FrancophonIA/ELRC3.0 huggingface dataset:
English: Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea).
Danish: Symptomerne på serotoninsyndrom kan omfatte: ændringer i mentaltilstand (f.eks. agitation, hallucinationer, koma), autonom ustabilitet (f.eks. takykardi, ustabilt blodtryk, hypertermi),
English: The MAH was asked to harmonise Section 4.5 in the Summary of Product Characteristics, for which the following differences between SPCs needed to be evaluated: - monoamine oxidase inhibitors.
Danish: Indehaveren af markedsføringstilladelsen blev anmodet om at harmonisere afsnit 4.5 i produktresuméet, hvori følgende forskelle mellem produktresuméerne skulle vurderes:
English: The balance of risks and benefits should be considered before prescribing venlafaxine to patients at high risk of serious cardiac arrhythmia.
Danish: Før venlafaxin ordineres til patienter, der har stor risiko for alvorlig hjertearytmi, bør balancen mellem risici og fordele tages i betragtning.
English: Trevilor Tabletten 25mg
Danish: Trevilor Tabletten 25mg 25 mg
English: Trevilor Tabletten 37.5mg
Danish: Trevilor Tabletten 37,5mg 37,5 mg
English: • Metabolism/nutritional disorders
Danish: • Stofskifte/ernæring
English: Imipramine
Danish: Fordøjelse
English: Venlafaxine must be discontinued for at least 7 days before starting treatment with an irreversible non-selective MAOI (see sections 4.3 and 4.4).
Danish: Venlafaxin skal have været seponeret i mindst 7 dage, før behandling med en irreversibel, ikkeselektiv MAO-hæmmer påbegyndes (se pkt.
English: Dobupal 50 mg comprimidos 50 mg
Danish: Dobupal 50 mg comprimidos
English: Trevilor Tabletten 50mg
Danish: Trevilor Tabletten 50mg 50 mg
English: Common: abnormal dreams; decreased libido; dizziness; increased muscle tonus; insomnia; nervousness; pins and needles; sedation; tremor; confusion; feeling separated (or detached) from yourself and reality
Danish: Almindelig: Unormale drømme, nedsat libido, svimmelhed, øget muskeltonus, søvnløshed, nervøsitet, sovende fornemmelse, mathed, rystelser, forvirring, følelse af at være adskilt fra
English: Dobupal 75 mg comprimidos 75 mg
Danish: Dobupal 75 mg comprimidos
English: • Digestive disorders
Danish: • Fordøjelsesforstyrrelser
English: Imipramine did not affect the pharmacokinetics of venlafaxine and O-desmethylvenlafaxine.
Danish: Imipramin påvirkede ikke venlafaxins og O-desmethylvenlafaxins farmakokinetik.
English: Venlafaxine does not possess monoamine oxidase (MAO) inhibitory activity.
Danish: Venlafaxin har ingen MAO-hæmmende aktivitet.
English: Trevilor Tabletten 75mg
Danish: Trevilor Tabletten 75mg 75 mg
English: Indinavir did not affect the pharmacokinetics of venlafaxine and O-desmethylvenlafaxine.
Danish: Indinavir påvirkede ikke venlafaxins og O-desmethylvenlafaxins farmakokinetik.
English: Asthenia (fatigue), Chills
Danish: Asteni (træthed), kuldegysninger
English: Syndrome (NMS), Serotonergic syndrome, Delirium, Extrapyramidal reactions (including dystonia and dyskinaesia), Tardive dyskinaesia, Suicidal ideation and behaviours**
Danish: dystoni og dyskinesi), tardive dyskinesier, suicidale forestillinger og adfærd**
English: VANDRAL 75 mg comprimidos 75 mg
Danish: VANDRAL 75 mg comprimidos
English: Dobupal 37,5 mg comprimidos 37.5 mg
Danish: Dobupal 37,5 mg comprimidos
English: Abnormal ejaculation/orgasm (males),
Danish: Ikke almindelig: Abnorm orgasme (kvinder)
English: 4.5 Interaction with other medicinal products and other forms of interaction Monoamine Oxidase Inhibitors (MAOI)
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion
English: Convulsions may occur with venlafaxine therapy.
Danish: Der kan forekomme kramper ved venlafaxinbehandling.
English: Not known: a high temperature with rigid muscles, confusion or agitation, and sweating, or if you experience jerky muscle movements which you can't control, these may be symptoms of serious conditions known as neuroleptic malignant syndrome; euphoric feelings, drowsiness, sustained rapid eye movement, clumsiness, restlessness, feeling of being drunk, sweating or rigid muscles, which are symptoms of serotonergic syndrome; disorientation and confusion often accompanied by hallucination (delirium); stiffness, spasms and involuntary movements of the muscles; thoughts of harming or killing yourself
Danish: Euforiske fornemmelser, døsighed, vedholdende hurtige øjenbevægelser, klodsethed, rastløshed, en følelse af at være fuld, svedtendens eller stive muskler, hvilket er symptomer på serotoninsyndrom: desorientering og forvirring ofte ledsaget af hallucinationer (delirum).
English: VANDRAL 50 mg comprimidos 50 mg
Danish: VANDRAL 50 mg comprimidos
English: Venlafaxine must be discontinued for at least 7 days before starting treatment with an irreversible MAOI (see sections 4.4 and 4.5).
Danish: Venlafaxin skal have været seponeret i mindst 7 dage, før behandling med en irreversibel MAOhæmmer påbegyndes (se pkt.
English: • Breathing disorders
Danish: • Luftvejssygdomme
English: Mucous membrane bleeding, Prolonged bleeding time, Thrombocytopaenia, Blood dyscrasias, (including agranulocytosis, aplastic anaemia, neutropaenia and pancytopaenia)
Danish: Blødning fra slimhinder, forlænget blødningstid, trombocytopeni, bloddyskrasier, (inkl.
English: Affects 1 to 10 users in 1,000
Danish: Ikke almindelig Påvirker 1 til 10 patienter ud af 1.000 Sjælden
English: Venlafaxine must not be initiated for at least 14 days after discontinuation of treatment with an irreversible non-selective MAOI.
Danish: Der skal gå mindst 14 dage efter seponering af behandling med en irreversibel, ikke-selektiv MAOhæmmer, inden behandling med venlafaxin må påbegyndes.
English: • Skin disorders
Danish: • Blodsygdomme
English: Co-administration of venlafaxine and weight loss agents is not recommended.
Danish: Samtidig behandling med venlafaxin og vægttabsmedicin frarådes.
English: Rare: a sensation of restlessness or an inability to sit or stand still; seizures or fits; feeling overexcited or euphoric
Danish: Sjælden: En følelse af rastløshed eller manglende evne til at sidde eller stå stille, kramper eller anfald, følelse af at være eksalteret eller euforisk Ikke kendt: Høj temperatur med stive muskler, forvirring eller ophidselse, svedtendens, eller hvis du oplever rykvise muskelbevægelser, som du ikke kan kontrollere.
English: HOW TO STORE EFEXOR
Danish: SÅDAN OPBEVARER DU EFEXOR
English: NAME OF THE MEDICINAL PRODUCT Efexor and associated names (see Annex I) 37.5 mg tablets [See Annex I - To be completed nationally] Venlafaxine
Danish: Efexor og tilhørende navne (se bilag I) 37.5 mg tabletter [Se bilag I - Udfyldes nationalt] Venlafaxin
English: PHARMACEUTICAL FORM Tablet.
Danish: Oversigt over indlægssedlen:
English: HOW TO TAKE EFEXOR
Danish: SÅDAN SKAL DU TAGE EFEXOR
English: Venlafaxine must not be initiated for at least 14 days after discontinuation of treatment with an irreversible MAOI.
Danish: Der skal gå mindst 14 dage efter seponering af behandling med en irreversibel MAO-hæmmer, inden behandling med venlafaxin må påbegyndes.
English: Common: yawning
Danish: Almindelig: Gaben
English: Neuroleptic Malignant
Danish: Nervesystem Mundtørhed hovedpine
English: BEFORE YOU TAKE EFEXOR
Danish: Hvis du har taget for meget Efexor
English: • Sight and hearing disorders Common: blurred vision
Danish: Almindelig: Sløret syn
English: NAME OF THE MEDICINAL PRODUCT Efexor and associated names (see Annex I) 50 mg tablets [See Annex I - To be completed nationally] Venlafaxine
Danish: Efexor og tilhørende navne (se bilag I) 50 mg tabletter [Se bilag I - Udfyldes nationalt] Venlafaxin
English: NAME OF THE MEDICINAL PRODUCT Efexor and associated names (see Annex I) 25 mg tablets [See Annex I - To be completed nationally] Venlafaxine
Danish: LÆGEMIDLETS NAVN Efexor og tilhørende navne (se bilag I)25 mg tabletter [Se bilag I - Udfyldes nationalt] Venlafaxin
English: NAME OF THE MEDICINAL PRODUCT Efexor and associated names (see Annex I) 75 mg tablets [See Annex I - To be completed nationally] Venlafaxine
Danish: Efexor og tilhørende navne (se bilag I) 75 mg tabletter [Se bilag I - Udfyldes nationalt] Venlafaxin
English: Yawning
Danish: Kramper
English: Digestive
Danish: Mundtørhed
English: CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of major depressive episodes.
Danish: Behandling af Major Depression (ICD-10 ”Moderat til svær depressiv episode”).
English: Moreover, the product was well tolerated.
Danish: Desuden var produktet veltolereret.
English: The reference product is authorised in Belgium since 1985.
Danish: Referenceproduktet har været godkendt i Belgien siden 1985.
English: It may be administered by parenteral route.
Danish: Det kan administreres parenteralt.
English: The product showed no accumulation during the treatment period (5 days).
Danish: Der sås ingen akkumulering af produktet i behandlingsperioden (5 dage).
English: Samples from treated animals were collected at 4, 8, 12, 16, 20, 24 and 28 days after the end of treatment.
Danish: Der blev indsamlet prøver fra behandlede dyr 4, 8, 12, 16, 20, 24 og 28 dage efter afsluttet behandling.
English: Belgium therefore considered that it is necessary to refer the matter to the CVMP in the interests of animal health and protecting consumer safety in the Union.
Danish: Belgien vurderede derfor, at det var nødvendigt at indbringe sagen for CVMP af hensyn til dyrenes sundhed og for at beskytte forbrugersikkerheden i EU.
English: Both the animal and analytical phases of the study were in compliance with GLP requirements and European guidelines.
Danish: Både studiets dyreforsøgs- og analysefaser opfyldte GLP-kravene og de europæiske retningslinjer.
English: The reference product is ‘Gabbrovet solution injectable', which has been authorised in a few Member States.
Danish: Referenceproduktet er "Gabbrovet solution injectable", der er godkendt i enkelte medlemsstater.
English: • If efficacy is demonstrated for a different dosage regimen compared to the authorised dosage regimen at the time of marketing authorisation suspension, the following points should be reviewed from a safety point of view:
Danish: • Hvis der påvises effekt ved et andet doseringsregime sammenholdt med det godkendte doseringsregime på tidspunktet for suspendering af markedsføringstilladelsen, bør følgende punkter gennemgås ud fra et sikkerhedsmæssigt synspunkt:
English: The target species are pigs and the route of administration is intramuscular.
Danish: Måldyrearten er svin, og administrationsvejen er intramuskulær.
English: Within this referral procedure, one of the marketing authorisation holders proposed the following indications as an amendment to the current indications:
Danish: I forbindelse med denne indbringelsesprocedure foreslog en af indehaverne af markedsføringstilladelsen indførelse af følgende indikationer som ændring af de nuværende indikationer:
English: The sampling size in target strains was not optimal to distinguish between wild type and a population with acquired resistance determinants.
Danish: Prøvestørrelsen for målstammerne var ikke optimal i forhold til at skelne mellem vildtype og en population med erhvervede resistensdeterminanter.
English: Hence, the veterinary medicinal product could be expected to be effective against E. coli as shown by the sensitivity results of a recent study, where 76% of the strains would be sensitive.
Danish: Derfor kunne veterinærlægemidlet forventes at være effektivt mod E. coli, som det fremgår af følsomhedsresultaterne fra et nyligt studie, hvor 76 % af stammerne var følsomme.
English: Due to the deficiencies noted in the study, a withdrawal period cannot be covered by any safety margin.
Danish: Med de mangler, der er bemærket i studiet, kan en tilbageholdelsestid ikke omfattes af en sikkerhedsmargin.
English: Moreover, product administration at an inappropriate dose poses an added risk of resistance development.
Danish: Administration af produktet i en uhensigtsmæssig dosis giver desuden en yderligere risiko for udvikling af resistens.
English: Paromomycin belongs to the group of aminoglycoside antibiotics.
Danish: Paromomycin tilhører gruppen af aminoglykosid-antibiotika.
English: Therefore a withdrawal period cannot be reliably estimated.
Danish: Derfor kan der ikke fastsættes en brugbar tilbageholdelsestid.
English: However, there are no pre-clinical and clinical data supporting the indication for the treatment of MMA in sows.
Danish: Der foreligger imidlertid ingen prækliniske og kliniske data, der understøtter indikationen behandling af MMA hos søer.
English: The national competent authorities shall ensure that the following conditions are fulfilled by the concerned marketing authorisation holders:
Danish: De nationale kompetente myndigheder skal sikre, at de berørte indehavere af markedsføringstilladelse opfylder nedenstående betingelser, idet de skal:
English: List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration, marketing authorisation holders in the Member States
Danish: Liste over veterinærlægemidlernes navne, lægemiddelformer, styrker, måldyrearter, administrationsveje og indehavere af markedsføringstilladelse i medlemsstaterne
English: Justification of the dose and the duration of treatment are required.
Danish: Dosen og behandlingsvarigheden skal underbygges.
English: The marketing authorisation holder also considered that the veterinary medicinal product could be used to treat Mastitis-Metritis-Agalactia (MMA) syndrome associated with E. coli, but acknowledged that further data are needed to assess the correct dose regimen in adult animals.
Danish: Indehaveren af markedsføringstilladelse vurderede også, at veterinærlægemidlet kan anvendes til behandling af mastitis-metritis-agalakti (MMA)-syndrom forbundet med E. coli, men anerkendte, at det er nødvendigt med flere data for at vurdere det rigtige dosisregime hos voksne dyr.
English: Overall summary of the scientific evaluation of Veterinary medicinal products containing paromomycin to be administered parenterally to pigs (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af paromomycin-holdige veterinærlægemidler, der administreres parenteralt til svin (se bilag I)
English: The most relevant tissues for the presence of paromomycin residue were muscle at the injection site and kidney.
Danish: De mest relevante væv, hvad angår restkoncentrationer af paromomycin, var muskelvævet ved injektionsstedet og nyrerne.
English: Furthermore, the duration of treatment has not been justified and no clinical data have been provided by the marketing authorisation holder to justify the recommended dose.
Danish: Derudover er behandlingsvarigheden ikke blevet godtgjort, og indehaveren af markedsføringstilladelse har ikke fremlagt kliniske data, der begrunder den anbefalede dosis.
English: The withdrawal period was determined in animals with a mean weight of 37.2 kg (range of 32 to 42.8 kg) treated according to the recommended posology at the longest duration of treatment.
Danish: Tilbageholdelsestiden blev fastsat hos dyr med en gennemsnitlig vægt på 37,2 kg (interval 3242,8 kg), der blev behandlet med den anbefalede dosis i den maksimale behandlingsvarighed.
English: Muscle of injection site is not the most reliable tissue for withdrawal time calculation, as it is often characterised by a high variability in residues levels, confirmed also in this case by the limited number of samples with concentrations above limit of quantification (2/4 on Day 12).
Danish: Muskelvæv ved injektionsstedet er ikke det mest velegnede væv til beregning af tilbageholdelsestiden, da dette væv ofte er kendetegnet ved stor variabilitet i restkoncentrationer, hvilket i dette tilfælde også bekræftes ved det begrænsede antal prøver med koncentrationer over kvantificeringsgrænsen (2/4 på dag 12).
English: In order to justify efficacy of the product, susceptibility data were provided for E. coli and A. pleuropneumoniae and a pharmacokinetics/pharmacodynamics (PK/PD) analysis was performed.
Danish: For at dokumentere produktets effekt blev der fremlagt følsomhedsdata for E. coli og A. pleuropneumoniae, og der blev udført en farmakokinetisk/farmakodynamisk analyse.
English: Paromomycin has broad spectrum activity against numerous Gram-positive and Gram-negative bacteria and acts in a concentrationdependent manner.
Danish: Paromomycin har bredspektret aktivitet mod en lang række grampositive og gramnegative bakterier og har koncentrationsafhængig effekt.
English: The veterinary medicinal products involved in this referral contain 250 mg/ml paromomycin sulfate as active substance (equivalent to 175 mg/ml paromomycin base or to a paromomycin activity of 175,000 IU/ml).
Danish: De veterinærlægemidler, der er omfattet af denne indbringelsesprocedure, indeholder 250 mg/ml paromomycinsulfat som aktivt stof (svarende til 175 mg/ml paromomycinbase eller en paromomycinaktivitet på 175.000 IE/ml).
English: The mechanism of action of paromomycin has been well described as well as the mechanisms of antimicrobial resistance to paromomycin.
Danish: Paromomycins virkningsmekanisme er velbeskrevet, og det samme gælder mekanismen for antimikrobiel resistens over for paromomycin.
English: In conclusion, the CVMP considered that the efficacy of these veterinary medicinal products was not supported for any indication and posology.
Danish: CVMP vurderer således, at effekten af disse veterinærlægemidler ikke er underbygget for nogen indikationer eller dosering.
English: Strength Pharmaceutical form
Danish: Styrke Lægemiddelform Dyrearter Administration svej
English: • To provide a benefit-risk assessment outlining that the clinical benefits of these veterinary medicinal products outweigh potential risks relating to animal health and the development of resistance, and (if applicable) environmental and user risks.
Danish: • Foretage en vurdering af benefit/risk-forholdet til bekræftelse af, at de kliniske fordele ved disse veterinærlægemidler opvejer de potentielle risici, hvad angår dyresundhed og udvikling af resistens samt (hvis relevant) de potentielle miljø- og brugerrisici.
English: An application was submitted under Article 13(1) of Directive 2001/82/EC, i.e. a generic application for a marketing authorisation under the decentralised procedure for the veterinary medicinal product ‘Parofor 175 mg/ml solution for injection', with Belgium as Reference Member State (BE/V/0027/003/DC).
Danish: Der blev indsendt en ansøgning i henhold til artikel 13, stk. 1, i direktiv 2001/82/EF, dvs. en generisk ansøgning om markedsføringstilladelse efter den decentrale procedure med Belgien som referencemedlemsstat for veterinærlægemidlet Parofor 175 mg/ml injektionsvæske, opløsning (BE/V/0027/003/DC).
English: The quantification of paromomycin in tissues was carried out by validated HPLC-MS/MS analytical methods.
Danish: Kvantificeringen af paromomycin i vævene blev udført under anvendelse af validerede HPLC- og MS/MS-analysemetoder.
English: Relevant clinical data (including GCP, randomised, blinded field study) are required for each claim related to a specific type of Escherichia coli.
Danish: Der skal foreligge relevante kliniske data (der omfatter et randomiseret, blindet GCP-feltstudie) for hver påberåbt behandlingseffekt ved en specifik type Escherichia coli.
English: Considering that colibacillosis is a disease complex (including neonatal diarrhoea, post-weaning diarrhoea, oedema disease, septicemia, polyserositis, coliform mastitis, and urinary tract infection) and is caused by different types of Escherichia coli (enteropathogenic E. coli, Shiga-toxin producing E. coli, enterotoxigenic E. coli, etc.), the marketing authorisation holders should define the clinical indication(s) as precisely as possible by including also the sub-category (age and production type) of the target animals.
Danish: Da colibacillose er et sygdomskompleks (neonatal diarré, diarré efter afvænning, ødemsyge, sepsis, polyserositis, coliform mastitis og urinvejsinfektion), der forårsages af forskellige typer Escherichia coli (enteropatogen E. coli, shigatoksin-producerende E. coli, enterotoksigen E. coli osv.), bør indehaverne af markedsføringstilladelse definere den eller de kliniske indikationer så nøjagtigt som muligt ved også at inkludere måldyrenes underkategori (alder og produktionstype).
English: Belgium Ceva Sante Animale NV Metrologielaan 6
Danish: Ceva Sante Animale NV Metrologielaan 6
English: For antimicrobials like paromomycin, whose efficacy is concentration-dependent, high plasma concentration levels relative to the MIC of the pathogen (Cmax/MIC ratio, also known as the inhibitory quotient or IQ) are a major determinant of clinical efficacy; a Cmax/MIC ratio > 8-10 is suggested to achieve optimal efficacy.
Danish: For antimikrobielle stoffer som paromomycin, hvis effekt er koncentrationsafhængig, er høje plasmaniveauer, hvad angår patogenets MIC (Cmax/MIC-ratio, også kaldet inhibitorisk kvotient (IQ)), en væsentlig determinant for klinisk effekt; en Cmax/MIC-ratio > 8-10 foreslås for at opnå optimal effekt.
English: Consequently, the Committee recommends the suspension of the existing marketing authorisations for the concerned veterinary medicinal products containing paromomycin to be administered parenterally to pigs.
Danish: Derfor anbefaler udvalget, at de eksisterende markedsføringstilladelser til de pågældende paromomycin-holdige veterinærlægemidler, der administreres parenteralt til svin, suspenderes.
English: Therefore, the indication against colibacillosis based on an overestimated success from a theoretical modelling, against E. coli strictly located in plasma, for an unjustified duration of treatment and not confirmed by clinical data, is not acceptable.
Danish: Indikationen behandling af colibacillose, der er baseret på et overvurderet positivt resultat fra en teoretisk model for behandling af E. coli i plasma alene, hvor behandlingsvarigheden ikke er godtgjort, og hvor der ikke foreligger underbyggende kliniske data, kan derfor ikke accepteres.
English: Moreover, this model holds true only for target strains in plasma or tissue sites with equivalent paromomycin distribution, no predictability can be expected against the pathogen located in other tissues.
Danish: Denne model er desuden kun relevant for målstammer i plasma eller vævsområder med ækvivalent paromomycin-fordeling, idet der ikke kan forventes nogen forudsigelighed over for patogenet i andre væv.
English: Scientific conclusions and grounds for suspension of the marketing authorisations
Danish: Videnskabelige konklusioner og begrundelser for suspendering af markedsføringstilladelserne
English: Samples of the target tissues were analysed by HPLC method coupled with MS/MS detection.
Danish: Prøver fra målvævene blev analyseret under anvendelse af HPLC-metoden kombineret med MS/MSmetoden.
English: During the aforementioned decentralised procedure, it has been noted that there are different approved indications, posology and withdrawal periods for veterinary medicinal products containing paromomycin to be administered parenterally to pigs across the European Union (EU).
Danish: I ovennævnte decentrale procedure er det blevet bemærket, at der er forskellige godkendte indikationer, doseringer og tilbageholdelsestider i den Europæiske Union (EU) for paromomycin-holdige veterinærlægemidler, der administreres parenteralt til svin.
English: Regarding A. pleuropneumoniae, the PK/PD analysis based on the inhibitory quotient (Cmax/MIC >8 to 10) shows that only 10% of the target bacterial population would be sensitive to paromomycin administered at the recommended posology.
Danish: Hvad angår A. pleuropneumoniae, viser den farmakokinetiske/farmakodynamiske analyse baseret på den inhibitoriske kvotient (Cmax/MIC > 8-10), at kun 10 % af målbakteriepopulationen vil være følsom over for paromomycin administreret i den anbefalede dosis.