FrancophonIA/ELRC3.0 huggingface dataset:
English: • liver damage
Danish: • leverbeskadigelse
English: Once rash has returned to Grade 1 or below, treatment can be resumed at 100 mg twice daily.
Danish: Når udslættet er vendt tilbage til grad 1 eller derunder, kan behandlingen genoptages med 100 mg to gange dagligt.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE ETIKETTERING PÅ TABLETBEHOLDER
English: If rash does not recur, the dose can be re-escalated to 150 mg twice daily at the discretion of the treating physician (see section 4.8).
Danish: Hvis udslættet ikke vender tilbage, kan dosis igen øges til 150 mg to gange dagligt efter den behandlende læges skøn (se pkt.
English: ANTICONVULSANTS
Danish: ANTIKONVULSIVA
English: • atorvastatin, lovastatin, simvastatin, medicines used to lower cholesterol
Danish: • atorvastatin, lovastatin, simvastatin, lægemidler, der anvendes til at sænke kolesterolniveauet Zydelig kan ordineres i kombination med andre lægemidler til behandling af CLL.
English: Polyvinyl alcohol (E1203) Macrogol 3350 (E1521) Titanium dioxide (E171) Talc (E553B) Sunset yellow FCF (E110)
Danish: Polyvinylalkohol (E1203) Macrogol 3350 (E1521) Titandioxid (E171) Talcum (E553B) Sunset yellow FCF (E110).
English: Polyvinyl alcohol (E1203) Macrogol 3350 (E1521) Titanium dioxide (E171) Talc (E553B) Iron oxide red (E172)
Danish: Filmovertræk Polyvinylalkohol (E1203) Macrogol 3350 (E1521) Titandioxid (E171) Talcum (E553B) Rød jernoxid (E172)
English: Polyvinyl alcohol (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc (E553B), iron oxide red (E172).
Danish: Polyvinylalkohol (E1203), macrogol 3350 (E1521), titandioxid (E171), talcum (E553B), rød jernoxid (E172).
English: • alfuzosin, a medicine used to treat an enlarged prostate • dabigatran, warfarin, medicines used to thin the blood
Danish: • dabigatran, warfarin, lægemidler, der anvendes til at fortynde blodet
English: What Zydelig is and what it is used for What you need to know before you take Zydelig How to take Zydelig
Danish: Det skal du vide, før du begynder at tage Zydelig Sådan skal du tage Zydelig Bivirkninger
English: ↑ serum concentrations Concurrent administration of salmeterol and idelalisib is not recommended.
Danish: ↑ serumkoncentrationer Salmeterol bør ikke administreres sammen med idelalisib.
English: ERGOT ALKALOIDS
Danish: SEKALEALKALOIDER
English: • rifampicin, a medicine used to prevent and treat tuberculosis and other infections • St. John's wort (Hypericum perforatum), a herbal remedy used for depression and anxiety
Danish: • Prikbladet perikon (Hypericum perforatum), et naturlægemiddel mod depression og angst
English: What Zydelig looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: ANTIARRHYTHMICS
Danish: ANTIARYTMIKA
English: 28 tablets (7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg)
Danish: 7 x 15 mg + 7 x
English: --1 - Eimeria acervulina, strain 003 - 332-450 sporulated oocysts - Eimeria brunetti, strain 034 - 213-288 sporulated oocysts - Eimeria maxima, strain 013 - 196-265 sporulated oocysts - Eimeria necatrix, strain 033 - 340-460 sporulated oocysts - Eimeria tenella, strain 004 - 276-374 sporulated oocysts
Danish: - Eimeria acervulina, stamme 003 - 332 - 450 sporulerede oocyster - Eimeria brunetti, stamme 034 - 213 - 288 sporulerede oocyster - Eimeria maxima, stamme 013 - 196 - 265 sporulerede oocyster - Eimeria necatrix, stamme 033 - 340 - 460 sporulerede oocyster - Eimeria tenella, stamme 004 - 276 - 374 sporulerede oocyster
English: Data from table 2.13 in Clinical Safety Report, dated 21 December 2001
Danish: Data fra tabel 2.13 i Klinisk sikkerhedsrapport dateret den 21. december 2001
English: It may harm them, even if their symptoms are the same as yours.
Danish: Det kan være skadeligt for dem, selvom de har de samme symptomer, som du har.
English: Serious adverse event/deaths/other significant events
Danish: Alvorlige bivirkninger/dødsfald/andre betydningsfulde hændelser
English: It was agreed that the following statement would be included:
Danish: Det blev vedtaget indsætte følgende erklæring:
English: Route of administration TOTPAR SPID IMP 1.
Danish: TOTPAR SPID IMP 1.
English: Very common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1000, <1/100); rare (≥1/10.000, <1/1.000); Very rare (<1/10.000).
Danish: Meget almindelig (≥1/10); Almindelig (≥1/100, <1/10); Ikke almindelig (≥1/1000, <1/100); Sjælden (≥1/10.000, <1/1.000); Meget sjælden (<1/10.000).
English: Overall discussion on RA With respect to RA, the following can be summarised:
Danish: Samlet diskussion vedrørende af RA Vedrørende RA kan følgende sammenfattes:
English: Included in analysis
Danish: Indgår i analyse
English: No differences were observed regarding the SPID parameter.
Danish: Der blev ikke iagttaget forskelle i parameteren SPID.
English: • Conclusions
Danish: • Konklusioner
English: The tablets should be taken before meals.
Danish: Tabletterne bør tages før et måltid.
English: More than 12,000 patients were included in the 103 studies of which 43 were classified as phase I with 810 patients.
Danish: Der indgik over 12 000 patienter i de 103 undersøgelser, af hvilke 43 var klassificeret som fase I og omfattede 810 patienter.
English: Overall the Applicant has responded to the questions raised during the procedure in a satisfactory way, although minor deficits exist in the MAH's efficacy and safety database mainly related to small shortterm clinical studies conducted 15-20 years ago.
Danish: Alt i alt har ansøgeren besvaret de under proceduren rejste spørgsmål tilfredsstillende, dog er der mindre mangler i ansøgerens database vedrørende virkning og sikkerhed, hovedsagelig i forbindelse med små, kortvarige kliniske undersøgelser, der er udført for 15-20 år siden.
English: These patients should commence treatment on the lowest dose available.
Danish: Disse patienter bør indlede behandlingen med den lavest mulige dosis.
English: Statistical analysis was therefore limited to a 4 week treatment phase which, based on international guidelines, is appropriate to assess therapeutic efficacy of NSAIDs in OA.
Danish: Den statistiske analyse blev derfor begrænset til en fire ugers behandlingsfase, der i henhold til internationale retningslinjer er passende til vurdering af den terapeutiske virkning af NSAID ved OA.
English: Less frequently, gastritis has been observed.
Danish: Gastritis ses mindre hyppigt.
English: A central effect on nociception which seems to be independent of anti-inflammatory effects has also been suggested.
Danish: En central effekt af nociception, som er uafhængig af de anti-inflammatoriske effekter, har også været foreslået.
English: For further instructions on handling of the product before administration, see section 6.1.
Danish: For yderligere instruktion omkring håndtering af produktet inden administration, se pkt.
English: Lornoxicam was tested in 34 pain studies with 7,761 patients.
Danish: Lornoxicam blev testet i 34 smerteundersøgelser med 7 761 patienter.
English: Solvent: Clear solution
Danish: Solvens: klar opløsning
English: The third died from myocardial infarction.
Danish: Den tredje patient døde af myokardieinfarkt.
English: Treatment of osteoarthritis has not been approved by 2/16 Member States (EE, IT).
Danish: Behandling af osteoartritis er ikke godkendt i 2 af 16 medlemsstater (EE, IT).
English: 1 set contains:
Danish: 1 sæt indeholder:
English: Clinical monitoring at regular intervals is recommended.
Danish: Klinisk overvågning med regelmæssige intervaller anbefales.
English: Listed below are undesirable effects which generally occurred in more than 0.05% of the 6.417 patients treated in clinical phase II, III and IV trials.
Danish: De bivirkninger, der anføres nedenfor, forekom generelt hos mere end 0,05% af de 6.417 patienter, der blev behandlet i de kliniske fase II-, III- og IV-forsøg.
English: No specific antidote is known to date.
Danish: Der er ingen kendt specifik antidot.
English: Additional information on special populations
Danish: Yderligere information om bestemte befolkningsgrupper
English: Read all of this leaflet carefully before you start taking this medicine.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at bruge medicinen.
English: (No interaction between lornoxicam and ranitidine, or lornoxicam and antacids has been demonstrated).
Danish: (Der er ikke påvist interaktion mellem lornoxicam og ranitidin, eller mellem lornoxicam og antacida).
English: Of the total number of patients 57.8% (7,046/12,192) received lornoxicam (see Table below).
Danish: Af det totale antal patienter fik 57,8 % (7 046/12 192) lornoxicam (se nedenstående tabel).
English: The recent PhVWP core information regarding cardiovascular safety of NSAIDs (January 2007) has also been taken into account.
Danish: De nye kerneoplysninger fra PhVWP vedrørende den kardiovaskulære sikkerhed af NSAID (januar 2007) er ligeledes taget i betragtning.
English: If visible signs of deterioration are seen in the medicinal product, the product must be disposed of in accordance with local requirements
Danish: Hvis der er synlige tegn på nedbrydning af lægemidlet, skal produktet kasseres i henhold til lokale retningslinier.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF XEFO AND ASSOCIATED NAMES (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF XEFO OG TILKNYTTEDE NAVNE (se bilag I)
English: The absorption of lornoxicam (calculated on AUC) can be reduced up to 20 %.
Danish: Absorptionen af lornoxicam (beregnet på AUC) kan blive reduceret med op til 20 %.
English: Incidence by dose was: 17.0% (8mg), 27.0% (12mg) and 22.7% (16mg).
Danish: Forekomsten fordelte sig således efter dosis: 17,0 % (8 mg), 27,0 % (12 mg) og 22,7 % (16 mg).
English: The osmolarity of the reconstituted solution is about 328 mosmol/kg and pH is about 8.7
Danish: Osmolariteten af den færdigblandede opløsning er omkring 328 mosmol/kg og pH er ca. 8.7.
English: The frequency of death per patient year for lornoxicam was 0.007; the corresponding number for active comparator treatment was almost three times as high (0.020).
Danish: Dødsraten pr. patientår for lornoxicam var 0,007; det tilsvarende tal for de aktive sammenligningspræparater var næsten tre gange så højt (0,020).
English: Very rare: Hepatocellular damage.
Danish: Meget sjælden: Hepatocellulær skade.
English: Studies included in meta-analyses Parameters used
Danish: Undersøgelser, der indgår i metaanalyserne Anvendte parametre
English: Lornoxicam is excreted in milk of lactating rats in relatively high concentrations.
Danish: Lornoxicam udskilles i mælken hos rotter i relativt høje koncentrationer.
English: From a microbiological point of view, the product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt bør produktet anvendes straks efter opløsning.
English: Two studies on third molar surgery were excluded from meta-analysis 1.
Danish: To undersøgelser vedrørende tredje molar blev udelukket af metaanalyse 1.
English: Food may decrease the absorption with about 20% and increase Tmax.
Danish: Indtagelse sammen med mad kan nedsætte absorptionen med ca. 20% og øge Tmax.
English: Number of Patients by Indication and Treatment
Danish: Antal patienter, fordelt på indikationer og behandlinger
English: After oral administration about 50% is excreted in the faeces and 42% through the kidneys, mainly as 5-hydroxylornoxicam.
Danish: Efter oral administration udskilles ca. 50% med fæces og 42% via nyrerne, hovedsagelig som 5-hydroxylornoxicam.
English: Difficulties with data interpretation due to differences in the applied methodology such as dose regimens, study designs and durations of treatment, resulted in only 4 of these studies being considered applicable for a scientifically sound overall analysis of efficacy data - meta analysis.
Danish: På grund af vanskelighederne ved at fortolke data som følge af forskelle i de anvendte metoder som dosisregime, undersøgelsesdesign og behandlingsvarighed kan kun fire af disse undersøgelser anses for en videnskabeligt holdbar samlet analyse af data vedrørende virkning - metaanalyse.
English: In addition the following wording has been included as agreed by the PhVWP in October 2005 and January 2007:
Danish: Derudover er indsat følgende ordlyd, som blev vedtaget af PhVWP i oktober 2005 og januar 2007:
English: The clinical development program for the effect of lornoxicam against pain consisted of 27 studies.
Danish: Det kliniske udviklingsprogram for virkningen af lornoxicam mod smerter omfattede 27 undersøgelser.
English: or intravenous (i.v.)
Danish: eller intravenøs (i.v.)
English: - Digoxin: Decreased renal clearance of digoxin.
Danish: - digoxin: medfører nedsættelse af den renale clearance af digoxin.
English: TOTPAR = total pain relief, SPID = sum of pain intensity differences, IMP = overall impression
Danish: TOTPAR = total smertelinding (total pain relief), SPID = samlet forskel i smerteintensitet (sum of pain intensity differences), IMP = samlet indtryk (overall impression)
English: Powder: Yellow, solid substance
Danish: Pulver: gult, fast materiale
English: Reactions relating to other System organs (SOCs) occurred in less than 1% of the patients.
Danish: Reaktioner vedrørende andre organklasser optrådte hos færre end 1 % af patienterne.
English: A total of 21% of the patients had at least one ADR.
Danish: I alt 21 % af patienterne fik mindst én bivirkning.
English: These symptoms have generally occurred in less than 10% of patients in available studies.
Danish: I tilgængelige studier er disse symptomer generelt observeret hos mindre end 10% af patienterne.
English: The medicinal product is for single use only
Danish: Lægemidlet er kun til engangsbrug.
English: Due to differences in study designs and dosage regimens, only 4 of these studies (CT18, CT33, CT63, CT80) were selected for a retrospective comprehensive evaluation.
Danish: Som følge af forskelle i undersøgelsesdesign og doseringsregime blev kun fire af disse undersøgelser (CT18, CT33, CT63, CT80) valgt til en retrospektiv tilbundsgående vurdering.
English: The reason for exclusion of study CT32 is not clear (it was included in meta-analysis 2; single doses were applied post surgery).
Danish: Grunden til udelukkelsen af undersøgelse CT32 er ikke klar (den indgik i metaanalyse 2; der blev anvendt enkeltdoser postoperativt).
English: In study CT02 there was no significant difference in TOTPAR between groups in the ITT population, but between placebo and active treatment in the PP-population.
Danish: I undersøgelse CT02 var der ingen signifikant forskel i TOTPAR mellem grupperne i ITT-populationen, men derimod mellem placebo og aktivt præparat i PP-populationen.
English: The duration of blinded treatment was 4 weeks for studies CT18 and CT80 and 12 weeks for CT33 and CT63.
Danish: Den blindede behandling varede fire uger for undersøgelse CT18 og CT80, og tolv uger for CT33 og CT63.
English: Each blister strip contains 10 film-coated tablets.
Danish: Hver blisterplade indeholder 10 filmovertrukne tabletter.
English: Severe urinary, CNS and skin reactions have not been reported.
Danish: Der er ikke indberettet om svære reaktioner fra urinveje, CNS eller hud.
English: Apart from reduced clearance, there is no significant change in the kinetic profile of lornoxicam in elderly patients.
Danish: Bortset fra reduceret clearance, er der ingen signifikant ændring i den farmakokinetiske profil for lornoxicam hos ældre patienter.
English: No first-pass effect has been observed.
Danish: Der er ikke observeret first-passeffekt.
English: Another three cases were caused by cardiovascular events and occurred in patients with rheumatological disorders participating in long-term studies.
Danish: Endnu tre dødsfald skyldtes kardiovaskulære hændelser hos patienter, der havde reumatologiske sygdomme og deltog i langtidsundersøgelser.
English: The MAH's response is considered acceptable and no further data are requested.
Danish: Besvarelsen af indehaveren af markedsføringstilladelsen anses for acceptabel, og der anmodes ikke om yderligere oplysninger.
English: A comparison of significance levels in the original data and in meta-analysis 2 was not performed and is missing in the response.
Danish: Der blev ikke foretaget en sammenligning af signifikansniveauet i de oprindelige data og i metaanalyse 2, og en sådan mangler i besvarelsen.
English: Some patients may need a further 8 mg given during the first 24 hours.
Danish: Hos nogle patienter kan der være behov for yderligere 8 mg, givet i de første 24 timer.
English: CYP2C9 is involved in this biotransformation of lornoxicam.
Danish: CYP2C9 er involveret i metaboliseringen af lornoxicam.
English: Lornoxicam is metabolised completely, and approximately 2/3 is eliminated via the liver and 1/3 via the kidneys as inactive substance.
Danish: Lornoxicam metaboliseres fuldstændigt, ca. 2/3 udskilles via leveren og ca. 1/3 via nyrerne som inaktiv substans.
English: Posology - Section 4.2
Danish: Dosering - afsnit 4.2
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6
Danish: 6.2 Uforligeligheder Dette lægemiddel må ikke blandes med andre lægemidler undtagen dem, der nævnes i pkt.
English: Lornoxicam has shown compatibility with 0.9% NaCl, 5% dextrose (glucose) and Ringer's solution.
Danish: Lornoxicam har vist forligelighed med 0,9 % NaCl, 5 % dextrose (glukose) og Ringer's opløsning.
English: On the other hand the parameter IMP (general impression) analysed in meta-analysis 3 is a week efficacy parameter, which can only be considered as supportive to the TOTPAR analysis and the judgement on efficacy has to be based mainly on meta-analysis 1 and 2.
Danish: På den anden side er parameteren IMP (generelt indtryk), der blev analyseret i metaanalyse 3, en svag virkningsparameter, der kun kan tages i betragtning som støtte for TOTPAR-analysen, hvorfor vurderingen af virkningen hovedsagelig må baseres på metaanalyse 1 og 2.
English: A meta-analysis consisting of three parts was performed to assess the overall analgesic effect of lornoxicam.
Danish: Der blev foretaget en metaanalyse i tre dele til vurdering af den overordnede analgetiske virkning af lornoxicam.
English: Increased toxicity may result.
Danish: Kan medføre øget toksisk virkning.
English: Unless compatibility is proven, Xefo 4 mg/ml solution for injection should always be administered separately.
Danish: Med mindre der er vist forligelighed, bør Xefo 4 mg/ml opløsning til injektion altid administreres separat.
English: The risk is believed to increase with dose and duration of therapy.
Danish: Risikoen menes at stige med øget dosis og behandlingsvarighed.
English: Precaution is advised in elderly postoperative patients.
Danish: Der bør udvises særlig forsigtighed over for ældre, postoperative patienter.
English: Due to the divergent national decisions taken by the Member States concerning the authorisation of the above-mentioned product, Nycomed Danmark ApS notified the EMEA of an official referral under Article 30 of Directive 2001/83/EC as amended in order to resolve divergences amongst the nationally authorised Product Information (SPCs, PLs and labellings) for the above-mentioned product and thus to harmonise the Product Information (SPCs, PLs and labellings) and Quality documentation across the EU
Danish: På grund af de divergerende nationale afgørelser, der er truffet af medlemsstaterne vedrørende godkendelsen af ovenstående produkt, indbragte Nycomed Danmark ApS sagen for EMEA i henhold til artikel 30 i direktiv 2001/83/EF, med senere ændringer, med henblik på at afhjælpe divergenserne mellem de nationalt godkendte produktinformationer (produktresumé, indlægsseddel og etikettering) og dermed harmonisere produktinformation og dokumentation vedrørende kvalitet i hele EU.
English: Infections and infestations Rare: Pharyngitis.
Danish: Infektioner og parasitære sygdomme Sjælden: Pharyngitis.
English: In addition, to reaching an agreement on the main quality part of the SPC (shelf-life, storage conditions), the CHMP also took the opportunity to harmonise the Quality documentation concerning a number of minor issues related to the Drug Substance and Finished Product manufacturing and control.
Danish: Udover at nå til enighed om den væsentligste del af produktresuméets kvalitetsafsnit (opbevaringstid, opbevaringsbetingelser) benyttede CHMP lejligheden til at harmonisere kvalitetsdokumentationen i flere mindre spørgsmål om lægemiddelstoffet og fremstilling og kontrol af færdigproduktet.
English: Titanium dioxide (E171) Talc
Danish: Titandioxid (E 171) Talcum
English: Rare: Confusion, nervousness, agitation.
Danish: Sjælden: Konfusion, nervøsitet, agitation.
English: Rare: Asthenia.
Danish: Sjælden: Astheni.
English: The posology agreed for acute pain is:
Danish: Den vedtagne dosering til akutte smerter er:
English: Lornoxicam is extensively metabolised in the liver, primarily to the inactive 5-hydroxylornoxicam by hydroxylation.
Danish: Lornoxicam metaboliseres i vid udstrækning i leveren primært til det inaktive 5-hydroxylornoxicam ved hydroxering.
English: Any risk is more likely with high doses and prolonged treatment.
Danish: Risikoen er forøget ved høje doser og længerevarende behandling.
English: Lornoxicam is found in the plasma in unchanged form and as its hydroxylated metabolite.
Danish: Lornoxicam findes i plasma både i uændret form og som den hydroxylerede metabolit.
English: Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment.
Danish: Risikoen for sådanne reaktioner synes at være størst tidligt i behandlingen, idet de fleste hudreaktioner forekommer inden for behandlingens første måned.
English: Indication lornoxicam dose
Danish: Indikation Lornoxicam-dosis
English: Interaction with other medicinal products and other forms of interaction - Section 4.5
Danish: Interaktion med andre lægemidler og andre former for interaktion - pkt.
English: This finding was supported by drug monitoring data from one year studies.
Danish: Dette underbygges af resultater fra kliniske 1- års studier.
English: Approximately 20% of patients treated with lornoxicam can be expected to experience adverse reactions.
Danish: Omkring 20 % af alle patienter, der behandles med lornixicam, kan forventes at få bivirkninger.
English: - Long term treatment (longer than 3 months): Regular laboratory assessments of haematology (haemoglobin), renal functions (creatinine) and liver enzymes are recommended.
Danish: - Langtidsbehandling (mere end 3 måneder): Det anbefales at udføre regelmæssige laboratorieundersøgelser af hæmatologi (hæmoglobin), nyrefunktion (kreatinin) og leverenzymer.
English: The elimination half-life of 5-hydroxylornoxicam is about 9 hours after a parenteral single or twice daily dose.
Danish: Eliminationshalveringstiden for 5-hydroxylornoxicam er ca. 9 timer efter en eller to daglige doser givet parenteralt.
English: Gastrointestinal disorders can for example be treated with a prostaglandin analogue or ranitidine.
Danish: Gastrointestinale symptomer kan f.eks. behandles med en prostaglandinanalog eller med ranitidin.
English: All deaths reported for lornoxicam were considered unrelated to treatment by the responsible investigator and may reflect the multimorbid patients taking part in these studies.
Danish: Alle de indberettede dødsfald for lornoxicam blev af den ansvarlige investigator anset for at være uden sammenhæng med den medikamentelle behandling og kan afspejle multimorbiditet hos de deltagende patienter.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJE, ANSØGERE, INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE
English: • Quality issues
Danish: • Spørgsmål vedrørende kvalitet
English: The hydroxylated metabolite exhibits no pharmacological activity.
Danish: Den hydroxerede metabolit udviser ingen farmokologisk aktivitet.