natgillin/translations-raw huggingface dataset:
Terapeutiske koncentrationsmålinger anbefales for immunosuppresive lægemidler (cyclosporin, tacrolimus, rapamycin), når disse administreres samtidig med Telzir (se pkt. 
Therapeutic concentration monitoring is recommended for immunosuppressant medicinal products (cyclosporine, tacrolimus, rapamycin) when co-administered with Telzir (see section 4.5).
Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig. 
Tell your doctor or pharmacist if you're taking or have recently taken any other medicinesthese include herbal medicines or other medicines you bought without a prescription.
Der er ikke foretaget studier af virkninger på evnen til at føre motorkøretøj eller betjene maskiner for Telzir i kombination med ritonavir. 
No studies on the effects of Telzir in combination with ritonavir on the ability to drive and use machines have been performed.
• maraviroc (mod hiv-infektion). 
• maraviroc (used to treat HIV infection)
AAUCMB gennemsnitlig forskel (97,5 % CI) 
AAUCMB Mean Diff (97.5% CI)
• ændringer i kropsfacon 
• Change in your body shape
APV29005 involverede 30 patienter mellem 6 og 11 år (hvoraf de fleste blev behandlet med 18 mg fosamprenavir/kg og 3 mg ritonavir/kg 2 gange daglig eller voksendoseringen) og 40 patienter mellem 12 og 18 år (hvoraf de fleste blev behandlet med voksendoseringen). 
APV29005 enrolled 30 patients aged 6 to 11 (the majority of whom were treated with fosamprenavir / ritonavir 18/3 mg/kg twice daily or the adult tablet regimen) and 40 patients aged 12 to 18 (the majority of whom were treated with the adult tablet regimen).
Denne anvendes til patienter, som ikke kan synke tabletter, og til pædiatriske patienter, som vejer under 39 kg (se i produktresuméet for Telzir oral suspension). 
Telzir is also available as an oral suspension for use in patients unable to swallow tablets, and in paediatric patients less than 39 kg (please refer to the Summary of Product Characteristics for Telzir oral suspension).
Når fosamprenavir og ritonavir administreres samtidig vil ritonavirs metaboliske interaktion tilsyneladende dominere, idet ritonavir er en mere potent CYP3A4-hæmmer. 
When fosamprenavir and ritonavir are co-administered, the ritonavir metabolic drug interaction profile may predominate because ritonavir is a more potent CYP3A4 inhibitor.
Hvis du ammer eller planlægger at amme:  Tal straks med lægen. 
If you are breast-feeding, or thinking about breast-feeding: →Talk to your doctor immediately.
Naturprodukter indeholdende perikon (Hypericum perforatum) må ikke anvendes samtidig med Telzir på grund af risiko for fald i plasmakoncentrationen og risiko for reduceret klinisk effekt af fosamprenavir (se pkt. 
Herbal preparations containing St John's wort (Hypericum perforatum) must not be used while taking Telzir due to the risk of decreased plasma concentrations and reduced clinical effects of amprenavir (see section 4.5).
Fænotype-resistens-test 
Phenotypic resistance testing
Cmax 56 % (-70 % til -34 %) AUC 54 % (-66 % til -37 %) Cmin 54 % (-74 % til -18 %) 
Cmax ↓ 56% (-70%; -34%) AUC ↓ 54% (-66%; -37%) Cmin ↓ 54 % (-74%; -18%)
Som en generel regel bør data fra dyrestudier såvel som klinisk erfaring fra gravide medtages i overvejelserne i beslutningen om, hvorvidt antiretrovirale lægemidler skal anvendes i behandlingen af hiv-infektion hos gravide for at nedsætte risikoen for vertikal transmission af hiv til den nyfødte. 
As a general rule, when deciding to use antiretroviral agents for the treatment of HIV infection in pregnant women and consequently for reducing the risk of HIV vertical transmission to the newborn, the animal data (see section 5.3) as well as the clinical experience in pregnant women should be taken into account.
Ved samtidig behandling af hepatitis B eller C med antivirale midler henvises til produktresumeet for disse lægemidler. 
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products.
• sildenafil, vardenafil eller tadalafil (mod impotens) 
• sildenafil, vardenafil or tadalafil (used to treat erectile dysfunction)
Lægemidler - interaktioner Brugen af Telzir sammen med halofantrin eller lidocain (systemisk) kan ikke anbefales. 
The use of Telzir concomitantly with halofantrine or lidocaine (systemic) is not recommended.
Lægemiddelrelaterede bivirkninger var mere almindelige i APV20003 (57 %), hvor patienterne fik behandling med fosamprenavir/ritonavir en gang daglig sammenlignet med APV29005 (33 %), hvor patienterne fik fosamprenavir/ritonavir 2 gange daglig. 
Drug-related adverse reactions were more common in APV20003 (57%) where subjects received once daily fosamprenavir / ritonavir when compared to APV29005 (33%) where subjects received twice daily fosamprenavir / ritonavir.
Tricykliske antidepressiva:  forventet 
Tricyclic antidepressant: ↑ expected
Både fosamprenavirs aktive metabolit, amprenavir, og ritonavir metaboliseres i leveren af CYP3A4. 
Additionally, both amprenavir, the active metabolite of fosamprenavir, and ritonavir are primarily metabolised in the liver by CYP3A4.
Kassér den orale suspension 28 dage efter første åbning af flasken 
EXP Discard 28 days after first opening
Dette lægemiddel indeholder konserveringsmidler: Methylparahydroxybenzoat (E218) og propylparahydroxybenzoat (E216), se indlægssedlen for flere oplysninger 
This product also contains preservatives: methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), see leaflet for further information
Forsøg på at modvirke denne reduktion i amprenavir-AUC, ved at øge dosis af andre proteasehæmmere sammen med ritonavir, resulterede i en højere forekomst af leverpåvirkninger. 
During attempts to overcome the decreased exposure by increasing the dose of other protease inhibitors with ritonavir, a high frequency of liver reactions was seen.
Kassér den orale suspension 28 dage efter første åbning af flasken. 
Discard 28 days after first opening.
Lægen kan nedsætte dosis af Telzir og ritonavir i forhold til din leverfunktion. 
Your doctor may lower your dose of Telzir and ritonavir depending on the amount of liver damage.
Metaboliske parameter: Kropsvægt og niveauerne af lipid og glucose i blodet kan stige under antiretroviral behandling (se pkt. 
Metabolic parameters: weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4).
Det er vigtigt, at du tager hele dagens dosis af både Telzir og ritonavir. 
It is very important that you take the full daily dose of Telzir and ritonavir as prescribed by your doctor.
Calciumchloriddihydrat Syntetisk grape-tyggegummismagsstof Naturligt pebermyntesmagsstof Renset vand 
Calcium chloride dihydrate Artificial grape bubblegum flavour Natural peppermint flavour Purified water
Den forventede eksponering er baseret på ekstrapolation af data efter administration af fosamprenavir 300 mg 2 gange daglig med ritonavir 100 mg én gang daglig hos personer med moderat nedsat leverfunktion. 
Predicted exposures are based on extrapolation from data observed following administration of fosamprenavir 300 mg twice daily with ritonavir 100 mg once daily in subjects with moderate hepatic impairment.
Løs afføring, kvalme, opkastning, mavesmerter 
Loose stools, nausea, vomiting, abdominal pain
Telzir i kombination med ritonavir bør anvendes med forsigtighed og i reducerede doser til voksne med let, moderat eller svært nedsat leverfunktion (se pkt. 
Telzir with ritonavir should be used with caution and at reduced doses in adults with mild, moderate or severe hepatic impairment (see section 4.2).
Hvis du tager Telzir og ritonavir samtidig med p-piller, kan det skade din lever og nedsætte virkningen af p-pillerne. 
Taking Telzir and ritonavir while taking the contraceptive pill may harm your liver and may stop the contraceptive from working properly.
Samtidig administration af Telzir og ritonavir må ikke kombineres med lægemidler, som har smalt terapeutisk vindue og som i høj grad er afhængig af CYP2D6 metabolisme, f.eks. flecainid og propafenon (se pkt. 
Telzir with ritonavir must not be co-administered with medicinal products with narrow therapeutic windows that are highly dependent on CYP2D6 metabolism, e.g. flecainide and propafenone (see section 4.5).
Effekten og bivirkningerne af tricykliske antidepressiva skal omhyggelig overvåges (se pkt. 
Careful monitoring of the therapeutic and adverse reactions of tricyclic antidepressants is recommended (see section
Den primære elimineringsvej for amprenavir og ritonavir er via leveren. 
The principal route of amprenavir and ritonavir elimination is hepatic metabolism.
Børn og unge over 6 år 
Children and adolescent patients above the age of six
Telzir bør seponeres permanent i tilfælde af sværere udslæt eller i tilfælde af moderat udslæt ledsaget af systemiske eller mucosale symptomer (se pkt. 
Telzir should be permanently discontinued in case of severe rash, or in case of rash of moderate intensity with systemic or mucosal symptoms (see section 4.8).
Hvis en patient allerede tager perikon, skal niveauet for amprenavir, ritonavir og hiv-RNA tjekkes og perikon seponeres. 
If a patient is already taking St John's wort, check amprenavir, ritonavir and HIV RNA and stop St John's wort.
Farmakokinetikken for fosamprenavir er ikke undersøgt hos patienter over 65 år (se pkt. 
The pharmacokinetics of fosamprenavir have not been studied in this patient population (see section 5.2).
Hos hanrotter sås en højere forekomst af interstitiel celle-hyperplasi ved eksponeringsniveauer 0,5 gange større end den humane, og i hunrotter sås en stigning i uterin endometrial adenocarcinomaer ved eksponeringsniveauer 1,1 gange større end den humane. 
In rats only there was an increase in interstitial cell hyperplasia in males at exposure levels equivalent to 0.5-fold those in humans, and an increase in uterine endometrial adenocarcinoma in females at an exposure level equivalent to 1.1-fold those in humans.
Telzir må ikke administreres samtidig med lægemidler, som har et smalt terapeutisk vindue, og som er substrater for CYP3A4, f.eks. alfuzosin, amiodaron, astemizol, bepridil, cisaprid, dihydroergotamin, ergotamin, pimozid, quetiapin, quinidin, terfenadin, oral midazolam (se pkt. 
Telzir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4), e.g. alfuzosin, amiodarone, astemizole, bepridil, cisapride, dihydroergotamine, ergotamine, pimozide, quetiapine, quinidine, terfenadine, oral midazolam (for caution on parenterally administered midazolam, see section 4.5), oral triazolam, sildenafil used for the treatment of pulmonary arterial hypertension (for use of sildenafil in patients with erectile dysfunction, see sections 4.4 and 4.5).
Den anbefalede dosis er 0,36 ml/kg Telzir oral suspension (18 mg pr. kg fosamprenavir) 2 gange daglig sammen med 3 mg/kg ritonavir oral opløsning 2 gange daglig. 
The recommended dose is 0.36 ml/kg of Telzir oral suspension (18 mg per kg fosamprenavir) twice daily with 3 mg/kg ritonavir oral solution twice daily.
Data for andre CYP3A4hæmmere indikerer, at midazolamkoncentrationen bliver signifikant højere, når midazolam gives oralt. 
Based on data with other protease inhibitors plasma concentrations of midazolam are expected to be significantly higher when midazolam is given orally.
• hvis du er allergisk over for fosamprenavir, amprenavir eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6) eller over for ritonavir 
• if you are allergic to fosamprenavir, amprenavir or any of the other ingredients of this medicine
YDRE KARTON TIL ORAL SUSPENSION 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR ORAL SUSPENSION
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 July 2004
Samtidig administration af Telzir/ritonavir og alfuzosin er kontraindiceret (se pkt. 
Co-administration of TELZIR/ritonavir with alfuzosin is contraindicated (see section 4.3).
• dolutegravir (mod hiv-infektion) 
• dolutegravir (used to treat HIV infection)
Dihydroergotamin:  forventet Ergometrin:  forventet Ergotamin:  forventet Methylergometrin:  forventet 
Ergonovine: ↑ expected Ergotamine: ↑ expected Methylergonovine: ↑ expected
Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se. bilag I: Produktresumé, pkt. 
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Telzir er et antiretroviralt lægemiddel. 
Telzir is a type of medicine known as an anti-retroviral.
PDE5-HÆMMERE 
PDE5 INHIBITORS
Problemer med knoglerne 
You may have problems with your bones
Hvis overdosering forekommer, bør patienten overvåges for tegn på toksicitet (se pkt. 
If overdose occurs, the patient should be monitored for evidence of toxicity (see section 4.8) and standard supportive treatment applied as necessary.
Cmax 25 % (-41 % til -4 %) AUC 25 % (-42 % til -3 %) Cmin 33 % (-50 % til -10 %) 
Cmax ↓ 25% (-41%; -4%) AUC ↓ 25% (-42%; -3%) Cmin ↓ 33% (-50%; -10%)
Maraviroc 300 mg 2 gange daglig 
Maraviroc 300 mg twice daily
Hepatitis C-virus (HCV) direkte virkende antivirale stoffer: Når hepatitis C-virus direkte virkende antivirale stoffer, som metaboliseres af CYP3A4, eller som er induktorer/hæmmere af CYP3A4, administreres samtidigt med fosamprenavir/ritonavir, kan ændrede plasmakoncentrationer forventes pga. hæmning eller induktion af CYP3A4-enzymaktivitet (se pkt. 
Hepatitis C virus (HCV) Direct-Acting Antivirals: When hepatitis C virus direct-acting antiviral (DAA) drugs, which are metabolised by CYP3A4 or are inducers/inhibitors of CYP3A4, are coadministered with fosamprenavir/ritonavir, altered plasma concentrations of medications are expected due to inhibition or induction of CYP3A4 enzyme activity (see section 4.3 and 4.5).
Terapeutiske koncentrationsmålinger anbefales for tricykliske antidepressiva (f.eks. desipramin og nortriptylin), når disse administreres samtidig med Telzir (se pkt. 
Therapeutic concentration monitoring is recommended for tricyclic antidepressants (e.g. desipramine and nortriptyline) when co-administered with Telzir (see section 4.5).
ViiV Healthcare Trading Services UK Limited 12 Riverwalk, Citywest Business Campus Dublin 24, 
ViiV Healthcare Trading Services UK Limited 12 Riverwalk,
HDPE flaske med børnesikret låg af polypropylen. 
HDPE bottles with a child resistant polypropylene closure containing 60 tablets.
Virkningsmekanisme 
Efficacy Outcomes
Amprenavirs farmakokinetik i plasma blev undersøgt i et 14-dages ”repeat-dose”-studie med hiv-1inficerede voksne personer med let, moderat eller svært nedsat leverfunktion. 
The plasma amprenavir pharmacokinetics were evaluated in a 14 day repeat-dose study in HIV-1 infected adult subjects with mild, moderate, or severe hepatic impairment receiving fosamprenavir with ritonavir compared to matched control subjects with normal hepatic function.
Sammenlignet med historiske data for voksne behandlet med samme doser havde de 12 til 18-årige 20 % lavere plasma APV AUC(0-24), 23 % lavere Cmax, og 20 % lavere Cmin-værdier. 
Compared to the historical adult population receiving fosamprenavir / ritonavir 700 / 100 mg twice daily, 12 to 18 year old subjects had 20 % lower plasma APV AUC(024), 23 % lower Cmax, and 20 % lower Cmin values.
• atorvastatin op til 20 mg om dagen (mod forhøjet kolesterol i blodet) 
• atorvastatin up to 20 mg per day (used to lower cholesterol)
Den nuværende (juli 2006) ANRS AC-11-algoritme for fosamprenavir/ritonavir definerer resistens som tilstedeværelsen af mutationerne V32I+I47A/V, eller I50V eller mindst fire af følgende mutationer: L10F/I/V, L33F, M36I, I54A/L/M/S/T/V, I62V, V82A/C/F/G, I84V og L90M. 
The current (July 2006) ANRS AC-11 algorithm for fosamprenavir / ritonavir defines resistance as the presence of the mutations V32I+I47A/V, or I50V, or at least four mutations among: L10F/I/V, L33F, M36I, I54A/L/M/S/T/V,
Patienter bør orienteres om, at Telzir eller enhver anden nuværende antiretroviral behandling ikke kurerer hiv. 
Patients should be advised that treatment with Telzir, or any other current antiretroviral therapy, does not cure HIV and that they may still develop opportunistic infections and other complications of HIV infection.
Etravirin AUC  
Norethisterone: AUC
Baseret på de observerede eksponerings-responssammenhænge fra kliniske data anbefales dosisjustering af fosamprenavir eller dolutegravir ikke. 
No dosage adjustment of fosamprenavir or dolutegravir is recommended based on observed exposureresponse relationships of clinical data.
Sådan skal du tage Telzir 
How to take Telzir
pimozid (til behandling af skizofreni) quetiapin (til behandling af skizofreni, bipolar (manio-depressiv) lidelse og svær depressiv sygdom) lurasidon (til behandling af skizofreni og bipolar (manio-depressiv) lidelse cisaprid (til behandling af fordøjelsesbesvær) sekalealkaloider (til behandling af migræne) rifampicin (til behandling af tuberkulose) amiodaron, quinidin, flecainid og propafenon (hjertemedicin) bepridil (til behandling af forhøjet blodtryk) oral midazolam eller oral triazolam (til behandling af angst) naturlægemidler, der indeholder perikon (hypericum perforatum) lovastatin, simvastatin (til behandling af forhøjet kolesterol i blodet) sildenafil, hvis det bliver anvendt til behandling af pulmonal arteriel hypertension (en sygdom, der påvirker blodkarrene til lungerne) paritaprevir (til behandling af hepatitis C-virusinfektion). 
- alfuzosin (used to treat a prostate problem) - astemizole or terfenadine (commonly used to treat allergy symptoms - these medicines may be available without prescription) - pimozide (used to treat schizophrenia) - quetiapine (used to treat schizophrenia, bipolar disorder and major depressive disorder) - lurasidone (used to treat schizophrenia and bipolar disorder) - cisapride (used to relieve indigestion) - ergot derivatives (used to treat headaches) - rifampicin (used to treat tuberculosis) - amiodarone, quinidine, flecainide and propafenone (heart medicines) - bepridil (used to treat high blood pressure) - oral midazolam or oral triazolam (used to treat anxiety) - products containing St John's wort (Hypericum perforatum) - lovastatin, simvastatin (used to lower cholesterol) - sildenafil if used to treat pulmonary arterial hypertension, (a condition affecting the blood vessels to your lungs) - paritaprevir (used to treat hepatitis C virus infection)
• midazolam som injektion (mod angst) 
• injectable midazolam (used to treat anxiety)
Oral suspension 
PHARMACEUTICAL FORM Oral suspension
Amprenavir bindes hovedsageligt til alfa-1-syre glycoprotein (AAG), men også til albumin. 
It is bound to the alpha-1acid glycoprotein (AAG) and albumin,but has a higher affinity for AAG.
Varigheden (median) af tidligere behandling med NRTI'er var 257 uger for patienter, som fik fosamprenavir og ritonavir 2 gange daglig (79 % havde tidligere fået  3 NRTI'er), og 210 uger for patienter, som fik lopinavir/ritonavir (64 % havde tidligere fået  3 NRTI'er). 
The median durations of prior exposure to NRTIs were 257 weeks for patients receiving fosamprenavir with ritonavir twice daily (79 % had ≥ 3 prior NRTIs) and 210 weeks for patients receiving lopinavir/ritonavir (64 % had ≥ 3 prior NRTIs).
Den fulde produktinformation for ritonavir skal derfor læses før påbegyndelse af kombinationsbehandling med Telzir og ritonavir. 
The full prescribing information for ritonavir must therefore be consulted prior to initiation of therapy with Telzir with ritonavir.
Telzir findes i plastbeholdere med 60 filmovertrukne tabletter. 
What Telzir looks like and contents of the pack Telzir is supplied in plastic bottles containing 60 film-coated tablets.
Amprenavir: Cmax * Amprenavir: AUC * Amprenavir: Cmin * * sammenlignet med historiske data 
Amprenavir: Cmax ↔* Amprenavir: AUC ↔* Amprenavir: Cmin ↔* * compared to historical data
Amprenavirs farmakokinetiske egenskaber efter samtidig administration af Telzir og ritonavir er undersøgt hos raske voksne forsøgspersoner og hos hiv-inficerede patienter. 
The pharmacokinetic properties of amprenavir following co-administration of Telzir with ritonavir have been evaluated in healthy adult subjects and HIV-infected patients and no substantial differences were observed between these two groups.
Børn bør anvende Telzir oral suspension, idet den nøjagtige dosering til denne patientgruppe baseres på kropsvægt. 
Telzir oral suspension is the recommended option for the most accurate dosing in children based on body weight.
APV29005 var et åbent, 48 ugers studie, som evaluerede den farmakokinetiske profil, sikkerheden og den antivirale aktivitet af fosamprenavir i kombination med ritonavir administreret 2 gange daglig hos hiv-1-positive patienter mellem 2 og 18 år. 
The benefit in this age group has mainly been derived from study APV29005, an open label 48 week study evaluating the pharmacokinetic profiles, safety, and antiviral activity of fosamprenavir with ritonavir administered twice daily to HIV 1 protease inhibitor experienced and naive patients 2 to 18 years of age.
• raltegravir (mod hiv-infektion) 
• raltegravir (used to treat HIV infection)
Den sædvanlige dosis er 14 ml Telzir oral suspension (700 mg fosamprenavir) 2 gange daglig sammen med 100 mg ritonavir (som kapsel eller oral opløsning) 2 gange daglig. 
The recommended dose is 14 ml Telzir oral suspension (700 mg fosamprenavir) twice daily with 100 mg ritonavir (as capsule or oral solution) twice daily.
Fordelingsvolumenet af amprenavir efter administration af Telzir er ca. 430 l (6 1/kg ved en kropsvægt på 70 kg). 
The apparent volume of distribution of amprenavir following administration of Telzir is approximately 430 l (6 l/kg assuming a 70 kg body weight), suggesting a large volume of distribution, with penetration of amprenavir freely into tissues beyond the systemic circulation.
25-32 kg Oral suspension 
Oral suspension should be taken with food 25-32 kg Oral suspension
20 mg én gang daglig 
20 mg once daily
I studiet ESS100732 fik 16 ud af 434 ART-naive patienter, der blev behandlet med 700 mg fosamprenavir/100 mg ritonavir 2 gange daglig, virologisk svigt efter 48 ugers behandling. 
Sixteen of 434 ART-naïve patients who received fosamprenavir 700 mg/ritonavir 100 mg twice daily in ESS100732 experienced virological failure by Week 48 with 14 isolates genotyped.
Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer): 
These may affect up to 1 in 10 people:
Administration af 700 mg fosamprenavir 2 gange daglig i kombination med 100 mg ritonavir 2 gange daglig resulterer i plasmakoncentrationer af amprenavir med proteinjusterede mediane ratioer for Cmin/IC50 og Cmin/IC95 på henholdsvis 21,7 (interval 1,19-240) og 3,21 (interval 0,26-30,0) (data fra studie APV30003 af patienter, der tidligere er behandlet med antiretrovirale midler). 
Administration of fosamprenavir 700 mg twice daily with ritonavir 100 mg twice daily results in plasma amprenavir concentrations (data from study APV30003 in antiretroviral experienced patients) which results in protein adjusted median ratios of Cmin/IC50 and Cmin/IC95 of 21.7 (range 1.19-240) and 3.21 (range 0.26-30.0), respectively.
I dyrestudier blev der observeret tegn på udviklingstoksicitet ved systemiske amprenavirplasmaniveauer (AUC), som var lavere end det terapeutiske niveau hos patienter, som behandles med Telzir (se pkt. 
In animal studies at systemic plasma exposures (AUC) to amprenavir lower than therapeutic exposure in patients treated with Telzir, some developmental toxicity was observed (see section 5.3).