natgillin/translations-raw huggingface dataset:
Indehaver af markedsføringstilladelsen Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB Storbritannien
Marketing Authorisation Holder Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom
Hvis du vil have yderligere oplysninger om Emselex, skal du henvende dig til den lokale repræsentant:
If you have any questions about this medicine, please contact the local representative of the Marketing Authorisation Holder.
42 België/ Belgique/ Belgien Novartis Pharma N. V.
42 België/ Belgique/ Belgien Novartis Pharma N. V.
- Lægen har ordineret Emselex til dig personligt.
- This medicine has been prescribed only for you.
kan være skadeligt for andre, selvom de har de samme symptomer, som du har.
even if their symptoms are the same as yours.
45 Vær ekstra forsigtig med at tage Emselex: • hvis du har autonom neuropati – din læge vil have fortalt dig det, hvis du lider af dette. • hvis du har halsbrand og opstød. • hvis du har besvær med at komme af med urinen og en svag urinstråle. • hvis du lider af svær forstoppelse (2 eller færre gange afføring om ugen). • hvis du har en obstruktiv mave- tarmlidelse – din læge vil have fortalt dig, hvis du lider af dette. • hvis du er i behandling for højt tryk i øjet (snævervinklet glaukom). • hvis du har en leversygdom. • hvis du har en nyresygdom.
45 Take special care with Emselex: • if you have autonomic neuropathy - your doctor will have told you if you have this. • if you have heartburn and belching. • if you have difficulties in passing urine and a weak stream of urine. • if you have severe constipation (less than or equal to 2 bowel movements per week). • if you have an obstructive gastrointestinal disorder - your doctor will have told you if you have this. • if you are receiving treatment for narrow-angle glaucoma. • if you have liver problems. • if you have kidney problems.
Emselex kan dog, som andre antimuskarine lægemidler, give bivirkninger så som svimmelhed, sløret syn, søvnproblemer og døsighed.
However, Emselex, like other antimuscarinic medicines, may cause effects such as dizziness, blurred vision, trouble sleeping or drowsiness.
46 For voksne og ældre er den anbefalede startdosis 7, 5 mg daglig.
46 For adults and older people, the recommended starting dose is 7.5 mg daily.
Det er derfor vigtigt at tage Emselex som beskrevet ovenfor.
Therefore, it is important to keep taking Emselex correctly, as described above.
Du må ikke stoppe behandlingen med Emselex før din læge siger, at du skal.
Do not stop taking Emselex until your doctor tells you to.
47 Almindelige bivirkninger (opleves af mindre end 10 af hver 100 patienter) Hovedpine, mavesmerter, nedsat fordøjelse, utilpashed, tørre øjne.
47 Common side effects (affecting less than 10 in every 100 patients) Headache, abdominal pain, indigestion, feeling sick, dry eyes.
Hver tablet indeholder 15 mg darifenacin.
Each tablet contains 15 mg darifenacin.
polyethylenglycol, talcum, titandioxid (E171), rød jernoxid (E172) og gul jernoxid (E172).
stearate, polyethylene glycol, talc, titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172).
Udseende og pakningsstørrelser Emselex 15 mg depottabletter er runde, konvekse, let ferskenfarvede tabletter, som er prægede med ” DF ” på den ene side og ” 15 ” på den anden.
What Emselex looks like and contents of the pack Emselex 15 mg prolonged-release tablets are round, convex light peach tablets and are debossed with “ DF” on one side and “ 15” on the other.
Hvis du vil have yderligere oplysninger om Emselex, skal du henvende dig til den lokale repræsentant:
48 If you have any questions about this medicine, please contact the local representative of the Marketing Authorisation Holder.
48 België/ Belgique/ Belgien Novartis Pharma N. V.
België/ Belgique/ Belgien Novartis Pharma N. V.
49 Lietuva Novartis Pharma Services Inc.
Lietuva Novartis Pharma Services Inc.
Det leveres som hvide og lyseblå kapsler (200 mg) og som oral opløsning (10 mg/ ml).
It is available as white and light blue capsules (200 mg) and as an oral solution (10 mg/ ml).
Dette virus er årsag til aids (erhvervet immundefektsyndrom).
It is used in combination with other antiviral medicines to treat adults and children infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Hos patienter, der tidligere har fået medicin mod deres hiv- infektion, uden at denne medicin har virket, bør lægen, inden Emtriva ordineres, gennemgå patientens tidligere antivirale medicin og vurdere chancen for, at infektionen med det pågældende virus kan behandles med nogle af de andre nye antivirale lægemidler, der eventuelt kan ordineres.
For patients who have taken medicines to treat their HIV infection before and failed to respond to that treatment, doctors should only prescribe Emtriva once they have looked at the antiviral medicines the patient has taken before and assessed the likelihood of the virus ’ s response to any new antiviral medicines that might be prescribed.
Påbegyndelse af behandling med Emtriva bør foretages af en læge med erfaring i behandling af hiv - infektion.
Treatment with Emtriva should be initiated by a doctor who has experience in the treatment of HIV infection.
De yderligere oplysninger fremgår af indlægssedlen.
For more information, see the Package Leaflet.
Når Emtriva anvendes i kombination med andre antivirale lægemidler, nedsætter det hiv- mængden i blodet og holder den nede.
Emtriva, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Emtriva helbreder ikke hiv- infektion eller aids, men kan sinke den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
Emtriva 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.
I den første undersøgelse blev Emtriva sammenlignet med stavudin (et andet antiviralt lægemiddel).
Emtriva has been studied in three main studies including 1,498 HIV-infected adults.
Undersøgelsen omfattede 571 voksne, der var "behandlingsnaive" (dvs. ikke tidligere behandlet for hiv- infektion).
The first study compared Emtriva with stavudine (another antiviral medicine) in 571 treatment-naïve adults (who had not received treatment for their HIV infection before).
Lægemidlerne blev her anvendt i kombination med stavudin og enten efavirenz eller nevirapin (andre antivirale lægemidler).
The second study compared Emtriva with lamivudine (another antiviral medicine) in 468 treatment-naïve adults, in combination with stavudine and either efavirenz or nevirapine (other antiviral medicines).
I denne undersøgelse sammenlignedes virkningen af på den ene side at erstatte lamivudin med Emtriva og på den ene side at lade patienterne fortsætte på den kombination af antivirale midler, de fik i forvejen.
The study compared the effects of replacing lamivudine with Emtriva, or remaining on the existing antiviral medicine combination.
To andre undersøgelser vedrørte virkningen af Emtriva i kombination med andre antivirale midler og omfattede 120 hiv- inficerede patienter mellem 4 måneder og 18 år.
The effectiveness of Emtriva, in combination with other antiviral medicines, was also assessed in two studies including 120 HIV-infected patients aged between four months and 18 years.
Emtriva, kombineret med andre antivirale midler, mindskede virusindholdet hos hiv- inficerede patienter.
Emtriva, in combination with other antiviral medicines, reduced viral loads in HIV-infected patients.
I den første undersøgelse af behandlingsnaive voksne var der flere patienter af dem, der fik Emtriva, som havde et virusindhold på under 50 kopier/ ml efter 24 ugers behandling, end af dem, der fik stavudin (henholdsvis 81% og 70%%).
In the first study of treatment-naïve adults, more patients taking Emtriva had viral loads below 50 copies/ ml after 24 weeks of treatment than those taking stavudine (81% and 70%, respectively).
Denne forskel holdt sig efter 48 ugers behandling (73% og 56%).
This difference was maintained after 48 weeks of treatment (73% and 56%).
Efter 48 uger havde ca. to tredjedele af patienterne et virusindhold under 400 kopier/ ml, og en lidt mindre del havde et virusindhold under 50 kopier/ ml.
In the second study, Emtriva was as effective as lamivudine: after 48 weeks, around two thirds of the patients had viral loads below 400 copies/ ml, and slightly fewer had viral loads below 50 copies/ ml.
Hos tidligere behandlede patienter opnåede en ligeså stor andel af de patienter, der skiftede fra lamivudin til Emtriva, et virusindhold under 400 kopier/ ml, som af dem, der fortsatte med at tage lamivudin (henholdsvis 73 og 82%) efter 48 uger.
In treatment- experienced patients, the number of patients switching from lamivudine to Emtriva with viral loads below 400 copies/ ml was similar to the number who continued taking lamivudine after 48 weeks (73% and 82%, respectively).
Som med anden hiv- medicin kan patienter, der får Emtriva, få lipodystrofi (ændret fedtfordeling i kroppen), osteonekrose (knoglevævsdød) eller immunreaktiveringssyndrom (infektionslignende symptomer, der skyldes, at immunsystemet genvinder sin funktion).
As with other anti-HIV medicines, patients taking Emtriva 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).
Nyfødte børn, hvis mødre har fået Emtriva under graviditeten, kan få mitokondriel dysfunktion (beskadigelse af de energiproducerende cellebestanddele med blodproblemer til følge).
As with all other NRTIs, Emtriva may also cause lactic acidosis (a build-up of lactic acid in the body) and, in the babies of mothers taking Emtriva during pregnancy, mitochondrial dysfunction (damage to the energy-producing components within cells that can cause problems in the blood).
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Emtriva opvejer risiciene ved behandling af hiv- 1- inficerede voksne og børn, når det anvendes i kombination med andre antiretrovirale midler.
The Committee for Medicinal Products for Human Use (CHMP) decided that Emtriva’ s benefits are greater than its risks for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents.
Der er ikke erfaringer med anvendelse af Emtriva til patienter, hos hvilke anden medicin mod hiv ikke har virket.
The Committee noted that this indication is based on studies in patients who have not received HIV treatment before, or whose HIV is already well controlled with antiviral medicines, and that there was no experience of Emtriva in patients whose previous treatment for HIV was not working.
2/ 3 Andre oplysninger om Emtriva:
Other information about Emtriva:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Emtriva til Gilead Sciences International Limited den 24. oktober 2003.
The European Commission granted a marketing authorisation valid throughout the European Union for Emtriva to Gilead Sciences International Limited on 24 October 2003.
Den fuldstændige EPAR om Emtriva findes her
2/ 3 The full EPAR for Emtriva can be found here.
EU/ 1/ 03/ 261/ 001 EU/ 1/ 03/ 261/ 002
EU number EU/ 1/ 03/ 261/ 001 EU/ 1/ 03/ 261/ 002
Emtriva Emtriva
Invented name Emtriva Emtriva
200 mg 200 mg
Strength 200 mg 200 mg
Kapsel, hård Kapsel, hård
Pharmaceutical form Capsule, hard Capsule, hard
Oral anvendelse Oral anvendelse
Route of administration Oral use Oral use
Flaske (HDPE) Blister (Aclar/ poly - ethylen/ PVC)
Packaging Bottle (HDPE) Blister (Aclar/ polyethylene/ PVC)
30 kapsler 30 kapsler
Package size 30 capsules 30 capsules
Flaske (polyethylen - terephthalat)
Bottle (polyethylene terephthalate)
Hver hård kapsel indeholder 200 mg emtricitabin.
Each hard capsule contains 200 mg emtricitabine.
Hver kapsel har en hvid, uigennemsigtig hoveddel med en lyseblå, uigennemsigtig hætte.
Each capsule has a white opaque body with a light blue opaque cap.
Hver kapsel er påtrykt "200 mg" på hætten og "GILEAD" og [Gilead logo] på hoveddelen med sort farve.
Each capsule is printed with “ 200 mg” on the cap and “ GILEAD” and [Gilead logo] on the body in black ink.
Emtriva er indiceret til behandling af voksne og børn inficerede med HIV- 1 i kombination med andre antiretrovirale midler.
Emtriva is indicated for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents.
Denne indikation er baseret på undersøgelser af behandlingsnaive patienter og behandlingserfarne patienter med stabil, virologisk kontrol.
This indication is based on studies in treatment-naïve patients and treatment-experienced patients with stable virological control.
5. 1).
There is no experience of the use of Emtriva in patients who are failing their current regimen or who have failed multiple regimens (see section 5.1).
Behandlingen skal startes af en læge med erfaring i behandlingen af HIV- infektion.
Therapy should be initiated by a physician experienced in the management of HIV infection.
Den anbefalede dosis af Emtriva er én 200 mg hård kapsel, taget oralt, en gang daglig.
The recommended dose of Emtriva is one 200 mg hard capsule, taken orally, once daily.
Børn og unge mennesker op til 18 år:
Children and adolescents up to 18 years of age:
Den anbefalede dosis af Emtriva til børn og unge mennesker, som vejer mindst 33 kg, som kan synke hårde kapsler, er én 200 mg hård kapsel, taget oralt, en gang daglig.
The recommended dose of Emtriva for children and adolescents weighing at least 33 kg who are able to swallow hard capsules is one 200 mg hard capsule, taken orally, once daily.
Der foreligger ingen dokumentation med hensyn til virkningen og kun meget begrænset dokumentation vedrørende sikkerheden af emtricitabin hos børn under 4 måneder.
There are no data regarding the efficacy and only very limited data regarding the safety of emtricitabine in infants below 4 months of age.
Derfor bør Emtriva ikke anvendes hos børn yngre end 4 måneder.
Therefore Emtriva is not recommended for use in those aged less than 4 months.
5. 2.)
(For pharmacokinetic data in this age group, see section 5.2).
Se
Emtriva is also available as a 10 mg/ ml oral solution for use in infants older than 4 months of age, children and patients who are unable to swallow hard capsules and patients with renal insufficiency.
2 produktresumeet til Emtriva 10 mg/ ml oral opløsning.
Please refer to the Summary of Product Characteristics for Emtriva 10 mg/ ml oral solution.
5. 2).
2 presentations, 240 mg emtricitabine administered as the oral solution should provide similar plasma levels to those observed after administration of one 200 mg emtricitabine hard capsule (see section 5.2).
Der foreligger ingen data vedrørende sikkerhed og effekt hos patienter over 65 år.
There are no safety and efficacy data available in patients over the age of 65 years.
5. 2).
Emtricitabine is eliminated by renal excretion and exposure to emtricitabine was significantly increased in patients with renal insufficiency (see section 5.2).
4. 4).
Dose or dose interval adjustment is required in all patients with creatinine clearance < 50 ml/ min (see section 4.4).
Nedenstående skema giver retningslinjer for justering af dosisintervallet for 200 mg hårde kapsler i henhold til graden af nyreinsufficiens.
The table below provides dose interval adjustment guidelines for the 200 mg hard capsules according to the degree of renal insufficiency.
Sikkerheden og effekten af disse retningslinjer for justering af dosisintervallet er ikke blevet klinisk evalueret.
The safety and efficacy of these dose interval adjustment guidelines have not been clinically evaluated.
4. 4).
Therefore, clinical response to treatment and renal function should be closely monitored in these patients (see section 4.4).
Patienter med nyreinsufficiens kan også behandles ved indgivelse af Emtriva 10 mg/ ml oral opløsning for at give en reduceret daglig dosis af emtricitabin.
Patients with renal insufficiency can also be managed by administration of Emtriva 10 mg/ ml oral solution to provide a reduced daily dose of emtricitabine.
Se produktresumeet til Emtriva 10 mg/ ml oral opløsning.
Please refer to the Summary of Product Characteristics for Emtriva 10 mg/ ml oral solution.
Kreatininclearance (CLcr) (ml/ min)
Creatinine Clearance (CLcr) (ml/ min)
< 15 (svigt af nyrefunktion
< 15
med behov for periodisk hæmodialyse) * Anbefalet
(functionally anephric, requiring intermittent haemodialysis)* Recommended
Én 200 mg hård Én 200 mg hård Én 200 mg hård
One 200 mg hard One 200 mg hard One 200 mg hard One 200 mg hard
dosisinterval for 200 mg hårde kapsler
dose interval for 200 mg hard capsules
kapsel hver 24. time
capsule every 24 hours
kapsel hver 48. time
capsule every 48 hours
kapsel hver 72. time
capsule every 72 hours
kapsel hver 96. time
capsule every 96 hours
* Antager en 3 timers hæmodialysesession tre gange om ugen begyndende mindst 12 timer efter indgivelse af den sidste dosis af emtricitabin.
* Assumes a 3 h haemodialysis session three times a week commencing at least 12 h after administration of the last dose of emtricitabine.
Patienter med end- stage renal sygdom (End Stage Renal Disease, ESRD), behandlet med andre former for dialyse som f. eks. ambulant peritoneal dialyse, er ikke blevet undersøgt, og ingen dosisanbefalinger kan gives.
Patients with end-stage renal disease (ESRD) managed with other forms of dialysis such as ambulatory peritoneal dialysis have not been studied and no dose recommendations can be made.
Der foreligger ingen data, hvorpå der kan laves en dosisanbefaling til pædiatriske patienter med nyreinsufficiens.
No data are available on which to make a dosage recommendation in paediatric patients with renal insufficiency.
Der foreligger ingen data, hvorpå der kan laves en dosisanbefaling til patienter med leverinsufficiens.
No data are available on which to make a dose recommendation for patients with hepatic insufficiency.
5. 2).
However, based on the minimal metabolism of emtricitabine and the renal route of elimination it is unlikely that a dose adjustment would be required in patients with hepatic insufficiency (see section 5.2).
4. 4).
If Emtriva is discontinued in patients co-infected with HIV and HBV, these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
Emtriva bør ikke tages sammen med andre lægemidler, der indeholder emtricitabin eller lægemidler, der indeholder lamivudin.
Emtriva should not be taken with any other medicinal products containing emtricitabine or medicinal products containing lamivudine.
Emtricitabin anbefales ikke som monoterapi til behandling af HIV- infektion.
Emtricitabine is not recommended as monotherapy for the treatment of HIV infection.
Patienter, som får emtricitabin eller en anden antiretroviral behandling kan fortsætte med at udvikle opportunistiske infektioner og andre komplikationer af HIV- infektionen og bør derfor holdes under nøje klinisk observation af læger, som har erfaring i behandlingen af patienter med HIV- associerede sygdomme.
Patients receiving emtricitabine or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.
Patienter skal underrettes om, at det ikke er påvist, at antiretrovirale behandlinger, inklusiv emtricitabin, forebygger risikoen for overførsel af HIV til andre ved seksuel kontakt eller kontaminering af blod.
Patients should be advised that antiretroviral therapies, including emtricitabine, have not been proven to prevent the risk of transmission of HIV to others through sexual contact or blood contamination.
Der skal fortsat anvendes hensigtsmæssige forsigtighedsregler.
Appropriate precautions should continue to be used.
Patienter skal også oplyses om, at emtricitabin ikke helbreder HIV- infektion.
Patients should also be informed that emtricitabine is not a cure for HIV infection.
Nyrefunktion:
Renal function:
Emtricitabineksponering kan stige markant hos patienter med moderat eller svær nyreinsufficiens (kreatininclearance < 50 ml/ min), som får daglige doser af 200 mg emtricitabin som hårde kapsler eller 240 mg som oral opløsning.
Emtricitabine exposure may be markedly increased in patients with moderate or severe renal insufficiency (creatinine clearance < 50 ml/ min) receiving daily doses of 200 mg emtricitabine as hard capsules or 240 mg as the oral solution.
Derfor er enten en justering af dosisintervallet (med Emtriva 200 mg hårde kapsler) eller en reduktion i den daglige dosis af emtricitabin (med Emtriva 10 mg/ ml oral opløsning) nødvendig hos alle patienter med kreatininclearance < 50 ml/ min.
Consequently, either a dose interval adjustment (using Emtriva 200 mg hard capsules) or a reduction in the daily dose of emtricitabine (using Emtriva 10 mg/ ml oral solution) is required in all patients with creatinine clearance < 50 ml/ min.
4. 2 er baseret på farmakokinetiske data og modellering ved en enkelt dosis og er ikke blevet klinisk evalueret.
The safety and efficacy of the dose interval adjustment guidelines provided in section 4.2 are based on single dose pharmacokinetic data and modelling and have not been clinically evaluated.
4. 2 og 5. 2).
Therefore, clinical response to treatment and renal function should be closely monitored in patients treated with emtricitabine at prolonged dosing intervals (see sections 4.2 and 5.2).
4. 5).
Caution should be exercised when emtricitabine is co-administered with medicinal products that are eliminated by active tubular secretion as such co-administration may lead to an increase in serum concentrations of either emtricitabine or a co-administered medicinal product, due to competition for this elimination pathway (see section 4.5).
Lactatacidosis:
Lactic acidosis:
Lactatacidosis, som regel forbundet med steatosis hepatis, er blevet indberettet i forbindelse med brugen af nukleosidanaloger.
Lactic acidosis, usually associated with hepatic steatosis, has been reported with the use of nucleoside analogues.
Blandt de tidlige symptomer (symptomatisk hyperlaktatæmi) er godartede fordøjelsessymptomer (kvalme, opkastning og mavepine), uspecifik utilpashed, appetitløshed, vægttab, symptomer i åndedrætsorganer (hurtig og/ eller dyb vejrtrækning) eller neurologiske symptomer (herunder motorisk svaghed).
Early symptoms (symptomatic hyperlactataemia) include benign digestive symptoms (nausea, vomiting and abdominal pain), non-specific malaise, loss of appetite, weight loss, respiratory symptoms (rapid and/ or deep breathing) or neurological symptoms (including motor weakness).
Lactatacidosis har høj mortalitet og kan være forbundet med pancreatitis, leversvigt eller nyresvigt.
Lactic acidosis has a high mortality and may be associated with pancreatitis, liver failure or renal failure.
Lactatacidosis indtrådte som regel efter nogle få eller flere måneders behandling.
Lactic acidosis generally occurred after a few or several months of treatment.
Behandling med nukleosidanaloger bør seponeres i tilfælde af symptomatisk hyperlaktatæmi og metabolisk acidosis/ lactatacidosis, progressiv hepatomegali eller hurtigt stigende aminotransferaseniveauer.
Treatment with nucleoside analogues should be discontinued in the setting of symptomatic hyperlactataemia and metabolic/ lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
Patienter, som samtidig er inficeret med hepatitis C og behandles med alfa- interferon og ribavirin kan være udsat for særlig risiko.
Patients co-infected with hepatitis C and treated with alpha interferon and ribavirin may constitute a special risk.
Patienter med øget risiko bør følges nøje.
Patients at increased risk should be followed closely.
4 Lipodystrophia:
Lipodystrophy:
Antiretroviral kombinationsbehandling er blevet forbundet med omfordeling af legemsfedt (lipodystrophia) hos HIV- patienter.
Combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV patients.