natgillin/translations-raw huggingface dataset:
Mens De er i behandling med Iscover: • Bør De fortælle Deres læge, at De er i behandling med Iscover, hvis De skal have foretaget en planlagt operation (også hos tandlægen), • Skal De også fortælle det til Deres læge med det samme, hvis De udvikler en medicinsk tilstand, der giver feber og blå mærker under huden, der kan fremstå som små røde prikker, med eller uden uforklarlig ekstrem træthed, forvirring, gulning af huden eller øjnene (gulsot) (se ’ BIVIRKNINGER ’) • Kan det tage lidt længere end normalt, før blødningen stopper, hvis De skærer Dem eller kommer til skade.
While you are taking Iscover: • You should tell your doctor if a surgery (including dental) is planned. • You should also tell your doctor immediately if you develop a medical condition that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see ‘POSSIBLE SIDE EFFECTS’). • If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Iscover må normalt ikke bruges samtidigt med medicin, der tages gennem munden, og som modvirker blodets størkning (orale antikoagulantia)
The use of oral anticoagulants (medicines used to reduce blood clotting) with Iscover is not recommended.
Hvis De har haft alvorlige brystsmerter (hjertekrampe (ustabil angina pectoris) eller hjertetilfælde),, vil Deres læge måske indlede behandlingen ved at give Dem 300 mg Iscover på en gang (1 tablet à 300 mg, eller 4 tabletter à 75 mg).
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Iscover (1 tablet of 300 mg or 4 tablets of 75 mg) once at the start of treatment.
Derefter er den normale dosis 1 tablet Iscover à 75 mg daglig, som indtages gennem munden alene eller i forbindelse med et måltid.
Then, the usual dose is one 75 mg tablet of Iscover per day to be taken orally with or without food, and at the same time each day.
Kontakt Deres læge eller tag på den nærmeste skadestue på grund af den øgede blødningsrisiko.
You should take Iscover for as long as your doctor continues to prescribe it.
Hvis De har glemt at tage Iscover:
If you take more Iscover than you should:
Hvis De glemmer at tage en tablet i over 12 timer, skal De blot tage den næste enkeltdosis til sædvanlig tid.
Contact your doctor or the nearest emergency department because of the increased risk of bleeding.
Kontakt Deres læge eller apoteket, før De holder op.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
forbindelse med blødninger, som viser sig under huden som små røde prikker, og/ eller forvirring (se ’ Vær ekstra forsigtig med at tage Iscover ’)
not associated with bleeding which appears under the skin as red pinpoint dots, and/or confusion (see ‘Take special care with Iscover’).
Den mest almindelige bivirkning (hos 1 til 10 patienter ud af 100) der er set med Iscover er blødning Blødning kan forekomme i form af blødninger fra mave eller tarm, blå mærker, hæmatom (usædvanlig blødning eller blodudtrædning i underhuden), næseblod, blod i urinen,.
The most common side effect (affects 1 to 10 patients in 100) reported with Iscover is bleeding.
I nogle enkelte tilfælde er der indberettet blødning i øjne, hoved, lunger eller led.
Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or
Iscover 300 mg filmovertrukne tabletter er aflange, lyserøde, og er præget på den ene side med tallet ’ 300 ’ og på den anden side med tallet "1332".
Iscover 300-mg tablets are oblong, pink, film-coated tablets engraved on one side with the number ‘300’ and on the other side with the number ‘1332’.
De udleveres i pakninger der indeholder 4x1, 30x1 eller 100x1 tabletter ialuminium perforerede dosisblister.
47 4x1, 30x1 and 100x1 tablets in all aluminium perforated unit-dose blisters.
Isentress er et lægemiddel, som indeholder det aktive stof raltegravir.
Isentress is a medicine that contains the active substance raltegravir.
Det leveres som en lyserød, oval tablet (400 mg).
It is available as pink, oval tablets (400 mg).
Isentress er et antiviralt lægemiddel.
Isentress is an antiviral medicine.
Det anvendes i kombination med andre antivirale lægemidler til behandling af voksne patienter smittet med humant immundefektvirus (hiv- 1), der er et virus, som forårsager erhvervet immundefektsyndrom (aids).
It is used in combination with other antiviral medicines to treat adults infected with human immunodeficiency virus (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Isentress anvendes kun til patienter, der allerede er i behandling for hiv, hvis en test viser, at virusset formerer sig i blodet på trods af behandlingen.
Isentress is only used in patients who are already being treated for their HIV infection, if tests show that the virus is multiplying in the blood despite treatment.
Behandling med Isentress bør indledes af en læge med erfaring i behandling af hiv- infektion.
Treatment with Isentress should be started by a doctor who has experience in the management of HIV infection.
Det gives som en tablet to gange dagligt med eller uden et måltid.
It is given as one tablet twice a day, with or without food.
Isentress bør anvendes med forsigtighed, når det anvendes til behandling af ældre patienter eller patienter med svære leverproblemer.
Care should be taken when it is given to elderly patients or patients with severe liver problems.
Raltegravir, det aktive stof i Isentress, er en integrasehæmmer.
The active substance in Isentress, raltegravir, is an integrase inhibitor.
Det blokerer et enzym kaldet integrase, som indgår i et trin i hiv- virussets formering.
It blocks an enzyme called integrase, which is involved in a step in the reproduction of HIV.
Når enzymet blokeres, kan virusset ikke formere sig normalt, hvorved spredningen af infektionen mindskes.
When the enzyme is blocked, the virus cannot reproduce normally, slowing down the spread of infection.
Når Isentress tages sammen med andre antivirale lægemidler, reduceres mængden af hiv i blodet og holdes på et lavt niveau.
Isentress, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Isentress helbreder ikke hiv- infektion eller aids, men det kan forsinke skaden på immunsystemet og udviklingen af infektioner og sygdomme forbundet med aids.
Isentress does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Virkningerne af Isentress blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Isentress were first tested in experimental models before being studied in humans.
Der gennemføres for øjeblikket to hovedundersøgelser af Isentress hos i alt 699 hiv - smittede patienter, som efter planen skal vare i op til tre år.
The two main studies of Isentress, still ongoing and scheduled to last up to three years, have included a total of 699 HIV-infected patients.
Alle patienterne har modtaget en ” optimeret baggrundsbehandling ” (en kombination af andre antivirale lægemidler, der vælges for hver enkelt patient ud fra, hvad der er størst sandsynlighed for vil nedbringe mængden af hiv i blodet)
All of the patients have been receiving ‘ optimised background therapy’ (a combination of other antiviral medicines chosen for each patient as it had the best chances of reducing the levels of HIV in the blood) to which either Isentress or placebo (a dummy treatment) has been added.
Reproduction is authorised provided the source is acknowledged. sammen med enten Isentress eller placebo (uvirksom behandling).
Reproduction is authorised provided the source is acknowledged.
Isentress var mere effektiv end placebo til at reducere virusbelastningen.
Isentress was more effective than placebo in reducing viral load.
Efter 16 uger havde 77% af de patienter, der fik Isentress sammen med den optimerede baggrundsbehandling, en virusbelastning på under 400 kopier/ ml blod sammenlignet med 42% af de patienter, der havde fået placebo sammen med den optimerede baggrundsbehandling.
After 16 weeks, 77% of the patients who took Isentress in addition to optimised background therapy had viral loads below 400 copies per millilitre of blood, compared with 42% of the patients who received placebo plus optimised background therapy.
CHMP vurderede også resultaterne efter 24 og 48 ugers behandling, som viste, at den opnåede virkning efter 16 uger blev fastholdt i mindst 48 uger.
The CHMP also considered the results seen after 24 and 48 weeks, which showed that the response seen at 16 weeks was sustained for at least 48 weeks.
De mest almindelige bivirkninger ved Isentress (set hos mellem 1 og 10 patienter ud af 100) er søvnløshed, svimmelhed, hovedpine, absominal distension (oppustethed), mavesmerter, konstipation, diarré, flatulens (luft i maven), kvalme, opkastninger, hyperhidrose (forøget svedafsondring), natlige hedeture, kløe, udslæt, ledsmerter, kraftesløshed, træthed og øget antal leverenzymer i blodet (alanin aminotransferase og aspartat aminotransferase), triglycerider (en form for fedt), creatinin kinase (et enzym, som findes i muskler) og lipase (et enzym, som findes i pancreas).
The most common side effects with Isentress (seen in between 1 and 10 patients in 100) are insomnia (difficulty sleeping), dizziness, headache, abdominal distension (bloating), abdominal (tummy) pain, constipation, diarrhoea, flatulence (gas), nausea (feeling sick), vomiting, hyperhidrosis (excessive sweating), night sweats, pruritus (itching), rash, arthralgia (joint pain), asthenia (weakness), fatigue (tiredness) and increased blood levels of liver enzymes (alanine aminotransferase and aspartate aminotransferase), triglycerides (a type of fat), creatinine kinase (an enzyme found in muscles) and lipase (an enzyme found in the pancreas).
Den fuldstændige liste over alle de indberettede bivirkninger ved Isentress fremgår af indlægssedlen.
For the full list of all side effects reported with Isentress, see the Package Leaflet.
Patienter, der kan være overfølsomme (allergiske) over for raltegravir eller andre af indholdsstofferne, bør ikke anvende Isentress.
Isentress should not be used in people who may be hypersensitive (allergic) to raltegravir or to any of the other ingredients.
Ligesom med andre anti- hiv- lægemidler risikerer patienter, der behandles med Isentress, at blive ramt af knoglevævsdød eller immunreaktiveringssyndrom (infektionslignende symptomer, der skyldes, at immunsystemet er ved at genvinde sin funktion).
As with other anti-HIV medicines, patients taking Isentress may be at risk of osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
I løbet af de kliniske undersøgelser udviklede patienter, der blev behandlet med Isentress, flere tilfælde af kræft end de patienter, der havde fået en optimeret baggrundsbehandling.
During the studies, patients receiving Isentress developed more cancers than patients receiving optimised background therapy.
Det vides ikke, om disse kræfttilfælde skyldtes Isentress.
It is not known if these cancers were due to Isentress.
Udvalget for Humanmedicinske Lægemidler konkluderede, at fordelene ved Isentress i kombination med andre antiretrovirale lægemidler opvejer risiciene ved behandling af hiv- 1- infektion i behandlingserfarne voksne patienter med påvist hiv- 1- formering på trods af igangværende antiretroviral behandling.
The Committee for Medicinal Products for Human Use (CHMP) decided that Isentress’ s benefits, when taken in combination with other antiretroviral medicinal products, outweigh its risks for the treatment of HIV-1 infection in treatment-experienced adult patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
Indikationen er baseret på data efter 48 ugers behandling fra to undersøgelser, hvor produktet blev sammenlignet med placebo.
This indication is based on 48-week data from two studies comparing it with placebo.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Isentress.
The Committee recommended that Isentress be given marketing authorisation.
Isentress er blevet godkendt under særlige omstændigheder.
Isentress has been given ‘ Conditional Approval’.
Det betyder, at der vil blive tilvejebragt yderligere oplysninger om lægemidlet.
This means that there is more evidence to come about the medicine.
Hvert år gennemgår Det Europæiske Lægemiddelagentur (EMEA) alle nye oplysninger, der måtte være tilgængelige, og opdaterer om nødvendigt dette sammendrag.
Every year, the European Medicines Agency (EMEA) will review any new information that may become available, and this summary will be updated as necessary.
Hvilke oplysninger afventes der stadig for Isentress?
What information is still awaited for Isentress?
Firmaet, som fremstiller Isentress, vil indlede undersøgelser med henblik på at undersøge udviklingen af resistens over for raltegravir.
The company that makes Isentress will set up studies to monitor the development of resistance to raltegravir.
Andre oplysninger om Isentress:
Other information about Isentress:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Isentress til Merck Sharp & Dohme Limited den 20. december 2007.
The European Commission granted a marketing authorisation valid throughout the European Union for Isentress to Merck Sharp & Dohme Limited on 20 December 2007.
Den fuldstændige EPAR for Isentress findes her.
The full EPAR for Isentress can be found here.
Dette sammendrag er sidst ajourført i 12- 2008.
This summary was last updated in 12-2008.
EU- nummer EU/ 1/ 07/ 436/ 001 EU/ 1/ 07/ 436/ 002
EU Number EU/ 1/ 07/ 436/ 001 EU/ 1/ 07/ 436/ 002
Særnavn ISENTRESS ISENTRESS
Invented name ISENTRESS ISENTRESS
Styrke 400 mg 400 mg
Strength 400 mg 400 mg
Lægemiddelform Filmovertrukne tabletter Filmovertrukne tabletter
Pharmaceutical Form Film-coated tablets Film-coated tablets
Indgivelsesvej Oral anvendelse Oral anvendelse
Route of Administration Oral use Oral use
Pakningsstørrelse 60 tabletter 180 (3x60) tabletter
Package size 60 tablets 180 (3x60) tablets
Hver tablet indeholder 26, 06 mg lactosemonohydrat.
Each tablet contains 26.06 mg lactose monohydrate.
ISENTRESS er, i kombination med andre antiretrovirale lægemidler, indiceret til behandling af human immundefekt virus (HIV- 1) infektion hos behandlingserfarne voksne patienter med evidens for HIV - 1- replikation på trods af igangværende antiretroviral behandling.
ISENTRESS is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-experienced adult patients with evidence of HIV-1 replication despite ongoing anti-retroviral therapy.
Denne indikation er baseret på effekt - og sikkerheds- data fra to dobbeltblindede, placebokontrollerede undersøgelser af 48 ugers varighed hos behandlingserfarne patienter (se 5. 1).
This indication is based on safety and efficacy data from two double-blind, placebo-controlled trials of 48 weeks duration in treatment-experienced patients (see section 5.1).
4. 4 og 5. 1).
ISENTRESS should be used in combination with other active anti-retroviral therapies (ARTs) (see sections 4.4 and 5.1).
Dosering Voksne Den anbefalede dosering for ISENTRESS er 400 mg to gange dagligt med eller uden føde.
Posology Adults The recommended dosage of ISENTRESS is 400 mg administered twice daily with or without food.
Fødeindtagelses virkning på absorption af raltegravir er uvis (se pkt.
The effect of food on absorption of raltegravir is uncertain (see section 5.2).
Tabletterne bør ikke tygges, knuses eller deles.
It is not recommended to chew, crush or split the tablets.
5. 2).
Elderly There is limited information regarding the use of ISENTRESS in the elderly (see section 5.2).
5. 1 og 5. 2).
Children and adolescents Safety and efficacy have not been established in patients below 16 years of age (see sections 5.1 and 5.2).
5. 2).
Renal impairment No dosage adjustment is required for patients with renal impairment (see section 5.2).
2 Leverinsufficiens Dosisjustering er ikke nødvendig hos patienter med mild til moderat leverinsufficiens.
2 Hepatic impairment No dosage adjustment is required for patients with mild to moderate hepatic impairment.
Sikkerhed for og effekt af ISENTRESS er ikke påvist hos patienter med svær tilgrundliggende leversygdom.
The safety and efficacy of ISENTRESS have not been established in patients with severe underlying liver disorders.
4. 4 og 5. 2).
Therefore ISENTRESS should be used with caution in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Indgivelsesmåde Oral.
Method of administration Oral
Patienterne bør informeres om, at antiretroviral behandling hverken kan helbrede HIV eller er bevist at kunne forhindre overførsel af HIV til andre via blod eller seksuel kontakt.
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 or sexual contact.
Der bør stadig tages passende forholdsregler.
Appropriate precautions should continue to be employed.
4. 5 og 5. 2).
Overall, considerable inter- and intra-subject variability was observed in the pharmacokinetics of raltegravir (see sections 4.5 and 5.2).
Et bedre respons er observeret hos patienter med genotypisk sensitivitets- score (GSS) > 0.
Higher response rates were observed in patients with Genotypic Sensitivity Score (GSS) > 0.
Patienter med GSS eller fænotypisk sensitivitets- score (PSS) =0 havde større risiko for at udvikle resistens over for raltegravir (se pkt.
Patients with GSS or Phenotypic Sensitivity Score (PSS) = 0 had a higher risk of developing resistance to raltegravir (see section 5.1).
Raltegravir bør anvendes i kombination med mindst et andet aktivt antiretroviralt middel for at forstærke den gavnlige virkning, reducere risikoen for virologisk svigt og forhindre udvikling af resistens over for raltegravir.
Raltegravir should be used in combination with at least one other active agent to enhance benefit and to reduce the risk of virologic failure and development of resistance to raltegravir.
ISENTRESS 'sikkerhed og effekt er ikke påvist hos patienter med svær tilgrundliggende leversygdom.
The safety and efficacy of ISENTRESS have not been established in patients with severe underlying liver disorders.
4. 2 og 5. 2).
Therefore ISENTRESS should be used with caution in patients with severe hepatic impairment (see sections 4.2 and 5.2).
Hvis der er tegn på forværring af leversygdommen, bør det overvejes at afbryde eller stoppe behandlingen.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment should be considered.
Der er kun begrænsede data om brug af raltegravir hos patienter, der er koinficerede med HIV og hepatitis B- virus (HBV) eller hepatitis C- virus (HCV).
There are very limited data on the use of raltegravir in patients co-infected with HIV and hepatitis B virus (HBV) or hepatitis C virus (HCV).
Patienter med kronisk hepatitis B eller C, der har fået antiretroviral kombinationsbehandling, har større risiko for at få svære og potentielt fatale leverbivirkninger.
Patients with chronic hepatitis B or C and treated with combination anti-retroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse events.
Osteonekrose Selvom ætiologien anses for at være multifaktoriel (inklusive kortikosteroid anvendelse, alkoholforbrug, svær immunosuppression, højere BMI), er tilfælde af osteonekrose blevet observeret især blandt patienter med fremskreden HIV- sygdom og/ eller langvarig eksponering for antiretroviral kombinationsbehandling.
Osteonecrosis Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/ or long-term exposure to combination anti-retroviral therapy.
Patienterne bør tilrådes at søge lægehjælpved ledsmerter, ledstivhed eller bevægelsesbesvær.
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Immunreaktiveringssyndrom Blandt HIV- inficerede patienter med svær immuninsufficiens kan der ved påbegyndelse af antiretroviral kombinationsbehandling (CART) opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske patogener, som kan forårsage alvorlige kliniske tilstande eller forværring af symptomerne.
Immune reactivation syndrome In HIV-infected patients with severe immune deficiency at the time of institution of combination anti- retroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Relevante eksempler er cytomegalovirus retinitis, generaliserede og/ eller fokale mycobakterielle infektioner og pneumoni forårsaget af pneumocystis jiroveci (tidligere
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections and pneumonia caused by Pneumocystis jiroveci (formerly known as Pneumocystis carinii).
Forsigtighed bør udvises, når ISENTRESS administreres sammen med stærke inducere af uridindiphosphat glucuronyltransferase (UGT) 1A1 (f. eks. rifampicin).
3 Caution should be used when co-administering ISENTRESS with strong inducers of uridine diphosphate glucuronosyltransferase (UGT) 1A1 (e. g., rifampicin).
4. 5).
However, if co-administration with rifampicin is unavoidable, a doubling of the dose of ISENTRESS can be considered (see section 4.5).
Myopati og rhabdomyolyse har været rapporteret; men forbindelsen mellem ISENTRESS og disse hændelser er ikke afklaret.
Myopathy and rhabdomyolysis have been reported; however, the relationship of ISENTRESS to these events is not known.
4. 8).
Use with caution in patients who have had myopathy or rhabdomyolysis in the past or have any predisposing issues including other medicinal products associated with these conditions (see section 4.8).
Ved de kliniske undersøgelser med behandlingserfarne HIV- inficerede patienter, blev en mindre øgning i forekomsten af cancer observeret i raltegravirgruppen i sammenligning med gruppen, der kun fik optimeret baggrundsterapi.
During the clinical studies in treatment-experienced HIV-infected patients there was a slightly higher rate of cancer in the raltegravir group compared to the group that received only optimised background therapy.
4. 8).
At present there are insufficient data to be able to exclude the possibility that raltegravir might be associated with a risk of cancer (see section 4.8).
ISENTRESS indeholder lactose.
ISENTRESS contains lactose.
Patienter med sjældne, arvelige sygdomme som galactoseintolerance, Lapp lactasemangel eller glucose/ galactose malabsorption bør ikke tage denne medicin.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Raltegravir er ikke et substrat for cytochrom P450 (CYP) - enzymer, hæmmer ikke CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 eller CYP3A og inducerer ikke CYP3A4.
Raltegravir is not a substrate of cytochrome P450 (CYP) enzymes, does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A, and does not induce CYP3A4.
Raltegravir er ikke en hæmmer af UDP- glucuronosyltransferaser (UGTer) 1A1 og 2B7, og raltegravir hæmmer ikke P- glycoproteinmedieret transport.
Raltegravir is not an inhibitor of the UDP-glucuronosyltransferases (UGTs) 1A1 and 2B7, and raltegravir does not inhibit P-glycoprotein-mediated transport.
Baseret på disse data forventes ISENTRESS ikke at påvirke farmakokinetikken af lægemidler, der er substrater for disse enzymer eller P- glycoprotein.
Based on these data, ISENTRESS is not expected to affect the pharmacokinetics of medicinal products that are substrates of these enzymes or P-glycoprotein.