natgillin/translations-raw huggingface dataset:
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.
Roflumilast should not be used during breast-feeding.
Roflumilast se med dojenjem ne sme uporabljati.
You should not become pregnant during treatment with this medicine and should use an effective method of contraception during therapy, because Libertek may be harmful for the unborn baby.
Ves čas zdravljenja morate uporabljati učinkovito kontracepcijo, saj lahko zdravilo Libertek škodljivo vpliva na nerojenega otroka.
10 film-coated tablets 30 film-coated tablets 90 film-coated tablets
10 filmsko obloženih tablet 30 filmsko obloženih tablet 90 filmsko obloženih tablet
There is a lack of relevant experience with Libertek under these conditions.
V takšnih primerih ni ustreznih izkušenj z uporabo zdravila Libertek.
There is no relevant use of Libertek in the paediatric population (under 18 years) in the indication COPD.
Uporaba zdravila Libertek za indikacijo KOPB pri pediatrični populaciji (mlajših od 18 let) ni primerna.
• insomnia, anxiety, depression, changes in behaviour or mood, suicidal ideation or behaviour
• nespečnost, tesnobo, depresijo, spremembe v vedenju ali razpoloženju, samomorilne misli ali vedenje
The clinical data with Libertek in patients with mild hepatic impairment classified as Child-Pugh A are insufficient to recommend a dose adjustment (see section 5.2) and therefore Libertek should be used with caution in these patients.
Klinični podatki o uporabi zdravila Libertek pri bolnikih z blago okvaro jeter stopnje Child-Pugh A ne zadostujejo, da bi lahko priporočili prilagoditev odmerka (glejte poglavje 5.2), zato je pri teh bolnikih treba zdravilo Libertek uporabljati previdno.
Driving and using machines Libertek has no influence on the ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Libertek nima vpliva na sposobnost vožnje in upravljanja s stroji.
The pharmacokinetics of roflumilast 250 micrograms once-daily was tested in 16 patients with mild to moderate hepatic impairment classified as Child-Pugh A and B. In these patients, the total PDE4 inhibitory activity was increased by about 20% in patients with Child-Pugh A and about 90% in patients with Child-Pugh B. Simulations suggest dose proportionality between roflumilast 250 and 500 micrograms in patients with mild and moderate hepatic impairment.
Farmakokinetiko roflumilasta v odmerku 250 mikrogramov enkrat na dan so preizkusili pri 16 bolnikih z blago do zmerno jetrno okvaro stopnje Child-Pugh A in B. V tej skupini bolnikov je bilo skupno inhibitorno delovanje na PDE4 povečano za približno 20 % pri bolnikih s stopnjo Child-Pugh A in za približno 90 % pri bolnikih s stopnjo Child-Pugh B. Za bolnike z blago in zmerno jetrno okvaro simulacije kažejo sorazmernost z velikostjo odmerkov roflumilast 250 in 500 mikrogramov.
The recommended dose is one 500 micrograms tablet once daily.
Priporočeni odmerek je ena tableta 500 mikrogramov enkrat na dan.
Libertek tablets contain lactose.
Zdravilo Libertek vsebuje laktozo.
• Summary of Product Characteristics and Patient Information Leaflet for Libertek
• Povzetek glavnih značilnosti zdravila in navodilo za uporabo zdravila Libertek
If you have taken more tablets than you should, you may experience the following symptoms: headache, nausea, diarrhoea, dizziness, throbbing of your heart, light-headedness, clamminess and low blood pressure.
Če ste vzeli večji odmerek zdravila Libertek, kot bi smeli Če ste vzeli več tablet kot bi smeli, se lahko pojavijo naslednji simptomi: glavobol, slabost, driska, omotica, udarjanje srca, vrtoglavica, vlažna in hladna koža ter nizek krvni tlak.
Upon in vitro stimulation of human neutrophils, monocytes, macrophages or lymphocytes, roflumilast and roflumilast N-oxide suppress the release of inflammatory mediators e.g. leukotriene B4, reactive oxygen species, tumor necrosis factor α, interferon γ and granzyme B.
N-oksid po in vitro stimulaciji človeških nevtrofilcev, monocitov, makrofagov ali limfocitov inhibirata sproščanje vnetnih mediatorjev, npr. levkotriena B4, reaktivnih vrst kisika, tumorje nekrotizirajočega faktorja α, interferona γ in grancima B.
(i.e. focal haemorrhages, haemosiderin deposits and lympho-histiocytic cell infiltration in the right atria in dogs, and decreased blood pressure and increased heart rate in rats, guinea pigs and dogs).
fokalne krvavitve, depoziti hemosiderina in infiltracija limfo-histiocitnih celic v desnem atriju psov, znižan krvni tlak in povišana frekvenca srca pri podganah, morskih prašičkih in psih).
Libertek is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.
Zdravilo Libertek je indicirano za vzdrževalno zdravljenje hude oblike kronične obstruktivne pljučne bolezni (KOPB) (FEV1 po bronhodilatatorju manjši od 50 % pričakovane vrednosti), povezane s kroničnim bronhitisom, pri odraslih bolnikih z anamnezo pogostih poslabšanj bolezni kot dopolnilo zdravljenju z bronhodilatatorji.
In clinical studies and post-marketing experience, rare instances of suicidal thinking and behaviour (including suicide) were reported.
V kliničnih študijah in med spremljanjem zdravila po pridobitvi dovoljenja za promet so poročal or redkih primerih samomorilnih misli in vedenja (vključno s samomorom).
Libertek is used for maintenance treatment of severe COPD in adults who in the past had frequent worsening of their COPD symptoms (so-called exacerbations) and who have chronic bronchitis.
Zdravilo Libertek uporabljamo za vzdrževalno zdravljenje KOPB pri odraslih, ki so v preteklosti imeli pogosta poslabšanja simptomov KOPB in imajo kronični bronhitis.
What Libertek contains - The active substance is roflumilast.
Kaj vsebuje zdravilo Libertek - Zdravilna učinkovina je roflumilast.
Post-bronchodilator FEV1 showed a clinically significant improvement in favour of Roflumilast by 56 mL over placebo (95% CI: 38, 73 mL).
Vrednost FEV1 po bronhodilatatorju kaže na klinično pomembno izboljšanje v korist roflumilasta nad placebom za 56 ml (95 % interval zaupanja: 38, 73 ml).
In the two six-month studies, pre-bronchodilator FEV1 was significantly improved by 49 ml (primary endpoint, p<0.0001) beyond the bronchodilator effect of concomitant treatment with salmeterol in study M2-127 and by 80 ml (primary endpoint, p<0.0001) incremental to concomitant treatment with tiotropium in study M2-128.
V teh dveh šestmesečnih študijah se je FEV1 pred bronhodilatatorjem statistično pomembno izboljšal za 49 ml (primarni klinični izid, p < 0,0001) preko bronhodilatatorskega učinka sočasnega zdravljenja s salmeterolom v študiji M2-127 in za 80 ml (primarni klinični izid, p < 0,0001) preko učinka sočasnega zdravljenja s tiotropijem v študiji M2-128.
Libertek is contraindicated in patients with moderate or severe liver impairment (Child-Pugh B or C).
Zdravilo Libertek je kontraindicirano pri bolnikih z zmerno ali hudo okvaro jeter (Child-Pugh B ali C).
A total of 1935 patients were randomised to double-blind medication and approximately 70% were also using a long-acting muscarinic antagonist (LAMA) through the course of the trial.
Na dvojno slepo zdravljenje je bilo vsega skupaj randomiziranih 1.935 bolnikov, približno 70 % bolnikov pa je med preskušanjem uporabljalo tudi dolgodelujoče antagoniste muskarinskih receptorjev (LAMA).
Roflumilast is a PDE4 inhibitor, a non-steroid, anti-inflammatory active substance designed to target both the systemic and pulmonary inflammation associated with COPD.
Roflumilast je inhibitor PDE4, nesteroidna protivnetna zdravilna učinkovina, zasnovana tako, da učinkuje na sistemsko in pljučno vnetje, povezano s KOPB.
Libertek may be taken with other medicines used in the treatment of COPD such as inhaled or oral corticosteroids or bronchodilators.
Zdravilo Libertek lahko jemljete skupaj z drugimi zdravili za zdravljenje KOPB, kot so inhalacijski ali peroralni bronhodilatatorji.
The rate (per patient per year) of moderate exacerbations (requiring intervention with systemic glucocorticosteroids) or severe exacerbations (resulting in hospitalisation and/or leading to death) after 1 year was 1.142 with roflumilast and 1.374 with placebo corresponding to a relative risk reduction of 16.9% (95%CI: 8.2% to 24.8%) (primary endpoint, p=0.0003).
Pogostnost (na bolnika na leto) zmernih poslabšanj (ki so zahtevala uporabo sistemskih glukokortikoidov) ali resnih poslabšanj (ki so imela za posledico sprejem v bolnišnico in/ali so povzročila smrt) po 1 letu je znašala 1,142 za roflumilast in 1,374 za placebo, kar pomeni zmanjšanje relativnega tveganja za 16,9 % (95 % interval zaupanja: 8,2 % do 24,8 % (primarni klinični izid, p = 0,0003).
In the subgroup of patients with history of frequent exacerbations (at least 2 exacerbations during the last year), the rate of exacerbations was 1.526 with roflumilast and 1.941 with placebo corresponding to a relative risk reduction of 21.3% (95%CI: 7.5% to 33.1%).
V podskupini bolnikov z anamnezo pogostih poslabšanj (vsaj 2 poslabšanji v preteklem letu) je pogostnost poslabšanj znašala 1,526 ob roflumilastu in 1,941 ob placebu, kar pomeni zmanjšanje relativnega tveganja za 21,3 % (95 % interval zaupanja: 7,5 % do 33,1 %).
Warnings and precautions Talk to your doctor or pharmacist before taking Libertek
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Libertek se posvetujte z zdravnikom ali s farmacevtom.
If patients suffer from new or worsening psychiatric symptoms, or suicidal ideation or suicidal attempt, it is recommended to discontinue treatment with Libertek.
Če bolniki trpijo zaradi novih ali zaradi poslabšanja psihiatričnih simptomov ali če se ugotovi pojav samomorilnih misli ali poskus samomora, je priporočljivo prekiniti zdravljenje z zdravilom Libertek.
That Libertek may cause weight loss and patients should weigh themselves regularly and record their weight on the patient card.
Da zdravilo Libertek lahko povzroči izgubo telesne mase in, da se morajo redno tehtati ter beležiti svojo telesno maso na opozorilno kartico za bolnika.
Libertek contains the active substance roflumilast, which is an anti-inflammatory medicine called phosphodiesterase-4 inhibitor.
Zdravilo Libertek vsebuje zdravilno učinkovino roflumilast, ki je protivnetno zdravilo, imenovano zaviralec fosfodiesteraze 4.
How to store Libertek
Kako jemati zdravilo Libertek
Libertek contains lactose
Zdravilo Libertek vsebuje laktozo