natgillin/translations-raw huggingface dataset:
In an embryotoxicity study in the rabbit, a higher incidence of cardiovascular and skeletal malformations was observed at systemic exposure levels below the maximum clinical exposure (AUC). 
V študiji embriotoksičnosti pri zajcih, pri sistemskih izpostavitvah, nižjih od maksimalne klinične izpostavitve (AUC), so opazili večjo incidenco kardiovaskularnih in skeletnih malformacij.
YENTREVE 20 mg YENTREVE 20 mg is available in packs of 28, 56 and 98 hard gastro-resistant capsules. 
YENTREVE 20 mg Zdravilo YENTREVE 20 mg je na voljo v pakiranju po 28, 56 in 98 trdih gastrorezistentnih kapsul.
• headache, dizziness, feeling sluggish, feeling sleepy, tremor, numbness, including numbness, 
• glavobol, omotica, občutek nezbranosti, občutek zaspanosti, tresenje, otrplost, vključno z otrplostjo, zbadanjem ali mravljinčasto kožo • zamegljen vid
YENTREVE 20 mg is available in packs of 28, 56 and 98 capsules. 
Zdravilo YENTREVE 20 mg je na voljo v pakiranjih po 28, 56 in 98 kapsul.
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). 
Učinki duloksetina na druga zdravila Zdravila, ki jih presnavlja CYP1A2: sočasno dajanje duloksetina (60 mg dvakrat dnevno) ni značilno vplivalo na farmakokinetiko teofilina, substrata CYP1A2.
• weakness, shivering 
• šibkost, drgetanje
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 
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.
The concomitant use of YENTREVE with selective, reversible MAOIs, like moclobemide, is not recommended (see section 4.4). 
Sočasno uporabo zdravila YENTREVE s selektivnimi reverzibilnimi MAOI, kakršen je npr. moklobemid, odsvetujemo (glejte poglavje 4.4).
Medicines that increase the level of serotonin: Triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), SNRIs (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, St John's Wort and MAOIs (such as moclobemide and linezolid). 
Zdravila, ki zvišajo nivo serotonina: triptani, tramadol, triptofan, SSRI (kot sta paroksetin in fluoksetin), SNRI (kot je venlafaksin), triciklični antidepresivi (kot sta klomipramin, amitriptilin), petidin, šentjanževka in MAOI (kot sta moklobemid in linezolid).Ta zdravila povečajo tveganje za neželene učinke; če se pojavi kakršenkoli neobičajen simptom ob jemanju katerega od teh zdravil skupaj z zdravilom YENTREVE, obiščite svojega zdravnika.
Do not take more than the daily amount of YENTREVE that has been prescribed for you in one day. 
Ne zaužijte več zdravila YENTREVE v enem dnevu, kot vam je bilo predpisano.
Monoamine oxidase inhibitors (MAOIs): You should not take YENTREVE if you are taking or have recently taken (within the last 14 days) an antidepressant medicine called a monoamine oxidase inhibitor (MAOI). 
Zaviralci monoaminooksidaze (MAOI): zdravila YENTREVE ne smete jemati skupaj z drugim zdravilom za zdravljenje depresije imenovanim zaviralec monoaminooksidaze (MAOI) ali v 14 dneh po prenehanju jemanja MAOI.
Convulsions1,6 Myoclonus Akathisia6 
mioklonus akatizija6
Orthostatic hypotension2 Peripheral coldness 
rdečica sinkopa2 zvišan krvni tlak hipertenzivna kriza ortostatska hipotenzija2 hladni periferni deli
- are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6) - have liver disease - have severe kidney disease - are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI) (see ‘Other medicines and YENTREVE') - are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat some infections 
NE jemljite zdravila YENTREVE, če: - ste alergični (preobčutljivi) na duloksetin ali katerokoli pomožno snov tega zdravila (navedeno v poglavju 6) - imate obolenje jeter imate hudo obolenje ledvic - jemljete ali ste v zadnjih 14 dneh jemali drugo zdravilo, imenovano zaviralec monoaminooksidaze (MAOI) (glejte »Druga zdravila in zdravilo YENTREVE«)
Metabolism and nutrition disorders Appetite decreased 
Presnovne in prehranske motnje zmanjšanje apetita dehidracija hiperglikemija
Medicines that cause sleepiness: These include medicines prescribed by your doctor including benzodiazepines, strong painkillers, antipsychotics, phenobarbital and sedative antihistamines. 
V to skupino denimo uvrščajo benzodiazepine, močna zdravila proti bolečinam, antipsihotike, fenobarbital in sedativne antihistaminike.
Talk to your doctor before you take Yentreve if you: - are taking medicines to treat depression (see ‘Other medicines and YENTREVE') - 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 (see ‘Pregnancy and breast-feeding‘) - 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. 
- 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
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 prevzema serotonina (selective serotonin reuptake inhibitors, SSRI) in selektivnih zaviralcih prevzema noradrenalina (selectivenoradrenaline reuptake inhibitors, SNRI),
• abnormal periods, including heavy, painful, irregular or prolonged periods, unusually light or missed periods, abnormal production of breast milk 
• neobičajna menstruacija, vključno z močno, bolečo, neredno ali podaljšano menstruacijo, neobičajna blaga ali spuščena menstruacija, nenormalno nastajanje mleka v dojkah pri moških in ženskah • prekomerna krvavitev iz nožnice kmalu po porodu (poporodna krvavitev)
Suicidal behaviour5,6 
konvulzije1,6
Caution is advised in patients taking anticoagulants and/or medicinal products known to affect platelet function (e.g. NSAIDs or acetylsalicylic acid (ASA)), and in patients with known bleeding tendencies. 
Pri bolnicah, ki jemljejo sredstva proti strjevanju krvi in/ali druga zdravila, za katera je znano, da vplivajo na delovanje trombocitov (npr. nesteroidne protivnetne učinkovine (NSAID) ali acetilsalicilna kislina
Some patients may benefit from starting treatment at a dose of 20 mg twice daily for two weeks before increasing to the recommended dose of 40 mg twice daily. 
Nekaterim bolnicam lahko koristi začetno zdravljenje z odmerkom 20 mg dvakrat na dan za dva tedna pred zvišanjem na priporočeni odmerek 40 mg dvakrat na dan. Zviševanje odmerka lahko zmanjša, vendar ne odpravi tveganje za slabost in omotico.
YENTREVE with food, drink and alcohol 
Zdravilo YENTREVE skupaj s hrano, pijačo in z alkoholom Zdravilo YENTREVE lahko vzamete s hrano ali brez nje.
Muscle spasm 
propilenglikol šelak
If while on YENTREVE therapy, the patient develops agitation or depressive symptoms, specialised medical advice should be sought, as depression is a serious medical condition. 
se je treba posvetovati s specialistom, depresija je namreč resno bolezensko stanje.
Eli Lilly Benelux S.A./N.V. 
België/Belgique/Belgien S.A. Eli Lilly N.V.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS (20 mg hard gastroresistant capsules) 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU (20 mg trde gastrorezistentne kapsule)
The European Medicines Agency has waived the obligation to submit the results of studies with Yentreve in all subsets of the paediatric population in the treatment of stress urinary incontinence. 
YENTREVE za vse skupine pediatrične populacije pri zdravljenju stresne urinske inkontinence.
Call your doctor or pharmacist immediately if you take more than the amount of YENTREVE prescribed by your doctor. 
Če ste vzeli večji odmerek zdravila YENTREVE, kot bi smeli Če vzamete večjo količino zdravila YENTREVE, kot vam je predpisal vaš zdravnik, nemudoma pokličite svojega zdravnika ali farmacevta.
The clinical benefit of YENTREVE compared with placebo has not been demonstrated in women with mild SUI, defined in randomised trials as those with IEF < 14 per week. 
definirano tako v randomiziranih preskušanjih kot tistih z IEF < 14 na teden, niso dokazali.
However, the majority of the most frequent adverse events were mild to moderate and resolved within 30 days of occurrence (e.g. nausea). 
Vendar je bila večina najpogostejših neželenih učinkov blagih do zmernih in so minili v
If you get any side effects, talk to your doctor of pharmacist. 
- Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom ali s farmacevtom.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS (40 mg hard gastroresistant capsules) 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU (40 mg trde gastrorezistentne kapsule)
• diabetic neuropathic pain, depression, anxiety and urinary incontinence Using more than one of these medicines at the same time should be avoided. 
• bolečine zaradi diabetične nevropatije, depresije, anksioznosti in urinske inkontinence
YENTREVE 20 mg hard gastro-resistant capsules Duloxetine 
YENTREVE 20 mg trde gastrorezistentne kapsule duloksetin
YENTREVE 40 mg hard gastro-resistant capsules Duloxetine 
YENTREVE 40 mg trde gastrorezistentne kapsule duloksetin
• 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) 
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)
clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), fits, sudden involuntary jerks or twitches of the muscles, sensation of restlessness or an inability to sit or stand still, difficulty controlling movement e.g. lack of coordination or involuntary movements of the muscles, restless legs syndrome 
• serotoninski sindrom” (redka reakcija, ki lahko povzroči občutke velike sreče, zaspanost, okornost, nemir, občutek pijanosti, vročino, znojenje ali toge mišice), epileptični napadi, nenadni nehoteni gibi mišic ali mišično trzanje, občutek nemira ali nezmožnosti sedenja ali stanja pri miru, težave z nadziranjem gibov, npr. slaba koordinacija ali nehoteni gibi mišic, sindrom nemirnih nog
Musculoskeletal and connective tissue disorders Musculo-skeletal pain 
Bolezni mišično-skeletnega sistema in vezivnega tkiva mišično-skeletna bolečina napetost mišic mišični krč trizem trzanje mišic
How to store YENTREVE Keep this medicine out of the sight and reach of children. 
SHRANJEVANJE ZDRAVILA YENTREVE Zdravilo shranjujte nedosegljivo otrokom!
Caution is advisable if YENTREVE 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).
• dizziness, lightheadedness or fainting on standing up, cold fingers and/or toes 
• zvišan tlak v očesu (glavkom) • omotica, občutek omotičnosti ali omedlevice ob prehitrem vstajanju, občutek mraza v prstih in/ali prstih na nogah • napeto grlo, krvavitve iz nosu
YENTREVE 20 mg hard gastro-resistant capsules YENTREVE 40 mg hard gastro-resistant capsules 
YENTREVE 20 mg trde gastrorezistentne kapsule YENTREVE 40 mg trde gastrorezistentne kapsule
Reproductive system and breast disorders 
Infekcijske in parazitske bolezni laringitis
Each capsule contains 20 or 40 mg of duloxetine (as hydrochloride). 
Ena kapsula vsebuje 20 ali 40 mg duloksetina (v obliki klorida).
• muscle twitching 
• mišično trzanje
Check with your doctor or pharmacist if you are not sure. 
S svojim zdravnikom preverite,
Edible ink: 
Okvarjeno delovanje ledvic:
YENTREVE 40 mg Opaque orange body, imprinted with '40 mg' and an opaque blue cap, imprinted with ‘9545'. 
Neprozorno oranžno telo z vtisnjenim napisom ‘40 mg' ter neprozoren moder pokrovček z vtisnjeno oznako ‘9545'.
YENTREVE contains sucrose 
Zdravilo YENTREVE vsebuje saharozo
Incontinence Episode Frequency: In all four studies the duloxetine-treated group had a 50% or greater median decrease in IEF compared with 33% in the placebo-treated group. 
50 % ali večje mediano znižanje IEF v primerjavi s 33 % v skupini, ki je prejemala placebo.
Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Edible black ink 
YENTREVE 20 mg želatina natrijev lavrilsulfat titanov dioksid (E171) indigotin (E132)
• weight loss, weight gain 
• izguba telesne mase, zvečanje telesne mase
Black iron oxide - synthetic (E172) Propylene glycol 
Užitno črnilo: črni železov oksid - sintetični (E172)
YENTREVE 20 mg Opaque blue body, imprinted with ‘20 mg' and an opaque blue cap, imprinted with ‘9544'. 
Neprozorno oranžno telo z vtisnjenim napisom ‘20 mg' ter neprozoren moder pokrovček z vtisnjeno oznako ‘9544'.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR 40 MG HARD GASTRO-RESISTANT CAPSULES 
PODATKI NA ZUNANJI OVOJNINI ŠKATLE ZA 40 MG TRDE GASTROREZISTENTNE KAPSULE
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR 20 MG HARD GASTRO-RESISTANT CAPSULES 
PODATKI NA ZUNANJI OVOJNINI ŠKATLE ZA 20 MG TRDE GASTROREZISTENTNE KAPSULE
EU/1/04/280/006 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/280/006
The active substance is duloxetine. 
Kaj vsebuje zdravilo YENTREVE Učinkovina je duloksetin.
Eli Lilly Danmark A/S Tlf: +45 45 26 60 00 
Eli Lilly Danmark A/S, Útibú á Íslandi Tel: + 354 520 34 00
YENTREVE contains sucrose. 
Zdravilo YENTREVE vsebuje saharozo.
Hepatic impairment 
ušesna bolečina
Laryngitis 
trietilcitrat
Gynaecological haemorrhage Menopausal symptoms 
Motnje reprodukcije in dojk ginekološka krvavitev menopavzalni simptomi motnje menstruacije galaktoreja hiperprolaktinemija
What you need to know before you take YENTREVE DO NOT take YENTREVE if you: 
Pred jemanjem zdravila YENTREVE se posvetujte s svojim zdravnikom, če:
Adverse reactions may be more common during concomitant use of YENTREVE and herbal preparations containing St John's wort (Hypericum perforatum). 
Ob sočasni uporabi zdravila YENTREVE in pripravkov rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), so lahko neželeni učinki pogostejši.
Diarrhoea Abdominal pain Vomiting Dyspepsia 
Bolezni imunskega sistema preobčutljivost anafilaktična reakcija
EU/1/04/280/001 (56 hard gastro-resistant capsules) EU/1/04/280/007 (28 hard gastro-resistant capsules) EU/1/04/280/008 (98 hard gastro-resistant capsules) 
EU/1/04/280/008 (98 trdih gastrorezistentnih kapsul)
Each capsule contains 40 mg of duloxetine (as hydrochloride). 
Ena kapsula vsebuje 40 mg duloksetina (v obliki klorida).
YENTREVE is a hard gastro-resistant capsule. 
Izgled zdravila YENTREVE in vsebina pakiranja Zdravilo YENTREVE je trda gastrorezistentna kapsula.
• chest pain, feeling cold, thirst, feeling hot 
• neobičajna vaginalna krvavitev, menopavzalni simptomi • bolečina v prsnem košu, občutek mraza, žeja, občutek vročine
Each capsule contains 20 mg of duloxetine (as hydrochloride). 
Ena kapsula vsebuje 20 mg duloksetina (v obliki klorida).
• diarrhoea, stomach pain, being sick (vomiting), heartburn or indigestion 
• driska, bolečina v trebuhu, slabost (bruhanje), zgaga ali slaba prebava • povečano znojenje
Dermatitis contact Cold sweat Increased tendency to bruise 
Bolezni kože in podkožja povečano znojenje izpuščaj povečano nočno znojenje urtikarija kontaktni dermatitis hladen znoj nagnjenje k modricam
If a decision to initiate antidepressant pharmacological therapy is taken, the gradual discontinuation of YENTREVE is recommended (see section 4.2). 
V primeru, da se zdravnik odloči za farmakološko zdravljenje z antidepresivi, svetujemo postopno ukinjanje zdravila
Asthenia Chills 
KLINIČNI PODATKI
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 11. avgust 2004
Extra-pyramidal symptoms6 
psihomotorični nemir6 ekstrapiramidni simptomi6 diskinezija sindrom nemirnih nog
Gastrointestinal haemorrhage7 Gastroenteritis Stomatitis 
Bolezni prebavil navzea suha usta zaprtje driska bolečina v trebuhu bruhanje dispepsija gastrointestinalna krvavitev7 gastroenteritis stomatitis kolcanje gastritis disfagija napenjanje slab zadah hematohezija mikroskopski kolitis9
Uncommon side effects (may affect up to 1 in 100 people) 
Občasni neželeni učinki (se lahko pojavijo pri največ 1 od 100 bolnikov) • vnetje grla, ki povzroči hripav glas
Agitation 
• utrujenost
• serious allergic reaction which causes difficulty in breathing or dizziness with swollen tongue or lips 
Redki neželeni učinki (se lahko pojavijo pri največ 1 od 1.000 bolnikov) • resne alergične reakcije, ki povzročajo težave pri dihanju ali omotico z oteklim jezikom ali ustnicami
Feeling abnormal Feeling cold Thirst 
neobičajno počutje občutek mraza žeja bolehnost občutek vročine motnja hoje poporodna krvavitev6
YENTREVE 40 mg hard gastro-resistant capsules YENTREVE 20 mg hard gastro-resistant capsules 
NAVODILO ZA UPORABO YENTREVE 40 mg trde gastrorezistentne kapsule YENTREVE 20 mg trde gastrorezistentne kapsule duloksetin (v obliki klorida)
Caution is advised if YENTREVE 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). 
triciklični antidepresivi [tricyclic antidepressants, TCAs], kot so nortriptilin, amitriptilin in imipramin)
Throat tightness Epistaxis Interstitial lung disease10 
Bolezni dihal, prsnega koša in mediastinalnega prostora zehanje stisnjeno grlo epistaksa intersticijska bolezen pljuč10
Vascular disorders 
Okvarjeno delovanje jeter
SIADH6 
Tako CYP2D6
Pollakiuria Urine odour abnormal 
Bolezni sečil odlašanje uriniranja disurija nokturija polakiurija nenormalen vonj urina zastajanje urina6 poliurija slabši curek urina
• falls (mostly in elderly people), abnormal gait 
• nizka raven natrija v krvi (predvsem pri starejših; simptomi so lahko občutek vrtoglavice,
Blurred vision Mydriasis Visual impairment 
Očesne bolezni zamegljen vid midriaza okvara vida suho oko glavkom
56 hard gastro-resistant capsules 28 hard gastro-resistant capsules 98 hard gastro-resistant capsules 
FARMACEVTSKA OBLIKA IN VSEBINA 98 trdnih gastrorezistentnih kapsul
64331 Weiterstadt Germany 
64331 Weiterstadt Nemčija
Overall summary of the scientific evaluation of Norsed Combi D and associated names (see Annex I) 
Splošni povzetek znanstvenega vrednotenja zdravila Norsed Combi D in z njim povezanih imen (glejte Prilogo I)
Scientific conclusions and grounds for positive opinion 
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA POZITIVNO MNENJE
Procter & Gamble Pharmaceuticals France 163-165 Quai Aulagnier 92600 Asnières-sur-Seine France 
Procter & Gamble Pharmaceuticals France 163-165 Quai Aulagnier 92600 Asnières-sur-Seine Francija
List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, applicants and marketing authorisation holder in the Member States 
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
According to the CHMP Guideline on combination products, “combination packs would only be acceptable in exceptional cases, when there would be clear public health benefits of the treatment regimen and/or compliance, taking into account the required justifications set-out in section 5 of this guideline”. 
V skladu s Smernico CHMP za kombinirana zdravila so „kombinirana pakiranja sprejemljiva le v izjemnih primerih, ko obstajajo jasne koristi za javno zdravje zaradi režima zdravljenja in/ali upoštevanja navodil, če upoštevamo zahtevane utemeljitve v 5. poglavju omenjene smernice“.
The Applicant submitted an application for mutual recognition of the marketing authorisation granted by Sweden in 2006 for Norsed Combi D, a combination product consisting of risedronate sodium 35 mg film-coated tablets together with 1000 mg calcium carbonate and 880 IU colecalciferol effervescent granules. 
Predlagatelj je predložil vlogo za postopek z medsebojnim priznavanjem dovoljenja za promet z zdravilom, ki ga je odobrila Švedska leta 2006 za zdravilo Norsed Combi D, kombinirano zdravilo iz risedronat natrija 35 mg filmsko obložene tablete in 1000 mg kalcijevega karbonata ter 880 i.e. holekalciferola šumeča zrnca.
The objecting CMS considered the benefit-risk balance of Norsed Combi D to be unfavourable and presented specific points for objection to the application. 
Nasprotujoča zadevna država članica je upoštevala, da je razmerje koristi in tveganj za zdravilo Norsed Combi D neugodno ter predstavila specifične zadržke do vloge.
• the CHMP was convinced of the clear public health benefits and improved compliance resulting from the this product, the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Norsed Combi D and associated names (see Annex I). 
CHMP je priporočil odobritev dovoljenj za promet z zdravilom, katerih povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo ostanejo enaki zadnjim različicam, pripravljenim v postopku koordinacijske skupine in navedenim v Prilogi III za zdravilo Norsed Combi D in povezanih imen (glejte Prilogo I).
Italy sanofi-aventis S.p.A. viale Luigi Bodio, 37/B 20158 Milan Italy 
viale Luigi Bodio, 37/B 20158 Milan Italija
Sweden sanofi-aventis S.p.A. Viale Luigi Bodio, 37/b 20158 Milano Italy 
Viale Luigi Bodio, 37/b 20158 Milano Italija
Adopted at the 7-10 September 2015 PRAC 
Sprejeto na seji odbora PRAC med 7. in 10. septembrom 2015
What you need to know before you <take> <use> X: 
Kaj morate vedeti, preden <boste vzeli> <boste uporabili> zdravilo X:
EMA/PRAC/590265/2015 
EMA/PRAC/618068/2015 Corr1
Possible side effects Tell your doctor immediately if you experience: 
Možni neželeni učinki Nemudoma obvestite svojega zdravnika, če opazite:
Frequency ‘not known': pulmonary hypertension 
Pogostost »neznana«:: pljučna hipertenzija
Bisphosphonates (alendronic acid; alendronic acid, colecalciferol; clodronic acid; etidronic acid; ibandronic; neridronic acid; pamidronic acid; risedronic acid; tiludronic acid; zoledronic acid) - Osteonecrosis of the external auditory canal (EPITT no 18256) 
Bisfosfonati (alendronska kislina; alendronska kislina, holekalciferol; klodronska kislina; etidronska kislina; ibandronska kislina; neridronska kislina; pamidronska kislina; risedronska kislina; tiludronska kislina; zoledronska kislina) - Osteonekroza zunanjega slušnega kanala (EPITT št. 18256)