FrancophonIA/ELRC3.0 huggingface dataset:
English: Investigational studies have shown that adult CKD patients not on dialysis treated with cinacalcet have an increased risk for hypocalcaemia (serum calcium levels < 8.4 mg/dL [2.1 mmol/L]) compared with cinacalcet-treated CKD patients on dialysis, which may be due to lower baseline calcium levels and/or the presence of residual kidney function.
Slovenian: V raziskovalnih študijah se je pokazalo, da je pri odraslih bolnikih s kronično boleznijo ledvic, ki se ne zdravijo z dializo, prejemajo pa cinakalcet, tveganje za hipokalciemijo (koncentracije kalcija v serumu < 8,4 mg/dl [2,1 mmol/l]) večje v primerjavi z bolniki s kronično boleznijo ledvic, ki se zdravijo z dializo in prejemajo cinakalcet.
English: Dose adjustments of concomitant medicinal products may be required when Mimpara is administered with individually titrated, narrow therapeutic index substances that are predominantly metabolised by CYP2D6 (e.g. flecainide, propafenone, metoprolol, desipramine, nortriptyline, clomipramine).
Slovenian: Če bolnik dobiva zdravilo Mimpara sočasno z individualno titriranimi učinkovinami, ki imajo ozek terapevtski indeks in se pretežno presnavljajo s CYP2D6 (npr. flekainid, propafenon, metoprolol, dezipramin, nortriptilin, klomipramin), je lahko potrebna prilagoditev odmerka sočasno uporabljenih zdravil.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 1 mg, 2.5 mg or 5 mg cinacalcet (as hydrochloride).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena kapsula vsebuje 1 mg, 2,5 mg ali 5 mg cinakalceta (v obliki klorida).
English: Corrected serum calcium should be measured and monitored and should be at or above the lower limit of the normal range prior to administration of first dose of Mimpara (see section 4.4).
Slovenian: Prilagoditev odmerka glede na koncentracijo kalcija v serumu Meriti in nadzirati je treba koncentracijo korigiranega kalcija v serumu, le-ta mora biti pred uporabo prvega odmerka zdravila Mimpara na spodnji meji normalnega območja ali nad njo (glejte poglavje 4.4).
English: Hypersensitivity reactions
Slovenian: preobčutljivostne reakcije
English: Secondary hyperparathyroidism
Slovenian: Sekundarni hiperparatiroidizem
English: Administration using nasogastric or gastrostomy tubes
Slovenian: Uporaba po nazogastrični ali gastrostomijski sondi
English: INFORMATION IN BRAILLE mimpara 5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI mimpara 5 mg
English: Each 30 mg tablet contains 2.74 mg of lactose.
Slovenian: Mimpara 30 mg filmsko obložene tablete Ena 30 mg tableta vsebuje 2,74 mg laktoze.
English: Mimpara must be taken orally, with or shortly after food.
Slovenian: Zdravilo Mimpara morate zaužiti, in sicer s hrano ali kmalu po jedi.
English: Medicinal products known to reduce serum calcium
Slovenian: Zdravila, ki zmanjšajo koncentracijo kalcija
English: Do not take a double dose to make up for a forgotten dose.
Slovenian: Če ste pozabili vzeti zdravilo Mimpara Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na pretisnem omotu poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Mimpara 30 mg film-coated tablets Mimpara 60 mg film-coated tablets Mimpara 90 mg film-coated tablets
Slovenian: Mimpara 30 mg filmsko obložene tablete Mimpara 60 mg filmsko obložene tablete Mimpara 90 mg filmsko obložene tablete
English: What Mimpara looks like and contents of the pack Mimpara is a light green film-coated tablet.
Slovenian: Zdravilo Mimpara je svetlo zelena, filmsko obložena tableta.
English: Corrected serum calcium should be in the upper range of, or above, the age-specified reference interval prior to administration of first dose of Mimpara, and closely monitored (see section 4.4).
Slovenian: Preden se uporabi prvi odmerek zdravila Mimpara, mora biti koncentracija korigiranega kalcija v serumu v zgornjem razponu ali nad referenčnim intervalom, ki je specifičen za starost, ter skrbno nadzirana (glejte poglavje 4.4).
English: Light green, oval (approximately 13.9 mm long and 8.7 mm wide), film-coated tablet marked “AMG” on one side and “90” on the other.
Slovenian: Svetlo zelena, ovalna (približno 13,9 mm dolga in 8,7 mm široka), filmsko obložena tableta z oznako "AMG" na eni strani in "90" na drugi strani.
English: Light green, oval (approximately 12.2 mm long and 7.6 mm wide), film-coated tablet marked “AMG” on one side and “60” on the other.
Slovenian: Svetlo zelena, ovalna (približno 12,2 mm dolga in 7,6 mm široka), filmsko obložena tableta z oznako "AMG" na eni strani in "60" na drugi strani.
English: Serum calcium should be measured within 1 week after initiation or dose adjustment of Mimpara.
Slovenian: Kalcij v serumu je treba izmeriti v 1 tednu po začetku zdravljenja ali prilagoditvi odmerka zdravila Mimpara.
English: The capsules should not be swallowed.
Slovenian: Kapsul ne smete zaužiti.
English: Each film-coated tablet contains 30 mg, 60 mg or 90 mg of cinacalcet (as hydrochloride).
Slovenian: Ena filmsko obložena tableta vsebuje 30 mg, 60 mg ali 90 mg cinakalceta (v obliki klorida).
English: Light green, oval (approximately 9.7 mm long and 6.0 mm wide), film-coated tablet marked “AMG” on one side and “30” on the other.
Slovenian: Svetlo zelena, ovalna (približno 9,7 mm dolga in 6,0 mm široka), filmsko obložena tableta z oznako "AMG" na eni strani in "30" na drugi strani.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 30 mg, 60 mg or 90 mg cinacalcet (as hydrochloride).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 30 mg, 60 mg ali 90 mg cinakalceta (v obliki klorida).
English: Mimpara is available in blisters of 30 mg, 60 mg or 90 mg film-coated tablets.
Slovenian: Zdravilo Mimpara je na voljo v pretisnih omotih, ki vsebujejo 30 mg, 60 mg ali 90 mg filmsko obložene tablete.
English: Mimpara 1 mg granules in capsules for opening Mimpara 2.5 mg granules in capsules for opening Mimpara 5 mg granules in capsules for opening Cinacalcet
Slovenian: Mimpara 1 mg zrnca v kapsulah za odpiranje Mimpara 2,5 mg zrnca v kapsulah za odpiranje Mimpara 5 mg zrnca v kapsulah za odpiranje cinakalcet
English: What Mimpara contains
Slovenian: Kaj vsebuje zdravilo Mimpara
English: Each capsule contains 1 mg, 2.5 mg or 5 mg of cinacalcet (as hydrochloride) granules.
Slovenian: Ena kapsula vsebuje 1 mg, 2,5 mg ali 5 mg zrnc cinakalceta (v obliki klorida).
English: INFORMATION IN BRAILLE mimpara 90
Slovenian: PODATKI V BRAILLOVI PISAVI mimpara 90
English: Dose adjustment based on serum calcium levels Serum calcium should be measured within 1 week after initiation or dose adjustment of Mimpara.
Slovenian: Prilagoditev odmerka glede na koncentracijo kalcija v serumu Kalcij v serumu je treba izmeriti v obdobju 1 tedna po začetku zdravljenja oz. po prilagoditvi odmerka zdravila Mimpara.
English: • if you start or stop smoking, as this may affect the way Mimpara works.
Slovenian: Med zdravljenjem z zdravilom Mimpara morate svojemu zdravniku povedati: • če začnete ali prenehate kaditi, kajti to lahko vpliva na delovanje zdravila Mimpara.
English: Hypersensitivity reactions including angioedema and urticaria have been identified during post-marketing use of Mimpara.
Slovenian: Med uporabo zdravila Mimpara v obdobju trženja zdravila so bile ugotovljene preobčutljivostne reakcije, vključno z angioedemom in urtikarijo.
English: Capsule consists of a dark green colour cap, marked “AMG” and white opaque body, marked “1 mg”.
Slovenian: Kapsula je sestavljena iz temnozelenega pokrovčka, na katerem je oznaka "AMG", in belega motnega telesa, na katerem je oznaka "1 mg".
English: INFORMATION IN BRAILLE mimpara 30
Slovenian: PODATKI V BRAILLOVI PISAVI mimpara 30
English: • high potassium levels in the blood (hyperkalaemia)
Slovenian: • visoka koncentracija kalija v krvi (hiperkaliemija),
English: Tablet coat
Slovenian: Prevleka tablete karnauba vosek
English: Mimpara daily dose in paediatric patients Patient dry weight (kg)
Slovenian: Preglednica 1: Dnevni odmerek zdravila Mimpara pri pediatričnih bolnikih
English: Capsule consists of a blue colour cap, marked “AMG” and white opaque body, marked “5 mg”.
Slovenian: Kapsula je sestavljena iz modrega pokrovčka, na katerem je oznaka "AMG", in belega motnega telesa, na katerem je oznaka "5 mg".
English: Capsule consists of a rich yellow colour cap, marked “AMG” and white opaque body, marked “2.5 mg”.
Slovenian: Kapsula je sestavljena iz močno rumenega pokrovčka, na katerem je oznaka "AMG", in belega motnega telesa, na katerem je oznaka "2,5 mg".
English: INFORMATION IN BRAILLE mimpara 60
Slovenian: PODATKI V BRAILLOVI PISAVI mimpara 60
English: • Over a clean work surface remove from the bottle the number of capsules your doctor or pharmacist told you to use.
Slovenian: • Nad čisto delovno površino vzemite iz plastenke toliko kapsul,
English: Parathyroid carcinoma and Primary Hyperparathyroidism
Slovenian: Paratiroidni karcinom in primarni hiperparatiroidizem
English: After oral administration of Mimpara, maximum plasma cinacalcet concentration is achieved in approximately 2 to 6 hours.
Slovenian: Cinakalcet doseže največjo koncentracijo v plazmi v približno 2 do 6 urah po peroralni uporabi zdravila Mimpara.
English: Mimpara is available in bottles of 30 mg, 60 mg or 90 mg film-coated tablets, inside a carton.
Slovenian: Mimpara je na voljo v plastenkah (30 mg, 60 mg ali 90 mg filmsko obložene tablete) v škatli.
English: The mean (SD) iPTH concentrations at baseline were 757.1 (440.1) pg/mL for the cinacalcet group and 795.8 (537.9) pg/mL for the placebo group.
Slovenian: Večina bolnikov (91 %) je izhodiščno uporabljala sterole vitamina D. Povprečna (standardni odklon) izhodiščna koncentracija iPTH je bila 757,1 (440,1) pg/ml v skupini s cinakalcetom in 795,8 (537,9) pg/ml v skupini s placebom.
English: Life threatening events and fatal outcomes associated with hypocalcaemia have been reported in adult and paediatric patients treated with Mimpara.
Slovenian: Pri odraslih in pediatričnih bolnikih, zdravljenih z zdravilom Mimpara, so bili opisani življensko ogrožujoči dogodki in smrtni izidi, povezani s hipokalciemijo.
English: Seizures† Dizziness Paraesthesia Headache
Slovenian: Bolezni živčevja pogosti konvulzije† omotica parestezija glavobol
English: • Microcrystalline cellulose
Slovenian: • mikrokristalna celuloza,
English: Patients receiving concomitant medications known to prolong the corrected QT interval were excluded from the study.
Slovenian: V študijo niso bili vključeni bolniki, sočasno zdravljeni z zdravili, ki podaljšajo korigirani interval QT.
English: Do not initiate cinacalcet or increase the dose if non-compliance is suspected.
Slovenian: Če sumite, da komplianca ni ustrezna, ne uvajajte zdravljenja s cinakalcetom in ne večajte odmerka.
English: Once the maintenance dose has been established, weekly measurement of serum calcium is recommended.
Slovenian: Ko je vzdrževalni odmerek določen, je koncentracijo kalcija v serumu priporočljivo meriti vsak teden.
English: NAME OF THE MEDICINAL PRODUCT Mimpara 1 mg granules in capsules for opening Mimpara 2.5 mg granules in capsules for opening Mimpara 5 mg granules in capsules for opening
Slovenian: Mimpara 1 mg zrnca v kapsulah za odpiranje Mimpara 2,5 mg zrnca v v kapsulah za odpiranje Mimpara 5 mg zrnca v v kapsulah za odpiranje
English: • liver problems;
Slovenian: • težave z jetri,
English: • seizures (convulsions or fits)
Slovenian: • konvulzije (napadi krčev),
English: 4.7 Effects on ability to drive and use machines Dizziness and seizures, which may have major influence on the ability to drive and use machines, have been reported by patients taking Mimpara (see section 4.4).
Slovenian: Pri bolnikih, ki so jemali zdravilo Mimpara, so poročali o omotici in konvulzijah, ki imajo lahko pomemben vpliv na sposobnost vožnje in upravljanja strojev (glejte poglavje 4.4).
English: • Pre-gelatinised maize starch
Slovenian: • predgelirani koruzni škrob,
English: During dose titration, serum calcium levels should be monitored frequently, and within 1 week of initiation or dose adjustment of Mimpara.
Slovenian: Med titriranjem odmerka pogosto kontrolirajte koncentracijo kalcija v serumu; prav tako jo kontrolirajte v 1 tednu po začetku zdravljenja ali po prilagoditvi odmerka zdravila Mimpara.
English: Three, 6-month, double-blind, placebo-controlled clinical studies were conducted in ESRD patients with uncontrolled secondary HPT receiving dialysis (n = 1,136).
Slovenian: Pri dializnih bolnikih s končno odpovedjo ledvic in neobvladanim sekundarnim hiperparatiroidizmom (n = 1.136) so opravili tri 6-mesečne, dvojno slepe, s placebom nadzorovane klinične študije.
English: Mimpara 1 mg granules in capsules for opening
Slovenian: Mimpara 1 mg zrnca v kapsulah za odpiranje
English: Closely monitor serum calcium levels (see section 4.2) and patient compliance during treatment with cinacalcet.
Slovenian: Med zdravljenjem s cinakalcetom natančno kontrolirajte koncentracijo kalcija v serumu (glejte poglavje 4.2) in bolnikovo komplianco.
English: Life threatening events and fatal outcomes associated with low calcium levels (hypocalcaemia) have been reported in adults and children treated with Mimpara.
Slovenian: Pri odraslih in pediatričnih bolnikih, zdravljenih z zdravilom Mimpara, so poročali o življensko ogrožujočih dogodkih in smrtnih izidih, povezanih z nizko koncentracijo kalcija (hipokalciemijo).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BOTTLE
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PRETISNI OMOT
English: Adverse reaction
Slovenian: Preobčutljivostne reakcije
English: Pharmacotherapeutic group: Calcium homeostasis, anti-parathyroid agents.
Slovenian: Farmakoterapevtska skupina: Zdravila za uravnavanje homeostaze kalcija; zdravila, ki zavirajo paratiroideo, oznaka ATC: H05BX01.
English: Iron oxide yellow (E172) Titanium dioxide (E171)
Slovenian: Mimpara 2,5 mg zrnca v kapsulah za odpiranje želatina rumeni železov oksid (E172) titanov dioksid (E171)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTER
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PLASTENKO
English: Secondary hyperparathyroidism, parathyroid carcinoma and primary hyperparathyroidism Based on available data from patients receiving cinacalcet in placebo-controlled studies and single-arm studies the most commonly reported adverse reactions were nausea and vomiting.
Slovenian: Na osnovi razpoložljivih podatkov o bolnikih, ki so cinakalcet prejemali v študijah, kontroliranih s placebom, in študijah z enim krakom, sta bila najpogosteje poročana neželena učinka navzea in bruhanje.
English: Corrected total serum calcium is above age-specified lower limit of normal, and
Slovenian: Korigirani celotni kalcij v serumu je nad spodnjo mejo za starost normalnega območja in simptomi hipokalciemije so izginili
English: Not known*
Slovenian: Srčne bolezni neznana*
English: Mimpara 2.5 mg granules in capsules for opening
Slovenian: Mimpara 2,5 mg zrnca v kapsulah za odpiranje
English: The mean (SD) iPTH concentrations at baseline were 946 (635) pg/mL for the cinacalcet + SOC group and 1228 (732) pg/mL for the SOC group.
Slovenian: Večina bolnikov (75 %) je izhodiščno uporabljala sterole vitamina D. Povprečna (standardni odklon) izhodiščna koncentracija iPTH je bila 946 (635) pg/ml v skupini s cinakalcetom + SOC in 1.228 (732) pg/ml v skupini s SOC.
English: The capsule shell is not for ingestion.
Slovenian: Ovojnica kapsule ni za zaužitje.
English: The mean (SD) corrected total serum calcium concentrations at baseline were 9.8 (0.6) mg/dL for the cinacalcet + SOC group and 9.8 (0.6) mg/dL for the SOC group.
Slovenian: Povprečna (standardni odklon) korigirana koncentracija celokupnega kalcija v serumu je bila izhodiščno 9,8 (0,6) mg/dl v skupini s cinakalcetom + SOC in 9,8 (0,6) mg/dl v skupini s SOC. 25 preiskovancev je prejelo vsaj en odmerek cinakalceta in povprečni največji dnevni odmerek cinakalceta je bil 0,55 mg/kg/dan.
English: Mimpara 5 mg granules in capsules for opening
Slovenian: Mimpara 5 mg zrnca v kapsulah za odpiranje
English: Mimpara 30 mg film-coated tablets
Slovenian: Mimpara 30 mg filmsko obložene tablete
English: METHOD AND ROUTE OF ADMINISTRATION For oral use
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA peroralna uporaba
English: • muscle spasms
Slovenian: • spazmi mišic,
English: STATEMENT OF ACTIVE SUBSTANCE Each capsule contains 1 mg of cinacalcet (as hydrochloride).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena kapsula vsebuje 1 mg cinakalceta (v obliki klorida).
English: Mimpara 90 mg film-coated tablets
Slovenian: Mimpara 90 mg filmsko obložene tablete
English: Mimpara 60 mg film-coated tablets
Slovenian: Mimpara 60 mg filmsko obložene tablete
English: Immune system disorders
Slovenian: Bolezni imunskega sistema pogosti*
English: MARKETING AUTHORISATION NUMBER EU/1/04/292/008
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/292/008
English: • Colloidal anhydrous silica
Slovenian: • brezvodni koloidni silicijev dioksid.
English: Nausea Vomiting
Slovenian: Okvara jeter
English: STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 30 mg of cinacalcet (as hydrochloride).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 30 mg cinakalceta (v obliki klorida).
English: STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 90 mg of cinacalcet (as hydrochloride).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 90 mg cinakalceta (v obliki klorida).
English: Cinacalcet is not indicated for CKD patients not on dialysis.
Slovenian: Bolniki s kronično boleznijo ledvic, ki se ne zdravijo z dializo Cinakalcet ni indiciran za bolnike s kronično boleznijo ledvic, ki se ne zdravijo z dializo.
English: NAME OF THE MEDICINAL PRODUCT Mimpara 90 mg film-coated tablets Cinacalcet
Slovenian: IME ZDRAVILA Mimpara 90 mg tableta cinakalcet
English: Mimpara 2.5 mg granules in capsules for opening Gelatin
Slovenian: Mimpara 2,5 mg zrnca v kapsulah za odpiranje cinakalcet
English: STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 60 mg of cinacalcet (as hydrochloride).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 60 mg cinakalceta (v obliki klorida).
English: STATEMENT OF ACTIVE SUBSTANCE Each capsule contains 2.5 mg of cinacalcet (as hydrochloride).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena kapsula vsebuje 2,5 mg cinakalceta (v obliki klorida).
English: STATEMENT OF ACTIVE SUBSTANCE Each capsule contains 5 mg of cinacalcet (as hydrochloride).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena kapsula vsebuje 5 mg cinakalceta (v obliki klorida).
English: Magnesium stearate Colloidal anhydrous silica
Slovenian: Jedro tablete predgelirani škrob (koruzni) mikrokristalna celuloza povidon krospovidon magnezijev stearat brezvodni koloidni silicijev dioksid
English: NAME OF THE MEDICINAL PRODUCT Mimpara 30 mg film-coated tablets Cinacalcet
Slovenian: IME ZDRAVILA Mimpara 30 mg tableta cinakalcet
English: • a medicine used to relieve cough (dextromethorphan);
Slovenian: • zdravilo za lajšanje kašlja (dekstrometorfan),
English: How to store Mimpara
Slovenian: Shranjevanje zdravila Mimpara
English: Mimpara 5 mg granules in capsules for opening Gelatin
Slovenian: Mimpara 5 mg zrnca v kapsulah za odpiranje cinakalcet
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: Če opazite katerega koli od neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom ali medicinsko sestro.
English: Mimpara 1 mg granules in capsules for opening Gelatin
Slovenian: Mimpara 1 mg zrnca v kapsulah za odpiranje cinakalcet
English: NAME OF THE MEDICINAL PRODUCT Mimpara 60 mg film-coated tablets Cinacalcet
Slovenian: IME ZDRAVILA Mimpara 60 mg tableta cinakalcet
English: The primary endpoint of the study was a reduction of serum calcium of ≥ 1 mg/dL (≥ 0.25 mmol/L).
Slovenian: Cinakalcet so dobivali v odmerkih od 30 mg dvakrat na dan do 90 mg štirikrat na dan. Primarni cilj študije je bilo znižanje kalcija v serumu za ≥ 1 mg/dl (≥ 0,25 mmol/l).
English: FD&C Blue (E132), iron oxide yellow (E172))
Slovenian: (E132), rumeni železov oksid (E172))
English: Significant reductions in iPTH, serum calcium-phosphorus product (Ca x P), calcium, and phosphorus were observed in the cinacalcet-treated patients compared with placebo-treated patients receiving standard of care, and the results were consistent across the 3 studies.
Slovenian: Pri prejemnikih cinakalceta so v primerjavi z bolniki, ki so prejemali placebo in standardno oskrbo, ugotovili značilno znižanje iPTH, zmnožka kalcija in fosforja v serumu (Ca x P) ter kalcija in fosforja.
English: MARKETING AUTHORISATION NUMBER EU/1/04/292/004
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/292/004
English: Talk to your doctor, pharmacist or nurse before taking Mimpara.
Slovenian: Pred začetkom jemanja zdravila Mimpara se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: 1, 2.5, 5, 7.5, 10 and 15
Slovenian: 1; 2,5; 5; 7,5; 10 in 15
English: MARKETING AUTHORISATION NUMBER EU/1/04/292/012
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/292/012
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti okužba zgornjih dihal dispneja kašelj
English: MARKETING AUTHORISATION NUMBER EU/1/04/292/015
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/292/015
English: Nervous system disorders
Slovenian: Organski sistem po MedDRA Pogostnost
English: MARKETING AUTHORISATION NUMBERS EU/1/04/292/005 - carton of 14 tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/292/005 - škatla s 14 tabletami EU/1/04/292/006 - škatla z 28 tabletami EU/1/04/292/007 - škatla s 84 tabletami
English: MARKETING AUTHORISATION NUMBERS EU/1/04/292/001 - carton of 14 tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/292/001 - škatla s 14 tabletami EU/1/04/292/002 - škatla z 28 tabletami EU/1/04/292/003 - škatla s 84 tabletami
English: MARKETING AUTHORISATION NUMBER EU/1/04/292/014
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/292/014
English: Iron oxide yellow (E172) Indigo carmine (E132)
Slovenian: Mimpara 1 mg zrnca v kapsulah za odpiranje želatina rumeni železov oksid (E172) indigotin (E132) titanov dioksid (E171)
English: MARKETING AUTHORISATION NUMBERS EU/1/04/292/009 - carton of 14 tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/292/009 - škatla s 14 tabletami EU/1/04/292/010 - škatla z 28 tabletami EU/1/04/292/011 - škatla s 84 tabletami
English: MARKETING AUTHORISATION NUMBER EU/1/04/292/013
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/292/013
English: Upper respiratory infection Dyspnoea
Slovenian: Žilne bolezni pogosti hipotenzija
English: Dizziness and seizures have been reported by patients taking Mimpara.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Pri bolnikih, ki so jemali zdravilo Mimpara, so poročali o omotici in napadih krčev.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva pogosti mialgija spazmi mišic bolečine v hrbtu
English: • Hives (urticaria)
Slovenian: • koprivnica (urtikarija),
English: Side effects seen in studies were generally benign and were considered manageable.
Slovenian: Neželeni učinki, opaženi v študijah, so bili običajno blagi in obvladljivi.
English: This medicine is the same as Ultibro Breezhaler, which is already authorised in the European Union (EU).
Slovenian: To zdravilo je enako zdravilu Ultibro Breezhaler, ki je že odobreno v Evropski uniji (EU).
English: However, the CHMP considered that its effects on reducing the rate of exacerbations were too small to recommend use in reducing exacerbations.
Slovenian: Vendar je odbor CHMP menil, da so njegovi učinki na zmanjšanje števila poslabšanj prešibki, da bi ga lahko priporočil za to indikacijo.