natgillin/translations-raw huggingface dataset:
In permanent AF, the AF has been present for a long time (at least during 6 months) and a decision has been made not to change back your heart rhythm to atrial normal rhythm with a treatment called cardioversion, - if you have instability (drops) in your blood pressure which can lead to inadequate arterial blood flow to your organs, 
Pri permanentni (trajni) AF je AF prisotna že dolgo (vsaj 6 mesecev) in odločeno je bilo, da vašega srčnega ritma ne bodo znova vračali v normalen preddvorni ritem z zdravljenjem, ki ga imenujemo kardioverzija.
MULTAQ 400 mg 
PODATKI V BRAILLOVI PISAVI MULTAQ 400 mg
Dronedarone was not shown to alter fertility in animal studies. 
V študijah na živalih dronedaron ni vplival na plodnost.
Talk to your doctor straight away, if you notice any of the following serious side effects - you may need urgent medical assistance 
Če opazite katerega od naslednjih resnih neželenih učinkov, se takoj posvetujte z zdravnikommorda boste potrebovali nujno zdravniško pomoč Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov)
How to take MULTAQ 
Kako jemati zdravilo MULTAQ
Interaction with warfarin and losartan (CYP 2C9 substrates) Warfarin and other vitamin K antagonists 
Medsebojno delovanje z varfarinom in losartanom (substratoma CYP 2C9)
Fatigue Asthenia 
Žilne bolezni
No interaction was observed between dronedarone and losartan and an interaction between dronedarone and other AIIRAs is not expected. 
Losartan in drugi antagonisti receptorjev angiotenzina II (Angiotensin II Receptor Antagonists AIIRA) Medsebojnih delovanj med dronedaronom in losartanom niso opazili in medsebojnih delovanj med dronedaronom in drugimi antagonisti receptorjev angiotenzina II ni pričakovati.
• Co-administration with dabigatran 
• Sočasno jemanje z dabigatranom.
Do not take MULTAQ: 
Hkrati z zdravilom MULTAQ ne smete jemati:
Take: 
Lot:
What MULTAQ looks like and content of the pack MULTAQ is a white, oval, film-coated tablet (tablet) with a double wave marking on one side and “4142” on the other side. 
Tablete MULTAQ so bele, ovalne filmsko obložene tablete z oznako dvojnega vala na eni strani in kodo "4142" na drugi strani.
If ALT levels are confirmed to be ≥3 × ULN, treatment with dronedarone should be withdrawn. 
Če je raven ALT potrjeno ≥ 3 × ZMN, je treba zdravljenje z dronedaronom končati.
Tell your doctor, he/she will check your lung. 
To morate povedati zdravniku, ki bo preveril vaša pljuča.
However, clinically significant INR elevations (≥5) usually within 1 week after starting dronedarone were reported in patients taking oral anticoagulants. 
Pri bolnikih, ki jemljejo oralne antikoagulante so poročali o klinično signifikantnem zvišanju internacionalnega normaliziranega razmerja (INR) (≥5), običajno v 1 tednu po začetku jemanja dronedarona.
If AF reoccurs, discontinuation of dronedarone should be considered. 
Če se AF znova pojavi, je treba razmisliti o prenehanju uporabe dronedarona.
Their co-administration is contraindicated (see section 4.3). 
Sočasno jemanje omenjenih zdravil je kontraindicirano (glejte poglavje 4.3).
NAME OF THE MEDICINAL PRODUCT MULTAQ 400 mg film-coated tablets 
IME ZDRAVILA MULTAQ 400 mg filmsko obložene tablete
If left ventricular systolic dysfunction develops, treatment with dronedarone should be discontinued. 
Če se pojavi sistolična disfunkcija levega prekata, je treba zdravljenje z dronedaronom ukiniti.
If heart failure develops, treatment with dronedarone should be discontinued. 
Če se pojavi srčno popuščanje, je treba zdravljenje z dronedaronom ukiniti.
NAME OF THE MEDICINAL PRODUCT MULTAQ 400 mg tablets dronedarone 
IME ZDRAVILA MULTAQ 400 mg tablete dronedaron
Screen patients before treatment initiation Contra indication of Permanent Atrial fibrillation Contra indication of history, or current heart failure or left ventricular systolic dysfunction (LVSD) 
Kontraindikacija v primeru stalne atrijske fibrilacije Kontraindikacija v primeru srčnega popuščanja v anamnezi ali trenutnega srčnega popuščanja ali sistolične disfunkcije levega prekata (LVSD) Preprečevanje medsebojnega delovanja zdravil
• St John's Wort - a herbal medicine for depression, 
• šentjanževko - zeliščno zdravilo proti depresiji,
Potent CYP3A4 inducers 
Močni induktorji CYP3A4
Calcium antagonists also have their exposure increased by dronedarone (400 mg twice daily) (verapamil by 1.4-fold, and nisoldipine by 1.5-fold). 
Dronedaron (400 mg dvakrat na dan) poveča tudi izpostavljenost kalcijevim antagonistom (izpostavljenost verapamilu za 1,4-krat in nisoldipinu za 1,5-krat).
• you have breathlessness or non-productive cough. 
- če imate kratko sapo ali kašelj brez izmečka (neproduktiven kašelj).
Overall, due to the pharmacokinetic interaction and possible pharmacodynamic interaction, calcium antagonists with depressant effects on sinus and atrio-ventricular node such as verapamil and diltiazem should be used with caution when associated with dronedarone. 
Na splošno je treba kalcijeve antagoniste z depresorskim delovanjem na sinusni in atrioventrikularni vozel (npr. verapamil in diltiazem) zaradi farmakokinetičnih in možnih farmakodinamičnih medsebojnih delovanj uporabljati previdno, kadar so uporabljeni obenem z dronedaronom.
• Opaque PVC/Aluminium blister in packs of 20, 50 and 60 film-coated tablets • Opaque PVC/Aluminium perforated unit dose blister in packs of 100x1 film-coated tablets. 
- neprozorni pretisni omoti za enkratni odmerek iz PVC/aluminija v pakiranju po 100 x 1 filmsko obložena tableta.
Monitoring of their plasma concentrations and appropriate dose adjustment is recommended in case of coadministration with dronedarone. 
V primeru sočasne uporabe z dronedaronom je priporočljivo kontrolirati njuno koncentracijo v plazmi in ustrezno prilagoditi odmerek.
Dronedarone had no genotoxic effects, based on one in vivo micronucleus test in mice and four in vitro tests. 
Na podlagi mikrojedrnega testa in vivo pri miših ter štirih testov in vitro dronedaron nima genotoksičnih učinkov.
Also contains: lactose. 
SEZNAM POMOŽNIH SNOVI Vsebuje tudi: laktozo.
No decreases in ethinylestradiol and levonorgestrel were observed in healthy subjects receiving dronedarone (800 mg twice daily) concomitantly with oral contraceptives. 
Pri zdravih preiskovankah, ki so dobivale dronedaron (800 mg dvakrat na dan) sočasno s peroralnimi kontraceptivi, niso opazili znižanja etinilestradiola in levonorgestrela.
Since antiarrhythmic medicinal products may be ineffective or may be arrhythmogenic in patients with hypokalaemia, any potassium or magnesium deficiency should be corrected before initiation and during dronedarone therapy. 
Antiaritmična zdravila so lahko pri bolnikih s hipokaliemijo neučinkovita ali celo aritmogena.
• you have swollen feet or legs, trouble breathing when lying down or sleeping, shortness of breath when moving around, or weight increase (which are signs and symptoms of heart failure), 
Zdravilo MULTAQ morate prenehati jemati, - če imate otekla stopala ali noge, težko dihanje v leže ali med spanjem, kratko sapo med gibanjem ali povečanje telesne mase (to so znaki in simptomi srčnega popuščanja).
In patients already on calcium antagonists at time of dronedarone initiation, an ECG should be performed and the calcium antagonist dose should be adjusted if needed (see section 4.4). 
Bolnikom, ki v času uvedbe dronedarona že dobivajo kalcijeve antagoniste, je treba posneti EKG in jim odmerek kalcijevega antagonista prilagoditi, če je treba (glejte poglavje 4.4).
Dronedarone (400 mg twice daily) increased simvastatin and simvastatin acid exposure by 4-fold and 2-fold respectively. 
Dronedaron (dvakrat na dan) je povečal izpostavljenost simvastatinu za 4-krat in simvastatinski kislini za 2-krat.
Contact immediately your doctor or the nearest emergency department or hospital. 
Če ste vzeli večji odmerek zdravila MULTAQ, kot bi smeli Takoj se posvetujte s svojim zdravnikom, najbližjo ambulanto za nujno medicinsko pomoč ali bolnišnico.
No dose adjustment is required in patients with mild or moderate hepatic impairment (see section 5.2). 
Bolnikom z blago ali zmerno okvaro jeter odmerka ni treba prilagoditi (glejte poglavje
EU/1/09/591/001 20 film-coated tablets EU/1/09/591/002 50 film-coated tablets EU/1/09/591/003 60 film-coated tablets EU/1/09/591/004 100x1 film-coated tablets 
EU/1/09/591/004 100 x 1 filmsko obložena tableta
MULTAQ does not usually affect your ability to drive or use machine. 
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo MULTAQ navadno ne vpliva na sposobnost upravljanja vozil in strojev.
• skin problems such as rash or itching, 
• težave s kožo, npr. izpuščaj ali srbenje,
The co-administration of beta-blockers or calcium antagonists with depressant effect on sinus and atrio-ventricular node should be undertaken with caution. 
Zaviralci adrenergičnih receptorjev beta in kalcijevi antagonisti Previdnost je potrebna v primeru sočasne uporabe zaviralcev adrenergičnih receptorjev beta ali kalcijevih antagonistov z zaviralnim delovanjem na sinusni in atrioventrikularni vozel.
Interaction with medicinal products metabolized by CYP 3A4 Dabigatran 
Medsebojna delovanja z zdravili, ki se presnovijo s CYP 3A4
Other moderate inhibitors of CYP3A4 are also likely to increase dronedarone exposure. 
Drugi zmerni/šibki zaviralci CYP 3A4 Verjetnost večje izpostavljenosti dronedaronu obstaja tudi pri drugih zmernih zaviralcih CYP 3A4.
Dronedarone 400 mg twice daily does not increase the steady state theophylline exposure. 
Medsebojno delovanje s teofilinom (substratom CYP 1A2) Dronedaron 400 mg dvakrat na dan ne poveča izpostavljenosti teofilinu v stanju dinamičnega ravnovesja.
Hepatocellular liver injury, including life-threatening acute liver failure, has been reported in patients treated with dronedarone in the post-marketing setting. 
V obdobju trženja je bila pri bolnikih, ki so prejemali dronedaron, opisana hepatocelularna poškodba jeter, vključno s smrtno nevarno akutno odpovedjo jeter.
The incidence of the main safety endpoint defined as the occurrence of thyroid, hepatic, pulmonary, neurological, skin, eye or gastrointestinal specific events or premature study drug discontinuation following any adverse event was reduced by 20% in the dronedarone group compared to the amiodarone group (p = 0.129). 
Glavna končna točka varnosti je bila opredeljena kot pojav specifičnih učinkov na ščitnici, jetrih, pljučih, živčevju, koži, očeh ali prebavilih ali predčasno prenehanje uporabe raziskovanega zdravila po neželenem učinku.
An increase in plasma creatinine (mean increase 10 μmol/L) has been observed with dronedarone 400 mg twice daily in healthy subjects and in patients. 
Pri zdravih preiskovancih in pri bolnikih so med uporabo 400 mg dronedarona dvakrat na dan opazili porast kreatinina v plazmi (povprečen porast 10 µmol/l).
CYP 3A4 inducers 
Induktorji CYP 3A4
The efficacy of dronedarone in the reduction of risk of AF-related hospitalisation was demonstrated in patients with AF or a history of AF and additional risk factors in the ATHENA multicenter, multinational, double blind, and randomised placebo-controlled study. 
Multicentrična, mednarodna, dvojno slepa, randomizirana, s placebom kontrolirana študija ATHENA je dokazala učinkovitost dronedarona za zmanjšanje tveganja hospitalizaciji, povezanih z AF, pri bolnikih z AF ali anamnezo AF in dodatnimi dejavniki tveganja.
International Normalised Ratio (INR) should be closely monitored after initiating dronedarone in patients taking vitamin K antagonists as per their label. 
Po uvedbi dronedarona je treba bolnikom, ki prejemajo antagoniste vitamina K, natančno kontrolirati INR (internacionalno normalizirano razmerje), v skladu z navodili za posamezen antagonist.
Talk to your doctor or pharmacist before taking MULTAQ if 
• Če dojite, se posvetujte z zdravnikom, preden vzamete zdravilo MULTAQ.
• you have a condition when the vessel that supplies blood to heart muscle becomes hardened and narrowed (coronary artery disease). 
- če ste starejši od 75 let, - če imate bolezen, pri kateri žile, ki dovajajo kri v srčno mišico, otrdijo in se zožijo (bolezen koronarnih arterij).
In patients already taking beta-blockers at time of dronedarone initiation, an ECG should be performed and the dose of beta-blocker should be adjusted if needed (see section 4.4). 
Bolnikom, ki v času uvedbe dronedarona že dobivajo zaviralce beta, je treba posneti EKG in jim odmerek zaviralca beta prilagoditi, če je potrebno (glejte poglavje 4.4).
Heart Failure (including use in patients with unstable hemodynamic conditions with history of, or current heart failure or left ventricular systolic dysfunction, and pre-renal azotemia) Use in Permanent atrial fibrillation defined as an AF duration ≥6 months (or duration unknown) and attempts to restore sinus rhythm no longer considered by the physician Pulmonary-interstitial lung disease (ILD) 
Uporaba pri stalni atrijski fibrilaciji (opredeljeni kot AF, ki traja ≥ 6 mesecev, ali njeno trajanje ni znano), pri kateri zdravnik ne predvideva več poskusov za obnovitev sinusnega ritma Pljučna - intersticijska bolezen pljuč (IBP)
Titanium dioxide (E171) Carnauba wax (E903) 
Obloga tablete hipromeloza (E464) makrogol 6000 titanov dioksid (E171) karnauba vosek (E903)
If you have had a pacemaker fitted for this problem, you can use MULTAQ, - if you have a very slow heart beat (less than 50 beats a minute), - if your ECG (electrocardiogram) shows a heart problem called “prolonged QT corrected interval” (this interval is more than 500 milliseconds), - if you have a type of atrial fibrillation called permanent atrial fibrillation (AF). 
- če vaš EKG (elektrokardiogram) pokaže srčno motnjo, ki jo imenujemo "podaljšan korigirani interval QT" (interval, daljši od 500 milisekund).
Cases of interstitial lung disease including pneumonitis and pulmonary fibrosis have been reported in post-marketing experience. 
Med obdobjem trženja so bili opisani primeri intersticijske bolezni pljuč, vključno s pnevmonitisom in pljučno fibrozo.
Patients with history of, or current heart failure or left ventricular systolic dysfunction 
Bolniki s srčnim popuščanjem ali sistolično disfunkcijo levega prekata trenutno ali v anamnezi
Beta-blockers that are metabolised by CYP 2D6 can have their exposure increased by dronedarone. 
Dronedaron lahko poveča izpostavljenost zaviralcem beta, ki se presnavljajo s CYP 2D6.
• History of, or current heart failure or left ventricular systolic dysfunction 
• Srčno popuščanje ali sistolična disfunkcija levega prekata trenutno ali v anamnezi.
This will give you more details on exactly what medicines you cannot take with MULTAQ), - if you have a severe liver problem, - if you have a severe kidney problem, - if you take dabigatran (see section below on “Other medicines and MULTAQ”). 
Tam boste našli več podrobnosti o tem, katerih zdravil ne smete jemati hkrati z zdravilom MULTAQ).
In EURIDIS and ADONIS, a total of 1,237 patients with a prior episode of AF or AFL were randomised in an outpatient setting and treated with either dronedarone 400 mg twice daily (n = 828) or placebo (n = 409) on top of conventional therapies (including oral anticoagulants, beta-blockers, ACE inhibitors or AIIRAs, chronic antiplatelet agents, diuretics, statins, digitalis, and calcium antagonists). 
Bolniki so dobivali bodisi dronedaron 400 mg dvakrat na dan (n = 828) ali placebo (n = 409) poleg konvencionalnih zdravil (vključno s peroralnimi antikoagulansi, zaviralci beta,
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 400 mg dronedarone (as hydrochloride). 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 400 mg dronedarona (v obliki klorida).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
Datum zadnjega podaljšanja:
MULTAQ contains lactose 
Zdravilo MULTAQ vsebuje laktozo
Diarrhoea Vomiting Nausea 
Bolezni živčevja dizgevzija agevzija
Prevention of drug-drug interaction 
Medsebojno delovanje zdravil
tricyclic antidepressants, terfenadine and certain oral macrolides (such as erythromycin), Class I 
• Zdravila, ki inducirajo torsades de pointes, npr. fenotiazini, cisaprid, bepridil, triciklični antidepresivi, terfenadin in nekateri peroralni makrolidi (kot eritromicin), antiaritmiki iz I. in III. skupine (glejte poglavje 4.5).
- if you are allergic to dronedarone or to any of the other ingredients of this medicine (listed in section 6), - if you have a problem with the nerves in your heart (heart block). 
Ne uporabljajte zdravila MULTAQ - če ste alergični na dronedaron ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Potent CYP 3A4 inhibitors 
Močni zaviralci CYP 3A4
PHARMACEUTICAL FORM AND CONTENTS 20 film-coated tablets 
20 filmsko obloženih tablet
Drug interaction 
Zaviralci beta
Other moderate/weak CYP 3A4 Inhibitors 
Zmerni/šibki zaviralci CYP 3A4:
Rare (1/10,000 to disorders test abnormalities liver injury, including life-threatening acute liver failure (see section 4.4) 
Redki ( 1/10.000 do odpovedjo jeter (glejte poglavje
How to store MULTAQ 
Shranjevanja zdravila MULTAQ
sinus node dysfunction, atrial conduction defects, or sick sinus syndrome (except when used in conjunction with a functioning pacemaker) 
• Atrioventrikularni blok druge ali tretje stopnje, popolni kračni blok, distalni blok, disfunkcija sinusnega vozla, atrijske prevodne motnje, ali bolezen sinusnega vozla (razen če ima bolnik delujoč srčni spodbujevalnik).
MULTAQ. 
Pogosti
• Stop taking your tablets and talk to your doctor straight away if you get pregnant while taking 
• Če med jemanjem zdravila MULTAQ zanosite, nehajte jemati tablete in se takoj posvetujte z zdravnikom.
• Problem where your heart does not adequately pump the blood round your body as well as it should (congestive heart failure) In clinical studies, this side effect was observed at a similar rate in patients receiving MULTAQ and in patients receiving placebo. 
V kliničnih študijah so ta neželeni učinek opažali podobno pogosto med bolniki, ki so dobivali zdravilo MULTAQ, in med bolniki, ki so dobivali placebo.
• Co-administration with potent cytochrome P 450 (CYP) 3A4 inhibitors, such as ketoconazole, 
• Sočasna uporaba z močnimi zaviralci citokroma P 450 (CYP) 3A4, npr. ketokonazolom, itrakonazolom, vorikonazolom, pozakonazolom, telitromicinom, klaritromicinom, nefazodonom ali ritonavirjem (glejte poglavje 4.5).
General disorders and administration site conditions 
Splošne težave in spremembe na mestu aplikacije utrujenost astenija
• one tablet with the evening meal. 
Vzeti ga je treba kot eno tableto z jutranjim obrokom in eno tableto z večernim obrokom.
You may have swollen feet or legs, trouble breathing when lying down or sleeping, or shortness of breath when moving around, - if the percentage of blood leaving your heart each time it contracts is too low (condition called left ventricular dysfunction), - if you took amiodarone (another antiarrhythmic medicine) previously and experienced lung or liver problems, - if you take medicines for infection (including fungal infection or AIDS), allergies, heart beat problems, depression, after a transplant (see section below on “Other medicines and MULTAQ”. 
- če jemljete zdravila za okužbe (vključno z glivičnimi okužbami ali aidsom), alergije, težave z bitjem srca, depresijo ali po presaditvi (glejte spodaj, poglavje "Druga zdravila in zdravilo MULTAQ ".
• Severe hepatic impairment 
• Huda okvara jeter.
• you have a problem that gives you a low level of potassium or magnesium in your blood. 
Pred začetkom jemanja zdravila MULTAQ se posvetujte z zdravnikom ali s farmacevtom - če imate kakšno težavo, zaradi katere imate v krvi majhno koncentracijo kalija ali magnezija.
The European Commission issued a decision on 16 December 2011. 
Evropska komisija je odločbo izdala dne 16. decembra 2011.
What is the background to the current investigation? 
Kakšno je ozadje sedanje preiskave?
What are the recommendations for patients and prescribers? 
Kakšna so priporočila za bolnike in zdravnike, ki predpisujejo zdravilo?
What are the risks of exposure to endotoxins? 
Kakšna so tveganja zaradi izpostavljenosti endotoksinom?
Which products are affected by the review? 
Katere izdelke zadeva ta pregled?
These include changes to the design of the plant, new cleaning regimens and the introduction of improved testing methods. 
Med njimi so spremembe v zasnovi obrata, novi režimi čiščenja in uvajanje izboljšanih načinov testiranja.
It also cleaned the other tanks and pipework involved in the production. 
Poleg tega je poskrbela za čiščenje drugih posod in cevi, vključenih v proizvodnjo.
However the Committee aimed to reduce reliance on the plant and made recommendations in January 2011 for the use of products imported from four production sites outside the EU (in Canada, USA, Singapore and Turkey). 
Kljub temu si je prizadeval zmanjšati odvisnost od tega obrata in v januarju 2011 pripravil priporočila za uporabo izdelkov, uvoženih iz štirih proizvodnih obratov zunaj EU (iz Kanade, ZDA, Singapurja in Turčije).
The Committee also adopted a strategy to ensure adequate supply of products in the EU should problems reoccur in the future. 
Odbor je izdelal tudi strategijo za zagotavljanje zadostne preskrbe z izdelki v EU, če bi se tovrstne težave ponovile.
The Irish medicines agency will inspect the plant again in October 2011 after which it will go through a 12-month ‘requalification period' where the plant will be carefully monitored and the products will undergo rigorous testing. 
Irska agencija za zdravila bo v oktobru 2011 ponovno pregledala obrat, ki bo nato 12 mesecev v „obdobju ponovnega kvalificiranja“; v tem času bo obrat pod natančnim nadzorom, izdelke pa bodo podrobno testirali.
• Patients who have any questions should contact their doctors to discuss their treatment. 
• Bolniki, ki imajo kakršna koli vprašanja, naj se o zdravljenju posvetujejo z zdravnikom.
As part of the future risk management plan the Committee adopted proposals for a period of intense monitoring of any reports of aseptic peritonitis during the initial months of marketing new products from CastleBar. 
V okviru načrta za obvladovanje tveganj v prihodnosti je odbor CHMP sprejel predloge za obdobje intenzivnega spremljanja vseh poročil o aseptičnem peritonitisu v prvih mesecih trženja novih izdelkov iz Castlebara.
The CHMP started the current review to investigate fully the issues related to the endotoxin contamination and to make recommendations to help protect public health and to prevent future supply shortages. 
Odbor CHMP je začel sedanji pregled, da bi v celoti raziskal vprašanja glede kontaminacije z endotoksini in pripravil priporočila, ki bi pomagala zaščititi javno zdravje in preprečiti prihodnje pomanjkanje v preskrbi.
All affected products from Castlebar were eventually recalled in stages across the EU. 
Vsi oporečni izdelki iz Castlebara so bili postopoma odpoklicani po vsej Evropski uniji.
The European Medicines Agency has completed an investigation into the production processes at Baxter's manufacturing plant in Castlebar, Ireland. 
Evropska agencija za zdravila je zaključila preiskavo proizvodnih postopkov v proizvodnem obratu družbe Baxter v Castlebaru na Irskem.
If a patient receives a medicine that contains endotoxins, there is a risk that the immune system, the body's defence mechanism, will react against the endotoxins and cause inflammation. 
Če bolnik dobi zdravilo, ki vsebuje endotoksine, je v nevarnosti, da se bo njegov imunski sistem (tj. obrambni mehanizem telesa) odzval proti endotoksinom z vnetjem.
The CHMP concluded that the root cause of the presence of endotoxins in the affected production lines was a combination of factors: undetected cracks in equipment may have allowed the growth of bacteria, while the design of the plant and the cleaning methods used may have allowed the contamination to spread. 
Odbor CHMP je zaključil, da je glavni vzrok prisotnosti endotoksinov v oporečnih proizvodnih linijah kombinacija dejavnikov: neodkrite razpoke v opremi so morda omogočile razraščanje bakterij, medtem ko so zasnova obrata in uporabljeni načini čiščenja lahko pripomogli k razširjenju kontaminacije.