natgillin/translations-raw huggingface dataset:
Spørg din læge eller apoteket til råds, inden du tager nogen form for medicin.
Ask your doctor or hospital pharmacist for advice before taking any medicine.
SÅDAN SKAL DU BRUGE INTEGRILIN
HOW TO TAKE INTEGRILIN
INTEGRILIN gives i en vene ved direkte injektion efterfulgt af infusion (drop).
INTEGRILIN is given into the vein by direct injection followed by an infusion (drip solution).
Den sædvanlige dosis er 180 mikrogram/ kg indgivet som bolus (hurtig intravenøs injektion), efterfulgt af infusion (drop) på 2, 0 mikrogram/ kg/ minut i op til 72 timer.
The recommended dose is 180 microgram/ kg administered as a bolus (rapid intravenous injection), followed by an infusion (drip solution) of 2.0 microgram/ kg/ minute for up to 72 hours.
Hvis du har nedsat nyrefunktion, kan dosis blive nedsat til 1 mikrogram/ kg/ minut.
If you have kidney disease the infusion dose may be reduced to 1.0 microgram/ kg/ minute.
Hvis perkutan koronar intervention (PCI) foretages under behandlingen med INTEGRILIN, kan denne fortsættes i indtil 96 timer.
If percutaneous coronary intervention (PCI) is performed during INTEGRILIN therapy, the intravenous solution may be continued for up to 96 hours.
Du skal også have acetylsalicylsyre og heparin (med mindre du ikke kan tåle disse).
You must also be given doses of acetylsalicylic acid (aspirin) and heparin (if not contraindicated in your case).
Det er usandsynligt, at du får for en stor dosis INTEGRILIN.
It is unlikely that you will be given too large a dose of INTEGRILIN.
Hvis du imidlertid får en uventet eller svær blødning, skal behandlingen muligvis afbrydes.
However, if you have unexpected or severe bleeding, the intravenous solution may be discontinued.
I meget sjældne tilfælde kan der om nødvendigt gives en blodtransfusion.
In very rare cases, if necessary, a blood transfusion could be given.
INTEGRILIN kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, INTEGRILIN can cause side effects, although not everybody gets them.
Meget almindelig (det sker hos flere end 1 ud af 10 patienter):
Very common side effects These may affect more than 1 in 10 people − minor or major bleeding, (for example, blood in urine, blood in stool, vomiting blood, or bleeding with surgical procedures) − anaemia (decreased number of red blood cells).
Almindelig (det sker hos mellem 1 og 10 ud af 100 patienter):
42 Common side effects These may affect up to 1 in 10 people − inflammation of a vein.
42 Meget sjælden (det sker hos færre end 1 ud af 10. 000 patienter):
Uncommon These may affect up to 1 in 100 people − reduction in the number of platelets (blood cells necessary for blood clotting) − reduced blood flow to the brain.
- Alvorlig blødning (fx blødende mavesår, hjerneblødning, eller blødning i lungerne)
Very rare These may affect less than 1 in 10,000 people − serious bleeding (for example, bleeding inside the abdomen, inside the brain, and into the lungs) − fatal bleeding − severe reduction in the number of platelets (blood cells necessary for blood clotting) − skin rash (such as hives) − sudden, severe allergic reaction.
Hvis du bemærker nogen tegn på blødning, så kontakt straks læge eller sygeplejerske.
If you notice any signs of bleeding, notify your doctor or nurse immediately.
Blødning har i sjældne tilfælde vist sig at være meget alvorlig eller endog dødelig.
Very rarely, bleeding has become severe and even fatal.
Hvis du får en alvorlig allergisk reaktion eller kløende udslæt, så kontakt straks læge eller sygeplejerske.
If you develop severe allergic reaction or hives, notify your doctor or nurse immediately.
Øvrige bivirkninger, der kan forekomme hos patienter, der har behov for denne slags behandling, er forbundet med den sygdom, du behandles for, såsom hurtigt eller uregelmæssigt hjerteslag, lavt blodtryk, chok eller hjertestop.
Other events that may occur in patients who require this type of treatment, include those that are related to the condition you are having treated, such as rapid or irregular heart beat, low blood pressure, shock or cardiac arrest.
SÅDAN OPBEVARER DU INTEGRILIN
HOW TO STORE INTEGRILIN
Brug ikke INTEGRILIN efter den udløbsdato, der står på pakningen.
Do not use after the expiry date stated on the carton.
Opbevares i den originale yderpakning for at beskytte mod lys.
Keep the vial in the outer carton.
Det er ikke nødvendigt at beskytte INTEGRILIN mod lys under behandlingen.
However, protection of INTEGRILIN solution from light is not necessary during administration.
Brug ikke INTEGRILIN, hvis der er bundfald.
INTEGRILIN should not be used if it is noticed that particulate matter or discoloration is present.
Spørg på apoteket hvordan du skal aflevere medicinrester.
Any unused material after opening should be discarded.
INTEGRILIN indeholder:
FURTHER INFORMATION
- Aktivt stof( fer): eptifibatid 0, 75 mg/ ml
What INTEGRILIN contains − The active substance is 0.75 mg/ ml eptifibatide. − The other ingredients are citric acid monohydrate, sodium hydroxide and water for injections.
INTEGRILINS udseende og pakningstørrelse INTEGRILIN infusionsvæske:
What INTEGRILIN looks like and contents of the pack INTEGRILIN solution for infusion:
100 ml hætteglas, pakning med et hætteglas (anvendes sammen med INTEGRILIN injektionsvæske, opløsning).
100 ml vial, pack of one vial (to be used with INTEGRILIN solution for injection).
Klar, farveløs opløsning i 100 ml hætteglas, lukket med butylgummiprop og forseglet med krympesegl i aluminum.
The clear, colourless solution is contained in a 100 ml glass vial, which is closed with a butyl rubber stopper and sealed with a crimped aluminium seal.
43 Indehaveren af markedsføringstilladelsen og fremstiller
Marketing Authorisation Holder and manufacturer
Glaxo Group Ltd., Greenford, Middlesex, UB6 0NN, Storbritannien
UB6 0NN, United Kingdom
SP Labo N. V., Industriepark 30, B- 2220 Heist- op- den- Berg, Belgien
SP Labo N. V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium
Glaxo Operations UK Ltd., Harmire Road, Barnard Castle, Durham, DL12 8DT, Storbritannien
Glaxo Operations UK Ltd., (Trading as Glaxo Wellcome Operations), Harmire Road, Barnard Castle, Co. Durham, DL12 8DT, United Kingdom
44 Hvis du vil have yderligere oplysninger om INTEGRILIN, skal du henvende dig til den lokale repræsentant:
44 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
45 Italia GlaxoSmithKline S. p. A.
Italia GlaxoSmithKline S. p. A.
Denne indlægsseddel blev senest godkendt den {MM/ ÅÅÅÅ}
Tel: + 386 (0)1 280 25 00 medical. x. si@gsk. com
Du kan finde yderligere information om XXX på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
- INTEGRILIN anbefales kun til anvendelse hos voksne patienter indlagt på hjerteafdeling.
47 Take special care with INTEGRILIN: − INTEGRILIN is recommended for use only in adult, hospitalized patients in coronary care units. − INTEGRILIN is not intended for use in children or adolescents less than 18 years of age. − Before and during your treatment with INTEGRILIN, samples of your blood will be tested as a safety measure to limit the possibility of unexpected bleeding. − During use of INTEGRILIN, you will be checked carefully for any signs of unusual or unexpected bleeding.
48 Ikke almindelig (det sker hos mellem 1 og 10 ud af 1. 000 patienter):
48 Common side effects These may affect up to 1 in 10 people − inflammation of a vein
Meget sjælden (det sker hos færre end 1 ud af 10. 000 patienter):
Uncommon These may affect up to 1 in 100 people − reduction in the number of platelets (blood cells necessary for blood clotting) − reduced blood flow to the brain
Øvrige bivirkninger, der kan forekomme hos patienter, der har behov for denne slags behandling, er forbundet med den sygdom, du behandles for, såsom hurtigt eller uregelmæssigt hjerteslag, lavt blodtryk, chok eller hjertestop.
Other events that may occur in patients who require this type of treatment include those that are related to the condition you are having treated, such as rapid or irregular heart beat, low blood pressure, shock or cardiac arrest.
- Øvrige indholdsstoffer: citronsyre, natriumhydroxid og vand til injektionsvæske
What INTEGRILIN contains − The active substance is 2 mg/ ml eptifibatide. − The other ingredients are citric acid monohydrate, sodium hydroxide and water for injections.
INTEGRILINS udseende og pakningstørrelse INTEGRILIN injektionsvæske:
What INTEGRILIN looks like and contents of the pack INTEGRILIN solution for injection:
10 ml hætteglas, pakning med et hætteglas (anvendes sammen med INTEGRILIN infusionsvæske, opløsning).
10 ml vial, pack of one vial (to be used with INTEGRILIN solution for infusion).
Klar, farveløs opløsning i 10 ml hætteglas, lukket med butylgummiprop og forseglet med krympesegl i
The clear, colourless solution is contained in a 10 ml glass vial, which is closed with a butyl rubber stopper and sealed with a crimped aluminium seal.
49 aluminum.
Marketing Authorisation Holder and manufacturer
Indehaver af markedsføringstilladelsen:
Glaxo Group Ltd, Greenford, Middlesex.
50 Hvis du vil have yderligere oplysninger om INTEGRILIN, skal du henvende dig til den lokale repræsentant:
50 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
51 Italia GlaxoSmithKline S. p. A.
Italia GlaxoSmithKline S. p. A.
Intelence er et lægemiddel, der indeholder det aktive stof etravirin.
Intelence is a medicine containing the active substance etravirine.
Det fås som hvide, ovale tabletter (100 mg).
It is available as white, oval tablets (100 mg).
Intelence er et antiviralt lægemiddel.
Intelence is an antiviral medicine.
Det anvendes til behandling af voksne, der er smittet med humant immundefektvirus type 1 (HIV- 1), som er et virus, der forårsager erhvervet immundefekt syndrom (aids).
It is used to treat adults who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Intelence anvendes kun hos patienter, der tidligere er blevet behandlet for deres HIV - infektion.
Intelence is only used in patients who have been treated for their HIV infection before.
Intelence skal anvendes sammen med andre antivirale lægemidler, som skal omfatte en "boosted proteasehæmmer".
Intelence must be used together with other antiviral medicines which have to include a ‘ boosted protease inhibitor’.
Behandlingen med Intelence skal indledes af en læge med erfaring i behandling af HIV- infektion.
Treatment with Intelence should be started by a doctor who has experience in the treatment of HIV infection.
Den anbefalede dosis Intelence er to tabletter to gange dagligt efter et måltid.
The recommended dose of Intelence is two tablets twice a day taken after a meal.
Rør godt rundt i vandet, indtil blandingen har et mælkeagtigt udseende, og drik det straks.
For patients who are unable to swallow the tablets, Intelence tablets can be dispersed by stirring them in a glass of water to form a milky solution, which has to be drunk immediately.
Intelence skal anvendes med forsigtighed til patienter, som har moderate leverproblemer.
Intelence should be used with caution in patients who have moderate problems with their liver.
Det anbefales ikke til patienter med alvorlige leverproblemer eller børn under 18 år, da der ikke foreligger oplysninger om dets sikkerhed og virkning i disse grupper.
It is not recommended for use in patients with severe liver problems or in patients under 18 years of age because of a lack of information on safety and effectiveness in these groups.
Der bør udvises forsigtighed ved anvendelse til patienter over 65 år, da der foreligger begrænsede oplysninger om brug i denne aldersgruppe.
It should be used with caution in patients over 65 years of age because there is limited information on its use in this age group.
Det aktive stof i Intelence, etravirin, er en non- nukleosid revers transkriptase- hæmmer (NNRTI).
The active substance in Intelence, etravirine, is a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Det blokerer aktiviteten af revers transkriptase, et enzym, som produceres af HIV, og som gør det muligt for det at inficere celler i kroppen og producere mere virus.
It blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells in the body and make more viruses.
Ved at blokere dette enzym reducerer Intelence, når det tages i kombination med andre antivirale lægemidler, koncentrationen af HIV i blodet og holder den på et lavt niveau.
By blocking this enzyme, Intelence, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Intelence kurerer ikke HIV- infektion eller aids, men det kan udsætte beskadigelsen af immunsystemet og udviklingen af infektioner og sygdomme, der er forbundet med aids.
Intelence 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 Intelence blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Intelence were first tested in experimental models before being studied in humans.
Intelence er blevet undersøgt i to hovedundersøgelser med i alt 1 203 voksne med HIV- infektion, som var blevet behandlet med lægemidler mod HIV, der ikke længere virkede, og som havde få eller ingen behandlingsmuligheder tilbage.
Intelence has been studied in two main studies involving a total of 1,203 HIV-infected adults who had been taking anti-HIV therapy that was not working any longer and who had few or no treatment options remaining.
I begge undersøgelser blev virkningen af Intelence sammenlignet med et placebo (fiktiv behandling), når det blev indtaget sammen med darunavir (en proteasehæmmer) samt mindst to andre antivirale lægemidler, som blev udvalgt for hver enkelt patient, da de havde de bedste chancer for at nedbringe HIV- niveauet i blodet.
Both studies compared the effectiveness of Intelence with that of placebo (a dummy treatment), when they were taken with boosted darunavir (a protease inhibitor), as well as at least two other antiviral medicines that were chosen for each patient as they had the best chances of reducing the levels of HIV in the blood.
Det primære effektmål var andelen af patienter, hvis mængde HIV i blodet (viral belastning) var under 50 kopier/ ml efter 24 ugers behandling.
The main measure of effectiveness was the number of patients with a level of HIV in the blood (viral load) that was below 50 copies/ ml after 24 weeks of treatment.
Intelence var mere effektivt end placebo til at nedbringe den virale belastning.
Intelence was more effective than placebo at reducing viral load.
Tages de to undersøgelser under et, var patienternes gennemsnitlige virale belastning 70 000 kopier/ ml ved undersøgelsernes start.
Looking at the two studies taken together, the average patients’ viral load was 70,000 copies/ ml at the start of the studies.
Efter 24 uger havde 59% af de patienter, der fik Intelence sammen med andre lægemidler mod HIV (353 ud af 599), en viral belastning under 50 kopier/ ml sammenlignet med 41% af patienterne, der fik placebo sammen med andre lægemidler mod HIV (248 ud af 604).
After 24 weeks, 59% of the patients taking Intelence in combination with other anti-HIV medicines (353 out of 599) had a viral load below 50 copies/ ml, compared with 41% of the patients taking placebo in combination with other anti-HIV medicines (248 out of 604).
De mest almindelige bivirkninger ved Intelence (observeret hos imellem 1 og 10 patienter af 100) er udslæt, diarré, kvalme, trombocytopeni (lavt antal blodplader), anæmi (lavt antal røde blodlegemer), perifer neuropati (nerveskader i hænder og fødder), hovedpine, gastroøsofageal refluks (syreopstød i spiserøret), opkastning, mavesmerter, flatulens (luft), gastritis (betændelse i mavesækkens slimhinde), nyresvigt, diabetes, hyperglykæmi (højt niveau af glukose i blodet), hypertension (højt blodtryk), træthed, angst og søvnløshed (problemer med at sove), unormale niveauer af fedt i blodet, stigninger i indholdet af visse proteiner i blodet og fald i antallet af neutrofiler (en type hvide blodlegemer).
The most common side effects with Intelence (seen in between 1 and 10 patients in 100) are rash, diarrhoea, nausea (feeling sick), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), peripheral neuropathy (nerve damage in the hands and feet), headache, gastro-oesophageal reflux disease (acid reflux into the gullet), vomiting, abdominal (tummy) pain, flatulence (wind), gastritis (inflammation of the stomach lining), kidney failure, diabetes, hyperglycaemia (high blood glucose levels), hypertension (high blood pressure), fatigue (tiredness), anxiety, and insomnia (difficuly sleeping), abnormal levels of fat in the blood, increases in blood levels of some proteins and decreases in neutrophils (a type of white blood cell).
Den fuldstændige liste over de indberettede bivirkninger ved Intelence fremgår af indlægssedlen.
For the full list of all side effects reported with Intelence, see the Package Leaflet.
Intelence bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for etravirin eller andre af indholdsstofferne.
Intelence should not be used in people who may be hypersensitive (allergic) to etravirine or any of the other ingredients.
Der er rapporteret om alvorlige hudreaktioner i forbindelse med Intelence (udslæt med vabler, typisk på læberne, i munden, i øjnene og nogle gange med afskalning af huden), og behandlingen med Intelence bør stoppes, hvis der opstår alvorlige hudreaktioner.
Severe skin reactions have been reported with Intelence (rash with blisters typically on lips, mouth and eyes, sometimes with skin peeling), and treatment with Intelence should be stopped if a severe skin reaction develops.
Ligesom med andre lægemidler mod HIV kan der ved brug af Intelence være risiko for, at patienterne får lipodystrofi (forandringer i fordelingen af kropsfedt), knoglenekrose (knoglevævsdød) eller immunreaktiveringssyndrom (symptomer på infektion, der skyldes, at immunsystemet genvinder sin funktion).
As with other anti-HIV medicines, patients taking Intelence may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Patienter med hepatitis B - eller C- infektion kan have øget risiko for leverbeskadigelse, når de tager Intelence.
Patients who have hepatitis B or C infection may be at an elevated risk of liver damage when taking Intelence.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Intelence er større end risiciene, når det anvendes i kombination med en boosted proteasehæmmer og andre antiretrovirale lægemidler til behandling af infektion med HIV- 1 hos antiretroviralt behandlingserfarne voksne patienter.
The Committee for Medicinal Products for Human Use (CHMP) decided that Intelence’ s benefits are greater than its risks when used in combination with a boosted protease inhibitor and other antiretroviral medicines for the treatment of HIV-1 infection in antiretroviral treatment-experienced adult patients.
Denne indikation er baseret på resultaterne af to undersøgelser af 24 ugers varighed af Intelence taget i kombination med andre lægemidler mod HIV, herunder darunavir boosted med ritonavir, der blev gennemført hos patienter med virus, der ikke reagerede på NNRTI' er eller proteasehæmmere.
This indication is based on the results of two 24-week studies of Intelence taken in combination with other anti-HIV medicines including darunavir boosted with ritonavir, which were carried out in patients with virus that was not responding to NNRTIs or protease inhibitors.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Intelence.
The Committee recommended that Intelence be given marketing authorisation.
Der er udstedt ” betinget godkendelse ” for Intelence.
Intelence has been given ‘ Conditional Approval’.
Det betyder, at der afventes yderligere dokumentation om lægemidlet, navnlig dets sikkerhed og virkning.
This means that there is more evidence to come about the medicine, in particular further information on its effectiveness and safety.
Det Europæiske Lægemiddelagentur (EMEA) vil hvert år gennemgå alle nye oplysninger, der måtte blive til rådighed, og vil ajourføre dette sammendrag, når der bliver behov for det.
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 Intelence?
What information is still awaited for Intelence?
Virksomheden, som fremstiller Intelence vil fremlægge de endelige 48 ugers- resultater af de to hovedundersøgelser af Intelence og vil gennemføre en supplerende undersøgelse for at påvise tilsvarende resultater hos patienter, der tager andre proteasehæmmere end boosted darunavir.
The company that makes Intelence will supply the final 48-week results of the two main studies with Intelence, and will conduct an additional study to demonstrate that similar results are also seen in patients taking protease inhibitors other than boosted darunavir.
2/ 3 Andre oplysninger om Intelence:
2/ 3 Other information about Intelence:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Intelence til Janssen- Cilag International NV den 28. august 2008.
The European Commission granted a marketing authorisation valid throughout the European Union for Intelence to Janssen-Cilag International NV on 28 August 2008.
Den fuldstændige EPAR for Intelence findes her.
The full EPAR for Intelence can be found here.
EU- nummer EU/ 1/ 08/ 468/ 001
EU/ 1/ 08/ 468/ 001
Særnavn INTELENCE
INTELENCE
Lægemiddelform Tablet
Tablet
Indgivelsesvej Oral brug
Oral use
Emballage Beholder (HDPE)
Bottle (HDPE)
Pakningsstørrelse 120 tabletter
120 tablets
Hver tablet indeholder 100 mg etravirin.
Each tablet contains 100 mg of etravirine.
Hver tablet indeholder 160 mg lactose.
Each tablet contains 160 mg lactose.
Ovale, hvide eller offwhite tabletter præget med "T125" på den ene side og "100" på den anden side.
White to off-white, oval tablet, debossed with “ T125” on one side and “ 100” on the other side.
4. 4, 4. 5 og 5. 1).
INTELENCE, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients (see sections 4.4, 4.5 and 5.1).
5. 1).
This indication is based on week 24 analyses from 2 randomised, double-blind, placebo-controlled Phase III trials in highly pre-treated patients with viral strains harbouring mutations of resistance to non-nucleoside reverse transcriptase inhibitors and protease inhibitors, where INTELENCE was investigated in combination with an optimised background regimen (OBR) which included darunavir/ ritonavir (see section 5.1).
Behandlingen bør iværksættes af en læge med erfaring i behandling af HIV- infektion.
Therapy should be initiated by a physician experienced in the management of HIV infection.
5. 2).
Adults The recommended dose of INTELENCE is 200 mg (two 100 mg tablets) taken orally twice daily (b. i. d.), following a meal (see section 5.2).
Patienter, som ikke kan synke INTELENCE- tabletterne hele, kan opløse tabletterne i et glas vand.
Patients who are unable to swallow INTELENCE tablets whole may disperse the tablets in a glass of water.
Når tabletterne er opløst, omrøres blandingen grundigt og drikkes straks.
Once dispersed, patients should stir the dispersion well and drink it immediately.
Glasset bør skylles med vand flere gange, og alt skyllevandet drikkes for at sikre, at hele dosis bliver indtaget.
The glass should be rinsed with water several times and each rinse completely swallowed to ensure the entire dose is consumed.