FrancophonIA/ELRC3.0 huggingface dataset:
English: The patient should be monitored closely and treated symptomatically with supportive measures.
Slovenian: Bolnika je treba pozorno spremljati in mu nuditi simptomatsko zdravljenje ter podporne ukrepe.
English: • bone infections.
Slovenian: • okužbe kosti.
English: In this case the kidney function must be frequently (twice per week) monitored.
Slovenian: V tem primeru je treba delovanje ledvic spremljati redno (dvakrat na teden);
English: During or after treatment - if one of the following conditions occurs:
Slovenian: Med zdravljenjem in po njem - če se pojavi kateri koli od naslednjih znakov:
English: You should consult your doctor if you are pregnant or wish to become pregnant.
Slovenian: Povejte zdravniku, če ste noseči ali želite zanositi.
English: Species for which acquired resistance may be a problem Gram-positive aerobes
Slovenian: Vrste, pri katerih je pridobljena rezistenca lahko težava Grampozitivni aerobi:
English: • myastenia gravis (a particular type of muscle weakness).
Slovenian: • miastenija gravis (posebna vrsta mišične šibkosti).
English: If you are older than 65 years your doctor may prescribe you a dose based on your kidney function and severity of disease.
Slovenian: Če ste starejši od 65 let, vam lahko zdravnik predpiše odmerek na podlagi delovanja ledvic in stopnje bolezni.
English: Your doctor will check your renal function carefully.
Slovenian: Zdravnik bo pozorno pregledal vaše ledvice;
English: • certain lower respiratory tract infections including pneumonia
Slovenian: • nekatere okužbe spodnjih dihal, vključno s pljučnico;
English: In steady-state conditions the apparent distribution volume of ciprofloxacin is situated between 1,7 and 2,7 l/kg.
Slovenian: V pogojih ravnotežnega stanja je navidezni volumen porazdelitve ciprofloksacina med 1,7 in 2,7 l/kg.
English: With regard to the safety and use of ciprofloxacin in children, see also section 4.4
Slovenian: Za informacije o varnosti in uporabi ciprofloksacina pri otrocih, glejte tudi poglavje 4.4;
English: The frequency of side effects is classified into the following categories: Very common in more than 1 in 10 patients
Slovenian: Pogostnost neželenih učinkov je razvrščena na naslednji način: Zelo pogosti pri več kot 1 od 10 bolnikov
English: The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Slovenian: Prevalenca pridobljene rezistence se lahko pri določenih organizmih razlikuje glede na kraj in čas, lokalni podatki o rezistenci pa so zaželeni, zlasti pri zdravljenju hudih okužb.
English: For any information about this medicine, please contact the the Marketing Authorisation Holder.
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na imetnika dovoljenja za promet z zdravilom.
English: Chemical and physical in-use stability has been demonstrated immediately after dilution, after 24 hours at 2-8°C and after 24 hours at room temperature.
Slovenian: Dokazano je, da je raztopina kemijsko in fizikalno stabilna takoj po redčenju, 24 ur, če se hrani pri temperaturi 2-8 °C, in 24 ur, če se hrani pri sobni temperaturi.
English: In this case you should immediately consult your doctor.
Slovenian: V tem primeru se morate takoj posvetovati z zdravnikom.
English: The renal clearance constitutes 60%-70% of the total body clearance and is approximately 3 times higher than the creatinine clearance.
Slovenian: Ledvični očistek tvori 60-70 % skupnega očistka in je približno 3-krat večji od kreatininskega očistka.
English: If one of the above-mentioned situations is applicable to you, your doctor may decide to prescribe you another medicine or to adjust the dose of Ciprofloxacin Hikma or the other medicine.
Slovenian: Če kateri koli od zgoraj omenjenih pogojev velja za vas, vam bo morda zdravnik predpisal drugo zdravilo ali pa vam bo prilagodil odmerek zdravila Ciprofloxacin Hikma ali drugega zdravila.
English: Determination of serum concentrations, especially of theophylline, and dose adjustments may be necessary.
Slovenian: Morda bo nujno določanje serumskih koncentracij, zlasti teofilina, in prilagajanje odmerkov.
English: • severe and continuous diarrhoea during treatment, possibly with blood and mucus.
Slovenian: • huda in neprekinjena driska med zdravljenjem, po možnosti s krvjo in sluzjo.
English: Other specific situations such as osteomyelitis and paediatric patients are stated under Posology.
Slovenian: Drugi posebni primeri, kot so osteomielitis in pediatrični bolniki, so navedeni v tem poglavju.
English: In order to avoid treatment failure and emergence of resistance it is a prerequisite that patient's compliance and dosing be adequate.
Slovenian: Da bi se izognili neuspehu pri zdravljenju in pojavu odpornosti, je predpogoj za uspešno zdravljenje doslednost bolnika pri jemanju zdravil in ustrezno odmerjanje zdravila.
English: The duration of treatment depends upon the severity of infection, clinical response and bacteriological findings.
Slovenian: Trajanje zdravljenja je odvisno od stopnje okužbe, kliničnega odziva in rezultatov bakterioloških preizkusov.
English: Due to the higher plasma levels in the elderly it is advisable to administer a doses based on creatinine clearance and severity of disease.
Slovenian: Zaradi večjih koncentracij v plazmi pri starejših je priporočljivo določiti odmerke na podlagi kreatininskega očistka in stopnje bolezni.
English: Patients with pre-existent significant renal disorders should be carefully monitored to detect any deterioration in function.
Slovenian: Bolnike z obstoječimi hudimi okvarami ledvic je treba pozorno spremljati, da bi odkrili morebitno poslabšanje delovanja.
English: During the growth phase of bacteria, a partial rolling up and unfolding of chromosomes takes place.
Slovenian: V fazi rasti bakterije se pojavlja delno zavijanje in odvijanje kromosoma.
English: In the case of concomitant administration of these products, prothrombin time (PT) or other suitable coagulation tests should be monitored.
Slovenian: Pri sočasni uporabi teh zdravil je treba spremljati protrombinski čas (PČ) ali druge ustrezne teste koagulacije.
English: An overdose of 12 g has been reported to lead to mild symptoms of toxicity.
Slovenian: Poročali so, da preveliko odmerjanje z odmerkom 12 g povzroča blage simptome toksičnosti.
English: • allergic reactions after the first administration of this medicine.
Slovenian: • alergijske reakcije po prvem odmerku zdravila.
English: The ciprofloxacin concentration in the sputum consists of 50-70% of the serum concentration.
Slovenian: Koncentracija ciprofloksacina v sputumu je 50-70 % koncentracije v serumu.
English: Very rare: increment of amylase/lipase levels.
Slovenian: Zelo redki: zvišanje ravni amilaz/lipaz.
English: Prior to initiation of therapy, bacteriological sensitivity tests should be conducted.
Slovenian: Pred začetkom zdravljenja je treba opraviti bakteriološke preizkuse občutljivosti.
English: Therefore, the serum creatinine concentration must be checked regularly (twice per week) in these patients.
Slovenian: Pri teh bolnikih je zato treba koncentracijo kreatinina v serumu redno pregledovati (dvakrat na teden).
English: In this case you should immediately consult your doctor, since you may have a severe inflammation of the large intestine (pseudo membranous colitis).
Slovenian: V tem primeru se morate takoj posvetovati z zdravnikom, ker morda imate hudo vnetje debelega črevesa (psevdomembranski kolitis).
English: - The requested amendments to section 5.1 of the Summary of Product Characteristics including the breakpoints relevant to the indications are acceptable.
Slovenian: - sprejemljivosti vseh zahtevanih dopolnil poglavja 5.1 v Povzetku glavnih značilnosti zdravila, vključno s prelomnimi točkami, ki so pomembne za indikacije,
English: 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.
Slovenian: 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.
English: If such reactions occur, a physician must immediately be consulted.
Slovenian: Če se pojavijo take reakcije, se je treba takoj posvetovati z zdravnikom.
English: The blood level of this medicine can be increased or reduced.
Slovenian: Raven tega zdravila v krvi se lahko poveča ali zmanjša;
English: Therefore, the use of ciprofloxacin in children is generally not recommended, except for cystic fibrosis patients (see section 4.1).
Slovenian: Zato njegova uporaba pri otrocih na splošno ni priporočena, razen za zdravljenje bolnikov s cistično fibrozo (glejte poglavje 4.1).
English: In acute and extreme overdosage, reversible kidney damage is seen.
Slovenian: Pri akutnem in ekstremnem prevelikem odmerjanju so opazili reverzibilne poškodbe ledvic.
English: In patients with severely impaired renal function (creatinine clearance <30 ml/min) the elimination half-life may be prolonged by a factor of 2.
Slovenian: Pri bolnikih s hudo okvaro delovanja ledvic (kreatininski očistek < 30 ml/min) je lahko razpolovni čas izločanja podaljšan za faktor 2.
English: In case of mixed infections with anaerobes ciprofloxacin must be combined with other antibiotics effective against anaerobes.
Slovenian: Pri mešanih okužbah z anaerobnimi bakterijami je treba ciprofloksacin kombinirati z drugimi antibiotiki, učinkovitimi proti anaerobom.
English: • methotrexate (used to treat cancer or suppress the immune system).
Slovenian: • metotreksat (uporablja se za zdravljenje raka ali zaviranje imunskega sistema).
English: These may be manifested as local skin reactions, which rapidly disappear after the infusion has been completed.
Slovenian: Lahko se pojavijo v obliki kožnih reakcij, ki po koncu infundiranja hitro izginejo.
English: Compatibility with these solutions has been proven in ciprofloxacin concentrations of 1 mg/ml.
Slovenian: Združljivost s temi raztopinami so dokazali pri koncentraciji ciprofloksacina 1 mg/ml.
English: For more details regarding some of the side effects please see Section 2, ‘Take special care with Ciprofloxacin Hikma- During or after treatment'.
Slovenian: Za dodatne podrobnosti o nekaterih neželenih učinkih glejte poglavje 2, "Bodite posebno pozorni pri uporabi zdravila Ciprofloxacin Hikma - med zdravljenjem ali po njem".
English: • feeling depressed or confused after administration of Ciprofloxacin Hikma.
Slovenian: • občutek depresije ali zmedenosti po uporabi zdravila Ciprofloxacin Hikma.
English: Ciprofloxacin is mainly excreted unchanged.
Slovenian: Ciprofloksacin se večinoma izloča nespremenjen.
English: • In children aged below 5 years
Slovenian: • pri otrocih, mlajših od 5 let;
English: Rare: transpiration.
Slovenian: Redki: transpiracija.
English: If necessary, the oral anticoagulant dose should be adjusted as appropriate.
Slovenian: Odmerek antikoagulansa je treba po potrebi prilagoditi.
English: In this case consult your doctor as your urine needs to be tested.
Slovenian: V tem primeru se posvetujte z zdravnikom, ker bo moral opraviti pregled urina.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CIPROFLOXACIN HIKMA AND ASSOCIATED NAMES (see Annex I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA CIPROFLOXACIN HIKMA IN Z NJIM POVEZANIH IMEN (glejte Dodatek I)
English: • cyclosporine (used to prevent rejection reactions after organ transplantations).
Slovenian: • ciklosporin (uporablja se za preprečevanje reakcij po presaditvi organa).
English: At haemodialysis or peritoneal dialysis only a modest amount of ciprofloxacin (less than 10%) is eliminated.
Slovenian: S hemodializo ali peritonealno dializo se izloči le majhna količina ciprofloksacina (manj kot 10 %).
English: This has to be taken into consideration for patients on a controlled sodium diet.
Slovenian: To je treba upoštevati pri bolnikih na dieti z malo natrija.
English: In case of very serious, life-threatening or recurrent infections the dosage can be increased to 400 mg three times daily.
Slovenian: Pri zelo resnih, smrtno nevarnih okužbah ali rekurentnih okužbah, se lahko odmerek poveča na 400 mg trikrat na dan.
English: The renal clearance occurs through glomerular filtration and active tubular secretion.
Slovenian: Ledvični očistek poteka z glomerularno filtracijo in aktivno tubulno sekrecijo.
English: Fax: +351 219 615 102 e-mail: geral@hikma.pt
Slovenian: Faks: +351 219 615 102 e-pošta: geral@hikma.pt
English: If you suffer from dizziness, do not drive or operate machines, which require your full concentration.
Slovenian: Če ste omotični ne vozite avtomobila ali upravljate strojev, pri katerih morate biti popolnoma zbrani.
English: • crystalluria (presence of crystals in the urine with discomfort when passing urine).
Slovenian: • kristalurija (prisotnost kristalov v urinu in neprijeten občutek med uriniranjem).
English: This medicinal product is authorised in the Member States of EEA under the following names: Austria - Ciprofloxacin Hikma 200mg/100ml Infusionslösung Germany - Ciprofloxacin Hikma 200mg/100ml Lösung zur Intravenösen Anwendung Ireland - Ciprofloxacin Hikma 200mg/100ml Solution for Infusion Italy - Ciprofloxacin Hikma 200mg/100ml Soluzione per Infusione Endovenosa United Kingdom - Ciprofloxacin Hikma 200mg/100ml Solution for Infusion The Netherlands - Ciprofloxacine Hikma 200mg/100ml Oplossing voor Intraveneuze Infusie
Slovenian: Zdravilo je pridobilo dovoljenje za promet v državah članicah EGP pod naslednjimi imeni: Avstrija - Ciprofloxacin Hikma 200 mg/100 ml Infusionslösung Nemčija - Ciprofloxacin Hikma 200 mg/100 ml Lösung zur Intravenösen Anwendung Irska - Ciprofloxacin Hikma 200 mg/100 ml Solution for Infusion Italija - Ciprofloxacin Hikma 200 mg/100 ml Soluzione per Infusione Endovenosa Velika Britanija - Ciprofloxacin Hikma 200 mg/100 ml Solution for Infusion Nizozemska - Ciprofloxacine Hikma 200 mg/100 ml Oplossing voor Intraveneuze Infusie
English: They may take the form of local skin reactions, such as reddening of the skin, irritation or pain, which usually disappear quickly after termination of the infusion.
Slovenian: Lahko v obliki lokalnih kožnih reakcij, kot je rdečica kože, draženje ali bolečina, ki ponavadi preneha kmalu po koncu infundiranja.
English: 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
Slovenian: 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).
English: Any unused solution and the vial should be adequately disposed of in accordance with local requirements.
Slovenian: Neuporabljeno raztopino in viale zavrzite v skladu z lokalnimi predpisi.
English: • If nevertheless complaints occur, such as fever, rash, itching, small red spots on the skin, you should consult your doctor since the treatment may need to be discontinued.
Slovenian: • če se kljub temu pojavijo težave, kot so zvišana telesna temperatura, izpuščaj, srbenje ali majhne rdeče pike na koži, se morate takoj posvetovati z zdravnikom, ker bo morda treba prekiniti zdravljenje;
English: The treatment of acute pulmonary infections in children and adolescents with cystic fibrosis will take 10-14 days.
Slovenian: Zdravljenje akutne okužbe pljuč pri otrocih in mladostnikih s cistično fibrozo traja 10-14 dni.
English: An extensive destruction of red blood cells (haemolytic reactions) may occur, causing anaemia.
Slovenian: Lahko pride do obsežnega uničenja eritrocitov (hemolitične reakcije), ki povzroči anemijo.
English: The CHMP has recommended that the indication should be complicated urinary tract infections with a recommended dose of 200 - 400 mg twice daily.
Slovenian: je CHMP je priporočil, naj se indikacija nanaša na zapletene okužbe sečil s priporočenim odmerkom 200 do 400 mg dvakrat dnevno.
English: Ciprofloxacin Hikma has minor or moderate influence on the ability to drive and use machines.
Slovenian: Ciprofloxacin Hikma ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
English: It is also effective against Gram-positive organisms, such as staphylococci and streptococci.
Slovenian: Učinkovit je tudi proti grampozitivnim organizmom, kot so stafilokoki in streptokoki.
English: • If exposure to sunlight or UV light is inevitable you should use sun cream to protect yourself.
Slovenian: • če se sončni svetlobi ali UV-svetlobi ne morete izogniti, morate uporabiti kremo za zaščito proti soncu;
English: The peak plasma concentration is reached 0.5 - 2 hours after taking 50 - 1000 mg p.o. and varies from 0.3 - 5.9 mg/l.
Slovenian: Največja koncentracija v plazmi je dosežena v 0,5-2 urah po peroralnem odmerku 50-1000 mg, spreminja pa se od 0,3 do 5,9 mg/l.
English: Ciprofloxacin and other fluoroquinolones may cause photosensibility.
Slovenian: Ciprofloksacin in drugi fluorokinoloni lahko povzročijo fotosenzitivnost.
English: Ciprofloxacin inhibits CYP1A2 and thus may cause increased serum concentration of concomitantly administered substances metabolised by this enzyme (e.g. theophylline, clozapine, tacrine, ropinirol, tizanidine).
Slovenian: Ciprofloksacin zavira encim CYP1A2 in zato lahko poveča serumske koncentracije sočasno uporabljenih snovi, ki jih ta encim presnavlja (npr. teofilin, klozapin, takrin, ropinirol, tizanidin).
English: As a result of its mechanism of action, ciprofloxacin does not show cross-resistance with other important, chemically different groups of substances such as beta-lactam antibiotics, aminoglycosides, tetracyclines, macrolides and polypeptides, sulphonamides, trimethoprim and nitrofurantoine.
Slovenian: Zaradi svojega načina delovanja ciprofloksacin nima navzkrižne rezistence z drugimi pomembnimi, kemijsko različnimi skupinami zdravil, kot so betalaktamski antibiotiki, aminoglikozidi, tetraciklini, makrolidi in polipetidi, sulfonamidi, trimetoprim in nitrofurantoin.
English: The elimination half-life of ciprofloxacin after single or multiple oral dosage is between 3.4 and 6.9 hours.
Slovenian: Razpolovni čas izločanja ciprofloksacina po enkratnem ali večkratnem peroralnem odmerku je med 3,4 in 6,9 ur.
English: Pharmacotherapeutic group: Antibacterial quinolones, ATC code: J01MA02
Slovenian: Farmakoterapevtska skupina: kinolonske protimikrobne učinkovine, oznaka ATC: J01MA02
English: You should avoid long exposure to strong sunlight, sunlamps or other sources of UV radiation.
Slovenian: Morate se izogibati dolgem izpostavljanju soncu, solariju ali drugim virom UV-sevanja;
English: Generally, acute and chronic infections (e.g. osteomyelitis and prostatitis, etc), where the causative organism is known to be sensitive to ciprofloxacin, should be treated for at least three days after the signs and symptoms of the infection have disappeared.
Slovenian: Na splošno velja, da je treba akutne in kronične okužbe (npr. osteomielitis in prostatitis), pri katerih je znano, da je povzročitelj občutljiv na ciprofloksacin, zdraviti vsaj še tri dni po izginotju znakov in simptomov okužbe.
English: The bioavailability is lower if antacids that contain aluminium and/or magnesium hydroxide, and calcium and iron salts are used concomitantly.
Slovenian: Biološka uporabnost je manjša ob sočasni uporabi antacidov, ki vsebujejo aluminijev in/ali magnezijev hidroksid, ter kalcijevih ali železovih soli.
English: The phototoxic, photomutagenic and photocarcinogenic potential of ciprofloxacin is comparable to that of other gyrase inhibitors.
Slovenian: Fototoksični, fotomutageni in fotokarcinogeni potencial ciprofloksacina je primerljiv z drugimi zaviralci giraze.
English: Fax: +351 219 615 102 geral@hikma.pt
Slovenian: Faks: +351 219 615 102 geral@hikma.pt
English: When used simultaneously, ciprofloxacin may, in certain cases, increase the effect of glibenclamide (hypoglycaemia).
Slovenian: Pri sočasni uporabi lahko ciprofloksacin v nekaterih primerih poveča učinek glibenklamida (hipoglikemija).
English: Animal trials have shown that the concurrent administration of very high doses of fluoroquinolones and certain NSAIDs (but not acetylsalicylic acid) may provoke convulsions.
Slovenian: Preskušanja na živalih so pokazala, da lahko sočasna uporaba zelo velikih odmerkov fluorokinolonov in nekaterih nesteroidnih protivnetnih zdravil (vendar ne acetilsalicilne kisline) izzove konvulzije.
English: • If you experience these symptoms you should immediately consult your doctor and rest the respective leg.
Slovenian: • če imate te simptome, se morate takoj posvetovati z zdravnikom, prizadete noge pa ne smete obremenjevati;
English: 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).
Slovenian: 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).
English: • complicated skin and soft tissue infections
Slovenian: • zapletene okužbe kože in mehkih tkiv;
English: The dosage in children with impaired renal and/or hepatic function has not been investigated.
Slovenian: Odmerjanja pri otrocih z okvarjenim delovanjem ledvic in/ali jeter niso raziskovali.
English: • If Ciprofloxacin Hikma and tizanidine (used to treat muscle spasms) are given at the same time.
Slovenian: • če zdravilo Ciprofloxacin Hikma in tizanidin (uporablja se za zdravljenje mišičnih krčev) uporabljate sočasno.
English: It is contained in a type I, clear, colourless glass vial containing 100 ml solution.
Slovenian: Pakirano je v vialo iz prozornega, brezbarvnega stekla vrste I, ki vsebuje 100 ml raztopine.
English: Management of patients with complicated urinary tract infections (UTIs) currently includes empirical treatment with a broad-spectrum antibiotic (fluoroquinolone), and potential subsequent treatment for 1014 days based on urine culture and sensitivity.
Slovenian: 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.
English: The ciprofloxacin level in the blood can be increased.
Slovenian: Lahko se poveča raven ciprofloksacina v krvi;
English: In patients on haemodialysis or CAPD, the maximum daily intravenous dose is also 400 mg. On the dialysis days, the dose is given after the haemodialysis session.
Slovenian: Pri bolnikih na hemodializi ali KAPD je dnevni intravenski odmerek prav tako 400 mg. Na dneve, ko je bolnik na dializi, se odmerek daje po hemodializi.
English: The bioavailability of ciprofloxacin after oral administration is between 70 % and 85 %.
Slovenian: Biološka uporabnost ciprofloksacina po peroralni uporabi je med 70 in 85 %.