FrancophonIA/ELRC3.0 huggingface dataset:
English: Don't take Tivicay with the following medicine: • dofetilide, used to treat heart conditions
Danish: Tag ikke Tivicay sammen med følgende lægemiddel: • dofetilid (anvendes til behandling af hjertelidelser).
English: There are no data on the effects of dolutegravir on human male or female fertility.
Danish: Der foreligger ingen data om dolutegravirs virkning på fertiliteten hos mænd eller kvinder.
English: 35 mg once daily (Taken as one 25 mg and one 10 mg tablet)
Danish: 35 mg én gang daglig (Indtaget som én 25 mg og én 10 mg tablet)
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Tivicay in paediatric patients aged 4 weeks to below 6 years with HIV infection (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Tivicay i alle undergrupper af den pædiatriske population i alderen 4 uger til under 6 år med hiv-infektion (se pkt.
English: Seven hundred and five raltegravir resistant isolates from raltegravir experienced patients were analyzed for susceptibility to dolutegravir.
Danish: 705 raltegravirresistente isolater fra raltegravirerfarne patienter blev analyseret for følsomhed over for dolutegravir.
English: The film-coated tablets are provided in bottles containing 30 or 90 tablets.
Danish: De filmovertrukne tabletter fås i pakninger med 30 eller 90 tabletter.
English: Week 48 outcomes (including outcomes by key baseline covariates) for SAILING are shown in Table 6.
Danish: Udfaldene i uge 48 (herunder udfald efter nøgle-baseline-kovariater) i SAILING er vist i tabel 6.
English: The most severe adverse reaction, seen in an individual patient, was a hypersensitivity reaction that included rash and severe liver effects (see section 4.4).
Danish: Den alvorligste bivirkning, der blev set hos en enkelt patient, var en overfølsomhedsreaktion, som omfattede udslæt og svære leverpåvirkninger (se pkt.
English: If you could get pregnant while receiving Tivicay, you need to use a reliable method of barrier contraception (for example, a condom) with other methods of contraception including oral (pill) or other hormonal contraceptives (for example, implants, injection), to prevent pregnancy.
Danish: Hvis du kan blive gravid, mens du får Tivicay, skal du bruge sikker prævention i form af en barrieremetode (f.eks. kondom) sammen med en anden præventionsmetode, herunder p-piller eller andre hormonelle præventionsmidler (fx implantat, injektion) for at undgå graviditet.
English: Within-subject variability (CVw%) is lower than between-subject variability.
Danish: Intraindivid-variabiliteten (CVw%) er lavere end inter-individ-variabiliteten.
English: No dose adjustment of oral contraceptives is necessary when co-administered with dolutegravir.
Danish: Det er ikke nødvendigt at justere dosis af orale kontraceptiva, når de administreres samtidigt med dolutegravir.
English: In the presence of integrase class resistance, Tivicay should preferably be taken with food to enhance exposure (particularly in patients with Q148 mutations) (see section 5.2).
Danish: Ved resistens over for integrasehæmmere, skal Tivicay helst tages sammen med mad for at øge eksponeringen (særligt hos patienter med Q148-mutationer) (se pkt.
English: There is no evidence that common polymorphisms in drug metabolising enzymes alter dolutegravir pharmacokinetics to a clinically meaningful extent.
Danish: Der er ingen tegn på, at almindelige polymorfismer i lægemiddelmetaboliserende enzymer ændrer dolutegravirs farmakokinetik i et klinisk betydningsfuldt omfang.
English: Tivicay is used to treat HIV (human immunodeficiency virus) infection in adults, adolescents and children over 6 years old, who weigh at least 15 kg.
Danish: Tivicay anvendes til behandling af hiv (humant immundefektvirus)-infektion hos voksne, unge og børn over 6 år, som vejer mindst 15 kg.
English: The systemic exposure at this dose (based on AUC) to dolutegravir was ~17-20-fold higher than humans at the recommended pediatric exposure.
Danish: Den systemiske eksponering for dolutegravir ved denne dosis (baseret på AUC) var ~17-20 gange højere end hos mennesker ved den anbefalede pædiatriske eksponering.
English: Polymorphisms in drug metabolising enzymes
Danish: Polymorfismer i lægemiddelmetaboliserende enzymer
English: Median CD4 change from baseline * Adjusted for baseline stratification factors.
Danish: Medianændring i CD4 i forhold til baseline *Justeret for stratificeringsfaktorer ved baseline.
English: The median change in CD4+ T cell count from baseline for VIKING-3 based on observed data was 61 cells/mm3 at Week 24 and 110 cells/mm3 at Week 48.
Danish: Medianændringen i CD4+ T-celletallet i forhold til baseline for VIKING-3, baseret på observerede data, var 61 celler/mm3 ved uge 24 og 110 celler/mm3 ved uge 48.
English: b Confirmed plasma HIV-1 RNA levels to ≥200 cps/mL after prior confirmed suppression to <200 cps/mL.
Danish: b bekræftede plasma hiv-1 RNA-niveauer til ≥ 200 kopier/ml efter tidligere bekræftet suppression til < 200 kopier/ml.
English: Primary mutation other than Q148H/K/R2
Danish: Primær mutation forskellig fra Q148H/K/R2
English: 20 mg once daily (Taken as two 10 mg tablets)
Danish: 20 mg én gang daglig (Indtaget som to 10 mg tabletter)
English: Dolutegravir is primarily metabolized and eliminated by the liver.
Danish: Dolutegravir metaboliseres og elimineres primært af leveren.
English: AUC in cervicovaginal fluid, cervical tissue and vaginal tissue were 6-10% of those in corresponding plasma at steady state.
Danish: AUC i cervikalvæske, cervikalt væv og vaginal væv var 6-10 % af AUC-værdierne i tilsvarende plasma ved steady state.
English: Cohort I (12 to <18 years) (n=23)
Danish: Kohorte I (12 år til < 18 år) (n=23)
English: Antacids and supplements Magnesium/ aluminium-containing antacid
Danish: Antacida og tilskud Antacida indeholdende magnesium/ aluminium
English: In patients without a primary mutation detected at baseline (N=60) (i.e. RAL/EVG not part of current failing therapy) there was a 1.63 log10 reduction in viral load at day 8.
Danish: Hos patienter, der ikke havde en opdaget primær mutation ved baseline (N = 60) (f.eks. RAL/EVG ikke en del af nuværende svigtende behandling) var der en 1,63 log10 reduktion i viralt load på dag 8.
English: The apparent oral clearance (CL/F) is approximately 1L/hr in HIV-infected patients based on a population pharmacokinetic analysis.
Danish: Den angivelige orale clearance (CL/F) er ca. 1 l/t hos hiv-inficerede patienter baseret på en farmakokinetisk populationsanalyse.
English: The results of the pooled analysis were in line with those of the individual studies, for which the primary endpoint (difference in proportion <50 copies/mL plasma HIV-1 RNA at week 48 based on the Snapshot algorithm) was met.
Danish: Resultaterne af den samlede analyse var i overensstemmelse med de enkelte studier, hvor det primære endepunkt (proportionsforskel < 50 kopier/ml plasma hiv-1 RNA i uge 48 baseret på snapshot-algoritmen) blev opfyldt.
English: Primary mutations for raltegravir/elvitegravir (Q148H/R/K, N155H, Y143R/H/C, E92Q and T66I) do not affect the in vitro susceptibility of dolutegravir as single mutations.
Danish: Primære mutationer for raltegravir/elvitegravir (Q148H/R/K, N155H, Y143R/H/C, E92Q og T66I) påvirker ikke følsomheden over for dolutegravir in vitro som enkeltvise mutationer.
English: The primary endpoint and other week 48 outcomes (including outcomes by key baseline covariates) for SPRING-2 and SINGLE are shown in Table 4.
Danish: Det primære endepunkt og andre resultater fra uge 48 (herunder resultater fra nøgle-baseline-kovariater) i SPRING-2 og SINGLE er vist i tabel 4.
English: The mean IC50 for 3 HIV-2 isolates was 0.18 nM (range 0.09-0.61).
Danish: Den gennemsnitlige IC50-værdi for 3 hiv-2isolater var 0,18 nM (interval 0,09-0,61).
English: Dolutegravir should be administered twice daily in this population when co-administered with some medicines (e.g. efavirenz, nevirapine, tipranavir/ritonavir, or rifampicin).
Danish: Dolutegravir skal administreres to gange daglig i denne population, når det gives samtidig med visse lægemidler (f.eks. efavirenz, nevirapin, tipranavir/ritonavir eller rifampicin).
English: • symptoms of infections and inflammation
Danish: • symptomer på infektion og betændelse
English: Children and adolescents weighing at least 40 kg can take the adult dose of one tablet (50 mg), once a day.
Danish: Børn og unge, som vejer mindst 40 kg, kan tage den samme dosis som voksne på én tablet (50 mg) én gang daglig.
English: If possible, show them the Tivicay pack.
Danish: Tag Tivicay-pakningen med, hvis det er muligt.
English: Background Regimen Genotypic Susceptibility Score* <2 Genotypic Susceptibility Score* =2 Use of DRV in background regimen No DRV use DRV use with primary PI mutations DRV use without primary PI mutations Gender Male Female Race White African-America/African Heritage/Other Age (years)
Danish: genotypisk følsomhed* = 2 Brug af DRV i baggrundsregime Ingen brug af DRV Brug af DRV med primære PI-mutationer Brug af DRV uden primære PI-mutationer Køn Mand Kvinde Race Hvid Afroamerikansk/afrikansk oprindelse/andet Alder (år)
English: Table 5 Response (<50 cps/ml, snapshot) in GEMINI 1 + 2, pooled data.
Danish: Tabel 5 Respons (< 50 kopier/ml, snapshot) i GEMINI 1 + 2, samlede data.
English: The absorption of dolutegravir is reduced by certain anti-acid agents (see Table 2).
Danish: Absorptionen af dolutegravir reduceres af visse syreneutraliserende lægemidler (se tabel 2).
English: When excluding patients who stopped therapy for non-efficacy reasons, and those with major protocol deviations (incorrect dolutegravir dosing, intake of prohibited co-medication), namely, “the Virological Outcome (VO)-population)”, the corresponding response rates were 75% (120/161, week 24) and 69% (111/160, week 48).
Danish: Ved eksklusion af patienter, der stoppede behandling pga. manglende effekt og dem med store afvigelser fra protokollen (ukorrekt dosering af dolutegravir, brug af forbudt anden medicin samtidig), dvs. ”Virologisk Resultat (VR)-populationen”, var den tilsvarende responsrate 75 % (120/161, uge 24) og 69 % (111/160, uge 48).
English: Based on limited available data in children and adolescents (6 to less than 18 years of age and weighing at least 15 kg), there were no additional types of adverse reactions beyond those observed in the adult population.
Danish: Baseret på en begrænset mængde data hos børn og unge (i alderen 6 år til under 18 år og med en vægt på mindst 15 kg) er der ingen yderligere bivirkninger ud over dem, der blev set hos den voksne population.
English: * particularly in patients who have had depression or mental health problems before
Danish: • muskelsmerter *særligt hos patienter, som tidligere har haft depression eller psykiske problemer.
English: Antiviral activity in combination with other antiviral agents No antagonistic effects in vitro were seen with dolutegravir and other antiretrovirals tested: stavudine, abacavir, efavirenz, nevirapine, lopinavir, amprenavir, enfuvirtide, maraviroc and raltegravir.
Danish: Antiviral aktivitet i kombination med andre antivirale midler Der blev ikke set nogen antagonistisk virkning in vitro med dolutegravir og andre afprøvede antiretrovirale midler: stavudin, abacavir, efavirenz, nevirapin, lopinavir, amprenavir, enfuvirtid, maraviroc og raltegravir.
English: Treatment-emergent mutations or mixtures of mutations observed were L74I (n=1), N155H (n=2).
Danish: Mutationer eller blandinger af mutationer, der opstod under behandlingen var L741 (n = 1), N155H (n = 2).
English: All patients adjusted diff -1.7% (CI95-4.4, 1.1) a
Danish: Alle patienter justeret forskel -1.7 % (CI95 -4,4; 1,1) a
English: When using the lab-strain HIV-1 IIIB during passage over 112 days, mutations selected appeared slowly, with substitutions at positions S153Y and F, resulting in a maximal fold change in susceptibility of 4 (range 2-4).
Danish: Når laboratoriestammen hiv 1-IIIB blev brugt, viste de selekterede mutationer sig langsomt under passage over 112 dage, med substitutioner på position S153Y og F, resulterende i en maksimal foldændring i følsomhed på 4 (interval 2-4).
English: • phenytoin and phenobarbital, to treat epilepsy
Danish: • phenytoin og phenobarbital, til behandling af epilepsi.
English: The adjusted difference was -2.6% (95% CI: -6.7; 1.5) for GEMINI-1 and -0.7% (95% CI: -4.3; 2.9) for GEMINI-2 with a prespecified non-inferiority margin of 10%.
Danish: Den justerede forskel var -2,6 % (95 % CI: -6,7; 1,5) for GEMINI-1 og -0,7 % (95 % CI: -4,3; 2,9) for GEMINI-2 med en forudbestemt non-inferioritetsmargin på 10 %.
English: Alternatives to carbamazepine should be used where possible for INI resistant patients.
Danish: Om muligt bør alternativer til carbamazepin anvendes til INIresistente patienter.
English: The between-subject PK variability of dolutegravir was higher in HIV-infected subjects than healthy subjects.
Danish: PK-variabiliteten af dolutegravir mellem individerne var højere hos hiv-inficerede personer end hos raske personer.
English: Don't take other medicines for the infection without your doctor's advice.
Danish: Tag ikke andre lægemidler mod infektionen, medmindre lægen har foreskrevet det.
English: Cohort IIA (6 to <12 years) (n=23)
Danish: Kohorte IIA (6 år til < 12 år) (n=23)
English: When mutations listed as secondary integrase inhibitor associated mutations (for raltegravir/elvitegravir) are added to these primary mutations in experiments with site directed mutants, dolutegravir susceptibility is still unchanged (FC <2 vs wild type virus), except in the case of Q148-mutations, where a FC of 5-10 or higher is seen with combinations of certain secondary mutations.
Danish: Når mutationer anført som sekundære integrasehæmmer-relaterede mutationer (for raltegravir/elvitegravir) lægges til disse primære mutationer i eksperimenter med stedspecifikke mutanter, er følsomheden over for dolutegravir stadig uændret (FC < 2 vs. vildtypevirus), bortset fra i tilfældet med Q148-mutationer, hvor der blev set en FC på 510 eller højere med kombinationer af visse sekundære mutationer.
English: Dolutegravir is eliminated mainly through metabolism by UGT1A1.
Danish: Dolutegravir elimineres overvejende gennem metabolisering via UGT1A1.
English: What you need to know before you take Tivicay 3.
Danish: Det skal du vide, før du begynder at tage Tivicay 3.
English: Iron oxide yellow (E172) (for 25 mg and 50 mg tablets)
Danish: Gult jernoxid (E172) (for 25 mg og 50 mg tabletter) 6.2 Uforligeligheder
English: Dolutegravir belongs to a group of anti-retroviral medicines called integrase inhibitors (INIs).
Danish: Dolutegravir tilhører en gruppe af antiretrovirale lægemidler, der kaldes integrasehæmmere (INI'er).
English: Corticosteroids Prednisone
Danish: Kortikosteroider Prednison
English: Interactions between dolutegravir and co-administered medicinal products are listed in Table 2 (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, area under the concentration versus time curve as “AUC”, maximum observed concentration as “Cmax”, concentration at end of dosing interval as “Cτ”).
Danish: Interaktioner mellem dolutegravir og samtidigt administrerede lægemidler er anført i tabel 1 (stigning er angivet som "↑", fald som "↓", ingen ændring som "↔", arealet under koncentrations-tids-kurven som "AUC", den observerede maksimumskoncentration som "Cmax" og koncentrationen ved slutningen af doseringsinterval som ” Cτ”).
English: • calcium supplements, iron supplements and multivitamins.
Danish: • Calciumtilskud, jerntilskud og multivitaminer.
English: Dolutegravir pharmacokinetics are similar between healthy and HIV-infected subjects.
Danish: Dolutegravirs farmakokinetik er omtrent den samme hos raske og hiv-inficerede personer.
English: The bottles contain 30 or 90 film-coated tablets.
Danish: Beholderne indeholder 30 eller 90 filmovertrukne tabletter.
English: But if your next dose is due within 4 hours, skip the dose you missed and take the next one at the usual time.
Danish: Hvis din næste dosis skal tages inden for 4 timer, skal du dog springe den glemte dosis over og tage den næste dosis på det sædvanlige tidspunkt.
English: Signs include:
Danish: Tegnene omfatter:
English: G118R lowers the susceptibility to dolutegravir in site directed mutants (FC 10), but was not detected in patients receiving dolutegravir in the Phase III program.
Danish: G118R nedsætter følsomheden over for dolutegravir i stedspecifikke mutanter (FC 10), men blev ikke påvist hos patienter, der fik dolutegravir i fase IIIprogrammet.
English: While the total dolutegravir concentration in plasma was similar, a 1.5- to 2-fold increase in unbound exposure to dolutegravir was observed in subjects with moderate hepatic impairment compared to healthy controls.
Danish: Mens den totale koncentration af dolutegravir i plasma var tilsvarende, blev en 1,52-gange øgning i ubundet eksponering for dolutegravir observeret hos patienter med moderat nedsat leverfunktion sammenlignet med raske kontroller.
English: Of these four, two subjects had a unique R263K integrase substitution, with a maximum FC of 1.93, one subject had a polymorphic V151V/I integrase substitution, with maximum FC of 0.92, and one subject had pre-existing integrase mutations and is assumed to have been integrase experienced or infected with integrase resistant virus by transmission.
Danish: Af disse fire havde 2 personer en unik R263K-integrasesubstitution, med en FC på maksimalt 1,93, en person havde en polymorf V151V/I-integrasesubstitution, med en FC på maksimalt 0,92, og 1 person havde eksisterende integrasemutationer og anses for at have været integraseerfaren eller inficeret med integraseresistent virus ved overførsel.
English: The VIKING-4 study examined dolutegravir (plus optimized background therapy) in subjects with primary genotypic resistance to INIs at Screening in 30 subjects.
Danish: VIKING 4-studiet undersøgte dolutegravir (plus optimeret baggrundsbehandling) hos 30 patienter med primær genotypisk INI-resistens ved screening.
English: If you forget to take Tivicay
Danish: Hvis du har glemt at tage Tivicay
English: In serial passage with strain NL432, starting with site directed mutants harbouring N155H or E92Q, no further selection of resistance was seen (FC unchanged around 1).
Danish: I seriepassage med stamme NL432, som startede med de stedspecifikke mutanter, der husede N155H eller E92Q, blev der ikke set nogen yderligere selektion af resistens (FC uændret omkring 1).
English: In the rat pre/post-natal development study, decreased body weight of the developing offspring was observed during lactation at a maternally toxic dose (approximately 27 times human exposure at the maximum recommended human dose).
Danish: I et præ-/post-natalt udviklingsstudie hos rotter blev der observeret nedsat kropsvægt hos afkommet under dieperioden ved en maternel toksisk dosis (ca. 27 gange den humane eksponering ved den maksimalt anbefalede humane dosis).
English: No dosage adjustment is required in patients with mild, moderate or severe (CrCl <30 mL/min, not on dialysis) renal impairment.
Danish: Det er ikke nødvendigt at justere dosis hos patienter med let, moderat eller svær (CrCl < 30 ml/min, ikke i dialysebehandling) nedsat nyrefunktion.
English: There are limited data on subjects with hepatitis B co-infection.
Danish: Der findes en begrænset mængde data om personer, som er co-inficeret med hepatitis B-virus.
English: 8%b a 22 subjects contributed Week 48 CD4+ cell count data b 21 subjects contributed Week 24 CD4+ cell count data
Danish: 8 %b a 22 patienter bidrog med data for CD4+-celletal ved uge 48 b 21 patienter bidrog med data for CD4+-celletal ved uge 24
English: In vitro, dolutegravir inhibited the renal organic cation transporter 2 (OCT2) and multidrug and toxin extrusion transporter (MATE) 1.
Danish: In vitro hæmmede dolutegravir den renale transporter 2 af organiske kationer (OCT2) og multidrug og toksin ekstruderingstransporter (MATE) 1.
English: GlaxoSmithKline Pharmaceuticals S.A., ul., Grunwaldzka 189, 60-322 Poznan, Poland.
Danish: GlaxoSmithKline Pharmaceuticals S.A., ul., Grunwaldzka 189, 60-322 Poznan, Polen.
English: In vivo, dolutegravir did not have an effect on midazolam, a CYP3A4 probe.
Danish: In vivo havde dolutegravir ingen effekt på midazolam, et CYP3A4-probesubstrat.
English: In vivo, dolutegravir may increase plasma concentrations of medicinal products in which excretion is dependent upon OCT2 or MATE-1 (e.g. dofetilide, metformin) (see Table 2 and section 4.3).
Danish: In vivo kan dolutegravir øge plasmakoncentrationerne af lægemidler, for hvilke udskillelsen afhænger af OCT2 eller MATE-1 (f.eks. dofetilid, metformin) (se tabel 2 og pkt.
English: It should not be taken as five 10 mg tablets.
Danish: Den må ikke tages som fem 10 mg tabletter.
English: Antidiabetics Metformin
Danish: Antidiabetika Metformin
English: • metformin, to treat diabetes
Danish: • metformin, til behandling af diabetes (sukkersyge).
English: No dosage adjustment is required in patients with mild or moderate hepatic impairment (Child-Pugh grade A or B).
Danish: Det er ikke nødvendigt at justere dosis hos patienter med let til moderat nedsat leverfunktion (Child-Pughklasse A eller B).
English: Statistically fewer subjects failed therapy with treatment-emergent integrase resistance on Tivicay (4/354, 1%) than on raltegravir (17/361, 5%) (p=0.003) (refer to section ‘Resistance in vivo' above for details).
Danish: Statistisk færre personer oplevede behandlingssvigt med integraseresistens, som opstod under behandlingen, på Tivicay (4/354, 1 %) end på raltegravir (17/361, 5 %) (p = 0,003) (se afsnittet 'Resistens in vivo' ovenfor for detajler).
English: Lamivudine and dolutegravir
Danish: Lamivudin og dolutegravir
English: A study of the pharmacokinetics of dolutegravir was performed in subjects with severe renal impairment (CLcr <30 mL/min) and matched healthy controls.
Danish: Et studie af dolutegravirs farmakokinetik blev udført hos personer med svært nedsat nyrefunktion (CLcr < 30 ml/min) og svarede til kontroller for raske.
English: In SINGLE, the median time to viral suppression was shorter in the dolutegravir treated patients (28 vs 84 days, (p<0.0001, analysis pre-specified and adjusted for multiplicity).
Danish: I SINGLE var den gennemsnitlige tid til viral hæmning kortere hos patienter behandlet med dolutegravir (28 vs. 84 dage, p < 0,0001, analysen var forudspecificeret og justeret for multiplicitet).
English: Do not remove the desiccant.
Danish: Fjern ikke tørremidlet.
English: Dolutegravir ↓ (Not studied, a similar reduction in exposure as observed with efavirenz is expected, due to induction)
Danish: Dolutegravir  (Ikke undersøgt, et lignende fald i eksponering som set med efivarenz forventes, pga. induktion)
English: Common Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) elevations Common Creatine phosphokinase (CPK) elevations
Danish: og/eller aspartataminotransferase (ASAT) Almindelig Forhøjet niveau af kreatinfosfokinase (CPK)
English: Sixteen of 30 subjects (53%) harboured Q148 virus at baseline.
Danish: 16 ud af 30 patienter (53 %) havde virus med Q148-mutationen ved baseline.
English: Interaction Geometric mean change
Danish: Interaktion Geometrisk middelændring (%)
English: • If you are taking certain other medicines, the dose is one 50 mg tablet twice a day.
Danish: • Hvis du tager visse andre lægemidler er dosis én 50 mg tablet 2 gange daglig.
English: CD4+ Cell Count
Danish: CD4+-celletal
English: If you are breast-feeding, or thinking about breast-feeding: → Talk to your doctor immediately.
Danish: Hvis du ammer eller planlægger at amme:  Tal straks med lægen.
English: Extremadura 3, 09400 Aranda de Duero, Burgos, Spain GlaxoSmithKline Pharmaceuticals S.A., ul., Grunwaldzka 189, 60-322 Poznan, Poland.
Danish: Extremadura 3, 09400 Aranda de Duero, Burgos, Spanien GlaxoSmithKline Pharmaceuticals S.A., ul., Grunwaldzka 189, 60-322 Poznan, Polen.