FrancophonIA/ELRC3.0 huggingface dataset:
English: • the CVMP on the basis of the available data considered that a satisfactory efficacy towards Linognatus vituli, Bovicola bovis and Solenopotes capillatus can be expected in the field;
Danish: • CVMP fandt på baggrund af de foreliggende data, at en tilfredsstillende virkning mod Linognatus vituli, Bovicola bovis og Solenopotes capillatus kan forventes inden for feltet
English: Marketing authorisation holder
Danish: indehaver av markedføringstilladelsen
English: Cydectin TriclaMox pour-on solution is a veterinary medicinal product containing 5 mg moxidectin per ml and 200 mg triclabendazole per ml.
Danish: Cydectin TriclaMox, pour-on-opløsning, er et veterinærlægemiddel, der indeholder 5 mg moxidectin pr. ml og 200 mg triclabendazol pr. ml.
English: In order to address the concerns raised by Belgium the MAH provided data to support the noninterference between triclabendazole and moxidectin, a clinical study regarding the efficacy against Linognatus vituli and Bovicola bovis and literature on the efficacy of moxidectin against lice species.
Danish: For at imødekomme de af Belgien fremførte betænkeligheder fremlagde indehaveren af markedsføringstilladelsen data til støtte for ikke-indblanding mellem triclabendazol og moxidectin, en klinisk undersøgelse af virkningen mod Linognatus vituli og Bovicola bovis samt litteratur vedrørende moxidectins virkning mod lusearter.
English: PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE
English: The CVMP based the extrapolation of the efficacy of the product on Linognatus vituli to the two other lice species proposed (Bovicola bovis and Solenopotes capillatus) on the results of a dose determination study with the monoproduct containing moxidectin as active substance where the three proposed claimed lice species were shown to be controlled (>95 % except for Solenopotes capillatus adult before day 21) at half dose for the monoproduct (0.25 mg/kg bw instead of 0.5 mg/kg bw), supported by the pharmacokinetics finding giving no strong signal of interaction between the two active substances in Cydectin TriclaMox.
Danish: CVMP begrundede ekstrapolering af produktets virkning på Linognatus vituli til de to andre foreslåede lusearter (Bovicola bovis og Solenopotes capillatus) på grundlag af resultaterne af en dosisfastsættelsesundersøgelse med monoproduktet, der indeholder moxidectin som aktivt stof, hvori det blev påvist, at de tre foreslåede påståede lusearter var kontrolleret (> 95 % med undtagelse af voksne individer af Solenopotes capillatus før dag 21) ved halv dosis for monoproduktet (0,25 mg/kg kropsvægt i stedet for 0,5 mg/kg kropsvægt ), hvilket understøttes af farmakokinetiske resultater, der ikke giver noget stærkt signal om samspillet mellem de to aktive stoffer i Cydectin TriclaMox.
English: A confirmatory trial was provided where the efficacy of moxidectin/triclabendazole pour-on combination in cattle was studied at the recommended dose rate of Cydectin TriclaMox (0.5 mg moxidectin/20 mg triclabendazole/kg body weight) against natural infestations of sucking and/or biting lice, with emphasis primarily on Linognatus vituli and secondarily on Bovicola bovis by comparison with a placebo-treated control group.
Danish: Der var fremlagt en bekræftende undersøgelse, hvori virkningen af pour-on-kombinationen moxidectin/triclabendazol hos kvæg var blevet undersøgt ved den anbefalede dosishyppighed af Cydectin TriclaMox (0,5 mg moxidectin/20 mg triclabendazol/kg kropsvægt) mod naturlige angreb af blodsugende og/eller bidende lus, med vægt primært på Linognatus vituli og sekundært på Bovicola bovis og sammenlignet med en placebokontrolgruppe.
English: Based on (i) the comparable pharmacokinetic profiles for moxidectin when administered as the combination product compared with moxidectin alone in the same vehicle, (ii) the findings of the confirmatory study with Linognatus vituli and (iii) the data from the original moxidectin 0.5% pour-on dossier showing that Linognatus vituli, Bovicola bovis and Solenopotes capillatus were sensitive to moxidectin at half the recommended dose rate (0.25 mg/kg), the CVMP considered that a satisfactory efficacy towards Linognatus vituli, Bovicola bovis and Solenopotes capillatus can be expected in the field for Cydectin TriclaMox.
Danish: På baggrund af i) de sammenlignelige farmakokinetiske profiler for moxidectin, når det administreres som kombinationsprodukt, sammenlignet med moxidectin alene i samme medie, ii) resultaterne af den bekræftende undersøgelse med Linognatus vituli og iii) data fra det oprindelige dossier for moxidectin, 0,5 % pour-on, der viser, at Linognatus vituli, Bovicola bovis og Solenopotes capillatus var sensitive over for moxidectin ved halvdelen af den anbefalede dosis (0,25 mg/kg), fandt CVMP, at en tilfredsstillende virkning mod Linognatus vituli, Bovicola bovis og Solenopotes capillatus kan forventes inden for feltet for Cydectin TriclaMox.
English: The benefit-risk evaluation is deemed to be positive for granting of the variation to the terms of the marketing authorisations for Cydectin TriclaMox concerning treatment of Linognatus vituli, Bovicola bovis and Solenopotes capillatus infestations caused by moxidectin sensitive strains.
Danish: Vurderingen af benefit/risk-forholdet anses for at være positiv til godkendelse af ændringen af betingelserne for markedsføringstilladelserne for Cydectin TriclaMox til behandling af angreb fra Linognatus vituli, Bovicola bovis og Solenopotes capillatus forårsaget af moxidectinfølsomme stammer.
English: Treatment of mixed trematode (fluke) and nematode infections and certain arthropod infestations caused by moxidectin and triclabendazole sensitive strains of:
Danish: Behandling af blandede infektioner med trematoder (ikter) og nematoder samt infestationer med visse leddyr forårsaget af moxidectin og triclabendazol-følsomme stammer af:
English: Treatment of mixed trematode (fluke) and nematode infections and certain arthropod infestations caused by moxidectin and triclabendazole sensitive strains.
Danish: Behandling af blandede infektioner med trematoder (ikter) og nematoder samt infestationer med visse leddyr forårsaget af moxidectin og triclabendazol-følsomme stammer.
English: Overall summary of the scientific evaluation of Cydectin TriclaMox (5 mg/ml and 200 mg/ml) pour-on solution for cattle (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Cydectin TriclaMox (5 mg/ml og 200 mg/ml), pour-on-opløsning, til kvæg (se bilag I)
English: 1 CVMP guideline on specific efficacy requirements for ectoparasiticides in cattle (EMEA/CVMP/625/03)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004643.pdf
Danish: 1 CVMP guideline on specific efficacy requirements for ectoparasiticides in cattle (EMEA/CVMP/625/03)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004643.pdf anbefalede CVMP godkendelse af ændringen af betingelserne for markedsføringstilladelser for de veterinærlægemidler, der er henvist til i bilag I. De anbefalede ændringer til de relevante afsnit i produktinformationen er anført bilag III.
English: While acknowledging the absence of commingling of the animals which is a worst-case-scenario according to the CVMP guideline on specific efficacy requirements for ectoparasiticides in cattle (EMEA/CVMP/625/03)1, as a limitation in the study, the CVMP considered the study well conducted.
Danish: Udvalget for Veterinærlægemidler (CVMP) vurderede, at undersøgelsen er veludført, selv om udvalget erkender, at manglen på sammenblanding af dyrene, som er et worst-case-scenarium i henhold til CVMP's retningslinje om specifikke virkningskrav for ektoparasitter hos kvæg (EMEA/CVMP/625/03)1, begrænser undersøgelsen.
English: Pfizer Hellas AE Mesogion Avenue 243 154 51 N. Psychiko Athens
Danish: Grækenland Pfizer Hellas AE Mesogion Avenue 243
English: NEMATODES
Danish: NEMATODER
English: Pfizer GmbH Linkstraße 10 10785 Berlin Germany
Danish: Tyskland Pfizer GmbH Linkstraße 10
English: Belgium Pfizer Animal Health s.a. Rue Laid Burniat 1
Danish: Pfizer Animal Health s.a. Rue Laid Burniat 1 1348 Louvain-la-Neuve Belgien
English: Slovenia
Danish: Belgien
English: MA (EU) number
Danish: MF (EU)-nummer Særnavn
English: 1 Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/California/7/2009 (H1N1)v like strain used (X-179A)
Danish: Povrchové antigeny chřipkového viru (hemaglutinin a neuraminidáza)* kmene: A/California/7/2009 (H1N1)v.varianta kmene (X-179A)
English: 7.5 micrograms** per 0.5 ml dose
Danish: 7,5 mikrogramů** v 0,5 ml dávce
English: Adjuvant MF59C.1 containing squalene (9.75 milligrams), polysorbate 80 (1.175 milligrams), sorbitan trioleate (1.175 milligrams)
Danish: Adjuvans MF59C.1 obsahuje skvalen (9,75 miligramů ), polysorbát 80 (1,175 miligramů), sorbitan- trioleát (1,175 miligramů).
English: Package size
Danish: Velikosti balení
English: Packagin
Danish: Obal
English: 1 pre-filled syringe
Danish: 1 předplněná injekční stříkačka
English: * propagated in eggs ** expressed in microgram haemagglutinin.
Danish: ** vyjádřeno v mikrogramech hemaglutininu.
English: EU Number
Danish: Číslo EU Název Síla
English: 10 multidose vials
Danish: 10 předplněných injekčních stříkaček
English: Route of Administration
Danish: Léková forma Cesta podání
English: Content (concentration)
Danish: Obsah
English: 10 pre-filled syringes vial (glass) 5.0 ml
Danish: 5,0 ml (1 dávka = 0,5 ml)
English: Strength Pharmaceutical Form
Danish: Handelsnavn Styrke Lægemiddelform
English: Content Package size Withdrawal period
Danish: Emballage Indhold Pakningsstørrelse
English: 3 syringes in a carton box
Danish: 3 injektionssprøjter i en papæske
English: EU Number Invented Name
Danish: EU-nummer
English: 1 syringe in a carton box
Danish: 1 injektionssprøjte i en papæske
English: San Sebastian de los Reyes, Spain
Danish: San Sebastian de los Reyes, Spanien
English: Frequency cannot be estimated from the available data
Danish: Hyppigheden kan ikke fastsættes ud fra forhåndenværende data
English: Take Efexor depot at approximately the same time each day, either in the morning or in the evening.
Danish: Tag Efexor Depot på omtrent samme tidspunkt hver dag, enten om morgenen eller om aftenen.
English: 2130 AG HOOFDDORP The Netherlands
Danish: 2130 AG HOOFDDORP Holland
English: There is no evidence that higher doses confer any additional benefit.
Danish: Der er ingen evidens for, at højere doser giver nogen yderligere fordel.
English: If you are being treated for panic disorder, your doctor will start with a lower dose (37.5 mg) and then increase the dose gradually.
Danish: Hvis du behandles for panikangst, vil din læge starte med en lavere dosis (37.5 mg) og derefter gradvist øge dosis.
English: Belgium, Luxembourg
Danish: Belgien, Luxemburg
English: Antidepressive medicinal products should continue for at least six months following remission.
Danish: Behandling med antidepressiv medicin bør fortsætte i mindst 6 måneder efter remission.
English: In the majority of cases, these complications are observed immediately or within 24 hours after partus.
Danish: I de fleste af tilfældende blev disse komplikationer observeret umiddelbart eller inden for 24 timer efter fødslen.
English: Patients should be treated for a sufficient period of time, usually several months or longer.
Danish: Patienter skal behandles i en tilstrækkelig lang periode, normalt flere måneder eller længere.
English: Efexor depot is a treatment for adults with depression.
Danish: Efexor Depot er en behandling til voksne med depression.
English: Despite this, your doctor may prescribe Efexor depot for patients under 18 because he/she decides that this is in their best interests.
Danish: Trods dette kan din læge vælge at ordinere Efexor Depot til patienter under 18 år, fordi han/hun beslutter, at det er i deres interesse.
English: Ireland, Malta, United Kingdom
Danish: Irland, Malta, Storbritannien
English: Treatment of panic disorder, with or without agoraphobia.
Danish: Behandling af panikangst med eller uden agorafobi.
English: You should use Efexor depot only after discussing the potential benefits and the potential risks to your unborn child with your doctor.
Danish: Du må kun bruge Efexor Depot, efter at du har drøftet de mulige fordele og risici for dit ufødte barn med din læge.
English: If your doctor thinks that you no longer need Efexor depot, he/she may ask you to reduce your dose slowly before stopping treatment altogether.
Danish: Hvis din læge mener, at du ikke længere har brug for Efexor Depot, kan han/hun bede dig reducere din dosis langsomt, før du helt holder op med behandlingen.
English: Do not be concerned if you see small white granules or balls in your stools after taking Efexor depot.
Danish: Du skal ikke være bekymret, hvis du ser nogle små, hvide granulater eller kugler i afføringen efter at have taget Efexor Depot.
English: In most of the cases, the recommended dose in prevention of recurrence of MDE is the same as the one used during the current episode.
Danish: I de fleste tilfælde er den anbefalede dosis til forebyggelse af ny depressiv episode den samme, som anvendes ved den igangværende episode.
English: Therefore, your doctor may wish to do blood tests occasionally, particularly if you have been taking Efexor depot for a long time.
Danish: Det kan derfor ske, at din læge vil tage blodprøver fra tid til anden, især hvis du har taget Efexor Depot i lang tid.
English: Denmark, Finland, Iceland, Norway, Sweden Efexor Depot France
Danish: Danmark, Finland, Island, Norge, Sverige Efexor Depot Frankrig
English: Do not take more than the daily amount of Efexor depot that has been prescribed for you in one day.
Danish: Du må ikke tage mere end den daglige mængde Efexor Depot, som du har fået ordineret, på én dag.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF EFEXOR DEPOT AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF EFEXOR DEPOT OG TILKNYTTEDE NAVNE (SE BILAG I)
English: Do not drive or use any tools or machines until you know how Efexor depot affects you.
Danish: Du må ikke køre bil eller arbejde med værktøj eller maskiner, før du ved, hvordan Efexor Depot påvirker dig.
English: If your doctor has prescribed Efexor depot for a patient under 18, and you want to discuss this, please go back to your doctor.
Danish: Hvis din læge har ordineret Efexor Depot til en patient under 18 år, og du gerne vil tale om dette, skal du henvende dig til din læge.
English: Side effects are known to occur when people stop using Efexor depot, especially when Efexor depot is stopped suddenly or the dose is reduced too quickly.
Danish: Det er kendt, at der er opstået bivirkninger, når personer er holdt op med at bruge Efexor Depot, navnlig når de pludseligt er holdt op med Efexor Depot, eller når dosis reduceres for hurtigt.
English: These symptoms may be due to either serotonergic effects or exposure symptoms.
Danish: Disse symptomer kan skyldes enten serotonerge virkninger eller være eksponeringssymptomer.
English: • If your cholesterol levels get higher.
Danish: - Hvis dit kolesteroltal stiger.
English: A warning on the use of Efexor depot in the treatment of children and adolescents under the age of 18 years was also agreed upon and introduced in Section 4.4.
Danish: En advarsel om brugen af Efexor depot til behandling af børn og unge under 18 år blev også vedtaget og indført i afsnit 4.4.
English: The following medicines may also interact with Efexor depot and should be used with caution.
Danish: Følgende medicin kan også indvirke på Efexor Depot og skal bruges med forsigtighed.
English: It is unknown whether a pharmacokinetic and/or pharmacodynamic interaction with other benzodiazepines exists.
Danish: Det er uvist, om der en farmakokinetisk og/eller farmakodynamisk interaktion med andre benzodiazepiner.
English: If you are depressed and/or have anxiety disorders, you can sometimes have thoughts of harming or killing yourself.
Danish: Hvis du har en depression og/eller lider af angst, kan du nogle gange have tanker om at skade dig selv eller slå dig selv ihjel.
English: While there was also evidence for superiority over placebo for the 37.5 mg/day dose, this dose was not as consistently effective as the higher doses.
Danish: Selv om der også var evidens for, at en dosis på 37.5 mg/dag var bedre end placebo, var denne dosis ikke så konsekvent effektiv som de højere doser.
English: Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour, and to seek medical advice immediately if these symptoms present.
Danish: Patienterne og deres omsorgsgivere skal være opmærksomme på behovet for at monitorere enhver klinisk forværring, selvmordsadfærd eller -tanker og usædvanlige ændringer i opførsel, og de skal omgående søge lægelig rådgivning, hvis disse symptomer viser sig.
English: No safety problems were associated with doses higher than 75mg/day, which may also be beneficial for some patients.
Danish: Der var ikke sikkerhedsproblemer forbundet med doser over 75 mg/dag, som også kan være fordelagtige for nogle patienter.
English: Do not use Efexor depot after the expiry date, which is stated on the packaging.
Danish: Brug ikke Efexor Depot efter den udløbsdato, der står på pakningen.
English: Czech Republic, Romania
Danish: Tsjekkiet, Rumænien
English: Venlafaxine is not indicated for weight loss alone or in combination with other products.
Danish: Venlafaxin er ikke indiceret til vægttab alene eller i kombination med andre produkter.
English: • If you are also taking or have taken any time within the last 14 days any medicines known as irreversible monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson's disease.
Danish: - Hvis du også tager eller inden for de sidste 14 dage har taget nogen form for medicin, der kaldes irreversible monoaminoxidasehæmmere (MAO-hæmmere), som bruges til behandling af depression eller Parkinsons sygdom.
English: Efexor depot may cause a sensation of restlessness or an inability to sit or stand still.
Danish: Efexor Depot kan medføre en følelse af rastløshed eller manglende evne til at sidde eller stå stille.
English: 126, Kyprou & 25th Martiou str., 164 52 Argyroupolis-Athens Greece
Danish: 126, Kyprou & 25th Martiou str., 164 52 Argyroupolis-Athen Grækenland
English: Use in patients with renal impairment: it was agreed that the individualisation of the dosage may be desirable, and this concept was introduced in the text for harmonization.
Danish: Anvendelse til patienter med nedsat nyrefunktion: Der var enighed om, at individualisering af dosis kan være ønskelig, og dette begreb blev indført i teksten til harmonisering.
English: Treatment should be reassessed regularly, on a case-by-case basis.
Danish: Behandlingen skal revurderes med regelmæssige intervaller, der fastsættes fra sag til sag.
English: Taking an irreversible MAOI together with other medicines, including Efexor depot, can cause serious or even life-threatening side effects.
Danish: Hvis du tager en irreversibel MAO-hæmmer sammen med anden medicin, herunder også Efexor Depot, kan det give alvorlige eller endda livstruende bivirkninger.
English: Like all medicines, Efexor depot can cause side effects, although not everybody gets them.
Danish: Efexor Depot kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: The frequency (likelihood of occurring) of side effects is classified as follows:
Danish: Fuldstændig liste over bivirkninger Hyppigheden af bivirkningerne (sandsynligheden for at de opstår) inddeles som følger:
English: *In pooled clinical trials, the incidence of headache was 30.3% with venlafaxine versus 31.3% with placebo.
Danish: * I sammenlagte kliniske undersøgelser var incidensen af hovedpine 30,3 % for venlafaxin mod 31,3 % for placebo.
English: Patients continued to receive the same dose of venlafaxine prolonged-release that they had taken at the end of the open-label phase (75, 150, or 225 mg).
Danish: Patienterne fortsatte med at få samme dosis venlafaxin depot, som de havde taget ved slutningen af den åbne fase (75, 150 eller 225 mg).
English: The insoluble portion of these spheroids is eliminated and may be seen in faeces.
Danish: Den uopløselige del af disse sfæroider udskilles og kan ses i fæces.
English: Efexor depot is also a treatment for adults with the following anxiety disorders: generalised anxiety disorder, social anxiety disorder (fear or avoidance of social situations) and panic disorder (panic attacks).
Danish: Efexor Depot er også en behandling til voksne med følgende angstlidelser: Generaliseret angst, socialfobi (frygt for eller undgåelse af sociale situationer), panikangst (panikanfald).
English: • If you have a history of aggressive behaviour.
Danish: - Hvis du har eller har haft en aggressiv adfærd.
English: This group of medicines is used to treat depression and other conditions such as anxiety disorders.
Danish: Det er en gruppe medicin, der anvendes til at behandle depression og andre lidelser, såsom angstlidelser.
English: - “treatment of generalized anxiety disorder (GAD)” excluding “treatment of special anxiety cases”, given that the latter is not a recognised DSM indication.
Danish: - “behandling af generaliseret angst”, eksklusive “behandling af specielle angsttilfælde”, når det tages i betragtning, at sidstnævnte ikke er en anerkendt DSM-indikation.
English: Major Depressive Episodes: the CHMP considered that the maximum dose of 375mg/day Efexor depot is safe and effective in a long term perspective and recommended that it is approved without duration limitations in the harmonized SPC.
Danish: Svære depressive episoder: CHMP mente, at en maksimal dosis Efexor depot på 375 mg/dag er sikker og effektiv ved langtidsbehandling og anbefalede, at den godkendes uden tidsbegrænsninger i det harmoniserede produktresumé.
English: Box 255
Danish: P.O. Box 255
English: Germany Wyeth Pharma GmbH Wienburgstrasse 207, D-48159 Muenster
Danish: Wyeth Pharma GmbH Wienburgstrasse 207, D-48159 Münster Tyskland
English: If any of these conditions apply to you, please talk with your doctor before taking Efexor depot.
Danish: Hvis nogen af disse forhold passer på dig, skal du tale med din læge, før du tager Efexor Depot.
English: Call your doctor or pharmacist immediately if you take more than the amount of Efexor depot prescribed by your doctor.
Danish: Kontakt lægen eller apoteket straks, hvis du tager mere Efexor Depot, end du har fået ordineret af lægen.
English: If you are taking Efexor depot during pregnancy, let your midwife and/or doctor know, as your baby might have some symptoms when it is born.
Danish: Hvis du tager Efexor Depot, når du er gravid, skal du fortælle det til din jordemoder og/eller læge, da dit barn kan have symptomer, når det fødes.
English: Treating depression or anxiety disorders properly is important to help you get better.
Danish: Det er vigtigt at behandle depression eller angstlidelser, for at du kan få det bedre.
English: 171 42 Solna, Sweden
Danish: 171 42 Solna, Sverige
English: If concomitant treatment of venlafaxine with an SSRI, an SNRI or a serotonin receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
Danish: Hvis samtidig behandling med venlafaxin og en SSRI, en SNRI eller en serotonin-receptoragonist (triptan) er klinisk berettiget, tilrådes det at overvåge patienten nøje, navnlig under iværksættelse af behandlingen og forhøjelser af dosis.
English: It is recommended that venlafaxine prolonged-release capsules be taken with food, at approximately the same time each day.
Danish: Det anbefales at tage venlafaxin depotkapslerne sammen med mad på omtrent samme tidspunkt hver dag.
English: • If you have eye problems, such as certain kinds of glaucoma (increased pressure in the eye).
Danish: - Hvis du har problemer med øjnene, såsom visse typer grøn stær (forhøjet tryk i øjet).