FrancophonIA/ELRC3.0 huggingface dataset:
English: • shortness of breath
Danish: • følelse af varme
English: How to store Thyrogen
Danish: Hvis du har fået for meget Thyrogen
English: • if you have reduced kidney function and he will decide how much radioiodine to give you.
Danish: Lægen vil beslutte, hvor meget radioaktivt iod, du skal have.
English: VIAL
Danish: MedDRA
English: Thyrogen Thyroid Hormone Withdrawal (THW)
Danish: Seponering af thyroideahormon
English: Vascular disorders flushing
Danish: Vaskulære sygdomme rødme
English: • flu symptoms
Danish: • influenzasymptomer
English: Before You Start
Danish: Før du starter
English: Make sure you and your child are ready!
Danish: Sørg for, at du og dit barn er klar!
English: • Put your child in a safe place.
Danish: • Sæt dit barn på et sikkert sted.
English: • At the request of the the European Medicines Agency
Danish: • på anmodning fra Det Europæiske Lægemiddelagentur
English: • The dose will change over time.
Danish: • Dosis ændrer sig over tid.
English: Typically, such reactions have been observed within the first weeks or months of initiation of CART.
Danish: Typisk er sådanne reaktioner observeret inden for de første uger eller måneder efter initiering af CART.
English: Date of first authorisation: 20 December 2007 Date of latest renewal: 14 May 2014
Danish: Dato for første markedsføringstilladelse: 20. december 2007 Dato for seneste fornyelse: 14. maj 2014
English: Put everything in a clean, dry place.
Danish: Anbring det hele på et rent, tørt sted.
English: Do not stop taking it because:
Danish: Hold ikke op med at tage det da:
English: • Be sure you understand these instructions before you start.
Danish: • Vær sikker på, at du har forstået disse instruktioner, før du starter.
English: a clean glass
Danish: et rent glas
English: This kit has changed and may be different than the one you have used before.
Danish: Dette sæt er blevet ændret og kan være anderledes end det sæt, du tidligere har brugt.
English: Use a clock or timer to time for 45 seconds.
Danish: Brug et ur eller et stopur til at tage tid i 45 sekunder.
English: Stop when you get to the 10 mL mark.
Danish: Stop, når du kommer til 10 ml-mærket.
English: Sweeteners contained in this medicine may be harmful to teeth.
Danish: Sødemidlerne i dette lægemiddel kan være skadelige for tænderne.
English: • It is very important to take all your HIV medicines as prescribed and at the right times of day.
Danish: • Det er vigtigt at tage al din hiv-medicin som foreskrevet og på det rigtige tidspunkt på dagen.
English: Volume (Dose) of Suspension to be Administered
Danish: Volumen (dosis) af suspension, der skal administreres
English: This means that you may keep getting infections or other illnesses associated with HIV.
Danish: Dette betyder, at du måske bliver ved med at få infektioner eller andre sygdomme, der er forbundet med hiv.
English: The doctor will tell you if and when to stop giving Isentress to your baby.
Danish: Lægen vil fortælle dig, hvis og hvornår du skal stoppe med at give Isentress til din baby.
English: 15 to 18 days
Danish: 15 til 18 dage
English: • Wash your hands with soap and water.
Danish: • Vask dine hænder med vand og sæbe.
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Danish: Det muliggør løbende overvågning af benefit/risk-forholdet for lægemidler.
English: Choose the syringe you need
Danish: Vælg den sprøjte, du har brug for
English: At least 40
Danish: Mindst 40
English: However, breaking the tablets should be avoided whenever possible.
Danish: Deling af tabletterne bør dog så vidt muligt undgås.
English: Fill a glass with water
Danish: Fyld et glas med vand
English: • The amount of Isentress depends on your child'sage and weight, so it will change over time.
Danish: • Mængden af Isentress afhænger af dit barns alder og vægt, så den vil ændre sig over tid.
English: • suicide intention or attempt
Danish: • Selvmordshensigt eller -forsøg
English: Table 1 displays all available interaction study data along with recommendations for co-administration.
Danish: Tabel 1 viser alle tilgængelige data fra interaktionsstudier sammen med anbefalinger vedrørende samtidig administration.
English: During your child's first week of life, you will give Isentress 1 time a day.
Danish: I løbet af dit barns første leveuge skal du give Isentress 1 gang om dagen.
English: 2 years for unopened sachet.
Danish: 2 år i uåbnet foliepose.
English: • If you forget to take a dose, take it as soon as you remember it.
Danish: • Hvis du glemmer at tage en dosis, skal du tage den, så snart du kommer i tanke om det.
English: • The granules need to be mixed with water before use.
Danish: • Granulatet skal blandes med vand før anvendelse.
English: HIV-1 Exposed Neonates
Danish: Hiv-1-eksponerede nyfødte
English: • Your child's dose may be different from the one shown in this figure.
Danish: • Dit barns dosis kan være forskellig fra den dosis, der er vist i figuren.
English: Make sure to follow the instructions of your doctor.
Danish: Sørg for at følge anvisningerne fra din læge.
English: Additional formulations and strengths available
Danish: Yderligere tilgængelige formuleringer og styrker
English: Birth - 48 hours
Danish: Fødsel - 48 timer
English: You should keep seeing your doctor regularly while taking this medicine.
Danish: Du skal fortsætte med at gå til lægen regelmæssigt, imens du tager dette lægemiddel.
English: Give Isentress to your baby
Danish: Giv Isentress til din baby
English: Taking Isentress with food and drink See section 3.
Danish: Brug af Isentress sammen med mad og drikke Se punkt 3.
English: • It is very important that you measure the water and Isentress carefully using the correct syringe.
Danish: • Det er meget vigtigt, at du afmåler vandet og Isentress nøje med den korrekte sprøjte.
English: You will need both hands to prepare Isentress.
Danish: Du skal bruge begge hænder til at klargøre Isentress.
English: This may mean that the HIV virus will develop resistance to Isentress and become harder to treat.
Danish: Dette kan betyde, at hiv-virus vil udvikle resistens over for Isentress og dermed blive vanskeligere at behandle.
English: It is important that your child takes all of the prescribed dose (a little left in the syringe tip is OK).
Danish: Det er vigtigt, at dit barn får hele den ordinerede dosis (en lille rest i sprøjtespidsen er OK).
English: 3 to less than 20 kg Oral suspension
Danish: 3 til under 20 kg Oral suspension
English: Note: If the mother has taken ISENTRESS 2-24 hours before delivery, the infant's first dose should be given between 24-48 hours after birth.
Danish: Bemærk: Hvis moderen har taget ISENTRESS 2-24 timer før fødslen, skal spædbarnets første dosis gives mellem 24-48 timer efter fødslen.
English: Do not wash in the dishwasher.
Danish: Må ikke vaskes i opvaskemaskinen.
English: IMPORTANT: If your child does not take all of the prescribed dose or spits some of it out, call your doctor to find out what to do.
Danish: VIGTIGT: Hvis dit barn ikke tager hele den ordinerede dosis eller spytter noget af det ud igen, skal du kontakte lægen for at finde ud af, hvad du skal gøre.
English: • Take out what you need to make 1 dose and place on a clean surface:
Danish: • Tag de ting frem, som du skal bruge til at fremstille 1 dosis og placer dem på en ren overflade:
English: Frequencies are defined as common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), and not known (cannot be estimated from the available data).
Danish: Hyppighed er defineret som almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: See section 5.2 regarding the limited data on which these dose recommendations are based.
Danish: 5.2 vedrørende de begrænsede data, som doseringsanbefalingerne er baseret på.
English: Remember that the dose may change each time you go to the doctor, so make sure you have all the recent information.
Danish: Husk, at dosis kan ændre sig, hver gang du har været til lægen, så sørg for, at du har alle de nyeste oplysninger.
English: 2 and above
Danish: 2 og højere
English: Do not take more tablets than the doctor recommends.
Danish: Tag ikke flere tabletter, end lægen anbefaler.
English: Use the dose amount in ‘mL' prescribed by the doctor.
Danish: Brug den dosismængde i ‘ml', som er ordineret af lægen.
English: The virus produces an enzyme called HIV integrase.
Danish: Virus producerer et enzym, der hedder hiv-integrase.
English: • Instructions (this booklet)
Danish: • Instruktioner (dette hæfte)
English: Dose (See Table 2)
Danish: Dosis (se tabel 2)
English: Passing HIV to others
Danish: Overførsel af hiv-infektion til andre
English: Sensitivity score (GSS)
Danish: Sensitivitets-score (GSS)
English: No data are available in this population and no dosing recommendations can be made.
Danish: Der foreligger ingen data for denne population, og der kan ikke gives doseringsanbefalinger.
English: Gender, race, ethnicity and body weight
Danish: Køn, race, etnicitet og kropsvægt
English: Common: the following may affect up to 1 in 10 people
Danish: Almindelige: følgende kan berøre op til 1 ud af 10 personer
English: • certain kinds of rash (more often when used in combination with darunavir)
Danish: • Visse former for udslæt (oftest ved anvendelse sammen med darunavir)
English: • Granules for oral suspension should be given to the patient within 30 minutes of mixing.
Danish: • Granulat til oral suspension skal gives til patienten inden for 30 minutter efter blanding.
English: See section 4.4 regarding the need to administer raltegravir with two other active agents.
Danish: 4.4 om nødvendigheden af at administrere raltegravir sammen med to andre aktive lægemidler.
English: During a short break in taking the medicine the amount of virus in your blood may increase.
Danish: Under en kort afbrydelse af medicinen kan mængden af virus i blodet stige.
English: This helps the virus to multiply in the cells in your body.
Danish: Dette hjælper virus med at formere sig i kroppens celler.
English: After reconstitution: 30 minutes when stored at or below 30 C.
Danish: Efter rekonstitution: 30 minutter ved opbevaring ved højst 30 °C.
English: Serious side effects - these are uncommon (may affect up to 1 in 100 people) See a doctor immediately, if you notice any of the following:
Danish: Alvorlige bivirkninger - disse er ikke almindelige (kan berøre op til 1 ud af 100 personer) Søg straks læge, hvis du bemærker en eller flere af følgende bivirkninger:
English: If you stop taking Isentress It is important that you take Isentress exactly as your doctor has instructed.
Danish: Hvis du holder op med at tage Isentress Det er vigtigt, at du tager Isentress nøjagtigt, som din læge har anvist.
English: The risk of developing cancer in these studies was similar in the groups receiving raltegravir and in the groups receiving comparators.
Danish: Risikoen for udvikling af cancer i disse studier var den samme i de grupper, som fik raltegravir og i de grupper, der fik sammenligningspræparater.
English: Your doctor may consider increasing your dose of Isentress if you are taking rifampicin.
Danish: Lægen kan overveje at øge din Isentress-dosis, hvis du tager rifampicin.
English: All interaction studies have been performed in adults.
Danish: Alle interaktionsstudier er kun udført hos voksne.
English: Gender, race and BMI
Danish: Køn, race og BMI
English: (Have one of each size ready, but you only need 1 or 2, depending on the size of the dose)
Danish: 3 sprøjter (Hav en af hver størrelse klar, men du får kun brug for 1 eller 2, afhængigt af dosisstørrelsen)
English: The types and rates of specific cancers were those expected in a highly immunodeficient population.
Danish: Type og hyppighed af de specifikke cancerformer svarede til dem, som kan forventes i en yderst immundeficient population.
English: After that, you will give it 2 times a day.
Danish: Herefter skal du give det til dit barn 2 gange om dagen.
English: For weight between 11 and 20 kg either formulation can be used.
Danish: Ved en vægt på mellem 11 og 20 kg kan begge formuleringer anvendes.
English: PET/aluminium/LLDPE sachets.
Danish: PET/aluminium/LLDPE folieposer.
English: Additional side effects in children and adolescents • hyperactivity
Danish: Yderligere bivirkninger hos børn og unge • Hyperaktivitet.
English: Children and adolescents 2 to 18 years of age
Danish: Børn og unge i alderen 2 til 18 år
English: Make sure the sachet is completely empty.
Danish: Sørg for, at folieposen er helt tom.
English: • Make sure the doctor, pharmacist or nurse explains how to mix and give the right dose to your child.
Danish: • Sørg for, at lægen, apotekspersonalet eller sygeplejersken forklarer dig, hvordan du skal blande og give den korrekte dosis til dit barn.
English: Adverse reactions Raltegravir (alone or in combination with other ART)
Danish: Bivirkninger Raltegravir (alene eller i kombination med anden ART)
English: If your child fusses, take the tip of the syringe out of the mouth and try again.
Danish: Hvis dit barn laver vrøvl, skal du tage sprøjtespidsen ud af munden og prøve igen.
English: Dose for children of 2 through 11 years of age
Danish: Dosis til børn i alderen 2 til 11 år
English: Note: Make sure your doctor shows you how to prepare and give Isentress for oral suspension.
Danish: Bemærk: Sørg for, at lægen viser dig, hvordan du skal klargøre og give Isentress til oral suspension.
English: Instructions for Use for babies
Danish: Brugsvejledning til babyer
English: It is unknown whether raltegravir/metabolites are excreted in human milk.
Danish: Det er ukendt, om raltegravir/metabolitter udskilles i human mælk.
English: Be sure to keep your doctor's appointments so you always know how much Isentress to give.
Danish: Sørg for at overholde alle besøg hos lægen, så du altid ved, hvor meget Isentress, du skal give.
English: Parents and/or caregivers should be instructed to read the instructions for use booklet before preparing and administering ISENTRESS granules for oral suspension to paediatric patients.
Danish: Forældre og/eller omsorgspersoner skal anmodes om at læse hæftet med brugsvejledningen før klargøring og administration af ISENTRESS granulat til oral suspension til pædiatriske patienter.
English: Fill the blue syringe with water
Danish: Fyld den blå sprøjte med vand
English: The dose recommended for neonates less than 4 weeks of age takes into consideration the rapidly increasing UGT1A1 activity and drug clearance from birth to 4 weeks of age.
Danish: Den anbefalede dosis til nyfødte, der er under 4 uger gamle, tager hensyn til den hurtigt stigende UGT1A1-aktivitet og lægemiddel-clearance fra fødsel til 4 ugers alderen.
English: Sources of variability may include differences in co-administration with food and concomitant medicines.
Danish: Årsager til variabiliteten kan omfatte forskelle i samtidig administration af mad og medicin.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections and pneumonia caused by Pneumocystis jiroveci (formerly known as Pneumocystis carinii).
Danish: Relevante eksempler er cytomegalovirus retinitis, generaliserede og/eller fokale mycobakterielle infektioner og pneumoni forårsaget af pneumocystis jiroveci (tidligere kendt som pneumocystis carinii).
English: Be sure you read and understand these instructions for use.
Danish: Sørg for, at du har læst og forstået disse instruktioner.
English: Tell your doctor, pharmacist or nurse if you have had problems with your liver before, including hepatitis B or C. Your doctor may evaluate how severe your liver disease is before deciding if you can take this medicine.
Danish: Fortæl det til lægen, apotekspersonalet eller sundhedspersonalet, hvis du tidligere har haft problemer med leveren, herunder hepatitis B eller C. Din læge kan vurdere, hvor alvorlig din leversygdom er, før han/hun beslutter, om du kan tage dette lægemiddel.
English: The 100 mg chewable tablet can be split into equal halves if necessary; however, breaking the tablets should be avoided.
Danish: 100 mg tyggetabletten kan deles i to lige store dele om nødvendigt; det skal dog helst undgås at bryde tabletterne.
English: Number with genotype available One patient had a mutation at the 155 position.
Danish: Antal patienter med tilgængelig genotype En patient havde en mutation ved position 155.
English: Reducing the amount of HIV in the blood may improve the functioning of your immune system.
Danish: Nedsættelse af hiv-mængden i blodet kan forbedre funktionen af immunforsvaret.
English: Choose the correct syringe for your child's dose:
Danish: Vælg den korrekte sprøjte til dit barns dosis:
English: The expiry date is printed on the carton and the Isentress sachets.
Danish: Udløbsdatoen er trykt på kartonen og folieposerne med Isentress.
English: UGT1A1 catalytic activity is negligible at birth and matures after birth.
Danish: UGT1A1-katalytisk aktivitet er ubetydelig ved fødslen og modnes efter fødslen.
English: Check to make sure the granules are mixed.
Danish: Kontroller, at granulatet er helt blandet.
English: Dosing is weight based from birth as specified in Table 1 and Table 2.
Danish: Dosering er vægtbaseret fra fødsel som specificeret i tabel 1 og tabel 2.
English: Patients should be advised that current anti-retroviral therapy does not cure HIV and has not been proven to prevent the transmission of HIV to others through blood contact.
Danish: Patienterne bør informeres om, at antiretroviral behandling hverken kan helbrede hiv eller er bevist at kunne forhindre overførsel af hiv til andre via blod.
English: (mechanism of interaction unknown)
Danish: (interaktionsmekanisme ukendt)
English: The tablets should not be chewed, crushed or split due to anticipated changes in the pharmacokinetic profile.
Danish: Tabletterne må ikke tygges, knuses eller deles på grund af forventede ændringer i den farmakokinetiske profil.
English: With twice-daily dosing, pharmacokinetic steady state is achieved rapidly, within approximately the first 2 days of dosing.
Danish: Med dosering to gange dagligt opnåedes farmakokinetisk steady state hurtigt, cirka inden for de første 2 dage af doseringen.
English: Raltegravir was administered with an optimised background regimen.
Danish: Raltegravir blev administreret med optimeret baggrundsregime.
English: • Do not start taking a new medicine without telling your doctor.
Danish: • Du må ikke begynde at tage ny medicin uden først at tale med lægen.
English: These median proportions are approximately 3- to 6-fold lower than the free fraction of raltegravir in plasma.
Danish: Disse gennemsnitlige mængdeforhold er ca. 3-6 gange lavere end den frie fraktion af raltegravir i plasma.
English: Raltegravir is approximately 83 % bound to human plasma protein over the concentration range of 2 to 10 µM.
Danish: Raltegravir er bundet ca. 83% bundet til det humane plasmaprotein i koncentrationsområdet 2-10 μM.
English: Do not chew, crush or split the tablets because it may change the level of medicine in your body.
Danish: Du må ikke tygge, knuse eller dele tabletterne, da dette kan ændre koncentrationen af medicin i kroppen.
English: After administration of the required volume, the remaining suspension in the mixing cup cannot be reused and must be discarded.
Danish: Efter administration af den påkrævede volumen må den overskydende suspension i blandebægeret ikke genbruges og skal bortskaffes.
English: • Store in the original package with the bottle tightly closed.
Danish: • Opbevares i den originale yderpakning med flasken tæt lukket.
English: The initial dose finding stage included intensive pharmacokinetic evaluation.
Danish: Den initiale dose finding fase omfattede intensiv farmakokinetisk evaluering.
English: Place the tip of the syringe inside your child's mouth so that it touches either the right or left cheek.
Danish: Placer sprøjtespidsen i dit barns mund, ind mod enten højre eller venstre kind.
English: • There will usually be some leftover, prepared Isentress in the mixing cup.
Danish: • Der vil som regel være en rest af klargjort Isentress i blandebægeret.
English: Therefore, no dose adjustment is required.
Danish: Dosisjustering er derfor ikke nødvendig.
English: HIV genomes that fail to integrate cannot direct the production of new infectious viral particles, so inhibiting integration prevents propagation of the viral infection.
Danish: Hiv-genomer, som ikke integrerer, kan ikke lede produktionen af nye infektiøse viruspartikler, så integrationshæmning hindrer udbredelse af virusinfektionen.
English: Clinical status including liver aminotransferases should be monitored and appropriate therapy initiated.
Danish: Klinisk status inklusive leveraminotransferaser bør monitoreres og hensigtsmæssig behandling initieres.
English: Isentress is used to treat adults, adolescents, children, toddlers and infants who are infected by HIV and to treat newborn babies exposed to HIV-1 infection from the mother.
Danish: Isentress bruges til behandling af voksne, unge, børn, småbørn og spædbørn, som er smittet med hiv, og til behandling af nyfødte babyer, som er blevet udsat for hiv-1-infektion fra moderen.
English: • However, if it is time for your next dose, skip the missed dose and go back to your regular schedule.
Danish: • Hvis det imidlertid er tid for din næste dosis, skal du springe den glemte dosis over og tage den næste tablet til sædvanlig tid.
English: If you do take too many tablets, contact your doctor.
Danish: Hvis du tager for mange tabletter, skal du kontakte lægen.
English: Uncommon: the following may affect up to 1 in 100 people
Danish: Ikke almindelige: følgende kan berøre op til 1 ud af 100 personer
English: Therefore, whenever possible, raltegravir should be administered with two other active ARTs to minimise the potential for virological failure and the development of resistance (see section 5.1).
Danish: Derfor bør raltegravir, når det er muligt, administreres sammen med to andre aktive ARTer for at minimere potentialet for virologisk svigt og udvikling af resistens (se pkt.
English: Check for air bubbles
Danish: Kontroller for luftbobler
English: Agents that increase gastric pH
Danish: Lægemidler, der øger gastrisk pH
English: Isentress stops this enzyme from working.
Danish: Isentress stopper virkningen af dette enzym.
English: Raltegravir was administered without regard to food in the pivotal safety and efficacy studies in HIV-infected patients.
Danish: Raltegravir blev administreret uden hensyntagen til mad i de centrale sikkerheds- og effektstudier hos hiv-inficerede patienter.
English: HORMONAL CONTRACEPTIVES Ethinyl Estradiol
Danish: HORMONEL ANTIKONCEPTION Ethinylestradiol
English: A carcinogenicity study of raltegravir in mice did not show any carcinogenic potential.
Danish: Et karcinogenicitetsstudie med raltegravir i mus viste ikke nogen potentiel karcinogenicitet.
English: The kit has an extra cup and set of syringes in case one is lost or damaged.
Danish: Dette sæt indeholder et ekstra blandebæger og et ekstra sæt sprøjter i tilfælde af, at et af disse bliver væk eller bliver beskadiget.
English: Two components, namely raltegravir and raltegravir-glucuronide, were detected in urine and accounted for approximately 9 and 23 % of the dose, respectively.
Danish: To komponenter, nemlig raltegravir og raltegravir-glucuronid, blev påvist i urinen og udgjorde henholdsvis cirka 9% og 23% af dosis.
English: Renal clearance of unchanged medicinal product is a minor pathway of elimination.
Danish: Renal clearance af uomdannet lægemiddel er en ubetydelig eliminationsvej.
English: Treatment-naïve adult patients
Danish: Behandlingsnaive voksne patienter
English: Gently swirl the mixing cup for 45 seconds in a circular motion to mix the granules and water.
Danish: Hvirvl forsigtigt blandebægeret rundt i 45 sekunder for at blande granulat og vand.
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Danish: Patienter med sjældne arvelige problemer med fructoseintolerans bør ikke tage dette lægemiddel.