FrancophonIA/ELRC3.0 huggingface dataset:
English: > 50 and ≤ 200 cells/mm
Danish: > 50 og ≤ 200 celler/mm > 200 celler/mm
English: At the highest dose levels, 400 mg/kg/day in females and 250 mg/kg/day in males, systemic exposure was similar to that at the clinical dose of 1,200 mg once daily.
Danish: Ved det højeste dosisniveau, 400 mg/kg/dag i hunmus og 250 mg/kg/dag i hanmus, var den systemiske eksponering sammenlignelig med eksponeringen ved kliniske doser på 1.200 mg en gang dagligt.
English: Table 3 Pharmacokinetic Interaction Data
Danish: Tabel 3 Farmakokinetiske interaktionsdata
English: Excipient with known effect Each tablet contains 26.06 mg lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 26,06 mg lactose (som monohydrat).
English: Raltegravir 400 mg twice daily + OBT (N = 462)
Danish: Raltegravir 400 mg to gange dagligt + OBT (N = 462)
English: The impact of medicinal products that are strong inducers of UGT1A1 such as rifampicin on raltegravir 1,200 mg once daily is unknown, but co-administration is likely to decrease raltegravir trough levels based on the reduction in trough concentrations observed with raltegravir 400 mg twice daily; therefore, co-administration with raltegravir 1,200 mg once daily is not recommended.
Danish: Indvirkningen af lægemidler, som er stærke inducere af UGT1A1 såsom rifampicin, på raltegravir 1.200 mg en gang dagligt er ukendt, men samtidig administration vil sandsynligvis nedsætte raltegravirs dalkoncentration på basis af reduktionen i dalkoncentration, der blev observeret med raltegravir 400 mg to gange dagligt.
English: In adults and paediatric patients (weighing at least 40 kg), the recommended dosage is 1,200 mg (two 600 mg tablets) once daily for treatment-naïve patients or patients who are virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily.
Danish: Hos voksne og pædiatriske patienter (som vejer mindst 40 kg) er den anbefalede dosering 1.200 mg (to 600 mg tabletter) en gang dagligt til behandlingsnaive patienter eller til patienter, som var virologisk supprimerede på et initialt regime med ISENTRESS 400 mg to gange dagligt.
English: Additional considerations
Danish: Yderligere forhold, som skal tages i betragtning
English: Cohort 1 (N=16, 10 exposed and 6 unexposed to raltegravir in utero) received 2 single doses of raltegravir GFS (within 48 hours and 7 - 10 days after birth); Cohort 2 (N=26, all raltegravir unexposed in utero) received raltegravir GFS for 6 weeks: 1.5 mg/kg once daily starting within 48 hours of birth through Week 1; 3 mg/kg twice daily Weeks 2 to 4; and 6 mg/kg twice daily Weeks 5 and 6.
Danish: Nyfødte i kohorte 2 (N=26, ingen var blevet eksponeret for raltegravir in utero) fik raltegravir GFS i 6 uger: 1,5 mg/kg en gang dagligt startende inden for 48 timer efter fødslen til og med uge 1; 3 mg/kg to gange dagligt i uge 2 til 4; og 6 mg/kg to gange dagligt i uge 5 og 6.
English: emtricitabine and tenofovir disoproxil fumarate (raltegravir 1,200 mg (2 x 600 mg) Once Daily)
Danish: emtricitabin og tenofovirdisoproxilfumarat (raltegravir 1.200 mg (2 x 600 mg) en gang dagligt)
English: WHITE
Danish: HVID
English: 492 cells/mm
Danish: 492 celler/mm
English: There was no clinically meaningful effect of age on raltegravir pharmacokinetics over the age range studied with raltegravir 400 mg twice daily.
Danish: Alder havde ingen klinisk relevant effekt på raltegravirs farmakokinetik i den aldersgruppe, som blev undersøgt med raltegravir 400 mg to gange dagligt.
English: Uncommon immune reconstitution syndrome, drug hypersensitivity, hypersensitivity
Danish: Ikke almindelig Immunreaktiveringssyndrom, lægemiddeloverfølsomhed, overfølsomhed
English: Contains fructose, sorbitol and sucrose.
Danish: Indeholder fructose, sorbitol og sucrose.
English: HCV ANTIVIRALS NS3/4A protease inhibitors (PI) boceprevir (raltegravir 400 mg Single Dose)
Danish: LÆGEMIDLER MOD HCV NS3/4A proteasehæmmere (PI) boceprevir (raltegravir 400 mg enkeltdosis)
English: PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER
English: Baseline Characteristics and Efficacy Outcomes at Weeks 24 and 48 from IMPAACT P1066 (4 weeks to less than 2 years of age)
Danish: Karakteristika ved baseline og effektresultater ved uge 24 og 48 fra IMPAACT P1066 (i alderen 4 år til under 2 år)
English: Uncommon mental disorder, suicide attempt, anxiety, confusional state, depressed mood, major depression, middle insomnia, mood altered, panic attack, sleep disorder, suicidal ideation, suicidal behaviour (particularly in patients with a pre-existing history of psychiatric illness)
Danish: Mentale forstyrrelser, selvmordsforsøg, angst, konfusion, forsænket stemningsleje, major depression, afbrudt søvnmønster, ændret stemningsleje, panikanfald, søvnforstyrrelser, suicidale tanker, suicidal adfærd (især hos patienter med psykisk sygdom i anamnesen)
English: A moderate amount of data on pregnant women (between 300 - 1,000 pregnancy outcomes from first trimester exposure) indicate no malformative or feto/neonatal toxicity of raltegravir 400 mg film-coated tablets twice daily.
Danish: Data fra anvendelse af raltegravir hos et begrænset antal gravide kvinder (mellem 300 og 1.000 i første trimester) indikerer ingen misdannelser eller føtal/neonatal toksicitet af raltegravir 400 mg filmovertrukne tabletter to gange dagligt.
English: The treatment difference (raltegravir 1,200 mg once daily-raltegravir 400 mg twice daily) was 1.5 % with an associated 95 % CI of (-4.4, 7.3).
Danish: Behandlingsdifferencen (raltegravir 1.200 mg en gang dagligtraltegravir 400 mg to gange dagligt) var 1,5% med associeret 95% konfidensinterval (-4,4; 7,3).
English: The major circulating entity was raltegravir and represented approximately 70 % of the total radioactivity; the remaining radioactivity in plasma was accounted for by raltegravir-glucuronide.
Danish: Den største cirkulerende enhed var raltegravir, som repræsenterede cirka 70% af den samlede radioaktivitet.
English: ISENTRESS is also available for adults and paediatric patients (weighing at least 40 kg), as a 600 mg tablet to be administered as 1,200 mg once daily (two 600 mg tablets) for treatment-naïve patients or patients who are virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily.
Danish: ISENTRESS fås også til voksne og pædiatriske patienter (som vejer mindst 40 kg), som en 600 mg tablet, der skal administreres som 1.200 mg en gang dagligt (to 600 mg tabletter) til behandlingsnaive patienter eller til patienter, som var virologisk supprimerede på et initialt regime med ISENTRESS 400 mg to gange dagligt.
English: Renal impairment No dosage adjustment is required for patients with renal impairment (see section 5.2).
Danish: Nedsat nyrefunktion Dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion (se pkt.
English: • acne; unusual hair loss or thinning; redness of skin; unusual distribution of fat on the body, this may include loss of fat from legs, arms, and face, and increase in abdomen fat; excessive sweating; night sweats; thickening and itching of the skin due to repeated scratching; skin lesion; dry skin
Danish: • Uren hud (akne), usædvanligt hårtab, rødme af huden, unormal fordeling af fedt på kroppen, som kan omfatte fedttab fra ben, arme og ansigt og øget fedt på maven, kraftig svedafsondring, nattesved, fortykkelse af huden og kløe i huden på grund af gentagen kradsen, hudlæsioner, tør hud
English: Inducers of drug metabolizing enzymes
Danish: Inducere af lægemiddelmetaboliserende enzymer
English: ISENTRESS 600 mg film-coated tablets is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults, and paediatric patients weighing at least 40 kg (see sections 4.2, 4.4, 5.1 and 5.2).
Danish: ISENTRESS 600 mg filmovertrukne tabletter er, i kombination med andre antiretrovirale lægemidler, indiceret til behandling af infektion med humant immundefekt-virus (hiv-1) hos voksne og pædiatriske patienter, som vejer mindst 40 kg (se pkt.
English: In this study, administration of the chewable tablet with a high fat meal led to an average 6 % decrease in AUC, 62 % decrease in Cmax, and 188 % increase in C12hr compared to administration in the fasted state.
Danish: I dette studie førte administration af tyggetabletten sammen med et måltid med højt fedtindhold til et gennemsnitligt fald på 6% i AUC, 62% fald i Cmax og 188% stigning i C12t sammenlignet med administration under faste.
English: • infection of the hair roots; influenza; skin infection due to virus; vomiting or diarrhoea due to an infectious agent; upper respiratory tract infection; lymph node abscess
Danish: • Infektion i hårsækkene, influenza, hudinfektion fremkaldt af virus, opkastning eller diarré forårsaget af smitstof, infektion i øvre luftveje, byld i lymfeknude
English: 500 cells/mm
Danish: 500 celler/mm
English: • decreased white blood cell count; decreased count of platelets in blood (a kind of cell that helps blood clot); blood test showing reduced kidney function; high blood sugar level; increased muscle enzyme in blood; sugar present in urine; red blood cells present in urine; weight gain; increase in waist size; decreased blood protein (albumin); increase in time for blood to clot
Danish: • Fald i antal hvide blodlegemer, fald i antal blodplader (celler der får blodet til at størkne), blodprøver med tegn på nedsat nyrefunktion, forhøjet blodsukker, forhøjet mængde muskelenzymer i blodet, sukker i urinen, røde blodlegemer i urinen, vægtøgning, øget taljemål, fald i blodprotein (albumin), forlængelse af blodets størkningstid.
English: Each single-use sachet of granules for oral suspension contains 100 mg of raltegravir (as potassium).
Danish: Hver foliepose til engangsbrug med granulat til oral suspension indeholder 100 mg raltegravir (som kalium).
English: In general, the safety profile of raltegravir in patients with hepatitis B and/or hepatitis C virus co-infection was similar to that in patients without hepatitis B and/or hepatitis C virus co-infection, although the rates of AST and ALT abnormalities were somewhat higher in the subgroup co-infected with hepatitis B and/or hepatitis C virus.
Danish: Generelt var sikkerhedsprofilen for raltegravir hos patienter med hepatitis B- og/eller hepatitis C-viruskoinfektion den samme som hos patienter uden hepatitis B- og/eller hepatitis C-viruskoinfektion, selvom hyppigheden af uregelmæssigheder vedrørende ASAT og ALAT var noget højere i undergruppen koinficeret med hepatitis B- og/eller hepatitis C-virus.
English: Based on these findings, co-administration of aluminium/magnesium and calcium carbonate containing antacids with raltegravir 1,200 mg once daily is not recommended.
Danish: På basis af disse resultater frarådes administration af aluminium/magnesium- og calciumcarbonatholdige antacida sammen med raltegravir 1.200 mg en gang dagligt.
English: ISENTRESS chewable tablets contain fructose and sorbitol.
Danish: ISENTRESS tyggetabletter indeholder fructose og sorbitol.
English: 2 to less than 3
Danish: 2 til under 3
English: Read the package leaflet and booklet before use.
Danish: Læs indlægssedlen og hæftet med brugsvejledning inden brug.
English: At 96-weeks, in treatment-experienced patients, Grade 2 or higher laboratory abnormalities that represent a worsening Grade from baseline of AST, ALT or total bilirubin occurred in 29 %, 34 % and 13 %, respectively, of co-infected patients treated with raltegravir as compared to 11 %, 10 % and 9 % of all other patients treated with raltegravir.
Danish: Abnorme laboratorieværdier af grad 2 eller højere hos behandlingserfarne patienter, som viser en forværring af ASAT, ALAT eller totalbilirubin i forhold til baseline, forekom ved uge 96 hos henholdsvis 29%, 34% og 13% af de koinficerede patienter, der fik raltegravir, sammenlignet med henholdsvis 11%, 10% og 9% af alle andre patienter, der blev behandlet med raltegravir.
English: The SWITCHMRK 1 & 2 (Protocols 032 & 033) studies evaluated HIV-infected patients receiving suppressive (screening HIV RNA < 50 copies/mL; stable regimen > 3 months) therapy with lopinavir 200 mg (+) ritonavir 50 mg 2 tablets twice daily plus at least 2 nucleoside reverse transcriptase inhibitors and randomised them 1:1 to continue lopinavir (+) ritonavir 2 tablets twice daily (n=174 and n=178, respectively) or replace lopinavir (+) ritonavir with raltegravir 400 mg twice daily (n=174 and n=176, respectively).
Danish: SWITCHMRK 1 og 2-studierne (Protokol 032 og 033) vurderede hiv-1-inficerede patienter, der fik suppressiv (screening hiv-RNA <50 kopier/ml; stabilt regime >3 måneder) behandling med lopinavir 200 mg (+) ritonavir 50 mg 2 tabletter to gange dagligt plus mindst 2 nukleoside reverse transkriptasehæmmere og randomiserede dem 1:1 til at fortsætte med lopinavir (+) ritonavir 2 tabletter to gange dagligt (n = henholdsvis 174 og 178) eller erstatte lopinavir (+) ritonavir med raltegravir 400 mg to gange dagligt (n = henholdsvis 174 og 176).
English: Uncommon visual impairment
Danish: Ikke almindelig Synssvækkelse
English: • loss of memory; pain in the hand due to nerve compression; disturbance in attention; dizziness with rapid changes in posture; abnormal taste; increased sleepiness; lack of energy; forgetfulness; migraine headache; loss of feeling, numbness or weakness of the arms and/or legs; tingling; sleepiness; tension headache; tremors; poor quality sleep
Danish: • Hukommelsestab, smerter i hænderne på grund af tryk på nerver, opmærksomhedsforstyrrelse, svimmelhed i forbindelse med hurtig ændring af stilling, smagsforstyrrelse, øget søvnbehov, mangel på energi, glemsomhed, migrænelignende hovedpine, følelsesløshed eller følelse af svaghed i arme og/eller ben, prikkende fornemmelse, søvnighed, spændingshovedpine, rysten, dårlig søvnkvalitet
English: ANTIMICROBIALS Antimycobacterial rifampicin (raltegravir 400 mg Single Dose)
Danish: ANTIMIKROBIELLE LÆGEMIDLER Svampemidler rifampicin (raltegravir 400 mg enkeltdosis)
English: To monitor maternal-foetal outcomes in patients inadvertently administered raltegravir while pregnant, an Anti-retroviral Pregnancy Registry has been established.
Danish: Der er oprettet et antiretroviralt graviditetsregister med henblik på monitorering af maternelle/føtale resultater fra patienter, der uforvarende har fået raltegravir under graviditeten.
English: Raltegravir chewable tablets should be used during pregnancy only if the expected benefit justifies the potential risk to the foetus.
Danish: Raltegravir tyggetabletter må kun anvendes under graviditet, hvis den forventede fordel opvejer den potentielle risiko for fosteret.
English: Keep the drying agent in the bottle to protect from moisture.
Danish: Behold tørremidlet i flasken til at beskytte mod fugt.
English: In adults, there were no clinically important pharmacokinetic differences between patients with severe renal insufficiency and healthy subjects (see section 4.2).
Danish: Hos voksne var der ingen klinisk betydningsfulde farmakokinetiske forskelle mellem patienter med svært nedsat nyrefunktion og raske personer (se pkt.
English: Film-coating - Polyvinyl alcohol - Titanium dioxide - Polyethylene glycol 3350 - Talc - Red iron oxide - Black iron oxide
Danish: Filmovertræk - Polyvinylalkohol - Titandioxid - Polyethylenglycol 3350 - Talcum - Rød jernoxid - Sort jernoxid
English: • anaemia including due to low iron
Danish: • Blodmangel, fx pga. jernmangel
English: 1 sachet of Isentress granules
Danish: 1 foliepose med Isentress granulat
English: Your doctor can tell you if it is safe to take Isentress with other medicines.
Danish: om det er sikkert at tage Isentress sammen med anden medicin.
English: Each chewable tablet contains approximately 0.46 mg fructose, approximately 0.05 mg phenylalanine (as a component of aspartame) and approximately 1.4 mg sorbitol.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på 25 mg Hver tyggetablet indeholder ca. 0,46 mg fructose, ca. 0,05 mg phenylanalin (som en komponent af aspartam) og ca. 1,4 mg sorbitol.
English: If it is not mixed, swirl it some more.
Danish: Hvirvl granulatet lidt mere rundt, hvis det ikke er helt blandet.
English: With respect to the primary efficacy endpoint, the proportion of patients achieving HIV RNA < 50 copies/mL at Week 48 was 241/280 (86.1 %) in the group receiving raltegravir and 230/281 (81.9 %) in the group receiving efavirenz.
Danish: Med hensyn til det primære endepunkt var andelen af patienter, der opnåede hiv-RNA <50 kopier/ml i uge 48, 241/280 (86,1%) i gruppen, der fik raltegravir, og 230/281 (81,9%) i gruppen, der fik efavirenz.
English: The recommended dose is 1 tablet (400 mg) by mouth twice a day.
Danish: Den anbefalede dosis Isentress er 1 tablet (400 mg) gennem munden to gange dagligt.
English: One carton contains 60 sachets, two 1 mL, two 3 mL and two 10 mL oral dosing syringes and 2 mixing cups.
Danish: En karton indeholder 60 folieposer, to 1 ml, to 3 ml og to 10 ml doseringssprøjter til oral anvendelse og 2 blandebægre.
English: Excipient with known effect Each 600 mg tablet contains 5.72 mg lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver 600 mg tablet indeholder 5,72 mg lactose (som monohydrat).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.emea.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.emea.europa.eu.
English: If you do take more than you should, contact your doctor.
Danish: Hvis du tager for meget, skal du kontakte lægen.
English: • Prescribing leaflet
Danish: • Indlægsseddel
English: Therefore, co administration of emtricitabine/tenofovir disaproxil fumarate and raltegravir 1,200 mg once daily ispermitted.
Danish: Derfor er administration af emtricitabin/tenofovirdisaproxilfumarat sammen med raltegravir 1.200 mg en gang dagligt tilladt.
English: Weight based dosing, see dosing Table 1 19 *Number of patients with intensive pharmacokinetic (PK) results at the final recommended dose.
Danish: Vægtbaseret dosering, se doseringstabel 1 19 *Antal patienter med intensive farmakokinetiske resultater ved den anbefalede slutdosis.
English: The effect of severe hepatic insufficiency on the pharmacokinetics of raltegravir has not been studied (see sections 4.2 and 4.4).
Danish: Effekten af svær leverinsufficiens på raltegravirs farmakokinetik er ikke undersøgt (se pkt.
English: The 100 mg chewable tablet can be divided into equal halves.
Danish: 100 mg tyggetabletten kan deles i to lige store dele.
English: efavirenz (raltegravir 1,200 mg single dose)
Danish: efavirenz (raltegravir 1.200 mg enkeltdosis)
English: Two pack sizes are available: 1 bottle with 60 tablets, and a multipack containing 180 (3 bottles of 60) tablets.
Danish: Der findes to pakningsstørrelser: 1 flaske med 60 tabletter og en multipakning med 180 tabletter (3 flasker med 60 tabletter i hver).
English: Scheduled appointments for the patient should be kept because the ISENTRESS dosage should be adjusted as the child grows.
Danish: Patienterne skal instrueres i at overholde de planlagte besøg hos lægen, da doseringen af ISENTRESS skal justeres, efterhånden som barnet vokser.
English: • NEW Syringe sizes to measure the dose
Danish: • NYE sprøjtestørrelser til afmåling af dosis
English: Infections and infestations Uncommon genital herpes, folliculitis, gastroenteritis, herpes simplex, herpes virus infection, herpes zoster, influenza, lymph node abscess, molluscum contagiosum, nasopharyngitis, upper respiratory tract infection
Danish: Ikke almindelig Genital herpes, folliculitis, gastroenteritis, herpes simplex, herpes virusinfektion, herpes zoster, influenza, byld i lymfeknude, molluscum contagiosum, nasofaryngitis, øvre luftvejsinfektion
English: Because the formulations have different pharmacokinetic profiles neither the granules for oral suspension nor the chewable tablets should be substituted for the 400 mg tablet or 600 mg tablet (see section 5.2).
Danish: Da formuleringerne har forskellige farmakokinetiske profiler, bør hverken granulatet til oral suspension eller tyggetabletterne erstatte 400 mg tabletten eller 600 mg tabletten (se pkt.
English: In addition, the film coating contains the following inactive ingredients: lactose monohydrate, hypromellose 2910, titanium dioxide, triacetin, iron oxide yellow and black iron oxide.
Danish: Derudover indeholder filmovertrækket følgende inaktive indholdsstoffer: lactosemonohydrat, hypromellose 2910, titaniumdioxid, triacetin, gul jernoxid og sort jernoxid.
English: A slight increase in incidence of supernumerary ribs, a variant in the normal developmental process, was observed in rat foetuses of dams exposed to raltegravir at approximately 4.4-fold human exposure at the recommended human dose (RHD) based on AUC0-24 hr. No development effects were seen at 3.4-fold human exposure at the RHD.
Danish: En lille stigning i forekomsten af overtallige ribben, en variant i den normale udviklingsproces, blev set i rottefostre fra moderdyr, der havde været eksponeret for raltegravir i doser, der var cirka 4,4 gange højere end human eksponering ved den anbefalede humane dosis baseret på AUC0-24t.
English: Taking an aluminium and magnesium antacid within 6 hours of raltegravir administration significantly decreased raltegravir plasma levels.
Danish: Indtagelse af aluminium og magnesiumholdige antacida inden for 6 timer af administration af raltegravir reducerede raltegravirs plasmakoncentration væsentligt.
English: atazanavir (raltegravir 1,200 mg single dose)
Danish: atazanavir (raltegravir 1.200 mg enkeltdosis)
English: High density polyethylene (HDPE) bottle with a child-resistant polypropylene closure, induction seal and silica gel dessicant.
Danish: Højdensitetspolyethylen (HDPE) flaske med børnesikker polypropylenlukning, forsegling og silica geltørremiddel.
English: In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, red iron oxide and black iron oxide.
Danish: Derudover indeholder filmovertrækket følgende inaktive indholdsstoffer: Polyvinylalkohol; titandioxid; polyethylenglycol 3350; talcum; rød jernoxid og sort jernoxid.
English: At Week 96, the proportion of patients achieving HIV RNA < 40 copies/mL was 433/531(81.5 %) in the group receiving raltegravir 1,200 mg once daily and 213/266 (80.1 %) in the group receiving raltegravir 400 mg twice daily.
Danish: Ved uge 96 var andelen af patienter, der opnåede hiv-RNA < 40 kopier/ml, 433/531 (81,5%) i den gruppe, der fik raltegravir 1.200 mg en gang dagligt og 213/266 (80,1%) i den gruppe, der fik raltegravir 400 mg to gange dagligt.
English: • trouble sleeping; abnormal dreams; nightmare; abnormal behaviour; feelings of deep sadness and unworthiness
Danish: • Besvær med at sove, unormale drømme, mareridt, unormal adfærd, depression
English: The other ingredients are: microcrystalline cellulose, hypromellose 2910, croscarmellose sodium and magnesium stearate.
Danish: Øvrige indholdsstoffer: mikrokrystallinsk cellulose, hypromellose 2910, croscarmellosenatrium og magnesiumstearat.
English: Because the formulations have different pharmacokinetic profiles neither the chewable tablets nor the granules for oral suspension should be substituted for the 400 mg tablet or 600 mg tablet (see section 5.2).
Danish: Da formuleringerne har forskellige farmakokinetiske profiler, bør hverken tyggetabletterne eller granulatet til oral suspension erstatte 400 mg tabletten eller 600 mg tabletten (se pkt.
English: Each single-use sachet contains 100 mg of raltegravir which is to be suspended in 10 mL of water giving a final concentration of 10 mg per mL (see section 6.6).
Danish: Hver foliepose til engangsbrug indeholder 100 mg raltegravir, som opløst i 10 ml vand giver en slutkoncentration på 10 mg pr. ml (se pkt.
English: No dose adjustment required for raltegravir or tenofovir disoproxil fumarate.
Danish: Dosisjustering af raltegravir eller tenofovirdisoproxilfumarat er ikke nødvendig.