FrancophonIA/ELRC3.0 huggingface dataset:
English: You should not eat anything for at least 2 hours before taking COMETRIQ and for 1 hour after taking the medicine.
Danish: Du bør ikke spise noget i mindst 2 timer før, du tager COMETRIQ og i 1 time efter at have taget lægemidlet.
English: In case of hypertensive crisis, cabozantinib should be discontinued.
Danish: I tilfælde af hypertensiv krise, bør cabozantinib seponeres.
English: What you need to know before you take COMETRIQ 3.
Danish: Det skal du vide, før du begynder at tage COMETRIQ 3.
English: In the 2-year rat carcinogenicity study, cabozantinib-related neoplastic findings consisted of an increased incidence of benign pheochromocytoma, alone or in combination with malignant pheochromocytoma/complex malignant pheochromocytoma of the adrenal medulla in both sexes at exposures well below the intended exposure in humans.
Danish: I det 2-årige karcinogenicitetsstudie med rotter bestod de cabozantinib-relaterede neoplastiske fund af en øget forekomst af benignt fæokromocytom, alene eller i kombination med malignt fæokromocytom/komplekst malignt fæokromocytom i binyremarven hos begge køn ved eksponering et stykke under den tilsigtede eksponering hos mennesker.
English: In rat and dog repeat-dose toxicity studies up to 6 months duration, target organs for toxicity were GI tract, bone marrow, lymphoid tissues, kidney, adrenal and reproductive tract tissues.
Danish: Hos rotte og hund i gentaget-dosis toksicitetsstudier op til 6 måneders varighed, var målorganer for toksicitet mave-tarmkanalen, lymfevæv, nyre-, binyre- og reproduktionsvejs-væv.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE ANVENDT LÆGEMIDDEL SAMT AFFALD HERAF Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: Black iron oxide (E172) (20 mg capsules only) Red iron oxide (E172) (80 mg capsules only) Titanium dioxide (E171)
Danish: Sort jernoxid (E172) (kun 20 mg kapsler) Rød jernoxid (E172) (kun 80 mg kapsler) Titandioxid (E171)
English: Protein binding was not altered in subjects with mild or moderately impaired renal or hepatic function.
Danish: Proteinbindingen var ikke ændret hos forsøgspersoner med let til moderat nedsat nyre- eller leverfunktion.
English: Juvenile rats (comparable to a >2 year old pediatric population) administered cabozantinib showed increased WBC parameters, decreased haematopoiesis, pubescent/immature female reproductive system (without delayed vaginal opening), tooth abnormalities, reduced bone mineral content and density, liver pigmentation and bile duct hyperplasia.
Danish: Juvenile rotter (sammenlignelig med en >2 år gammel pædiatrisk population), der fik cabozantinib, udviste øgede WBC-parametre, nedsat hæmatopoiese, pubertetsalder/umodent kvindeligt reproduktionssystem (uden forsinket vaginal åbning), abnormaliteter af tænderne, reduceret mineralindhold og densitet af knoglerne, leverpigmentering og hyperplasi af galdeveje.
English: • Skin ulcers, cysts, red spots on the face or thighs
Danish: • Hudsår, cyster, røde pletter i ansigtet eller på lårene
English: Therefore, concomitant use of MRP2 inhibitors (e.g. cyclosporine, efavirenz, emtricitabine) should be approached with caution.
Danish: Derfor skal samtidig anvendelse af MRP2-hæmmere (f.eks. ciclosporin, efavirenz, emtricitabin) ske med forsigtighed.
English: • Decreased appetite, weight loss, altered sense of taste
Danish: • Nedsat appetit, vægttab, ændret smagsans
English: Cabozantinib exhibited dose-related tumour growth inhibition, tumor regression, and/or inhibited metastasis in a broad range of preclinical tumour models.
Danish: Cabozantinib udviste dosis-relateret hæmning af tumorvækst, tumor regression og/eller hæmmede metastase i en lang række præ-kliniske tumormodeller.
English: Within a 48-day collection period after a single dose of 14C-cabozantinib in healthy volunteers, approximately 81% of the total administered radioactivity was recovered with 54% in faeces and 27% in urine.
Danish: cabozantinib hos raske frivillige, blev cirka 81 % af den totalt administrerede radioaktivitet genfundet med 54 % i fæces og 27 % i urin.
English: 11.2 months
Danish: 11,2 måneder
English: • Blood clots in the veins and the lungs
Danish: • Blodpropper i venerne og i lungerne
English: Cabozantinib should be discontinued in patients who develop nephrotic syndrome.
Danish: Cabozantinib bør seponeres hos patienter, der udvikler nefrotisk syndrom.
English: How to take COMETRIQ 4.
Danish: Sådan skal du tage COMETRIQ 4.
English: • Infection and inflammation in the lung, collapse of lung
Danish: • Infektion og inflammation i lungen, kollaps af lunge
English: Cabozantinib should not be administered to patients with serious haemorrhage or recent haemoptysis.
Danish: Cabozantinib bør ikke gives til patienter med alvorlig hæmoragi eller nylig hæmoptyse.
English: Concomitant treatment with strong CYP3A4 inhibitors, which may increase cabozantinib plasma concentrations, should be used with caution.
Danish: Samtidig behandling med potente CYP3A4-hæmmere, der kan øge plasmakoncentrationerne af cabozantinib, bør anvendes med forsigtighed.
English: Subjects should be cautioned regarding taking a P-gp substrate (e.g., fexofenadine, aliskiren, ambrisentan, dabigatran etexilate, digoxin, colchicine, maraviroc, posaconazole, ranolazine, saxagliptin, sitagliptin, talinolol, tolvaptan) while receiving cabozantinib.
Danish: Patienter bør advares mod at tage et P-gp substrat (f.eks. fexofenadin, aliskiren, ambrisentan, dabigatran etexilat, digoxin, colchicin, maraviroc, posaconazol, ranolazin, saxagliptin, sitagliptin, talinolol, tolvaptan), mens de får cabozantinib.
English: A high-fat meal moderately increased Cmax and AUC values (41% and 57%, respectively) relative to fasted conditions in healthy volunteers administered a single 140 mg oral cabozantinib dose.
Danish: Et måltid med højt fedtindhold øgede moderat Cmax - og AUC-værdier (henholdsvis 41 % og 57 %) relativt til fastende tilstande hos raske frivillige, der fik en enkelt 140 mg oral cabozantinib dosis.
English: Cabozantinib should be discontinued in patients with wound healing complications requiring medical intervention.
Danish: Cabozantinib bør seponeres hos patienter med sårhelingskomplikationer, der kræver medicinsk intervention.
English: COMETRIQ is indicated for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma.
Danish: COMETRIQ er indiceret til behandling af voksne patienter med progressiv, inoperable, lokal fremskreden eller metastatisk thyroideacarcinom.
English: The result of the PFS analysis, based on the central review RECIST assessment, demonstrated a statistically significant difference in the duration of PFS with cabozantinib versus placebo: the median duration was 11.2 months for subjects in the cabozantinib arm versus 4.0 months for subjects in the placebo arm (stratified Hazard Ratio [HR] = 0.28; 95% CI: 0.19, 0.40; p<0.0001; Figure 1).
Danish: Resultatet af PFS-analysen, baseret på den centrale gennemgang RECIST vurdering, påviste en statistisk signifikant forskel i varigheden af PFS med cabozantinib versus placebo: Median varigheden var 11,2 måneder for forsøgspersoner i cabozantinib-armen versus 4,0 måneder for forsøgspersoner i placebo-armen (stratifieret fareratio [HR] = 0,28; 95 % CI: 0,19, 0,40; p<0,0001; Figur 1).
English: COMETRIQ should not be taken with food.
Danish: COMETRIQ bør ikke tages sammen med mad.
English: Patients with severe renal impairment have not been studied.
Danish: Patienter med svært nedsat leverfunktion er ikke blevet undersøgt.
English: For invasive dental procedures, cabozantinib treatment should be held at least 28 days prior to scheduled surgery, if possible.
Danish: Ved invasive dentale indgreb bør behandling med cabozantinib om muligt stoppes mindst 28 dage forud for den planlagte operation.
English: • Inflammation of the abdomen or pancreas
Danish: • Inflammation af abdomen eller bugspytkirtlen
English: Ear and labyrinth disorders ear pain, tinnitus hypoacusis
Danish: Øre og labyrint ørepine, tinnitus hypoacusis
English: A significant improvement in OS was observed in the subgroup of RET M918T mutation positive patients (n=81/219 cabozantinib arm): 44.3 months in the cabozantinib arm vs. 18.9 months in the placebo arm (HR = 0.60, p = 0.0255).
Danish: En signifikant forbedring i OS blev observeret i undergruppen af RET-M918T-mutationspositive patienter (n=81/219 i cabozantinib-armen): 44,3 måneder i cabozantinib-armen vs. 18,9 måneder i placebo-armen (HR = 0,60; p = 0,0255).
English: NOAEL for embryo-foetal toxicity and teratogenic findings were below human clinical exposure levels at intended therapeutic dose.
Danish: NOAEL for embryo-føtal toksicitet og teratogene fund var under humane kliniske eksponeringsniveauer ved den tilsigtede terapeutiske dosis.
English: 14.6 months
Danish: 14,6 måneder
English: The active substance is cabozantinib (S)-malate.
Danish: Aktivt stof: cabozantinib (S)-malat.
English: Patients with cardiac impairment
Danish: Patienter med nedsat hjertefunktion
English: The no observed adverse effect level (NOAEL) for these findings were below human clinical exposure levels at intended therapeutic dose.
Danish: Niveauet uden observerede bivirkninger (NOAEL) for disse fund var under humane kliniske eksponeringsniveauer ved den tilsigtede terapeutiske dosis.
English: No dose adjustment is indicated when gastric pH modifying agents (i.e., PPIs, H2 receptor antagonists, and antacids) are co-administered with cabozantinib.
Danish: Dosisjustering er ikke nødvendig, når midler til modificering af gastrisk pH (dvs. PPI'er, H2-receptorantagonister og antacida) administreres sammen med cabozantinib.
English: 26.6 months
Danish: 26,6 måneder
English: Cabozantinib should be used with caution in patients who are at risk for, or who have a history of, these events.
Danish: Cabozantinib bør anvendes med forsigtighed hos patienter med risiko for, eller som har en anamnese, for disse bivirkninger.
English: Patients who have had recent radiotherapy, have inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, peritonitis, or diverticulitis), have tumour infiltration of trachea, bronchi, or oesophagus, have complications from prior GI surgery (particularly when associated with delayed or incomplete healing), or have complications from prior radiation therapy to the thoracic cavity (including mediastinum) should be carefully evaluated before initiating cabozantinib therapy and subsequently they should be monitored closely for symptoms of perforations and fistulas.
Danish: Patienter, som for nylig har fået strålebehandling, har inflammatorisk tarmsygdom (f.eks. Crohn's sygdom, ulcerativ colitis, peritonitis eller diverticulitis), har tumorinfiltration af trachea, bronkierne eller øsofagus, har komplikationer fra tidligere GI-kirurgi (især i forbindelse med forsinket eller ufuldstændig opheling) eller har komplikationer fra tidligere strålebehandling af thorakshulen (inklusive mediastinum), bør omhyggeligt evalueres inden indledning af behandling med cabozantinib, og de bør efterfølgende monitoreres tæt for symptomer på perforationer og fistler.
English: Four metabolites were present in plasma at exposures (AUC) greater than 10% of parent: XL184-N-oxide, XL184 amide cleavage product, XL184 monohydroxy sulfate, and 6-desmethyl amide cleavage product sulfate.
Danish: Der var fire metaboliter tilstede i plasma ved eksponeringer (AUC) større end 10 % af moderstoffet: XL184-N-oxid, XL184 amid spaltningsprodukt, XL184 monohydroxysulfat og 6-desmethylamid spaltningsprodukt sulfat.
English: • Chest pain due to blockage in arteries, rapid heartbeat
Danish: • Brystsmerter, som skyldes blokeringer i arterierne, hurtig hjertefrekvens
English: • Seizures, headaches, confusion, or finding it difficult to concentrate.
Danish: • Krampeanfald, hovedpiner, konfusion eller problemer med at koncentrere sig.
English: The final analysis of OS was conducted after 218 events (deaths) occurred and shows a trend for an increase in median survival of 5.5 months in the cabozantinib arm: median (months) 26.6 cabozantinib vs. 21.1 placebo (HR = 0.85 [95% CI: 0.64, 1.12], p = 0.2409).
Danish: Den endelige analyse af OS blev gennemført, efter at 218 hændelser (dødsfald) var forekommet og viser en tendens til en øgning i median overlevelse på 5,5 måneder i cabozantinib-armen: Median (måneder) 26,6 for cabozantinib vs. 21,1 for placebo (HR = 0,85 [95 % CI: 0,64-1,12], p = 0,2409).
English: These could be signs of bone damage in the jaw (osteonecrosis).
Danish: Dette kunne være tegn på knoglebeskadigelse af kæben (osteonekrose).
English: Infections and infestations abscess (including visceral, skin, tooth), pneumonia, folliculitis, fungal infection (including skin, oral, genital)
Danish: Infektioner og parasitære sygdomme absces (inklusive visceral, hud, tand), pneumoni, folliculitis, svampeinfektion (inklusive hud, oral, genital)
English: confusion, or finding it difficult to concentrate
Danish: hovedpine, konfusion, eller besvær med at koncentrere sig
English: Cabozantinib should be used with caution in patients with mild or moderate renal impairment.
Danish: Cabozantinib bør anvendes med forsigtighed hos patienter med let eller moderat nedsat nyrefunktion.
English: Further, hypospermatogenesis was observe in male dogs at exposure levels below human clinical exposure levels at intended therapeutic dose.
Danish: Ydermere blev der observeret hypospermatogenese hos hanhunde ved eksponeringsniveauer under det kliniske eksponeringsniveau ved den tilsigtede terapeutiske dosis til mennesker.
English: Cabozantinib treatment should be discontinued in patients with RPLS.
Danish: Behandling med cabozantinib bør seponeres hos patienter med RPLS.
English: Co-administration of proton pump inhibitor (PPI) esomeprazole (40 mg daily for 6 days) with a single dose of 100 mg cabozantinib to healthy volunteers resulted in no clinically-significant effect on plasma cabozantinib exposure (AUC).
Danish: Administration af protonpumpe-hæmmeren (PPI) esomeprazol (40 mg daglig i 6 dage) sammen med en enkelt dosis 100 mg cabozantinib til raske frivillige resulterede ikke i nogen klinisk signifikant effekt på cabozantinibs plasmaeksponering (AUC).
English: COMETRIQ 80 mg capsules are orange and have “XL184 80mg” printed on one side.
Danish: COMETRIQ 80 mg kapsler er orange og har “XL184 80mg” trykt på den ene side.
English: Taking COMETRIQ with food
Danish: Brug af COMETRIQ sammen med mad
English: INFORMATION IN BRAILLE COMETRIQ 20 mg
Danish: INFORMATION I BRAILLESKRIFT COMETRIQ 20 mg
English: Metabolism and nutrition disorders decreased appetite, hypocalcaemia, hypophosphataemia, hyperbilirubinemia, hypokalaemia, hypomagnesaemia dehydration, hypoalbuminaemia
Danish: Metabolisme og ernæring nedsat appetit, hypokalcæmi, hypofosfatæmi, hyperbilirubinæmi, hypokaliæmi, hypomagnesiæmi dehydrering, hypoalbuminæni
English: 21.1 months HR: 0.85 (0.64, 1.12) p = 0.2409
Danish: HR: 0,85 (0,64-1,12) p = 0,2409
English: Cabozantinib was an inhibitor (IC50 = 7.0 μM), but not a substrate, of P-gp transport activities in a bi-directional assay system using MDCK-MDR1 cells.
Danish: Cabozantinib var en hæmmer (IC50 = 7,0 μM), men ikke et substrat, af P-gp transportaktiviteter i et torettet assay-system, der anvender MDCK-MDR1 celler.
English: The most common laboratory abnormalities were increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), increased alkaline phosphatase (ALP), lymphopenia, hypocalcaemia, neutropenia, thrombocytopenia, hypophosphataemia, hyperbilirubinemia, hypomagnesaemia, and hypokalaemia.
Danish: De mest almindelige laboratorieabnormaliteter var øget aspartat aminotransferase (ASAT), øget alanin aminotransferase (ALAT), øget alkalisk fosfatase (ALP), lymfopeni, hypokalcæmi, neutropeni, thrombocytopeni, hypofosfatæmi, hyperbililirubinæmi, hypomagnesiæmi og hypokaliæmi.
English: The PFS results were consistent across all baseline and demographic subgroups evaluated, including prior therapy with tyrosine kinase inhibitors (which may have consisted of agents targeting pathways associated with anti-angiogenesis), RET mutational status (including subjects documented not to have RET mutations), prior anticancer or radiotherapy status, or the existence of bone metastases.
Danish: PFSresultaterne var konsistente på tværs af alle evaluerede baseline og demografiske undergrupper, inklusive forudgående behandling med tyrosinkinase-hæmmere (der kan have bestået af midler målrettet mod veje forbundet med anti-angiogenese), RET-mutationsstatus (inklusive forsøgspersoner dokumenteret ikke at have RET-mutationer), forudgående anticancer- eller strålebehandlingsstatus eller eksistensen af knogle-metastaser.
English: The most frequent adverse reactions of any grade (experienced by at least 20% of patients) included diarrhoea, PPES, weight decreased, decreased appetite, nausea, fatigue, dysgeusia, hair colour changes, hypertension, stomatitis, constipation, vomiting, mucosal inflammation, asthenia, and dysphonia.
Danish: De hyppigste bivirkninger af en hvilken som helst grad (oplevet af mindst 20 % af patienterne) omfatter diaré, PPES, vægttab, nedsat appetit, kvalme, træthed, dysgeusi, ændringer i hårfarve, hypertension, stomatitis, konstipation, opkastning, slimhindeinflammation, asteni og dysphoni.
English: When dose reduction is necessary, it is recommended to reduce to 100 mg daily, taken as one 80 mg orange capsule and one 20 mg grey capsule, and then to 60 mg daily, taken as three 20 mg grey capsules.
Danish: Når dosisreduktion er nødvendig, anbefales det at reducere til 100 mg daglig, administreret som én 80 mg orange kapsel og én 20 mg grå kapsel, og derefter til 60 mg daglig, administreret som tre 20 mg grå kapsler.
English: one orange 80 mg + one grey 20 mg
Danish: én orange 80 mg + én grå 20 mg
English: You should not take COMETRIQ with food.
Danish: Du må ikke tage COMETRIQ sammen med mad.
English: Therefore co-administration of strong CYP3A4 inhibitors (e.g., ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice) with cabozantinib should be approached with caution.
Danish: Derfor bør co-administration af potente CYP3A4-hæmmere (f.eks. ritonavir, itraconazol, erythromycin, clarithromycin, grapefrugtjuice) med cabozantinib foretages med forsigtighed.
English: Very common side effects (may affect more than 1 in 10 people)
Danish: Meget almindelige bivirkninger (kan påvirke flere end 1 ud af 10 mennesker)
English: • Generalised pain, chest or muscle pain, ear pain, ringing in ears
Danish: • Generaliserede smerter, bryst- eller muskelsmerter, ørepine, ringen for ørerne
English: Cabozantinib was an inhibitor (IC50 = 7.0 μM), but not a substrate, of P-glycoprotein (P-gp) transport activities in a bi-directional assay system using MDCK-MDR1 cells.
Danish: Cabozantinib var en hæmmer (IC50 = 7,0 μM), men ikke et substrat, af P-glykoprotein (P-gp) transportaktiviteter i et to-rettet assay-system, der anvender MDCK-MDR1 celler.
English: Results from a study in patients with hepatic impairment indicate that exposure (AUC0-inf) increased by 81% and 63% in subjects with mild and moderate hepatic impairment, respectively (90% CI for AUC0-inf: 121.44% to 270.34% for mild and 107.37% to 246.67% for moderate).
Danish: Resultater fra et studie med patienter med nedsat leverfunktion indikerer, at eksponeringen (AUC0-inf) øgedes med henholdsvis 81 % og 63 % hos forsøgspersoner med let og moderat nedsat leverfunktion (90 % CI for AUC0-inf: 121,44 % til 270,34 % ved let og 107,37 % til 246,67 % ved moderat nedsat leverfunktion).
English: The hard capsules are grey with “XL184 20mg” printed in black on the body of the capsule.
Danish: De hårde kapsler er grå med “XL184 20mg” trykt i sort på kapslens krop.
English: • Pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
Danish: • Smerter i munden, tænderne og/eller kæben, hævelse eller sår inde i munden, manglende følelse i eller en følelse af tyngde i kæben eller løsnen af en tand.
English: - Keep this leaflet.
Danish: - Gem indlægsedlen.
English: Catalent UK Packaging Limited Lancaster Way, Wingates Industrial Park, Westboughton, Bolton, Lancashire, BL5 3XX, United Kingdom
Danish: Lancaster Way, Wingates Industrial Park, Westhoughton, Bolton,
English: Two non-conjugated metabolites (XL184-N-oxide and XL184 amide cleavage product), which possess <1% of the on-target kinase inhibition potency of parent cabozantinib, each represent <10% of total drug-related plasma exposure.
Danish: (XL184-N-oxid og XL184 amid spaltningsprodukt), der besidder <1 % af on-target kinasehæmningspotentialet af moderstoffet cabozantinib, hver repræsenterende <10 % af total lægemiddelrelateret plasmaeksponering.
English: three grey 20 mg
Danish: tre grå 20 mg
English: Patients with severe hepatic impairment have not been studied.
Danish: Patienter med svært nedsat nyrefunktion er ikke blevet undersøgt.
English: Gastric pH modifying agents
Danish: Midler til modificering af gastrisk pH
English: The most common serious adverse reactions associated with cabozantinib are pneumonia, mucosal inflammation, hypocalcaemia, dysphagia, dehydration, pulmonary embolism, and hypertension.
Danish: De mest almindelige alvorlige bivirkninger forbundet med cabozantinib er pneumoni, slimhinde inflammation, hypokalcæmi, dysfagi, dehydrering, lungeemboli og hypertension.
English: Caution is required when administering cabozantinib with agents that are strong CYP3A4 inhibitors.
Danish: Der kræves forsigtighed ved administration af cabozantinib med midler, der er stærke CYP3A4-hæmmere.
English: • Fatigue, weakness, headache, dizziness
Danish: • Træthed, svaghed, hovedpine, svimmelhed
English: The hard capsules are orange with “XL184 80mg” printed in black on the body of the capsule.
Danish: De hårde kapsler er orange med ”XL184 80mg” trykt i sort på kapslens krop.
English: Results from a study in patients with renal impairment indicate that the ratios of geometric LS mean for plasma cabozantinib, Cmax and AUC0-inf were 19% and 30% higher, for subjects with mild renal impairment (90% CI for Cmax 91.60% to 155.51%; AUC0-inf 98.79% to 171.26%) and 2% and 6-7% higher (90% CI for Cmax 78.64% to 133.52%; AUC0-inf 79.61% to 140.11%), for subjects with moderate renal impairment compared to subjects with normal renal function.
Danish: Resultater fra et studie hos patienter med nedsat nyrefunktion indikerer, at ratioerne af middelværdierne beregnet ved mindste kvadraters metode for plasme-cabozantinib, Cmax og AUC0-inf var 19 % og 30 % højere hos forsøgspersoner med let nedsat nyrefunktion (90 % CI for Cmax 91,60 % til 155,51 %; AUC0-inf 98,79 % til 171,26 %) og 2 % og 6-7 % højere (90 % CI for Cmax 78,64 % til 133,52 %; AUC0-inf 79,61 % til 140,11 %) hos forsøgspersoner med moderat nedsat nyrefunktion sammenlignet med forsøgspersoner med normal nyrefunktion.
English: Capsule content Microcrystalline cellulose Croscarmellose sodium Sodium starch glycolate Silica colloidal anhydrous Stearic acid
Danish: Kapslens indhold Mikrokrystallinsk cellulose Croscarmellosenatrium Natriumstivelsesglycolat Kolloid vandfri silica Stearinsyre
English: Package leaflet inside pouch.
Danish: Indlægsseddel er inden i posen.
English: • Symptoms including pain in the abdomen, nausea, vomiting, constipation, or fever.
Danish: • Symptomer omfattende smerter i maven, kvalme, opkastning, forstoppelse eller feber.
English: • 140 mg (1 orange 80 mg capsule and 3 grey 20 mg capsules)
Danish: • 140 mg (1 orange 80 mg kapsel og 3 grå 20 mg kapsler)