FrancophonIA/ELRC3.0 huggingface dataset:
English: Plasma clearance of total ceftriaxone (bound and unbound) is 10 - 22 ml/min.
Slovenian: Očistek skupnega ceftriaksona v plazmi (vezanega in nevezanega) je 10-22 ml/min.
English: The dose depends on the severity, susceptibility, site and type of infection and on the age and hepato-renal function of the patient.
Slovenian: Odmerek je odvisen od resnosti, dovzetnosti, mesta in vrste okužbe ter od bolnikove starosti in njegovega delovanja jeter in ledvic.
English: In an in-vitro study antagonistic effects have been observed with the combination of chloramphenicol and ceftriaxone.
Slovenian: V študiji in vitro so opazili antagonistične učinke pri kombinaciji kloramfenikola in ceftriaksona.
English: The dose will depend on the severity and type of infection; whether you are on any other antibiotics; your weight and age; how well your kidneys and liver are working.
Slovenian: Odmerek je odvisen od resnosti in vrste okužbe, od uporabe drugih antibiotikov, od vaše telesne mase in starosti ter od tega, kako dobro delujejo vaše ledvice in jetra.
English: Non-linearity is due to saturation of plasma protein binding and is therefore observed for total plasma ceftriaxone but not for free (unbound) ceftriaxone.
Slovenian: Nelinearnost je posledica zasičenja vezave na beljakovine v plazmi, zato je prisotna pri skupnem ceftriaksonu v plazmi, ne pa tudi pri prostem (nevezanem) ceftriaksonu.
English: Reports of diarrhoea following the use of ceftriaxone may be associated with Clostridium difficile.
Slovenian: Poročila o driski po uporabi ceftriaksona so lahko povezana s Clostridium difficile.
English: Ceftriaxone is excreted into human milk in low concentrations but at therapeutic doses of ceftriaxone no effects on the breastfed infants are anticipated.
Slovenian: Ceftriakson se v nizkih koncentracijah izloča v materino mleko, vendar pa se učinki ceftriaksona na dojene otroke v terapevtskih odmerkih ne pričakujejo.
English: In the available scientific data, there are no reports of confirmed intravascular precipitations in patients, other than neonates, treated with ceftriaxone and calcium-containing solutions or any other calcium-containing products.
Slovenian: Med razpoložljivimi znanstvenimi podatki ni poročil o potrjenih intravaskularnih oborinah pri drugih bolnikih, razen pri novorojencih, zdravljenih s ceftriaksonom in raztopinami, ki vsebujejo kalcij, ali drugimi zdravili, ki vsebujejo kalcij.
English: Contraindications to lidocaine, warnings and other relevant information as detailed in the Summary of Product Characteristics of lidocaine must be considered before use (see section 4.3).
Slovenian: Pred uporabo je treba upoštevati kontraindikacije na lidokain, opozorila in druge pomembne informacije, navedene v povzetku glavnih značilnosti zdravila za lidokain (glejte poglavje 4.3).
English: • reduced affinity of penicillin-binding proteins for ceftriaxone.
Slovenian: • zmanjšana afiniteta penicilin-vezavnih beljakovin za ceftriakson,
English: Rocephin can also lead to false-positive test results for galactosaemia (see section 4.8).
Slovenian: Zdravilo Rocephin lahko povzroči tudi lažno pozitivne rezultate testa za galaktozemijo (glejte poglavje 4.8).
English: In patients requiring continuous infusion with calcium-containing total parenteral nutrition (TPN) solutions, healthcare professionals may wish to consider the use of alternative antibacterial treatments which do not carry a similar risk of precipitation.
Slovenian: Pri bolnikih, pri katerih je potrebna stalna infuzija z raztopinami s popolno parenteralno prehrano (TPN, total parenteral nutrition), ki vsebujejo kalcij, naj zdravstveno osebje razmisli o uporabi alternativnih oblik protimikrobnega zdravljenja, pri katerih podobno tveganje obarjanja ne obstaja.
English: Neonates 0-14 days
Slovenian: Novorojenci 0-14 dni
English: Before beginning treatment, it should be established whether the patient has a history of severe hypersensitivity reactions to ceftriaxone, to other cephalosporins or to any other type of beta-lactam agent.
Slovenian: Pred začetkom zdravljenja je treba ugotoviti, ali ima bolnik anamnezo hudih preobčutljivostnih reakcij na ceftriakson, druge cefalosporine ali druge vrste betalaktamskih učinkovin.
English: Contraindications to lidocaine must be excluded before intramuscular injection of ceftriaxone when lidocaine solution is used as a solvent (see section 4.4).
Slovenian: Kontraindikacije na lidokain je treba pred intramuskularnim injiciranjem ceftriaksona izključiti, če se kot vehikel uporablja raztopina lidokain (glejte poglavje 4.4).
English: The half-life of ceftriaxone is prolonged in neonates.
Slovenian: Razpolovni čas ceftriaksona se pri novorojencih podaljša.
English: Hypersensitivity to ceftriaxone, to any other cephalosporin or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na ceftriakson, kateri drugi cefalosporin ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: • to treat specific sexually transmitted infections (gonorrhoea and syphilis).
Slovenian: Daje se lahko: • za zdravljenje specifičnih spolno prenosljivih okužb (gonoreja in sifilis),
English: Long term treatment
Slovenian: Dolgotrajno zdravljenje
English: Interference with Coombs tests may occur, as Rocephin may lead to false-positive test results.
Slovenian: Pojavijo se lahko motnje pri Coombsovem testu, saj lahko zdravilo Rocephin povzroči lažno pozitivne rezultate testa.
English: If the use of ceftriaxone is considered necessary in patients requiring continuous nutrition, TPN solutions and ceftriaxone can be administered simultaneously, albeit via different infusion lines at different sites.
Slovenian: Če se meni, da je uporaba ceftriaksona potrebna pri bolnikih, ki potrebujejo stalno prehranjevanje, se lahko raztopine TPN in ceftriakson dajeta sočasno, vendar skozi različne linije za infundiranje na različnih mestih.
English: b. Susceptibility inferred from penicillin susceptibility.
Slovenian: b. Občutljivost, o kateri se sklepa na podlagi občutljivosti na penicilin.
English: In symptomatic cases, conservative nonsurgical management is recommended and discontinuation of ceftriaxone treatment should be considered by the physician based on specific benefit risk assessment (see section 4.8).
Slovenian: V simptomatskih primerih se priporoča konservativno nekirurško obvladovanje, zdravnik pa mora razmisliti o prekinitvi zdravljenja s ceftriaksonom na podlagi individualne ocene koristi in tveganj (glejte poglavje 4.8).
English: In patients with both severe renal and hepatic dysfunction, close clinical monitoring for safety and efficacy is advised.
Slovenian: Pri bolnikih s hudo okvaro delovanja ledvic in jeter se priporoča skrbno spremljanje varnosti in učinkovitosti.
English: Rocephin is indicated for the treatment of the following infections in adults and children including term neonates (from birth):
Slovenian: Zdravilo Rocephin je indicirano za zdravljenje spodaj navedenih okužb pri odraslih in otrocih, vključno z donošenimi novorojenci (od rojstva naprej):
English: Protein binding
Slovenian: Vezava na beljakovine
English: After intravenous infusion of ceftriaxone 500 mg, 1 g and 2 g, the plasma ceftriaxone levels are approximately 80, 150 and 250 mg/l respectively.
Slovenian: Po intravenskem infundiranju ceftriaksona 500 mg, 1 g in 2 g so bile ravni ceftriaksona v plazmi približno 80, 150 oz. 250 mg/l.
English: Ceftriaxone crosses the placental barrier and is excreted in the breast milk at low concentrations (see section 4.6).
Slovenian: Ceftriakson prehaja skozi posteljico in se v nizkih koncentracijah izloča v materino mleko (glejte poglavje 4.6).
English: Limited data suggest that in cases where the child is severely ill or initial therapy has failed, Rocephin may be effective when given as an intramuscular dose of 50 mg/kg daily for 3 days.
Slovenian: Omejeni podatki kažejo, da je morda pri hudo bolnih otrocih ali pri neuspeli začetni terapiji zdravilo Rocephin učinkovito, kadar se ga daje 3 dni v obliki intramuskularnega odmerka 50 mg/kg na dan.
English: However, in patients older than 28 days of age ceftriaxone and calcium-containing solutions may be administered sequentially one after another if infusion lines at different sites are used or if the infusion lines are replaced or thoroughly flushed between infusions with physiological salt-solution to avoid precipitation.
Slovenian: Vendar pa se pri bolnikih, starejših od 28 dni, ceftriakson in raztopine, ki vsebujejo kalcij, lahko dajejo zaporedoma ena za drugo, če se uporabijo različne linije za infundiranje na različnih mestih infundiranja, ali če se linije za infundiranje med infuzijama zamenjajo ali dobro izplaknejo s fiziološko raztopino, da ne pride do obarjanja.
English: There have been no reports of an interaction between ceftriaxone and oral calcium-containing products or interaction between intramuscular ceftriaxone and calcium-containing products (intravenous or oral).
Slovenian: Ni poročil o medsebojnem delovanju med ceftriaksonom in peroralnimi zdravili, ki vsebujejo kalcij, ali o medsebojnem delovanju med intramuskularnim ceftriaksonom in zdravili, ki vsebujejo kalcij (intravenskimi ali peroralnimi).
English: Treatment frequency
Slovenian: Pogostnost zdravljenja
English: • Reduction in number of red blood cells (anaemia).
Slovenian: • zmanjšanje števila rdečih krvnih celic (anemija)
English: Ceftriaxone is contraindicated in neonates (≤ 28 days) if they require (or are expected to require) treatment with calcium-containing intravenous solutions, including continuous calcium-containing infusions such as parenteral nutrition, because of the risk of precipitation of ceftriaxone-calcium (see section 4.3).
Slovenian: Ceftriakson je kontraindiciran pri novorojencih (≤ 28 dni), če jih je treba (ali se pričakuje, da jih bo treba) zdraviti z intravenskimi raztopinami, ki vsebujejo kalcij, vključno s stalnimi infuzijami, ki vsebujejo kalcij, kot je parenteralna prehrana, zaradi tveganja obarjanja ceftriakson-kalcija (glejte poglavje 4.3).
English: • 20 - 50 mg Rocephin for each kg of the child's body weight once a day depending on the severity and type of infection.
Slovenian: • 20-50 mg zdravila Rocephin za vsak kg telesne mase otroka enkrat na dan, odvisno od resnosti in vrste okužbe.
English: your doctor will give you a higher dose (up to 4 g once a day).
Slovenian: Če imate resno okužbo, vam bo zdravnik dal večji odmerek (do 4 g enkrat na dan).
English: • Abnormal kidney function test (blood creatinine increased).
Slovenian: • nenormalni rezultati testa delovanja ledvic (zvišan kreatinin v krvi)
English: Rocephin may be used:
Slovenian: Zdravilo Rocephin lahko uporabljamo:
English: There is conflicting evidence regarding a potential increase in renal toxicity of aminoglycosides when used with cephalosporins.
Slovenian: Dokazi o možnemu povečanju ledvične toksičnosti aminoglikozidov pri uporabi s cefalosporini so si nasprotujoči.
English: In overdose, the symptoms of nausea, vomiting and diarrhoea can occur.
Slovenian: Pri prevelikem odmerjanju se lahko pojavijo simptomi navzee, bruhanja in driske.
English: • 50-80 mg Rocephin for each kg of the child's body weight once a day depending on the severity and type of infection.
Slovenian: • 50-80 mg zdravila Rocephin za vsak kg telesne mase otroka enkrat na dan, odvisno od resnosti in vrste okužbe.
English: METHOD OF ADMINISTRATION Do not mix with calcium-containing solutions.
Slovenian: POSTOPEK UPORABE Ne mešajte z raztopinami, ki vsebujejo kalcij.
English: The recommended monitoring of aminoglycoside levels (and renal function) in clinical practice should be closely adhered to in such cases.
Slovenian: V klinični praksi je treba v teh primerih natančno upoštevati priporočeno spremljanje ravni aminoglikozida (in delovanja ledvic).
English: However, a risk of diarrhoea and fungal infection of the mucous membranes cannot be excluded.
Slovenian: Vendar pa tveganja za drisko in glivično okužbo sluznic ni mogoče izključiti.
English: There are limited amounts of data from the use of ceftriaxone in pregnant women.
Slovenian: Podatki o uporabi ceftriaksona pri nosečnicah so omejeni.
English: Ceftriaxone solutions containing lidocaine should never be administered intravenously.
Slovenian: Raztopin ceftriaksona, ki vsebujejo lidokain, se ne sme nikoli dajati intravensko.
English: • Abnormalities with your white blood cells (such as a decrease of leucocytes and an increase of eosinophils) and platelets (decrease of thrombocytes).
Slovenian: • nenormalno število belih krvnih celic (kot je zmanjšanje levkocitov in povečanje eozinofilcev)
English: The generally recommended doses are 500 mg-1 g once daily increased to 2 g once daily for neurosyphilis for 10-14 days.
Slovenian: Na splošno priporočeni odmerki so 500 mg-1 g enkrat na dan, ki se povečajo na 2 g enkrat na dan za nevrosifilis za 10-14 dni.
English: It is recommended that the International Normalised Ratio (INR) is monitored frequently and the posology of the anti-vitamin K drug adjusted accordingly, both during and after treatment with ceftriaxone (see section 4.8).
Slovenian: Priporočljivo je, da INR (International Normalised Ratio) merimo pogosto in da odmerjanje zdravila, ki ima učinek nasproten vitaminu K ustrezno prilagodimo med zdravljenjem s ceftriaksonom in po njem (glejte poglavje 4.8).
English: Rocephin is contraindicated in premature and full-term neonates at risk of developing bilirubin encephalopathy (see section 4.3).
Slovenian: Zdravilo Rocephin je kontraindicirano pri prezgodaj rojenih in normalno donošenih novorojencih, pri katerih obstaja tveganje za razvoj bilirubinske encefalopatije (glejte poglavje 4.3).
English: If you accidentally receive more than your prescribed dose, contact your doctor or nearest hospital straight away.
Slovenian: Če dobite večji odmerek zdravila Rocephin, kot bi smeli Če boste nenamerno prejeli večji odmerek od predpisanega, se takoj posvetujte z zdravnikom ali pojdite v najbližjo bolnišnico.
English: Therefore, ceftriaxone and calcium-containing solutions must not be mixed or administered simultaneously (see sections 4.3, 4.4 and 6.2).
Slovenian: Zato se ceftriaksona in raztopin, ki vsebujejo kalcij, ne sme mešati ali dajati sočasno (glejte poglavja 4.3, 4.4 in 6.2).
English: For initial treatment of acute otitis media, a single intramuscular dose of Rocephin 50 mg/kg can be given.
Slovenian: Za začetno zdravljenje akutnega vnetja srednjega ušesa se lahko uporabi en intramuskularni odmerek zdravila Rocephin 50 mg/kg.
English: In case a lidocaine solution is used as a solvent, ceftriaxone solutions must only be used for intramuscular injection.
Slovenian: Če se kot vehikel uporabi raztopina lidokaina, se lahko raztopina ceftriaksona uporabi le v obliki intramuskularne injekcije.
English: The generally recommended dose is 50 mg/kg once daily for 10-14 days.
Slovenian: Na splošno priporočeni odmerek je 50 mg/kg enkrat na dan za 10-14 dni.
English: Neonates, infants and children 15 days to 12 years of age (< 50 kg) For children with bodyweight of 50 kg or more, the usual adult dosage should be given.
Slovenian: Novorojenci, dojenčki in otroci, stari od 15 dni do 12 let (< 50 kg) Za otroke s telesno maso 50 kg ali več je treba uporabiti običajni odmerek za odrasle.
English: • You have liver or kidney problems.
Slovenian: • če imate težave z jetri ali ledvicami;
English: Rocephin should be co-administered with other antibacterial agents whenever the possible range of causative bacteria would not fall within its spectrum (see section 4.4).
Slovenian: Zdravilo Rocephin je treba uporabiti skupaj z drugimi protimikrobnimi učinkovinami, kadar je možno, da bakterija povzročiteljica ne sodi v njegov spekter delovanja (glejte poglavje 4.4).
English: Data to determine the frequency of ceftriaxone ADRs was derived from clinical trials.
Slovenian: Podatki za določanje pogostnosti neželenih učinkov ceftriaksona so izpeljani iz kliničnih preskušanj.
English: The signs include severe pain in the stomach which spreads to your back.
Slovenian: • vnetje trebušne slinavke (pankreatitis); znaki vključujejo hudo bolečino v trebuhu, ki se širi v hrbet
English: If lidocaine is used as a solvent, the resulting solution should never be administered intravenously (see section 4.3).
Slovenian: Če se kot vehikel uporabi lidokain, se ne sme nastale raztopine nikoli dajati intravensko (glejte poglavje 4.3).
English: Others:
Slovenian: Drugo:
English: In patients undergoing dialysis no additional supplementary dosing is required following the dialysis.
Slovenian: Pri bolnikih na dializi dodatni odmerki po dializi niso potrebni.
English: Alternatively, infusion of TPN solution could be stopped for the period of ceftriaxone infusion and the infusion lines flushed between solutions (see sections 4.3, 4.8, 5.2 and 6.2).
Slovenian: Alternativno se lahko infundiranje raztopine TPN ustavi za čas infundiranja ceftriaksona, linije za infundiranje pa se med raztopinama izperejo (glejte poglavja 4.3, 4.8, 5.2 in 6.2).
English: Urine glucose determination during therapy with Rocephin should be done enzymatically (see section 4.8).
Slovenian: Določanje glukoze v urinu med zdravljenjem z zdravilom Rocephin mora biti encimsko (glejte poglavje 4.8).
English: a. Susceptibility inferred from cefoxitin susceptibility.
Slovenian: a. Občutljivost, o kateri se sklepa na podlagi občutljivosti na cefoksitin.
English: Gram-positive aerobes
Slovenian: Grampozitivni aerobi
English: Non-enzymatic methods for the glucose determination in urine may give false-positive results.
Slovenian: Rezultati neencimskih metod za določanje glukoze v urinu so lahko lažno pozitivni.
English: • Problems with your gallbladder, which may cause pain, feeling sick and being sick.
Slovenian: • težave z žolčnikom, ki lahko povzročajo bolečine, siljenje na bruhanje in bruhanje,
English: • to treat Lyme disease (caused by tick bites) in adults and children including newborn babies from
Slovenian: • za zdravljenje lymske bolezni (ki jo povzroča ugriz klopa) pri odraslih in otrocih, vključno z novorojenci, starejšimi od 15 dni,
English: The lidocaine solution should never be administered intravenously.
Slovenian: Raztopine lidokaina se ne sme nikoli dajati intravensko.
English: In patients of any age ceftriaxone must not be mixed or administered simultaneously with any calciumcontaining intravenous solutions, even via different infusion lines or at different infusion sites.
Slovenian: Pri bolnikih vseh starosti se ceftriakson ne sme mešati ali dajati sočasno z nobenimi intravenskimi raztopinami, ki vsebujejo kalcij, niti ne skozi različne linije za infundiranje ali mesta infundiranja.
English: For this reason, glucose level determination in urine during therapy with ceftriaxone should be carried out enzymatically.
Slovenian: Zaradi tega je treba za določanje ravni glukoze v urinu med zdravljenjem s ceftriaksonom uporabljati encimsko metodo.
English: • You have gall stones or kidney stones
Slovenian: • če imate žolčne ali ledvične kamne,
English: The area under the plasma concentration-time curve after intramuscular administration is equivalent to that after intravenous administration of an equivalent dose.
Slovenian: Površina pod krivuljo plazemske koncentracije v odvisnosti od časa po intramuskularnem dajanju je ekvivalentna tisti po intravenskem dajanju ekvivalentnega odmerka.
English: If a patient develops anaemia while on ceftriaxone, the diagnosis of a cephalosporin-associated anaemia should be considered and ceftriaxone discontinued until the aetiology is determined.
Slovenian: Če se pri bolniku med zdravljenjem s ceftriaksonom razvije anemija, je treba razmisliti o diagnozi anemije, povezane s cefalosporinom, in prenehati z uporabo ceftriaksona, dokler se ne ugotovi vzroka.
English: In symptomatic cases, sonography should be performed.
Slovenian: V simptomatskih primerih je treba opraviti ultrazvok.
English: A trigger or cofactor of Rocephin-related biliary precipitation cannot be ruled out.
Slovenian: Sprožitelja ali sodejavnika žolčnega obarjanja, povezanega z zdravilom Rocephin, ni mogoče izključiti.
English: • Pain or a burning feeling along the vein where Rocephin has been given.
Slovenian: • bolečine ali skelenje vzdolž žile, v katero prejmete zdravilo Rocephin bolečina na mestu dajanja injekcije
English: Indications for adults and children over 12 years of age (≥ 50 kg) that require specific dosage schedules:
Slovenian: Indikacije za odrasle in otroke, stare več kot 12 let (≥ 50 kg), za katere so potrebne posebne sheme odmerjanja:
English: An immune mediated haemolytic anaemia has been observed in patients receiving cephalosporin class antibacterials including Rocephin (see section 4.8).
Slovenian: Imunsko pogojeno hemolitično anemijo so opazili pri bolnikih, ki so prejemali protimikrobne učinkovine iz razreda cefalosporinov, vključno z zdravilom Rocephin (glejte poglavje 4.8).
English: the abdomen and abdominal wall (peritonitis).
Slovenian: • trebuha in trebušne stene (peritonitis),
English: For doses greater than 2 g intravenous administration should be used.
Slovenian: Odmerke, večje od 2 g, je treba dati intravensko.
English: The information in the Summary of Product Characteristics of lidocaine should be considered.
Slovenian: Upoštevajte informacije v povzetku glavnih značilnosti zdravila za lidokain.
English: Cases of renal lithiasis have been reported, which is reversible upon discontinuation of ceftriaxone (see section 4.8).
Slovenian: Poročali so o primerih ledvične litiaze, ki je reverzibilna ob prekinitvi uporabe ceftriaksona (glejte poglavje 4.8).
English: You must not be given Rocephin if:
Slovenian: Zdravila Rocephin ne smete dobiti:
English: Following intramuscular injection, mean peak plasma ceftriaxone levels are approximately half those observed after intravenous administration of an equivalent dose.
Slovenian: Po intramuskularnem injiciranju so bile povprečne najvišje ravni ceftriaksona v plazmi približno polovične glede na tiste, ki so jih opazili po intravenskem dajanju ekvivalentnega odmerka.
English: Germany, Hungary, Netherlands, Portugal: Rocephin Italy: Rocefin
Slovenian: Nemčija, Madžarska, Nizozemska, Portugalska: Rocephin Italija: Rocefin
English: How Rocephin is given
Slovenian: Kako se daje zdravilo Rocephin
English: How to store Rocephin [To be completed nationally]
Slovenian: Shranjevanje zdravila Rocephin [Izpolni država članica]
English: • Inflammation of the mucus lining of the mouth (stomatitis).
Slovenian: • vnetje sluznice v ustih (stomatitis)
English: When shadows are observed on sonograms, consideration should be given to the possibility of precipitates of calcium ceftriaxone.
Slovenian: Pri sencah na ultrazvoku je treba pomisliti na možnost obarjanja ceftriakson-kalcija.
English: £ All methicillin-resistant staphylococci are resistant to ceftriaxone.
Slovenian: £ Vsi na meticilin odporni stafilokoki so odporni na ceftriakson.
English: Discontinuation of therapy with ceftriaxone and the administration of specific treatment for Clostridium difficile should be considered.
Slovenian: Razmisliti je treba o prekinitvi zdravljenja s ceftriaksonom in uvedbi ustreznega zdravljenja proti Clostridium difficile.
English: Colitis/Overgrowth of non-susceptible microorganisms Antibacterial agent-associated colitis and pseudo-membranous colitis have been reported with nearly all antibacterial agents, including ceftriaxone, and may range in severity from mild to life-threatening.
Slovenian: Kolitis/prekomerna rast neobčutljivih mikroorganizmov Za skoraj vse protimikrobne učinkovine, vključno s ceftriaksonom, so poročali o kolitisu, povezanem s protimikrobnimi učinkovinami, in o psevdo-membranskem kolitisu, ki sta lahko blaga do življenjsko nevarna.
English: Ceftriaxone must not be mixed or administered simultaneously with calcium containing solutions including total parenteral nutrition (see section 4.2, 4.3, 4.4 and 4.8).
Slovenian: Ceftriaksona se ne sme mešati ali dajati sočasno z raztopinami, ki vsebujejo kalcij, vključno s popolno parenteralno prehrano (glejte poglavja 4.2, 4.3, 4.4 in 4.8).