natgillin/translations-raw huggingface dataset:
Continued, long-term efficacy after stabilisation with Fanaptum has been studied and demonstrated in Study 2301, in which patients continuing on Fanaptum had a significantly lower rate of relapses or impending relapses compared to patients switched to placebo. 
V študiji 2301, v kateri je bilo število relapsov ali število neizbežnih relapsov pri bolnikih, ki so nadaljevali zdravljenje z zdravilom Fanaptum, v primerjavi z bolniki, ki so prešli na placebo, znatno nižje, so preučili in dokazali neprekinjeno, dolgotrajno učinkovitost po stabilizaciji z zdravilom Fanaptum.
Iloperidone lacks any significant affinity for cardiac sodium and/or calcium channels at therapeutic plasma concentrations. 
Iloperidon v terapevtskih plazemskih koncentracijah nima nobene pomembne afinitete do natrijevih in/ali kalcijevih kanalčkov v srcu.
In particular, Akathisia was reported at lower rates in patients treated with Iloperidone than in patients treated with the active comparators in the active-controlled trials submitted, where the comparators were antipsychotics with an acknowledged degree of propensity to cause Akathisia at the doses studied. 
Zlasti je bilo v primerjavi z bolniki, zdravljenimi z aktivnimi primerjalnimi zdravili v predloženih aktivno nadzorovanih preskušanjih, pri katerih so bila primerjalna zdravila antipsihotiki s potrjeno stopnjo nagnjenosti k povzročanju akatizije pri proučevanih odmerkih, manj poročil o akatiziji pri bolnikih, zdravljenih z iloperidonom.
No QT prolongation was observed in the in vivo dog studies. 
V študijah pri psih in vivo niso opazili podaljšanja intervala QT.
Children and adolescents Use in children under 18 years is not recommended. 
Otroci in mladostniki Uporaba pri otrocih, mlajših od 18 let, ni priporočljiva.
Frequencies are defined as: 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 the available data). 
Pogostnosti so opredeljene takole: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), ni znano (ni mogoče oceniti na podlagi podatkov, ki so na voljo).
Your doctor will advise you to discontinue this medicine. 
Zdravnik vam bo svetoval, da prenehate uporabljati to zdravilo.
Pioglitazone Actavis has no or negligible effect on the ability to drive and use machines. 
Pioglitazon Actavis Group nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
If you have the impression that the effect of Pioglitazone Actavis is too weak, talk to your doctor. 
Če menite, da je učinek zdravila Pioglitazon Actavis prešibak, se posvetujte z zdravnikom.
If you take more Pioglitazone Actavis than you should If you accidentally take too many tablets, or if someone else or a child takes your medicine, talk to a doctor or pharmacist immediately. 
Če ste vzeli večji odmerek zdravila Pioglitazon Actavis, kot bi smeli Če pomotoma vzamete preveč tablet, ali če vaše zdravilo vzame kdo drug ali otrok, se nemudoma posvetujte z zdravnikom ali farmacevtom.
When Pioglitazone Actavis is taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines. 
Če uporabljate zdravilo Pioglitazon Actavis v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni (npr. z insulinom, klorpropamidom, glibenklamidom, gliklazidom, tolbutamidom), vam bo zdravnik povedal, ali morate uporabiti manjši odmerek zdravil.
Oedema was reported in 6-9% of patients treated with pioglitazone over one year in controlled clinical trials. 
O edemih so poročali pri 6 do 9 % bolnikov, ki so v kontroliranih kliničnih preskušanjih prejemali pioglitazon več kot eno leto.
Do not take Pioglitazone Actavis - if you are hypersensitive (allergic) to pioglitazone or any of the other ingredients of 
Ne jemljite zdravila Pioglitazon Actavis - če ste preobčutljivi za (alergični na) pioglitazon ali katero koli sestavino zdravila Pioglitazon
If you stop using Pioglitazone Actavis, your blood sugar may go up. 
Če prenehate jemati zdravilo Pioglitazon Actavis, se vam lahko krvni sladkor zviša.
Pioglitazone Actavis contains lactose monohydrate If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Pioglitazone Actavis. 
Zdravilo Pioglitazon Actavis vsebuje lakotozo monohidrat Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se z njim posvetujte, preden vzamete to zdravilo Pioglitazon Actavis.
Your blood sugar will be checked, and your dose of Pioglitazone Actavis may need to be changed. 
Kontroliral vam bo krvni sladkor in morda bo treba prilagoditi odmerek zdravila Pioglitazon Actavis.
Do not use Pioglitazone Actavis after the expiry date which is stated on the carton and the blister pack after the word “EXP”. 
Zdravila Pioglitazon Actavis ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake "EXP".
What Pioglitazone Actavis is and what it is used for What you need to know before you take Pioglitazone Actavis How to take Pioglitazone Actavis Possible side effects 
Kaj je zdravilo Pioglitazon Actavis in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Pioglitazon Actavis Kako jemati zdravilo Pioglitazon Actavis Možni neželeni učinki
For the 14, 28, 56, 84 and 98 tablets pack sizes, you can check the day on which you last took a tablet of Pioglitazone Actavis by referring to the calendar printed on the blister. 
Pri pakiranih s 14, 28, 56, 84 in 98 tabletami lahko dan, ko ste vzeli zadnjo tableto zdravila Pioglitazon Actavis, preverite na koledarčku, ki je natisnjen na pretisnem omotu.
What Pioglitazone Actavis is and what it is used for 
Kaj je zdravilo pioglitazon actavis in za kaj ga uporabljamo
If you take Pioglitazone Actavis with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level (hypoglycaemia). 
Če jemljete zdravilo Pioglitazon Actavis skupaj z drugimi zdravili za sladkorno bolezen, obstaja večja možnost za znižanje krvnega sladkorja pod normalno raven (hipoglikemija).
Visual disturbance has been reported mainly early in treatment and is related to changes in blood glucose due to temporary alteration in the turgidity and refractive index of the lens as seen with other hypoglycaemic treatments. 
O motnjah vida so poročali predvsem zgodaj med zdravljenjem, povezane pa so s spremembami vrednosti glukoze v krvi, in sicer zaradi začasnih sprememb nabreklosti (turgidnosti) in refrakcijskega indeksa leče, kakršne se pojavljajo tudi pri drugih zdravilih za znižanje glikemije.
Before you start taking Pioglitazone Actavis you will have a blood sample taken to check your liver function. 
Pred začetkom jemanja zdravila Pioglitazon Actavis boste morali opraviti preiskavo krvi za kontrolo delovanja jeter.
What you need to know before you take Pioglitazone Actavis 
Kaj morate vedeti, preden boste vzeli zdravilo pioglitazon actavis
Pioglitazone Actavis can be taken with or without food. 
Zdravilo Pioglitazon Actavis lahko vzamete s hrano ali brez nje.
Pioglitazone Actavis (see section 6 for a list of ingredients). 
Actavis (za seznam sestavin glejte poglavje 6).
Postmarketing, bone fractures have been reported in both male and female patients (see section 4.4). 
V obdobju trženja zdravila so poročali o zlomih kosti tako pri bolnikih kot bolnicah (glejte poglavje 4.4).
If you are following a diabetic diet, you should continue with this while you are taking Pioglitazone Actavis. 
Če se držite diabetične diete, dieto nadaljujte tudi med jemanjem zdravila Pioglitazon Actavis.
Your doctor will ask you to have blood tests periodically during treatment with Pioglitazone Actavis. 
Zdravnik vam bo naročil, da med zdravljenjem z zdravilom Pioglitazon Actavis redno opravljate preiskave krvi.
You can usually continue to take other medicines whilst you are being treated with Pioglitazone Actavis. 
Po navadi lahko med jemanjem zdravila Pioglitazon Actavis še naprej jemljete tudi druga zdravila.
Immune System Disorders Hypersensitivity and allergic reactions not known not known not known not known not known 
Preobčutljivost in alergijske reakcije ni znano ni znano ni znano ni znano ni znano
Pioglitazone Actavis helps control the level of sugar in your blood when you have type 2 diabetes by helping your body make better use of the insulin it produces. 
Zdravilo Pioglitazon Actavis pri sladkorni bolezni tipa 2 pomaga obvladati koncentracijo krvnega sladkorja, ker telesu pomaga bolje izrabiti insulin.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
Drugiha zdravila in zdravilo Pioglitazon Actavis Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
Your doctor will check whether Pioglitazone Actavis is working 3 to 6 months after you start taking it. 
Vaš zdravnik bo od 3 do 6 mesecev potem, ko boste začeli jemati zdravilo Pioglitazon Actavis, preveril, ali zdravilo pri vas deluje.
Pioglitazone Actavis with food and drink You may take your tablets with or without food. 
Zdravilo Pioglitazon Actavis skupaj s hrano in pijačo Tablete lahko vzamete s hrano ali brez nje.
Postmarketing reports of hypersensitivity reactions in patients treated with pioglitazone have been reported. 
V poročilih po pridobitvi dovoljenja za promet so poročali o preobčutljivostnih reakcijah pri bolnikih zdravljenih s pioglitazonom.
Pioglitazone Actavis tablets contain lactose monohydrate and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. 
Tablete Pioglitazon Actavis vsebujejo laktoza monohidrat, zato bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze, ne smejo jemati tega zdravila.
In comparator groups, addition of sulphonylurea to metformin resulted in a mean weight gain of 1.3 kg and addition of metformin to a sulphonylurea a mean weight loss of 1.0 kg. 
primerjalnih skupinah je dodatek sulfonilsečnine metforminu povzročil povprečno povečanje telesne mase za 1,3 kg in dodatek metformina sulfonilsečnini povprečno zmanjšanje telesne mase za 1,0 kg.
In controlled clinical trials the incidence of reports of heart failure with pioglitazone treatment was the same as in placebo, metformin and sulphonylurea treatment groups, but was increased when used in combination therapy with insulin. 
V kontroliranih kliničnih preskušanjih je bila incidenca srčnega popuščanja med zdravljenjem s pioglitazonom enaka kot med prejemniki placeba, metformina in sulfonilsečnine, večja pa je bila med uporabo v kombiniranem zdravljenju z insulinom.
How to store Pioglitazone Actavis Contents of the pack and other information 
Shranjevanje zdravila Pioglitazon Actavis Vsebina pakiranja in dodatne informacije
The packs with 14, 28, 56, 84 and 98 tablets contain blisters with abbreviations for days of the week printed on the blister (Mon, Tue, Wed, Thu, Fri, Sat, Sun). 
Pakiranja s 14, 28, 56, 84 in 98 tabletami vsebujejo pretisne omote, na katerih so natisnjene okrajšave za dneve v tednu (PON, TOR, SRE, ČET, PET, SOB, NED).
The usual starting dose is one tablet of 15 mg or of 30 mg of pioglitazone to be taken once daily. 
Običajni začetni odmerek je ena 15-miligramska ali 30-miligramska tableta pioglitazona enkrat na dan.
Pioglitazone Actavis contains pioglitazone. 
Zdravilo Pioglitazon Actavis vsebuje pioglitazon.
as monotherapy - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. 
- pri odraslih bolnikih (zlasti bolnikih s čezmerno telesno maso), ki imajo bolezen nezadostno urejeno z dieto in telesno dejavnostjo in za katere metformin ni primeren zaradi kontraindikacij ali neprenašanja.
A pooled analysis was conducted of adverse reactions of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8100 patients in the pioglitazone-treated groups and 7400 in the comparator-treated groups of up to 3.5 years duration. 
Opravljena je bila kumulativna analiza neželenih učinkov zlomov kosti iz randomiziranih, s primerjalnim zdravilom kontroliranih, dvojno slepih kliničnih preskušanj pri več kot 8100 bolnikih, zdravljenih s pioglitazonom, in 7400 bolnikih, ki so prejemali primerjalna zdravila, v obdobju do 3,5 leta.
Neoplasms benign, malignant and unspecified (including cysts and polyps) bladder cancer uncommon uncommon uncommon uncommon uncommon 
Benigne, maligne in neopredeljene neoplazme (vključno s cistami in polipi) rak sečnega mehurja občasno občasno občasno občasno občasno
There may be an increased possibility of becoming pregnant because you may ovulate again when you take Pioglitazone Actavis. 
Obstaja lahko večja možnost, da zanosite, ker se lahko ob uporabi zdravila Pioglitazon Actavis znova pojavi ovulacija (sprostitev jajčeca).
In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2-3 kg over one year. 
V preskušanjih, kontroliranih s primerjalnim zdravilom, je bilo povprečno povečanje telesne mase s pioglitazonom v monoterapiji od 2 do 3 kg v enem letu.
How to take Pioglitazone Actavis 
Kako jemati zdravilo pioglitazon actavis
Monotherapy 
Kot monoterapija
Pioglitazone Actavis 15 mg, 30 mg and 45 mg tablets Pioglitazone Actavis 15 mg tablets 
Pioglitazon Actavis 15 mg, 30 mg in 45 mg tablete Pioglitazon Actavis 15 mg tablete
What Pioglitazone Actavis contains - The active substance is pioglitazone. 
Kaj vsebuje zdravilo Pioglitazon Actavis - Zdravilna učinkovina je pioglitazon.
Broken bones have been reported commonly (up to 1 in 10 people) in female patients taking pioglitazone and have also been reported in male patients (frequency cannot be estimated from the available data) taking pioglitazone. 
O zlomih so poročali tudi pri bolnikih, ki so se zdravili s pioglitazonom (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
Musculoskeletal and connective tissue disorders fracture bone common common common common common arthralgia common common common back pain common 
Bolezni mišičnoskeletnega sistema in vezivnega tkiva zlom kosti pogosto pogosto pogosto pogosto pogosto artralgija pogosto pogosto pogosto bolečine v hrbtu pogosto
General disorders and administration site conditions oedema very common fatigue uncommon 
Splošne težave in spremembe na mestu aplikacije edemi zelo pogosto utrujenost občasno
If you experience this side effect, talk to your doctor as soon as possible. 
Če se vam pojavi ta neželeni učinek, se čim prej posvetujte z zdravnikom.
What Pioglitazone Actavis looks like and contents of the pack Pioglitazone Actavis 15 mg tablets are white, round, flat, bevelled, 5.5 mm in diameter and engraved with ‘TZ15' on one side. 
Izgled zdravila Pioglitazon Actavis in vsebina pakiranja Tablete Pioglitazon Actavis 15 mg so bele, okrogle, ploščate, na obeh straneh izbočene tablete s premerom 5,5 mm, ki imajo na eni strani vtisnjeno oznako 'TZ15'.
Cardiac disorders heart failure common 
Srčne bolezni srčno popuščanje pogosto
Investigations weight increased common common common common common blood creatine phospho-kinase increased common increased lactic dehydro-genase uncommon 
Preiskave povečanje telesne mase pogosto pogosto pogosto pogosto pogosto zvišanje kreatin-fosfokinaze pogosto zvišanje laktat-dehidrogenaz e občasno
Pioglitazone Actavis may be used on its own in patients who are unable to take metformin, and where treatment with diet and exercise has failed to control blood sugar or may be added to other therapies (such as metformin, sulphonylurea or insulin) which have failed to provide sufficient control of blood sugar. 
Zdravilo Pioglitazon Actavis lahko uporabljamo samo pri bolnikih, ki ne morejo jemati metformina, in ko zdravljenje z dieto in telesno vadbo ni uspešno pri nadzoru krvnega sladkorja.
Pioglitazone Actavis should be used every day to work properly. 
Če ste prenehali jemati zdravilo Pioglitazon Actavis Zdravilo Pioglitazon Actavis morate vzeti vsak dan, da bo delovalo pravilno.
Pioglitazone Actavis 30 mg 
Pioglitazon Actavis 30 mg
Pioglitazone Actavis 45 mg 
Pioglitazon Actavis 45 mg
Take Pioglitazone Actavis daily as prescribed. 
Če ste pozabili vzeti zdravilo Pioglitazon Actavis Zdravilo Pioglitazon Actavis vzemite vsak dan, kot je predpisano.
Allergic reactions have been reported (frequency not known) in patients taking Pioglitazone Actavis. 
Pri bolnikih, ki jemljejo zdravilo Pioglitazon Actavis, so poročali o alergijskih reakcijah (pogostnost ni znana).
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. 
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.
Pioglitazone Actavis 15 mg 
Pioglitazon Actavis 15 mg
NAME OF THE MARKETING AUTHORISATION HOLDER Actavis Group PTC ehf. 
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Actavis Group PTC ehf.
Other medicines and Pioglitazone Actavis 
Shranjevanje zdravila pioglitazon actavis
Pioglitazone Actavis 45 mg tablets are white, round, flat, bevelled, 8 mm in diameter and engraved with ‘TZ45' on one side. 
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'.
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] 
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]
Pioglitazone Actavis 30 mg tablets are white, round, flat, bevelled, 7 mm in diameter and engraved with ‘TZ30' on one side. 
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'.
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] 
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]
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] 
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]
Pioglitazone Actavis 30 mg tablets 
Pioglitazon Actavis 30 mg tablete
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 
Očesne bolezni motnje vida pogosto pogosto občasno edem makule ni znano ni znano ni znano ni znano ni znano
Pioglitazone Actavis 45 mg tablets 
Pioglitazon Actavis 45 mg tablete
Pioglitazone Actavis 15 mg tablets 
Pioglitazon Actavis 15 mg tablete
Co-administration of pioglitazone with rifampicin (an inducer of cytochrome P450 2C8) 
Opisano je, da sočasna uporaba pioglitazona z rifampicinom (induktor citokroma P450 2C8) zmanjša AUC pioglitazona za 54 %.
• The committee considered the referral under Article 30 of Directive 2001/83/EC, 
• Odbor je obravnaval napotitev na podlagi člena 30 Direktive 2001/83/ES.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.” 
Upoštevati je treba uradna navodila glede ustrezne uporabe antibakterijskih zdravil.“
The studies were performed in a period in which acquired resistance was not a critical problem. 
Študije so opravili v obdobju, v katerem pridobljena odpornost ni bila kritična.
Septicaemia and meningitis 
Septikemija in meningitis
• Intra-abdominal infections (see section 4.4). 
• intraabdominalne okužbe (glejte poglavje 4.4).
Overall summary of the scientific evaluation of Zinacef and associated names (see Annex I) 
Splošni povzetek znanstvenega vrednotenja zdravila Zinacef in povezanih imen (glejte Prilogo I)
Zinacef was first approved in Europe in the early 1980's and is available as parenteral formulations. 
Zdravilo je bilo v Evropi prvič odobreno v zgodnjih 80. let prejšnjega stoletja in je na voljo v parenteralnih oblikah.
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. 
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.
“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). 
„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).
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. 
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.
The CHMP considered the indication to be acceptable for all populations. 
Menil je, da je indikacija sprejemljiva za vse populacije.
The CHMP reviewed the studies on septicaemia which were old, non-comparative and included small numbers of patients. 
Odbor CHMP je pregledal študije o septikemiji, ki so bile stare, neprimerjalne in so vključevale majhno število bolnikov.
In conclusion, the CHMP adopted the following harmonised indications and wording for Section 4.1: 
Na koncu je sprejel naslednje usklajene indikacije in besedilo za poglavje 4.1:
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. 
Odbor je zato sklenil, da obstaja dovolj podatkov za podporo indikacije pri odraslih in da je mogoče podatke za odrasle ekstrapolirati na pediatrično populacijo.
Cefuroxime exerts a bactericidal action by inhibiting bacterial enzymes necessary for cell-wall synthesis (peptidoglycan synthesis), thereby causing cell death. 
Cefuroksim deluje baktericidno z zaviranjem bakterijskim encimov, potrebnih za sintezo celične stene (peptidoglikanska sinteza), in tako povzroči celično smrt.