FrancophonIA/ELRC3.0 huggingface dataset:
English: Pioglitazone Actavis should be used every day to work properly.
Slovenian: Če ste prenehali jemati zdravilo Pioglitazon Actavis Zdravilo Pioglitazon Actavis morate vzeti vsak dan, da bo delovalo pravilno.
English: Pioglitazone Actavis 30 mg
Slovenian: Pioglitazon Actavis 30 mg
English: Pioglitazone Actavis 45 mg
Slovenian: Pioglitazon Actavis 45 mg
English: Take Pioglitazone Actavis daily as prescribed.
Slovenian: Če ste pozabili vzeti zdravilo Pioglitazon Actavis Zdravilo Pioglitazon Actavis vzemite vsak dan, kot je predpisano.
English: Allergic reactions have been reported (frequency not known) in patients taking Pioglitazone Actavis.
Slovenian: Pri bolnikih, ki jemljejo zdravilo Pioglitazon Actavis, so poročali o alergijskih reakcijah (pogostnost ni znana).
English: as dual oral therapy in combination with - metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin.
Slovenian: kot dvojno peroralno zdravljenje v kombinaciji: - z metforminom pri odraslih bolnikih (predvsem bolnikih s prekomerno telesno maso) z nezadostnim nadzorom glikemije kljub najvišjemu toleriranemu odmerku metformina v monoterapiji - s sulfonilsečnino, le pri odraslih bolnikih, ki ne prenašajo metformina ali je metformin pri njih kontraindiciran, z nezadostnim nadzorom glikemije kljub najvišjemu toleriranemu odmerku sulfonilsečnine v monoterapiji.
English: Pioglitazone Actavis 15 mg
Slovenian: Pioglitazon Actavis 15 mg
English: NAME OF THE MARKETING AUTHORISATION HOLDER Actavis Group PTC ehf.
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Actavis Group PTC ehf.
English: Other medicines and Pioglitazone Actavis
Slovenian: Shranjevanje zdravila pioglitazon actavis
English: Pioglitazone Actavis 45 mg tablets are white, round, flat, bevelled, 8 mm in diameter and engraved with ‘TZ45' on one side.
Slovenian: Tablete Pioglitazon Actavis 45 mg so bele, okrogle, ploščate, na obeh straneh izbočene tablete s premerom 8 mm, ki imajo na eni strani vtisnjeno oznako 'TZ45'.
English: EU/1/12/755/001 [14 tablets] EU/1/12/755/002 [28 tablets] EU/1/12/755/003 [30 tablets] EU/1/12/755/004 [50 tablets] EU/1/12/755/005 [56 tablets] EU/1/12/755/006 [84 tablets] EU/1/12/755/007 [90 tablets] EU/1/12/755/008 [98 tablets] EU/1/12/755/009 [100 tablets]
Slovenian: EU/1/12/755/001 [14 tablet] EU/1/12/755/002 [28 tablet] EU/1/12/755/003 [30 tablet] EU/1/12/755/004 [50 tablet] EU/1/12/755/005 [56 tablet] EU/1/12/755/006 [84 tablet] EU/1/12/755/007 [90 tablet] EU/1/12/755/008 [98 tablet] EU/1/12/755/009 [100 tablet]
English: Pioglitazone Actavis 30 mg tablets are white, round, flat, bevelled, 7 mm in diameter and engraved with ‘TZ30' on one side.
Slovenian: Tablete Pioglitazon Actavis 30 mg so bele, okrogle, ploščate, na obeh straneh izbočene tablete s premerom 7 mm, ki imajo na eni strani vtisnjeno oznako 'TZ30'.
English: EU/1/12/755/019 [14 tablets] EU/1/12/755/020 [28 tablets] EU/1/12/755/021 [30 tablets] EU/1/12/755/022 [50 tablets] EU/1/12/755/023 [56 tablets] EU/1/12/755/024 [84 tablets] EU/1/12/755/025 [90 tablets] EU/1/12/755/026 [98 tablets] EU/1/12/755/027 [100 tablets]
Slovenian: EU/1/12/755/019 [14 tablet] EU/1/12/755/020 [28 tablet] EU/1/12/755/021 [30 tablet] EU/1/12/755/022 [50 tablet] EU/1/12/755/023 [56 tablet] EU/1/12/755/024 [84 tablet] EU/1/12/755/025 [90 tablet] EU/1/12/755/026 [98 tablet] EU/1/12/755/027 [100 tablet]
English: EU/1/12/755/010 [14 tablets] EU/1/12/755/011 [28 tablets] EU/1/12/755/012 [30 tablets] EU/1/12/755/013 [50 tablets] EU/1/12/755/014 [56 tablets] EU/1/12/755/015 [84 tablets] EU/1/12/755/016 [90 tablets] EU/1/12/755/017 [98 tablets] EU/1/12/755/018 [100 tablets]
Slovenian: EU/1/12/755/010 [14 tablet] EU/1/12/755/011 [28 tablet] EU/1/12/755/012 [30 tablet] EU/1/12/755/013 [50 tablet] EU/1/12/755/014 [56 tablet] EU/1/12/755/015 [84 tablet] EU/1/12/755/016 [90 tablet] EU/1/12/755/017 [98 tablet] EU/1/12/755/018 [100 tablet]
English: Pioglitazone Actavis 30 mg tablets
Slovenian: Pioglitazon Actavis 30 mg tablete
English: Eye disorders visual disturbance common common uncommon macular oedema not known not known not known not known not known Ear and labyrinth disorders vertigo uncommon
Slovenian: Očesne bolezni motnje vida pogosto pogosto občasno edem makule ni znano ni znano ni znano ni znano ni znano
English: Pioglitazone Actavis 15 mg tablets pioglitazone
Slovenian: Pioglitazon Actavis 15 mg tablete pioglitazon
English: Pioglitazone Actavis 45 mg tablets
Slovenian: Pioglitazon Actavis 45 mg tablete
English: Pioglitazone Actavis 30 mg tablets pioglitazone
Slovenian: Pioglitazon Actavis 30 mg tablete pioglitazon
English: Pioglitazone Actavis 15 mg tablets
Slovenian: Pioglitazon Actavis 15 mg tablete
English: Pioglitazone Actavis 45 mg tablets pioglitazone
Slovenian: Pioglitazon Actavis 45 mg tablete pioglitazon
English: Aurobindo Pharma B.V. Tel: +31 (0)35 542 99 33
Slovenian: Tel: +31 (0)35 542 99 33
English: Co-administration of pioglitazone with rifampicin (an inducer of cytochrome P450 2C8)
Slovenian: Opisano je, da sočasna uporaba pioglitazona z rifampicinom (induktor citokroma P450 2C8) zmanjša AUC pioglitazona za 54 %.
English: • The committee considered the referral under Article 30 of Directive 2001/83/EC,
Slovenian: • Odbor je obravnaval napotitev na podlagi člena 30 Direktive 2001/83/ES.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.”
Slovenian: Upoštevati je treba uradna navodila glede ustrezne uporabe antibakterijskih zdravil.“
English: The studies were performed in a period in which acquired resistance was not a critical problem.
Slovenian: Študije so opravili v obdobju, v katerem pridobljena odpornost ni bila kritična.
English: Septicaemia and meningitis
Slovenian: Septikemija in meningitis
English: • Intra-abdominal infections (see section 4.4).
Slovenian: • intraabdominalne okužbe (glejte poglavje 4.4).
English: Gonorrhoea
Slovenian: Gonoreja
English: Overall summary of the scientific evaluation of Zinacef and associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Zinacef in povezanih imen (glejte Prilogo I)
English: Zinacef was first approved in Europe in the early 1980's and is available as parenteral formulations.
Slovenian: Zdravilo je bilo v Evropi prvič odobreno v zgodnjih 80. let prejšnjega stoletja in je na voljo v parenteralnih oblikah.
English: A referral under Article 30(2) of Directive 2001/83/EC was therefore triggered to resolve these divergences and thus to harmonise the Product Information (PI) across the EU.
Slovenian: Zato je bila na podlagi člena 30(2) Direktive 2001/83/ES, kakor je bila spremenjena, sprožena napotitev za razrešitev teh razhajanj in s tem uskladitev informacij o zdravilu v EU.
English: “Zinacef is indicated for the treatment of the infections listed below in adults and children, including neonates (from birth) (see sections 4.4 and 5.1).
Slovenian: „Zdravilo Zinacef je indicirano za zdravljenje spodaj naštetih okužb pri odraslih in otrocih, vključno z novorojenčki (od rojstva dalje) (glejte poglavji 4.4 in 5.1).
English: The CHMP defined neonates as infants younger than 3 weeks, including newborns and agreed that cefuroxime has been used in neonates for many years without any serious safety concerns.
Slovenian: Novorojenčke je opredelil kot dojenčke, stare manj kot tri tedne, vključno z novorojenci, in se strinjal, da se cefuroksim pri novorojenčkih uporablja že vrsto let brez resnih pomislekov glede njegove varnosti za uporabo.
English: The CHMP considered the indication to be acceptable for all populations.
Slovenian: Menil je, da je indikacija sprejemljiva za vse populacije.
English: The CHMP reviewed the studies on septicaemia which were old, non-comparative and included small numbers of patients.
Slovenian: Odbor CHMP je pregledal študije o septikemiji, ki so bile stare, neprimerjalne in so vključevale majhno število bolnikov.
English: In conclusion, the CHMP adopted the following harmonised indications and wording for Section 4.1:
Slovenian: Na koncu je sprejel naslednje usklajene indikacije in besedilo za poglavje 4.1:
English: The CHMP therefore concluded that there is enough data to support the indication in adults and that the adult efficacy data could be extrapolated to the paediatric population.
Slovenian: Odbor je zato sklenil, da obstaja dovolj podatkov za podporo indikacije pri odraslih in da je mogoče podatke za odrasle ekstrapolirati na pediatrično populacijo.
English: Cefuroxime exerts a bactericidal action by inhibiting bacterial enzymes necessary for cell-wall synthesis (peptidoglycan synthesis), thereby causing cell death.
Slovenian: Cefuroksim deluje baktericidno z zaviranjem bakterijskim encimov, potrebnih za sintezo celične stene (peptidoglikanska sinteza), in tako povzroči celično smrt.
English: In the treatment and prevention of infections in which it is very likely that anaerobic organisms will be encountered, cefuroxime should be administered with additional appropriate antibacterial agents.
Slovenian: Pri zdravljenju in preprečevanju okužb, pri katerih zelo verjetno sodelujejo anaerobni organizmi, je treba cefuroksim uporabiti skupaj z ustreznimi dodatnimi antibiotiki.
English: In conclusion, the CHMP adopted a harmonised wording for Section 4.2.
Slovenian: Na koncu je sprejel usklajeno besedilo za poglavje 4.2.
English: The CHMP concluded that the clinical data and the data from the European Committee on Antimicrobial Susceptibility Testing (EUCAST) did not support the treatment of meningitis.
Slovenian: Odbor je zaključil, da klinični podatki in podatki Evropskega odbora za testiranje protimikrobne občutljivosti (European Committee on Antimicrobial Susceptibility Testing - EUCAST) ne podpirajo zdravljenja meningitisa.
English: Regarding patients with renal impairment, the CHMP reviewed the data and considered the proposed dosing guidelines to be acceptable.
Slovenian: V zvezi z bolniki z okvarjenim delovanjem ledvic je odbor CHMP pregledal podatke in menil, da so predlagane smernice za odmerjanje sprejemljive.
English: Regarding patients with hepatic impairment, the CHMP stated that hepatic dysfunction is not expected to affect the pharmacokinetics of cefuroxime.
Slovenian: Glede bolnikov z okvarjenim delovanjem jeter je navedel, da ni pričakovati, da bi okvara jeter vplivala na farmakokinetiko cefuroksima.
English: Having considered the data submitted by the Marketing Authorisation Holder, the rapporteur and co-rapporteur assessment reports and the scientific discussions within the Committee, the CHMP was of the opinion that the benefit-risk ratio of Zinacef and associated names is favourable.
Slovenian: Po proučitvi podatkov, ki jih je predložil imetnik dovoljenja za promet z zdravilom, poročil o oceni, ki sta jih priskrbela poročevalec in soporočevalec, in znanstvenih razprav v odboru CHMP, je ta menil, da je razmerje med koristmi in tveganji za zdravilo Zinacef in povezana imena ugodno.
English: The CHMP agreed that neonates may be given a similar total daily dose as recommended for infants (30 to 100 mg/kg/day) but at a reduced daily frequency of 2 or 3 divided doses, due to the longer serum half-life.
Slovenian: Strinjal se je, da lahko novorojenčki prejmejo podoben skupni odmerek, kot se priporoča za dojenčke (30 do 100 mg/kg/dan), vendar je treba pogostnost dajanja zmanjšati na dva ali tri ločene odmerke zaradi daljšega razpolovnega časa v serumu.
English: The CHMP agreed that the commonly used intravenous and intramuscular dosing regimens (e.g., 750 mg to 1500 mg given every 8 hours) are expected to provide efficacy for organisms with minimum inhibitory concentrations (MICs) up to, and including, 8 μg/mL.
Slovenian: Strinjal se je, da se pričakuje, da intravenski in intramuskularni režimi uporabe (npr. 750 mg do 1 500 mg vsakih osem ur), ki se pogosto uporabljajo, učinkujejo proti organizmom z minimalnimi inhibicijskimi koncentracijami (MIK) do vključno 8 μg/ml.
English: Regarding meningitis, the CHMP noted that the majority of the studies identified H. influenzae, N. meningitidis, S. pneumonia and S. aureus (non-MRSA) as the predominant bacterial species, which does not reflect the present EU situation, where aerobic Gram-negative bacilli are increasingly important as causative agents.
Slovenian: V zvezi z meningitisom je opomnil, da so bile v večini študij bakterije H. influenzae, N. meningitidis, S. pneumonia in S. aureus (ne-MRSA) opredeljene kot prevladujoče bakterijske vrste, kar pa ni prikaz sedanjega stanja v EU, kjer so vedno bolj pomemben povzročitelji aerobne gramnegativne bakterije.
English: Regarding the method of administration, the CHMP stated that Zinacef should be administered by intravenous injection over a period of 3 to 5 minutes directly into a vein or via a drip tube or infusion over 30 to 60 minutes, or by deep intramuscular injection.
Slovenian: Glede načina dajanja je navedel, da je treba zdravilo Zinacef uporabiti v obliki intravenske injekcije, ki se daje v obdobju 3 do 5 minut, neposredno v žilo prek kapalne cevke, v obliki 30- do 60-minutne infuzije ali kot globoko intramuskularno injekcijo.
English: In conclusion, the CHMP judged the data insufficient to support the septicaemia and meningitis indications and therefore recommended their removal.
Slovenian: Na koncu je ocenil, da podatki ne zadoščajo za podprtje indikacij septikemije in meningitisa, zato je priporočil, da se odstrani.
English: The CHMP noted the large amount of clinical experience supporting the use of cefuroxime in this indication.
Slovenian: Upošteval je številne klinične izkušnje, ki podpirajo uporabo cefuroksima pri tej indikaciji.
English: The CHMP reviewed the presented clinical studies but considered the data to be insufficient.
Slovenian: Pregledal je predložene klinične študije, vendar je menil, da so podatki nezadostni.
English: The CHMP reviewed the dosage recommendations for each individual indication.
Slovenian: Pregledal je priporočila za odmerjanje za vsako posamezno indikacijo.
English: The CHMP therefore recommended the removal of this indication.
Slovenian: Zato je priporočil, da se ta indikacija odstrani.
English: • The committee reviewed the data submitted by the MAH, including data from clinical trials, published literature and clinical documentation, justifying the proposed harmonised Product Information,
Slovenian: • Odbor je pregledal podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom, vključno s podatki kliničnih preskušanj, objavljene literature in klinične dokumentacije, ki utemeljujejo predlagano uskladitev informacij o zdravilu.
English: The CHMP noted the large degree of divergences in the nationally approved posologies and recommendations and therefore reviewed the available data to support a harmonised Section 4.2.
Slovenian: Odbor CHMP je opazil veliko razhajanje v nacionalno odobrenih odmerjanjih in priporočilih, zato je pregledal razpoložljive podatke, ki podpirajo usklajeno poglavje 4.2.
English: Indication in neonates
Slovenian: Indikacije pri novorojenčkih
English: The CHMP considered that the data on bone penetration did not outweigh the lack of supportive clinical data.
Slovenian: Ocenil je, da podatki o penetraciji v kosti ne odtehtajo pomanjkanja podpornih kliničnih podatkov.
English: The CHMP reviewed the submitted studies, the majority of which used cefuroxime in combination with probenecid rather than cefuroxime alone.
Slovenian: Odbor CHMP je pregledal predložene študije, v katerih so večinoma uporabili cefuroksim v kombinaciji s probenecidom, ne pa cefuroksima samega.
English: The CHMP reviewed the submitted data and considered the distributions of infections in the two largest submitted studies to be supportive of the proposed indication, although cefuroxime is not suitable for the treatment of infections caused by Gram-negative non-fermenting bacteria.
Slovenian: Odbor CHMP je pregledal predložene podatke in upošteval, da porazdelitev okužb v dveh največjih predloženih študijah podpira predlagano indikacijo, čeprav cefuroksim ni primeren za zdravljenje okužb, ki jih povzročajo gramnegativne nefermentativne bakterije.
English: Annex II Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisations
Slovenian: Znanstveni zaključki in podlaga za spremembo pogojev dovoljenja za promet z zdravilom
English: The CHMP recommended the removal of the option of parenteral-to-oral sequential therapy for all patients, due to the significant reduction in exposure to active drug when switching to the oral formulation.
Slovenian: Odbor CHMP je priporočil, da se možnost sekvenčnega zdravljenja s parenteralno obliko s prehodom na peroralno obliko izbriše za vse bolnike zaradi bistveno zmanjšane izpostavljenosti zdravilni učinkovini ob prehodu na peroralno obliko zdravila.
English: The CHMP also noted that there are few treatment options available for pregnant women with pyelonephritis.
Slovenian: Prav tako je upošteval, da je za nosečnice s pielonefritisom na voljo manj oblik zdravljenja.
English: The CHMP considered the submitted data, consisting of eleven small, non-comparative studies and two open labelled, comparative studies.
Slovenian: Odbor CHMP je ocenil predložene podatke, sestavljene iz enajstih kratkih, neprimerjalnih študij in dveh odprtih, primerjalnih študij.
English: The CHMP also noted that no comparative, placebo-controlled or double-blinded studies were available in the restricted indication severe ear, nose and throat-infections.
Slovenian: Menil je tudi, da ni na voljo primerjalnih, s placebom nadzorovanih ali dvojno slepih študij za omejeno indikacijo hude okužbe ušes, nosu in grla.
English: Zinacef contains cefuroxime sodium, a second generation cephalosporin antibacterial agent.
Slovenian: Zdravilo Zinacef vsebuje natrijev cefuroksimat, antibiotik druge generacije cefalosporinov.
English: Zinacef was included in the list of products for Summary of Product Characteristics (SmPC) harmonisation, due to divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product.
Slovenian: Zdravilo Zinacef je bilo vključeno na seznam zdravil za uskladitev povzetka glavnih značilnosti zdravila zaradi različnih nacionalnih odločitev držav članic glede dovoljenja za promet z navedenim zdravilom.
English: Having reviewed all submitted data to support the various prophylaxis indications proposed for cefuroxime, the CHMP considered the indication “Prophylaxis against infection in gastrointestinal (including oesophageal), orthopaedic, cardiovascular and gynaecological surgery (including caesarean section)” to be acceptable.
Slovenian: Po pregledu vseh predloženih podatkov, ki podpirajo različne profilaktične indikacije, predlagane za cefuroksim, je odbor CHMP menil, da je indikacija „Preprečevanje okužb pri gastrointestinalnem (vključno z ezofagealnim), ortopedskem, kardiovaskularnem in ginekološkem kirurškem posegu (vključno s carskim rezom)“ sprejemljiva.
English: The CHMP noted that although only one double-blind study was submitted, several other comparatorcontrolled and randomised studies were also submitted, several of which were performed recently and showed adequate efficacy of cefuroxime.
Slovenian: Odbor CHMP je opazil, da je bilo kljub predložitvi ene same dvojno slepe študije predloženih več drugih naključnih študij, nadzorovanih s primerjalnim zdravilom, med katerimi jih je bilo več izvedenih šele pred kratkim in ki so prikazovale ustrezno učinkovitost cefuroksima.
English: The CHMP noted the large degree of divergences in the nationally approved indications and therefore reviewed the available data supporting each indvidual indication and the patient age groups.
Slovenian: Odbor CHMP je opazil, da nacionalno odobrene indikacije precej odstopajo, zato je pregledal razpoložljive podatke, ki podpirajo vsako posamezno indikacijo in starostne skupine bolnikov.
English: • Soft-tissue infections: cellulitis, erysipelas and wound infections.
Slovenian: • okužbe mehkega tkiva: celulitis, erizipel in okužba ran;
English: The CHMP also noted that although the most common coexisting pathogen in patients with gonorrhoea is Chlamydia trachomatis, no data on combination therapy (cefuroxime with other antibiotic) for treatment of patients co-infected by N. gonorrhoeae and C. trachomatis, or by N. gonorrhoeae and anaerobic bacteria, was submitted.
Slovenian: Opazil je, da čeprav je najpogostejši sočasni povzročitelj, ki se pojavlja pri bolnikih z gonorejo, Chlamydia trachomatis, podatki o kombiniranem zdravljenju (cefuroksim z drugimi antibiotiki) za zdravljenje bolnikov, sočasno okuženih z bakterijo N. gonorrhoeae in C. trachomatis ali z bakterijo N. gonorrhoeae in anaerobno bakterijo, niso bili predloženi.
English: The CHMP reviewed the submitted data and agreed that staphylococci and streptococci, the bacterial species most frequently involved in skin and soft tissue infections, are sensitive to cefuroxime.
Slovenian: Odbor CHMP je pregledal predložene podatke in se strinjal, da so stafilokoki in streptokoki, bakterijski vrsti, ki najpogosteje povzročita okužbe kože in mehkega tkiva, občutljivi na cefuroksim.
English: Acute exacerbations of chronic bronchitis
Slovenian: Akutne eksacerbacije kroničnega bronhitisa
English: Having reviewed the available data, consisting of small non-comparative studies, the CHMP considered it to be very limited and of questionable methodology.
Slovenian: Ob upoštevanju razpoložljivih podatkov, sestavljenih iz kratkih neprimerjalnih študij, je odbor CHMP menil, da so ti podatki zelo omejeni, metodologija študij pa vprašljiva.
English: The CHMP reviewed the two open studies submitted but stated that cefuroxime is not active against many of the bacterial species isolated in obstetric and gynaecological infections, either due to inherent resistance or due to acquired resistance.
Slovenian: Odbor CHMP je pregledal dve predloženi odprti študiji, vendar je navedel, da cefuroksim ni aktiven proti več bakterijskim vrstam, izoliranih pri okužbah rodil in spolovil, bodisi zaradi inherentne ali pridobljene odpornosti.
English: The CHMP considered the proposed indication wording to be too general and noted that most upper respiratory tract infections respond well to oral therapy or are spontaneously cured.
Slovenian: Odbor CHMP je menil, da je besedilo predlagane indikacije preveč splošno, in opomnil, da se večina okužb zgornjih dihal dobro odziva na peroralno zdravljenje ali se pozdravijo spontano.
English: The CHMP reviewed the data in neonates, including the data on dosing range and dosing interval.
Slovenian: Odbor CHMP je pregledal podatke pri novorojencih, vključno s podatki o razponu odmerkov in razmikih med odmerki.
English: The CHMP also adopted a harmonised wording for the remaining sections of the Zinacef SmPC and brought the labelling and the package leaflet in line with the adopted harmonised SmPC.
Slovenian: Odbor CHMP je sprejel tudi usklajeno besedilo za preostala poglavja povzetka glavnih značilnosti zdravila Zinacef in uskladil označevanje in navodilo za uporabo s sprejetim usklajenim povzetkom glavnih značilnosti zdravila.
English: • The committee agreed the harmonisation of the summary of product characteristic, labelling and package leaflet proposed by the marketing authorisation holders,
Slovenian: • Odbor se je strinjal s predlagano uskladitvijo povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo, kot je to predlagal imetnik dovoljenja za promet z zdravilom,
English: The CHMP considered that the available data did not support this indication and therefore recommended its removal.
Slovenian: Menil je, da razpoložljivi podatki ne podpirajo te indikacije, zato je priporočil, da se odstrani.
English: • The committee considered the identified divergences for Zinacef and associated names regarding the therapeutic indications and the posology and method of administration sections, as well as in the remaining sections of the SmPC,
Slovenian: • Odbor je obravnaval ugotovljena razhajanja za zdravilo Zinacef in povezana imena glede poglavij o terapevtskih indikacijah, odmerjanju in načinih uporabe ter preostalih poglavij povzetka glavnih značilnosti zdravila.
English: Skin and soft-tissue infections
Slovenian: Okužbe kože in mehkega tkiva