FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, this SPC, labelling and package leaflet may not necessarily represent the current text.
Slovenian: Zato priloženi povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo ne predstavljajo nujno tudi končno besedilo.
English: Take special care with Octegra
Slovenian: Bodite posebno pozorni pri uporabi zdravila Octegra
English: Both in preclinical investigations and in humans, changes in cardiac electrophysiology have been observed following exposure to moxifloxacin, in the form of QT prolongation.
Slovenian: Tako v predkliničnih študijah kot tudi v študijah pri ljudeh so med zdravljenjem z moksifloksacinom opazili spremembe elektrofiziologije srca (v obliki podaljšanega intervala QT).
English: Clinical studies have shown no interactions following concomitant administration of moxifloxacin with: ranitidine, probenecid, oral contraceptives, calcium supplements, morphine administered parenterally, theophylline or itraconazole.
Slovenian: Klinične študije so pokazale, da ob sočasni uporabi moksifloksacina in ranitidina, probenecida, peroralnih kontraceptivov, nadomestkov kalcija, parenteralno danega morfina, teofilina ali itrakonazola, ni interakcij.
English: The CHMP acknowledges that a drug prolonging the QTc does not necessarily translate into a higher risk of cardiac ADRs, including arrhythmias.
Slovenian: CHMP potrjuje, da ni nujno, da zdravilo, ki podaljša QTc, tudi poviša tveganje za neželene učinke, povezane s srcem, ki vključujejo aritmijo.
English: - The active substance is moxifloxacin.
Slovenian: Zdravilna učinkovina je moksifloksacin.
English: The trends described require years of observations before a clear association between use of either fluoroquinolone and resistance patterns, including mutation patterns can be established.
Slovenian: Preden se določi jasna povezava med uporabo katerega koli fluorokinolona in vzorcev odpornosti, vključno z vzorci mutacij, je potrebno večletno opazovanje opisanih trendov.
English: In skin blister fluid concentrations of 1.75 mg/l were observed 10 h after intravenous administration.
Slovenian: V tekočini kožnih mehurjev je bila 10 ur po intravenski aplikaciji koncentracija 1,75 mg/l.
English: The Applicant discussed the safety overview of sequential IV/oral moxifloxacin, overall and specifically in cSSSIs and analysed data on the incidence of liver events from sequential IV/oral clinical studies (overall and cSSSIs), stating that there was no difference in overall incidences of hepatic adverse events and adverse drug reactions between moxifloxacin and comparators.
Slovenian: Predlagatelj je razpravljal o pregledu varnosti zaporednega intravenoznega/peroralnega zdravljenja z moksifloksacinom, na splošno in specifično pri zapletenih okužbah kože in mehkih tkiv, analiziral je podatke o pojavnosti jetrnih dogodkov iz kliničnih študij zaporednega intravenoznega/peroralnega zdravljenja (na splošno in pri zapletenih okužbah kože in mehkih tkiv), ter navedel, da glede splošne pojavnosti z jetri povezanih neželenih učinkov in neželenih učinkov zdravila med moksifloksacinom in primerjalnimi zdravili ni razlik.
English: “Complicated skin and skin structure infections only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection (see section
Slovenian: „Zapletene okužbe kože in mehkih tkiv, le ko uporaba protibakterijskih učinkovin, ki jih ponavadi priporočajo za začetno zdravljenje teh okužb (glejte poglavje 4.4), ni primerna.“
English: In conclusion, the efficacy data for IV/PO moxifloxacin in treatment of CAP and cSSSI are considered to be sufficient but not overwhelmingly convincing and suggest that IV/PO moxifloxacin is not among the optimal treatments for either of these indications.
Slovenian: Zaključili so, da so podatki o učinkovitosti intravenoznega/peroralnega zdravljenja z moksifloksacinom pri izvenbolnišnično pridobljeni pljučnici in zapletenih okužbah kože in mehkih tkiv zadostni, vendar ne pretirano prepričljivi, kažejo pa na to, da intravenozno/peroralno zdravljenje z moksifloksacinom ni med optimalnimi oblikami zdravljenja za katerokoli od teh indikacij.
English: Uncommon: Low red blood cell count, low white blood cells count, low numbers of special white blood cells (neutrophils), decrease or increase of special blood cells necessary for blood clotting, increased specialised white blood cells (eosinophils), decreased blood clotting
Slovenian: zmanjšano število eritrocitov, zmanjšano število levkocitov, zmanjšano število posebnih vrst levkocitov (nevtrofilcev), zmanjšano ali zvečano število posebnih vrst krvnih celic, ki so potrebne pri strjevanju krvi, zvečano število posebnih vrst levkocitov (eozinofilcev), krajši čas strjevanja krvi Zelo redki: podaljšan čas strjevanja krvi
English: loss of smell), abnormal dreams, balance disorder and poor co-ordination (due to dizziness), convulsions, disturbed concentration, impaired speech, partial or total loss of memory
Slovenian: moteni občutki na koži, spremembe voha (tudi izguba voha), nočne more, motnje ravnotežja in slaba koordinacija (zaradi omotice), krči, motnje pozornosti, motnje govora, delna ali popolna izguba spomina Zelo redki: povečana občutljivost kože
English: - If you suffer from epilepsy or a condition which makes you likely to have convulsions, tell your doctor before taking Octegra.
Slovenian: Če imate epilepsijo ali stanja, ki povzročajo krče, o tem pred začetkom jemanja zdravila Octegra obvestite svojega zdravnika.
English: However, the CHMP maintained its position, stating that the clinical and microbiological responses point to a conclusion that moxifloxacin IV/PO is not among the optimal treatments for cSSSI.
Slovenian: Kljub temu pa je CHMP še naprej menil, da klinični in mikrobiološki odzivi kažejo na zaključek, da intravenozno/peroralno zdravljenje z moksifloksacinom ni med optimalnimi oblikami zdravljenja zapletenih okužb kože in mehkih tkiv.
English: Moxifloxacin should be used with caution in patients who are taking medication that can reduce potassium levels or medication that is associated with clinically significant bradycardia.
Slovenian: Moksifloksacin je treba uporabljati previdno pri bolnikih, ki jemljejko zdravila, ki lahko zmanjšajo vrednosti kalija in zdravila, ki so povezana s klinično pomembno bradikardijo.
English: The Applicant provided further justifications supporting the indication in CAP.
Slovenian: Predlagatelj je predložil dodatne utemeljitve, ki podpirajo indikacijo izvenbolnišnično pridobljene pljučnice.
English: - If you are currently taking any medicine that decreases your blood potassium levels, consult your doctor before taking Octegra because this can increase the risk of heart rhythm disturbances.
Slovenian: Če jemljete druga zdravila, ki zmanjšajo vrednost kalija v krvi, se posvetujte s svojim zdravnikom preden vzamete zdravilo Octegra, ker to lahko poveča tveganje za pojav motenj srčnega ritma.
English: Therefore no clinically relevant interaction was observed between moxifloxacin and glibenclamide.
Slovenian: Med moksifloksacinom in glibenklamidom zato niso opazili klinično pomembnih interakcij.
English: - If you experience palpitations or irregular heart beat during the period of treatment, you should stop taking Octegra and inform your doctor immediately.
Slovenian: Če imate med zdravljenjem palpitacije ali nepravilen srčni utrip, prenehajte z jemanjem zdravila Octegra in o tem takoj obvestite svojega zdravnika.
English: If you think you are affected consult your doctor immediately.
Slovenian: Takoj se posvetujte s svojim zdravnikom.
English: The Applicant discussed the efficacy and safety of sequential IV/oral moxifloxacin in the treatment of cSSSI and concluded that non-inferiority was demonstrated, and that the clinical studies and post-marketing safety data show no evidence that moxifloxacin-treated patients are at greater risk for morbidity, including cardiac and hepatic morbidity, than patients receiving comparator antibiotics.
Slovenian: Zdravljenje zapletenih okužb kože in mehkih tkiv Predlagatelj je razpravljal o učinkovitosti in varnosti zaporednega intravenoznega / peroralnega zdravljenja zapletenih okužb kože in mehkih tkiv z moksifloksacinom in zaključil, da so dokazali neinferiornost ter da klinične študije in podatki o varnosti po začetku trženja ne dajejo nobenih dokazov, da bi imeli bolniki, zdravljeni z moksifloksacinom, večje tveganje obolevnosti, vključno z obolevnostjo srca in jeter, kot bolniki, ki prejemajo primerjalne antibiotike.
English: An analysis of cardiac safety in sequential IV/oral clinical studies (overall and cSSSIs) was presented, along with an overview of the incidence of treatmentemergent adverse events relevant as surrogates for arrhythmia.
Slovenian: Predstavili so analizo varnosti srca v kliničnih študijah zaporednega intravenoznega/peroralnega zdravljenja (na splošno in pri zapletenih okužbah kože in mehkih tkiv), skupaj s pregledom pojavnosti neželenih učinkov, ki zahtevajo nujno zdravljenje, pomembnih kot nadomestki pri aritmiji.
English: Fluoroquinolones exhibit a concentration dependent killing of bacteria.
Slovenian: Baktericidnost fluorokinolonov je odvisna od njihovih koncentracij.
English: Anxiety reactions Psychomotor hyperactivity / agitation
Slovenian: zaskrbljenost, vznemirjenost/agitacija
English: Adverse reactions observed in clinical trials with moxifloxacin 400 mg daily administered by the intravenous or oral route sorted by frequencies are listed below:
Slovenian: V nadaljevanju so našteti neželeni učinki zdravila, ki so jih opazili v kliničnih študijah z moksifloksacinom v odmerku 400 mg na dan (intravensko in peroralno zdravljenje) in so razvrščeni po pogostosti.
English: Moxifloxacin solution for infusion should not be co-infused with other drugs.
Slovenian: Raztopine moksifloksacina za infundiranje ne smete sočasno infundirati z drugimi zdravili.
English: - the efficacy of IV (followed by PO) moxifloxacin in the treatment of CAP and cSSTI is established, however the safety profile of intravenous moxifloxacin when used to treat CAP or cSSTI raises some concerns, particularly with regard to hepatotoxicity and cardiac conduction effects,
Slovenian: - učinkovitost intravenozne (in zatem peroralne) uporabe moksifloksacina pri zdravljenju izvenbolnišnično pridobljene pljučnice in zapletenih okužb kože in mehkih tkiv je dokazana, vendar pa je profil varnosti intravenoznega moksifloksacina, ko se uporablja za zdravljenje izvenbolnišnično pridobljene pljučnice ali zapletenih okužb kože in mehkih tkiv, razlog za zadržke, zlasti glede hepatotoksičnosti in učinkov na prevodnost srca;
English: affects 1 to 10 users in 100
Slovenian: pojavijo se pri 1 do 10 bolnikih od 100 bolnikov
English: - Cases of bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported with moxifloxacin (see section 4.8).
Slovenian: Pri uporabi moksifloksacina so poročali o buloznih kožnih spremembah, npr. StevensJohnsonovem sindromu ali toksični epidermalni nekrolizi (glejte poglavje 4.8).
English: The following solutions were incompatible with Octegra: Sodium chloride 10% and 20% solutions, Sodium bicarbonate 4.2% and 8.4% solutions
Slovenian: Z zdravilom Octegra so bile inkompatibilne naslednje raztopine: 10 % in 20 % raztopina natrijevega klorida, 4,2 % in 8,4 % raztopina natrijevega karbonata
English: Nervous system disorders
Slovenian: Živčni sistem Pogosti:
English: In the absence of human data and due to the experimental risk of damage by fluoroquinolones to the weight-bearing cartilage of immature animals, breast-feeding is contraindicated during moxifloxacin therapy (see section 4.3).
Slovenian: Zaradi pomanjkanja podatkov pri ljudeh in z eksperimenti dokazanega tveganja, da moksifloksacin povzroča okvare hrustanca nosilnih sklepov nerazvitih živali, je med zdravljenjem z moksifloksacinom dojenje kontraindicirano (glejte poglavje
English: affects 1 to 10 users in 10,000
Slovenian: pojavijo se pri 1 do 10 bolnikih od 10.000 bolnikov
English: The Applicant concluded that the QTc prolongation seen for moxifloxacin has not translated into a higher risk of developing clinical cardiac events, including arrhythmias, compared to other agents.
Slovenian: Predlagatelj je zaključil, da, v primerjavi z drugimi učinkovinami, podaljšanje QTc pri moksifloksacinu ne pomeni povišanega tveganja za razvoj kliničnih srčnih dogodkov, ki vključujejo aritmije.
English: The Applicant reiterated that the QTc changes observed did not translate into a higher risk to develop a clinical cardiac event.
Slovenian: Varnost pri zdravljenju izvenbolnišnično pridobljene pljučnice Predlagatelj je znova poudaril, da opažene spremembe QTc ne pomenijo povišanega tveganja za razvoj kliničnih dogodkov srca.
English: Patients were more likely to have a notable increase in QTc on intravenous moxifloxacin than on oral moxifloxacin.
Slovenian: Večja verjetnost za znatno povišanje QTc je bila pri bolnikih z intravenoznim zdravljenjem z moksifloksacinom kot pri tistih s peroralnim zdravljenjem.
English: increase in special kidney laboratory test results like urea and creatinine), kidney failure
Slovenian: motnje v delovanju ledvic (tudi zvečane vrednosti posebnih ledvičnih laboratorijskih testov; sečnine in kreatinina), ledvična odpoved
English: Octegra is packaged in cartons containing 250ml polyolefine bags with polypropylene port sealed in aluminium foil overwrap.
Slovenian: Zdravilo Avelox je pakirano v škatle, ki vsebujejo 250 ml poliolefinske vreče s polipropilensko zaporko in omot iz aluminija.
English: Apart from nausea and diarrhoea all adverse reactions were observed at frequencies below 3%.
Slovenian: Vsi neželeni učinki (razen slabosti in driske) so se pojavili pri manj kot 3 % bolnikov.
English: No adjustment of dosage is required in patients with mild to severely impaired renal function or in patients on chronic dialysis i.e. haemodialysis and continuous ambulatory peritoneal dialysis (see section 5.2 for more details).
Slovenian: Bolnikom z blago do hudo oslabljeno ledvično funkcijo ali bolnikom na kronični dializi (hemodializi in kontinuirani ambulantni peritonealni dializi) odmerka ni treba prilagajati (za podrobnosti glejte poglavje
English: If you miss a dose of Octegra If you are concerned that you may have missed a dose of Octegra, contact your doctor immediately.
Slovenian: Če niste dobili odmerek zdravila Octegra Če menite, da niste dobili odmerek zdravila Octegra, se takoj posvetujte z zdravnikom.
English: The analysis of outlying QTc values demonstrated a consistent excess risk for moxifloxacin for the data from the CAP studies with ECG data.
Slovenian: Analiza izstopajočih vrednosti QTc dokazuje skladen presežek tveganja pri moksifloksacinu po podatkih iz študij izvenbolnišnično pridobljene pljučnice in podatkih EKG.
English: The following co-infusions were found to be compatible with moxifloxacin 400 mg solution for infusion: Water for injections, Sodium chloride 0.9%, Sodium chloride 1 molar, Glucose 5%/10%/40%, Xylitol 20%, Ringer's solution, Compound Sodium Lactate Solution (Hartmann's Solution, Ringer-Lactate Solution).
Slovenian: Raztopina moksifloksacina za infundiranje je kompatibilna z naslednjimi raztopinami: vodo za injekcije, 0,9 % raztopino natrijevega klorida, 1 molarno raztopino natrijevega klorida, 5 %/10 %/40 % raztopino glukoze, 20 % raztopino ksilitola, Ringerjevo raztopino, sestavljeno raztopino natrijevega laktata (Hartmannova raztopina, raztopina Ringerjevega laktata).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER PACKAGING FOR MULTIPACK - GLASS BOTTLE
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA Z VEČ PAKIRANJI - STEKLENICA
English: A feeling of self-detachment (not being yourself), insanity (potentially leading to self-harm) Nervous System
Slovenian: Zelo redki: motnja samozavedanja (nezavedanje samega sebe), duševna zmedenost (potencialno samoogrožajoče vedenje)
English: The risks may be even greater with intravenous use due to the differences in pharmacokinetics and the likely higher predisposition of patients with more severe CAP and with cSSSI to develop certain adverse reactions.
Slovenian: Ob intravenozni uporabi je zaradi razlik v farmakokinetiki in verjetno višje dovzetnosti bolnikov s hudo obliko izvenbolnišnično pridobljene pljučnice in zapleteno okužbo kože in mehkih tkiv za razvoj določenih neželenih učinkov tveganje lahko še višje.
English: Moxifloxacin should be used with caution in patients who are taking medication that can reduce potassium levels.
Slovenian: Moksifloksacin je treba uporabljati previdno pri bolnikih, ki jemljejo zdravila za zmanjševanje vrednosti kalija.
English: Nausea, vomiting, stomach and abdominal ache, diarrhoea Uncommon: Loss of appetite, wind and constipation, stomach upset (indigestion/heartburn), inflammation of the stomach, increase of a special digestive enzyme in the blood (amylase)
Slovenian: izguba teka, napenjanje in zaprtost, želodčne težave (slaba prebava/zgaga), vnetje želodca, zvečane vrednosti posebnih prebavnih encimov v krvi (amilaze)
English: Leucopenia(s) Neutropenia Thrombocytopenia Thrombocythemia Blood eosinophilia Prothrombin time prolonged / INR increased
Slovenian: bolezni krvi in limfatičnega sistema anemija levkopenija nevtropenija trombocitopenija trombocitemija eozinofilija v krvi podaljšan protrombinski čas/zvišane vrednosti INR
English: In Phase III-IV clinical studies, the rates of cardiac adverse events, drug-related cardiac adverse events and serious cardiac adverse events were similar between moxifloxacin and the comparator.
Slovenian: V kliničnih študijah 3. in 4. faze so bile stopnje neželenih učinkov na srce, z zdravili povezanih neželenih učinkov na srce in hudih neželenih učinkov na srce pri moksifloksacinu in primerjalnih zdravilih podobne.
English: PHARMACEUTICAL FORM AND CONTENTS 5 bags with 250 ml solution for infusion 12 bags with 250 ml solution for infusion
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 5 vreč z 250 ml raztopine za infundiranje 12 vreč z 250 ml raztopine za infundiranje
English: Each bottle bag contains 400mg moxifloxacin (as hydrochloride).
Slovenian: Vsaka steklenica vreča vsebuje 400 mg moksifloksacina v obliki moksifloksacinijevega klorida.
English: Pseudomonas aeruginosa *Activity has been satisfactorily demonstrated in clinical studies.
Slovenian: Proteus mirabilis* anaerobni mikroorganizmi bacteroides fragilis odporni organizmi aerobni, po Gramu negativni mikroorganizmi Pseudomonas aeruginosa *Učinek so zadovoljivo dokazali v kliničnih študijah.
English: The CHMP considers that the benefit-risk relationship for IV/PO moxifloxacin in the management of cSSSI is only favourable with qualification of the indication for use.
Slovenian: CHMP je menil, da je razmerje med koristmi in tveganji pri intravenoznem/peroralnem zdravljenju z moksifloksacinom za obvladovanje zapletenih okužb kože in mehkih tkiv ugodno le ob prilagoditvi indikacij za uporabo.
English: What Octegra contains
Slovenian: Kaj vsebuje zdravilo Octegra
English: Increase of a special liver enzyme in the blood (gamma-glutamyl-transferase) Uncommon: Abnormal fast heart rate, low blood pressure, swelling (of the hands, feet, ankles, lips, mouth, throat), severe diarrhoea containing blood and/or mucus (antibiotic associated colitis) which in very rare circumstances, may develop into complications that are lifethreatening, convulsions, hallucination, kidney impairment (incl.
Slovenian: nenormalen hiter srčni ritem, znižan krvni tlak, otekline (rok, stopal, gležnjev, ustnic, ust in grla), huda driska, ki vsebuje kri in/ali sluz (kolitis, povezan z antibiotičnim zdravljenjem), ki se v zelo redkih primerih lahko razvije v smrtno nevarne zaplete, krči, halucinacije, motnje v delovanju ledvic (tudi zvečane vrednosti posebnih ledvičnih laboratorijskih testov; sečnine in kreatinina), ledvična odpoved
English: Octegra and associated names (see Annex I) 400mg/250ml solution for infusion
Slovenian: Octegra in povezana imena (Glejte Dodatek I) 400 mg/250 ml raztopina za infundiranje
English: - Moxifloxacin should be used with caution in patients with myasthenia gravis because the symptoms can be exacerbated.
Slovenian: Pri bolnikih z miastenijo gravis, je treba moksifloksacin uporabljati previdno, ker se simptomi bolezni lahko poslabšajo.
English: At cool storage temperatures precipitation may occur, which will re-dissolve at room temperature.
Slovenian: Če zdravilo hranite pri nizkih temperaturah lahko pride do obarjanja, oborina pa se pri sobni temperaturi ponovno raztopi.
English: - Patients with a family history of, or actual glucose-6-phosphate dehydrogenase deficiency are prone to haemolytic reactions when treated with quinolones.
Slovenian: Ker so bolniki, ki imajo pomanjkanje glukoza-6-fosfat dehidrogenaze ali pa je ta motnja prisotna v družinski anamnezi, med zdravljenjem s kinoloni nagnjeni k hemolitičnim reakcijam, morajo moksifloksacin uporabljati previdno.
English: - If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately.
Slovenian: Če se pojavijo motnje vida ali kakršnekoli očesne spremembe, mora bolnik takoj obiskati oftalmologa.
English: A slightly increased incidence of vertebral and rib malformations was observed in foetuses of rabbits but only at a dose (20 mg/kg i.v.)
Slovenian: Opazili so, da se je pri fetusih kuncev nekoliko povečala pojavnost malformacij vretenc in reber, vendar le pri odmerku 20 mg/kg i.v., ki je bil povezan z resno maternalno toksičnostjo.
English: Blood and lymphatic system disorders
Slovenian: Kri in limfatični sistem Občasni:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally.]
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET [Izpolni država članica]
English: - The other ingredients are sodium chloride, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment) and water for injections
Slovenian: Pomožne snovi so natrijev klorid, klorovodikova kislina (za uravnavanje pH), natrijev hidroksid (za uravnavanje pH) in voda za injekcije.
English: Reproductive studies performed in rats, rabbits and monkeys indicate that placental transfer of moxifloxacin occurs.
Slovenian: S študijami o vplivu moksifloksacina na sposobnost razmnoževanja pri podganah, kuncih in opicah so ugotovili, da moksifloksacin prehaja skozi posteljico.
English: - Antibiotic associated diarrhoea (AAD) and antibiotic-associated colitis (AAC), including pseudomembranous colitis and Clostridium difficile-associated diarrhoea, has been reported in association with the use of broad spectrum antibiotics including moxifloxacin and may range in severity from mild diarrhoea to fatal colitis.
Slovenian: Pri uporabi antibiotikov širokega spektra, vključno z moksifloksacinom, so poročali o driski povezani z antibiotičnim zdravljenjem (AAD - antibiotic associated diarrhoea), o kolitisu povezanim z antibiotičnim zdravljenjem (AAC - antibiotic associated colitis), vključno z psevdomembranskim kolitisom in o driski, povezani s Clostridium difficile.
English: Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment) Water for injections
Slovenian: 6.1 Seznam pomožnih snovi natrijev klorid klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH) voda za injekcije
English: - This medicinal product contains 787 mg (approximately 34 mmol) sodium per dose.
Slovenian: Zdravilo vsebuje 787 mg (približno 34 mmolov) natrija na odmerek, kar je treba upoštevati pri bolnikih, ki so na dieti z malo natrija.
English: Pruritus Rash Urticaria Dry skin
Slovenian: srbenje, izpuščaji, koprivnica, suha koža
English: - You may develop diarrhoea whilst taking, or after taking, antibiotics including Octegra.
Slovenian: Med ali po jemanju antibiotikov (tudi zdravila Octegra) se lahko pojavi driska.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR OVERWRAP - BAG
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA OMOT - VREČA
English: Infections caused by resistant bacteria or fungi e.g. oral and vaginal infections caused by Candida
Slovenian: okužbe z odpornimi bakterijami ali glivicami (okužbe v ustih in nožnici s Candido)