natgillin/translations-raw huggingface dataset:
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. 
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.
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. 
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.
Fluoroquinolones exhibit a concentration dependent killing of bacteria. 
Baktericidnost fluorokinolonov je odvisna od njihovih koncentracij.
Anxiety reactions Psychomotor hyperactivity / agitation 
zaskrbljenost, vznemirjenost/agitacija
Adverse reactions observed in clinical trials with moxifloxacin 400 mg daily administered by the intravenous or oral route sorted by frequencies are listed below: 
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.
Moxifloxacin solution for infusion should not be co-infused with other drugs. 
Raztopine moksifloksacina za infundiranje ne smete sočasno infundirati z drugimi zdravili.
- 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, 
- 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;
affects 1 to 10 users in 100 
pojavijo se pri 1 do 10 bolnikih od 100 bolnikov
- Cases of bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported with moxifloxacin (see section 4.8). 
Pri uporabi moksifloksacina so poročali o buloznih kožnih spremembah, npr. StevensJohnsonovem sindromu ali toksični epidermalni nekrolizi (glejte poglavje 4.8).
The following solutions were incompatible with Octegra: Sodium chloride 10% and 20% solutions, Sodium bicarbonate 4.2% and 8.4% solutions 
Z zdravilom Octegra so bile inkompatibilne naslednje raztopine: 10 % in 20 % raztopina natrijevega klorida, 4,2 % in 8,4 % raztopina natrijevega karbonata
Nervous system disorders 
Živčni sistem Pogosti:
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). 
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
affects 1 to 10 users in 10,000 
pojavijo se pri 1 do 10 bolnikih od 10.000 bolnikov
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. 
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.
The Applicant reiterated that the QTc changes observed did not translate into a higher risk to develop a clinical cardiac event. 
Varnost pri zdravljenju izvenbolnišnično pridobljene pljučnice Predlagatelj je znova poudaril, da opažene spremembe QTc ne pomenijo povišanega tveganja za razvoj kliničnih dogodkov srca.
Patients were more likely to have a notable increase in QTc on intravenous moxifloxacin than on oral moxifloxacin. 
Večja verjetnost za znatno povišanje QTc je bila pri bolnikih z intravenoznim zdravljenjem z moksifloksacinom kot pri tistih s peroralnim zdravljenjem.
increase in special kidney laboratory test results like urea and creatinine), kidney failure 
motnje v delovanju ledvic (tudi zvečane vrednosti posebnih ledvičnih laboratorijskih testov; sečnine in kreatinina), ledvična odpoved
Octegra is packaged in cartons containing 250ml polyolefine bags with polypropylene port sealed in aluminium foil overwrap. 
Zdravilo Avelox je pakirano v škatle, ki vsebujejo 250 ml poliolefinske vreče s polipropilensko zaporko in omot iz aluminija.
Apart from nausea and diarrhoea all adverse reactions were observed at frequencies below 3%. 
Vsi neželeni učinki (razen slabosti in driske) so se pojavili pri manj kot 3 % bolnikov.
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). 
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
If you miss a dose of Octegra If you are concerned that you may have missed a dose of Octegra, contact your doctor immediately. 
Če niste dobili odmerek zdravila Octegra Če menite, da niste dobili odmerek zdravila Octegra, se takoj posvetujte z zdravnikom.
The analysis of outlying QTc values demonstrated a consistent excess risk for moxifloxacin for the data from the CAP studies with ECG data. 
Analiza izstopajočih vrednosti QTc dokazuje skladen presežek tveganja pri moksifloksacinu po podatkih iz študij izvenbolnišnično pridobljene pljučnice in podatkih EKG.
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). 
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).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER PACKAGING FOR MULTIPACK - GLASS BOTTLE 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA Z VEČ PAKIRANJI - STEKLENICA
A feeling of self-detachment (not being yourself), insanity (potentially leading to self-harm) Nervous System 
Zelo redki: motnja samozavedanja (nezavedanje samega sebe), duševna zmedenost (potencialno samoogrožajoče vedenje)
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. 
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.
Moxifloxacin should be used with caution in patients who are taking medication that can reduce potassium levels. 
Moksifloksacin je treba uporabljati previdno pri bolnikih, ki jemljejo zdravila za zmanjševanje vrednosti kalija.
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) 
izguba teka, napenjanje in zaprtost, želodčne težave (slaba prebava/zgaga), vnetje želodca, zvečane vrednosti posebnih prebavnih encimov v krvi (amilaze)
Leucopenia(s) Neutropenia Thrombocytopenia Thrombocythemia Blood eosinophilia Prothrombin time prolonged / INR increased 
bolezni krvi in limfatičnega sistema anemija levkopenija nevtropenija trombocitopenija trombocitemija eozinofilija v krvi podaljšan protrombinski čas/zvišane vrednosti INR
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. 
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.
PHARMACEUTICAL FORM AND CONTENTS 5 bags with 250 ml solution for infusion 12 bags with 250 ml solution for infusion 
FARMACEVTSKA OBLIKA IN VSEBINA 5 vreč z 250 ml raztopine za infundiranje 12 vreč z 250 ml raztopine za infundiranje
Each bottle bag contains 400mg moxifloxacin (as hydrochloride). 
Vsaka steklenica vreča vsebuje 400 mg moksifloksacina v obliki moksifloksacinijevega klorida.
Pseudomonas aeruginosa *Activity has been satisfactorily demonstrated in clinical studies. 
Proteus mirabilis* anaerobni mikroorganizmi bacteroides fragilis odporni organizmi aerobni, po Gramu negativni mikroorganizmi Pseudomonas aeruginosa *Učinek so zadovoljivo dokazali v kliničnih študijah.
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. 
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.
What Octegra contains 
Kaj vsebuje zdravilo Octegra
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. 
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
Octegra and associated names (see Annex I) 400mg/250ml solution for infusion 
Octegra in povezana imena (Glejte Dodatek I) 400 mg/250 ml raztopina za infundiranje
- Moxifloxacin should be used with caution in patients with myasthenia gravis because the symptoms can be exacerbated. 
Pri bolnikih z miastenijo gravis, je treba moksifloksacin uporabljati previdno, ker se simptomi bolezni lahko poslabšajo.
At cool storage temperatures precipitation may occur, which will re-dissolve at room temperature. 
Če zdravilo hranite pri nizkih temperaturah lahko pride do obarjanja, oborina pa se pri sobni temperaturi ponovno raztopi.
- Patients with a family history of, or actual glucose-6-phosphate dehydrogenase deficiency are prone to haemolytic reactions when treated with quinolones. 
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.
- If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately. 
Če se pojavijo motnje vida ali kakršnekoli očesne spremembe, mora bolnik takoj obiskati oftalmologa.
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.) 
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.
Blood and lymphatic system disorders 
Kri in limfatični sistem Občasni:
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally.] 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET [Izpolni država članica]
- The other ingredients are sodium chloride, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment) and water for injections 
Pomožne snovi so natrijev klorid, klorovodikova kislina (za uravnavanje pH), natrijev hidroksid (za uravnavanje pH) in voda za injekcije.
Reproductive studies performed in rats, rabbits and monkeys indicate that placental transfer of moxifloxacin occurs. 
S študijami o vplivu moksifloksacina na sposobnost razmnoževanja pri podganah, kuncih in opicah so ugotovili, da moksifloksacin prehaja skozi posteljico.
- 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. 
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.
Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment) Water for injections 
6.1 Seznam pomožnih snovi natrijev klorid klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH) voda za injekcije
- This medicinal product contains 787 mg (approximately 34 mmol) sodium per dose. 
Zdravilo vsebuje 787 mg (približno 34 mmolov) natrija na odmerek, kar je treba upoštevati pri bolnikih, ki so na dieti z malo natrija.
Pruritus Rash Urticaria Dry skin 
srbenje, izpuščaji, koprivnica, suha koža
- You may develop diarrhoea whilst taking, or after taking, antibiotics including Octegra. 
Med ali po jemanju antibiotikov (tudi zdravila Octegra) se lahko pojavi driska.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR OVERWRAP - BAG 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA OMOT - VREČA
Infections caused by resistant bacteria or fungi e.g. oral and vaginal infections caused by Candida 
okužbe z odpornimi bakterijami ali glivicami (okužbe v ustih in nožnici s Candido)
PHARMACEUTICAL FORM AND CONTENTS 1 bottle with 250 ml solution for infusion Component of a multipack 
FARMACEVTSKA OBLIKA IN VSEBINA 1 steklenica z 250 ml raztopine za infundiranje Sestavni del več pakiranj
[Moxifloxacin] 400 mg solution for infusion is indicated for the treatment of: - Community acquired pneumonia - Complicated skin and structure infections 
[Moksifloksacin] 400 mg raztopina za infundiranje je indicirana za zdravljenje:
The activity of moxifloxacin is not affected by mechanisms of resistance that are specific to antibacterial agents of other classes. 
Mehanizmi odpornosti, ki so značilni za protimikrobna zdravila iz drugih skupin, ne vplivajo na protimikrobno aktivnost moksifloksacina.
For Octegra be aware of the following: - If you are taking other medicines that affect your heart during treatment with Octegra there is an increased risk for altering your heart rhythm. 
Če med zdravljenjem z zdravilom Octegra jemljete druga zdravila, ki vplivajo na srce, obstaja povečano tveganje za spremembe srčnega ritma.
Uncommon ≥ 1/1,000 to 
občasni > 1/1.000 do <
Moxifloxacin was non-carcinogenic in an initiation-promotion study in rats. 
V iniciacijsko promocijski študiji na podganah niso ugotovili karcinogenega delovanja moksifloksacina.
A large number of cases showing an increase in oral anticoagulant activity have been reported in patients receiving antibacterial agents, especially fluoroquinolones, macrolides, tetracyclines, cotrimoxazole and some cephalosporins. 
Spremembe internacionalnega normaliziranega razmerja (INR) Pri bolnikih, ki so dobivali antibiotike, predvsem fluorokinolone, makrolide, tetracikline, kotrimoksazol in nekatere cefalosporine, so poročali o velikem številu primerov pri katerih se je aktivnost peroralnega antikoagulanta zvečala.
Concomitant administration of moxifloxacin with ranitidine or probenecid did not alter renal clearance of the parent drug. 
Sočasna uporaba moksifloksacina in ranitidina ali probenecida ne vpliva na ledvični očistek prvotne učinkovine.
There is no data available in lactating or nursing women. 
Podatkov o uporabi moksifloksacina pri doječih ženskah ni na voljo.
- Cases of fulminant hepatitis potentially leading to liver failure (including fatal cases) have been reported with moxifloxacin (see section 4.8). 
V povezavi z moksifloksacinom so poročali o primerih fulminantnega hepatitisa, ki lahko povzroči jetrno odpoved (vključno s smrtnimi primeri) (glejte poglavje 4.8).
No prolongation of the QT interval was seen when a dose of 30 mg/kg was infused over 60 minutes. 
Če so odmerek 30 mg/kg infundirali v 60 minutah, niso opazili podaljšanja intervala QT.
Toxic effects on the CNS were observed in monkeys. 
Pri opicah so opazili toksične učinke na osrednje živčevje.
Quinolones, including moxifloxacin, are known to cause lesions in the cartilage of the major diarthrodial joints in immature animals. 
Znano je, da kinoloni povzročajo poškodbe sklepnega hrustanca v nosilnih sklepih nerazvitih živalskih mladičev.
PHARMACEUTICAL FORM AND CONTENTS 1 bag with 250 ml solution for infusion 
FARMACEVTSKA OBLIKA IN VSEBINA 1 vreča z 250 ml raztopine za infundiranje
Resistance to fluoroquinolones can arise through mutations in DNA gyrase and topoisomerase IV. Other mechanisms may include over-expression of efflux pumps, impermeability, and protein-mediated protection of DNA gyrase. 
Drugi mehanizmi so lahko prekomerno izraženi mehanizmi prehoda, neprepustnost in zaščita giraze DNK s pomočjo proteinov.
Intravenous use 400 mg / 250 ml 
400 mg raztopina za infundiranje intravenska uporaba 400 mg / 250 ml
NAME OF THE MEDICINAL PRODUCT Octegra and associated names (see Annex I) 400 mg/250 ml solution for infusion [See Annex I - To be completed nationally] Moxifloxacin 
Octegra in povezana imena (Glejte Dodatek I) 400 mg/250 ml raztopina za infundiranje [Glejte Dodatek I - Izpolni država članica] moksifloksacin
In the interstitial fluid unbound concentration time profiles similar to those in plasma were found with unbound peak concentrations of 1.0 mg/l (geometric mean) reached approximately 1.8 h after an intravenous dose. 
Največja koncentracija nevezane učinkovine 1,0 mg/l (geometrijska sredina) je bila dosežena približno 1,8 ure po intravenski uporabi.
Superinfections due to resistant bacteria or fungi e.g. oral and vaginal candidiasis 
zelo redki infekcijske in parazitske bolezni superinfekcije z odpornimi bakterijami ali glivicami (npr. kandidoza v ustih in vaginalna kandidoza)
very rarely life-threatening shock (e.g. difficulty in breathing, drop of blood pressure, fast pulse), swelling (incl. 
huda, nenadna splošna alergijska reakcija, tudi zelo redko smrtno nevaren šok (npr. težave pri dihanju, zmanjšanje krvnega tlaka, hiter utrip), otekline (tudi potencialno smrtno nevarna oteklina v dihalnih poteh)
It was considered that the same restrictions should apply to the indications for both CAP and cSSTI as already adopted by CHMP for oral moxifloxacin to treat CAP. Intravenous moxifloxacin is almost always followed by oral treatment and as such the restriction for use of oral moxifloxacin should be reflected in the SPC of the intravenous product. 
Menili so, da naj bi enake omejitve veljale za indikacije tako za izvenbolnišnično pridobljeno pljučnico kot tudi za zapletene okužbe kože in mehkih tkiv, kot jih je že določil CHMP za peroralni moksifloksacin za zdravljenje izvenbolnišnično pridobljene pljučnice.
CARTON FOR UNIT PACK AND LABEL - GLASS BOTTLE 
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA Z ENIM PAKIRANJEM IN NALEPKA - STEKLENICA
However, studies have shown that moxifloxacin has a lower risk to induce photosensitivity. 
Ugotovili so, da kinoloni pri bolnikih povzročajo fotosenzitivne reakcije, vendar pa so s študijami dokazali, da je pri moksifloksacinu tveganje za nastanek fotosenzitivnosti manjše.
Netherlands Bayer HealthCare AG 51368 Leverkusen Germany 
Nizozemska Bayer HealthCare AG 51368 Leverkusen
BEFORE YOU USE OCTEGRA 
Pred prvo uporabo zdravila Octegra
NAME OF THE MEDICINAL PRODUCT Octegra and associated names (see Annex I) 400 mg/250 ml solution for infusion [See Annex I - To be completed nationally] 
Octegra in povezana imena (Glejte Dodatek I) 400 mg/250 ml raztopina za infundiranje [Glejte Dodatek I - Izpolni država članica]
PHARMACEUTICAL FORM AND CONTENTS 5 bottles with 250 ml solution for infusion Multipack 
FARMACEVTSKA OBLIKA IN VSEBINA 5 steklenic z 250 ml raztopine za infundiranje Več pakiranj
- Quinolones have been shown to cause photosensitivity reactions in patients. 
Znano je, da kinoloni povzročajo epileptične napade.
Species for which acquired resistance may be a problem Aerobic Gram-positive micro-organisms 
Mycoplasma pneumoniae* vrste, pri katerih je pridobljena odpornost lahko vprašljiva aerobni, po Gramu pozitivni mikroorganizmi Enterococcus faecalis* aerobni, po Gramu negativni mikroorganizmi Enterobacter cloacae
PK/PD 
FK/FD (farmakokinetika/farmakodinamika)
Intra-arterial administration should be avoided since preclinical studies demonstrated peri-arterial tissue inflammation following infusion by this route. 
Ker so v predkliničnih študijah dokazali vnetje periarterialnega tkiva, ki se je pojavilo, če so zdravilo infundirali intraarterialno, se je treba temu načinu dajanja izogibati.
frequency cannot be estimated from the available data 
pojavijo se pri manj kot 1 bolniku od 100.000 bolnikov Neznana pogostnost: pogostnosti iz razpoložljivih podatkov ni mogoče oceniti
Use should be with caution in patients with CNS disorders which may predispose to seizures or lower the seizure threshold. 
Bolniki z motnjami osrednjega živčevja jih morajo uporabljati previdno, saj lahko povzročijo epileptične napade ali znižajo prag njihovega pojava.
- Elderly patients with renal disorders should use moxifloxacin with caution if they are unable to maintain adequate fluid intake, because dehydration may increase the risk of renal failure. 
Starejši bolniki z motnjami v delovanju ledvic, ki ne morejo skrbeti za zadosten vnos tekočine, morajo uporabljati moksifloksacin previdno.
Moxifloxacin IV for cSSSI was approved in 2005 in all countries that had already approved the intravenous formulation for use in CAP. No consensus was reached on Day 60 of the CMD(h) referral and the procedure was therefore referred to the CHMP. 
Intravenozni moksifloksacin za zapletene okužbe kože in mehkih tkiv je bil leta 2005 odobren v vseh državah, ki so že odobrile intravenozno formulacijo za uporabo pri izvenbolnišnično pridobljeni pljučnici.
Pain or inflammation at injection site Uncommon: Inflammation of a vein 
bolečina ali vnetje na mestu injiciranja
HOW TO STORE OCTEGRA 
SHRANJEVANJE ZDRAVILA OCTEGRA