FrancophonIA/ELRC3.0 huggingface dataset:
English: Lorviqua 100 mg is provided in blisters of 10 tablets, which are available in packs containing 30 tablets (3 blisters).
Danish: Lorviqua 100 mg leveres i blistere med 10 tabletter, som fås i pakker med 30 tabletter (3 blisterkort).
English: The most common cognitive effect of any grade was memory impairment (11.5%), and the most common Grade 3 or 4 reactions were cognitive effect and confusional state (0.7% each).
Danish: Den mest almindelige kognitive påvirkning af en hvilken som helst grad var nedsat hukommelsesfunktion (11,5 %) og de mest almindelige bivirkninger af grad 3 og 4 var kognitive påvirkninger og konfusionstilstand (begge 0,7 %).
English: Česká republika
Danish: Slovenská republika
English: Other medicines and Lorviqua
Danish: Brug af anden medicin sammen med Lorviqua
English: • medicines containing St. John's wort (Hypericum perforatum, a herbal preparation)
Danish: • medicin, der indeholder prikbladet perikum (Hypericum perforatum, et naturlægemiddel)
English: Information for lorlatinib use in patients with severe (CLcr: < 30 mL/min) renal impairment is very limited.
Danish: Information om anvendelse af lorlatinib hos patienter med svært (CLcr: < 30 ml/min) nedsat nyrefunktion er meget begrænset.
English: An alternative concomitant medicinal product with less potential to inhibit CYP3A4/5 should be considered.
Danish: Overvej et alternativt samtidigt lægemiddel med mindre risiko for at hæmme CYP3A4/5.
English: Caution should be exercised when driving or operating machines as patients may experience CNS effects (see section 4.8).
Danish: Der skal udvises forsigtighed, når der føres motorkøretøj eller betjenes maskiner, da patienter kan opleve virkninger i centralnervesystemet (se pkt.
English: Population pharmacokinetic analyses have shown that lorlatinib exposure was not clinically meaningfully altered in patients with mild (n = 103) or moderate (n = 41) renal impairment (CLcr > 30 mL/min).
Danish: Populationsfarmakokinetiske analyser har vist, at lorlatinibeksponeringen ikke blev ændret klinisk relevant hos patienter med let (n = 103) eller moderat (n = 41) nedsat nyrefunktion (CLcr > 30 ml/min).
English: Amylase increased Electrocardiogram PR prolongation
Danish: PR forlængelse i elektrokardiogram
English: Frequency category All Grades
Danish: Hyppighedskategori
English: Lorlatinib dosing PR interval prolongation/Atrioventricular (AV) block
Danish: Forlængelse af PR-interval/atrioventrikulær (AV-) blok
English: h Vision disorder (including diplopia, photophobia, photopsia, vision blurred, visual acuity reduced, visual impairment, vitreous floaters).
Danish: Synsforstyrrelser (herunder diplopi, fotofobi, fotopsi, sløret syn, nedsat synsskarphed, synsnedsættelse, mouches volantes).
English: In vitro studies indicated that lorlatinib may have the potential to inhibit UGT1A1.
Danish: In vitro-studier af hæmning af UGT In vitro-studier indikerede, at lorlatinib muligvis kan hæmme UGT1A1.
English: These symptoms could be signs of pancreatitis.
Danish: Disse symptomer kan være tegn på kronisk betændelse i bugspytkirtlen (pankreatitis).
English: Male fertility may be compromised during treatment with lorlatinib (see section 5.3).
Danish: Den mandlige fertilitet kan blive kompromitteret under behandling med lorlatinib (se pkt.
English: Lorlatinib dosing Hypercholesterolaemia or hypertriglyceridaemia Mild hypercholesterolaemia (cholesterol between ULN and 300 mg/dL or between ULN and 7.75 mmol/L)
Danish: Dosering af lorlatinib Hyperkolesterolæmi eller hypertriglyceridæmi Let hyperkolesterolæmi (kolesterol mellem ULN og 300 mg/dl eller mellem ULN og 7,75 mmol/l)
English: Information for lorlatinib use in patients with severe renal impairment (CLcr < 30 mL/min) is limited (n = 1).
Danish: Information om anvendelse af lorlatinib hos patienter med alvorlig nedsat nyrefunktion (CLcr < 30 ml/min) er begrænset (n = 1).
English: Lorlatinib was studied in a population of patients that excluded those with second-degree or third-degree AV block (unless paced) or any AV block with PR interval > 220 msec. PR interval prolongation and AV block have been reported in patients receiving lorlatinib (see section 5.2).
Danish: Lorlatinib blev undersøgt i en patientpopulation, der ekskluderede patienter med grad 2 eller grad 3 AV-blok (medmindre de havde pacemaker) eller AV-blok med et PR-interval på > 220 msek.
English: Lorviqua belongs to the group of medicines that inhibit an enzyme called anaplastic lymphoma kinase (ALK).
Danish: Lorviqua tilhører en gruppe lægemidler, som hæmmer et enzym ved navn anaplastisk-tyrosinkinase (ALK).
English: Re-challenge at same lorlatinib dose while maximising lipid-lowering therapyb in accordance with respective prescribing information.
Danish: Genoptag behandlingen ved samme lorlatinibdosis, mens den lipidsænkende behandling b maksimeres i henhold til den respektive doseringsanvisning.
English: Elevations of lipase and/or amylase have occurred in patients receiving lorlatinib (see section 4.8).
Danish: Der er forekommet stigninger i lipase og/eller amylase hos patienter, der fik lorlatinib (se pkt.
English: If pacemaker placed, resume lorlatinib at full dose.
Danish: Hvis en pacemaker indsættes, genoptages behandlingen med lorlatinib ved fuld dosis.
English: Do not use this medicine after the expiry date which is stated on the blister foil and carton after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Lorviqua contains sodium
Danish: Lorviqua indeholder natrium
English: NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer (as MA holder logo)
Danish: Pfizer (som logo for indehaveren af markedsføringstilladelsen)
English: If a strong CYP3A4/5 inhibitor must be co-administered, the starting lorlatinib dose of 100 mg once daily should be reduced to once daily 75 mg dose (see sections 4.5 and 5.2).
Danish: Hvis en stærk CYP3A4/5hæmmer skal administreres samtidigt, skal startdosis af 100 mg lorlatinib en gang dagligt reduceres til 75 mg en gang dagligt (se pkt.
English: The main toxicities observed were inflammation across multiple tissues (skin and cervix of rats and lung, trachea, skin, lymph nodes and/or the oral cavity including mandibular bone of dogs; associated with increases in white blood cells, fibrinogen, and/or globulin and decreases in albumin) and changes in the pancreas (with increases in amylase and lipase), hepatobiliary system (with increases in liver enzymes), male reproductive system, cardiovascular system, kidneys and gastrointestinal tract, peripheral nerves and the CNS (potential for cognitive functional impairment) at dose equivalent to human clinical exposure at the recommended posology.
Danish: De væsentligste toksiciteter, der blev observeret, var inflammation i flere væv (hud og cervix hos rotter og lunge, trakea, hud, lymfeknuder og/eller mundhulen, herunder kæbeknoglen hos hunde, forbundet med stigninger i de hvide blodlegemer, fibrinogen og/eller globulin og fald i albumin) samt ændringer i bugspytkirtlen (med stigninger i amylase og lipase), det hepatobiliære system (med stigninger i leverenzymer), det hanlige reproduktionssystem, det kardiovaskulære system, nyrer og mave-tarm-kanal, perifere nerver og centralnervesystemet (risiko for kognitiv funktionsnedsættelse) ved doser, der svarer til den humane kliniske eksponering ved den anbefalede dosering.
English: No information is available for lorlatinib in patients with moderate or severe hepatic impairment.
Danish: Der foreligger ingen information om lorlatinib hos patienter med moderat eller svært nedsat leverfunktion.
English: Concomitant administration of lorlatinib with strong CYP3A4/5 inhibitors (e.g. boceprevir, cobicistat, itraconazole, ketoconazole, posaconazole, troleandomycin, voriconazole, ritonavir, paritaprevir in combination with ritonavir and ombitasvir and/or dasabuvir, and ritonavir in combination with either elvitegravir, indinavir, lopinavir or tipranavir) may increase lorlatinib plasma concentrations.
Danish: Samtidig administration af lorlatinib med stærke CYP3A4/5-hæmmere (f.eks. boceprevir, cobicistat, itraconazol, ketoconazol, posaconazol, troleandomycin, voriconazol, ritonavir, paritaprevir i kombination med ritonavir og ombitasvir og/eller dasabuvir samt ritonavir i kombination med enten elvitegravir, indinavir, lopinavir eller tipranavir) kan øge lorlatinibs plasmakoncentration.
English: Your doctor may investigate further and may decide to reduce the dose of Lorviqua.
Danish: Din læge kan undersøge det yderligere og kan beslutte sig for at nedsætte dosen af Lorviqua.
English: If you forget to take Lorviqua
Danish: Hvis du har glemt at tage Lorviqua
English: No starting dose adjustments are recommended for patients with mild or moderate renal impairment.
Danish: Der anbefales ingen startdosisjusteringer for patienter med let eller moderat nedsat nyrefunktion.
English: inhibitors; or - you have been previously treated with crizotinib followed by another ALK inhibitor.
Danish: - hvis du tidligere er blevet behandlet med crizotinib efterfulgt af en anden ALK-hæmmer.
English: Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel.: + 386 (0)1 52 11 400
Danish: Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel.: + 386 (0)1 52 11 400
English: Second degree AV block Symptomatic
Danish: Grad 2 AV-blok Symptomatisk
English: Second degree AV block Asymptomatic
Danish: Grad 2 AV-blok Asymptomatisk
English: • alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or
Danish: • alectinib eller ceritinib, som den første ALK tyrosinkinasehæmmer (TKI) behandling, eller • crizotinib og mindst en anden ALK TKI.
English: • enzalutamide (used to treat prostate cancer)
Danish: • enzalutamid (anvendes til at behandle prostatakræft)
English: If you vomit after taking a dose of Lorviqua, do not take an extra dose, just take your next dose at the usual time.
Danish: Hvis du kaster op, efter at du har taget din dosis Lorviqua, må du ikke tage en ekstra dosis.
English: If you stop taking Lorviqua
Danish: Hvis du holder op med at tage Lorviqua
English: If subsequent ECG does not show second degree AV block, resume lorlatinib at 1 reduced dose level.
Danish: Hvis efterfølgende EKG-målinger ikke viser grad 2 AV-blok, genoptages behandlingen med lorlatinib ved 1 reduceret dosisniveau.
English: Severe or life-threatening pulmonary adverse reactions consistent with ILD/pneumonitis have occurred with lorlatinib (see section 4.8).
Danish: Der er forekommet alvorlige eller livstruende pulmonale bivirkninger svarende til ILS/pneumonitis ved anvendelse af lorlatinib (se pkt.
English: First degree AV block: Symptomatic
Danish: Grad 1 AV-blok: Symptomatisk
English: Other adverse reactions Grade 1: Mild
Danish: Andre bivirkninger Grad 1: Let
English: b Per ICR.
Danish: Ifølge ICR.
English: Therefore, lorlatinib is not recommended in patients with moderate to severe hepatic impairment (see section 5.2).
Danish: Derfor anbefales lorlatinib ikke hos patienter med moderat til alvorlig nedsat leverfunktion (se pkt.
English: If symptoms resolve, resume lorlatinib at 1 reduced dose level.
Danish: Hvis symptomerne forsvinder, genoptages behandlingen med lorlatinib ved 1 reduceret dosisniveau.
English: Dose modification may be required for those patients who develop AV block (see section 4.2).
Danish: Det kan være nødvendigt med en dosisjustering for de patienter, der udvikler AV-blok (se pkt.
English: In vitro data indicate that lorlatinib is metabolised primarily by CYP3A4 and UGT1A4, with minor contribution from CYP2C8, CYP2C19, CYP3A5 and UGT1A3.
Danish: In vitro-data indikerer, at lorlatinib primært metaboliseres af CYP3A4 og UGT1A4, med mindre bidrag fra CYP2C8, CYP2C19, CYP3A5 og UGT1A3.
English: If you vomit after taking Lorviqua
Danish: Hvis du kaster op efter at have taget Lorviqua
English: Peripheral neuropathy (including burning sensation, carpal tunnel syndrome, dysaesthesia, formication, gait disturbance, hypoaesthesia, muscular weakness, neuralgia, neuropathy peripheral, neurotoxicity,
Danish: Perifer neuropati (herunder en brændende fornemmelse, karpaltunnelsyndrom, dysæstesi, myrekryb, gangforstyrrelse, hypoæstesi, muskelsvækkelse, neuralgi, perifer neuropati, neurotoksicitet, paræstesi, perifer, sensorisk neuropati, peroneal nerveparese, sensorisk forstyrrelse).
English: b Lipid-lowering therapy may include: HMG CoA reductase inhibitor, nicotinic acid, fibric acid derivatives, or ethyl esters of omega-3 fatty acids.
Danish: Kategorierne er baseret på NCI CTCAE-klassificering Lipidsænkende behandling kan omfatte: HMG CoA-reduktasehæmmer, nikotinsyre, fibrinsyrederivater eller ethylestere af omega-3-fedtsyrer.
English: A highly effective non-hormonal method of contraception is required for female patients during treatment with lorlatinib, because lorlatinib can render hormonal contraceptives ineffective (see sections 4.5 and 4.6).
Danish: En meget effektiv, ikke-hormonel kontraceptionsmetode er påkrævet til kvindelige patienter under behandling med lorlatinib, eftersom lorlatinib kan ødelægge virkningen af hormonel prævention (se pkt.
English: m Fatigue (including asthenia, fatigue).
Danish: Træthed (herunder asteni, træthed).
English: • mitotane (used to treat cancer of the adrenal glands)
Danish: • mitotan (anvendes til at behandle kræft i binyrerne)
English: Talk to your doctor before taking Lorviqua: - if you have high levels of blood cholesterol or triglycerides - if you have high levels of the enzymes known as amylase or lipase in the blood or a condition such as pancreatitis that can raise the levels of these enzymes - if you have problems with your heart, including heart failure, slow heart rate, or if electrocardiogram (ECG) results show that you have an abnormality of the electrical activity of your heart known as prolonged PR interval or AV block.
Danish: Kontakt lægen, før du tager Lorviqua: - hvis du har et højt niveau af kolesterol eller triglycerider i blodet; - hvis du har et højt niveau af enzymer kendt som amylase eller lipase i blodet, eller en lidelse som kronisk betændelse i bugspytkirtlen (pankreatitis), der kan øge niveauet af disse enzymer; - hvis du har problemer med hjertet, herunder hjertesvigt, langsom hjertefrekvens, eller hvis et elektrokardiogram (EKG) har vist, at dit hjertes elektriske aktivitet ikke er normalt, og viser et forlænget PR-interval eller AV-blok; - hvis du har hoste, brystsmerter, stakåndethed eller en forværring af åndedrætssymptomer, eller hvis du nogensinde har haft en lungelidelse kaldet pneumonitis.
English: Itraconazole, a strong inhibitor of CYP3A4/5, administered at oral doses of 200 mg once daily for 5 days, increased the mean lorlatinib AUC by 42% and Cmax by 24% of a single 100 mg oral dose of lorlatinib in healthy volunteers.
Danish: Itraconazol, en stærk CYP3A4/5- hæmmer, administreret ved orale doser på 200 mg en gang dagligt i 5 dage, øgede middel-AUC for lorlatinib med 42 % og Cmax med 24 % for en enkelt 100 mg oral dosis lorlatinib hos raske frivillige.
English: Lorviqua contains lactose
Danish: Lorviqua indeholder lactose
English: - Contraception - information for men You should not father children during treatment with Lorviqua because this medicine could harm the baby.
Danish: Du må ikke gøre en kvinde gravid under behandling med Lorviqua, da denne medicin kan skade barnet.
English: Always take this medicine exactly as your doctor, pharmacist or nurse has told you.
Danish: Tag altid lægemidlet nøjagtigt efter lægens, apotekspersonalets eller sygeplejerskens anvisning.
English: If a strong CYP3A4/5 inhibitor must be concomitantly administered, a dose reduction of lorlatinib is recommended (see section 4.2).
Danish: Hvis en stærk CYP3A4/5-hæmmer skal administreres samtidigt, anbefales en dosisreduktion af lorlatinib (se pkt.
English: Lorlatinib dosing
Danish: Dosering af lorlatinib
English: CYP3A4/5 inducers
Danish: CYP3A4/5-inducere
English: In vitro data indicate that lorlatinib is primarily metabolised by CYP3A4 and uridine diphosphate-glucuronosyltransferase (UGT)1A4, with minor contributions from CYP2C8, CYP2C19, CYP3A5 and UGT1A3.
Danish: In vitro-data indikerer, at lorlatinib primært metaboliseres af CYP3A4 og uridindiphosphat-glucuronosyltransferase (UGT)1A4, med mindre bidrag fra CYP2C8, CYP2C19, CYP3A5 og UGT1A3.
English: Resume lorlatinib at 1 reduced dose level.
Danish: Fortsæt lorlatinib ved 1 reduceret dosisniveau.
English: Lorlatinib may reduce the effectiveness of hormonal contraceptive methods (for example, birth control pill); therefore, hormonal contraceptives may not be considered highly effective.
Danish: Lorlatinib kan nedsætte virkningen af hormonel prævention (f.eks. p-piller).
English: Life-threatening hypercholesterolaemia (cholesterol over 500 mg/dL or over 12.92 mmol/L)
Danish: Livstruende hyperkolesterolæmi (kolesterol over 500 mg/dl eller over 12,92 mmol/l)
English: System organ class and adverse reaction
Danish: Bivirkninger Systemorganklasse og bivirkninger
English: Lorlatinib demonstrated activity in mice bearing orthotopic EML4-ALK or EML4-ALKL1196M brain tumour implants.
Danish: Lorlatinib viste aktivitet hos mus, der bar ortotopisk EML4-ALK eller EML4ALK
English: Lorviqua may affect male fertility.
Danish: Lorviqua kan muligvis påvirke mænds frugtbarhed.
English: If the results are abnormal, your doctor may decide to reduce the dose of Lorviqua or stop your treatment.
Danish: Hvis resultaterne er unormale kan din læge beslutte sig for at nedsætte dosen af Lorviqua eller standse behandlingen.
English: Concomitant use with moderate CYP3A4/5 inducers should be avoided, if possible, as they may also reduce lorlatinib plasma concentrations (see section 4.5).
Danish: Samtidig anvendelse med moderate CYP3A4/5inducere skal om muligt undgås, da disse også kan reducere lorlatinibs plasmakoncentrationer (se pkt.
English: No information is available for patients with moderate or severe hepatic impairment.
Danish: Der foreligger ingen information for patienter med moderat eller svært nedsat leverfunktion.
English: dementia, disturbance in attention, memory impairment, mental impairment; and also including events from SOC Psychiatric disorders: attention deficit/hyperactivity disorder, confusional state, delirium, disorientation, reading disorder).
Danish: Kognitive virkninger (herunder hændelser fra systemorganklassen Nervesystemet: amnesi, kognitiv forstyrrelse, demens, opmærksomhedsforstyrrelse, nedsat hukommelsesfunktion, psykisk svækkelse, og også inklusive hændelser fra systemorganklassen Psykiske forstyrrelser: mangel på opmærksomhed/hyperaktivitet, konfusionstilstand, delirium, desorientering, læsebesvær).
English: Moderate hypercholesterolaemia (cholesterol between 301 and 400 mg/dL or between 7.76 and 10.34 mmol/L)
Danish: Moderat hyperkolesterolæmi (kolesterol mellem 301 og 400 mg/dl eller mellem 7,76 og 10,34 mmol/l)
English: Each film-coated tablet contains 25 mg of lorlatinib.
Danish: Hver filmovertrukket tablet indeholder 25 mg lorlatinib.
English: Metabolism and nutrition disorders Hypercholesterolaemiaa Hypertriglyceridaemiab
Danish: Metabolisme og ernæring Hyperkolesterolæmi Hypertriglyceridæmi
English: Lorviqua inhibits a type of enzyme called tyrosine kinase and triggers the death of cancer cells in patients with alterations in genes for ALK. Lorviqua is only given to patients whose disease is due to an alteration in the gene for ALK tyrosine kinase.
Danish: Lorviqua hæmmer et enzym kaldet tyrosinkinase og medfører, at kræftcellerne dør hos patienter med ændringer i ALK-genet.
English: Foetal morphologic abnormalities included rotated limbs, supernumerary digits, gastroschisis, malformed kidneys, domed head, high arched palate, and dilation of ventricles of the brain.
Danish: Føtale, morfologiske anormaliteter omfattede roterede lemmer, overtallige fingre/tæer, gastroschisis, deforme nyrer, hvælvede hoveder, en høj, buet gane og udvidelse af hjerneventriklerneS.
English: Lorviqua 100 mg is supplied as oval dark pink film-coated tablets, debossed with “Pfizer” on one side and “LLN 100” on the other side.
Danish: Lorviqua 100 mg leveres som ovale, mørkt lyserøde filmovertrukne tabletter med ”Pfizer” præget på den ene side og ”LLN 100” på den anden side.
English: An alternative concomitant medicinal product with less potential to inhibit CYP3A4/5 should be considered (see section 4.5).
Danish: Overvej et alternativt samtidigt lægemiddel med mindre risiko for at hæmme CYP3A4/5 (se pkt.
English: Therefore, lorlatinib is not recommended in patients with severe renal impairment (see section 5.2).
Danish: Derfor anbefales lorlatinib ikke hos patienter med svært nedsat nyrefunktion (se pkt.
English: Rifampin, a strong inducer of CYP3A4/5, administered at oral doses of 600 mg once daily for 12 days, reduced the mean lorlatinib area under curve (AUC) by 85% and Cmax by 76% of a single 100 mg oral dose of lorlatinib in healthy volunteers; increases in AST and ALT were also observed.
Danish: Rifampin, en stærk CYP3A4/5-inducer, administreret ved orale doser på 600 mg en gang dagligt i 12 dage, reducerede middelværdien for arealet under kurven (AUC) for lorlatinib med 85 % og Cmax med 76 % i en enkelt 100 mg oral dosis lorlatinib hos raske frivillige.
English: NR (4.1, NR)
Danish: IN (4,1; IN)
English: Severe hypercholesterolaemia (cholesterol between 401 and 500 mg/dL or between 10.35 and 12.92 mmol/L)
Danish: Alvorlig hyperkolesterolæmi (kolesterol mellem 401 og 500 mg/dl eller mellem 10,35 og 12,92 mmol/l)
English: Permanently discontinue lorlatinib.
Danish: Seponér lorlatinib permanent.
English: What you need to know before you take Lorviqua
Danish: Det skal du vide, før du begynder at tage Lorviqua
English: 120 film-coated tablets
Danish: 90 filmovertrukne tabletter 120 filmovertrukne tabletter
English: Dose modification or discontinuation may be required for those patients who develop CNS effects (see section 4.2).
Danish: Det kan være nødvendigt med en dosisjustering eller seponering for de patienter, der udvikler virkninger i centralnervesystemet (se pkt.
English: Skin and subcutaneous tissue disorders Rashj
Danish: Hud og subkutane væv Udslæt
English: Lorviqua 25 mg: each film-coated tablet (tablet) contains 25 mg lorlatinib.
Danish: Lorviqua 25 mg: hver filmovertrukket tablet (tablet) indeholder 25 mg lorlatinib.
English: Iron oxide black (E172)
Danish: Titandioxid (E171) Jernoxid, sort (E172) Jernoxid, rød (E172)
English: Respiratory, thoracic and mediastinal disorders
Danish: Luftveje, thorax og mediastinum Pneumonitis
English: Life-threatening hypertriglyceridaemia (triglycerides over 1,000 mg/dL or over 11.4 mmol/L)
Danish: Livstruende hypertriglyceridæmi (triglycerider over 1.000 mg/dl eller over 11,4 mmol/l)