FrancophonIA/ELRC3.0 huggingface dataset:
English: People who are hypersensitive (allergic) to NSAIDs should avoid contact with Melovem.
Danish: Personer, som er overfølsomme (allergiske) over for NSAID'er, skal undgå kontakt med Melovem.
English: It must not be used in animals which are hypersensitive (allergic) to the active substance or any of the other ingredients.
Danish: Det må ikke gives til dyr, der er overfølsomme (allergiske) over for det aktive stof eller andre af indholdsstofferne.
English: Therefore, the CVMP's view was that, as for Metacam, Melovem's benefits are greater than its risks for the approved indications and the Committee recommended that Melovem be given a marketing authorisation.
Danish: CVMP var derfor af den opfattelse, at fordelene ved Melovem ligesom Metacam er større end risiciene, når det anvendes til de godkendte indikationer, og udvalget anbefalede udstedelse af markedsføringstilladelse for Melovem.
English: If used for the treatment of diarrhoea in cattle, Melovem must not be used in animals of less than one week of age.
Danish: Hvis Melovem anvendes til behandling af diarré hos kvæg, må det ikke anvendes til dyr, der er under en uge gamle.
English: For meat the withdrawal period is five days.
Danish: Tilbageholdelsestiden er 5 dage for kød.
English: For meat the withdrawal period is 15 days and for milk it is five days.
Danish: Tilbageholdelsestiden er 15 dage for kød og 5 dage for mælk.
English: What is the risk associated with Melovem?
Danish: Hvilken risiko er der forbundet med Melovem?
English: Melovem contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Danish: Melovem indeholder meloxicam, som tilhører en lægemiddelgruppe, der kaldes ikke-steroide antiinflammatoriske lægemidler (NSAID'er).
English: Melovem is a medicine that contains the active substance meloxicam.
Danish: Melovem er et lægemiddel, der indeholder det aktive stof meloxicam.
English: In very rare cases, potentially serious or fatal anaphylactoid reactions (similar to severe allergic reactions) may occur following injection and should be treated symptomatically.
Danish: Der kan i meget sjældne tilfælde forekomme potentielt alvorlige eller dødelige anafylaktoide reaktioner (svarende til stærk overfølsomhed) efter indgivelsen, og disse skal behandles symptomatisk.
English: Why has Melovem been approved?
Danish: Hvorfor blev Melovem godkendt?
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption or eggs or milk used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter injektion af lægemidlet, før dyret kan slagtes, og kødet kan anvendes til menneskeligt konsum eller æg eller mælk kan anvendes til menneskeligt konsum.
English: A slight temporary swelling at the injection site following injection under the skin and in the muscle was observed in cattle and pigs.
Danish: Der blev observeret en let og forbigående hævelse på injektionsstedet efter injektion under huden og i musklerne hos kvæg og grise.
English: This means that Melovem is similar to a ‘reference veterinary medicine' containing the same active substance.
Danish: Det betyder, at Melovem er identisk med et ”referenceveterinærlægemiddel”, der indeholder det samme aktive stof.
English: The CVMP decided that, in accordance with European Union requirements, Melovem has been shown to be bioequivalent to Metacam.
Danish: CVMP vurderede, at det i overensstemmelse med EU-kravene er blevet påvist, at Melovem er bioækvivalent med Metacam.
English: It is available as a solution for injection (5 mg/ml, 20 mg/ml and 30 mg/ml).
Danish: Det fås som en opløsning til injektion (5 mg/ml, 20 mg/ml og 30 mg/ml).
English: As Melovem is considered to be bioequivalent to the reference medicine, its benefit is taken as being the same as that of the reference medicine.
Danish: Da Melovem anses for at være bioækvivalent med referencelægemidlet, anses fordelene ved Melovem for at være de samme som for referencelægemidlet.
English: Melovem is a ‘generic'.
Danish: Melovem er et ”generisk lægemiddel”.
English: Meloxicam acts by blocking an enzyme called cyclo-oxygenase which is involved in the production of prostaglandins.
Danish: Meloxicam virker ved at blokere et enzym kaldet cyklooxygenase, der medvirker ved dannelsen af prostaglandin.
English: Studies have been carried out, both in calves and in pigs, to show that Melovem is bioequivalent to the reference medicine, Metacam.
Danish: Der gennemført undersøgelser hos både kalve og svin for at dokumentere, at Melovem er bioækvivalent med referencelægemidlet Metacam.
English: What is Melovem?
Danish: Hvad er Melovem?
English: Melovem must not be used in animals with liver, heart or kidney problems, bleeding disorders, or suffering from irritation or ulcers of the digestive tract.
Danish: Melovem må ikke anvendes til dyr med lever-, hjerte- og nyreproblemer, blødningsforstyrrelser eller som lider af irritation eller sår i fordøjelseskanalen.
English: It can be used in combination with oral rehydration therapy (medicines given by mouth to restore water levels in the body) for diarrhoea in calves of over one week of age and young, non-lactating cattle.
Danish: Det kan anvendes ved diarré i kombination med oral tilførsel af vand (lægemidler, der indgives gennem munden for at genoprette væskebalancen i kroppen) hos kalve, der er mere end én uge gamle, og hos ungkvæg, som ikke er diegivende.
English: Melovem is used in cattle, together with appropriate antibiotic therapy, to reduce the signs of acute respiratory infections (infection of the lung and airways).
Danish: Melovem anvendes til kvæg i kombination med passende antibiotikabehandling til at mindske symptomerne ved akut respiratorisk infektion (infektion i lunger og luftveje).
English: What is Melovem used for?
Danish: Hvad anvendes Melovem til?
English: How has Melovem been studied?
Danish: Hvordan blev Melovem undersøgt?
English: Melovem solution for injection (5 mg/ml, 20 mg/ml and 30 mg/ml) is used in pigs to reduce the symptoms of lameness (inability to walk normally) and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move).
Danish: Melovem opløsning til injektion (5 mg/ml, 20 mg/ml og 30 mg/ml) anvendes til svin til at mindske symptomerne på halten (evnen til at gå normalt) og inflammation i forbindelse med ikkesmitsomme sygdomme i bevægeapparatet (sygdomme, som påvirker bevægelsesevnen).
English: The 20 mg/ml and 30 mg/ml solutions for injection are also used in combination with antibiotic therapy to treat acute mastitis (inflammation of the udder).
Danish: 20 mg/ml- og 30 mg/ml-opløsningerne til injektion anvendes også i kombination med antibiotikabehandling til behandling af akut mastitis (yverbetændelse).
English: While the reference medicine, Metacam, is available as 5 mg/ml and 20 mg/ml solutions for injection, Melovem is also available as a 30 mg/ml solution for injection.
Danish: Referencelægemidlet Metacam fås som en 5 mg/ml- og 20 mg/ml-opløsning til injektion, og Melovem fås desuden som en 30 mg/mlopløsning til injektion.
English: Melovem solution for injection (20 mg/ml) is used in horses to relieve colic (abdominal pain) and the inflammation and pain in musculo-skeletal disorders.
Danish: Melovem opløsning til injektion (20 mg/ml) anvendes til heste til at afhjælpe kolik (mavesmerter) og betændelse og smerter ved lidelser i bevægeapparatet.
English: The 20 mg/ml and 30 mg/ml solution for injection can be used together with appropriate antibiotic therapy for the treatment of diseases that occur after farrowing (giving birth) such as puerperal septicaemia (bacteria present in blood) and toxaemia (a toxic state) (mastitismetritis-agalactia syndrome).
Danish: 5 mg/ml, 20 mg/ml og 30 mg/ml-opløsningerne til injektion kan anvendes sammen med passende antibiotikabehandling til behandling af sygdomme, der opstår efter faring, såsom puerperal septikæmi (bakterier i blodet) og toksæmi (en forgiftningstilstand) (mastitismetritis-agalactia-syndrom).
English: What benefit has Melovem shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Melovem?
English: The 5 mg/ml solution for injection can be used for the relief of post-operative pain associated with minor soft tissue surgery such as castration (surgical removal of the testicles).
Danish: 5 mg/ml-opløsningen til injektion kan anvendes til lindring af smerter efter mindre bløddelskirurgi som f.eks. kastration
English: How does Melovem work?
Danish: Hvordan virker Melovem?
English: Number (%)
Danish: Antal (%)
English: The above are some reasons why this product may not be suitable for you.
Danish: De ovennævnte punkter er nogle af årsagerne til, at dette produkt måske ikke egner sig til dig.
English: if you are pregnant or could still become pregnant.
Danish: hvis du er gravid eller stadig kan blive gravid.
English: Date of latest renewal: 17 April 2014
Danish: Dato for seneste fornyelse: 17. april 2014
English: Date of first authorisation: 17 April 2009
Danish: Dato for første tilladelse: 17. april 2009
English: The raloxifene group was discontinued during the first 2-year extension.
Danish: Raloxifen-gruppen blev stoppet i løbet af den første 2-årige forlængelse.
English: It must not be taken by women who are pregnant or who could still have a baby.
Danish: Det må ikke tages af kvinder, der er gravide, eller som stadig kan få børn.
English: Relative risk reduction (95% CI)
Danish: Relativt fald i risiko (95 %-CI)
English: The clinical relevance of these changes has not been established.
Danish: Den kliniske betydning af disse ændringer er ikke blevet fastlagt.
English: This lipid profile was maintained throughout the 7 years of treatment.
Danish: Denne lipidprofil blev opretholdt under de 7 års behandling.
English: Its safety in premenopausal women has not been established, and its use is not recommended in this population.
Danish: Dets sikkerhed hos præmenopausale kvinder er ikke blevet fastslået, og det anbefales ikke at bruge det i denne population.
English: Absolute risk reduction
Danish: Absolut fald i risiko
English: Other sources of information
Danish: Andre informationskilde
English: If you get any of the problems listed under ‘Do not take CONBRIZA'
Danish: Hvis du får nogen af problemerne nævnt under ”Tag ikke CONBRIZA”
English: Speak with your doctor to see if you are at increased risk for blood clots.
Danish: Tal med din læge for at finde ud af, om du har en øget risiko for blodpropper.
English: Serious side effects - Stop taking CONBRIZA and see a doctor immediately
Danish: Alvorlige bivirkninger - stop med at tage CONBRIZA og kontakt lægen omgående.
English: It works by slowing or stopping the thinning of bone in these women.
Danish: Det virker ved at hæmme eller stoppe mindskningen af knogletætheden hos disse kvinder.
English: If you forget to take a tablet, take it as soon as you remember.
Danish: Hvis du har glemt at tage en tablet, skal du tage den så snart, du kommer i tanker om det.
English: In addition, women taking CONBRIZA should be advised to move about periodically during prolonged travel.
Danish: Derudover skal kvinder, der tager CONBRIZA, rådes til jævnligt at bevæge sig i forbindelse med langvarig rejse.
English: if you have active uterine cancer.
Danish: hvis du har aktiv livmoderkræft.
English: Do not take CONBRIZA
Danish: Tag ikke CONBRIZA
English: In the case of overdose, there is no specific antidote, and treatment should be symptomatic.
Danish: Der er ingen specifik antidot i tilfælde af overdosering, og behandlingen bør være symptomatisk.
English: While very infrequent, these clots can cause serious medical problems, disability or death.
Danish: Selvom disse blodpropper ikke forekommer særligt hyppigt, kan de medføre alvorlige medicinske problemer, invaliditet eller død.
English: The safety data in the following table are derived from both clinical trials and spontaneous post-marketing reporting.
Danish: Sikkerhedsdata i den følgende tabel stammer fra både kliniske studier samt spontan indberetning efter markedsføringen.
English: However, if it is almost time to take your next dose of this medicine, skip the dose you missed and only take your next scheduled dose.
Danish: Hvis det imidlertid næsten er tid til din næste dosis af dette lægemiddel, skal du springe den dosis over, som du glemte at tage, og tage din næste planlagte dosis.
English: This increase was most likely attributed to age-related changes in hepatic function.
Danish: Denne stigning kunne mest sandsynligt henføres til aldersrelaterede ændringer i leverfunktionen.
English: The concentrations of this glucuronide are approximately 10-fold higher than those of unchanged active substance in plasma.
Danish: Koncentrationerne af dette glukuronid er ca. 10 gange højere end koncentrationerne af det uomdannede aktive stof i plasma.
English: This medicine may cause harm to your unborn child if taken during pregnancy.
Danish: Denne medicin kan skade dit ufødte barn, hvis det tages undergraviditeten.
English: Effects on the uterus
Danish: Virkning på uterus
English: if you are allergic to bazedoxifene or any of the other ingredients of this medicine (listed in section 6).
Danish: hvis du er allergisk over for bazedoxifen eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Cl/F (l/h/kg)
Danish: Cl/F (l/t/kg)
English: If you need to remain immobile for an extended period of time or are scheduled to have surgery, it is important for you to talk to your doctor about ways you can reduce the risk of blood clots.
Danish: Hvis du er nødt til at sidde eller ligge stille i længere tid eller venter på en planlagt operation, er det vigtigt, at du taler med lægen om, hvordan du kan mindske risikoen for blodpropper.
English: Therefore, bazedoxifene is not recommended for treatment or prevention of breast cancer.
Danish: Bazedoxifen anbefales derfor ikke til behandling eller forebyggelse af brystcancer.
English: Some patients have experienced the following side effects while taking CONBRIZA:
Danish: Visse patienter oplever følgende bivirkninger, når de tager CONBRIZA
English: Because these changes are not considered clinically relevant, bazedoxifene can be administered without regard to meals.
Danish: Da disse ændringer ikke betragtes som klinisk relevante, kan bazedoxifen administreres uden hensyntagen til måltider.
English: Adverse reactions are categorized according to the following frequencies: 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); not known (cannot be estimated from the available data).
Danish: Bivirkningerne er opstillet ud fra følgende 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), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Doses higher than 20 mg are not recommended because there is no demonstrable increased efficacy and higher doses may be associated with additional risk (see section 5.1).
Danish: Doser højere end 20 mg anbefales ikke, da der ikke er nogen påviseligt øget effekt, og da højere doser kan være forbundet med øget risiko (se pkt.
English: Hypromellose Titanium dioxide (E171) Macrogol 400
Danish: Filmovertræk: Hypromellose Titandioxid (E171) Macrogol 400
English: There is no evidence of endometrial proliferation.
Danish: Der er ikke påvist nogen endometrieproliferation.
English: Steady-state concentrations are achieved by the second week of once-daily administration.
Danish: Steady state-koncentrationer opnås i den anden uge ved administration én gang dagligt.
English: Any uterine bleeding during CONBRIZA therapy is unexpected and should be fully investigated.
Danish: Enhver uterin blødning under behandling med CONBRIZA er uventet og bør undersøges grundigt.
English: Race No pharmacokinetic differences based on ethnic group were observed.
Danish: Race Der blev ikke observeret nogen farmakokinetiske forskelle på baggrund af etnisk gruppe.
English: Multiple dose 20 mg/day 6.2 ± 2.2 1.7 ± 1.8 28 ± 11 82 ± 37 4.1 ± 1.7
Danish: Multiple doser 20 mg/dag 6,2 ± 2,2 1,7 ± 1,8 28 ± 11 82 ± 37 4,1 ± 1,7
English: Not known (frequency cannot be estimated from the available data):
Danish: Ikke kendt hyppighed (kan ikke estimeres ud fra forhåndenværende data):
English: No foetal developmental anomalies were observed.
Danish: Der blev ikke observeret nogen anomalier i fosterudvikling.
English: The safety of CONBRIZA in patients with breast cancer has not been studied.
Danish: Sikkerheden ved CONBRIZA for patienter med brystcancer er ikke blevet undersøgt.
English: You can take the tablet at any time of the day, with or without food.
Danish: Du kan tage tabletten på et hvilket som helst tidspunkt af dagen i forbindelse med et måltid eller mellem måltider.
English: This medicine contains lactose (a type of sugar).
Danish: Denne medicin indeholder lactose, der er en sukkerart.
English: tmax (h)
Danish: tmax (t)
English: Bazedoxifene 20 mg
Danish: Bazedoxifen 20 mg
English: If you are traveling on long trips, you should walk around or exercise your legs and feet at regular intervals.
Danish: Hvis du er på længerevarende rejser, bør du rejse dig og gå omkring eller bruge dine ben og fødder regelmæssigt.
English: This pharmacological effect of bazedoxifene can also be expected in pre-menopausal women, but is considered clinically irrelevant in post-menopausal women.
Danish: Denne farmakologiske virkning ved bazedoxifen kan også forventes hos præmenopausale kvinder, men den betragtes som klinisk irrelevant hos postmenopausale kvinder.
English: Manufacturer: PfizerIrelandPharmaceuticals, Little Connell,Newbridge, County Kildare, Ireland.
Danish: Fremstiller: Pfizer Ireland Pharmaceuticals, Little Connell Newbridge, County Kildare, Irland.
English: You may notice problems with your eyesight such as blurred vision while taking this medicine.
Danish: Du kan muligvis opleve problemer med dit syn, f.eks.sløret syn, mens du tager dette lægemiddel.
English: The underlying nature of these events is uncertain.
Danish: Den underliggende årsag til disse bivirkninger er usikker.
English: It is not known whether bazedoxifene is excreted in human milk.
Danish: Det vides ikke, om bazedoxifen udskilles i human mælk.
English: Do not take this medicine if you are breast-feeding, because it is not known whether it is excreted in mother's milk.
Danish: Tag ikke dette lægemiddel, hvis du ammer, da det ikke vides, om det udskilles i modermælken.
English: In clinical trials, somnolence was reported as an adverse reaction, and patients should be advised on the potential effect on driving and using machines.
Danish: I kliniske forsøg blev søvnighed dog rapporteret som en bivirkning, og patienterne skal informeres om den mulige virkning på evnen til at føre motorkøretøj og betjene maskiner.
English: EU/1/09/511/001 28 tablets EU/1/09/511/002 30 tablets EU/1/09/511/003 84 tablets EU/1/09/511/004 90 tablets EU/1/09/511/005 7 tablets
Danish: EU/1/09/511/001 28 tabletter EU/1/09/511/002 30 tabletter EU/1/09/511/003 84 tabletter EU/1/09/511/004 90 tabletter EU/1/09/511/005 7 tabletter
English: 7 film-coated tablets 28 film-coated tablets 30 film-coated tablets 84 film-coated tablets 90 film-coated tablets
Danish: 7 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter 84 filmovertrukne tabletter 90 filmovertrukne tabletter
English: If such symptoms occur, patients should avoid driving or use of machines that requires accurate visual perception until symptoms have resolved, or until they have received medical advice that it is safe to do so.
Danish: Hvis sådanne symptomer forekommer, skal patienterne informeres om ikke at føre motorkøretøj eller betjene maskiner, som kræver præcis visuel perception, før symptomerne er forsvundet, eller før de har talt med en læge om, at det er sikkert at gøre det.
English: If you take supplemental calcium and/or vitamin D, it may be taken at the same time as this medicine.
Danish: Hvis du tager supplerende calcium og/eller D-vitamin, kan det tages samtidig med dette lægemiddel.
English: The rate of VTE was highest in the first year with a relative risk of 2.69.
Danish: VTE-raten var højest i det første år med en relativ risiko på 2,69.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Patienter med sjælden arvelig galaktoseintolerans, Lapp-laktase-mangel eller glukose-galaktose-malabsorption bør ikke behandles med dette lægemiddel.
English: In long-term studies renal tumours (adenomas and carcinomas) were observed at all doses tested, most likely as a consequence of this chronic renal damage.
Danish: I langtidsundersøgelser blev der observeret nyretumorer (adenomer og carcinomer) ved alle de afprøvede doser, hvilket mest sandsynligt er en konsekvens af denne kroniske beskadigelse af nyrerne.
English: Total number of subjects n=1,724 n=1,741
Danish: Antal forsøgsdeltagere i alt n = 1.724 n = 1.741
English: CONBRIZA should be discontinued prior to and during prolonged immobilisation (e.g., post-surgical recovery, prolonged bed rest), and therapy should be resumed only after the patient is fully ambulatory.
Danish: CONBRIZA bør afbrydes før og under langvarig immobilisering (f.eks. postoperativ restitution og langvarigt sengeleje), og den bør først genoptages, når patienten er fuldt mobiliseret.
English: Other venous thromboembolic events could also occur.
Danish: Andre tromboemboliske hændelser forekom også.
English: AUC (ngh/ml)
Danish: AUC (ngt/ml)
English: This medicine should not be used for the treatment of osteoporosis in men.
Danish: Dette lægemiddel bør ikke anvendes til behandling af knogleskørhed hos mænd.
English: If you decide to stop taking this medicine before finishing the prescribed course of treatment, you should talk to your doctor first.
Danish: Hvis du beslutter dig til at holde op med at tage dette lægemiddel før planlagt afslutning, skal du først tale med din læge herom.
English: Supplemental calcium and/or vitamin D should be added to the diet if daily intake is inadequate.
Danish: Der bør tages supplerende calcium og/eller vitamin D, hvis den daglige indtagelse er utilstrækkelig.
English: Bazedoxifene does not induce or inhibit the activities of major CYP isoenzymes.
Danish: Bazedoxifen hverken inducerer eller hæmmer aktiviteten i de vigtigste CYP-isoenzymer.
English: These tumours are considered as spontaneous renal cell carcinomas that are known to occur in nonhuman primates and are unlikely to be relevant to humans.
Danish: Disse tumorer menes at være spontane nyrecellecancere, som er kendt for at forekomme hos ikke-humane primater og er sandsynligvis ikke relevante for mennesker.
English: if you have or have had a blood clot (for example, in the blood vessels in your legs, lungs, or eyes).
Danish: hvis du har eller har haft en blodprop (for eksempel i blodkarrene i dine ben, lunger eller øjne).
English: The 3-year core study was extended twice, with two 2-year double-blind, placebocontrolled extensions, resulting in a total treatment duration of up to 7 years (7-year study).
Danish: Det 3-årige hovedforsøg blev forlænget to gange med to 2-års dobbeltblind, placebo-kontrollerede forlængelser, hvilket gav en samlet behandlingevarighed på op til 7 år (7-årigtforsøg).
English: if you are suffering from breast cancer, as there is insufficient experience with this medicine use in women with this disease.
Danish: Tal med med lægen om det. hvis du har brystkræft, da der ikke er tilstrækkelig erfaring med brug af denne medicin til kvinder med denne sygdom.
English: Talk to your doctor or pharmacist before taking CONBRIZA
Danish: Kontakt lægen eller apoteket, før du tager CONBRIZA
English: Bazedoxifene is highly bound (98% - 99%) to plasma proteins in vitro.
Danish: Bazedoxifen har en høj plasmaproteinbinding (98 % - 99 %) in vitro.