natgillin/translations-raw huggingface dataset:
Fertilitet, peri - og postnatal udvikling blev ikke påvirket og embryo - toksiske/ teratogene virkninger blev ikke observeret i rotter eller kaniner ved plasmakoncentrationer, der var lavere end de, der blev opnået hos mennesker ved den anbefalede kliniske dosis af Invirase boostet med ritonavir.
Fertility, peri- and postnatal development were not affected, and embryotoxic / teratogenic effects were not observed in rats or rabbits at plasma exposures lower than those achieved in humans at the recommended clinical dose of ritonavir boosted Invirase.
Distributionsundersøgelser i disse arter viste at placentaoverførslen af saquinavir er lav (mindre end 5% af maternelle plasmakoncentrationer).
Distribution studies in these species showed that the placental transfer of saquinavir is low (less than 5% of maternal plasma concentrations).
Lactose (vandfri), Mikrokrystallinsk cellulose, Povidon, Natriumstivelsesglycollat, Talcum, Magnesiumstearat.
22 Lactose (anhydrous), Microcrystalline cellulose, Povidone, Sodium starch glycollate, Talc, Magnesium stearate.
Gelatine, Sort jernoxid, rød og gul jernoxid (E172), Indigotin (E132), Titandioxid (E171).
Gelatine, Iron oxide black, red and yellow (E172), Indigo carmine (E132), Titanium dioxide (E171).
Tryksværte:
Printing ink:
Titandioxid (E 171), Shellak, Sojalecitin, Polydimetylsiloxan.
Titanium dioxide (E 171), Shellac, Soya lecithin, Polydimethylsiloxane.
22 Ingen særlige forholdsregler.
No special requirements.
Dato for første godkendelse:
23 Date of first authorisation:
4. oktober 1996 Dato for sidste forlængelse:
04 October 1996 Date of last renewal:
4. oktober 2006
04 October 2006
Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: //. emea. europa. eu /.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Indeholder vandfrit lactose:
Contains lactose monohydrate:
Lyseorange til grålig - eller brunligorange filmovertrukne, ovale, cylindriske, bikonvekse tabletter mærket ” SQV 500 ” på den ene side og ” ROCHE ” på den anden side.
Light orange to greyish or brownish orange film-coated tablet of oval cylindrical biconvex shape with the marking "SQV 500" on the one side and "ROCHE" on the other side.
I kombination med ritonavir Den anbefalede dosis af Invirase er 1000 mg (2 x 500 mg filmovertrukne tabletter) to gange daglig sammen med 100 mg ritonavir to gange daglig i kombination med andre antiretrovirale stoffer.
In combination with ritonavir The recommended dose of Invirase is 1000 mg (2 x 500 mg film-coated tablets) two times daily with ritonavir 100 mg two times daily in combination with other antiretroviral agents.
5. 2).
Invirase film-coated tablets should be swallowed whole and taken at the same time as ritonavir with or after food (see section 5.2).
4. 3 og 4. 4).
Invirase/ritonavir is contraindicated in patients with decompensated hepatic impairment (see sections 4.3 and 4.4).
Erfaring med Invirase til behandling af børn under 16 år og voksne over 60 år er begrænset.
The experience with In virase in children below the age of 16 and adults over 60 years is limited.
24 4. 3 Kontraindikationer
4.3 Contraindications
4. 4).
Invirase/ritonavir is contraindicated in decompensated liver disease (see section 4.4).
Invirase/ ritonavir bør ikke gives sammen med andre lægemidler, som kan interagere og medføre potentielt livstruende uønskede hændelser.
25 Invirase/ritonavir should not be given together with other medicinal products which may interact and result in potentially life threatening undesirable effects.
4. 4, 4. 5 og 4. 8).
Medicinal products which should not be given with Invirase/ritonavir include: • terfenadine, astemizole, pimozide, cisapride, amiodarone, propafenone and flecainide (potential for life threatening cardiac arrhythmia) • midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5), triazolam (potential for prolonged or increased sedation, respiratory depression) • simvastatin, lovastatin (increased risk of myopathy including rhabdomyolysis) • ergot alkaloids (e.g. ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (potential for acute ergot toxicity) • rifampicin (risk of severe hepatocellular toxicity) (see sections 4.4, 4.5, and 4.8).
Derfor bør saquinavir/ ritonavir anvendes med forsigtighed til denne gruppe af patienter.
The safety and efficacy of saquinavir/ritonavir has not been established in patients with significant underlying liver disorders, therefore saquinavir/ritonavir should be used cautiously in this patient population.
4. 3).
Invirase/ritonavir is contraindicated in patients with decompensated liver disease (see section 4.3).
Da sådanne undersøgelser ikke findes, bør der udvises forsigtighed fordi forhøjelser af saquinavir- plasmakoncentrationen og/ eller forhøjelse af leverenzymer kan forekomme.
In the absence of such studies, caution should be exercised, as increases in saquinavir levels and/or increases in liver enzymes may occur.
Renal clearance er kun en mindre udskillelsesvej.
Renal impairment:
Den primær metabolisme og udskillelse af saquinavir finder sted i leveren.
Renal clearance is only a minor elimination pathway, the principal route of metabolism and excretion for saquinavir being via the liver.
Derfor bør der udvises forsigtighed når saquinavir/ ritonavir anvendes til denne patientpopulation.
However, patients with severe renal impairment have not been studied and caution should be exercised when prescribing saquinavir/ritonavir in this population.
25 Patienter med kronisk diarré eller malabsorption:
Patients with chronic diarrhoea or malabsorption:
Laktoseintolerans:
26 Lactose intolerance:
Invirase 500 mg filmovertrukne tabletter indeholder lactose.
Invirase 500 mg film-coated tablets contain lactose.
Patienter med sjældne arvelige problemer i form af galaktoseintolerans, Lapp- lactasedeficit eller glukose - galaktosemalabsorption bør ikke tage dette lægemidel.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Mange patienter havde flere sygdomme hvoraf nogle krævede behandling med lægemidler som har været ledsaget af diabetes mellitus eller hyperglykæmi.
Many patients had confounding medical conditions, some of which required therapy with agents that have been associated with the development of diabetes mellitus or hyperglycaemia.
Ætiologien anses dog for at være multifaktoriel (omfattende anvendelse af kortikosteroider, alkoholforbrug, svær immunosuppression, højere Body Mass Index (BMI)).
Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV–disease and/or long-term exposure to combination antiretroviral therapy (CART).
Relevante eksempler er cytomegalovirus retinitis, generaliserede og/ eller fokale mycobakterielle infektioner og pneumocystis carinii pneumoni.
Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis carinii pneumonia.
26 Interaktion med tipranavir:
Interaction with tipranavir:
Interaktion med HMG- CoA- reduktasehæmmere:
Interaction with HMG-CoA reductase inhibitors:
Der skal også udvises forsigtighed hvis Invirase/ ritonavir indtages samtidig med atorvastatin, som metaboliseres i mindre grad af CYP3A4.
Caution must be exercised if Invirase/ritonavir is used concurrently with atorvastatin, which is metabolised to a lesser extent by CYP3A4.
Orale kontraceptiva:
27 Oral contraceptives:
4. 5).
Because concentration of ethinyl estradiol may be decreased when co- administered with Invirase/ritonavir, alternative or additional contraceptive measures should be used when oestrogen-based oral contraceptives are co-administered (see section 4.5).
Observationerne fra lægemiddelinteraktionsundersøgelserne med ikke- boostet saquinavir er ikke repræsentative for de virkninger som ses med saquinavir/ ritonavir- behandling.
Observations from drug interaction studies done with unboosted saquinavir might not be representative of the effects seen with saquinavir/ritonavir therapy.
Desuden er de resultater som ses med saquinavir bløde kapsler ikke prædiktive for størrelsesordenen af disse interaktioner med Invirase/ ritonavir.
Furthermore, results seen with saquinavir soft capsules may not predict the magnitude of these interactions with Invirase/ritonavir.
Derfor kan lægemidler, som enten benytter den samme metaboliseringsvej eller som modificerer aktiviteten af CYP3A4 og/ eller af P- gp (se ” Andre potentielle interaktioner ”), måske modificere saquinavirs farmakokinetik.
Therefore, medicinal products that either share this metabolic pathway or modify CYP3A4 and/or P-gp activity (see "Other potential interactions") may modify the pharmacokinetics of saquinavir.
27 Tabel 1:
28 Table 1:
Zalcitabin og/ eller zidovudin (saquinavir/ ritonavir)
Zalcitabine and/or Zidovudine (saquinavir/ritonavir)
Zalcitabin og/ eller zidovudin (ikke- boostet saquinavir)
Zalcitabine and/or Zidovudine (unboosted saquinavir)
Didanosin 400 mg enkeltdosis (saquinavir/ ritonavir 1600/ 100 mg 1 gang daglig)
Didanosine 400 mg single dose (saquinavir/ritonavir 1600/100 mg qd)
Tenofovirdisoproxil fumarat 300 mg 1 gang daglig (saquinavir/ ritonavir 1000/ 100 mg 2 gange daglig)
Tenofovir disoproxil fumarate 300 mg qd (saquinavir/ritonavir 1000/100 mg bid)
Delavirdin (saquinavir/ ritonavir)
Delavirdine (saquinavir/ritonavir)
Interaktion med Invirase/ ritonavir er ikke undersøgt.
Interaction with Invirase/ritonavir not studied.
↓ indikerer fald, ↑ indikerer stigning, ↔ indikerer ingen ændring, ↑↑ indikerer markant stigning
Efavirenz 600 mg qd (saquinavir/ritonavir 1600/200 mg qd, or saquinavir/ritonavir 1000/100 mg bid, or saquinavir/ritonavir 1200/100 mg qd)
Saquinavir ↔ Efavirenz ↔
Saquinavir ↔ Efavirenz ↔
- Nevirapin (saquinavir/ ritonavir)
- Nevirapine (saquinavir/ritonavir)
- Interaktion med Invirase/ ritonavir er ikke undersøgt.
- Interaction with Invirase/ritonavir not studied.
- Nevirapin (ikke- boostet saquinavir) Hiv- proteasehæmmere (PI´er)
- Nevirapine (unboosted saquinavir)
- Saquinavir AUC ↓ 24% Nevirapin AUC ↔
- Saquinavir AUC ↓ 24% Nevirapine AUC ↔
Atazanavir 300 mg 1 gang Saquinavir AUC ↑ 60% daglig (saquinavir/ ritonavir 1600/ 100 mg 1 gang daglig)
HIV protease inhibitors (PIs) Atazanavir 300 mg qd (saquinavir/ritonavir 1600/100 mg qd)
Saquinavir Cmax ↑ 42% Ritonavir AUC ↑ 41% Ritonavir Cmax ↑ 34% Atazanavir ↔ Der er ingen tilgængelige kliniske data med kombinationen af saquinavir/ ritonavir 1000/ 100 mg 2 gange daglig og atazanavir.
Saquinavir AUC ↑ 60% Saquinavir Cmax ↑ 42% Ritonavir AUC ↑ 41% Ritonavir Cmax ↑ 34% Atazanavir ↔ No clinical data available for the combination of saquinavir/ritonavir 1000/100 mg bid and atazanavir.
Fosamprenavir 700 mg 2 gange daglig (saquinavir/ ritonavir 1000/ 100 mg 2 gange daglig)
Fosamprenavir 700 mg bid (saquinavir/ritonavir 1000/100 mg bid)
Der behøves ingen dosisjustering for Invirase/ ritonavir.
No dose adjustment required for Invirase/ritonavir.
- Indinavir (saquinavir/ ritonavir)
- Indinavir (saquinavir/ritonavir) - Indinavir 800 mg tid (saquinavir 600-1200 mg single dose)
- Indinavir 800 mg 3 gange daglig (saquinavir 600- 1200 mg enkeltdosis)
Lopinavir/ritonavir 400/100 mg bid (saquinavir/ritonavir 1000/100 mg bid in combination with 2 or 3 NRTIs)
- Saquinavir AUC ↑ 4, 6- 7, 2 gange Indinavir ↔ Der foreligger ingen sikkerheds - og effektdata om anvendelsen af denne kombination.
Saquinavir ↔ Ritonavir ↓ (effectiveness as boosting agent not modified).
Lopinavir/ ritonavir
Lopinavir ↔ (based on historical comparison with unboosted lopinavir)
Nelfinavir 1250 mg 2 gange daglig (saquinavir/ ritonavir 1000/ 100 mg 2 gange daglig)
- Nelfinavir 1250 mg bid (saquinavir/ritonavir 1000/100 mg bid)
27↓ - 61↑) Nelfinavir AUC ↓ 6% (90% konfidensinterval:
27↓ - 61↑) Nelfinavir AUC ↓ 6% (90% CI:
28↓ - 22↑) Nelfinavir Cmax ↓ 5%
28↓ - 22↑) Nelfinavir Cmax ↓ 5% (90% CI:
5. 2).
Saquinavir ↑ Ritonavir ↔ In HIV-infected patients, Invirase or saquinavir soft capsules in combination with ritonavir at doses of 1000/100 mg twice daily provide a systemic exposure of saquinavir over a 24 hour period similar to or greater than that achieved with saquinavir soft capsules 1200 mg three times daily (see section 5.2).
Tipranavir/ ritonavir (saquinavir/ ritonavir) Hiv- fusionshæmmer
Tipranavir/ritonavir (saquinavir/ritonavir) HIV fusion inhibitor
Der anbefales ikke at administrere tripranavir i kombination med lavdosis ritonavir, samtidig med saquinavir/ ritonavir.
Concomitant administration of tipranavir, co-administered with low dose ritonavir, with saquinavir/ritonavir, is not recommended.
Enfuvirtid (saquinavir/ ritonavir 1000/ 100 mg 2 gange daglig) Andre lægemidler Antiarytmika
Enfuvirtide (saquinavir/ritonavir 1000/100 mg bid) Other medicinal products Antiarrhythmics
Bepridil lidokain (systemisk) chinidin (saquinavir/ ritonavir)
Bepridil Lidocaine (systemic) Quinidine (saquinavir/ritonavir) Amiodarone flecainide propafenone (saquinavir/ritonavir) Anticoagulant
Koncentrationer af bepridil, systemisk lidokain eller chinidin kan være øget ved co- administration med Invirase/ ritonavir.
Concentrations of amiodarone, flecainide or propafenone may be increased when co-administered with Invirase/ritonavir.
4. 3).
Contraindicated in combination with saquinavir/ritonavir due to potentially life threatening cardiac arrhythmia (see section 4.3).
Warfarin (saquinavir/ ritonavir) Antikonvulsiva
Warfarin (saquinavir/ritonavir) Anticonvulsants
30 Lægemidler opdelt efter terapeutisk område (dosering af Invirase anvendt i studie)
- Carbamazepine Phenobarbital Phenytoin (saquinavir/ritonavir)
Interaktion
- Interaction with Invirase/ritonavir not studied.
- Interaktion med Invirase/ ritonavir er ikke undersøgt.
Tricyclic antidepressants (e.g. amitriptyline, imipramine) (saquinavir/ritonavir)
- Carbamazepin phenobarbital phenytoin (ikke- boostet saquinavir) Antidepressiva
Invirase/ritonavir may increase concentrations of tricyclic antidepressants.
Tricykliske antidepressiva (f. eks. amitriptylin, imipramin) (saquinavir/ ritonavir)
31 Medicinal product by therapeutic area (dose of Invirase used in study)
Det anbefales at monitorere den terapeutiske koncentration.
Recommendations concerning co - administration
- Nefazodon (saquinavir/ ritonavir)
- Nefazodone (saquinavir/ritonavir)
- Interaktion med saquinavir/ ritonavir er ikke undersøgt.
- Interaction with saquinavir/ritonavir not evaluated.
Terfenadin astemizol (saquinavir/ ritonavir) Anti- infektiva
Terfenadine Astemizole (saquinavir/ritonavir) Anti-infectives
- Clarithromycin (saquinavir/ ritonavir)
- Clarithromycin (saquinavir/ritonavir)
- Clarithromycin 500 mg 2 gange daglig (ikke- boostet saquinavir 1200 mg 3 gange daglig) - Erythromycin (saquinavir/ ritonavir)
- Clarithromycin 500 mg bid (unboosted saquinavir 1200 mg tid) - Erythromycin (saquinavir/ritonavir)
- Saquinavir AUC ↑ 177% Saquinavir Cmax ↑ 187% Clarithromycin AUC ↑ 40% Clarithromycin Cmax ↑ 40%. - Interaktion med Invirase/ ritonavir er ikke undersøgt.
- Saquinavir AUC ↑ 177% Saquinavir Cmax ↑ 187% Clarithromycin AUC ↑ 40% Clarithromycin Cmax ↑ 40% - Interaction with Invirase/ritonavir not studied.
- Streptogramin - antibiotika (saquinavir/ ritonavir)
- Streptogramin antibiotics (saquinavir/ritonavir)
- Streptogramin- antibiotika som f. eks. quinupristin/ dalfopristin hæmmer CYP3A4.
- Streptogramin antibiotics such as quinupristin/dalfopristin inhibit CYP3A4.
Ketoconazol 200 mg 1 gang daglig (saquinavir/ ritonavir 1000/ 100 mg 2 gange daglig)
Ketoconazole 200 mg qd (saquinavir/ritonavir 1000/100 mg bid)
Saquinavir AUC ↔ Saquinavir Cmax ↔ Ritonavir AUC ↔ Ritonavir Cmax ↔ Ketoconazol AUC ↑ 168% (90% konfidensinterval 146% - 193%) Ketoconazol Cmax ↑ 45% (90% konfidensinterval 32% - 59%)
Saquinavir AUC ↔ Saquinavir Cmax ↔ Ritonavir AUC ↔ Ritonavir Cmax ↔ Ketoconazole AUC ↑ 168% (90% CI 146%-193%) Ketoconazole Cmax ↑ 45% (90% CI 32%-59%)
Der behøves ingen dosisjustering når saquinavir/ ritonavir kombineres med ≤ 200 mg ketoconazol/ dag.
No dose adjustment required when saquinavir/ritonavir combined with ≤ 200 mg/day ketoconazole.
Høje doser af ketoconazol (> 200 mg/ dag) anbefales ikke.
High doses of ketoconazole (> 200 mg/day) are not recommended.
- Itraconazol (saquinavir/ ritonavir)
- Itraconazole (saquinavir/ritonavir)
Fluconazol/ miconazol (saquinavir/ ritonavir) Antimykobakterielle midler
Fluconazole/miconazole (saquinavir/ritonavir) Antimycobacterials
Rifampicin 600 mg 1 gang daglig (saquinavir/ ritonavir 1000/ 100 mg 2 gange daglig)
Rifampicin 600 mg qd (saquinavir/ritonavir 1000/100 mg bid)
Rifampicin er kontraindiceret i kombination med Invirase/ ritonavir (se pkt.
Rifampicin is contraindicated in combination with Invirase/ritonavir (see section 4.3).
Rifabutin (saquinavir/ ritonavir 1000/ 100 mg 2 gange daglig) Benzodiazepiner
Rifabutin (saquinavir/ritonavir 1000/100 mg bid) Benzodiazepines
Interaktion med saquinavir/ ritonavir 1000/ 100 mg er ikke undersøgt.
Interaction with saquinavir/ritonavir 1000/100 mg not studied.
Patienter, som behandles med en kombination af rifabutin og Invirase/ ritonavir, skal overvåges nøje for stigninger i leverfunktionstest og forekomst af uønskede hændelser forbundet med rifabutinbehandling.
Patients receiving rifabutin with Invirase/ritonavir should be closely monitored for liver function test elevations and emergence of adverse events associated with rifabutin therapy.
Midazolam 7, 5 mg enkeltdosis (oral) (saquinavir/ ritonavir 1000/ 100 mg 2 gange daglig)
Midazolam 7.5 mg single dose (oral) (saquinavir/ritonavir 1000/100 mg bid)
Midazolam AUC ↑ 12, 4 gange Midazolam Cmax ↑ 4, 3 gange Midazolam t1/ 2 ↑ fra 4, 7 til 14, 9 timer Der er ingen tilgængelige data om samtidig anvendelse af ritonavir boostet saquinavir og intravenøs admininistration af midazolam.
Midazolam AUC ↑ 12.4 fold Midazolam Cmax ↑ 4.3 fold Midazolam t1/2 ↑ from 4.7 h to 14.9 h No data are available on concomitant use of ritonavir boosted saquinavir with intravenous midazolam.
Studier med andre CYP3A - modulatorer og i. v. midazolam tyder på en mulig forhøjelse af midazolams plasmakoncentrationer på 3- 4 gange.
Studies of other CYP3A modulators and i.v. midazolam suggest a possible 3- 4 fold increase in midazolam plasma levels.
4. 3).
Co-administration of Invirase/ritonavir with orally administered midazolam is contraindicated (see section 4.3).
Samtidig administration af Invirase og parenteralt administreret midazolam bør foregå på en intensivafdeling eller et lignende sted, hvor nøje klinisk overvågning og passende medicinsk behandling kan foretages i tilfælde af respirationsdepression og/ eller forlænget sedation.
If Invirase is co-administered with parenteral midazolam it should be done in an intensive care unit (ICU) or similar setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Alprazolam clorazepat diazepam
Alprazolam Clorazepate Diazepam Flurazepam (saquinavir/ritonavir)
Koncentrationer af disse lægemidler kan være øget ved co- administration med Invirase/ ritonavir.
Concentrations of these medicinal products may be increased when co- administered with Invirase/ritonavir.
Det anbefales at monitorere patienterne omhyggeligt mht. sedativ effekt.
Careful monitoring of patients with regard to sedative effects is warranted.
Det kan blive nødvendigt at
A decrease in the dose of the benzodiazepine may be required.
Lægemidler opdelt efter terapeutisk område (dosering af Invirase anvendt i studie)
Triazolam (saquinavir/ritonavir) Calcium channel blockers
Anbefalinger vedrørende co - administration
Concentrations of triazolam may be increased when co-administered with Invirase/ritonavir.
nedsætte benzodiazepindosis.
Contraindicated in combination with saquinavir/ritonavir, due to the risk of potentially prolonged or increased sedation and respiratory depression (see section 4.3).
Triazolam (saquinavir/ ritonavir) Calciumkanalblokkere
Felodipine, nifedipine, nicardipine, diltiazem, nimodipine, verapamil, amlodipine, nisoldipine, isradipine (saquinavir/ritonavir)
Koncentrationer af triazolam kan være øget ved co- administration med Invirase/ ritonavir.
Concentrations of these medicinal products may be increased when co- administered with Invirase/ritonavir.
Felodipin, nifedipin, nicardipin, diltiazem, nimodipin, verapamil, amlodipin, nisoldipin, isradipin (saquinavir/ ritonavir) Kortikosteroider
33 Medicinal product by therapeutic area (dose of Invirase used in study) Corticosteroids
Forsigtighed er påkrævet og klinisk monitorering af patienterne anbefales.
Recommendations concerning co - administration
- Dexamethason (saquinavir/ ritonavir)
- Dexamethasone (saquinavir/ritonavir)
Hos patienter, der fik ritonavir og inhaleret eller intranasalt fluticasonpropionat, er der rapporteret om systemiske bivirkninger forårsaget af kortikosteroider, herunder Cushings syndrom og binyrebarksuppression, hvilket også kan forekomme med andre kortikosteroider, som metaboliseres via P450 3A, som f. eks. budesonid.
Systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression have been reported in patients receiving ritonavir and inhaled or intranasally administered fluticasone propionate; this could also occur with other corticosteroids metabolised via the P450 3A pathway e.g. budesonide.
4. 4).
Concomitant administration of boosted saquinavir and fluticasone propionate and other corticosteroids metabolised via the P450 3A pathway (e.g. budesonide) is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
I tilfælde af behandlingsophør med
Dose reduction of the glucocorticoid should be considered with close monitoring of local and systemic effects or a switch to a glucocorticoid, which is not a substrate for CYP3A4 (e.g.
Lægemidler der er substrater for P- glycoprotein Digitalis glykosider Digoxin 0, 5 mg enkeltdosis (saquinavir/ ritonavir 1000/ 100 mg 2 gange daglig)
Medicinal products that are substrates of P-glycoprotein Digitalis glycosides Digoxin 0.5 mg single dose (saquinavir/ritonavir 1000/100 mg bid)
En stor stigning i digoxinkoncentrationer kan forventes, når saquinavir/ ritonavir administreres til patienter, der allerede er i behandling med digoxin.
Large increments of digoxin may be expected when saquinavir/ritonavir is introduced in patients already treated with digoxin.
Der skal udvises forsigtighed, når Invirase/ ritonavir og digoxin administreres samtidigt.
Caution should be exercised when Invirase/ritonavir and digoxin are co- administered.
Ranitidin (saquinavir/ ritonavir)
Ranitidine (saquinavir/ritonavir)
HMG- CoA- reduktasehæmmere Pravastatin fluvastatin (saquinavir/ ritonavir)
HMG-CoA reductase inhibitors Pravastatin Fluvastatin (saquinavir/ritonavir)
Simvastatin lovastatin (saquinavir/ ritonavir)
Simvastatin Lovastatin (saquinavir/ritonavir)
Disse lægemidler er derfor kontraindiceret til anvendelse sammen med Invirase/ ritonavir (se pkt.
These medicinal products are contraindicated for use with Invirase/ritonavir (see section 4.3).
Atorvastatin (saquinavir/ ritonavir) Immunosuppressiva
Atorvastatin (saquinavir/ritonavir) Immunosuppressants
Når det anvendes sammen med Invirase/ ritonavir, skal der administreres den lavest mulige atorvastatindosis, og patienterne bør kontrolleres omhyggeligt for tegn/ symptomer på myopati (muskelslaphed, muskelsmerter, stigende plasmakreatininkinase).
When used with Invirase/ritonavir, the lowest possible dose of atorvastatin should be administered and the patient should be carefully monitored for signs/symptoms of myopathy (muscle weakness, muscle pain, rising plasma creatinine kinase).
Ciclosporin tacrolimus rapamycin (saquinavir/ ritonavir) Narkotiske analgetika
Ciclosporin Tacrolimus Rapamycin (saquinavir/ritonavir) Narcotic analgesics