FrancophonIA/ELRC3.0 huggingface dataset:
English: Primary hypercholesterolaemia and combined (mixed) hyperlipidaemia The majority of patients are controlled with {PRODUCT NAME} 10 mg once a day.
Slovenian: Primarna hiperholesterolemija in kombinirana (mešana) hiperlipidemija Pri večini bolnikov se stanje obvladuje z zdravilom {IME ZDRAVILA} v odmerku 10 mg enkrat na dan. Terapevtski odziv je očiten že po dveh tednih zdravljenja, največji terapevtski odziv pa se doseže v štirih tednih.
English: The following wording was agreed by the CHMP: ‘Posology
Slovenian: CHMP je potrdil naslednje besedilo: “Odmerjanje
English: The dose may be increased to 80 mg daily, according to the response and tolerability.
Slovenian: Priporočeni začetni odmerek pri tej populaciji je 10 mg atorvastatina na dan. Odmerek se lahko glede na odziv in prenašanje poveča do 80 mg na dan.
English: • the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Lipitor and associated names (see Annex I).
Slovenian: • Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki jih je predlagal imetnik dovoljenja za promet, so bili ocenjeni na osnovi predložene dokumentacije in strokovne razprave v Odboru.
English: The MAH has used the MRP SmPC text as the proposed harmonised SmPC text as the overdose wording across the Member State SmPCs is essentially identical to the current MRP SmPC text.
Slovenian: Imetnik dovoljenja za promet z zdravilom je uporabil povzetek glavnih značilnosti zdravila iz postopka z medsebojnim priznavanjem kot predlagano besedilo za usklajen povzetek glavnih značilnosti zdravila, saj je besedilo v povzetkih glavnih značilnosti zdravila v državah članicah glede prekomernega odmerjanja v osnovi enako besedilu iz trenutnega povzetka glavnih značilnosti zdravila iz postopka z medsebojnim priznavanjem.
English: Higher doses may be necessary in order to attain (LDL-) cholesterol levels according to current guidelines……………… Method of administration {PRODUCT NAME} is for oral administration.
Slovenian: V preskušanjih primarnega preprečevanja je bil odmerek 10 mg na dan. Za zagotovitev ravni (LDL-) holesterola v skladu s trenutnimi smernicami bodo morda potrebni večji odmerki........... Način uporabe
English: For the indication relating to the prevention of cardiovascular disease, the dosing information is taken from the MRP SmPC.
Slovenian: Za indikacije glede preprečevanja kardiovaskularne bolezni so podatki o odmerjanju vzeti iz povzetka glavnih značilnosti zdravila iz postopka z medsebojnim priznavanjem.
English: Thereafter, either the dose may be increased to a maximum of 80 mg daily or a bile acid sequestrant may be combined with 40 mg atorvastatin once daily.
Slovenian: Zdravljenje bolnikov z zdravilom {IME ZDRAVILA} je treba začeti z odmerkom 10 mg na dan. Odmerek je treba prilagodili posamezniku in prilagajati vsake štiri tedne do odmerka 40 mg na dan. Nato se lahko odmerek poveča na največ 80 mg na dan ali pa se z odmerkom 40 mg atorvastatina enkrat na dan kombinira sekvestrant žolčne kisline.
English: The harmonized text is identical to the current approved MRP SPC.
Slovenian: Usklajeno besedilo je enako trenutno odobrenemu povzetku glavnih značilnosti zdravila iz postopka z medsebojnim priznavanjem.
English: Changes to the wording of certain terms as well as justifications for retaining some others were accepted by the CHMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom se je strinjal z zahtevo CHMP in premestil določene neželene učinke v organski sistem po MedDRA. CHMP je sprejel spremembe določenih izrazov in utemeljitev za ohranitev nekaterih drugih.
English: The usual starting dose is 10 mg once a day.
Slovenian: Običajni začetni odmerek je 10 mg enkrat na dan. Odmerek je treba prilagajati vsake štiri tedne ali pogosteje.
English: The resulting harmonised SPC, labelling and package leaflet was agreed by the CHMP.
Slovenian: CHMP je potrdil končni usklajeni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo.
English: Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the Member States The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented: The Member State shall agree the details of the Prescriber kit and a controlled distribution system with the Marketing Authorisation Holder (MAH) and must implement such programme nationally prior to launch to ensure that:
Slovenian: Države članice morajo zagotoviti implementacijo vseh spodaj opisanih pogojev in omejitev v zvezi z varno in učinkovito uporabo zdravila,: Država članica se o podrobnostih kompleta za zdravnike, ki zdravilo predpisujejo, in o nadziranem sistemu razdeljevanja dogovori z imetnikom dovoljenja za promet z zdravilom in ta program uvede nacionalno pred dajanjem v promet, s čimer zagotovi:
English: Annex related to the Art. 127a Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the Member States
Slovenian: Priloga v povezavi s členom 127a
English: • Prior to prescribing (where appropriate, and in agreement with the National Competent Authority, dispensing) all healthcare professionals who intend to prescribe (and dispense) are provided with a prescriber kit containing the following: o Educational Health Care Professional's kit o Educational brochures for Patients o Patient cards o Summary of Product Characteristics (SmPC) and Package Leaflet and Labelling.
Slovenian: • Pred predpisovanjem (kjer je ustrezno in v skladu s pristojnimi nacionalnimi organi izdajati pred razdeljevanjem) morajo vsi zdravstveni delavci, ki nameravajo zdravilo predpisovati (ali razdeljevati) prejmejo komplet s podatki za zdravnike, ki zdravilo predpisujejo, ki vsebuje naslednje:
English: What you need to know before you take Urorec Do not take Urorec if you are allergic to silodosin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Urorec Ne jemljite zdravila Urorec če ste alergični na silodozin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Baseline value (± SD)
Slovenian: Izhodišč na vrednost (±SD)
English: Difference (95 % CI) vs placebo
Slovenian: Razlika (95% CI) v primerjavi s placebom
English: If you have moderate kidney problems, your doctor will start Urorec with caution and possibly with a lower dose (see section 3 “Dose”).
Slovenian: Če imate zmerne težave z ledvicami, bo zdravnik začel zdravljenje z zdravilom Urorec previdno in morda z nižjim odmerkom (glejte poglavje 3 »Odmerek«).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29/01/2010
Slovenian: Datum prve odobritve: 29/01/2010 Datum zadnjega podaljšanja: 18/09/2014
English: Urorec has minor or moderate influence on the ability to drive and use machines.
Slovenian: Zdravilo Urorec ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja s strojev.
English: Dizziness when standing up and occasionally fainting may occur when taking Urorec, particularly when starting treatment or if you are taking other medicines that lower blood pressure.
Slovenian: Ob jemanju zdravila Urorec se lahko pojavita omotica ob vstajanju v pokončni položaj in občasno tudi omedlevica, še zlasti na začetku zdravljenja ali če jemljete druga zdravila za zniževanje krvnega tlaka.
English: It is important that you immediately inform your eye specialist if you are using or have previously used Urorec.
Slovenian: Pomembno je, da takoj obvestite svojega očesnega zdravnika, če uporabljate ali ste v preteklosti uporabljali zdravilo Urorec.
English: What Urorec is and what it is used for What you need to know before you take Urorec How to take Urorec
Slovenian: Kaj je zdravilo Urorec in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Urorec Kako jemati zdravilo Urorec
English: • If you have severe liver problems, you should not take Urorec, as it was not tested in this condition.
Slovenian: • Če imate hude težave z jetri, ne smete jemati zdravila Urorec, ker zdravilo pri takih bolnikih ni bilo preizkušeno.
English: Other medicines and Urorec
Slovenian: Druga zdravila in zdravilo Urorec
English: • If you have ever fainted or felt dizzy when suddenly standing up, please inform your doctor before taking Urorec.
Slovenian: • Če ste kdajkoli omedleli ali občutili omotico ob nenadnem vstajanju v pokončni položaj, povejte svojemu zdravniku pred pričetkom jemanja zdravila Urorec.
English: This effect disappears after discontinuation of Urorec.
Slovenian: Ta učinek izzveni po prekinitvi zdravljenja z zdravilom Urorec.
English: If you stop taking Urorec
Slovenian: Če ste prenehali jemati zdravilo Urorec
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the sight and reach of children.
Slovenian: POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
English: • If you are undergoing eye surgery because of cloudiness of the lens (cataract surgery), it is important that you immediately inform your eye specialist that you are using or have previously used Urorec.
Slovenian: • Če se pripravljate na očesno operacijo zaradi zamotnitve očesne leče (katarakta, operacija sive mrene), je pomembno, da takoj poveste svojemu očesnemu zdravniku, da uporabljate ali ste uporabljali zdravilo Urorec.
English: If you have taken more than one capsule, inform your doctor as soon as possible.
Slovenian: Če ste vzeli večji odmerek zdravila Urorec, kot bi smeli Če ste vzeli več kot eno kapsulo, čimprej obvestite svojega zdravnika.
English: For special patient populations, one capsule of Urorec 4 mg daily is recommended (see below).
Slovenian: Pri posebnih skupinah bolnikov je priporočena ena kapsula zdravila Urorec 4 mg na dan (glejte spodaj).
English: • medicines for epilepsy or rifampicin (a medicine to treat tubercolosis), since the effect of Urorec may be reduced.
Slovenian: • zdravila za zdravljenje epilepsije ali rifampicin (zdravilo za zdravljenje tuberkuloze), ker se učinek zdravila Urorec lahko zmanjša.
English: If you forget to take Urorec
Slovenian: Če ste pozabili vzeti zdravilo Urorec
English: Elderly No dose adjustment is required in the elderly (see section 5.2).
Slovenian: Pri starejših bolnikih prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
English: If you have severe kidney problems, you should not take Urorec.
Slovenian: Če imate hude težave z ledvicami, ne smete jemati zdravila Urorec.
English: Urorec does not treat prostate cancer.
Slovenian: Zdravilo Urorec ne zdravi raka prostate.
English: Urorec belongs to a group of medicines called alpha1A-adrenoreceptor blockers.
Slovenian: Urorec sodi v skupino zdravil, imenovanih zaviralci alfa1A-adrenergičnih receptorjev.
English: * p < 0.001 vs Placebo; ° p = 0.002 vs Placebo
Slovenian: Evropa silodozin tamsulozin placebo * p < 0,001 v primerjavi s placebom;°p = 0,002 v primerjavi s placebom
English: • Since a benign enlargement of the prostate and prostate cancer may present the same symptoms, your doctor will check you for prostate cancer before starting treatment with Urorec.
Slovenian: • Ker imata nenevarno povečanje prostate in rak prostate lahko enake simptome, vas bo zdravnik pred pričetkom zdravljenja z zdravilom Urorec poslal na kontrolni pregled za raka prostate.
English: Urorec is available in packs containing 5, 10, 20, 30, 50, 90, 100 capsules.
Slovenian: Zdravilo Urorec je na voljo v pakiranjih po 5, 10, 20, 30, 50, 90, 100 kapsul.
English: • antifungal medicines (such as ketoconazole or itraconazole), medicines used for HIV-AIDS (such as ritonavir) or medicines used after transplants to prevent organ rejection (such as cyclosporin) because these medicines can increase the blood concentration of Urorec.
Slovenian: • zdravila proti glivicam (kot sta ketokonazol ali itrakonazol), zdravila za zdravljenje okužbe z virusom HIV/AIDS (kot je ritonavir) ali zdravila, ki se uporabljajo po presaditvi organov za preprečevanje zavrnitve organa (kot je ciklosporin), ker ta zdravila lahko zvišajo koncentracijo zdravila Urorec v krvi.
English: The requirements for submission of marketing authorisation holder shall submit periodic safety update reports for this medicinal product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
English: • medicines used for treating problems in getting or keeping an erection (such as sildenafil or tadalafil), since the concomitant use with Urorec might lead to a slight decrease in blood pressure.
Slovenian: • zdravila za zdravljenje težav z nastankom ali ohranitvijo erekcije (kot sta sildenafil ali tadalafil), ker uporaba skupaj z zdravilom Urorec lahko vodi v rahlo znižanje krvnega tlaka.
English: • medicines which lower blood pressure (in particular, medicines called alpha1-blockers, such as prazosin or doxazosin) as there may be the potential risk that the effect of these medicines is increased whilst taking Urorec.
Slovenian: • zdravila za zniževanje krvnega tlaka (zlasti zdravila, imenovana zaviralci alfa1 kot sta prazosin ali doksazosin), ker obstaja tveganje, da se ob jemanju zdravila Urorec učinek teh zdravil okrepi.
English: Urorec may reduce the amount of sperm, and so could temporarily affect your ability to father a child.
Slovenian: Zdravilo Urorec lahko zmanjša količino sperme, zaradi česar lahko začasno vpliva na sposobnost zaploditve otroka.
English: • The treatment with Urorec may lead to an abnormal ejaculation (decrease in the amount of semen released during sex) that may temporarily affect male fertility.
Slovenian: • Zdravljenje z zdravilom Urorec lahko povzroči nenormalno ejakulacijo (zmanjšanje količine sperme, izločene pri spolnem odnosu), kar lahko začasno prizadene moško plodnost.
English: There is inadequate information about the safe use of silodosin in association with other α-adrenoreceptor antagonists.
Slovenian: Podatki o varni uporabi silodozina v povezavi z drugimi antagonisti α-adrenergičnih receptorjev so nezadostni.
English: Urorec may cause complications during a cataract surgery (eye surgery because of cloudiness of the lens, see section “Warnings and precautions”).
Slovenian: Zdravilo Urorec lahko povzroči zaplete med operacijo sive mrene (operacija očesa zaradi zamotnitve leče, glejte poglavje »Opozorila in previdnostni ukrepi«).
English: Urorec is not intended for use by women.
Slovenian: Zdravilo Urorec ni namenjeno ženskam.
English: Intraoperative Floppy Iris Syndrome (IFIS)
Slovenian: Medoperacijski sindrom ohlapne šarenice (IFIS - Intraoperative Floppy Iris Syndrome)
English: Yellow iron oxide (E172) (4 mg capsules only)
Slovenian: Ovojnica kapsule želatina titanov dioksid (E171) rumeni železov oksid (E172) (samo 4 mg kapsula)
English: Urorec is used in adult men to treat the urinary symptoms associated with benign enlargement of the prostate (prostatic hyperplasia), such as:
Slovenian: Zdravilo Urorec se pri odraslih moških uporablja za zdravljenje simptomov mokrenja, ki so povezani z nenevarnim povečanjem prostate (hiperplazijo prostate), kot na primer:
English: Name and address of the manufacturers responsible for batch release
Slovenian: Ime in naslov izdelovalca , odgovornega za sproščanje serij
English: Česká republika Herbacos Recordati s.r.o.
Slovenian: Herbacos Recordati s.r.o.
English: In a Phase II dose-finding, double-blind, placebo-controlled clinical study with silodosin 4 or 8 mg once daily, a greater improvement in American Urologic Association (AUA) symptom index score was observed with silodosin 8 mg (-6.8 ± 5.8, n = 90; p = 0.0018) and silodosin 4 mg (-5.7 ± 5.5, n = 88; p = 0.0355) as compared to placebo (-4.0 ± 5.5, n = 83).
Slovenian: Klinična učinkovitost in varnost V dvojno slepi s placebom nadzorovani klinični študiji faze II za določanje odmerka s 4 ali 8 mg silodozinom enkrat na dan je bilo v primerjavi s placebom (-4,0 ± 5,5, n = 83) pri uporabi 8 mg silodozina (-6,8 ± 5,8, n = 90; p = 0,0018) in 4 mg silodozina (-5,7 ± 5,5, n = 88; p = 0,0355) opaženo večje izboljšanje točkovnega rezultata po vprašalniku Ameriškega urološkega združenja (AUA-American Urologic Association).
English: Österreich Haemo Pharma GmbH Tel: + 43 2689 31160
Slovenian: Haemo Pharma GmbH Tel: + 43 2689 31160
English: Alpha-blockers
Slovenian: Blokatorji alfa
English: Elimination Following oral administration of 14C-labelled silodosin, the recovery of radioactivity after 7 days was approximately 33.5% in urine and 54.9% in faeces.
Slovenian: Po peroralnem vnosu s 14C-označenega silodozina je bilo po 7 dneh v urinu zaznane približno 33,5%
English: In the table below, adverse reactions reported in all clinical studies and in the worldwide post-marketing experience for which a reasonable causal relationship exists are listed by MedDRA system organ class and frequency: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from available data).
Slovenian: V spodnji preglednici so vsi neželeni učinki, o katerih so poročali iz vseh kliničnih študij in iz globalnih izkušenj po začetku trženja, za katere obstaja razumna vzročna povezava, navedene glede na organski sistem in pogostnost po MedDRA klasifikaciji: zelo pogosti (≥ 1/10); pogosti (≥ 1/100
English: What Urorec is and what it is used for
Slovenian: Kaj je zdravilo Urorec in za kaj ga uporabljamo Kaj je zdravilo Urorec
English: There is no relevant use of Urorec in the paediatric population for the indication of benign prostatic hyperplasia (BPH).
Slovenian: Pediatrična populacija Zdravilo Urorec ni namenjeno za uporabo pri pediatrični populaciji za navedeno benigne hiperplazije prostate (BHP).
English: Allergic-type reactions including facial swelling, swollen tongue and pharyngeal oedema1
Slovenian: vključno z oteklostjo obraza, oteklostjo jezika in faringealnim edemom1
English: The European Medicines Agency has waived the obligation to submit the results of studies with Urorec in all subsets of the paediatric population in BPH (see section 4.2 for information on paediatric use).
Slovenian: Urorec za vse podskupine pediatrične populacije z BHP (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: The recommended dose is one capsule of Urorec 8 mg daily.
Slovenian: Priporočeni odmerek je ena kapsula zdravila Urorec 8 mg na dan.
English: IFIS (a variant of small pupil syndrome) has been observed during cataract surgery in some patients on α1-blockers or previously treated with α1-blockers.
Slovenian: Med operacijo sive mrene so pri nekaterih bolnikih, ki so bili sočasno ali predhodno zdravljeni z zaviralci α1 receptorjev, opazili IFIS (različica sindroma majhne zenice).
English: How to take Urorec
Slovenian: Kako jemati zdravilo Urorec
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Urorec Vsebina pakiranja in dodatne informacije
English: Skin rash1, Pruritus1
Slovenian: Bolezni kože in podkožja kožni izpušèaj1, pruritus1
English: Deutschland Recordati Pharma GmbH Tel: + 49 731 70470
Slovenian: Recordati Pharma GmbH Tel: + 49 731 70470
English: Urorec is selective for the receptors located in the prostate, bladder and urethra.
Slovenian: Zdravilo Urorec se selektivno veže na receptorje, ki se nahajajo v prostati, mehurju in sečnici.
English: Very rare
Slovenian: izjemno visoko.
English: What Urorec is used for
Slovenian: Za kaj uporabljamo zdravilo Urorec
English: United Kingdom Recordati Pharmaceuticals Ltd. Tel: + 44 1491 576336
Slovenian: Recordati Pharmaceuticals Ltd. Tel: + 44 1491 576336
English: Paediatric population Silodosin has not been evaluated in patients less than 18 years of age.
Slovenian: Uporaba silodozina pri bolnikih, mlajših od 18 let, ni bila ovrednotena.
English: Recordati Hellas Pharmaceuticals A.E. Τηλ: + 30 210-6773822
Slovenian: Τηλ: + 30 210-6773822
English: Since no data are available in patients with severe hepatic impairment, the use of silodosin in these patients is not recommended (see sections 4.2 and 5.2).
Slovenian: Okvarjeno delovanje jeter Zaradi pomanjkanja podatkov o bolnikih s hudo okvaro delovanja jeter uporaba silodozina pri teh bolnikih ni priporočljiva (glejte poglavji 4.2 in 5.2).
English: Urorec 4 mg and 8 mg hard capsules
Slovenian: Urorec 4 mg in 8 mg trde kapsule
English: Not known (frequency cannot be estimated from the available data) • Floppy pupil during cataract surgery (see also above, in this section)
Slovenian: Neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
English: The recommended dose is one capsule of Urorec 8 mg per day by oral administration.
Slovenian: Priporočeni odmerek je ena kapsula zdravila Urorec 8 mg enkrat na dan peroralno (zaužita skozi usta).
English: In patients with severe renal impairment administration of Urorec is not recommended.
Slovenian: Pri bolnikih s hudo okvaro delovanja ledvic uporaba zdravila Urorec ni priporočljiva.
English: Papaloisou Ltd. Τηλ: + 357 22 49 03 05
Slovenian: Τηλ: + 357 22 49 03 05
English: Over 800 patients with moderate to severe symptoms of BPH (International Prostate Symptom Score, IPSS, baseline value ≥13) received silodosin 8 mg once daily in two Phase III placebo-controlled clinical studies conducted in the United States and in one placebo- and active-controlled clinical study conducted in Europe.
Slovenian: Score; izhodiščna vrednost ≥ 13) je v dveh s placebom nadzorovanih kliničnih študijah Faze III v Združenih državah Amerike in v eni s placebom in z zdravilno učinkovino nadzorovani klinični študiji, izpeljani v Evropi, prejemalo 8 mg silodozin enkrat na dan.
English: For this purpose Urorec 4 mg hard capsules are available.
Slovenian: ta namen je na voljo zdravilo Urorec 4 mg trde kapsule.
English: België/Belgique/Belgien Recordati Ireland Ltd.
Slovenian: België/Belgique/Belgien
English: Urorec 8 mg hard capsules Each hard capsule contains 8 mg silodosin.
Slovenian: Urorec 8 mg trde kapsule Ena trda kapsula vsebuje 8 mg silodozina.
English: Ask your doctor whether or not you should postpone or temporarily stop taking Urorec when undergoing cataract surgery.
Slovenian: Če se pripravljate na operacijo sive mrene, vprašajte svojega zdravnika, če lahko odložite začetek jemanja ali začasno prenehate z jemanjem zdravila Urorec.
English: Europe
Slovenian: Österreich
English: Urorec 8 mg hard capsules
Slovenian: Urorec 8 mg trde kapsule
English: Urorec 4 mg hard capsules Each hard capsule contains 4 mg silodosin.
Slovenian: Urorec 4 mg trde kapsule Ena trda kapsula vsebuje 4 mg silodozina.
English: Urorec 4 mg hard capsules
Slovenian: Urorec 4 mg trde kapsule
English: Dizziness
Slovenian: Izločanje
English: Urorec 8 mg hard capsules Urorec 4 mg hard capsules
Slovenian: Urorec 4 mg trde kapsule Urorec 8 mg trde kapsule
English: Reproductive system and breast disorders
Slovenian: Motnje reprodukcije in dojk motnje ejakulacije,
English: No. of patients
Slovenian: Študija Skupina Število bolnikov
English: NAME OF THE MEDICINAL PRODUCT Urorec 4 mg hard capsules silodosin
Slovenian: Urorec 4 mg trde kapsule silodozin
English: NAME OF THE MEDICINAL PRODUCT Urorec 8 mg hard capsules silodosin
Slovenian: Urorec 8 mg trde kapsule silodozin
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Slovenian: A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET
English: How to store Urorec
Slovenian: Shranjevanje zdravila Urorec