FrancophonIA/ELRC3.0 huggingface dataset:
English: The absolute bioavailability of a single dose of inhaled fluticasone propionate in healthy subjects varies between approximately 5 to 11% of the nominal dose depending on the inhalation device used.
Slovenian: Absolutna biološka uporabnost inhaliranega flutikazonpropionata pri zdravih preiskovancih je med približno 5 in 11 % nominalnega odmerka, odvisno od uporabljene inhalacijske naprave.
English: Very rare cases of adrenal suppression and acute adrenal crisis have also been described with doses of fluticasone propionate between 500 and less than 1000 micrograms.
Slovenian: Zelo redki primeri zavrtega delovanja nadledvičnih žlez in akutne adrenalne krize so opisani tudi z odmerki flutikazonipropionata od 500 do manj kot 1.000 mikrogramov.
English: There was a trend towards improved survival in subjects treated with salmeterol/fluticasone propionate compared with placebo over 3 years however this did not achieve the statistical significance level p≤0.05.
Slovenian: Izkazan je bil trend izboljšanja preživetja pri osebah, zdravljenih s salmeterolom/flutikazonpropionatom, v primerjavi s placebom po 3 letih, kljub temu pa ni dosegel nivoja statistične razlike pri vrednosti p ≤ 0,05.
English: This is to ensure that they understand how to use the inhaler correctly, and so that they understand the need to breathe in forcefully when inhaling to obtain the required dose.
Slovenian: S tem se zagotovi, da razumejo, kako je treba inhalator pravilno uporabljati, in silovito vdihniti, da zagotovijo potrebni odmerek.
English: Route of administration: Inhalation use
Slovenian: Pot uporabe: za inhaliranje
English: The safety and efficacy of Aerivio Spiromax in this young population have not been established.
Slovenian: Varnost in učinkovitost zdravila Aerivio Spiromax pri tej mladi populaciji še nista bili dokazani.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics, ATC code: R03AK06
Slovenian: Farmakoterapevtska skupina: zdravila za obstruktivne pljučne bolezni, adrenergiki v kombinaciji s kortikosteroidi ali drugimi učinkovinami razen antiholinergikov, oznaka ATC: R03AK06
English: Suomi/Finland Teva FinlandPuh/Tel: +358 20 180 5900
Slovenian: Suomi/Finland Teva Finland Puh/Tel: +358 20 180 5900
English: • Pneumonia and bronchitis (lung infection).
Slovenian: • pljučnica in bronhitis (okužba pljuč).
English: If an individual patient should require dosages outside the recommended regimen, appropriate doses of β2 agonist and/or corticosteroid should be prescribed
Slovenian: Če posamezni bolnik potrebuje odmerke zunaj priporočene sheme, mu je treba predpisati ustrezne odmerke agonista β2 in/ali
English: Method of administration/Instructions for use
Slovenian: Način uporabe/navodila za uporabo
English: The secondary endpoints of combined all cause death or life-threatening experience, all cause death, or all cause hospitalisation did not reach statistical significance in the whole population.
Slovenian: Sekundarni opazovani dogodki - kombinacija smrtnih izidov ali življenje ogrožajočih dogodkov iz katerega koli vzroka, smrtni izidi iz katerega koli vzroka ali sprejemi v bolnišnico iz katerega koli vzroka v celotni populaciji niso dosegli statistične značilnosti.
English: The primary endpoint in SMART was the combined number of respiratory-related deaths and respiratory-related life-threatening experiences.
Slovenian: Primarni opazovani dogodek v študiji SMART je bilo kombinirano število z dihali povezanih smrti in z dihali povezanih življenje ogrožajočih dogodkov.
English: Salmeterol produces a longer duration of bronchodilation, lasting for at least 12 hours, than recommended doses of conventional short-acting β2 agonists.
Slovenian: Salmeterol povzroči dolgotrajnejšo (vsaj 12-urno) bronhodilatacijo kot priporočeni odmerki konvencionalnih kratkodelujočih agonistov β2.
English: You may notice a taste when you take your inhalation.
Slovenian: Morda boste ob inhaliranju začutili okus.
English: The lowest dose of inhaled corticosteroid should be used.
Slovenian: Uporabiti je treba najmanjši odmerek inhalacijskega kortikosteroida.
English: Close your lips around the mouthpiece.
Slovenian: Stisnite ustnice okoli ustnika.
English: Chronic overdose: Adrenal reserve should be monitored and treatment with a systemic corticosteroid may be necessary.
Slovenian: Kronično preveliko odmerjanje: Spremljati je treba adrenalno rezervo; morda bo potrebno zdravljenje s sistemskim kortikosteroidom.
English: Concomitant use of systemic ketoconazole significantly increases systemic exposure to salmeterol.
Slovenian: Sočasna uporaba sistemskega ketokonazola znatno poveča sistemsko izpostavljenost salmeterolu.
English: This makes it easier for air to get in and out.
Slovenian: To olajšuje dotok in iztok zraka.
English: There is likely to be a similar risk of interaction with other potent CYP3A4 inhibitors (e.g. itraconazole, telithromycin, ritonavir).
Slovenian: Verjetno je podobno tveganje tudi pri interakciji z drugimi močnimi zaviralci CYP3A4 (npr. itrakonazol, telitromicin, ritonavir).
English: • Diabetes mellitus (Aerivio Spiromax may increase your blood sugar)
Slovenian: • sladkorno bolezen (zdravilo Aerivio Spiromax lahko zviša krvni sladkor)
English: • Inflammation of sinuses (sinusitis, a feeling of tension or fullness in the nose, cheeks and behind the eyes, sometimes with a throbbing ache).
Slovenian: • vnetje sinusov (sinusitis, občutek napetosti ali polnosti nosu, lic in predela za očmi, včasih z utripajočo bolečino);
English: Children may also experience anxiety, sleep disorders and behavioural changes, including hyperactivity and irritability.
Slovenian: Pri otrocih se lahko pojavijo tudi tesnobnost, motnje spanja in vedenjske spremembe, vključno s hiperaktivnostjo in razdražljivostjo.
English: Two children on salmeterol/fluticasone propionate and 5 children on fluticasone propionate withdrew because of worsening asthma.
Slovenian: Dva otroka na salmeterolu/flutikazonpropionatu in 5 otrok na flutikazonproprionatu je zaradi poslabšanja astme izstopilo iz študije.
English: • Fluticasone propionate is a corticosteroid which reduces swelling and irritation in the lungs.
Slovenian: • Flutikazonpropionat je kortikosteroid, ki zmanjšuje otekanje in draženje v pljučih.
English: You may be very wheezy and cough or be short of breath.
Slovenian: Morda boste zelo piskajoče dihali, kašljali ali ostali brez sape.
English: • Very fast heart beat (tachycardia).
Slovenian: • zelo hitro utripanje srca (tahikardija);
English: If necessary you may wipe the mouthpiece of your inhaler after use with a dry cloth or tissue.
Slovenian: Po potrebi lahko ustnik inhalatorja po uporabi obrišete s suho krpo ali robčkom.
English: These are often used to treat asthma.
Slovenian: Ta se pogosto uporabljajo za zdravljenje
English: It is impossible to accidentally take extra medicine or a double dose in
Slovenian: Nemogoče je, da bi po nesreči uporabili več zdravila ali dvojni odmerek v eni inhalaciji.
English: All subjects with asthma or COPD achieved PIFR values greater than 60L/min after optimal training.
Slovenian: Vse osebe z astmo ali KOPB so dosegle vrednosti PIFR nad 60 l/min po optimalni vadbi.
English: Administration of Aerivio Spiromax to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.
Slovenian: Zato naj se zdravilo Aerivio Spiromax pri nosečnicah uporablja samo, če so pričakovane koristi za mater večje od vseh možnih tveganj za plod.
English: In a small study in healthy volunteers, the slightly less potent CYP3A inhibitor ketoconazole increased the exposure of fluticasone propionate after a single inhalation by 150%.
Slovenian: V majhni študiji pri zdravih prostovoljcih je nekoliko manj močan zaviralec CYP3A ketokonazol zvišal izpostavljenost flutikazonpropionatu po enkratni inhalaciji za 150 %.
English: It is important to inhale forcefully to ensure optimal dosing.
Slovenian: Za zagotovitev optimalnega odmerjanja je pomembno silovito vdihniti.
English: Oral corticosteroids and antibiotics were allowed for the acute treatment of COPD exacerbations with specific guidelines for use.
Slovenian: Peroralni kortikosteroidi in antibiotiki so bili dovoljeni za akutno zdravljenje poslabšanj KOPB s posebnimi navodili za uporabo.
English: • The mouthpiece will still ‘click' even when your inhaler is empty.
Slovenian: • Ustnik še naprej klika, tudi ko je inhalator prazen.
English: Each dose contains approximately 10 milligrams of lactose (as monohydrate).
Slovenian: En odmerek vsebuje približno 10 miligramov laktoze (v obliki monohidrata).
English: Do not try to take your inhaler apart, remove or twist the mouthpiece cover.
Slovenian: Ne poskušajte razstaviti inhalatorja oziroma odstraniti ali zasukati pokrovčka ustnika.
English: • Use your Aerivio Spiromax every day until your doctor advises you to stop.
Slovenian: • Zdravilo Aerivio Spiromax uporabljajte vsak dan, dokler vam zdravnik ne svetuje, da nehate.
English: You may also notice itching, a rash (hives) and swelling (usually of the face, lips, tongue or throat), or you may suddenly feel that your heart is beating very fast or you feel faint and light headed (which may lead to collapse or loss of consciousness).
Slovenian: Opazite lahko tudi srbenje, izpuščaj (koprivnico) in oteklost (običajno obraza, ustnic, jezika ali žrela) ali pa nenadoma čutite zelo hitro utripanje srca, omedlevico ali omotico (kar lahko vodi v kolaps ali izgubo zavesti).
English: In TORCH, older patients, patients with a lower body mass index (<25 kg/m2) and patients with very severe disease (FEV1<30% predicted) were at greatest risk of developing pneumonia regardless of treatment.
Slovenian: V študiji TORCH so pri starejših bolnikih, bolnikih z nižjim indeksom telesne mase (< 25 kg/m2) in bolnikih z zelo hudo obliko bolezni (pričakovan FEV1 < 30 %) opazili največje tveganje za pojav pljučnice ne glede na zdravljenje.
English: Aerivio Spiromax is not available on the market at strengths lower than 50/500 microgram.
Slovenian: Zdravilo Aerivio Spiromax na trgu ni na voljo v jakosti, manjši od 50/500 mikrogramov.
English: Co-administration with erythromycin was not associated with any serious adverse effects.
Slovenian: Sočasna uporaba eritromicina ni bila povezana z nobenimi resnimi neželenimi učinki.
English: If you get any of these effects or if they happen suddenly after using Aerivio Spiromax, stop using Aerivio Spiromax and tell your doctor straight away.
Slovenian: Če se pojavi kateri koli od teh neželenih učinkov ali če se ti pojavijo nenadoma po uporabi zdravila Aerivio Spiromax, takoj prenehajte uporabljati zdravilo Aerivio Spiromax in to takoj povejte zdravniku.
English: • Uneven or irregular heart beat or an extra heart beat (arrhythmias).
Slovenian: • neenakomerno ali nepravilno bitje srca ali dodatni srčni utrip (aritmije).
English: If you are using Aerivio Spiromax for asthma, your doctor will want to check your symptoms regularly.
Slovenian: Če uporabljate zdravilo Aerivio Spiromax za astmo, bo zdravnik redno spremljal vaše simptome.
English: The benefits of inhaled fluticasone propionate therapy should minimise the need for oral steroids, but patients transferring from oral steroids may remain at risk of impaired adrenal reserve for a considerable time.
Slovenian: Koristni učinki vdihanega flutikazonpropionata bi morali minimizirati potrebo po peroralnih steroidih, toda bolnike, ki preidejo s peroralnih steroidov, lahko še dolgo ogroža zmanjšanje adrenalne rezerve.
English: • Medicines to treat infections (such as ritonavir, ketoconazole, itraconazole and erythromycin).
Slovenian: • Zdravila za zdravljenje okužb (kot so ritonavir, ketokonazol, itrakonazol in eritromicin).
English: Your doctor will help you to manage your asthma and will adjust the dose of this medicine to the lowest dose that controls your asthma.
Slovenian: Zdravnik vam bo pomagal pri obvladovanju astme in prilagodil odmerek tega zdravila na najmanjši odmerek, ki nadzoruje vašo astmo.
English: Your doctor, nurse or pharmacist should provide you with training on how to use your inhaler, including how to take a dose effectively.
Slovenian: Zdravnik, medicinska sestra ali farmacevt vas morajo naučiti pravilne uporabe inhalatorja, vključno z učinkovitim jemanjem odmerka.
English: In a 12-week trial of children 4 to 11 years of age [n=203] randomized in a parallel-group study with persistent asthma and who were symptomatic on inhaled corticosteroid, safety was the primary objective.
Slovenian: V 12-tedenskem preskušanju pri otrocih s persistentno astmo, starih od 4 do 11 let [n = 203], ki so imeli simptome ob uporabi inhalacijskih kortikosteroidov in so bili randomizirani v študijo s paralelnimi skupinami, je bila varnost glavni cilj preskušanja.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: The disposition of fluticasone propionate is characterised by high plasma clearance (1150 mL/min), a large volume of distribution at steady-state (approximately 300 L) and a terminal half-life of approximately 8 hours.
Slovenian: Za razporeditev flutikazonpropionata so značilni velik očistek iz plazme (1.150 ml/min), velik volumen porazdelitve v stanju dinamičnega ravnovesja (približno 300 l) in približno 8-urni končni razpolovni čas.
English: Read the package leaflet carefully before use.
Slovenian: Pred uporabo preberite priloženo navodilo!
English: Then breathe out gently (do not breathe out through the inhaler).
Slovenian: Nato nežno izdihnite (ne izdihnite skozi inhalator).
English: This will make sure that it works properly in controlling your asthma or COPD.
Slovenian: To zagotavlja njegovo ustrezno učinkovanje in nadzor vaše astme ali KOPB.
English: Combined asthma-related death or life-threatening experience
Slovenian: Kombinacija z astmo povezanih smrtnih izidov ali življenje ogrožajočih dogodkov
English: In addition there are only limited data available on the pharmacokinetics of salmeterol because of the technical difficulty of assaying the drug in plasma due to the low plasma concentrations at therapeutic doses (approximately 200 picogram/mL or less) achieved after inhaled dosing.
Slovenian: Podatki o farmakokinetiki salmeterola so poleg tega omejeni zaradi tehnične težavnosti določanja koncentracije v plazmi, ki je po vdihavanju terapevtskih odmerkov nizka (približno 200 pikogramov/ml ali manj).
English: • Chronic obstructive pulmonary disease (COPD), to reduce the number of flare ups of symptoms.
Slovenian: • kronične obstruktivne pljučne bolezni (KOPB), za zmanjšanje števila izbruhov simptomov.
English: Systemic effects may occur, particularly at high doses prescribed for long periods.
Slovenian: Lahko se pojavijo sistemski učinki, zlasti pri zdravljenju z velikimi odmerki, predpisanimi za daljše obdobje.
English: Allergic reactions: you may notice your breathing suddenly gets worse immediately after using Aerivio Spiromax.
Slovenian: Alergijske reakcije: opazite lahko, da se dihanje poslabša takoj po uporabo zdravila Aerivio Spiromax.
English: Breathe in forcefully and deeply through the mouthpiece.
Slovenian: Skozi ustnik silovito in globoko vdihnite.
English: Acute: Acute inhalation of fluticasone propionate doses in excess of those recommended may lead to temporary suppression of adrenal function.
Slovenian: Akutno: Akutno vdihavanje flutikazonpropionata v odmerkih, ki presegajo priporočene, lahko povzroči prehodno zavrtje delovanja nadledvičnih žlez.
English: If you open and close the mouthpiece without taking an inhalation the dose will be securely held inside the inhaler ready for the next inhalation.
Slovenian: Če ustnik odprete in zaprete, odmerka pa ne inhalirate, ostane odmerek varno shranjen znotraj inhalatorja in pripravljen za naslednjo inhalacijo.
English: Patients should be given a strength of salmeterol/fluticasone propionate inhaler containing the appropriate fluticasone propionate dosage for the severity of their disease.
Slovenian: Bolnikom je treba dati jakost inhalatorja s salmeterolom/flutikazonpropionatom, ki vsebuje ustrezen odmerek flutikazonpropionata glede na resnost njihove bolezni.
English: The use of concurrent inhaled long-acting β2 agonists and anticholinergic drugs, salbutamol/ipratropium bromide combination products, oral β2 agonists and theophylline preparations were not allowed during the treatment period.
Slovenian: Sočasna uporaba inhaliranih dolgodelujočih agonistov β2 in antiholinergičnih zdravil, salbutamola/ipratropijevega bromida, peroralnih agonistov β2 in zdravil s teofilinom v času zdravljenja ni bila dovoljena.
English: The Salmeterol Multi-center Asthma Research Trial (SMART)
Slovenian: Multicentrično raziskovalno preskušanje zdravljenja astme s salmeterolom (SMART, The Salmeterol Multi-center Asthma Research Trial)
English: Situations, which could potentially trigger acute adrenal crisis include trauma, surgery, infection or any rapid reduction in dosage.
Slovenian: Med okoliščinami, ki lahko sprožijo akutno adrenalno krizo, so poškodbe, kirurški posegi, okužbe in vsako hitro zmanjšanje odmerka.
English: The pharmacological effects of β2 agonist treatment, such as tremor, palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy.
Slovenian: Poročali so o farmakoloških učinkih zdravljenja z agonisti β2, kot so tremor, palpitacije in glavobol, ki so bili običajno prehodni in so se pri rednem zdravljenju ublažili.
English: Consideration should be given to increasing corticosteroid
Slovenian: Razmisliti je treba o povečanju terapije s kortikosteroidom.
English: Place the mouthpiece between the teeth with the lips closed around the mouthpiece, do not bite the mouthpiece of the inhaler.
Slovenian: Namestite ustnik med zobe in okoli njega stisnite ustnice, ne da bi v ustnik inhalatorja ugriznili.
English: • The dose indicator shows the number of inhalations remaining in even numbers only.
Slovenian: • Kazalnik odmerka pokaže število inhalacij, ki je preostalo, samo za soda števila.
English: Your doctor has prescribed this medicine for the treatment of either • Severe asthma, to help prevent attacks of breathlessness and wheeziness,
Slovenian: Zdravnik vam je to zdravilo predpisal za zdravljenje: • hude astme, da prepreči napade zasoplosti in piskajočega dihanja
English: Hence, clinically significant drug interactions mediated by fluticasone propionate
Slovenian: Klinično pomembne interakcije zdravil zaradi flutikazonpropionata zato
English: Breathe: Breathe out gently (as far as is comfortable).
Slovenian: Vdihnite: Nežno izdihnite (dokler to še ne predstavlja težave).
English: Co-administration with ketoconazole did not increase the elimination half-life of salmeterol or increase salmeterol accumulation with repeat dosing.
Slovenian: Sočasno dajanje s ketokonazolom ni povečalo razpolovnega časa salmeterola ali povečalo kopičenja salmeterola ob ponavljajočih odmerkih.
English: Open: Hold the Spiromax with the mouthpiece cover at the bottom and open the mouthpiece cover by folding it down until it is fully opened when one click is heard.
Slovenian: Odprite: Držite inhalator Spiromax pokonci, tako da je ustnik spodaj, in pokrovček ustnika odprite tako, da ga preganete navzdol, dokler ni povsem odprt in se zasliši klik.
English: The percentage of patients who died within 3 years due to COPD-related causes was 6.0% for placebo, 6.1% for salmeterol, 6.9% for FP and 4.7% for salmeterol/fluticasone propionate.
Slovenian: Odstotek bolnikov, ki so v teku 3 let umrli zaradi razlogov, povezanih s KOPB, je bil 6,0 % za placebo, 6,1 % za salmeterol, 6,9 % za FP in 4,7 % za salmeterol/flutikazonpropionat.
English: Adverse reactions which have been associated with salmeterol/fluticasone propionate are given below, listed by system organ class and frequency.
Slovenian: Neželeni učinki, povezani s salmeterolom/flutikazonpropionatom, so navedeni spodaj po organskem sistemu in pogostnosti.
English: The results of this study suggest that salmeterol/fluticasone propionate 50/100 micrograms twice daily may be considered as initial maintenance therapy in patients with moderate persistent asthma for whom rapid control of asthma is deemed essential (see section 4.2).
Slovenian: Izsledki te študije kažejo, da se lahko salmeterol/flutikazonpropionat 50/100 mikrogramov dvakrat na dan uporablja kot uvodno vzdrževalno zdravljenje za bolnike z zmerno, perzistentno astmo, pri katerih je hitro obvladovanje astme ključno (glejte poglavje 4.2).
English: A similar incidence of pneumonia in the salmeterol/fluticasone propionate group was seen across all studies.
Slovenian: Podobno incidenco pljučnice so v skupini, ki je prejemala salmeterol/flutikazonpropionat, opazili v vseh študijah.
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within
Slovenian: Imetnik dovoljenja za promet z zdravilom mora prvo redno posodobljeno poročilo o varnosti zdravila za to zdravilo predložiti v 6 mesecih po pridobitvi dovoljenja za promet.
English: Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods.
Slovenian: Sistemski učinki se lahko pojavijo pri zdravljenju s katerim koli inhalacijskim kortikosteroidom, zlasti v primeru velikih odmerkov, predpisanih za daljše obdobje.
English: The signs and symptoms of salmeterol overdose are dizziness, increases in systolic blood pressure, tremor, headache and tachycardia.
Slovenian: Znaki in simptomi prevelikega odmerjanja salmeterola so omotica, povečanje sistoličnega krvnega tlaka, tremor, glavobol in tahikardija.
English: You must use Aerivio Spiromax every day as directed by your doctor.
Slovenian: Zdravilo Aerivio Spiromax morate uporabljati vsak dan, kot vam je predpisal zdravnik.
English: The studies described below (GOAL, TORCH and SMART) were carried out with this same fixed-dose combination, salmeterol xinafoate and fluticasone propionate, but studied a previously authorised product; the studies described were not carried out with Aerivio Spiromax.
Slovenian: Študije, opisane v nadaljevanju (GOAL, TORCH in SMART), so bile izvedene z enako fiksno kombinacijo odmerkov salmeterolijevega ksinafoata in flutikazonpropionata, vendar s predhodno odobrenim zdravilom; opisane študije niso bile izvedene z zdravilom Aerivio Spiromax.
English: This medicine should not be used in children or adolescents under the age of 18 years.
Slovenian: Tega zdravila se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
English: It is unknown whether salmeterol and fluticasone propionate /metabolites are excreted in human milk.
Slovenian: Ni znano, ali se salmeterol in flutikazonpropionat/presnovki izločajo v materino mleko.
English: Packs of 1 and 3 inhalers.
Slovenian: Velikosti pakiranja 1 inhalator ali 3 inhalatorji.
English: This may lead to an increase in the incidence of other systemic effects of salmeterol treatment (e.g. prolongation of QTc interval and palpitations) compared with salmeterol or ketoconazole treatment alone (see section 4.4).
Slovenian: To lahko povzroči povečanje incidence drugih sistemskih učinkov zdravljenja s salmeterolom (npr. podaljšanje intervala QTc in palpitacije) v primerjavi z zdravljenjem s samo salmeterolom ali ketokonazolom (glejte
English: There was no increase in pneumonia related deaths; deaths while on treatment that were adjudicated as primarily due to pneumonia were 7 for placebo, 9 for salmeterol, 13 for FP and 8 for salmeterol/fluticasone propionate.
Slovenian: Porasta smrti, povezanih s pljučnico, ni bilo; v času zdravljenja je bilo število smrti, ki so bile primarno pripisane pljučnici, 7 za placebo, 9 za salmeterol, 13 za FP in 8 za salmeterol/flutikazonpropionat.
English: Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Netherlands
Slovenian: Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Nizozemska