FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Versican Plus DHPPi/L4 exceed the risks for the approved indications and recommended that Versican Plus DHPPi/L4 be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved DHPPi/L4 overstiger risiciene til de godkendte anvendelser, og anbefalede udstedelse af markedsføringstilladelse for Versican Plus DHPPi/L4.
English: The dogs were either vaccinated twice with a three to four week interval or they received a single annual booster vaccination.
Danish: Hundene blev enten vaccineret to gange med tre til fire ugers mellemrum eller fik en enkelt årlig forstærkningsdosis (boosterdosis).
English: When Versican Plus DHPPi/L4 is given to dogs, the animals' immune system recognises the viruses and bacteria as ‘foreign' and makes antibodies against them.
Danish: Når Versican Plus DHPPi/L4 gives til hunde, registrerer dyrenes immunsystem virusserne og bakterierne som "fremmede« og reagerer ved at danne antistoffer mod dem.
English: • canine parainfluenza virus and canine adenovirus type 2, which cause kennel cough;
Danish: • hundeparainfluenzavirus og hundeadenovirus type 2, der er årsag til kennelhoste,
English: Versican Plus DHPPi/L4 is a vaccine.
Danish: Versican Plus DHPPi/L4 er en vaccine.
English: • canine adenovirus type 1, which causes an acute liver infection that may produce signs of jaundice (yellowing of the skin and eyes);
Danish: • hundeadenovirus type 1, der forårsager akut leverbetændelse, eventuelt med gulsot af hud og øjne
English: Versican Plus DHPPi/L4 is a veterinary vaccine that contains live attenuated (weakened) canine distemper virus, canine adenovirus type 2, canine parvovirus type 2b and canine parainfluenza virus type 2 as well as inactivated (killed) strains of Leptospira bacteria.
Danish: Versican Plus DHPPi/L4R er en dyrevaccine, der indeholder levende, svækket hundesygevirus, hundeadenovirus type 2, hundeparvovirus type 2b og hundeparainfluenzavirus type 2 samt dræbte (inaktiverede) stammer af Leptospira-bakterier.
English: This will help protect them against distemper, adenovirus liver infection, parvovirosis, kennel cough and leptospirosis.
Danish: Derved er de beskyttet mod hundesyge, adenovirus-leverbetændelse, parvovirose, kennelhoste og leptospirose.
English: The field study showed that vaccination with Versican Plus DHPPi/L4 resulted in levels of antibodies that were sufficient to protect against canine distemper virus and canine adenovirus in all dogs.
Danish: Feltundersøgelsen viste, at vaccination med Versican Plus DHPPi/L4 hos alle hundene gav tilstrækkelig antistofkoncentration til at beskytte mod hundesygevirus og hundeadenovirus.
English: • canine distemper, an infectious disease which is sometimes called ‘hard pad' since dogs can develop thickening of the skin on the foot pads, as well as runny nose, cough, fever, vomiting, diarrhoea, excessive salivation and in some cases fits;
Danish: • hundesyge, en smitsom sygdom, der på engelsk også kaldes »hard pad disease«, fordi hundene kan få fortykket hud på trædepuderne foruden løbende snude, hoste, feber, opkastning, diarré,
English: Annual revaccination is required for protection against parainfluenza virus and leptospirosis.
Danish: Der revaccineres en gang om året mod parainfluenzavirus og leptospirose.
English: For revaccination, a single dose of Versican Plus DHPPi/L4 is required every three years for distemper, canine adenovirus (type 1 and type 2) and parvovirus.
Danish: Revaccination er nødvendig en gang hvert tredje år med en enkelt dosis af Versican Plus DHPPi/L4 mod hundesyge, hundeadenovirus (type 1 og 2) og parvovirus.
English: Versican Plus DHPPi/L4 is used to protect dogs against:
Danish: Versican Plus DHPPi/L4 anvendes til at vaccinere hunde mod:
English: • canine parvovirus disease, an infection that may severely affect puppies, resulting in lethargy, fever, vomiting and bloody diarrhoea;
Danish: • hundeparvovirus, der hos hvalpe kan medføre svær sygdom med sløvhed, feber, opkastning og blodig diarré
English: Versican Plus DHPPi/L4 is available as a lyophilisate (freeze-dried pellet) with a solvent for injection.
Danish: Versican Plus DHPPi/L4 fås som en frysetørret pellet (et lyofilisat) med opløsningsvæske (solvens) og gives ved indsprøjtning.
English: Versican Plus DHPPi/L4 contains an adjuvant (aluminium hydroxide) to enhance the immune response.
Danish: Versican Plus DHPPi/L4 indeholder aluminiumhydroxid, der forstærker immunreaktionen (et adjuvans)
English: Other information about Versican Plus DHPPi/L4:
Danish: Andre oplysninger om Versican Plus DHPPi/L4:
English: Canine distemper, canine adenovirus, canine parvovirosis, canine parainfluenza virus (live attenuated) and canine leptospirosis (inactivated) vaccine
Danish: Vaccine mod hundesyge, hundeadenovirus, hundeparvovirus, hundeparainfluenzavirus (levende, svækket) og hundeleptospirose (inaktiveret)
English: Why has Versican Plus DHPPi/L4 been approved?
Danish: Hvorfor blev Versican Plus DHPPi/L4 godkendt?
English: hepatitis (inflammation of the liver) and jaundice or nephritis (kidney inflammation).
Danish: leverbetændelse og gulsot eller nyrebetændelse
English: What is the risk associated with Versican Plus DHPPi/L4?
Danish: Hvilken risiko er der forbundet med Versican Plus DHPPi/L4?
English: What is Versican Plus DHPPi/L4?
Danish: Hvad er Versican Plus DHPPi/L4?
English: How has Versican Plus DHPPi/L4 been studied?
Danish: Hvordan blev Versican Plus DHPPi/L4 undersøgt?
English: The viruses in Versican Plus DHPPi/L4 are alive but they have been attenuated (weakened) so that they do not cause disease; they are combined with killed (inactivated) strains of Leptospira bacteria.
Danish: Viraene i Versican Plus DHPPi/L4 er levende, men svækkede, så de ikke kan forårsage sygdom.
English: How does Versican Plus DHPPi/L4 work?
Danish: Hvordan virker Versican Plus DHPPi/L4?
English: What is Versican Plus DHPPi/L4 used for?
Danish: Hvad anvendes Versican Plus DHPPi/L4 til?
English: What benefit has Versican Plus DHPPi/L4 shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Versican Plus DHPPi/L4?
English: It's especially important to mention:
Danish: Det er især vigtigt at nævne:
English: Both groups had similar demographics.
Danish: De to grupper havde sammenlignelig demografi.
English: Date of first authorisation: 22 March 2002 Date of latest renewal: 24 January 2012
Danish: Dato for første markedsføringstilladelse: 22. marts 2002 Dato for seneste fornyelse: 24. januar 2012
English: These effects are usually reversible.
Danish: Disse virkninger er normalt reversible.
English: It is to be reconstituted only with one of the following:
Danish: Det må kun rekonstitueres i en af følgende:
English: No formal interaction studies have been done.
Danish: Der er ikke udført formelle interaktionsundersøgelser.
English: Dynastat must be reconstituted before use.
Danish: Dynastat skal rekonstitueres før anvendelse.
English: Therefore, the concomitant administration of these drugs should be done with caution.
Danish: Samtidig administration af disse lægemidler bør derfor ske med forsigtighed.
English: CABG post-operative safety studies
Danish: CABG post-operative sikkerhedsundersøgelser
English: The following solutions cannot be used for reconstitution:
Danish: Følgende opløsninger kan ikke anvendes til rekonstituering:
English: The entire contents of the vial should be withdrawn for a single administration.
Danish: Hele hætteglassets indhold bør udtages til en enkelt administration.
English: ▪ NSAIDs, including Dynastat, may make it more difficult to become pregnant.
Danish: • NSAID-præparater, herunder Dynastat, kan gøre det sværere at blive gravid.
English: Children and adolescents Children and adolescents under the age of 18 should not be given Dynastat.
Danish: Børn og unge Børn og unge under 18 år må ikke få Dynastat.
English: Thus, 24 hours should be considered the maximum shelf life of the reconstituted product.
Danish: 24 timer skal anses som den maksimale opbevaringstid for rekonstitueret produkt.
English: Some of these cases have occurred without other signs of anaphylaxis.
Danish: Nogle af disse tilfælde er opstået uden andre tegn på anafylaksi.
English: The physician should be prepared to treat severe hypotension.
Danish: Lægen skal være forberedt på at behandle alvorlig hypotension.
English: The shelf life of the unreconstituted product is 3 years.
Danish: Opbevaringstid for ikke rekonstitueret produkt er 3 år.
English: Dynastat is not recommended in the first 6 months of pregnancy and you must not receive Dynastat in the last three months of pregnancy.
Danish: Dynastat anbefales ikke i de første 6 måneder af graviditeten, og De må ikke få Dynastat i de sidste 3 måneder af graviditeten.
English: Dynastat works by lowering the amount of these prostaglandins.
Danish: Dynastat virker ved at mindske antallet af disse prostaglandiner.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden De får dette lægemiddel, da den indeholder vigtige oplysninger.
English: If a dose lower than 40 mg is required, excess medicine should be discarded.
Danish: Hvis en dosis mindre end 40 mg skal anvendes, skal overskydende medicin smides væk.
English: You will not be given more than 80 mg in 24 hours.
Danish: De vil højest få 80 mg i løbet af 24 timer.
English: Opioid-sparing effects
Danish: Opioid-besparende effekt
English: Dynastat has been administered to 335 elderly patients (65-96 years of age) in pharmacokinetic and therapeutic trials.
Danish: Dynastat er givet til 335 ældre patienter (65-96 år) i farmakokinetiske og terapeutiske undersøgelser.
English: Two isoforms, COX-1 and COX-2, have been identified.
Danish: Der er identificeret 2 iso-former, COX-1 og COX-2.
English: Such effects may occur shortly after treatment initiation and are usually reversible.
Danish: Sådanne virkninger kan sætte ind kort tid efter påbegyndt behandling og er oftest irreversible.
English: Reports from post-marketing experience have been listed as “frequency not known” because the respective frequencies cannot be estimated from the available data.
Danish: Bivirkninger, der er indberettet efter markedsføring, er anført som “frekvens ikke kendt”, da frekvenser ikke kan estimeres ud fra forhåndenværende data.
English: Unless such requirements are met, in-storage times and conditions prior to use are the responsibility of the user, and would not normally be longer than 12 hours at 25C.
Danish: Medmindre disse forudsætninger er opfyldt, er opbevaringstid og -betingelser før anvendelse på brugerens ansvar, og vil normalt ikke være længere end 12 timer ved 25C.
English: It is recommended that Dynastat is used as soon as possible after it is mixed with solvent, although it may be stored if the instructions at the end of the leaflet are strictly followed.
Danish: Det anbefales, at Dynastat anvendes så hurtigt som muligt efter, at det er blevet blandet med solvens, selv om det kan opbevares, hvis instruktionen i slutningen af denne indlægsseddel følges meget nøje.
English: Injury, poisoning and procedural complications Post procedural complication (skin)
Danish: Traumer, forgiftninger og behandlingskomplikationer Komplikationer efter procedure (hud)
English: About 70% of the dose is excreted in the urine as inactive metabolites.
Danish: Ca. 70% af dosis udskilles i urinen som inaktive metabolitter.
English: Aseptic technique is required for its preparation.
Danish: Aseptisk teknik skal anvendes ved tilberedningen.
English: If blood pressure rises significantly, alternative treatment should be considered.
Danish: Hvis blodtrykket stiger signifikant, bør andre behandlingsmuligheder overvejes.
English: The solution is for single use only and must not be stored in a refrigerator or freezer.
Danish: Opløsningen er kun beregnet til engangsbrug og må ikke opbevares i køleskab eller nedfryses.
English: For the short-term treatment of postoperative pain in adults.
Danish: Til kortvarig behandling af postoperative smerter hos voksne.
English: Congestive heart failure (NYHA II-IV).
Danish: Venstresidig hjerteinsufficiens (NYHA II-IV).
English: In case of overdose, patients should be managed by symptomatic and supportive care.
Danish: I tilfælde af overdosering bør patienter have symptomatisk og understøttende behandling.
English: Therefore, parecoxib is not recommended in these patients.
Danish: Derfor anbefales parecoxib ikke til disse patienter.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af at der er nået en vigtig milepæl (lægemiddelovervågning eller risikominimering).
English: Solvent: clear and colourless solution.
Danish: Solvens: klar og farveløs opløsning.
English: Use with oral anticoagulants
Danish: Brug sammen med orale antikoagulantia
English: Your doctor may reduce the dose of Dynastat or other medicines, or you may need to take a different medicine.
Danish: Deres læge vil muligvis nedsætte mængden af Dynastat eller af andre lægemidler, eller det kan være nødvendigt, at De tager et andet lægemiddel.
English: Plasma protein binding is approximately 98% over the concentration range achieved with the highest recommended dose, 80 mg/day.
Danish: Plasmaproteinbindingen er ca. 98% i koncentrationsområdet opnået ved den højest anbefalede dosis, 80 mg/dag.
English: Dynastat and opioids should not be administered together in the same syringe.
Danish: Dynastat og opioider bør ikke administreres samtidig i den samme sprøjte.
English: You will only be given Dynastat for short periods, and only for pain relief.
Danish: De vil kun få Dynastat i korte perioder og kun til smertelindring.
English: Patients should be adequately hydrated and the need to monitor the renal function should be assessed at the beginning of the concomitant treatment and periodically thereafter.
Danish: Patienter bør være tilstrækkeligt hydreret, og behovet for monitorering af nyrefunktionen bør vurderes ved initiering af den samtidige behandling og jævnligt derefter.
English: Studies in types of surgery other than CABG procedures included patients with American Society of Anaesthesiology (ASA) Physical Status Class I-III only.
Danish: Undersøgelser på andre former for operationer end CABG omfatter kun patienter med American Society of Anaesthesiology (ASA) Physical Status klasse I-III.
English: Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis
Danish: Stevens-Johnsons syndrom, erythema multiforme, dermatitis exfoliativa
English: Use of parecoxib beyond 3 days
Danish: Anvendelse af parecoxib i mere end 3 dage
English: SOLVENT AMPOULE LABEL : 2 ml
Danish: SOLVENS AMPUL ETIKET: 2 ml
English: The reconstituted product should be used immediately (up to 24 hours if prepared aseptically), and should not be frozen or refrigerated.
Danish: Rekonstitueret lægemiddel skal anvendes straks (op til 24 timer hvis fremstillet aseptisk), og må ikke nedfryses eller opbevares i køleskab.
English: You should tell your doctor if you are planning to become pregnant or if you have problems becoming pregnant.
Danish: De skal fortælle det til lægen, hvis De har planer om at blive gravid, eller hvis De har problemer med at blive gravid.
English: Dynastat is used for the short-term treatment of pain in adults after an operation.
Danish: Dynastat bruges til korttidsbehandling af smerter hos voksne efter operation.
English: Active peptic ulceration or gastrointestinal (GI) bleeding.
Danish: Aktivt peptisk ulcus eller gastrointestinal (GI) blødning.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: De eller Deres pårørende kan også indberette bivirkninger via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: The most common adverse reaction for Dynastat is nausea.
Danish: Den mest almindelige bivirkning ved Dynastat er kvalme.
English: Gastrointestinal studies
Danish: Gastrointestinale undersøgelser
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge eller sygeplejersken til råds, før De får dette lægemiddel.
English: All patients received standard of care analgesia during treatment.
Danish: Alle patienter fik standard smertelindringsbehandling under forløbet.
English: Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, Coxibs, ATC code: M01AH04
Danish: Farmakoterapeutisk klassifikation: Antiinflammatoriske og antirheumatiske midler, Coxiber, ATC kode: M01AH04
English: Talk to your doctor or nurse before using Dynastat:
Danish: Fortæl det til lægen eller sygeplejersken, før De får Dynastat:
English: It represents approximately 10% of the concentration of valdecoxib; because of this metabolite's low concentration, it is not expected to contribute a significant clinical effect after administration of therapeutic doses of parecoxib.
Danish: Den udgør ca. 10% af valdecoxibkoncentrationen; på grund af denne metabolits lave koncentration forventes den ikke at bidrage med en klinisk signifikant effekt efter administration af parecoxib i terapeutiske doser.
English: After reconstitution, the liquid should be a clear solution.
Danish: Efter rekonstitution skal væsken være en klar opløsning.
English: Pain and swelling are sometimes caused by substances in the body called prostaglandins.
Danish: Smerter og hævelser kan sommetider skyldes nogle stoffer i kroppen, som kaldes prostaglandiner.
English: Clinical trials indicate that Dynastat can be given with low dose acetylsalicylic acid ( 325 mg).
Danish: Kliniske undersøgelser tyder på, at Dynastat kan gives sammen med lav-dosis acetylsalicylsyre (≤ 325 mg).
English: The safety and efficacy of parecoxib in children under 18 years old have not been established.
Danish: Parecoxibs sikkerhed og virkning hos børn i alderen under 18 år er ikke klarlagt.
English: Adverse Drug Reaction Frequency Very Common
Danish: Bivirkningsfrekvens Meget almindelig
English: In the pooled analysis of 676 patients, 318 received placebo and 358 received parecoxib.
Danish: I den samlede analyse af 676 patienter fik 318 patienter placebo og 358 patienter parecoxib.
English: Parecoxib has been used in a range of major and minor surgeries.
Danish: Parecoxib er blevet anvendt ved en række større og mindre indgreb.
English: The effect of enzyme induction has not been studied.
Danish: Virkninger af enzyminduktion er ikke undersøgt.
English: No dose adjustment is generally necessary in elderly patients (≥65 years).
Danish: Sædvanligvis er dosisjustering ikke nødvendig til ældre patienter ( 65 år).
English: Parecoxib should be used with caution in patients with hypertension.
Danish: Parecoxib bør anvendes med forsigtighed til patienter med hypertension.
English: Your doctor may want to monitor your blood pressure during treatment with Dynastat.
Danish: Deres læge vil muligvis måle Deres blodtryk, mens De er i behandling med Dynastat.
English: If you are given more Dynastat than you should you may experience side-effects that have been reported with recommended doses.
Danish: Hvis De får mere Dynastat end De bør, kan De få bivirkninger, som er set ved anbefalede doser.
English: The injection solution should be a clear colourless liquid.
Danish: Injektionsvæsken skal være en klar farveløs væske.
English: The effects of parecoxib have not been evaluated in late pregnancy or in the pre- and postnatal period.
Danish: Virkningerne af parecoxib er ikke blevet undersøgt i sengraviditet eller i den præ- og postnatale periode.
English: Data from 3 randomised placebo-controlled trials, where the protocols allowed treatment of parecoxib for >3 days was pooled and analysed.
Danish: Data fra 3 randomiserede placebokontrollerede studier, hvor behandling med parecoxib ifølge protokollen var tilladt i > 3 dage, blev samlet og analyseret.
English: During the first and second trimester of pregnancy, Dynastat should not be given unless clearly necessary.
Danish: Dynastat bør ikke anvendes i første og andet trimester af graviditeten, medmindre det er klart nødvendigt.
English: These results indicate that although valdecoxib is not metabolised by CYP2C19, it may be an inhibitor of this isoenzyme.
Danish: Disse resultater viser, at selvom valdecoxib ikke metaboliseres af CYP2C19, kan det være en hæmmer af dette isoenzym.
English: If there are particles in the injection solution or if either the powder or solution is discoloured, the solution will not be used.
Danish: Hvis der er partikler i injektionsvæsken, eller hvis pulveret eller opløsningen er misfarvet, må opløsningen ikke anvendes.
English: Added pain relief compared to opioids alone was shown.
Danish: Der blev påvist øget smertelindring sammenlignet med opioider alene.
English: The following adverse reactions were reported for patients who received parecoxib (N=5,402) in 28 placebo-controlled clinical trials.
Danish: Følgende bivirkninger er rapporteret for patienter, som fik parecoxib (N=5.402) i 28 placebokontrollerede kliniske forsøg.
English: Myocardial infarction, bradycardia
Danish: Myokardieinfarkt, bradykardi
English: There are no adequate data from the use of parecoxib in pregnant women or during labour.
Danish: Der er utilstrækkelige data fra anvendelse af parecoxib til gravide kvinder eller under fødsel.
English: COX-2 has been identified in tissue around gastric ulcers in man but its relevance to ulcer healing has not been established.
Danish: COX-2 er påvist i vævet omkring gastriske ulcera hos mennesker, men dets relevans ved heling af ulcera er ikke fastslået.
English: Dynastat contains
Danish: Dynastat indeholder
English: Patients received low-dose acetylsalicylic acid prior to randomization and throughout the two CABG surgery studies.
Danish: Patienterne fik lav-dosis acetylsalicylsyre forud for randomisering og gennem begge de 2 CABGundersøgelser.
English: Higher doses were associated with aggravation and delayed healing of skin infections, an effect probably associated with COX-2 inhibition.
Danish: Højere doser er forbundet med forværring og forsinket helbredelse af hudinfektioner, en effekt der muligvis er forbundet med COX-2-hæmning.
English: Patients who experience dizziness, vertigo or somnolence after receiving Dynastat should refrain from driving or operating machines.
Danish: Patienter, der oplever svimmelhed eller søvnighed efter at have fået Dynastat, bør undgå at føre motorkøretøj eller betjene maskiner.
English: In this case, it is advisable to rehydrate patients first and then start therapy with Dynastat.
Danish: I sådanne tilfælde anbefales det at rehydrere patienten først, og derefter starte behandling med Dynastat.
English: In addition to routine adverse event reporting, pre-specified event categories, adjudicated by an independent expert committee, were examined in two placebo-controlled safety studies in which patients received parecoxib for at least 3 days and then were transitioned to oral valdecoxib for a total duration of 10-14 days.
Danish: Foruden rutineindberetninger af uønskede hændelser blev præ-definerede kategorier af hændelser, udvalgt af en uafhængig ekspertkomité, undersøgt i 2 placebokontrollerede sikkerhedsundersøgelser, hvor patienterne fik parecoxib i mindst 3 dage og derefter blev skiftet til oral valdecoxib i ialt 10-14 dage.
English: The carcinogenic potential of parecoxib has not been evaluated.
Danish: Parecoxibs karcinogene potentiale er ikke undersøgt.