FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon: Angioedema, rash generalised, skin discolouration, hyperhidrosis, rash papular, dermatitis bullous, swelling face, pigmentation disorder, dry skin, cold sweat, livedo reticularis, nail disorder, pruritus allergic, skin disorder
Danish: Ikke almindelig: Angioødem, generaliseret udslæt, misfarvning af huden, hyperhidrose, papuløst udslæt, bulløs dermatitis, hævelse i ansigtet, pigmentforstyrrelse, tør hud, koldsved, livedo reticularis, negleproblemer, allergisk pruritus, hudforstyrrelse
English: Uncommon: Death, multi-organ failure, oedema, administration site pain, catheter site haemorrhage, catheter site oedema, local swelling, generalised oedema, hernia, chest pain, influenza like illness, localised oedema, hypothermia, chills, feeling hot
Danish: Ikke almindelig: Død, multiorgansvigt, ødem, smerter på administrationsstedet, hæmoragi ved kateteret, ødem ved kateteret, lokal hævelse, generaliseret ødem, brok, brystsmerter, influenza-lignende symptomer, lokaliseret ødem, hypotermi, kulderystelser, varmefornemmelse
English: Uncommon: Haemarthrosis, musculoskeletal discomfort, sensation of heaviness
Danish: Ikke almindelig: Hæmartrose, muskuloskeletalt ubehag, tyngdefølelse
English: Uncommon: Circulatory collapse, venous thrombosis, vasculitis, thrombosis, hypertension, deep vein thrombosis, lymphoedema, phlebitis superficial, thrombophlebitis, blood pressure fluctuation, haemorrhage, angiopathy, hot flush, pallor
Danish: Ikke almindelig: Kredsløbskollaps, venetrombose, vaskulitis, trombose, hypertension, dyb venetrombose, lymfødem, superficiel flebitis, tromboflebitis, svingende blodtryk, hæmoragi, angiopati, hedeture, bleghed
English: In view of this, and of the potential for frailty and co-morbidities, elderly patients should be carefully monitored.
Danish: På den baggrund bør ældre patienter overvåges omhyggeligt, også under hensyn til deres potentielle skrøbelighed og komorbiditeter.
English: Oedema peripheral, pain, pyrexia, chest discomfort, hyperthermia, face oedema
Danish: Perifert ødem, smerter, pyreksi, ubehag i brystet, hypertermi, ansigtsødem
English: • cimetidine: a medicine to reduce stomach acid
Danish: • cimetidin: et lægemiddel mod for meget mavesyre
English: • Common (may affect up to 1 in 10 people):
Danish: • Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 patienter):
English: − N-(13-cis-retinoyl)-L-cysteic acid methyl ester sodium salt
Danish: − N-(13-cis-retinoyl)-L-cysteinsyre-methylester-natriumsalt
English: Abdominal pain, constipation, abdominal pain upper, flatulence, dry mouth, stomatitis
Danish: Mavesmerter, forstoppelse, smerter i øvre maveregion, flatulens, mundtørhed, stomatitis
English: • inflammation of the stomach lining, abdominal discomfort or bloating, lower abdominal pain
Danish: • betændelse i maveslimhinden, ubehag i maven (oppustethed), smerter i nedre maveregion
English: − N-(all-trans-retinoyl)-L-cysteic acid methyl ester sodium salt
Danish: − N-(all-trans-retinoyl)-L-cysteinsyre-methylester-natriumsalt
English: One vial of powder contains 60 mg paclitaxel.
Danish: Et hætteglas pulver indeholder 60 mg paclitaxel.
English: • liver inflammation or disorder, raised liver enzyme in your blood
Danish: • leverbetændelse eller forstyrret leverfunktion, forhøjede leverenzymer i blodet
English: • difficulty producing voice sounds
Danish: • problemer med stemmen
English: Talk to your doctor or nurse, if you are not sure if any of the above applies to you.
Danish: Spørg lægen eller sygeplejersken, hvis der er noget, du er i tvivl om.
English: In case of discolouration (orange), discard the vial.
Danish: Hvis pulveret er misfarvet (orange), skal hætteglasset kasseres.
English: − blood vessel inflammation
Danish: − betændelse i blodkar
English: No clinical studies in patients with renal impairment have been undertaken with Apealea (see section 4.2 for dose recommendations).
Danish: Der er ikke gennemført kliniske studier med Apealea hos patienter med nedsat leverfunktion (se pkt.
English: • If you have any further questions, ask your doctor or nurse.
Danish: • Spørg lægen eller sygeplejersken, hvis der er mere, du vil vide.
English: • disturbed blood clotting mechanisms in the body
Danish: • forstyrrelser i blodets evne til at størkne
English: The safety and efficacy of
Danish: Trafik- og arbejdssikkerhed
English: • reduced sense of touch or sensation
Danish: • nedsat berørings- eller følesans
English: Severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4).
Danish: Svær overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Very common: Neutropeniaa Common:
Danish: Blod og lymfesystem Meget almindelig: Neutropenia Almindelig:
English: Uncommon (may affect up to 1 in 100 people):
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter):
English: • chest pain or discomfort
Danish: • brystsmerter eller ubehag i brystet
English: • low muscle tone, facial palsy
Danish: • lav muskelspænding, lammet ansigtsmuskulatur
English: Uncommon: Cardiac arrest, cardiac failure chronic, cyanosis, atrial fibrillation, sinus tachycardia, palpitations, sinus bradycardia
Danish: Ikke almindelig: Hjertestop, kronisk hjerteinsufficiens, cyanose, atrieflimren, sinustakykardi, palpitationer, sinusbradykardi
English: Delay of next cycle Apealea/carboplatin
Danish: Paclitaxel Carboplatin
English: Breast-feeding (see section 4.6).
Danish: 6.1 (se pkt.
English: Frequency not known (cannot be estimated from the available data):
Danish: Frekvens ikke kendt (kan ikke estimeres ud fra forhåndenværende data): • rødme og hævelse af håndfladerne eller fodsålerne, som kan få huden til at skalle af
English: Uncommon: Respiratory failure, epistaxis, cough, rhinorrhoea, oropharyngeal pain, pharyngeal disorder, asphyxia, bronchospasm, dysphonia, rhinitis allergic, allergic cough, oropharyngeal discomfort Gastrointestinal disorders Very common: Diarrhoeaa, nauseaa, vomitinga
Danish: Ikke almindelig: Respirationsinsufficiens, næseblod, hoste, næseflåd, orofaryngeale smerter, forstyrrelser i svælget, asfyksi, bronkospasme, dysfoni, allergisk rhinitis, allergisk hoste, orofaryngealt ubehag
English: • low level of white blood cells called leukocytes and granulocytes
Danish: • lavt leukocyt- og granulocyt-tal (lavt antal af bestemte typer hvide blodlegemer)
English: Single-use vial
Danish: Lever og galdeveje
English: • dizziness or feeling of spinning
Danish: • svimmelhed eller ørhed
English: • bleeding into a joint
Danish: • blødning i led
English: Administration in patients with hepatic impairment defined as total bilirubin > 1 to ≤ 5 × ULN and AST ≤ 10 × ULN (see section 4.2) should therefore be performed with caution and they should be closely monitored with regard to increased liver impairment and myelosuppression.
Danish: Administration hos patienter med nedsat leverfunktion defineret som total bilirubin > 1-≤ 5 × ULN og ASAT ≤ 10 × ULN (se pkt.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Apealea in all subsets of the paediatric population in the treatment of ovarian carcinoma (excluding rhabdomyosarcoma and germ cell tumours), peritoneal carcinoma (excluding blastomas and sarcomas) and fallopian tube carcinoma (excluding rhabdomyosarcoma and germ cell tumours) (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Apealea i alle undergrupper af den pædiatriske population til behandling af ovariekarcinom (ekskl.
English: Uncommon: Abdominal distension, gastritis, abdominal discomfort, abdominal pain lower, dyspepsia, faecaloma, intestinal functional disorder, gingival bleeding, haematochezia, paraesthesia oral
Danish: Ikke almindelig: Oppustethed, gastritis, ubehag i maven, smerter i nedre maveregion, dyspepsi, fækalom, forstyrret tarmfunktion, tandkødsblødning, hæmatokeksi, oral paræstesi
English: • tissue swelling caused by excess fluid
Danish: • hævelse i vævet på grund af væskeophobning
English: • low level of white blood cells called neutrophils
Danish: • lavt neutrofil-tal (lavt antal af en bestemt type hvide blodlegemer)
English: • dry mouth, inflammation of the inner lining of the mouth
Danish: • mundtørhed, betændelse i mundslimhinden
English: Breast-feeding must be discontinued for the duration of therapy.
Danish: Patienten må ikke amme, så længe behandlingen varer.
English: Only reconstitute Apealea using one of the following commercially available solutions for reconstitution: - sodium chloride 9 mg/mL (0.9%) solution suitable for infusion; - lactated Ringer's solution suitable for infusion; - acetated Ringer's solution suitable for infusion.
Danish: • natriumchloridopløsning 9 mg/ml (0,9 %) egnet til infusion,
English: • lung failure, narrowing of airways
Danish: • lungesvigt, forsnævring af luftvejene
English: Shelf life after reconstitution
Danish: Holdbarhed efter rekonstitution
English: • breathing difficulties, nasal congestion
Danish: • vejrtrækningsbesvær, tilstoppet næse
English: Excipients
Danish: − hedeture
English: • hernia
Danish: • brok
English: • vaginal bleeding
Danish: • vaginalblødning
English: • abdominal pain, constipation, wind
Danish: • mavesmerter, forstoppelse, luft i maven
English: Hepatic impairment
Danish: n Hænde lser
English: − allergic reactions, such as breathing difficulties, fainting, swelling of the face, itching, feeling hot, chills, particularly during your infusion.
Danish: besvimelse, hævelse i ansigtet, kløe, varmefornemmelse, kulderystelser.
English: This is similar to that seen in most of the earlier studies.
Danish: Dette svarer til det, man har konstateret i de fleste tidligere undersøgelser.
English: Contact with skin and eyes should be avoided.
Danish: Kontakt med hud og øjne bør undgås.
English: MANUFACTURER'S BATCH NUMBER Lot {number}:
Danish: FREMSTILLERENS BATCHNUMMER Lot {nummer}:
English: 00330 Helsinki
Danish: 00330 Helsinki Finland
English: Chickens were authorised as a target species in Belgium, France, Hungary and Poland.
Danish: Kyllinger var tilladt som måldyreart i Belgien, Frankrig, Ungarn og Polen.
English: The main areas of disharmony in the existing product information relate to:
Danish: De vigtigste uoverensstemmelser mellem de eksisterende produktinformationer vedrører:
English: D-10785 Berlin
Danish: D-10785 Berlin Germany
English: The referral leads to full harmonisation of the product information.
Danish: Indbringelsen fører til en fuldstændig harmonisering af produktinformationen.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten efter “EXP”.
English: The following indications for Lincocin and its associated names can be supported based on the data provided:
Danish: Følgende indikationer for Lincocin og relaterede navne kan støttes på baggrund af de fremlagte data:
English: • The restriction of the indications to those that are adequately substantiated by efficacy data;
Danish: • Begrænsning af indikationerne til dem, der er tilstrækkeligt underbygget med data om virkning
English: EXP {month/year}: MMM/YY
Danish: EXP {måned/år}: MMM/ÅÅ
English: The description and validation of the GC/MS analytical method was considered acceptable.
Danish: Beskrivelsen og valideringen af GC/MS-analysemetoden blev betragtet som acceptabel.
English: Average daily water intake (litre/animal)
Danish: Gennemsnitligt dagligt vandindtag (liter/dyr)
English: As such, these data are considered to support extrapolation of the findings from the abovementioned studies conducted in the USA in the 1980s to the current EU situation.
Danish: Disse data anses som sådan for at underbygge en ekstrapolering af fundene fra ovennævnte undersøgelser, der blev udført i USA i 1980'erne, til den aktuelle situation i EU.
English: Both of these studies included 1116 birds which were divided into treatment and negative control groups.
Danish: Begge disse undersøgelser omfattede 1 116 fugle, der blev opdelt i behandlingsgrupper og negative kontrolgrupper.
English: Zoetis UK Limited 5th Floor, 6 St.
Danish: Storbritannien Zoetis UK Limited 5th Floor, 6 St.
English: Poland Zoetis Polska Sp. z o.o.
Danish: Zoetis Polska Sp. z o.o.
English: Do not eat, drink or smoke while handling the product.
Danish: Undlad at spise, drikke eller ryge under håndtering af produktet.
English: High concentrations of the active form are observed in the intestine.
Danish: Kraftige koncentrationer af den aktive form er observeret intestinalt.
English: ATC Vet Code: QJ01FF02
Danish: ATCvet-kode: QJ01FF02
English: Overall summary of the scientific evaluation of Lincocin and its associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Lincocin og relaterede navne (se bilag I)
English: The possible risk for the environment has not been considered as part of this referral.
Danish: Den mulige miljørisiko er ikke blevet taget i betragtning i forbindelse med denne indbringelse.
English: A single (optimal) dose level was considered
Danish: Et enkelt (optimalt) dosisniveau var at foretrække.
English: However, also see text under Special warnings for each target species.
Danish: Se dog også teksten under Særlige advarsler for hver dyreart.
English: Andrew Street London EC4A 3AE United Kingdom
Danish: London EC4A 3AE United Kingdom
English: This evaluation focuses on issues in regards to the harmonisation that may change the benefit-risk balance.
Danish: Vurderingen fokuserer på de punkter i forbindelse med harmoniseringen, som kan ændre benefit/risk-forholdet.
English: Dosing guidance and recommended doses:
Danish: Doseringsvejledning og anbefalede doser:
English: The European Commission referred the issue due to divergent national decisions having been taken by the Member States (EU/EEA) resulting in discrepancies in the product information for Lincocin and its associated names (thereafter called Lincocin).
Danish: Europa-Kommissionen indbragte sagen, fordi der som følge af divergerende nationale afgørelser truffet af medlemsstaterne (EU/EØS) er uoverensstemmelse mellem produktinformationerne for Lincocin og relaterede navne (herefter kaldet Lincocin).
English: After the end of the medication period, the water supply system should be cleaned appropriately to avoid intake of sub-therapeutic amounts of the active substance.
Danish: Efter medicineringsperioden bør vandforsyningssystemet renses behørigt for at undgå indtagelse af subterapeutiske mængder af det aktive stof.
English: To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.
Danish: For at sikre korrekt dosering bør kropsvægten bestemmes så nøjagtigt som muligt for at undgå underdosering.
English: In both studies significant differences were noted in mortality rates between birds treated with lincomycin (0% and 0.7%, respectively) and negative controls (14% and 7.5%, respectively).
Danish: I begge undersøgelser var der signifikante forskelle i dødelighedsprocenterne mellem fugle behandlet med lincomycin (henholdsvis 0 % og 0,7 %) og negative kontroller (henholdsvis 14 % og 7,5%).
English: The presence of the disease in the group must be established before the product is used.
Danish: Forekomst af sygdommen i bestanden skal fastlægges, før lægemidlet anvendes.
English: Satisfactory withdrawal periods have been set to provide assurance of consumer safety.
Danish: Der er fastsat tilfredsstillende tilbageholdelsestider til sikring af forbrugersikkerheden.
English: = ___ mg product per litre drinking water
Danish: = ___ mg produkt pr. liter drikkevand
English: The bioequivalence between the soluble powder and the premix formulation was investigated in two studies, but could not be formally demonstrated.
Danish: Bioækvivalensen mellem det opløselige pulver og premixformuleringen blev undersøgt i to undersøgelser, men kunne ikke formelt påvises.
English: Wash hands and any exposed skin with soap and water immediately after use.
Danish: Vask straks hænder og eventuel eksponeret hud med vand og sæbe efter brugen.
English: The uptake of water should be monitored frequently.
Danish: Vandindtaget bør monitoreres ofte.
English: The number of animals (18 castrated males and 18 females) included in the study and their weights (36.5 to 71 kg) were adequate.
Danish: Antallet af dyr (18 kastrerede hangrise og 18 hungrise) i undersøgelsen og deres vægt (36,5 til 71 kg) var passende.
English: The indication against swine dysentery caused by B. hyodysenteriae could no longer be maintained and was removed.
Danish: Indikationen mod svinedysenteri forårsaget af B. hyodysenteriae kunne ikke længere opretholdes og blev slettet.
English: No other source of drinking water should be available.
Danish: Der bør ikke være adgang til andre former for drikkevand.
English: The daily amount is to be added to the drinking water in such a way that all medication will be consumed within 24 hours.
Danish: Den daglige mængde skal føjes til drikkevandet på en sådan måde, at alt lægemiddel vil være indtaget i løbet af 24 timer.
English: However, as the dosing regimens and indications have not been extended, there is no increase in the exposure of the environment to the active substance.
Danish: Eftersom dosisregimerne og indikationerne ikke er blevet udvidet, er der dog ingen stigning i miljøets eksponering for det aktive stof.
English: Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used.
Danish: Der bør tages højde for officielle, nationale og regionale antibiotikapolitikker, når dette veterinærlægemiddel anvendes.
English: Repeated or prolonged use should be avoided by improving the farm management and hygiene practices.
Danish: Gentagen eller længerevarende brug bør undgås ved at forbedre driften af landbruget og dets hygiejnemæssige foranstaltninger.
English: The CVMP noted that a residue depletion study using Lincocin itself (or a bioequivalent product) would have been preferable.
Danish: CVMP bemærkede, at en restkoncentrationsundersøgelse med selve Lincocin (eller et bioækvivalent lægemiddel) ville have været at foretrække.
English: Germany Zoetis Deutschland GmbH
Danish: Zoetis Deutschland GmbH
English: The oral absorption of lincomycin was found to be 53% ± 19%.
Danish: Den orale absorption af lincomycin viste sig at være 53 % ± 19 %.
English: The doses used in these studies were in line with the proposed dose of 10 mg/kg body weight.
Danish: De doser, der blev brugt i disse undersøgelser, var i overensstemmelse med den foreslåede dosis på 10 mg/kg kropsvægt.
English: In case of insufficient uptake of water, pigs should be treated parenterally.
Danish: I tilfælde af utilstrækkeligt indtag af vand bør svin behandles parenteralt.
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: Oversigt over navne, lægemiddelform, styrker af veterinærlægemidlet, dyrearter, indgivelsesvej, indehaver af markedsføringstilladelsen i medlemslandene
English: Do not use in cases of known resistance to lincosamides.
Danish: Må ikke anvendes i tilfælde af kendt modstandsdygtighed over for lincosamider.
English: There is often complete cross-resistance between lincomycin and clindamycin.
Danish: Der er ofte komplet krydsresistens mellem lincomycin og clindamycin.
English: Once opened: use immediately.
Danish: Efter åbning: anvendes straks.
English: Given the results from the provided residue depletion study and the calculations made by the CVMP, a withdrawal period of 1 day was recommended.
Danish: I betragtning af resultaterne af den fremlagte restkoncentrationsundersøgelse og de beregninger, som CVMP har foretaget, blev en tilbageholdelsestid på 1 dag anbefalet.
English: The use of suitably calibrated weighing equipment is recommended if part packs are used.
Danish: Det anbefales at bruge vejeudstyr kalibreret på passende vis, hvis pakningerne anvendes delvist.
English: On rare occasions some pigs may show reddening of the skin and mild irritable behaviour.
Danish: Nogle svin kan i sjældne tilfælde udvise rødme af huden og en let irritabel adfærd.
English: • The revised harmonised SPC of Lincocin contains the necessary information to ensure the safe and effective use of the product.
Danish: • Det reviderede harmoniserede produktresumé for Lincocin indeholder de nødvendige oplysninger til at sikre risikofri og effektiv anvendelse af lægemidlet.
English: Allergic/hypersensitive reactions occur on rare occasions.
Danish: Allergiske reaktioner/overfølsomhedsreaktioner forekommer i sjældne tilfælde.
English: Pigs were already authorised as a target species for all products concerned by this referral procedure.
Danish: Svin var allerede tilladt som måldyreart for alle lægemidler, der er omfattet af denne indbringelsesprocedure.
English: • Withdrawal periods.
Danish: • Tilbageholdelsestider.
English: The elimination half-life of lincomycin is greater than 3 hours.
Danish: Halveringstiden for lincomycin overstiger 3 timer.
English: The concentration to be used depends on the actual body weight and the water consumption of the animals and can be calculated according to the following formula:
Danish: Den anvendte koncentration afhænger af den faktiske kropsvægt og dyrenes vandindtag og kan beregnes ud fra følgende formel:
English: The harmonised warnings and precautions proposed in the product information were considered adequate to ensure safety to users of the product.
Danish: De harmoniserede advarsler og forsigtighedsregler, der foreslås i produktinformationen, blev betragtet som tilstrækkelige til at garantere sikkerheden for lægemidlets brugere.
English: A withdrawal period of 1 day was therefore recommended for pig meat and offal as this gives a sufficient margin of safety.
Danish: Derfor anbefales en tilbageholdelsestid på 1 dag for kød og slagteaffald fra svin, da det giver en tilstrækkelig sikkerhedsmargin.
English: • The inclusion of information about resistance status and warnings about prudent use as regards resistance, in SPC sections 4.4 ‘Special warnings for each target species', 4.5 (i) ‘Special precautions for use in animals' and 5.1 ‘Pharmacodynamic properties'.
Danish: • Medtagelse af oplysninger om resistensstatus og advarsler om forsvarlig brug med hensyn til resistens i produktresuméets punkt 4.4 "Særlige advarsler for hver enkelt dyreart, som lægemidlet er beregnet til", 4.5 (i) "Særlige forsigtighedsregler vedrørende brug til dyr" og 5.1 "Farmakodynamiske egenskaber".
English: Lincomycin is eliminated unchanged or in the form of various metabolites in bile and urine.
Danish: Lincomycin elimineres uændret eller i form af forskellige metabolitter i galden og urinen.
English: Metabolites comprised more than 75% of total residues in the liver.
Danish: Metabolitter stod for mere end 75 % af de samlede rester i leveren.
English: The dosage of 3.9 mg/kg body weight was investigated in another two trials with similar designs, under simulated natural conditions.
Danish: En dosis på 3,9 mg/kg kropsvægt blev undersøgt i to andre undersøgelser med lignende design under simulerede naturlige betingelser.
English: The slaughter times (0 hours after 3 days of medication and 0, 6, 12 and 24 hours after 21 days of medication) were well distributed to support the proposed zero-day withdrawal period.
Danish: Slagtningstidspunkterne (0 timer efter 3 dages administration af lægemidlet og 0, 6, 12 og 24 timer efter 21 dages administration af lægemidlet) var godt fordelt og underbyggede den foreslåede tilbageholdelsestid på nul dage.
English: Resistance can be a direct concern when affecting zoonotic pathogens such as Campylobacter and Enterococcus, or can be transferred horizontally to human pathogens via mobile genetic elements.
Danish: Resistens kan være et direkte problem, når den omfatter zoonotiske patogener som Campylobacter og Enterococcus eller kan overføres horisontalt til humane patogener via mobile genetiske elementer.