FrancophonIA/ELRC3.0 huggingface dataset:
English: maraviroc - the combination tablet containing efavirenz, emtricitabine, and tenofovir should not be taken with Efavirenz Teva unless recommended by your doctor since it contains efavirenz, the active ingredient of Efavirenz Teva.
Danish: Må ikke tages sammenen med Efavirenz Teva, medmindre din læge anbefaler det, da dette indeholder efavirenz, der er det aktive stof i Efavirenz Teva.
English: Buprenorphine/naloxone/ efavirenz
Danish: Buprenorphin/naloxon/efavire nz
English: Atazanavir/ritonavir/efavirenz (400 mg once daily/200 mg once daily/600 mg once daily, all administered with food)
Danish: Atazanavir/ritonavir/efavirenz (400 mg én gang dagligt/200 mg én gang dagligt/600 mg én gang dagligt, alle administreret sammen med mad)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER BUNDLE LABEL FOR MULTIPACKS OF 90 (3 PACKS OF 30 x 1 FILM-COATED TABLET) - WITH THE BLUE BOX
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE BUNDT-ETIKET TIL MULTIPACKS À 90 (3 PAKNINGER À 30 X 1 FILMOVERTRUKKET TABLET) - MED BLUE BOX
English: 90 x 1 film-coated tablet in white opaque PVC/PVdC-aluminium perforated unit-dose blisters.
Danish: 90 x 1 filmovertrukket tablet i hvide gennemsigtige PVC/PVdC-aluminium perforeret enkeltdosisblisterpakninger.
English: See below and section 5.3.
Danish: Se nedenfor samt pkt.
English: Pimozide, imipramine, amitriptyline or clomipramine (used to treat certain mental conditions) elbasvir or grazoprevir (used to treat hepatitis C) St John's wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety) flecainide, metoprolol (used to treat irregular heart beat) certain antibiotics (macrolides, fluoroquinolones, imidazole)
Danish: perikon (Hypericum perforatum) (et naturlægemiddel mod depression og angst) flecainid, metoprolol (til behandling af uregelmæssig hjerterytme) visse antibiotika (makrolider, fluoroquinoloner, imidazol)
English: PARTICULARS TO APPEAR ON THE OUTER CARTON COMPONENT OF MULTIPACK OF 90 (3 PACKS OF 30 x 1 FILM-COATED TABLETS)WITHOUT BLUE BOX
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MULTIPACK-KOMPONENT À 90 (3 PAKNINGER À 30 x 1 FILMOVERTRUKNE TABLETTER) - UDEN BLUE BOX
English: Co-administration with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) because competition for CYP3A4 by efavirenz could result in inhibition of metabolism and create the potential for serious and/or life-threatening adverse reactions [for example, cardiac arrhythmias, prolonged sedation or respiratory depression] (see section 4.5).
Danish: Samtidigt administration med terfenadin, astemizol, cisaprid, midazolam, triazolam, primozid, bepridil eller ergotalkaloider (fx ergotamin, dihydroergotamin, ergonovin og methylergonovin) da konkurrence om CYP3A4 fra efavirenz kan resultere i hæmning af metaboliseringen.
English: EU/1/11/742/005 (carton multi-pack - blister PVC/PVDC/alu) EU/1/11/742/010 (carton multi-pack - blister alu/alu)
Danish: EU/1/11/742/005 (multi-pack-æske - blister PVC/PVDC/alu) EU/1/11/742/010 (multi-pack-æske - blister alu/alu)
English: Indinavir/efavirenz (800 mg q8h/200 mg once daily)
Danish: Indinavir/efavirenz (800 mg q8h/200 mg én gang dagligt)
English: When using efavirenz with low-dose ritonavir, the possibility of an increase in the incidence of
Danish: Når efavirenz gives sammen med ritonavir i lav dosis, bør muligheden for stigning i incidensen af efavirenzassocierede bivirkninger overvejes på grund af eventuel farmakodynamisk interaktion.
English: Phenytoin, phenobarbital, and other anticonvulsants that are substrates of CYP450 isoenzymes
Danish: Phenytoin, phenobarbital og andre antikonvulsiva, som er
English: The median increase from baseline in CD4+ count at 48 weeks of therapy was 238 cells/mm3 and the median increase in CD4+ percentage was 13%.
Danish: Den mediane stigning i CD4+ tal ved uge 48 fra baseline var 238 celler/mm3, og den mediane stigning i CD4+ procent var 13%.
English: Efavirenz Teva", at the start of Section 2.
Danish: Disse er nævnt under Tag ikke Efavirenz Teva i begyndelsen af pkt.
English: Your doctor may need to consider giving you a different anticonvulsant.
Danish: Lægen vil måske overveje at give dig et andet lægemiddel mod krampeanfald.
English: Telaprevir/efavirenz (1,125 mg q8h/600 mg once daily)
Danish: Telaprevir/efivarenz (1.125 mg q8h/600 mg én gang daglig)
English: (see section 4.3).
Danish: 4.3 og 4.4).
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to combination antiretroviral therapy (CART).
Danish: Ætiologien anses dog for at være multifaktoriel (omfattende anvendelse af kortikosteroider, alkoholforbrug, svær immunosuppression, højere Body Mass Index (BMI)).
English: Concomitant administration of velpatasvir/sofosbuvir/voxilaprevir with efavirenz is not recommended (see section 4.5).
Danish: Samtidig administration af velpatasvir/sofosbuvir/voxilaprevir med efavirenz anbefales ikke (se pkt.
English: Nelfinavir/efavirenz (750 mg q8h/600 mg once daily)
Danish: Nelfinavir/efavirenz (750 mg q8h/600 mg én gang dagligt)
English: AUC: ↓ 75% (↓ 59 to ↓ 84) Cmax: ↓ 64% (↓ 57 to ↓ 69) Cmin: ↓ 62% (↓ 44 to ↓ 75)
Danish: AUC: ↓ 75% (↓ 59 til ↓ 84) Cmax: ↓ 64% (↓ 57 til ↓ 69) Cmin: ↓ 62% (↓ 44 til ↓ 75)
English: General disorders and administration site conditions Common Fatigue *,†, ‡ See section c. Description of selected adverse reactions for more details.
Danish: Almene symptomer og reaktioner på administrationsstedet Almindelig Træthed *,†,‡ Se pkt.
English: Azithromycin/efavirenz (600 mg single dose/400 mg once daily)
Danish: Azithromycin/efavirenz (600 mg enkeltdosis/400 mg én gang dagligt)
English: Simeprevir/efavirenz (150 mg once daily /600 mg once daily)
Danish: Simeprevir/efavirenz (150 mg en gang dagligt/600 mg en gang dagligt)
English: Hepatic failure
Danish: Akut hepatitis
English: How to take Efavirenz Teva
Danish: Sådan skal du tage Efavirenz Teva
English: Common Abnormal dreams, anxiety, depression, insomnia* Uncommon Affect lability, aggression, confusional state, euphoric mood, hallucination, mania,
Danish: Agitation, amnesi, ataksi, unormal koordination, kramper, abnorm tankevirksomhed*, tremor†
English: ANTIANXIETY AGENTS Lorazepam/efavirenz (2 mg single dose/600 mg once daily)
Danish: Lorazepam/efavirenz (2 mg enkeltdoser/600 mg én gang dagligt)
English: ANTI-INFECTIVES
Danish: ANTI-INFEKTIVA Lægemidler mod hiv
English: Dose adjustment of atorvastatin may be required (refer to the Summary of Product Characteristics for atorvastatin).
Danish: Dosisjustering af atorvastatin kan være påkrævet (se SPC for
English: (CYP3A4 induction) Efavirenz:
Danish: Cmax: ↓ 15% (CYP3A4-induktion) Efavirenz:
English: Morning Cmax: ↑ 24% (↑ 12 to ↑ 38)
Danish: Cmax morgen: ↑ 24% (↑ 12 til Cmax aften: ↔
English: Efavirenz may be an inducer of CYP2C19 and CYP2C9; however inhibition has also been observed in vitro and the net effect of co-administration with substrates of these enzymes is not clear (see section 5.2).
Danish: Der er dog også blevet observeret hæmning in vitro, og nettoeffekten ved samtidig administration af substrater for disse enzymer er ikke klarlagt (se pkt.
English: Evening Cmin: ↑ 24% (↑ 3 to ↑ 50) b
Danish: Cmin morgen: ↑ 42% (↑ 9 til ↑ 86) b Cmin aften: ↑ 24% (↑ 3 til ↑ 50) b
English: You should consult your doctor if you have a rash, since some rashes may be serious; however, most cases of rash disappear without any change to your treatment with Efavirenz Teva.
Danish: De fleste tilfælde af udslæt forsvinder dog uden ændring af din behandling med Efavirenz Teva.
English: Voriconazole/efavirenz (400 mg twice daily/300 mg once daily)
Danish: Voriconazol/efavirenz (400 mg to gange dagligt/300 mg én gang dagligt)
English: EFV + NRTIs NFV + NRTIs Study 020
Danish: EFV + NRTI'ere 65 58 (46, 70) NFV + NRTI'ere 66 30 (19, 42) Undersøgelse 020
English: Fosamprenavir/ritonavir/ efavirenz (700 mg twice daily/100 mg twice daily/600 mg once daily)
Danish: Fosamprenavir/ritonavir/efavir enz (700 mg to gange dagligt/100 mg to gange dagligt/600 mg én gang dagligt)
English: Delusion ‡, neurosis ‡, completed suicide‡,* Nervous system disorders Common Cerebellar co-ordination and balance disturbances†, disturbance in attention (3.6%), dizziness (8.5%), headache (5.7%), somnolence (2.0%)* Uncommon Agitation, amnesia, ataxia, co-ordination abnormal, convulsions, thinking abnormal*, tremor†
Danish: (3,6%), svimmelhed (8,5%), hovedpine (5,7%), døsighed (2,0%)*
English: Since decreased concentrations of artemether, dihydroartemisinin, or lumefantrine may result in a decrease of antimalarial efficacy, caution is recommended when efavirenz and artemether/lumefantrine tablets are coadministered.
Danish: Forsigtighed tilrådes, når efavirenz og artemether/lumefantrin-tabletter tages samtidigt, da fald i koncentrationen af artemether, dihydroartemisinin eller lumefantrin kan resultere i nedsat effekt mod malaria.
English: Indinavir/ritonavir/efavirenz (800 mg twice daily/100 mg twice daily/600 mg once daily)
Danish: Indinavir/ritonavir/efavirenz (800 mg to gange dagligt/100 mg to gange dagligt/600 mg én gang dagligt)
English: Saquinavir/ritonavir/efavirenz
Danish: Darunavir/ritonavir/efavirenz
English: AUC: ↑ 17% (↑ 6 to ↑ 29) ** Cmax: ↔** *compared to 200 mg twice daily alone ** compared to 600 mg once daily alone (Competitive inhibition of oxidative metabolism)
Danish: Cmax: ↔** * sammenlignet med 200 mg alene to gange dagligt
English: ANTIHISTAMINES Cetirizine/efavirenz (10 mg single dose/600 mg once daily)
Danish: Cetirizin/efavirenz (10 mg enkeltdoser/600 mg én gang dagligt)
English: CD4+ count at 48 weeks was 215 cells/mm3 and the median increase in CD4+ percentage was 6%.
Danish: Den mediane stigning i CD4+ tal ved uge 48 fra baseline var 215 celler/mm3, og den mediane stigning i CD4+ procent var 6%.
English: Atazanavir/ritonavir/efavirenz (400 mg once daily/100 mg once daily/600 mg once daily, all administered with food)
Danish: Proteasehæmmere (PIer) Atazanavir/ritonavir/efavirenz (400 mg én gang dagligt/100 mg én gang dagligt/600 mg én gang dagligt, alle administreret sammen med mad)
English: Fluconazole/efavirenz (200 mg once daily/400 mg once daily)
Danish: Fluconazol/efavirenz (200 mg én gang dagligt/400 mg én gang dagligt)
English: Fluoxetine/efavirenz
Danish: Fluoxetin/efavirenz
English: Rifampicin/efavirenz (600 mg once daily/600 mg once daily)
Danish: Rifampicin/efavirenz (600 mg én gang dagligt/600 mg én gang dagligt)
English: Ritonavir/efavirenz (500 mg twice daily/600 mg once daily)
Danish: Ritonavir/efavirenz (500 mg to gange dagligt/600 mg én gang dagligt)
English: AUC: ↓ 18% (↓ 8 to ↓ 27) Cmax: ↓ 14% (↓ 3 to ↓ 24) Cmin: ↓ 25% (↓ 14 to ↓ 34)% Efavirenz:
Danish: AUC: ↓ 18% (↓ 8 til ↓ 27) Cmax: ↓ 14% (↓ 3 til ↓ 24) Cmin: ↓ 25% (↓ 14 til ↓ 34)
English: Skin and subcutaneous tissue disorders Very common Rash (11.6%)*
Danish: Hud og subkutane væv Meget almindelig
English: AUC: ↓ 7% (↓ 23 to ↑ 13) * Cmax: ↑ 23% (↓ 1 to ↑ 53) *
Danish: Cmax: ↑ 23% (↓ 1 til ↑ 53) *
English: What Efavirenz Teva is and what it is used for What you need to know before you take Efavirenz Teva How to take Efavirenz Teva Possible side effects
Danish: Det skal du vide, før du begynder at tage Efavirenz Teva Sådan skal du tage Efavirenz Teva Bivirkninger
English: Voriconazole/efavirenz (200 mg twice daily/400 mg once daily)
Danish: Voriconazol/efavirenz (200 mg to gange dagligt/400 mg én gang dagligt)
English: Nervous system symptoms usually begin during the first one or two days of therapy and generally resolve after the first 2-4 weeks.
Danish: Symptomer fra nervesystemet debuterer sædvanligvis i løbet af de første 1-2 behandlingsdage og forsvinder i reglen efter de første 2-4 uger.
English: Valproic acid/efavirenz (250 mg twice daily/600 mg once daily)
Danish: Valproinsyre/efavirenz (250 mg to gange dagligt/600 mg én gang dagligt)
English: Hepatitis C antivirals Boceprevir/efavirenz (800 mg 3 times daily/600 mg
Danish: Boceprevir/efavirenz (800 mg 3 gange daglig/600 mg en gang daglig)
English: Paroxetine/efavirenz (20 mg once daily/600 mg once daily)
Danish: Paroxetin/efavirenz (20 mg én gang dagligt/600 mg én gang dagligt)
English: ANTICONVULSANTS Carbamazepine/efavirenz (400 mg once daily/600 mg once daily)
Danish: Carbamazepin/efavirenz (400 mg én gang dagligt/600 mg én gang dagligt)
English: Simvastatin/efavirenz (40 mg once daily/600 mg once daily)
Danish: Simvastatin/efavirenz (40 mg én gang dagligt/600 mg én gang dagligt)
English: Pravastatin/efavirenz (40 mg once daily/600 mg once daily)
Danish: Pravastatin/efavirenz (40 mg én gang dagligt/600 mg én gang dagligt)
English: Possible side effects
Danish: 4 Bivirkninger).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR MULTIPACKS OF 90 (3 PACKS OF 30 x 1 FILM-COATED TABLETS) - WITH THE BLUE BOX
Danish: YDRE ÆSKE TIL MULTIPACKS À 90 (3 PAKNINGER À 30 x 1 FILMOVERTRUKNE TABLETTER) - MED BLUE BOX
English: ANTIDEPRESSANTS
Danish: ANTIKONVULSIVA
English: Teva
Danish: Hos
English: Itraconazole/efavirenz (200 mg q12h/600 mg once daily)
Danish: Itraconazol/efavirenz (200 mg hver 12. time/600 mg én gang dagligt)
English: Efavirenz Teva contains lactose
Danish: Efavirenz Teva indeholder lactose
English: Plasma trough concentrations of boceprevir were decreased when
Danish: Plasmakoncenrationerne af boceprevir faldt ved administration med efavirenz.
English: If you need help in planning the best times to take your medicine, ask your doctor or pharmacist.
Danish: Spørg din læge eller apotek, hvis du har brug for hjælp til at planlægge, hvornår det er bedst at tage din medicin.
English: Nervous system symptoms usually begin soon after therapy onset and generally resolve after the first 24 weeks.
Danish: Symptomer fra nervesystemet starter sædvanligvis hurtigt efter initiering af behandling og forsvinder generelt efter de første 2-4 uger.
English: Hepatic failure‡,*
Danish: Hyperkolesterolæmi*
English: Lopinavir/ritonavir tablets/ efavirenz
Danish: Lopinavir/ritonavirtabletter/efa virenz
English: Cmax: ↓ 17% (↓ 6 to ↓ 26) b Cmin: ↓ 50% (↓ 40 to ↓ 59)
Danish: AUC: ↓ 25% (↓ 16 til ↓32) b Cmax: ↓ 17% (↓ 6 til ↓ 26) b Cmin: ↓ 50% (↓ 40 til ↓ 59) b
English: Medicines used to treat depression such as imipramine, amitriptyline or clomipramine Antibiotics, including the following types: macrolides, fluoroquinolones or imidazole.
Danish: - Lægemidler til behandling af depression, fx imipramin, amitriptylin eller clomipramin.
English: Antimycobacterials Rifabutin/efavirenz (300 mg once daily/600 mg once daily)
Danish: Rifabutin/efavirenz (300 mg én gang dagligt/600 mg én gang dagligt)
English: AUC: ↓ 64% (↓ 62 to ↓ 67) Cmax: ↓ 46% (↓ 39 to ↓ 52) Cmin: ↓ 82% (↓ 79 to ↓ 85)
Danish: AUC: ↓ 64% (↓ 62 til ↓ 67) Cmax: ↓ 46% (↓ 39 til ↓ 52)
English: Non-sustained convulsions were observed in some monkeys receiving efavirenz for ≥ 1 year, at doses yielding plasma AUC values 4- to 13-fold greater than those in humans given the recommended dose (see sections 4.4 and 4.8).
Danish: AUC-værdier 4-13 gange højere end dem, der er set hos mennesker ved anbefalet dosis (se pkt.
English: Uncommon Vision blurred Ear and labyrinth disorders
Danish: Øre og labyrint Ikke almindelig
English: Photoallergic dermatitis†
Danish: Fotoallergisk dermatit† Det reproduktive system og mammae Ikke almindelig
English: AUC: ↓ 18% (↓ 10 to ↓ 26) Cmax: ↓ 24% (↓ 15 to ↓ 32)
Danish: AUC: ↓ 18% (↓ 10 til ↓26) Cmax: ↓ 24% (↓ 15 til ↓ 32) Cmin: ↓ 10% (↑ 1 til ↓ 19)%
English: EXP {MM/YYYY}
Danish: <MM/ÅÅÅÅ>
English: Antifungals
Danish: ANTIKOAGULANTIA
English: Cmax: ↔ 8%
Danish: Cmin: ↓ 31%
English: Dose
Danish: Gynækomasti
English: Efavirenz regimen Control regimen (n=1,008)
Danish: (n=1.008)
English: These
Danish: Øjne
English: Recommendation concerning co-administration with efavirenz efavirenz for any of these medicinal products.
Danish: Anbefaling vedrørende samtidig administration med efavirenz behandling med efavirenz igangsættes eller seponeres.
English: Norepinephrine and dopamine reuptake inhibitor Bupropion/efavirenz [150 mg single dose (sustained release)/600 mg once daily]
Danish: Bupropion/efavirenz [150 mg enkeltdosis (som depot)/600 mg én gang dagligt]
English: Taking Efavirenz Teva on an empty stomach may reduce the undesirable effects.
Danish: Det kan nedsætte bivirkningerne, hvis Efavirenz Teva tages på tom mave.
English: Dose-related increases in
Danish: Tilstrækkelige data vedrørende tolerans af
English: It must always be taken in combination with other anti-HIV medicines.
Danish: Efavirenz Teva skal altid tages sammen med andre anti-hiv-lægemidler.
English: - Efavirenz Teva is for oral use.
Danish: - Efavirenz Teva skal tages gennem munden.
English: NNRTIs/efavirenz
Danish: NNRTIer/efavirenz
English: NRTIs
Danish: ANTACIDA
English: - skin rash
Danish: Gul jernoxid
English: The harmonised product information were implemented in the Member States end of 2004-beginning of 2005.
Danish: De harmoniserede produktoplysninger blev indført i medlemsstaterne i slutningen af 2004/begyndelsen af 2005.
English: In Europe, nimesulide is nationally authorised in 16 Member States (Austria, Belgium, Bulgaria, Czech Republic, Cyprus, France, Greece, Hungary, Italy, Latvia, Lithuania, Malta, Portugal, Romania, Slovakia and Slovenia).
Danish: I Europa har nimesulide en national godkendelse i 17 medlemsstater (Østrig, Belgien, Bulgarien, Den Tjekkiske Republik, Cypern, Frankrig, Grækenland, Ungarn, Italien, Letland, Litauen, Malta, Polen, Portugal, Rumænien, Slovakiet og Slovenien).
English: Conditions of the Marketing Authorisations are identified in Annex IV of this Opinion.
Danish: Betingelserne for markedsføringstilladelserne findes i bilag IV til denne beslutning.
English: Nimesulide-containing medicinal products are currently marketed in more than 50 countries worldwide, particularly in Europe and South America.
Danish: Lægemidler indeholdende nimesulide markedsføres nu i over 50 lande i verden, især i Europa og Sydamerika.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF NIMESULIDE CONTAINING MEDICINAL PRODUCTS (SYSTEMIC FORMULATIONS) (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF LÆGEMIDLER INDEHOLDENDE NIMESULIDE (SYSTEMISKE FORMULERINGER) (se bilag I)
English: - The maximum duration of a treatment course with nimesulide is 15 days.
Danish: - Den maksimale varighed af et behandlingsforløb med nimesulide er 15 dage.
English: letter
Danish: Communication'-brev.
English: The assessment of these consequences were supported by a simulation of the possible impact of nimesulide withdrawal in Italy.
Danish: Vurderingen af disse konsekvenser blev underbygget af en simulation af de mulige følgevirkninger af en tilbagekaldelse af nimesulide i Italien.
English: Having considered all of the available evidence, the CHMP concluded that the data did not support a suspension of all marketing authorisations in Europe.
Danish: Efter vurdering af al foreliggende dokumentation konkluderede CHMP, at dataene ikke underbyggede en suspension af alle markedsføringstilladelser i Europa.
English: Nimesulide is a non-steroidal anti-inflammatory drug (NSAID), available only on prescription and authorised in Europe since 1985.
Danish: Nimesulide er et nonsteroidt antiinflammatorisk lægemiddel (NSAID), som kun udleveres efter recept, og som har været tilladt i Europa siden 1985.
English: This simulation showed a notable reduction of hospitalisation due to liver injuries whilst hospitalisation due to gastroinstestinal toxicity might increase.
Danish: Denne simulation viste et væsentligt fald i hospitalisering som følge af leverskader, mens hospitalisering som følge af gastrointestinal toksicitet kunne stige.
English: Having reviewed all available data on hepatotoxicity, the CHMP concluded the following.
Danish: Efter gennemgang af alle foreliggende data om hepatotoksicitet konkluderede CHMP:
English: The use of nimesulide in strict accordance with the Product Information recommendations has been shown to be equally effective in reducing hepatic toxicity.
Danish: Anvendelsen af nimesulide i nøje overensstemmelse med anbefalingerne i produktoplysningerne har vist sig at være lige så effektiv til nedsættelse af levertoksicitet.
English: The review concluded that a small increase in the absolute risk for hepatotoxic reactions associated with nimesulide cannot be excluded although the overall risk benefit/balance remains positive.
Danish: Konklusionen på gennemgangen var, at en mindre stigning i den absolutte risiko for hepatotoksiske reaktioner med tilknytning til nimesulide ikke kan udelukkes, selv om det samlede risk/benefit-forhold stadig er positivt.
English: This decision was endorsed by the European Commission in April 2004 and the product information was subsequently amended to contraindicate its use in patients with hepatic impairment, and to include warnings about the risk of hepatitis, fulminant hepatitis (including fatal cases), jaundice and cholestasis.
Danish: Denne beslutning blev godkendt af Europa-Kommissionen i april 2004, og produktoplysningerne blev følgelig ændret, så lægemidlet blev kontraindiceret til anvendelse hos patienter med nedsat leverfunktion, og så de indeholdt advarsler om risikoen for hepatitis, fulminant hepatitis (inklusive dødstilfælde), gulsot og kolestase.
English: - The limitation of treatment with nimesulide not longer than 15 days may limit the risk of acute liver injury.
Danish: - Begrænsningen af behandlingen med nimesulide til højst 15 dage kan begrænse risikoen for akut leverskade.
English: Furthermore the maintenance of the Marketing Authorisations is linked to the conditions, below: - Submission of 6-monthly PSURs - Implementation of a retrospective study, followed by a prospective study in transplant centres - Update of Risk Management Plan - Information of healthcare professional via a ‘Direct Healthcare Professional Communication'
Danish: Endvidere sættes der følgende betingelser for at opretholde markedsføringstilladelserne: - Fremlæggelse af halvårlige PSUR - Gennemførelse af en retrospektiv undersøgelse efterfulgt af en prospektiv undersøgelse i transplantationscentre - Ajourføring af risikostyringsplanen - Underretning af fagfolk inden for sundhedssektoren via et ‘Direct Healthcare Professional
English: The additional Product Information restrictions together with a limitation of duration of treatment and withdrawal of the pack sizes above 30 units aim at further minimising such risk, together with the conditions (see Annex IV) and the effort of national competent authorities in education and information activities on both prescribers and patients.
Danish: De supplerende begrænsninger i produktoplysningerne, begrænsningen af behandlingsvarigheden og tilbagekaldelsen af pakningsstørrelser over 30 enheder tager sige på at nedsætte denne risiko yderligere, hvilket skal sammenholdes med betingelserne (se bilag IV) og de nationale kompetente myndigheders bestræbelser på at gennemføre uddannelses- og oplysningsaktiviteter for såvel ordinerende læger som patienter.
English: The CHMP reviewed the data presented, including answers provided by the Marketing Authorisations Holders (MAHs), pharmacovigilance data provided by the Member States, data provided by the EMEA and literature review.
Danish: CHMP gennemgik de fremlagte data, herunder svarene fra indehaverne af markedsføringstilladelserne, lægemiddelovervågningsdata fra medlemsstaterne, data fra EMEA og faglitteraturen.
English: The CHMP agreed, that the risk minimisation measures adopted at the end of the first referral have been able to contain the incidence of the most serious liver injuries.
Danish: Der var enighed i CHMP om, at de risikonedsættende foranstaltninger, som var blevet vedtaget ved færdigbehandlingen af den først indbragte sag, har kunnet begrænse forekomsten af de mest alvorlige leverskader.