natgillin/translations-raw huggingface dataset:
Estimated frequency of post-marketing surveillance reported adverse reactions; not observed in placebocontrolled clinical trials. 
Ocenjena pogostnost pojava neželenih učinkov v študijah iz obdobja trženja zdravila; omenjenih učinkov v s placebom nadzorovanih kliničnih študijah niso opazili.
The active substance is duloxetine. 
Učinkovina je duloksetin.
unusual dreams 
Pomožne snovi
Edible gold ink: shellac, propylene glycol, strong ammonia solution, yellow iron oxide (E172). 
Užitno zlato črnilo: šelak, propilenglikol, amoniak, koncentrirana raztopina, rumeni železov oksid (E172).
How to take Duloxetine Mylan 
Kako jemati zdravilo Duloksetin Mylan
Concomitant use of Duloxetine Mylan with nonselective, irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated (see section 4.5). 
Zdravila Duloksetin Mylan ne smemo uporabljati sočasno z neselektivnimi ireverzibilnimi zaviralci monoaminooksidaze - MAOI (glejte poglavje 4.5).
Caution is advisable if Duloxetine Mylan 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). 
Če zdravilo Duloksetin Mylan uporabljamo sočasno s serotonergičnimi zdravili, kot so SSRI, SNRI, s tricikličnimi antidepresivi, 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).
Cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.4). 
Med zdravljenjem z duloksetinom ali kmalu po prekinitvi zdravljenja so poročali o primerih samomorilnih misli in samomorilnega vedenja (glejte poglavje 4.4).
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 
Mylan«) - jemljete šentjanževko, zdravilo rastlinskega izvora (Hypericum perforatum) - imate ledvično bolezen - ste imeli epileptične napade (krče) - ste imeli manijo - imate bipolarno motnjo - imate težave z očmi, denimo določene vrste glavkoma (zvišan očesni tlak) - ste v preteklosti imeli motnje strjevanja krvi (nagnjenost k razvoju podplutb), sploh če ste noseči (glejte ‘Nosečnost in dojenje‘) - imate tveganje za nizek nivo natrija (če na primer jemljete diuretike, sploh če ste starejši) - se trenutno zdravite z drugimi zdravili, ki lahko povzročijo poškodbo jeter - jemljete druga zdravila, ki vsebujejo duloksetin (glejte »Druga zdravila in zdravilo Duloksetin
- 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') 
Ne jemljite zdravila Duloksetin Mylan, če: - ste alergični na duloksetin ali katerokoli drugo sestavino tega zdravila (navedeno v poglavju 6) - imate obolenje jeter - imate hudo obolenje ledvic - jemljete ali ste v zadnjih 14 dneh jemali drugo antidepresivno zdravilo, imenovano zaviralec monoaminooksidaze (MAOI) (glejte »Druga zdravila in zdravilo Duloksetin Mylan«) - jemljete fluvoksamin, ki se običajno uporablja za zdravljenje depresije, ciprofloksacin ali enoksacin, ki se uporablja za zdravljenje nekaterih okužb
Syncope Hypertension Orthostatic hypotension Peripheral coldness 
Žilne bolezni zvišan krvni tlak rdečica sinkopa hipertenzija ortostatska hipotenzija hladne okončine hipertenzivna kriza
There was no statistically significant difference in discontinuation due to adverse events between duloxetine and placebo groups during the 10 week acute treatment phase. 
Med skupino z duloksetinom in skupino s placebom v 10tedenski fazi akutnega zdravljenja ni bilo statistično pomembne razlike v prekinitvi zdravljenja zaradi neželenih učinkov.
Hepatic failure Jaundice 
Okvarjeno delovanje ledvic
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. 
60 mg kapsule imajo rumeno neprozorno telo in moder neprozoren pokrovček ter z belim črnilom vtisnjeno oznako ‘MYLAN' preko 'DL 60' na pokrovčku in telesu kapsule.
heat, cold or pressure may cause pain) 
V prizadetem področju lahko pride do izgube zaznavanja, ali pa lahko občutki, denimo dotik, toplota, mraz ali pritisk, povzročajo bolečino)
The efficacy and safety of duloxetine 30-120 mg once daily in elderly patients with generalised anxiety disorder was similar to that seen in studies of younger adult patients. 
120 mg enkrat na dan pri starejših bolnikih z generalizirano anksiozno motnjo sta bili podobni kot vštudijah z mlajšimi odraslimi bolniki.
Gastrointestinal disorders Nausea 
gastrointestinalna krvavitev gastroenteritis,
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. 
PVC/PCTFE/aluminijevi ali OPA/Al/PVC - aluminijevi perforirani enoodmerni pretisni omoti s po 7 x 1, 28 x 1 in 30 x 1 trdo gastrorezistentno kapsulo.
You should ask your doctor or pharmacist for advice. 
Posvetujte se z zdravnikom ali farmacevtom.
Medicinal products metabolised by CYP1A2: The pharmacokinetics of theophylline, a CYP1A2 substrate, were not significantly affected by co-administration with duloxetine (60 mg twice daily). 
Sočasno dajanje duloksetina (60 mg dvakrat na dan) ni značilno vplivalo na farmakokinetiko teofilina, substrata CYP1A2.
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. 
30 mg kapsule imajo belo neprozorno telo in moder neprozoren pokrovček ter z zlatim črnilom vtisnjeno oznako ‘MYLAN' preko 'DL 30' na pokrovčku in telesu kapsule.
The use of Duloxetine Mylan while breast-feeding is not recommended. 
Uporabo zdravila Duloksetin Mylan v času dojenja odsvetujemo.
Method of administration For oral use. 
Način uporabe peroralna uporaba
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 
Pri starejših depresivnih bolnikih ( 65 let) so posebej preučevali učinek duloksetina 60 mg enkrat na dan v študiji, ki je pokazala statistično pomembno razliko v zmanjšanju HAMD17 rezultata za bolnike, ki so bili zdravljeni z duloksetinom, v primerjavi s tistimi, ki so prejemali placebo.
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. 
Rumena neprozorna kapsula z modrim neprozornim pokrovčkom, velikosti priližno 21,7 mm in z belim črnilom vtisnjeno oznako ‘MYLAN' preko 'DL 60', na pokrovčku in telesu kapsule.
• increased pressure in the eye (glaucoma) 
• zvišan očesni tlak (glavkom)
60 mg capsules Each capsule contains 60 mg of duloxetine (as hydrochloride). 
60 mg kapsule Ena kapsula vsebuje 60 mg duloksetina (v obliki duloksetinijevega klorida).
Duloxetine Mylan with food, drink and alcohol 
Zdravilo Duloksetin Mylan skupaj s hrano, pijačo in alkoholom Zdravilo Duloksetin Mylan lahko vzamete s hrano ali brez nje.
60 mg capsules 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 
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
Each capsule contains 30 mg or 60 mg of duloxetine (as hydrochloride). 
Ena kapsula vsebuje 30 mg ali 60 mg duloksetina (v obliki duloksetinijevega klorida).
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. 
Bela neprozorna kapsula z modrim neprozornim pokrovčkom, velikosti približno 15,9 mm in z zlatim črnilom vtisnjeno oznako ‘MYLAN' preko 'DL 30' na pokrovčku in telesu kapsule.
• blurred eyesight 
• zamegljen vid
Adverse reactions may be more common during concomitant use of Duloxetine Mylan and herbal preparations containing St John's wort (Hypericum perforatum). 
Ob sočasni uporabi zdravila Duloksetin Mylan in pripravkov rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), so lahko neželeni učinki pogostejši.
What Duloxetine Mylan contains 
Kaj vsebuje zdravilo Duloksetin Mylan
PVC/PE/PVdC/Aluminium perforated unit dose blister pack containing 7 x 1 and 28 x 1 hard gastro-resistant capsules. 
PVC/PE/PVdC/aluminijevi perforirani enoodmerni pretisni omoti s po 7 x 1 in 28 x 1 trdo gastrorezistentno kapsulo.
Duloxetine Mylan 30 mg hard gastro-resistant capsules Duloxetine Mylan 60 mg hard gastro-resistant capsules duloxetine (as hydrochloride) 
Duloksetin Mylan 30 mg trde gastrorezistentne kapsule Duloksetin Mylan 60 mg trde gastrorezistentne kapsule duloksetin (v obliki duloksetinijevega klorida)
Malaise 
Midriaza
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. 
PVC/PCTFE/aluminijevi ali OPA/Al/PVC - aluminijevi perforirani enoodmerni pretisni omoti s po 28 x 1, 30 x 1, 100 x 1 trdo gastrorezistentno kapsulo.
How to store Duloxetine Mylan 
Shranjevanje zdravila Duloksetin Mylan
Yellow iron oxide (E172) Titanium dioxide (E171) Gelatin 
Belo črnilo vsebuje šelak propilenglikol natrijev hidroksid povidon titanov dioksid (E171)
Duloxetine Mylan 60 mg hard gastro-resistant capsules duloxetine 
Duloksetin Mylan 60 mg trde gastrorezistentne kapsule duloksetin
Anticoagulants and antiplatelet agents: Caution should be exercised when duloxetine is combined with oral anticoagulants or antiplatelet agents due to a potential increased risk of bleeding attributable to a pharmacodynamic interaction. 
Zaradi možnega povečanega tveganja za krvavitev, ki ga lahko pripišemo farmakodinamični interakciji, je potrebna previdnost pri kombinaciji duloksetina s peroralnimi antikoagulanti ali antitrombotičnimi zdravili.
Duloxetine Mylan 30 mg hard gastro-resistant capsules duloxetine 
Duloksetin Mylan 30 mg trde gastrorezistentne kapsule duloksetin
BLISTER INNER CARTON FOR MULTIPACK FOR 60 MG HARD GASTRO RESISTANT CAPSULES, WITHOUT BLUE BOX 
VMESNA ŠKATLA SKUPNEGA PAKIRANJA ZA 60 MG TRDE GASTROREZISTENTNE KAPSULE (BREZ MODREGA OKENCA)
Duloxetine Mylan 30 mg hard gastro-resistant capsules Duloxetine Mylan 60 mg hard gastro-resistant capsules 
Duloksetin Mylan 30 mg trde gastrorezistentne kapsule Duloksetin Mylan 60 mg trde gastrorezistentne kapsule
BLISTER INNER CARTON FOR MULTIPACK FOR 30 MG HARD GASTRO RESISTANT CAPSULES, WITHOUT BLUE BOX 
VMESNA ŠKATLA SKUPNEGA PAKIRANJA ZA 30 MG TRDE GASTROREZISTENTNE KAPSULE (BREZ MODREGA OKENCA)
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. 
PVC/PCTFE/aluminijevi ali OPA/Al/PVC - aluminijevi pretisni omoti s po 14, 28, 84, 98 in skupno pakiranje s po 98 (2 škatli po 49) trdih gastrorezistentnih kapsul.
There have been reports of bleeding abnormalities, such as ecchymoses, purpura and gastrointestinal haemorrhage with selective serotonin reuptake inhibitors (SSRIs) and serotonin/noradrenaline reuptake inhibitors (SNRIs), including duloxetine. 
Pri selektivnih zaviralcih privzema serotonina (SSRI) in selektivnih zaviralcih privzema noradrenalina (SNRI), vključno z duloksetinom, so poročali o nenormalnih krvavitvah, kot so ekhimoze, purpure in krvavitve iz prebavil.
Propylene glycol Strong ammonia solution Yellow iron oxide (E172) 
Zlato črnilo vsebuje šelak propilenglikol amoniak, koncetrirana raztopina rumeni železov oksid (E172)
Interstitial lung disease 
Infekcijske in parazitske bolezni laringitis
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. 
PVC/PCTFE/aluminijevi ali OPA/AL/PVC - aluminijevi pretisni omoti s po 7, 14, 28, 98 in skupno pakiranje s po 98 (2 škatli po 49) trdih gastrorezistentnih kapsul.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 
Zdravilo Duloksetin Mylan vsebuje saharozo in natrij Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred jemanjem tega zdravila pogovorite z njim.
Each capsule contains 30 mg of duloxetine (as hydrochloride). 
Ena kapsula vsebuje 30 mg duloksetina (v obliki duloksetinijevega klorida).
Somnolence 
Krvavitev
PVC/PE/PVdC/Aluminium blister pack containing 7, 14, 28, 49, 98 and multipacks containing 98 (2 packs of 49) hard gastro resistant capsules. 
PVC/PE/PVdC/aluminijevi pretisni omoti s po 7, 14, 28, 49, 98 in skupno pakiranje s po 98 (2 škatli po 49) trdih gastrorezistentnih kapsul.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
Sestavni del skupnega pakiranja.
Each capsule contains 60 mg of duloxetine (as hydrochloride). 
Ena kapsula vsebuje 60 mg duloksetina (v obliki duloksetinijevega klorida).
Duloxetine Mylan is for oral use. 
Zdravilo Duloksetin Mylan jemljemo peroralno.
PVC/PE/PVdC/Aluminium blister pack containing 14, 28, 49, 98 and multipacks containing 98 (2 packs of 49) hard gastro-resistant capsules. 
PVC/PE/PVdC/aluminijevi pretisni omoti s po 14, 28, 49, 98 in skupno pakiranje s po 98 (2 škatli po 49) trdih gastrorezistentnih kapsul.
Sugar spheres (sucrose, maize starch) Hypromellose 
Vsebina kapsule sladkorne kroglice (saharoza, koruzni škrob) hipromeloza makrogol krospovidon smukec saharoza hipromelozaftalat dietilftalat
• contraction of the jaw muscle 
• krčenje mišice čeljusti
BLISTER OUTER CARTON FOR MULTIPACK FOR 60 MG HARD GASTRO RESISTANT CAPSULES, WITH BLUE BOX 
ŠKATLA ZA SKUPNO PAKIRANJE S PRETISNIMI OMOTI ZA 60 MG TRDE GASTROREZISTENTNE KAPSULE (VKLJUČNO Z MODRIM OKENCEM)
CLINICAL PARTICULARS 
Posebne skupine bolnikov
BLISTER OUTER CARTON FOR MULTIPACK FOR 30 MG HARD GASTRO RESISTANT CAPSULES, WITH BLUE BOX 
ŠKATLA ZA SKUPNO PAKIRANJE S PRETISNIMI OMOTI ZA 30 MG TRDE GASTROREZISTENTNE KAPSULE (VKLJUČNO Z MODRIM OKENCEM)
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 
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 EU/1/15/1010/053 EU/1/15/1010/054
BOTTLE CARTON FOR 30 MG HARD GASTRO RESISTANT CAPSULES 
ŠKATLA ZA PRETISNE OMOTE ZA 30 MG TRDE GASTROREZISTENTNE KAPSULE
BLISTER FOR 60 MG HARD GASTRO RESISTANT CAPSULES 
PRETISNI OMOT ZA 60 MG TRDE GASTROREZISTENTNE KAPSULE
BOTTLE CARTON FOR 60 MG HARD GASTRO RESISTANT CAPSULES 
ŠKATLA ZA PRETISNE OMOTE ZA 60 MG TRDE GASTROREZISTENTNE KAPSULE
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
Samo za pakiranje v plastenkah:
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 
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
Reproductive system and breast disorders Erectile dysfunction 
dehidracija, hiponatremija, sindrom neustreznega izločanja antidiuretičnega hormona
BLISTER FOR 30 MG HARD GASTRO RESISTANT CAPSULES 
PRETISNI OMOT ZA 30 MG TRDE GASTROREZISTENTNE KAPSULE
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 an antidepressant 
(mlajših od 25 let) z motnjami razpoloženja med zdravljenjem z antidepresivi obstaja večje tveganje za pojav samomorilnega vedenja
Dehydration Hyponatraemia SIADH 
Zaviralci monoaminooksidaze (MAOI):
The main ingredient of Duloxetine Mylan, duloxetine, is used in other medicines for other conditions: • diabetic neuropathic pain, depression, anxiety and urinary incontinence 
• bolečina diabetične nevropatije, depresije, anksioznosti in urinske inkontinence
• muscle tightness, muscle twitching 
• mišična napetost, trzanje mišic
Breast feeding 
PODATKI NA ZUNANJI OVOJNINI
28 x 1 hard gastro-resistant capsules 30 x 1 hard gastro-resistant capsules 100 x 1 hard gastro-resistant capsules 
14 trdih gastrorezistentnih kapsul 28 trdih gastrorezistentnih kapsul 49 trdih gastrorezistentnih kapsul 84 trdih gastrorezistentnih kapsul 98 trdih gastrorezistentnih kapsul 28 x 1 trda gastrorezistentna kapsula 30 x 1 trda gastrorezistentna kapsula 100 x 1 trda gastrorezistentna kapsula
Not all pack sizes may be marketed. 
Ni za posamezno prodajo.
List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, applicants and marketing authorisation holders in the member states 
Dodatek I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila,
Concentrate for solution for infusion 
Koncentrat za pripravo raztopine za infundiranje
1 mg/ml (5ml) 
1 mg/ml (5ml) Raztopina za injiciranje
Solution for infusion Intravenous use 
Raztopina za infundiranje
The European Commission issued a decision on 30 September 2010. 
Evropska komisija je odločbo izdala dne 30. septembra 2010.
Further treatment can be given under medical supervision. 
Nadaljnjo zdravljenje lahko poteka le pod zdravniškim nadzorom.
Jens Ersbøll (Denmark) 
Jens Ersbøll (Danska)
The recommended treatment period for the ointment is four weeks. 
Priporočeno obdobje zdravljenja z mazilom je štiri tedne.
Daivobet ointment was authorised in some Member States through a mutual recognition procedure and in others through national procedures. 
Daivobet mazilo je bilo odobreno v nekaterih državah članicah s postopkom z medsebojnim priznavanjem, v drugih pa z nacionalnimi postopki.
The company that markets these medicines is Leo Pharmaceutical Products. 
Družba, ki trži ti zdravili, je Leo Pharmaceutical Products.
Daivobet gel was authorised via a decentralised procedure. 
Daivobet gel je bil odobren z decentraliziranim postopkom.
It is available as a gel and ointment and is used topically (applied on the skin). 
Na voljo je v obliki gela in mazila in se uporablja topično (nanaša se na kožo).
Why was Daivobet reviewed? 
Zakaj je bilo zdravilo Daivobet pregledano?
The European Medicines Agency has completed a review of Daivobet. 
Evropska agencija za zdravila je zaključila pregled zdravila Daivobet.
The Committee also harmonised a list of contra-indications related to skin conditions, including viral lesions of the skin, fungal or bacterial skin infections, parasitic infections and skin problems caused by tuberculosis or syphilis. 
Odbor je uskladil tudi seznam kontraindikacij v zvezi s stanjem kože, vključno z virusnimi lezijami kože, glivičnimi ali bakterijskimi okužbami kože, parazitnimi okužbami in težavami s kožo, ki jih povzročata tuberkuloza ali sifilis.
It must also not be used in patients with abnormal levels of calcium in their blood. 
Prav tako ga ne smejo uporabljati bolniki z nenormalno vsebnostjo kalcija v krvi.
Daivobet is also available in the EU under the trade name Dovobet. 
Zdravilo Daivobet je v EU na voljo tudi pod tržnim imenom Dovobet.
Questions and answers on Daivobet and associated names (calcipotriol/betamethasone gel and ointment, 50 micrograms/0.5 mg per g) EMA/CHMP/466386/2010 
Vprašanja in odgovori v zvezi z zdravilom Daivobet in povezanimi imeni (kalcipotriol/betametazon gel in mazilo, 50 mikrogramov/0,5 mg na g) EMA/CHMP/466386/2010
Daivobet should be applied once a day on the affected areas of the skin. 
Zdravilo Daivobet je treba nanesti enkrat dnevno na prizadete dele kože.
Because of this, there are some differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicines are marketed. 
Zato se pojavljajo razlike v povzetkih glavnih značilnosti zdravila, označevanju in navodilih za uporabo v državah, v katerih se zdravili tržita.
What is Daivobet? 
Kaj je zdravilo Daivobet?
The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU. 
CHMP je ob upoštevanju predloženih podatkov in znanstvenih razprav v okviru Odbora menil, da je treba povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo uskladiti v celotni EU.
Questions and answers on Daivobet and associated names (calcipotriol/betamethasone gel and ointment, 50 micrograms/0.5 mg per g) 
Vprašanja in odgovori v zvezi z zdravilom Daivobet in povezanimi imeni (kalcipotriol/betametazon gel in mazilo, 50 mikrogramov/0,5 mg na g)
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Daivobet in the European Union (EU). 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je treba v Evropski uniji (EU) uskladiti podatke o predpisovanju zdravila Daivobet.
No more than 15 g of the gel or ointment should be used in one day. 
Na dan se lahko uporabi največ 15 g gela ali mazila.
The Committee also harmonised other sections of the SmPC, including the sections on special warnings, pregnancy and lactation and undesirable effects. 
Odbor je uskladil tudi druga poglavja povzetka glavnih značilnosti zdravila, vključno s poglavjem s posebnimi opozorili ter poglavji o nosečnosti, dojenju in neželenih učinkih.
22 July 2010 
22. julij 2010
Daivobet contains two active substances: calcipotriol and betamethasone. 
Zdravilo Daivobet vsebuje dve zdravilni učinkovini: kalcipotriol in betametazon.
Calcipotriol, a substance derived from vitamin D, acts through receptors in the skin to prevent the multiplication of cells that cause the scaly patches in psoriasis. 
Kalcipotriol, snov, pridobljena iz vitamina D, deluje prek receptorjev v koži in tako preprečuje razmnoževanje celic, ki povzročajo luskaste površine pri psoriazi.
The CHMP agreed that Daivobet ointment is to be used for the treatment of adults with plaque psoriasis where it is possible to use a topical medicine. 
CHMP se je strinjal, da naj bi se Daivobet mazilo uporabljalo za zdravljenje odraslih bolnikov s psoriazo s plaki, kadar je možno zdravljenje z uporabo topičnih zdravil.