FrancophonIA/ELRC3.0 huggingface dataset:
English: 2 year follow-up
Danish: 2 års opfølgning
English: The pharmacokinetics of dasatinib were evaluated in 229 adult healthy subjects and in 84 patients.
Danish: Dasatinibs farmakokinetik er evalueret hos 229 voksne, raske frivillige og hos 84 patienter.
English: Following oral administration, the increase in the mean exposure (AUCτ) is approximately proportional to the dose increment across doses ranging from 25 mg to 120 mg twice daily.
Danish: Efter oral administration er stigningen i gennemsnitlig eksponering (AUCτ) ca. proportional med dosisstigningen over et dosisspænd på 25-120 mg 2 gange dagligt.
English: Of note, major haematologic responses (MaHR) were achieved quickly (most within 35 days of first dasatinib administration for patients with lymphoid blast CML, and within 55 days for patients with Ph+ ALL).
Danish: Det bør bemærkes, at der hurtigt blev opnået større hæmatologisk respons (MaHR) (de fleste inden for 35 dage efter første administration af dasatinib til patienter med CML i lymfoid blastfase, og inden for 55 dage for patienter med Ph+ ALL).
English: In adult and paediatric patients with chronic phase CML, complete blood counts should be performed every 2 weeks for 12 weeks, then every 3 months thereafter or as clinically indicated.
Danish: Hos voksne og pædiatriske patienter med CML i kronisk fase bør der tages fuldstændigt blodbillede hver anden uge i 12 uger, derefter hver tredje måned eller som klinisk indiceret.
English: SPRYCEL powder for oral suspension contains approximately 0.29 g/mL of sucrose upon constitution with water.
Danish: SPRYCEL pulver til oral suspension indeholder ca. 0,29 g/ml saccharose efter rekonstitution med vand.
English: If neutropaenia and/or thrombocytopaenia result in delay of the next block of treatment by more than 14 days, SPRYCEL should be interrupted and resumed at the same dose level once the next block of treatment is started.
Danish: Hvis neutropeni og/eller trombocytopeni medfører en udsættelse af den næste behandlingsserie på mere end 14 dage, skal behandlingen med SPRYCEL afbrydes og genoptages på samme dosisniveau, når næste behandlingsserie påbegyndes.
English: Forty-two percent of the imatinib-resistant patients with no prior MCyR to imatinib (n= 188) achieved a MCyR with dasatinib.
Danish: Toogfyrre procent af de imatinib resistente patienter uden tidligere MCyR med imatinib (n= 188) opnåede MCyR med dasatinib.
English: The starting dose of SPRYCEL for children is calculated by body weight as shown below:
Danish: Startdosis af SPRYCEL til børn beregnes efter legemsvægten som vist nedenfor:
English: Median duration of treatment was approximately 6 months (range 0.03-31 months).
Danish: Medianbehandlingsvarighed var ca. 6 måneder (0,03-31 måneder interval).
English: These data should be considered if patients are to switch from powder for oral suspension to tablets or vice versa.
Danish: Disse data bør tages med i overvejelserne, hvis patienter skal skifte fra oral suspension til tabletter eller omvendt.
English: d Excludes gastrointestinal bleeding and CNS bleeding; these adverse reactions are reported under the gastrointestinal disorders system organ class and the nervous system disorders system organ class, respectively.
Danish: d Eksklusive gastrointestinal blødning og CNS-blødning; disse bivirkninger er indberettet under organklasserne henholdsvis mave-tarmkanalen og nervesystemet.
English: In the overall population of 2,712 SPRYCEL-treated adult subjects, 520 (19%) experienced adverse reactions leading to treatment discontinuation.
Danish: I den samlede population på 2.712 patienter, der blev behandlet med SPRYCEL, oplevede 520 (19%) bivirkninger, der medførte seponering.
English: Among dasatinib-treated patients with drug-related pleural effusion (n=73), 45 (62%) had dose interruptions and 30 (41%) had dose reductions.
Danish: Blandt de dasatanib behandlede patienter, som fik pleuraeffusion (n=73), fik 45 (62%) afbrudt behandlingen og 30 (41%) fik dosis reduceret.
English: Uncommon hypersensitivity (including erythema nodosum)
Danish: Immunsystemet Ikke almindelig overfølsomhed (inklusive erythema nodosum)
English: Cardiac adverse reactions were more frequent in patients with risk factors or a history of cardiac disease.
Danish: Hjertebivirkninger forekom hyppigere hos patienter med risikofaktorer eller hjertesygdom i anamnesen.
English: In an additional analysis, more dasatinib-treated patients (84%) achieved early molecular response (defined as BCR-ABL levels ≤ 10% at 3 months) compared with imatinib-treated patients (64%).
Danish: I en yderligere analyse opnåede flere patienter behandlet med dasatinib (84%) tidlig molekylært respons (defineret som BCR-ABL-niveauer ≤ 10% efter 3 måneder) sammenlignet med patienter behandlet med imatinib (64%).
English: In addition, there were two studies in a total of 161 paediatric patients with Ph+ ALL in which SPRYCEL was administered in combination with chemotherapy.
Danish: Der var desuden to studier med i alt 161 pædiatriske patienter med Ph+ ALL, som fik SPRYCEL administreret i kombination med kemoterapi.
English: The rate of MMR at any time in each risk group determined by Hasford score was higher in the SPRYCEL group compared with the imatinib group (low risk: 90% and 69%; intermediate risk: 71% and 65%; high risk: 67% and 54%, respectively).
Danish: Raten for MMR til enhver tid for hver risikogruppe, defineret ved Hasford-score, var større i SPRYCEL gruppen end i imatinib gruppen (lav risiko: henholdsvis 90% og 69%; middel risiko: henholdsvis 71% og 65%; høj risiko: 67% og 54%).
English: Table 7: Adverse reactions reported in ≥10% of paediatric patients with Ph+ ALL treated with SPRYCEL on a continuous dosing regimen in combination with chemotherapy (N=126)a
Danish: Tabel 7: Bivirkninger rapporteret hos ≥10% af pædiatriske patienter med Ph+ ALL behandlet med SPRYCEL i et kontinuerligt dosisregime i kombination med kemoterapi (N=126)a
English: Table 5: Tabulated summary of adverse reactions
Danish: Tabel 5: Tabeloversigt over bivirkninger
English: Patients at risk
Danish: Risikopatienter
English: Active substances that may decrease dasatinib plasma concentrations When dasatinib was administered following 8 daily evening administrations of 600 mg rifampicin, a potent CYP3A4 inducer, the AUC of dasatinib was decreased by 82%.
Danish: Aktive substanser der kan reducere plasmakoncentration af dasatinib Når dasatinib administreredes efter 8 daglige aften-administrationer af 600 mg rifampicin, der er en potent CYP3A4-induktor, faldt AUC af dasatinib med 82%.
English: SPRYCEL should not be used during pregnancy unless the clinical condition of the woman requires treatment with dasatinib.
Danish: SPRYCEL bør ikke anvendes under graviditeten, medmindre kvindens kliniske tilstand kræver behandling med dasatinib.
English: Among the dasatinib-treated patients with pleural effusion, 96% achieved a cCCyR, 82% achieved a MMR, and 50% achieved a MR4.5 despite dose interruptions or dose adjustment.
Danish: Blandt de dasatinib behandlede patienter med pleuraeffusion opnåede 96% cytogenetisk respons (cCCyR), 82% opnåede MMR, og 50% opnåede MR4.5 på trods af afbrydelser i behandlingen eller dosisjusteringer.
English: achieved in 93% of the overall patient population.
Danish: imatinib sås hos 93% af den overordnede patientpopulation.
English: The effect of stopping treatment on long-term disease outcome after the achievement of a cytogenetic or molecular response [including complete cytogenetic response (CCyR), major molecular response (MMR) and MR4.5] has not been investigated.
Danish: Det er ikke undersøgt, hvilken effekt det på lang sigt har på sygdomsforløbet at seponere behandlingen, efter der er opnået cytogenetisk eller molekylært respons [herunder fuldstændigt cytogenetisk respons (CCyR), major molekylært respons (MMR) og MR4,5].
English: OUTER CARTON AND LABEL FOR BOTTLE PACK OUTER CARTON FOR BLISTER PACK
Danish: YDRE KARTON OG ETIKET TIL FLASKE YDRE KARTON TIL BLISTERPAKNING
English: NEL: same criteria as for CHR but ANC ≥ 500/mm3 and < 1,000/mm3, or platelets ≥ 20,000/mm3 and
Danish: NEL: samme kriterier som for CHR, men ANC ≥ 500/mm3 og < 1.000/mm3 eller trombocytter ≥ 20.000/mm3 og
English: Eighty-two patients received dasatinib tablets exclusively and 24 patients received dasatinib powder for oral suspension at least once, 8 of whom received dasatinib powder for oral suspension exclusively.
Danish: 82 patienter fik udelukkende dasatinib tabletter, og 24 patienter fik dasatinib pulver til oral suspension mindst én gang, ud af dem fik 8 patienter udelukkende dasatinib pulver til oral suspension.
English: Dasatinib may be resumed at the original dose for mild/moderate adverse reactions (≤ grade 2) and resumed at a dose level reduction for severe adverse reactions (≥ grade 3) (see section 4.2).
Danish: Behandling med dasatinib kan genoptages ved den oprindelige dosis for milde/moderate bivirkninger (≤ grad 2) og genoptages ved en reduceret dosis ved svære bivirkninger (≥ grad 3) (se pkt.
English: The starting dose of SPRYCEL is calculated by body weight as shown below:
Danish: Startdosis af SPRYCEL beregnes ud fra legemsvægt som vist nedenfor:
English: Breast-feeding should be stopped during treatment with SPRYCEL.
Danish: Amning skal ophøre under behandling med SPRYCEL.
English: at least 45 kg
Danish: mindst 45 kg
English: At baseline, the distribution of Hasford Scores was similar in the SPRYCEL and imatinib treatment groups (low risk: 33% and 34%; intermediate risk 48% and 47%; high risk: 19% and 19%, respectively).
Danish: Ved baseline var fordelingen af Hasford-scores den samme for SPRYCEL og imatinib behandlingsgrupperne (lavrisiko: 33% og 34%; middelrisiko 48% og 47%; højrisiko: 19% og 19%).
English: Pleural effusion was usually reversible and managed by interrupting SPRYCEL treatment and using diuretics or other appropriate supportive care measures (see sections 4.2 and 4.4).
Danish: Pleuraeffusion var sædvanligvis reversibel og blev håndteret ved at seponere behandlingen med SPRYCEL og ved at anvende diuretika eller anden passende støttende behandling (se pkt.
English: OUTER CARTON AND LABEL FOR BOTTLE PACK
Danish: YDRE KARTON OG ETIKET TIL FLASKE
English: Rare diabetes mellitus Psychiatric disorders
Danish: Sjælden diabetes mellitus Psykiske forstyrrelser
English: newly diagnosed Ph+ ALL in combination with chemotherapy.
Danish: nydiagnosticeret Ph+ ALL i kombination med kemoterapi.
English: Efficacy results are presented in Tables 12 and 13.
Danish: Effektresultaterne er vist i tabel 12 og 13.
English: This medicinal product contains 2.1 mg sodium (main component of cooking/table salt) per mL of SPRYCEL oral suspension.
Danish: Dette lægemiddel indeholder 2,1 mg natrium (hovedkomponent af madlavnings-/bordsalt) pr. ml SPRYCEL oral suspension.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Patienter med sjældne arvelige problemer med galactoseintolerans, total lactasemangel eller glucose-/galactose-malabsorption bør ikke tage dette lægemiddel.
English: Pharmacokinetics of the tablet formulation of dasatinib were evaluated for 72 paediatric patients with relapsed or refractory leukaemia or solid tumours at oral doses ranging from 60 to 120 mg/m2 once daily and 50 to 110 mg/m2 twice daily.
Danish: Farmakokinetikken for tabletformuleringen af dasatinib blev evalueret i 72 pædiatriske patienter med recidiv eller refraktær leukæmi eller solide tumorer ved orale doser, der strækker sig fra 60 til 120 mg/m2 én gang dagligt og 50 til 110 mg/m2 to gange dagligt.
English: The other ingredients are: Tablet core: lactose monohydrate (see section 2 "SPRYCEL contains lactose"); microcrystalline cellulose; croscarmellose sodium; hydroxypropylcellulose; magnesium stearate Film-coating: hypromellose; titanium dioxide (E171); macrogol 400
Danish: Øvrige indholdsstoffer: Tabletkerne: lactosemonohydrat (se punkt 2 ”SPRYCEL indeholder lactose”); mikrokrystallinsk cellulose; croscarmellosenatrium; hydroxypropylcellulose; magnesiumstearat Filmovertræk: hypromellose; titandioxid (E171); macrogol 400
English: Elimination is predominantly in the faeces, mostly as metabolites.
Danish: Udskillelse finder primært sted gennem fæces, mest i form af metabolitter.
English: Carriers of HBV who require treatment with SPRYCEL should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy (see section 4.8).
Danish: Bærere af HBV, hvor behandling med SPRYCEL er nødvendig, skal overvåges tæt for tegn og symptomer på aktiv HBV-infektion i hele behandlingsperioden og i flere måneder efter behandlingsophør (se pkt.
English: 70 mg at least 45 kg
Danish: 70 mg mindst 45 kg
English: For paediatric patients with Ph+ ALL, no dose modification is recommended in cases of haematologic Grade 1 to 4 toxicities.
Danish: For pædiatriske patienter med Ph+ ALL frarådes dosisændringer i tilfælde af grad 1 til 4 hæmatologiske toksiciteter.
English: Patients with risk factors or a history of cardiac disease should be monitored carefully for signs or symptoms consistent with cardiac dysfunction and should be evaluated and treated appropriately (see section 4.4).
Danish: Patienter med risikofaktorer eller med hjertesygdom i anamnesen bør monitoreres omhyggeligt for kliniske tegn eller symptomer på nedsat hjertefunktion og bør vurderes og behandles på behørig vis (se pkt.
English: ______ Dasatinib 100 mg once daily --------- Imatinib 400 mg once daily
Danish: ______ Dasatinib 100 mg 1 gang dagligt --------- Imatinib 400 mg én gang dagligt
English: The pharmacokinetics of dasatinib have been evaluated in 104 paediatric patients with leukaemia or solid tumours (72 who received the tablet formulation and 32 who received the powder for oral suspension).
Danish: Farmakokinetikken af dasatinib er blevet evauleret i 104 pædiatriske patienter med leukæmi eller solide tumorer (72, som fik tabletformuleringen og 32, som fik pulveret til oral suspension).
English: The main secondary endpoint was MCyR by total daily dose level in the imatinib-resistant patients.
Danish: Det vigtigste sekundære endepunkt var MCyR i forhold til total daglig dosis hos imatinib resistente patienter.
English: All patients Imatinib-resistant patients a Results reported in recommended starting dose of 100 mg once daily.
Danish: Alle patienter Imatinib resistente patienter a Resultater rapporteret med anbefalet startdosis på 100 mg én gang dagligt.
English: Once constituted, the oral suspension should only be administered using the oral dosing syringe supplied with each pack.
Danish: Efter rekonstitution må den orale suspension kun administreres ved brug af den orale doseringssprøjte, der medfølger i hver pakning.
English: The safety profile of SPRYCEL administered as single-agent therapy in paediatric patients with Ph+ CML-CP was comparable to the safety profile in adults.
Danish: Sikkerhedsprofilen for SPRYCEL administreret som enkeltstofbehandling hos pædiatriske patienter med Ph+ CML-CP var sammenlignelig med sikkerhedsprofilen hos voksne.
English: The safety profile of SPRYCEL administered in combination with chemotherapy in paediatric patients with Ph+ ALL was consistent with the known safety profile of SPRYCEL in adults and the expected effects of chemotherapy, with the exception of a lower pleural effusion rate in paediatric patients as compared to adults.
Danish: Sikkerhedsprofilen for SPRYCEL administreret i kombination med kemoterapi hos pædiatriske patienter med Ph+ ALL var i overensstemmelse med den kendte sikkerhedsprofil for SPRYCEL hos voksne og de forventede bivirkninger af kemoterapi, med undtagelse af en lavere frekvens af pleuraeffusion hos pædiatriske patienter sammenlignet med voksne.
English: If these clinical signs or symptoms develop, physicians are advised to interrupt dasatinib administration and consider the need for alternative CML-specific treatment.
Danish: Hvis disse kliniske tegn eller symptomer opstår, tilrådes det at seponere behandlingen med dasatinib og overveje behovet for alternativ CML-specifik behandling.
English: In the paediatric ALL studies, the rates of laboratory abnormalities were consistent with the known profile for laboratory parameters in adults, within the context of an acute leukaemia patient receiving a background chemotherapy regimen.
Danish: I de pædiatriske ALL-studier var frekvenserne af laboratorieabnormiteter konsistente med den kendte profil for laboratorieparametre hos voksne inden for konteksten af en patient med akut leukæmi, der får et baggrundskemoterapiregime.
English: A total of 43% of the patients in the dasatinib arm, and 82% in the imatinib arm had treatment failure, defined as disease progression or cross-over to the other treatment (lack of response, intolerance of study medicinal product, etc.).
Danish: I alt 43% af patienterne i dasatinib armen og 82% i imatinib armen oplevede behandlingssvigt, defineret som sygdomsprogression eller crossover til den anden behandling (manglende respons, intolerans over for forsøgslægemidlet mv.).
English: Do not use this medicine after the expiry date which is stated on the bottle label, blister or carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på flaskeetiketten, blister eller kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Most bleeding related adverse reactions in these patients were typically associated with grade 3 or 4 thrombocytopaenia (see section 4.8).
Danish: De fleste blødningsrelaterede bivirkninger hos disse patienter var typisk forbundet med trombocytopeni grad 3 eller 4 (se pkt.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.
Danish: Patienter med sjældne arvelige problemer med fructoseintolerans, glucose-galaktose-malabsorbtion eller sucrase-isomaltasemangel bør ikke tage dette lægemiddel.
English: The estimated 60-month survival rates for dasatinib and imatinib-treated patients were 90.9% (CI: 86.6% - 93.8%) and 89.6% (CI: 85.2% - 92.8%), respectively.
Danish: Den estimerede 60-måneders overlevelsesrate for patienter, der blev behandlet med dasatinib og imatinib, var henholdsvis 90,9% (CI: 86,6% - 93,8%) og 89,6% (CI: 85,2% - 92,8%).
English: Other medicines and SPRYCEL Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med SPRYCEL Fortæl altid lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: Instructions for constitution of powder for oral suspension
Danish: Instruktioner for rekonstitution af pulver til oral suspension
English: Active substances that may increase dasatinib plasma concentrations In vitro studies indicate that dasatinib is a CYP3A4 substrate.
Danish: Aktive substanser der kan øge plasmakoncentrationer af dasatinib In vitro studier tyder på, at dasatinib er et CYP3A4-substrat.
English: These 6 cases included cases of epiphyses delayed fusion, osteopaenia, growth retardation, and gynecomastia (see section 5.1).
Danish: Disse 6 tilfælde inkluderede tilfælde af forsinket epifysefusion, osteopeni, væksthæmning og gynækomasti (se pkt.
English: PHARMACEUTICAL FORM AND CONTENTS 30 x 1 film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 30 × 1 filmovertrukne tabletter
English: 3 If platelets < 25 x 109/L and/or recurrence of ANC < 0.5 x 109/L for > 7 days, repeat step 1 and resume treatment at a reduced dose of 80 mg once daily for second episode.
Danish: 3 Ved trombocytter < 25 × 109/l og/eller recidiv af ANC < 0,5 × 109/l i > 7 dage, gentages trin 1 og behandlingen genoptages med reduceret dosis på 80 mg 1 gang dagligt ved anden episode.
English: If marrow cellularity is <10%, treatment with SPRYCEL should be interrupted until ANC >500/μL (0.5 x 109/L), at which time treatment may be resumed at full dose.
Danish: Hvis marvcellulariteten er <10%, skal behandlingen med SPRYCEL afbrydes, indtil ANC > 500/μl (0,5 × 109/l), hvor behandlingen kan genoptages på fuld dosis.
English: Rate of OS was consistently higher in dasatinib treated patients who achieved BCR-ABL level ≤ 10% at 3 months than those who did not.
Danish: Samlet overlevelsesrate var konsekvent højere hos dasatinib behandlede patienter, som opnåede BCR-ABL-niveau ≤ 10% ved måned 3, sammenlignet med dem, der ikke gjorde.
English: A prior MCyR to imatinib was achieved in 28% and 29% of the patients in the dasatinib and imatinib arms, respectively.
Danish: Tidligere MCyR med imatinib sås hos henholdsvis 28% og 29% af patienterne i dasatinib og imatinib armen.
English: newly diagnosed Ph+ acute lymphoblastic leukaemia (ALL) in combination with chemotherapy.
Danish: nydiagnosticeret Ph+ akut lymfoblastisk leukæmi (ALL) i kombination med kemoterapi.
English: Additionally, in vitro and in vivo platelet assays suggest that SPRYCEL treatment reversibly affects platelet activation.
Danish: Derudover tyder in vitro og in vivo undersøgelser på, at behandling med SPRYCEL reversibelt påvirker aktiveringen af blodplader.
English: Total prescribed dose (mL)
Danish: Total ordineret dosis (ml)
English: Time-to cCCyR
Danish: Tid-til cCCyR
English: The mean terminal half-life of dasatinib is 3 hours to 5 hours.
Danish: Dasatinibs gennemsnitlige terminale halveringstid er 3-5 timer.
English: The majority of SPRYCEL-treated patients experienced adverse reactions at some time.
Danish: Størstedelen af SPRYCEL behandlede patienter oplevede på et tidspunkt bivirkninger.
English: Myeloid blast phase CML
Danish: CML i myeloid blastfase
English: Patients with risk factors (e.g. hypertension, hyperlipidaemia, diabetes) or a history of cardiac disease (e.g. prior percutaneous coronary intervention, documented coronary artery disease) should be monitored carefully for clinical signs or symptoms consistent with cardiac dysfunction such as chest pain, shortness of breath, and diaphoresis.
Danish: Patienter med risikofaktorer (f.eks. hypertension, hyperlipidæmi, diabetes) eller med hjertesygdom i anamnesen (f.eks. tidligere perkutan koronar intervention, dokumenteret koronararteriesygdom) bør monitoreres omhyggeligt for kliniske tegn eller symptomer på nedsat hjertefunktion som f.eks. brystsmerter, åndenød og diaforese.
English: This medicinal product contains lactose monohydrate.
Danish: Dette produkt indeholder lactosemonohydrat.
English: 1 Check if cytopaenia is related to leukaemia (marrow aspirate or biopsy).
Danish: 1 Undersøg om cytopeni er relateret til leukæmi (marvaspirat eller biopsi).
English: Each mL of oral suspension contains approximately 291 mg of sucrose, 2.1 mg of sodium, 0.25 mg of sodium benzoate, 0.25 mg of benzoic acid, 0.017 mg of benzyl alcohol and <10 ppm of sulphur dioxide (E220).
Danish: Hver ml oral suspension indeholder omtrent 291 mg saccharose, 2,1 mg natrium, 0,25 mg natriumbenzoat, 0,25 mg benzoesyre, 0,017 mg benzylalkohol og <10 ppm svovldioxid (E220).
English: Rare hyperthyroidism, thyroiditis Metabolism and nutrition disorders
Danish: Sjælden hypertyreoidisme, tyroiditis Metabolisme og ernæring
English: 2 year n/a 60% (50-70) 41% (21-60) 10% (0-28) 24% (2-47) Cytogenetic responsec (%)
Danish: 2 år n/a 60% (50-70) 41% (21-60) 10% (0-28) 24% (2-47)
English: The efficacy of SPRYCEL in combination with chemotherapy was evaluated in a pivotal study in paediatric patients over one year of age with newly diagnosed Ph+ ALL.
Danish: Effekten af SPRYCEL i kombination med kemoterapi blev vurderet i et pivotalt studie med pædiatriske patienter, der var over 1 år og havde nydiagnosticeret Ph+ ALL.
English: Powder for oral suspension Outer Carton:
Danish: Pulver til oral suspension Ydre karton:
English: Constituted oral suspension may be further mixed with milk, yogurt, apple juice, or applesauce.
Danish: Rekonstitueret oral suspension kan yderligere blandes med mælk, yoghurt, æblejuice eller æblemos.
English: Each pack also contains a press-in-bottle adapter (PIBA) and a 12-mL oral dosing syringe in a sealed plastic bag.
Danish: Hver pakning indeholder også en adapter til flasken, som kan presses i (PIBA) og en 12-ml doseringssprøjte i en forseglet plastikpose.