FrancophonIA/ELRC3.0 huggingface dataset:
English: Regarding the prevention of non-steroidal anti-inflammatory drug (NSAID) -associated gastric ulcers, duodenal ulcers or gastroduodenal erosions in patients at risk, prevention of ulcer formation in at risk NSAID users is a reasonable course of action, given the high and increasing incidence.
Slovenian: V zvezi s preprečevanjem razjed želodca in dvanajstnika ter gastroduodenalnih erozij, povezanih z nesteroidnimi protivnetnimi zdravili pri bolnikih s tveganjem, je preprečevanje nastanka razjede pri uporabnikih nesteroidnih protivnetnih zdravil, ki so izpostavljeni tveganju, utemeljen ukrep glede na visoko pojavnost, ki še narašča.
English: Similarly, the CHMP considered that there is sufficient evidence from the literature and long-term post marketing experience that omeprazole 20 mg daily is a safe dosage over 14 days.
Slovenian: Podobno je CHMP menil, da literatura in izkušnje iz dolgega obdobja po pridobitvi dovoljenja za promet z zdravilom zadostno dokazujejo, da je odmerek 20 mg na dan varen v obdobju 14 dni.
English: The SPC therefore states that co-administration of atazanavir and nelfinavir with proton pump inhibitors is not recommended and that if co-administration is judged unavoidable, close clinical monitoring is recommended together with an increase of the anti-retroviral drug dose, as plasma levels of nelfinavir and atazanavir are decreased in case of co-administration with omeprazole.
Slovenian: V povzetku glavnih značilnosti zdravila je zato navedeno, da sočasna uporaba atazanavirja in nelfinavirja z zaviralci protonske črpalke ni priporočljiva in da je v primeru, ko se sočasna uporaba šteje za neizogibno, priporočljivo skrbno klinično spremljanje skupaj s povečanjem odmerka protiretrovirusnega zdravila, saj se ravni nelfinavirja in atazanavirja med sočasno uporabo z omeprazolom znižajo.
English: • Long-term management of patients with healed reflux esophagitis
Slovenian: • dolgotrajno obvladovanje pri bolnikih z ozdravljenim refluksnim ezofagitisom,
English: PPIs are also effective for primary prevention of NSAID-associated ulcers.
Slovenian: Zaviralci protonske črpalke so učinkoviti tudi za primarno preprečevanje razjed, povezanih z nesteroidnimi protivnetnimi zdravili.
English: Regarding the method of administration of the capsules and tablets, with regards to patients with swallowing difficulties, the CHMP agreed that the capsule can be opened and the contents swallowed based on the in-vivo (bioequivalence) as well as in-vitro studies on the intake as dispersed/suspended tablets/granules of the oral pharmaceutical forms.
Slovenian: V zvezi z načinom uporabe kapsul in tablet pri bolnikih s težavami pri požiranju se je CHMP na osnovi študij in vivo (biološka enakovrednost) in študij in vitro o vnosu dispergiranih/suspendiranih tablet/zrnc peroralnih farmacevtskih oblik strinjal, da lahko kapsule odpremo in vsebino pogoltnemo.
English: a) “Treatment of symptomatic gastro-oesophageal reflux disease (GERD)” The MAH proposed that both duodenal and gastric ulcers be presented in individual indications separate from the GERD indication.
Slovenian: a) „Zdravljenje simptomatske gastroezofagealne refluksne bolezni (GERB)“ Imetnik dovoljenja za promet z zdravilom je predlagal, da sta razjedi na dvanajstniku in želodcu prisotni pri posameznih indikacijah, ločeno od indikacije GERB.
English: • Treatment of symptomatic gastro-esophageal reflux disease
Slovenian: • zdravljenje simptomatske gastroezofagealne refluksne bolezni,
English: These are based on established data and are currently confirmed as the most efficacious combinations, and are intended to allow treatment alternatives according to local needs and clinical practice.
Slovenian: Ta temeljijo na uveljavljenih podatkih in so trenutno potrjena kot najbolj učinkovite kombinacije.
English: For the prevention of relapse of duodenal ulcer in H. pylori negative patients or when H. pylori eradication is not possible the recommended dose is 20 mg once daily.
Slovenian: Priporočeni odmerek za preprečevanje ponovitve razjede dvanajstnika pri bolnikih, ki so negativni za H. pylori, ali ko eradikacija H. pylori ni možna, je 20 mg enkrat dnevno.
English: Section 4.1 - Therapeutics indications in adults - powder for injection and powder for infusion
Slovenian: Poglavje 4.1 - Terapevtske indikacije pri odraslih - prašek za injiciranje in prašek za infundiranje
English: None have been found to be dose-related and the reactions are classified according to frequency.
Slovenian: Reakcije so razvrščene po pogostnosti.
English: Based on the review of data and taking into account the commitments provided by the MAH to submit an update of Module 3 in May 2010, the CHMP adopted a harmonised Module 3.
Slovenian: CHMP je sprejel usklajen modul 3 na osnovi pregleda podatkov in upoštevanja obvez, ki jih je prevzel imetnik dovoljenja za promet z zdravilom, da bo predložil posodobljen modul 3 do maja 2010.
English: The SPC also mentions that the benefit-risk of omeprazole treatment in the maintenance setting should be continuously re-evaluated and that patients should be kept under regular surveillance, especially when exceeding a treatment period of 1 year.
Slovenian: V povzetku glavnih značilnosti zdravila je omenjeno, da je treba razmerje koristi in tveganja vzdrževalnega zdravljenja z omeprazolom stalno pregledovati in bolnike redno nadzorovati, zlasti če je zdravljenje daljše od enega leta.
English: The CHMP concluded that omeprazole is a suitable medication to relief heartburn and acid regurgitation in the OTC setting, provided that the patient complies with the recommended dosing and correct use, as instructed by the SPC and the Patient Leaflet.
Slovenian: CHMP je zaključil, da je omeprazol primerno zdravilo za lajšanje zgage in regurgitacije kisline v okviru izdaje zdravil brez recepta pod pogojem, da bolnik upošteva priporočeno odmerjanje in navodilo za pravilno uporabo, ki je navedeno v povzetku glavnih značilnosti zdravila in navodilu za uporabo.
English: e) “Treatment of NSAID-associated gastric and duodenal ulcers” and “Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk”
Slovenian: e) “Zdravljenje razjed želodca in dvanajstnika, povezanih z nesteroidnimi protivnetnimi zdravili”, in “Preprečevanje razjed želodca in dvanajstnika, povezanih z nesteroidnimi protivnetnimi zdravili, pri bolnikih s tveganjem”
English: The SPC therefore states that omeprazole is a CYP2C19 inhibitor and that inconsistent data has been reported from observational and clinical studies on the clinical implications of the PK/PD interaction in terms of major cardiovascular events.
Slovenian: V povzetku glavnih značilnosti zdravila je zato navedeno, da je omeprazol zaviralec CYP2C19 in da so podatki iz opazovalnih in kliničnih študij kliničnih posledic farmakokinetičnih in farmakodinamičnih interakcij v smislu glavnih srčno-žilnih dogodkov nedosledni.
English: A warning that the H. pylori status should be determined before treatment was included in the SPC.
Slovenian: V povzetek glavnih značilnosti zdravila je bilo dodano opozorilo, da je treba pred zdravljenjem določiti status H. pylori.
English: For the prevention of NSAID-associated gastric ulcers or duodenal ulcers in patients at risk (age> 60, previous history of gastric and duodenal ulcers, or of upper GI bleeding) the recommended dose is 20 mg once daily.
Slovenian: Priporočeni odmerek za zdravljenje razjed želodca in dvanajstnika, ki so povezane z nesteroidnimi protivnetnimi zdravili, pri bolnikih v tveganju (starost > 60, anamneza razjed želodca in dvanajstnika ali krvavitev v zgornjih prebavilih), je 20 mg enkrat na dan.
English: c) “Treatment of duodenal ulcers” and “Prevention of relapse of duodenal ulcers” The indication in H. pylori negative ulcers was split from the indication with concomitant H. pylori infection.
Slovenian: c) „Zdravljenje razjed dvanajstnika“ in „Preprečevanje ponovitve razjed dvanajstnika“ Indikacijo za razjede, negativne za H. pylori, so ločili od indikacije za sočasno okužbo s H. pylori.
English: The marketing authorisation holder (MAH) also took the opportunity to harmonise Module 3.
Slovenian: Imetnik dovoljenja za promet z zdravilom je ob tej priložnosti uskladil tudi 3. modul.
English: The prophylactic use of Losec, as distinct from the treatment indications was also discussed and justified.
Slovenian: Razpravljal in utemeljeval je tudi profilaktično uporabo zdravila Losec, ki se razlikuje od terapevtskih indikacij.
English: Section 4.1 - Therapeutics indications in adults - capsules and tablets
Slovenian: Poglavje 4.1 - Terapevtske indikacije pri odraslih - kapsule in tablete
English: The CHMP considered that the increased occurrence of gastrointestinal bacterial infections due to decreased gastric acidity should be mentioned in the SPC.
Slovenian: CHMP je menil, da je treba v povzetku glavnih značilnosti zdravila omeniti povečano pojavnost bakterijskih želodčnih okužb zaradi zmanjšane kislosti v želodcu.
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Losec and associated names (see Annex I).
Slovenian: CHMP je priporočil dopolnitev dovoljenj za promet z zdravilom Losec in z njim povezanih ime (glejte Dodatek I), katerega povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so navedeni v Dodatku III.
English: f) “In combination with appropriate antibiotics, Helicobacter pylori (H. pylori) eradication in peptic ulcer disease”
Slovenian: f) „Eradikacija Helicobacter pylori (H. pylori) pri bolnikih s peptičnimi razjedami v kombinaciji z ustreznimi antibiotiki“
English: • Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk
Slovenian: • preprečevanje razjed želodca in dvanajstnika, ki so povezane z nesteroidnimi protivnetnimi zdravili, pri bolnikih s tveganjem,
English: For long-term management of patients with healed reflux oesophagitis, the recommended dose is 10 mg once daily.
Slovenian: Priporočeni odmerek za dolgotrajno obvladovanje pri bolnikih z ozdravljenim refluksnim ezofagitisom je 10 mg enkrat na dan.
English: Losec MUPS (multiple unit pellet system) tablets are also available as OTC.
Slovenian: Kot zdravilo za izdajo brez recepta so na voljo tudi tablete Losec MUPS (večodmerni peletni sistem).
English: The CHMP assessed the MAH proposal taking into account the current national SPCs and scientific knowledge and discussed indications for each individual medical condition.
Slovenian: CHMP je ovrednotil predlog imetnika dovoljenja za promet z zdravilom ob upoštevanju trenutnih nacionalnih povzetkov glavnih značilnosti zdravila ter strokovnega znanja.
English: The scope of the referral included all licences, whether prescription only (POM/Rx) or non-prescription (over-thecounter or OTC).
Slovenian: Obseg napotitve je obsegal vse licence, tj. zdravila za izdajo na recept in zdravila za izdajo brez recepta.
English: In patients with severe oesophagitis 40 mg once daily is recommended and healing is usually achieved within eight weeks.
Slovenian: Pri bolnikih s hudim ezofagitisom je priporočeni odmerek 40 mg enkrat na dan. Ozdravitev ponavadi dosežemo v osmih tednih.
English: Section 4.1 - Therapeutics indications in paediatric patients - capsules and tablets
Slovenian: Poglavje 4.1 - Terapevtske indikacije pri otrocih - kapsule in tablete
English: • Treatment of reflux esophagitis
Slovenian: • zdravljenje refluksnega ezofagitisa,
English: • Symptomatic treatment of heartburn and acid regurgitation in gastro-esophageal reflux disease In children and adolescents over 4 years of age
Slovenian: • simptomatsko zdravljenje zgage in regurgitacije kisline pri gastroezofagealni refluksni bolezni.
English: d) “Treatment of gastric ulcers” and “Prevention of relapse of gastric ulcers” The gastric ulcer indications were separated from the duodenal ulcer indications as well as from the NSAID-related and H. pylori positive ulcers.
Slovenian: d) „Zdravljenje razjed želodca“ in „Preprečevanje ponovitve razjed želodca“ Indikacije razjed želodca so ločili od indikacij razjed dvanajstnika ter od razjed zaradi nesteroidnih protivnetnih zdravil in za H. pylori pozitivnih razjed.
English: Patients may respond adequately to 10 mg daily, and therefore individual dose adjustment should be considered.
Slovenian: Priporočeni odmerek za zdravljenje simptomatske gastroezofagealne refluksne bolezni je 20 mg na dan. Bolniki se lahko zadostno odzovejo na odmerek 10 mg na dan, zato je morda treba individualno prilagajati odmerek.
English: • In combination with appropriate antibiotics, Helicobacter pylori (H. pylori) eradication in peptic ulcer disease
Slovenian: • eradikacija Helicobacter pylori (H. pylori) pri bolnikih s peptičnimi razjedami v kombinaciji z ustreznimi antibiotiki,
English: Prevention of ulcers is currently started on a regular basis in a considerable number of patients using NSAIDs and the superior efficacy PPIs over H2 antagonists in the healing of gastroduodenal ulcers associated with NSAIDs when NSAIDs cannot be discontinued has been demonstrated.
Slovenian: Dokazano je bilo, da so zaviralci protonske črpalke učinkovitejši od antagonistov H2 v smislu ozdravitve gastroduodenalne razjede v povezavi z nesteroidnimi protivnetnimi zdravili, če zdravljenja z njimi ni mogoče prekiniti.
English: The CHMP noted that although Losec is not likely to affect the ability drive or use machines, dizziness and visual disturbances have been observed with the use of Losec, and stated that patients experiencing these adverse drug reactions should not drive or operate machinery.
Slovenian: Poglavje 4.7: Vpliv na sposobnost vožnje in upravljanja s stroji - vse formulacije CHMP je ugotovil, da čeprav zdravilo Losec verjetno ne vpliva na sposobnost vožnje in upravljanja s stroji, so zaradi opažene omotice in motnje vida pri uporabi tega zdravila navedli, da bolniki s temi neželenimi reakcijam ne smejo voziti ali upravljati s stroji.
English: Adult posology: capsule and tablet
Slovenian: Odmerjanje pri odraslih bolnikih: kapsula ali tableta
English: The CHMP considered that the prevention of relapse of H. pylori negative gastric ulcers is sufficiently demonstrated and considered these indications to be approvable.
Slovenian: CHMP je menil, da je preprečevanje ponovitve razjed želodca, negativnih za H. pylori, zadostno dokazano, zato je menil, da je te indikacije možno odobriti.
English: For prevention of relapse in patients with poorly responsive gastric ulcer the recommended dose is 20 mg once daily.
Slovenian: Priporočeni odmerek za preprečevanje ponovitve pri bolnikih s slabim odzivom razjede želodca je 20 mg enkrat na dan.
English: The CHMP considered that the prevention of NSAID ulcers is sufficiently demonstrated and considered these indications to be approvable.
Slovenian: CHMP je menil, da je preprečevanje razjed zaradi nesteroidnih protivnetnih zdravil zadostno dokazano, zato je menil, da je te indikacije možno odobriti.
English: Paediatric posology: capsule and tablet
Slovenian: Odmerjanje pri otrocih: kapsula ali tableta
English: In patients with poorly responsive duodenal ulcer 40 mg once daily is recommended and healing is usually achieved within four weeks.
Slovenian: Pri bolnikih s slabim odzivom razjede dvanajstnika je priporočeni odmerek 40 mg enkrat na dan. Ozdravitev ponavadi dosežemo v štirih tednih.
English: Treatment of reflux oesophagitis includes acid reduction and PPIs are currently considered the most effective treatment for reflux oesophagitis and the CHMP therefore considered this indication to be approvable.
Slovenian: Zdravljenje refluksnega ezofagitisa obsega zmanjšanje izločanja kisline in zaviralci protonske črpalke se trenutno štejejo za najučinkovitejše zdravljenje te bolezni.
English: Symptoms responding adequately to an acid suppressant and returning upon discontinuation allow a diagnosis of GERD.
Slovenian: Diagnozo GERB dokažemo s simptomi, ki se ustrezno odzovejo na zaviralca kisline in ponovijo po prekinitvi zdravljenja.
English: The OTC SPC will diverge most notably in the indications, posology and warnings sections.
Slovenian: Povzetek glavnih značilnosti zdravila, ki se izdaja brez recepta, se bo najbolj razlikoval v indikacijah, odmerjanju in opozorilih.
English: In patients with poorly responsive gastric ulcer 40 mg once daily is recommended and healing is usually achieved within eight weeks.
Slovenian: Pri bolnikih s slabim odzivom razjede želodca je priporočeni odmerek 40 mg enkrat na dan. Ozdravitev ponavadi dosežemo v osmih tednih.
English: The CHMP considered that prevention of relapse of H. pylori negative duodenal ulcers is sufficiently demonstrated and considered these indications to be approvable.
Slovenian: CHMP je štel, da je preprečevanje ponovitve razjed dvanajstnika, negativnih za H. pylori, zadostno dokazano, zato je menil, da je te indikacije možno odobriti.
English: The CHMP considered that there is sufficient information on human experience to state that excretion of omeprazole in milk is low and unlikely to influence the child. Data from epidemiological studies on use of Losec during pregnancy indicates no adverse effects and the CHMP considered that omeprazole can be used during pregnancy.
Slovenian: Podatki iz epidemioloških študij uporabe zdravila Losec med nosečnostjo ne kažejo neželenih učinkov, zato je CHMP menil, da se omeprazol lahko uporabi med nosečnostjo.
English: For the treatment of Zollinger-Ellison syndrome, the dose should be individually adjusted and treatment continued as long as clinically indicated.
Slovenian: Odmerek za zdravljenje Zollinger-Ellisonovega sindroma je treba prilagoditi posameznemu bolniku.
English: For the treatment of reflux oesophagitis, the recommended dose is 20 mg once daily.
Slovenian: Priporočeni odmerek za zdravljenje refluksnega ezofagitisa je 20 mg enkrat na dan.
English: • Prevention of relapse of duodenal ulcers
Slovenian: • preprečevanje ponovitev razjed dvanajstnika,
English: For the treatment of NSAID-associated gastric and duodenal ulcers, the recommended dose is 20 mg once daily.
Slovenian: Priporočeni odmerek za zdravljenje razjed želodca in dvanajstnika, ki so povezane z nesteroidnimi protivnetnimi zdravili, je 20 mg enkrat na dan.
English: • In combination with antibiotics in treatment of duodenal ulcer caused by H. pylori
Slovenian: • zdravljenje razjede dvanajstnika zaradi H. pylori v kombinaciji z antibiotiki.
English: • Treatment of NSAID-associated gastric and duodenal ulcers
Slovenian: • zdravljenje razjed želodca in dvanajstnika, ki so povezane z nesteroidnimi protivnetnimi zdravili,
English: In general, the SPC and the PL of the OTC Losec presentation was aligned to that of the Prescription-only products.
Slovenian: Na splošno so povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Losec za izdajo brez recepta uskladili z oblikami za izdajo na recept.
English: PRESCRIPTION-ONLY PRESENTATIONS
Slovenian: OBLIKE NA RECEPT
English: For the treatment of duodenal ulcers, the recommended dose is 20 mg once daily.
Slovenian: Priporočeni odmerek za zdravljenje razjed dvanajstnika je 20 mg enkrat na dan.
English: • Prevention of relapse of gastric ulcers
Slovenian: • preprečevanje ponovitev razjed želodca,
English: • pain due to diabetic peripheral neuropathy (damage to the nerves in the feet, legs, hands and arms that can occur in patients with diabetes);
Slovenian: • bolečino zaradi diabetične periferne nevropatije (poškodbe živcev v stopalih, nogah, dlaneh in rokah, ki se lahko pojavijo pri bolnikih s sladkorno boleznijo);
English: The full EPAR and risk management plan summary for Duloxetine Zentiva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Duloxetine Zentiva sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Most patients will need to take 60 mg per day.
Slovenian: Večina bolnikov bo potrebovala odmerek 60 mg na dan.
English: Since these neurotransmitters are involved in maintaining mood and reducing the sensation of pain, blocking their re-uptake into nerve cells can improve the symptoms of depression, anxiety and neuropathic pain.
Slovenian: Ker ti živčni prenašalci sodelujejo pri ohranjanju dobrega razpoloženja in zmanjševanju občutka bolečine, lahko zaviranje njihovega ponovnega privzema v živčne celice izboljša simptome depresije, tesnobe in nevropatske bolečine.
English: This is a summary of the European public assessment report (EPAR) for Duloxetine Zentiva.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Duloxetine Zentiva.
English: Duloxetine Zentiva is available as gastroresistant capsules (30 and 60 mg).
Slovenian: Zdravilo Duloxetine Zentiva je na voljo v obliki gastrorezistentnih kapsul (30 mg in 60 mg).
English: By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters in the spaces between nerve cells, increasing the level of communication between the cells.
Slovenian: Duloksetin z zaviranjem njihovega ponovnega privzema povečuje količino teh živčnih prenašalcev v prostorih med živčnimi celicami in s tem poveča stopnjo komunikacije med celicami.
English: It works by preventing the neurotransmitters serotonin (5-hydroxytryptamine) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Slovenian: Deluje tako, da preprečuje ponovni privzem nevrotransmitorjev (živčnih prenašalcev) serotonina (5-hidroksitriptamina) in noradrenalina v živčne celice v možganih in hrbtenjači.
English: Duloxetine Zentiva is used to treat adults with the following diseases:
Slovenian: Zdravilo Duloxetine Zentiva se uporablja za zdravljenje odraslih z naslednjimi boleznimi:
English: The Committee recommended that Duloxetine Zentiva be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Duloxetine Zentiva odobri za uporabo v EU.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Duloxetine Zentiva has been shown to have comparable quality to Cymbalta and to be bioequivalent to Cymbalta.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Duloxetine Zentiva primerljivo raven kakovosti kot zdravilo Cymbalta ter da mu je biološko enakovredno.
English: Duloxetine Zentiva duloxetine
Slovenian: Duloxetine Zentiva duloksetin
English: This means that Duloxetine Zentiva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Cymbalta.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Cymbalta.
English: In patients who respond to Duloxetine Zentiva, treatment should continue for several months to prevent the disease coming back, or for longer in patients who have had repeated periods of depression in the past.
Slovenian: Pri bolnikih, ki se odzovejo na zdravilo Duloxetine Zentiva, mora zdravljenje trajati več mesecev, da se prepreči ponoven pojav bolezni, ali dlje, če so bolniki v preteklosti imeli ponavljajoča se obdobja depresije.
English: What measures are being taken to ensure the safe and effective use of Duloxetine Zentiva?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Duloxetine Zentiva?
English: A risk management plan has been developed to ensure that Duloxetine Zentiva is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Duloxetine Zentiva je bil pripravljen načrt obvladovanja tveganj.