FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH proposed the same indications for the 2:1, 4:1, 7:1 and 8:1 ratios and these are discussed in common.
Slovenian: Imetniki dovoljenj za promet z zdravilom so predlagali enake indikacije za razmerja 2:1, 4:1, 7:1 in 8:1, zato se te skupine razmerij obravnavajo skupaj.
English: Dosing recommendations for Augmentin ES are supported by clinical safety and efficacy data in AOM.
Slovenian: Priporočila za odmerjanje zdravila Augmentin ES podpirajo podatki o klinični varnosti in učinkovitosti pri akutnem vnetju srednjega ušesa.
English: In adults, the higher dosage is recommended for severe infections, including chronic and recurrent urinary tract infections and lower respiratory tract infections.
Slovenian: Pri odraslih je večji odmerek priporočen za hude okužbe, vključno s kroničnimi in ponavljajočimi se okužbami sečil in spodnjih dihal.
English: Thus, the maximum daily dose of amoxicillin delivered with the 2:1 ratio is 750 mg.
Slovenian: Zato je 750 mg največji dnevni odmerek amoksicilina, ki se vnese z razmerjem 2:1.
English: The MAH agreed to the withdrawal of the septicaemia indication from of all the oral and parental formulations SPCs.
Slovenian: Imetniki dovoljenj za promet z zdravilom so se strinjali z umikom indikacije septikemija iz vseh peroralnih in parenteralnih formulacij povzetka glavnih značilnosti zdravila.
English: The MAH also listed a number of published studies and discussed other indications, such as skin and soft tissue infections (SSTI), bone and joint infections, abdominal infection, pelvic inflammatory disease, UTI and dental infections.
Slovenian: Imetniki dovoljenj za promet z zdravilom so navedli številne objavljene študije in razpravljali o drugih indikacijah, kot so okužbe kože in mehkih tkiv, okužbe kosti in sklepov, abdominalne okužbe, medenične vnetne bolezni, okužbe sečil in dentalne okužbe.
English: 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 Augmentin and associated names (see Annex I).
Slovenian: je CHMP priporočil dopolnitev dovoljenj za promet z zdravilom Augmentin in povezanih imen (glejte Dodatek I).
English: The MAH concluded that Augmentin therapy for osteomyelitis should be initially parenteral, followed by a switch to oral.
Slovenian: da mora biti zdravljenje osteomielitisa z zdravilom Augmentin uvedeno kot parenteralno, čemur sledi prehod na peroralno obliko.
English: In children, the higher dosage is recommended for infections such as otitis media, sinusitis, lower respiratory tract infections and urinary tract infections.
Slovenian: Pri otrocih je večji odmerek priporočen za okužbe, kot so okužba srednjega ušesa, sinusitis, okužbe spodnjih dihal in sečil.
English: The CHMP endorsed the MAH data and rationale, especially the polymicrobial nature of intra-abdominal infections and the recent use of Augmentin in controlled trials support the use of Augmentin for both initial empirical IV treatment and continued oral treatment after switch from IV treatment.
Slovenian: Zlasti polimikrobna narava intraabdominalnih okužb in nedavna uporaba zdravila Augmentin v kontroliranih preskušanjih podpirajo uporabo tega zdravila za začetno empirično i.v.
English: The MAH updated the Augmentin SPCs in line with the CHMP's guidance on the development of antibacterial agents.
Slovenian: Imetniki dovoljenj za promet z zdravilom so posodobili povzetke glavnih značilnosti zdravila v skladu s smernicami CHMP o razvoju protibakterijskih zdravil.
English: A full PIQ review was also conducted and the PL was revised accordingly.
Slovenian: Opravljen je bil popoln pregled kakovosti informacij o zdravilu (PIQ) in skladno s tem je bilo popravljeno navodilo za uporabo.
English: The CHMP concluded that due to the lack of efficacy data, bridging from efficacy in AOM to ABS it not supported.
Slovenian: CHMP je menil, da zaradi pomanjkanja podatkov o učinkovitosti, prenos iz učinkovitosti pri akutnem vnetju srednjega ušesa na učinkovitost pri akutnem bakterijskem sinusitisu ni podprt.
English: Therefore the following wording was adopted for all Augmentin IV formulations by the CHMP:
Slovenian: Zato je CHMP sprejel naslednje besedilo za vse i.v.
English: The 8:1 Augmentin ratio was licensed in 1990, developed in response to concerns over the increasing prevalence of resistant S. pneumoniae strains in France, particularly amongst young children with acute otitis media.
Slovenian: Razvito je bilo kot odziv na zadržke o povečanju pogostnosti odpornih sevov S. pneumoniae v Franciji, zlasti med majhnimi otroci z akutnim vnetjem srednjega ušesa.
English: In particular, data on renal impairment, crystalluria and overgrowth of fungal infections and acute generalised exanthematous pustulosis (AGEP) was reviewed and proposals for a harmonised wording were made.
Slovenian: Zlasti so bili pregledani podatki o okvarjenem delovanju ledvic, kristaluriji, prerasti gliv in akutni generalizirani eksantemski pustulozi (AGEP).
English: During the evaluation, outstanding issues were identified, to be addressed by the MAH.
Slovenian: Med vrednotenjem so bili ugotovljeni nerešeni zadržki, ki jih morajo rešiti imetniki dovoljenj za promet z zdravilom.
English: THERAPEUTIC INDICATIONS FOR AUGMENTIN 16:1 RATIO (ORAL - SR)
Slovenian: TERAPEVTSKE INDIKACIJE ZA ZDRAVILO AUGMENTIN Z RAZMERJEM 16:1 (PERORALNO - SR)
English: Amoxicillin works by inhibiting the transpeptidase enzyme responsible for cross-linking peptidoglycan in the bacterial cell wall, weakening, the cell wall and making the cell swell and rupture.
Slovenian: Amoksicilin deluje z zaviranjem encima transpeptidaze, ki je odgovoren za mrežno povezanost peptidoglikana v bakterijski celični steni.
English: However, because no supporting documentation was provided in support of indications other than AOM and CAP, the remaining indications should be deleted.
Slovenian: Vendar je bila predložena samo dokumentacija v podporo indikacijam akutno vnetje srednjega ušesa in izvenbolnišnično pridobljena pljučnica, zato je treba ostale indikacije izbrisati.
English: Surgical prophylaxis with Augmentin IV should aim to protect the patient for the period of risk of infection.
Slovenian: mora ščititi bolnika v obdobju tveganja okužbe.
English: Amoxicillin/clavulanic acid was originally developed in response to the need for an oral broad-spectrum antibiotic that covered β-lactamase-producing pathogens.
Slovenian: Kombinacija amoksicilin/klavulanska kislina je bila sprva razvita kot odziv na potrebo po peroralnem širokospektralnem antibiotiku, ki bi pokril patogene, ki tvorijo laktamazo β. Peroralne formulacije zdravila Augmentin so bile po svetu na voljo od leta 1981, intravenske pa od leta 1984.
English: The CHMP recommended including the following in the harmonised SPC:
Slovenian: CHMP je priporočil vključitev naslednjih besedil v usklajene povzetke glavnih značilnosti zdravila:
English: The MAH listed the currently approved indications and discussed data from clinical trials in paediatric patients and adults in the treatment of otitis media and UTIs, demonstrating the bioequivalence of the 8:1 adult regimen to the 8:1 paediatric regimen and the efficacy of the 8:1 ratio BID in adults; consequently this regimen has now become well established in France for the treatment of respiratory tract infections in adults, including CAP, AECB, acute bronchitis, AOM and sinusitis.
Slovenian: Imetniki dovoljenj za promet z zdravilom so navedli trenutno odobrene indikacije in razpravljali o podatkih iz kliničnih preskušanj pri otrocih in odraslih bolnikih za zdravljenje srednjega ušesa in okužb sečil, ki dokazujejo biološko enakovrednost odraslega režima 8:1 z otroškim režimom 8:1 ter učinkovitost razmerja 8:1 dvakrat dnevno pri odraslih.
English: The MAH listed the currently approved indications and discussed respiratory tract infections (RTIs), AOM, community acquired pneumonia (CAP), tonsillo-pharyngitis and sinusitis, skin and soft tissue infections (SSTI) and urinary tract infections (UTI).
Slovenian: Imetniki dovoljenj za promet z zdravilom so navedli trenutno odobrene indikacije in razpravljali o okužbah dihal, akutnem vnetju srednjega ušesa, izvenbolnišnično pridobljeni pljučnici, tonzilo-faringitisu in sinusitisu, okužbah kože in mehkih tkiv ter okužbah sečil.
English: This is further supported by several Guidance documents and the CHMP adopted the indication: “Intra-abdominal infections” for the IV Augmentin formulations.
Slovenian: formulacije zdravila Augmentin sprejel indikacijo: “intraabdominalne okužbe”.
English: The major indications discussed for the 2:1 Augmentin ratio included genito-urinary tract infections, RTIs, and SSTIs.
Slovenian: Poglavitne indikacije, obravnavane za zdravilo Augmentin v razmerju 2:1, so bile okužbe spolovil in sečil, okužbe dihal ter okužbe kože in mehkih tkiv.
English: The MAH provided a large body of data supporting the use of IV Augmentin, including studies and review articles confirming the efficacy of both IV and sequential IV/oral Augmentin therapy in the treatment of LRTIs.
Slovenian: zdravila Augmentin, vključno s študijami in preglednimi članki, ki potrjujejo učinkovitost tako i.v.
English: The MAH provided a comprehensive summary of the key studies evaluated and further justifications and data to support the indication in CAP, ABS and acute exacerbations of chronic bronchitis (AECB).
Slovenian: Pregledani podatki dokazujejo klinične koristne učinke formulacije SR, kar je znanstvena osnova za odobritev trenutnih nacionalnih licenc za Augmentin SR. Imetniki dovoljenj za promet z zdravilom so predložili obsežen povzetek ovrednotenih ključnih študij ter dodatne utemeljitve in podatke v podporo indikaciji izvenbolnišnično pridobljena pljučnica, akutni bakterijski sinusitis in akutno poslabšanje kroničnega bronhitisa.
English: The CHMP noted that tonsillitis/pharyngitis and uncomplicated sinusitis are often viral in origin, and when due to bacteria, the most common pathogen is S. pyogenes, which is always susceptible to penicillin, to be treated with amoxicillin alone or with penicillin.
Slovenian: Klavulanska kislina ščiti amoksicilin pred inaktivacijo v primerih, ko so okužbe polimikrobne ali ko so prisotni nepatogeni organizmi, ki tvorijo laktamazo β. CHMP je izpostavil, da so tonzilitis/faringitis ter nezapleteni sinusitis pogosto virusnega vzroka, kadar pa so vzrok zanje bakterije, pa je najpogostejši patogen S. pyogenes, ki je vedno občutljiv za penicillin in se zdravi samo z amoksicilinom ali s penicilinom.
English: PK/PD analyses predict that the 2:1 Augmentin oral formulation (250/125mg) TID would achieve maximum eradication against S. pneumoniae strains with amoxicillin or amoxicillin/clavulanic acid MICs of ≤1 μg/mL whereas the 4:1 ratio (500/125mg) TID would be effective against strains with MICs of ≤ 2μg/mL.
Slovenian: trikrat dnevno dosegla največjo eradikacijo sevov S. pneumoniae, ki imajo MIC za amoksicilin ali kombinacijo amoksicilin/klavulanska kislina ≤1 μg/mL, razmerje 4:1 (500/125mg) trikrat dnevno pa bi bilo učinkovito proti sevom z vrednostmi MIC ≤2 μg/mL.
English: The CHMP noted the detailed literature search and analyses of available data carried out by the MAH, and agreed with the text on oral anticoagulants but requested the MAH to include a statement on the interaction with methotrexate.
Slovenian: Odbor se je strinjal z besedilom o peroralnih antikoagulacijskih zdravilih, vendar je od imetnikov dovoljenj za promet z zdravilom zahteval izjavo o interakciji z metotreksatom.
English: • Acute otitis media • Community acquired pneumonia.
Slovenian: • akutno vnetje srednjega ušesa • izvenbolnišnično pridobljena pljučnica.
English: In summary, the following harmonised wording for inclusion in the harmonised SPCs was agreed and adopted by the CHMP:
Slovenian: CHMP je potrdil in sprejel naslednje usklajeno besedilo, ki se vključi v usklajene povzetke glavnih značilnosti zdravila:
English: The indication in community acquired pneumonia (CAP) is supported but the indications for ABS and AECB required further discussion.
Slovenian: Indikacija izvenbolnišnično pridobljene pljučnice je podprta, vendar indikaciji akutni bakterijski sinusitis in akutno poslabšanje kroničnega bronhitisa zahtevata dodatno razpravo.
English: A BID regimen would therefore probably not attain the required PK/PD target required to eradicate pathogens with higher MICs.
Slovenian: Režim dvakrat dnevno zato verjetno ne bo dosegel ciljne farmakokinetike/farmakodinamike, ki sta potrebni za eradikacijo patogenov z vrednostjo MIC. Patogeni z višjimi vrednostmi MIC so nagnjeni k večji pogostnosti pri bolnikih z resnejšimi okužbami, zato lahko i.v.
English: • Acute otitis media
Slovenian: • akutno vnetje srednjega ušesa
English: A harmonised wording was agreed by the CHMP for inclusion in the harmonised SPCs.
Slovenian: CHMP se je strinjal z usklajenim besedilom, ki se vključi v usklajene povzetke glavnih značilnosti zdravila.
English: THERAPEUTIC INDICATION FOR AUGMENTIN 8:1 RATIO (ORAL)
Slovenian: TERAPEVTSKA INDIKACIJA ZA ZDRAVILO AUGMENTIN Z RAZMERJEM 8:1 (PERORALNO)
English: In line with the previous discussion on 12-hour dosing, the CHMP changed the posology for the 10:1 IV ratio accordingly.
Slovenian: razmerja 10:1 skladno s predhodno razpravo o 12-urnem odmerjanju.
English: THERAPEUTIC INDICATIONS FOR AUGMENTIN 14:1 RATIO (ORAL - ES)
Slovenian: TERAPEVTSKE INDIKACIJE ZA ZDRAVILO AUGMENTIN Z RAZMERJEM 14:1 (PERORALNO - ES)
English: The CHMP generally agreed with the MAH conclusion, but further discussed the indications in LRTIs, URTIs, UTIs, gynaecological infections, SSTIs, bone and joint infections and the prophylaxis of surgical infections and agreed and adopted the following harmonised wording for inclusion in the harmonised SPCs:
Slovenian: CHMP se je na splošno strinjal z zaključki imetnikov dovoljenj za promet z zdravilom, vendar je dodatno razpravljal o indikacijah okužbe spodnjih dihal, okužbe zgornjih dihal, okužbe sečil, ginekološke okužbe, okužbe kože in mehkih tkiv, okužbe kosti in sklepov ter profilaksa kirurških okužb.
English: THERAPEUTIC INDICATIONS FOR AUGMENTIN 7:1 RATIO (ORAL)
Slovenian: TERAPEVTSKE INDIKACIJE ZA ZDRAVILO AUGMENTIN Z RAZMERJEM 7:1 (PERORALNO)
English: The CHMP agreed with the MAH proposal to include wording in the SPC of several Augmentin formulations regarding the possibility to switch from IV to oral treatment for a number of indications but was of the opinion that switch from IV to oral therapy is not restricted to particular indications and should be an option for all indications.
Slovenian: CHMP se je strinjal s predlogom imetnikov dovoljenj za promet z zdravilom, da se v povzetek glavnih značilnosti več formulacij zdravila Augmentin vključi besedilo o možnosti prehoda iz i.v.
English: In addition, IV-to-oral switch therapy for Augmentin 14:1 (ES) and 16:1 (SR) was considered a valuable option for switch from IV treatment in infections where PRSP are, or are thought to be the causative agent and where oral continuation of Augmentin treatment is necessary.
Slovenian: na peroralno zdravljenje za zdravili Augmentin 14:1 (ES) in 16:1 (SR) štel za dobro možnost prehoda z i.v.
English: THERAPEUTIC INDICATIONS FOR AUGMENTIN 2:1 RATIO (ORAL)
Slovenian: TERAPEVTSKE INDIKACIJE ZA ZDRAVILO AUGMENTIN Z RAZMERJEM 2:1 (PERORALNO)
English: In summary, a harmonised wording for inclusion in the harmonised SPCs was agreed and adopted by the CHMP.
Slovenian: CHMP je potrdil in sprejel usklajeno besedilo, ki se vključi v usklajene povzetke glavnih značilnosti zdravila.
English: The CHMP also differentiated between the 2:1 tablets (and dispersible tablets) and the powder for oral suspension.
Slovenian: Besedilo o odmerjanju je popravljeno in sedaj vsebuje priporočila o odmerjanju za uporabo zdravila Augmentin suspenzija pri otrocih, starejših od 6 let in lažjih od 40 kg. CHMP razlikuje tudi med tabletami (in disperzibilnimi tabletami) 2:1 ter praškom za peroralno suspenzijo.
English: The CHMP noted the clinical trials comparing the efficacy of the different dosing regimens of amoxicillin/clavulanic acid in recurrent tonsillitis and that a number of national guidelines recommend
Slovenian: CHMP je preučil klinična preskušanja, v katerih so primerjali učinkovitost različnih režimov odmerjanja kombinacije amoksicilin/klavulanska kislina za ponovitve tonzilitisa, in številne nacionalne smernice, ki priporočajo uporabo zdravila Augmentin ali kombinacijo penicilin + zaviralec beta laktamaze kot zdravila prve izbire za akutno vnetje srednjega ušesa, običajno bakterijsko superinfekcijo s prurulentno ali mikroprurulentno tekočino srednjega ušesa.
English: POSOLOGY AND METHOD OF ADMINISTRATION FOR AUGMENTIN 16:1 RATIO (ORAL - SR)
Slovenian: ODMERJANJE IN NAČIN UPORABE ZDRAVILA AUGMENTIN Z RAZMERJEM 16:1 (PERORALNO - SR)
English: Whereas
Slovenian: • prebavila
English: THERAPEUTIC INDICATIONS FOR AUGMENTIN 4:1 RATIO (ORAL)
Slovenian: TERAPEVTSKE INDIKACIJE ZA ZDRAVILO AUGMENTIN Z RAZMERJEM 4:1 (PERORALNO)
English: The MAH listed the currently approved indications, discussing in particular its use in SSTIs and recurrent tonsillitis, otitis media, sinusitis, LRTIs and UTIs, as well as URTIs and genito-urinary tract infections, and discussed the PK/PD, demonstrating the bacteriological equivalence of the BID and TID formulations.
Slovenian: Imetniki dovoljenj za promet z zdravilom so navedli trenutno odobrene indikacije in zlasti razpravljali o uporabi tega zdravila pri okužbah kože in mehkih tkiv, ponovitvah tonzilitisa, okužbah srednjega ušesa, sinusitisu, okužbah spodnjih dihal in sečil ter zgornjih dihal in spolovil ter sečil.
English: • Biliary tract surgery.
Slovenian: Kirurška profilaksa z zdravilom Augmentin i.v.
English: POSOLOGY AND METHOD OF ADMINISTRATION FOR AUGMENTIN 10:1 RATIO (INTRAVENOUS)
Slovenian: ODMERJANJE IN NAČIN UPORABE ZDRAVILA AUGMENTIN Z RAZMERJEM 10:1 (INTRAVENSKO)
English: Antiadiposo has been used for the treatment of obesity.
Slovenian: Zdravilo Antiadiposo se je uporabljalo za zdravljenje debelosti.
English: The CHMP discussed the matter at its September 2009 plenary meeting and the procedure in accordance with Article 107(2) of Directive 2001/83/EC, as amended was started.
Slovenian: CHMP je o zadevi razpravljal na svojem plenarnem zasedanju septembra 2009 in začel postopek v skladu s členom 107(2) Direktive 2001/83/ES, kakor je bila spremenjena.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCT(S) CONTAINING IODOCASEIN/THIAMINE (see Annex I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVIL, KI VSEBUJEJO KOMBINACIJO JODOKAZEINA IN TIAMINA (glejte Dodatek I)
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE REVOCATION OF THE MARKETING AUTHORISATION
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA RAZVELJAVITEV DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: The amount of iodine released per each tablet (i.e. 9.4 mg) is noted to be 60 times higher than the daily recommended iodine dose of 150 mcg.
Slovenian: Količina joda, ki se sprosti iz vsake tablete (tj. 9,4 mg) je 60-krat večja od dnevnega priporočenega odmerka joda, ki znaša 150 mcg.
English: This over stimulation of the metabolism is also frequently accompanied by tachycardia, palpitations and anxiety.
Slovenian: To čezmerno stimulacijo presnove pogosto spremljajo tahikardija, palpitacija in anksioznost.
English: These clinical conditions translate the overproduction and consequent excess of circulating free thyroid hormones with effects in every type of tissue.
Slovenian: Ti klinični stanji povzročita čezmerno nastajanje in posledično čezmerno količino krožečih prostih ščitničnih hormonov z učinki na vse vrste tkiv.
English: However, this daily dose represents an iodine dose intake which is 120 times higher than the recommended daily dose.
Slovenian: Vendar ta dnevni odmerek predstavlja vnos joda, ki je 120-krat večji od priporočenega dnevnega odmerka.
English: All reported cases were related with iodocasein/thiamine and 6 cases considered serious.
Slovenian: Vsi prijavljeni primeri so bili povezani s kombinacijo jodokazeina in tiamina, 6 primerov se je štelo za resne.
English: However, this measure is not sufficient to address the risks for hyperthyroidism and thyrotoxicosis associated with the iodocasein/thiamine treatment as above described.
Slovenian: Vendar ta ukrep ni zadosten za obravnavo tveganja hipertiroidizma in tirotoksikoze, povezanih z zdravljenjem z zgoraj opisano kombinacijo jodokazeina in tiamina.
English: • The Committee concluded, after having reviewed the available data, that iodocasein/thiamine is associated with serious cases of hyperthyroidism and thyrotoxicosis.
Slovenian: • Odbor je po pregledu razpoložljivih podatkov zaključil, da je kombinacija jodokazeina in tiamina povezana z resnimi primeri hipertiroidizma in tirotoksikoze.
English: On 16 September 2009, the Italian Competent Authority (AIFA) issued a Rapid Alert informing the Members States, the EMEA and the European Commission (EC) in accordance with Article 107 of Directive 2001/83/EC, as amended, of the suspension of the Marketing Authorisation of iodocasein/thiamine containing medicinal product (Antiadiposo) in its Member State, due to serious cases of hyperthyroidism and thyrotoxicosis.
Slovenian: Dne 16. septembra 2009 je italijanski pristojni organ (AIFA) izdala hitro obvestilo in države članice, agencijo EMEA in Evropsko komisijo (EK) v skladu s členom 107 Direktive 2001/83/ES, kakor je bila spremenjena, obvestil o svoji odločitvi, da v Italiji začasno umakne dovoljenje za promet z zdravilom (Antiadiposo), ki vsebuje kombinacijo jodokazeina in tiamina, zaradi resnih primerov hipertiroidizma in tirotoksikoze.
English: Iodocasein 125mg (7.6% of iodine) and thiamine as nitrate 12.33 mg are the active substances for Antiadiposo, approved since 1955 in Italy for the treatment of obesity resulting from metabolic disorders.
Slovenian: Jodokazein 125 mg (7,6 % joda) in tiamin v obliki nitrata 12,33 mg sta zdravilni učinkovini zdravila Antiadiposo, ki je od leta 1955 v Italiji odobren za zdravljenje debelosti zaradi presnovnih bolezni.
English: The product information lists hyperthyroidism as a contra-indication and advises on the need for a regular control of the thyroid function during treatment with recommendation for discontinuation of the treatment in case of abnormal tests results of thyroid function, with symptoms of hyperthyroidism, tachycardia and arrhythmia.
Slovenian: V informacijah o zdravilu je hipertiroidizem naveden kot kontraindikacija z nasvetom o potrebnem rednem nadzoru funkcije ščitnice med zdravljenjem in priporočilom o prekinitvi zdravljenja v primeru nenormalnih rezultatov testov funkcije ščitnice, simptomov hipertiroidizma, tahikardije ali aritmije.
English: The majority of the cases occurred at a dose of two tablets per day which is the recommended daily dose.
Slovenian: Večina primerov bolezni se je pojavila pri odmerku dveh tablet na dan, kar je priporočeni dnevni odmerek.
English: • The Committee considered the procedure under Article 107 of Directive 2001/83/EC, as amended, for medicinal products containing iodocasein/thiamine.
Slovenian: • Odbor je obravnaval zadevo v skladu s členom 107 Direktive 2001/83/ES, kakor je bila spremenjena, za zdravila, ki vsebujejo kombinacijo jodokazeina in tiamina.
English: Taking all the above elements in consideration and the fact that there are other therapeutic alternatives available for the treatment of obesity, the CHMP concluded that the benefit/risk balance for iodocasein/thiamine is not considered favourable and recommended the revocation of the Marketing Authorisation for the medicinal product referred to in Annex I.
Slovenian: CHMP je ob upoštevanju zgornjih informacij in dejstva, da obstajajo druge terapevtske možnosti za zdravljenje debelosti, zaključil, da razmerje med koristmi in tveganji, povezanimi s kombinacijo jodokazeina in tiamina, ni ugodno in je zato priporočil razveljavitev dovoljenja za promet z zdravilom, ki je navedeno v Dodatku I.
English: Benefits
Slovenian: Koristi