
English: For more information about treatment with Raloxifene Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Raloxifene Teva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This means that Raloxifene Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Evista.
Danish: Det betyder, at Raloxifene Teva er identisk med et ‘referencelægemiddel', der allerede er godkendt i Den Europæiske Union (EU), og som hedder Evista.
English: Therefore, the CHMP's view was that, as for Evista, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Evista.
English: The recommended dose of Raloxifene Teva is one tablet taken once a day.
Danish: Den anbefalede dosis Raloxifene Teva er én tablet én gang dagligt.
English: The CHMP concluded that, in accordance with EU requirements, Raloxifene Teva has been shown to have comparable quality and to be bioequivalent to Evista.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Raloxifene Teva er af sammenlignelig kvalitet og er bioækvivalent med Evista.
English: Raloxifene has the same effect as oestrogen in the bone, but it does not have an effect in the breast or the womb.
Danish: Raloxifene har samme effekt som østrogen i knoglerne, men det har ikke nogen effekt i bryst og livmoder.
English: Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down.
Danish: Osteoporose opstår, når der ikke dannes tilstrækkeligt knoglemasse til at erstatte den, som nedbrydes naturligt.
English: Other information about Raloxifene Teva
Danish: Andre oplysninger om Raloxifene Teva
English: Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall: oestrogen slows down bone breakdown and makes the bones less likely to fracture.
Danish: Osteoporose er mere almindelig hos kvinder efter overgangsalderen, når mængden af det kvindelige hormon østrogen falder: østrogen gør knoglenedbrydningen langsommere, hvilket bevirker, at det er mindre sandsynligt, at knoglerne brækker.
English: Patients may also receive calcium and vitamin D supplements if they do not get enough from their diet. Raloxifene Teva is intended for long-term use.
Danish: Patienterne kan også få calcium- og vitamin D-tilskud, hvis de ikke får tilstrækkeligt gennem deres kost.
English: The active substance in Raloxifene Teva, raloxifene, is a selective oestrogen receptor modulator (SERM).
Danish: Det aktive stof i Raloxifene Teva, Raloxifene, er en selektiv østrogen receptor modulator (SERM).
English: Gradually, the bones become thin and fragile, and more likely to break (fracture).
Danish: Knoglerne bliver gradvis tynde og skøre, og sandsynligheden for brud (fraktur) øges.
English: Raloxifene Teva is a ‘generic medicine'.
Danish: Raloxifene Teva er et ‘generisk lægemiddel'.
English: Raloxifene Teva is a medicine that contains the active substance raloxifene hydrochloride.
Danish: Raloxifene Teva er et lægemiddel, der indeholder det aktive stof raloxifenehydrochlorid.
English: Raloxifene Teva has been shown to significantly reduce vertebral fractures (breaks in the spine), but not hip fractures.
Danish: Det er påvist, at Raloxifene Teva i væsentlig grad begrænser forekomsten af vertebrale frakturer (brud på rygsøjlen), men ikke hoftefrakturer.
English: Raloxifene acts as an ‘agonist' of the oestrogen receptor (a substance that stimulates the receptor for oestrogen) in some tissues in the body.
Danish: Raloxifene virker som en østrogenreceptor “agonist” (et stof, som stimulerer østrogenreceptoren) i visse former for kropsvæv.
English: Raloxifene Teva raloxifene hydrochloride
Danish: Raloxifene Teva raloxifenehydrochlorid
English: Raloxifene Teva is used for the treatment and prevention of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause.
Danish: Raloxifene Teva anvendes til behandling og forebyggelse af osteoporose (en sygdom, der gør knoglerne skøre) hos kvinder, der er forbi overgangsalderen.
English: Because Raloxifene Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Raloxifene Teva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: What are the benefit and risk of Raloxifene Teva?
Danish: Hvilken fordel og risiko er der forbundet med Raloxifene Teva?
English: The Committee recommended that Raloxifene Teva be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Raloxifene Teva.
English: Because Raloxifene Teva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Evista.
Danish: Da Raloxifene Teva er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Evista.
English: Why has Raloxifene Teva been approved?
Danish: Hvorfor blev Raloxifene Teva godkendt?
English: What is Raloxifene Teva?
Danish: Hvad er Raloxifene Teva?
English: How has Raloxifene Teva been studied?
Danish: Hvordan blev Raloxifene Teva undersøgt?
English: What is Raloxifene Teva used for?
Danish: Hvad anvendes Raloxifene Teva til?
English: How is Raloxifene Teva used?
Danish: Hvordan anvendes Raloxifene Teva?
English: How does Raloxifene Teva work?
Danish: Hvordan virker Raloxifene Teva?
English: If more than 50 broachings are required, the use of a draw-off needle is recommended.
Danish: Hvis mere end 50 broachings er påkrævet, er brugen af en draw-off nål anbefales.
English: Povidone K30
Danish: Povidon K30
English: Avoid skin and eye contact with the product.
Danish: Undgå hud- og øjenkontakt med produktet.
English: Date of first authorisation: 10/02/2009 Date of last renewal: 23/01/2019
Danish: Dato for første markedsføringstilladelse: 10/02/2009 Dato for seneste fornyelse af markedsføringstilladelse: 23/01/2019
English: Commonly, a reduction in blood albumin concentration will occur during the period of treatment (up to 14 days).
Danish: Normalt vil der forekomme en reduktion i blodets albuminkoncentration i behandlingsperioden (op til 14 dage).
English: Acute mastitis.
Danish: Akut mastitis.
English: In this case do not use oral follow up treatment.
Danish: I dette tilfælde må oral opfølgningsbehandling ikke anvendes.
English: Avoid introduction of contamination during use.
Danish: Undgå at indføre kontamination under anvendelsen.
English: Dogs and cats.
Danish: Hunde og katte.
English: However, no data have been generated in horses.
Danish: Der er dog ikke genereret nogen data for heste.
English: Do not exceed 50 broachings per vial.
Danish: Må ikke overstige 50 broachings per hætteglas.
English: Please carefully follow the instructions of the veterinarian.
Danish: Følg omhyggeligt dyrlægens anvisninger.
English: The metabolism is qualitatively similar in rats, mini-pigs, humans, cattle and pigs although quantitatively there are differences.
Danish: Metabolismen er kvalitativt svarende til det, der ses hos rotter, minigrise, mennesker, kvæg og svin, selv om der kvantitativt er forskelle.
English: Dosage for each species:
Danish: Dosering til de enkelte arter:
English: When the product is used according to the recommended dosage regime the oral bioavailability is approximately 98%.
Danish: Når produktet benyttes i overensstemmelse med det anbefalede doseringsregime, er den orale biotilgængelighed cirka 98 %.
English: Treatment of calves with Loxicom 20 minutes before dehorning reduces post-operative pain.
Danish: Behandling af kalve med Loxicom 20 minutter før afhorning reducerer postoperativ smerte.
English: Loxicom alone will not provide adequate pain relief during the dehorning procedure.
Danish: Loxicom alene vil ikke give tilstrækkelig smertelindring under afhorning.
English: ATCvet code: QM01AC06
Danish: ATCvet-kode: QM01AC06
English: When anaesthesia and NSAID are concomitantly administered, a risk for renal function cannot be excluded.
Danish: Hvor anæstesi og NSAID administreres samtidigt kan en risiko for nyresvigt ikke udelukkes.
English: Dispose of in accordance with local requirements.
Danish: Bortskaffes i overensstemmelse med lokale krav.
English: Acute respiratory infection.
Danish: Akut respiratorisk infektion.
English: Non-infectious locomotor disorders.
Danish: Ikke-smitsomme lokomotoriske forstyrrelser.
English: Do not exceed the recommended dose or duration of treatment due to the possibility of severe adverse reactions.
Danish: Overskrid ikke den den anbefalede dosis eller behandlingsvarighed på grund af muligheden for alvorlige bivirkninger.
English: The major metabolites found in all species were the 5-hydroxyand 5-carboxy-metabolites and the oxalyl-metabolite.
Danish: De vigtigste metabolitter, der fandtes hos alle arter, var 5hydroxy- og 5-carboxy-metabolitter og oxalyl-metabolitten.
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation (see section 4.3).
Danish: Veterinærlægemidlets sikkerhed under drægtighed og laktation er ikke fastlagt (Se afsnit 4.3).
English: ADVICE ON CORRECT ADMINISTRATION
Danish: Råd om korrekt administration:
English: To be administered directly into the mouth over the back of the tongue keeping the animal's head raised until swallowed.
Danish: Indgives direkte i munden over den bageste ende af tungen, idet dyrets hoved holdes højt, til pastaen er sunket.
English: 1 syringe 7 syringes 14 syringes
Danish: 1 sprøjte 7 sprøjter 14 sprøjter
English: The accumulation factor of 1.08 suggests that meloxicam does not accumulate when administered daily.
Danish: Akkumulationsfaktoren på 1,08 tyder på, at meloxicam ikke akkumuleres ved daglig indgivelse.
English: A suitably graduated 1 ml syringe should be used for administration of the product to cats.
Danish: En 1 ml sprøjte med passende graduering bør anvendes til administration af produktet til katte.
English: Dose scheme for the maintenance dose:
Danish: Doseringsskema over vedligeholdelsesdosis:
English: See section 4.10.
Danish: Se afsnit 4.10.
English: Not all pack sizes may be marketed
Danish: Ikke alle pakningsstørrelser vil blive markedsført
English: 10 tablets 20 tablets 100 tablets 500 tablets
Danish: 10 tabletter 20 tabletter 100 tabletter 500 tabletter