FrancophonIA/ELRC3.0 huggingface dataset:
English: In people with diabetic neuropathic pain it can take some weeks before you feel better.
Slovenian: Pri večini bolnikov z bolečino pri diabetični nevropatiji traja nekaj tednov, preden se vaše počutje izboljša.
English: These symptoms are usually not serious and disappear within a few days, but if you have symptoms that are troublesome you should ask your doctor for advice.
Slovenian: Ti simptomi običajno niso resni in v nekaj dneh izzvenijo, vendar se posvetujte s svojim zdravnikom,
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines., including medicines obtained without a prescription.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali, ali pa boste morda začeli jemati katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: Do not stop taking ARICLAIM, or change your dose, without talking to your doctor.
Slovenian: Ne prenehajte jemati zdravila ARICLAIM in ne spreminjajte odmerka, ne da bi se posvetovali s svojim zdravnikom.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
Slovenian: D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: • Tell your doctor if you become pregnant, or you are trying to become pregnant, while you are taking ARICLAIM.
Slovenian: • Obvestite svojega zdravnika, če zanosite ali poskušate zanositi, medtem ko jemljete zdravilo ARICLAIM.
English: Your doctor should decide whether you can take ARICLAIM with other medicines.
Slovenian: Vaš zdravnik se mora odločiti, ali lahko jemljete zdravilo ARICLAIM z drugimi zdravili.
English: Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of ARICLAIM in this age group have not yet been demonstrated.
Slovenian: Dolgoročni učinki zdravila ARICLAIM na varnost glede rasti, dozorevanja in kognitivnega ter vedenjskega razvoja v tej starostni skupini tudi še niso bili ugotovljeni.
English: • Ariclaim may cause effects that you may not be aware of, such as increases in liver enzymes or blood levels of potassium, creatine phosphokinase, sugar, or cholesterol
Slovenian: • Ariclaim lahko povzroči tudi neželene učinke, ki se jih morda ne zavedate, kot povišanje jetrnih encimov ali krvnega nivoja kalija, kreatinske fosfokinaze, sladkorja ali holesterola.
English: If your doctor has prescribed ARICLAIM for a patient under 18 and you want to discuss this, please go back to your doctor.
Slovenian: Če je vaš zdravnik predpisal zdravilo ARICLAIM bolniku, mlajšemu od 18 let, in se želite o tem pogovoriti,
English: If you take ARICLAIM near the end of your pregnancy, your baby might have some symptoms when it is born.
Slovenian: Če zdravilo ARICLAIM jemljete proti koncu nosečnosti, se lahko po rojstvu pri vašem otroku pojavijo nekateri simptomi.
English: You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking ARICLAIM.
Slovenian: Svojega zdravnika obvestite, če se kateri od zgoraj naštetih simptomov pri bolniku, mlajšemu od 18 let, ki jemlje zdravilo ARICLAIM, pojavi ali poslabša.
English: If your doctor thinks that you no longer need ARICLAIM he or she will ask you to reduce your dose over at least 2 weeks before stopping treatment altogether.
Slovenian: Če bo vaš zdravnik menil, da zdravila ARICLAIM ne potrebujete več, vam bo naročil/naročila, da pred prenehanjem zdravljenja 2 tedna postopoma znižujte svoj odmerek.
English: Contents of the pack and other information What ARICLAIM contains
Slovenian: VSEBINA PAKIRANJA IN DODATNE INFORMACIJE Kaj vsebuje zdravilo ARICLAIM
English: The main ingredient of ARICLAIM, duloxetine, is used in other medicines for other conditions:
Slovenian: Poglavitno sestavino zdravila ARICLAIM, duloksetin, uporabljamo tudi v drugih zdravilih za zdravljenje drugih bolezni:
English: Use in children and adolescents under 18 years of age ARICLAIM should not be used in the treatment of children and adolescents under the age of 18 years.
Slovenian: Uporaba pri otrocih in mladostnikih, mlajših od 18 let Zdravila ARICLAIM pri zdravljenju otrok in mladostnikov, mlajših od 18 let, ne smemo uporabljati.
English: ARICLAIM increases the levels of serotonin and noradrenaline in the nervous system.
Slovenian: Zdravilo ARICLAIM zviša nivo serotonina in noradrenalina v živčnem sistemu.
English: The corresponding figures for at least 50% pain reduction were 50% and 26% respectively.
Slovenian: zmanjšanje bolečine so 50 % oziroma 26 %.
English: INFORMATION IN BRAILLE ARICLAIM 60 mg
Slovenian: PODATKI V BRAILLOVI PISAVI ARICLAIM 60 mg
English: However, the majority of common adverse reactions were mild to moderate, they usually started early in therapy, and most tended to subside even as therapy was continued.
Slovenian: Vendar je bila večina najpogostejših neželenih učinkov blagih do zmernih, navadno so se pojavili na začetku zdravljenja in večina jih je tekom nadaljevanja zdravljenja izzvenela.
English: If you take more ARICLAIM than you should
Slovenian: Če ste vzeli večji odmerek zdravila ARICLAIM, kot bi smeli
English: Other medicines and ARICLAIM
Slovenian: Druga zdravila in zdravilo ARICLAIM:
English: • night sweats, hives, cold sweats, sensitivity to sunlight, increased tendency to bruise
Slovenian: • nočno potenje, koprivnica, hladen znoj, občutljivost na sončno svetlobo, povečano nagnjenje k
English: Duloxetine is used under different trademarks in several indications (treatment of diabetic neuropathic pain, major depressive disorder, generalised anxiety disorder and stress urinary incontinence).
Slovenian: Duloksetin se pod različnimi zaščitenimi imeni uporablja za več indikacij (zdravljenje bolečine zaradi diabetične nevropatije, velikih depresivnih motenj, generalizirane anksiozne motnje in stresne urinske inkontinence).
English: − are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6)
Slovenian: - ste alergični (preobčutljivi) na duloksetin ali katerokoli drugo sestavino tega zdravila (navedeno v
English: Do not take more than the daily amount of ARICLAIM that has been prescribed for you in one day.
Slovenian: Ne zaužijte več zdravila ARICLAIM v enem dnevu, kot vam je bilo predpisano.
English: When stopping treatment with ARICLAIM the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 and 4.8).
Slovenian: Ob prenehanju zdravljenja z zdravilom ARICLAIM je treba odmerek zdravila v obdobju najmanj enega do dveh tednov postopoma zmanjševati, da zmanjšamo tveganje za pojav odtegnitvenih reakcij (glejte poglavji 4.4 in 4.8).
English: Capsule content:
Slovenian: Ovojnica kapsule:
English: ARICLAIM should normally not be used for children and adolescents under 18 years.
Slovenian: Zdravila ARICLAIM pri otrocih in mladostnikih, mlajših od 18 let, običajno ne uporabljamo.
English: How to take ARICLAIM
Slovenian: KAKO JEMATI ZDRAVILO ARICLAIM
English: ARICLAIM is indicated in adults.
Slovenian: Zdravilo ARICLAIM je indicirano za zdravljenje odraslih.
English: ARICLAIM may cause a sensation of restlessness or an inability to sit or stand still.
Slovenian: Zdravilo ARICLAIM lahko povzroči občutek nemira ali nezmožnosti sedenja ali stanja pri miru.
English: ARICLAIM is available in 2 strengths: 30 mg and 60 mg.
Slovenian: Zdravilo ARICLAIM je na voljo v dveh jakostih: 30 in 60 mg.
English: Talk with your doctor about how long you should keep taking ARICLAIM.
Slovenian: S svojim zdravnikom se pogovorite o tem, kako dolgo boste jemali zdravilo ARICLAIM.
English: • menopausal symptoms, abnormal production of breast milk in men or women
Slovenian: • nenormalen vonj urina menopavzalni simptomi, nenormalno nastajanje mleka v dojkah pri moških in ženskah
English: Although ARICLAIM is not indicated for the treatment of depression, its active ingredient (duloxetine) also exists as an antidepressant medicinal product.
Slovenian: Čeprav zdravilo ARICLAIM ni indicirano za zdravljenje depresije, njegova zdravilna učinkovina (duloksetin) obstaja tudi kot antidepresiv.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI),, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE
English: ARICLAIM 30 mg is available in packs of 7, 28 and 98 capsules.
Slovenian: Zdravilo ARICLAIM 30 mg je na voljo v pakiranju po 7, 28 in 98 kapsul.
English: Eli Lilly Ges.m.b.H.
Slovenian: Österreich Eli Lilly Ges.m.b.H.
English: If while on ARICLAIM therapy, the patient develops agitation or depressive symptoms, specialised medical advice should be sought, as depression is a serious medical condition.
Slovenian: Če bolnik med zdravljenjem z zdravilom ARICLAIM postane agitiran ali razvije simptome depresije, se je treba posvetovati s specialistom, depresija je namreč resno bolezensko stanje.
English: If you forget to take ARICLAIM
Slovenian: Če ste pozabili vzeti zdravilo ARICLAIM
English: ARICLAIM may be associated with sedation and dizziness.
Slovenian: Zdravilo ARICLAIM je lahko povezano s sedacijo in omotico.
English: ARICLAIM should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/or seizures.
Slovenian: Zdravilo ARICLAIM je treba pri bolnikih z manijo v anamnezi ali z diagnozo bipolarne motnje in/ali epileptičnimi napadi uporabljati previdno.
English: Each capsule of ARICLAIM contains pellets of duloxetine hydrochloride with a covering to protect them from stomach acid.
Slovenian: Vsaka kapsula zdravila ARICLAIM vsebuje pelete duloksetinijevega klorida z oblogo za zaščito pred želodčno kislino.
English: What ARICLAIM looks like and contents of the pack ARICLAIM is a hard gastro-resistant capsule.
Slovenian: Izgled zdravila ARICLAIM in vsebina pakiranja Zdravilo ARICLAIM je trda gastrorezistentna kapsula.
English: Orthostatic hypotension2
Slovenian: ortostatska hipotenzija2
English: Consequently, caution is advised when ARICLAIM is taken in combination with other centrally acting medicinal products or substances, including alcohol and sedative medicinal products (e.g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Slovenian: Zato je pri jemanju zdravila ARICLAIM v kombinaciji z drugimi centralno delujočimi zdravili ali snovmi, ki vključujejo alkohol in pomirjevala (denimo benzodiazepini, morfinomimetiki, antipsihotiki, fenobarbital, sedirajoči antihistaminiki), potrebna previdnost.
English: Care should be taken if you drink alcohol while you are being treated with ARICLAIM.
Slovenian: Bodite posebej previdni, če med zdravljenjem z zdravilom ARICLAIM pijete alkohol.
English: ARICLAIM 60 mg is available in packs of 28 and 98 capsules.
Slovenian: Zdravilo ARICLAIM 60 mg je na voljo v pakiranjih po 28 in 98 kapsul.
English: The efficacy of duloxetine as a treatment for diabetic neuropathic pain was established in 2 randomised, 12-week, double-blind, placebo-controlled, fixed dose studies in adults (22 to 88 years) having diabetic neuropathic pain for at least 6 months.
Slovenian: Učinkovitost duloksetina kot zdravila za bolečino pri diabetični nevropatiji so ugotavljali v 2 randomiziranih 12-tedenskih dvojno slepih s placebom kontroliranih študijah z določenim odmerkom pri odraslih (starih od 22 do 88 let), ki so imeli bolečino zaradi diabetične nevropatije vsaj 6 mesecev.
English: If you stop taking ARICLAIM
Slovenian: Če ste prenehali jemati zdravilo ARICLAIM
English: The safety and efficacy of duloxetine for the treatment of diabetic peripheral neuropathic pain has not been studied.
Slovenian: Pediatrična populacija Varnost in učinkovitost duloksetina za zdravljenje bolečine periferne diabetične nevropatije nista bili dokazani.
English: ARICLAIM may make you feel sleepy or dizzy.
Slovenian: Zdravilo ARICLAIM lahko vpliva, da se počutite zaspani ali omotični.
English: The initiation of treatment with ARICLAIM is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis (see sections 4.4 and
Slovenian: Uvedba zdravljenja z zdravilom ARICLAIM je kontraindicirana pri bolnikih z nenadzorovano hipertenzijo, ki lahko izpostavi bolnike možnemu tveganju za hipertenzivno krizo (glejte poglavje 4.4 in 4.8).
English: ARICLAIM should not be used in combination with fluvoxamine, ciprofloxacin or enoxacin (i.e. potent CYP1A2 inhibitors) since the combination results in elevated plasma concentrations of duloxetine (see section 4.5).
Slovenian: Zdravila ARICLAIM ne smemo uporabljati v kombinaciji s fluvoksaminom, ciprofloksacinom ali enoksacinom (tj. močnimi zaviralci CYP1A2), saj kombinacija povzroči povišane plazemske koncentracije duloksetina (glejte poglavje 4.5).
English: Hyponatraemia has been reported when administering ARICLAIM, including cases with serum sodium lower than 110 mmol/l.
Slovenian: Ob dajanju zdravila ARICLAIM so poročali o hiponatriemiji, vključno s primeri, ko je bila serumska koncentracija natrija pod 110 mmol/l.
English: You must wait at least 14 days after you have stopped taking an MAOI before you can take ARICLAIM.
Slovenian: Po prenehanju jemanja MAOI morate počakati vsaj 14 dni, preden lahko vzamete zdravilo ARICLAIM.
English: No studies on the effects on the ability to drive and use machines have been performed.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Študij vpliva na sposobnost vožnje in upravljanja s stroji niso izvedli.
English: Make sure your midwife and/or doctor knows you are on ARICLAIM.
Slovenian: Svoji medicinski sestri, babici in/ali zdravniku povejte, da jemljete zdravilo ARICLAIM.
English: ARICLAIM hard gastro-resistant capsules contain sucrose.
Slovenian: ARICLAIM trde gastrorezistentne kapsule vsebujejo saharozo.
English: EU/1/04/283/012 (98 hard gastro-resistant capsules)
Slovenian: EU/1/04/283/012 (98 trdih gastrorezistentnih kapsul)
English: However, as with any medicine, caution should be exercised when treating the elderly (see section 5.2).
Slovenian: Pri zdravljenju starejših je, kot pri vsakem zdravilu, potrebna posebna previdnost (glejte poglavje 5.2).
English: Hence, some patients that respond insufficiently to 60 mg may benefit from a higher dose.
Slovenian: 60 mg odmerek ne odzovejo zadostno, koristi višji odmerek.
English: Despite this, your doctor may prescribe ARICLAIM for patients under 18 because he/she decides that this is in their best interests.
Slovenian: ARICLAIM tudi bolnikom, mlajšim od 18 let, če se odloči, da je to v njihovo najboljšo korist.
English: Hyponatraemia may be due to a syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Slovenian: Hiponatremija je lahko posledica sindroma neustreznega izločanja antidiuretičnega hormona (syndrome of inappropriate anti-diuretic hormone secretion, SIADH).
English: The most commonly reported adverse reactions in patients treated with ARICLAIM were nausea, headache, dry mouth, somnolence, and dizziness.
Slovenian: Neželeni učinki, o katerih so pri bolnikih, zdravljenih z zdravilom ARICLAIM najpogosteje poročali, so bili slabost, glavobol, suha usta, somnolenca in omotica.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/283/008 (7 hard gastro-resistant capsules) EU/1/04/283/009 (28 hard gastro-resistant capsules) EU/1/04/283/010 (98 hard gastro-resistant capsules)
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/283/008 (7 trdih gastrorezistentnih kapsul) EU/1/04/283/009 (28 trdih gastrorezistentnih kapsul) EU/1/04/283/010 (98 trdih gastrorezistentnih kapsul)
English: • abnormal vaginal bleeding, abnormal periods, including heavy, painful, irregular or prolonged periods, unusually light or missed periods, pain in the testicles or scrotum
Slovenian: • neobičajna vaginalna krvavitev, neobičajna menstruacija, vključno z močno, bolečo, neredno ali podaljšano menstruacijo, neobičajna blaga ali spuščena menstruacija, bolečina v modih ali mošnji
English: ARICLAIM must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min; see section 4.3).
Slovenian: Zdravila ARICLAIM ne smemo uporabljati pri bolnikih s hudo okvarjenim delovanjem ledvic (očistek kreatinina < 30 ml/min; glejte poglavje 4.3).
English: Hard gastro-resistant capsule.
Slovenian: Trda gastrorezistentna kapsula.
English: • suicidal thoughts, difficulty sleeping, grinding or clenching the teeth, feeling disorientated, lack
Slovenian: • samomorilne misli, težave s spanjem, škrtanje ali drgetanje z zobmi, občutek zmedenosti,
English: Your doctor will tell you if you should be taking ARICLAIM.
Slovenian: Vaš zdravnik vam bo povedal, če smete jemati zdravilo ARICLAIM.
English: The antibiotic linezolid is a reversible non-selective MAOI and should not be given to patients treated with ARICLAIM (see section 4.4).
Slovenian: Antibiotik linezolid je reverzibilen, neselektiven MAOI in ga bolniki, zdravljeni z zdravilom ARICLAIM, ne smejo prejemati (glejte poglavje 4.4).
English: Based on the half-life of duloxetine, at least 5 days should be allowed after stopping ARICLAIM before starting an MAOI (see section
Slovenian: Na podlagi razpolovnega časa duloksetina pa mora po prenehanju jemanja zdravila ARICLAIM preteči vsaj 5 dni pred začetkom jemanja MAOI (glejte poglavje 4.3).
English: Tachycardia Supra-ventricular arrhythmia, mainly atrial fibrillation
Slovenian: Srčne bolezni tahikardija supraventrikularna aritmija, zlasti atrijska fibrilacija
English: In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45% of patients treated with ARICLAIM and 23% of patients taking placebo.
Slovenian: V kliničnih preskušanjih so se neželeni učinki ob nenadni prekinitvi zdravljenja pojavili pri približno 45 % bolnikov, ki so jemali zdravilo ARICLAIM in pri 23 % bolnikov, ki so dobivali placebo.
English: ARICLAIM must not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
Slovenian: Zdravila ARICLAIM ne smemo uporabljati pri bolnikih z obolenjem jeter, katerega posledica je okvarjeno delovanje jeter (glejte poglavji 4.3 in 5.2).
English: Syncope2 Hypertension3,7
Slovenian: Žilne bolezni sinkopa Hipertenzija3,7
English: • sudden involuntary jerks or twitches of the muscles, sensation of restlessness or an inability to sit or stand still, feeling nervous, difficulty concentrating, changes in sense of taste, difficulty controlling movement e.g. lack of coordination or involuntary movements of the muscles, restless legs syndrome, poor sleep quality
Slovenian: • nenadni nehoteni gibi mišic ali mišično trzanje, občutek nemira ali nezmožnosti sedenja ali stanja pri miru, živčnost, težave s koncentracijo, spremenjeno okušanje stvari, težave z nadziranjem gibov, npr. slaba koordinacija ali nehoteni gibi mišic, sindrom nemirnih nog, slaba
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/283/008
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/04/283/008
English: As with other serotonergic agents, serotonin syndrome, a potentially life-threatening condition, may occur with duloxetine treatment, particularly with concomitant use of other serotonergic agents (including SSRIs, SNRIs tricyclic antidepressants or triptans), with agents that impair metabolism of serotonin such as MAOIs, or with antipsychotics or other dopamine antagonists that may affect the serotonergic neurotransmitter systems (see sections 4.3 and 4.5).
Slovenian: Kot pri drugih serotonergičnih zdravilih se lahko tudi pri zdravljenju z duloksetinom pojavi potencialno življenjsko ogrožujoče stanje, še posebej pri sočasni uporabi drugih serotonergičnih zdravil (vključno z SSRI, SNRI, tricikličnimi antidepresivi ali triptani), zdravil, ki vplivajo na presnovo serotonina, na primer zaviralcev MAO, antipsihotikov ali drugih dopaminskih antagonistov,
English: The 60 mg capsules are blue and green and are printed with ‘60 mg' and the code ‘9542'.
Slovenian: 60 mg kapsule imajo modra in zelena z vtisnjenim napisom ‘60 mg' oznako ‘9542'.
English: Therefore ARICLAIM should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
Slovenian: Zato zdravila ARICLAIM ne smemo dajati skupaj z močnimi zaviralci CYP1A2, denimo s fluvoksaminom (glejte poglavje 4.3).
English: The 30 mg capsules are blue and white and are printed with ‘30 mg' and the code ‘9543'.
Slovenian: 30 mg kapsule imajo modra in bela z vtisnjenim napisom ‘30 mg' in oznako ‘9543'.
English: The following are reasons why ARICLAIM may not be suitable for you.
Slovenian: Opozorila in previdnostni ukrepi Spodaj so našteti razlogi, zaradi katerih morda zdravilo ARICLAIM za vas ni ustrezno.
English: ARICLAIM with food, drink and alcohol
Slovenian: Zdravilo ARICLAIM skupaj s hrano, pijačo in z alkoholom Zdravilo ARICLAIM lahko vzamete s hrano ali brez nje.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/283/011
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/04/283/011
English: • dizziness, feeling sluggish, tremor, numbness, including numbness, pricking or tingling of the
Slovenian: • omotica, občutek nezbranosti, tresenje, otrplost, vključno z otrplostjo, zbadanjem ali
English: Monoamine oxidase inhibitors (MAOIs): You should not take ARICLAIM if you are taking, or have recently taken (within the last 14 days) an antidepressant medicine called a monoamine oxidase inhibitor (MAOI).
Slovenian: Svojemu zdravniku povejte tudi, če jemljete karkoli od naslednjega: Zaviralci monoaminooksidaze (MAOI): zdravila ARICLAIM ne smete jemati, če jemljete ali ste v zadnjih 14 dneh vzeli antidepresivno zdravilo, imenovano zaviralec monoaminooksidaze (MAOI).
English: Talk to your doctor before you take ARICLAIM if you:
Slovenian: Pred jemanjem zdravila ARICLAIM se posvetujte s svojim zdravnikom, če:
English: As the safety of duloxetine in infants is not known, the use of ARICLAIM while breast-feeding is not recommended.
Slovenian: Ker varnost uporabe duloksetina pri dojenčkih ni znana,
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska
English: Dosages above 60 mg once daily, up to a maximum dose of 120 mg per day administered in evenly divided doses, have been evaluated from a safety perspective in clinical trials.
Slovenian: V kliničnih preskušanjih so z vidika varnosti vrednotili odmerjanja prek 60 mg enkrat na dan, do najvišjega odmerka 120 mg na dan v enakomernih odmerkih.
English: The use of ARICLAIM while breastfeeding is not recommended.
Slovenian: Uporabo zdravila ARICLAIM v času dojenja odsvetujemo.
English: • trouble sleeping, feeling agitated, less sex drive, anxiety, difficulty or failure to experience
Slovenian: • težave s spanjem, občutek razdraženosti, manjša želja po spolnosti, nemirnost, težave ali nezmožnost doseči orgazem, nenavadne sanje
English: In an open label long-term uncontrolled study, the pain reduction in patients responding to 8-weeks of acute treatment of ARICLAIM 60 mg once daily was maintained for a further 6-months as measured by change on the Brief Pain Inventory (BPI) 24-hour average pain item.
Slovenian: tedensko akutno zdravljenje z zdravilom ARICLAIM 60 mg enkrat na dan, ohranilo nadaljnjih 6 mesecev (merjeno s spremembo postavke 24-urne povprečne bolečine vprašalnika BPI (Brief Pain Inventory)).
English: The active substance is duloxetine.
Slovenian: Zdravilna učinkovina je duloksetin.
English: Stevens-Johnson Syndrome6
Slovenian: StevensJohnsonov sindrom angionevrotični edem6