FrancophonIA/ELRC3.0 huggingface dataset:
English: Known hypersensitivity to lumiracoxib or to any of the excipients.
Danish: Kendt overfølsomhed over for lumiracoxib eller over for et eller flere af hjælpestofferne.
English: Relief of acute pain due to dental surgery: the maximum treatment duration in clinical studies was 24 hours.
Danish: Lindring af akut smerte grundet dental kirurgi: Den maksimale behandlingsvarighed i kliniske studier var 24 timer.
English: Common: influenza like symptoms, respiratory tract infection (e.g bronchitis), urinary tract infection Uncommon: candidiasis, ear infection, herpes simplex, tooth infection
Danish: Almindelige: Influenzalignende symptomer, luftvejsinfektion (f.eks. bronkitis), urinvejsinfektion Usædvanlig: Candidiasis, øreinfektion, herpes simplex, tandinfektion
English: Omeprazole: Omeprazole had no effect on the pharmacokinetics of lumiracoxib.
Danish: Omeprazol: Omeprazol havde ingen effekt på lumiracoxibs farmakokinetik.
English: Fluconazole: Co-administration of lumiracoxib with the potent CYP2C9 inhibitor fluconazole had no clinically relevant effect on the pharmacokinetics or the COX-2 selectivity of lumiracoxib.
Danish: Fluconazol: Samtidig administration af lumiracoxib og den potente CYP2C9-hæmmer fluconazol havde ingen klinisk relevant effekt på lumiracoxibs farmakokinetik eller COX-2 selektivitet.
English: CYP2C9 poor metabolisers: No dose adjustment is necessary in patients known to be CYP2C9 poor metabolisers (see section 5.2).
Danish: Patienter med nedsat CYP2C9-metabolisering: Dosisjustering er ikke nødvendig hos patienter med nedsat CYP2C9 metabolisme (se pkt.
English: Lumiracoxib is an orally active, selective cyclooxygenase-2 (COX-2) inhibitor within the clinical dose range.
Danish: Lumeracoxib er indenfor det kliniske dosisområde en oral aktiv selektiv cyclo-oxygenase-2 (COX-2) hæmmer.
English: To conduct physician surveys to monitor appropriate use.
Danish: Indehaveren af markedsføringstilladelsen foretager undersøgelser blandt læger for at kontrollere, at lægemidlet anvendes korrekt.
English: Chromosome aberrations were induced in V79 cells at high, cytotoxic concentrations of lumiracoxib,
Danish: Der er induceret kromosomafvigelser i V79-celller ved høje, cytotoksiske koncentrationer af lumiracoxib, som ikke anses som værende biologisk relevante for mennesker.
English: Relief of acute pain due to orthopaedic surgery: the maximum treatment duration in clinical studies was 5 days.
Danish: Lindring af akut smerte grundet ortopædisk kirurgi: Den maksimale behandlingsvarighed i kliniske studier var 5 dage.
English: - the new data provided on rofecoxib by the APPROVe clinical study, which revealed a risk of thrombotic CV events, - the data on celecoxib presented in the APC study, which suggested a dose-related increased risk of serious CV events, - the data on valdecoxib and parecoxib presented in the CABG (Coronary Artery Bypass Graft) and in the CABG II studies, which showed a higher rate of serious CV thromboembolic events in the parecoxib/valdecoxib treatment arm compared to the group of patients receiving placebo, - the data on etoricoxib in the EDGE study and pooled analyses of other clinical trials, which suggested an association with a higher thrombotic risk than naproxen, - the data on lumiracoxib in the Target study, which suggested a small increase in thrombotic events (especially myocardial infarction) versus naproxen, all available data show an increased risk of CV adverse reactions for Cox-2 inhibitors as a class and agreed that there is an association between duration and dose of intake and the probability of suffering a CV reaction.
Danish: - de nye oplysninger om rofecoxib fra den kliniske undersøgelse APPROVe, der viste risiko for thrombotiske kardiovaskulære hændelser, - oplysningerne om celecoxib i APC-undersøgelsen, som tydede på en dosisrelateret øget risiko for alvorlige kardiovaskulære hændelser, - oplysningerne om valdecoxib og parecoxib i CABG- (koronararterie-bypass transplantation) og CABG II-undersøgelserne, der viste en højere forekomst af alvorlige kardiovaskulære thromboemboliske hændelser i parecoxib/valdecoxib-behandlingsformen sammenlignet med patienter, der får placebo, - oplysningerne om etoricoxib i EDGE-undersøgelsen og i samlede analyser af andre kliniske undersøgelser, som tyder på, at den tilknyttede thromboserisiko er højere end for naproxen,
English: As with other drugs known to inhibit prostaglandin synthesis, fluid retention and oedema have been observed in patients taking lumiracoxib in clinical trials.
Danish: Som med andre lægemidler, der vides at hæmme prostaglandinsyntesen, er der set væskeretention og ødem hos patienter i behandling med lumiracoxib i kliniske studier.
English: Relief of pain due to primary dysmenorrhea: the maximum treatment duration in clinical studies was 3 days.
Danish: Lindring af smerte grundet primær dysmenorré: Den maksimale behandlingsvarighed i kliniske studier var 3 dage.
English: No dose adjustment is necessary in patients known to be CYP2C9 poor metabolisers.
Danish: Dosisjustering er ikke nødvendig hos patienter med nedsat CYP2C9metabolisme.
English: Common: fatigue, oedema (e.g lower limb) Uncommon: appetite increased or decreased, chest pain, rigors, thirst Rare: anaphylaxis
Danish: Almindelige: Træthed, ødem (f.eks. underekstremiteter) Usædvanlig: Øget eller nedsat appetit, brystsmerter, rigor, tørst Sjælden: Anafylaksi
English: In clinical studies, lumiracoxib 400 mg relieved pain in acute analgesic models of post-operative dental pain, post-orthopaedic surgical pain, and primary dysmenorrhea.
Danish: Lumiracoxib 400 mg har i kliniske forsøg lindret smerte i akutte analgetiske modeller af post-operative tandsmerter, post-operative ortopædiske smerter og primær dysmenorré.
English: Use of lumiracoxib, as with any drug known to inhibit COX-2, is not recommended in women attempting to conceive (see section 4.6).
Danish: Brug af lumiracoxib kan, ligesom andre lægemidler der hæmmer COX-2, ikke anbefales til kvinder, der forsøger at blive gravide (se pkt.
English: Uncommon: dyspnoea, epistaxis, rhinitis, sinus congestion, asthma
Danish: Usædvanling: Dyspnø, epistaxis, rinitis, sinuskongestion, astma
English: Uncommon: conjunctivitis, dry eye, visual disturbance (e.g. blurred vision) Rare: keratitis
Danish: Usædvanlig: Konjunktivitis, tørre øjne, synsforstyrrelser (f.eks. sløret syn) Sjældne: Keratitis
English: The use of lumiracoxib, as with any drug to inhibit COX-2, is not recommended in women attempting to conceive.
Danish: Brug af lumiracoxib frarådes, ligesom alle andre lægemidler der hæmmer COX-2, til kvinder der forsøger at blive gravide.
English: The changes of the Product Information related to the SCAR can be summarised as follows: - Addition of a warning to report that the onset of skin reactions occur in the majority of cases within the first month of treatment.
Danish: Ændringerne i produktinformationen vedrørende SCAR-undersøgelsen kan sammenfattes således: - tilføjelse af en advarsel med oplysning om, at de fleste tilfælde af hudreaktioner forekommer inden for den første måned af behandlingen, - tilføjelse af en advarsel til patienter med tidligere lægemiddelallergi af enhver art, - tilføjelse af en advarsel for at fremhæve, at der nu med Cox-2-hæmmere er forekommet alvorlige hudreaktioner med dødelig udgang, - tilføjelse af en detaljeret beskrivelse af de første tegn på hudreaktioner, som fører til behandlingsophør.
English: Skin and subcutaneous tissue disorders Uncommon: contusion, exanthem, pruritus, rash, urticaria Rare: angioedema
Danish: Sygdomme i hud og subkutane væv Usædvanlig: Kontusion, exanthem, pruritus, udslæt, urticaria Sjælden: Angioneurotisk ødem
English: Lumiracoxib is contraindicated in patients with moderate to severe renal impairment (estimated creatinine clearance <50 ml/min) (see section 4.3, 4.4 and 5.2).
Danish: Lumiracoxib er kontraindikeret hos patienter med moderat til svær nyreinsufficiens (estimeret creatininclearance ≤50 ml/min) se pkt.
English: Member State Marketing Authorisation Holder
Danish: Medlemsland Indehaver af markedsføringstilladelsen Særnavn
English: Cellulose microcrystalline, croscarmellose sodium, povidone, magnesium stearate
Danish: Cellulose, mikrokrystallinsk; croscarmellosenatrium; povidon; magnesiumstearat Overtræk:
English: Systemic exposure at levels with no adverse effect for these targets in rat (26-week study) and monkey (39-week study) were 6.5 and 22 times that in man following a 200 mg therapeutic dose, respectively.
Danish: Der sås hos rotter (26 ugers forsøg) og aber (39 ugers forsøg) ingen uønskede hændelser i disse organer ved systemisk optagelse af henholdsvis 6,5 og 22 gange større end hos mennesker efter en dosis på 200 mg.
English: Renal and urinary disorders Uncommon: dysuria, urinary frequency, cystitis Rare: chromaturia, renal failure
Danish: Sygdomme i nyre- og urinveje Usædvanlig: Dysuri, øget urinfrekvens, cystitis Sjældne: Chromaturi, nyresvigt
English: When lumiracoxib was administered to patients with end-stage renal disease, a 33% decrease in lumiracoxib Cmax and a 27% decrease in AUC were observed compared to healthy subjects.
Danish: Der er set 33% fald i lumiracoxib Cmax og 27% fald i AUC ved administration af lumiracoxib til patienter med terminal nyresygdom sammenlignet med raske frivillige.
English: Film-coated tablets 400 mg:
Danish: Filmovertrukne tabletter 400 mg:
English: Each 200 mg film-coated tablet contains 200 mg lumiracoxib.
Danish: Hver 200 mg filmovertrukken tablet indeholder 200 mg af lumiracoxib.
English: Each 400 mg film-coated tablet contains 400 mg lumiracoxib.
Danish: Hver 400 mg filmovertrukken tablet indeholder 400 mg af lumiracoxib.
English: There was no statistically significant difference between lumiracoxib and NSAIDs for incidence of MI (clinical MI and silent MI).
Danish: Der var ingen statistisk signifikant forskel i incidensen af MI (klinisk MI og ikke symptomgivende MI) mellem lumiracoxib og NSAID.
English: Film-coated tablets 100 mg:
Danish: Filmovertrukne tabletter 100 mg:
English: In clinical studies the following undesirable effects were reported at an incidence greater than placebo in patients with OA or RA treated with lumiracoxib 200 mg daily for up to one year (approximately 920 patients for three months and approximately 250 patients for one year).
Danish: I kliniske forsøg med patienter med OA eller RA, behandlet med lumiracoxib 200 mg daglig i op til 1 år (ca. 920 patienter i 3 måneder og ca. 250 patienter i 1 år), er følgende bivirkninger indberettet med en højere forekomst end placebo.
English: Infections
Danish: Øjensygdomme
English: 200 mg film-coated tablets: Ovaloid, red, tablets with “NVR” debossed on one side and “OC” on the other side.
Danish: 200 mg filmovertrukne tabletter: Ovale, røde tabletter med ”NVR” præget på én side og ”OC” præget på den anden side.
English: Each 100 mg film-coated tablet contains 100 mg lumiracoxib.
Danish: Hver 100 mg filmovertrukken tablet indeholder 100 mg af lumiracoxib.
English: Cellulose microcrystalline, croscarmellose sodium, lactose monohydrate, povidone, titanium dioxide, magnesium stearate
Danish: Cellulose, mikrokrystallinsk; croscarmellosenatrium; lactosemonohydrat; povidon; titandioxid; magnesiumstearat
English: 400 mg film-coated tablets: Ovaloid, red, tablets with “NVR” debossed on one side and “OD” on the other side.
Danish: 400 mg filmovertrukne tabletter: Ovale, røde tabletter med ”NVR” præget på én side og ”OD” præget på den anden side.
English: There were no cases of Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme reported in association with the use of lumiracoxib.
Danish: I forbindelse med anvendelsen af lumiracoxib var der hverken indberettet om tilfælde af Stevens-Johnsons syndrom, toksisk epidermal nekrolyse eller erythema multiforme.
English: 100 mg film-coated tablets: Ovaloid, red, tablets with “NVR” debossed on one side and “OB” on the other side.
Danish: 100 mg filmovertrukne tabletter: Ovale, røde tabletter med ”NVR” præget på én side og ”OB” præget på den anden side.
English: MARKETING AUTHORISATION NUMBER(S) PL 00101/0677
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)
English: Plasma protein binding of lumiracoxib was similar in healthy subjects and in patients with end-stage renal disease.
Danish: Plasma-proteinbindingen af lumiracoxib hos patienter med terminal nyresygdom svarede til den hos raske frivillige.
English: Across clinical pharmacology studies, lumiracoxib produced dose-dependent inhibition of COX-2 in plasma without inhibition of COX-1.
Danish: Den kliniske betydning af disse fund er endnu ikke klarlagt.I alle kliniske, farmakologiske undersøgelser forårsagede lumiracoxib, dosisafhængig hæmning af COX-2 i plasma uden hæmning af COX-1.
English: For systolic blood pressure, mean change from baseline were +0.4 mmHg for lumiracoxib and +2.1 mmHg for NSAIDs (p<0.0001).
Danish: Kardiorenal effekt i TARGET (12 måneders studie) For det systoliske blodtryk var den gennemsnitlige ændring fra basislinien +0,4 mmHg for lumiracoxib og +2,1 mmHg for NSAID (p<0,0001).
English: Lithium: NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance.
Danish: Litium: Der er set stigninger i plasmaniveauer af litium og fald i nyreudskillelsen af litium ved samtidig administration af NSAID.
English: Musculoskeletal disorders Uncommon: joint swelling, muscle cramps, arthralgia
Danish: Sygdomme i bevægeapparatet Usædvanlig: Hævede led, muskelkramper, artralgi
English: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs and some selective COX-2 inhibitors during post-marketing surveillance.
Danish: I forbindelse med overvågning efter markedsføring af NSAID og visse selektive COX-2 hæmmere er der meget sjældent indberettet alvorlige hudreaktioner, nogle fatale, inklusiv exfoliativ dermatitis, Steven-Johnson syndrom og toksisk epidermisk nekrolyse.
English: To conduct a Prescription Event Monitoring study.
Danish: Indehaveren af markedsføringstilladelsen foretager en kontrolundersøgelse af behandlingsforløb med det ordinerede lægemiddel.
English: In humans, lumiracoxib undergoes extensive hepatic metabolism.
Danish: Hos mennesker metaboliseres lumiracoxib i udstrakt grad via leveren.
English: Haemodialysis is unlikely to be an efficient method of drug removal due to high protein binding.
Danish: På grund af den høje proteinbinding, er det ikke sandsynligt, at lægemidlet kan fjernes ved hæmodialyse.
English: Compared to healthy subjects, exposure to lumiracoxib was not changed in patients with moderate hepatic impairment (Child-Pugh score 7-8).
Danish: Lumiracoxiboptagelsen ændredes ikke hos patienter med moderat leverinsufficiens (Child-Pugh score 7-8) sammenlignet med raske frivillige.
English: There is no significant inhibition of COX-1 (assessed as ex vivo inhibition of thromboxane B2) up to 800 mg in healthy volunteers.
Danish: Der er hos raske frivillige ingen signifikant hæmning af COX-1 (vurderet som ex vivo hæmning af tromboxan B2) ved op til 800 mg. Lumiracoxib 800 mg daglig medførte ingen klinisk betydningsfuld hæmning af den gastriske prostaglandinsyntese og påvirkede ikke trombocytfunktionen.
English: The patients need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis (see section 4.2, 4.3, 4.8 and 5.1).
Danish: Patientens behov for symptomlindring og respons på behandlingen bør løbende revurderes, specielt hos patienter med osteoarthrose (se pkt.
English: Clinical 6
Danish: Klinisk aspekt 6
English: In the overall population, the incidence of APTC events was 59/9117 patients (0.65%) for lumiracoxib versus 50/9127 patients (0.55%) for NSAIDs, with a HR of 1.14 [95% CI 0.781.66] p=0.5074.
Danish: I den samlede studiepopulation var incidensen af APTC-hændelser 59/9.117 (0,65%) for lumiracoxib mod 50/9.127 patienter (0,55%) for NSAID med et RF på 1,14 [95% KI 0,78-1,66] p=0,5074.
English: Clinical 7
Danish: Klinisk aspekt 7
English: Expedited reporting of a list of agreed SAEs.
Danish: Indehaveren af markedsføringstilladelsen foretager hasteindberetning af de alvorlige bivirkninger, som er opført på den godkendte liste.
English: Renal Insufficiency:
Danish: Leverinsufficiens:
English: In the low dose ASA group the incidence of POBs was 15/2167 patients (0.69%) for lumiracoxib versus 19/2159 patients (0.88%) for NSAIDs, with a HR of 0.79 [95% CI 0.401.55] (not statistically significant).
Danish: I lavdosis acetylsalicylsyregruppen var incidensen af POB 15/2.167 (0,69%) for lumiracoxib mod 19/2.159 patienter (0,88%) for NSAID, med et RF på 0,79 [95% KI 0,40-1,55] (ikke statistisk signifikant).
English: In the low-dose ASA group, the incidence of APTC events was 24/2167 patients (1.11%) for lumiracoxib versus 23/2159 patients (1.07%) for NSAIDs, with a hazard ratio (HR) of 1.04 [95% CI 0.59-1.84] p=0.8918.
Danish: I lavdosis acetylsalicylsyregruppen var incidensen af APTC-hændelser 24/2.167 patienter (1,11%) for lumiracoxib mod 23/2.159 patienter (1,07%) for NSAID, med et RF på 1,04 [95% KI 0,59-1,84] p=0,8918.
English: In the overall population, the incidence of MIs was 23/9117 patients (0.25%) for lumiracoxib versus 17/9127 patients (0.19%) for NSAIDs, with a HR of 1.31 [95% CI 0.70-2.45] p=0.4012.
Danish: I den samlede studiepopulation var incidensen af MI-hændelser 23/9.117 (0,25%) for lumiracoxib mod 17/9.127 patienter (0,19%) for NSAID med et RF på 1,31 [95% KI 0,70-2,45] p=0,4012.
English: In the overall population, the incidence of POBs was 29/9117 patients (0.32%) for lumiracoxib versus 83/9127 patients (0.91%) for NSAIDs, with a HR of 0.34 [95% CI 0.22-0.52] p<0.0001.
Danish: I den samlede studiepopulation var incidensen af POB 29/9.117 (0,32%) for lumiracoxib mod 83/9.127 patienter (0,91%) for NSAID med et RF på 0,34 [95% KI 0,22-0,52] p<0,0001
English: In the low-dose ASA group, the incidence of MI events was 9/2167 patients (0.42%) for lumiracoxib versus 8/2159 patients (0.37%) for NSAIDs, with a HR of 1.14 [95% CI 0.44-2.95] p=0.7899.
Danish: I lavdosis acetylsalicylsyregruppen var incidensen af MI-hændelser 9/2.167 patienter (0,42%) for lumiracoxib mod 8/2.159 patienter (0,37%) for NSAID, med et RF på 1,14 [95% KI 0,44-2,95] p=0,7899.
English: When compared separately to ibuprofen and naproxen, the HR were 0.75 [95% CI 0.20-2.79] p=0.6669 and 2.37 [95% CI 0.74-7.55] p=0.1454, respectively.
Danish: Sammenlignet individuelt med ibuprofen og naproxen var RF respektivt 0,75 [95% KI 0,20-2,79] p=0,6669 og 2,37 [0,95% KI 0,74-7,55] p=0,1454.
English: In the population not using low-dose aspirin, the incidence of APTC events was 35/6950 patients (0.50%) for lumiracoxib versus 27/6968 patients (0.39%) for NSAIDs, with a HR of 1.22 [95% CI 0.74-2.02] p=0.4343.
Danish: I studiepopulationen som ikke brugte lavdosis acetylsalicylsyre, var incidensen af APTC-hændelser 35/6.950 patienter (0,50%) for lumiracoxib mod 27/6.968 patienter (0,39%) for NSAID med et RF på 1,22 [95% KI 0,74-2,02] p=0,4343.
English: Film-coated tablets 200 mg:
Danish: Filmovertrukne tabletter 200 mg: Kerne:
English: In the population not using low-dose aspirin, the incidence of MI events was 14/6950 patients (0.20%) for lumiracoxib versus 9/6968 patients (0.13%) for NSAIDs, with a HR of 1.47 [95% CI 0.63-3.39] p=0.3706.
Danish: I studiepopulationen som ikke brugte lavdosis acetylsalicylsyre, var incidensen af MI-hændelser 14/6.950 patienter (0,20%) for lumiracoxib mod 9/6.968 patienter (0,13%) for NSAID med et RF på 1,47 [95% KI 0,63-3,39] p=0,3706.
English: When compared separately to ibuprofen and naproxen, the HR were 0.47 [95% CI 0.04-5.14] p=0.5328 and 1.36 [95% CI 0.47-3.93] p=0.5658, respectively.
Danish: Sammenlignet individuelt med ibuprofen og naproxen var RF respektivt 0,47 [95% KI 0,04-5,14] p=0,5328 og 1,36 [95% KI 0,47-3,93] p=0,5658.
English: In the population not using low-dose aspirin, the incidence of POBs was 14/6950 patients (0.2%) for lumiracoxib versus 64/6968 patients (0.92%) for NSAIDs, with a hazard ratio (HR) of 0.21 [95% CI 0.12-0.37] p<0.0001.
Danish: I studiepopulationen som ikke brugte lavdosis acetylsalicylsyre, var incidensen af POB 14/6.950 patienter (0,2%) for lumiracoxib mod 64/6.968 patienter (0,92%) for NSAID, med et risikoforhold (RF) på 0,21 [95% konfidensinterval (KI) 0,12-0,37] p<0,0001
English: In short-term, multiple-dose clinical studies of post-orthopaedic surgical pain and pain from primary dysmenorrhea, lumiracoxib 400 mg once daily was effective in relieving pain.
Danish: Lumiracoxib 400 mg, én gang daglig var effektivt smertelindrende i korterevarende kliniske forsøg med gentagne doser ved post-operative ortopædiske smerter og smerter fra primær dysmenorré.
English: When compared separately to ibuprofen and naproxen, the HR were 0.56 [95% CI 0.20-1.54] p=0.2603 and 1.42 [95% CI 0.70-2.90] p=0.3368, respectively.
Danish: Sammenlignet individuelt med ibuprofen og naproxen var RF respektivt 0,56 [95% KI 0,20-1,54] p=0,2603 og 1,42 [95% KI 0,70-2,90] p=0,3368.
English: Of the total drug related material in plasma, unchanged lumiracoxib is the major component.
Danish: Uomdannet lumiracoxib er den primære bestanddel af den totale mængde lægemiddelrelaterede materiale i plasma.
English: When compared separately to ibuprofen and naproxen, the HR were 0.66 [95% CI 0.21-2.09] p=0.4833 and 1.77 [95% CI 0.82-3.84] p=0.1471, respectively.
Danish: Sammenlignet individuelt med ibuprofen og naproxen, var RF respektivt 0,66 [95% KI 0,21-2,09] p=0,4833 og 1,77 [95% KI 0,82-3,84] p=0,1471.
English: When compared separately to ibuprofen and naproxen, the HR were 0.76 [95% CI 0.41-1.40] p=0.3775 and 1.46 [95% CI 0.89-2.37] p=0.1313, respectively.
Danish: Sammenlignet individuelt med ibuprofen og naproxen, var RF respektivt 0,76 [95% KI 0,41-1,40] p=0,3775 og 1,46 [95% KI 0,89-2,37] p=0,1313.
English: When compared separately to ibuprofen and naproxen, the HR were 0.94 [95% CI 0.44-2.04] p=0.8842 and 1.49 [95% CI 0.76-2.92] p=0.2417, respectively.
Danish: Sammenlignet individuelt med ibuprofen og naproxen var RF respektivt 0,94 [95% KI 0,44-2,04] p=0,8842 og 1,49 [0,95% KI 0,76-2,92] p=0,2417.
English: Uncommon: palpitations, myocardial infarction* Rare: cardiac failure, atrioventricular block of first degree Vascular disorders
Danish: Hjertesygdomme Usædvanlig: Palpitationer, myokardieinfarkt*
English: Hepatic Insufficiency:
Danish: Infektiøse sygdomme:
English: In a pre- and post-natal development study in rats, an increase in stillborn pups and reduced embryo/fetal survival was seen at maternally toxic doses ≥3 mg/kg.
Danish: Resorptionsforekomsten var øget hos kaniner ved en optagelse ca. 9 gange den humane optagelse efter en dosis på 200 mg. Ved niveauet uden embryo/føtal påvirkning, var den systemiske optagelse 8,6 (rotter) og 2,2 (kaniner) gange højere end hos mennesker efter en dosis på 200 mg. Der er i forsøg vedrørende præ- og post-natal udvikling hos rotter set en stigning i dødfødte unger og reduceret embryo/føtal overlevelse ved maternalt toksiske doser ≥3 mg/kg.
English: To monitor and report PSUR of a list of agreed AEs.
Danish: Indehaveren af markedsføringstilladelsen overvåger og foretager periodiske, opdaterede sikkerhedsindberetninger af de bivirkninger, som er opført på den godkendte liste.
English: Scientific conclusions and grounds for refusal presented by the European Medicines Agency
Danish: Videnskabelige konklusioner og begrundelse for afslag fremlagt af Det Europæiske Lægemiddelagentur
English: Overall summary of the scientific evaluation of Loraxin and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Loraxin og relaterede navne (se bilag I)
English: Sweden and Poland considered that the granting of the marketing authorisation constitutes a potential serious risk to public health.
Danish: Sverige og Polen fandt, at udstedelse af markedsføringstilladelsen udgør en potentiel alvorlig risiko for den offentlige sundhed.
English: However one of the reports does not contain any data regarding PK/PD (or dose-response) relationships.
Danish: Den ene rapport indeholder imidlertid ingen data om PK/PD-sammenhængen (eller dosis/respons).