FrancophonIA/ELRC3.0 huggingface dataset:
English: In an exploratory retrospective analysis of data from 13 completed randomised trials in patients with various tumour types, 3 patients out of 91 (3.3%) with brain metastases experienced CNS bleeding (all Grade 4) when treated with bevacizumab, compared to 1 case (Grade 5) out of 96 patients (1%) that were not exposed to bevacizumab.
Danish: I en retrospektiv, eksplorativ analyse af data fra 13 afsluttede, randomiserede studier hos patienter med forskellige tumortyper, udviklede 3 ud af 91 patienter (3,3 %) med hjernemetastaser CNS-blødning (grad 4 hos alle), når de blev behandlet med bevacizumab, i forhold til 1 tilfælde (grad 5) ud af 96 patienter (1 %), som ikke fik bevacizumab.
English: A total of 673 patients were randomized in equal proportions to the following two treatment arms:
Danish: I alt blev 673 patienter randomiseret ligeligt mellem to følgende behandlingsarme:
English: An increased incidence of CHF has been observed in a clinical trial of patients with diffuse large Bcell lymphoma when receiving bevacizumab with a cumulative doxorubicin dose greater than 300 mg/m2.
Danish: I et klinisk studie er der blevet set en øget hyppighed af CHF hos patienter med diffust storcellet Bcelle lymfom, der fik bevacizumab sammen med en kumulativ doxorubicindosis, som var større end 300 mg/m2.
English: In a study of platinum-resistant recurrent ovarian cancer patients, alopecia, mucosal inflammation, peripheral sensory neuropathy, proteinuria and hypertension were also reported and occurred at a rate at least 5% higher in the CT + BV arm for bevacizumab-treated patients ≥ 65 years of age compared with bevacizumab-treated patients aged < 65 years.
Danish: I et studie med patienter med platinresistent recidiverende ovariecancer blev der også rapporteret alopeci, slimhindeinflammation, perifer sensorisk neuropati, proteinuri og hypertension, og forekomsten var mindst 5 % højere i kemoterapi + bevacizumab-armen hos patienter ≥ 65 år, som fik bevacizumab, sammenlignet med patienter < 65 år, som fik bevacizumab.
English: ● Keep this leaflet.
Danish: • Gem indlægssedlen.
English: Eight hundred and thirteen patients were randomised to receive IFL + placebo (Arm 1) or IFL + Avastin (5 mg/kg every 2 weeks, Arm 2).
Danish: Der blev randomiseret 813 patienter til behandling med IFL + placebo (arm 1) eller IFL + Avastin (5 mg/kg hver 2. uge, arm 2).
English: • Paclitaxel 80 mg/m2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 every 4 weeks.
Danish: • Paclitaxel 80 mg/m2 som 1-times i.v.-infusion på dag 1, 8, 15 og 22 hver 4. uge.
English: The exploratory PFS and OS analyses by chemotherapy cohort (paclitaxel, topotecan and PLD) are summarized in Table 24.
Danish: De eksploratoriske PFS- og OS-analyser af kemoterapi-kohorten (paclitaxel, topotecan og pegyleret liposomal doxorubicin) vises i tabel 24.
English: Secondary efficacy endpoints included progression-free survival and objective response rate.
Danish: Sekundære endepunkter inkluderede progressionsfri overlevelse og objektiv responsrate.
English: A total of 361 patients were enrolled into this study and administered either chemotherapy (paclitaxel, topotecan, or pegylated liposomal doxorubicin (PLD) alone or in combination with bevacizumab:
Danish: Studiet omfattede ialt 361 patienter, der fik kemoterapi (paclitaxel, topotecan eller pegyleret liposomal doxorubicin) alene eller i kombination med bevacizumab:
English: • Topotecan 4 mg/m2 as a 30-minute IV infusion on Days 1, 8, and 15 every 4 weeks.
Danish: • Topotecan 4 mg/m2 som 30-minutters i.v.-infusion på dag 1, 8 og 15 hver 4. uge.
English: Three additional studies with bevacizumab have been conducted in mCRC patients: first-line (NO16966), second-line with no previous bevacizumab treatment (E3200), and second-line with previous bevacizumab treatment following disease progression in first-line (ML18147).
Danish: Yderligere tre studier med bevacizumab er blevet udført hos patienter med metastatisk kolorektalkræft: 1.-linje-behandling (NO16966), 2. linje-behandling uden tidligere bevacizumabbehandling (E3200) samt 2. linje-behandling efter sygdomsprogression efter i 1.-linje-behandling med bevacizumab (ML18147).
English: First-line treatment of non-squamous NSCLC in combination with platinum-based chemotherapy
Danish: 1.-linjebehandling af ikke-planocellulær NSCLC i kombination med platinbaseret kemoterapi
English: For further information please refer to Table 3 'Adverse reactions reported in post-marketing setting.'
Danish: For yderligere information henvises til Tabel 3 'Bivirkninger rapporteret post-marketing'.
English: When used for patients with breast cancer, it will be administered with a chemotherapy medicinal product called paclitaxel or capecitabine.
Danish: Når det anvendes til patienter med brystkræft, vil det blive givet sammen med et cytostatikum (lægemiddel mod kræft), der hedder paclitaxel eller capecitabin.
English: Posterior Reversible Encephalopathy Syndrome (PRES) (see section 4.8) There have been rare reports of Avastin-treated patients developing signs and symptoms that are consistent with PRES, a rare neurologic disorder, which can present with the following signs and symptoms among others: seizures, headache, altered mental status, visual disturbance, or cortical blindness, with or without associated hypertension.
Danish: 4.8) Der har været sjældne tilfælde af Avastinbehandlede patienter, som har udviklet symptomer, der stemmer overens med PRES, en sjælden neurologisk forstyrrelse, som kan optræde med blandt andre følgende tegn og symptomer: Kramper, hovedpine, forandret mental status, visuelle forstyrrelser eller kortikal blindhed, med eller uden tilknyttet hypertension.
English: Proteinuria ranged in severity from clinically asymptomatic, transient, trace proteinuria to nephrotic syndrome, with the great majority as Grade 1 proteinuria (NCI-CTCAE v.3).
Danish: Proteinurien varierede i sværhed fra klinisk symptomfri, forbigående, spor af protein i urinen til nefrotisk syndrom, dog med størstedelen som grad 1 proteinuri (NCI-CTCAE v. 3).
English: First-line treatment of non-squamous NSCLC with EGFR activating mutations in combination with erlotinib
Danish: 1.-linjebehandling af ikke-planocellulær NSCLC med EGFR aktiverende mutationer i kombination med erlotinib
English: This was a phase III randomised double-blind trial conducted to evaluate the efficacy and safety of Avastin in combination with interferon (IFN) alfa-2a versus IFN alfa-2a alone as first-line treatment in mRCC.
Danish: Dette var et fase III, randomiseret, dobbeltblindet studie, der blev udført for at undersøge effekt og sikkerhed ved Avastin i kombination med interferon (IFN) alfa-2a vs IFN alfa-2a alene som 1.linjebehandling af mRCC.
English: Best Overall Response - Primary analysis6
Danish: Bedste objektive respons (primær analyse)6 Respondenter (responsrate)2
English: The use of diuretics to manage hypertension is not advised in patients who receive a cisplatin-based chemotherapy regimen.
Danish: Diuretika bør ikke anvendes til behandling af hypertension hos patienter, som får cisplatinbaseret kemoterapi.
English: Number of Patients Overall Survival Median (months)
Danish: Antal patienter Samlet overlevelse Median (måneder)
English: Across all clinical trials, mucocutaneous haemorrhage has been seen in up to 50% of Avastin-treated patients.
Danish: På tværs af alle kliniske studier er der set slimhindeblødninger hos op til 50 % af patienterne, som fik Avastin.
English: Recto-vaginal fistulae are the most common fistulae in the GI-vaginal fistula category.
Danish: Rektovaginale fistler er de hyppigste fistler i kategorien gastrointestinale-vaginale fistler.
English: Gastrointestinal ulcera
Danish: Gastrointestinalt ulcusa
English: Hypersensitivity reactions and infusion reactions (not known); with the following possible co-manifestations: dyspnoea/difficulty breathing, flushing/redness/rash, hypotension or hypertension, oxygen desaturation, chest pain, rigors and nausea/vomiting (see also section 4.4 and Hypersensitivity reactions/infusion reactions above)
Danish: Overfølsomhedsreaktioner og infusionsreaktioner (ikke kendt) med følgende mulige co-manifestationer: Dyspnø/vejrtrækningsbesvær, blussen/rødme/udslæt, hypotension eller hypertension, nedsat iltmætning, brystsmerter, rigor og kvalme/opkastning (se også pkt.
English: Effect of bevacizumab on the pharmacokinetics of other antineoplastic agents No clinically relevant interaction of bevacizumab was observed on the pharmacokinetics of coadministered interferon alpha 2a, erlotinib (and its active metabolite OSI-420), or the chemotherapies irinotecan (and its active metabolite SN38), capecitabine, oxaliplatin (as determined by measurement of free and total platinum), and cisplatin.
Danish: Bevacizumabs effekt på farmakokinetikken af andre antineoplastiske lægemidlerDer er ikke observeret klinisk relevante interaktioner af bevacizumab på farmakokinetikken af samtidig administreret interferon alfa 2a, erlotinib (og den aktive metabolit OSI-420) eller af følgende kemoterapeutika: irinotecan (og den aktive metabolit SN38), capecitabin, oxaliplatin (bestemt ved måling af frit og totalt platin) og cisplatin.
English: These results demonstrate robustness of the analysis of PFS as shown in Table 16.
Danish: Disse resultater påviser robusthed af PFS-analysen vist i tabel 16.
English: Hypersensitivity, infusion reactionsa,b,d
Danish: Overfølsomhed Infusionsreaktionera,b,d
English: Eligible patients had epithelial ovarian, fallopian tube or primary peritoneal cancer that progressed within <6 months of previous platinum therapy consisting of a minimum of 4 platinum therapy cycles.
Danish: Studiet inkluderede patienter med epitelial ovariecancer, tubacancer eller primær peritonealcancer, der var progredieret < 6 måneder efter seneste platinbehandling, som bestod som minimum af 4 platinbehandlingsserier.
English: • sores in the mouth and the tube from the mouth to the stomach, which may be painful and cause difficulty swallowing,
Danish: • sår i munden og spiserøret, som kan være smertefulde og forårsage synkeproblemer,
English: Very common (affects more than 1 user in 10) side effects, which were not severe, include:
Danish: Meget almindelige bivirkninger (påvirker flere end 1 patient ud af 10), som ikke var alvorlige, omfatter:
English: Cisplatin/Gemcitabine + placebo
Danish: Cisplatin/Gemcitabin + placebo
English: The choices of chemotherapy included capecitabine, taxane (protein-bound paclitaxel, docetaxel), and anthracycline-based agents (doxorubicin/ cyclophosphamide, epirubicin/ cyclophosphamide, 5-fluorouracil/ doxorubicin/ cyclophosphamide, 5-fluorouracil/epirubicin/cyclophosphamide) given every three weeks (q3w).
Danish: Valg af kemoterapi omfattede capecitabin, taxan (proteinbundet paclitaxel, docetaxel) og antracyklinbaserede stoffer (doxorubicin/ cyclophosphamid, epirubicin/cyclophosphamid, 5-fluoruracil/doxorubicin/cyclophosphamid, 5fluoruracil/epirubicin/cyclophosphamid) administreret hver 3. uge.
English: In some cases underlying intra-abdominal inflammation was present, either from gastric ulcer disease, tumour necrosis, diverticulitis, or chemotherapy-associated colitis.
Danish: I nogle af disse tilfælde var intraabdominal inflammation allerede erkendt, enten fra mavesår, tumornekrose, divertikulitis eller kemoterapiassocieret colitis.
English: Intestinal perforation, Ileus, Intestinal obstruction, Recto-vaginal fistulaed,e,
Danish: Intestinal perforation Ileus Intestinal obstruktion Rektovaginal e fistlerd,e
English: ● This medicine increases the risk of having protein in your urine especially if you already have high blood pressure.
Danish: • Avastin kan øge risikoen for at få protein i urinen, især hvis du har forhøjet blodtryk.
English: The study evaluated the effect of adding Avastin to carboplatin+paclitaxel and continuing Avastin as a single agent until disease progression or unacceptable toxicity compared to carboplatin+paclitaxel alone.
Danish: Studiet evaluerede effekten af at tilføje Avastin til carboplatin+paclitaxel og fortsætte med Avastin som monoterapi til sygdomsprogession eller uacceptabel toksicitet, sammenlignet med carboplatin+paclitaxel alene.
English: Table 9
Danish: Tabel 9.
English: Hazard ratio (95% CI) > 12 months (n=282) Median
Danish: Hazard ratio (95 % konfidensinterval) > 12 måneder (n=282) Median
English: In addition, hypertension (including hypertensive crisis), elevated creatinine, and neurological symptoms were observed in some of these patients.
Danish: Nogle patienter kan derudover lide af hypertension (inklusive hypertensive kriser), forhøjet kreatinin og neurologiske symptomer.
English: 60.0 years in the CP arm and 59.0 years in the CPB arm.
Danish: Medianalderen var 60 år i CP-armen og 59 år i CPB-armen.
English: • high blood pressure.
Danish: • forhøjet blodtryk.
English: Hypersensitivity, infusion reactions a,b,c
Danish: Overfølsømhed Infusionsreaktioner a,b,c
English: Avastin vs. No Avastin
Danish: Avastin vs ingen Avastin
English: Relative to the control arm.
Danish: I forhold til kontrolarmen.
English: For patients in study AVF3694g who received anthracyclines concomitantly with bevacizumab, the incidences of Grade 3 or higher CHF for the respective bevacizumab and control arms were similar to those in the other studies in metastatic breast cancer: 2.9% in the anthracycline + bevacizumab arm and 0% in the anthracycline + placebo arm.
Danish: Hos patienter i studie AVF3694g, som fik antracykliner samtidig med bevacizumab, svarede hyppigheden af CHF af grad 3 eller højere i de respektive bevacizumab- og kontrolarme til de hyppigheder, som er set i andre studier af metastatisk brystkræft: 2,9 % i antracyklin + bevacizumab-armen og 0 % i antracyklin + placebo-armen.
English: It is recommended that treatment be continued until progression of the underlying disease or until unacceptable toxicity.
Danish: Det anbefales, at behandlingen fortsættes indtil progression af den underliggende sygdom eller indtil uacceptabel toksicitet.
English: Uncommon Rare Very Rare
Danish: Sjælden Meget sjælden
English: Summarised below are PFS results for the individual chemotherapy agents included in the indication:
Danish: Resultaterne for PFS af de individuelle kemoterapeutika inkluderet i indikationen er opsummeret nedenfor:
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA): http://www.ema.europa.eu
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om Avastin findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Across clinical trials, the following Grade 3 and 4 (NCI-CTCAE v.3) laboratory abnormalities occurred in patients treated with Avastin with at least a 2% difference compared to the corresponding control groups: hyperglycaemia, decreased haemoglobin, hypokalaemia, hyponatraemia, decreased white blood cell count, increased international normalised ratio (INR).
Danish: Hos de patienter, der blev behandlet med Avastin, er der fra kliniske studier set en stigning på mindst 2 % i hyppigheden af følgende grad 3 og 4 (NCI-CTCAE v. 3) laboratorieanormaliteter sammenlignet med kontrolgrupperne: Hyperglykæmi, nedsat hæmoglobin, hypokaliæmi, hyponatriæmi, nedsat antal hvide blodceller, stigning i international normaliseret ratio (INR).
English: Objective response rate Rate
Danish: Objektiv responsrate Rate
English: Patients with renal impairment: The safety and efficacy have not been studied in patients with renal impairment (see section 5.2).
Danish: Patienter med nedsat leverfunktion: Sikkerheden og effekten er ikke undersøgt hos patienter med nedsat leverfunktion (se pkt.
English: Duration of response Median time (months)
Danish: Responsvarighed Median tid (måneder)
English: 60 years in CPP and CPB15 arms and 59 years in CPB15+ arm; and 29% of patients in CPP or CPB15 and 26% in CPB15+ were over 65 years of age.
Danish: 29 % af patienterne i CPP- og CPB15-armene og 26 % i CPB15+-armen var over 65 år.
English: • high blood pressure,
Danish: • forhøjet blodtryk,
English: A total of 1528 patients were randomised in equal proportions to the following two arms:
Danish: Sammenlagt blev 1.528 patienter randomiseret til to lige store arme:
English: Posterior Reversible Encephalopathy Syndrome (PRES), (rare) (see also section 4.4)
Danish: Posteriort reversibelt encefalopati-syndrom (PRES) (sjælden) (se også pkt.
English: IRC Assessment
Danish: IRC-vurdering
English: Deep vein thrombosis
Danish: Dyb vene trombose
English: • In a single-arm study (PBTC-022), 18 children with recurrent or progressive non-pontine high-grade glioma (including 8 with glioblastoma [WHO Grade IV], 9 with anaplastic astrocytoma [Grade III] and 1 with anaplastic oligodendroglioma [Grade III]) were treated with bevacizumab (10 mg/kg) two weeks apart and then with bevacizumab in combination with CPT-11 (125-350 mg/m²) once every two weeks until progression.
Danish: ● I et enkelt-arms-studie (PBTC-022) blev18 børn med recidiverende eller progredierende højgrads-gliom, som ikke involverede hjernebroen (herunder 8 med glioblastom [WHO grad IV], 9 med anaplastisk astrocytom [grad III] og 1 med anaplastisk oligodendrogliom [grad III]), behandlet med bevacizumab (10 mg/kg) med 2 ugers mellemrum og derefter med bevacizumab i kombination med CPT-11 (125-350 mg/m²) hver anden uge indtil progression.
English: Severe side effects, which may be very common (affects more than 1 user in 10), include:
Danish: Alvorlige bivirkninger, som kan være meget almindelige (påvirker flere end 1 patient ud af 10), omfatter:
English: (p-value 0.3360)
Danish: (p-værdi 0,3360)
English: Patients were randomised to paclitaxel alone (90 mg/m2 IV over 1 hour once weekly for three out of four weeks) or in combination with Avastin (10 mg/kg IV infusion every two weeks).
Danish: Patienterne blev randomiseret til paclitaxel alene (90 mg/m2 indgivet intravenøst som 1-times infusion en gang ugentligt i tre ud af fire uger) eller i kombination med Avastin (10 mg/kg indgivet som intravenøs infusion hver 2. uge).
English: Progression-free survival - Primary analysis6 Median PFS (months)1
Danish: Sekundære endepunkter Progressionsfri overlevelse (primær analyse)6 Median PFS (måneder)1
English: 5-Fluorouracil: IV bolus injection immediately after leucovorin
Danish: bolusinjektion umiddelbart efter leucovorin
English: Cisplatin/Gemcitabine + Avastin
Danish: Cisplatin/Gemcitabin + Avastin
English: Patients treated with Avastin have an increased risk of haemorrhage, especially tumour-associated haemorrhage.
Danish: Patienter, som behandles med Avastin, har en øget risiko for at udvikle blødning, særligt tumorassocieret blødning.
English: • AVF2107g: A weekly schedule of irinotecan/bolus 5-fluorouracil/folinic acid (IFL) for a total of 4 weeks of each 6 week-cycle (Saltz regimen).
Danish: ● AVF2107g: Et ugentligt regime med irinotecan/bolus af 5-fluoruracil/folininsyre (IFL-regime) i 4 uger i hver 6 ugers cyklus (Saltz-regimet)
English: Treatment was given until progressive disease or unacceptable toxicity.
Danish: Behandlingen blev givet indtil sygdomsprogression eller indtil uacceptabel toksicitet.
English: ● Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures: Description
Danish: Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2°C - 8°C).
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i køleskab (2 ºC - 8 ºC) Må ikke nedfryses
English: Table 21 Progression-free survival by time from last platinum therapy to recurrence Investigator Assessment
Danish: Progressionsfri overlevelse efter tid fra sidste platinbehandling indtil recidiv.
English: • AVF0780g: In combination with bolus 5-fluorouracil/folinic acid (5-FU/FA) for a total of 6 weeks of each 8 week-cycle (Roswell Park regimen).
Danish: ● AVF0780g: I kombination med en bolus af 5-fluoruracil/folininsyre (5-FU/FA) i 6 uger i hver 8 ugers cyklus (Roswell Park regimet)
English: Therapy should be permanently discontinued in patients who develop arterial thromboembolic reactions.
Danish: Behandlingen skal seponeres permanent hos patienter, som udvikler arterielle tromboemboliske bivirkninger.
English: Study E3200 used a 5 mg/kg/week equivalent dose of bevacizumab in bevacizumab-naïve patients, while study ML18147 used a 2.5 mg/kg/week equivalent dose of bevacizumab in bevacizumabpretreated patients.
Danish: I E3200-studiet blev der anvendt en bevacizumabdosis svarende til 5 mg/kg/uge til bevacizumab-naive patienter, mens der i ML18147-studiet blev anvendt en bevacizumabdosis svarende til 2,5 mg/kg/uge til patienter, som tidligere var behandlet med bevacizumab.
English: • In a retrospective single institution series, 12 consecutive (2005 to 2008) children with relapsed or progressive high-grade glioma (3 with WHO Grade IV, 9 with Grade III) were treated with bevacizumab (10 mg/kg) and irinotecan (125 mg/m²) every 2 weeks.
Danish: ● I et retrospektivt studie på en enkelt institution blev 12 konsekutive børn (2005-2008) med recidiverende eller progredierende høj-grads-gliom (3 med WHO grad IV, 9 med grad III) behandlet med bevacizumab (10 mg/kg) og irinotecan (125 mg/m²) hver anden uge.
English: Later infusions may be given to you over 30 minutes.
Danish: Efterfølgende infusioner vil måske kun vare 30 minutter.
English: Patients treated for persistent, recurrent, or metastatic cervical cancer with Avastin are at increased risk of fistulae between the vagina and any part of the GI tract (Gastrointestinal-vaginal fistulae).
Danish: Patienter, behandlet med Avastin for persisterende, recidiverende eller metastatisk cervixcancer, har en øget risiko for dannelse af fistler mellem vagina og alle dele af mave-tarmkanalen (gastrointestinale-vaginale fistler).
English: In patients developing PRES, treatment of specific symptoms including control of hypertension is recommended along with discontinuation of Avastin.
Danish: For patienter, der udvikler PRES, anbefales behandling af symptomerne samt kontrol af hypertensionen samtidig med, at Avastinbehandlingen afbrydes.
English: Very Common
Danish: Meget almindelig Almindelig
English: The haemorrhagic reactions that have been observed in clinical trials were predominantly tumourassociated haemorrhage (see below) and minor mucocutaneous haemorrhage (e.g. epistaxis).
Danish: De blødninger, som blev observeret i de kliniske studier, var fortrinsvis tumorassocierede blødninger (se nedenfor) og mindre slimhindeblødninger (f.eks. epistaxis).
English: Randomised patients stage III optimally debulked disease 2,3
Danish: Randomiserede patienter med stadie III optimalt tumoreduceret sygdom 2,3
English: The primary endpoint was progression free survival, secondary endpoints for the trial included the duration of overall survival.
Danish: Det primære endepunkt var progressionsfri overlevelse og de sekundære endepunkter for studiet inkluderede længden af den samlede overlevelse.
English: If you stop treatment with Avastin
Danish: Hvis du holder op med at få Avastin
English: The first infusion will be given to you over 90 minutes.
Danish: Den første infusion vil vare 90 minutter.
English: Investigator assessment*
Danish: Investigators vurdering*
English: 0.65 (p < 0.0001) 95% CI (0.56; 0.76)
Danish: 0,65 (p < 0,0001) 95 % konfidensinterval (0,56-0,76)
English: Front-line treatment: Avastin is administered in addition to carboplatin and paclitaxel for up to 6 cycles of treatment followed by continued use of Avastin as single agent until disease progression or for a maximum of 15 months or until unacceptable toxicity, whichever occurs earlier.
Danish: Frontlinjebehandling: Avastin administreres sammen med carboplatin og paclitaxel i op til 6 behandlingsserier, efterfulgt af fortsat behandling med Avastin som monoterapi indtil sygdomsprogression eller i op til 15 måneder eller indtil uacceptabel toksicitet, alt efter hvad der forekommer først.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 400 mg/16 ml
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 400 mg/16 ml