FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore the revised indication ‘Ceftriaxone may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection' was proposed and considered acceptable by the CHMP.
Croatian: Stoga je predložena revidirana indikacija „Ceftriakson se može primjenjivati za upravljanje neutropnim bolesnicima s groznicom za koju se sumnja da je uzrokovana bakterijskom infekcijom”, koju je CHMP i prihvatio.
English: Ceftriaxone was demonstrated to have good clinical efficacy in the treatment of gonorrhoea when used as a single dose treatment.
Croatian: Ceftriakson je demonstrirao dobru kliničku djelotvornost u liječenju gonoreje kada je korišten kao terapija u jednoj dozi.
English: This section also states that ceftriaxone solutions containing lidocaine should never be administered intravenously.
Croatian: U ovom se dijelu navodi da se otopine ceftriaksona koje sadrže lidokain nikada ne smiju primjenjivati intravenozno.
English: • The committee considered the identified divergences for the Rocephin and associated names regarding with respect to the therapeutic indications, posology and method of administration sections, as well as the remaining sections of the SmPC.
Croatian: • je Povjerenstvo razmotrilo identificirane divergencije za lijek Rocephin i povezane nazive u svezi s dijelovima o terapijskim indikacijama, doziranjem i metodom primjene, kao i ostalim dijelovima SPC-a.
English: Ceftriaxone is not metabolised systemically; but is converted to inactive metabolites by the gut flora.
Croatian: Ceftriakson se ne može metabolizirati sistemski, već ga crijevna flora konvertira u neaktivne metabolite.
English: Rocephin is contraindicated in premature and in fullterm neonates at risk of developing bilirubin encephalopathy or receiving calcium-containing intravenous infusions.
Croatian: Rocephin je kontraindiciran u nedonoščadi i donošene novorođenčadi koja je izložena riziku od razvijanja bilirubinske encefalopatije ili primanja intravenoznih infuzija koje sadrže kalcij.
English: There is some evidence from clinical studies supporting the indication bone and joint infections.
Croatian: Postoje određeni dokazi iz kliničkih ispitivanja koji idu u prilog indikacije za infekcije kosti i zglobova.
English: Ceftriaxone has utility in cases of AECB, although the supporting study was small.
Croatian: Ceftriakson je od koristi u slučajevima AECB-a, iako su ispitivanja koja idu tome u prilog bila ograničena.
English: However IAI was accepted as the indication for ceftriaxone as there are increasing discrepancies in the definition of cIAI and a lack of acceptance of the term amongst many clinicians.
Croatian: No, IAI je prihvaćen kao indikacija za ceftriakson u slučajevima kada postoje rastuće razlike u definiciji cIAI-a i manjak prihvaćanja pojma među liječnicima.
English: Overall summary of the scientific evaluation of Rocephin and associated names (see Annex I)
Croatian: Cjelokupan sažetak znanstvene ocjene lijeka Rocephin i povezanih naziva (vidjeti Dodatak I)
English: Overall, the CHMP considered that ceftriaxone, used as a comparator agent in EU licensing trials, is an appropriate agent for the treatment of CAP in adults and children.
Croatian: Naposljetku, CHMP je zaključio da je ceftriakson, koji se koristio kao komparator u ispitivanjima licenciranima na razini EU, primjereno sredstvo za liječenje CAP-a u odraslih osoba i djece.
English: Rocephin is administered parenterally either by intramuscular injection, intravenous injection or infusion.
Croatian: Rocephin se primjenjuje parenteralno intramuskularnom injekcijom, intravenoznom injekcijom ili infuzijom.
English: For the preparation of the harmonised product information, the MAH considered the current registered SmPCs of all EU Member States with an active registration, the published literature and the cumulative safety experience with Rocephin as reported in the company's drug safety database and reflected in the appropriate sections of the company's Core Data Sheet (CDS).
Croatian: Za pripremu usklađenih informacija o lijekovima, podnositelj zahtjeva za stavljanje lijeka u promet razmatra aktualne prijavljene SPC-ove svih država članica EU s aktivnom registracijom, objavljenu literaturu i kumulativno iskustvo sigurne primjene s lijekom Rocephin kako je prijavljeno u bazi podataka o sigurnoj primjeni lijeka tvrtke i prikazano u odgovarajućim dijelovima Liste ključnih podataka (CDS, engl.
English: Nevertheless, ceftriaxone has a place where intravenous treatment is needed.
Croatian: Bez obzira na to, ceftriakson ima svoje mjesto u slučajevima kada je potrebno intravenozno liječenje.
English: The changes to the SmPC, when relevant for the user, have also been reflected in the PL and agreed by the CHMP.
Croatian: Izmijene SPC-a, ako su relevantne za korisnika, prenesene su i u Uputu o lijeku, te su odobrene od strane CHMP-a.
English: The most frequently reported adverse reactions for Rocephin are eosinophilia, leucopenia, thrombocytopenia, diarrhoea, rash, and increased hepatic enzymes.
Croatian: Najčešće prijavljene nuspojave od lijeka Rocephin su eozinofilija, leukopenija, trombocitopenija, proljev, osip i povišeni enzimi jetre.
English: On balance, the CHMP considered that the indication ‘Acute exacerbations of chronic obstructive pulmonary disease' is approvable.
Croatian: Naposljetku, CHMP je zaključio da se indikacija „Akutne egzacerbacije kronične opstruktivne pulmonalne bolesti” može odobriti.
English: Section 4.4 - Special warnings and precautions for use The information on C. difficile and antibiotic- associated colitis was re-worded in line with previous Article 30 harmonisation procedures for beta- lactams and to include hypersensitivity reactions and interactions with calcium-containing products.
Croatian: Informacije o C. difficile i kolitisu povezanom s antibiotikom ponovno su formulirane u skladu s postupkom usklađivanja sukladnim članku 30. za sredstva s betalaktamskim prstenom, te kako bi se uključile preosjetljive reakcije i interakcije s proizvodima koji sadrže kalcij.
English: Amendments were made to the wording for the period of lactation, mentioning the fact that the risk of diarrhoea and fungus infection of the mucous membranes cannot be excluded and that breastfeeding might have to be discontinued due to these effects.
Croatian: Dopune su izvršene u formulaciji za razdoblje dojenja, pri čemu se navodi činjenica da se ne može isključiti rizik od proljeva i infekcije gljivicama membrana sluznice te da će se dojenje možda morati prekinuti zbog ovih učinaka.
English: Total and renal plasma clearance (of total, i.e. free plus protein bound) ceftriaxone is dose dependent, while renal clearance of free ceftriaxone clearance is not.
Croatian: Ukupan klirens i bubrežni klirens iz plazme (ukupnog, odnosno slobodnog plus vezanog na protein) ceftriaksona ovisi o dozi, dok bubrežni klirens slobodnog ceftriaksona ne ovisi o dozi.
English: Overall, there is evidence from controlled clinical trials that ceftriaxone is effective in the treatment of AOM.
Croatian: Načelno postoje dokazi iz kontroliranih kliničkih ispitivanja da je ceftriakson djelotvoran u liječenju AOM-a.
English: Therefore the CHMP limited the indication to complicated UTI (cUTI), including pyelonephritis.
Croatian: Stoga je CHMP ograničio indikaciju na komplicirane infekcije urinarnog trakta (cUTI), uključujući i pijelonefritis.
English: The MAH has provided studies indicating that the pharmacokinetics of ceftriaxoneare not significantly altered in patients with renal and hepatic impairment, both of which may complicate acute infections.
Croatian: Nositelj odobrenja dostavio je ispitivanja koja signaliziraju da farmakokinetika ceftriaksonara nije značajno izmijenja u bolesnika s oštećenjem funkcije bubrega i jetre, pri čemu oba oštećenja mogu rezultirati komplikacijama akutnih infekcija.
English: Section 4.5- Interaction with other medicinal products and other forms of interaction In order to comply with the Guideline on the Summary of product Characteristics, the statement mentioning incompatibilities with amsacrine, vancomycin, fluconazole & aminoglycosides (which is included in the EU CSP) has been moved to Section 6.2 (Incompatibilities).
Croatian: Da bi su udovoljilo Smjernicama o Sažetku opisa svojstava lijeka, izjava kojom se navode nekompatibilnosti s amsakrinom, vankomicinom, flukonazolom i aminoglikozidima (koji su uključeni u CSP na razini EU) premještena je u dio 6.2 (Inkompatibilnosti).
English: the CHMP has recommended the variation to the terms of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Rocephin and associated names (see Annex I).
Croatian: CHMP je preporučio izmjene uvjeta odobrenja za stavljanje lijeka u promet za koje su sažetak opisa svojstava lijeka, etiketa i uputa o lijeku navedeni u Dodatku III za lijek Rocephin i povezane nazive (vidjeti Dodatak I).
English: Considering the submitted data, the CHMP was of the view that ceftriaxone is useful in the treatment of syphilis.
Croatian: Razmatrajući dostavljene podatke, CHMP je bio mišljenja da je ceftriakson koristan u liječenju sifilisa.
English: As agreed with the MAH, the CHMP was of the view that there is insufficient data to support the recommendation for subcutaneous administration of ceftriaxone.
Croatian: Sukladno dogovoru s nositeljem odobrenja, CHMP je bio mišljenja da ne postoji dovoljno podataka u prilog preporuke za potkožnu primjenu ceftriaksona.
English: • Community-acquired pneumonia (CAP)
Croatian: • Izvanbolnički stečena pneumonija (CAP)
English: Ceftriaxone is eliminated unchanged renally (by glomerular filtration) and biliary secretion.
Croatian: Ceftriakson se izlučuje nepromijenjen kroz bubrege (glomerularnom filtracijom) i sekrecijom u bubrezima.
English: Data to determine the frequency of Rocephin adverse drug reactions was derived from clinical trials.
Croatian: Podaci o utvrđivanju učestalosti nuspojava od lijeka Rocephin prikupljeni su iz kliničkih ispitivanja.
English: The amended wording was considered to be acceptable by the CHMP.
Croatian: CHMP smatra dopunjenu formulaciju prihvatljivom.
English: • The committee agreed the harmonisation of the summary of product characteristic, labelling and package leaflet proposed by the marketing authorisation holders.
Croatian: • je Povjerenstvo suglasno s usklađivanjem sažetka opisa svojstava lijeka, etiketom i uputi o lijeku predloženima od strane nositelja odobrenja.
English: The CHMP was of the opinion that overall, there is sufficient data from randomised controlled trials to support an indication in UTI (including pyelonephritis).
Croatian: Mišljenje je CHMP-a da načelno postoji dovoljno podataka iz nasumičnih kontroliranih ispitivanja kako bi se potkrijepila indikacija za infekcije urinarnog trakta (uključujući pijelonefritis).
English: The MAH's proposed text that the symptoms of overdose - nausea, vomiting and diarrhoea cannot be reduced by haemodialysis or peritoneal dialysis and that there is no specific antidote was considered to be acceptable by the CHMP.
Croatian: CHMP smatra prihvatljivim tekst kojeg je predložio nositelj odobrenja, a koji glasi da se simptomi predoziranja - mučnina, povraćanje i proljev ne mogu smanjiti hemodijalizom ili peritonejskom dijalizom te da ne postoji poseban protuotrov.
English: Adverse events such biliary lithiasis, biliary stasis and renal lithiasis have also been included with a cross reference to section 4.8 (undesirable effects).
Croatian: Nuspojave poput žučne litijaze, žučne staze i bubrežne litijaze uključene su u unakrsne reference u dijelu 4.8 (Nuspojave).
English: However, the use of ceftriaxone has been precluded if the patient has a history of a severe immediate hypersensitivity reaction to any other beta-lactam agent or any other cephalasporin.
Croatian: No, primjena ceftriaksona je kontraindicirana ako u bolesnika postoji anamneza ozbiljne neposredne preosjetljive reakcije na bilo koje drugo sredstvo s betalaktamskim prstenom ili na drugi cefalasporin.
English: Section 4.6 - Fertility, pregnancy and lactation The pregnancy statements suggest that there is limited human experience, that animal studies do not indicate an embryotoxic or teratogenic effect, and that caution should be exercised if using during pregnancy.
Croatian: Izjave o trudnoći sugeriraju da postoji skromno iskustvo u primjeni u ljudi, da ispitivanja na životinjama ne ukazuju na embriotoksično ili teratogeno djelovanje, te da se oprez treba primjenjivati ako se lijek primjenjuje tijekom trudnoće.
English: Therefore the MAH's proposal to add Stage II and Stage III nomenclature to this indication was considered to be acceptable by the CHMP.
Croatian: Stoga, CHMP smatra prihvatljivim prijedlog nositelja odobrenja da se doda nomenklatura Faza II i Faza III u ovu indikaciju.
English: The MAH's proposal to delete the indication for sinusitis, pharyngitis and prostatitis due to the scarcity of robust clinical trials in these conditions was agreed by the CHMP.
Croatian: CHMP je suglasan s prijedlogom nositelja odobrenja da se obriše indikacija za sinusitis, faringitis i prostatis zbog nedostatka robusnih kliničkih ispitivanja u ovim stanjima.
English: Due to the divergent national decisions taken by Member States concerning the authorisation of Rocephin and associated names, the European Commission notified the EMA of an official referral under Article 30 of Directive 2001/83/EC in order to resolve divergences amongst the nationally authorised product informations for the above-mentioned products and thus to harmonise them across the EU.
Croatian: Zbog različitih nacionalnih odluka usvojenih od strane država članica u vezi s izdavanjem odobrenja za lijek Rocephin i povezane nazive, Europska Komisija je obavijestila EMA-u o službenom postupku upućivanja sukladno članku 30.
English: Limited clinical data are available in support of the efficacy of ceftriaxone in the treatment of syphilis.
Croatian: U prilog djelotvornosti ceftriaksona u liječenju sifilisa dostupni su ograničeni klinički podaci.
English: You can start using [invented name] on any day which is best for you.
Croatian: Možete početi koristiti [zaštićeni naziv] na bilo koji dan koji je najbolji za Vas.
English: WHAT [invented name] IS AND WHAT IT IS USED FOR
Croatian: ŠTO JE [zaštićeni naziv] I ZA ŠTO SE KORISTI
English: [invented name] is not indicated during pregnancy.
Croatian: Trudnoća [zaštićeni naziv] nije indiciran tijekom trudnoće.
English: If you use more [invented name] than you should
Croatian: Ako primijenite više [zaštićeni naziv] nego što je potrebno
English: Treatment may be started on any convenient day.
Croatian: Liječenje može započeti na bilo koji prikladan dan.
English: He or she will also discuss other possibilities for treatment with you.
Croatian: On ili ona također će s Vama razmotriti druge mogućnosti liječenja.
English: Very rare: allergic reactions.
Croatian: Vrlo rijetko: alergijske reakcije.
English: This happens naturally after the menopause.
Croatian: To se događa prirodno nakon menopauze.
English: The additional risk becomes clear within a few years.
Croatian: Dodatni rizik postaje očigledan u roku od nekoliko godina.
English: Using other medicines
Croatian: Uporaba drugih lijekova
English: Do not use up any remaining content after completing treatment course.
Croatian: Nemojte koristiti preostali sadržaj nakon dovršetka ciklusa liječenja.
English: This part of section 3 has not been modified during this procedure]
Croatian: Ovaj dio dijela 3 nije izmijenjen tijekom ovog postupka]
English: Treatment should not be restarted until the woman is completely mobilised.
Croatian: Liječenje ne smije ponovno započeti sve dok žena ne postane potpuno pokretna.
English: A double dose should be avoided.
Croatian: Potrebno je izbjegavati uzimanje dvostruke doze.
English: HRT does not improve cognitive function.
Croatian: HNT ne poboljšava kognitivnu funkciju.
English: The maximum dose is once daily.
Croatian: Najveća doza je jednom dnevno.
English: See your doctor if you notice any changes such as:
Croatian: Posjetite svog liječnika ako primijetite bilo kakve promjene kao što su:
English: Regularly check your breasts.
Croatian: Redovito pregledavajte svoje dojke.
English: There are no data available.
Croatian: Nema dostupnih podataka.
English: The geometric mean half-life of E2 was 5.05 hours, with high interindividual variability.
Croatian: Geometrijska srednja vrijednost poluvijeka E2 bila je 5,05 sati s visokom interindividualnom varijabilnosti.
English: No known effect.
Croatian: Nema poznatih učinaka.
English: Your doctor will explain the effects of stopping treatment and when to stop it.
Croatian: Vaš liječnik objasnit će Vam učinke prekida liječenje i kada ga morate prekinuti.
English: Reasons for immediate withdrawal of therapy
Croatian: Razlozi za trenutnu obustavu terapije
English: However, it returns to normal within a few years (at most 5) after stopping treatment.
Croatian: Međutim, vraća se na normalni u roku od nekoliko godina (najviše 5) nakon prekida liječenja.
English: HRT will not prevent memory loss.
Croatian: HNT neće spriječiti gubitak pamćenja.
English: Free or biologically active hormone concentrations are unchanged.
Croatian: Koncentracije slobodnih ili biološki aktivnih hormona su nepromijenjene.
English: Free T4 and free T3 concentrations are unaltered.
Croatian: Koncentracije slobodnog T4 i T3 su nepromijenjene.
English: Results of the WHI studies are presented:
Croatian: Prikazani su rezultati WHI ispitivanja:
English: Continue with your treatment as normal.
Croatian: Nastavite terapiju kao i obično.
English: There is no evidence that HRT will prevent a heart attack.
Croatian: Nema dokaza da će HNT spriječiti srčani udar.
English: Changes in libido, mood disturbances
Croatian: Promjene u libidu, poremećaji raspoloženja
English: If your vaginal skin is very vulnerable, be careful when inserting the applicator into the vagina.
Croatian: Ako je koža Vaše vagine vrlo osjetljiva, budite oprezni prilikom umetanja aplikatora u vaginu.
English: The following risks apply to HRT medicines which circulate in the blood.
Croatian: Sljedeći rizici vrijede za HNT lijekove koji cirkuliraju u krvi.
English: After stopping treatment risk remain elevated for at least 10 years.
Croatian: Nakon prekida liječenja rizik ostaje povišen tijekom najmanje 10 godina.
English: [invented name] is unlikely to have any effect on alertness or coordination.
Croatian: Nije vjerojatno da će [zaštićeni naziv] imati učinak na budnost ili koordinaciju.
English: Please talk to your doctor.
Croatian: Molimo da se obratite svom liječniku.
English: The extra risk depends on how long you take HRT.
Croatian: Dodatni rizik ovisi o tome kako dugo uzimate HNT.
English: Therapeutic indications (areas of use):
Croatian: Terapijske indikacije (područja primjene):
English: Do not use a double dose of [invented name] to make up for a forgotten single dose.
Croatian: Nemojte uzeti dvostruku dozu [zaštićeni naziv] kako biste nadoknadili zaboravljenu pojedinačnu dozu.
English: If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised.
Croatian: Ako je prisutno bilo koje od sljedećih stanja ili ako su se ona dogodila već prije i/ili su se pogoršala tijekom trudnoće ili prethodnog hormonskog liječenja, bolesnika je potrebno pomno nadzirati.
English: In most cases, [invented name] is used for 2-3 weeks.
Croatian: U većini slučajeva [zaštićeni naziv] koristi se tijekom 2-3 tjedna.
English: If so, you should see your doctor more often for check-up's.
Croatian: U tom slučaju morate češće odlaziti k liječniku na preglede.
English: It is inserted into your vagina, so the hormone is released where it is needed.
Croatian: Umeće se u Vašu rodnicu tako da se hormon otpušta gdje je potreban.
English: Changes in weight (increase or decrease), increased triglycerides
Croatian: Promjene u tjelesnoj težini (porast ili pad), povišeni trigliceridi
English: Women should be advised what changes in their breasts should be reported to their doctor or nurse.
Croatian: Žene je potrebno savjetovati koje promjene na dojkama moraju prijaviti liječniku ili medicinskoj sestri.
English: - Estradiol is a female sex hormone.
Croatian: - Estradiol je ženski spolni hormon.
English: If a dose is forgotten, it should be taken as soon as the patient remembers.
Croatian: Ako bolesnik zaboravi dozu, mora je uzeti čim se sjeti.
English: Vaginitis, including vaginal candidiasis
Croatian: Vaginitis, uključujući i vaginalnu kandidijazu
English: Inform your doctor if any of these situations applies to you:
Croatian: Recite svom liječniku ako se bilo što od navedenog odnosi na Vas:
English: Talk to a doctor or pharmacist.
Croatian: Razgovarajte s liječnikom ili ljekarnikom.
English: In case the applicator is damaged you should not use it and inform the manufacturer.
Croatian: U slučaju oštećenja aplikatora, isti se ne smije koristiti te morate o tome obavijestiti proizvođača.
English: It should be taken into account that these conditions may recur or be aggravated during oestrogen treatment, in particular:
Croatian: Potrebno je uzeti u obzir da se ova stanja mogu povratiti ili pogoršati tijekom liječenja estrogenom, a posebice:
English: - dimpling of the skin - changes in the nipple - any lumps you can see or feel
Croatian: - promjene na bradavicama - bilo koju kvržicu koju možete vidjeti ili osjetiti
English: Before initiating or reinstituting hormone therapy, a complete personal and family medical history should be obtained.
Croatian: Prije početka ili ponovne uspostave hormonske terapije, potrebno je uzeti potpunu osobnu i obiteljsku anamnezu.
English: You are more likely to get a blood clot in your veins as you get older and if any of the following applies to you.
Croatian: Vjerojatnije je da ćete dobiti krvni ugrušak u venama što ste stariji te ako se nešto od sljedećeg odnosi na Vas.
English: The relative risk does not change with age or time since menopause.
Croatian: Relativni rizik se ne mijenja s dobi ili vremenom proteklim od menopauze.
English: For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also Section 4.4) should be used.
Croatian: Za početak i nastavak liječenja simptoma postmenopauze potrebno je koristiti najnižu djelotvornu dozu za najkraće trajanje (vidjeti također Dio 4.4).
English: * Taken from baseline incidence rates in developed countries.
Croatian: * Preuzeto iz početnih stopa incidencije u razvijenim zemljama.
English: [invented name] should not be used in the following cases:
Croatian: [zaštićeni naziv] ne smije se koristiti u sljedećim slučajevima:
English: Endogenous 17β-estradiol induces and maintains the primary and secondary female sexual characteristics.
Croatian: Endogeni 17β-estradiol inducira i održava primarne i sekundarne ženske spolne karakteristike.
English: Intravaginal applicator may cause minor local trauma, especially in women with serious vaginal atrophy.
Croatian: Intravaginalni aplikator može uzrokovati manje lokalne traume posebice u žena s ozbiljnom vaginalnom atrofijom.
English: This may include an examination of your breasts and/or internal examination, if necessary.
Croatian: To može uključivati pregled Vaših dojki i/ili ginekološki pregled, ako je potrebno.
English: Dosage instructions, method and duration of administration
Croatian: Upute za doziranje, način i trajanje primjene
English: − if you have ever developed malignant tumours which are sensitive to oestrogens
Croatian: − ako ste ikad razvili maligne tumore koji su osjetljivi na estrogen
English: - Probable dementia over the age of 65 (see section 4.4)
Croatian: - vjerojatna demencija nakon dobi od 65 godina (vidjeti dio 4.4)
English: [The following text should be inserted after the section “Clean the applicator after use”]
Croatian: [Sljedeći tekst potrebno je umetnuti nakon dijela „Očistite aplikator nakon uporabe”]