FrancophonIA/ELRC3.0 huggingface dataset:
English: It is especially important to mention these: other medicines to treat HIV infection (e.g. indinavir, nevirapine and efavirenz) boceprevir and sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C) sildenafil, vardenafil, or tadalafil (used by men to treat impotence (erectile dysfunction)) if you are taking an oral contraceptive ("the Pill") with REYATAZ to prevent pregancy, be sure to take it exactly as instructed by your doctor and not miss any doses any medicines used to treat diseases related to the acid in the stomach (e.g. antacids to be taken 1 hour before taking REYATAZ or 2 hours after taking REYATAZ, H2-blockers like famotidine and proton pump inhibitors like omeprazole) medicines to lower blood pressure, to slow heart rate, or to correct heart rhythm (amiodarone, diltiazem, systemic lidocaine, verapamil) atorvastatin, pravastatin, and fluvastatin (used to lower blood cholesterol) salmeterol (used to treat asthma) cyclosporin, tacrolimus, and sirolimus (medicines to decrease the effects of body's immune system) certain antibiotics (rifabutin, clarithromycin) ketoconazole, itraconazole, and voriconazole (antifungals) warfarin (anticoagulant, used to reduce the blood clots) carbamazepine, phenytoin, phenobarbital, lamotrigine (antiepileptics) irinotecan (used to treat cancer) sedative agents (e.g. midazolam administered by injection) buprenorphine (used to treat opioid addiction and pain).
Danish: Det er især vigtigt at nævne disse: anden medicin til behandling af hiv-infektion (f.eks. indinavir, nevirapin og efavirenz) boceprevir og sofosbuvir/velpatasvir/voxilaprevir (anvendes til at behandle hepatitis C) sildenafil, vardenafil eller tadalafil (anvendes af mænd til at behandle impotens (erektil dysfunktion)) hvis du tager p-piller samtidig med REYATAZ for at undgå graviditet, er det vigtigt, at du tager dem nøjagtigt som lægen har fortalt dig, og at du ikke glemmer en dosis medicin, der bruges til at behandle sygdomme, der er forbundet med indholdet af syre i maven (f.eks. antacida (syreneutraliserende), der tages 1 time før REYATAZ eller 2 timer efter REYATAZ, H2-hæmmere som f.eks. famotidin og protonpumpehæmmere som f.eks. omeprazol) medicin, der sænker blodtrykket eller sænker eller ændrer hjerterytmen (amiodaron, diltiazem, systemisk lidocain, verapamil) atorvastatin, pravastatin og fluvastatin (anvendes til at sænke mængden af kolesterol i blodet) salmeterol (anvendes til at behandle astma) ciclosporin, tacrolimus og sirolimus (anvendes til at svække kroppens immunsystem) visse antibiotika (rifabutin, clarithromycin) ketoconazol, itraconazol og voriconazol (svampemiddel) warfarin (blodfortyndende middel, anvendes til at mindske risiko for blodpropper) carbamazepin, phenytoin, phenobarbital, lamotrigin (anvendes mod epilepsi) irinotecan (anvendes til at behandle kræft) beroligende midler (såsom midazolam, som gives som indsprøjtning) buprenorphin (anvendes mod smerter og til at behandle opioidafhængighed).
English: REYATAZ with ritonavir must not be used in patients with moderate to severe hepatic impairment (see sections 4.3, 4.4 and 5.2).
Danish: REYATAZ med ritonavir må ikke anvendes til patienter med moderat til alvorligt nedsat leverfunktion (se pkt.
English: Co-administration of REYATAZ with glecaprevir/pibrentasvir is contraindicated because of the potential increase in the risk of ALT elevations due to a significant increase in glecaprevir and pibrentasvir plasma concentrations (see section 4.3)
Danish: Samtidig administration af REYATAZ med glecaprevir/pibrentasvir er kontraindiceret på grund af den potentielle stigning i risiko for ALAT-stigning, grundet signifikant stigning i plasmakoncentrationerne af glecaprevir og pibrentasvir (se pkt.
English: Your doctor will evaluate how severe your liver disease is before deciding whether you can take REYATAZ if you are taking any of these medicines: see also Other medicines and REYATAZ rifampicin (an antibiotic used to treat tuberculosis) astemizole or terfenadine (commonly used to treat allergy symptoms, these medicines may be available without prescription); cisapride (used to treat gastric reflux, sometimes called heartburn); pimozide (used to treat schizophrenia); quinidine or bepridil (used to correct heart rhythm); ergotamine, dihydroergotamine, ergonovine, methylergonovine (used to treat headaches); and alfuzosin (used to treat enlarged prostatic gland) quetiapine (used to treat schizophrenia, bipolar disorder and major depressive disorder); lurasidone (used to treat schizophrenia) medicines containing St. John's wort (Hypericum perforatum, a herbal preparation)
Danish: rifampicin (et antibiotikum, der bruges til at behandle tuberkulose) astemizol eller terfenadin (bruges almindeligvis til at behandle allergiske symptomer, det er medicin som muligvis kan fås uden recept); cisaprid (bruges til at behandle tilbageløb af maveindhold, nogle gange omtalt som sure opstød); pimozid (bruges til at behandle skizofreni); quinidin eller bepridil (bruges til at korrigere hjerterytme); ergotamin, dihydroergotamin, ergonovin, methylergonovin (bruges til at behandle migræne); og alfuzosin (bruges til at behandle forstørret blærehalskirtel (prostata))
English: Famotidine 20 mg twice daily Atazanavir AUC ↓21% (↓34% ↓4%) * Atazanavir Cmax ↓21% (↓36% ↓4%) * Atazanavir Cmin ↓19% (↓37% ↑5%) *
Danish: Atazanavir AUC ↓21% (↓34% ↓4%) * Atazanavir Cmax ↓21% (↓36% ↓4%) * Atazanavir Cmin ↓19% (↓37% ↑5%) *
English: Study 045 is a randomised, multicenter trial comparing REYATAZ/ritonavir (300/100 mg once daily) and REYATAZ/saquinavir (400/1,200 mg once daily), to lopinavir + ritonavir (400/100 mg fixed dose combination twice daily), each in combination with tenofovir disoproxil fumarate (see sections 4.5 and 4.8) and one NRTI, in patients with virologic failure on two or more prior regimens containing at least one PI, NRTI, and NNRTI.
Danish: Studie 045 er et randomiseret, multicenterstudie, der sammenligner REYATAZ/ritonavir (300/100 mg én gang dagligt) og REYATAZ/saquinavir (400/1.200 mg én gang dagligt) med lopinavir + ritonavir (400/100 mg fast dosiskombination to gange dagligt), hver i kombination med tenofovirdisoproxilfumarat (se pkt.
English: REYATAZ 200 mg hard capsules are also supplied in blister strips in packs of 60 capsules.
Danish: REYATAZ 200 mg hårde kapsler fås også som blisterkort pakket i æsker med 60 kapsler.
English: The mechanism of the clarithromycin/atazanavir interaction is CYP3A4 inhibition.
Danish: Interaktionsmekanismen for clarithromycin/atazanavir er CYP3A4hæmning.
English: Co-administration with glecaprevir/pibrentasvir fixed dose combination (see section 4.5)
Danish: Samtidig administration med fastdosis-kombination af glecaprevir/pibrentasvir (se pkt.
English: Ethinyloestradiol AUC ↑48% (↑31% Ethinyloestradiol Cmax ↑15% (↓1% Ethinyloestradiol Cmin ↑91% (↑57%
Danish: Ethinylestradiol Cmin ↑91% (↑57%
English: Co-administration of REYATAZ with glecaprevir/pibrentasvir fixed dose combination is contraindicated because of the potential increase in the risk of ALT elevations due to a significant increase in glecapreir and pibrentasvir plasma concentrations (see section 4.3).
Danish: Samtidig administration af REYATAZ med produkter indeholdende glecaprevir/pibrentasvir i fastdosis-kombination er kontraindiceret på grund af den potentielle stigning i risiko for ALATstigning, grundet signifikant stigning i plasmakoncentrationerne af glecaprevir og pibrentasvir (se pkt.
English: Opaque blue and white capsule printed with white and blue inks, with "BMS 100 mg" on one half and with "3623" on the other half.
Danish: Matblå og hvide kapsler påtrykt ”BMS 100 mg” på den ene halvdel og ”3623” på den anden halvdel med hvidt og blåt blæk.
English: SN:
Danish: Hjerte:
English: Phenobarbital and phenytoin should be used with caution in combination with REYATAZ/ritonavir.
Danish: Phenobarbital og phenytoin bør anvendes med forsigtighed sammen med
English: REYATAZ 150 mg hard capsules are supplied in bottles of 60 capsules.
Danish: REYATAZ 150 mg hårde kapsler fås i beholder med 60 kapsler.
English: Table 9: Steady-State Pharmacokinetics of Atazanavir with ritonavir in HIV-Infected Pregnant Women in the Fed State atazanavir 300 mg with ritonavir 100 mg Pharmacokinetic Parameter 2nd Trimester (n=9)
Danish: Tabel 9: Steady state farmakokinetik af atazanavir med ritonavir hos hiv-smittede gravide kvinder efter fødeindtagelse
English: 30 hard capsules: EU/1/03/267/009
Danish: Blisterpakning: 30 hårde kapsler: EU/1/03/267/009
English: Atazanavir AUC ↔3% (↓36% ↑67%) Atazanavir Cmax ↑12% (↓33% ↑18%) Atazanavir Cmin ↔3% (↓39% ↑73%)
Danish: Atazanavir, doseret 1 time efter ddI+d4T (fastende) Atazanavir AUC ↔3% (↓36% ↑67%) Atazanavir Cmax ↑12% (↓33% ↑18%) Atazanavir Cmin ↔3% (↓39% ↑73%)
English: REYATAZ once daily dose ritonavir once daily dosea
Danish: Ritonavir en daglig dosisa
English: Each capsule contains 200 mg of atazanavir (as sulphate).
Danish: Hver kapsel indeholder 200 mg atazanavir (som sulfat).
English: REYATAZ 200 mg hard capsules are supplied in bottles of 60 capsules.
Danish: REYATAZ 200 mg hårde kapsler fås i beholder med 60 kapsler.
English: REYATAZ 200 mg hard capsules atazanavir
Danish: REYATAZ 200 mg hårde kapsler atazanavir
English: (range: 84 to 5703 cells/mm 3) and mean baseline plasma HIV-1 RNA was 4.67 log10 copies/ml (range: 2.0 to 5.9 log10 copies/ml).
Danish: 1.441 celler/mm3 (interval: 84-5.703 celler/mm3), og middel-baseline-plasma hiv-1-RNA var 4,67 log10 kopier/ml (interval: 2,0-5,9 log10 kopier/ml).
English: triazolam and oral (taken by mouth) midazolam (used to help you sleep and/or to relieve anxiety) simvastatin and lovastatin (used to lower blood cholesterol).
Danish: quetiapin (bruges til at behandle skizofreni, bipolar lidelse (manio-depressiv sygdom) og moderat til svær depresssion); lurasidon (bruges til behandling af skizofreni) medicin, der indeholder perikon (Hypericum perforatum, naturlægemiddel) triazolam og oralt (indtaget gennem munden) midazolam (bruges som sovemedicin eller til at behandle angst) simvastatin og lovastatin (bruges til at sænke mængden af kolesterol i blodet).
English: Each capsule contains 150 mg of atazanavir (as sulphate).
Danish: Hver kapsel indeholder 150 mg atazanavir (som sulfat).
English: REYATAZ 100 mg hard capsules are supplied in bottles of 60 capsules.
Danish: REYATAZ 100 mg hårde kapsler fås i beholder med 60 kapsler.
English: REYATAZ 100 mg hard capsules atazanavir
Danish: REYATAZ 100 mg hårde kapsler atazanavir
English: ERECTILE DYSFUNCTION PDE5 Inhibitors
Danish: PDE5-hæmmere
English: Co-administration of REYATAZ/ritonavir with products containing St. John's wort is contraindicated.
Danish: Samtidig administration af REYATAZ/ritonavir og præparater indeholdende perikon er kontraindiceret.
English: Each sachet contains 50 mg of atazanavir (as sulphate).
Danish: Hvert brev indeholder 50 mg atazanavir (som sulfat).
English: REYATAZ 300 mg hard capsules atazanavir
Danish: REYATAZ 300 mg hårde kapsler atazanavir
English: Opaque blue and powder blue capsule printed with white and blue inks, with "BMS 150 mg" on one half and with "3624" on the other half.
Danish: Matblå og dueblå kapsler påtrykt ”BMS 150 mg” på den ene halvdel og ”3624” på den anden halvdel med hvidt og blåt blæk.
English: ACID REDUCING AGENTS
Danish: HMG-CoA-reduktasehæmmere
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 200 mg of atazanavir (as sulphate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder 200 mg atazanavir (som sulfat).
English: REYATAZ 100 mg hard capsules are also supplied in blister strips in packs of 60 capsules.
Danish: REYATAZ 100 mg hårde kapsler fås også som blisterkort pakket i æsker med 60 kapsler.
English: Each capsule contains 300 mg of atazanavir (as sulphate).
Danish: Hver kapsel indeholder 300 mg atazanavir (som sulfat).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 300 mg of atazanavir (as sulphate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder 300 mg atazanavir (som sulfat).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 150 mg of atazanavir (as sulphate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder 150 mg atazanavir (som sulfat).
English: REYATAZ/ritonavir, especially when commencing therapy.
Danish: Det anbefales at monitorere INR omhyggeligt under behandling med REYATAZ/ritonavir, særligt ved behandlingsstart.
English: the mean baseline CD4 cell count was 344 cells/mm3 (range: 2 to 800 cells/ mm3) and mean baseline plasma HIV-1 RNA was 4.67 log10 copies/ml (range: 3.70 to 5.00 log10 copies/ml).
Danish: For de behandlingsnaive pædiatriske patienter var middel baseline-CD4-celletal 344 celler/mm3 (interval 2-800 celler/mm3), og middel-baseline-plasma hiv-1RNA var 4,67 log10 kopier/ml (interval 3,70-5,00 log10 kopier/ml).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each sachet contains 50 mg of atazanavir (as sulphate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert brev indeholder 50 mg atazanavir (som sulfat).
English: Capsule shells: gelatine, red iron oxide, black iron oxide, yellow iron oxide, indigocarmin (E132) and titanium dioxide (E171)
Danish: Kapslens indhold: crospovidon, lactosemonohydrat og magnesiumstearat Kapslens skal: gelatine, rød jernoxid, sort jernoxid, gul jernoxid, indigocarmin (E132) og titandioxid (E171)
English: Each capsule contains 100 mg of atazanavir (as sulphate).
Danish: Hver kapsel indeholder 100 mg atazanavir (som sulfat).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 100 mg of atazanavir (as sulphate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder 100 mg atazanavir (som sulfat).
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occurs many months after initiation of treatment.
Danish: Autoimmune lidelser (såsom Graves sygdom og autoimmun hepatitis) er også rapporteret i forbindelse med immunreaktivering.
English: Ethinyloestradiol AUC ↓19% (↓25% Ethinyloestradiol Cmax ↓16% (↓26% Ethinyloestradiol Cmin ↓37% (↓45%
Danish: Ethinylestradiol Cmax ↓16% (↓26%
English: If you have any questions on how to prepare or give a dose of REYATAZ oral powder, talk to your doctor, pharmacist or nurse.
Danish: Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis du har spørgsmål vedrørende tilberedning eller indgivelse af en dosis REYATAZ oralt pulver.
English: Atazanavir AUC ↑43% (↑30% ↑57%) Atazanavir Cmax ↑12% (↑1% ↑24%) Atazanavir Cmin ↑23% (↑13% ↑134%) Grazoprevir AUC: ↑958% (↑678% Grazoprevir Cmax: ↑524% (↑342% Grazoprevir Cmin: ↑1064% (↑696%
Danish: Atazanavir AUC ↑43% (↑30% ↑57%) Atazanavir Cmax ↑12% (↑1% ↑24%) Atazanavir Cmin ↑23% (↑13% ↑134%)
English: Famotidine 40 mg twice daily Atazanavir AUC ↔2.3% (↓13%
Danish: Atazanavir AUC ↔2,3% (↓13%
English: Famotidine 20 mg twice daily Atazanavir AUC ↓18% (↓25% ↑1%) Atazanavir Cmax ↓20% (↓32% ↓7%)
Danish: Atazanavir AUC ↓18% (↓25% ↑1%) Atazanavir Cmax ↓20% (↓32% ↓7%) Atazanavir Cmin ↔1% (↓16% ↑18%)
English: What REYATAZ looks like and contents of the pack Each capsule of REYATAZ 200 mg contains 200 mg atazanavir.
Danish: Hver kapsel af REYATAZ 200 mg indeholder 200 mg atazanavir.
English: Co-administration with medicinal products that are substrates of the CYP3A4 isoform of cytochrome P450 and have narrow therapeutic windows (e.g., quetiapine, lurasidone, alfuzosin, astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5), and ergot alkaloids, particularly, ergotamine, dihydroergotamine, ergonovine, methylergonovine) (see section 4.5).
Danish: Samtidig administration af lægemidler, der er substrat for CYP3A4-isoformen af cytokrom P450 og har et snævert terapeutisk vindue (f.eks. quetiapin, lurasidon, alfuzosin, astemizol, terfenadin, cisaprid, pimozid, quinidin, bepridil, triazolam og midazolam administreret oralt (se pkt.
English: Co-administration with medicinal products that are substrates of the CYP3A4 isoform of cytochrome P450 and have narrow therapeutic windows (e.g., quetiapine, alfuzosin, astemizole, terfenadine, cisapride, pimozide, quinidine, lurasidone, bepridil, triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5), and ergot alkaloids, particularly, ergotamine, dihydroergotamine, ergonovine, methylergonovine) (see section 4.5).
Danish: Samtidig administration af lægemidler, der er substrat for CYP3A4-isoformen af cytokrom P450 og har et snævert terapeutisk vindue (f.eks. quetiapin, alfuzosin, astemizol, terfenadin, cisaprid, pimozid, quinidin, lurasidon, bepridil, triazolam og midazolam administreret oralt (se pkt.
English: Aspartame provides a source of phenylalanine and, therefore, may not be suitable for persons with phenylketonuria.
Danish: Kan være skadeligt for patienter med fenylketonuri.
English: a Mean baseline CD4 cell count was 214 cells/mm3 (range 2 to 810 cells/mm3) and mean baseline plasma HIV-1 RNA was 4.94 log10 copies/ml (range 2.6 to 5.88 log10 copies/ml)
Danish: a Gennemsnitligt CD4-celletal ved baseline var 214 celler/mm3 (i området 2 til 810 celler/mm3) og gennemsnitligt plasma hiv-1-RNA ved baseline var 4,94 log10 kopier/ml (i området 2,6 til 5,88 log10 kopier/ml) b REYATAZ/RTV med tenofovirdisoproxilfumarat/emtricitabin (fast dosis på 300 mg/200 mg tabletter én gang dagligt).
English: With Tenofovir disoproxil fumarate 300 mg once daily (equivalent to 245 mg tenofovir disoproxil) In HIV-infected patients with atazanavir/ritonavir at the recommended dose of 300/100 mg once daily
Danish: Med tenofovirdisoproxilfumarat 300 mg 1 gang dagligt (ækvivalent med 245 mg tenofovirdisoproxil)
English: 60 hard capsules: EU/1/03/267/004
Danish: Blisterpakning: 60 hårde kapsler: EU/1/03/267/004
English: 60 hard capsules: EU/1/03/267/006
Danish: Blisterpakning: 60 hårde kapsler: EU/1/03/267/006
English: Sofosbuvir AUC : ↑40% (↑25% ↑57%) Sofosbuvir Cmax :↑29% (↑9% ↑52%) Velpatasvir AUC: ↑93% (↑58% Velpatasvir Cmax : ↑29% (↑7% ↑56%) Voxilaprevir AUC : ↑331% (↑276% Voxilaprevir Cmax : ↑342% (↑265%
Danish: Sofosbuvir AUC: ↑40% (↑25% ↑57%) Sofosbuvir Cmax: ↑29% (↑9% ↑52%)
English: LIPID LOWERING AGENTS HMG-CoA reductase inhibitors
Danish: BETA-AGONISTER TIL INHALATION
English: Proton pump inhibitors Omeprazole 40 mg once daily (atazanavir 400 mg once daily with ritonavir 100 mg once daily)
Danish: Omeprazol 40 mg 1 gang dagligt (atazanavir 400 mg 1 gang dagligt med ritonavir 100 mg 1 gang dagligt)
English: What REYATAZ looks like and contents of the pack Each capsule of REYATAZ 150 mg contains 150 mg atazanavir.
Danish: Hver kapsel af REYATAZ 150 mg indeholder 150 mg atazanavir.
English: REYATAZ/ritonavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of REYATAZ to 400 mg with 100 mg of ritonavir; doses of proton pump inhibitors comparable to omeprazole 20 mg should not be exceeded (see section 4.4).
Danish: Hvis kombination af REYATAZ/ritonavir sammen med en protonpumpehæmmer vurderes at være nødvendig, anbefales omhyggelig monitorering og dosisøgning af REYATAZ til 400 mg med 100 mg ritonavir.
English: Co-administration of salmeterol with REYATAZ/ritonavir is not recommended (see section 4.4).
Danish: REYATAZ/ritonavir anbefales ikke (se pkt.
English: This leaflet was last revised in
Danish: Denne indlægsseddel blev senest ændret MM/ÅÅÅÅ
English: 60 hard capsules: EU/1/03/267/003
Danish: Beholderpakning: 60 hårde kapsler: EU/1/03/267/003
English: If the combination is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of REYATAZ to 400 mg with 100 mg of ritonavir; doses of proton pump inhibitors comparable to omeprazole 20 mg should not be exceeded (see section 4.4).
Danish: Hvis kombination vurderes at være nødvendig, anbefales omhyggelig monitorering og dosisøgning af REYATAZ til 400 mg med 100 mg ritonavir.
English: 60 hard capsules: EU/1/03/267/002
Danish: Blisterpakning: 60 hårde kapsler: EU/1/03/267/002
English: Atazanavir Cmin ↓19% (↓37% ↑5%) *
Danish: Rifabutin Cmin ↑40% (↑5% ↑87%) **
English: No dose adjustment is needed for REYATAZ/ritonavir.
Danish: REYATAZ/ritonavir.
English: Your doctor will discuss this risk with you.
Danish: Lægen vil drøfte denne risiko med dig.
English: Some cases had a fatal outcome.
Danish: Visse tilfælde havde dødeligt udfald.
English: The duration of treatment can last up to 5 days.
Danish: Behandlingen kan vare op til 5 dage.
English: Unopened vial 18 months.
Danish: Uåbnet hætteglas 18 måneder.
English: The action of succinyl-choline can be prolonged by 5 to 15 minutes.
Danish: Virkningen af succinylcholin kan forlænges med 5-15 minutter.
English: The following information is intended for healthcare professionals only.
Danish: Nedenstående oplysninger er til sundhedspersonale.
English: Date of first authorisation: 15 March 2010 Date of latest renewal: 15 March 2015
Danish: Dato for første markedsføringstilladelse:15. marts 2010 Dato for seneste fornyelse: 15. marts 2015
English: An inactivated virus vaccine should be used instead, whenever possible (poliomyelitis).
Danish: Der skal i stedet bruges en inaktiveret virusvaccine, når det er muligt (poliomyelitis).
English: Filtering does not alter solution potency.
Danish: Filtrering ændrer ikke opløsningens styrke.
English: These effects were seen at doses lower than those used in humans.
Danish: Disse virkninger blev konstateret ved doser, der var lavere end de doser, der bruges til mennesker.
English: No dose adjustment was deemed necessary.
Danish: Dosisjustering blev ikke skønnet nødvendig.
English: - TEPADINA does not contain any other ingredients.
Danish: - TEPADINA indeholder ikke andre ingredienser.
English: Each infusion will last 2-4 hours.
Danish: Hver infusion tager 2-4 timer.
English: Only colourless solutions, without any particulate matter, must be used.
Danish: Kun farveløse opløsninger uden partikler må anvendes.
English: Frequency of administration and duration of treatment depend on your disease.
Danish: Hyppigheden af doseringerne og varigheden af behandlingen afhænger af din sygdom.
English: Your doctor will calculate the dose according to your body surface or weight and your disease.
Danish: Lægen fastlægger din dosis ud fra din kropsoverflade eller -vægt og din sygdom.
English: Side effects of TEPADINA may occur with certain frequencies, which are defined as follows:
Danish: Bivirkninger ved TEPADINA kan forekomme med bestemte hyppigheder, som er defineret på følgende måde:
English: TEPADINA may cause another type of cancer in the future.
Danish: TEPADINA kan forårsage en anden kræfttype i fremtiden.
English: The elimination half-life varied from 1.5 to 4.1 hours.
Danish: Eliminationshalveringstiden varierede fra 1,5 til 4,1 timer.
English: The haematological recovery is in the expected time.
Danish: Hæmatologisk restitution forekommer inden for den forventede tid.
English: From a microbiological point of view, the product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt bør lægemidlet anvendes øjeblikkeligt.
English: Specific interactions with thiotepa
Danish: Specifik interaktion med thiotepa
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Therefore, thiotepa is contraindicated during pregnancy.
Danish: Thiotepa er derfor kontraindiceret under graviditet.