FrancophonIA/ELRC3.0 huggingface dataset:
English: The mother-infant pairs were randomised to receive either stavudine (N= 91), didanosine (N= 94), stavudine + didanosine (N= 88) or zidovudine (N= 89).
Danish: Parrene af moder-spædbarn blev randomiseret til at få enten stavudin (N = 91), didanosin (N = 94), stavudin + didanosin (N = 88) eller zidivudin (N = 89).
English: Symptoms may continue or worsen following discontinuation of therapy.
Danish: Symptomerne kan fortsætte eller forværres efter seponering af behandlingen.
English: This loss of body fat has been shown to be not fully reversible after discontinuation of stavudine.
Danish: Dette tab af kropsfedt har vist sig ikke at være fuldt reversibelt efter ophør med stavudin.
English: Mean renal clearance of the parent compound is approximately 272 ml/min, accounting for approximately 67% of the apparent oral clearance, indicating active tubular secretion in addition to glomerular filtration.
Danish: Den gennemsnitlige renale clearance af det oprindelige stof er omkring 272 ml/min, der udgør 67% af den tilsyneladende orale clearance, hvilket indikerer aktiv tubulær sekretion ud over glomerulær filtrering.
English: After intravenous administration, 42% (range: 13% to 87%) of dose is excreted unchanged in the urine.
Danish: Efter intravenøs administration udskilles 42% (13%-87%) af dosis uomdannet i urinen.
English: Special consideration should be given to the antiretroviral treatment history and the resistance profile of the HIV strain of the mother.
Danish: Der bør tages særligt hensyn til moderens antiretrovirale historik og resistensprofilen for HIVstammen.
English: It also inhibits viral DNA synthesis by causing DNA chain termination due to a lack of the 3'-hydroxyl group necessary for DNA elongation.
Danish: Det hæmmer også viral DNA-syntese ved at forårsage DNA-kædeafslutning på grund af mangel på 3'-hydroxylgruppen, som er nødvendig for DNA-forlængelse.
English: The results of AI455-099 and AI455-096 are presented in Table 1.
Danish: Resultaterne af AI455-099 og AI455-096 fremgår af tabel 1.
English: Binding of stavudine to serum proteins was negligible over the concentration range of 0.01 to 11.4 µg/ml.
Danish: Binding af stavudin til serum proteiner var ubetydelig i et koncentrationsinterval på 0,01 til 11,4 μg/ml.
English: In study AI455-094, performed in South-Africa, 362 mother-infant pairs were included in a prevention of mother-to-child-transmission study.
Danish: I studie AI455-094, udført i Sydafrika, blev 362 par af moder-spædbarn inkluderet i et studie af forebyggelse af moder-til-barn overførsel.
English: If you accidentally miss a dose, then simply take your normal dose when the next one is due.
Danish: Hvis du tilfældigvis har glemt at tage en dosis, skal du blot tage din næste dosis, som du plejer.
English: * Patients on haemodialysis should take Zerit after the completion of haemodialysis, and at the same time on non-dialysis days.
Danish: * Patienter i hæmodialyse skal tage Zerit efter afslutning af hæmodialysen og herefter på samme tidspunkt på ikke-dialyse dage.
English: The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Danish: Hyppigheden af uønskede hændelser anført nedenfor defineres i henhold til følgende konventioner: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000).
English: The possible benefits of a dose reduction should be balanced in each case against the risks - which may result from this measure (lower intracellular concentrations).
Danish: Mulig gavn af dosisreduktion skal i hvert tilfælde vurderes i forhold til de risici, som er forbundet med sådanne tiltag (lavere intracellulære koncentrationer).
English: Four hours after administration, the CSF/plasma ratio was 0.39±0.06.
Danish: Fire timer efter administration var CSF/plasma forholdet 0,39±0,06.
English: If you are allergic to stavudine or any of the other ingredients of this medicine (listed in section 6).
Danish: Hvis du er allergisk over for stavudin eller et af de øvrige indholdsstoffer (angivet i afsnit 6).
English: The patients usually experienced resolution of symptoms after dose reduction or interruption of stavudine.
Danish: Patienterne oplevede sædvanligvis ophør af symptomerne efter dosisreduktion eller seponering.
English: Data on lactic acid in serum were not collected in this study.
Danish: Der blev ikke indsamlet data om mælkesyre i serum i dette studie.
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Danish: I tilfælde af samtidig antiviral behandling for hepatitis B eller C bør de relevante produktinformationer for disse behandlingsregimer gennemgås grundigt.
English: A rat study also showed placental transfer of stavudine, with the foetal tissue concentration approximately 50% of the maternal plasma concentration.
Danish: Et studie med rotter viste også placentaoverførsel af stavudin, med den føtale vævskoncentration på cirka 50% af den maternelle plasmakoncentration.
English: Complications of chronic overdosage could include peripheral neuropathy and hepatic dysfunction.
Danish: Komplikationer ved kronisk overdosering kan omfatte perifer neuropati og hepatisk dysfunktion.
English: V75T is selected in vitro by stavudine and reduces susceptibility to stavudine by 2-fold.
Danish: V75T selekteres in vitro af stavudin og reducerer følsomhed over for stavudin med 2-fold.
English: If you forget to take Zerit
Danish: Hvis du har glemt at tage Zerit
English: Patients at increased risk should be followed closely (see also section 4.6).
Danish: Patienter med øget risiko bør følges nøje (se også pkt.
English: Hence, hydroxyurea should not be used in the treatment of HIV infection.
Danish: Derfor bør hydroxycarbamid ikke anvendes til behandling af HIV-infektion.
English: uncommon: arthralgia, myalgia
Danish: Ikke almindelig: artralgi, myalgi
English: Patients with a high risk of pancreatitis or those receiving products known to be associated with pancreatitis should be closely followed for symptoms of this condition.
Danish: Patienter med en høj risiko for pankreatitis eller patienter, der får præparater kendt for at være forbundet med pankreatitis, skal omhyggeligt observeres for symptomer på denne tilstand.
English: The prepared oral solution is stable for 30 days in a refrigerator (2°C -8°C).
Danish: Den tilberedte orale opløsning er stabil i 30 dage i køleskab (2º C-8 ºC).
English: Zidovudine is therefore not recommended to be used in combination with stavudine.
Danish: Zidovudin kan derfor ikke anbefales til brug i kombination med stavudin.
English: Relevant grade 3-4 laboratory abnormalities in the 91 stavudine treated infants were low neutrophils in 7%, low hemoglobin in 1%, ALT increase in 1% and no lipase abnormality.
Danish: Relevante grad 3-4 laboratorieabnormaliteter i de 91 stavudinbehandlede spædbørn var lave neutrofile hos 7%, lav hæmoglobin hos 1%, en øgning i ALT hos 1% og ingen lipaseabnormalitet.
English: Therefore, mothers should be instructed to discontinue breast-feeding prior to receiving Zerit.
Danish: Mødre bør derfor instrueres i at stoppe amningen før behandling med Zerit.
English: If this is not possible, Zerit may also be taken with a light meal.
Danish: Hvis dette ikke er muligt, kan Zerit også tages sammen med et let måltid.
English: In the rare cases when this is inappropriate, dose reduction of stavudine may be considered, while the symptoms of peripheral neuropathy are under close monitoring and satisfactory virological suppression is maintained.
Danish: I de sjældne tilfælde, hvor dette ikke er passende, kan dosisreduktion af stavudin overvejes, medens symptomerne for perifer neuropati monitoreres nøje og tilfredsstillende virologisk suppression opretholdes.
English: Since urinary excretion is also a major route of elimination of stavudine in paediatric patients, the clearance of stavudine may be altered in paediatric patients with renal impairment.
Danish: Da udskillelse via urinen også er hovedeliminationsvejen for stavudin hos pædiatriske patienter, kan stavudin clearance derfor ændres hos pædiatriske patienter med nyrefunktionsnedsættelse.
English: Treatment naive pregnant women were enrolled into the study at gestation week 34-36 and given antiretroviral treatment until delivery.
Danish: Behandlingsnaive, gravide kvinder blev indrulleret i studiet i graviditetsuge 34-36 og fik antiretroviral behandling frem til fødslen.
English: If this is not possible, the capsules may also be taken with a light meal.
Danish: Hvis dette ikke er muligt, kan kapslerne også tages sammen med et let måltid.
English: The evolution of motor weakness may mimic the clinical presentation of Guillain-Barré syndrome (including respiratory failure).
Danish: Udvikling af motorisk svækkelse kan ligne den kliniske tilstand ved Guillain-Barrés syndrom (inklusive respirationssvigt).
English: When these signs occur, Zerit should be stopped and your HIV treatment changed.
Danish: Hvis der ses tegn på lipoatrofi, skal behandlingen med Zerit stoppes og din hiv-behandling ændres.
English: Continue to take this medicine until your doctor tells you otherwise.
Danish: Du skal fortsætte med at tage medicinen, indtil din læge beslutter noget andet.
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Danish: Du kan stadig smitte andre med hiv, selvom du tager dette lægemiddel, men risikoen er nedsat ved effektiv antiretroviral terapi.
English: If you have problems swallowing capsules you should ask your doctor about the possibility of changing to the solution form of this medicine or you could carefully open the capsule and mix its contents with some food.
Danish: Hvis du har problemer med at sluge kapslerne, kan du spørge din læge om muligheden for at tage denne medicin som opløsning i stedet, eller du kan forsigtigt åbne kapslen og blande indholdet i noget mad.
English: Embryo-foetal toxicities were seen only at high exposure levels in animals.
Danish: Embryoføtalt toksicitet er kun set ved høje eksponeringsniveauer hos dyr.
English: Intra- and interindividual variation in pharmacokinetic characteristics of stavudine is low, approximately 15% and 25%, respectively, after oral administration.
Danish: Intra- og interindividuelle variationer i stavudins farmakokinetiske egenskaber er små, ca. 15% og 25% efter oral administration.
English: These capsules contain lactose.
Danish: Disse kapsler indeholder lactose.
English: A MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release Bristol-Myers Squibb S.r.l., Contrada Fontana del Ceraso, 03012 Anagni (FR), Italy Aesica Queenborough Limited, North Road, Queenborough, Kent, ME11 5EL, United Kingdom The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Danish: A. FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE Navn og adresse på de fremstillere, der er ansvarlige for batchfrigivelse Bristol-Myers Squibb S.r.l., Contrada Fontana del Ceraso, 03012 Anagni (FR), Italien Aesica Queenborough Limited, North Road, Queenborough, Kent, ME11 5EL, Storbritannien På lægemidlets trykte indlægsseddel skal der anføres navn og adresse på den fremstiller, som er ansvarlig for frigivelsen af den pågældende batch.
English: Antiretroviral prophylaxis, the same medications as given to the mother, was given to the new-born infant within 36 hours of delivery and continued for 6 weeks.
Danish: Antiretroviral profylakse med samme medicinering, der blev givet til moderen, blev givet til det nyfødte spædbarn inden for 36 timer efter fødslen og fortsatte i 6 uger.
English: Studies in lactating rats showed that stavudine is excreted in breast milk.
Danish: Studier med diegivende rotter har vist, at stavudin udskilles i modermælk.
English: For patients starting therapy with Zerit, the duration should be limited to the shortest time possible followed by a switch to an alternative appropriate therapy whenever possible.
Danish: For patienter, der påbegynder behandling med Zerit, skal varigheden begrænses til kortest muligt efterfulgt af skift til anden mere passende behandling, så snart muligt.
English: Preclinical studies showed placental transfer of stavudine (see section 5.3).
Danish: Prækliniske studier viste overførsel via placenta af stavudin (se pkt 5.3).
English: In the stavudine containing arms, the neonates were treated for 6 weeks with stavudine 1 mg/kg BID.
Danish: I de dele, der omfattede stavudin, blev de nyfødte behandlet i 6 uger med 1 mg/kg stavudin BID.
English: The apparent volume of distribution at steady state is 46±21 l. It was not possible to detect stavudine in cerebrospinal fluid until at least 2 hours after oral administration.
Danish: Det tilsyneladende distributionsvolumen ved steady state er 46±21 l. Det var ikke muligt at måle cerebrospinalvæske niveauer af stavudin før efter mindst 2 timer efter oral administration.
English: SPECIAL STORAGE CONDITIONS Store below 25°C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares ved temperaturer under 25 °C.
English: These are used to treat Human Immunodeficiency Virus (HIV) infection.
Danish: Denne form for medicin anvendes til at behandle humant immundefektvirus- (hiv-) infektion.
English: No clinically relevant pharmacokinetic interaction has, however, been seen with lamivudine.
Danish: Der er dog ikke set nogen klinisk relevante farmakokinetiske interaktioner med lamivudin.
English: However, clinically significant peripheral neuropathy is less frequent.
Danish: Klinisk signifikant perifer neuropati forekommer dog ikke så ofte.
English: After reconstitution, store the prepared oral solution in a refrigerator (2°C - 8°C) for 30 days.
Danish: Efter rekonstitution kan den tilberedte orale opløsning opbevares i køleskab (2°C-8°C) i 30 dage.
English: If you have taken too much of the solution, or if someone accidentally swallows some, there is no immediate danger.
Danish: Hvis du kommer til at tage for meget af opløsningen, eller hvis en eller anden ved en fejltagelse kommer til at sluge noget, er der ingen umiddelbare fare.
English: If you have taken too many capsules or if someone accidentally swallows some, there is no immediate danger.
Danish: Hvis du kommer til at tage for mange kapsler, eller hvis en anden ved en fejltagelse kommer til at sluge nogle, er der ingen umiddelbar fare.
English: LIST OF EXCIPIENTS Sucrose and preservatives (E218 and E216)
Danish: LISTE OVER HJÆLPESTOFFER Saccharose og konserveringsmidler (E218 og E216)
English: Caution should be exercised when administering stavudine to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease and hepatic steatosis (including certain medicinal products and alcohol).
Danish: Der bør udvises forsigtighed ved administration af stavudin til enhver patient (specielt overvægtige kvinder) med hepatomegali, hepatitis eller andre kendte risikofaktorer for leversygdom og hepatisk fedtinfiltration (inklusive visse lægemidler og alkohol).
English: Adolescents, children and infants: total exposure to stavudine was comparable between adolescents, children and infants ≥ 14 days receiving the 2 mg/kg/day dose and adults receiving 1 mg/kg/day.
Danish: Unge, børn og spædbørn: Total eksposition for stavudin var sammenlignelig for unge, børn og spædbørn ≥ 14 dage, der blev behandlet med 2 mg/kg/dag dosis, og voksne, der blev behandlet med 1 mg/kg/dag.
English: Tell your doctor if you notice any loss of fat from your legs, arms, and face.
Danish: Tal med din læge, hvis du bemærker fedttab på ben, arme og i ansigtet.
English: Cellular DNA polymerase γ is also sensitive to inhibition by stavudine triphosphate, while cellular polymerases α and β are inhibited at concentrations 4,000-fold and 40-fold higher, respectively, than that needed to inhibit HIV reverse transcriptase.
Danish: Cellulær DNA-polymerase γ er også følsom over for hæmning på grund af stavudintrifosfat, mens cellulær polymerase α og β hæmmes ved koncentrationer på henholdsvis 4.000 gange og 40 gange større end de koncentrationer, der kræves til hæmning af HIV revers transkriptase.
English: There are no dosage recommendations for paediatric patients under the age of 3 months with renal impairment.
Danish: Der findes ingen dosisanbefalinger for pædiatriske patienter under 3 måneder med nedsat nyrefunktion.
English: Adults: the recommended oral dosage is
Danish: Voksne: anbefalet oral dosis
English: This condition usually does not occur until a few months after onset of treatment.
Danish: En sådan tilstand vil sædvanligvis først optræde efter nogle få måneders behandling.
English: Zerit should be reconstituted with water to a 200 ml deliverable volume solution (stavudine concentration of 1 mg/ml).
Danish: Zerit skal rekonstitueres med vand til en 200 ml leveringsklar opløsning (stavudinkoncentration: 1 mg/ml).
English: Zerit + lamivudine + efavirenz n=391
Danish: Zerit + lamivudin + efavirenz n=391
English: Adolescents, children and infants: the recommended oral dosage is
Danish: Unge, børn og spædbørn: anbefalet oral dosis
English: The therapy should be initiated by a doctor experienced in the management of HIV infection (see also section 4.4).
Danish: Behandlingen skal iværksættes af en læge, der har erfaring med behandling af HIV-infektion (se også pkt.
English: Renal impairment: the following dosages are recommended
Danish: Nedsat nyrefunktion: Følgende doser anbefales
English: To reconsistute Zerit, add 202 ml of water to the original bottle (when the patient makes up the solution, they should be instructed to fill to the top edge of the bottle label, indicated by the arrow marks).
Danish: For at rekonstituere Zerit tilsættes 202 ml vand til den originale flaske (hvis patienten skal fremstille opløsningen, skal han/hun instrueres i at fylde op til den øverste kant af flaskens etiket som vist med pilene).
English: No carcinogenicity was noted at doses of 400 mg/kg/day in mice and 600 mg/kg/day in rats, corresponding to exposures ~ 39 and 168 times the expected human exposure, respectively, suggesting an insignificant carcinogenic potential of stavudine in clinical therapy.
Danish: Der bemærkedes ingen karcinogenecitet ved doser på 400 mg/kg/dag hos mus og 600 mg/kg/dag hos rotter, svarende til ekspositioner på henholdsvis ∼ 39 og 168 gange den forventede humane eksposition, hvilket antyder et ikke-signifikant karcinogent potentiale af stavudin ved klinisk anvendelse.
English: Lactic acidosis generally occurred after a few or several months of treatment.
Danish: Generelt optrådte laktatacidose efter få eller flere måneders behandling.
English: Since stavudine is actively secreted by the renal tubules, interactions with other actively secreted medicinal products are possible, e.g. with trimethoprim.
Danish: Da stavudin aktivt secerneres af renale tubuli er der mulighed for interaktion med andre lægemidler som aktivt secerneres, f.eks. med trimethoprim.
English: The clinical relevance of these findings suggest that stavudine should be generally avoided in the presence of TAMs, especially M41L and T215Y.
Danish: Den kliniske relevans af disse fund antyder, at stavudin generelt bør undgås ved tilstedeværelse af TAM'er, særligt M41L og T215Y .
English: Pancreatitis, occasionally fatal, has been reported in up to 2-3% of patients enrolled in monotherapy clinical studies (see section 4.4).
Danish: Pankreatitis, til tider letal, er rapporteret hos op til 2-3% hos patienter i kliniske studier med monoterapi (se pkt 4.4).
English: In vitro, stavudine triphosphate has an intracellular half-life of 3.5 hours in CEM T-cells (a human T-lymphoblastoid cell line) and peripheral blood mononuclear cells, supporting twice daily dosing.
Danish: In vitro har stavudintriphosphat en intracellulær halveringstid på 3,5 timer i CEM T-celler (en human T-lymfoblastoid cellelinie) og i mononukleære celler fra perifert blod, hvilket underbygger en dosering 2 gange dagligt.
English: Following an oral 80-mg dose of 14C-stavudine to healthy subjects, approximately 95% and 3% of the total radioactivity was recovered in urine and faeces, respectively.
Danish: Efter en oral 80-mg dosis af 14C-stavudin til raske personer genfandtes omtrent 95% og 3% af den totale radioaktivitet i henholdsvis urin og fæces.
English: The use of stavudine in adolescents, children and infants is supported by pharmacokinetic and safety data in paediatric patients (see also sections 4.8 and 5.2).
Danish: Brugen af stavudin hos unge, børn og spædbørn understøttes af farmakokinetiske data og sikkerhedsdata hos pædiatriske patienter (se også pkt.
English: Patients with a history of neuropathy, or with other risk factors (for example alcohol, medicines such as isoniazid) are at particular risk.
Danish: Patienter, der tidligere har haft perifer neuropati, og patienter med andre risikofaktorer (for eksempel alkohol, lægemidler som isoniazid) har en særlig risiko for at udvikle neuropati.
English: Hepatic impairment: no initial dosage adjustment is necessary.
Danish: Nedsat leverfunktion: Initial dosisjustering er ikke nødvendig.
English: Treatment with stavudine (Zerit) often causes a loss of fat from legs, arms and face (lipoatrophy).
Danish: Behandling med stavudin (Zerit) resulterer ofte i tab af fedt på benene, armene og i ansigtet (lipoatrofi).
English: Aclar/aluminum blisters with 14 hard capsules per card and 4 cards (56 hard capsules) per carton.
Danish: Aclar/aluminium blisterpakning med 14 hårde kapsler/kort og 4 kort (56 hårde kapsler) pr. pakke.
English: Other medicines and Zerit
Danish: Brug af anden medicin sammen med Zerit
English: Your doctor should monitor for signs of lipoatrophy.
Danish: Din læge vil holde øje med tegn på lipoatrofi.
English: 95% Confidence intervals for the mother-to-child-transmission rates were 5.4-19.3% (stavudine), 5.2-18.7% (didanosine); 1.3-11.2% (stavudine + didanosine); and 1.9-12.6% for zidovudine.
Danish: 95% konfidensintervaller for moder-til-barn overførselsrater var 5,4 -19,3% (stavudin), 5,2 - 18,7% (didanosin); 1,3 - 11,2% (stavudin + didanosin); og 1,9 - 12,6% for zidovudin.
English: Motor weakness has been reported rarely in patients receiving combination antiretroviral therapy including Zerit.
Danish: Motorisk svækkelse er i sjældne tilfælde blevet rapporteret hos patienter, der får antiretroviral kombinationsbehandling inkluderende Zerit.
English: Prepare the ready-to-use solution by mixing the powder with 202 ml of water or by slowly adding water up to the top edge of the bottle label shown by the arrow fill marks.
Danish: Tilbered den færdige opløsning ved at blande pulveret med 202 ml vand eller ved langsomt at tilsætte vand op til den øverste kant af flaskens etiket som vist med pilene.
English: CD4 Mean Change from Baseline, cells/mm3 All patients
Danish: CD4 Gennemsnitsændring fra baseline, celler/mm3 Alle patienter
English: Zerit + lamivudine + efavirenz n=76
Danish: Zerit + lamivudin + efavirenz n=76
English: * Adverse reactions observed post-marketing in association with stavudine-containing antiretroviral treatment ** See Section Description of selected adverse reactions for more details.
Danish: * Bivirkninger observeret post-marketing i forbindelse med antiretroviral behandling med stavudin ** Se afsnit Beskrivelse af udvalgte bivirkninger for flere detaljer.
English: If you are affected, do not drive and do not use any tools or machines.
Danish: Hvis du oplever dette, må du ikke køre bil eller motorcykel eller betjene maskiner.
English: Macrocytosis was not evaluated in these trials, but was found to be associated with Zerit in an earlier trial (MCV > 112 fl occurred in 30% of patients treated with Zerit).
Danish: Makrocytose blev ikke evalueret i disse studier, men blev fundet værende forbundet med Zerit i en tidligere afprøvning (MCV > 112 fl forekom hos 30% af patienterne behandlet med Zerit).