FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Zeleris (which may affect more than 1 in 10 animals) are reactions at the injection site (mostly swelling, hardness, heat and pain) after injection under the skin.
Danish: De hyppigste bivirkninger ved Zeleris (som kan optræde hos mere end 1 ud af 10 dyr) er reaktioner på injektionsstedet (hovedsagelig hævelse, hårdhed, varme og smerter) efter injektion under huden.
English: What is Zeleris and what is it used for?
Danish: Hvad er Zeleris, og hvad anvendes det til?
English: People who are hypersensitive (allergic) to florfenicol, meloxicam or any of the other ingredients of the medicine should avoid contact with Zeleris.
Danish: Personer, der er hypersensitive (allergiske) over for florfenicol, meloxicam eller andre af indholdsstofferne i lægemidlet, bør undgå kontakt med Zeleris.
English: Other information about Zeleris:
Danish: Andre oplysninger om Zeleris
English: Why is Zeleris approved?
Danish: Hvorfor er Zeleris blevet godkendt?
English: Meloxicam belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Danish: Meloxicam tilhører gruppen af nonsteroide antiinflammatoriske lægemidler (NSAID).
English: Zeleris contains the active substances florfenicol and meloxicam.
Danish: Zeleris indeholder de aktive stoffer florfenicol og meloxicam.
English: In a field study 329 calves with bovine respiratory disease and a body temperature of 40˚C or higher were treated either with Zeleris or florfenicol alone.
Danish: I en feltundersøgelse blev 329 kalve med luftvejsinfektion og en kropstemperatur på 40 ˚C eller derover behandlet med enten Zeleris eller florfenicol alene.
English: It is not intended to provide practical advice on how to use Zeleris.
Danish: Det er ikke en praktisk vejledning i, hvordan Zeleris bør anvendes.
English: The medicine is not authorised for use in cows producing milk for human consumption.
Danish: Lægemidlet må ikke anvendes til køer, der producerer mælk til menneskeligt konsum.
English: Florfenicol is a broad-spectrum antibiotic which stops bacteria from growing by blocking the activity of ribosomes, the part of the bacterial cells where proteins are produced.
Danish: Florfenicol er et bredspektret antibiotikum, der standser bakteriers vækst ved at blokere aktiviteten af ribosomerne, dvs. den del af bakteriecellen, der danner proteiner.
English: Zeleris is a veterinary medicine used to treat cattle with bovine respiratory disease (BRD, a condition affecting the lungs) associated with a high temperature, which is due to the bacteria Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Danish: Zeleris er et veterinærlægemiddel, som anvendes hos kvæg til behandling af luftvejsinfektioner, der angriber lungerne, er forbundet med høj temperatur og forårsages af bakterierne Mannheimia haemolytica, Pasteurella multocida og Histophilus somni.
English: What are the risks associated with Zeleris?
Danish: Hvilke risici er der forbundet med Zeleris?
English: It should also not be used in pregnant cows which are intended to produce milk for human consumption within two months of calving.
Danish: Det må heller ikke anvendes til drægtige køer, der er bestemt til at producere mælk til menneskeligt konsum, senere end 2 måneder inden kælvning.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Zeleris, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Zeleris, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret.
English: The European Commission granted a marketing authorisation valid throughout the EU for Zeleris on 15 May 2017.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for Zeleris den
English: Zeleris must not be given to bulls intended for breeding nor to animals with impaired liver, heart or kidney function, bleeding disorders or with gut ulceration.
Danish: Zeleris må ikke anvendes til avlstyre eller dyr med nedsat lever-, hjerte- eller nyrefunktion, blødningsforstyrrelser eller tarmsår.
English: How is Zeleris used?
Danish: Hvordan anvendes Zeleris?
English: What benefits of Zeleris have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Zeleris?
English: The medicine can only be obtained with a prescription and is available as a solution for injection.
Danish: Lægemidlet udleveres kun efter recept og fås som injektionsvæske, opløsning.
English: As prostaglandins are substances that trigger inflammation, pain, exudation (fluid that leaks out of blood vessels during an inflammation) and fever, meloxicam reduces these signs of disease.
Danish: Prostaglandiner er stoffer, der udløser inflammation, smerter og væskeudskillelse (ekssudation) fra blodkarrene under inflammation og feber.
English: For more information about treatment with Zeleris, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Zeleris, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: How does Zeleris work?
Danish: Hvordan virker Zeleris?
English: For practical information about using Zeleris, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Zeleris, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: Animal studies are insufficient.
Danish: Dyrestudier er utilstrækkelige.
English: After a single dose of
Danish: Efter en enkelt dosis
English: You do not need to take any action if this happens.
Danish: Du behøver ikke at gøre noget, hvis det sker.
English: PC: {number} {product code}
Danish: PC: {nummer} [produktkode]
English: Avoid taking alcohol until you have talked to your doctor.
Danish: Undgå at drikke alkohol før du har talt med din læge.
English: Some side effects can be serious and need immediate medical attention:
Danish: Nogle bivirkninger kan være alvorlige og kræver omgående lægehjælp:
English: NN: {number} {national reimbursement number or other national number identifying the medicinal product}
Danish: NN: {nummer} [nationalt refusionsnummer eller andet nationalt nummer, der identificerer lægemidlet]
English: Elimination Telmisartan: Following either intravenous or oral administration of
Danish: Elimination Telmisartan: Efter enten intravenøs eller oral administration af
English: SN: {number} {serial number}
Danish: SN: {nummer} [serienummer]
English: The recommended dose is one tablet a day.
Danish: Den anbefalede dosis er én tablet daglig.
English: Aluminium/aluminium blisters (PA/Al/PVC/Al or PA/PA/Al/PVC/Al).
Danish: Aluminium/aluminium blister (PA/Al/PVC/Al eller PA/PA/Al/PVC/Al).
English: In addition, an updated RMP should be submitted:
Danish: En opdateret RMP skal desuden fremsendes:
English: If these effects are not treated they could be fatal.
Danish: Hvis disse bivirkninger ikke bliver behandlet kan de være dødelige.
English: About 60 % of the oral dose is eliminated within 48 hours.
Danish: Ca. 60% af den orale dosis udskilles i løbet af 48 timer.
English: There is limited experience with hydrochlorothiazide during pregnancy, especially during the first trimester.
Danish: Der er begrænset erfaring med hydrochlorthiazid under graviditet, specielt i første trimester.
English: This is not considered to be of clinical relevance.
Danish: Dette anses ikke for at have klinisk relevans.
English: Only minute amounts were found in urine.
Danish: Kun ubetydelige mængder blev fundet i urinen.
English: Therefore, it is not expected to potentiate bradykininmediated adverse effects.
Danish: Derfor forventes det ikke, at bradykininmedierede bivirkninger potenseres.
English: There is limited information available for telmisartan with regard to overdose in humans.
Danish: Der er begrænset information for telmisartan i forbindelse med overdosis hos mennesker.
English: It is important that you take Kinzalkomb every day until your doctor tells you otherwise.
Danish: Det er vigtigt, at du tager Kinzalkomb hver dag, så længe din læge ikke siger andet.
English: Medicines to increase blood pressure, such as noradrenaline.
Danish: - Medicin til at øge blodtrykket, såsom noradrenalin.
English: You can take Kinzalkomb with or without food.
Danish: Du kan tage Kinzalkomb med eller uden mad.
English: See also information under the heading “Do not take Kinzalkomb”.
Danish: Se også information under overskriften ”Tag ikke Kinzalkomb”
English: The most common signs and symptoms of overdose are nausea and somnolence.
Danish: De hyppigst forekommende tegn og symptomer på overdosis er kvalme og somnolens.
English: You should see your doctor immediately if you experience any of the following symptoms:
Danish: Du skal straks kontakte din læge, hvis du får nogle af følgende symptomer:
English: Do not take a double dose to make up for forgotten individual doses.
Danish: Du må ikke tage en dobbeltdosis som erstatning for de glemte tabletter.
English: - Systemic lupus erythematosus (also called “lupus” or “SLE”) a disease where the body's immune system attacks the body.
Danish: • Bindevævssygdommen systemisk lupus erythematosus (også kaldet lupus eller SLE), en sygdom, hvor kroppens immunsystem angriber kroppen.
English: Individual dose titration with each of the two components is recommended before changing to the fixed dose combination.
Danish: Individuel dosistitrering med hver af de to komponenter anbefales, før der skiftes til den faste dosiskombination.
English: Amantadine (medicine used to treat Parkinson's disease and also used to treat or prevent certain illnesses caused by viruses).
Danish: - Amantadin (medicin til behandling af Parkinsons sygdom, som også bruges til at behandle eller forebygge visse sygdomme forårsaget af virus).
English: Metabolic and endocrine effects
Danish: Metaboliske og endokrine virkninger
English: The toxicological findings observed appear to have no relevance to human therapeutic use.
Danish: De observerede toksikologiske fund synes ikke at have nogen relevans for terapeutisk anvendelse til mennesker.
English: Calcium supplements and/or vitamin D supplements.
Danish: - Kalktilskud og/eller D-vitamintilskud.
English: Side effects of unknown frequency (frequency cannot be estimated from the available data):
Danish: Bivirkninger med ukendt hyppighed (hyppigheden kan ikke bestemmes ud fra de kendte data):
English: - If you have had skin cancer or if you develop an unexpected skin lesion during the treatment.
Danish: • Hvis du har haft hudkræft, eller hvis du udvikler en uventet hudlæsion under behandlingen.
English: Diabetes mellitus inadequate control
Danish: Utilstrækkelig diabetes mellitus kontrol
English: Chloride deficit is generally mild and usually does not require treatment.
Danish: Kloridmangelsymptomer er sædvanligvis milde og kræver normalt ingen behandling.
English: C-labelled telmisartan the glucuronide represents approximately 11 % of the measured radioactivity in plasma.
Danish: C-mærket telmisartan repræsenterer glucuronid ca. 11% af den målte radioaktivitet i plasma.
English: • if you have severe kidney disease.
Danish: • hvis du har alvorlig nyresygdom
English: Alcohol may make your blood pressure fall more and/or increase the risk of you becoming dizzy or feeling faint.
Danish: Alkohol kan få dit blodtryk til at falde yderligere og/eller øge risikoen for at du bliver svimmel eller føler dig mat.
English: Lithium containing medicines to treat some types of depression.
Danish: - Medicin, der indeholder lithium til behandling af visse typer af depression.
English: Telmisartan is highly bound to plasma proteins (>99.5 %) mainly albumin and alpha l- acid glycoprotein.
Danish: Telmisartan er i høj grad bundet til plasmaproteiner (>99,5%), hovedsagelig albumin og alfa-I-syre glycoprotein.
English: Renal excretion does not contribute to the clearance of telmisartan.
Danish: Renal udskillelse bidrager ikke til clearance af telmisartan.
English: If a readministration of the diuretic is deemed necessary, it is recommended to protect exposed areas to the sun or to artificial UVA.
Danish: Hvis fornyet indgift af diuretika er nødvendig anbefales det, at beskytte eksponerede områder mod solen og mod kunstig UVA.
English: Microcrystalline cellulose Povidone (K25)
Danish: Mikrokrystallinsk cellulose Povidon (K25)
English: The apparent volume of distribution for telmisartan is approximately 500 litres indicating additional tissue binding.
Danish: Det tilsyneladende fordelingsvolumen for telmisartan er ca. 500 l, hvilket tyder på ekstra vævsbinding.
English: 1: Based on post-marketing experience 2: For further description, please see sub-section “Description of selected adverse reactions”
Danish: 1: Baseret på erfaringer efter markedsføringen 2: For yderligere beskrivelse, se underpunktet ”Beskrivelse af udvalgte bivirkninger”
English: Hydrochlorothiazide should not be used for essential hypertension in pregnant women except in rare situations where no other treatment could be used.
Danish: Hydrochlorthiazid bør ikke anvendes til essentiel hypertension hos gravide kvinder med undtagelse af sjældne tilfælde, hvor ingen anden behandling kan anvendes.
English: Plasma concentrations of telmisartan are generally 2 - 3 times higher in females than in males.
Danish: Telmisartans plasmakoncentration er generelt 2-3 gange højere hos kvinder end hos mænd.
English: Triglycerides increased
Danish: Forhøjede triglycerider
English: However, the extensive human experience with hydrochlorothiazide has failed to show an association between its use and an increase in neoplasms.
Danish: Den omfattende humane erfaring med hydrochlorthiazid har imidlertid ikke vist nogen forbindelse mellem anvendelsen af stoffet og en stigning i forekomsten af neoplasmer.
English: The mechanism of the antihypertensive effect of thiazide diuretics is not fully known.
Danish: Mekanismen bag thiaziddiuretikas antihypertensive effekt kendes ikke fuldstændigt.
English: Serious angioedema may occur rarely (≥1/10,000 to <1/1,000).
Danish: Alvorligt angioødem kan forekomme i sjældne tilfælde (≥1/10.000 til <1/1.000).
English: C-labelled telmisartan most of the administered dose (>97 %) was eliminated in faeces via biliary excretion.
Danish: C-mærket telmisartan blev størstedelen af den indgivne dosis (> 97%) udskilt i fæces via biliær ekskretion.
English: The maximum reduction in blood pressure is generally attained 4-8 weeks after the start of treatment and is sustained during long-term therapy.
Danish: Den maksimale reduktion i blodtrykket opnås generelt 4-8 uger, efter behandlingen er påbegyndt og fastholdes gennem langtidsbehandling.
English: There was a trend towards higher plasma concentrations of hydrochlorothiazide in female than in male subjects.
Danish: Der er en tendens mod højere plasmakoncentrationer af hydrochlorthiazid hos kvinder end hos mænd.
English: The effect of pressor amines may be decreased.
Danish: Virkningen af pressor-aminer kan være forringet.
English: If Kinzalkomb is used during breast feeding, doses should be kept as low as possible.
Danish: Hvis Kinzalkomb anvendes under amning, skal dosis holdes så lav som muligt.
English: Gastric lesions could be prevented/ameliorated by oral saline supplementation and group housing of animals.
Danish: Gastriske læsioner kunne forhindres/afhjælpes ved oral salttilførsel og gruppevis opstaldning af dyrene.
English: These findings are considered to be due to the pharmacological activity of telmisartan.
Danish: Disse fund skønnes at være forårsaget af telmisartans farmakologiske aktivitet.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 April 2002
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 19. april 2002 Dato for seneste fornyelse: 23. april 2007
English: Epidemiological studies have shown that long-term treatment with hydrochlorothiazide reduces the risk of cardiovascular mortality and morbidity.
Danish: Epidemiologiske forsøg har vist, at langtidsbehandling med hydrochlorthiazid reducerer risikoen for kardiovaskulær mortalitet og morbiditet.
English: Try to take the tablet at the same time each day.
Danish: Det er bedst at indtage tabletten på samme tid hver dag.
English: Studies with hydrochlorothiazide have shown equivocal evidence for a genotoxic or carcinogenic effect in some experimental models.
Danish: Forsøg med hydrochlorthiazid har vist tvetydige tegn på en genotoksisk eller karcinogen effekt i nogle eksperimentelle modeller.
English: Increased incidence of sepsis has been observed with telmisartan only, however can not be ruled out for Kinzalkomb.
Danish: En øget forekomst af sepsis er kun set med telmisartan, men kan ikke udelukkes for Kinzalkomb.
English: The glucuronide of the parent compound is the only metabolite that has been identified in humans.
Danish: Glucuroniden af det oprindelige stof er den eneste metabolit, der er set hos mennesker.
English: Exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazide diuretics, including hydrochlorothiazide.
Danish: Forværring eller aktivering af systemisk lupus erythematosus er rapporteret ved anvendelsen af thiaziddiuretika, herunder hydrochlorthiazid.
English: Based on cumulative renal excretion of hydrochlorothiazide the absolute bioavailability was about 60 %.
Danish: Baseret på den kumulative nyreudskillelse af hydrochlorthiazid var den absolutte biotilgængelighed ca. 60%.
English: No dosage adjustment is necessary.
Danish: Det er ikke nødvendigt med dosisjustering.
English: Adverse reactions have been ranked under headings of frequency using the following convention: 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); very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Bivirkningerne er opdelt efter organklasse og opført efter hyppighed ud fra følgende konvention: 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); meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: (See section 5.3).
Danish: (angivet i punkt 6).
English: The combination of these ingredients has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.
Danish: Kombinationen af disse stoffer har en additiv antihypertensiv virkning, og reducerer blodtrykket i højere grad end de enkelte lægemidler hver for sig.
English: Hydrochlorothiazide is excreted almost entirely as unchanged substance in urine.
Danish: Hydrochlorthiazid udskilles næsten fuldstændigt uforandret i urinen.
English: Protect your skin from sun exposure and UV rays while taking Kinzalkomb.
Danish: Beskyt huden mod sollys og UVstråler, mens du tager Kinzalkomb.
English: With hydrochlorothiazide, onset of diuresis occurs in 2 hours, and peak effect occurs at about 4 hours, while the action persists for approximately 6-12 hours.
Danish: Med hydrochlorthiazid starter diuresen i løbet af 2 timer, og den maksimale effekt ses efter ca. 4 timer, mens virkningen varer ved i ca. 6-12 timer.
English: Thiazides in high doses causing intense diuresis can inhibit the milk production.
Danish: Thiazider i høje doser, der medfører voldsomme diureser, kan hæmme mælkeproduktionen.
English: The absolute bioavailability of telmisartan at 40 mg and 160 mg was 42 % and 58 %, respectively.
Danish: Den absolutte biotilgængelighed for telmisartan for 40 mg og 160 mg var hhv. 42% og 58%.
English: Increase in dosage of probenecid or sulfinpyrazone may be necessary.
Danish: Øgning af probenecid- eller sulfinpyrazondosis kan være nødvendig.
English: Muscle relaxing medicines, such as tubocurarine.
Danish: - Muskelafslappende medicin, såsom tubocurarin.
English: Pharmacotherapeutic group: Angiotensin II antagonists and diuretics, ATC code: C09DA07
Danish: Farmakoterapeutisk klassifikation: Angiotensin II-antagonister og diuretika: ATC-kode: C09DA07
English: • if you are allergic to hydrochlorothiazide or to any other sulfonamide-derived medicines.
Danish: • hvis du er allergisk over for hydrochlorthiazid eller et andet sulfonamidholdigt lægemiddel.
English: Medicinal products affected by serum potassium disturbances
Danish: Lægemidler, som påvirkes af serumkaliumforstyrrelser
English: - Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals).
Danish: • Forhøjet aldosteronniveau (vand og salt ophobning i kroppen og ubalance i blodets indhold af mineraler)
English: Periodic monitoring of renal function is advised (see section 4.4).
Danish: Periodisk monitorering af nyrefunktionen tilrådes (se pkt.
English: (It is also better to avoid Kinzalkomb in early pregnancy - see pregnancy section.)
Danish: (Du skal desuden helst undgå at bruge Kinzalkomb tidligt i graviditeten - se afsnittet om Graviditet)
English: Most cases of hepatic function abnormal / liver disorder from post-marketing experience with telmisartan occurred in Japanese patients.
Danish: De fleste tilfælde af unormal leverfunktion/leversygdom fra post marketing erfaring for telmisartan, forekom hos japanske patienter.
English: Cholestyramine and colestipol, medicines for lowering blood fat levels.
Danish: - Colestyramin og colestipol, medicin til at sænke blodets fedtindhold.
English: Telmisartan does not accumulate significantly in plasma on repeated administration.
Danish: Telmisartan akkumuleres ikke signifikant i plasma ved gentagen indgift.
English: In clinical trials however, no significant increases in blood pressure response or in the incidence of orthostatic hypotension were found in women.
Danish: I kliniske forsøg fandtes der imidlertid ikke signifikant større blodtryksrespons eller forekomst af ortostatisk hypotension hos kvinder.
English: Telmisartan showed no evidence of mutagenicity and relevant clastogenic activity in in vitro studies and no evidence of carcinogenicity in rats and mice.
Danish: Telmisartan viste intet tegn på mutagenicitet og relevant klastogen aktivitet ved in vitro-forsøg, og ingen tegn på karcinogenicitet i rotter og mus.
English: Activated charcoal may be useful in the treatment of overdose.
Danish: Aktivt kul kan ofte med fordel anvendes ved behandlingen af overdosis.
English: Medicines for the treatment of diabetes (insulins or oral agents such as metformin).
Danish: - Medicin til behandling af diabetes (insulin eller orale lægemidler såsom metformin).
English: The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible.
Danish: Den primære behandling er hurtigst mulig seponering af hydrochlorthiazid.
English: The following adverse reactions listed below have been accumulated from all clinical trials in patients treated with telmisartan for hypertension or in patients 50 years or older at high risk of cardiovascular events.
Danish: Følgende bivirkninger er samlet fra alle kliniske forsøg med patienter behandlet med telmisartan for hypertension eller med patienter på 50 år eller ældre med høj risiko for kardiovaskulære hændelser.
English: Telmisartan may increase the hypotensive effect of other antihypertensive agents.
Danish: Telmisartan kan øge den hypotensive virkning af andre antihypertensiva.
English: Some people feel dizzy or tired when taking Kinzalkomb.
Danish: Man kan føle sig svimmel eller blive træt, når man tager Kinzalkomb.
English: The antihypertensive effect persists constantly over 24 hours after dosing and includes the last 4 hours before the next dose as shown by ambulatory blood pressure measurements.
Danish: Den antihypertensive effekt holder sig konstant i 24 timer efter dosering, hvilket også gælder de sidste 4 timer forud for næste dosis som påvist ved døgnblodtryksmåling.