natgillin/translations-raw huggingface dataset:
McDermott Laboratories under forretningsnavnet Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Irland
McDermott Laboratories trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Samtidig administration af simvastatin eller lovastatin (se pkt.
Co-administration with simvastatin or lovastatin (see section 4.5).
Forhøjet plasmakoncentration af quetiapin kan medføre koma (se pkt.
Increased plasma concentrations of quetiapine may lead to coma (see section 4.3).
Asymptomatisk 1. og 2. grads AV-blok blev rapporteret hos pædiatriske patienter (se pkt.
Asymptomatic first- and second-degree AV block was reported in paediatric patients (see section 4.8).
Itraconazol
Itraconazole
Lægen vurderer, hvor omfattende leversygdommen er, inden det afgøres, om du kan bruge Atazanavir Mylan .
Your doctor will evaluate how severe your liver disease is before deciding whether you can take Atazanavir Mylan
Atazanavir/ritonavir-armen viste antiviral effekt svarende til lopinavir/ritonavir-armen (non-inferiør) vurderet ved andelen af patienter med HIV-RNA <50 kopier/ml ved uge 48 (tabel 5).
The atazanavir/ritonavir arm showed similar (non-inferior) antiviral efficacy compared to the lopinavir/ritonavir arm, as assessed by the proportion of patients with HIV RNA < 50 copies/ml at week 48 (Table 5).
Patienter, der tager tenofovirdisoproxilfumarat.
For patients who are taking tenofovir disoproxil fumarate,
I et flerdosis-studie med HIV-inficerede patienter, der fik 400 mg atazanavir én gang dagligt med et let måltid i 12 uger, kunne atazanavir påvises i cerebrospinalvæsken og sæd.
In a multiple-dose study in HIV-infected patients dosed with 400 mg of atazanavir once daily with a light meal for 12 weeks, atazanavir was detected in the cerebrospinal fluid and semen.
De farmakokinetiske data fra HIV-smittede gravide kvinder, der fik atazanavir kapsler med ritonavir, er beskrevet i Tabel 8.
The pharmacokinetic data from HIV-infected pregnant women receiving atazanavir capsules with ritonavir are presented in Table 8.
≥100.000 kopier/ml
≥100,000 copies/ml
Patienter med samtidigt forekommende tilstande
Patients with coexisting conditions
300 mg tenofovirdisoproxilfumarat er ækvivalent med 245 mg tenofovirdisoproxil.
300 mg tenofovir disoproxil fumarate is equivalent to 245 mg tenofovir disoproxil.
HDPE-flaske med polypropylenskruelåg indeholder 60 kapsler.
HDPE bottle with polypropylene screw cap containing 60 capsules.
Øvrige indholdsstoffer: lactosemonohydrat (se afsnit 2, Atazanavir Mylan indeholder lactose) crospovidon, magnesiumstearat.
- The other ingredients are lactose monohydrate (see section 2, ‘Atazanavir Mylan contains lactose'), crospovidone, magnesium stearate.
Samtidig indtag af fedtrigt måltid påvirkede ikke AUC for atazanavir i forhold til i fastende tilstand, og Cmax lå inden for 11% i forhold til faste-værdierne.
Co-administration with a high-fat meal did not affect the AUC of atazanavir relative to fasting conditions and the Cmax was within 11% of fasting values.
Der er i længerevarende studier af karcinogenecitet af atazanavir hos mus og rotter set en øget incidens af benigne hepatiske adenomer hos hunmus.
In long-term carcinogenicity studies of atazanavir in mice and rats, an increased incidence of benign hepatic adenomas was seen in female mice only.
Lactosemonohydrat Crospovidon Magnesiumstearat
Lactose monohydrate Crospovidone Magnesium stearate
Når rifabutin gives sammen med atazanavir, er den anbefalede rifabutindosis 150 mg 3 gange ugentligt på fastsatte dage (for eksempel mandag-onsdag-fredag).
When given with atazanavir, the recommended dose of rifabutin is 150 mg 3 times per week on set days (for example MondayWednesday-Friday).
Ved tegn på forværret leverlidelse hos sådanne patienter skal man overveje at afbryde eller seponere behandlingen.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Nogle patienter, der får flere slags antiretroviral medicin på samme tid, kan udvikle en knoglesygdom, der kaldes knoglenekrose (hvor knoglevævet dør på grund af nedsat blodtilførsel til knoglen).
Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Sammenlignet med atazanavir 300 mg med ritonavir 100 mg uden tenofovirdisoproxilfumarat forventes koncentrationen af atazanavir at falde yderligere med ca. 20%.
When compared to atazanavir 300 mg with ritonavir 100 mg without tenofovir disoproxil fumarate, atazanavir concentrations are expected to be additionally decreased by about 20%.
Den klonede, humane kardielle kaliumkanal, hERG, blev hæmmet med 15% i in vitro-studier ved en koncentration (30 μM) af atazanavir svarende til 30 gange den frie lægemiddelkoncentration ved Cmax hos mennesker.
During in vitro studies, cloned human cardiac potassium channel (hERG), was inhibited by 15% at a concentration (30 μM) of atazanavir corresponding to 30 fold the free drug concentration at Cmax in humans.
Andre markante, kliniske laboratoriemæssige abnormaliteter (grad 3 eller 4) rapporteret hos ≥2% af patienterne, der fik regimer indeholdende atazanavir og én eller flere NRTIer omfattede: forhøjet kreatinkinase (7%), forhøjet alaninaminotransferase/serum-glutamin-pyrudrue transaminase (ALAT/SGPT) (5%), lav neutrofiltælling (5%), forhøjet aspartataminotransferase/serum-glutaminoxalsyretransaminase (ASAT/SGOT) (3%) og forhøjet lipase (3%).
Other marked clinical laboratory abnormalities (Grade 3 or 4) reported in ≥ 2% of patients receiving regimens containing atazanavir and one or more NRTIs included: elevated creatine kinase (7%), elevated alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT) (5%), low neutrophils (5%), elevated aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) (3%), and elevated lipase (3%).
Didanosin skal tages fastende, 2 timer efter indtagelse af atazanavir, taget til et måltid.
Didanosine should be taken at the fasted state 2 hours after atazanavir taken with food.
BETA-AGONISTER TIL INHALATION Salmeterol
INHALED BETA AGONISTS Salmeterol
Hvis der opstår tegn eller symptomer på cholelithiasis, kan midlertidig afbrydelse eller seponering af behandlingen overvejes.
If signs or symptoms of cholelithiasis occur, temporary interruption or discontinuation of treatment may be considered.
Hvis du bemærker symptomer på infektion, skal du straks kontakte lægen.
If you notice any symptoms of infection, please inform your doctor immediately.
Voksne:
Adults
Når atazanavir/ritonavir administreres sammen med phenytoin eller phenobarbital, kan det være nødvendigt at justere dosis af phenytoin eller phenobarbital.
When atazanavir/ritonavir is co-administered with either phenytoin or phenobarbital, a dose adjustment of phenytoin or phenobarbital may be required.
Stop straks med at tage Atazanavir Mylan og tal med lægen, hvis du får alvorligt udslæt eller udslæt med influenzalignende symptomer, blærer, feber, forkølelsessår, muskel- eller ledsmerter, hævelse i ansigtet, øjenbetændelse, som forårsager røde øjne (konjunktivitis), smertefulde, varme eller røde knuder.
Stop taking Atazanavir Mylan and talk to your doctor immediately if you develop a severe rash or a rash with flu-like illness symptoms, blisters, fever, mouth sores, muscle or joint pain, swelling in the face, inflammation of the eye which causes redness (conjunctivitis), painful, warm, or red lumps (nodules).
Tabel 6: Effektresultater ved uge 48a og uge 96 (Studie 045)
a and at Week 96 (Study 045)
Efter åbning: Skal bruges inden for 90 dage Dato åbning:
Once opened: Use within 90 days Date opened:
Blandt 1.151 patienter, der fik 400 mg atazanavir én gang dagligt, var 177 patienter samtidig inficeret med kronisk hepatitis B eller C, og blandt 655 patienter, der fik 300 mg atazanavir én gang dagligt med 100 mg ritonavir én gang dagligt, var 97 patienter samtidig inficeret med kronisk hepatitis B eller C. Samtidigt inficerede patienter havde større sandsynlighed for forhøjede levertransaminaser ved baseline end de, der ikke havde kronisk viral hepatitis.
Among 1,151 patients receiving atazanavir 400 mg once daily, 177 patients were co-infected with chronic hepatitis B or C, and among 655 patients receiving atazanavir 300 mg once daily with ritonavir 100 mg once daily, 97 patients were co-infected with chronic hepatitis B or C. Co-infected patients were more likely to have baseline hepatic transaminase elevations than those without chronic viral hepatitis.
Der er vist effekt af atazanavir/ritonavir i kombination med tenofovirdisoproxilfumarat hos behandlingserfarne patienter i det kliniske studie 045 og hos behandlingsnaive patienter i det kliniske studie 138 (se pkt.
The efficacy of atazanavir/ritonavir in combination with tenofovir disoproxil fumarate in treatment-experienced patients has been demonstrated in clinical study 045 and in treatment naive patients in clinical study 138 (see sections 4.8 and 5.1).
b Se beskrivelse af udvalgte bivirkninger.
b See description of selected adverse reactions for more details.
Der er ikke fastlagt en sikker og effektiv dosis for sildenafil i kombination med atazanavir til behandling af pulmonal arteriel hypertension.
A safe and effective dose in combination with atazanavir has not been established for sildenafil when used to treat pulmonary arterial hypertension.
ikke almindelig: overfølsomhed
uncommon: hypersensitivity
Symptomerne på problemer med galdeblæren kan omfatte smerter i den højre side af maven eller midt i den øverste del af maven, kvalme, opkastning, feber eller gulfarvning af huden eller det hvide i øjnene.
Symptoms of gallbladder problems may include pain in the right or middle upper stomach area, nausea, vomiting, fever or yellowing your skin or the white part of your eyes.
Hvis du får tegn eller symptomer på nyresten (smerter i siden, blod i urinen, smerter ved vandladning), skal du straks kontakte lægen.
If you develop signs or symptoms of kidney stones (pain in your side, blood in your urine, pain when you urinate), please inform your doctor immediately.
50 to <100 celler/mm3
50 to <100 cells/mm
PDE5-hæmmere ved behandling af erektil dysfunktion: Der bør udvises særlig forsigtighed ved ordinering af PDE5-hæmmere (sildenafil, tadalafil eller vardenafil) til behandling af erektil dysfunktion hos patienter, der får Atazanavir Mylan.
PDE5 inhibitors used for the treatment of erectile dysfunction: particular caution should be used when prescribing PDE5-inhibitors (sildenafil, tadalafil, or vardenafil) for the treatment of erectile dysfunction in patients receiving Atazanavir Mylan.
Administration af atazanavir og ritonavir sammen med et let eller et fedtrigt måltid nedsatte variationskoefficienten for AUC og Cmax med ca. 25% sammenlignet med i fastende tilstand.
Administration of atazanavir with ritonavir with either a light or a high-fat meal decreased the coefficient of variation of AUC and Cmax by approximately 25% compared to the fasting state.
Der foreligger ingen farmakokinetiske data for atazanavir med ritonavir hos patienter med nyreinsufficiens.
There are no pharmacokinetic data available for atazanavir with ritonavir in patients with renal insufficiency.
Atazanavir metaboliseres og udskilles primært via leveren.
Atazanavir is metabolised and eliminated primarily by the liver.
Geometrisk gennemsnit (CV%)
Geometric mean (CV%)
Dosis af Atazanavir Mylan -kapsler til børn beregnes ud fra barnets vægt og skal tages en gang dagligt sammen med mad og 100 mg ritonavir som vist i tabellen nedenfor:
The dose of Atazanavir Mylan capsules for children is calculated by body weight and is taken once daily with food and 100 mg ritonavir as shown below:
Faldet i AUC, Cmax, and Cmin var ikke mindre, når en øget dosis af atazanavir /ritonavir (400/100 mg én gang dagligt) blev forskudt fra omeprazol med 12 timer.
The decrease in AUC, Cmax, and Cmin was not mitigated when an increased dose of atazanavir /ritonavir (400/100 mg once daily) was temporally separated from omeprazole by 12 hours.
To procent af patienterne behandlet med atazanavir oplevede samtidig grad 3-4 ALAT/ASAT og grad 3-4 forhøjelser af total bilirubin.
Two percent of patients treated with atazanavir experienced concurrent Grade 3-4 ALT/AST and Grade 3-4 total bilirubin elevations.
Resistensniveauerne over for atazanavir strakte sig fra 3,5 til 29 gange uden tegn på fænotypekrydsresistens over for andre PI'er (proteasehæmmere).
Resistance levels to atazanavir ranged from 3.5- to 29-fold without evidence of phenotypic cross resistance to other PIs.
11 forsøgspersoner (13%) i gruppen med ikke-boostet atazanavir og 6 forsøgspersoner (7%) i gruppen med atazanavir + ritonavir oplevede virologisk rebound.
Eleven subjects (13%) in the unboosted atazanavir group and 6 (7%) in the atazanavir + ritonavir group, had virologic rebound.
Autoimmune lidelser (såsom Graves sygdom og autoimmun hepatitis) er også set; tiden til udbrud er imidlertid mere variabel, og udbrud kan optræde mange måneder efter behandlingsstart (se pkt.
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occurs many months after initiation of treatment.
Valg af Atazanavir Mylan til behandlingserfarne voksne og pædiatriske patienter bør baseres på en individuel, viral resistenstest og patientens behandlingsanamnese (se pkt.
The choice of Atazanavir Mylan in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient's treatment history (see sections 4.4 and 5.1).
Patienter, der ikke tager tenofovir, hvis atazanavir 300 mg/ritonavir 100 mg og H2receptorantagonister administreres samtidigt, bør en dosis svarende til famotidin 20 mg 2 gange dagligt ikke overskrides.
For patients not taking tenofovir, if atazanavir 300 mg/ritonavir 100 mg and H2-receptor antagonists are co-administered, a dose equivalent to famotidine 20 mg twice daily should not be exceeded.
Den oftest rapporterede laboratoriemæssige anormalitet hos patienter, der fik regimer indeholdende atazanavir og én eller flere NRTIer, var forhøjet total bilirubin, primært indberettet som indirekte forhøjet [ukonjugeret] bilirubin (87% grad 1, 2, 3 eller 4).
The most frequently reported laboratory abnormality in patients receiving regimens containing atazanavir and one or more NRTIs was elevated total bilirubin reported predominantly as elevated indirect [unconjugated] bilirubin (87% Grade 1, 2, 3, or 4).
Hvis indiceret, kan udskillelse af uoptaget atazanavir opnås ved opkastning eller maveskylning.
If indicated, elimination of unabsorbed atazanavir should be achieved by emesis or gastric lavage.
Den øgede progesteron-eksponering kan medføre relaterede bivirkninger (f.eks. insulinresistens, dyslipidæmi, akne og pletblødning), hvorved compliance muligvis påvirkes.
The increase in progestin exposure may lead to related side-effects (e.g. insulin resistance, dyslipidemia, acne and spotting), thus possibly affecting the compliance.
Der er ingen doseringsanbefalinger for Atazanavir Mylan til børn under 3 måneder.
There are no dosing recommendations for Atazanavir Mylan in patients less than 3 months of age.
Ingen forsøgspersoner i de 2 grupper udviklede proteasehæmmer-resistens.
No subject in either group showed emergence of protease inhibitor resistance.
100 mg a Ritonavirkapsler, tabletter eller oral opløsning.
Ritonavir capsules, tablets or oral solution.
Personer med mindst én funktionel CYP2C19-allel.
Subjects with at least one functional CYP2C19 allele.
Atazanavir Mylan er ikke en kur mod HIV-infektion.
Atazanavir Mylan is not a cure for HIV infection.
ikke almindelig: vægttab, vægtstigning, anoreksi, øget appetit
uncommon: weight decreased, weight gain, anorexia, appetite increased
Du må ikke tage sildenafil sammen med Atazanavir Mylan, hvis sildenafil anvendes til behandling af pulmonal arteriel hypertension.
Do not take sildenafil with Atazanavir Mylan when sildenafil is used for the treatment of pulmonary arterial hypertension.
Risikoen for myopati, inklusive rabdomyolyse, kan også øges med atorvastatin, som også metaboliseres via CYP3A4.
The risk of myopathy including rhabdomyolysis may also be increased with atorvastatin, which is also metabolised by CYP3A4.
4.2 og for farmakokinetiske data, se pkt.
For dosing recommendations see section 4.2 and for pharmacokinetic data see section 5.2.
Immunreaktiveringssyndrom
Immune reactivation syndrome
Pædiatriske patienter (mindst 3 måneder og med en legemsvægt på mindst 5 kg): Andre formuleringer kan være tilgængelige til pædiatriske patienter, som er mindst 3 måneder og vejer mindst 5 kg (se relevant produktresume).
Paediatric patients (at least 3 months of age and weight at least 5 kg): Other formulations of this medicine may be available for paediatric patients at least 3 months of age and weighing at least 5 kg (see relevant Summary of Product Characteristics for alternative forms).
Ritonavir kan reducere plasmakoncentrationen af phenytoin og/eller phenobarbital på grund af CYP2C9- og CYP2C19-induktion.
Ritonavir may decrease plasma levels of phenytoin and/or phenobarbital due to CYP2C9 and
Samtidig administration af quetiapin og atazanavir er kontraindiceret, da atazanavir kan øge quetiapin-relateret toksicitet.
Co-administration of quetiapine with atazanavir is contraindicated as atazanavir may increase quetiapine-related toxicity.
Quinidin har et snævert terapeutisk indeks og er kontraindiceret pga. risiko for CYP3A-hæmning med atazanavir.
Quinidine has a narrow therapeutic window and is contraindicated due to potential inhibition of CYP3A by atazanavir.
HDPE-flaske med polypropylenskruelåg indeholder 30, 90 kapsler.
HDPE bottle with polypropylene screw cap containing 30, 90 capsules.
Patienterne bør informeres om, at der er indberettet svimmelhed ved behandling med regimer indeholdende atazanavir (se pkt.
Patients should be informed that dizziness has been reported during treatment with regimens containing atazanavir (see section 4.8).
Indinavir er ligeledes forbundet med indirekte (ukonjugeret) hyperbilirubinæmi relateret til hæmning af UGT.
Indinavir is also associated with indirect (unconjugated) hyperbilirubinaemia due to inhibition of UGT.
Hvis det vurderes nødvendigt, bør samtidig administration kun ske efter individuel vurdering hos patienter med supprimeret HIVvirusbelastning og med HIVvirusstamme uden mistænkt resistens over for HIVbehandlingen.
This co-administration might be considered on a case by case basis if deemed necessary, in patients with suppressed HIV viral loads and with HIV viral strain without any suspected resistance to the HIV regimen.
Kombination med PDE5-hæmmeren sildenafil udelukkende ved behandling af pulmonal arteriel hypertension (PAH) (se pkt.
Combination of the PDE5 inhibitor sildenafil when used for the treatment of pulmonary arterial hypertension (PAH) only (see section 4.5).
Kombinationer af atazanavir og indinavir er ikke undersøgt, og samtidig administration af disse lægemidler kan ikke anbefales (se pkt.
Combinations of atazanavir and indinavir have not been studied and co-administration of these medicinal products is not recommended (see section 4.5).
Studier udført med HIVinficerede patienter.
Studies conducted in HIV-infected patients.
Blandt patienter, der fik 300 mg atazanavir med 100 mg ritonavir, var frekvensen af gulsot 19%.
Among patients receiving atazanavir 300 mg with ritonavir 100 mg, the frequency of jaundice was 19%.
På grund af carbamazepins inducerende effekt kan nedsat eksponering for atazanavir ikke udelukkes.
Due to carbamazepine inducing effect, a reduction in atazanavir exposure cannot be ruled out.
ikke almindelig: depression, desorientering, ængstelse, søvnløshed, søvnforstyrrelser, abnorme drømme
uncommon: depression, disorientation, anxiety, insomnia, sleep disorder, abnormal dream
dKonfidensinterval.
Confidence interval.
I det kliniske studie AI424-182 blev atazanavir/ritonavir (300/100 mg eller 400/100 mg) administreret samtidig med zidovudin/lamivudin til 41 gravide kvinder i andet og tredje trimester.
In clinical trial AI424-182 atazanavir/ritonavir (300/100 mg or 400/100 mg) in combination with zidovudine/lamivudine was administered to 41 pregnant women during the second or third trimester.
Produktresumé for ritonavir bør kontrolleres, inden behandling med Atazanavir Mylan og ritonavir initieres.
The Summary of Product Characteristics for ritonavir must be consulted before initiation of therapy with Atazanavir Mylan and ritonavir.
Patienterne skal monitoreres tæt for tenofovirdisoproxilfumaratrelaterede bivirkninger, inklusive nyrefunktionspåvirkning.
Patients should be closely monitored for tenofovir disoproxil fumarate-associated adverse reactions, including renal disorders.
Det geometriske gennemsnit (CV%) for atazanavir Cmin og AUC var henholdsvis 654 (76%) ng/ml og 44185 (51%) ng•t/ml.
The geometric mean (CV%) for atazanavir Cmin and AUC was 654 (76%) ng/ml and 44185 (51%) ng•h/ml, respectively.
CD4-celletal <50 celler/mm3
CD4 count <50 cells/mm
Hos HIV-inficerede patienter med svær immuninsufficiens kan der ved påbegyndelse af antiretroviral kombinationsbehandling (CART) opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske infektioner.
In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Samtidig administration frarådes derfor.
Therefore, such co-administration is not recommended.
Øvrige indholdsstoffer: lactosemonohydrat, crospovidon, magnesiumstearat.
- The other ingredients are lactose monohydrate, crospovidone, magnesium stearate.
Hvis der opstår tegn eller symptomer på nefrolitiasis, kan midlertidig afbrydelse eller seponering af behandlingen overvejes.
If signs or symptoms of nephrolithiasis occur, temporary interruption or discontinuation of treatment may be considered.
Atazanavir, det aktive stof i Atazanavir Mylan, udskilles i modermælk.
Atazanavir, the active substance of Atazanavir Mylan, is excreted in human milk.
Atazanavir-koncentrationen faldt betydeligt ved samtidig administration af didanosin (tabletter med buffer) og stavudin.
Atazanavir concentrations were greatly decreased when co-administered with didanosine (buffered tablets) and stavudine.
Du må ikke holde op med at tage Atazanavir Mylan uden at have talt med lægen.
Do not stop taking Atazanavir Mylan before talking to your doctor.
Samtidig administration af atazanavir og ritonavir i doser over 100 mg én gang dagligt er ikke evalueret klinisk.
Co-administration of atazanavir with ritonavir at doses greater than 100 mg once daily has not been clinically evaluated.
Itraconazol er, som ketoconazol, en potent CYP3A4-hæmmer såvel som et CYP3A4-substrat.
Itraconazole, like ketoconazole, is a potent inhibitor as well as a substrate of CYP3A4.
Der var ingen tumorigene fund hos hanmus eller hos rotter.
There were no tumorigenic findings in male mice or in rats.
Hvis du bemærker ændringer i din hjerterytme (puls), skal du informere lægen.
If you notice a change in the way your heart beats (heart rhythm changes), please inform your doctor.
Samtidig administration af lamotrigin og atazanavir/ritonavir kan reducere plasmakoncentrationen af lamotrigin på grund af UGT1A4-induktion.
Co-administration of lamotrigine and atazanavir/ritonavir may decrease lamotrigine plasma concentrations due to UGT1A4 induction.
Hos HIV-inficerede patienter med svær immuninsufficiens kan der ved påbegyndelse af antiretroviral kombinationsbehandling (CART) opstå inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske patogener, som kan forårsage alvorlige kliniske tilstande eller forværring af symptomer.
In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.