natgillin/translations-raw huggingface dataset:
Read the package leaflet before use 
POSTOPEK UPORABE Pred uporabo preberite priloženo navodilo!
Frequency 
Pogostost
The solution is prepared by injecting the solvent slowly into the vial with a needle through the rubber stopper and by gently rotating the vial avoiding bubble formation. 
Raztopina se pripravi s počasnim injiciranjem vehikla v vialo z iglo skozi gumijasti pokrovček, pri čemer se vialo nekajkrat nežno krožno zavrti, da se prepreči nastajanje mehurčkov.
Powder for solution for injection 1 vial 
FARMACEVTSKA OBLIKA IN VSEBINA prašek za raztopino za injiciranje 1 viala
NUCEIVA is not recommended in breast-feeding women. 
Uporaba zdravila NUCEIVA ni priporočljiva pri ženskah, ki dojijo.
NUCEIVA 100 Units powder for solution for injection botulinum toxin type A 
NUCEIVA 100 enot prašek za raztopino za injiciranje botulinski toksin tipa A
NUCEIVA is reconstituted with sodium chloride 9 mg/ml (0.9%) solution for injection . 
Zdravilo NUCEIVA se rekonstituira z 0,9 % (9 mg/ml) raztopino natrijevega klorida za injiciranje.
2 (Moderate) Number Percentage 3 (Severe) Number Percentage Glabellar Line Scale (GLS); 0=no lines, 1=mild, 2=moderate, 3=severe. 
Lestvica za glabelarne gube (GLS); 0 = brez gub, 1 = blaga izraženost, 2 = zmerna izraženost, 3 =
Care should be taken to ensure that NUCEIVA is not injected into a blood vessel when it is injected in the glabellar lines seen at maximum frown (see section 4.2). 
Paziti je treba, da se zdravilo NUCIEVA med injiciranjem v glabelarne gube, vidne pri najmočnejšem mrščenju, ne injicira v krvno žilo (glejte poglavje 4.2).
Denominators are based on the number of subjects with the specified baseline severity at maximum contraction who had both baseline and Day 30 GLS scores at maximum contraction by investigator assessment 
Imenovalci temeljijo na številu oseb z določeno izhodiščno izraženostjo pri najmočnejšem mrščenju, pri katerih je bil na voljo tako izhodiščni rezultat kot rezultat na 30. dan pri najmočnejšem mrščenju na podlagi raziskovalčeve ocene
• Any spillage must be wiped up: either with an absorbent material soaked in a solution of sodium hypochlorite (Javel solution) in the case of the vacuum-dried product, or with a dry absorbent material in the case of the reconstituted product. 
• vsako razlitje je treba pobrisati: vakuumsko posušeni prašek z absorpcijskim materialom, namočenim v raztopini natrijevega hipoklorita (javelski raztopini), rekonstituirano zdravilo pa s suhim absorpcijskim materialom;
- If splashed, wash with a solution of sodium hypochlorite and then rinse thoroughly with plenty of water. 
- če zdravilo poškropite po koži, površino umijte z raztopino natrijevega hipoklorita in nato temeljito sperite z veliko vode;
Finally, the toxin is released into the cytosol with progressive inhibition of acetylcholine release. 
Proces spremlja progresivno zaviranje sproščanja acetilholina.
Antibody formation 
Nastajanje protiteles
Caution should be taken when the targeted muscle shows pronouced weakness or atrophy. 
Če ciljna mišica izkazuje izrazito šibkost ali atrofijo, je potrebna previdnost.
Four Units (4 U/ 0.1 mL) are administered in each of the 5 injection sites (see Figure 1): 2 injections in each corrugator muscle (inferior medial and superior medial aspect) and 1 injection in the procerus muscle for a total dose of 20 Units. 
Priporočeni odmerek injiciranja na mišično mesto je 4 enote/0,1 ml. Pet mest injiciranja (glejte sliko 1): po dve injiciranji v vsako mišico nagubalko obrvi (m. corrugator) (medialno navzdol in medialno navzgor) ter eno injiciranje v mišico m. procerus v skupnem odmerku 20 enot.
If you get hives, swelling, including swelling of the face or throat, wheezing, feeling faint or shortness of breath, contact your doctor immediately. 
Če dobite koprivnico, začnete otekati, vključno z otekanjem obraza ali grla, hropsti,
In pregnant rats, daily intramuscular injections of 0.5, 1, or 4 Units/kg during the period of organogenesis (from gestation days 6 to 16), did not induce significant test article-related toxicological effects on the dams and on embryo-fetal development. 
Pri brejih podganah dnevno intramuskularno injiciranje 0,5, 1 ali 4 enot/kg v obdobju organogeneze (od 6. do
How NUCEIVA is injected 
Kako se zdravilo NUCEIVA injicira
Sensory disturbance, head discomfort, dry eye, eyelid swelling, eye swelling, muscle twitching, injection site: redness, pain, tingling 
Motnje čutil, neprijeten občutek v glavi, suhe oči, otekanje očesnih vek, mišično trzanje, mesto injiciranja: rdečica, bolečina, ščemenje
Pharmacotherapeutic group: Muscle relaxants, other muscle relaxants, peripherally acting agents, ATC code: M03AX01. 
5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: mišični relaksanti, drugi periferno delujoči mišični relaksanti, oznaka
The vial has to be discarded if the vacuum does not pull the solvent into the vial. 
Če vakuum ne vsrka vehikla v vialo, vialo zavrzite.
Dermal cyst, erythema, photosensitivity reaction, skin mass, skin tightness 
preobčutljivostna reakcija na svetlobo, kožni vozliči, zategovanje kože
Table 4 - Exploratory Efficacy Endpoint - Glabellar Line Scale Score of 0 (none) or 1 (mild) at Day 30 by Investigator Assessment at Maximum Contraction for NUCEIVA Treated Subjects, by Baseline GLS Categories at Rest, ITT Population 
Preglednica 4 - Eksplorativni opazovani dogodek učinkovitosti - rezultat po lestvici za glabelarne gube 0 (brez gub) ali 1 (blaga izraženost) pri najmočnejšem mrščenju, na podlagi ocene, ki jo je opravil raziskovalec na 30. dan, za osebe, zdravljene z zdravilom NUCEIVA, glede na izhodiščne kategorije GLS v mirovanju, populacija ITT
Table 2 - Primary Efficacy Endpoint - Glabellar Line Scale Score of 0 (none) or 1 (mild) at Day 30 by Investigator Assessment at Maximum Contraction, PP Population 
Preglednica 2 - Primarni opazovani dogodek učinkovitosti - rezultat po lestvici za glabelarne gube 0 (brez gub) ali 1 (blaga izraženost) pri najmočnejšem mrščenju, na podlagi ocene, ki jo je opravil raziskovalec na 30. dan, za populacijo PP
- If you have any side effects, talk to your doctor or pharmacist. 
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
- Very rarely, an allergic reaction can occur after the injection of botulinum toxin. 
- Po injiciranju botulinskega toksina se zelo redko lahko pojavi alergijska reakcija.
Patients with unrecognised neuromuscular disorders may be at increased risk of clinically significant systemic effects, including severe dysphagia and respiratory compromise from typical doses of botulinum toxin type A. In some of these cases, dysphagia has lasted several months and required placement of a gastric feeding tube (see section 4.3). 
Pri bolnikih z neprepoznanimi živčno-mišičnimi motnjami je lahko pri običajnih odmerkih botulinskega toksina tipa A tveganje za pojav klinično pomembnih sistemskih učinkov večje, vključno z resno disfagijo in dihalno stisko.
Table 5 - Exploratory Efficacy Endpoint - Glabellar Line Scale Score >/=2 points better at day 30 by Investigator Assessment At Rest, PP Population 
Preglednica 5 - Eksplorativni opazovani dogodek učinkovitosti - za >/=2 točki boljši rezultat na lestvici za glabelarne gube v mirovanju na 30. dan na podlagi ocene raziskovalca, populacija PP Bolniki, ki so se odzvali, kar zadeva eksplorativni opazovani dogodek učinkovitosti
Antibodies to botulinum toxin type A may develop during treatment with botulinum toxin. 
Med zdravljenjem z botulinskim toksinom se lahko razvijejo protitelesa proti botulinskemu toksinu tipa A. Nekatera nastala protitelesa so nevtralizacijska, zaradi česar je lahko zdravljenje z botulinskim toksinom tipa A neuspešno.
Muscle weakness, dizziness, and visual disturbance with this medicine could make driving or the use of machines dangerous. 
Vpliv na sposobnost upravljanja vozil in strojev Pri tem zdravilu je lahko zaradi oslabelosti mišic, omotice in motnje vida upravljanje vozil ali strojev nevarno.
IM 
ALI
How to store NUCEIVA 
Shranjevanje zdravila NUCEIVA
Eyelid ptosis 
OVOJNINAH VIALA
Application site bruising, influenza like illness, injection site bruising, injection site pain, injection site swelling 
Pojav modric na mestu injiciranja, bolezen, podobna gripi, pojav modric na mestu injiciranja,
Package leaflet: Information for the user NUCEIVA 100 Units powder for solution for injection botulinum toxin type A 
Navodilo za uporabo NUCEIVA 100 enot prašek za raztopino za injiciranje botulinski toksin tipa A
NUCEIVA is presented as a white powder for solution for injection in a transparent glass vial. 
Izgled zdravila NUCEIVA in vsebina pakiranja Zdravilo NUCEIVA je na voljo v prozorni stekleni viali kot bel prašek za raztopino za injiciranje.
INFORMATION IN BRAILLE UNIQUE IDENTIFIER - 2D BARCODE UNIQUE IDENTIFIER - HUMAN READABLE DATA 
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
Epinephrine (adrenaline) or any other anti-anaphylactic measures should therefore be available. 
Po injiciranju botulinskega toksina lahko zelo redko nastopi anafilaktična reakcija, zato morajo biti na voljo epinefrin (adrenalin) ali drugi ukrepi proti anafilaktičnim reakcijam.
As per the dilution table below, the amount of sodium chloride 9 mg/ml (0.9%) solution for injection is drawn up into a syringe in order to obtain a reconstituted solution at a concentration of 4 Units/0.1 mL. 
V skladu s spodnjo preglednico za redčenje v brizgo potegnite količino 0,9 % (9 mg/ml) raztopine natrijevega klorida za injiciranje, da dobite rekonstituirano raztopino v koncentraciji 4 enote/0,1 ml. Količina vehikla (0,9 % (9 mg/ml) raztopina natrijevega klorida za injiciranje), dodanega 100 enotam viale
Read the package leaflet before use Intramuscular use Single use 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo!
Visit your doctor immediately if you find it difficult to swallow, to speak or to breathe after treatment. 
Če imate po zdravljenju težave pri požiranju, govoru ali dihanju, takoj obiščite zdravnika.
No cases of ingestion of botulinum toxin type A have been reported. 
O primerih zaužitja botulinskega toksina tipa A se ni poročalo.
Glabellar lines 
Glabelarne gube
Asthopenia, blepharospasm, brow ptosis, eyelid oedema, eye swelling, vision blurred 
Astenopija, blefarospazem,
- Too frequent or excessive dosing may lead to antibody formation. 
- Prepogosto ali preveliko odmerjanje lahko povzroči nastajanje protiteles, zaradi česar lahko botulinski toksin tipa A preneha delovati tudi pri uporabi za druge namene.
NUCEIVA contains sodium 
Zdravilo NUCEIVA vsebuje natrij.
Introduction of an in vitro method as a replacement for the potency assay of the Nuceiva finished product. 
Uvedba metode in vitro namesto preizkusa učinkovitosti končnega zdravila
- Avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes. 
- ne injicirajte v mišico dvigalko zgornje veke (m. levator palpebrae superioris), zlasti pri bolnikih z izrazitejšimi depresorji obrvi (m. depressor supercilii); - lateralni injiciranji v m. corrugator je treba opraviti vsaj 1 cm nad obrvnim lokom;
Undesirable effects of the substance class botulinum toxin type A 
Neželeni učinki skupine zdravil, ki vsebujejo botulinski toksin tipa A Atrofija mišic
- you had problems with previous botulinum toxin injections; 
- ste imeli težave pri predhodnih injiciranjih botulinskega toksina; - en mesec po prvem zdravljenju ne opazite bistvenega zmanjšanja gub;
Table 3 - Exploratory Efficacy Endpoint - Glabellar Line Scale Score of 0 (none) or 1 (mild) at Day 30 by Investigator Assessment at Maximum Contraction for NUCEIVA Treated Subjects, by Baseline GLS Score at Maximum Contraction, ITT Population 
Preglednica 3 - Eksplorativni opazovani dogodek učinkovitosti - rezultat po lestvici za glabelarne gube 0 (brez gub) ali 1 (blaga izraženost) pri najmočnejšem mrščenju, na podlagi ocene, ki jo je opravil raziskovalec na 30. dan, za osebe, zdravljene z zdravilom NUCEIVA,
- NUCEIVA is not recommended in patients who have had problems swallowing (dysphagia) and breathing. 
- Uporaba zdravila NUCEIVA ni priporočljiva pri bolnikih, ki so že imeli težave pri požiranju
BOTOX Vs. 
BOTOX v primerjavi s placebom
- Drooping of the eyelid may occur after treatment. 
- Po zdravljenju se lahko očesna veka povesi.
METHOD AND ROUTE(S) OF ADMINISTRATION 
Število Odstotek (% CI) P-vrednost
The chance of having a side effect is described by the following categories: Common (May affect up to 1 in 10 people) 
Možnost pojava neželenega učinka je opisana po naslednjih kategorijah:
Some of the antibodies formed are neutralising which may lead to treatment failure of botulinum toxin type A. It is mandatory that NUCEIVA is used for one single patient treatment only during a single session. 
Zdravilo NUCEIVA vsebuje učinkovino botulinski toksin tipa A. Preprečuje krčenje mišic, kar povzroči začasno paralizo.
Adverse reactions possibly related to the spread of toxin distant from the site of administration have been reported very rarely with botulinum toxin (see section 4.8). 
Širjenje učinka toksina lokalno in daleč od mesta injiciranja O neželenih učinkih, morebitno povezanih s širjenjem botulinskega toksina daleč od mesta injiciranja,
Paediatric population 
Žilne bolezni
Symptoms of overdose 
Očesne bolezni
Management of overdose 
NAČIN IZDAJANJA ZDRAVILA
- if you are allergic to botulinum toxin type A or any of the other ingredients of this medicine 
Kaj morate vedeti, preden boste uporabili zdravilo NUCEIVA Ne uporabljajte zdravila NUCEIVA: - če ste alergični na botulinski toksin tipa A ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
- Any spillage must be wiped up: either with an absorbent material soaked in a solution of sodium hypochlorite (Javel solution) in the case of the vacuum-dried product, or with a dry absorbent material in the case of the reconstituted product. 
namočenim v raztopini natrijevega hipoklorita (javelska raztopina), rekonstituirano zdravilo pa s suhim absorpcijskim materialom;
It prevents muscles from contracting, leading to a temporary paralysis. 
To povzroči mišično denervacijo in flakcidno paralizo.
An anaphylactic reaction may occur very rarely after injection of botulinum toxin. 
Po injiciranju botulinskega toksina lahko zelo redko nastopi anafilaktična reakcija, zato morajo biti na voljo adrenalin ali drugi ukrepi proti anafilaktičnim reakcijam.
Date of first authorisation: 28 February 2011 Date of latest renewal: 24 April 2015 
Datum prve odobritve: 28. februar 2011 Datum zadnjega podaljšanja: 24. april 2015
Children and adolescents Libertek should not be used by children and adolescents under 18 years of age. 
Otroci in mladostniki Zdravilo Libertek se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
You may need to take Libertek for several weeks to achieve its beneficial effect. 
Morda boste morali jemati zdravilo Libertek več tednov, da doseže svoj ugoden učinek.
Interim Study Reports - with each PSUR 
Vmesna poročila o študiji - z vsakim PSUR-om.
If on one day you have forgotten to take a tablet of Libertek, just carry on the next day with the next tablet as usual. 
Če ste na določen dan pozabili vzeti tableto zdravila Libertek, potem naslednji dan samo nadaljujte z naslednjo tableto kot običajno.
The need to inform patients about the risks of Libertek and the precautions for safe use including: 
Obveznost informiranja bolnikov o tveganjih zdravila Libertek in previdnostnih ukrepih za varno uporabo vključujoč:
In case of an allergic reaction, stop taking Libertek and contact your doctor immediately, or go immediately to the emergency department in the nearest hospital. 
V primeru pojava alergijske reakcije nemudoma prenehajte jemati zdravilo Libertek in se nemudoma posvetujte z zdravnikom ali poiščite nujno zdravniško pomoč na urgentnem oddelku najbližje bolnišnice.
Libertek may need to be taken for several weeks to achieve its effect (see section 5.1). 
Zdravilo Libertek je treba jemati nekaj tednov, preden doseže svoj učinek (glejte poglavje 5.1).
Thus Libertek eases breathing problems. 
Tako zdravilo Libertek olajša težave z dihanjem.
Before starting treatment with Libertek, inform your doctor if you are suffering from any symptoms of this kind and of any additional medicines you may take since some of those could increase the probability of these side effects. 
Pred začetkom zdravljenja z zdravilom Libertek obvestite zdravnika, če imate kakršne koli simptome te vrste ali, če morebiti jemljete še dodatna zdravila, ker lahko katero od teh poveča verjetnost teh neželenih učinkov.
Do not take Libertek if you are or plan to become pregnant, think you may be pregnant, or are breast-feeding. 
Ne jemljite zdravila Libertek, če ste noseči ali nameravate zanositi, mislite, da bi lahko bili noseči ali če dojite.
Do not take Libertek - if you are allergic to roflumilast or any of the other ingredients of this medicine (listed in section 
Ne jemljite zdravila Libertek - če ste alergični na roflumilast ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Other medicines and Libertek 
Druga zdravila in zdravilo Libertek
1 What Libertek is and what it is used for 
Kaj je zdravilo Libertek in za kaj ga uporabljamo
Libertek has been studied in clinical trials for up to one year. 
Klinične študije z zdravilom Libertek so trajale do enega leta.
All patients should be informed about the risks of Libertek and the precautions for safe use and should be given a patient card before starting Libertek. 
Vse bolnike je treba obvestiti o tveganjih zdravila Libertek in previdnostnih ukrepih za varno uporabo in jim je treba dati kartico za bolnike pred začetkom jemanja zdravila.
Libertek is to be used in addition to bronchodilators. 
Zdravilo Libertek se uporablja poleg bronhodilatatorjev.
The fact that Libertek is not indicated for the treatment of COPD patients outside of the approved indication, nor for use in patients with asthma or alpha-1 antitrypsin deficiency. 
Dejstvo, da zdravilo Libertek ni indicirano za zdravljenje bolnikov s KOPB izven odobrene indikacije, niti ni primerno za uporabo pri bolnikih z astmo ali pomanjkanjem alfa-1-antitripsina.
If you stop taking Libertek 
Če ste prenehali jemati zdravilo Libertek
PVC/PVDC aluminum blisters in packs of 10, 30, or 90 film-coated tablets. 
PVC/PVDC aluminijevi pretisni omoti v pakiranjih po 10, 30 ali 90 filmsko obloženih tablet.
Roflumilast or placebo treatment was added to continuous treatment with a long-acting bronchodilator, in particular salmeterol in study M2-127 or tiotropium in study M2-128. 
Zdravljenje z roflumilastom ali placebom so dodali trajnemu zdravljenju z dolgo-delujočim bronhodilatatorjem, natančneje salmeterolom v študiji M2-127 ali tiotropijem v študiji M2-128.
Libertek will not help you in this situation. 
Zdravilo Libertek v takšnih primerih ne pomaga.
Libertek should not be initiated or should be stopped in patients with cancers (except basal cell carcinoma). 
Zdravila Libertek se ne sme uvesti oz. ga je treba ukiniti pri bolnikih z rakom (z izjemo bazalnoceličnega karcinoma).
If you forget to take Libertek 
Če ste pozabili vzeti zdravilo Libertek
• Copies of the patient card to be given to patients or caregivers before they receive Libertek 
• Kopije opozorilne kartice za bolnika, ki naj bi jih bolniki ali skrbniki prejeli pred začetkom jemanja zdravila Libertek
The Marketing Authorisation Holder (MAH) should ensure that all Healthcare Professionals who are expected to prescribe Libertek are provided with an updated Educational pack. 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo imeli vsi zdravniki, ki bodo predpisovali zdravilo Libertek, na razpolago posodobljeno izobraževalno gradivo.
The rate of exacerbations (as defined in the protocols) were not significantly reduced by roflumilast in the individual studies (relative risk reduction: 13.5% in study M2-111 and 6.6% in study M2-112; p= not significant). 
Roflumilast ni pomembno zmanjšal pogostnosti poslabšanj (kot so opredeljena v protokolih) v posameznih študijah (zmanjšanje relativnega tveganja: 13,5 % v študiji M2-111 in 6,6 % v študiji M2-112; p = ni pomemben).
The risk of psychiatric disorders such as insomnia, anxiety, depression in patients receiving Libertek and the potential risk of suicide. 
Tveganje za psihiatrične motnje, npr. nespečnost, tesnobo, depresijo, pri bolnikih, ki jemljejo zdravilo Libertek in potencialno tveganje za samomor.
Co-administration with an antacid (combination of aluminium hydroxide and magnesium hydroxide) did not alter the absorption or pharmacokinetics of roflumilast or its N-oxide. 
Sočasna uporaba antacida (kombinacija aluminijevega hidroksida in magnezijevega hidroksida) ni spremenil absorpcije ali farmakokinetike roflumilasta ali njegovega N-oksida.
Following intravenous or oral administration of radiolabeled roflumilast, about 20% of the radioactivity was recovered in the faeces and 70% in urine as inactive metabolites. 
Po intravenski ali peroralni uporabi radioaktivno označenega roflumilasta so približno 20 % radioaktivnosti odkrili v blatu in 70 % v urinu v obliki neaktivnih presnovkov.
The potential risk of infections: Libertekshould not be initiated, or treatment should be stopped, in patients with severe acute infectious diseases. 
Potencialno tveganje za okužbe: zdravila Libertekse ne sme uvajati oz. zdravljenje je treba prekiniti pri bolnikih z resnimi oblikami akutnih infekcijskih bolezni.
You may also experience sleeplessness (common), anxiety (uncommon), nervousness (rare), panic attack (rare) or depressive mood (rare). 
Pojavi se lahko tudi zaspanost (pogosti), tesnoba (občasni), živčnost (redki), napad panike (redki) ali depresija (redki).
2 What you need to know before you take Libertek 
Kaj morate vedeti, preden boste vzeli zdravilo Libertek
Lactose monohydrate Maize starch Povidone (K90) Magnesium stearate 
Jedro laktoza monohidrat koruzni škrob povidon (K90) magnezijev stearat
The effect of Libertek may be reduced if taken together with rifampicin (an antibiotic medicine) or with phenobarbital, carbamazepine or phenytoin (medicines usually prescribed for the treatment of epilepsy). 
Učinek zdravila Libertek se lahko zmanjša, če istočasno jemljete rifampicin (antibiotik) ali fenobarbital, karbamazepin ali fenitoin (zdravila, ki so običajno predpisana za zdravljenje epilepsije).
Moderate or severe Moderate 
Zmerno ali hudo
These studies in rats with radiolabeled roflumilast also indicate low penetration across the blood-brain barrier. 
Študije na podganah z radioaktivno označenim roflumilastom kažejo tudi blago prehajanje preko krvno-možganske pregrade.
What Libertek is and what it is used for What you need to know before you take Libertek How to take Libertek 
Kaj je zdravilo Libertek in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Libertek Kako jemati zdravilo Libertek Možni neželeni učinki
Libertek is not intended for the treatment of a sudden attack of breathlessness (acute bronchospasms). 
Zdravilo Libertek ni namenjeno zdravljenju nenadnih napadov težkega dihanja (akutni bronhospazmi).
In two confirmative replicate one-year studies (M2-124 and M2-125) and two supplementary six-month studies (M2-127 and M2-128), a total number of 4,768 patients were randomized and treated of whom 2,374 were treated with roflumilast. 
V dve potrditveni ponovljeni enoletni študiji (M2-124 in M2-125) in dve dodatni šestmesečni študiji (M2-127 in M2-128) je bilo randomiziranih skupno 4.768 bolnikov, od tega jih je bilo 2.374 zdravljenih z roflumilastom.
Each pack contains 10, 30, or 90 film-coated tablets. 
Eno pakiranje vsebuje 10, 30 ali 90 filmsko obloženih tablet.
The potential cardiac risk: Libertek has not been studied in patients in congestive heart failure (NYHA grade 3 and 4); hence, it is not recommended in this population. 
Potencialno tveganje za srce: zdravilo Libertek ni bilo raziskano pri bolnikih s kongestivnim srčnim popuščanjem (NYHA stopnje 3 in 4); za to populacijo ni priporočljiv.
Libertek has no influence on the ability to drive and use machines. 
Zdravilo Libertek nima vpliva na sposobnost vožnje in upravljanja s stroji.