FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/98/069/013 - Cartons of 28 film-coated tablets in all aluminium blisters EU/1/98/069/014 - Cartons of 50x1 film-coated tablets in all aluminium blisters EU/1/98/069/015 - Cartons of 84 film-coated tablets in all aluminium blisters EU/1/98/069/016 - Cartons of 100 film-coated tablets in all aluminium blisters EU/1/98/069/017 - Cartons of 30 film-coated tablets in all aluminium blisters EU/1/98/069/018 - Cartons of 90 film-coated tablets in all aluminium blisters EU/1/98/069/019 - Cartons of 14 film-coated tablets in all aluminium blisters EU/1/98/069/020 - Cartons of 7 film-coated tablets in all aluminium blisters
Danish: EU/1/98/069/013 - Pakning med 28 filmovertrukne tabletter i blisterkort af aluminium EU/1/98/069/014 - Pakning med 50x1 filmovertrukne tabletter i blisterkort af aluminium EU/1/98/069/015 - Pakning med 84 filmovertrukne tabletter i blisterkort af aluminium EU/1/98/069/016 - Pakning med 100 filmovertrukne tabletter i blisterkort af aluminium EU/1/98/069/017 - Pakning med 30 filmovertrukne tabletter i blisterkort af aluminium EU/1/98/069/018 - Pakning med 90 filmovertrukne tabletter i blisterkort af aluminium EU/1/98/069/019 - Pakning med 14 filmovertrukne tabletter i blisterkort af aluminium EU/1/98/069/020 - Pakning med 7 filmovertrukne tabletter i blisterkort af aluminium
English: Plavix 75 mg film-coated tablets Pink, round, biconvex, engraved with «75» on one side and «1171» on the other side.
Danish: Lyserøde, runde og bikonvekse, med tallet "75" præget på den ene side og tallet "1171" på den anden side.
English: EU/1/98/069/001 28 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/069/002 50x1 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/069/003 84 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/069/004 100 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/069/005 30 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/069/006 90 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/069/007 14 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/069/011 7 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/069/013 28 film-coated tablets in all aluminium blisters EU/1/98/069/014 50x1 film-coated tablets in all aluminium blisters EU/1/98/069/015 84 film-coated tablets in all aluminium blisters EU/1/98/069/016 100 film-coated tablets in all aluminium blisters EU/1/98/069/017 30 film-coated tablets in all aluminium blisters EU/1/98/069/018 90 film-coated tablets in all aluminium blisters EU/1/98/069/019 14 film-coated tablets in all aluminium blisters EU/1/98/069/020 7 film-coated tablets in all aluminium blisters
Danish: EU/1/98/069/001 28 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/98/069/002 50x1 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/98/069/003 84 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/98/069/004 100 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/98/069/005 30 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/98/069/006 90 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/98/069/007 14 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/98/069/011 7 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/98/069/013 28 filmovertrukne tabletter i blisterkort af aluminium EU/1/98/069/014 50x1 filmovertrukne tabletter i blisterkort af aluminium EU/1/98/069/015 84 filmovertrukne tabletter i blisterkort af aluminium EU/1/98/069/016 100 filmovertrukne tabletter i blisterkort af aluminium EU/1/98/069/017 30 filmovertrukne tabletter i blisterkort af aluminium EU/1/98/069/018 90 filmovertrukne tabletter i blisterkort af aluminium EU/1/98/069/019 14 filmovertrukne tabletter i blisterkort af aluminium EU/1/98/069/020 7 filmovertrukne tabletter i blisterkort af aluminium
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP
English: 6 months; prior intracerebral hemorrhage; significant thrombocytopenia (platelet count < 50 x 109/l);
Danish: Udelukkelseskriteriet var hovedsageligt patienter med følgende sygdomme; dokumenteret peptisk ulcus inden for de sidste 6 måneder, intracerebral blødning i anamnesen, signifikant trombocytopeni (trombocyttal <50 x 10
English: 5 How to store Plavix Contents of the pack and other information
Danish: Pakningsstørrelser og yderligere oplysninger
English: sanofi-aventis groupe 54, rue La Boétie F-75008 Paris France
Danish: sanofi-aventis groupe 54, rue La Boétie F-75008 Paris Frankrig
English: sanofi-aventis groupe 54, rue La Boétie - F-75008 Paris France
Danish: sanofi-aventis groupe 54, rue La Boétie - F-75008 Paris Frankrig
English: Calendar days Mon
Danish: Kalenderdage Ma
English: What Plavix looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Rare
Danish: Gynækomasti
English: Haematuria
Danish: Sø
English: Method of administration For oral use
Danish: Elimination Efter en oral dosis af
English: - If you have any side effects, including any side effects not listed in this leaflet, talk to your doctor or pharmacist.
Danish: - Kontakt lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
English: This may cause stomach upset or diarrhoea.
Danish: Plavix indeholder hydrogeneret ricinusolie Dette kan forårsage mavetilfælde eller diarré.
English: Epistaxis
Danish: Fr
English: The number of patients experiencing the co-primary endpoint (CV death, MI, stroke or refractory ischaemia) was 1,035 (16.5%) in the clopidogrel-treated group and 1,187 (18.8%) in the placebo-treated group, a 14% relative risk reduction (95% CI of 6%-21%, p=0.0005) for the clopidogrel-treated group.
Danish: Antallet af patienter, som oplevede det primære endepunkt [kardiovaskulært dødsfald, myokardieinfarkt, apopleksi eller refraktær iskæmi] var 1035 (16,5 %) i clopidogrelgruppen og 1187
English: Belgium Effik Benelux
Danish: Effik Benelux
English: Gedeon Richter România S.A.
Danish: Rumænien Gedeon Richter România S.A.
English: Belgium Exeltis Germany Gmbh Serisima Continu Dienogest 2mg Tablet, Ethinylestradiol 0.03mg Tablet $
Danish: Exeltis Germany Gmbh Serisima Continu Dienogest 2 mg tablet, ethinylestradiol 0,03 mg tablet $ placebo 0 mg tablet
English: Dienogest 2mg, Ethinylestradiol 0.03mg $ Lactose Anhydrous 37.26mg
Danish: Dienogest 2mg, ethinylestradiol 0,03 mg $ lactoseanhydrat 37,26mg
English: Dienogest 2mg Tablet, Ethinylestradiol 0.03mg Tablet $ Lactose Monohydrate 60.9mg Tablet
Danish: Dienogest 2 mg tablet, ethinylestradiol 0,03 mg tablet $ lactosemonohydrat 60,9 mg tablet
English: Dienogest 2mg Tablet, Ethinylestradiol 0.03mg Tablet $ Lactose Anhydrous 37.26mg Tablet
Danish: Dienogest 2 mg tablet, ethinylestradiol 0,03 mg tablet $ lactoseanhydrat 37,26 mg tablet
English: Mistral Continuous Dienogest 2mg, Ethinylestradiol 0.03mg $ Lactose Anhydrous 37.26mg
Danish: Mistral Continuous Dienogest 2mg, ethinylestradiol 0,03 mg $ lactoseanhydrat
English: Dienogest 2mg Tablet, Ethinylestradiol 0.03mg Tablet $ Lactose Monohydrate 55.5mg Tablet
Danish: Dienogest 2 mg tablet, ethinylestradiol 0,03 mg tablet $ lactosemonohydrat 55,5 mg tablet
English: Dienogest 2mg Tablet, Ethinylestradiol 0.03mg Tablet $ Lactose Monohydrate 55mg Tablet
Danish: Dienogest 2 mg tablet, ethinylestradiol 0,03 mg tablet $ lactosemonohydrat 55 mg tablet
English: Bulgaria
Danish: Belgien
English: INN & Strength
Danish: INN & Styrke
English: Plasma protein binding is high (over 90%).
Danish: Plasmaproteinbindingsevnen er høj (over 90%).
English: General warnings and advice relating to antimicrobial resistance have been strengthened.
Danish: Generelle advarsler og råd i forbindelse med antimikrobiel resistens er blevet styrket.
English: Do not smoke, eat or drink while handling the product.
Danish: Undgå at ryge, spise eller drikke under håndteringen af produktet.
English: The final conclusion for the benefit-risk balance for the use of the product remains positive.
Danish: Den endelige konklusion vedrørende benefit/risk-forholdet for brugen af lægemidlet er fortsat positiv.
English: ATC vet code: QJ 01 AA 02
Danish: ATCvet-kode: QJ 01 AA 02
English: • Indications;
Danish: • Indikationer;
English: The lack of an epidemiologically based surveillance programme and standardised susceptibility testing methodology complicates interpretation of reports.
Danish: Manglen på et epidemiologisk baseret overvågningsprogram og standardiseret metodologi til følsomhedstestning komplicerer fortolkningen af rapporterne.
English: Bioavailability in non-fasted pigs is approximately 21%.
Danish: Biotilgængeligheden hos fastende svin er cirka 21%.
English: During the treatment period animals should not have access to other water sources than the medicated water.
Danish: I behandlingsperioden må dyrene ikke have adgang til andre vandkilder end det medicinerede vand.
English: Wash hands and contaminated skin immediately after handling the product.
Danish: Vask hænder og kontamineret hud øjeblikkeligt efter håndtering af produktet.
English: It is clear that there are very limited scientific data available to support many of the proposed indications for use of the product, however it could be considered to have “well established use”.
Danish: Det fremgår klart, at der foreligger meget begrænsede videnskabelige data til at understøtte mange af de foreslåede indikationer for brug af lægemidlet, men det kan dog anses for at nyde "almindeligt anerkendt anvendelse".
English: Keep the bag tightly closed after first opening in order to protect from moisture.
Danish: Hold posen tæt tillukket efter første åbning for at beskytte mod fugt.
English: Overdoses up to 1.6 times the label recommended dose resulted in no clinical signs that could be attributed to treatment.
Danish: En overdosering på op til 1,6 gange den anbefalede dosis resulterede ikke i kliniske tegn, som kunne tilskrives behandlingen.
English: 1 gram of powder contains:
Danish: 1 gram pulver indeholder:
English: Medicated drinking water should be refreshed or replaced every 24 hours.
Danish: Det medicinerede drikkevand skal fornys eller udskiftes hver 24 timer.
English: The following formula can be used to calculate the concentration of the product in drinking water:
Danish: Nedenstående formel kan anvendes til beregning af produktkoncentrationen i drikkevandet:
English: For O. rhinotracheale, no therapeutic dose could be confirmed.
Danish: For O. rhinotracheale kunne der ikke bekræftes nogen terapeutisk dosis.
English: Tetracyclines may - in very rare cases - induce photosensitivity and allergic reactions.
Danish: Tetracycliner kan - i meget sjældne tilfælde - virke fotosensibiliserende og fremkalde allergiske reaktioner.
English: To ensure a correct dosage body weight should be determined as accurately as possible.
Danish: For at sikre en korrekt dosering skal kropsvægten bestemmes så nøjagtigt som muligt.
English: The daily amount is to be added to the drinking water such that all medication will be consumed in 24 hours.
Danish: Den daglige mængde skal tilsættes til drikkevandet på en sådan måde, at hele lægemiddelmængden indtages i løbet af 24 timer.
English: Pigs: - Meat and offal: 4 days
Danish: Svin: - Kød og indvolde: 4 dage
English: In order to obtain the correct dosage the concentration of doxycycline has to be adjusted accordingly.
Danish: For at opnå en korrekt dosering, skal koncentrationen af doxycyclin justeres i overensstemmelse hermed.
English: If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.
Danish: Hvis dette ikke er muligt, skal behandlingen baseres på lokale (regionale, på gårdniveau) epidemiologiske oplysninger om målbakteriens følsomhed.
English: No further clinical trial or field trial data were submitted.
Danish: Der blev ikke fremsendt yderligere data fra kliniske undersøgelser eller feltundersøgelser.
English: = .... mg product per l drinking water
Danish: = .... mg produkt per l drikkevand
English: There are no changes to the dosing regimen being proposed for either chickens or pigs therefore there will be no increased exposure of the environment to doxycycline.
Danish: Der er ikke nogen ændringer i den foreslåede dosering for hverken kyllinger eller svin, derfor vil der ikke være nogen øget eksponering af miljøet for doxycyclin.
English: There was no clear discrepancy between Member States in the dose regimen for use of the product in pigs.
Danish: Der var ikke nogen tydelig uoverensstemmelse mellem medlemsstaterne i doseringen til brug af lægemidlet hos svin.
English: Doxycycline is listed as a “highly important antimicrobial” for human use, and “critically important” for veterinary use according to the WHO criteria, 2007.
Danish: Doxycyclin er opført som et "yderst vigtigt antimikrobielt middel" til mennesker og er af "kritisk betydning" til veterinær brug i henhold til WHO-kriterierne, 2007.
English: In the event of eye or skin contact, rinse the affected area with large amounts of clean water and if irritation occurs, seek medical attention.
Danish: I tilfælde af øjen- eller hudkontakt skylles det ramte område med store mængder rent vand, og hvis der opstår irritation, søges lægehjælp.
English: It is recommended to prepare a concentrated pre-solution - approximately 100 grams product per litre drinking water - and to dilute this further to therapeutic concentrations if required.
Danish: Det anbefales at klargøre en koncentreret foropløsning - cirka 100 gram produkt per liter drikkevand - og efter behov fortynde denne foropløsning yderligere til terapeutiske koncentrationer.
English: Although resistance in the latter pathogens may be of less significance to public health, provision of an appropriate dosing regimen to limit the development of resistance is necessary to protect animal health.
Danish: Selvom resistens over for de sidstnævnte patogener muligvis har mindre betydning for folkesundheden, er det nødvendigt med et passende doseringsregime, som begrænser udviklingen af resistens, for at beskytte dyrs sundhed.
English: Especially cell-division and the formation of the cell wall are impaired.
Danish: Særligt hæmmes celledelingen og dannelsen af cellevæggen.
English: Alternatively, the concentrated solution can be used in a proportional water medicator.
Danish: Alternativt kan den koncentrerede opløsning anvendes i en proportionel medicinblander.
English: The use of suitably calibrated weighing equipment is recommended if part packs are used.
Danish: Det anbefales at anvende passende kalibreret vejeudstyr, hvis der kun anvendes en del af pakningens indhold.
English: Overall summary of the scientific evaluation of Doxyfar 50% and associated names (see annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Doxyfar 50% og relaterede navne (se bilag I)
English: Pigs and non-egg laying chickens.
Danish: Svin and non-egg laying Kyllinger.
English: In response to this the Marketing Authorisation Holder submitted PSUR data covering the past 5 years.
Danish: Som svar herpå fremsendte indehaveren af markedsføringstilladelsen PSUR-data, der dækker de seneste 5 år.
English: These warnings have been broadened to take account of resistance to tetracyclines recognised in isolates from pigs.
Danish: Disse advarsler er blevet udvidet til at tage højde for resistens over for tetracycliner, som er blevet fundet i isolater fra svin.
English: Use at minimum concentrations of 200 mg powder per litre drinking water in areas with hard alkaline drinking water (hardness above 10.2 °d and pH more than 8.1).
Danish: Brug en minimumskoncentration på 200 mg pulver per liter drikkevand i områder med hårdt, alkalisk drikkevand (hårdhed over 10,2 °d og pH på over 8,1).
English: Avoid direct contact with skin and eyes when handling the product to prevent sensitisation and contact dermatitis.
Danish: Undgå direkte kontakt med hud og øjne under håndteringen af produktet for at forebygge sensibilisering og kontaktdermatitis.
English: If no improvement in clinical signs is seen within this time, the diagnosis should be reviewed and treatment changed.
Danish: Hvis der ingen tegn ses på klinisk bedring i løbet af denne tidsperiode, skal diagnosen revideres, og behandlingen ændres.
English: The full text will be printed on the single sachet/bag Format used is especially for this type of labelling
Danish: Den fulde tekst trykkes på det enkelte brev/den enkelte pose Formatet er specifikt beregnet til denne type etikettering
English: Precipitation will occur in an alkaline solution.
Danish: Der opstår præcipitation i alkaliske opløsninger.
English: If the same feed is provided ad libitum throughout the day the lung concentration rises to 2.9 +/- 0.6 µg/ml.
Danish: Hvis det samme foder er til rådighed ad libitum i løbet af hele dagen, stiger lungekoncentrationen til 2,9 +/- 0,6 µg/ml.
English: Swelling of the face, lips or eyes, or difficulty with breathing are more serious symptoms and require urgent medical attention.
Danish: Hævelser af ansigt, læber eller øjne eller vejrtrækningsbesvær er alvorlige symptomer, som kræver øjeblikkelig lægehjælp.
English: Due to the divergent national decisions taken by Member States concerning the authorisation of Doxyfar 50 % and associated names, the issue was referred to CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve divergences amongst the nationally authorised Summary of Product Characteristics (SPC) across the European Union.
Danish: På grund af de divergerende nationale beslutninger truffet af medlemsstaterne vedrørende godkendelse af Doxyfar 50% og relaterede navne blev sagen indbragt for CVMP i henhold til artikel 34, stk. 1, i direktiv 2001/82/EF for at løse divergenser mellem de nationalt godkendte produktresuméer i EU.
English: mg product / kg body weight / day x
Danish: ..... mg produkt / kg kropsvægt / dag x
English: Tetracycline resistance is usually acquired by means of plasmids or other mobile elements (e.g. conjugative transposones).
Danish: Tetracyclinresistens erhverves normalt via plasmider eller andre mobile elementer (f.eks. konjugative transposoner).
English: The recommended dose in chickens is:
Danish: Den anbefalede dosis til kyllinger er:
English: The uptake of medicated drinking water depends on the clinical condition of the pigs/chickens.
Danish: Indtagelsen af medicineret drikkevand afhænger af svinenes/kyllingernes kliniske tilstand.
English: There have been no data to indicate increasing levels of resistance and the relevance of cross resistance between doxycycline and older tetracyclines was also discussed but again data were insufficient to enable firm conclusions to be reached.
Danish: Der har ikke været nogen data, der viste stigende resistensniveauer, og relevansen af krydsresistens mellem doxycyclin og ældre tetracycliner blev ligeledes diskuteret, men igen var dataene utilstrækkelige til, at der kunne opnås klare konklusioner.
English: Published data related to existing levels of resistance to doxycycline in target pathogens was also submitted.
Danish: Publicerede data vedrørende eksisterende resistensniveauer over for doxycyclin hos målpatogener blev også fremsendt.
English: In addition, no evidence from pharmacovigilance of serious risk has been demonstrated to be associated with the current dosing regimens for chickens or pigs and as such they can be maintained.
Danish: Desuden har ingen dokumentation fra lægemiddelovervågning påvist alvorlig risiko i forbindelse med de aktuelle doseringer for kyllinger eller svin, og de kan som sådan bibeholdes.
English: PROHIBITION OF SALE, SUPPLY AND/OR USE To be completed nationally
Danish: FORBUD MOD SALG, UDLEVERING OG/ELLER BRUG Udfyldes nationalt
English: Doxycyline hyclate can be considered to have “well established use”.
Danish: Doxycylinhyclat kan anses for at nyde "almindeligt anerkendt anvendelse".
English: In addressing the dosing regimen the Marketing Authorisation Holder has not discussed Pharmacokinetic/Pharmacodynamic in terms of a parameter that will limit the development of resistance.
Danish: Under håndteringen af doseringen har indehaveren af markedsføringstilladelsen ikke drøftet farmakodynamik og farmakokinetik i forhold til en parameter, som vil begrænse udviklingen af resistens.
English: The Marketing Authorisation Holder provided persuasive argument that in the field differentiation between Pasteurellosis and O. rhinotracheale in poultry could be readily achieved.
Danish: Indehaveren af markedsføringstilladelsen fremlagde overbevisende argumenter for, at der i felten let kunne opnås en differentiering mellem Pasteurellosis og O. rhinotracheale hos fjerkræ.
English: The recommended dose in pigs is:
Danish: Den anbefalede dosis til svin er:
English: Do not use in animals with an impaired liver function.
Danish: Må ikke anvendes til dyr med nedsat leverfunktion.
English: During preparation and administration of the medicated drinking water, skin contact with the product and inhalation of dust particles should be avoided.
Danish: Under klargøring og administration af det medicinerede drikkevand skal hudkontakt med produktet og indånding af støvpartikler undgås.
English: O. rhinotracheale.
Danish: rhinotracheale.
English: For Ornithobacterium rhinotracheale results demonstrate a great variation from high to low susceptibility, depending on the geographical region where isolates came from.
Danish: For Ornithobacterium rhinotracheale viser resultaterne en omfattende variation fra høj til lav følsomhed afhængig af, hvilken geografisk region isolaterne kom fra.
English: Data were inconclusive with regards to the indication for O. rhinotracheale, but it was concluded that on the basis of well established use and as there have been no reports of adverse events, including suspected lack of expected efficacy, the current dosage could be considered to be safe and effective.
Danish: Data med hensyn til indikationen for O. Rhinotracheale var ikke fyldestgørende, men det blev konkluderet, at på baggrund af en veldokumenteret brug, og eftersom der ikke har været nogen rapporter om bivirkninger, herunder formodning om manglende forventet virkning, kunne den aktuelle dosering betragtes som sikker og effektiv.
English: Doxycycline is absorbed in the stomach and the first part of the duodenum.
Danish: Doxycyclin absorberes i maven og i den første del af duodenum.
English: It was noted that there have been no “real” divergent decisions taken by the Member States regarding the target species (chickens and pigs) because the Marketing Authorisation Holder‘s decisions for inclusion/exclusion of chickens and/or pigs as target species were based on commercial grounds and the data in support of the applications was the same.
Danish: Det blev bemærket, at der ikke er blevet truffet nogen "virkeligt" divergerende beslutninger af medlemsstaterne vedrørende de dyrearter, som lægemidlet er beregnet til (kyllinger og svin), eftersom indehaveren af markedsføringstilladelsens beslutning om medtagelse/udelukkelse af kyllinger og/eller svin som dyrearter, som lægemidlet er beregnet til, var baseret på kommercielle begrundelser, og dataene til støtte for ansøgningerne var de samme.
English: 6 The ARBAO-II study, Occurrence of antimicrobial resistance among bacterial pathogens and indicator bacteria in pigs in different European countries form year 2002-2004, Acta Veterinaria Scandinavica 50(19) (2008)
Danish: Chemotherapy 63, 7336The ARBAO-II study, Occurrence of antimicrobial resistance among bacterial pathogens and indicator bacteria in pigs in different European countries form year 2002-2004, Acta Veterinaria Scandinavica 50(19) (2008)
English: No negative effects were observed in poultry after the administration of therapeutic doses of doxycycline.
Danish: Der sås ingen negative effekter i fjerkræ efter administration af terapeutiske doser doxycyclin.
English: • Withdrawal periods.
Danish: • Tilbageholdelsestid.
English: From these data it may be predicted that doxycycline concentrations would exceed the MIC in the target tissue for the majority of the named pathogens in pigs.
Danish: Ud fra disse data kan det forudsiges, at doxycyclinkoncentrationerne vil overstige MIC i målvævet for de fleste af de navngivne patogener hos svin.