FrancophonIA/ELRC3.0 huggingface dataset:
English: 4 Inspect the syringe and solution.
Danish: 4 Kontrollér injektionssprøjten og opløsningen
English: This may be a sign of a problem with your spleen (splenomegaly)
Danish: Det kan være tegn på problemer med milten (forstørret milt).
English: In a phase II (n = 37) multicentre, randomised, open-label study of paediatric sarcoma patients receiving 100 μg/kg pegfilgrastim following cycle 1 of vincristine, doxorubicin and cyclophosphamide (VAdriaC/IE) chemotherapy, a longer duration of severe neutropenia (neutrophils < 0.5 x 109) was observed in younger children aged 0-5 yrs (8.9 days) compared to older children aged 6-11 years and 12-21 years (6 days and 3.7 days, respectively) and adults.
Danish: I et randomiseret, åbent, fase II multicenterstudie (n = 37) med pædiatriske patienter med sarkom, som fik 100 μg/kg pegfilgrastim efter cyklus 1 kemoterapi med vincristin, doxorubicin og cyclophosphamid (VAdriaC/IE), blev der observeret længere varighed af svær neutropeni (neutrofile granulocytter < 0,5 x 109) hos mindre børn i alderen 0-5 år (8,9 dage) sammenlignet med større børn i alderen 6-11 år og 12-21 år (henholdsvis 6 dage og 3,7 dage) og voksne.
English: The youngest age group (0-5 years) had a higher mean exposure to pegfilgrastim (AUC) (± Standard Deviation) (47.9 ± 22.5 μg·hr/ml) than older children aged 6-11 years and 12-21 years (22.0 ± 13.1 μg hr/ml and 29.3 ± 23.2 μg·hr/ml, respectively) (see section 5.1).
Danish: Den yngste aldersgruppe (0-5 år) havde en højere middeleksponering for pegfilgrastim (AUC) (± standarddeviation) (47,9 ± 22,5 µg·t/ml) end ældre børn i alderen 6-11 år og 12-21 år (henholdsvis 22,0 ± 13,1 µg·t/ml og 29,3 ± 23,2 µg·t/ml) (se pkt.
English: *The active substance is a covalent conjugate of filgrastim produced in Escherichia coli cells by recombinant DNA technology with polyethylene glycol (PEG).
Danish: Det aktive stof er et kovalent konjugat af filgrastim produceret i Escherichia coli-celler vha. rekombinant DNA-teknologi med polyethylenglykol (PEG).
English: These have generally occurred in patients with advanced malignant diseases, sepsis, taking multiple chemotherapy medicinal products or undergoing apheresis (see section 4.4).
Danish: Generelt er disse opstået i forbindelse med fremskredne maligne sygdomme eller sepsis hos patienter, der har fået flere kemoterapilægemidler, eller som har gennemgået aferese (se pkt.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SYRINGE LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET TIL INJEKTIONSSPRØJTEN
English: • get left upper abdominal pain or pain at the tip of your shoulder.
Danish: • får smerter øverst i venstre maveregion eller smerter nederst på skulderen.
English: • are planning to have a baby
Danish: • planlægger at blive gravid
English: What UDENYCA contains - The active substance is pegfilgrastim.
Danish: UDENYCA indeholder: - Aktivt stof: pegfilgrastim.
English: Pull the needle cap straight off (see Figure 10).
Danish: Træk kanylehætten lige af (se figur 10).
English: • have recently had a serious lung infection (pneumonia), fluid in the lungs (pulmonary oedema), inflammation of the lungs (interstitial lung disease) or an abnormal chest x-ray (lung infiltration)
Danish: • for nylig har haft en alvorlig lungebetændelse (pneumoni), væske i lungerne (lungeødem), inflammation (betændelseslignende reaktion) i lungerne (interstitiel lungesygdom) eller fået taget røntgenbilleder af brystet, der viste unormale forhold (lungeinfiltration).
English: In two randomised, double-blind, pivotal studies in patients with high risk stage II-IV breast cancer undergoing myelosuppressive chemotherapy consisting of doxorubicin and docetaxel, use of pegfilgrastim, as a single once per cycle dose, reduced the duration of neutropenia and the incidence of febrile neutropenia similarly to that observed with daily administrations of filgrastim (a median of 11 daily administrations).
Danish: I to randomiserede, dobbelt-blinde, pivotale studier hos patienter med brystkræft i højrisikogrupperne II-IV, der fik myelosupressiv kemoterapi bestående af doxorubicin og docetaxel, reducerede brug af pegfilgrastim, ved dosering en gang pr. cyklus, varigheden af neutropeni, og incidensen af febril neutropeni på samme måde som blev observeret med daglig administration af filgrastim (median på 11 daglige administrationer).
English: SC
Danish: SN
English: Sickle cell crises have been associated with the use of pegfilgrastim in patients with sickle cell trait or sickle cell disease (see section 4.8).
Danish: Seglcellekriser er blevet forbundet med brugen af pegfilgrastim til patienter med seglcelletræk eller seglcelleanæmi (se pkt.
English: The incidence of hospitalisations and IV anti-infective use associated with a clinical diagnosis of febrile neutropenia was lower in the pegfilgrastim group compared with placebo (1% versus 14%, p < 0.001; and 2% versus 10%, p < 0.001).
Danish: infektionshæmmende midler forbundet med en klinisk diagnose af febril neutropeni var lavere i den gruppe, som fik pegfilgrastim, end i placebogruppen (1% kontra 14%, p < 0,001, og 2 % kontra 10 %, p < 0,001).
English: Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythaema, flushing, and hypotension occurred on initial or subsequent treatment with pegfilgrastim (uncommon).
Danish: Overfølsomhedslignende reaktioner, herunder hududslæt, urticaria, angioødem, åndenød, erytem, rødmen og hypotension, optrådte initialt og under vedligeholdelsesbehandling med pegfilgrastim (ikke almindelig).
English: If leukocyte counts exceed 50 x 109/l after the expected nadir, this medicine should be discontinued immediately.
Danish: Dette lægemiddel skal straks seponeres, hvis leukocyttallet overstiger 50 x 109/l efter det forventede nadir.
English: Pegfilgrastim is a protein produced by biotechnology in bacteria called E. coli followed by conjugation with polyethylene glycol (PEG) It belongs to a group of proteins called cytokines.
Danish: Pegfilgrastim er et protein, der produceres ved hjælp af bioteknologi i bakterier, der kaldes for E. coli, efterfulgt af konjugation med polyethylenglykol (PEG).
English: Prepare the injection
Danish: Forberedelse af indsprøjtningen
English: Pre-filled syringe, with a coated bromobutyl rubber stopper and a stainless steel needle with automatic needle guard.
Danish: Fyldt injektionssprøjte med en coated bromobutylgummiprop og en kanyle af rustfrit stål med automatisk kanylebeskyttelse
English: Then move your other hand into injection position with your thumb on the plunger head (see Figure 14).
Danish: Gør klar til injektion med den anden hånd og placér tommelfingeren på stempelhovedet (se figur 14).
English: What you need to know before you use UDENYCA Do not use UDENYCA - if you are allergic to pegfilgrastim, filgrastim, or any of the other ingredients of this medicine.
Danish: Brug ikke UDENYCA - hvis De er allergisk over for pegfilgrastim, filgrastim, eller et af de øvrige indholdsstoffer i dette lægemiddel.
English: Pegfilgrastim is injected subcutaneously.
Danish: Pegfilgrastim injiceres subkutant..
English: With the exception of the youngest age group (0-5 years), the mean AUC in paediatric subjects appeared similar to that for adult patients with high-risk stage II-IV breast cancer and receiving 100 μg/kg pegfilgrastim after the completion of doxorubicin/docetaxel (see sections 4.8 and 5.1).
Danish: Bortset fra den yngste aldersgruppe (0-5 år) var middeleksponeringen for pegfilgrastim (AUC) hos pædiatriske patienter den samme som for voksne patienter med højrisiko-brystcancer stadie II-IV, der fik 100 µg pegfilgrastim/kg efter kemoterapi med doxorubicin/docetaxel (se pkt.
English: In a second study (n = 310), which used a weight-adjusted dose (100 μg/kg), the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.7 days, compared with 1.8 days in the filgrastim group (difference 0.03 days, 95% CI -0.36, 0.30).
Danish: I et andet studie (n = 310), hvor der benyttedes en vægtjustered dosis (100 µg /kg), var den gennemsnitlige varighed af grad 4 neutropeni 1,7 dage for pegfilgrastim gruppen, sammenlignet med 1,8 dage for filgrastim gruppen (forskel på 0,03 dage, 95% CI -0,36; 0,30).
English: This can be a sign of Acute Respiratory Distress Syndrome (ARDS)
Danish: Det kan være et tegn på shocklunge (ARDS).
English: Cases of capillary leak syndrome have been reported in the post marketing setting with G-CSF use.
Danish: Efter markedsføring af produktet er der indberettet tilfælde af kapillærlækage-syndrom i forbindelse med anvendelse af G-CSF.
English: Rare side effects (may affect up to 1 in 1,000 people)
Danish: Sjældne bivirkninger (kan berøre op til 1 ud af 1.000 personer )
English: DO NOT use if the solution appears discoloured or cloudy.
Danish: Brug ikke opløsningen, hvis den er misfarvet eller uklar.
English: Each pack contains 1 glass pre-filled syringe with an attached stainless steel needle and needle cap.
Danish: Hver pakning indeholder 1 fyldt injektionssprøjte af glas med en påsat kanyle af rustfrit stål og kanylehætte.
English: FIGURE 8
Danish: FIGUR 8
English: Pegfilgrastim contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say, essentially 'sodium-free'.
Danish: Pegfilgrastim indeholder mindre end 1 mmol (23 mg) natrium pr. 6 mg dosis.
English: • coughing up blood (haemoptysis)
Danish: • opkastning af blod (hæmoptyse)
English: DO NOT recap the syringe.
Danish: Sæt ikke hætten tilbage på sprøjten.
English: DO NOT shake the pre-filled syringe.
Danish: Ryst ikke den fyldte sprøjte.
English: DO NOT use the pre-filled syringe if it has been dropped with the needle cap removed.
Danish: Anvend ikke den fyldte sprøjte, hvis De har tabt den uden kanylebeskyttelseshætten på.
English: 2 Allow medicine to reach room temperature and gather supplies.
Danish: 2 Lad den fyldte injektionssprøjte opnå stuetemperatur og saml de ting sammen, der skal bruges til injektionen.
English: There is insufficient information on the excretion of pegfilgrastim/ metabolites in human milk, a risk to the newborns/infants cannot be excluded.
Danish: Data for udskillelse af pegfilgrastim /metabolitter i human mælk er utilstrækkelige.
English: • experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash and itchy skin
Danish: • får en allergisk reaktion, herunder svaghedsfølelse, blodtryksfald, åndedrætsbesvær, hævelse i ansigtet (anafylaksi), rødme, hududslæt og kløende områder på huden.
English: • increased spleen size
Danish: • forstørret milt
English: • redness at the site of injection
Danish: • rødme på injektionsstedet
English: If you become pregnant during UDENYCA treatment, please inform your doctor.
Danish: De skal informere Deres læge, hvis De bliver gravid, mens De er i behandling med UDENYCA
English: B: Remove the syringe from the sealed tray as follows: peel the cover off the tray, remove the syringe by grasping the middle of the syringe body (see Figure 6) DO NOT handle the syringe by the plunger, plunger head, or needle cap.
Danish: B: Tag den fyldte sprøjte ud af den forseglede bakke på følgende måde: træk låget af sprøjtens bakke og tag sprøjten ud ved at holde midt på den (se figur 6).
English: Transient elevations in LFT's for ALT or AST1
Danish: Forbigående stigning i leverfunktionstest ALAT og ASAT1
English: FIGURE 5
Danish: FIGUR 5
English: FIGURE 2
Danish: FIGUR 2
English: 7 Remove needle cap.
Danish: 7 Fjern kanylehætten.
English: 1 single-use pre-filled syringe with automatic needle guard.
Danish: 1 fyldt injektionssprøjte til engangsbrug med automatisk kanylebeskyttelse.
English: The injections should be given into the thigh, abdomen or upper arm. For instructions on handling of the medicinal product before administration, see section
Danish: For instruktioner om håndtering af lægemidlet før administration, se pkt.
English: FIGURE 9
Danish: FIGUR 9
English: FIGURE 14
Danish: FIGUR 14
English: Bone pain Musculoskeletal pain (myalgia, arthralgia, pain in extremity, back pain,
Danish: Knoglesmerter Muskuloskeletale smerter (myalgi, artralgi, ekstremitetssmerter, rygsmerter, nakkesmerter)
English: (see Figure 8)
Danish: • Balder (se figur 8)
English: Each pre--filled syringe contains 30 mg sorbitol
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver fyldt injektionssprøjte indeholder 30 mg sorbitol.
English: FIGURE 15
Danish: FIGUR 15
English: UDENYCA 6 mg solution for injection in pre-filled syringe pegfilgrastim
Danish: UDENYCA 6 mg injektionsvæske i fyldt injektionssprøjte pegfilgrastim
English: FIGURE 7
Danish: FIGUR 7
English: Inject the dose
Danish: Injicer dosen
English: FIGURE 13
Danish: FIGUR 13
English: Sodium acetate trihydrate (for pH adjustment) Acetic acid (for pH adjustment) Sorbitol (E420)
Danish: Natriumacetattrihydrat (til justering af pH)
English: FIGURE 10
Danish: FIGUR 10
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml solution.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver fyldt injektionssprøjte indeholder 6 mg pegfilgrastim i 0,6 ml injektionsvæske.
English: FIGURE 11
Danish: FIGUR 11
English: NAME OF THE MEDICINAL PRODUCT UDENYCA 6 mg solution for injection in pre-filled syringe
Danish: LÆGEMIDLETS NAVN UDENYCA 6 mg injektionsvæske, opløsning i fyldt sprøjte.
English: Do not use this medicine if you notice it is cloudy or there are particles in it.
Danish: Brug ikke lægemidlet, hvis De bemærker, at det er grumset eller at der er partikler i det. Spørg på apoteket, hvordan De skal bortskaffe medicinrester.
English: FIGURE 4
Danish: FIGUR 4
English: FIGURE 6
Danish: FIGUR 6
English: FIGURE 3
Danish: FIGUR 3
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med UDENYCA Fortæl det altid til lægen eller apotekspersonalet, hvis De bruger anden medicin eller har gjort det for nylig.
English: Your doctor may decide that it would be more convenient for you to inject UDENYCA yourself.
Danish: Hvis De selv skal foretage indsprøjtning med UDENYCA Deres læge kan beslutte, at det vil være praktisk for Dem, hvis De selv indsprøjter UDENYCA.
English: Acute Respiratory Distress Syndrome2; Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis)
Danish: Pulmonale bivirkninger (interstitiel pneumoni, lungeødem, lungeinfiltrater og lungefibrose) Hæmoptyse
English: Before administration, pegfilgrastim solution should be inspected visually for particulate matter.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Før anvendelse bør pegfilgrastim-- injektionsvæsken undersøges visuelt for partikler.
English: Capillary Leak Syndrome, which can be life-threatening if treatment is delayed, has been reported as uncommon in cancer patients undergoing chemotherapy following administration of G-CSFs; see section 4.4 and section “Description of selected adverse reactions” below.
Danish: Der er indberettet kapillærlækage-syndrom hos cancerpatienter, der fik kemoterapi efter indgift afGCSF´er, med frekvensen ”ikke almindelig” Kapillærlækage-syndrom kan være livstruende, hvis behandlingen heraf bliver forsinket; se pkt.
English: This will retract the needle and secure it inside the syringe body.
Danish: På den måde trækkes kanylen ud og sikkert ind i injektionssprøjten igen.
English: Posology
Danish: Kontrolvindue
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 6 mg of pegfilgrastim * in 0.6 ml solution for injection.
Danish: Hver fyldt injektionssprøjte indeholder 6 mg pegfilgrastim* i 0,6 ml injektionsvæske, opløsning.
English: Haemoptysis
Danish: Stempelhoved
English: Solution for injection in pre-filled syringe (0.6 ml).
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Injektionsvæske, opløsning i en fyldt injektionssprøjte (0,6 ml).
English: Breast-feeding
Danish: Mave Balder
English: • Thighs
Danish: • Lår
English: Nausea1
Danish: Kapillærlækagesyndrom1
English: What is in this leaflet
Danish: hævelse i ansigtet)
English: Injection site pain1
Danish: Smerter på injektionsstedet1
English: For further instructions on how to inject yourself with UDENYCA, please read the section at the end of this leaflet.
Danish: i denne indlægsseddel for at få yderligere vejledning i, hvordan De selv indsprøjter UDENYCA.
English: C: If you see drops of blood at the injection site, treat by pressing a cotton ball or gauze to the site as needed
Danish: FIGUR 16 C: Tryk en tot vat eller et gazecompres ned på injektionsstedet, hvis det bløder.
English: Rare
Danish: Lår
English: Other published data support these conclusions.
Danish: Andre publicerede data supporterer disse konklusioner.
English: One year later, the child's development remained normal.
Danish: Et år senere var barnets udvikling inden for normalområdet.
English: Date of first authorisation: 30 November 2009 Date of latest renewal: 26 August 2014
Danish: Dato for første markedsføringstilladelse: 30. november 2009 Dato for seneste fornyelse: 26. august 2014
English: It is particularly important that you tell your doctor if you are taking or have recently taken:
Danish: Det er særligt vigtigt, at du fortæller det til din læge, hvis du er i behandling med eller for nylig har taget:
English: Also, both dosing regimens were effective in reducing the viral load.
Danish: Desuden var begge doseringsregimer effektive til at nedsætte viral belastning.
English: There are no adequate and well-controlled studies in pregnant women.
Danish: Der findes ingen fyldestgørende, gennemkontrollerede studier, hvori der indgår gravide .
English: ND = Not Determined, ↑ = Increased, ↓ = Decreased, ↔ = No Effect
Danish: ND = non-detekterbar, ↑ = øget, ↓ = Formindsket, ↔ = Ingen effekt
English: Recommendations concerning co-administration
Danish: Anbefalinger ved coadministration
English: ANTIVIRALS FOR CHRONIC HEPATITIS B AND C
Danish: ANTIVIRALE MIDLER TIL KRONISK HEPATITIS B OG C
English: One side is debossed with "N", a scoreline and "200".
Danish: Den ene side er præget med "N", en delekærv og "200".
English: Frequency is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Danish: Hyppighed er defineret i henhold til følgende konvention: Meget almindelig (≥1/10); Almindelig (≥1/100 til <1/10); Ikke almindelig (≥1/1.000 til <1/100); Sjælden (≥1/10.000 til <1/1.000); Meget sjælden (<1/10.000).
English: The interaction data is presented as geometric mean value with 90% confidence interval (90% CI) whenever these data were available.
Danish: Interaktionsdata er angivet som en geometrisk gennemsnitsværdi med et 90 % konfidensinterval (90 % CI) når disse data er tilgængelige.
English: Weight and metabolic parameters:
Danish: Vægt og metaboliske parametre:
English: In the case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Danish: I tilfælde af samtidig antiviral behandling for hepatitis B eller C, vær venlig også at se efter i den relevante produktinformation for disse lægemidler.
English: Methadone Individual Patient Dosing
Danish: Methadon Individuel patientdosering
English: Patients who participated in the 2NN study and were still under active follow-up at week 48 when the study closed and were still being treated at the study clinic, were asked to participate in this study.
Danish: De patienter i 2NN-studiet, som ved studiets afslutning i uge 48 stadig blev behandlet i klinikken og var i aktiv behandling, blev tilbudt at deltage i dette studie.
English: Metabolite 25-O-desacetylrifabutin
Danish: Metabolit 25-O-desacetylrifabutin
English: Hypersensitivity (allergic) reactions can occur.
Danish: Overfølsomhedsreaktioner (allergiske reaktioner) kan forekomme.
English: The clinical outcome of this observed reduction of boceprevir trough concentrations has not been directly assessed.
Danish: betydning af denne observerede reduktion af trough-koncentrationen af boceprevir er ikke blevet direkte vurderet.
English: A clinically not relevant increase in the apparent clearance of nevirapine (by 9%) compared to historical data was reported.
Danish: Der sås en klinisk ikke relevant stigning i clearance af nevirapin (med 9 %) sammenlignet med historiske data.
English: Gender and older people
Danish: Køn og ældre personer
English: These reactions occur mainly in the first 18 weeks of treatment with Nevirapine Teva.
Danish: Disse reaktioner opstår primært i de første 18 uger af behandlingen med Nevirapin Teva.
English: Metabolite 14-OH clarithromycin
Danish: Metabolit 14-OH clarithromycin
English: Greater than 80 % of the radioactivity in urine was made up of glucuronide conjugates of hydroxylated metabolites.
Danish: Mere end 80 % af radioaktiviteten i urinen består af glucuronidkonjugater af hydroxylerede metabolitter.
English: Numerous studies have been performed examining the use of nevirapine in regards to perinatal transmission, most notably HIVNET 012.
Danish: Utallige studier er udført for at undersøge brugen af nevirapin i forhold til perinatal transmission, især HIVNET 012.
English: Monitoring of hepatic tests should be done every two weeks during the first 2 months of treatment, at the 3rd month and then regularly thereafter.
Danish: Monitorering af levertests bør foretages hver anden uge i løbet af de første 2 måneder af behandlingen, efter 3 måneders behandling og derefter regelmæssigt.
English: Y181C, K101E, G190A/S, K103N, V106A/M, V108I, Y188C/L, A98G, F227L and M230L.
Danish: Y181C, K101E, G190A/S, K103N, V106A/M, V108I, Y188C/L, A98G, F227L og M230L.
English: The opposite side is debossed with a scoreline.
Danish: Den modsatte side er præget med delekærv.
English: Long-term efficacy appears to be most likely in patients whose nevirapine trough levels exceed 3.5 μg/ml.
Danish: Langvarig virkning synes at være mere sandsynlig hos patienter, hvis nevirapindalniveauer overstiger 3,5 μg/ml.
English: Since neither body weight nor Body Mass Index (BMI) had influence on the clearance of nevirapine, the effect of gender cannot be explained by body size.
Danish: Eftersom hverken kropsvægt eller body mass index (BMI) havde indflydelse på clearance af nevirapin, kan forskellen mellem kønnene ikke forklares med kropsstørrelse.
English: Contains lactose: see leaflet for further information.
Danish: Indeholder lactose: se indlægssedlen for mere information
English: If Nevirapine Teva has been prescribed for your child, please note that all information in this leaflet is addressed to your child (in this case please read “your child” instead of “you”).
Danish: Hvis Nevirapin Teva er blevet ordineret til dit barn, så bemærk venligst, at denne information er beregnet til dit barn, og du skal i dette tilfælde erstatte ”du” med ”dit barn”.
English: Where other antiretroviral medicines are accessible, the single dose nevirapine regimen should be combined with additional effective antiretroviral medicines (as recommended in internationally recognized guidelines).
Danish: Hvor andre antiretrovirale lægemidler er tilgængelige, bør enkeltdosis-nevirapin-regime kombineres med supplerende effektive antiretrovirale lægemidler (som anbefalet i internationalt anerkendte retningslinjer).
English: There are no specific studies about the ability to drive vehicles and use machinery.
Danish: Der er ikke foretaget specifikke undersøgelser af virkningen på evnen til at føre motorkøretøjer eller betjene maskiner.
English: The consolidated analysis of Paediatric AIDS Clinical Trials Group (PACTG) protocols 245, 356, 366, 377, and 403 allowed for the evaluation of paediatric patients less than 3 months of age (n=17) enrolled in these PACTG studies.
Danish: Den samlede analyse af Paediatric AIDS Clinical Trials Group (PACTG)-protokoller 245, 356, 366, 377 og 403 tillod evaluering af pædiatriske patienter yngre end 3 måneder (n=17) i disse PACTGstudier.