natgillin/translations-raw huggingface dataset:
You must wait at least 14 days after you have stopped taking an MAOI before you can take ARICLAIM.
Po prenehanju jemanja MAOI morate počakati vsaj 14 dni, preden lahko vzamete zdravilo ARICLAIM.
No studies on the effects on the ability to drive and use machines have been performed.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Študij vpliva na sposobnost vožnje in upravljanja s stroji niso izvedli.
Make sure your midwife and/or doctor knows you are on ARICLAIM.
Svoji medicinski sestri, babici in/ali zdravniku povejte, da jemljete zdravilo ARICLAIM.
ARICLAIM hard gastro-resistant capsules contain sucrose.
ARICLAIM trde gastrorezistentne kapsule vsebujejo saharozo.
EU/1/04/283/012 (98 hard gastro-resistant capsules)
EU/1/04/283/012 (98 trdih gastrorezistentnih kapsul)
However, as with any medicine, caution should be exercised when treating the elderly (see section 5.2).
Pri zdravljenju starejših je, kot pri vsakem zdravilu, potrebna posebna previdnost (glejte poglavje 5.2).
Hence, some patients that respond insufficiently to 60 mg may benefit from a higher dose.
60 mg odmerek ne odzovejo zadostno, koristi višji odmerek.
Despite this, your doctor may prescribe ARICLAIM for patients under 18 because he/she decides that this is in their best interests.
ARICLAIM tudi bolnikom, mlajšim od 18 let, če se odloči, da je to v njihovo najboljšo korist.
Hyponatraemia may be due to a syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Hiponatremija je lahko posledica sindroma neustreznega izločanja antidiuretičnega hormona (syndrome of inappropriate anti-diuretic hormone secretion, SIADH).
The most commonly reported adverse reactions in patients treated with ARICLAIM were nausea, headache, dry mouth, somnolence, and dizziness.
Neželeni učinki, o katerih so pri bolnikih, zdravljenih z zdravilom ARICLAIM najpogosteje poročali, so bili slabost, glavobol, suha usta, somnolenca in omotica.
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)
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)
• abnormal vaginal bleeding, abnormal periods, including heavy, painful, irregular or prolonged periods, unusually light or missed periods, pain in the testicles or scrotum
• neobičajna vaginalna krvavitev, neobičajna menstruacija, vključno z močno, bolečo, neredno ali podaljšano menstruacijo, neobičajna blaga ali spuščena menstruacija, bolečina v modih ali mošnji
ARICLAIM must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min; see section 4.3).
Zdravila ARICLAIM ne smemo uporabljati pri bolnikih s hudo okvarjenim delovanjem ledvic (očistek kreatinina < 30 ml/min; glejte poglavje 4.3).
Hard gastro-resistant capsule.
Trda gastrorezistentna kapsula.
• suicidal thoughts, difficulty sleeping, grinding or clenching the teeth, feeling disorientated, lack
• samomorilne misli, težave s spanjem, škrtanje ali drgetanje z zobmi, občutek zmedenosti,
Your doctor will tell you if you should be taking ARICLAIM.
Vaš zdravnik vam bo povedal, če smete jemati zdravilo ARICLAIM.
The antibiotic linezolid is a reversible non-selective MAOI and should not be given to patients treated with ARICLAIM (see section 4.4).
Antibiotik linezolid je reverzibilen, neselektiven MAOI in ga bolniki, zdravljeni z zdravilom ARICLAIM, ne smejo prejemati (glejte poglavje 4.4).
Based on the half-life of duloxetine, at least 5 days should be allowed after stopping ARICLAIM before starting an MAOI (see section
Na podlagi razpolovnega časa duloksetina pa mora po prenehanju jemanja zdravila ARICLAIM preteči vsaj 5 dni pred začetkom jemanja MAOI (glejte poglavje 4.3).
Tachycardia Supra-ventricular arrhythmia, mainly atrial fibrillation
Srčne bolezni tahikardija supraventrikularna aritmija, zlasti atrijska fibrilacija
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.
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.
ARICLAIM must not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
Zdravila ARICLAIM ne smemo uporabljati pri bolnikih z obolenjem jeter, katerega posledica je okvarjeno delovanje jeter (glejte poglavji 4.3 in 5.2).
Syncope2 Hypertension3,7
Žilne bolezni sinkopa Hipertenzija3,7
• 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
• 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
MARKETING AUTHORISATION NUMBER(S) EU/1/04/283/008
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/04/283/008
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).
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,
The 60 mg capsules are blue and green and are printed with ‘60 mg' and the code ‘9542'.
60 mg kapsule imajo modra in zelena z vtisnjenim napisom ‘60 mg' oznako ‘9542'.
Therefore ARICLAIM should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
Zato zdravila ARICLAIM ne smemo dajati skupaj z močnimi zaviralci CYP1A2, denimo s fluvoksaminom (glejte poglavje 4.3).
The 30 mg capsules are blue and white and are printed with ‘30 mg' and the code ‘9543'.
30 mg kapsule imajo modra in bela z vtisnjenim napisom ‘30 mg' in oznako ‘9543'.
The following are reasons why ARICLAIM may not be suitable for you.
Opozorila in previdnostni ukrepi Spodaj so našteti razlogi, zaradi katerih morda zdravilo ARICLAIM za vas ni ustrezno.
ARICLAIM with food, drink and alcohol
Zdravilo ARICLAIM skupaj s hrano, pijačo in z alkoholom Zdravilo ARICLAIM lahko vzamete s hrano ali brez nje.
MARKETING AUTHORISATION NUMBER(S) EU/1/04/283/011
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/04/283/011
• dizziness, feeling sluggish, tremor, numbness, including numbness, pricking or tingling of the
• omotica, občutek nezbranosti, tresenje, otrplost, vključno z otrplostjo, zbadanjem ali
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).
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).
Talk to your doctor before you take ARICLAIM if you:
Pred jemanjem zdravila ARICLAIM se posvetujte s svojim zdravnikom, če:
As the safety of duloxetine in infants is not known, the use of ARICLAIM while breast-feeding is not recommended.
Ker varnost uporabe duloksetina pri dojenčkih ni znana,
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska
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.
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.
The use of ARICLAIM while breastfeeding is not recommended.
Uporabo zdravila ARICLAIM v času dojenja odsvetujemo.
• trouble sleeping, feeling agitated, less sex drive, anxiety, difficulty or failure to experience
• težave s spanjem, občutek razdraženosti, manjša želja po spolnosti, nemirnost, težave ali nezmožnost doseči orgazem, nenavadne sanje
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.
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)).
The active substance is duloxetine.
Zdravilna učinkovina je duloksetin.
Stevens-Johnson Syndrome6
StevensJohnsonov sindrom angionevrotični edem6
• 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.
• 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
ARICLAIM contains the active substance duloxetine.
Zdravilo ARICLAIM vsebuje zdravilno učinkovino duloksetin.
− are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI) (see ‘Other medicines and ARICLAIM')
- 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
MARKETING AUTHORISATION NUMBER(S) EU/1/04/283/011 (28 hard gastro-resistant capsules)
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/283/011 (28 trdih gastrorezistentnih kapsul)
Hypertensive crisis3,6
hladni periferni deli hipertenzivna kriza3,6
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT REACH AND SIGHTREACH OF CHILDREN
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN
− are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat some infections
- 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«)
The concomitant use of ARICLAIM with selective, reversible MAOIs, like moclobemide, is not recommended (see section 4.4).
Sočasno uporabo zdravila ARICLAIM s selektivnimi reverzibilnimi MAOI, kakršen je npr. moklobemid, odsvetujemo (glejte poglavje 4.4).
• “Serotonin syndrome” (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles),
• “serotoninski sindrom” (redka reakcija, ki lahko povzroči občutke velike sreče, zaspanost,
Opaque green body, imprinted with ‘60 mg' and an opaque blue cap, imprinted with ‘9542'.
Neprozorno zeleno telo z vtisnjenim napisom ‘60 mg' ter neprozoren moder pokrovček z vtisnjeno oznako ‘9542'.
Package leaflet: information for the user ARICLAIM 30 mg hard gastro-resistant capsules ARICLAIM 60 mg hard gastro-resistant capsules Duloxetine (as hydrochloride)
NAVODILO ZA UPORABO ARICLAIM 30 mg trde gastrorezistentne kapsule ARICLAIM 60 mg trde gastrorezistentne kapsule duloksetin (v obliki klorida)
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Imetnik dovoljenja za promet z zdravilom: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska.
• 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)
• 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
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Izdaja zdravila je le na recept.
Extra-pyramidal symptoms6
psihomotorični nemir6 ekstrapiramidni simptom
If you get any side effects, talk to your doctor or pharmacist.
- Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom ali s farmacevtom.
Concomitant use of ARICLAIM with nonselective, irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated (see section 4.5).
Zdravila ARICLAIM ne smemo uporabljati sočasno z neselektivnimi ireverzibilnimi zaviralci monoaminooksidaze - MAOI (glejte poglavje 4.5).
Nervous system disorders Headache
Bolezni živčevja glavobol zaspanost
• constipation, diarrhoea, stomach pain, being sick (vomiting), heartburn or indigestion, breaking
• zaprtje, driska, bolečina v trebuhu, slabost (bruhanje), zgaga ali slaba prebava, vetrovi
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
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.
Stomatitis Haematochezia Breath odour Microscopic colitis
gastroenteritis kolcanje gastritis disfagija stomatitis hematohezija slab zadah mikroskopski kolitis
Call your doctor or pharmacist immediately if you take more than the amount of ARICLAIM prescribed by your doctor.
Če vzamete večjo količino zdravila ARICLAIM, kot vam je predpisal vaš zdravnik, nemudoma pokličite svojega zdravnika ali farmacevta.
Edible green ink contains: Black iron oxide - synthetic (E172) Yellow iron oxide - synthetic (E172) Propylene glycol
Užitno zeleno črnilo: sintetični črni železov oksid (E172), sintetični rumeni železov oksid (E172),
7 hard gastro-resistant capsules 28 hard gastro-resistant capsules 98 hard gastro-resistant capsules
7 trdih gastrorezistentnih kapsul 28 trdih gastrorezistentnih kapsul 98 trdih gastrorezistentnih kapsul za peroralno uporabo Pred uporabo preberite priloženo navodilo.
Gastrointestinal disorders Nausea
Gastrointestinalna krvavitev7
What you need to know before you take ARICLAIM
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO ARICLAIM NE jemljite zdravila ARICLAIM, če:
Very rare side effects (may affect up to 1 in 10,000 people) • inflammation of the blood vessels in the skin (cutaneous vasculitis)
Občasni neželeni učinki (se lahko pojavijo pri največ 1 od 100 bolnikov) • vnetje grla, ki povzroči hripav glas
Angio-neurotic oedema6
StevensJohnsonov sindrom angionevrotičn i edem6
ARICLAIM contains sucrose.
Zdravilo ARICLAIM vsebuje saharozo.
Adverse reactions may be more common during concomitant use of ARICLAIM and herbal preparations containing St John's wort (Hypericum perforatum).
Ob sočasni uporabi zdravila ARICLAIM in pripravkov rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), so lahko neželeni učinki pogostejši.
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).
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).
Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Edible green ink
30 mg: želatina natrijev lavrilsulfat titanov dioksid (E171) indigotin (E132)
NAME OF THE MEDICINAL PRODUCT ARICLAIM 30 mg hard gastro-resistant capsules
IME ZDRAVILA ARICLAIM 30 mg trde gastrorezistentne kapsule
Infections and infestations Immune system disorders
Infekcijske in parazitske bolezni laringitis
ARICLAIM contains sucrose
Zdravilo ARICLAIM vsebuje saharozo
NAME OF THE MEDICINAL PRODUCT ARICLAIM 60 mg hard gastro-resistant capsules
IME ZDRAVILA ARICLAIM 60 mg trde gastrorezistentne kapsule
ARICLAIM is for oral use.
Zdravilo ARICLAIM jemljemo peroralno.
Musculoskeletal and connective tissue disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva napetost mišic trzanje mišic trizem
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.
(Pogosto jo opisujejo kot pekočo, zbadajočo, pikajočo, prebadajočo ali podobno stresanju elektrike.
Blood cholesterol increased
Preiskave povečanje telesne mase zvišanje krvne kreatininfosfokinaze zvišanje krvnega kalija zvišanje krvnega holesterola
Gynaecological haemorrhage Menstrual disorder Sexual dysfunction Testicular pain
Motnje reprodukcije in dojk disfunkcija motnje ejakulacije zapoznela ejakulacija ginekološka krvavitev motnje menstruacije spolna disfunkcija bolečina v testisih menopavzalni simptomi galaktoreja hiperprolaktinemija
If a decision to initiate antidepressant pharmacological therapy is taken, the gradual discontinuation of ARICLAIM is recommended (see section 4.2).
V primeru, da se zdravnik odloči za farmakološko zdravljenje z antidepresivi, svetujemo postopno ukinjanje zdravila
Suicidal behaviour5,7
motnje spanja bruksizem dezorientacija apatija samomorilno obnašanje5,7
Hypertension3,7 Orthostatic hypotension2 Peripheral coldness
zvišan krvni tlak hladni periferni deli hipertenzivna kriza3,6
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.
Čeprav se zdravilo ARICLAIM ne uporablja za zdravljenje depresije, se njegova zdravilna učinkovina (duloksetin) uporablja tudi kot antidepresiv.
Also, you need to wait at least 5 days after you stop taking ARICLAIM before you take a MAOI.
5 dni, preden lahko vzamete MAOI.
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
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).
(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.
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.
V povezavi z duloksetinom so poročali o midriazi, zato je pri predpisovanju zdravila ARICLAIM
NAME OF THE MEDICINAL PRODUCT ARICLAIM 30 mg hard gastro-resistant capsules Duloxetine
ARICLAIM 30 mg trde gastrorezistentne kapsule duloksetin
Respiratory, thoracic and mediastinal disorders Yawning
Bolezni dihal, prsnega koša in mediastinalnega prostora zehanje stisnjeno grlo epistaksa
NAME OF THE MEDICINAL PRODUCT ARICLAIM 60 mg hard gastro-resistant capsules Duloxetine
ARICLAIM 60 mg trde gastrorezistentne kapsule duloksetin
Metabolism and nutrition disorders
Presnovne in prehranske motnje hiperglikemija
- 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')
- 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)
− have liver disease
Očesne bolezni okvara vida glavkom
Convulsion
Krvavitev
Do not store above 30º C.
dezipramina narasel 3-kratno.
28 hard gastro-resistant capsules 98 hard gastro-resistant capsules
60 mg trde gastrorezistentne kapsule
You should tell your doctor if this happens to you.
Če se pri vas pojavijo taki občutki, o tem obvestite svojega zdravnika.
Ejaculation
Saharoza
Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Yellow iron oxide (E172) Edible white ink
indigotin (E132) rumeni železov oksid (E172)
− are taking other medicines containing duloxetine (see ‘Other medicines and ARICLAIM') Talk to your doctor if you have high blood pressure or heart disease.
Pogovorite se s svojim zdravnikom, če imate nenadzorovan visok krvni tlak ali srčno bolezen.
− have severe kidney disease
- imate ledvično bolezen - imeli ste epileptične napade (krče)
Very Rare disorder Ejaculation delayed disorder Sexual dysfunction Testicular pain
Ušesne bolezni, vključno z motnjami labirinta vrtoglavica ušesna bolečina
* inducing a virus neutralising antibody response in chickens of ≥ 5.0 log2
* pri piščancih vzbudi titer protiteles z nevtralizirajočim učinkom na virus ≥ 5,0 log2
The timetable for the implementation of the agreement is set out in Annex III.
Časovni razpored za izvajanje sporazuma je opredeljen v Prilogi III.
The treatment duration was up to 2 years.
Zdravljenje je trajalo do 2 leti.
Spontaneous reports
Spontana poročila
The first Marketing Authorisation in the EU was granted in France on 10 December 1982.
Prvo dovoljenje za promet z zdravilom v EU je bilo odobreno 10. decembra 1982 v Franciji.
In addition, the PRAC noted that the mechanism of these 2 adverse reactions remains unknown.
Poleg tega je PRAC upošteval, da mehanizem teh dveh neželenih učinkov še vedno ni znan.