natgillin/translations-raw huggingface dataset:
COX-2 has been identified in tissue around gastric ulcers in man but its relevance to ulcer healing has not been established.
COX- 2 so pri cloveku našli v tkivu okoli želodcnih ulkusov, a njena vloga pri celjenju ulkusov ni ugotovljena.
The difference in antiplatelet activity between some COX-1 inhibiting NSAIDs and COX-2 selective inhibitors may be of clinical significance in patients at risk of thrombo-embolic reactions.
Razlika v antitrombocitni aktivnosti med nekaterimi nesteroidnimi antirevmatiki, ki zavirajo COX- 1, in selektivnimi zaviralci COX- 2 bi lahko bila klinicno pomembna pri bolnikih, ki jih ogrožajo trombembolicne reakcije.
Celecoxib is a diaryl-substituted pyrazole, chemically similar to other non-arylamine sulfonamides (e. g. thiazides, furosemide) but differs from arylamine sulfonamides (e. g. sulfamethoxizole and other sulfonamide antibiotics).
Celekoksib je diaril- substituiran pirazol, kemicno podoben drugim nearilaminskim sulfonamidom (npr. tiazidom, furosemidu), a drugacen od arilaminskih sulfonamidov (npr. sulfametoksazola in drugih sulfonamidnih antibiotikov).
Celecoxib was evaluated for the treatment of the inflammation and pain of OA of the knee and hip in approximately 4200 patients in placebo and active controlled trials of up to 12 weeks duration.
Za zdravljenje vnetja in bolecin pri osteoartritisu kolena in kolka so celekoksib ocenili pri približno 4. 200 bolnikih v preskušanjih, kontroliranih s placebom ali aktivno ucinkovino, ki so trajala do 12 tednov.
It was also evaluated for treatment of the inflammation and pain of RA in approximately 2100 patients in placebo and active controlled trials of up to 24 weeks duration.
Ocenili so ga tudi za zdravljenje vnetja in bolecin pri revmatoidnem artritisu, in sicer pri približno 2. 100 bolnikih v preskušanjih, kontroliranih s placebom ali aktivno ucinkovino, ki so trajala do 24 tednov.
Celecoxib at daily doses of 200 mg – 400 mg provided pain relief within 24 hours of dosing.
Celekoksib v dnevnih odmerkih od 200 mg do 400 mg je bolecine olajšal v 24 urah po uporabi.
Five randomised double-blind controlled studies have been conducted including scheduled upper gastrointestinal endoscopy in approximately 4500 patients free from initial ulceration (celecoxib doses from 50 mg-400 mg BID).
Izvedenih je bilo pet randomiziranih, dvojno slepih kontroliranih študij, ki so vkljucevale elektivno endoskopijo zgornjih prebavil, pri približno 4. 500 bolnikih, ki uvodoma niso imeli ulkusov (odmerki celekoksiba od 50 mg do 400 mg dvakrat na dan).
In twelve week endoscopy studies celecoxib (100-800 mg per day) was associated with a significantly lower risk of gastroduodenal ulcers compared with naproxen (1000 mg per day) and ibuprofen (2400 mg per day).
V dvanajsttedenskih endoskopskih študijah je bilo tveganje za ulkuse na želodcu in dvanajstniku s celekoksibom (100 do 800 mg na dan) znacilno manjše kot z naproksenom (1. 000 mg na dan) oz. ibuprofenom (2. 400 mg na dan).
In two of the 12-week studies the percentage of patients with endoscopic gastroduodenal ulceration were not significantly different between placebo and celecoxib 200 mg BID and 400 mg BID.
400 mg dvakrat na dan.
In a prospective long-term safety outcome study (6 to 15 month duration, CLASS study), 5,800 OA and 2,200 RA patients received celecoxib 400 mg BID (4-fold and 2-fold the recommended OA and RA doses, respectively), ibuprofen 800 mg TID or diclofenac 75 mg BID (both at therapeutic doses).
V prospektivni dolgorocni študiji varnosti (trajanje od 6 do 15 mesecev, študija CLASS) je 5. 800 bolnikov z osteoartritisom in 2. 200 bolnikov z revmatoidnim artritisom dobivalo 400 mg celekoksiba dvakrat na dan (4- kratni priporoceni odmerek za osteoartritis oz.
Twenty-two percent of enrolled patients took concomitant low-dose acetylsalicylic acid (≤ 325 mg/ day), 26 primarily for cardiovascular prophylaxis.
Dvaindvajset odstotkov vkljucenih bolnikov je hkrati jemalo nizke odmerke acetilsalicilne kisline (≤ 325 mg/ dan), predvsem za kardiovaskularno profilakso.
Also for the combined NSAID group there was no statically significant difference for complicated ulcers (relative risk 0,77, 95% CI 0.41-1.46, based on entire study duration).
Tudi v primerjavi s kombinirano skupino nesteroidnih antirevmatikov glede zapletenih ulkusov ni bilo statisticno znacilne razlike (relativno tveganje 0, 77, 95% IZ 0, 41– 1, 46, na podlagi celotnega trajanja študije).
For the combined endpoint, complicated and symptomatic ulcers, the incidence was significantly lower in the celecoxib group compared to the NSAID group, relative risk 0.66, 95% CI 0.45-0.97 but not between celecoxib and diclofenac.
Glede kombinirane koncne tocke, ki so jo predstavljali zapleteni in simptomatski ulkusi, je bila incidenca v skupini s celekoksibom znacilno manjša kot v skupini z nesteroidnimi antirevmatiki (relativno tveganje 0, 66, 95% IZ 0, 45– 0, 97), ne pa med celekoksibom in diklofenakom.
Those patients on celecoxib and concomitant low- dose acetylsalicylic acid experienced 4 fold higher rates of complicated ulcers as compared to those on celecoxib alone.
Med bolniki, ki so hkrati dobivali celekoksib in nizke odmerke acetilsalicilne kisline, je bil delež zapletenih ulkusov 4- krat vecji kot pri uporabnikih celekoksiba samega.
The incidence of clinically significant decreases in haemoglobin (> 2 g/ dL), confirmed by repeat testing, was significantly lower in patients on celecoxib compared to the NSAID group, relative risk 0.29, 95% CI 0.17- 0.48.
Incidenca klinicno pomembnega znižanja hemoglobina (> 2 g/ dl), potrjenega s ponovnim testiranjem, je bila znacilno manjša med bolniki, ki so dobivali celekoksib, kot med bolniki, ki so dobivali nesteroidne antirevmatike (relativno tveganje 0, 29, 95% IZ 0, 17– 0, 48).
Preliminary safety information from three long-term studies involving patients with Sporadic Adenomatous Polyps or who were predisposed to developing Alzheimer’ s disease treated with celecoxib is available.
Klinicne študije, ki še potekajo: na voljo so preliminarne varnostne informacije iz treh dolgorocnih študij, ki so zajele bolnike s sporadicnimi adenomatoznimi polipi in bolnike s predispozicijo za Alzheimerjevo bolezen, zdravljene s celekoksibom.
In one of the three studies, the APC (Prevention of Sporadic Colorectal Adenomas with Celecoxib), there was a dose-related increase in cardiovascular events (mainly myocardial infarction, MI) at celecoxib doses of 200 mg BID and 400 mg BID compared to placebo.
27 adenomov s celekoksibom), so pri celekoksibu v odmerkih 200 mg dvakrat na dan in 400 mg dvakrat na dan v primerjavi s placebom, ugotovili z odmerkom povezano povecanje srcnožilnih incidentov (predvsem miokardnega infarkta, MI).
The relative risk (RR) for the composite endpoint (cardiovascular death, MI or stroke) was 3.4 (95% CI 1.4 - 8.5) for the higher dose and 2.5 (95% CI 1.0 - 6.4) for the lower dose of celecoxib, compared to placebo.
Relativno tveganje (RT) za sestavljen opazovani dogodek (srcnožilna smrt, MI ali možganska kap) je bilo pri višjem odmerku celekoksiba v primerjavi s placebom 3, 4 (95% IZ 1, 4- 8, 5) in pri manjšem odmerku celekoksiba 2, 5 (95% IZ 1, 0- 6, 4).
The absolute risk for the composite endpoint was 3.0% for the higher dose of celecoxib, 2.2% for the lower dose of celecoxib, and 0.9% for placebo.
Absolutno tveganje za sestavljen opazovani dogodek je bilo 3, 0% pri višjem odmerku celekoksiba, 2, 2% pri manjšem odmerku celekoksiba in 0, 9% pri placebu.
5.2 Pharmacokinetic properties Celecoxib is well absorbed reaching peak plasma concentrations after approximately 2-3 hours.
Celekoksib se dobro absorbira in doseže najvecjo koncentracijo v plazmi po približno 2– 3 urah.
Less than 1% of the dose is excreted unchanged in urine.
Manj kot 1% odmerka se nespremenjenega izloci v urinu.
The inter-subject variability in the exposure of celecoxib is about 10-fold.
Variabilnost v interindividualni izpostavljenosti celekoksibu je približno 10- kratna.
Celecoxib exhibits dose- and time-independent pharmacokinetics in the therapeutic dose range.
V obmocju terapevtskih odmerkov farmakokinetika celekoksiba ni odvisna od odmerka in casa.
Plasma protein binding is about 97% at therapeutic plasma concentrations and the drug is not preferentially bound to erythrocytes.
Pri terapevtskih koncentracijah v plazmi je vezava na beljakovine v plazmi približno 97- odstotna; zdravilo se ne veže prednostno na eritrocite.
The main metabolites found in the circulation have no detectable COX-1 or COX-2 activity.
Glavni presnovki v obtoku ne delujejo zaznavno na COX- 1 ali COX- 2.
Less than 1% of the population are poor metabolisers and have an enzyme with decreased activity.
Manj kot 1% populacije z njim slabo presnavlja; te osebe imajo encim z zmanjšano aktivnostjo.
The plasma concentration of celecoxib is approximately 100% increased in elderly women (> 65 years).
Pri starejših ženskah (> 65 let) je koncentracija celekoksiba v plazmi za približno 100% višja.
Compared to subjects with normal hepatic function, patients with mild hepatic impairment had a mean increase in Cmax of 53% and in AUC of 26% of celecoxib.
Pri bolnikih z blago okvaro jeter je bila Cmax celekoksiba v povprecju za 53% vecja, AUC pa za 26% vecja kot pri preiskovancih z normalnim delovanjem jeter.
The corresponding values in patients with moderate hepatic impairment were 41% and 146% respectively.
Ustrezni vrednosti pri bolnikih z zmerno okvaro jeter sta bili 41% in 146%.
Treatment should be initiated at half the recommended dose in patients with moderate liver impairment (with serum albumin 25-35g/ L).
Pri bolnikih z zmerno okvaro jeter (albumin v serumu od 25 do 35 g/ l) je treba zdravljenje zaceti s polovico priporocenega odmerka.
Patients with severe hepatic impairment (serum albumin < 25 g/ l) have not been studied and celecoxib is contraindicated in this patient group.
Študij pri bolnikih s hudo okvaro jeter (albumin v serumu < 25 g/ l) ni bilo in pri teh bolnikih je celekoksib kontraindiciran.
The pharmacokinetics of celecoxib has not
Farmakokinetika celekoksiba pri bolnikih z okvaro jeter ni raziskana, vendar ni verjetno, da bi bila izrazito spremenjena.
27 been studied in patients with renal impairment but is unlikely to be markedly changed in these patients.
Pri zdravljenju bolnikov z okvaro ledvic je potrebna previdnost.
Thus caution is advised when treating patients with renal impairment.
Huda okvara ledvic je kontraindikacija.
Severe renal impairment is contraindicated.
5. 3 Predklinicni podatki o varnosti
5.3 Preclinical safety data Conventional embryo-fetal toxicity studies resulted in dose dependent occurrences of diaphragmatic hernia in rat fetuses and of cardiovascular malformations in rabbit fetuses at systemic exposures to free drug approximately 5X (rat) and 3X (rabbit) higher than those achieved at the maximum recommended daily human dose (400 mg).
Konvencionalne raziskave toksicnosti zdravila za zarodek in plod so pokazale od odmerka odvisno pojavnost hernije diafragme pri podganjih plodih in od odmerka odvisno pojavnost srcnožilnih malformacij pri kuncjih plodih pri sistemski izpostavljenosti prostemu zdravilu, ki je bila približno 5x (podgane) oz.
Diaphragmatic hernia was also seen in a peri-post natal toxicity study in rats, which included exposure during the organogenetic period.
3x (kunci) višja kot jo dosežemo z maksimalnim priporocenim dnevnim odmerkom za ljudi (400 mg).
In the latter study, at the lowest systemic exposure where this anomaly occurred in a single animal, the estimated margin relative to the maximum recommended daily human dose was 3X.
V tej raziskavi, v kateri se je
In animals, exposure to celecoxib during early embryonic development resulted in pre-implantation and post-implantation losses.
28 pri najmanjši sistemski izpostavljenosti zdravilu ta anomalija pokazala le pri eni eksperimentalni živali, so ocenili, da je mejna vrednost 3x maksimalni priporoceni odmerek za ljudi.
In a peri-post natal study in rats, pup toxicity was observed.
V neki raziskavi peri - in postnatalne toksicnosti zdravila pri podganah so opažali toksicne ucinke pri mladicih.
In a two-year toxicity study an increase in nonadrenal thrombosis was observed in male rat at high doses.
Na podlagi konvencionalnih raziskav toksicnosti, genotoksicnosti ali kancerogenosti veckratnih odmerkov zdravila menijo, da zdravilo ne pomeni posebnega tveganja za ljudi, t. j. ne vec od tistega, kar je že bilo omenjeno v drugih poglavjih tega dokumenta.
Capsule shells contain gelatin, titanium dioxide E171; ink contains indigotine E132
6. 1 Seznam pomožnih snovi
Capsules 200 mg contain lactose monohydrate, sodium lauryl sulphate, povidone K30, croscarmellose sodium and magnesium stearate.
Kapsule vsebujejo laktozo monohidrat, natrijev lavrilsulfat, povidon K30, natrijev karmelozat, premreženi in magnezijev stearat.
6.2 Incompatibilities Not applicable.
Se ne nanaša na ta primer.
6.3 Shelf-life 3 years.
3 leta
6.4 Special precautions for storage Do not store above 30oC.
6. 5 Vrsta ovojnine in vsebina
6.5 Nature and content of container Clear or opaque PVC blisters or aluminium cold-formed blisters.
100 mg kapsule: škatla s 30 trdimi kapsulami (3 x 10 kapsul v pretisnem omotu).
Pack of 2, 5, 6, 10, 20, 30, 40, 50, 60, 100, 10x10, 10x30, 10x50, 1x50 unit dose, 1x100 unit dose.
200 mg kapsule: škatla z 20 trdimi kapsulami (2 x 10 kapsul v pretisnem omotu).
6.6 Instructions for use and handling, and disposal (if appropriate) No special requirements.
6. 6 Navodila za pripravo in ravnanje z zdravilom
{Name and address} [Country name in the language of the text, NO telephone, fax numbers, e-mail
(Ime in naslov) / Besedilo, številka telefona in faksa, elektronska pošta ali internetni naslov je v jeziku države. /
8 MARKETING AUTHORISATION NUMBER(S)
ŠTEVILKA DOVOLJENJA ZA PROMET
[Item to be completed by the Marketing Authorisation Holder once the Marketing Authorisation has been granted.]
29 Tocka bo dopolnjena s strani imetnika dovoljenja za promet, po izdaji odlocbe.
9 DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATUM DOVOLJENJA ZA PROMET
[Item to be completed by the Marketing Authorisation Holder once the Marketing Authorisation has been granted or renewed.]
Tocka bo dopolnjena s strani imetnika dovoljenja za promet, po izdaji ali podaljšanju odlocbe.
30 Follow-up measures of the Marketing Authorisation Holder
30 DODATEK IV
As requested by the CHMP, the MAH agreed to submit the follow-up measures as listed below:
Glede na zahteve CHMP se je imetnik dovoljenja za promet strinjal, da bo izvedel nadaljnje ukrepe, kot so navedeni spodaj:
Area Description Clinical 1
Podrocje Klinicni vidik 1
The MAH commits to performing a global CV study to confirm long term CV safety of Celecoxib.
Opis Imetnik dovoljenja za promet se zavezuje, da bo izvedel globalno kardiovaskularno študijo za potrditev dolgorocne kardiovaskularne varnosti celekoksiba.
Furthermore, the MAH commits to continue dialogue with EMEA/ CHMP with regard to study design
Poleg tega se imetnik dovoljenja za promet zavezuje, da se bo v zvezi z nacrtom študije še naprej posvetoval z EMEA/ CHMP.
To provide final study reports for the following long-term trials APC/ Pre- SAP/ ADAPT in full, when available.
Da bo predložil zakljucna porocila za sledeca dolgorocna preizkušanja APC/ PreSAP/ ADAPT v celoti, ko bodo na voljo.
Where full study reports are not available to the MAH, it agrees to provide publications/ manuscripts in lieu of the study report(s).
Kjer imetnik dovoljenja za promet ne bo imel na razpolago celotnih porocil o študijah, se strinja, da bo namesto porocil o študiji( ah) predložil publikacije/ zapise.
To provide all ongoing epidemiological studies in accordance with updates on on-going post marketing activities (for example, within PSURs for Celebra).
Da bo zagotovil, da so vse potekajoce epidemiološke študije usklajene s posodobitvami potekajocih postmarketinških dejavnosti (na primer, s PSUR- i za zdravilo Celebra).
1 Member
1 Država članica
Pharmaceutical
Imetnik dovoljenja za promet Predlagatelj z zdravilom
Authorisation Holder
Farmacevtska oblika
(concentration)
vsebina (koncentracija)
NL
Nizozemska
Hikma Farmacêutica (Portugal) Lda.
Hikma Farmaceutica (Portugal), Lda.
Estrada do Rio da Mó, nº8, 8A & 8B, Fervença, 2705-906 Terrugem SNT, PORTUGAL
Estrada do Rio da Mó n. o 8, 8A
Ciprofloxacin Hikma 200mg/ 100ml Oplossing voor Intraveneuze Infusie
Ciprofloxacin Hikma 200 mg/ 100 ml
AT
voor
Estrada do Rio da Mó, nº8, 8A & 8B, Fervença, 2705-906 Terrugem SNT, PORTUGAL
Estrada do Rio da Mó n. o 8,
Ciprofloxacin Hikma 200mg/ 100ml Infusionslösung
Ciprofloxacin Hikma 200 mg/ 100 ml
Solution for infusion
Raztopina za Intravenska infundiranje uporaba
Intravenous use
200 mg/ 100 ml
200mg/ 100ml
Infusionslösung
DE
Nemčija
Estrada do Rio da Mó, nº8, 8A & 8B, Fervença, 2705-906 Terrugem SNT, PORTUGAL
Estrada do Rio da Mó n. o 8, 8A e 8B – Fervença 2705- 906 Terrugem SNT Portugalska
Intravenous use
Raztopina za Intravenska infundiranje uporaba
IT
Italija
UK
Združeno kraljestvo (Velika
3 SCIENTIFIC CONCLUSIONS
3 DODATEK II
Management of patients with complicated urinary tract infections (UTIs) currently includes empirical treatment with a broad-spectrum antibiotic (fluoroquinolone), and potential subsequent treatment for 10- 14 days based on urine culture and sensitivity.
Zdravljenje bolnikov z zapletenimi okužbami sečil (urinary tract infections, UTIs) trenutno obsega empirično zdravljenje z antibiotiki širokega spektra (fluorokinolon) in morebitno naknadno 10 do 14 dni trajajoče zdravljenje, odvisno od izsledkov na urinski kulturi in občutljivosti bolnika.
In order to avoid treatment failure and emergence of resistance it is a prerequisite that patient’ s compliance and dosing be adequate.
Da bi se izognili neuspehu pri zdravljenju in pojavu odpornosti, je predpogoj za uspešno zdravljenje doslednost bolnika pri jemanju zdravil in ustrezno odmerjanje zdravila.
The applicant/ MAH did not submit any clinical data to address the CHMP questions related to the risk/ benefit of the proposed dose in UTIs and the maximum adult daily dose, as this application is a so called ″ generic″ application (reference product/ originator Ciproxin from Bayer).
Vlagatelj/ imetnik dovoljenja za promet ni predložil kliničnih podatkov, s katerimi bi odgovoril na vprašanja CHMP glede tveganj in koristi predlaganega odmerka za zdravljenje okužb sečil ter glede največjega odmerka za odrasle, saj gre pri tej vlogi za t. i. "generično" vlogo (referenčno zdravilo / originator je Ciproxin družbe Bayer).
This product being a solution intended for intravenous infusion, should be restricted to the treatment of complicated UTI’ s.
Ker je zdravilo raztopina za pripravo intravenske infuzije, bi njegovo uporabo morali omejiti na zdravljenje zapletenih okužb sečil.
From the published data, which have demonstrated for the proposed maximum dose 400 mg intravenous three times daily as a maximum dose, a superior prevention of antibiotic resistance without a significant increase in adverse reactions in serious and life-threatening infections of other organ systems, there is no reason to conclude that this favourable risk/ benefit profile would differ significantly in the treatment of complicated UTIs.
Na podlagi objavljenih podatkov, ki so za predlagani največji odmerek 400 mg intravensko trikrat dnevno kot največji odmerek dokazali izvrstno sposobnost preprečevanja odpornosti na antibiotike brez znatne ojačitve neželenih reakcij pri resnih in življenjsko nevarnih okužbah drugih organskih sistemov, ne obstaja razloga za zaključek, da bo ta ugoden profil tveganj in koristi znatno drugačen pri zdravljenju zapletenih okužb sečil.
GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
5 PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO
- The literature provided by the applicant support a dose of 200 – 400 mg twice daily in the treatment of
- literature, ki jo je predložil vlagatelj in ki govori v prid odmerku 200 do 400 mg dvakrat dnevno
complicated urinary tract infections and a maximum adult daily dose of 400 mg three times daily.
pri zdravljenju zapletenih okužb sečil ter največjemu odmerku pri odraslih, ki znaša 400 mg trikrat dnevno,
- The requested amendments to section 5.1 of the Summary of Product Characteristics including the
- sprejemljivosti vseh zahtevanih dopolnil poglavja 5. 1 v Povzetku glavnih značilnosti zdravila,
breakpoints relevant to the indications are acceptable.
vključno s prelomnimi točkami, ki so pomembne za indikacije,
The CHMP has recommended that the indication should be complicated urinary tract infections with a recommended dose of 200 – 400 mg twice daily.
je CHMP je priporočil, naj se indikacija nanaša na zapletene okužbe sečil s priporočenim odmerkom 200 do 400 mg dvakrat dnevno.
The CHMP has therefore recommended the granting of the Marketing Authorisation(s) and the amendment of the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State.
CHMP je zato priporočil odobritev dovoljenj( a) za promet z zdravilom in dopolnil Povzetka glavnih značilnosti zdravila, označevanja in Navodila za uporabo za referenčno državo članico.
6 1.
6 POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Ciprofloxacin Hikma 200 mg/ 100 ml, solution for infusion [To be completed nationally]
Ciprofloxacin Hikma 200 mg/ 100 ml, raztopina za infundiranje [Izpolni država članica.]
Ciprofloxacin lactate equivalent to 2 mg ciprofloxacin.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Each vial with 100 ml contains 200 mg ciprofloxacin.
Vsaka 100- mililitrska viala vsebuje 200 mg ciprofloksacina.
Excipient 15.4 mmol (354 mg) sodium per 100 ml of solution for infusion For a full list of excipients, see section 6.1.
15, 4 mmol (354 mg) natrija na 100 ml raztopine za infundiranje Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
Solution for infusion Clear, colourless to slightly yellow solution pH of the solution:
Raztopina za infundiranje Bistra, brezbarvna do rahlo rumena raztopina pH raztopine:
3.9 – 4.5
3, 9- 4, 5
Ciprofloxacin Hikma is indicated for the treatment of serious and/ or life-threatening infections caused by ciprofloxacin-susceptible pathogens.
Zdravilo Ciprofloxacin Hikma je indicirano za zdravljenje resnih in/ ali smrtno nevarnih okužb, ki jih povzročajo patogeni mikroorganizmi, dovzetni za ciprofloksacin.
The following indications can be considered for treatment with Ciprofloxacin Hikma when oral therapy is not possible or not reliable:
Zdravilo Ciprofloxacin Hikma se lahko uporabi za naslednje indikacije, kadar peroralno zdravljenje ni mogoče ali zanesljivo:
- complicated urinary tract infections
- zapletene okužbe sečil;
- infections of the lower respiratory tract including pneumonia caused by aerobic gram-negative
- okužbe spodnjih dihal, vključno s pnevmonijo, ki jo povzročajo aerobne grampozitivne
bacteria, in case of Streptococcus pneumoniae infections ciprofloxacin is not the substance of first choice.
bakterije; pri okužbah z bakterijo Streptococcus pneumoniae, ciprofloksacin ni zdravilo prve izbire;
- complicated skin and soft tissue infections
- zapletene okužbe kože in mehkih tkiv;
- osteomyelitis
- osteomielitis.
The adult dosage is 200 - 400 mg ciprofloxacin twice daily.
Odmerek za odrasle je 200- 400 mg ciprofloksacina dvakrat na dan.
As with all other antibiotics, the patient should be monitored during therapy for the development of resistant strains of initially sensitive bacteria, especially P. aeruginosa and S. aureus (see the relevant statements in section
Kot pri drugih antibiotikih je treba med zdravljenjem bolnika spremljati zaradi možnosti razvoja rezistentnih sevov sprva občutljivih bakterij, zlasti P. aeruginosa in S. aureus (glejte ustrezne navedbe v poglavju 5. 1).
Impaired renal function:
8 Okvarjeno delovanje ledvic:
In patients with a creatinine clearance in the range 31 - 60 ml/ minute/ 1.73 m2 or a serum creatinine concentration in the range 124 - 174 µmol/ l, the maximum daily intravenous dose is 800 mg.
Pri bolnikih s kreatininskim očistkom od 31 do 60 ml/ min/ 1, 73 m2 ali koncentracijo kreatinina v serumu od 124 do 174 µmol/ l je največji dnevni intravenski odmerek 800 mg.