FrancophonIA/ELRC3.0 huggingface dataset:
English: The clinical relevance of these preclinical data is unknown, however, the potential cardiac effects of this product in humans cannot be ruled out (see also sections 4.4 and 4.8).
Danish: Den kliniske relevans af disse prekliniske data er ukendt, men det kan ikke udelukkes at dette lægemiddel har potentielle kardiale virkninger (se pkt.
English: The 230/57.5 mg/m2 twice daily regimen without nevirapine and the 300/75 mg/m2 twice daily regimen with nevirapine provided lopinavir plasma concentrations similar to those obtained in adult patients receiving the 400/100 mg twice daily regimen without nevirapine.
Danish: Behandling med 230/57,5 mg/m2 to gange dagligt uden nevirapin og 300/75 mg/m2 to gange dagligt med nevirapin gav lopinavir plasmakoncentrationer, der var sammenlignelige med de plasmakoncentrationer, der blev påvist i voksne efter indtagelse af 400/100 mg to gange dagligt uden nevirapin.
English: Increased plasma concentrations of colchicine.
Danish: Forhøjede plasmakoncentrationer af colchicin.
English: The median EC50 of lopinavir against isolates with 0 − 3, 4 − 5, 6 − 7 and 8 − 10 mutations at the above amino acid positions was 0.8, 2.7 13.5 and 44.0-fold higher than the EC50 against wild type HIV, respectively.
Danish: Middeltallet for EC50 for lopinavir mod isolater med 0- 3, 4-5, 6-7 og 8-10 mutationer i de aminosyre codons, der er beskrevet ovenfor, var henholdsvis 0,8, 2,7, 13,5 og 44,0 gange højere end EC50 mod vildtype hiv.
English: Kaletra must not be administered once daily in combination with phenytoin.
Danish: Kaletra må ikke indgives en gang dagligt i kombination med phenytoin.
English: AUC: ↑ 49-fold
Danish: AUC: ↑49-gange
English: Concomitant Therapy: Efavirenz or nevirapine The following table contains dosing guidelines for Kaletra tablets based on BSA when used in combination with efavirenz or nevirapine in children.
Danish: Følgende tabel indeholder doseringsvejledning for Kaletra tabletter baseret på BSA, når det anvendes til børn i kombination med efavirenz eller nevirapin
English: 300 ml (5 bottles x 60 ml) oral solution with five 5 ml oral dosing syringes.
Danish: Multipakning: 300 ml (5 flasker x 60 ml i hver) oral opløsning med fem 5 ml orale doseringssprøjter.
English: (25/150/100 mg QD + 400 mg BID)
Danish: (25/150/100 mg en gang dagligt + 400 mg 2 gange dagligt)
English: ≥ 0.8 to < 1.2
Danish: ≥ 0,8 til < 1,2
English: See adult dosage recommendation *weight based dosing recommendations are based on limited data ** the volume (ml) of oral solution represents the average dose for the weight range
Danish: Se dosisvejledningen for voksne * dosisanbefalinger baseret på vægt er baseret på begrænset dokumentation.
English: Fosamprenavir (1400 mg BID)
Danish: Fosamprenavir (1400 mg to gange dagligt)
English: Anti-gout agents: Colchicine single dose
Danish: Midler mod arthritis urica: Colchicin enkelt dosis
English: M98-957 is a randomised, open-label study evaluating Kaletra treatment at two dose levels (400/100 mg and 533/133 mg, both twice daily) plus efavirenz (600 mg once daily) and nucleoside reverse transcriptase inhibitors in 57 multiple protease inhibitor experienced, non-nucleoside reverse transcriptase inhibitor naïve patients.
Danish: M98-957 er et randomiseret åbent studie af Kaletra i to dosisniveauer (400/100 mg og 533/133 mg, begge to gange dagligt) og efavirenz (600 mg en gang dagligt) og nukleosid revers transkriptasehæmmere i 57 patienter, der tidligere er blevet behandlet med flere proteasehæmmere, men ikke med non-nukleosid revers transkriptasehæmmere.
English: Uncommon Hepatic steatosis, hepatomegaly, cholangitis, hyperbilirubinemia
Danish: Ikke almindelig Leversteatosis, hepatomegali, kolangit, hyperbilirubinæmi
English: Push the plunger all of the way into the barrel.
Danish: Tryk stemplet hele vejen ind i sprøjtecylinderen.
English: Colloidal anhydrous silica, copovidone, sodium stearyl fumarate, sorbitan laurate.
Danish: Kolloid vandfri silica, copovidon, natriumstearylfumarat og sorbitanlaurat.
English: Increased plasma concentrations of pimozide.
Danish: Forhøjede plasmakoncentrationer af pimozid.
English: Sorbitan laurate Colloidal anhydrous silica Sodium stearyl fumarate
Danish: Sorbitanlaurat Silica, kolloid vandfri Natriumstearylfumarat
English: The pharmacokinetics of Kaletra oral solution 300/75 mg/m2 twice daily and 230/57.5 mg/m2 twice daily have been studied in a total of 53 paediatric patients, ranging in age from 6 months to 12 years.
Danish: Farmakokinetiske parametre af Kaletra 300/75 mg/m2 to gange dagligt og 230/57,5 mg/m2 to gange dagligt er blevet undersøgt på i alt 53 pædiatriske patienter i alderen fra 6 måneder til 12 år.
English: The pharmacokinetic data from HIV-1 infected pregnant women receiving lopinavir/ritonavir tablets 400/100 mg twice daily are presented in Table 6 (see section 4.2).
Danish: I tabel 6 ses farmakokinetiske data fra hiv-1 inficerede gravide kvinder, som fik lopinavir/ritonavir tabletter 400/100 mg to gange dagligt (se pkt.
English: • enlargement of the lymph nodes;
Danish: • forstørrede lymfeknuder;
English: The concomitant administration with lurasidone is contraindicated (see section 4.3).
Danish: Samtidig administration med lurasidon er kontraindiceret (se pkt.
English: Table 6
Danish: Tabel 6
English: Concomitant medicinal product levels increased Alpha1-adrenoreceptor antagonist
Danish: Lægemidler, hvor samtidig administration giver øgede koncentrationer Adrenerg alfa1antagonist
English: Dihydroergotamine, ergonovine, ergotamine, methylergonovine
Danish: Dihydroergotamin, ergonovin, ergotamin, methylergonovin
English: Rilpivirine (Lopinavir/ritonavir capsule 400/100 mg BID)
Danish: Rilpivirin (Lopinavir/ritonavir kapsel 400/100 mg to
English: 120 ml (2 bottles x 60 ml) oral solution with two 2 ml oral dosing syringes.
Danish: Multipakning:120 ml (2 flasker x 60 ml i hver) oral opløsning med to 2 ml orale doseringssprøjter.
English: Using the 2 ml oral dosing syringe for doses up to 2 ml
Danish: Brug doseringssprøjten på 2 ml til doser op til 2 ml
English: The concomitant administration of Kaletra and ranolazine is contraindicated (see section 4.3).
Danish: Samtidig administration af Kaletra og ranolazin er kontraindiceret (se pkt.
English: In the absence of human serum, the mean IC50 of lopinavir was 6.5 nM against several HIV-1 clinical isolates.
Danish: Den gennemsnitlige IC50 for lopinavir mod flere kliniske hiv-1-isolater var 6.5 nM i fravær af humant serum.
English: Uncommon Atherosclerosis such as myocardial infarction, atrioventricular block, tricuspid valve incompetence
Danish: Ikke almindelig Aterosklerose såsom myokardieinfarkt, atrioventrikulært blok, trikuspidalklapinsufficiens
English: Acid reducing agents Omeprazole (40 mg QD) Omeprazole: ↔
Danish: Syrepumpehæmmere Omeprazol (40 mg en Omeprazol: ↔
English: Herbal products St John's wort (Hypericum perforatum)
Danish: Naturlægemidler Perikon (Hypericum perforatum)
English: No dose adjustment is needed for Kaletra.
Danish: Justering af Kaletra-dosis er ikke nødvendig.
English: • ombitasvir/paritaprevir/ritonavir with or without dasabuvir (used to treat chronic hepatitis C
Danish: • ombitasvir/paritaprevir/ritonavir med eller uden dasabuvir bruges til at behandle kronisk hepatitis C-virus [HCV]);
English: Copovidone, sorbitan laurate, colloidal anhydrous silica, sodium stearyl fumarate.
Danish: Copovidon, sorbitanlaurat, kolloid vandfri silica, copovidon, natriumstearylfumarat.
English: ≥ 0.9 to < 1.4
Danish: ≥ 0,9 til < 1,4
English: Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du eller dit barn tager anden medicin eller har gjort det for nylig.
English: Thereby, increasing the risk of serious haematologic abnormalities, or other serious adverse effects from this agent (see section 4.5).
Danish: Derved øges risikoen for alvorlige hæmatologiske afvigelser eller andre alvorlige bivirkninger af dette lægemiddel (se pkt.
English: Includes: alcohol (42 % v/v see leaflet), high fructose corn syrup, propylene glycol, glycerol, polyoxyl 40 hydrogenated castor oil, potassium (as acesulfame potassium).
Danish: Indeholder: alkohol (42 % v/v, se indlægsseddel), majssirup (højt fruktoseindhold), propylenglykol, glycerol, polyoxyleret 40 hydrogeneret ricinusolie, kalium (som kaliumacesulfam).
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE CARTON Inner carton of multipack of 120 (3 packs of 40) 200 mg/50 mg film-coated tablets) - without blue box
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Indre emballage af multipakning a 120 (3 æsker a 40 200/50 mg filmovertrukne tabletter) - uden blue box
English: Paediatric dosing guidelines without concomitant efavirenz or nevirapine*
Danish: Pædiatrisk Doseringsvejledning uden samtidig efavirenz eller nevirapin
English: HIV RNA < 50 copies/ml*†
Danish: hiv-RNA < 50 kopier/ml*†
English: AUC: ↑ 3-fold Cmax: ↑ 1.8-fold
Danish: AUC: ↑ 3-gange Cmax: ↑ 1,8-gange
English: Sustained virological response to Kaletra (in combination with nucleoside/nucleotide reverse transcriptase inhibitors) has been also observed in a small Phase II study (M97-720) through 360 weeks of treatment.
Danish: Et længerevarende virologisk respons er ligeledes observeret i et mindre fase II studie (M97-720) efter 360 ugers behandling med Kaletra (i kombination med nukleosid/nukleotid revers transkriptasehæmmere).
English: Paediatric dosing guidelines with concomitant efavirenz or nevirapine
Danish: Pædiatrisk doseringsvejledning med samtidig efavirenz eller nevirapin
English: Cmax: ↑ 4.7-fold Due to CYP3A inhibition by lopinavir/ritonavir.
Danish: Cmax: ↑ 4,7-gange På grund af lopinavir/ritonavirs hæmning af CYP3A.
English: (Ritonavir 200 mg twice daily)
Danish: (Ritonavir 200 mg to gange dagligt)
English: In the absence and presence of 50% human serum, the mean IC50 of lopinavir against HIV-1IIIB in MT4 cells was 17 nM and 102 nM, respectively.
Danish: Den gennemsnitlige IC50 for lopinavir mod hiv-1IIIB i MT4 celler var 17 nM og 102 nM ved henholdsvis fravær eller tilstedeværelse af 50 % humant serum.
English: * intent to treat analysis where patients with missing values are considered virologic failures Paediatric Use
Danish: *”Intent-to-treat” analyse hvor patienter med manglende værdier anses for at have virologisk svigt
English: Tenofovir disoproxil fumarate (DF), 300 mg QD
Danish: Tenofovirdisoproxilfumar at (DF), 300 mg en gang dagligt
English: Pregnancy and postpartum
Danish: Graviditet og efter fødsel
English: Co-administration of abemaciclib and Kaletra should be avoided.
Danish: Samtidig administration af abemaciclib og Kaletra bør undgås.
English: − If you have any further questions, ask your doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet.
English: The median EC50 of lopinavir against isolates with 0 − 3, 4 − 5, 6 − 7 and 8 − 10 mutations at the above amino acid positions was 0.8, 2.7 13.5 and 44.0-fold higher than the EC50 against wild type
Danish: Middeltallet for EC50 for lopinavir mod isolater med 0-3, 4-5, 6-7 og 8-10 mutationer i de aminosyre codons, der er beskrevet ovenfor, var henholdsvis 0,8, 2,7, 13,5 og 44,0 gange højere end EC50 mod vildtype hiv.
English: • anti-gout medicines (e.g. colchicine).
Danish: • lægemidler mod urinsyregigt (f.eks. colchicin).
English: A series of blood samples were collected pre-dose and at intervals over the course of 12 hours in trimester 2 and trimester 3, at birth, and 4-6 weeks postpartum (in women who continued treatment post-delivery) for pharmacokinetic analysis of total and unbound levels of plasma lopinavir concentrations.
Danish: Til farmakokinetisk analyse af total og ubundet lopinavir plasmakoncentration, blev en række blodprøver indsamlet før dosering og med intervaller i løbet af 12 timer i 2. og 3. trimester, ved fødslen, og 4-6 uger efter fødslen (hos kvinder som fortsatte behandlingen efter fødslen).
English: Amiodarone, Dronedarone Amiodarone, Dronedarone: Concentrations may be increased due to CYP3A4 inhibition by lopinavir/ritonavir.
Danish: Amiodaron, dronedaron Amiodaron, dronedaron: Koncentrationerne kan være forøget, da lopinavir/ritonavir hæmmer CYP3A4.
English: If treatment with a HMG-CoA reductase inhibitor is indicated, pravastatin or fluvastatin is recommended (see section 4.5).
Danish: Hvis behandling med en HMG-CoA reduktasehæmmer er indikeret, anbefales pravastatin eller fluvastatin (se pkt.
English: Because Kaletra oral solution contains alcohol, it is not recommended for use with polyurethane feeding tubes due to potential incompatibility.
Danish: Brug af polyurethan ernæringssonder anbefales ikke på grund af mulig uforlignelighed, da Kaletra oral opløsning indeholder alkohol.
English: Lopinavir/ritonavir was administered twice daily at 16/4 mg/kg for subjects 2 months to < 6 months, 12/3 mg/kg for subjects ≥ 6 months and < 15 kg, 10/2.5 mg/kg for subjects ≥ 6 months and ≥ 15 kg to < 40 kg, or 400/100 mg for subjects ≥ 40 kg.
Danish: Lopinavir/ritonavir blev administreret 2 gange dagligt med 16/4 mg/kg til forsøgspersoner på 2 måneder til < 6 måneder, 12/3 mg/kg til forsøgspersoner på ≥ 6
English: Concomitant administration of Kaletra with colchicine in patients with renal and/or hepatic impairment is contraindicated due to a potential increase of colchicine-related serious and/or life-threatening reactions such as neuromuscular toxicity (including rhabdomyolysis) (see sections 4.3 and 4.4).
Danish: Samtidig administration af Kaletra og colchicin er kontraindiceret til patienter med nedsat nyre-og/eller leverfunktion på grund af risikoen for øgede colchicin-relaterede alvorlige og livstruende reaktioner som neuromuskulær toksicitet (inklusive rabdomyolyse) (se pkt.4.3 og 4.4).
English: Kaletra must not be co-administered with oral midazolam (see section 4.3), whereas caution should be used with co-administration of Kaletra and parenteral midazolam.
Danish: 4.3), mens der bør udvises forsigtighed ved samtidig administration af Kaletra og parenteral midazolam.
English: Concomitant administration of elbasvir/grazoprevir with Kaletra is contraindicated (see section
Danish: Samtidig administration af elbasvir/grazoprevir med Kaletra er kontraindiceret (se pkt.
English: • lower respiratory tract infection;
Danish: • infektioner i nedre luftveje;
English: Co-administration of encorafenib with Kaletra may increase encorafenib exposure which may increase the risk of toxicity, including the risk of serious adverse events such as QT interval prolongation.
Danish: Samtidig administration af encorafenib og Kaletra kan øge encorafenib-eksponeringen, hvilket kan øge risikoen for toksicitet inklusive risikoen for alvorlige bivirkninger såsom forlænget QTinterval.
English: Tipranavir/ritonavir (500/100 mg BID)
Danish: Tipranavir/ritonavir (500/100 mg to gange dagligt)
English: It is important that Kaletra tablets are swallowed whole and not chewed, broken or crushed.
Danish: Det er vigtigt, at Kaletra-tabletter synkes hele og ikke tygges, deles eller knuses.
English: Body Surface Area* (m2) Twice daily oral solution dose (dose in mg)
Danish: Dosis 2 gange dagligt oral opløsning (dosis i mg)
English: Each tablet of Kaletra contains 100 mg of lopinavir and 25 mg of ritonavir
Danish: Hver Kaletra-tablet indeholder 100 mg lopinavir og 25 mg ritonavir
English: Concomitant administration with colchicine is contraindicated in patients with renal and/or hepatic impairment (see sections 4.3 and 4.5).
Danish: Samtidg administration af colchicin er kontraindiceret til patienter med nedsat nyre- og/eller leverfunktion (se pkt.
English: Package leaflet: Information for the user Kaletra 100 mg/25 mg film-coated tablets lopinavir/ritonavir
Danish: Indlægsseddel: Information til brugeren Kaletra 100 mg/25 mg filmovertrukne tabletter lopinavir/ritonavir
English: Co-administration of Kaletra with tadalafil is not recommended.
Danish: Samtidig administration af Kaletra og tadalafil anbefales ikke.
English: Concomitant administration of Kaletra and pimozide is contraindicated as it may increase the risk of serious haematologic abnormalities or other serious adverse effects from this agent (see section 4.3)
Danish: Samtidig administration af Kaletra og pimozid er kontraindiceret, idet risikoen for alvorlige hæmatologiske afvigelser eller andre bivirkninger fra dette lægemiddel øges (se pkt 4.3)
English: Kaletra 200 mg film-coated tablets and Kaletra 100 mg/25 mg film-coated tablets: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
Danish: Kaletra 200 mg/50 mg filmovertrukne tabletter og Kaletra 100 mg/25 mg filmovertrukne tabletter: AbbVie Deutschland GmbH & Co.
English: Caution should be exercised in administering phenytoin with Kaletra.
Danish: Der bør udvises forsigtighed ved samtidig administration af phenytoin med Kaletra.
English: More frequent electrocardiogram monitoring and monitoring of transaminases is recommended (see section 4.4 and refer to the bedaquiline SmPC).
Danish: Hyppigere monitorering af elektrokardiogram og monitoring af aminotransferaser anbefales (se pkt.
English: Package leaflet: Information for the user Kaletra 200 mg/50 mg film-coated tablets lopinavir/ritonavir
Danish: Indlægsseddel: Information til brugeren Kaletra 200 mg/50 mg filmovertrukne tabletter lopinavir/ritonavir
English: Due to BCRP (breast cancer resistance protein/ABCG2) and acute P-gp inhibition by lopinavir/ritonavir.
Danish: På grund lopinavir/ritonavirs hæmning af BCRP (Brystcancerresistensprotein/ABCG2) og P-gp
English: Kaletra is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children aged from 14 days and older.
Danish: Kaletra er indiceret til behandling af humant immundefektvirus (hiv-1)-smittede voksne, unge og børn i alderen fra 14 dage og ældre i kombination med andre antiretrovirale stoffer.
English: • If the ‘ml' mark on the black ‘O' ring is more than the prescribed dose, push the plunger to the prescribed dose.
Danish: • Hvis ”ml” markeringen på den sorte ”O” ring er højere end den ordinerede dosis, tryk stemplet ind til den ordinerede dosis.
English: Increased plasma concentrations of lomitapide (see section 4.5).
Danish: Forhøjede plasmakoncentrationer af lomitapid (se pkt.
English: Kaletra must not be administered once daily in combination with amprenavir.
Danish: Kaletra må ikke indgives en gang dagligt i kombination med amprenavir.
English: Each 1 ml of Kaletra oral solution contains 80 mg of lopinavir co-formulated with 20 mg of ritonavir as a pharmacokinetic enhancer.
Danish: Hver 1 ml Kaletra oral opløsning indeholder 80 mg lopinavir formuleret sammen med 20 mg ritonavir, der virker som en farmakokinetisk forstærker.
English: AUC: ↑ 2-fold Cmax: ↑ 5-fold
Danish: AUC: ↑ 2-gange Cmax: ↑ 5-gange
English: Cmax: ↑ 5-fold
Danish: Cmax: ↑ 5-gange
English: What you need to know before you or your child takes Kaletra Do not take Kaletra if:
Danish: Det skal du vide, før du eller dit barn begynder at tage Kaletra Tag ikke Kaletra
English: HIV RNA < 400 copies/ml Mean increase from baseline in CD4+ T-cell count (cells/mm3)
Danish: hiv-RNA < 400 kopier/ml Gennemsnitlig stigning i CD4+ T-celletælling(celler/mm3) fra baseline
English: • If you have any further questions, ask your doctor or pharmacist.
Danish: • Er du i tvivl om, hvordan du skal tage medicinen, så spørg lægen eller apotekspersonalet.
English: Kaletra contains potassium as acesulfame potassium, which may be harmful to people on a low potassium diet. High potassium in the blood can cause stomach upset and diarrhoea.
Danish: Kaletra indeholder kalium som kaliumacesulfam, hvilket kan være skadeligt for personer på en diæt med lavt kalium indhold.
English: • vomiting, enlarged abdomen, pain in the lower and upper stomach area, passing wind, indigestion, decreased appetite, reflux from your stomach to your oesophagus which may cause pain;
Danish: • opkastning, forstørret mave, smerter i den nederste og øverste del af maven, luft i tarmen, fordøjelsesbesvær, nedsat appetit, tilbageløb af maveindholdet til spiserøret, hvilket kan give smerter; Fortæl din læge, hvis du oplever kvalme, opkastning eller mavesmerter, da dette kan være tegn på pankreatitis (betændelse i bugspytkirtlen).
English: Concentrations may be decreased due to CYP3A induction by dexamethasone.
Danish: Koncentrationerne kan være nedsat på grund af CYP3Ainduktion af dexamethason.
English: Along with nucleoside reverse transcriptase inhibitors (NRTIs), in some studies, Kaletra was used in combination with efavirenz or nevirapine.
Danish: I nogle studier blev Kaletra anvendt i kombination med efavirenz og nevirapin sammen med nukleosid revers transkriptase hæmmere (NRTIs).
English: Uncommon Creatinine clearance decreased, nephritis, haematuria
Danish: Ikke almindelig Nedsat kreatinin-clearance, nefrit, hæmaturi
English: AUC: ↑ 2-fold
Danish: AUC: ↑ 2-gange
English: Kaletra oral solution comes in a multiple-dose 60 ml amber bottle.
Danish: Kaletra oral opløsning leveres i en gulbrun fler-dosis 60 ml flaske.
English: Each tablet of Kaletra contains 200 mg of lopinavir and 50 mg of ritonavir
Danish: • Hver Kaletra-tablet indeholder 200 mg lopinavir og 50 mg ritonavir
English: Concomitant administration of Kaletra with fusidic acid is contraindicated in dermatological indications due to the increased risk of adverse events related to fusidic acid, notably rhabdomyolysis (see section 4.3).
Danish: Samtidig administration af Kaletra og fusidinsyre er kontraindiceret ved dermatologiske infektioner på grund af den forøgede risiko for bivirkninger, især rhabdomyolyse (se pkt.
English: Vasodilating agents Bosentan
Danish: Vasodilaterende midler: Bosentan
English: Concomitant administration of Kaletra and ergot alkaloids are contraindicated as it may lead to acute ergot toxicity, including vasospasm and ischaemia (see section 4.3).
Danish: Samtidig administration af Kaletra og sekalealkaloider er kontraindiceret, da det kan føre til akut sekalealkaloider-toksicitet inklusive vasospasmer og iskæmi (se pkt.
English: Analysis of resistance in ARV-naïve patientsIn clinical studies with a limited number of isolates analysed, the selection of resistance to lopinavir has not been observed in naïve patients without significant protease inhibitor resistance at baseline.
Danish: I kliniske studier, hvor der kun er analyseret et begrænset antal isolater, er resistens overfor lopinavir kun observeret hos naïve patienter, som havde væsentlig proteasehæmmerresistens ved baseline.
English: If the benefit is considered to outweigh the risk and Kaletra must be used, reduce the ibrutinib dose to 140 mg and monitor patient closely for toxicity.
Danish: Reducer ibrutinib-dosis til 140 mg, og monitorer patienten tæt for toksicitet, hvis Kaletra skal anvendes, og fordelene vurderes at opveje risikoen.
English: Before prescribing Kaletra 100/25 mg tablets, infants and young children should be assessed for the ability to swallow intact tablets.
Danish: Spædbørn og små børns evne til at synke hele tabletter skal vurderes, inden ordination af Kaletra 100/25 mg tabletter.
English: Apalutamide
Danish: Apalutamid
English: Kaletra is also supplied as 200 mg/50 mg film-coated tablets.
Danish: Kaletra fås også som 200 mg/50 mg filmovertrukne tabletter.
English: Kaletra (80 mg + 20 mg) / ml oral solution
Danish: Kaletra (80 mg + 20 mg) / ml oral opløsning
English: Kaletra 200 mg/50 mg tablets
Danish: Kaletra 200 mg/50 mg tabletter
English: Concomitant use of neratinib with Kaletra is contraindicated due to serious and/or life-threatening potential reactions including hepatotoxicity (see section 4.3).
Danish: Samtidig brug af neratinib med Kaletra er kontraindiceret på grund af risiko for alvorlige og livstruende reaktioner inklusive levertoksisitet (se pkt.
English: Kaletra 100 mg/25 mg film-coated tablets lopinavir/ritonavir
Danish: Kaletra 100 mg/25 mg filmovertrukne tabletter lopinavir/ritonavir
English: • erectile dysfunction medicines (e.g. sildenafil and tadalafil);
Danish: • lægemidler til behandling af rejsningsproblemer (f.eks. sildenafil og tadalafil);