FrancophonIA/ELRC3.0 huggingface dataset:
English: You must wait at least 14 days after you have stopped taking an MAOI before you can take Duloxetine Mylan.
Croatian: Nakon što ste prestali uzimati inhibitor MAO, morate pričekati najmanje 14 dana prije nego počnete uzimati lijek Duloxetine Mylan.
English: Rare side effects (may affect up to 1 in 1,000 people)
Croatian: Rijetke nuspojave (mogu se javiti u do 1 do 1000 osoba)
English: 49 hard gastro-resistant capsules Component of a multipack, can't be sold separately.
Croatian: Sastavni dio višekratnog pakiranja („multipack“), ne može se prodavati zasebno
English: Duloxetine Mylan may be taken with or without food.
Croatian: Duloxetine Mylan s hranom, pićem i alkoholom Duloxetine Mylan se može uzimati s hranom ili bez nje.
English: If you stop taking Duloxetine Mylan
Croatian: Ako prestanete uzimati lijek Duloxetine Mylan
English: Dizziness, sensory disturbances (including paraesthesia or electric shock like sensations, particularly in the head), sleep disturbances (including insomnia and intense dreams), fatigue, somnolence, agitation or anxiety, nausea and/or vomiting, tremor, headache, myalgia, irritability, diarrhoea, hyperhydrosis and vertigo are the most commonly reported reactions.
Croatian: Najčešće prijavljene reakcije su omaglica, senzorni poremećaji (uključujući paresteziju ili osjete nalik elektrošoku, osobito u glavi), poremećaji spavanja (uključujući nesanicu i intenzivne snove), umor, somnolencija, agitacija ili anksioznost, mučnina i/ili povraćanje, tremor, glavobolja, mialgija, razdražljivost, proljev, hiperhidroza i vrtoglavica.
English: The incidence of relapse during the 6-months double-blind follow-up period was 17% and 29% for duloxetine and placebo, respectively.
Croatian: Incidencija relapsa tijekom 6-mjesečnog razdoblja dvostruko slijepog praćenja iznosila je 17% u bolesnika koji su uzimali duloksetin i 29% u onih koji su uzimali placebo.
English: Concomitant use of Duloxetine Mylan with nonselective, irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated (see section 4.5).
Croatian: Kontraindicirana je istodobna primjena lijeka Duloxetine Mylan s neselektivnim, ireverzibilnim inhibitorima monoaminooksidaze (MAOI) (vidjeti dio 4.5).
English: If you forget to take Duloxetine Mylan
Croatian: Ako ste zaboravili uzeti lijek Duloxetine Mylan
English: Talk to your doctor before you take Duloxetine Mylan if you: - are taking other medicines to treat depression (see ‘Other medicines and Duloxetine Mylan') - 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), especially if you are pregnant
Croatian: Mylan') - ako uzimate biljni lijek gospinu travu (Hypericum perforatum) - ako imate bolest bubrega - ako ste imali napadaje (konvulzije) - ako ste imali maniju - ako patite od bipolarnog poremećaja - ako imate tegobe s očima poput određenih vrsta glaukoma (povišen očni tlak) - ako u povijesti bolesti imate poremećaje krvarenja (sklonost pojavi modrica), osobito ako ste trudni (pogledajte dio „Trudnoća i dojenje“) - imate rizik od pojave niske razine natrija (primjerice, ako uzimate diuretike, osobito ako ste starija osoba) - ako se trenutačno liječite nekim drugim lijekom koji može izazvati oštećenje jetre - ako uzimate druge lijekove koji sadrže duloksetin (pogledajte ‘Drugi lijekovi i Duloxetine
English: Absorption: Duloxetine is well absorbed after oral administration with a Cmax occurring 6 hours post dose.
Croatian: Apsorpcija: Duloksetin se nakon peroralne primjene dobro apsorbira, pri čemu se Cmax postiže
English: Mylan BV, Dieselweg 25, 3752 LB Bunschoten, The Netherlands
Croatian: Mylan Hungary Kft., Mylan utca 1, Komárom, 2900, Mađarska Mylan BV, Dieselweg 25, 3752 LB Bunschoten, Nizozemska
English: Duloxetine demonstrated statistical superiority over placebo as measured by improvement in the 17-item Hamilton Depression Rating Scale (HAM-D) total score (including both the emotional and somatic symptoms of depression).
Croatian: Hamilton Depression Rating Scale, HAM-D) zasnovanom na 17 pokazatelja (uključujući emocionalne i somatske simptome depresije).
English: • constipation, diarrhoea, stomach pain, being sick (vomiting), heartburn or indigestion, breaking wind
Croatian: • zatvor, proljev, bol u želucu, povraćanje, žgaravica ili probavne tegobe, vjetrovi
English: Edible gold ink: shellac, propylene glycol, strong ammonia solution, yellow iron oxide (E172).
Croatian: Jestiva zlatna tinta: šelak, propilenglikol, jaka otopina amonijaka, žuti željezov oksid (E172).
English: The effect of duloxetine 60 mg once a day in elderly depressed patients (≥65 years) was specifically examined in a study that showed a statistically significant difference in the reduction of the HAMD17
Croatian: Učinak duloksetina u dozi od 60 mg jednom dnevno u starijih depresivnih bolesnika (≥ 65 godina) posebno je ispitivan u ispitivanju koje je pokazalo statistički značajnu razliku u smanjenju broja bodova na HAMD17 ljestvici u bolesnika liječenih duloksetinom u odnosu na one koji su uzimali placebo.
English: Also, you need to wait at least 5 days after you stop taking Duloxetine Mylan before you take a MAOI.
Croatian: Također, nakon što ste prestali uzimati lijek Duloxetine Mylan, morate pričekati najmanje 5 dana prije nego počnete uzimati inhibitor MAO.
English: In a relapse prevention study, patients responding to 12-weeks of acute treatment with open-label duloxetine 60 mg once daily were randomised to either duloxetine 60 mg once daily or placebo for a further 6-months.
Croatian: U ispitivanju prevencije relapsa, bolesnici koji su reagirali na otvoreno akutno liječenje duloksetinom u dozi od 60 mg jednom dnevno u trajanju od 12 tjedana randomizirani su ili u skupinu koja je sljedećih 6 mjeseci uzimala duloksetin u dozi od 60 mg jednom dnevno ili u skupinu koja je uzimala placebo.
English: - are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI) (see ‘Other medicines and Duloxetine Mylan') - are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat some infections - are taking other medicines containing duloxetine (see ‘Other medicines and Duloxetine Mylan')
Croatian: − ako uzimate ili ste u posljednjih 14 dana uzimali drugi lijek koji se zove inhibitor monoaminooksidaze (MAOI) (pogledajte ‘Drugi lijekovi i Duloxetine Mylan')
English: Duloxetine Mylan may make you feel sleepy or dizzy.
Croatian: Duloxetine Mylan može izazvati pospanost ili omaglicu.
English: 49 hard gastro-resistant capsules
Croatian: 49 tvrdih želučanootpornih kapsula
English: Adverse reactions may be more common during concomitant use of Duloxetine Mylan and herbal preparations containing St John's wort (Hypericum perforatum).
Croatian: Pri istodobnom uzimanju lijeka Duloxetine Mylan i biljnih pripravaka koji sadrže gospinu travu (Hypericum perforatum) nuspojave mogu biti češće.
English: • feeling sick (nausea), dry mouth
Croatian: • mučnina, suha usta
English: The concomitant use of Duloxetine Mylan with selective, reversible MAOIs, like moclobemide, is not recommended (see section 4.4).
Croatian: Ne preporučuje se istodobna primjena lijeka Duloxetine Mylan sa selektivnim reverzibilnim inhibitorima MAO, poput moklobemida (vidjeti dio 4.4).
English: Hard gastro-resistant capsule
Croatian: Tvrda želučanootporna kapsula
English: There may be loss of feeling in the affected area, or sensations such as touch,
Croatian: Moguć je gubitak osjeta u zahvaćenom području ili osjeti poput dodira, topline, hladnoće ili pritiska mogu izazvati bol).
English: Puh/Tel: +358 20 720 9555
Croatian: Suomi/Finland Mylan Finland OY Puh/Tel: +358 20 720 9555
English: How to store Duloxetine Mylan
Croatian: Kako čuvati lijek Duloxetine Mylan
English: The 60 mg capsules have an opaque blue cap and opaque yellow body, imprinted in white ink with ‘MYLAN' over ‘DL 60' on both the cap and the body.
Croatian: 60 mg kapsule imaju neprozirnu plavu kapicu i neprozirno tijelo žute boje s oznakom "MYLAN" otisnutom bijelom tintom iznad oznake "DL 60" na kapici i na tijelu.
English: Do not eat the desiccant.
Croatian: Sredstvo za sušenje ne smije se pojesti.
English: Opaque blue cap and opaque yellow body approximately 21.7 mm, imprinted in white ink with ‘MYLAN' over ‘DL 60' on both the cap and the body.
Croatian: Neprozirna plava kapica i neprozirno tijelo žute boje približne duljine 21,7 mm, s oznakom "MYLAN" otisnutom bijelom tintom iznad oznake "DL 60" na kapici i na tijelu.
English: How to take Duloxetine Mylan
Croatian: Kako uzimati lijek Duloxetine Mylan
English: Yellow iron oxide (E172) Titanium dioxide (E171) Gelatin
Croatian: Brilliant blue (E133) žuti željezov oksid (E172) titanijev dioksid (E171) želatina bijela tinta
English: Propylene glycol Strong ammonia solution Yellow iron oxide (E172)
Croatian: Zlatna tinta sadrži šelak propilenglikol jaku otopinu amonijaka žuti željezov oksid (E172)
English: Opaque blue cap and opaque white body approximately 15.9 mm, imprinted in gold ink with ‘MYLAN' over ‘DL 30' on both the cap and the body.
Croatian: Neprozirna plava kapica i neprozirno tijelo bijele boje približne duljine 15,9 mm, s oznakom "MYLAN" otisnutom zlatnom tintom iznad oznake "DL 30" na kapici i na tijelu.
English: The use of Duloxetine Mylan while breast-feeding is not recommended.
Croatian: Ne preporučuje se uzimanje lijeka Duloxetine Mylan za vrijeme dojenja.
English: 60 mg capsules Each capsule contains 60 mg of duloxetine (as hydrochloride).
Croatian: 60 mg kapsule Jedna kapsula sadrži 60 mg duloksetina (u obliku duloksetinklorida).
English: Each capsule contains 30 mg or 60 mg of duloxetine (as hydrochloride).
Croatian: Jedna kapsula sadrži 30 mg ili 60 mg duloksetina (u obliku duloksetinklorida).
English: The 30 mg capsules have an opaque blue cap and opaque white body, imprinted in gold ink with ‘MYLAN' over ‘DL 30' on both the cap and the body.
Croatian: 30 mg kapsule imaju neprozirnu plavu kapicu i neprozirno tijelo bijele boje s oznakom "MYLAN" otisnutom zlatnom tintom iznad oznake "DL 30" na kapici i na tijelu.
English: Suicidal ideation Sleep disorder Bruxism Disorientation Apathy
Croatian: Psihijatrijski poremećaji nesanica agitacija smanjen libido anksioznost abnormalni orgazam abnormalni snovi suicidalne misli poremećaj spavanja bruksizam dezorijentacija apatija suicidalno ponašanje manija halucinacije agresija i bijes
English: Gynaecological haemorrhage Menstrual disorder Sexual dysfunction Testicular pain
Croatian: Poremećaji reproduktivnog sustava i dojki erektilna disfunkcija poremećaj ejakulacije odgođena ejakulacija ginekološko krvarenje menstrualni poremećaj seksualna disfunkcija bol u testisima simptomi menopauze galaktoreja hiperprolaktinemija poslijeporođajno krvarenje
English: PVC/PE/PVdC/Aluminium perforated unit dose blister pack containing 7 x 1 and 28 x 1 hard gastro-resistant capsules.
Croatian: Pakiranje s PVC/PVdC/aluminij perforiranim blisterima djeljivima na jedinične doze koji sadrži 7 x 1 i 28 x 1 tvrdu želučanootpornu kapsulu.
English: PVC/PCTFE/Aluminium or OPA/Aluminium/PVC - Aluminium perforated unit dose blister pack containing 7 x 1, 28 x 1 and 30 x 1 hard gastro-resistant capsules.
Croatian: Pakiranje s PVC/PCTFE/aluminij perforiranim blisterima ili s OPA/aluminij/PVC-aluminij perforiranim blisterima, djeljivima na jedinične doze koji sadrži 7 x 1, 28 x 1 i 30 x 1 tvrdu želučanootpornu kapsulu.
English: CLINICAL PARTICULARS
Croatian: Posebne skupine bolesnika
English: Syncope Hypertension Orthostatic hypotension Peripheral coldness
Croatian: Krvožilni poremećaji povišen krvni tlak crvenilo uz osjećaj vrućine sinkopa hipertenzija ortostatska hipotenzija periferna hladnoća hipertenzivna kriza
English: 30 mg capsules Capsule shell Brilliant blue (E133) Titanium dioxide (E171) Gelatin
Croatian: Brilliant blue (E133) titanijev dioksid (E171) želatina zlatna tinta
English: • muscle pain, muscle spasm
Croatian: • bol u mišićima, grč mišića
English: Dosages above 60 mg once daily, up to a maximum dose of 120 mg per day have been evaluated from a safety perspective in clinical trials.
Croatian: U kliničkim je ispitivanjima ocijenjena sigurnost primjene doza većih od 60 mg jednom dnevno, do najviše 120 mg na dan primijenjenih u ravnomjerno podijeljenim dozama.
English: Duloxetine Mylan 60 mg hard gastro-resistant capsules duloxetine
Croatian: Duloxetine Mylan 60 mg tvrde želučanootporne kapsule duloksetin
English: Duloxetine Mylan 30 mg hard gastro-resistant capsules Duloxetine Mylan 60 mg hard gastro-resistant capsules duloxetine (as hydrochloride)
Croatian: Duloxetine Mylan 30 mg tvrde želučanootporne kapsule Duloxetine Mylan 60 mg tvrde želučanootporne kapsule duloksetin (u obliku duloksetinklorida)
English: Hard gastro-resistant capsules
Croatian: Tvrde želučanootporne kapsule
English: Mydriasis Visual impairment
Croatian: Tablični prikaz nuspojava
English: Duloxetine Mylan 30 mg hard gastro-resistant capsules duloxetine
Croatian: Duloxetine Mylan 30 mg tvrde želučanootporne kapsule duloksetin
English: Duloxetine Mylan 30 mg hard gastro-resistant capsules Duloxetine Mylan 60 mg hard gastro-resistant capsules
Croatian: Duloxetine Mylan 30 mg tvrde želučanootporne kapsule Duloxetine Mylan 60 mg tvrde želučanootporne kapsule
English: PVC/PCTFE/Aluminium or OPA/Aluminium/PVC - Aluminium perforated unit dose blister pack containing 28 x 1, 30 x 1 and 100 x 1 hard gastro resistant capsules PVC/PE/PVdC/Aluminium perforated unit dose blister pack containing 28 x 1 hard gastro-resistant capsules.
Croatian: Pakiranje s PVC/PCTFE/aluminij perforiranim blisterima ili s OPA/aluminij/PVC-aluminij perforiranim blisterima, djeljivima na jedinične doze koji sadrži 28 x 1, 30 x 1 i 100 x 1 tvrdu želučanootpornu kapsulu.
English: 30 mg capsules EU/1/15/1010/001 EU/1/15/1010/002 EU/1/15/1010/003 EU/1/15/1010/004 EU/1/15/1010/005 EU/1/15/1010/006 EU/1/15/1010/007 EU/1/15/1010/008 EU/1/15/1010/009 EU/1/15/1010/010 EU/1/15/1010/021 EU/1/15/1010/022 EU/1/15/1010/023 EU/1/15/1010/024 EU/1/15/1010/025 EU/1/15/1010/026 EU/1/15/1010/027 EU/1/15/1010/028 EU/1/15/1010/037 EU/1/15/1010/038 EU/1/15/1010/041 EU/1/15/1010/042 EU/1/15/1010/043 EU/1/15/1010/044 EU/1/15/1010/045 EU/1/15/1010/046 EU/1/15/1010/047 EU/1/15/1010/048
Croatian: 30 mg kapsule EU/1/15/1010/001 EU/1/15/1010/002 EU/1/15/1010/003 EU/1/15/1010/004 EU/1/15/1010/005 EU/1/15/1010/006 EU/1/15/1010/007 EU/1/15/1010/008 EU/1/15/1010/009 EU/1/15/1010/010 EU/1/15/1010/021 EU/1/15/1010/022 EU/1/15/1010/023 EU/1/15/1010/024 EU/1/15/1010/025 EU/1/15/1010/026 EU/1/15/1010/027 EU/1/15/1010/028 EU/1/15/1010/037 EU/1/15/1010/038 EU/1/15/1010/041 EU/1/15/1010/042 EU/1/15/1010/043 EU/1/15/1010/044 EU/1/15/1010/045 EU/1/15/1010/046 EU/1/15/1010/047 EU/1/15/1010/048
English: BOTTLE LABEL FOR 60 MG HARD GASTRO RESISTANT CAPSULES
Croatian: NALJEPNICA ZA BOČICU ZA 60 MG TVRDE ŽELUČANOOTPORNE KAPSULE
English: Symptoms of overdose include sleepiness, coma, serotonin syndrome (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), fits, vomiting and fast heart rate.
Croatian: (rijetka reakcija koja može izazvati osjećaj velike sreće, omamljenost, nespretnost, nemir, osjećaj poput opijenosti, vrućicu, znojenje ili ukočenost mišića), napadaje, povraćanje i ubrzan rad srca.
English: Urine odour abnormal
Croatian: • nenormalan miris mokraće
English: PVC/PE/PVdC/Aluminium blister pack containing 7, 14, 28, 49, 98 and multipacks containing 98 (2 packs of 49) hard gastro resistant capsules.
Croatian: Pakiranje s PVC/PE/PVdC/aluminij blisterima koji sadrži 7, 14, 28, 49, 98 želučanootpornih kapsula i višekratno pakiranje („multipack“) koje sadrži 98 (2 pakiranja od 49) tvrdih želučanootpornih kapsula.
English: PVC/PE/PVdC/Aluminium blister pack containing 14, 28, 49, 98 and multipacks containing 98 (2 packs of 49) hard gastro-resistant capsules.
Croatian: Pakiranje s PVC/PE/PVdC/aluminij blisterima koji sadrži 14, 28, 49, 98 želučanootpornih kapsula i višekratno pakiranje („multipack“) koje sadrži 98 (2 pakiranja od 49) tvrdih želučanootpornih kapsula.
English: BLISTER OUTER CARTON FOR MULTIPACK FOR 60 MG HARD GASTRO RESISTANT CAPSULES, WITH BLUE BOX
Croatian: VANJSKA KUTIJA BLISTERA ZA 60 MG TVRDE ŽELUČANOOTPORNE KAPSULE ZA VIŠEKRATNO („MULTIPACK“) PAKIRANJE S BLUE BOX
English: Constipation Diarrhoea Abdominal pain Vomiting Dyspepsia Flatulence
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja zijevanje stezanje u grlu epistaksa intersticijska plućna bolest eozinofilna pneumonija
English: BLISTER CARTON FOR 30 MG HARD GASTRO RESISTANT CAPSULES
Croatian: KUTIJA BLISTERA ZA 30 MG TVRDE ŽELUČANOOTPORNE KAPSULE
English: BLISTER OUTER CARTON FOR MULTIPACK FOR 30 MG HARD GASTRO RESISTANT CAPSULES, WITH BLUE BOX
Croatian: VANJSKA KUTIJA BLISTERA ZA 30 MG TVRDE ŽELUČANOOTPORNE KAPSULE ZA VIŠEKRATNO („MULTIPACK“) PAKIRANJE S BLUE BOX
English: Serotonin syndrome Convulsion Psychomotor restlessness Extra-pyramidal symptoms
Croatian: Poremećaji živčanog sustava glavobolja somnolencija omaglica letargija tremor parestezija mioklonus akatizija nervoza smetnje pozornosti disgeuzija diskinezija sindrom nemirnih nogu loša kvaliteta sna serotoninski sindrom konvulzije psihomotorni nemir ekstrapiramidni simptomi
English: Each capsule contains 60 mg of duloxetine (as hydrochloride).
Croatian: Jedna kapsula sadrži 60 mg duloksetina (u obliku duloksetinklorida)
English: • contraction of the jaw muscle
Croatian: • stezanje mišića čeljusti
English: BLISTER CARTON FOR 60 MG HARD GASTRO RESISTANT CAPSULES
Croatian: KUTIJA BLISTERA ZA 60 MG TVRDE ŽELUČANOOTPORNE KAPSULE
English: Tel: +39 02 612 46921
Croatian: Mylan Italia S.r.l. Tel: + 39 02 612 46921
English: BOTTLE CARTON FOR 60 MG HARD GASTRO RESISTANT CAPSULES
Croatian: KUTIJA BOČICE ZA 60 MG TVRDE ŽELUČANOOTPORNE KAPSULE
English: BOTTLE LABEL FOR 30 MG HARD GASTRO RESISTANT CAPSULES
Croatian: NALJEPNICA NA BOČICI ZA 30 MG TVRDE ŽELUČANOOTPORNE KAPSULE
English: BOTTLE CARTON FOR 30 MG HARD GASTRO RESISTANT CAPSULES
Croatian: KUTIJA BOČICE ZA 30 MG TVRDE ŽELUČANOOTPORNE KAPSULE
English: PVC/PCTFE/Aluminium or OPA/Aluminium/PVC - Aluminium blister pack containing 14, 28, 84, 98 and multipacks containing 98 (2 packs of 49) hard gastro resistant capsules.
Croatian: Pakiranje s PVC/PCTFE/aluminij ili s OPA/aluminij/PVC-aluminij blisterima koje sadrži 14, 28, 84, 98 tvrdih želučanootpornih kapsula i višekratno pakiranje („multipack“) koje sadrži 98 kapsula u dvije kutije od kojih svaka sadrži 49 tvrdih želučanootpornih kapsula.
English: Pollakiuria
Croatian: OBLIK
English: Chest pain Feeling abnormal Feeling cold Thirst
Croatian: Opći poremećaji i reakcije na mjestu primjene padovi umor bol u prsištu neuobičajeno osjećanje osjećaj hladnoće žeđ zimica malaksalost osjećaj vrućine smetnje hoda
English: PVC/PCTFE/Aluminium or OPA/Aluminium/PVC - Aluminium blister pack containing 7, 14, 28, 98 and multipacks containing 98 (2 packs of 49) hard gastro-resistant capsules.
Croatian: Pakiranje s PVC/PCTFE/aluminij blisterima ili s OPA/aluminij/PVC-aluminij blisterima koje sadrži 7, 14, 28, 98 tvrdih želučanootpornih kapsula i višekratno pakiranje („multipack“) koje sadrži 98 kapsula u dvije kutije od kojih svaka sadrži 49 tvrdih želučanootpornih kapsula.
English: EU/1/15/1010/016 EU/1/15/1010/017 EU/1/15/1010/018 EU/1/15/1010/019 EU/1/15/1010/020 EU/1/15/1010/029 EU/1/15/1010/030 EU/1/15/1010/031 EU/1/15/1010/032 EU/1/15/1010/033 EU/1/15/1010/034 EU/1/15/1010/035 EU/1/15/1010/036 EU/1/15/1010/039 EU/1/15/1010/040 EU/1/15/1010/049 EU/1/15/1010/050 EU/1/15/1010/051 EU/1/15/1010/052 EU/1/15/1010/053 EU/1/15/1010/054
Croatian: 60 mg kapsule EU/1/15/1010/011 EU/1/15/1010/012 EU/1/15/1010/013 EU/1/15/1010/014 EU/1/15/1010/015 EU/1/15/1010/016 EU/1/15/1010/017 EU/1/15/1010/018 EU/1/15/1010/019 EU/1/15/1010/020 EU/1/15/1010/029 EU/1/15/1010/030 EU/1/15/1010/031 EU/1/15/1010/032 EU/1/15/1010/033 EU/1/15/1010/034 EU/1/15/1010/035 EU/1/15/1010/036 EU/1/15/1010/039 EU/1/15/1010/040 EU/1/15/1010/049 EU/1/15/1010/050 EU/1/15/1010/051 EU/1/15/1010/052
English: In a relapse prevention study, patients responding to 6 months of acute treatment with open-label duloxetine were randomised to either duloxetine or placebo for a further 6-months.
Croatian: U ispitivanju prevencije relapsa bolesnici koji su reagirali na otvoreno akutno liječenje duloksetinom u dozi od 60 mg jednom dnevno u trajanju od 6 mjeseci randomizirani su ili u skupinu koja je sljedećih 6 mjeseci uzimala duloksetin ili u skupinu koja je uzimala placebo.
English: If you take more Duloxetine Mylan than you should Call your doctor or pharmacist immediately if you take more than the amount of Duloxetine Mylan prescribed by your doctor.
Croatian: Ako uzmete više lijeka Duloxetine Mylan nego što ste trebali
English: BLISTER INNER CARTON FOR MULTIPACK FOR 60 MG HARD GASTRO RESISTANT CAPSULES, WITHOUT BLUE BOX
Croatian: UNUTARNJA KUTIJA BLISTERA ZA 60 MG TVRDE ŽELUČANOOTPORNE KAPSULE ZA VIŠEKRATNO („MULTIPACK“) PAKIRANJE S BLUE BOX
English: • throat tightness, nose bleeds
Croatian: • stezanje u grlu, krvarenje iz nosa
English: BLISTER INNER CARTON FOR MULTIPACK FOR 30 MG HARD GASTRO RESISTANT CAPSULES, WITHOUT BLUE BOX
Croatian: UNUTARNJA KUTIJA BLISTERA ZA 30 MG TVRDE ŽELUČANOOTPORNE KAPSULE ZA VIŠEKRATNO („MULTIPACK“) PAKIRANJE S BLUE BOX
English: Duloxetine Mylan 60 mg is available in blister packs of 14, 28, 49, 84, 98 and in a multipack of 98 comprising 2 cartons, each containing 49 capsules, in perforated blister packs containing 28 x 1, 30 x 1, and 100 x 1capsules and bottles containing 30, 100, 250 and 500 capsules and a desiccant.
Croatian: kapsula; u perforiranim blister pakiranjima koja sadrže 28 x 1, 30 x 1 i 100 x 1 kapsulu i bočicama koje sadrže 30, 100, 250 i 500 kapsula i sredstvo za sušenje.
English: Sugar spheres (sucrose, maize starch) Hypromellose
Croatian: Sadržaj kapsule šećerne kuglice (saharoza, kukuruzni škrob) hipromeloza makrogol krospovidon talk saharoza hipromelozaftalat dietilftalat
English: Duloxetine Mylan is for oral use.
Croatian: Duloxetine Mylan se uzima kroz usta.
English: Posology
Croatian: DODATAK
English: The main ingredient of Duloxetine Mylan, duloxetine, is used in other medicines for other conditions: • diabetic neuropathic pain, depression, anxiety and urinary incontinence
Croatian: • bol kod dijabetičke neuropatije, depresije, tjeskobe i inkontinencije mokraće
English: Salomone Pharma Ltd. Tel: + 356 21 22 01 74
Croatian: Mylan Healthcare d.o.o. Tel: + 386 1 23 63 180
English: Gastrointestinal haemorrhage Gastroenteritis Eructation Gastritis Dysphagia
Croatian: Poremećaji probavnog sustava mučnina suha usta konstipacija proljev bol u abdomenu povraćanje dispepsija flatulencija gastrointestinalno krvarenje gastroenteritis podrigivanje gastritis disfagija stomatitis svježa krv u stolici neugodan zadah mikroskopski kolitis
English: Magyarország Mylan EPD Kft Tel: + 36 1 465 2100
Croatian: Mylan Hrvatska d.o.o. Tel: +385 1 23 50 599
English: No. 1 Croydon,
Croatian: 1 Croydon,
English: List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, applicants and marketing authorisation holders in the member states
Croatian: Popis naziva, farmaceutskog oblika, jačina lijekova, puta primjene, podnositelja zahtjeva i nositelja odobrenja u državama članicama
English: 2403 EG Alphen aan den Rijn
Croatian: 2403 EG Alphen aan den Rijn The Netherlands
English: Concentrate for solution for infusion
Croatian: koncentrat za otopinu za infuziju u venu
English: VASONASE 1 mg/ml solución para perfusión
Croatian: VASONASE 1 mg/ml solución para perfusión otopina za infuziju u venu
English: Ericapark 38
Croatian: Magenta Pharma Consulting Ericapark 38
English: Astellas Pharma B.V. Sylviusweg 62
Croatian: Sylviusweg 62
English: 1 mg/ml (5ml)
Croatian: 1 mg/ml (5 ml) otopina za injekciju u venu
English: Belgium
Croatian: FRANCE
English: Drink it straight away.
Croatian: Odmah popijte.
English: Do not take two doses in one day.
Croatian: Ne uzimajte dvostruku dozu u jednom danu.