natgillin/translations-raw huggingface dataset:
Koncentrationer af disse lægemidler kan være øget ved co- administration
Concentrations of these medicinal products may be increased when co- administered with Invirase/ ritonavir.
Det anbefales at monitorere patienterne omhyggeligt mht. sedativ
Careful monitoring of patients with regard to sedative effects is warranted.
Lægemidler opdelt efter terapeutisk område (dosering af Invirase anvendt i studie)
A decrease in the dose of the benzodiazepine may be required.
Anbefalinger vedrørende co - administration
Triazolam (saquinavir/ ritonavir) Calcium channel blockers
diazepam flurazepam (saquinavir/ ritonavir)
Concentrations of triazolam may be increased when co-administered with Invirase/ ritonavir.
Det kan blive nødvendigt at 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.
4. 3).
Caution is warranted and clinical monitoring of patients is recommended.
Felodipin, nifedipin, nicardipin, diltiazem, nimodipin, verapamil, amlodipin, nisoldipin, isradipin (saquinavir/ ritonavir) Kortikosteroider
10 Medicinal product by therapeutic area (dose of Invirase used in study) Corticosteroids
Koncentrationer af disse lægemidler kan være øget ved co- administration med Invirase/ ritonavir.
Interaction
Forsigtighed er påkrævet og klinisk monitorering af patienterne anbefales.
Recommendations concerning co- administration
- Dexamethason (saquinavir/ ritonavir)
- Dexamethasone (saquinavir/ ritonavir)
- Dexamethason (ikke- boostet saquinavir)
- Dexamethasone (unboosted saquinavir)
- Dexamethason inducerer CYP3A4 og kan nedsætte koncentrationer af saquinavir.
- Dexamethasone induces CYP3A4 and may decrease saquinavir concentrations.
- Anvendes med forsigtighed.
- Use with caution.
Saquinavir kan være mindre effektivt hos patienter som tager dexamethason.
Saquinavir may be less effective in patients taking dexamethasone.
Fluticasonpropionat ↑ Intern kortisol ↓ 86% (90% konfidensinterval 82% - 89%) Større påvirkning kan forventes når fluticasonpropionat inhaleres.
Fluticasone propionate ↑ Intrinsic cortisol ↓ 86% (90% CI 82%-89%) Greater effects may be expected when fluticasone propionate is inhaled.
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.
Påvirkning af ritonavirplasmakoncentrationer ved systemisk høje fluticasonkoncentrationer er endnu ukendt.
Effects of high fluticasone systemic exposure on ritonavir plasma levels yet unknown.
glukokortikoider kan nedtrapningen ske gradvist over en længere periode.
In case of withdrawal of glucocorticoids progressive dose reduction may have to be performed over a longer period.
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)
Digoxin AUC0- 72 ↑ 49% Digoxin Cmax ↑ 27% Digoxinkoncentrationerne kan ændre sig over tid.
Digoxin AUC0-72 ↑ 49% Digoxin Cmax ↑ 27% Digoxin levels may differ over time.
11
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.
Serumkoncentrationen af digoxin skal overvåges, og det bør overvejes at reducere digoxindosis hvis nødvendigt.
The serum concentration of digoxin should be monitored and a dose reduction of digoxin should be considered if necessary.
Histamin H2- receptorantagonist -
Histamine H2-receptor antagonist -
Ranitidin (saquinavir/ ritonavir)
Ranitidine (saquinavir/ ritonavir)
Ranitidin (ikke- boostet saquinavir)
Ranitidine (unboosted saquinavir)
- Saquinavir AUC ↑ 67% -
- Saquinavir AUC ↑ 67%
HMG- CoA- reduktasehæmmere Pravastatin fluvastatin (saquinavir/ ritonavir)
HMG-CoA reductase inhibitors Pravastatin Fluvastatin (saquinavir/ ritonavir)
Hvis ingen alternative behandlingsmuligheder er tilgængelige, skal de anvendes med omhyggelig monitorering.
If no alternative treatment is available, use with careful monitoring.
Simvastatin lovastatin (saquinavir/ ritonavir)
Simvastatin Lovastatin (saquinavir/ ritonavir)
Simvastatin ↑↑ Lovastatin ↑↑ Plasmakoncentrationer afhænger i høj grad af CYP3A4- metabolisme.
Simvastatin ↑↑ Lovastatin ↑↑ Plasma concentrations highly dependent on CYP3A4 metabolism.
Forhøjede koncentrationer af simvastatin og lovastatin er blevet forbundet med rhabdomyolosis.
Increased concentrations of simvastatin and lovastatin have been associated with rhabdomyolysis.
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
Koncentrationer af disse lægemidler øges mange gange ved co - administration med Invirase/ ritonavir.
Concentrations of these medicinal products increase several fold when co-administered with Invirase/ ritonavir.
Nøje overvågning af de terapeutiske koncentrationer af de immunosuppressive lægemidler er nødvendig, når de gives sammen med Invirase/ ritonavir.
Careful therapeutic drug monitoring is necessary for immunosuppressants when co-administered with Invirase/ ritonavir.
Metadon 60- 120 mg 1 gang daglig (saquinavir/ ritonavir 1000/ 100 mg 2 gange daglig) Neuroleptika
Methadone 60-120 mg qd (saquinavir/ ritonavir 1000/ 100 mg bid) Neuroleptics
Metadon AUC ↓ 19% (90% konfidensinterval 9% to 29%) Ingen af de 12 patienter oplevede abstinenssymptomer.
Methadone AUC ↓ 19% (90% CI 9% to 29%) None of the 12 patients experienced withdrawal symptoms.
Der behøves ingen dosisjustering.
No dosage adjustment required.
Pimozid (saquinavir/ ritonavir) Orale kontraceptiva
Pimozide (saquinavir/ ritonavir) Oral contraceptives
Koncentrationer af pimozid kan være øget ved co- administration med Invirase/ ritonavir.
Concentrations of pimozide may be increased when co-administered with Invirase/ ritonavir.
4. 3).
Due to a potential for life threatening cardiac arrhythmias, Invirase/ ritonavir is contra-indicated in combination with pimozide (see section 4.3).
Ethinylestradiol (saquinavir/ ritonavir)
Ethinyl estradiol (saquinavir/ ritonavir)
Koncentrationen af ethinylestradiol kan falde når det administreres sammen med Invirase/ ritonavir.
Concentration of ethinyl estradiol may be decreased when co- administered with Invirase/ ritonavir.
Der bør anvendes andre eller ekstra præventionsmidler når estradiolbaserede orale kontraceptiva co- administreres.
Alternative or additional contraceptive measures should be used when oestrogen-based oral contraceptives are co-administered.
Phosphodiesterase- type - Sildenafil
Phosphodiesterase type 5 (PDE5) inhibitors -
5- hæmmere (PDE5- hæmmere) - Interaktion med Invirase/ ritonavir
Sildenafil (saquinavir/ ritonavir)
(saquinavir/ ritonavir)
-
er ikke undersøgt.
Interaction with Invirase/ ritonavir not studied.
12
-
Lægemidler opdelt efter terapeutisk område (dosering af Invirase anvendt i studie)
Sildenafil 100 mg (single dose) (unboosted saquinavir
Interaktion
Saquinavir ↔ Sildenafil Cmax ↑ 140% Sildenafil AUC ↑ 210%
Anbefalinger vedrørende co - administration
- Use sildenafil with caution at reduced doses of no more than 25 mg every 48 hours with
- Sildenafil 100 mg (enkeltdosis) (ikke- boostet saquinavir 1200 mg 3 gange daglig)
1200 mg tid)
- Saquinavir ↔ Sildenafil Cmax ↑ 140% Sildenafil AUC ↑ 210% - Sildenafil er et substrat for CYP3A4.
Sildenafil is a substrate of CYP3A4.
- Sildenafil skal anvendes med forsigtighed i reducerede doser på ikke over 25 mg hver 48. time, når det anvendes samtidigt med Invirase/ ritonavir og monitoreringen af uønskede hændelser skal øges.
increased monitoring of adverse events when administered concomitantly with Invirase/ ritonavir.
Vardenafil (saquinavir/ ritonavir)
Vardenafil (saquinavir/ ritonavir)
Koncentrationer af vardenafil kan være øget ved co- administration med Invirase/ ritonavir.
Concentrations of vardenafil may be increased when co-administered with Invirase/ ritonavir.
Vardenafil skal anvendes med forsigtighed i reducerede doser på ikke over 2, 5 mg hver 72. time, når det anvendes samtidigt med Invirase/ ritonavir og monitoreringen af uønskede hændelser skal øges.
Use vardenafil with caution at reduced doses of no more than 2.5 mg every 72 hours with increased monitoring of adverse events when administered concomitantly with Invirase/ ritonavir.
Tadalafil (saquinavir/ ritonavir) Syrepumpehæmmere
Tadalafil (saquinavir/ ritonavir)
Koncentrationer af tadalafil kan være øget ved co- administration med Invirase/ ritonavir.
Concentrations of tadalafil may be increased when co-administered with Invirase/ ritonavir.
Tadalfil skal anvendes med forsigtighed i reducerede doser på ikke over 10 mg hver 72. time, når det anvendes samtidigt med Invirase/ ritonavir og monitoreringen af uønskede hændelser skal øges.
Use tadalafil with caution at reduced doses of no more than 10 mg every 72 hours with increased monitoring of adverse events when administered concomitantly with Invirase/ ritonavir.
Omeprazol 40 mg 1 gang daglig (saquinavir/ ritonavir 1000/ 100 mg 2 gange daglig)
Omeprazole 40 mg qd (saquinavir/ ritonavir 1000/ 100 mg bid)
Saquinavir AUC ↑ 82% (90% konfidensinterval 44 - 131%) Saquinavir Cmax ↑ 75% (90% konfidensinterval 38 - 123%) Ritonavir ↔
Saquinavir AUC ↑ 82% (90% CI 44-131%) Saquinavir Cmax ↑ 75% (90% CI 38-123%) Ritonavir ↔
Det anbefales at monitorere potentielle toksiciteter af saquinavir.
Monitoring for potential saquinavir toxicities is recommended.
Andre syrepumpehæmmere (saquinavir/ ritonavir 1000/ 100 mg 2 gange daglig) Andre
Other proton pump inhibitors (saquinavir/ ritonavir 1000/ 100 mg bid) Others
Der er ingen tilgængelig data om samtidig administration af Invirase/ ritonavir og andre syrepumpehæmmere.
No data are available on the concomitant administration of Invirase/ ritonavir and other proton pump inhibitors.
Hvis omeprazol eller andre syrepumpehæmmere administreres samtidigt med Invirase/ ritonavir, anbefales det at monitorere potentielle toksiciteter af saquinavir.
If omeprazole or other proton pump inhibitors are taken concomitantly with Invirase/ ritonavir, monitoring for potential saquinavir toxicities is recommended.
Sekalealkaloider (f. eks. ergotamin, dihydroergotamin, ergonovin og methylergonovin) (saquinavir/ ritonavir)
Ergot alkaloids (e. g. ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (saquinavir/ ritonavir)
Invirase/ ritonavir kan øge eksponering af sekalealkaloider og som en konsekvens af dette øge risikoen for akut ergotamintoksicitet.
Invirase/ ritonavir may increase ergot alkaloids exposure, and consequently, increase the potential for acute ergot toxicity.
4. 3).
The concomitant use of Invirase/ ritonavir and ergot alkaloids is contra-indicated (see section 4.3).
- Grapefrugtjuice (saquinavir/ ritonavir)
- Grapefruit juice (saquinavir/ ritonavir)
- Grapefrugtjuice (enkeltdosis) (ikke- boostet saquinavir)
- Grapefruit juice (single dose) (unboosted saquinavir)
- Saquinavir ↑ 50% (normal styrke grapefrugtjuice) - Saquinavir ↑ 100% (dobbelt styrke grapefrugtjuice).
- Saquinavir ↑ 50% (normal strength grapefruit juice) - Saquinavir ↑ 100% (double strength grapefruit juice)
- Stigning anses ikke for klinisk relevant.
- Increase not thought to be clinically relevant.
- Hvidløgskapsler (saquinavir/ ritonavir)
- Garlic capsules (saquinavir/ ritonavir)
- Hvidløgskapsler (dosis svarer til ca. to fed hvidløg på 4 g hver daglig) (ikke- boostet saquinavir 1200 mg 3 gange daglig)
- Garlic capsules (dose approx. equivalent to two 4 g cloves of garlic daily) (unboosted saquinavir 1200 mg tid)
- Saquinavir AUC ↓ 51% Saquinavir Ctrough ↓ 49% (8 timer efter indtagelse) Saquinavir Cmax ↓ 54%.
- Saquinavir AUC ↓ 51% Saquinavir Ctrough ↓ 49% (8 hours post dose) Saquinavir Cmax ↓ 54%.
- Patienter i saquinavirbehandling må ikke indtage hvidløgskapsler på grund af risikoen for fald i plasmakoncentrationer og tab af virologisk respons samt mulig resistens overfor en eller flere af komponenterne i den
- Patients on saquinavir treatment must not take garlic capsules due to the risk of decreased plasma concentrations and loss of virological response and possible resistance to one or more components of the antiretroviral regimen.
13
13 Medicinal product by therapeutic area (dose of Invirase used in study)
Anbefalinger vedrørende co - administration antiretrovirale regime.
Recommendations concerning co- administration
- Prikbladet perikum (Hypericum perforatum) (saquinavir/ ritonavir)
John’ s wort (saquinavir/ ritonavir)
- Prikbladet perikum (Hypericum perforatum) (ikke- boostet saquinavir)
John’ s wort (unboosted saquinavir) Other potential interactions
- Plasmakoncentrationer af saquinavir kan reduceres ved samtidigt brug af urtepræparatet prikbladet perikum (Hypericum perforatum).
John’ s wort (Hypericum perforatum).
Dette skyldes at prikbladet perikum virker inducerende på lægemiddelmetaboliserende enzymer og/ eller kan påvirke transportproteiner.
John’ s wort.
- Urtepræparater indeholdende prikbladet perikum må ikke anvendes samtidig med Invirase.
John’ s wort must not be used concomitantly with Invirase.
Hvis patienten allerede tager prikbladet perikum, skal brug af prikbladet perikum ophøre og virusmængden og, om muligt, saquinavirkoncentrationer kontrolleres.
John’ s wort, check viral levels and if possible saquinavir levels.
Saquinavirkoncentrationer kan stige ved ophør med prikbladet perikum og det kan blive nødvendigt at justere saquinavirdosis.
John’ s wort, and the dose of saquinavir may need adjusting.
Den inducerende effekt af prikbladet perikum kan vedvare i mindst 2 uger efter ophør af behandling.
John’ s wort may persist for at least 2 weeks after cessation of treatment.
Andre potentielle interaktioner Lægemidler som er substrater for CYP3A4 F. eks. dapson, disopyramid, kinin, fentanyl og alfentanyl (ikke- boostet saquinavir)
Medicinal products that are substrates of CYP3A4 e. g. dapsone, disopyramide, quinine, fentanyl, and alfentanyl (unboosted saquinavir)
Selvom der ikke er udført specifikke undersøgelser, kan samtidig administration af Invirase/ ritonavir og lægemidler, som hovedsageligt metaboliseres af CYP3A4, muligvis medføre stigninger i plasmakoncentrationer af disse lægemidler.
Although specific studies have not been performed, co-administration of Invirase/ ritonavir with medicinal products that are mainly metabolised by CYP3A4 pathway may result in elevated plasma concentrations of these medicinal products.
Disse kombinationer bør administreres med forsigtighed.
These combinations should be given with caution.
Lægemidler som nedsætter den Metoclopramid
Medicinal products reducing gastrointestinal transit time Metoclopramide
gastrointestinale transittid Det vides ikke om lægemidler, der nedsætter den gastrointestinale transittid, kan medføre lavere plasmakoncentrationer af saquinavir.
It is unknown whether medicinal products which reduce the gastrointestinal transit time could lead to lower saquinavir plasma concentrations.
Vurdering af eksperimentelle dyreundersøgelser indicerer ikke nogle direkte eller indirekte skadelige virkninger med hensyn til udviklingen af embryonet eller fostret, forløbet af svangerskabet og den peri - eller postnatale udvikling.
Evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect to the development of the embryo or foetus, the course of gestation and peri- and post-natal development.
Der findes kun begrænsede kliniske erfaringer på gravide kvinder:
Clinical experience in pregnant women is limited:
Kongenitte misdannelser, fødselsskader og andre lidelser (uden kongenitte misdannelser) er blevet rapporteret sjældent hos gravide kvinder, der har fået saquinavir i kombination med andre antiretrovirale stoffer.
Congenital malformations, birth defects and other disorders (without a congenital malformation) have been reported rarely in pregnant women who had received saquinavir in combination with other antiretroviral agents.
5. 3).
Saquinavir should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus (see section 5.3).
Der findes ingen data fra laboratoriedyr eller humane data om udskillelse af saquinavir i modermælk.
There are no laboratory animal or human data available on secretion of saquinavir in breast milk.
Det anbefales at hiv- inficerede kvinder under ingen omstændigheder ammer deres børn for at undgå overførsel af hiv.
It is recommended that HIV-infected women do not breast feed their infants under any circumstances in order to avoid transmission of HIV.
14 4. 7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner
4.7 Effects on ability to drive and use machines
Invirase kan i mindre grad påvirke evnen til at føre bil, motorkøretøj eller betjene maskiner.
Invirase may have a minor influence on the ability to drive and use machines.
Der er blevet rapporteret om svimmelhed og træthed under behandling med Invirase.
Dizziness and fatigue have been reported during treatment with Invirase.
4. 8 Bivirkninger
14 4.8 Undesirable effects
Kvalme, diarré, træthed, opkastning, flatulens og mavesmerter.
The following adverse events with an at least possible relationship to ritonavir boosted saquinavir (i. e. adverse reactions) were reported most frequently: nausea, diarrhoea, fatigue, vomiting, flatulence, and abdominal pain.
Inden for hver enkelt frekvensgruppering er bivirkningerne opstillet efter, hvor alvorlige de er.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Bivirkninger fra kliniske undersøgelser, hvor saquinavir var boostet med ritonavir
Adverse reactions from clinical trials where saquinavir was boosted with ritonavir
Der er begrænset information tilgængelig fra to undersøgelser, hvor sikkerheden af saquinavir bløde kapsler (1000 mg to gange daglig) blev anvendt i kombination med lavdosis ritonavir (100 mg to gange daglig) i mindst 48 uger hos 311 patienter.
Limited data is available from two studies where the safety of saquinavir soft capsule (1000 mg twice daily) used in combination with low dose ritonavir (100 mg twice daily) for at least 48 weeks was studied in 311 patients.
Bivirkninger i disse to pivotale undersøgelser, er opstillet i tabel 2.
Adverse reactions in these two pivotal studies are summarised in Table 2.
Listen inkluderer også ændrede laboratorieværdier, der blev observeret efter kombination af saquinavir bløde kapsler og ritonavir (ved 48 uger).
The list also includes marked laboratory abnormalities that have been observed with the saquinavir soft capsule in combination with ritonavir (at 48 weeks).
15 Tabel 2:
15 Table 2:
Hyppigheder af bivirkninger og ændrede laboratorieværdier fra MaxCmin1 - og MaxCmin2 - studiet.
Incidences of Adverse Reactions and marked laboratory abnormalities from the MaxCmin1 and MaxCmin2 study.
(Meget almindelig (≥ 10%), almindelig (≥ 1% og < 10%))
(Very common (≥ 10%); common (≥ 1% and < 10%))
Organklasse Bivirkningsfrekvens
Body System Frequency of Reaction
Blod og lymfesystem
Adverse Reactions
Grad 3 og 4
Grades 3 & 4
Almindelig Immunsystemet
Blood and the lymphatic system disorders Common Immune system disorders
Almindelig Metabolisme og ernæring
Common
Almindelig Psykiske forstyrrelser
Metabolism and nutrition disorders Common Psychiatric disorders
Diabetes mellitus, anorexi, øget appetit
Diabetes mellitus, anorexia, increased appetite
Almindelig Nervesystemet
Common Nervous System Disorders
Almindelig Luftveje, thorax og mediastinum
Common
Almindelig Mave- tarmkanalen
Respiratory, thoracic and mediastinal disorders Common Gastrointestinal disorders
Almindelig Hud og subkutane væv
Common
Diarré, kvalme, opkastning
Diarrhoea, nausea, vomiting
Opkastning, abdominal udspilning, abdominale smerter, øvre abdominale smerter, obstipation, mundtørhed dyspepsi, opstød, flatulens, tørre læber, løs afføring
Vomiting, abdominal distension, abdominal pain, upper abdominal pain, constipation, dry mouth, dyspepsia, eructation, flatulence, lip dry, loose stools
Almindelig Knogler, led, muskler og bindevæv
Skin and subcutaneous tissue disorders Common
Erhvervet lipodystrofi
Acquired lipodystrophy
Erhvervet lipodystrofi, alopecia, tør hud, eksem, lipoatrofi, pruritus, udslæt
Acquired lipodystrophy, alopecia, dry skin, eczema, lipoatrophy, pruritus, rash
Almindelig Almene symptomer og reaktioner på
Musculoskeletal and connective tissue disorders Common General disorders and administration site conditions
Almindelig Undersøgelser
Common Fatigue Investigations
Asteni, træthed, øget fedtvæv, generel utilpashed
Asthenia, fatigue, increased fat tissue, malaise
Forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, forhøjet cholesterol, forhøjede triglycerider, forhøjet LDL, nedsat antal blodplader
Increased alanine aminotransferase, increased aspartate aminotransferase, increased blood cholesterol, increased blood triglycerides, increased low density lipoprotein, decreased platelet count
Forhøjet amylase, forhøjet bilirubin, forhøjet creatinin, nedsat hæmoglobin, nedsat lymfocyttal, nedsat antal hvide blodlegemer
Increased blood amylase, increased blood bilirubin, increased blood creatinine, decreased haemoglobin, decreased lymphocyte count, decreased white blood cell count
Erfaringer efter markedsføring af
Post-marketing experience with saquinavir
4. 8, og hvor en kausal sammenhæng med saquinavir ikke kan udelukkes, er nævnt nedenfor.
Serious and non-serious adverse reactions from post-marketing spontaneous reports (where saquinavir was taken as the sole protease inhibitor or in combination with ritonavir), not mentioned previously in section 4.8, for which a causal relationship to saquinavir cannot be excluded, are summarised below.