natgillin/translations-raw huggingface dataset:
Almindelig: Unormale drømme, nedsat libido, svimmelhed, øget muskeltonus, søvnløshed, nervøsitet, sovende fornemmelse, mathed, rystelser, forvirring, følelse af at være adskilt fra 
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
Dobupal 75 mg comprimidos 
Dobupal 75 mg comprimidos 75 mg
• Fordøjelsesforstyrrelser 
• Digestive disorders
Imipramin påvirkede ikke venlafaxins og O-desmethylvenlafaxins farmakokinetik. 
Imipramine did not affect the pharmacokinetics of venlafaxine and O-desmethylvenlafaxine.
Venlafaxin har ingen MAO-hæmmende aktivitet. 
Venlafaxine does not possess monoamine oxidase (MAO) inhibitory activity.
Trevilor Tabletten 75mg 75 mg 
Trevilor Tabletten 75mg
Indinavir påvirkede ikke venlafaxins og O-desmethylvenlafaxins farmakokinetik. 
Indinavir did not affect the pharmacokinetics of venlafaxine and O-desmethylvenlafaxine.
Asteni (træthed), kuldegysninger 
Asthenia (fatigue), Chills
dystoni og dyskinesi), tardive dyskinesier, suicidale forestillinger og adfærd** 
Syndrome (NMS), Serotonergic syndrome, Delirium, Extrapyramidal reactions (including dystonia and dyskinaesia), Tardive dyskinaesia, Suicidal ideation and behaviours**
VANDRAL 75 mg comprimidos 
VANDRAL 75 mg comprimidos 75 mg
Dobupal 37,5 mg comprimidos 
Dobupal 37,5 mg comprimidos 37.5 mg
Ikke almindelig: Abnorm orgasme (kvinder) 
Abnormal ejaculation/orgasm (males),
4.5 Interaktion med andre lægemidler og andre former for interaktion 
4.5 Interaction with other medicinal products and other forms of interaction Monoamine Oxidase Inhibitors (MAOI)
Der kan forekomme kramper ved venlafaxinbehandling. 
Convulsions may occur with venlafaxine therapy.
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). 
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
VANDRAL 50 mg comprimidos 
VANDRAL 50 mg comprimidos 50 mg
Venlafaxin skal have været seponeret i mindst 7 dage, før behandling med en irreversibel MAOhæmmer påbegyndes (se pkt. 
Venlafaxine must be discontinued for at least 7 days before starting treatment with an irreversible MAOI (see sections 4.4 and 4.5).
• Luftvejssygdomme 
• Breathing disorders
Blødning fra slimhinder, forlænget blødningstid, trombocytopeni, bloddyskrasier, (inkl. 
Mucous membrane bleeding, Prolonged bleeding time, Thrombocytopaenia, Blood dyscrasias, (including agranulocytosis, aplastic anaemia, neutropaenia and pancytopaenia)
Ikke almindelig Påvirker 1 til 10 patienter ud af 1.000 Sjælden 
Affects 1 to 10 users in 1,000
Der skal gå mindst 14 dage efter seponering af behandling med en irreversibel, ikke-selektiv MAOhæmmer, inden behandling med venlafaxin må påbegyndes. 
Venlafaxine must not be initiated for at least 14 days after discontinuation of treatment with an irreversible non-selective MAOI.
• Blodsygdomme 
• Skin disorders
Samtidig behandling med venlafaxin og vægttabsmedicin frarådes. 
Co-administration of venlafaxine and weight loss agents is not recommended.
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. 
Rare: a sensation of restlessness or an inability to sit or stand still; seizures or fits; feeling overexcited or euphoric
SÅDAN OPBEVARER DU EFEXOR 
HOW TO STORE EFEXOR
Efexor og tilhørende navne (se bilag I) 37.5 mg tabletter [Se bilag I - Udfyldes nationalt] Venlafaxin 
NAME OF THE MEDICINAL PRODUCT Efexor and associated names (see Annex I) 37.5 mg tablets [See Annex I - To be completed nationally] Venlafaxine
Oversigt over indlægssedlen: 
PHARMACEUTICAL FORM Tablet.
SÅDAN SKAL DU TAGE EFEXOR 
HOW TO TAKE EFEXOR
Der skal gå mindst 14 dage efter seponering af behandling med en irreversibel MAO-hæmmer, inden behandling med venlafaxin må påbegyndes. 
Venlafaxine must not be initiated for at least 14 days after discontinuation of treatment with an irreversible MAOI.
Almindelig: Gaben 
Common: yawning
Nervesystem Mundtørhed hovedpine 
Neuroleptic Malignant
Hvis du har taget for meget Efexor 
BEFORE YOU TAKE EFEXOR
Almindelig: Sløret syn 
• Sight and hearing disorders Common: blurred vision
Efexor og tilhørende navne (se bilag I) 50 mg tabletter [Se bilag I - Udfyldes nationalt] Venlafaxin 
NAME OF THE MEDICINAL PRODUCT Efexor and associated names (see Annex I) 50 mg tablets [See Annex I - To be completed nationally] Venlafaxine
LÆGEMIDLETS NAVN Efexor og tilhørende navne (se bilag I)25 mg tabletter [Se bilag I - Udfyldes nationalt] Venlafaxin 
NAME OF THE MEDICINAL PRODUCT Efexor and associated names (see Annex I) 25 mg tablets [See Annex I - To be completed nationally] Venlafaxine
Efexor og tilhørende navne (se bilag I) 75 mg tabletter [Se bilag I - Udfyldes nationalt] Venlafaxin 
NAME OF THE MEDICINAL PRODUCT Efexor and associated names (see Annex I) 75 mg tablets [See Annex I - To be completed nationally] Venlafaxine
Kramper 
Yawning
Mundtørhed 
Digestive
Behandling af Major Depression (ICD-10 ”Moderat til svær depressiv episode”). 
CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of major depressive episodes.
Desuden var produktet veltolereret. 
Moreover, the product was well tolerated.
Referenceproduktet har været godkendt i Belgien siden 1985. 
The reference product is authorised in Belgium since 1985.
Det kan administreres parenteralt. 
It may be administered by parenteral route.
Der sås ingen akkumulering af produktet i behandlingsperioden (5 dage). 
The product showed no accumulation during the treatment period (5 days).
Der blev indsamlet prøver fra behandlede dyr 4, 8, 12, 16, 20, 24 og 28 dage efter afsluttet behandling. 
Samples from treated animals were collected at 4, 8, 12, 16, 20, 24 and 28 days after the end of treatment.
Belgien vurderede derfor, at det var nødvendigt at indbringe sagen for CVMP af hensyn til dyrenes sundhed og for at beskytte forbrugersikkerheden i EU. 
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.
Både studiets dyreforsøgs- og analysefaser opfyldte GLP-kravene og de europæiske retningslinjer. 
Both the animal and analytical phases of the study were in compliance with GLP requirements and European guidelines.
Referenceproduktet er "Gabbrovet solution injectable", der er godkendt i enkelte medlemsstater. 
The reference product is ‘Gabbrovet solution injectable', which has been authorised in a few Member States.
• 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: 
• 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:
Måldyrearten er svin, og administrationsvejen er intramuskulær. 
The target species are pigs and the route of administration is intramuscular.
I forbindelse med denne indbringelsesprocedure foreslog en af indehaverne af markedsføringstilladelsen indførelse af følgende indikationer som ændring af de nuværende indikationer: 
Within this referral procedure, one of the marketing authorisation holders proposed the following indications as an amendment to the current indications:
Prøvestørrelsen for målstammerne var ikke optimal i forhold til at skelne mellem vildtype og en population med erhvervede resistensdeterminanter. 
The sampling size in target strains was not optimal to distinguish between wild type and a population with acquired resistance determinants.
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. 
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.
Med de mangler, der er bemærket i studiet, kan en tilbageholdelsestid ikke omfattes af en sikkerhedsmargin. 
Due to the deficiencies noted in the study, a withdrawal period cannot be covered by any safety margin.
Administration af produktet i en uhensigtsmæssig dosis giver desuden en yderligere risiko for udvikling af resistens. 
Moreover, product administration at an inappropriate dose poses an added risk of resistance development.
Paromomycin tilhører gruppen af aminoglykosid-antibiotika. 
Paromomycin belongs to the group of aminoglycoside antibiotics.
Derfor kan der ikke fastsættes en brugbar tilbageholdelsestid. 
Therefore a withdrawal period cannot be reliably estimated.
Der foreligger imidlertid ingen prækliniske og kliniske data, der understøtter indikationen behandling af MMA hos søer. 
However, there are no pre-clinical and clinical data supporting the indication for the treatment of MMA in sows.
De nationale kompetente myndigheder skal sikre, at de berørte indehavere af markedsføringstilladelse opfylder nedenstående betingelser, idet de skal: 
The national competent authorities shall ensure that the following conditions are fulfilled by the concerned marketing authorisation holders:
Liste over veterinærlægemidlernes navne, lægemiddelformer, styrker, måldyrearter, administrationsveje og indehavere af markedsføringstilladelse i medlemsstaterne 
List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration, marketing authorisation holders in the Member States
Dosen og behandlingsvarigheden skal underbygges. 
Justification of the dose and the duration of treatment are required.
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. 
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.
Samlet resumé af den videnskabelige vurdering af paromomycin-holdige veterinærlægemidler, der administreres parenteralt til svin (se bilag I) 
Overall summary of the scientific evaluation of Veterinary medicinal products containing paromomycin to be administered parenterally to pigs (see Annex I)
De mest relevante væv, hvad angår restkoncentrationer af paromomycin, var muskelvævet ved injektionsstedet og nyrerne. 
The most relevant tissues for the presence of paromomycin residue were muscle at the injection site and kidney.
Derudover er behandlingsvarigheden ikke blevet godtgjort, og indehaveren af markedsføringstilladelse har ikke fremlagt kliniske data, der begrunder den anbefalede dosis. 
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.
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. 
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.
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). 
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).
For at dokumentere produktets effekt blev der fremlagt følsomhedsdata for E. coli og A. pleuropneumoniae, og der blev udført en farmakokinetisk/farmakodynamisk analyse. 
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.
Paromomycin har bredspektret aktivitet mod en lang række grampositive og gramnegative bakterier og har koncentrationsafhængig effekt. 
Paromomycin has broad spectrum activity against numerous Gram-positive and Gram-negative bacteria and acts in a concentrationdependent manner.
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). 
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).
Paromomycins virkningsmekanisme er velbeskrevet, og det samme gælder mekanismen for antimikrobiel resistens over for paromomycin. 
The mechanism of action of paromomycin has been well described as well as the mechanisms of antimicrobial resistance to paromomycin.
CVMP vurderer således, at effekten af disse veterinærlægemidler ikke er underbygget for nogen indikationer eller dosering. 
In conclusion, the CVMP considered that the efficacy of these veterinary medicinal products was not supported for any indication and posology.
Styrke Lægemiddelform Dyrearter Administration svej 
Strength Pharmaceutical form
• 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. 
• 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.
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). 
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).
Kvantificeringen af paromomycin i vævene blev udført under anvendelse af validerede HPLC- og MS/MS-analysemetoder. 
The quantification of paromomycin in tissues was carried out by validated HPLC-MS/MS analytical methods.
Der skal foreligge relevante kliniske data (der omfatter et randomiseret, blindet GCP-feltstudie) for hver påberåbt behandlingseffekt ved en specifik type Escherichia coli. 
Relevant clinical data (including GCP, randomised, blinded field study) are required for each claim related to a specific type of Escherichia coli.
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). 
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.
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. 
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.
Derfor anbefaler udvalget, at de eksisterende markedsføringstilladelser til de pågældende paromomycin-holdige veterinærlægemidler, der administreres parenteralt til svin, suspenderes. 
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.
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. 
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.
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. 
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.
Videnskabelige konklusioner og begrundelser for suspendering af markedsføringstilladelserne 
Scientific conclusions and grounds for suspension of the marketing authorisations
Prøver fra målvævene blev analyseret under anvendelse af HPLC-metoden kombineret med MS/MSmetoden. 
Samples of the target tissues were analysed by HPLC method coupled with MS/MS detection.
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. 
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).
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. 
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.
Ved E. coli var den farmakokinetiske/farmakodynamiske analyse kun favorabel for stammer med en MIC-værdi på 4,44 µg/ml eller derunder. 
In the case of E. coli, the PK/PD analysis was only favourable for strains with MICs equal to or below 4.44 µg/ml.
Endelig kan den farmakokinetiske/farmakodynamiske model ikke godtgøre behandlingsvarigheden. 
Finally the PK/PD model does not allow justifying the duration of treatment.
• Fremskaffe relevante kliniske data til understøttelse af indikationen behandling af colibacillose ved den anbefalede dosis og behandlingsvarighed. 
• To provide adequate clinical data in support of an indication against colibacillosis at the recommended dose and duration of treatment.
CVMP blev anmodet om at gennemgå alle tilgængelige prækliniske/kliniske data og restkoncentrationsdata for paromomycin-holdige veterinærlægemidler, der administreres parenteralt til svin, og anbefale relevante indikationer, doseringer og tilbageholdelsestider. 
The CVMP was requested to review all available pre-clinical, clinical and residue depletion data for veterinary medicinal products containing paromomycin to be administered parenterally to pigs and recommend appropriate indications, dosing recommendations and withdrawal periods.
Samme indehaver af markedsføringstilladelse fremlagde data for at understøtte anvendelse af "Gabbrovet solution injectable" hos svin i en dosis på 14 mg paromomycinbase/kg kropsvægt i 5 dage i træk. 
The same marketing authorisation holder provided data in order to justify the use of ‘Gabbrovet solution injectable' in pigs at a dose of 14 mg paromomycin base/kg bodyweight for 5 consecutive days.
På baggrund af de forhold, der er beskrevet i indbringelsesanmeldelsen, blev CVMP også anmodet om at anbefale, hvorvidt markedsføringstilladelserne til de pågældende veterinærlægemidler bør opretholdes, ændres, suspenderes eller tilbagekaldes. 
The CVMP was also asked to recommend whether in view of the elements described in the referral notification the marketing authorisations for the veterinary medicinal products concerned should be maintained, varied, suspended, or withdrawn.
De mangler, der er bemærket i studiet (fravær af data om opbevaringsstabilitet, det brede interval af restkoncentration fundet i muskelprøver og fravær af en ringprøve i forbindelse med prøvetagning fra injektionsstedet), kan imidlertid ikke omfattes af en sikkerhedsmargin. 
However, the deficiencies noted in the study (absence of data on storage stability, the wide recovery rates in muscle samples and the absence of ring sample in the sampling of the injection site) cannot be covered by any safety span.
• Fremskaffe relevante kliniske data (der omfatter et randomiseret, blindet GCP-feltstudie) til understøttelse af behandling af pleuropneumoni forårsaget af Actinobacillus pleuropneumoniae ved den anbefalede dosis og behandlingsvarighed. 
• To provide adequate clinical data (including GCP, randomised, blinded field study) in support of the treatment of pleuropneumonia caused by Actinobacillus pleuropneumoniae at the recommended dose and duration of treatment.
Denne indbringelsesprocedure omfatter ikke sikkerhed for måldyrearten, men der er ingen kendte bivirkninger hos svin. 
While target animal safety was not in the scope of this referral, there are no known adverse events in pigs.