FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH shall ensure that, following discussion and agreement with the National Competent Authorities in each Member State where AUBAGIO is marketed, at launch and after launch, all healthcare professionals who are expected to use AUBAGIO are provided with the following items:
Danish: I ethvert land, hvor AUBAGIO bliver markedsført, skal MAH efter diskussion og enighed med de nationale myndigheder sikre, at alle sundhedspersoner, som forventes at anvende AUBAGIO, i forbindelse med markedsføring og efter markedsføring får udleveret følgende materialer:
English: Based on the half-life of fingolimod, a 6-week interval without therapy is needed for clearance from the circulation and a 1 to 2 month period is needed for lymphocytes to return to normal range following discontinuation of fingolimod.
Danish: Baseret på fingolimods halveringstid er en 6-ugers behandlingsfri periode efter seponering af fingolimod nødvendig for clearance fra kredsløbet, og 1-2 måneder for at lymfocyttallet kan vende tilbage til baseline.
English: Polyamide/aluminium/poly(vinyl chloride) -aluminium blisters inserted in wallets (14 and 28 film-coated tablets) and packed in cartons containing 14, 28, 84 (3 wallets of 28), and 98 (7 wallets of 14) film-coated tablets.
Danish: Polyamid/aluminium/poly(vinylchlorid)-aluminium-blister indsat i hylster (14 og 28 filmovertrukne tabletter) og pakket i æsker med 14, 28, 84 (3 hylstre med 28) og 98 (7 hylstre med 14) filmovertrukne tabletter.
English: The number of patients with permanent treatment discontinuation in the subcutaneous interferon beta-1a group was 30 out of 104 (28 .8%), the reasons being adverse events (21.2%), lack of efficacy (1.9%), other reason (4.8%) and poor compliance to protocol (1%).
Danish: Antallet af patienter med permanent behandlingsophør i gruppen med subkutan interferon beta-1a var 30 ud af 104 (28,8 %) med årsagerne bivirkninger (21,2 %), manglende effekt (1,9 %), andre årsager (4,8 %) og dårlig compliance til protokollen (1 %).
English: A majority of patients (67.2%) had not received disease-modifying therapy during the 2 years before study entry.
Danish: Størstedelen af patienterne (67,2 %) havde ikke fået nogen form for sygdomsbehandling i de 2 forudgående år op til studiestart.
English: • Risk of hematologic effects o the need for complete blood cell counts before treatment and periodically during treatment based on signs and symptoms
Danish: • Risiko for hæmatologiske virkninger o Nødvendigheden af komplet blodtælling før behandlingen og periodevist under behandling baseret på tegn og symptomer.
English: TOPIC was a double-blind, placebo-controlled study that evaluated once daily doses of teriflunomide 7 mg and 14 mg for up to 108 weeks in patients with first clinical demyelinating event (mean age 32.1 years).
Danish: TOPIC var et dobbeltblindet, placebokontrolleret studie, som evaluerede doser af teriflunomid 7 mg og 14 mg indgivet en gang dagligt i op til 108 uger hos patienter med første kliniske demyeliniserende issolerede hændelse/syndrom (CIS) (gennemsnitsalder 32,1 år).
English: In case of ulcerative stomatitis, teriflunomide administration should be discontinued.
Danish: I tilfælde af ulcerøs stomatitis skal teriflunomid seponeres.
English: 14 film-coated tablets 28 film-coated tablets
Danish: 14 filmovertrukne tabletter 28 filmovertrukne tabletter
English: - you have severe skin reactions.
Danish: - Hvis du har svære hudreaktioner.
English: The median EDSS score at baseline was 2.50; 249 patients (22.9%) had an EDSS score › 3.5 at baseline.
Danish: Median EDSS-score ved bassisniveau var 2,50; 249 patienter (22,9 %) havde en EDSS-score > 3,5 ved baseline.
English: Therefore, medicinal products metabolised by CYP2C8, such as repaglinide, paclitaxel, pioglitazone or rosiglitazone, should be used with caution during treatment with teriflunomide.
Danish: Derfor skal lægemidler, der metaboliseres af CYP2C8, som f.eks. repaglinid, paclitaxel, pioglitazon og rosiglitazon, anvendes med forsigtighed under behandling med teriflunomid.
English: The frequency of elevations above 3-fold ULN and higher was balanced across treatment groups.
Danish: Hyppigheden af stigning ≥ 3 gange ULN var jævnt fordelt på tværs af alle behandlingsgrupper.
English: The majority of patients had relapsing-remitting multiple sclerosis (97.5%), but a subgroup of patients had secondary progressive (0.8%) or progressive relapsing multiple sclerosis (1.7%).
Danish: Størstedelen af patienterne havde recidiverende remitterende multipel sklerose (97,5 %), men en undergruppe havde sekundær progressiv (0,8 %) ellerprogressiv recidiverende multipel sklerose (1,7 %).
English: Blood pressure must be checked before the start of teriflunomide treatment and periodically thereafter.
Danish: Blodtrykket skal kontrolleres, før behandling med teriflunomid påbegyndes og periodisk derefter.
English: After stopping treatment with teriflunomide:
Danish: Efter seponering af teriflunomid:
English: If this is not well tolerated, cholestyramine 4 g three times a day for 11 days can be used.
Danish: Hvis dette ikke tolereres godt, kan colestyramin 4 g tre gange dagligt i 11 dage anvendes.
English: AUBAGIO 14 mg film-coated tablets (tablets) are pale blue to pastel blue, pentagonal film-coated tablets with imprint on one side (‘14') and engraved with a corporate logo on the other side.
Danish: AUBAGIO 14 mg filmovertrukne tabletter (tabletter) er svagt blå til pastelblå femkantede filmovertrukne tabletter med påtryk (‘14') på den ene side og præget med virksomhedens logo på den anden side.
English: In the pivotal, placebo-controlled studies, the incidence of peripheral neuropathy confirmed by nerve conduction studies was 1.9% (17 patients out of 898) on 14 mg of teriflunomide, compared with 0.4% (4 patients out of 898) on placebo.
Danish: I de pivotale placebokontrollerede studier var forekomsten af perifer neuropati bekræftet med nerveimpulsoverlednings-studier henholdsvis 1,9 % (17 patienter ud af 898) for 14 mg teriflunomid, sammenlignet med 0,4 % (4 patienter ud af 898) for placebo.
English: Each film-coated tablet contains 14 mg of teriflunomide.
Danish: Hver filmovertrukket tablet indeholder 14 mg teriflunomid.
English: Without an accelerated elimination procedure, it takes an average of 8 months to reach plasma concentrations less than 0.02 mg/l, although due to individual variation in substance clearance it may take up to 2 years.
Danish: Uden en accelereret eliminationsprocedure tager det i gennemsnit 8 måneder at nå en plasmakoncentration på under 0,02 mg/l, men på grund af individuelle forskelle i clearance af stoffet kan det tage op til 2 år.
English: Cases of severe skin reactions have been reported postmarketing (including Stevens-Johnson syndrome and toxic epidermal necrolysis).
Danish: Efter markedsføringen er der rapporteret tilfælde om alvorlige hudreaktion med teriflunomid (herunder Stevens-Johnsons syndrom eller toksisk epidermal nekrolyse).
English: Treatment with AUBAGIO will be overseen by a doctor who is experienced in the treatment of multiple sclerosis.
Danish: Behandlingen med AUBAGIO vil blive styret af en læge, der har erfaring med behandling af multipel sclerose.
English: To encourage the patients to read the PIL thoroughly 4.
Danish: Opfordre patienterne til at læse hele indlægssedlen igennem.
English: In placebo-controlled studies, frequencies for asthenia were 2.0%, 1.6% and 2.2% in the placebo, teriflunomide 7 mg and teriflunomide 14 mg group, respectively.
Danish: I placebokontrollerede studier var forekomsten af asteni 2,0 %, 1,6 % og 2,2 % i henholdsvis placebogruppen, gruppen med teriflunomid 7 mg og gruppen med teriflunomid 14 mg.
English: A total of 618 patients were randomised to receive 7 mg (n=205) or 14 mg (n=216) of teriflunomide or placebo (n=197).
Danish: I alt 618 patienter blev randomiseret til at modtage 7 mg (n=205) eller 14 mg (n=216) teriflunomid eller placebo (n=197).
English: Potent cytochrome P450 (CYP) and transporter inducers Co-administration of repeated doses (600 mg once daily for 22 days) of rifampicin (a CYP2B6, 2C8, 2C9, 2C19, 3A inducer), as well as an inducer of the efflux transporters P-glycoprotein [P-gp] and breast cancer resistant protein [BCRP] with teriflunomide (70 mg single dose) resulted in an approximately 40% decrease in teriflunomide exposure.
Danish: Samtidig administration af gentagne doser (600 mg én gang dagligt i 22 dage) rifampicin (en CYP2B6-, 2C8-, 2C9-, 2C19- og 3A-induktor), samt en induktor af efflux-transporterne P-glykoprotein [P-gp] og brystcancer-resistent protein [BCRP] med teriflunomid (70 mg enkeltdosis) resulterede i et fald på cirka 40 % i teriflunomid-eksponeringen.
English: Each tablet contains 14 mg of teriflunomide.
Danish: Hver tablet indeholder 14 mg teriflunomid.
English: For other substrates of BCRP (e.g., methotrexate, topotecan, sulfasalazine, daunorubicin, doxorubicin) and the OATP family especially HMG-Co reductase inhibitors (e.g., simvastatin, atorvastatin, pravastatin, methotrexate, nateglinide, repaglinide, rifampicin) concomitant administration of teriflunomide should also be undertaken with caution.
Danish: For andre BCRP-substrater (f.eks. methotrexat, topotecan, sulfasalazin, daunorubicin, doxorubicin) og OATP-familien, særligt HMG-CoA-reduktaseinhibitorer (f.eks. simvastatin, atorvastatin, pravastatin, methotrexat, nateglinid, repaglinid, rifampicin) skal samtidig administration af teriflunomid også ske med forsigtighed.
English: It is recommended that patients receiving teriflunomide are not treated with cholestyramine or activated charcoal because this leads to a rapid and significant decrease in plasma concentration unless an accelerated elimination is desired.
Danish: Medmindre en accelereret udvaskning er ønskelig, anbefales det, at patienter, der får teriflunomid, ikke behandles med colestyramin eller aktivt kul, da dette medfører et hurtigt og signifikant fald i plasmakoncentrationen.
English: There were no external malformations in the offspring of male rats administered teriflunomide prior to mating with untreated female rats.
Danish: Der var ingen ydre misdannelser hos afkommet fra hanrotter, der havde fået teriflunomid før parring med ubehandlede hunrotter.
English: If an accelerated elimination procedure is not used, teriflunomide plasma levels can be expected to be above 0.02 mg/l for an average of 8 months, however, in some patients it may take up to 2 years to reach plasma concentration below 0.02 mg/l.
Danish: Hvis en accelereret eliminationsprocedure ikke benyttes, må plasmakoncentrationen af teriflunomid forventes at være over 0,02 mg/l i gennemsnitligt 8 måneder, men hos nogle patienter kan det dog tage op til 2 år at nå plasmakoncentrationer under 0,02 mg/l.
English: In cases of severe haematological reactions, including pancytopenia, AUBAGIO and any concomitant myelosuppressive treatment must be discontinued and a teriflunomide accelerated elimination procedure should be considered.
Danish: I tilfælde af alvorlige hæmatologiske reaktioner, herunder pancytopeni, skal AUBAGIO og anden samtidig behandling med myelosuppressive lægemidler seponeres, og den accelererede eliminationsprocedure for teriflunomid overvejes.
English: The elimination of teriflunomide from the circulation can be accelerated by administration of cholestyramine or activated charcoal, presumably by interrupting the reabsorption processes at the intestinal level.
Danish: Accelereret eliminationsprocedure: Colestyramin og aktivt kul Elimineringen af teriflunomid fra kredsløbet kan accelereres ved administration af colestyramin eller aktivt kul, sandsynligvis fordi dette afbryder reabsorptionsprocessen på intestinalt niveau.
English: Teriflunomide 14 mg
Danish: Teriflunomid 14 mg
English: The number of patients with permanent treatment discontinuation in the teriflunomide 14 mg group was 22 out of 111 (19.8%), the reasons being adverse events (10.8%), lack of efficacy (3.6%), other reason (4.5%) and lost to follow-up (0.9%).
Danish: Antallet af patienter med permanent behandlingsophør i gruppen med 14 mg teriflunomid var 22 ud af 111 (19,8 %) med årsagerne bivirkninger (10,8 %), manglende effekt (3,6 %), andre årsager (4,5 %) og manglende opfølgning (0,9 %).
English: Alopecia was reported as hair thinning, decreased hair density, hair loss, associated or not with hair texture change, in 13.9% of patients treated with 14 mg teriflunomide versus 5.1% in patients treated with placebo.
Danish: Alopeci blev indberettet som udtynding af håret, nedsat hårtæthed, hårtab, eventuelt med en ændring af hårets tekstur, hos 13,9 % af de patienter, der blev behandlet med 14 mg teriflunomid sammenlignet med 5,1 % hos placebobehandlede patienter.
English: Effect of teriflunomide on oral contraceptives: 0.03 mg ethinylestradiol and 0.15 mg levonorgestrel There was an increase in mean ethinylestradiol Cmax and AUC0-24 (1.58- and 1.54-fold, respectively) and levonorgestrel Cmax and AUC0-24 (1.33- and 1.41-fold, respectively) following repeated doses of teriflunomide.
Danish: Virkningen af teriflunomid på orale kontraceptiva: 0,03 mg ethinylestradiol og 0,15 mg levonorgestrel Der var en stigning i middel-ethinylestradiol-Cmax og -AUC0-24 (henholdsvis 1,58 og 1,54 gange) og levonorgestrel-Cmax og -AUC0-24 (henholdsvis 1,33 og 1,41 gange) efter gentagne doser teriflunomid.
English: ALT increase (based on laboratory data) according to baseline status - Safety population in placebocontrolled studies
Danish: ALAT-stigning (baseret på laboratoriedata) i forhold til baselineSikkerhedspopulation i placebokontrollerede studier placebo (N=997)
English: For patients testing positive in tuberculosis screening, treat by standard medical practice prior to therapy with AUBAGIO.
Danish: Patienter, der testes positive i en tuberkulosescreening, skal behandles i henhold til gældende retningslinjer før behandling med AUBAGIO.
English: The European Medicines Agency has waived the obligation to submit the results of studies with AUBAGIO in children from birth to less than 10 years in treatment of multiple sclerosis (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet til at fremlægge resultaterne af studier med AUBAGIO hos børn fra fødslen til mindre end 10 år med multipel sklerose (se pkt.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR WALLET
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER TIL HYLSTER
English: • Complete blood cell count including differential white blood cell and platelet count.
Danish: • Komplet blodtælling inklusive differentialtælling og trombocyttal.
English: System organ class
Danish: Systemorganklasse Megetalmindelig
English: The risk of male-mediated embryo-fetal toxicity through teriflunomide treatment is considered low.
Danish: Risikoen for embryoføtal toksicitet på grund af mandlig partner i behandling med teriflunomid betragtes som lav.
English: Palpitations
Danish: Palpitation
English: If you forget to take AUBAGIO
Danish: Hvis du har glemt at tage AUBAGIO
English: Therefore, when teriflunomide is coadministered with substrates of OAT3, such as cefaclor, benzylpenicillin, ciprofloxacin, indometacin, ketoprofen, furosemide, cimetidine, methotrexate, zidovudine, caution is recommended.
Danish: Derfor tilrådes forsigtighed, når teriflunomid administreres samtidig med OAT3-substrater som f.eks. cefaclor, benzylpenicillin, ciprofloxacin, indomethacin, ketoprofen, furosemid, cimetidin, methotrexat og zidovudin.
English: Gadolinium-enhancing lesions at baseline: no data.
Danish: Der foreligger ingen data om gadolinium-forstærkede læsioner ved baseline.
English: Pregnant women, or women of childbearing potential who are not using reliable contraception during treatment with teriflunomide and thereafter as long as its plasma levels are above 0.02 mg/l (see section 4.6).
Danish: Gravide kvinder og kvinder i den fertile alder, som ikke anvender pålidelig antikonception under behandlingen med teriflunomid og efterfølgende, så længe plasmaniveauet er over 0,02 mg/l (se pkt.
English: If cholestyramine 8 g three times a day is not well-tolerated, cholestyramine 4 g three times a day can be used.
Danish: Hvis colestyramin 8 g tre gange dagligt ikke tolereres, kan colestyramin 4 g tre gange dagligt anvendes.
English: The primary biotransformation pathway for teriflunomide is hydrolysis, with oxidation being a minor pathway.
Danish: Den primære metaboliseringsvej for teriflunomid er hydrolyse, mens oxidation udgør en sekundær omdannelsesvej.
English: Annualised relapse rate
Danish: Årlig attak-rate
English: An accelerated elimination procedure can be used at any time after discontinuation of teriflunomide (see sections 4.6 and 5.2 for procedural details).
Danish: En accelereret eliminationsprocedure kan anvendes på et hvilket som helst tidspunkt efter seponeringen af teriflunomid (se pkt.
English: Use in males
Danish: Brug til mænd
English: Sanofi Winthrop Industrie 56, route de Choisy au Bac 60205 Compiègne France
Danish: Sanofi Winthrop Industrie 56, route de Choisy au Bac 60205 Compiègne Frankrig
English: In multiple sclerosis, inflammation destroys the protective sheath (called myelin) around the nerves in the CNS.
Danish: Ved multipel sclerose ødelægger betændelse den beskyttende kappe (kaldet myelin), som ligger omkring nerverne i centralnervestsyemet, hvilket forhindrer nerverne i at fungere normalt.
English: There was an increase in mean rosuvastatin Cmax and AUC (2.65- and 2.51-fold, respectively), following repeated doses of teriflunomide.
Danish: Der var en stigning i middel-rosuvastatin-Cmax og -AUC (henholdsvis 2,65 og 2,51 gange) efter gentagne doser teriflunomid.
English: Not known (frequency cannot be estimated from the available data) - Severe infections (including sepsis) - Severe allergic reactions (including anaphylaxis) - Pulmonary reaction (interstitial lung disease, ILD) - Inflammation of the liver, pancreas, or mouth/lips - Severe skin reactions - Abnormal levels of fats (lipids) in the blood - Psoriasis
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenværende data) - Alvorlige infektioner (herunder blodforgiftning) - Alvorlige allergiske reaktioner (herunder anafylaksi) - Lungereaktion (interstitiel lungesygdom, ILD) - Betændelse i leveren, bugspytkirtlen eller munden/læberne - Alvorlige hudreaktioner - Unormalt indhold af fedt (lipider) i blodet - Psoriasis
English: Patients with severe hypoproteinaemia, e.g. in nephrotic syndrome.
Danish: Patienter med svær hypoproteinæmi, f.eks. ved nefrotisk syndrom.
English: Pale blue to pastel blue, pentagonal film-coated tablets with imprint on one side (‘14') and engraved with a corporate logo on the other side.
Danish: Svagt blå til pastelblå femkantede filmovertrukne tabletter med påtryk (‘14') på den ene side og præget med virksomhedens logo på den anden side.
English: If you stop taking AUBAGIO
Danish: Hvis du holder op med at tage AUBAGIO
English: Pharmacokinetic interactions of teriflunomide on other substances
Danish: Teriflunomids farmakokinetiske interaktioner med andre stoffer - virkning på andre stoffer
English: No dosage adjustment is necessary for patients with mild, moderate or severe renal impairment not undergoing dialysis.
Danish: Dosisjustering er ikke nødvendig til patienter med let, moderat eller alvorligt nedsat nyrefunktion, som ikke er i dialyse.
English: Other medicines and AUBAGIO
Danish: Brug af anden medicin sammen med AUBAGIO
English: If a patient taking AUBAGIO develops a confirmed peripheral neuropathy, consider discontinuing AUBAGIO therapy and performing the accelerated elimination procedure.
Danish: Hvis perifer neuropati diagnosticeres hos en patient i behandling med AUBAGIOi, bør det overvejes at seponere AUBAGIO og iværksætte den accelererede eliminationsprocedure.
English: Mild increases in transaminase, ALT below or equal to 3-fold ULN were more frequently seen in teriflunomide-treated groups as compared to placebo.
Danish: Let forhøjede aminotransferaser, ALAT ≤ med 3 gange ULN, sås hyppigere i de teriflunomid-behandlede grupper sammenlignet med placebo.
English: Influenza, Upper respiratory tract infection, Urinary tract infection, Bronchitis, Sinusitis, Pharyngitis, Cystitis, Gastroenteritis viral,
Danish: Influenza, Infektion i de øvre luftveje, Urinvejsinfektion, Bronkitis, Sinusitis,
English: All patients had a definite diagnosis of MS (based on McDonald criteria (2005)), exhibited a relapsing clinical course, with or without progression, and experienced at least 1 relapse over the year preceding the trial or at least 2 relapses over the 2 years preceding the trial.
Danish: Alle patienter havde en klar diagnose på MS (baseret på McDonald kriterier (2005)), udviste et recidiverende klinisk forløb med eller uden progression og havde haft mindst 1 attak i løbet af året forud for undersøgelsen eller mindst 2 attakker i løbet af de sidste 2 år forud for undersøgelsen.
English: Women of childbearing potential have to use effective contraception during treatment and after treatment as long as teriflunomide plasma concentration is above 0.02 mg/l.
Danish: Kvinder i den fertile alder skal anvende sikker antikonception under og efter behandlingen, så længe plasmakoncentrationen af teriflunomid er over 0,02 mg/l.
English: The time can be reduced to a few weeks by taking certain medicines which speed up removal of AUBAGIO from your body.
Danish: Den normale udskillelse af det aktive stof kan vare op til 2 år, men tiden kan reduceres til nogle få uger ved at tage visse bestemte lægemidler, som øger den hastighed, hvormed AUBAGIO udskilles fra kroppen.
English: Package leaflet: Information for the patient AUBAGIO 14 mg film-coated tablets teriflunomide
Danish: Indlægsseddel: Information til patienten AUBAGIO 14 mg filmovertrukne tabletter
English: Food does not have a clinically relevant effect on teriflunomide pharmacokinetics.
Danish: Fødeindtagelse har ingen klinisk relevant effekt på teriflunomids farmakokinetik.
English: Change relative to placebo Mean Number of Gdenhancing lesions at week
Danish: Forskel i BOD uge 108 Forskel relativ til placebo Gennemsnitligt antal Gdforstærkede læsioner ved uge 108
English: A total of 1169 patients with RMS were randomised in TOWER to receive 7 mg (n=408) or 14 mg (n=372) of teriflunomide or placebo (n= 389) for a variable treatment duration ending at 48 weeks after last patient randomised.
Danish: I TOWER blev i alt 1.169 patienter med RMS randomiseret til 7 mg (n=408) eller 14 mg (n=372) teriflunomid eller placebo (n= 389) i en variabel behandlingsperiode, der sluttede 48 uger efter randomisering af den sidste patient.
English: All patients had a definite diagnosis of MS (based on McDonald criteria (2001)), exhibited a relapsing clinical course, with or without progression, and experienced at least 1 relapse over the year preceding the trial or at least 2 relapses over the 2 years preceding the trial.
Danish: Alle patienter havde en klar diagnose på MS (baseret på McDonald kriterier (2001)), udviste et recidiverende klinisk forløb med eller uden progression og havde haft mindst 1 attak i løbet af året forud for undersøgelsen eller mindst 2 attakker i løbet af de sidste 2 år forud for undersøgelsen.
English: AUBAGIO is used in adults to treat relapsing remitting multiple sclerosis (MS).
Danish: AUBAGIO anvendes til behandling af voksne patienter med attakvis multipel sklerose (MS).
English: Polyamide/aluminium/poly(vinyl chloride) -aluminium perforated unit-dose blister packs in cartons containing 10x1 film-coated tablets.
Danish: Pakninger med perforerede en-dosis blister i polyamid/aluminium/poly(vinylchlorid)-aluminium i æsker med 10 x1 filmovertrukne tabletter.
English: Cases of peripheral neuropathy have been reported in patients receiving AUBAGIO (see section 4.8).
Danish: Der er rapporteret perifer neuropati hos patienter i behandling med AUBAGIO (se pkt.
English: AUBAGIO is available in cardboard cartons containing: - 14, 28, 84 and 98 tablets in wallet packs with integrated aluminium blisters; - 10x1 tablet in all aluminium perforated unit-dose blisters.
Danish: AUBAGIO leveres i kartonæsker indeholdende: - 14, 28, 84 og 98 tabletter i hylsterpakninger med integrerede aluminiumsblistere.