FrancophonIA/ELRC3.0 huggingface dataset:
English: Amylase increased Abdominal paink
Danish: Forhøjet amylase Abdominalsmerterk
English: Alunbrig dose modification levels are summarised in Table 1.
Danish: Dosisreduktioner for Alunbrig er anført i tabel 1.
English: Severe, life-threatening, and fatal pulmonary adverse reactions, including those with features consistent with ILD/pneumonitis, can occur in patients treated with Alunbrig (see section 4.8).
Danish: Der kan forekomme svære, livstruende og letale pulmonale bivirkninger hos patienter i behandling med Alunbrig, herunder symptomer overensstemmende med ILD/pneumonitis (se pkt.
English: Patients were randomised in a 1:1 ratio to receive Alunbrig either 90 mg once daily (90 mg regimen, N = 112) or 180 mg once daily with 7-day lead-in at 90 mg once daily (180 mg regimen, N = 110).
Danish: Patienterne blev randomiseret i et 1:1-forhold til at få Alunbrig med en dosis på enten 90 mg en gang daglig (90 mg-regime, N = 112) eller 180 mg en gang daglig med en 7-dages opstartsperiode med 90 mg en gang daglig (180 mg-regime, N = 110).
English: What you need to know before you take Alunbrig Do not take Alunbrig:
Danish: Det skal du vide, før du begynder at tage Alunbrig Sådan skal du tage Alunbrig Bivirkninger
English: Brigatinib may impair male fertility.
Danish: Brigatinib kan hæmme handyrs fertilitet.
English: 13.9 mmol/L) or greater
Danish: Ved Grad 3 (over 250 mg/dl eller 13,9 mmol/l) eller højere
English: • reduced blood level of magnesium
Danish: • nedsat niveau af magnesium i blodet
English: Prior to launch of Alunbrig in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: • Yderligere risikominimeringsforanstaltninger Før lancering af Alunbrig skal Markedsføringsindehaver (MAH) opnå enighed med den nationale kompetente myndighed i hver medlemsstat omkring indhold og format af et risikominimeringsprogram.
English: EU/1/18/1264/012 7 x 90 mg + 21 x 180 mg tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/18/1264/012 7 x 90 mg + 21 x 180 mg tabletter
English: • If ILD/pneumonitis occurs during the first 7 days of treatment, Alunbrig should be withheld until recovery to baseline, then resumed at next lower dose level as described in Table 1 and not escalated to 180 mg once daily.
Danish: • Hvis ILD/pneumonitis forekommer inden for de første 7 dages behandling, skal behandling med Alunbrig afbrydes, indtil bedring til baseline-niveau er opnået, og derefter genoptages med det nærmeste lavere dosistrin, som beskrevet i tabel 1 uden at eskalere til 180 mg daglig.
English: • sulfasalazine: a medicine to treat severe bowel and rheumatic joint inflammation
Danish: • sulfasalazin: et lægemiddel til behandling af svær tarmbetændelse og reumatisk ledbetændelse
English: A patient alert card
Danish: Patientkort
English: Upon recovery, the dose should be modified accordingly (see section 4.2).
Danish: Efter bedring skal dosis ændres tilsvarende (se pkt.
English: In Study 101, following administration of a single oral dose of brigatinib (30-240 mg) in patients, the median time to peak concentration (Tmax) was 1-4 hours postdose.
Danish: I Studie 101 var mediantiden til højeste koncentration (Tmax) hos patienterne efter administration af en enkelt oral dosis brigatinib (30-240 mg) 1-4 timer efter dosis.
English: The pharmacokinetics of brigatinib was similar between healthy subjects with normal hepatic function and patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment.
Danish: Brigatinibs farmakokinetik var stort set ens blandt raske forsøgspersoner med normal leverfunktion og patienter med let (Child-Pugh-klasse A) eller moderat (Child-Pugh-klasse B) nedsat leverfunktion.
English: Patients were randomised in a 1:1 ratio to receive Alunbrig either 90 mg once daily continuously (90 mg regimen) or 180 mg once daily with 7-day lead-in at 90 mg once daily (180 mg regimen).
Danish: Patienterne blev randomiseret i et 1:1-forhold til at få Alunbrig med en dosis på enten 90 mg en gang daglig kontinuerligt (90 mg-regime) eller 180 mg en gang daglig med en 7-dages opstartsperiode med 90 mg en gang daglig (180 mg-regime).
English: • dabigatran: a medicine to inhibit blood clotting
Danish: • dabigatran: et lægemiddel, der hæmmer koagulering af blod
English: • symptoms such as numbness, tingling, prickling sensation, weakness or pain in hands or feet
Danish: • symptomer som for eksempel følelsesløshed, en snurrende eller prikkende fornemmelse,
English: Tell your doctor if you have any unexplained muscle pain, tenderness or weakness.
Danish: Fortæl det til lægen, hvis du har uforklarlige muskelsmerter eller ømme eller svage muskler.
English: 7 tablets of Alunbrig 90 mg
Danish: 7 tablets med Alunbrig 90 mg
English: Tell your doctor or pharmacist if you notice any of the following side effects
Danish: Fortæl det til lægen eller apotekspersonalet med det samme, hvis du får en eller flere af følgende alvorlige bivirkninger:
English: • If ILD/pneumonitis occurs after the first 7 days of treatment, Alunbrig should be withheld until recovery to baseline.
Danish: • Hvis ILD/pneumonitis forekommer efter de første 7 dages behandling, skal behandling med Alunbrig afbrydes, indtil bedring til baseline-niveau er opnået.
English: Agents that may increase brigatinib plasma concentrations
Danish: Stoffer, der kan øge plasmakoncentrationerne af brigatinib
English: • If ILD/pneumonitis occurs after the first 7 days of treatment, Alunbrig should be withheld until recovery to baseline, then resumed at same dose level.
Danish: • Hvis ILD/pneumonitis forekommer efter de første 7 dages behandling, skal behandling med Alunbrig afbrydes, indtil bedring til baseline-niveau er opnået, og derefter genoptages med samme dosis.
English: A reduced starting dose of 60 mg once daily for the first 7 days, then 90 mg once daily is recommended for patients with severe renal impairment (eGFR < 30 mL/min) (see section 5.2).
Danish: Der anbefales en reduceret startdosis på 60 mg en gang daglig i de første 7 dage og derefter 90 mg en gang daglig for patienter med svært nedsat nyrefunktion (eGFR < 30 ml/min.)
English: • increased blood level of lactate dehydrogenase - may indicate tissue breakdown
Danish: • forhøjede niveauer af laktatdehydrogenase i blodet - kan være tegn på nedbrydning af væv
English: • Alunbrig should be withheld until recovery to asymptomatic bradycardia or to a resting heart rate of 60 bpm or above.
Danish: • Afbryd behandling med Alunbrig indtil opnået bedring til asymptomatisk bradykardi eller til en hvilepuls på 60 bpm eller derover.
English: Hypophosphataemia Hyperglycaemia Hyponatraemia Hypokalaemia Decreased appetite
Danish: Hypophosphatæmi Hyperglykæmi Hyponatriæmi Hypokaliæmi Nedsat appetit
English: Men receiving treatment with Alunbrig are advised not to father a child during treatment and to use effective contraception during treatment and for 3 months after stopping.
Danish: Mænd i behandling med Alunbrig bør undgå at gøre en kvinde gravid og benytte effektiv prævention under behandlingen og i 3 måneder efter endt behandling.
English: • colchicine: a medicine to treat gout attacks
Danish: • colchicin: et lægemiddel til behandling af gigtanfald
English: • Alunbrig 180 mg film-coated tablets 3 clear thermoformable poly-chloro-tri-fluoro-ethylene (PCTFE) blisters with heat sealable paper-laminated foil lidding in a carton, containing 21 film-coated tablets.
Danish: • Alunbrig 180 mg filmovertrukne tabletter 3 blisterkort bestående af gennemsigtig, termoformbart polychlortrifluorethylen (PCTFE) med bagside af varmeforseglet papirlamineret folie i en pakning indeholdende 21 filmovertrukne tabletter.
English: In vitro studies demonstrated that brigatinib is a substrate of CYP3A4/5.
Danish: In vitro-forsøg har påvist, at brigatinib er et substrat af CYP3A4/5.
English: Patients with severe renal impairment should be closely monitored for new or worsening respiratory symptoms that may indicate ILD/pneumonitis (e.g., dyspnoea, cough, etc.) particularly in the first week (see section 4.4).
Danish: Patienter med svært nedsat nyrefunktion skal overvåges nøje, især i den første uge, for nye eller forværrede åndedrætssymptomer (for eksempel dyspnø, hoste osv.), da de kan være tegn på ILD eller pneumonitis (se pkt.
English: Table 2: Recommended Alunbrig dose modifications for adverse reactions Adverse reaction Severity*
Danish: Tabel 2: Anbefalet dosisændringer for Alunbrig ved forekomst af bivirkninger Bivirkning
English: Common Pain Non-cardiac chest pain Chest discomfort
Danish: Almindelig Smerter Smerter i brystet, der ikke stammer fra hjertet
English: Within each frequency grouping, undesirable effects are presented in order of frequency.
Danish: De mest hyppige bivirkninger er anført først i hver gruppe.
English: Table 3: Adverse reactions reported in patients treated with Alunbrig in ALTA and Study 101 (per Common Terminology Criteria for Adverse Events (CTCAE) version 4.0) System organ class
Danish: Common Terminology Criteria for Adverse Events (CTCAE) version 4.0) Systemorganklasse
English: The maximum mean QTcF (corrected QT by the Fridericia method) change from baseline was less than 10 msec. An exposure-QT analysis suggested no concentration-dependent QTc interval prolongation.
Danish: Ændringen i den maksimale middel-QTcF (QT korrigeret med Fridericia-metoden) fra baseline var under 10 msek.
English: Other possible side effects are:
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Ydre karton:
English: Common Dyspepsia Flatulence
Danish: Almindelig Dyspepsi Flatulens
English: • Alunbrig should be withheld until recovery to baseline, then resumed at the same dose level.
Danish: • Behandling med Alunbrig skal afbrydes indtil opnået bedring til baseline og derefter genoptages med samme dosisniveau.
English: 21 tablets of Alunbrig 180 mg
Danish: 21 tabletter Alunbrig 180 mg
English: 7 film-coated tablets of Alunbrig 90 mg 21 film-coated tablets of Alunbrig 180 mg
Danish: 7 filmovertrukne tabletter med Alunbrig 90 mg 21 filmovertrukne tabletter med Alunbrig 180 mg
English: In rats, findings included lower weight of testes, seminal vesicles and prostate gland, and testicular tubular degeneration; these effects were not reversible during the recovery period.
Danish: Fund hos rotter omfattede lavere vægt af testikler, sædblærer og prostatakirtel samt tubulær degeneration af testiklerne.
English: • If ILD/pneumonitis recurs, Alunbrig should be permanently discontinued.
Danish: • Hvis ILD/pneumonitis forekommer igen, skal behandling med Alunbrig seponeres.
English: Breast-feeding should be stopped during treatment with Alunbrig.
Danish: Amning skal ophøre under behandling med Alunbrig.
English: The pharmacokinetics of brigatinib is similar in patients with normal renal function and in patients with mild or moderate renal impairment (eGFR ≥ 30 mL/min) based on the results of population pharmacokinetic analyses.
Danish: Brigatinibs farmakokinetik er stort set ens hos patienter med normal nyrefunktion og patienter med let eller moderat nedsat nyrefunktion (eGFR ≥ 30 ml/min.)
English: The dose should be modified accordingly (see section 4.2).
Danish: Dosis skal tilsvarende tilpasses (se pkt.
English: Agents that may have their plasma concentrations altered by brigatinib
Danish: Stoffer, hvis plasmakoncentrationer kan påvirkes af brigatinib
English: Dose reduction for CPK elevation occurred in 6.4% patients at the 180 mg regimen (see sections 4.2 and 4.4).
Danish: Dosis blev nedsat på grund af forhøjet CK for 6,4 % af patienterne i 180 mg-regimet (se pkt.
English: Agents that may decrease brigatinib plasma concentrations
Danish: Stoffer, der kan reducere plasmakoncentrationerne af brigatinib
English: • Alunbrig 30 mg: 28, 56 or 112 film-coated tablets
Danish: • Alunbrig 30 mg: 28, 56 eller 112 filmovertrukne tabletter
English: Bradycardia In ALTA, bradycardia was reported in 4.5% of patients treated with Alunbrig at the 180 mg regimen.
Danish: I ALTA blev bradykardi rapporteret hos 4,5 % af patienterne i behandling med Alunbrig med 180 mg-regimet.
English: Dose reduction for visual disturbance occurred in two patients (1.8%) at the 180 mg regimen (see sections 4.2 and 4.4).
Danish: Dosis blev nedsat på grund af synsforstyrrelser for to patienter (1,8 %) behandlet i 180 mg-regimet (se pkt.
English: Following oral administration of a single 180 mg dose of [14C]brigatinib to healthy subjects, N-demethylation and cysteine conjugation were the two major metabolic clearance pathways.
Danish: Efter oral administration af en enkelt 180 mg dosis [14C]brigatinib til raske forsøgspersoner var
English: Men with female partners of childbearing potential should be advised to use effective contraception during treatment and for at least 3 months after the last dose of Alunbrig (see section 4.6).
Danish: Mænd med kvindelig partner i fødedygtig alder, skal rådes til at bruge effektiv kontraception under behandlingen og i mindst 3 måneder efter den sidst indtagne dosis Alunbrig (se pkt.
English: Electrocardiogram QT prolonged
Danish: Forlænget QT på elektrokardiogram
English: Very common Pneumoniaa Upper respiratory tract infection
Danish: Pneumonia Infektion i de øvre luftveje
English: In the event of an overdose, monitor the patient for adverse reactions (see section 4.8) and provide appropriate supportive care.
Danish: I tilfælde af en overdosis skal patienten overvåges for bivirkninger (se pkt.
English: Alunbrig 90 mg once daily for the first 7 days, then Alunbrig 180 mg once daily.
Danish: Alunbrig 90 mg tages en gang daglig i de første 7 dage og derefter tages Alunbrig 180 mg en gang daglig.
English: In healthy subjects, coadministration of multiple 200 mg twice daily doses of itraconazole, a strong CYP3A inhibitor, with a single 90 mg brigatinib dose increased brigatinib Cmax by 21%, AUC0-INF by 101% (2-fold), and AUC0-120 by 82% (< 2-fold), relative to a 90 mg brigatinib dose administered alone.
Danish: Hos raske forsøgspersoner medførte samtidig administration af flere doser på 200 mg itraconazol, en stærk CYP3A-hæmmer to gange daglig sammen med en enkelt dosis på 90 mg brigatinib, en forøgelse af brigatinib Cmax med 21 %, AUC0-INF med 101 % (fordobling) og AUC0-120 med 82 % (< fordobling) i forhold til en dosis på 90 mg brigatinib administreret alene.
English: In healthy subjects, coadministration of multiple 600 mg twice daily doses of gemfibrozil, a strong CYP2C8 inhibitor, with a single 90 mg brigatinib dose reduced brigatinib Cmax by 41%, AUC0-INF by 12%, and AUC0-120 by 15%, relative to a 90 mg brigatinib dose administered alone.
Danish: Hos raske forsøgspersoner medførte samtidig administration af flere doser på 600 mg gemfibrozil, en kraftig CYP2C8-hæmmer to gange daglig med en enkelt dosis på 90 mg brigatinib en reduktion af brigatinib Cmax med 41 %, AUC0-INF med 12 % og AUC0-120 med 15 % i forhold til en dosis på 90 mg brigatinib administreret alene.
English: • Each 30 mg tablet contains 30 mg brigatinib.
Danish: • En 30 mg tablet indeholder 30 mg brigatinib.
English: • Alunbrig 30 mg: 60 or 120 film-coated tablets
Danish: • Alunbrig 30 mg: 60 eller 120 filmovertrukne tabletter
English: Oval, white to off-white film-coated tablet of approximately 19 mm in length with debossed “U13” on one side and plain on the other side.
Danish: Oval, hvid til offwhite filmovertrukken tablet med en længde på ca. 19 mm, med “U13” præget på den ene side og intet på den anden side.
English: • reduced blood level of phosphorus
Danish: • nedsat niveau af fosfor i blodet
English: • The film-coated tablets are approximately 7 mm in diameter with “U3” on one side and plain on the other side.
Danish: • Den filmovertrukne tablet er ca. 7 mm i diameter og har “U3” præget på den ene side og intet på den anden side.
English: • Alunbrig 180 mg: 30 film-coated tablets
Danish: • Alunbrig 180 mg: 30 filmovertrukne tabletter
English: • The film-coated tablets are approximately 19 mm long with “U13” on one side and plain on the other side.
Danish: • Den filmovertrukne tablet er ca. 19 mm lang og har “U13” præget på den ene side og intet på den anden side.
English: Tηλ: +30 210 6387800 gr.info@takeda.com
Danish: TAKEDA ΕΛΛΑΣ Α.Ε Tηλ: +30 210 6387800 gr.info@takeda.com
English: • Each 180 mg tablet contains 180 mg brigatinib.
Danish: • En 180 mg tablet indeholder 180 mg brigatinib.
English: How to take Alunbrig
Danish: Sådan skal du tage Alunbrig
English: Alunbrig 30 mg film-coated tablets 3 years
Danish: Alunbrig 30 mg filmovertrukne tabletter 3 år
English: Oval, white to off-white film-coated tablet of approximately 15 mm in length with debossed “U7” on one side and plain on the other side.
Danish: Oval, hvid til offwhite filmovertrukken tablet med en længde på ca. 15 mm, med “U7” præget på den ene side og intet på den anden side.
English: In healthy subjects, coadministration of multiple 600 mg daily doses of rifampicin, a strong CYP3A inducer, with a single 180 mg brigatinib dose decreased brigatinib Cmax by 60%, AUC0-INF by 80% (5-fold), and AUC0-120 by 80% (5-fold), relative to a 180 mg brigatinib dose administered alone.
Danish: Hos raske forsøgspersoner medførte samtidig administration af flere doser 600 mg rifampicin, en kraftig CYP3A- induktor, en gang daglig med en enkelt dosis på 180 mg brigatinib, en reduktion af brigatinib Cmax med 60 %, AUC0-INF med 80 % (femdobling) og AUC0-120 med 80 % (femdobling) i forhold til en dosis på 180 mg brigatinib administreret alene.
English: In ALTA, elevations of amylase and lipase were reported in 43% and 50% of patients treated with Alunbrig, respectively at the 180 mg regimen.
Danish: I ALTA blev forhøjede amylase- og lipaseværdier rapporteret hos henholdsvis 43 % og 50 % af patienterne i behandling med Alunbrig behandlet i 180 mg-regimet.
English: Intracranial objective response rate
Danish: Intrakraniel objektiv responsrate 95 % CI
English: • Alunbrig should be withheld until hypertension has recovered to Grade ≤ 1 (SBP < 140 mmHg and DBP < 90 mmHg), then resumed at same dose.
Danish: • Behandling med Alunbrig skal afbrydes indtil bedring af hypertension til Grad ≤ 1 (SYS < 140 mmHg og DIA < 90 mmHg) og derefter genoptages behandling med samme dosis.
English: • The film-coated tablets are approximately 15 mm long with “U7” on one side and plain on the other side.
Danish: • Den filmovertrukne tablet er ca. 15 mm lang og har “U7” præget på den ene side og intet på den anden side.
English: Men with female partners of reproductive potential should be advised to use effective contraception during treatment and for at least 3 months after the last dose of Alunbrig.
Danish: Mænd med fertile kvindelige partnere skal rådes til at bruge effektiv kontraception under behandlingen og minimum 3 måneder efter den sidste dosis Alunbrig er indtaget.
English: Women of childbearing potential should be advised to use effective non-hormonal contraception during treatment with Alunbrig and for at least 4 months following the final dose.
Danish: Kvinder i den fødedygtige alder skal rådes til at bruge effektiv ikke-hormonel kontraception under behandlingen med Alunbrig og i mindst 4 måneder efter den sidst indtagne dosis.
English: Based on the severity of the CPK elevation, treatment with Alunbrig should be withheld, and the dose modified accordingly (see section 4.2).
Danish: Med baggrund i sværhedsgraden af en forhøjet CK-værdi, skal behandling med Alunbrig tilbageholdes og dosis justeres tilsvarende (se pkt.
English: • Alunbrig 180 mg: 28 film-coated tablets
Danish: • Alunbrig 180 mg: 28 filmovertrukne tabletter
English: • Each 90 mg tablet contains 90 mg brigatinib.
Danish: • En 90 mg tablet indeholder 90 mg brigatinib.
English: Alunbrig 30 mg film-coated tablets Alunbrig 90 mg film-coated tablets Alunbrig 180 mg film-coated tablets
Danish: Alunbrig 30 mg filmovertrukne tabletter Alunbrig 90 mg filmovertrukne tabletter Alunbrig 180 mg filmovertrukne tabletter
English: Alunbrig 180 mg film-coated tablets 2 years
Danish: Alunbrig 180 mg filmovertrukne tabletter 2 år
English: Elevations of amylase and lipase have occurred in patients treated with Alunbrig (see section 4.8).
Danish: Der er forekommet forhøjede amylase- og lipaseværdier hos patienter i behandling med Alunbrig (se pkt.
English: The adverse reactions described in this section were identified from two clinical trials: Study 201 (ALTA): A randomised, open-label, multicentre trial in patients treated with Alunbrig (N = 219) with ALK+ NSCLC who previously progressed on crizotinib.
Danish: Studie 201 (ALTA): Et randomiseret, åbent multicenterforsøg med patienter i behandling med Alunbrig (N = 219) med ALK + NSCLC, som tidligere progredierede med crizotinib.
English: Each pack contains 7 film-coated tablets of Alunbrig 90 mg
Danish: Indeholder 7 filmovertrukne tabletter med Alunbrig 90 mg
English: Patients should be monitored for new or worsening respiratory symptoms (e.g., dyspnoea, cough, etc.), particularly in the first week of treatment.
Danish: Især i den første behandlingsuge, skal patienter overvåges nøje for nye eller forværrede åndedrætssymptomer (for eksempel dyspnø, hoste osv.).
English: CPK levels should be monitored regularly during Alunbrig treatment.
Danish: CK-værdier skal vurderes regelmæssigt under behandling med Alunbrig.
English: Alunbrig 30 mg film-coated tablets
Danish: Alunbrig 30 mg filmovertrukne tabletter
English: • musculoskeletal chest pain
Danish: • muskel- og knoglesmerter i brystet
English: Round, white to off-white film-coated tablet of approximately 7 mm in diameter with debossed “U3” on one side and plain on the other side.
Danish: Rund, hvid til offwhite filmovertrukken tablet med en diameter på ca. 7 mm, med “U3” præget på den ene side og intet på den anden side.
English: Clear thermoformable poly-chloro-tri-fluoro-ethylene (PCTFE) blister with heat sealable paper-laminated foil lidding in a carton, containing either 28, 56 or 112 film-coated tablets.
Danish: Blisterkort bestående af gennemsigtig, termoformbart polychlortrifluorethylen (PCTFE) med bagside af varmeforseglet papirlamineret folie i en pakning med enten 28, 56 eller 112 filmovertrukne tabletter.
English: • muscle and joint stiffness
Danish: • stivhed i muskler og led
English: In ALTA, elevations of ALT and AST were reported in 46% and 65% of patients treated with Alunbrig, respectively at the 180 mg regimen.
Danish: I ALTA blev forhøjet ALAT og ASAT rapporteret hos henholdsvis 46 % og 65 % af patienterne i behandling med Alunbrig med 180 mg-regimet.
English: Based on the severity of the laboratory abnormalities, treatment with Alunbrig should be withheld, and the dose modified accordingly (see section 4.2).
Danish: Alt efter sværhedsgraden af afvigende laboratorieværdier skal behandling med Alunbrig afbrydes og dosis justeres tilsvarende (se pkt.
English: Very common Blood creatinine increased
Danish: Forhøjet kreatinin i blodet
English: Bradycardia has occurred in patients treated with Alunbrig (see section 4.8).
Danish: Der er set forekomst af bradykardi hos patienter i behandling med Alunbrig (se pkt.
English: • Alunbrig should be withheld until recovery to baseline or less than or equal to 3 × ULN, then resumed at next lower dose per Table 1.
Danish: • Behandling med Alunbrig skal afbrydes indtil opnået bedring til baseline eller mindre end eller lig 3 × ULN og derefter genoptages dosering med det nærmeste lavere dosistrin iht.
English: Round wide mouth high density polyethylene (HDPE) bottles with two-piece polypropylene child resistant screw cap closures with foil induction seal liner, containing either 60 or 120 film-coated tablets, together with one HDPE canister containing a molecular sieve desiccant.
Danish: Beholder af polyethylen med høj densitet (HDPE) med bred åbning og todelt, børnesikret skruelåg med folieforsegling indeholdende enten 60 eller 120 filmovertrukne tabletter og én HDPE-kapsel med tørremiddel.
English: • Alunbrig 90 mg: 7 or 30 film-coated tablets
Danish: • Alunbrig 90 mg: 7 eller 30 filmovertrukne tabletter
English: Each pack contains 21 film-coated tablets of Alunbrig 180 mg
Danish: Indeholder 21 filmovertrukne tabletter med Alunbrig 180 mg