FrancophonIA/ELRC3.0 huggingface dataset:
English: • dizziness, tingling feelings like pins and needles or electric shock-like feelings (particularly in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, sleepiness, feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), shaking (tremor), headaches, muscle pain, feeling irritable, diarrhoea, excessive sweating or vertigo.
Slovenian: • omotica, ščemenje (občutek zbadanja z iglami) ali občutki, podobni električnemu šoku (predvsem v glavi), motnje spanja (žive sanje, nočne more, nezmožnost spanja), utrujenost, zaspanost, občutek nemira ali razburjenosti, občutek strahu, slabost ali bruhanje, tresenje, glavoboli, bolečina v mišicah, občutek razdraženosti, driska, prekomerno znojenje ali
English: ARICLAIM contains the active substance duloxetine.
Slovenian: Zdravilo ARICLAIM vsebuje zdravilno učinkovino duloksetin.
English: − are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI) (see ‘Other medicines and ARICLAIM')
Slovenian: - jemljete ali ste v zadnjih 14 dneh jemali drugo antidepresivno zdravilo, imenovano zaviralec monoaminooksidaze (MAOI) (glejte »Druga zdravila in zdravilo ARICLAIM«) - imate obolenje jeter - imate hudo obolenje ledvic
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/283/011 (28 hard gastro-resistant capsules)
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/283/011 (28 trdih gastrorezistentnih kapsul)
English: Hypertensive crisis3,6
Slovenian: hladni periferni deli hipertenzivna kriza3,6
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT REACH AND SIGHTREACH OF CHILDREN
Slovenian: POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN
English: − are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat some infections
Slovenian: - jemljete fluvoksamin, ki se običajno uporablja za zdravljenje depresije, ciprofloksacin ali enoksacin, ki se uporablja za zdravljenje nekaterih okužb - jemljete katerokoli drugo zdravilo, ki vsebuje duloksetin (glejte »Druga zdravila in zdravilo ARICLAIM«)
English: The concomitant use of ARICLAIM with selective, reversible MAOIs, like moclobemide, is not recommended (see section 4.4).
Slovenian: Sočasno uporabo zdravila ARICLAIM s selektivnimi reverzibilnimi MAOI, kakršen je npr. moklobemid, odsvetujemo (glejte poglavje 4.4).
English: • “Serotonin syndrome” (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles),
Slovenian: • “serotoninski sindrom” (redka reakcija, ki lahko povzroči občutke velike sreče, zaspanost,
English: Opaque green body, imprinted with ‘60 mg' and an opaque blue cap, imprinted with ‘9542'.
Slovenian: Neprozorno zeleno telo z vtisnjenim napisom ‘60 mg' ter neprozoren moder pokrovček z vtisnjeno oznako ‘9542'.
English: Package leaflet: information for the user ARICLAIM 30 mg hard gastro-resistant capsules ARICLAIM 60 mg hard gastro-resistant capsules Duloxetine (as hydrochloride)
Slovenian: NAVODILO ZA UPORABO ARICLAIM 30 mg trde gastrorezistentne kapsule ARICLAIM 60 mg trde gastrorezistentne kapsule duloksetin (v obliki klorida)
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Slovenian: Imetnik dovoljenja za promet z zdravilom: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska.
English: • dehydration, low levels of sodium in the blood (mostly in elderly people; the symptoms may include feeling dizzy, weak, confused, sleepy or very tired, or feeling or being sick, more serious symptoms are fainting, fits or falls), syndrome of inappropriate secretion of anti-diuretic hormone (SIADH)
Slovenian: • dehidracija, nizka raven natrija v krvi (predvsem pri starejših; simptomi so lahko občutek vrtoglavice, oslabelosti, zmedenosti, zaspanosti ali močne utrujenosti, slabost; resnejši simptomi so lahko omedlevica, epileptični napad ali padci), sindrom nezadostnega izločanja antidiuretičnega hormona (SIADH - syndrome of inadequate secretion of anti-diuretic hormone) samomorilno vedenje, manija (prevelika aktivnost, bežeče misli in zmanjšana potreba po spanju), halucinacije, agresivnost in jeza
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Izdaja zdravila je le na recept.
English: Extra-pyramidal symptoms6
Slovenian: psihomotorični nemir6 ekstrapiramidni simptom
English: If you get any side effects, talk to your doctor or pharmacist.
Slovenian: - Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom ali s farmacevtom.
English: Concomitant use of ARICLAIM with nonselective, irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated (see section 4.5).
Slovenian: Zdravila ARICLAIM ne smemo uporabljati sočasno z neselektivnimi ireverzibilnimi zaviralci monoaminooksidaze - MAOI (glejte poglavje 4.5).
English: Nervous system disorders Headache
Slovenian: Bolezni živčevja glavobol zaspanost
English: • constipation, diarrhoea, stomach pain, being sick (vomiting), heartburn or indigestion, breaking
Slovenian: • zaprtje, driska, bolečina v trebuhu, slabost (bruhanje), zgaga ali slaba prebava, vetrovi
English: Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with
Slovenian: Podatki iz kliničnih preskušanj kažejo, da pri mlajših odraslih osebah (mlajših od 25 let) z motnjami razpoloženja med zdravljenjem z antidepresivi obstaja večje tveganje za pojav samomorilnega vedenja.
English: Stomatitis Haematochezia Breath odour Microscopic colitis
Slovenian: gastroenteritis kolcanje gastritis disfagija stomatitis hematohezija slab zadah mikroskopski kolitis
English: Call your doctor or pharmacist immediately if you take more than the amount of ARICLAIM prescribed by your doctor.
Slovenian: Če vzamete večjo količino zdravila ARICLAIM, kot vam je predpisal vaš zdravnik, nemudoma pokličite svojega zdravnika ali farmacevta.
English: Edible green ink contains: Black iron oxide - synthetic (E172) Yellow iron oxide - synthetic (E172) Propylene glycol
Slovenian: Užitno zeleno črnilo: sintetični črni železov oksid (E172), sintetični rumeni železov oksid (E172),
English: 7 hard gastro-resistant capsules 28 hard gastro-resistant capsules 98 hard gastro-resistant capsules
Slovenian: 7 trdih gastrorezistentnih kapsul 28 trdih gastrorezistentnih kapsul 98 trdih gastrorezistentnih kapsul za peroralno uporabo Pred uporabo preberite priloženo navodilo.
English: Gastrointestinal disorders Nausea
Slovenian: Gastrointestinalna krvavitev7
English: What you need to know before you take ARICLAIM
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO ARICLAIM NE jemljite zdravila ARICLAIM, če:
English: Very rare side effects (may affect up to 1 in 10,000 people) • inflammation of the blood vessels in the skin (cutaneous vasculitis)
Slovenian: Občasni neželeni učinki (se lahko pojavijo pri največ 1 od 100 bolnikov) • vnetje grla, ki povzroči hripav glas
English: Angio-neurotic oedema6
Slovenian: StevensJohnsonov sindrom angionevrotičn i edem6
English: ARICLAIM contains sucrose.
Slovenian: Zdravilo ARICLAIM vsebuje saharozo.
English: Adverse reactions may be more common during concomitant use of ARICLAIM and herbal preparations containing St John's wort (Hypericum perforatum).
Slovenian: Ob sočasni uporabi zdravila ARICLAIM in pripravkov rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), so lahko neželeni učinki pogostejši.
English: Caution is advisable if ARICLAIM is used concomitantly with serotonergic agents like SSRIs, SNRIs, tricyclic antidepressants like clomipramine or amitriptyline, MAOIs like moclobemide or linezolid, St John's wort (Hypericum perforatum) or triptans, tramadol, pethidine and tryptophan (see section 4.4).
Slovenian: denimo, klomipraminom ali amitriptilinom, z MAOI, denimo moklobemidom ali linezolidom, s šentjanževko (Hypericum perforatum), triptani, tramadolom, petidinom in triptofanom, priporočamo previdnost (glejte poglavje 4.4).
English: Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Edible green ink
Slovenian: 30 mg: želatina natrijev lavrilsulfat titanov dioksid (E171) indigotin (E132)
English: NAME OF THE MEDICINAL PRODUCT ARICLAIM 30 mg hard gastro-resistant capsules
Slovenian: IME ZDRAVILA ARICLAIM 30 mg trde gastrorezistentne kapsule
English: Infections and infestations Immune system disorders
Slovenian: Infekcijske in parazitske bolezni laringitis
English: ARICLAIM contains sucrose
Slovenian: Zdravilo ARICLAIM vsebuje saharozo
English: NAME OF THE MEDICINAL PRODUCT ARICLAIM 60 mg hard gastro-resistant capsules
Slovenian: IME ZDRAVILA ARICLAIM 60 mg trde gastrorezistentne kapsule
English: ARICLAIM is for oral use.
Slovenian: Zdravilo ARICLAIM jemljemo peroralno.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva napetost mišic trzanje mišic trizem
English: ARICLAIM is used in adults to treat a condition called diabetic neuropathic pain (often described as burning, stabbing, stinging, shooting or aching or like an electric shock.
Slovenian: (Pogosto jo opisujejo kot pekočo, zbadajočo, pikajočo, prebadajočo ali podobno stresanju elektrike.
English: Blood cholesterol increased
Slovenian: Preiskave povečanje telesne mase zvišanje krvne kreatininfosfokinaze zvišanje krvnega kalija zvišanje krvnega holesterola
English: Gynaecological haemorrhage Menstrual disorder Sexual dysfunction Testicular pain
Slovenian: Motnje reprodukcije in dojk disfunkcija motnje ejakulacije zapoznela ejakulacija ginekološka krvavitev motnje menstruacije spolna disfunkcija bolečina v testisih menopavzalni simptomi galaktoreja hiperprolaktinemija
English: If a decision to initiate antidepressant pharmacological therapy is taken, the gradual discontinuation of ARICLAIM is recommended (see section 4.2).
Slovenian: V primeru, da se zdravnik odloči za farmakološko zdravljenje z antidepresivi, svetujemo postopno ukinjanje zdravila
English: Suicidal behaviour5,7
Slovenian: motnje spanja bruksizem dezorientacija apatija samomorilno obnašanje5,7
English: Hypertension3,7 Orthostatic hypotension2 Peripheral coldness
Slovenian: zvišan krvni tlak hladni periferni deli hipertenzivna kriza3,6
English: Thoughts of suicide and worsening of depression or anxiety disorder Although ARICLAIM is not indicated for the treatment of depression, its active ingredient (duloxetine) is used as an antidepressant medicine.
Slovenian: Čeprav se zdravilo ARICLAIM ne uporablja za zdravljenje depresije, se njegova zdravilna učinkovina (duloksetin) uporablja tudi kot antidepresiv.
English: Also, you need to wait at least 5 days after you stop taking ARICLAIM before you take a MAOI.
Slovenian: 5 dni, preden lahko vzamete MAOI.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: Caution is advised if ARICLAIM is co-administered with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs] such as nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such as flecainide, propafenone and metoprolol).
Slovenian: (risperidon, triciklični antidepresivi [tricyclic antidepressants, TCAs], kot so nortriptilin, amitriptilin in imipramin) in zlasti če imajo ozek terapevtski indeks (kot na primer s flekainidom, propafenonom in metoprololom), svetujemo previdnost.
English: Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing ARICLAIM to patients with increased intraocular pressure, or those at risk of acute narrow-angle glaucoma.
Slovenian: V povezavi z duloksetinom so poročali o midriazi, zato je pri predpisovanju zdravila ARICLAIM
English: NAME OF THE MEDICINAL PRODUCT ARICLAIM 30 mg hard gastro-resistant capsules Duloxetine
Slovenian: ARICLAIM 30 mg trde gastrorezistentne kapsule duloksetin
English: Respiratory, thoracic and mediastinal disorders Yawning
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora zehanje stisnjeno grlo epistaksa
English: NAME OF THE MEDICINAL PRODUCT ARICLAIM 60 mg hard gastro-resistant capsules Duloxetine
Slovenian: ARICLAIM 60 mg trde gastrorezistentne kapsule duloksetin
English: Metabolism and nutrition disorders
Slovenian: Presnovne in prehranske motnje hiperglikemija
English: - are taking medicines to treat depression (see ‘Other medicines and ARICLAIM') - are taking St. John's Wort, a herbal treatment (Hypericum perforatum) - have kidney disease - have had seizures (fits) - have had mania - suffer from bipolar disorder - have eye problems, such as certain kinds of glaucoma (increased pressure in the eye) - have a history of bleeding disorders (tendency to develop bruises) - are at risk of low sodium levels (for example if you are taking diuretics, especially if you are elderly) - are currently being treated with another medicine which may cause liver damage - are taking other medicines containing duloxetine (see ‘Other medicines and ARICLAIM')
Slovenian: - ste v preteklosti imeli motnje strjevanja krvi (nagnjenost k razvoju podplutb) - imate tveganje za nizek nivo natrija (če na primer jemljete diuretike, sploh če ste starejši)
English: − have liver disease
Slovenian: Očesne bolezni okvara vida glavkom
English: Convulsion
Slovenian: Krvavitev
English: Do not store above 30º C.
Slovenian: dezipramina narasel 3-kratno.
English: 28 hard gastro-resistant capsules 98 hard gastro-resistant capsules
Slovenian: 60 mg trde gastrorezistentne kapsule
English: You should tell your doctor if this happens to you.
Slovenian: Če se pri vas pojavijo taki občutki, o tem obvestite svojega zdravnika.
English: Ejaculation
Slovenian: Saharoza
English: Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Yellow iron oxide (E172) Edible white ink
Slovenian: indigotin (E132) rumeni železov oksid (E172)
English: − are taking other medicines containing duloxetine (see ‘Other medicines and ARICLAIM') Talk to your doctor if you have high blood pressure or heart disease.
Slovenian: Pogovorite se s svojim zdravnikom, če imate nenadzorovan visok krvni tlak ali srčno bolezen.
English: − have severe kidney disease
Slovenian: - imate ledvično bolezen - imeli ste epileptične napade (krče)
English: Very Rare disorder Ejaculation delayed disorder Sexual dysfunction Testicular pain
Slovenian: Ušesne bolezni, vključno z motnjami labirinta vrtoglavica ušesna bolečina
English: * inducing a virus neutralising antibody response in chickens of ≥ 5.0 log2
Slovenian: * pri piščancih vzbudi titer protiteles z nevtralizirajočim učinkom na virus ≥ 5,0 log2
English: The timetable for the implementation of the agreement is set out in Annex III.
Slovenian: Časovni razpored za izvajanje sporazuma je opredeljen v Prilogi III.
English: The treatment duration was up to 2 years.
Slovenian: Zdravljenje je trajalo do 2 leti.
English: Spontaneous reports
Slovenian: Spontana poročila
English: The first Marketing Authorisation in the EU was granted in France on 10 December 1982.
Slovenian: Prvo dovoljenje za promet z zdravilom v EU je bilo odobreno 10. decembra 1982 v Franciji.
English: In addition, the PRAC noted that the mechanism of these 2 adverse reactions remains unknown.
Slovenian: Poleg tega je PRAC upošteval, da mehanizem teh dveh neželenih učinkov še vedno ni znan.
English: In 50% of the cases, a neuropathy was also reported.
Slovenian: V 50 % primerov so poročali tudi o nevropatiji.
English: Data from clinical trials
Slovenian: Podatki iz kliničnih preskušanj
English: In addition, France had concerns with regards to the benefit of almitrine in its approved indications.
Slovenian: Poleg tega je imela Francija pomisleke glede koristi almitrina pri odobrenih indikacijah.
English: • Respiratory events, mainly due to awareness of respiratory movements
Slovenian: • dogodki na dihalih, zlasti zaradi zavedanja dihalnih gibov;
English: The mean time to onset for the cases reported was 5 months but time to onset was variable ranging from 15 days to 2,5 years.
Slovenian: Povprečen čas do pojava neželenih učinkov pri zabeleženih primerih je bil 5 mesecev, vendar pa je bil čas spremenljiv in je znašal od 15 dni do 2,5 leta.
English: Weight loss observed in patients with respiratory insufficiency is progressive.
Slovenian: Zmanjšanje telesne mase, ki ga opažajo pri bolnikih z dihalno insuficienco, je progresivno.
English: Scientific conclusions and grounds for the revocation of the marketing authorisations
Slovenian: Znanstveni zaključki in podlaga za odvzem dovoljenj za promet z zdravili
English: Grounds for PRAC recommendation
Slovenian: Podlaga za priporočilo PRAC
English: Almitrine containing medicinal products for oral use are currently authorised in 3 European Member States (France, Poland and Portugal) and only marketed in France and Poland (see Annex I for the list of almitrine containing medicinal products for oral use authorised in the EU).
Slovenian: Zdravila za peroralno uporabo, ki vsebujejo almitrin, so trenutno odobrena v 3 evropskih državah članicah (v Franciji, na Poljskem in Portugalskem), tržijo pa se samo v Franciji in na Poljskem (za seznam zdravil za peroralno uporabo, ki vsebujejo almitrin in so odobrena za uporabo v EU, glejte Prilogo I).
English: In November 2012 the French National Competent Authority considered that the above-mentioned major safety concerns were not fully controlled in clinical practice despite the risk minimisation measures in place.
Slovenian: Novembra 2012 je francoski pristojni nacionalni organ ugotovil, da zgoraj omenjeni veliki zadržki v zvezi z varnostjo kljub izvajanju ukrepov za zmanjšanje tveganja v klinični praksi niso dovolj nadzorovani.
English: No effect was nor observed on pulmonary functional status.
Slovenian: Prav tako niso opazili učinka na funkcionalno stanje pljuč.
English: In the view of the negative benefit risk balance, patients will need to be switched to alternative therapies.
Slovenian: Zaradi negativnega razmerja med tveganji in koristmi bodo morali bolniki poseči po alternativnih oblikah zdravljenja.
English: Globally, an important proportion of cases had an outcome reported as not recovered or recovered with sequelae (489 cases out of the 2304 reported, i.e. 21.2%).
Slovenian: Skupno so pri velikem odstotku primerov poročali o tem, da se bolezen ni popravila ali da je pustila posledice (489 od 2 304 primerov, tj. 21,2 %).
English: Regarding weight loss, 795 cases were reported since launch, some of them severe.
Slovenian: V zvezi z zmanjšanjem telesne mase so od začetka trženja poročali o 795 primerih, med katerimi so bili tudi resni primeri.
English: Besides, the PRAC also noted that the knowledge in physiopatholigical mechanism and management of COPD (including life expectancy in COPD) has been considerably improved.
Slovenian: Poleg tega je PRAC upošteval tudi, da sta se znanje o fiziopatološkem mehanizmu in zdravljenje KOPB (vključno s pričakovano življenjsko dobo pri KOPB) znatno izboljšala.
English: In view of the 11 above mentioned published clinical studies, it is acknowledged that efficacy results among clinical studies are contradictory and extrapolations not feasible.
Slovenian: V zvezi z zgoraj omenjenimi 11 objavljenimi kliničnimi študijami je bilo ugotovljeno, da so si rezultati o učinkovitosti iz kliničnih študij nasprotujoči, zato ekstrapolacije niso mogoče.
English: Almitrine for oral use was studied in several clinical studies.
Slovenian: Almitrin za peroralno uporabo so raziskali v več kliničnih študijah.
English: The MAH has never performed trials or investigations to document/establish the mechanism of action of these adverse effects.
Slovenian: Imetnik dovoljenja za promet z zdravilom ni izvedel nobenih preskušanj ali raziskav, s katerimi bi dokumentiral/ugotovil mehanizem delovanja teh neželenih učinkov.
English: Spontaneous reports of peripheral neuropathies persist even after the introduction of sequential administration scheme.
Slovenian: Spontana poročila o periferni nevropatiji beležijo tudi po uvedbi sekvenčne sheme odmerjanja.
English: During the period September 2003 to December 2012, 20 cases of peripheral neuropathies were reported, suggesting that the risk minimisation measures are not able to prevent the occurrence of these reactions.
Slovenian: V obdobju med septembrom 2003 in decembrom 2012 so poročali o 20 primerih periferne nevropatije, kar kaže na to, da ukrepi za zmanjšanje tveganja niso preprečili pojavljanja teh neželenih učinkov.
English: Consideration that long-term oxygen therapy can be discontinued, delayed or even avoided with almitrine is not based on scientific or clinical evidence.
Slovenian: Trditev, da je z almitrinom mogoče prekiniti, odložiti ali celo preprečiti trajno zdravljenje s kisikom, ni utemeljena z znanstvenimi ali kliničnimi dokazi.
English: The decrease in reporting of peripheral neuropathy mentioned by the MAH, is probably mainly related to the decrease in sales over the last 10 years.
Slovenian: Zmanjšanje števila poročil o periferni nevropatiji, ki ga je izpostavil imetnik dovoljenja za promet, je verjetno povezano predvsem z upadom prodaje v zadnjih 10 letih.
English: The PRAC considered that many of the publications reported that a clinical benefit of oral almitrine could not be seen in terms of exacerbations or hospitalisation, exercise capacity, clinical outcome, survival, or quality of life.
Slovenian: PRAC je upošteval, da številne publikacije navajajo, da almitrin za peroralno uporabo ni izkazal kliničnih koristi v smislu eksacerbacij ali hospitalizacije, telesne zmogljivosti, kliničnega izida, preživetja ali kakovosti življenja.
English: The NCAs should undertake timely actions allowing an appropriate switching of patients to other therapeutic alternatives.
Slovenian: Pristojne nacionalne agencije morajo nemudoma ukrepati in omogočiti bolnikom, da preidejo na druge oblike zdravljenja.
English: This adverse effect was also clearly recognised in the trials comparing almitrine at high doses to placebo.
Slovenian: Ta neželeni učinek so jasno prepoznali tudi v preskušanjih, v katerih so almitrin pri visokih odmerkih primerjali s placebom.
English: In France, almitrine containing medicinal products for oral use have been under close monitoring due to serious adverse reaction .
Slovenian: V Franciji so zdravila za peroralno uporabo, ki vsebujejo almitrin, podrobno spremljali zaradi resnih neželenih učinkov.
English: Finally the PRAC noted that the current international consensus for the management of COPD and chronic hypoxemia (Global Initiative for Obstructive Lung Disease (GOLD) and other practical recommendation) does no longer refer to the use of almitrine.
Slovenian: Prav tako je PRAC upošteval, da trenutne mednarodne smernice za zdravljenje KOPB in kronične hipoksemije (Globalna iniciativa za obstruktivno pljučno bolezen (Global Initiative for Obstructive Lung Disease - GOLD) in druga praktična priporočila) za uporabo almitrina ne veljajo več.
English: Risk minimisation measures (reduction of the dose and implementation of a sequential treatment scheme ) were implemented since the initial marketing authorisation.
Slovenian: Ukrepi za zmanjšanje tveganja (zmanjšanje odmerka in uvedba sekvenčne sheme zdravljenja) se izvajajo od odobritve prvega dovoljenja za promet z zdravilom.
English: The doses of 100-200 mg of almitrine continuously were associated with a higher incidence of adverse effects and withdrawals compared to placebo.
Slovenian: Neprekinjeno dajanje odmerkov od 100-200 mg almitrina je bilo povezano z večjo pojavnostjo neželenih učinkov in prekinitev zdravljenja v primerjavi s placebom.