FrancophonIA/ELRC3.0 huggingface dataset:
English: [The following phrase is deleted as it was duplication]
Croatian: [Sljedeća rečenica se briše jer je bila duplicirana]
English: How to take {Paracetamol/Ibuprofen 500 mg/150mg film coated tablets}{Novogesic 500 mg/150 mg film coated tablets}
Croatian: Kako uzimati {Paracetamol/Ibuprofen 500 mg/150 mg filmom obložene tablete }{Novogesic 500 mg/150 mg filmom obložene tablete}
English: This medicine is for short term use and is not recommended for use beyond 3 days.
Croatian: Ovaj lijek je za kratkotrajnu primjenu i ne preporučuje se primjenjivati ga dulje od 3 dana.
English: [The wording below should be inserted in this section] Treatment should be stopped in those patients who develop severe renal failure (see section 4.3).
Croatian: [Sljedeću rečenicu potrebno je umetnuti u ovaj dio] Liječenje se mora zaustaviti kod bolesnika koji razviju teško zatajenje bubrega (vidjeti dio 4.3).
English: What {Paracetamol/Ibuprofen 500 mg/150mg film coated tablets}{Novogesic 500 mg/150 mg film coated tablets}contain macrogol/PEG 4000
Croatian: Što {Paracetamol/Ibuprofen 500 mg/150 mg filmom obložene tablete }{Novogesic 500 mg/150 mg filmom obložene tablete} sadrži
English: For short term use only (not more than 3 days).
Croatian: Samo za kratkotrajnu primjenu (ne dulje od 3 dana).
English: Adults: [The wording below should be inserted in this section] Do not take for more than 3 days.
Croatian: Odrasli: [Tekst u nastavku potrebno je umetnuti u ovaj dio] Nemojte uzimati dulje od 3 dana.
English: Section 4.2 Posology and method of administration
Croatian: Dio 4.2. Doziranje i način primjene
English: [The phrase below should be inserted] This medicine is for short term use and is not recommended for use beyond 3 days.
Croatian: [Sljedeću rečenicu potrebno je umetnuti] Ovaj lijek je za kratkotrajnu primjenu i ne preporučuje se primjenjivati ga dulje od 3 dana.
English: For oral administration and short term use only (not more than 3 days).
Croatian: Za peroralnu primjenu i samo za kratkotrajnu primjenu (ne dulje od 3 dana).
English: [The wording below should be inserted in this section] - You should not take this product for longer than 3 days.
Croatian: [Tekst u nastavku potrebno je umetnuti u ovaj dio] - Ne smijete uzimati ovaj lijek dulje od 3 dana.
English: B. Labelling Carton
Croatian: Označivanje Kutija
English: Do not take if you: [The wording below should be inserted in this section]
Croatian: Nemojte uzimati ako: [Tekst u nastavku potrebno je umetnuti u ovaj dio]
English: Hepatic Impairment
Croatian: Oštećenje funkcije bubrega
English: [The phrase below should be amended as follows]
Croatian: [Tekst u nastavku potrebno je izmijeniti kako slijedi]
English: [The following wording should be amended as follows] For oral use.
Croatian: [Sljedeći tekst potrebno je izmijeniti kako slijedi]
English: Ibuprofen [The following phrase is deleted]
Croatian: Dio 5.3 Neklinički podaci o sigurnosti primjene Ibuprofen [Sljedeća rečenica se briše]
English: Section 5.3 Preclinical data
Croatian: Dio 6.1 Popis pomoćnih tvari
English: List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, applicant in the Member States
Croatian: Popis naziva, farmaceutskog oblika, jačina lijekova, puta primjene, podnositelja zahtjeva u državama članicama
English: Each pack also contains:
Croatian: Svako pakovanje također sadrži:
English: CEPROTIN with food and drink
Croatian: CEPROTIN s hranom i pićem
English: If such a reaction occurs, your doctor will decide on the most appropriate treatment.
Croatian: Ako se pojavi takva reakcija, Vaš će liječnik odlučiti o najprikladnijem liječenju.
English: No interactions with other medicinal products are currently known.
Croatian: Trenutno nisu poznate interakcije s drugim lijekovima.
English: (See section 4.2).
Croatian: (Vidjeti dio 4.2.).
English: CIOMS frequency categories: Very Common (>=10%); Common (>=1%<10%),Uncommon (>=0.1% - <1%), Rare (>=0.01% - <0.1%), Very Rare (<0.01%).
Croatian: Kategorije učestalosti nuspojava prema radnoj skupini CIOMS: vrlo često (>=10%), često (>=1% - <10%), manje često (>=0,1% - <1%), rijetko (>=0,01% - <0,1%), vrlo rijetko (<0,01%).
English: In case you administered more CEPROTIN than recommended, please inform your doctor as soon as possible.
Croatian: U slučaju da ste primijenili više lijeka CEPROTIN nego što je preporučeno, molimo obavijestite Vašeg liječnika što je prije moguće.
English: Nevertheless, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Croatian: Bez obzira na to, obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli bilo koji drugi lijek, uključujući lijekove dobivene bez recepta.
English: Repeated toxicity studies were not conducted because prior experience with coagulation preparations had shown them to be of limited value.
Croatian: Ponavljana ispitivanja toksičnosti nisu provedena jer su ranija iskustva s koagulacijskim pripravcima pokazala da su ona od ograničene vrijednosti.
English: The individual half-lives varied from 4.4 to 15.8 hours using a compartmental model and from 4.9 to 14.7 using the non-compartmental method.
Croatian: Pojedinačni poluvijekovi variraju od 4,4 do 15,8 sati koristeći kompartment model i od 4,9 do 14,7 koristeći nekompartment metodu.
English: Patients should be advised to immediately contact their physician if these symptoms occur (see section 4.4).
Croatian: Bolesnicima treba savjetovati da se odmah jave svome liječniku ako se pojave ti simptomi (vidjeti dio 4.4.).
English: Talk to your doctor or pharmacist before using CEPROTIN.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite CEPROTIN.
English: Date of first authorisation: 16 July 2001 Date of last renewal: 16 July 2006
Croatian: Datum posljednje obnove odobrenja: 16. srpnja 2006.
English: However, this has not been observed in the clinical studies to date.
Croatian: Međutim, to u dosadašnjim kliničkim ispitivanjima nije uočeno.
English: See section 4.4 for information on parvovirus B19 infection.
Croatian: Vidjeti dio 4.4. za informacije o infekciji parvovirusom B19.
English: Other medicines and CEPROTIN
Croatian: Drugi lijekovi i CEPROTIN
English: In the context of clinical experience several bleeding episodes have been observed.
Croatian: U okviru kliničkog iskustva zabilježeno je nekoliko epizoda teškog krvarenja.
English: In total 6375 administrations of CEPROTIN have been given.
Croatian: Ukupno je bilo 6375 primjena lijeka CEPROTIN.
English: APC has also been shown to have profibrinolytic effects.
Croatian: Pokazalo se i da APC ima profibrinolitički učinak.
English: However, several small retrospective and prospective studies investigating other clinical application areas have been published in this population.
Croatian: Međutim, objavljeno je nekoliko manjih retrospektivnih i prospektivnih ispitivanja koja su istraživala druga područja kliničke primjene u ovoj populaciji.
English: Do not stop using CEPROTIN without consulting your doctor.
Croatian: Ne prekidajte primjenu lijeka CEPROTIN bez savjetovanja sa svojim liječnikom.
English: Pharmacotherapeutic group: group antithrombotic; ATC Code: B01AD12
Croatian: Farmakoterapijska skupina: skupina antitrombotika; ATK oznaka: B01AD12
English: If you have APC resistance which is a thromboembolic risk factor present in up to 5 % of the population in Europe your doctor may need to adjust your treatment accordingly.
Croatian: Ako imate APC rezistenciju koja je rizični čimbenik za tromboemboliju prisutan u 5 % europske populacije, Vaš će liječnik prema tome možda trebati prilagoditi liječenje.
English: Therefore, the benefit of using CEPROTIN during pregnancy or lactation must be judged against the risk for the mother and baby, and should be used only if clearly needed.
Croatian: Stoga je potrebno procijeniti prednost korištenja lijeka CEPROTIN tijekom trudnoće i dojenja u odnosu na rizik za majku i dijete, i koristiti ga samo kad je to jasno potrebno.
English: What CEPROTIN is and what it is used for
Croatian: Što je CEPROTIN i za što se koristi
English: The patients differed significantly in age, body weight and plasma volume.
Croatian: Bolesnici su se značajno razlikovali po dobi, tjelesnoj težini i volumenu plazme.
English: Your doctor will decide if CEPROTIN may be used during pregnancy and lactation.
Croatian: Liječnik će odlučiti može li se CEPROTIN primjenjivati tijekom trudnoće i dojenja.
English: The potency (IU) is determined using a chromogenic substrate method against the World Health Organisation (WHO) International standard.
Croatian: Potentnost (IU) je određena korištenjem metode kromogenog supstrata prema međunarodnom standardu Svjetske zdravstvene organizacije (SZO).
English: The distribution of the related ADRs is as follows:
Croatian: Raspodjela povezanih nuspojava je sljedeća:
English: Take special care with CEPROTIN if symptoms of allergy occur.
Croatian: Budite posebno oprezni s lijekom CEPROTIN ako se pojave simptomi alergije.
English: After reconstitution the solution has a pH of between 6.7 and 7.3 and an osmolality of not lower than 240 mosmol/kg.
Croatian: Nakon pripreme otopina ima pH između 6,7 i 7,3 i osmolalnost ne manju od 240 mosmol/kg.
English: Furthermore no information on excretion of protein C in the milk is available.
Croatian: Nadalje, nisu dostupni podaci o izlučivanju proteina C u mlijeko.
English: If you use more CEPROTIN than you should
Croatian: Ako primijenite više lijeka CEPROTIN nego što ste trebali
English: Important information about some of the ingredients of CEPROTIN
Croatian: Važne informacije o nekim sastojcima lijeka CEPROTIN
English: This leaflet was last approved in
Croatian: Ova uputa je zadnji puta revidirana u .
English: A protein C activity of 100 % should be achieved initially and the activity should be maintained above 25 % for the duration of the treatment.
Croatian: Na početku je potrebno postići aktivnost proteina C od 100 % i tijekom trajanja liječenja potrebno ju je održavati iznad 25 %.
English: In case of acute thrombosis CEPROTIN may be administered to you every 6 hours.
Croatian: U slučaju akutne tromboze CEPROTIN se može primjenjivati svakih 6 sati.
English: All unused solution, empty vials and used needles and syringes must be discarded appropriately.
Croatian: Sve neiskorištene otopine, prazne bočice i iskorištene igle i štrcaljke treba zbrinuti na prikladan način.
English: Furthermore, during the initiation of oral anticoagulant therapy it is advisable to start with a low dose and adjust this incrementally, rather than use a standard loading dose.
Croatian: Nadalje, tijekom započinjanja oralnog antikoagulantnog liječenja preporučuje se početi niskom dozom i postupno je prilagođavajući povećavati, radije nego koristiti standardnu punu dozu.
English: Single dose toxicity testing showed that even doses of several times the recommended human dosage per kilogram body weight (10-fold) did not result in toxic effects on rodents.
Croatian: Testiranje toksičnosti pojedinačne doze pokazalo je da čak i doze nekoliko puta veće od preporučene ljudske doze po kilogramu tjelesne težine (10-erostruko) nisu prouzročile toksičan učinak na glodavcima.
English: What CEPROTIN looks like and contents of the pack
Croatian: Kako CEPROTIN izgleda i sadržaj pakiranja
English: The wide variation in individual responses implies that the effects of CEPROTIN on coagulation parameters should be checked regularly.
Croatian: Velike razlike u individualnom odgovoru upućuju na to da je potrebno redovito provjeravati utjecaj lijeka CEPROTIN na parametre zgrušavanja.
English: Dosage will vary depending on your condition and your body weight.
Croatian: Doziranje će ovisiti o Vašem stanju i tjelesnoj težini.
English: This medicine contains Protein C, a natural protein that is made in the liver and is present in your blood.
Croatian: Ovaj lijek sadrži protein C, prirodni protein koji se stvara u jetri i prisutan je u Vašoj krvi.
English: The frequency of these ADRs is not known.
Croatian: Učestalost ovih nuspojava nije poznata.
English: This also applies to any unknown or emerging viruses or other types of infections.
Croatian: To se također odnosi na sve nepoznate ili nove viruse, ili druge vrste infekcija.
English: Patients with HIT should avoid the use of heparin containing drugs in the future.
Croatian: Bolesnici s HIT-om u budućnosti trebaju izbjegavati korištenje lijekova koji sadrže heparin.
English: Your physician will take several blood drawings over time to determine how long protein C is remaining in your body.
Croatian: Liječnik će uzeti nekoliko uzoraka krvi tijekom vremena kako bi utvrdio kako dugo se protein C zadržava u Vašem tijelu.
English: 500 IU and 1000 IU: CEPROTIN powder comes in vials of neutral glass of either hydrolytic type I (500 IU) or hydrolytic type II (1000 IU).
Croatian: 500 IU i 1000 IU: CEPROTIN prašak dostupan je u bočicama s neutralnim staklom bilo hidrolitičkog tipa I (500 IU) ili hidrolitičkog tipa II (1000 IU).
English: CEPROTIN belongs to a class of medicines called antithrombotics.
Croatian: CEPROTIN pripada skupini lijekova zvanih antitrombotici.
English: What CEPROTIN contains
Croatian: Što CEPROTIN sadrži
English: What you need to know before you use CEPROTIN
Croatian: Što morate znati prije nego počnete primjenjivati CEPROTIN
English: Subsequently, in the initial phase of treatment, the activity of protein C is more rapidly suppressed than that of the procoagulant factors.
Croatian: Posljedično, u početnoj fazi liječenja, aktivnost proteina C brže je suprimirana od one prokoagulantnih faktora.
English: No experience in the treatment of patients with renal and/or hepatic impairment is available and therefore it is recommended that such patients be monitored more closely.
Croatian: Nema iskustva u liječenju bolesnika s bubrežnim i/ili jetrenim oštećenjem, te se stoga preporučuje pažljivije praćenje tih bolesnika.
English: Each pack also contains one transfer needle and one filter needle.
Croatian: Svako pakovanje također sadrži jednu iglu za prijenos i jednu filter iglu.
English: The preparation may contain traces of heparin and/or mouse protein as a result of the manufacturing process.
Croatian: Pripravak može sadržavati heparin u tragovima i/ili mišjeg proteina kao posljedicu postupka proizvodnje.
English: If these symptoms occur, they should inform the physician.
Croatian: Ako se pojave ti simptomi, trebaju obavijestiti liječnika.
English: 3 years The reconstituted solution should be used immediately.
Croatian: 3 godine Pripremljena otopina treba se odmah primijeniti.
English: An initial dose of 60 to 80 IU/kg for determination of recovery and half-life is advised.
Croatian: Savjetuje se početna doza od 60 do 80 IU/kg za određivanje povrata i poluvijeka.
English: - if you are allergic to Human Protein C or any of the other ingredients of this medicine (listed in section 6) including mouse protein or heparin.
Croatian: - ako ste alergični na humani protein C ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) uključujući mišji protein ili heparin.
English: * One International Unit (IU) of protein C corresponds to the amidolytically measured activity of protein C in 1 ml of normal plasma.
Croatian: * Jedna internacionalna jedinica (IU) proteina C odgovara amidolitički mjerenoj aktivnosti proteina C u 1 ml normalne plazme.
English: The quantity of sodium in the maximum daily dose may exceed 200 mg.
Croatian: Količina natrija pri maksimalnoj dnevnoj dozi može prijeći 200 mg.
English: However, it cannot be completely ruled out that the administration of CEPROTIN further contributed to these bleeding events.
Croatian: Međutim, nije moguće potpuno isključiti da je primjena lijeka CEPROTIN dodatno doprinijela ovim krvarenjima.
English: No symptoms of overdose with CEPROTIN have been reported.
Croatian: Nisu prijavljeni simptomi predoziranja lijekom CEPROTIN.
English: • when coumarin therapy alone is not sufficient
Croatian: • kad liječenje samo kumarinom nije dovoljno
English: CEPROTIN is intended for intravenous administration (infusion into a vein).
Croatian: CEPROTIN je namijenjen za intravensku primjenu (infuzija u venu).
English: Although CEPROTIN has been used safely in the treatment of pregnant protein C-deficient women, its safety for use in human pregnancy has not been established in controlled clinical trials.
Croatian: Iako se CEPROTIN sigurno koristi u liječenju trudnica s manjkom proteina C, sigurnost za njegovo korištenje u ljudskoj trudnoći nije utvrđena kontroliranim kliničkim ispitivanjima.
English: Based on the limited clinical experience in children from reports and studies covering 83 patients, dosing guidelines for adult subjects are considered valid for neonatal and paediatric patient population (see section 5.1).
Croatian: Na temelju ograničenog kliničkog iskustva u djece iz izvješća i ispitivanja koja obuhvaćaju 83 bolesnika, smjernice doziranja za odrasle smatraju se važećima za novorođenačku i pedijatrijsku populaciju (vidjeti dio 5.1.).
English: As the quantity of sodium in the maximum daily dose may exceed 200 mg, this should be taken into consideration by patients on a controlled sodium diet.
Croatian: Budući da količina natrija pri maksimalnoj dnevnoj dozi može prijeći 200 mg, to je potrebno uzeti u obzir kod bolesnika na dijeti s ograničenim unosom natrija.
English: If HIT is suspected, the number of thrombocytes should be determined immediately and if necessary therapy with CEPROTIN should be stopped.
Croatian: Pri sumnji na HIT potrebno je odmah odrediti broj trombocita i ako je potrebno zaustaviti liječenje lijekom CEPROTIN.
English: Skin and subcutaneous tissue disorders hyperhydrosis
Croatian: Poremećaji kože i potkožnog tkiva hiperhidroza
English: If such symptoms occur during the administration of CEPROTIN, injection should be stopped.
Croatian: Ako se ti simptomi pojave tijekom primjene lijeka CEPROTIN, mora se prekinuti ubrizgavanje.
English: In the case of an acute thrombotic event these should be performed every 6 hours until your condition is stabilised, thereafter twice a day and always immediately before the next injection.
Croatian: U slučaju akutnog trombotskog događaja to je potrebno raditi svakih 6 sati sve dok Vaše stanje nije stabilizirano, nakon toga dva puta na dan i uvijek neposredno prije sljedeće injekcije.
English: Patients treated during the acute phase of their disease may display much lower increases in protein C activity.
Croatian: Bolesnici liječeni u akutnoj fazi svoje bolesti mogu pokazivati mnogo manji porast aktivnosti proteina C.
English: Indication was prevention and treatment of purpura fulminans and thrombotic disease, enrolling overall 14 subjects of 2 days old throughout adolescence.
Croatian: Indikacija su bile prevencija i liječenje purpure fulminans i trombotske bolesti, uključujući ukupno 14 ispitanika starosti od 2. dana do adolescencije.
English: WATER FOR INJECTIONS
Croatian: VODA ZA INJEKCIJE
English: In case of shock, the current medical standards for shock treatment are to be observed.
Croatian: U slučaju šoka, potrebno je slijediti važeće medicinske smjernice za liječenje šoka.
English: In patients starting treatment with oral anticoagulants belonging to the class of vitamin K antagonists (e.g. warfarin), a transient hypercoagulable state may arise before the desired anticoagulant effect becomes apparent.
Croatian: Kod bolesnika koji započinju liječenje oralnim antikoagulansima koji spadaju u skupinu antagonista vitamina K (npr. varfarin) moguća je pojava prolaznog hiperkoagulabilnog stanja prije nego se očituje željeni antikoagulantni učinak.
English: In the case of an acute thrombotic event these should be performed every 6 hours until the patient is stabilised, thereafter twice a day and always immediately before the next injection.
Croatian: U slučaju akutnog trombotskog događaja to je potrebno raditi svakih 6 sati sve dok bolesnik nije stabiliziran, nakon toga dva puta na dan i uvijek neposredno prije sljedeće injekcije.
English: What CEPROTIN is and what it is used for What you need to know before you use CEPROTIN How to use CEPROTIN
Croatian: Što je CEPROTIN i za što se koristi Što morate znati prije nego počnete primjenjivati CEPROTIN Kako primjenjivati CEPROTIN Moguće nuspojave
English: Such symptoms may constitute an allergic reaction to any of the components, to mouse protein or heparin.
Croatian: Ovi simptomi mogu predstavljati alergijsku reakciju na bilo koji od sastojaka lijeka, mišji protein ili heparin.
English: The dose should be adjusted on the basis of laboratory assessment for each individual case.
Croatian: Dozu je potrebno prilagoditi na temelju laboratorijskih nalaza za svaki pojedini slučaj.
English: 1221 Vienna
Croatian: 1221 Beč
English: In children with a body weight of less than 10 kg, the injection rate should not exceed a rate of 0.2 ml/kg/min.
Croatian: Kod djece tjelesne težine manje od 10 kg, brzina ubrizgavanja ne bi trebala prijeći 0,2 ml/kg/min.
English: This also applies to unknown or emerging viruses and other pathogens.
Croatian: To se također odnosi na sve nepoznate ili nove viruse, i ostale patogene.
English: CEPROTIN should be administered at a maximum injection rate of 2 ml per minute except for children with a body weight of < 10 kg, where the injection rate should not exceed a rate of 0.2 ml/kg/min.
Croatian: CEPROTIN je potrebno primjenjivati maksimalnom brzinom injiciranja od 2 ml u minuti, osim kod djece s tjelesnom težinom < 10 kg pri čemu brzina injiciranja ne smije prijeći 0,2 ml/kg/min.
English: Dosages of the above studies, covering 83 patients, indicate that dosing guidelines for adult subjects are also valid for neonatal and paediatric patient population.
Croatian: Doziranja u gore navedenim ispitivanjima koja obuhvaćaju 83 bolesnika upućuju na to da smjernice doziranja za odrasle vrijede i za novorođenačku i pedijatrijsku populaciju.
English: CEPROTIN should be administered at a maximum injection rate of 2 ml per minute.
Croatian: CEPROTIN se primjenjuje maksimalnom brzinom ubrizgavanja od 2 ml u minuti.
English: 2H2O: 22 mg/vial
Croatian: 2H2O: 22 mg/bočica
English: For the events that allergic symptoms arise which are of an acute and life-threatening nature, administration should be made within reach of life-supporting facilities.
Croatian: Zbog slučajeva pojave alergijskih simptoma koji su akutni i ugrožavaju život, primjenu je potrebno vršiti unutar dohvata prostorija za održavanje života.
English: Gently rotate the vial until all powder is dissolved.
Croatian: Nježno okrećite bočicu dok se prašak potpuno ne otopi.
English: 2H2O: 44 mg/vial
Croatian: 2H2O: 44 mg/bočica
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection, and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Croatian: Standardne mjere prevencije infekcija uzrokovanih korištenjem lijekova pripremljenih od ljudske krvi ili plazme uključuju odabir davatelja, probir pojedinačnih donacija i pulova prikupljene plazme za određene pokazatelje infekcije i uključivanje učinkovitih proizvodnih postupaka za inaktivaciju/uklanjanje virusa.
English: The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Croatian: Poduzete mjere mogu imati ograničenu vrijednost protiv virusa bez ovojnice kao što je parvovirus B19.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to mouse protein or heparin, except for control of life-threatening thrombotic complications.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 ili na mišji protein ili heparin, osim radi kontrole po život opasnih trombotskih komplikacija.
English: Other experience with CEPROTIN covers case reports and a clinical study in overall 69 paediatric patients with acquired protein C deficiency.
Croatian: Druga iskustva s lijekom CEPROTIN obuhvaćaju izvješća o slučajevima i kliničko ispitivanje na ukupno 69 pedijatrijskih bolesnika sa stečenim nedostatkom proteina C.