natgillin/translations-raw huggingface dataset:
Der var ingen forskelle i forhold til doseringform (200 mg tabletter to gange dagligt eller depotform én gang dagligt).
There were no differences based on the formulation taken (immediate-release twice daily or prolonged-release once daily).
Enkeltdosis-farmakokinetikken af nevirapin er blevet sammenlignet mellem 23 patienter med enten let (50≤CLcr< 80 ml/min), moderat (30 ≤ CLcr < 50 ml/min) eller svært nedsat nyrefunktion (CLcr < 30 ml/min) eller dialysekrævende end-stage nyresygdom (ESRD) og 8 patienter med normal nyrefunktion (CLcr > 80 ml/min).
Renal impairment: The single-dose pharmacokinetics of nevirapine has been compared in 23 patients with either mild (50  CLcr  80 ml/min), moderate (30  CLcr  50 ml/min) or severe renal dysfunction (CLcr  30 ml/min), renal impairment or end-stage renal disease (ESRD) requiring dialysis, and 8 patients with normal renal function (CLcr  80 ml/min).
De nedenfor anførte frekvenser er baseret på incidensrater for bivirkninger set hos de grupper, der fik Viramune med umiddelbar frigivelse (optrapningsfase, tabel 1) og Viramune depottabletter (randomiseret /vedligeholdelse, tabel 2) i det kliniske studie 1100.1486, hvor 1.068 patienter blev behandlet med Viramune og tenofovir/emtricitabin som tillægsbehandling.
The frequencies given below are based on crude incidence rates of adverse reactions observed in the Viramune immediate-release (lead-in phase, table 1) and Viramune prolonged-release (randomised-phase/maintenance phase, table 2) groups of clinical study 1100.1486 with 1,068 patients exposed to Viramune on a backbone of tenofovir/emtricitabine.
Patienter i samtidig behandling med nevirapin og zidovudinog især pædiatriske patienter, patienter, som får højere doser af zidovudin, samt patienter med ringe knoglemarvsreserve, specielt patienter med fremskreden hiv-sygdom, har derfor øget risiko for granulocytopeni.
Therefore, patients who receive nevirapine and zidovudine concomitantly and especially paediatric patients and patients who receive higher zidovudine doses or patients with poor bone marrow reserve, in particular those with advanced HIV disease, have an increased risk of granulocytopenia.
Endvidere kan risikoen for hepatotoksicitet hos mor og barn ikke udelukkes i de tilfælde, hvor Viramune gives som enkeltdosis for at forebygge vertikal transmission af hiv-1-infektion.
Furthermore, in the case Viramune is used as single dose to prevent vertical transmission of HIV-1 infection, the risk of hepatotoxicity in mother and child cannot be excluded.
Især patienter med et hiv-1 viralt plasmaniveau på 50 kopier/ml eller flere og kvinder med CD4-celletal > 250 celler/mm
Predominantly patients with a plasma HIV-1 viral load of 50 copies/ml or higher, women with CD4 counts >250 cells/mm
Det er meget vigtigt, at du kun tager én Viramune tablet om dagen i de første 14 dage ("optrapningsperioden").
It is very important that you take only one Viramune tablet a day for the first 14 days (“lead-in” period).
Viramune oral suspension, hvor doseringen kan tilpasses efter vægt eller legemsoverfladeareal, kan anvendes til børn under 16 år, der vejer mindre end 50 kg, eller hvis legemsoverfladeareal er mindre end 1,25 m² (se produktresuméet for Viramune oral suspension).
An oral suspension dosage form, which can be dosed according to body weight or body surface area, is available for children in this age group weighing less than 50 kg or whose body surface area is below 1.25 m2 (please refer to the
Det anbefales ikke at coadministrere atazanavir/ritonavir og Viramune (se pkt.
It is not recommended to coadminister atazanavir/ritonavir and Viramune (see section 4.4).
Nogle patienter, som blev behandlet med nevirapin, udviklede alvorlige og livstruende hudreaktioner, herunder Stevens-Johnsons syndrom (SJS) og toksisk epidermal nekrolyse (TEN).
Severe and life-threatening skin reactions have occurred in patients treated with nevirapine, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
LÆGEMIDLETS NAVN Viramune 50 mg/5 ml, oral suspension
NAME OF THE MEDICINAL PRODUCT Viramune 50 mg/5 ml oral suspension
Patienter skal informeres om, at træthed kan optræde som en bivirking ved Viramune-behandlingen.
However, patients should be advised that they may experience adverse reactions such as fatigue during treatment with Viramune.
Sjælden (kan forekomme hos op til 1 ud af 1.000 patienter): - pludselig og alvorlig leverbetændelse (fulminant leverbetændelse) - lægemiddelforårsaget udslæt (med eosinofili og systemiske symptomer)
Rare (may affect up to 1 in 1000 people): - sudden and intense inflammation of the liver (fulminant hepatitis) - drug reaction with systemic symptoms (drug reaction with eosinophilia and systemic symptoms)
Nevirapin bør ikke bruges til patienter med svært nedsat leverfunktion (Child-Pugh C, se pkt.
Nevirapine should not be used in patients with severe hepatic impairment (Child-Pugh C, see section 4.3).
Enkeltdosis farmakokinetik for nevirapin med umiddelbar frigivelse er blevet sammenlignet mellem 23 patienter med enten let (50 ≤ CLcr < 80 ml/min, moderat (30 ≤ CLcr < 50 ml/min) eller svært nedsat nyrefunktion (CLcr < 30 ml/min) eller dialysekrævende end-stage nyresygdom (ESRD), og 8 patienter med normal nyrefunktion (CLcr > 80 ml/min).
Renal impairment: The single-dose pharmacokinetics of nevirapine immediate-release has been compared in 23 patients with either mild (50  CLcr  80 ml/min), moderate (30  CLcr  50 ml/min) or severe renal dysfunction (CLcr  30 ml/min), renal impairment or end-stage renal disease (ESRD) requiring dialysis, and 8 patients with normal renal function (CLcr  80 ml/min).
Hvis du får alvorlige hududslæt eller overfølsomhedsreaktioner (allergiske reaktioner som kan forekomme i form af hududslæt), samtidig med andre bivirkninger såsom - feber - blæredannelse - sår i munden - øjenbetændelse - hævelse i ansigtet - generel hævelse - åndenød - muskel- eller ledsmerter - generel følelse af at være syg - eller mavesmerter
If you experience severe rash or hypersensitivity (allergic reactions that may appear in the form of rash) accompanied by other side effects such as - fever, - blistering, - mouth sores, - inflammation of the eye, - swelling of the face, - general swelling, - shortness of breath, - muscle or joint pain, - general feelings of illness, - or abdominal pain
Hvis der opstår overfølsomhedsreaktioner, karakteriseret ved udslæt med konstitutionelle symptomer såsom feber, artralgi, myalgi og lymfadenopati samt organpåvirkning, såsom hepatitis, eosinofili, granulocytopeni og nyresvigt, skal nevirapin stoppes permanent og ikke genintroduceres (se pkt.
If a hypersensitivity reaction occurs, characterised by rash with constitutional symptoms such as fever, arthralgia, myalgia and lymphadenopathy, plus visceral involvement, such as hepatitis, eosinophilia, granulocytopenia, and renal dysfunction, nevirapine must be permanently stopped and not be reintroduced (see section 4.3).
Viramune tabletter skal sluges.
Only take Viramune tablets by mouth.
Patienter, som udvikler udslæt under de 14-dages lead-in periode, må ikke få initieret behandlingen med Viramune depottabletter, før udslættet er forsvundet.
Patients experiencing rash during the 14-day lead-in period should not initiate treatment with Viramune prolonged-release tablets until the rash has resolved.
Tag ikke Viramune hvis du er blevet udsat for hiv, med mindre du er blevet diagnosticeret med hiv og lægen har foreskrevet det. Viramune kan ikke helbrede en hiv-infektion.
Do not take Viramune after an exposure to HIV unless you have been diagnosed with HIV and instructed to do so by your doctor.
Legemsoverfladeareal (BSA) område (m
BSA range (m
- Aktivt stof: Nevirapin - Øvrige indholdsstoffer: - mikrokrystallinsk cellulose, - lactose (som monohydrat), - povidon, - natriumstivelsesglycolat, - kolloid silica og - magnesiumstearat.
- The other ingredients are: microcrystalline cellulose, lactose (as monohydrate), povidone K25, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate.
Lactose: Ved den maksimale, anbefalede daglige dosis af Viramune depottabletter indtages 400 mg lactose.
Lactose: Viramune prolonged-release tablets contain 400 mg of lactose per maximum recommended daily dose.
Dosis for børn er 4 mg/kg legemsvægt eller 150 mg/m² legemsoverfladeareal 1 gang dagligt i de første 14 dage af behandlingen (optrapningsfasen).
The dose for children is 4 mg/kg body weight or 150 mg/m2 body surface area once a day for the first
Zidovudin 100-200 mg 3 gange dagligt
Zidovudine 100-200 mg TID
Nogle risikofaktorer for at udvikle alvorlige kutane reaktioner er blevet identificeret og inkluderer undladelse i at følge den anbefalede lead-in dosis i løbet af optrapningsperioden og en lang forsinkelse mellem de første symptomer og lægekonsultation.
Some risk factors for developing serious cutaneous reactions have been identified; they include failure to follow the initial dosing during the lead-in period and a long delay between the initial symptoms and medical consultation.
I ACTG 245, et dobbeltblindt, placebokontrolleret studie, var forekomsten af alvorlig, lægemiddelrelateret granulocytopeni 5/305 (1,6 %).
In ACTG 245, a double-blind placebo controlled study, the frequency of serious medicinal product-related granulocytopenia was 5/305 (1.6 %).
55216 Ingelheim am Rhein Tyskland eller
55216 Ingelheim am Rhein Germany or
Viramune forhandles også som 200 mg tabletter til patienter på 16 år og derover eller til ældre børn specielt unge, der vejer 50 kg eller mere, eller hvis legemsoverfladearealet er over 1,25 m².
Viramune is also available as a 200 mg tablet for patients 16 years and older, or for older children, particularly adolescents, weighing 50 kg or more or whose BSA is above 1.25 m
LÆGEMIDLETS NAVN Viramune 50 mg/5 ml oral suspension nevirapin
NAME OF THE MEDICINAL PRODUCT Viramune 50 mg/5 ml oral suspension nevirapine
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 ml oral suspension indeholder 10 mg nevirapin (som hemihydrat)
STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of oral suspension contains 10 mg of nevirapine (as hemihydrate)
Behandlingsnaive kvindelige patienter og behandlingsnaive patienter med høje CD4-celletal ved initiering af behandling med nevirapin har en højere risiko for leverpåvirkninger.
Female gender and higher CD4 counts at the initiation of nevirapine therapy in treatment-naïve patients is associated with increased risk of hepatic adverse reactions.
Viramune 200 mg tabletter, kan anvendes i den ovenfor beskrevne dosering til større børn, specielt unge, der er yngre end 16 år, og som vejer mere end 50 kg eller hvis legemsoverfladeareal er mere end 1,25 m² i henhold til Mosteller formlen.
Viramune 200 mg tablets, following the dosing schedule described above, are suitable for larger children, particularly adolescents, below the age of 16 who weigh more than 50 kg or whose body surface area is above 1.25 m2 according to the Mosteller formula.
Som forklaret under ”Advarsler og forsigtighedsregler” så vil din læge følge dig ved at få undersøgt leverfunktionen eller undersøge dig for bivirkninger såsom hududslæt.
As explained in 'Warnings and precautions', above, your doctor will monitor you with liver tests or for undesirable effects such as rash.
Stivhed, ømhed og smerter i leddene (især hofte, knæ og skulder) samt besvær med at bevæge sig er tegn på knoglenekrose.
Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Mindre børn kan tage depottabletter i lavere styrker eller en oral suspension (mikstur).
For smaller children smaller prolonged-release tablets or an oral suspension liquid form are available.
De er ca. 9 mm i diameter, og præget med V01 og firmalogo.
The prolonged-release tablets are approximately 9 mm in diameter, debossed with V01 on one side and company symbol on the other side.
Lægen vil informere dig om den korrekte dosis til barnet og vil løbende kontrollere barnets vægt og legemsoverfladeareal, for at sikre den korrekte dosering.
Your child's doctor will continually check your child's weight or body surface area to ensure the correct dose.
I studie 1100.1090 blev bivirkningen granolucytopeni ( n=28) rapporteret hyppigere i placebogruppen (3,3%) end i nevirapingruppen (2,5%).
In study 1100.1090, from which the majority of related adverse events (n=28) were received, patients on placebo had a higher incidence of events of granulocytopenia (3.3 %) than patients on nevirapine
I studie 1100.1526 (TRANxITION) blev patienterne efter minimum 18 ugers behandling medViramune 200 mg tabletter to gange dagligt, randomiseret til enten Viramune 400 mg depottabletter én gang dagligt (n = 295) eller fortsætte behandling med Viramune 200 mg tabletter to gange dagligt (n = 148).
In study 1100.1526 (TRANxITION) patients on Viramune 200 mg immediate-release twice daily treatment for at least 18 weeks were randomised to either receive Viramune 400 mg prolonged-release once daily (n=295) or remain on their Viramune immediate-release treatment (n=148).
Ved dosering af Viramune i depotform sammen med et måltid med højt fedtindhold, var AUC0-24,ss og Cmin,ss for nevirapin henholdsvis ca. 94 % og 98 % af AUC0-24,ss og Cmin,ss, i forhold til patienter, der fik Viramune 200 mg tabletter.
When Viramune prolonged-release was dosed with a high fat meal, the nevirapine AUC0-24,ss and Cmin,ss were approximately 94 % and 98 %, respectively, of the AUC0-24,ss and Cmin,ss measured when patients were dosed with Viramune immediate-release tablets.
Viramune tabletter indeholder lactose.
Viramune tablets contain lactose (milk sugar).
Hvis en dosis ikke er blevet indtaget, og der er gået mere end 12 timer, skal patienten vente og tage den næste dosis som normalt.
If a dose is missed and it is more than 12 hours later, the patient should only take the next dose at the usual time.
MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE FLASKE ETIKET
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Hvis du oplever, at du bliver træt, skal du undgå at foretage dig ting, der kan være farlige, såsom bilkørsel eller brug af værktøj eller maskiner.
If you experience fatigue you should avoid potentially hazardous tasks such as driving or using any tools or machines.
Hver depottablet indeholder 400 mg nevirapin.
Each prolonged-release tablet contains 400 mg nevirapine.
I et enkeltdosisstudie (studie 1100.1485) undersøgtes nevirapins farmakokinetik hos 17 raske frivillige ved Viramune i depotform.
The pharmacokinetics of nevirapine has been studied in a single dose study (study 1100.1485) of Viramune prolonged-release in 17 healthy volunteers.
VERxVE (studie 1100.1486) er et fase III-studie, hvor behandlingsnaive patienter fik Viramune 200 mg én gang dagligt i 14 dage og derefter blev randomiseret til at få enten Viramune 200 mg tabletter to gange dagligt eller Viramune 400 mg depottabletter én gang dagligt.
VERxVE (study 1100.1486) is a phase 3 study in which treatment-naïve patients received Viramune 200 mg immediate-release once daily for 14 days and then were randomised to receive either Viramune 200 mg immediate-release twice daily or Viramune 400 mg prolonged-release once daily.
Den anbefalede dosis Viramune er én tablet 200 mg daglig i de første 14 dage (denne optrapningsperiode bør benyttes, idet den har vist sig at mindske hyppigheden af udslæt) efterfulgt af én tablet 200 mg 2 gange daglig i kombination med mindst to andre antiretrovirale lægemidler.
The recommended dose of Viramune is one 200 mg tablet daily for the first 14 days (this lead-in period should be used because it has been found to lessen the frequency of rash), followed by one 200 mg tablet twice daily, in combination with at least two additional antiretroviral agents.
Den sædvanlige dosis er 1 tablet på 200 mg hver dag i de første 14 dage af behandlingen (optrapningsfase).
The dose is one 200 mg tablet per day for the first 14 days of treatment (“lead-in” period).
Patienter, som afbryder behandling med nevirapin i mere end 7 dage, bør genstarte det anbefalede doseringsregimen med en 2 ugers optrapningsperiode med Viramune 200 mg.
Patients who interrupt nevirapine dosing for more than 7 days should restart the recommended dosing regimen using the two week lead-in period of Viramune immediate-release.
Hvis en dosis ikke er blevet indtaget, og der er gået mindre end 12 timer siden den skulle have været indtaget, skal patienten tage den manglende dosis så hurtigt som muligt.
If a dose is recognized as missed within 12 hours of when it was due, the patient should take the missed dose as soon as possible.
Du bør tage den dosis, som er foreskrevet af lægen.
You must take the dose of Viramune as prescribed by your doctor.
Bør ikke anvendes til patienter med heriditær fructoseintolerans, glucose/galactosemalabsorption og sucraseisomaltasemangel.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Viramune hjælper med at kontrollere hiv-1-infektion ved at forhindre enzymet i at arbejde.
By stopping reverse transcriptase from working, Viramune helps control HIV-1 infection.
Viramune er i kombination med andre antiretrovirale lægemidler indiceret til behandling af hiv-1 smittede voksne, unge og børn på tre år og derover, og som kan sluge tabletter (se pkt.
Viramune is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children three years and above and able to swallow tablets (see section 4.2).
Viramune 200 mg tabletter
Viramune 200 mg Tablets
Kvinder har 3 gange større risiko end mænd for symptomatiske, ofte udslætassocierede leverpåvirkninger (5,8% versus 2,2%), og behandlingsnaive patienter af begge køn med detekterbart hiv-1-RNA i plasma og med et højere CD4-celletal ved behandlingsstart med nevirapin, har en større risiko for symptomatisk leverpåvirkning under nevirapinbehandling.
Women have a three fold higher risk than men for symptomatic, often rash-associated, hepatic events (5.8 % versus 2.2 %), and treatment-naïve patients of either gender with detectable HIV-1 RNA in plasma with higher CD4 counts at initiation of nevirapine therapy are at higher risk for symptomatic hepatic events with nevirapine.
Farmakokinetiske data på nevirapin er baseret på to store kilder: Dels et 48-ugers pædiatrisk studie i Sydafrika (BI1100.1368) med 123 hiv-1 positive, antiretroviralt naive patienter i en alder fra 3 måneder og op til 16 år samt en samlet analyse af fem Paediatric aids Clinical Trials Group (PACTG)'s protokoller, der omfatter 495 patienter i alderen fra 14 dage op til 19 år.
Data concerning the pharmacokinetics of nevirapine has been derived from two major sources: a 48 week paediatric study in South Africa (BI 1100.1368) involving 123 HIV-1 positive, antiretroviral naïve patients aged 3 months to 16 years; and a consolidated analysis of five Paediatric AIDS Clinical Trials Group (PACTG) protocols comprising 495 patients aged 14 days to 19 years.
Farmakokinetiske data på nevirapin er baseret på to store kilder: Dels et 48-ugers pædiatrisk studie i Sydafrika (BI1100.1368) med 123 hiv-1 positive, antiretroviralt naive patienter i en alder fra 3 måneder og op til 16 år samt en samlet analyse af fem Paediatric AIDS Clinical Trials Group (PACTG)'s protokoller, der omfatter 495 patienter i alderen fra 14 dage op til 19 år.
Data concerning the pharmacokinetics of nevirapine have been derived from two major sources: a 48 week paediatric study in South Africa (BI 1100.1368) involving 123 HIV-1 positive, antiretroviral naïve patients aged 3 months to 16 years; and a consolidated analysis of five Paediatric AIDS Clinical Trials Group (PACTG) protocols comprising 495 patients aged 14 days to 19 years.
Blister i polyvinylchlorid (PVC)/aluminiumsfolie (blisterark med 7 tabletter).
Polyvinyl chloride (PVC)/aluminium foil push-through blister units (blister card of 7 tablets).
- Øvrige indholdsstoffer: - lactose (som monohydrat) - hypromellose - gul jernoxid - magnesiumstearat
Lactose (as monohydrate) Hypromellose Iron oxide yellow Magnesium stearate
Viramune i depotform n = 505
Viramune prolonged-release n=505
Der blev demonstreret ækvivalens inden for 10 % mht. behandlingssvigt mellem ”Viramune 2 gange daglig” og efavirenz.
A durable response to Viramune for at least three years was documented in this study, and equivalence within a 10 % range was demonstrated between Viramune 200 mg twice daily and efavirenz with respect to treatment failure.
Kropsvægt og lipid og glucose-koncentrationerne i blodet kan stige under antiretroviral behandling (se pkt.
Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section
Hjælpestoffer, som behandleren skal være opmærksom på En tablet indeholder 318 mg lactose (som monohydrat).
Each tablet contains 318 mg of lactose (as monohydrate).
Overfølsomhedsreaktioner kan også forekomme som udslæt med andre bivirkninger såsom: - feber - blærer på huden - sår i munden - øjenbetændelse - hævelse i ansigtet - generel hævelse - åndenød - muskel- eller ledsmerter - nedsat antal hvide blodlegemer (granulocytopeni) - generel følelse af at være syg - alvorlige problemer med lever eller nyrer (lever- eller nyresvigt).
Hypersensitivity reactions can also occur as rash with other side effects such as: - fever - blistering of your skin - mouth sores - inflammation of the eye - swelling of the face - general swelling - shortness of breath - muscle or joint pain - a reduction in the number of your white blood cells (granulocytopaenia) - general feelings of illness - severe problems with liver or kidneys (liver or kidney failure).
Nevirapin: Zidovudin har ikke nogen virkning på nevirapins farmakokinetik.
Nevirapine: Zidovudine had no effect on its pharmacokinetics.
Viramune 200 mg tabletter nevirapin
Viramune 200 mg tablets nevirapine
Saccharose: Viramune oral suspension indeholder 150 mg saccharose pr. ml.
Sucrose: Viramune oral suspension contains 150 mg of sucrose per ml.
Blister i polyvinylchlorid (PVC)/aluminiumsfolie (blisterark med 10 tabletter).
Polyvinyl chloride (PVC)/aluminium foil push-through blister units (blister card of 10 tablets).
Postmarketing-erfaring har vist, at de alvorligste bivirkninger er Stevens-Johnsons syndrom/toksisk epidermal nekrolyse, alvorlig hepatitis/leversvigt, og lægemiddelreaktion med eosinofili og systemiske symptomer, karakteriseret ved udslæt med symptomer, såsom feber, artralgi, myalgi, lymfadenopati samt organpåvirkning, såsom hepatitis, eosinofili, granulocytopeni og nedsat nyrefunktion.
The postmarketing experience has shown that the most serious adverse reactions are Stevens-Johnson syndrome/ toxic epidermal necrolysis, serious hepatitis/hepatic failure, and drug reaction with eosinophilia and systemic symptoms, characterised by rash with constitutional symptoms such as fever, arthralgia, myalgia and lymphadenopathy, plus visceral involvement, such as hepatitis, eosinophilia, granulocytopenia, and renal dysfunction.
Baseline-hiv-1-virusbelastningsstratum (kopier/ml)
Baseline HIV−1 viral load stratum (copies/ml)
Ved en retrospektiv gennemgang af data fra især patienter med et hiv-1 viralt plasmaniveau på 50 kopier/ml eller flere, havde kvinder med CD4-celletal >250 celler/mm
In a retrospective review of predominantly patients with a plasma HIV-1 viral load of 50 copies/ml or higher, women with CD4 counts >250 cells/mm
CD4-celletal (celler/mm
Baseline CD4 count (cells/mm - Mean (SD)
I forhold til sikkerhed og virkning for nevirapinbehandlede patienter, er der ikke fastlagt doser for hormonel antikonception (oral eller anden administration) ud over DMPA.
Appropriate doses for hormonal contraceptives (oral or other forms of application) other than DMPA in combination with Viramune have not been established with respect to safety and efficacy.