FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose for children is 80 mg piperacillin /10 mg tazobactam per kilogram body weight every six hours for neutropenic children and 100 mg piperacillin /12.5 mg tazobactam per kg body weight every eight hours for children with complicated intra-abdominal infections.
Danish: Dosis til børn er 80 mg piperacillin /10 mg tazobactam pr. kilo legemsvægt hver sjette time til neutropeniske børn og 100 mg piperacillin /12,5 mg tazobactam pr. kilo legemsvægt hver ottende time til børn med komplicerede intraabdominale infektioner.
English: • complicated intra-abdominal infections (infections within the abdomen)
Danish: • komplicerede intraabdominale infektioner (infektioner i maveregionen)
English: • complicated skin and soft tissue infections, including diabetic foot infections.
Danish: • komplicerede hud- og bløddelsinfektioner, herunder diabetiske fodinfektioner.
English: Questions and answers on Tazocin and associated names (piperacillin and tazobactam, 2/0.25 g and 4/0.5 g powder for solution for infusion)
Danish: Spørgsmål og svar vedrørende Tazocin og relaterede navne (piperacillin og tazobactam, 2/0,25 g og 4/0,5 g pulver til infusionsvæske, opløsning)
English: The company that markets these medicines is Pfizer.
Danish: Disse lægemidler markedsføres af virksomheden Pfizer.
English: For severe pneumonia and bacterial infections in neutropenic patients, the recommended dose is 4 g piperacillin /0.5 g tazobactam given every six hours.
Danish: Ved svær pneumoni og bakterieinfektioner hos neutropeniske patienter er den anbefalede dosis 4 g piperacillin /0,5 g tazobactam givet hver sjette time.
English: In adults and adolescents the usual dose is 4 g piperacillin /0.5 g tazobactam given every eight hours.
Danish: Til voksne og unge er den sædvanlige dosis 4 g piperacillin /0,5 g tazobactam givet hver ottende time.
English: Beta-lactamases break down beta-lactam antibiotics such as piperacillin, making the bacteria resistant to these medicines.
Danish: Betalaktamaser nedbryder betalaktam-antibiotika såsom piperacillin, hvilket gør bakterierne resistente over for disse lægemidler.
English: Tazocin was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Danish: Det blev bestemt af den humanmedicinske koordineringsgruppe for gensidig anerkendelse og decentrale procedurer (CMD(h)), at Tazocin skulle harmoniseres.
English: By blocking the action of beta-lactamases, tazobactam stops bacteria from being resistant to piperacillin, thereby making piperacillin more effective at killing them.
Danish: Ved at hæmme betalaktamasernes virkning forhindrer tazobactam bakterierne i at blive resistente over for piperacillin, hvilket gør piperacillin mere effektivt til at slå bakterierne ihjel.
English: • severe pneumonia (infection of the lungs), including infections acquired in hospital or by patients on a mechanical ventilator
Danish: • svær pneumoni (infektion i lungerne), herunder hospitals- eller respiratorerhvervede infektioner
English: Tazobactam blocks the action of bacterial enzymes called beta-lactamases.
Danish: Tazobactam hæmmer virkningen af bakterielle enzymer, der kaldes betalaktamaser.
English: Observed data
Danish: Observerede data
English: Component of a multipack, can't be sold separately.
Danish: En del af en multipakning, må ikke sælges separat.
English: Currently available data are described in section 5.2 but no recommendation on a posology can be made.
Danish: Nuværende forhåndenværende data er beskrevet i punkt 5.2, men der kan ikke gives nogen anbefaling vedrørende dosering.
English: − For children, your doctor will decide the right dose (number of tablets) based on the child's height and weight.
Danish: Til børn vil lægen fastsætte den korrekte dosis (antal tabletter) på baggrund af barnets højde og vægt.
English: * Body surface area can be calculated with the following equation:
Danish: * Legemsoverflade (BSA) kan udregnes ved hjælp af følgende ligning:
English: Events noted as having frequency “Not known” were identified via post-marketing surveillance.
Danish: Bivirkninger opført med hyppigheden ”ikke kendt” er identificeret via post-marketing overvågning.
English: Further stratification within each group was 1:1 (tablet versus.
Danish: Yderligere stratificering inden for hver gruppe var 1:1 (tablet over for blød kapsel).
English: Around 85% of patients had a viral load of < 100,000 copies/ml.
Danish: Omkring 85 % af patienterne havde en virusbelastning på < 100.000 kopier/ml.
English: Administration of activated charcoal may also be used to aid in removal of unabsorbed active substance.
Danish: Ligeledes kan administration af aktivt kul anvendes for at lette fjernelsen af ikke-absorberet aktivt stof.
English: Voriconazole: Concentrations may be decreased.
Danish: Voriconazol: Koncentrationerne kan være nedsat.
English: If you are currently taking any of these medicines, ask your doctor about making necessary changes either in the treatment for your other condition(s) or in your antiretroviral treatment.
Danish: Hvis du i øjeblikket tager et af disse lægemidler, skal du bede din læge om at foretage de nødvendige ændringer enten i behandlingen af dine andre sygdomme eller i din antiretrovirale behandling.
English: BATCH NUMBER Batch/Lot
Danish: BATCHNUMMER Batch/Lot
English: How much Lopinavir/Ritonavir Mylan should be taken and when?
Danish: Hvor meget Lopinavir/Ritonavir Mylan skal der tages og hvornår?
English: Stevens-Johnson syndrome, erythema multiforme
Danish: Stevens-Johnsons syndrom og erythema multiforme
English: − If you cannot contact your doctor, go to the hospital.
Danish: Hvis du ikke kan komme i kontakt med din læge, skal du henvende dig på hospitalet.
English: Thirty-nine patients (39%) discontinued the study, including 16 (16%) discontinuations due to adverse events, one of which was associated with a death.
Danish: Niogtredive patienter (39 %) afbrød deres deltagelse i studiet, herunder 16 (16 %) som afbrød på grund af bivirkninger, hvoraf en var associeret med et dødsfald.
English: The clinical significance of reduced abacavir and zidovudine concentrations is unknown.
Danish: Den kliniske betydning af reducerede abacavir- og zidovudinkoncentrationer er ukendt.
English: BSA (m2) = √ (Height (cm) X Weight (kg) / 3600)
Danish: BSA (m2) =  (Højde (cm) X Vægt (kg) / 3600)
English: Maximum PR interval was 286 ms and no second or third degree heart block was observed (see section 4.4).
Danish: Det maksimale PR-interval var 286 ms og der blev ikke observeret nogen anden- eller tredjegrads hjerte-blokade (se pkt.
English: − Continue to take this medicine until your doctor tells you otherwise.
Danish: Fortsæt med at tage denne medicin, indtil lægen anbefaler noget andet.
English: Safety, efficacy and pharmacokinetic profiles of the two dose regimens were assessed after 3 weeks of therapy in each patient.
Danish: Sikkerhed, effekt og farmakokinetiske profiler af de to forskellige doser blev bestemt i hver patient efter 3 ugers behandling.
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, selvom risikoen er nedsat ved effektiv antiretroviral terapi.
English: Patients had a mean age of 5 years (range 6 months to 12 years) with 14 patients less than 2 years old and 6 patients one year or less.
Danish: Patienterne havde en gennemsnitsalder på 5 år (interval: 6 måneder til 12 år) og færre end 14 % var under 2 år og 6 patienter var et år eller derunder.
English: The increased digoxin level may lessen over time as Pgp induction develops.
Danish: Det øgede digoxin-niveau kan mindskes med tiden, efterhånden som Pgpinduktion udvikles.
English: − It is recommended that HIV-infected women do not breast-feed their infants because there is a possibility that the baby can be infected with HIV through your breast milk.
Danish: Det anbefales, at hiv-smittede kvinder ikke ammer deres spædbørn, da der er risiko for, at barnet kan blive smittet med hiv gennem mælken.
English: Special Populations
Danish: Særlige befolkningsgrupper
English: NAME OF THE MARKETING AUTHORISATION HOLDER Mylan SAS
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Mylan SAS
English: - This medicine has been prescribed for you or your child only.
Danish: Lægen har ordineret dette lægemiddel til dig eller dit barn personligt.
English: No subject experienced an increase in QTcF of ≥ 60 ms from baseline or a QTcF interval exceeding the potentially clinically relevant threshold of 500 ms.
Danish: Ingen individer oplevede en stigning i QTcF på  60 ms fra baseline eller et QTcF-interval, som oversteg den potentielt kliniske relevante grænse på 500 ms.
English: − Muscle pain, tenderness or weakness, particularly in combination with these medicines.
Danish: Muskelsmerter, ømhed eller svækkelse, især i kombination med disse lægemidler.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 January 2016
Danish: Dato for første markedsføringstilladelse: 14 januar 2016
English: The safety and efficacy of lopinavir/ritonavir in children aged less than 2 years have not yet been established.
Danish: Sikkerhed og effekt af lopinavir/ritonavir hos børn under 2 år er endnu ikke fastlagt.
English: Effects on drug levels Geometric Mean Change (%) in AUC, Cmax, Cmin Mechanism of interaction
Danish: Virkning på lægemiddelniveauer Geometrisk gennemsnitsændring (%) i AUC, Cmax, Cmin Interaktionsmekanisme
English: The dose increase did not result in a significant increase in the plasma lopinavir concentration.
Danish: Den øgede dosis resulterede ikke i en signifikant stigning i plasmakoncentrationen af lopinavir.
English: Pharmacotherapeutic group: antivirals for systemic use, antivirals for treatment of HIV infections, combinations, ATC code: J05AR10
Danish: Farmakoterapeutisk klassifikation: Antiviralt middel til systemisk brug, antivirale midler til behandling af hiv-infektioner, kombinationer, ATC-kode: J05AR10
English: In post-marketing surveillance through the Antiretroviral Pregnancy Registry, established since January 1989, an increased risk of birth defects exposures with lopinavir/ritonavir has not been reported among over 1000 women exposed during the first trimester.
Danish: Gennem post-marketing overvågning i det Antiretrovirale Graviditetsregister, etableret i januar 1989, er der ikke rapporteret om forøget risiko for fødselsdefekter ved eksponering for lopinavir/ritonavir blandt mere end 1000 kvinder, som blev eksponeret i første trimester.
English: The enrolled population was moderately PI-experienced with more than half of patients having never received prior PI and around 80% of patients presenting a viral strain with less than 3 PI mutations.
Danish: Den deltagende population var moderat PI-erfarne med mere end halvdelen af patienterne, som aldrig tidligere havde fået PI og omkring 80 % af patienterne, som havde en virusstamme med mindre end 3 PI-mutationer.
English: At least 13 lopinavir oxidative metabolites have been identified in man.
Danish: Der er identificeret mindst 13 lopinavirmetabolitter i mennesket.
English: Lopinavir/ritonavir has not specifically been tested for its possible effects on the ability to drive a car or operate machines.
Danish: Lopinavir/ritonavir er ikke specifikt afprøvet med hensyn til mulige virkninger på evnen til at køre bil eller betjene maskiner.
English: − Do not stop or change the daily dose of lopinavir/ritonavir without first consulting with your doctor.
Danish: Du må ikke ændre eller holde op med at tage den daglige dosis lopinavir/ritonavir uden først at konsultere din læge.
English: Mylan SAS 117 Allee des Parcs 69800 Saint-Priest France
Danish: Mylan SAS 117 Allee des Parcs 69800 Saint-Priest Frankrig
English: In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Danish: Foruden opportunistiske infektioner kan autoimmune sygdomme (skyldes, at immunsystemet går til angreb på rask kropsvæv) også forekomme efter, at du er startet på at tage medicin til behandling af din hiv-infektion.
English: − Tell your doctor immediately if you are planning to have a baby, you are pregnant, think you may be pregnant or if you are breast-feeding.
Danish: Fortæl omgående din læge, hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, eller hvis du ammer.
English: Mild renal tubular degeneration was confined to mice exposed with at least twice the recommended human exposure; the kidney was unaffected in rats and dogs.
Danish: Let renal tubulær degenerering blev udelukkende observeret i mus, der blev eksponeret til mindst to gange den anbefalede humane eksponering, nyrerne var upåvirkede i rotter og hunde.
English: Of these, isolates from 96 nelfinavir-treated patients and 51 lopinavir/ritonavir-treated patients could be amplified for resistance testing.
Danish: Af disse kunne isolater fra 96 nelfinavir-behandlede forsøgspersoner og 51 lopinavir/ritonavir-behandlede forsøgspersoner undersøges ved amplifikation.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100) and not known (cannot be estimated from the available data).
Danish: De alvorligste er anført først: meget almindelig ( 1/10), almindelig ( 1/100 til  1/10), ikke almindelig (1/1000 til 1/100) og ikke kendt (kan ikke estimeres ud fra de forhåndenværende data).
English: Table 6 Mean (%CV) Steady-State Pharmacokinetic Parameters of Lopinavir in HIV-Infected Pregnant Women
Danish: Gennemsnitlige (% CV) steady-state farmakokinetiske parametre for lopinavir hos hiv-inficerede gravide kvinder
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you or your child. - Keep this leaflet.
Danish: Læs denne indlægsseddel grundigt, inden du eller dit barn begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger.
English: 1 See section 4.4: pancreatitis and lipids c.
Danish: 4.4: pankreatit og lipider c.
English: − Taking lopinavir/ritonavir as recommended should give you the best chance of delaying the development of resistance to the product.
Danish: Hvis du tager lopinavir/ritonavir som anbefalet, burde du få de bedste muligheder for at forsinke udvikling af resistens over for medicinen.
English: • No dose adjustment is required for lopinavir/ritonavir during pregnancy and postpartum.
Danish: • Der er ikke behov for dosisjustering af lopinavir/ritonavir under graviditet og postpartum.
English: Headache (including migraine), neuropathy (including peripheral neuropathy), dizziness, insomnia
Danish: Almindelig Hovedpine (inklusive migræne), neuropati (inklusive perifer neuropati), svimmelhed, søvnløshed
English: When you travel or need to stay in the hospital make sure you will have enough lopinavir/ritonavir to last until you can get a new supply.
Danish: Når du er på rejse eller skal indlægges på hospital, skal du sørge for at have tilstrækkeligt med lopinavir/ritonavir , indtil du kan få en ny forsyning.
English: Treatment of overdose with lopinavir/ritonavir is to consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Danish: Behandling af overdosering med lopinavir/ritonavir bør bestå i generelle forholdsregler såsom overvågning af vitale tegn og observation af patientens kliniske tilstand.
English: The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations and sinus tachycardia.
Danish: Kombinationen kan medføre forøget risiko for kardiovaskulære bivirkninger associeret med salmeterol, inklusive QTforlængelse, palpitationer og sinus takykardi.
English: Lamotrigine and Valproate Lamotrigine: AUC: ↓ 50%
Danish: Lamotrigin og valproat Lamotrigin: AUC: ↓ 50%
English: Since these patients had not previously been exposed to either lopinavir/ritonavir or efavirenz, part of the response may be attributed to the antiviral activity of efavirenz, particularly in patients harbouring highly lopinavir resistant virus.
Danish: Da disse patienter ikke tidligere har været udsat for hverken lopinavir/ritonavir eller efavirenz, kan en del af dette respons skyldes efavirenz' antivirale aktivitet, især hos patienter der er inficeret med virus med udtalt lopinavir-resistens.
English: Incremental resistance was most common in subjects whose baseline isolates had several protease inhibitor-associated mutations, but < 40-fold reduced susceptibility to lopinavir at baseline.
Danish: Forøgelse af resistens var mest almindelig i forsøgspersoner, hvis baseline-isolater havde adskillige proteasehæmmere-associerede mutationer, men < 40-gange formindsket følsomhed for lopinavir ved baseline.
English: − Always keep enough lopinavir/ritonavir on hand so you don't run out.
Danish: Sørg altid for at have tilstrækkeligt med lopinavir/ritonavir på lager, så du ikke løber tør.
English: 3 tablets (300/75 mg) 4 tablets (400/100 mg)
Danish: 3 tabletter (300/75 mg) 4 tabletter (400/100 mg)
English: - Your doctor has prescribed lopinavir/ritonavir to help to control your Human Immunodeficiency Virus (HIV) infection.
Danish: Din læge har ordineret lopinavir/ritonavir som hjælp til at kontrollere din hiv-infektion (humant immundefektvirus-infektion).
English: However, such a dose adjustment might be associated with ALT/AST elevations and with increase in gastrointestinal disorders.
Danish: Sådan en dosisjustering kan imidlertid være forbundet med ALT/ASTstigninger og med øgning i gastrointestinale lidelser.
English: Patients with pre-existing liver dysfunction including chronic hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Danish: Patienter med allerede eksisterende leverdysfunktion inklusiv kronisk hepatitis har en øget frekvens af leverfunktionsabnormiteter ved antiretroviral kombinationsbehandling og bør kontrolleres efter gældende praksis.
English: Telaprevir 750 mg three times daily
Danish: Telaprevir 750 mg tre gange daglig
English: − The usual adult dose is 400 mg/100 mg twice a day i.e. every 12 hours, in combination with other antiHIV medicines.
Danish: Den sædvanlige voksendosis er 400 mg/100 mg to gange dagligt, dvs. hver 12. time, sammen med andre anti-hiv-lægemidler.
English: All interaction studies, when otherwise not stated, were performed using lopinavir/ritonavir capsules, which gives an approximately 20% lower exposure of lopinavir than the 200/50 mg tablets.
Danish: Alle interaktionsstudier er, med mindre der er anført noget andet, udført med lopinavir/ritonavir kapsler, som giver en cirka 20% mindre eksposition af lopinavir end 200/50 mg tabletterne.
English: Please refer to the Aptivus Summary of Product Characteristics for additional information on the use of tipranavir, including genotypic predictors of response, in treatment of lopinavir-resistant HIV-1 infection.
Danish: Se venligt produktresuméet for Aptivis for yderligere information om anvendelsen af tipranavir, inklusiv genotype forudsigelse af respons, i behandling af lopinavir-resistent hiv-1-infektion.
English: It is therefore important that you remain under the supervision of your doctor while taking lopinavir/ritonavir.
Danish: Det er derfor vigtigt, at din læge fortsat overvåger dig, mens du tager lopinavir/ritonavir.
English: Adequate exposure to lopinavir/ritonavir may be achieved when a higher dose of lopinavir/ritonavir is used but this is associated with a higher risk of liver and gastrointestinal toxicity.
Danish: Man kan opnå tilstrækkelig eksposition til lopinavir/ritonavir, når man anvender en højere dosis af lopinavir/ritonavir, men dette er forbundet med en højere risiko for lever- og gastrointestinal toksicitet.
English: Interactions between lopinavir/ritonavir and co-administered medicinal products are listed in the table below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, once daily as “QD”, twice daily as “BID” and three times daily as "TID").
Danish: Interaktioner mellem lopinavir/ritonavir og lægemidler indgivet samtidig er opført i tabellen nedenfor (øgning er indikeret som “↑”, fald som “↓”, ingen ændring som “↔”, en gang daglig som “en gang dagligt”, to gange dagligt som “to gange dagligt” og tre gange dagligt som ”tre gange dagligt”).
English: Thereby, increasing the potential for sildenafilassociated adverse events (which include hypotension and syncope).
Danish: Dermed øges risikoen for sildenafilassocierede bivirkninger (som omfatter hypotension og synkope).
English: − Lopinavir/ritonavir should always be taken every day to help control your HIV infection, no matter how much better you feel.
Danish: Du skal altid tage lopinavir/ritonavir to gange daglig for at bidrage med kontrollere din hivinfektion, lige meget hvor meget bedre du føler dig.
English: Lopinavir binds to both alpha1-acid glycoprotein (AAG) and albumin however, it has a higher affinity for AAG.
Danish: Lopinavir bindes både til alfa-1syre glucoprotein (AAG) og albumin, men har støre affinitet overfor AAG .
English: The efficacy data favouring the twice-daily regimen are reinforced by a differential in pharmacokinetic parameters significantly favouring the twice-daily regimen (see section 5.2).
Danish: Disse effekt-data, som taler til fordel for regimet med to daglige doser, understøttes af forskelle i farmakokinetiske parametre, der er signifikant bedre for regimet med to daglige administrationer (se pkt.
English: The 4-oxo and 4hydroxymetabolite epimeric pair are the major metabolites with antiviral activity, but comprise only minute amounts of total plasma radioactivity.
Danish: 4-oxo- og 4-hydroxymetabolit epimere par er de primære metabolitter med antiviral effekt, men de udgør kun en lille del af den samlede plasmaradioaktivitet.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. tablet, dvs. den er i det væsentlige natrium-fri.
English: Dieselweg 25, 3752 Bunschoten The Netherlands
Danish: Dieselweg 25, 3752 Bunschoten Holland
English: The 19 isolates demonstrated a 4.3-fold increase in IC50 compared to baseline isolates (from 6.2- to 43-fold, compared to wild-type virus).
Danish: De 19 isolater demonstrerede en 4,3-gange stigning i IC50 sammenlignet med baseline-isolater (fra 6,2- til 43-gange, sammenlignet med vild-type virus).
English: − If you are currently using an oral contraceptive or using a patch contraceptive to prevent pregnancy, you should use an additional or different type of contraception (e.g. condom) as lopinavir/ritonavir may reduce the effectiveness of oral and patch contraceptives.
Danish: Hvis du i øjeblikket bruger et oralt præventionsmiddel eller et depotplaster til forebyggelse af graviditet, skal du bruge et supplerende eller en anden type præventionsmiddel (f.eks. kondom), da lopinavir/ritonavir kan forringe virkningen af orale præventionsmidler og depotplastre.
English: Lopinavir/ritonavir is an antiretroviral medicine.
Danish: Lopinavir/ritonavir er et antiretroviralt lægemiddel.
English: Protocol defined non-inferiority of once daily dosing compared with twice daily dosing was demonstrated if the lower bound of the 95% confidence interval for the difference in proportion of subjects responding (once daily minus twice daily) excluded -12% at Week 48.
Danish: Protokoldefineret non-inferioritet af dosering en gang dagligt sammenlignet med dosering to gange dagligt blev påvist, hvis den nedre grænse af 95 % konfidensintervallet for forskellen i forholdet af forsøgspersoner, som responderede (en gang dagligt minus to gange dagligt) udelukkede -12 % ved uge 48.