FrancophonIA/ELRC3.0 huggingface dataset:
English: What you need to know before you use <Product name>
Croatian: Što morate znati prije nego što počnete primjenjivati <naziv lijeka> Upozorenja i mjere opreza
English: Xylometazoline - Serious ventricular arrhythmia in patients with long QT syndrome (EPITT no 19242)
Croatian: Ksilometazolin - ozbiljna ventrikularna aritmija u bolesnika sa sindromom dugog QT intervala (EPITT br.
English: For package leaflets which do not mention ‘heart disease', a bullet point on ‘heart disease (e.g. long QT syndrome)' should be added, in line with the wording above.
Croatian: U uputama o lijeku u kojima se ne spominje „srčana bolest” treba dodati natuknicu „ako bolujete od srčanih bolesti (npr. sindrom dugog QT intervala)” u skladu s gore navedenim tekstom.
English: Patients with long QT syndrome treated with xylometazoline may be at increased risk of serious ventricular arrhythmias.
Croatian: Posebna upozorenja i mjere opreza pri uporabi Bolesnici sa sindromom dugog QT intervala koji se liječe ksilometazolinom mogu biti izloženi povećanom riziku od ozbiljnih ventrikularnih aritmija.
English: Note: in the package leaflet the text ‘(e.g. long QT syndrome)' should be added to the bullet point mentioning heart disease, taking into account the already existing wording for nationally authorised medicinal products.
Croatian: ako bolujete od srčanih bolesti (npr. sindrom dugog QT intervala) Napomena: u uputi o lijeku tekst „(npr. sindrom dugog QT intervala)” treba dodati u natuknicu u kojoj se spominje srčana bolest, uzimajući u obzir već postojeći tekst za nacionalno odobrene lijekove.
English: Package leaflet
Croatian: Uputa o lijeku
English: [To be filled in nationally]
Croatian: [Ispunjava se nacionalno]
English: Do not touch the dropper.
Croatian: Ne dirajte kapaljku.
English: Available data are described in sections 4.8 and 5.1.
Croatian: Dostupni podaci opisani su u dijelovima 4.8 i 5.1.
English: If necessary, they can be diluted in water (see above).
Croatian: Ako je potrebno, mogu se razrijediti u vodi (vidi prethodno).
English: If appropriate, speak to your doctor.
Croatian: Ako je potrebno, razgovarajte sa svojim liječnikom.
English: Please interrupt treatment, temporarily.
Croatian: Privremeno prekinite terapiju.
English: This will cause slight turbidity.
Croatian: To će uzrokovati laganu zamućenost.
English: However, based on these limited data the safety profile for children and adolescents is considered to be comparable to that of adults.
Croatian: Međutim, na temelju tih ograničenih podataka smatra se da je sigurnosni profil za djecu i adolescente usporediv sa sigurnosnim profilom za odrasle.
English: These reactions usually disappear within a few days even if treatment is continued.
Croatian: Te nuspojave obično nestaju unutar nekoliko dana, čak i ako se liječenje nastavi.
English: Duration of use of 8 weeks is recommended.
Croatian: Preporučuje se primjena u trajanju od 8 tjedana.
English: Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.
Croatian: Obavijestite svojeg liječnika ili ljekarnika ako uzimate/primjenjujete, nedavno ste uzeli/primijenili ili biste mogli uzeti/primijeniti bilo koje druge lijekove.
English: Duration of treatment
Croatian: Trajanje terapije
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svojem liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
English: The text below should be inserted by replacing the existing text of this section: Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Croatian: U ovom dijelu treba umetnuti tekst u nastavku, kojim se zamjenjuje postojeći tekst: Uvijek uzmite ovaj lijek točno onako kako je opisano u ovoj uputi ili kako vam je rekao vaš liječnik ili ljekarnik.
English: In a non-interventional study with 203 children aged 4-18 years no undesirable effects were reported.
Croatian: U neintervencijskom ispitivanju u kojem je sudjelovalo 203 djece u dobi od 4 do 18 godina nisu prijavljene nuspojave.
English: The speed at which the drops come out can be changed by varying the angle at which the bottle is held.
Croatian: Brzina kojim kapi izlaze može se mijenjati promjenom kuta pod kojim se bočica drži.
English: You can also report side effects directly via the national reporting system: [to be filled in nationally]
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: [Ispunjava se nacionalno]
English: Antibiotics may inhibit the Escherichia coli bacteria and thus reduce the efficacy of this medicine.
Croatian: Antibiotici mogu sprječavati aktivnost (inhibirati) bakterije Escherichia coli i tako smanjiti djelotvornost ovog lijeka.
English: Not known: flatulence, nausea, diarrhoea.
Croatian: Nepoznato: flatulencija, mučnina, proljev.
English: This can be prevented by opening the bottle for a short time only when using this product, and by dispensing the drops carefully.
Croatian: To se može spriječiti tako da bočicu otvarate nakratko, samo kada koristite lijek, te da pažljivo kapate kapi.
English: The efficacy and safety in children and adolescents have not been established.
Croatian: Djelotvornost i sigurnost u djece i adolescenata još nije ustanovljena.
English: No countermeasures are necessary.
Croatian: Nije potrebno poduzeti protumjere.
English: Only limited experience of adverse reactions in children from pharmacovigilance data is available.
Croatian: Dostupni su samo ograničeni farmakovigilancijski podaci o nuspojavama u djece.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system (details see below).
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava (pojedinosti su navedene u nastavku).
English: The drops are taken orally during the meals.
Croatian: Kapi se uzimaju peroralno, uz obrok.
English: Overall, there is a shift in activity in favour of Th1 helper cells, accompanied by inhibition of the Th2 helper cells.
Croatian: Uglavnom, postoji pomak u aktivnosti Th1 pomoćnih stanica uz inhibiciju Th2 pomoćnih stranica.
English: Talk to your doctor or pharmacist before taking Symbioflor E. coli.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Symbioflor E. coli.
English: If and to what extend these results are applicable for the use in patients is not yet known.
Croatian: Još nije poznato mogu li se i u kojoj mjeri ti rezultati prenijeti na primjenu u bolesnika.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Croatian: Nadležna tijela država članica mogu, prema potrebi, naknadno ažurirati informacije o lijeku u suradnji s referentnom državom članicom, u skladu s postupcima navedenima u poglavlju 4. Glave III.
English: Efficacy and safety beyond 8 weeks have not been studied.
Croatian: Djelotvornost i sigurnost primjene lijeka nakon 8 tjedana nisu ispitane.
English: Do not take Symbioflor E. coli during acute illnesses with fever.
Croatian: Nemojte uzimati Symbioflor E. coli tijekom akutne bolesti popraćene vrućicom.
English: Symbioflor E. coli contains no preservatives and is therefore susceptible to contamination in the event of improper use.
Croatian: Symbioflor E. coli ne sadrži konzervanse i stoga je osjetljiv na zagađenje u slučaju nepravilne uporabe.
English: Section 4 Possible side effects
Croatian: Dio 4. Moguće nuspojave:
English: The existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below] Summary of product characteristics
Croatian: Postojeće informacije o lijeku treba izmijeniti (umetnuti, zamijeniti ili izbrisati tekst, kako je prikladno) na način da odgovaraju dogovorenom tekstu, kako je navedeno u nastavku.
English: No recommendation on a posology can be made as the efficacy and safety in children and adolescents have not been established.
Croatian: Preporuke o doziranju nije moguće dati jer djelotvornost i sigurnost u djece i adolescenata nije utvrđena.
English: After one week, the dose is increased to 20 drops three-times daily.
Croatian: Nakon jednog tjedna, doza se povećava na 20 kapi tri puta dnevno.
English: Although there are no known harmful effects of Symbioflor E. coli on the unborn child, the drops should be used during pregnancy and when breast-feeding only after a careful benefit-risk assessment by the doctor.
Croatian: Iako nisu poznati štetni učinci lijeka Symbioflor E. coli na nerođeno dijete, kapi se smiju koristiti u trudnoći i tijekom dojenja samo nakon što liječnik pažljivo procijeni omjer koristi i rizika.
English: Section 2 What you need to know before you take Symbioflor E. coli The text below should be inserted by replacing the existing text of this section:
Croatian: Što morate znati prije nego počnete uzimati Symbioflor E. coli U ovom dijelu treba umetnuti tekst u nastavku, kojim se zamjenjuje postojeći tekst:
English: Severe organic diseases of the gastrointestinal tract such as acute cholecystitis, acute pancreatitis, ileus, as well as cachexia and marasmus.
Croatian: Teške organske bolesti gastrointestinalnog trakta kao što su akutni kolecistitis, akutni pankreatitis, ileus, kao i kaheksija i marazam.
English: Symbioflor E. coli has no or negligible influence on the ability to drive or use machines.
Croatian: Symbioflor E. coli ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The qualitative effect on the gene expression in the mucosal epithelial cells, the key control elements of immune function in the human intestine, is similar to that exerted by the natural, physiological intestinal flora.
Croatian: Kvalitativni učinak na ekspresiju gena u epitelnim stanicama sluznice, ključnim kontrolnim elementima imunološke funkcije u ljudskim crijevima, sličan je učinku koji izaziva prirodna, fiziološka crijevna flora.
English: In the group of children aged 12 - 18 years with the IBS subtype “pain + alternating diarrhoea and constipation” the physician's and patient/parent's assessment of efficacy was lowest (55 % or 66 %, respectively).
Croatian: U skupini djece u dobi od 12 do 18 godina s podvrstom sindroma iritabilnog crijeva „bol + izmjenični proljev i konstipacija”, ocjena djelotvornosti od strane liječnika i bolesnika/roditelja bila je najmanja (55 % odnosno 66 %).
English: Not known (cannot be estimated from the available data): - Flatulence - Nausea - Diarrhoea
Croatian: Nepoznato (učestalost se ne može procijeniti na temelju dostupnih podataka): - vjetrovi - mučnina - proljev
English: The investigator's global assessment of tolerability was predominantly good to very good and balanced between Symbioflor E. coli and placebo.
Croatian: Ukupna ocjena ispitivača o podnošljivosti bila je uglavnom dobra do vrlo dobra i uravnotežena kad se uspoređuje Symbioflor E. coli i placebo.
English: In a human whole-blood culture model, Symbioflor E. coli exerts strong modulating effects on the physiologically induced synthesis and release of cytokines and chemokines.
Croatian: U modelu kulture ljudske pune krvi lijek Symbioflor E. coli ima jake modulacijske učinke na fiziološki induciranu sintezu i otpuštanje citokina i kemokina.
English: Prior to a diagnosis of 'irritable bowel syndrome', your doctor should exclude organic causes of the gastrointestinal disorders.
Croatian: Prije dijagnosticiranja „sindroma iritabilnog crijeva” liječnik treba isključiti organske uzroke gastrointestinalnih poremećaja.
English: At the beginning of the treatment: 10 drops three-times daily.
Croatian: Na početku liječenja: 10 kapi tri puta dnevno.
English: The most common undesirable effects observed in the clinical trial, predominantly observed within the first 4 weeks of treatment, were abdominal pain and urticaria.
Croatian: Najčešće nuspojave primijećene u kliničkom ispitivanju uglavnom u prva 4 tjedna liječenja su bol u trbuhu i urtikarija.
English: A clinical trial including 298 patients with irritable bowel syndrome recruited in primary care centres showed a good or very good treatment success on Symbioflor E. coli in 62.9 % of the patients and in 39.4 % of the patients treated with placebo based on the investigator's global assessment of efficacy on a 4-point rating scale
Croatian: Kliničko ispitivanje u kojem je sudjelovalo 298 bolesnika sa sindromom iritabilnog crijeva i koje je provedeno u centrima primarne zdravstvene zaštite pokazalo je dobar ili vrlo dobar uspjeh liječenja lijekom Symbioflor E. coli u 62,9 % bolesnika i u 39,4 % bolesnika koji su liječeni placebom na temelju ukupne ocjene ispitivača (engl. investigator's global assessment) o djelotvornosti na temelju ljestvice s 4 moguće ocjene.
English: The text below should be inserted by replacing the existing text of this section: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: U ovom dijelu treba umetnuti tekst u nastavku, kojim se zamjenjuje postojeći tekst: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Release of the drops is started by holding the bottle at an angle and tapping lightly on the bottom.
Croatian: Kapi se ispuštaju tako da držite bočicu nagnutu i lagano udarate dno bočice.
English: In a non-interventional post-marketing high-dose safety study in healthy volunteers, two of five subjects experienced side effects.
Croatian: Nakon stavljanja lijeka u promet, u neintervencijskom sigurnosnom ispitivanju primjene visoke doze, u kojem su dobrovoljno sudjelovali zdravi ispitanici, u dvoje od petero ispitanika javile su se nuspojave.
English: Escherichia coli, the active substance in Symbioflor E. coli, is a living bacterium that is present in the healthy intestinal flora of humans.
Croatian: Escherichia coli, djelatna tvar u lijeku Symbioflor E. coli živa je bakterija prisutna u zdravoj crijevnoj flori ljudi.
English: The text below should be inserted by replacing the existing text of this section: Prior to a diagnosis of ‚irritable bowel syndrome‘, organic causes of the gastrointestinal disorders must be excluded.
Croatian: U ovom dijelu treba umetnuti tekst u nastavku, kojim se zamjenjuje postojeći tekst: Prije dijagnosticiranja „sindroma iritabilnog crijeva” moraju se isključiti organski uzroci gastrointestinalnih poremećaja.
English: In an in-vitro gastric exposure model mimicking the human stomach and ileus under fasting conditions 1 ml (less than a single dose) of Symbioflor E. coli was tested for the survivability of the E. coli production strain.
Croatian: U in-vitro modelu gastrične izloženosti koji oponaša ljudski želudac i ileus u uvjetima natašte, ispitana je doza od 1 ml (manje od jedne doze) lijeka Symbioflor E. coli kako bi se saznalo kako djeluje na preživljavanje proizvodnog soja bakterije E. coli.
English: The number of patients free of all the assessed IBS relevant symptoms after the treatment period of 8 weeks was significantly higher for Symbioflor E. coli treatment compared to placebo
Croatian: Broj bolesnika koji nisu imali nijedan od ocjenjivanih simptoma relevantnih za sindrom iritabilnog crijeva nakon razdoblja liječenja od 8 tjedana bio je značajno veći za lijek Symbioflor E. coli u usporedbi s placebom.
English: Efficacy was confirmed when using two post-hoc defined patient assessed endpoints, i.e. patient's assessment of symptoms and abdominal discomfort/pain comprising each of 8 or respectively 5 IBS relevant symptoms.
Croatian: Djelotvornost je potvrđena na temelju dvije post-hoc definirane mjere ishoda koje su ocjenjivali bolesnici, odnosno na temelju ocjene koju su bolesnici dodijelili simptomima i nelagodi/boli u trbuhu, pri čemu se svaka sastojala od 8 ili 5 simptoma relevantnih za sindrom iritabilnog crijeva.
English: During acute febrile diseases, Symbioflor E. coli should be temporarily discontinued.
Croatian: Tijekom akutnih febrilnih bolesti, potrebno je privremeno prekinuti primjenu lijeka Symbioflor E. coli.
English: An in-vitro study carried out using polymerase chain reaction (PCR) to investigate the effects of Symbioflor E. coli on epithelial cells (SW 480) from the human intestinal mucosa showed an upregulation of the cytokines IL-1β, TNF-α, GM-CSF and the chemokine IL-8.
Croatian: In-vitro ispitivanje u kojem su pomoću lančane reakcije polimeraze (PCR) ispitivani učinci lijeka Symbioflor E. coli na epitelnim stanicama (SW 480) iz ljudske crijevne sluznice pokazalo je povećanje (up-regulation) citokina IL-1β, TNF-α, GM-CSF i kemokina IL-8.
English: Symbioflor E. coli with food and drink Take the drops during meals (see section 3 How to take Symbioflor E. coli)
Croatian: Symbioflor E. coli s hranom i pićem Kapi uzmite uz obrok (vidi dio 3. Kako uzimati Symbioflor E. coli)
English: Shake Symbioflor E. coli well before use.
Croatian: Dobro protresite Symbioflor E. coli prije upotrebe.
English: Because of the high surface tension of Symbioflor E. coli, problems with starting and stopping release of the drops of solution cannot be completely avoided.
Croatian: Budući da Symbioflor E. coli ima veliku površinsku napetost, problemi s početkom i završetkom kapanja ne mogu se u potpunosti izbjeći.
English: Do not take a double dose to make up for a forgotten dose, but continue taking the dosage prescribed.
Croatian: Ako ste zaboravili uzeti Symbioflor E. coli Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu, već nastavite uzimati propisane doze.
English: Pharmacotherapeutic group: Other immunostimulants, Antidiarrheal microorganisms ATC code: L03AX, A07FA
Croatian: U ovom dijelu treba umetnuti tekst u nastavku, kojim se zamjenjuje postojeći tekst: Farmakoterapijska skupina: ostali imunostimulatori, antidijaroični mikroorganizmi, ATK oznaka: L03AX, A07FA
English: In this model enough bacteria of the E. coli strain survived the acid stomach passage so that their number increased again when they reached the small intestine conditions.
Croatian: U tom modelu, dovoljno bakterija soja E. coli preživio je prolazak kroz kiselinu u želucu tako da se broj bakterija ponovno povećao nakon što su stigle u uvjete tankog crijeva.
English: Other medicines and Symbioflor E. coli
Croatian: Drugi lijekovi i Symbioflor E. coli
English: When the same volume was tested in the SHIME model (Simulation of the Human Intestinal Microbial Ecosystem) under conditions simulating food intake fewer bacteria were killed in the stomach while their numbers were relatively stable in the conditions simulating the upper gastrointestinal tract.
Croatian: Simulation of the Human Intestinal Microbial Ecosystem) u uvjetima koji simuliraju unos hrane, u želucu je ubijeno manje bakterija, dok je njihov broj bio relativno stabilan u uvjetima koji simuliraju gornji gastrointestinalni trakt.
English: 5.2 Pharmacokinetic properties
Croatian: 5.2. Farmakodinamička svojstva
English: Symbioflor E. coli should not be taken during a treatment with antibiotics or within 5 days after the end of such a treatment (see also section 4.5).
Croatian: Symbioflor E. coli ne smije se uzimati tijekom liječenja antibioticima ili unutar 5 dana nakon završetka takvog liječenja (vidi također dio 4.5.).
English: Common: abdominal pain (including upper abdominal pain and abdominal discomfort).
Croatian: Često: bol u trbuhu (uključujući bol u gornjem dijelu trbuha i nelagodu u trbuhu).
English: In a non-interventional study with 203 children aged 4 - 18 years, that were diagnosed for having IBS based on the ROM III criteria for children, the overall assessment of efficacy for all 4 IBS subtypes was very good to good in more than 80 % of the children for both, the physician's and the patient/parent's assessment.
Croatian: U neintervencijskom ispitivanju u kojem je sudjelovalo 203 djece u dobi od 4 do 18 godina s dijagnosticiranim sindromom iritabilnog crijeva na temelju kriterija ROM III za djecu, ukupna ocjena djelotvornosti i od strane liječnika i od strane bolesnika/roditelja za sve 4 podvrste sindroma iritabilnog crijeva bila je vrlo dobra ili dobra u više od 80 % djece.
English: If symptoms worsen during treatment or persist after 8 weeks of treatment, the patient should seek medical advice.
Croatian: Ako se simptomi pogoršaju tijekom terapije ili su i dalje prisutni nakon 8 tjedana terapije, bolesnik treba potražiti savjet liječnika.
English: Adults take 10 drops orally three-times daily during meals at the beginning of treatment.
Croatian: Na početku terapije odrasli uzimaju 10 kapi kroz usta (peroralno) tri puta dnevno uz obrok.
English: The high dose study (see section 4.9) demonstrated that the specific E. coli strain cultivates the human gut at least for days but also for up to months after a single dose.
Croatian: Ispitivanje uz visoku dozu (vidi dio 4.9.) pokazalo je da nakon jednokratne doze, određeni soj bakterije E. coli kultivira ljudsko crijevo u periodu mjerljivom najmanje danima pa sve do onog mjerljivog mjesecima.
English: The wording of the indication should be deleted and the text below should be inserted in its place: Irritable bowel syndrome
Croatian: Tekst indikacije treba izbrisati i zamijeniti sljedećim tekstom: sindrom iritabilnog crijeva
English: Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare not known (cannot be estimated from the available data) The following undesirable effects may occur: Immune system disorders Common: urticaria
Croatian: Manje često (≥1/1000 i <1/100) Rijetko (≥1/10 000 i <1/1000) Vrlo rijetko (<1/10 000)
English: If you take more Symbioflor E. coli than you should
Croatian: Ako uzmete više lijeka Symbioflor E. coli nego što ste trebali
English: The text below should be inserted by replacing the existing text of this section: Summary of safety profile
Croatian: U ovom dijelu treba umetnuti tekst u nastavku, kojim se zamjenjuje postojeći tekst: Sažetak sigurnosnog profila
English: If symptoms worsen during treatment or persist after 8 weeks of treatment, seek medical advice.
Croatian: Ako se simptomi pogoršaju tijekom terapije ili su i dalje prisutni i nakon 8 tjedana od početka terapije, potražite savjet liječnika.
English: Only non-serious and already known side effects as described in section 4.8 were reported upon administration of single doses up to 20 times higher than the recommended daily dose.
Croatian: Nakon primjene jednokratne doze lijeka do 20 puta veće od preporučene dnevne doze prijavljene su samo poznate nuspojave koje nisu ozbiljne i koje su opisane u dijelu 4.8.
English: If gastrointestinal symptoms (like abdominal pain, flatulence or diarrhoea) worsen or occur more frequently at the beginning of the treatment, please refer to section 4.2 for measures to be taken to reduce or avoid these symptoms.
Croatian: Ako se gastrointestinalni simptomi (kao što su bol u trbuhu, flatulencija ili proljev) pogoršaju ili se pojavljuju češće na početku terapije, pogledajte dio 4.2. kako biste saznali koje mjere treba poduzeti kako biste smanjili ili izbjegli te simptome.
English: If symptoms are more severe, e.g. acute diarrhoea with high fever or with blood in stool or the diarrhoea lasts longer than 2 days, or if other, longer-lasting or unexplained gastrointestinal symptoms occur, treatment should be discontinued and a doctor should be consulted.
Croatian: Ako se radi o težim simptomima, na primjer ako se pojavi akutni proljev popraćen visokom temperaturom ili krvlju u stolici ili proljev koji traje dulje od 2 dana ili neki drugi dugotrajni ili neobjašnjivi gastrointestinalni simptomi, liječenje treba prekinuti i potražiti savjet liječnika.
English: The evaluation of undesirable effects is based on the following frequencies: Very common (≥1/10)
Croatian: Vrlo često (≥1/10)