FrancophonIA/ELRC3.0 huggingface dataset:
English: These related to the risk of cross-contamination (the possible transfer of one medicine to another) and deficiencies in the systems for ensuring medicines' quality (quality assurance).
Danish: Disse vedrørte risikoen for krydskontaminering (den mulige overførsel af ét lægemiddel til et andet) og mangler i systemerne til kvalitetssikring af lægemidlerne.
English: On 15 September the European Medicines Agency (EMA) recommended that medicines manufactured by Pharmaceutics International Inc, located in the United States, should no longer be available in the EU, except Ammonaps (sodium phenylbutyrate), which is considered critical for public health.
Danish: Den 15. september anbefalede Det Europæiske Lægemiddelagentur (EMA), at lægemidler, der er fremstillet af Pharmaceutics International Inc. i USA, ikke længere skulle være til rådighed i EU, bortset fra Ammonaps (natriumphenylbutyrat), der anses for kritisk vigtigt for den offentlige sundhed.
English: The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which has adopted the Agency's opinion.
Danish: Gennemgangen blev foretaget af Udvalget for Lægemidler til Mennesker (CHMP), som har ansvar for spørgsmål vedrørende lægemidler til mennesker, og som har vedtaget agenturets endelige udtalelse.
English: Although there was no evidence of a defect in any of the medicines produced at the site or of harm to patients, the site was required to implement corrective measures to ensure compliance with GMP standards.
Danish: Skønt der ikke var tegn på mangler i nogen af de lægemidler, der var fremstillet på fremstillingsstedet, eller på, at patienter havde lidt skade, blev det krævet, at der på fremstillingsstedet skulle gennemføres korrigerende foranstaltninger for at sikre overholdelse af GMP-standarderne.
English: The recommendation from EMA's Committee for Medicinal Products for Human Use (CHMP) has the following impact on availability of medicines from Pharmaceutics International Inc:
Danish: Anbefalingen fra EMA's Udvalg for Lægemidler til Mennesker (CHMP) vil få følgende betydning for tilgængeligheden af lægemidler fra Pharmaceutics International Inc.:
English: There were also problems with the way data were generated and checked and deficiencies in the systems for ensuring medicines' quality (quality assurance).
Danish: Der var desuden problemer, hvad angår den måde, data blev genereret og kontrolleret på, og der var mangler i systemerne til kvalitetssikring af lægemidlerne.
English: In EU countries where treatment alternatives exist, Ammonaps will be recalled.
Danish: I EU-lande, hvor der forefindes andre behandlingsmuligheder, vil Ammonaps blive tilbagekaldt.
English: • Failings have been found at a manufacturing site in the United States that produces medicines marketed in the EU.
Danish: • Der er fundet mangler på fremstillingsstedet i USA for visse lægemidler, der markedsføres i EU.
English: Ammonaps granules should only be used in patients who have a feeding tube such as a nasogastric tube or gastrostomy and require the medicine.
Danish: Ammonaps granulat bør kun anvendes hos patienter, som får sondemad gennem en nasogastrisk sonde eller gastrostomi og behøver lægemidlet.
English: Ammonaps may still be supplied where no alternatives are available
Danish: Ammonaps kan stadig udleveres, når der ikke forefindes alternativer
English: • In patients receiving Ammonaps orally (either as tablets or granules), other phenylbutyratecontaining medicines should be considered instead.
Danish: • Ved oral anvendelse af Ammonaps (enten som tabletter eller granulat) bør andre lægemidler indeholdende phenylbutyrat overvejes i stedet.
English: The medicines that are produced at the Pharmaceutics International Inc site in the United States are: Ammonaps (sodium phenylbutyrate), Dutasteride Actavis (dutasteride), Lutigest/Lutinus (progesterone) and SoliCol D3 (colecalciferol).
Danish: De lægemidler, der fremstilles på fremstillingsstedet Pharmaceutics International Inc. i USA, er: Ammonaps (natriumphenylbutyrat), Dutasteride Actavis (dutasterid), Lutigest/Lutinus (progesteron) og SoliCol D3 (cholecalciferol).
English: • The manufacturing site Pharmaceutics International Inc in the United States which makes a number of medicines has been found to have several shortcomings in its good manufacturing practice.
Danish: • På fremstillingsstedet Pharmaceutics International Inc. i USA fremstilles der en række lægemidler, som er konstateret at være behæftet med en række mangler, hvad angår god fremstillingspraksis.
English: Pharmaceutics International Inc, US: supply of noncritical medicines to EU stopped due to manufacturing failings
Danish: Pharmaceutics International Inc., USA: Udlevering af lægemidler af ikkekritisk betydning i EU standset på grund af fremstillingsmæssige mangler
English: Although there was no evidence of harm or lack of effectiveness with any of the medicines, as a precaution, non-critical medicines from this site are no longer available in the EU.
Danish: Der var ikke tegn på skade eller manglende virkning i forbindelse med nogen af disse lægemidler, men som sikkerhedsforanstaltning er lægemidler af ikkekritisk betydning fra dette fremstillingssted ikke længere tilgængelige i EU.
English: Ammonaps should only be used in patients when no alternative treatment is available.
Danish: Ammonaps bør kun anvendes, når der ikke forefindes andre behandlingsmuligheder.
English: • SoliCol D3 (cholecalciferol), a medicine for vitamin D deficiency which is also exclusively produced at Pharmaceutics International Inc but has not yet been marketed in the EU, will not be made available in the EU.
Danish: • SoliCol D3 (cholecalciferol), som er et lægemiddel mod vitamin D-mangel, der ligeledes udelukkende fremstilles hos Pharmaceutics International Inc., men endnu ikke er markedsført i EU, vil ikke blive tilgængeliggjort i EU.
English: • Other Pharmaceutics International Inc medicines have alternative manufacturing sites and therefore their availability is unaffected.
Danish: • Andre lægemidler fra Pharmaceutics International Inc. fremstilles på andre fremstillingssteder, og deres tilgængelighed vil derfor ikke blive berørt.
English: The review was started after a follow-up inspection of the site by the UK medicines regulatory agency (MHRA) and the US FDA.
Danish: Gennemgangen blev iværksat, efter at Det Forenede Kongeriges lægemiddelstyrelse (MHRA) og USA's FDA havde foretaget en opfølgende inspektion på fremstillingsstedet.
English: • Other medicines (Dutasteride Actavis (dutasteride), Lutigest/Lutinus (progesterone), and associated names) produced at the site have alternative manufacturing sites and the availability of these medicines is unaffected.
Danish: • Andre lægemidler (Dutasteride Actavis (dutasterid), Lutigest/Lutinus (progesteron) og relaterede navne), der fremstilles på fremstillingsstedet, har alternative fremstillingssteder, og deres tilgængelighed berøres ikke.
English: • One of the medicines affected, Ammonaps (sodium phenylbutyrate), used to treat inherited metabolic disorders, is considered a critical medicine and remains on the market where there are no alternatives.
Danish: • Et af de berørte lægemidler, Ammonaps (natriumphenylbutyrat), som anvendes til behandling af arvelige stofskiftesygdomme, anses for at være et lægemiddel af kritisk betydning og vil fortsat være på markedet, hvor der ikke er andre behandlingsmuligheder.
English: • One of the medicines manufactured at this site is Ammonaps (sodium phenylbutyrate), a medicine to treat urea cycle disorders.
Danish: • Et af de lægemidler, der fremstilles på dette fremstillingssted, er Ammonaps (natriumphenylbutyrat), der anvendes til behandling af forstyrrelser i urinsyrecyklus.
English: Ammonaps has been recalled in countries where alternatives are available.
Danish: Ammonaps er tilbagekaldt i lande, hvor der er andre behandlingsmuligheder til rådighed.
English: • If you have any questions about your treatment with Ammonaps, speak to your doctor or pharmacist.
Danish: • Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide om behandlingen med Ammonaps.
English: • Ammonaps, a medicine for treating urea cycle disorders which is exclusively manufactured at Pharmaceutics International Inc, remains available where there are no treatment alternatives.
Danish: • Ammonaps, der er et lægemiddel til behandling af forstyrrelser i urinstofcyklus og udelukkende fremstilles hos Pharmaceutics International Inc., vil fortsat være tilgængeligt, hvor der ikke forefindes andre behandlingsmuligheder.
English: • The medicines Dutasteride Actavis (dutasteride), Lutigest/Lutinus (progesterone), and associated names, are registered to be produced at Pharmaceutics International Inc, but are now
Danish: • Lægemidlerne Dutasteride Actavis (dutasterid) og Lutigest/Lutinus (progesteron) og relaterede navne er registreret som værende fremstillet hos Pharmaceutics International Inc., men fremstilles nu på andre registrerede fremstillingssteder.
English: • However, as a precautionary measure, medicines manufactured by Pharmaceutics International Inc that are not considered critical to public health are no longer to be used in the EU.
Danish: • Lægemidler, der er fremstillet af Pharmaceutics International Inc. og ikke anses for at have kritisk betydning for den offentlige sundhed, vil dog som sikkerhedsforanstaltning ikke længere blive anvendt i EU.
English: This conclusion was accepted.
Danish: Denne konklusion blev godtaget.
English: The CVMP Opinion was adopted on 18 April 2007 and the subsequent Commission Decision on 10 July 2007.
Danish: CVMP's udtalelse blev vedtaget den 18. april 2007, og Kommissionens efterfølgende beslutning blev vedtaget den 10. juli 2007.
English: In June 2006 a Mutual Recognition Procedure started with The Netherlands as Reference Member State and six Concerned Member States.
Danish: I juni 2006 blev der indledt en gensidig godkendelsesprocedure med Nederlandene som referencemedlemsstat og seks berørte medlemsstater.
English: The CVMP, therefore, concluded that the benefit/risk for this product was favourable.
Danish: CVMP konkluderede derfor, at benefit/risk-forholdet for dette produkt var gunstigt.
English: Efficacy data are connected to several shortcomings and the amount of data available is sparse.
Danish: Effektivitetsoplysningerne er forbundet med adskillige mangler, og mængden af tilgængelige oplysninger er sparsom.
English: London, June 2008 EMEA/532222/2007 - Rev.1
Danish: London, juni 2008 EMEA/532222/2007- Rev.1
English: The matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures CMD(v) and subsequently to the Committee for Medicinal Products for Veterinary Use.
Danish: Sagen blev indbragt for koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede procedurer - veterinære anliggender (CMD(v)) og efterfølgende for Udvalget for Veterinærlægemidler.
English: Italy could have accepted the application but with revised wording in the SPC.
Danish: Italien kunne have godtaget ansøgningen, blot med en revideret ordlyd i produktresuméet.
English: France and Italy could not agree to the granting of a marketing authorisation as they considered there were potentially serious risks for animal health.
Danish: Frankrig og Italien kunne ikke tilslutte sig udstedelse af en markedsføringstilladelse, da de fandt, at der forelå potentielt alvorlige risici for dyrs sundhed.
English: These results were convincing when compared to the 20 % placebo treated animals that became continent in study ACE129801.
Danish: Disse resultater var overbevisende ved sammenligning med de 20 % placebo-behandlede dyr, som blev kontinente i undersøgelse ACE129801.
English: OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR ENURACE 50
Danish: UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 33, STK. 4 VEDRØRENDE ENURACE 50
English: EMEA/532222/2007 - Rev.1
Danish: EMEA/532222/2007 - Rev.1-DA
English: However, the study where Enurace 50 is compared to Propaline (ACE129802) is convincing although a non-inferiority analysis has not been performed.
Danish: Undersøgelsen, hvor Enurace 50 sammenlignes med Propaline (ACE129802), er dog overbevisende, selv om der ikke er gennemført en analyse af noninferioritet.
English: The CVMP during its meeting of December 2006 started a referral procedure under Article 33(4) of Directive 2001/82/EC as amended for Enurace 50.
Danish: CVMP indledte ved sit møde i december 2006 en indbringelsesprocedure for Eurace 50 i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF, med senere ændringer.
English: The Marketing Authorisation Holder was requested to provide all supporting data to justify a positive benefit/risk ratio for the treated animal.
Danish: Indehaveren af markedsføringstilladelsen blev anmodet om at fremlægge alle oplysninger, der kunne understøtte et positivt benefit/risk-forhold for det behandlede dyr.
English: France considered the benefit/risk analysis unfavourable for the animal when the adverse effects were weighed against the potential benefits of effective treatment of incontinence.
Danish: Frankrig mente, at benefit/risk-analysen var ugunstig for dyret, når bivirkningerne blev opvejet mod de mulige fordele ved effektiv behandling af inkontinens.
English: In response to the questions related to toxicity, the applicant argued that due to the pharmacologic effect of ephedrine and the individual variation in receptor density no safety margin could be determined and increasing doses will be associated to increased intensity and frequency of well known adverse effects.
Danish: Som svar på spørgsmål relateret til toksicitet fremførte ansøgeren, at der på grund af ephedrins farmakologiske virkning og den individuelle variation i receptordensitet ikke kunne fastlægges nogen sikkerhedsmargin, og at stigende doser vil være forbundet med øget intensitet og frekvens af kendte bivirkninger.
English: With regard to the related to cardiovascular diseases, the SPC is to be modified under section 4.5 to include the sentence “the dog's cardiovascular functionality should be carefully assessed before the start of the treatment with Enurace 50 and it should be periodically monitored during the treatment”.
Danish: Med hensyn til sikkerheden relateret til kardiovaskulære sygdomme skal produktresuméet ændres under punkt 4.5, så det indeholder sætningen “hundens kardiovaskulære funktion skal nøje vurderes, før behandling med Enurace 50 indledes, og den skal jævnligt overvåges under behandlingen”.
English: At the recommended dose level, which according to the suggested SPC should be individually adjusted, safety is ensured to a reasonable level.
Danish: I den anbefalede dosis, som skal justeres individuelt i henhold til det foreslåede produktresumé, er produktets sikkerhed etableret på et rimeligt niveau.
English: Enurace 50 is a tablet formulation containing ephedrine as active ingredient and is indicated for treatment of urinary incontinence caused by urethral sphincter mechanism incompetence in ovariohysterectomised dogs.
Danish: Enurace 50 er et præparat i tabletform, der indeholder ephedrin som aktivt indholdsstof og er indiceret til behandling af urininkontinens forårsaget af insufficiens i den uretrale sfinkters funktion hos ovariohysterektomerede hunde.
English: Although toxicity data for the target animal may be scarce, the adverse effects connected to ephedrine treatment are well known from human use, and the applicant had provided some post-marketing information regarding the use in dogs.
Danish: Selv om toksicitetsoplysningerne for måldyret kan være sparsomme, er bivirkningerne, der er forbundet med ephedrinbehandling, velkendte fra brug på mennesker, og ansøgeren havde fremlagt oplysninger efter markedsføring vedrørende brug til hunde.
English: The raw outcome shows good effect in both test and control groups, an effect that might be somewhat higher in treatment naïve animals.
Danish: resultatet viser god effekt hos både test- og kontrolgrupper.
English: - a recent serious injury.
Danish: - en nylig alvorlig kvæstelse.
English: DuoPlavin is not recommended in this population.
Danish: DuoPlavin anbefales ikke til denne population.
English: Refer to local requirements for disposal.
Danish: Der henvises til lokale retningslinjer vedrørende bortskaffelse.
English: DuoPlavin is not intended for use in children or adolescents less than 18 years of age.
Danish: DuoPlavin er ikke tiltænkt anvendelse hos børn og unge under 18 år.
English: Therefore DuoPlavin should be used with caution in these patients.
Danish: DuoPlavin bør derfor anvendes med forsigtighed hos disse patienter.
English: Date of latest renewal: 19 November 2014
Danish: Dato for første godkendelse: 15. marts 2010 Dato for seneste fornyelse: 19. november 2014
English: * Information reported in published information for ASA with frequency “not known”.
Danish: * Rapporteret i publiceret information for ASA med frekvens ”ikke kendt”.
English: Depending on your condition, your doctor will determine the length of time for which you need to take DuoPlavin.
Danish: Ud fra din sygdom vil lægen bestemme, hvor lang tid du skal tage DuoPlavin.
English: There is an increased risk of bleeding due to the potential additive effect.
Danish: Der er en øget risiko for blødning på grund af mulig additiv effekt.
English: Medicinal products associated with bleeding risk
Danish: Lægemidler, der er forbundet med risiko for blødning
English: Some other medicines may influence the use of DuoPlavin or vice versa.
Danish: Visse andre typer medicin kan påvirke virkningen af DuoPlavin eller omvendt.
English: Their frequency is defined using the following conventions: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppigheden defineres i henhold til følgende konvention: almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden <1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Do not use this medicine if you notice any visible sign of deterioration.
Danish: Brug ikke lægemidlet, hvis der er synlige tegn på nedbrydning.
English: Following toxic doses (10 20 g), the plasma half-life may be increased to over 20 hours.
Danish: Efter toksiske doser (10-20 g) kan plasmahalveringstiden øges til over 20 timer.
English: DuoPlavin should not be used during the first two trimesters of pregnancy unless the clinical condition of the woman requires treatment with clopidogrel/ASA.
Danish: DuoPlavin bør ikke anvendes i graviditetens første to trimestre, medmindre den kliniske situation for kvinden kræver behandling med clopidogrel/ASA.
English: Due to the presence of both components of the medicinal product, DuoPlavin is contraindicated in case of:
Danish: På grund af tilstedeværelsen af begge komponenter i lægemidlet er DuoPlavin kontraindiceret i tilfælde af:
English: Do not stop the treatment unless your doctor tells you so.
Danish: Du må ikke stoppe behandlingen, medmindre din læge har bedt dig om det.
English: Minor GI symptoms, such as dyspepsia, are common and can occur anytime during therapy.
Danish: Mindre GI-symptomer såsom dyspepsi er almindelige og kan forekomme på alle tidspunkter i behandlingen.
English: ** Information related to clopidogrel with frequency “not known”.
Danish: ** Relateret til clopidogrel med frekvens ”ikke kendt”.
English: - a planned surgery (including dental) in the next seven days.
Danish: - et planlagt kirurgisk indgreb (gælder også tandoperationer) inden for de næste 7 dage.
English: It is preferable not to take this medicine during first and second trimesters of pregnancy.
Danish: Det er bedst ikke at tage dette lægemiddel under graviditens første og andet trimester.
English: This randomized, open-label trial included ACS patients requiring PCI.
Danish: Dette randomiseret, open-label studie inkluderede ACS patienter, som kræver PCI.
English: System organ class
Danish: Systemorganklasse Almindelig
English: For the 14, 28 and 84 tablets pack sizes you can check the day on which you last took a tablet of DuoPlavin by referring to the calendar printed on the blister.
Danish: For pakninger med 14, 28 og 84 stk. tabletter kan du tjekke på hvilken dag, du sidst tog en tablet, ved at se på kalenderen trykt på blisterpakningen.
English: • opioids: while you are treated with clopidogrel, you should inform your doctor before being prescribed any opioids (used to treat severe pain).
Danish: • opioider: mens du er i behandling med clopidogrel, bør du fortælle det til lægen, før du får ordineret enhver form for behandling med opioider (anvendes til behandling af svære smerter).
English: Therefore, this combination should be used with caution in patients taking low dose ASA for cardioprotection .
Danish: Derfor bør denne kombination anvendes med forsigtighed hos patienter, der får lavdosis ASA for kardioprotektion.
English: There are no fertility data with DuoPlavin.
Danish: Der findes ingen fertilitetsdata for DuoPlavin.
English: In patients with ST segment elevation acute myocardial infarction: Therapy should be started as early as possible after symptoms start and continued for at least four weeks.
Danish: - Hos patienter med akut myokardieinfarkt med elevation af ST-segmentet: Behandling bør startes så tidligt som muligt, efter symptomerne viser sig, og fortsættes i mindst 4 uger.
English: A patient with poor metaboliser status will possess two loss-offunction alleles as defined above.
Danish: En patient med status som poor metabolisers vil besidde to ikke-funktionelle alleller, som beskrevet ovenfor.
English: Repeat-dose toxicity studies have shown that levels up to 200 mg/kg/day are well tolerated in rats; dogs appear to be more sensitive, probably due to the high sensitivity of canines to the ulcerogenic effects of NSAIDs.
Danish: Undersøgelser af toksicitet ved gentagne doser har vist, at niveauer op til 200 mg/kg/dag er veltolererede i rotter; hunde er tilsyneladende mere sensitive, sandsynligvis grundet hundes høje følsomhed for ulcerogene effekter af NSAID'er.
English: Reproduction toxicity data show that ASA is teratogenic in several laboratory animals.
Danish: Undersøgelser om reproduktionstoksicitet viser, at ASA er teratogent i adskillige forsøgsdyr.
English: From the beginning of the sixth month of pregnancy, all prostaglandin synthesis inhibitors may expose:
Danish: Fra begyndelsen af sjette måned af graviditeten kan alle prostaglandinsyntesehæmmere
English: Patients should also be told that it might take longer than usual to stop bleeding when they take DuoPlavin, and that they should report any unusual bleeding (site or duration) to their physician.
Danish: Patienter bør også informeres om, at det kan tage længere tid end normalt at standse blødninger, når de tager DuoPlavin, samt at de bør kontakte deres læge ved enhver usædvanlig blødning (sted eller varighed).
English: In any case, you should take it for as long as your doctor continues to prescribe it.
Danish: Under alle omstændigheder skal du fortsætte med at tage DuoPlavin, så længe din læge udskriver det til dig.
English: Salicylic acid in DuoPlavin has a plasma half-life of approximately 2 hours.
Danish: Salicylsyren i DuoPlavin har en plasmahalveringstid på ca. 2 timer.
English: Do not take DuoPlavin during third trimester of pregnancy.
Danish: Du må ikke tage DuoPlavin under graviditetens tredje trimester.
English: • if you have a condition known as glucose-6-phosphate dehydrogenase (G6PD) deficiency because of the risk of a particular form of anaemia (low number of red blood cells).
Danish: • hvis du har en lidelse, der kaldes glucose-6-phosphatdehydrogenase(G6PD)-mangel, da G6PDmangel øger risikoen for en særlig form for anæmi (lavt antal røde blodceller).
English: If you experience prolonged bleeding when taking DuoPlavin If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Danish: Hvis du får langvarige blødninger, mens du tager DuoPlavin Hvis du skærer dig eller kommer til skade, kan det tage lidt længere end normalt, før blødningen stopper.
English: It also contains: lactose and hydrogenated castor oil.
Danish: Indeholder også: Lactose og hydrogeneret ricinusolie.