natgillin/translations-raw huggingface dataset:
VIRAMUNE må ikke readministreres til patienter, hvor en seponering af nivirapin har været begrundet i klinisk hepatitis.
VIRAMUNE must not be readministered to patients who have required permanent discontinuation for clinical hepatitis due to nevirapine.
Lever Sygdom
Liver Disease
Sikkerheden og virkningen er ikke blevet undersøgt hos patienter med betydende underliggende leversygdomme.
The safety and efficacy of VIRAMUNE has not been established in patients with significant underlying liver disorders.
4. 3).
VIRAMUNE is contraindicated in patients with severe hepatic impairment (Child-Pugh C, see section 4.3).
Pharmakokinetiske resultater antyder, at man bør udvise forsigtighed med at ordinere VIRAMUNE til patienter med moderat nedsat leverfunktion (Child- Pugh B).
Pharmacokinetic results suggest caution should be exercised when VIRAMUNE is administered to patients with moderate hepatic dysfunction (Child-Pugh B).
Patienter med kronisk hepatitis B eller C, som er i behandling med antiretroviral kombinationsbehandling, er i en højere risiko for alvorlige og potentielle fatale hepatiske bivirkninger.
Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse events.
Patienter med før- eksisterende leverfunktionssvigt inklusiv kronisk aktiv hepatitis har en højere risiko for leverfunktions abnormaliteter under antiretroviral kombinationsbehandling og bør monitoreres ifølge standard i praksis.
Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Post- eksponerings- profylakse:
Post-Exposure-Prophylaxis:
Alvorlig hepatotoksicitet, inkl. leversvigt påkrævende transplantation, er blevet rapporteret hos ikke HIV- smittede personer, som fik multiple doser af VIRAMUNE i forbindelse med post- eksponerings- profylakse (PEP), en ikke godkendt anvendelse.
Serious hepatotoxicity, including liver failure requiring transplantation, has been reported in HIV-uninfected individuals receiving multiple doses of VIRAMUNE in the setting of post-exposure-prophylaxis (PEP), an unapproved use.
Brugen af VIRAMUNE er ikke blevet evalueret ved et specifikt studie på PEP, specielt med henblik på behandlingsvarighed, og frarådes derfor kraftigt.
The use of VIRAMUNE has not been evaluated within a specific study on PEP, especially in term of treatment duration and therefore, is strongly discouraged.
Kombinationsbehandling med VIRAMUNE er ikke en helbredende behandling af patienter smittet med HIV- 1; nogle patienter kan fortsat udvikle sygdom i forbindelse med HIV- 1 infektion, inkl. opportunistiske infektioner.
Combination therapy with VIRAMUNE is not a curative treatment of patients infected with HIV-1; patients may continue to experience illnesses associated with advanced HIV-1 infection, including opportunistic infections.
6 Kombinationsbehandling med VIRAMUNE har ikke vist reduktion i transmissionsrisikoen for HIV- 1 til andre gennem seksuel kontakt eller kontamineret blod.
6 HIV-1 to others through sexual contact or contaminated blood.
Hormonel kontraceptiva, bortset fra depotmedroxyprogesteronacetat DMPA bør ikke bruges som eneste antikonception af kvinder, som tager VIRAMUNE, da nevirapin kan sænke plasmakoncentrationen af disse lægemidler.
Hormonal methods of birth control other than DMPA should not be used as the sole method of contraception in women taking VIRAMUNE, since nevirapine might lower the plasma concentrations of these medications.
Af denne grund og for at reducere risikoen for HIV- smitte så bør barrierekontraception (f. eks. kondom) anbefales.
For this reason, and to reduce the risk of HIV transmission, barrier contraception (e. g., condoms) is recommended.
Ved postmenopausal hormonbehandling bør den terapeutiske virkning monitoreres når der samtidig behandles med VIRAMUNE.
Additionally, when postmenopausal hormone therapy is used during administration of VIRAMUNE, its therapeutic effect should be monitored.
Hos HIV- smittede patienter er omfordeling af kropsfedt (lipodystrofi) blevet kædet sammen med antiretroviral kombinationsbehandling.
Combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV infected patients.
Det antages, at der er en sammenhæng mellem visceral lipomatose og protease- hæmmere og lipoatrofi - og nukleosid- reverse transcriptase- hæmmere.
A connection between visceral lipomatosis and PIs and lipoatrophy and NRTIs has been hypothesised.
En forøget risiko for lipodystrofi er blevet sat i forbindelse med individuelle faktorer såsom højere alder samt med lægemiddelrelaterede faktorer såsom længere antiretroviral behandlingstid og ledsagende metaboliske forstyrrelser.
A higher risk of lipodystrophy has been associated with individual factors such as older age, and with drug related factors such as longer duration of antiretroviral treatment and associated metabolic disturbances.
Objektiv undersøgelse bør inkludere evaluering af fysiske tegn på omfordeling af kropsfedt.
Clinical examination should include evaluation for physical signs of fat redistribution.
Kontrol af serumlipider og blodglukose ved faste bør overvejes.
Consideration should be given to the measurement of fasting serum lipids and blood glucose.
Relevante eksempler er cytomegalovirus retinitis, generaliserede og/ eller fokale mycobakterielle infektioner og pneumocystis jiroveci pneumoni.
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections, and Pneumocystis jiroveci pneumonia.
4. 5).
The available pharmacokinetic data suggest that the concomitant use of rifampicin and VIRAMUNE is not recommended (please also refer to section 4.5).
Ved den maksimale, anbefalede daglige dosis af VIRAMUNE tabletter indtages 636 mg lactose.
VIRAMUNE tablets contain 636 mg of lactose per maximum recommended daily dose.
VIRAMUNE tabletter bør ikke anvendes til patienter med arvelig galactose- intolerans, en særlig form for hereditær lactasemangel (Lapp Lactase deficiency), eller glukose/ galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance e. g. galactosaemia, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Nevirapine inducerer CYP3A og potentielt CYP2B6 med maksimal induktion indenfor 2- 4 uger efter flerdosis behandling er startet.
Nevirapine is an inducer of CYP3A and potentially CYP2B6, with maximal induction occurring within 2-4 weeks of initiating multiple-dose therapy.
Plasmakoncentrationen for lægemidler, der metaboliseres via disse enzymsystemer kan eventuelt være nedsat når de gives samtidig med VIRAMUNE.
Compounds using this metabolic pathway may have decreased plasma concentrations when co- administered with VIRAMUNE.
Den terapeutiske virkning af stoffer, der metaboliseres af P450 bør derfor monitoreres nøje ved co- administration med VIRAMUNE.
Careful monitoring of the therapeutic effectiveness of P450 metabolised medicinal products is recommended when taken in combination with VIRAMUNE.
Interaktionsdata er angivet som en geometrisk gennemsnitsværdi med et 90% konfidensinterval (90% CI) når disse data er tilgængelige.
7 The interaction data is presented as geometric mean value with 90% confidence interval (90% CI) whenever these data were available.
ND = non- detekterbar, ↑ = øget, ↓ = Formindsket, ↔ = Ingen effekt
ND = Not Determined, ↑ = Increased, ↓ = Decreased, ↔ = No Effect
7 Lægemidler efter terapeutiske områder ANTI- INFEKTIVA Antivirale lægemidler NRTIs
Medicinal products by therapeutic areas ANTI-INFECTIVES Antiretrovirals NRTIs
Rekommendationer ved co - administration med Viramune
Recommendations concerning co- administration
Didanosin 100- 150 mg 2 gange daglig
Didanosine 100-150 mg BID
Didanosin og VIRAMUNE kan co- administreres uden dosisjustering.
Didanosine and VIRAMUNE can be co-administered without dose adjustments.
Lamivudin og VIRAMUNE kan co- administreres uden dosisjustering.
Lamivudine and VIRAMUNE can be co-administered without dose adjustments.
Stavudin 30/ 40 mg 2 gange daglig
30/ 40 mg BID
Stavudin og VIRAMUNE kan co - administreres uden dosisjustering.
Stavudine and VIRAMUNE can be co-administered without dose adjustments.
Sammenlignet med historiske kontroller, var plasmakoncentrationen tilsyneladende uændret.
Nevirapine: compared to historical controls, levels appeared to be unchanged.
Tenofovir plasmakoncentrationer forbliver uændret ved co - administration med nevirapin.
Tenofovir plasma levels remain unchanged when co-administered with Nevirapine.
Tenofovir og VIRAMUNE kan co- administreres uden dosisjustering.
Tenofovir and VIRAMUNE can be co-administered without dose adjustments.
Nevirapins plasmakoncentrationer blev ikke ændret ved samtidig co - administration af tenofovir.
Nevirapine plasma levels were not altered by co-administration of tenofovir.
Zidovudin 100- 200 mg 3 gange daglig
Zidovudine 100-200 mg TID
Zidovudin og VIRAMUNE kan co- administreres uden dosisjustering.
Zidovudine and VIRAMUNE can be co-administered without dose adjustments
Zidovudin har ikke nogen virkning på nevirapins pharmakokinetik.
Zidovudine had no effect on its pharmacokinetics.
NNRTI’ ere Efavirenz 600 mg 4 gange daglig
NNRTIs Efavirenz 600 mg QD
Co- administration af efavirenz og VIRAMUNE anbefales ikke på grund af den additive toksicitet og ingen fordele med hensyn til virkning af NNRTI alene.
It is not recommended to co- administer efavirenz and VIRAMUNE, because of additive toxicity and no benefit in terms of efficacy over either NNRTI alone.
PI’ ere
PIs
Atazanavir/ ritonavir 300/ 100 mg 4 gange daglig 400/ 100 mg 4 gange daglig
Atazanavir/ ritonavir 300/ 100 mg QD 400/ 100 mg QD
Atazanavir/ r 300/ 100mg:
Atazanavir/ r 300/ 100mg:
Atazanavir/ r AUC ↓ 0, 58 (0, 48- 0, 71) Atazanavir/ r Cmin ↓ 0, 28 (0, 20- 0, 40) Atazanavir/ r Cmax ↓ 0, 72 (0, 60- 0, 86) Atazanavir/ r 400/ 100mg Atazanavir/ r AUC ↓ 0, 81 (0, 65- 1, 02)
Atazanavir/ r AUC ↓ 0.58 (0.48-0.71) Atazanavir/ r Cmin ↓ 0.28 (0.20-0.40) Atazanavir/ r Cmax ↓ 0.72 (0.60-0.86)
Det anbefales ikke at co - administrere atazanavir/ ritonavir og VIRAMUNE.
It is not recommended to co- administer atazanavir/ ritonavir and VIRAMUNE.
8 Atazanavir/ r Cmin ↓ 0, 41 (0, 27- 0, 60) Atazanavir/ r Cmax ↔ 1, 02 (0, 85– 1, 24) (sammenlignet med 300/ 100mg uden nevirapin)
Atazanavir/ r AUC ↓ 0.81 (0.65-1.02) Atazanavir/ r Cmin ↓ 0.41 (0.27-0.60) Atazanavir/ r Cmax ↔ 1.02 (0.85– 1.24) (compared to 300/ 100mg without nevirapine)
Nevirapin AUC ↑ 1, 25 (1, 17- 1, 34) Nevirapin Cmin ↑ 1, 32 (1, 22– 1, 43) Nevirapin Cmax ↑ 1, 17 (1, 09- 1, 25)
Nevirapine AUC ↑ 1.25 (1.17-1.34) Nevirapine Cmin ↑ 1.32 (1.22– 1.43) Nevirapine Cmax ↑ 1.17 (1.09-1.25)
Darunavir/ ritonavir 400/ 100 mg 2 gange daglig
Darunavir/ ritonavir 400/ 100 mg BID
Darunavir og VIRAMUNE kan co- administreres uden dosisjustering.
Darunavir and VIRAMUNE can be co-administered without dose adjustments.
Fosamprenavir 1400 mg 2 gange daglig
Fosamprenavir 1400 mg BID,
Det anbefales ikke at co - administrere fosamprenavir og VIRAMUNE, hvis fosamprenavir ikke co- administreres sammen
It is not recommended to co- administer fosamprenavir and VIRAMUNE if fosamprenavir is not co-administered with ritonavir.
Fosamprenavir/ ritonav ir 700/ 100 mg 2 gange daglig
Fosamprenavir/ ritona vir 700/ 100 mg BID
Fosamprenavir/ ritonavir og VIRAMUNE kan co- administreres uden dosisjustering.
Fosamprenavir/ ritonavir and VIRAMUNE can be co-administered without dose adjustments
Lopinavir/ ritonavir (kapsler) 400/ 100 mg 2 gange daglig
Lopinavir/ ritonavir (capsules) 400/ 100 mg BID
Patienter:
patients:
En dosisøgning af lopinavir/ rito - navir til 533/ 133 mg (4 kapsler) 2 gange daglig eller 500/ 125 mg (5 tabletter á 100/ 25 mg) 2 gange daglig i kombination med VIRAMUNE indtaget sammen med mad anbefales.
An increase in the dose of lopinavir/ ritonavir to 533/ 133 mg (4 capsules) or 500/ 125 mg (5 tablets with 100/ 25 mg each) twice daily with food is recommended in combination with VIRAMUNE.
Dosisjustering for VIRAMUNE er ikke påkrævet når der co - administreres med lopinavir.
Dose adjustment of VIRAMUNE is not required when co-administered with lopinavir.
Lopinavir/ ritonavir (oral opløsning) 300/ 75 mg/ m2 to gange daglig
9 Lopinavir/ ritonavir (oral solution) 300/ 75 mg/ m2 BID
Hos børn bør det overvejes at øge dosis af lopinavir/ ritonavir til 300/ 75 mg/ m2 2 gange daglig sammen med mad når det co - administreres med VIRAMUNE, specielt hos patienter, hvor der er mistanke om en reduceret følsomhed for lopinavir/ ritonavir.
For children, increase of the dose of lopinavir/ ritonavir to 300/ 75 mg/ m2 twice daily with food should be considered when used in combination with VIRAMUNE, particularly for patients in whom reduced susceptibility to lopinavir/ ritonavir is suspected.
750 mg 3 gange daglig
Nelfinavir 750 mg TID
Cmin ↔ 0, 68 (0, 50- 1, 5)
Nelfinavir AUC ↔ 1.06 (0.78-1.14) Cmin ↔ 0.68 (0.50-1.5) Cmax ↔ 1.06 (0.92-1.22)
dosisjustering.
Nelfinavir and VIRAMUNE can be co-administered without dose adjustments.
Nelfinavir metabolit M8:
Nelfinavir metabolite M8:
Sammenlignet med historiske kontroller var niveauerne uændret.
Nevirapine: compared to historical controls, levels appeared to be unchanged.
Ritonavir og VIRAMUNE kan co - administreres uden dosisjustering.
Ritonavir and VIRAMUNE can be co-administered without dose adjustments.
Co- administration af ritonavir giver ingen klinisk relevante ændringer i plasmakoncentrationerne af nevirapin.
Co-administration of ritonavir does not lead to any clinically relevant change in nevirapine plasma levels.
Saquinavir/ ritonavir
Saquinavir/ ritonavir
De begrænsede data, der er tilgængelige for saquinavir soft gel kapslen boosted med ritonavir, indikerer, at der ikke skulle være klinisk signifikante interaktioner mellem saquinavir boosted med ritonavir og nevirapin.
The limited data available with saquinavir soft gel capsule boosted with ritonavir do not suggest any clinically relevant interaction between saquinavir boosted with ritonavir and Nevirapine
Saquinavir/ ritonavir og VIRAMUNE kan co- administreres uden dosisjustering.
Saquinavir/ ritonavir and VIRAMUNE can be co-administered without dose adjustments.
Tipranavir/ ritonavir 500/ 200 mg BID
Tipranavir/ ritonavir 500/ 200 mg BID
De begrænsede data fra et fase IIa studie hos HIV patienter har vist en 20% reduktion af TPV Cmin, der ikke var klinisk signifikant.
The limited data available from a phase IIa study in HIV-infected patients have shown a clinically non significant 20% decrease of TPV Cmin.
Tipranavir og VIRAMUNE kan co- administreres uden dosisjustering.
Tipranavir and VIRAMUNE can be co-administered without dose adjustments.
Fusionshæmmere Enfuvirtid
Entry Inhibitors Enfuvirtide
Enfuvirtid og VIRAMUNE kan co- administreres uden dosisjustering.
Enfuvirtide and VIRAMUNE can be co-administered without dose adjustments.
Maraviroc 300 mg 4 gange daglig
10 Maraviroc 300 mg QD
Maraviroc AUC ↔ 1, 01 (0, 6 - 1, 55) Maraviroc Cmin ND Maraviroc Cmax ↔ 1, 54 (0, 94- 2, 52) Sammenlignet med historiske kontroller
Maraviroc AUC ↔ 1.01 (0.6 -1.55) Maraviroc Cmin ND Maraviroc Cmax ↔ 1.54 (0.94-2.52) compared to historical controls
Maraviroc og VIRAMUNE kan co- administreres uden dosisjustering.
Maraviroc and VIRAMUNE can be co-administered without dose adjustments.
Integrasehæmmere Raltegravir 400 mg 2 gange daglig
Integrase Inhibitors Raltegravir 400 mg BID
Der forventes ingen interaktion på grund af
Due to the metabolic pathway of raltegravir no interaction is expected.
Raltegravir og VIRAMUNE kan co- administreres uden
Raltegravir and VIRAMUNE can be co-administered without dose adjustments.
Clarithromycin AUC ↓ 0, 69 (0, 62 - 0, 76) Clarithromycin Cmin ↓ 0, 44 (0, 30- 0, 64) Clarithromycin Cmax ↓ 0, 77 (0, 69- 0, 86)
Clarithromycin AUC ↓ 0.69 (0.62- 0.76) Clarithromycin Cmin ↓ 0.44 (0.30- 0.64) Clarithromycin Cmax ↓ 0.77 (0.69- 0.86)
Plasmakoncentrationen af clari - thromycin var signifikant reduceret, og plasmakoncen - trationen af 14- OH metabolit var øget.
Clarithromycin exposure was significantly decreased, 14-OH metabolite exposure increased.
Et alternativ til clarithro - mycin, såsom azithromycin bør
Because the clarithromycin active metabolite has reduced activity against Mycobacterium avium- intracellulare complex overall activity against the pathogen may be
Metabolit 14- OH clarithromycin AUC ↑ 1, 42 (1, 16- 1, 73) Metabolit 14- OH clarithromycin Cmin ↔ 0 (0, 68- 1, 49) Metabolit 14- OH clarithromycin Cmax ↑ 1, 47 (1, 21- 1, 80)
Metabolite 14-OH clarithromycin AUC ↑ 1.42 (1.16-1.73) Metabolite 14-OH clarithromycin Cmin ↔ 0 (0.68-1.49) Metabolite 14-OH clarithromycin Cmax ↑ 1.47 (1.21-1.80)
overvejes, da clarithromycins aktive metabolit har en reduceret virkning over for Mycobacterium avium- intracellulær kompleks.
Alternatives to clarithromycin, such as azithromycin should be considered.
Nevirapin AUC ↑ 1, 26 Nevirapin Cmin ↑ 1, 28 Nevirapin Cmax ↑ 1, 24 Sammenlignet med historiske kontroller.
Nevirapine AUC ↑ 1.26 Nevirapine Cmin ↑ 1.28 Nevirapine Cmax ↑ 1.24 compared to historical controls.
Ingen signifikant virkning på rifabutin og VIRAMUNE gennemsnitlige farmakokinetiske (PK) parametre er observeret.
No significant effect on rifabutin and VIRAMUNE mean PK parameters is seen.
Rifabutin og VIRAMUNE kan co - administreres uden dosisjustering.
Rifabutin and VIRAMUNE can be co-administered without dose
Der sås en klinisk ikke relevant stigning i clearance af nevirapin (med 9%) sammenlignet med historiske farmakokinetiske data.
Metabolite 25-O-desacetylrifabutin AUC ↑ 1.24 (0.84-1.84) Metabolite 25-O-desacetylrifabutin Cmin ↑ 1.22 (0.86-1.74) Metabolite 25-O-desacetylrifabutin Cmax ↑ 1.29 (0.98-1.68) A clinically not relevant increase in the apparent clearance of nevirapine (by 9%) compared to historical data was reported.
rifabutintoksicitet.
adjustments.
Rifampicin 600 mg 4 gange daglig
11 Rifampicin 600 mg QD
4. 4).
It is not recommended to co- administer rifampicin and VIRAMUNE (see section 4.4).
Ved behandling af patienter, der er
Physicians needing to treat patients
Nevirapin AUC ↓ 0, 42 Nevirapin Cmin ↓ 0, 32 Nevirapin Cmax ↓ 0, 50 Sammelignet med historiske kontroller.
Nevirapine AUC ↓ 0.42 Nevirapine Cmin ↓ 0.32 Nevirapine Cmax ↓ 0.50 compared to historical controls.
smittet med tuberkulose, som samtidig får VIRAMUNE, bør anvendelsen af rifabutin overvejes.
co-infected with tuberculosis and using a VIRAMUNE containing regimen may consider co- administration of rifabutin instead.
Svampemidler Fluconazol 200 mg 4 gange daglig
Fluconazole 200 mg QD
Nevirapin eksponering: ↑100% sammenlignet med historiske data, hvor nevirapin blev administreret
Fluconazole AUC ↔ 0.94 (0.88- 1.01) Fluconazole Cmin ↔ 0.93 (0.86-1.01) Fluconazole Cmax ↔ 0.92 (0.85-0.99) Nevirapine: exposure: ↑ 100% compared with historical data where nevirapine was administered alone.
patienterne bør monitoreres nøje.
Because of the risk of increased exposure to VIRAMUNE, caution should be exercised if the medicinal products are given concomitantly and patients should be monitored closely.
Itraconazol AUC ↓ 0, 39 Itraconazol Cmin ↓ 0, 13 Itraconazol Cmax ↓ 0, 62
Itraconazole AUC ↓ 0.39 Itraconazole Cmin ↓ 0.13 Itraconazole Cmax ↓ 0.62 Nevirapine: there was no significant difference in Nevirapine pharmacokinetic parameters.
Ketoconazol AUC ↓ 0, 28 (0, 20- 0, 40) Ketoconazol Cmin ND Ketoconazol Cmax ↓ 0, 56 (0, 42- 0, 73)
Ketoconazole AUC ↓ 0.28 (0.20- 0.40) Ketoconazole Cmin ND Ketoconazole Cmax ↓ 0.56 (0.42- 0.73)
Det anbefales ikke at co - administrer ketoconazol og VIRAMUNE.
It is not recommended to co- administer ketoconazole and VIRAMUNE.
Plasmakoncentrationer: ↑ 1, 15- 1, 28 sammenlignet med historiske kontroller.
Nevirapine: plasma levels: ↑ 1.15- 1.28 compared to historical controls.
Ingen signifikant virkning på cimetidin PK parametre er observeret.
Cimetidine: no significant effect on cimetidine PK parameters is seen.
Cimetidin og VIRAMUNE kan co- administreres uden dosisjustering.
Cimetidine and VIRAMUNE can be co-administered without dose adjustments.
Nevirapin Cmin ↑ 1, 07 ANTITHROMBOTIKA Warfarin KONTRACEPTIVA
Nevirapine Cmin ↑ 1.07 ANTITHROMBOTICS Warfarin
Interaktionen mellem nevirapin og warfarin er kompleks med potentiale for både stigning og fald i koagulationstiden.
The interaction between Nevirapine and the antithrombotic agent warfarin is complex, with the potential for both increases and decreases in coagulation time when used concomitantly.
Depo - medroxyprogesteron acetat (DMPA) 150 mg hver 3. måned
12 CONTRACEPTIVES Depo- medroxyprogesterone acetate (DMPA) 150 mg every 3
DMPA AUC ↔ DMPA Cmin ↔ DMPA Cmax ↔ Nevirapin AUC ↑ 1, 20 Nevirapin Cmax ↑ 1, 20
DMPA AUC ↔ DMPA Cmin ↔ DMPA Cmax ↔
VIRAMUNE co- administration ændrede ikke DMPA’ s suppression af ovulation.
Viramune co-administration did not alter the ovulation suppression effects of DMPA.
DMPA og VIRAMUNE kan co - administreres uden dosisjustering.
DMPA and VIRAMUNE can be co-administered without dose
Ethinyl estradiol (EE) 0. 035 mg
Ethinyl estradiol (EE) 0.035 mg
Oral hormonel anticonception bør ikke anvendes, som den eneste svangerskabsforebyggende metode hos kvinder, der behandles
Oral hormonal contraceptives should not be used as the sole method of contraception in women taking VIRAMUNE (see section 4.4).
Norethindrone (NET) 1. 0 mg 4 gange daglig
Norethindrone (NET) 1.0 mg QD
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.
Metadon individuel patient dosering
DRUG ABUSE Methadone Individual Patient Dosing
Methadon AUC ↓ 0, 40 (0, 31 – 0, 51) Methadon Cmin ND Methadon Cmax ↓ 0, 58 (0, 50 – 0, 67)
Methadone AUC ↓ 0.40 (0.31 - 0.51) Methadone-maintained patients Methadone Cmin ND beginning VIRAMUNE therapy Methadone Cmax ↓ 0.58 (0.50 - 0.67) should be monitored for evidence of withdrawal and methadone dose should be adjusted accordingly.
Narkotikaabstinenssymptomer er rapporteret af patienter behandlet med VIRAMUNE og metadon samtidigt.
HERBAL PRODUCTS
NATURLÆGEMIDLER Prikbladet perikon
John's Wort
Serum niveauer af nevirapin kan være reducerede ved samtidig brug af naturlægemidlet, prikbladet perikon (Hypericum perforatum), Det skyldes, at prikbladet perikon, inducerer metaboliske enzymer over for lægemidler og/ eller inducerer transportproteiner.
John’ s Wort.
Naturlægemidler indeholdende prikbladet perikon og VIRAMUNE må ikke co - administreres (se pkt.
Herbal preparations containing St.
Hvis en patient allerede anvender prikbladet perikon skal serumniveauet for nevirapin kontroleres samt, hvis muligt, også virusniveauer.
If a patient is already taking St.
Behandling med prikbladet perikon bør samtidig stoppes.
John‘ s Wort check nevirapine and if possible viral levels and stop St John‘ s Wort.
Nevirapinniveauet kan stige ved ophør med prikbladet perikon.
Nevirapine levels may increase on stopping St John‘ s Wort.
VIRAMUNE dosering skal muligvis justeres.
The dose of VIRAMUNE may need adjusting.
Den inducerede virkning kan fortsætte i mindst 2 uger efter ophør af behandling med prikbladet perikon.
John‘ s Wort.
Nevirapin metabolitter:
Nevirapine metabolites:
Studier med humane levermikrosomer indikerede, at dannelsen af hydroxylerede metabolitter af nevirapin ikke var påvirket af tilstedeværelsen af dapson, rifabutin, rifampicin, og trimethoprim/ sulfamethoxazol.
Studies using human liver microsomes indicated that the formation of nevirapine hydroxylated metabolites was not affected by the presence of dapsone, rifabutin, rifampicin, and trimethoprim/ sulfamethoxazole.
4. 6 Graviditet og amning
13 4.6 Pregnancy and lactation
De data der er tilgængelige for gravide kvinder tyder ikke på misdannelser eller føtal/ neonatal toksicitet.
Currently available data on pregnant women indicate no malformative or foeto/ neonatal toxicity.