FrancophonIA/ELRC3.0 huggingface dataset:
English: Cough, Sore throat, Rhinorrhea
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja kašalj, grlobolja, rinoreja
English: Eczema,
Croatian: FARMACEUTSKI
English: Oseltamivir carboxylate inhibits influenza A and B neuraminidases in vitro.
Croatian: Oseltamivir karboksilat inhibira neuraminidazu virusa gripe
English: • Pain in limb
Croatian: bol u abdomenu
English: This is called overgrowth.
Croatian: To se naziva pretjeranim rastom.
English: Gram-positive microorganisms:
Croatian: Gram-pozitivni mikroorganizmi:
English: Such reactions may be life-threatening.
Croatian: Te reakcije mogu biti opasne po život.
English: Date of first authorisation: 19/03/2015 Date of latest renewal: 13/01/2020
Croatian: Datum prvog odobrenja: 19/03/2015 Datum posljednje obnove odobrenja: 13/01/2020
English: 20060 Masate (MI) Italy
Croatian: 20060 Masate (MI) Italija
English: Other types of infections have not been studied.
Croatian: Druge vrste infekcija nisu ispitane.
English: S=Susceptible, R=Resistant
Croatian: S=osjetljiva, R=rezistentna
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego dobijete ovaj lijek jer sadrži Vama važne podatke.
English: Oritavancin is approximately 85% bound to human plasma proteins.
Croatian: Oritavancin je približno 85% vezan za proteine ljudske plazme.
English: This leaflet was last revised in: Other sources of information
Croatian: Ova uputa je zadnji puta revidirana u Ostali izvori informacija
English: The safety and efficacy of oritavancin in children and adolescents (<18 years) have not yet been established.
Croatian: Sigurnost i djelotvornost oritavancina u djece i adolescenata (<18 godina) nisu još ustanovljene.
English: Duration of interference
Croatian: Trajanje interferencije
English: Orbactiv should not to be used in children or adolescents below the age of 18.
Croatian: Orbactiv se ne smije primjenjivati u djece ili adolescenata mlađih od 18 godina.
English: Red man syndrome
Croatian: Sindrom crvenog čovjeka
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego dobijete ovaj lijek.
English: If you experience these types of reactions, your doctor may decide to stop or slow the infusion.
Croatian: Ako doživite takve reakcije, Vaš će liječnik možda odlučiti prekinuti ili usporiti infuziju.
English: Intravenous infusion over 3 hours (see section 6.6).
Croatian: Intravenska infuzija u trajanju od 3 sata (vidjeti dio 6.6).
English: It is for use in adults only.
Croatian: Namijenjen je primjeni samo u odraslih osoba.
English: Your doctor will decide how to treat you, including stopping the treatment and monitoring for signs of ill effects.
Croatian: Vaš liječnik će odlučiti kako Vas liječiti, uključujući prekid liječenja i praćenje radi uočavanja znakova štetnih učinaka.
English: Other medicines and Orbactiv
Croatian: Drugi lijekovi i Orbactiv
English: International normalized ratio (INR)
Croatian: Međunarodni normalizirani omjer (INR)
English: • Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus)
Croatian: • Streptococcus anginosus skupina (uključuje S. anginosus, S. intermedius i S. constellatus)
English: Tell your doctor or nurse immediately if you experience a reaction to the infusion including any of the following symptoms:
Croatian: Odmah obavijestite svog liječnika ili medicinsku sestru ako imate reakciju na infuziju koja obuhvaća bilo koji od sljedećih simptoma:
English: After being given Orbactiv, you may get a new infection at another site on your skin.
Croatian: Nakon što dobijete Orbactiv, možda dobijete novu infekciju na drugom mjestu na koži.
English: You should not be given this medicine during pregancy unless the benefit is considered to be greater than the risk to the baby.
Croatian: Ovaj lijek ne smijete primiti tijekom trudnoće osim ako se smatra da je korist veća od rizika za dijete.
English: In such a circumstance, the use of supportive measures together with the administration of specific treatment for Clostridioides difficile should be considered.
Croatian: U takvoj okolnosti treba razmotriti primjenu standardnih potpornih mjera zajedno s primjenom specifičnog liječenja za Clostridioides difficile.
English: Contents of the pack and other information What Orbactiv contains
Croatian: Sadržaj pakiranja i druge informacije Što Orbactiv sadrži
English: These reactions were associated with mortality at lower dosages in male than in female rats in single dose studies; however, the same gender-related differences were not observed in other species.
Croatian: Te su reakcije bile povezane sa smrtnosti pri nižim dozama u mužjaka nego u ženki štakora u ispitivanjima s jednokratnom dozom; međutim, ista razlika povezana sa spolom nije uočena u drugim vrstama.
English: Talk to your doctor or nurse before receiving Orbactiv if you:
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije nego primite Orbactiv:
English: • Swelling around throat or under the skin that develops over a short period of time;
Croatian: • Oticanje oko grla ili ispod kože koje se razvija u kratkom roku;
English: What Orbactiv is and what it is used for 2.
Croatian: Što je Orbactiv i za što se koristi 2.
English: • Infection getting worse or new infection at another site on your skin;
Croatian: • Pogoršanje infekcije ili nova infekcija na drugom mjestu na koži;
English: What Orbactiv looks like and contents of the pack
Croatian: Kako Orbactiv izgleda i sadržaj pakiranja
English: If reactions do occur, stopping or slowing the infusion may result in cessation of these symptoms (see section 4.8).
Croatian: Ako se pojavi reakcija, zaustavljanje ili usporavanje infuzije može dovesti do prestanka tih simptoma (vidjeti dio 4.8).
English: While antibiotics, including Orbactiv, fight certain bacteria, they may not be active against other bacteria or fungi, which may, therefore, continue to grow.
Croatian: Premda se antibiotici, uključujući Orbactiv, koriste protiv određenih bakterija, oni možda neće biti aktivni protiv drugih vrsta bakterija ili gljivica, koje stoga mogu nastaviti rasti.
English: • Fewer red blood cells or less haemoglobin than normal;
Croatian: • Manji broj crvenih krvnih stanica ili manje hemoglobina nego što je normalno;
English: • Decrease in blood pressure (which could make you feel faint or dizzy).
Croatian: • Sniženje krvnog tlaka (zbog kojeg možete osjetiti nesvjesticu ili omaglicu).
English: What Orbactiv is and what it is used for
Croatian: Što je Orbactiv i za što se koristi
English: If you are going to be given a blood thinner called unfractionated heparin, then tell your doctor if you have received Orbactiv within the last 5 days (120 hours).
Croatian: Ako ćete dobiti lijek za razrjeđivanje krvi koji se naziva nefrakcionirani heparin, recite svom liječniku ako ste primili Orbactiv unutar zadnjih 5 dana (120 sati).
English: • PT and INR for up to 12 hours,
Croatian: • PV i INR tijekom 12 sati
English: • Swollen, red area of skin or underneath skin that feels hot and tender;
Croatian: • Otečeno, crveno područje na koži ili ispod kože koje je vruće i osjetljivo;
English: Studies in pregnant rats and rabbits do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Croatian: Ispitivanja na skotnim štakorima i kunićima ne upućuju na izravne ili neizravne štetne učinke s obzirom na trudnoću, embrionalni/fetalni razvoj, porod ili postnatalni razvoj.
English: • More enzymes produced by your liver (as shown in blood tests);
Croatian: • Više enzima koje proizvodi jetra (što je vidljivo iz krvnih pretraga);
English: The most common reported reasons for discontinuation were cellulitis (0.4%) and osteomyelitis (0.3%).
Croatian: Najčešće prijavljivani razlozi za prekid liječenja bili su celulitis (0,4%) i osteomijelitis (0,3%).
English: The most commonly reported serious adverse reaction was cellulitis (1.1%).
Croatian: Najčešće prijavljivana ozbiljna nuspojava bila je celulitis (1,1%).
English: Prothrombin time (PT)
Croatian: Protrombinsko vrijeme (PT)
English: Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Oritavancin is given via intravenous infusion over 3 hours to minimise the risk of infusion related reactions.
Croatian: Oritavancin se daje intravenskom infuzijom u trajanju od 3 sata radi smanjenja rizika od reakcija povezanih s infuzijom.
English: No mass balance study has been conducted in humans.
Croatian: Nije provedeno ispitivanje masene bilance u ljudi.
English: The use of antibacterial medicinal products may increase the risk of overgrowth of non-susceptible micro-organisms.
Croatian: Primjena antibakterijskih lijekova može povećati rizik od pretjeranog rasta mikroorganizama koji nisu osjetljivi na ovaj lijek.
English: Effects of age, weight, gender and race
Croatian: Utjecaj dobi, tjelesne težine, spola i rase
English: Beta-haemolytic streptococci Groups A, B, C, G 0.25 Viridans group streptococci (S. anginosus group only)
Croatian: Beta-hemolitički streptokoki skupine A, B, C, G 0,25 Skupina viridans streptokoka (samo skupina S. anginosus)
English: In addition, medicinal products formulated at a basic or neutral pH may be incompatible with oritavancin (see section 6.6).
Croatian: Osim toga, lijekovi formulirani u bazičnom ili neutralnom pH području mogu biti inkompatibilni s oritavancinom (vidjeti dio 6.6).
English: The population mean total clearance is estimated at 0.445 L/h (27.2 % CV).
Croatian: Procjenjuje se da je srednji ukupni klirens populacije 0,445 l/h (27,2 %CV).
English: • Dilute Russell's Viper Venom Test (DRVVT) for up to 72 hours.
Croatian: • Dilute Russell's Viper Venom Test (DRVVT) tijekom 72 sata.
English: If you are given more Orbactiv than you should
Croatian: Ako dobijete više lijeka Orbactiv nego što ste trebali
English: Orbactiv is intended for intravenous (IV) administration, only after reconstitution and dilution.
Croatian: Orbactiv je namijenjen za intravensku (i.v.) primjenu, tek nakon rekonstitucije i razrjeđivanja.
English: - Orbactiv is available in cartons containing 3 vials.
Croatian: - Orbactiv je dostupan u kutijama koje sadrže 3 bočice.
English: Pharmacotherapeutic group: Antibacterials for systemic use, glycopeptide antibacterials, ATC code: J01XA05
Croatian: Farmakoterapijska skupina: antibakterijski lijekovi za sustavnu primjenu, glikopeptidni antibakterijski lijekovi, ATK oznaka: J01XA05
English: • Accumulation of pus underneath the skin.
Croatian: • Nakupljanje gnoja ispod kože.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from oritavancin therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Croatian: Mora se odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja oritavancinom uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: Therefore, other substances, additives or other medicinal products mixed in sodium chloride solution for intravenous use should not be added to oritavancin single-use vials or infused simultaneously through the same intravenous line or through a common intravenous port.
Croatian: Stoga se druge tvari, aditivi ili drugi lijekovi miješani u otopini natrijevog klorida za intravensku primjenu ne smiju dodavati u bočice oritavancina za jednokratnu uporabu niti primjenjivati istovremeno infuzijom kroz istu intravensku liniju ili kroz zajednički intravenski ulaz.
English: • Silica Clot Time (SCT) for up to 18 hours, and
Croatian: • vrijeme zgrušavanja silicijem (SVZ) tijekom 18 sati i
English: Orbactiv can only be used to treat infections caused by bacteria known as Gram positive bacteria.
Croatian: Orbactiv se smije koristiti samo za liječenje infekcija prouzročenih bakterijama koje se nazivaju gram pozitivne bakterije.
English: • have developed severe diarrhoea during or following antibiotic treatment in the past.
Croatian: • ako ste dobili teški proljev za vrijeme ili nakon liječenja antibiotikom u prošlosti,
English: Oritavancin is active against Gram positive bacteria only (see section 5.1).
Croatian: Oritavancin je aktivan samo protiv gram-pozitivnih bakterija (vidjeti dio 5.1).
English: Need for additional antibacterial agents
Croatian: Potreba za dodatnim antibakterijskim lijekovima
English: - The other ingredients are mannitol and phosphoric acid.
Croatian: - Drugi sastojci su manitol i fosfatna kiselina.
English: Based on population PK analysis, the population mean total volume of distribution is estimated to be approximately 87.6 L, indicating oritavancin is extensively distributed into the tissues.
Croatian: Na temelju populacijske farmakokinetičke analize, procjenjuje se da je srednja vrijednost ukupnog volumena distribucije u populaciji približno 87,6 l, što pokazuje da se oritavancin opsežno distribuira u tkiva.
English: Sodium chloride solution should not be used for dilution as it is incompatible with oritavancin and may cause precipitation of the medicinal product.
Croatian: Otopina natrijevog klorida se ne smije koristiti za razrjeđivanje jer je inkompatibilna s oritavancinom i može prouzročiti precipitaciju lijeka.
English: Lifetime studies in animals have not been conducted to evaluate the carcinogenic potential of oritavancin.
Croatian: Nisu provedena cjeloživotna ispitivanja na životinjama s ciljem procjene kancerogenog potencijala oritavancina.
English: It is particularly important to tell your doctor if you are using medicines that prevent blood from clotting (oral anticoagulants, e.g.coumarin anticoagulants ).
Croatian: Osobito je važno da obavijestite svog liječnika ako primjenjujete lijekove koji sprječavaju zgrušavanje krvi (oralni antikoagulansi, npr. kumarinski antikoagulansi).
English: Oritavancin concentrations achieved in the blood after 1,200 mg doses may produce falsely elevated results from certain laboratory tests (see Table 1).
Croatian: Koncentracije oritavancina dostignute u krvi nakon doza od 1200 mg mogu proizvesti lažno povišene vrijednosti kod određenih laboratorijskih testova (vidjeti Tablicu 1).
English: From a microbiological point of view, the product should be used immediately.
Croatian: S mikrobiološkog stajališta, lijek je potrebno primijeniti odmah.
English: When administered intravenously at doses up to 30 mg/kg, oritavancin did not affect the fertility or reproductive performance of male and female rats.
Croatian: Kod intravenske primjene u dozama do 30 mg/kg, oritavancin nije utjecao na plodnost ili reproduktivnu sposobnost mužjaka i ženki štakora.
English: • Rapid or weak pulse;
Croatian: • Ubrzan ili slab puls;
English: Exposures (AUC0-24) of oritavancin in skin blister fluid were 20% of those in plasma after a single 800 mg dose in healthy subjects.
Croatian: Izloženosti (AUC0-24) oritavancinu u tekućini unutar mjehura na koži bile su 20% od onih u plazmi nakon jedne doze od 800 mg u zdravih ispitanika.
English: Oritavancin is not removed from blood by haemodialysis procedures.
Croatian: Oritavancin se ne uklanja iz krvi postupcima hemodijalize.
English: Oritavancin has three mechanisms of action: (i) inhibition of the transglycosylation (polymerization) step of cell wall biosynthesis by binding to the stem peptide of peptidoglycan precursors; (ii) inhibition of the transpeptidation (crosslinking) step of cell wall biosynthesis by binding to the peptide bridging segments of the cell wall; and (iii) disruption of bacterial membrane integrity, leading to depolarization, permeabilization, and rapid cell death.
Croatian: Oritavancin ima tri mehanizma djelovanja: (i) inhibiciju koraka transglikozilacije (polimerizacije) u biosintezi stanične stijenke vezivanjem za osnovni peptid prekursora peptidoglikana; (ii) inhibiciju koraka transpeptidacije (unakrsnog povezivanja) u biosintezi stanične stijenke vezivanjem za peptidne premosne segmente stanične stijenke i (iii) narušavanje integriteta bakterijske membrane, dovodeći do depolarizacije, permeabilizacije i brze stanične smrti.
English: - The active substance is oritavancin.
Croatian: - Djelatna tvar je oritavancin.
English: Menarini International O. L. S.A. 1, Avenue de la Gare, L-1611 Luxembourg Luxembourg
Croatian: Menarini International O. L. S.A. 1, Avenue de la Gare L-1611, Luxembourg Luksemburg
English: As a precautionary measure, it is preferable to avoid the use of oritavancin during pregnancy unless the potential benefit justifies the potential risk to the foetus.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu oritavancina tijekom trudnoće, osim ako moguća korist od liječenja ne opravdava mogući rizik za plod.
English: Dose modification based on height is not necessary.
Croatian: Nije potrebna prilagodba doze prema visini.
English: Gram-negative organisms are intrinsically resistant to all glycopeptides, including oritavancin.
Croatian: Gram-negativni organizmi intrinzično su rezistentni na sve glikopeptide, uključujući oritavancin.
English: Female patients had a higher reporting rate for adverse reactions than male patients.
Croatian: Bolesnice su imale višu stopu prijavljivanja nuspojava nego bolesnici.
English: • have ever had an allergic reaction to another glycopeptide antibiotic (such as vancomycin and telavancin)
Croatian: • ako ste ikada imali alergijsku reakciju na drugi glikopeptidni antibiotik (kao što su vankomicin i telavancin),
English: Studies in neonatal rats and dogs for 30 days showed the same tissue effects as those seen in adult animals including sensitivity to the oritavancin-mediated histamine-like infusion reactions.
Croatian: Ispitivanja u novorođenih štakora i pasa tijekom 30 dana pokazala su iste učinke na tkivo kao i one opažene u odraslih životinja, uključujući osjetljivost na reakcije na infuziju nalik na histaminski odgovor posredovane oritavancinom.
English: If superinfection occurs, appropriate measures should be taken.
Croatian: Ako nastupi superinfekcija, potrebno je poduzeti odgovarajuće mjere.
English: However, APCR is a phospholipid-based test and it cannot be ruled out that higher concentrations of oritavancin that may occur during clinical use could interfere with this test.
Croatian: Međutim, APCR je test temeljen na fosfolipidima i ne može se isključiti da bi više koncentracije oritavancina koje mogu nastati tijekom kliničke upotrebe mogle utjecati na ovaj test.
English: No dosage adjustment is warranted in these subpopulations.
Croatian: Nije potrebna prilagodba doziranja u tim podskupinama.
English: What you need to know before you are given Orbactiv 3.
Croatian: Što morate znati prije nego dobijete Orbactiv
English: Available pharmacodynamic/toxicological data in animals have shown excretion of oritavancin in milk (see section 5.3).
Croatian: Dostupni farmakodinamički/toksikološki podaci u životinja pokazuju da se oritavancin izlučuje u mlijeko (vidjeti dio 5.3).
English: Due to the possibility of cross-hypersensitivity, there should be careful monitoring of patients with any history of glycopeptide hypersensitivity during and after the infusion.
Croatian: Zbog mogućnosti križne preosjetljivosti, potrebno je pažljivo pratiti bolesnike koji u anamnezi imaju bilo kakvu preosjetljivost na glikopeptide tijekom i nakon infuzije.
English: Powder for concentrate
Croatian: Prašak za koncentrat
English: Activated partial thromboplastin time (aPTT)
Croatian: Aktivirano parcijalno tromboplastinsko vrijeme (aPTT)
English: Susceptibility Interpretive Criteria for Oritavancin Organism group
Croatian: Kriteriji za interpretaciju osjetljivosti za oritavancin
English: Elderly (≥ 65 years) No dosage adjustment is required for patients ≥ 65 years of age (see section 5.2).
Croatian: Stariji (≥65 godina) Nije potrebno prilagođavati dozu u bolesnika u dobi od ≥65 godina (vidjeti dio 5.2).
English: The area under the concentration-time curve (AUC) to minimum inhibitory concentration (MIC) ratio of oritavancin for the infecting organism has been shown to be the parameter that best correlates with efficacy.
Croatian: Omjer površine ispod krivulje koncentracija-vrijeme (AUC) i minimalne inhibicijske koncentracije (MIK) oritavancina za infektivni organizam pokazao se parametrom koji je najbolje povezan s djelotvornošću.
English: If an acute hypersensitivity reaction occurs during oritavancin infusion, oritavancin should be discontinued immediately and appropriate supportive care should be instituted.
Croatian: Ako se pojavi akutna reakcija preosjetljivosti tijekom infuzije oritavancina, potrebno je odmah prekinuti infuziju i osigurati odgovarajuće potporno liječenje.
English: Table 2:
Croatian: Tablica 2:
English: Patients should be monitored for signs and symptoms of osteomyelitis after administration of oritavancin.
Croatian: Bolesnike treba nadzirati kako bi se uočili znakovi i simptomi osteomijelitisa nakon primjene oritavancina.
English: • have or are suspected to have a bone infection caused by bacteria (osteomyelitis).
Croatian: • ako imate ili postoji sumnja da imate infekciju kosti prouzročenu bakterijama (osteomijelitis).
English: The exposure in rats at the no observed adverse effect level (NOAEL) was less to only slightly higher than the human exposure based on the AUC.
Croatian: Izloženost u štakora pri razini na kojoj nije opažen štetni učinak (NOAEL) bila je manja do samo nešto viša u odnosu na ljudsku izloženost na temelju AUC.
English: This histopathological finding correlated with an enlargement and an increase in the weight of the spleen.
Croatian: Taj histopatološki nalaz povezan je s povećanjem i porastom težine slezene.
English: Pharmacokinetic/Pharmacodynamic (PK/PD) relationship
Croatian: Farmakokinetički/farmakodinamički (FK/FD) odnos
English: This yields a concentration of 1.2 mg/mL of oritavancin.
Croatian: Time se dobiva koncentracija od 1,2 mg/ml oritavancina.
English: Oritavancin concentrations that are found in the blood of patients following administration of a single dose have been shown to artificially prolong:
Croatian: Koncentracije oritavancina koje su pronađene u krvi bolesnika nakon primjene jedne doze pokazale su da umjetno produljuju:
English: The European Medicines Agency has deferred the obligation to submit the results of studies with oritavancin in one or more subsets of the paediatric population in the treatment of acute bacterial skin and skin structure infections (see section 4.2 for information on paediatric use).
Croatian: Pedijatrijska populacija Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja oritavancina u jednoj ili više podskupina pedijatrijske populacije u liječenju akutnih bakterijskih infekcija kože i kožnih struktura (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Use of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after oritavancin administration because the activated partial thromboplastin time (aPTT) test results may remain falsely elevated for up to 120 hours after oritavancin administration (see sections 4.4 and 4.5).
Croatian: Uporaba intravenskog nefrakcioniranog heparinnatrija je kontraindicirana tijekom 120 sati (5 dana) nakon primjene oritavancina jer rezultati testa aktiviranog parcijalnog tromboplastinskog vremena (aPTV) mogu ostati lažno povišeni tijekom 120 sati nakon primjene oritavancina (vidjeti dijelove 4.4 i