FrancophonIA/ELRC3.0 huggingface dataset:
English: Microcrystalline cellulose Magnesium stearate Hydroxypropylcellulose Croscarmellose sodium Colloidal hydrated silica Colloidal anhydrous silica Crospovidone Talc
Danish: Mikrokrystallinsk cellulose Magnesiumstearat Hydroxypropylcellulose Croscarmellosenatrium Hydratiseret kolloid silica Vandfri kolloid silica Crospovidon
English: Hypromellose Titanium dioxide (E171) Ethylcellulose Iron oxide yellow (E172) Triacetin
Danish: Hypromellose Titandioxid (E171) Ethylcellulose Jernoxid, gul (E172) Triacetin
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Bør ikke anvendes til patienter med arvelig galactoseintolerans, total lactase deficiency eller glucose/galactosemalabsorption.
English: In a study in healthy subjects, 120 mg febuxostat QD resulted in a mean 22% increase in AUC of desipramine, a CYP2D6 substrate indicating a potential weak inhibitory effect of febuxostat on the CYP2D6 enzyme in vivo.
Danish: I en studie med raske forsøgspersoner resulterede 120 mg febuxostat en gang dagligt i en gennemsnitlig stigning på 22% i AUC for desipramin, et CYP2D6-substrat, hvilket indikerer, at febuxostat har en potentiel, svag hæmmende virkning på CYP2D6-enzymet in vivo.
English: FACT Study: The Febuxostat Allopurinol Controlled Trial (FACT) Study was a Phase 3, randomized, double-blind, multicenter, 52-week study.
Danish: FACT-studiet: FACT-studiet (Febuxostat Allopurinol Controlled Trial) var et fase 3, randomiseret, dobbeltblind, multicenterstudie over 52 uger.
English: Febuxostat treatment should be immediately stopped if serious allergic/hypersensitivity reactions, including Stevens-Johnson Syndrome, occur since early withdrawal is associated with a better prognosis.
Danish: Behandlingen med febuxostat bør omgående seponeres i tilfælde af alvorlige reaktioner pga. allergi/overfølsomhed inklusive Stevens-Johnsons syndrom, da prognosen er bedre ved hurtig seponering.
English: If patient has developed allergic/hypersensitivity reactions including Stevens-Johnson Syndrome and acute anaphylactic reaction/shock, febuxostat must not be re-started in this patient at any time.
Danish: Hvis en patient udvikler allergiske reaktioner eller overfølsomhedsreaktioner, inklusive Stevens-Johnsons syndrom og akut anafylaksi/shock, må denne patient ikke på noget tidspunkt genoptage behandlingen med febuxostat.
English: Uncommon Dyspnoea, bronchitis, upper respiratory tract infection, cough
Danish: Ikke almindelige Dyspnø, bronkitis, øvre luftvejsinfektion, hoste
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis De tager anden medicin eller har gjort det for nylig.
English: For renally impaired subjects who were randomized to allopurinol, the dose was capped at 100 mg QD.
Danish: For forsøgspersoner med nedsat nyrefunktion, som var randomiseret til allopurinol, blev der lagt loft over dosen ved 100 mg en gang dagligt.
English: • loss of sex drive
Danish: • tab af sexlyst
English: Atrial fibrillation, palpitations, ECG abnormal Rare
Danish: Atrieflimren, palpitationer, unormalt ekg Sjældne
English: For any information about this medicine, please contact the local representative of the Marketing
Danish: Hvis De vil have yderligere oplysninger om febuxostat, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen.
English: Febuxostat can be co-administered with colchicine or indomethacin with no dose adjustment of febuxostat or the co-administered active substance being necessary.
Danish: Febuxostat kan administreres samtidig med colchicin eller indometacin, uden at det er nødvendigt at justere dosis af hverken febuxostat eller det samtidigt administrerede aktive stof.
English: Uncommon Hypertension, flushing, hot flush
Danish: Ikke almindelige Hypertension, flushing, hedeture
English: Febuxostat Mylan is for adults.
Danish: Febuxostat Mylan anvendes til voksne.
English: Film-coating: hypromellose, titanium dioxide (E171), ethylcellulose, iron oxide yellow (E172), triacetin and iron oxide black (E172).
Danish: Filmbelægning: hypromellose, titandioxid (E171), ethylcellulose, gul jernoxid (E172), triacetin og sort jernoxid (E172).
English: The primary efficacy endpoint in the APEX and FACT studies was the proportion of patients whose last 3 monthly serum uric acid levels were < 6.0 mg/dL (357 µmol/L).
Danish: Det primære effektmål i APEX- og FACT-studierne var den andel af patienterne, hvis sidste tre månedlige serumurinsyreniveauer var < 357 µmol/l (6,0 mg/dl).
English: The efficacy of febuxostat was demonstrated in three Phase 3 pivotal studies (the two pivotal APEX and FACT studies, and the additional CONFIRMS study described below) that were conducted in 4101 patients with hyperuricaemia and gout.
Danish: Virkningen af febuxostat blev påvist i tre pivotale fase 3-studier (de to pivotale studier APEX og FACT og det supplerende CONFIRMS-studie beskrevet nedenfor), der blev gennemført med 4.101 patienter med hyperurikæmi og arthritis urica.
English: In patients with very high urate levels (e.g. those undergoing cancer chemotherapy), treatment with uric acid-lowering medicines could lead to the build-up of xanthine in the urinary tract, with possible stones, even though this has not been observed in patients being treated with febuxostat for Tumor Lysis Syndrome.
Danish: Hos patienter, hvis urinsyreniveau er meget højt (f.eks. hvis man er i kemobehandling), kan behandling med urinsyresænkende medicin medføre, at der ophobes xanthin i urinvejene, evt. med dannelse af nyresten, selvom dette ikke er blevet observeret hos patienter, der behandles med febuxostat mod tumorlyse-syndrom.
English: Gout flares were commonly observed soon after the start of treatment and during the first months.
Danish: Udbrud af arthritis urica sås hyppigt umiddelbart efter behandlingsstart og i de første måneder.
English: Study
Danish: Studie
English: Febuxostat at oral doses up to 48 mg/kg/day was found to have no effect on fertility and reproductive performance of male and female rats.
Danish: Febuxostat ved orale doser på op til 48 mg/kg/dag havde ingen virkning på fertilitet og reproduktion hos han- og hunrotter.
English: APEX Study: The Allopurinol and Placebo-Controlled Efficacy Study of Febuxostat (APEX) was a Phase 3, randomized, double-blind, multicenter, 28-week study.
Danish: APEX-studiet: APEX-studiet (Allopurinol and Placebo-Controlled Efficacy Study of Febuxostat) var et fase 3, randomiseret, dobbeltblind, multicenterstudie over 28 uger.
English: No difference in the proportion of patients requiring treatment for gout flares was observed between the febuxostat 80 mg and 40 mg groups.
Danish: Der sås ingen forskel i andelen af patienter, der behøvede behandling for udbrud af arthritis urica, mellem grupperne, der fik hhv. febuxostat 80 mg og 40 mg.
English: See leaflet for further information.
Danish: Læs indlægssedlen for yderligere oplysninger.
English: FLORENCE was a randomized (1:1), double blind, phase III, pivotal trial comparing febuxostat 120 mg once daily with allopurinol 200 to 600 mg daily (mean allopurinol daily dose [± standard deviation]: 349.7 ± 112.90 mg) in terms of control of serum uric acid level.
Danish: FLORENCE var et randomiseret (1:1), dobbeltblindet, pivotalt fase 3-studie, der sammenlignede febuxostat 120 mg en gang dagligt med allopurinol 200 til 600 mg dagligt (daglig gennemsnitsdosis allopurinol (± standard afvigelse): 349,7 ± 112,90 mg) i forhold til kontrol af serumurinsyreniveau.
English: In the additional phase 3 CONFIRMS study, for which results became available after the marketing authorisation for febuxostat was first issued, the primary efficacy endpoint was the proportion of patients whose serum urate level was < 6.0 mg/dL at the final visit.
Danish: I det supplerende fase 3-studie CONFIRMS, hvis resultater blev offentliggjort efter den første udstedelse af markedsføringstilladelse for febuxostat, var det primære effektmål andelen af patienter med serumurat < 357 µmol/l (6,0 mg/dl) ved det sidste besøg.
English: In patients in whom the rate of urate formation is greatly increased (e.g. malignant disease and its treatment, Lesch-Nyhan syndrome) the absolute concentration of xanthine in urine could, in rare cases, rise sufficiently to allow deposition in the urinary tract.
Danish: Hos patienter, hvor hastigheden af uratdannelsen er kraftigt forøget (f.eks. malign sygdom og dens behandling, Lesch-Nyhan-syndrom), kan den absolutte koncentration af xanthin i urinen, i sjældne tilfælde stige så meget, at der sker aflejring i urinvejene.
English: A numerical greater incidence of investigator-reported cardiovascular APTC events (defined endpoints from the Anti-Platelet Trialists' Collaboration (APTC) including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) was observed in the febuxostat total group compared to the allopurinol group in the APEX and FACT studies (1.3 vs. 0.3 events per 100 Patient Years (PYs)), but not in the CONFIRMS study (see section 5.1 for detailed characteristics of the studies).
Danish: Der sås en numerisk højere forekomst af investigator-indberettede kardiovaskulære APTC-hændelser (definerede endepunkter fra Anti-Platelet Trialists' Collaboration (APTC)), der inkluderer kardiovaskulær død, ikke-letalt myokardieinfarkt, ikke-letal apopleksi) i den samlede febuxostatgruppe sammenlignet med allopurinolgruppen i APEX- og FACT-studierne (1,3 versus 0,3 hændelser pr. 100 patientår), men ikke i CONFIRMS-studiet (se pkt.
English: • nervousness
Danish: • nervøsitet
English: Naproxen and other inhibitors of glucuronidation
Danish: Naproxen og andre hæmmere af glukuronidering
English: In healthy subjects, maximum plasma concentrations (Cmax) and area under the plasma concentration time curve (AUC) of febuxostat increased in a dose proportional manner following single and multiple doses of 10 mg to 120 mg. For doses between 120 mg and 300 mg, a greater than dose proportional increase in AUC is observed for febuxostat.
Danish: Hos raske forsøgspersoner øgedes febuxostats maksimumplasmakoncentrationerne (Cmax) og arealet under plasmakoncentrationstidskurven (AUC) for febuxostat dosisproportionalt efter enkelte og gentagne doser på 10 mg til 120 mg. For doser mellem 120 mg og 300 mg blev der observeret en større end dosisproportional stigning i febuxostats AUC.
English: Febuxostat Mylan is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS).
Danish: Febuxostat Mylan er indikeret til forebyggelse og behandling af hyperurikæmi hos voksne patienter i behandling med kemoterapi for hæmatologiske maligniteter med en middel til høj risiko for tumorlyse-syndrom.
English: Febuxostat Mylan works sufficiently quickly to allow retesting of the serum uric acid after 2 weeks.
Danish: Febuxostat Mylan virker tilstrækkeligt hurtigt til, at serumurinsyren kan testes igen efter to uger.
English: Excipient with known effect Each tablet contains 236.0 mg of lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 236,0 mg lactose.
English: Febuxostat Mylan tablets contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Danish: Febuxostat Mylan tabletter indeholder mindre end 1 mmol natrium (23 mg) pr. tablet, hvilket vil sige i det væsentlige natriumfrit.
English: CARES Study was a multicenter, randomized, double-blind, non inferiority trial comparing CV outcomes with febuxostat versus allopurinol in patients with gout and a history of major CV disease including MI, hospitalization for unstable angina, coronary or cerebral revascularization procedure, stroke, hospitalized transient ischemic attack, peripheral vascular disease, or diabetes mellitus with evidence of microvascular or macrovascular disease.
Danish: CARES-studiet var et multicenter, randomiseret, dobbeltblindet, non-inferioritetsforsøg, der sammenlignede de kardiovaskulære resultater for febuxostat med resultaterne for allopurinol hos patienter med arthritis urica og med alvorlige kardiovaskulære sygdomme i anamnesen, herunder myokardieinfarkt, indlæggelse for ustabil angina, koronar eller cerebral revaskularisering, slagtilfælde, transitorisk iskæmisk attack, der krævede indlæggelse, perifer vaskulær sygdom eller diabetes mellitus med tegn på mikro- eller makrovaskulær sygdom.
English: Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).
Danish: Behandling af kronisk hyperurikæmi, hvor der allerede er urataflejringer (herunder en anamnese med eller tilstedeværelse af tophi og/eller arthritis urica).
English: The mean total AUC of febuxostat increased by approximately 1.8-fold from 7.5 µg⋅h/mL in the normal renal function group to 13.2 µg.h/mL in the severe renal dysfunction group.
Danish: Febuxostats gennemsnitlige totale AUC steg cirka 1,8 gange fra 7,5 µg time/ml hos gruppen med normal nyrefunktion til 13,2 µg time/ml hos gruppen med svært nedsat nyrefunktion.
English: It is unknown whether febuxostat is excreted in human breast milk.
Danish: Det vides ikke, om febuxostat udskilles i human mælk.
English: Febuxostat was shown to be a weak inhibitor of CYP2D6 in vitro.
Danish: Febuxostat viste sig at være en svag hæmmer af CYP2D6 in vitro.
English: Thus, co-administration of febuxostat with rosiglitazone or other CYP2C8 substrates is not expected to require any dose adjustment for those compounds.
Danish: Det forventes derfor ikke, at samtidig administration af febuxostat og rosiglitazon eller andre CYP2C8-substrater kræver dosisjustering af disse stoffer.
English: Following multiple oral 80 mg once daily doses or a single 120 mg dose with a high fat meal, there was a 49% and 38% decrease in Cmax and an 18% and 16% decrease in AUC, respectively.
Danish: Efter gentagne orale doser på 80 mg én gang dagligt eller en enkelt dosis på 120 mg sammen med et meget fedtholdigt måltid var der et fald på henholdsvis 49% og 38% i Cmax og et fald på henholdsvis 18% og 16% i AUC.
English: Conversely, cessation of treatment of an inducer might lead to increased plasma levels of febuxostat.
Danish: Omvendt kan seponering af en induktor forårsage øgede plasmaniveauer af febuxostat.
English: [Bottles]
Danish: [Tabletholdere]
English: In addition to the urinary excretion, approximately 45% of the dose was recovered in the faeces as the unchanged febuxostat (12%), the acyl glucuronide of the active substance (1%), its known oxidative metabolites and their conjugates (25%), and other unknown metabolites (7%).
Danish: Foruden renal udskillelse blev cirka 45% af dosis genfundet i fæces som uændret febuxostat (12%), det aktive stofs acyl-glukuronid (1%), dets kendte oxidative metabolitter og deres konjugater (25%) samt andre ukendte metabolitter (7%).
English: Following multiple doses of 80 mg of febuxostat in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment, the Cmax and AUC of febuxostat and its metabolites did not change significantly compared to subjects with normal hepatic function.
Danish: Efter gentagne doser på 80 mg febuxostat hos patienter med let (Child-Pugh klasse A) eller moderat (Child-Pugh klasse B) nedsat leverfunktion ændredes Cmax og AUC for febuxostat og dets metabolitter ikke signifikant sammenlignet med forsøgspersoner med normal leverfunktion.
English: • yellowing of the skin (jaundice)
Danish: • gulfarvning af huden (gulsot)
English: Febuxostat was shown to be a weak inhibitor of CYP2C8 in vitro.
Danish: Febuxostat er påvist at være en svag CYP2C8-hæmmer in vitro.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: D BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Therefore, febuxostat may be taken without regard to antacid use.
Danish: Febuxostat kan derfor tages uden hensyn til brug af antacida.
English: As there has been no experience with febuxostat, its use in these populations is not recommended.
Danish: Da der ikke er erfaring med febuxostat, frarådes brugen af febuxostat til disse patientpopulationer.
English: However, no dose adjustment is necessary in patients with mild or moderate renal impairment.
Danish: Dosisjustering er imidlertid ikke nødvendig hos patienter med let eller moderat nedsat nyrefunktion.
English: • Azathioprine (used to reduce immune response)
Danish: • Azathioprin (anvendes til at hæmme immunsystemet)
English: The incidence of investigator-reported cardiovascular APTC events in the combined Phase 3 studies (APEX, FACT and CONFIRMS studies) was 0.7 vs. 0.6 events per 100 PYs.
Danish: Forekomsten af investigator-indberettede kardiovaskulære APTC-hændelser i de kombinerede fase 3-studier (APEX, FACT og CONFIRMS) var 0,7 versus 0,6 hændelser pr. 100 patientår.
English: At treatment initiation with febuxostat flare prophylaxis for at least 6 months with an NSAID or colchicine is recommended (see section 4.2).
Danish: Det anbefales at give anfaldsprofylaktisk behandling med et NSAID eller colchicin i mindst seks måneder i starten af behandlingen med febuxostat (se pkt.
English: Febuxostat Mylan is available as either an 80 mg tablet or a 120 mg tablet.
Danish: Febuxostat Mylan udleveres som enten en 80 mg tablet eller en 120 mg tablet.
English: Theophylline
Danish: Theophyllin
English: EXCEL Study (C02-021): The Excel study was a three years Phase 3, open label, multicenter, randomised, allopurinol-controlled, safety extension study for patients who had completed the pivotal Phase 3 studies (APEX or FACT).
Danish: EXCEL-studiet (C02-021): Excel-studiet var et treårigt åbent, randomiseret, allopurinol-kontrolleret, forlænget fase 3-multicenterstudie til evaluering af sikkerheden hos patienter, som havde gennemført de pivotale fase 3-studier (APEX eller FACT).
English: Following multiple doses of 80 mg of febuxostat in patients with mild, moderate or severe renal impairment, the Cmax of febuxostat did not change, relative to subjects with normal renal function.
Danish: Efter gentagne doser på 80 mg febuxostat hos patienter med let, moderat eller svært nedsat nyrefunktion ændredes febuxostats Cmax ikke sammenlignet med forsøgspersoner med normal nyrefunktion.
English: Inhibition of XO by febuxostat may cause increased plasma concentrations of these drugs leading to toxicity.
Danish: Febuxostats hæmning af XO kan øge plasmakoncentrationen af disse lægemidler, hvilket kan medføre toksicitet.
English: Febuxostat can be co-administered with naproxen with no dose adjustment of febuxostat or naproxen being necessary.
Danish: Febuxostat kan administreres samtidig med naproxen, og det er ikke nødvendigt at justere dosis af febuxostat eller naproxen.
English: In a study in healthy subjects, coadministration of 120 mg febuxostat QD with a single 4 mg oral dose of rosiglitazone had no effect on the pharmacokinetics of rosiglitazone and its metabolite N-desmethyl rosiglitazone, indicating that febuxostat is not a CYP2C8 enzyme inhibitor in vivo.
Danish: I et studie med raske forsøgsdeltagere havde samtidig administration af 120 mg febuxostat én gang dagligt og en enkelt oral dosis på 4 mg rosiglitazon ingen indvirkning på farmakokinetikken af rosiglitazon eller dets metabolit N-desmethylrosiglitazon, hvilket tyder på, at febuxostat ikke hæmmer CYP2C8-enzymet in vivo.
English: Rare side effects (may affect up to 1 in 1,000 people) are:
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 personer):
English: Serum urate levels were maintained over time (i.e. 91% and 93% of patients on initial treatment with febuxostat 80 mg and 120 mg, respectively, had sUA <6 mg/dL at Month 36).
Danish: Serumuratniveauerne blev opretholdt over tid (dvs. 91% og 93% af de patienter, der fik initial behandling med henholdsvis febuxostat 80 mg og 120 mg, havde serumurat < 357 µmol/l (6 mg/dl) ved måned 36).
English: Febuxostat Mylan is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).
Danish: Febuxostat Mylan er indikeret til behandling af kronisk hyperurikæmi, hvor der allerede er urataflejringer (herunder en anamnese med eller tilstedeværelse af tophi og/eller arthritis urica).
English: Dizziness, paraesthesia, hemiparesis, somnolence, altered taste, hypoaesthesia, hyposmia
Danish: Svimmelhed, paræstesi, hemiparese, døsighed, smagsforandringer, hypæstesi, hyposmi
English: • dizziness, numbness, tingling, reduced or altered sensation (hypoesthesia, hemiparesis or paraesthesia), altered sense of taste, diminished sense of smell (hyposmia)
Danish: • svimmelhed, følelsesløshed, prikkende fornemmelse, nedsat eller ændret følefornemmelse (hypæstesi, hemiparese eller paræstesi), ændret smagssans,nedsat lugtesans (hyposmi)
English: • If you have thyroid problems.
Danish: • hvis De har problemer med skjoldbruskkirtlen
English: • If you have or have had liver disease or liver function test abnormalities
Danish: • hvis De har eller tidligere har haft en leversygdom, eller hvis en prøve for leverfunktionen viste leverpåvirkning
English: Febuxostat use is not recommended in patients concomitantly treated with mercaptopurine/azathioprine as inhibition of xanthine oxidase by febuxostat may cause increased plasma concentrations of mercaptopurine/azathioprine that could result in severe toxicity.
Danish: Febuxostat bør ikke anvendes til patienter, der samtidig er i behandling med mercaptopurin/azathioprin da hæmning af xanthinoxidase forårsaget af febuxostat kan medføre øgede plasmakoncentrationer af mercaptopurin/azathioprin, som kan føre til alvorlig forgiftning.
English: BOTTLE LABEL
Danish: FLASKEETIKET
English: 116 patients were enrolled and received initially febuxostat 80 mg QD.
Danish: 116 patienter indgik i studiet og fik initialt febuxostat 80 mg en gang dagligt.
English: Reproductive system and breast disorder
Danish: Det reproduktive system og mammae
English: Therefore, possible interactions with any concomitantly administered cytotoxic drug cannot be ruled out.
Danish: Det kan derfor ikke udelukkes, at der kan være interaktion ved samtidig administration af et cytotoksisk lægemiddel.
English: The effect of febuxostat on human fertility is unknown.
Danish: Det er ukendt, om febuxostat påvirker human fertilitet.
English: • abnormal ECG heart tracing, irregular or rapid heartbeats, feeling your heart beat (palpitation)
Danish: • unormalt hjertekardiogram (ekg), uregelmæssig eller hurtig puls, hjertebanken
English: After the 8-week prophylaxis period, the incidences of flares increased and gradually decreased over time (64% and 70% of subjects received treatment for gout flares from Week 8-52).
Danish: Udbruddene tog til efter den 8 ugers profylaktiske periode, hvorefter de aftog gradvist med tiden (henholdsvis 64% og 70% af deltagerne blev behandlet for udbrud af arthritis urica i perioden uge 852).
English: No dose adjustment is necessary in patients with mild or moderate renal impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let eller moderat nedsat nyrefunktion.
English: Febuxostat Mylan 80 mg and 120 mg film-coated tablets are available in blister packs of 14, 28, 42 and 84 tablets, calendar blister packs of 28 and 84 tablets, and perforated unit dose blister packs of 28 x 1 tablets and in multipacks of 84 film-coated tablets comprising 2 packs, each containing 42 film-coated tablets.
Danish: Febuxostat Mylan 80 mg og 120 mg filmovertrukne tabletter fås i blisterpakker med 14, 28, 42 eller 84 tabletter, kalenderblisterpakker med 28 eller 84 tabletter og perforerede enkeltdosisblisterpakninger med 28 x 1 tablet og multipakninger med 84 filmovertrukne tabletter med 2 pakker, som hver indeholder 42 filmovertrukne tabletter.