FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, no reproductive or developmental toxicity is to be expected.
Croatian: Stoga se ne očekuje reproduktivna ili razvojna toksičnost.
English: Other possible side effects may include:
Croatian: Druge moguće nuspojave mogu uključivati:
English: Wait until your next meal, and take your usual number of capsules with your meal.
Croatian: Pričekajte do sljedećeg obroka i uzmite uobičajeni broj kapsula uz Vaš obrok.
English: Approximately half of the patients were ages 1 to 3 years.
Croatian: Približno pola bolesnika bilo je u dobi od 1 do 3 godina.
English: If your doctor advises you to increase the number of capsules you take each day, you should do so slowly over several days.
Croatian: Ako Vam liječnik savjetuje da povećate broj kapsula koji uzimate svaki dan, trebate to učiniti sporo tijekom nekoliko dana.
English: Patients should be instructed not to increase the dosage on their own.
Croatian: Bolesnike treba upozoriti da ne povećavaju dozu sami.
English: Keep taking your medicine until your doctor tells you to stop.
Croatian: Nastavite uzimati lijek dok Vam liječnik ne kaže da prestanete.
English: Changes in dosage may require an adjustment period of several days.
Croatian: Prilagođavanje doze može zahtijevati razdoblje prilagođavanja od nekoliko dana.
English: Do not take a double dose or extra capsules to make up for a forgotten dose.
Croatian: Nemojte uzeti dvostruku dozu ili dodatne kapsule kako biste nadoknadili zaboravljenu dozu.
English: Results are presented above.
Croatian: Rezultati su prikazani u gornjem tekstu.
English: Study EUR 1009-M
Croatian: Ispitivanje EUR 1009-M
English: Opening date :
Croatian: Datum otvaranja:
English: Enzepi can only be sprinkled on certain food (see section 3).
Croatian: Enzepi se smije posipati samo na određenu hranu (vidjeti dio 3).
English: N: number of patients; SD: standard deviation; LS: least squares.
Croatian: N: broj bolesnika; SD: standardna devijacija; LS: najmanji kvadrati.
English: Stabilization of the symptoms had to be obtained before the end of the first 14 days of each treatment period.
Croatian: Bilo je potrebno postići stabilizaciju simptoma prije kraja prvih 14 dana za svako razdoblje liječenja.
English: *Symptoms of allergic reactions.
Croatian: *Simptomi alergijskih reakcija.
English: Other reported clinical experience has not identified differences in responses between the elderly and young patients.
Croatian: Druga prijavljena klinička iskustva nisu utvrdila razlike u odgovorima između starijih i mlađih bolesnika.
English: The dose is measured in ‘lipase units'.
Croatian: Doza se mjeri u "jedinicama lipaze".
English: The frequency of these two side effects is not known.
Croatian: Učestalost tih dviju nuspojava nije poznata.
English: Standard treatment (N=83)
Croatian: Standardno liječenje (N=83)
English: Variable statistic
Croatian: Statistička varijabla
English: No clinically relevant interactions are expected.
Croatian: Ne očekuju se klinički značajne interakcije.
English: Children (between 1 and 4 years of age)
Croatian: Djeca (između 1 i 4 godine)
English: Do not take more capsules in a day than the amount your doctor has told you (total daily dose).
Croatian: Nemojte uzimati više kapsula na dan od količine koju Vam je liječnik preporučio (ukupna dnevna doza).
English: Do not chew the capsules.
Croatian: Ne žvakati kapsule.
English: What Enzepi looks like and contents of the pack
Croatian: Kako Enzepi izgleda i sadržaj pakiranja
English: Enzepi is indicated in infants, children, adolescents and adults.
Croatian: Enzepi je indiciran u dojenčadi, djece, adolescenata i odraslih.
English: What Enzepi is and what it is used for
Croatian: Što je Enzepi i za što se koristi
English: Ask your doctor about other foods you can sprinkle Enzepi granules on.
Croatian: Upitajte liječnika o drugoj hrani na koju možete posuti granule Enzepi.
English: Children (over 1 year of age), adolescents and adults
Croatian: Djeca (starija od 1 godine), adolescenti i odrasli
English: Moreover three supportive studies were conducted in 34 paediatric patients.
Croatian: Štoviše, tri suportivna ispitivanja provedena su u 34 pedijatrijska bolesnika.
English: Depending on what strength of Enzepi you take, your doctor will tell you how many capsules you need to take with each meal or snack.
Croatian: Ovisno o jačini lijeka Enzepi koji ćete uzeti, Vaš liječnik će Vam reći koliko kapsula trebate uzeti uz svaki obrok ili međuobrok.
English: Therapy should be initiated at the lowest recommended dose and gradually increased under medical supervision with careful monitoring of the patient's response and symptoms.
Croatian: Potrebno je započeti terapiju najnižom preporučenom dozom i postupno povećavati pod liječničkim nadzorom uz pažljivo praćenje odgovora i simptoma u bolesnika.
English: You may also sprinkle the granules directly into your child's mouth.
Croatian: Granule možete posuti i izravno u usta Vašeg djeteta.
English: Overall, caregivers were satisfied with using apple sauce as a dosing method compared with apple juice.
Croatian: Sveukupno, njegovatelji su bili zadovoljniji korištenjem pirea od jabuke kao metode doziranja u usporedbi sa sokom od jabuke.
English: Do not take Enzepi - if you are allergic to the active subtance or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Enzepi - ako ste alergični na djelatnu tvar ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: OTHER SPECIAL WARNING(S), IF NECESSARY Do not swallow the desiccant.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Nemojte progutati sredstvo za sušenje.
English: If required, carefully open the capsule and administer the contents (granules) to the patient as described in section 4.2.
Croatian: Ako je potrebno, pažljivo otvorite kapsulu i primijenite sadržaj (granule) u bolesnika kao što je opisano u dijelu 4.2.
English: No specific adverse reactions were identified in the elderly population.
Croatian: Nisu utvrđene specifične nuspojave u starijoj populaciji.
English: The primary objective was to assess the acceptability of 2 modes of administration using an acceptability questionnaire that was completed by the caregiver.
Croatian: Primarni cilj bio je procijeniti prihvatljivost 2 načina primjene korištenjem upitnika prihvatljivosti koji je ispunjavao njegovatelj.
English: Very common (may affect more than 1 in 10 people): stomach pain.
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 osoba): bol u trbuhu.
English: The granules may be administered with a small amount of appropriate acidic food or directly into the mouth.
Croatian: Granule se mogu primijeniti s malom količinom odgovarajuće kisele hrane ili direktno u usta.
English: Patients unable to swallow capsules whole
Croatian: Bolesnici koji ne mogu progutati cijele kapsule
English: It is not known if Enzepi will affect your ability to get pregnant or if it harms your unborn baby.
Croatian: Nije poznato hoće li Enzepi utjecati na Vašu sposobnost da zatrudnite ili šteti li Vašem nerođenom djetetu.
English: Severe allergic reaction
Croatian: Teška alergijska reakcija
English: If you take more Enzepi than you should If you take more Enzepi than you should drink plenty of water and talk to your doctor as soon as possible.
Croatian: Ako uzmete više lijeka Enzepi nego što ste trebali morate popiti puno vode i obratiti se što prije Vašem liječniku.
English: If you are breast-feeding or plan to breast-feed, or if you are pregnant, 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 dojite ili planirate dojiti, ili ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
English: Difference in LS means (95% confidence limits)
Croatian: Razlika u srednjim vrijednostima dobivenim metodom LS (95%-tna granica pouzdanosti)
English: Patients were administered Enzepi at the same dose they were taking at the end of Study PR-011.
Croatian: Bolesnici su primili Enzepi u istoj dozi koju su uzimali na kraju Ispitivanja PR-011.
English: Maximum recommended dose
Croatian: Najveća preporučena doza
English: If you are diabetic, you should speak with your doctor, if you notice any changes in your blood glucose levels.
Croatian: Ako imate šećernu bolest, morate razgovarati sa svojim liječnikom ako primijetite promjene u razinama glukoze u krvi.
English: Then, starting on the second day, the dose of assigned treatment could be changed (titrated up and/or titrated down) to stabilize the symptoms of EPI.
Croatian: Zatim, počevši od drugog dana, doza dodijeljenog liječenja mogla se izmijeniti (titrirana naviše i/ili titrirana nadolje) radi stabiliziranja simptoma EPI-ja.
English: Pack size of 20, 50, 100, and 200 capsules.
Croatian: Veličine pakiranja od 20, 50, 100 i 200 kapsula.
English: Paediatric population below 1 year of age
Croatian: Pedijatrijska populacija mlađa od 1 godine
English: The difference in means was -1.25 (95% CI, -3.62 to 1.12), with p=0.2972.
Croatian: Razlika u srednjim vrijednostima bila je -1,25 (95% CI, od -3,62 do 1,12) uz p= 0,2972.
English: If this reaction occurs, patients should be advised to discontinue treatment immediately and seek urgent medical assistance.
Croatian: Ako dođe do takve reakcije, bolesnike treba savjetovati da odmah prekinu liječenje i zatraže hitnu medicinsku pomoć.
English: The capsule should be carefully opened to empty the content (granules).
Croatian: Kapsulu treba pažljivo otvoriti da se isprazni sadržaj (granule).
English: A total of 96 patients, aged 12 to 43 years, were randomized in the intent-to-treat population.
Croatian: Ukupno 96 bolesnika u dobi od 12 do 43 godine bilo je randomizirano u populaciji predviđenoj za liječenje (ITT).
English: Your child should take all the food mixture and should then drink enough liquid straight after to wash down all the medicine.
Croatian: Vaše dijete treba uzeti svu mješavinu hrane i odmah zatim popiti dovoljno tekućine kako bi potpuno progutalo sav lijek.
English: If you or your child eat a lot of meals or snacks in a day, be careful not to go over your total daily dose of Enzepi.
Croatian: Ako Vi ili Vaše dijete uzimate mnogo obroka ili međuobroka dnevno, pazite da ne prekoračite Vašu ukupnu dnevnu dozu lijeka Enzepi.
English: Study EUR-1008-M
Croatian: Ispitivanje EUR-1008-M
English: Enzepi is designed to release most of the enzymes in vivo at pH greater than 5.5.
Croatian: Enzepi je dizajniran za otpuštanje većine enzima in vivo pri pH većem od 5,5.
English: You and your doctor should decide if you will take Enzepi or breast-feed.
Croatian: Vi i Vaš liječnik trebate odlučiti hoćete li uzeti Enzepi ili dojiti.
English: A dose adjustment may be necessary.
Croatian: Možda bude potrebno prilagoditi dozu.
English: Carefully open the capsule and empty the granules on a small amount of acidic food (see above).
Croatian: Pažljivo otvorite kapsulu i ispraznite granule na malu količinu kisele hrane (vidjeti gore).
English: There are no adequate data from the use of this medicinal product in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni ovog lijeka u trudnica.
English: Twelve patients completed the study.
Croatian: Ispitivanje je dovršilo dvanaest bolesnika.
English: The pivotal study PR-005 was conducted in Europe.
Croatian: Pivotalno ispitivanje PR-005 provedeno je u Europi.
English: For each snack, half of the prescribed Enzepi dose for a full meal should be given.
Croatian: Za svaki međuobrok, potrebno je uzeti pola propisane doze lijeka Enzepi za cijeli obrok.
English: Anaphylactic shock is a severe, potentially life-threatening allergic reaction that can develop rapidly.
Croatian: Anafilaktički šok je teška, potencijalno opasna po život alergijska reakcija koja se može brzo razviti.
English: What Enzepi is and what it is used for What you need to know before you take Enzepi How to take Enzepi
Croatian: Što je Enzepi i za što se koristi Što morate znati prije nego počnete uzimati Enzepi
English: MedDRA System Organ Classification and are ranked under headings of frequency, using the following categories: 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) and not known (cannot be estimated from the available data).
Croatian: Razvrstani su prema MedDRA klasifikaciji organskih sustava i prikazani prema sljedećim kategorijama učestalosti: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000) te nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Study PR-018 was a 12-month open-label extension of Study PR-011.
Croatian: Ispitivanje PR-018 bilo je 12-mjesečni otvoreni nastavak Ispitivanja PR-011.
English: The risk and benefit of this medicinal product should be considered in the context of the need to provide adequate nutritional support to a pregnant woman with exocrine pancreatic insufficiency.
Croatian: Potrebno je razmotriti rizik i korist ovog lijeka u kontekstu potrebe za pružanjem odgovarajuće nutritivne podrške trudnici s egzokrinom insuficijencijom gušterače.
English: If an allergic reaction occurs, stop your treatment and talk to your doctor.
Croatian: Ako se javi alergijska reakcija, prekinite liječenje i razgovarajte s liječnikom.
English: Higher doses should be used with caution if warranted (see sections 4.4 and 4.9) and only if they are documented to be effective by 3day faecal fat measurements that indicate a significantly improved coefficient of fat absorption.
Croatian: Više doze treba uzimati uz oprez ako je njihovo uzimanje opravdano (vidjeti dijelove 4.4 i 4.9) i samo ako su dokumentirano učinkovite trodnevnim mjerenjem masnoća u stolici, što označava značajno poboljšan koeficijent apsorpcije masti.
English: Model-based statistics (Enzepi minus Creon) LS mean (standard error)
Croatian: Statistike na bazi modela (Enzepi minus Creon) srednja vrijednost dobivena metodom LS (standardna pogreška)
English: In clinical trials, 110 children with CF (cystic fibrosis) aged 1 month and older received Enzepi at a dose that ensured stabilization of symptoms.
Croatian: U kliničkim ispitivanjima, 110 djece sa CF-om (cistična fibroza) u dobi od 1 mjeseca i više dobivalo je Enzepi u dozi koja je osigurala stabilizaciju simptoma.
English: Many patients will need to take pancreatic enzyme replacement medicines for the rest of their life.
Croatian: Mnogi bolesnici će trebati nadomjesno liječenje enzimima gušterače do kraja života.
English: It is also not known whether this medicinal product can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity.
Croatian: Također nije poznato može li ovaj lijek oštetiti plod kada se primjenjuje u trudnica ili može li utjecati na sposobnost reprodukcije.
English: The safety and efficacy in the paediatric patients in this study was similar to the adult patients.
Croatian: Sigurnost i djelotvornost u pedijatrijskih bolesnika u ovom ispitivanju bile su slične onima u odraslih bolesnika.
English: Supportive measures including stopping pancreatic enzyme therapy and ensuring adequate rehydration are recommended.
Croatian: Preporučuju se potporne mjere koje uključuju prekid liječenja enzimima gušterače i osiguravanje prikladne rehidracije.
English: As a precaution, unusual abdominal symptoms or changes in abdominal symptoms should be medically assessed to exclude the possibility of fibrosing colonopathy, especially if the patient is taking in excess of 10,000 lipase units/kg/day.
Croatian: Kao mjera opreza, potrebna je liječnička procjena neobičnih abdominalnih simptoma ili promjena u abdominalnim simptomima kako bi se isključila mogućnost fibrozirajuće kolonopatije, naročito ako bolesnik uzima više od 10 000 jedinica lipaze/kg/dan.
English: What you need to know before you take Enzepi
Croatian: Što morate znati prije nego počnete uzimati Enzepi
English: It is important to ensure adequate hydration of patients at all times whilst dosing Enzepi.
Croatian: Važno je osigurati odgovarajuću hidraciju bolesnika cijelo vrijeme dok se uzima Enzepi.
English: EUR-1008-M was conducted in 34 patients with EPI due to CF, 26 of whom were children, including 8 children aged 7 to 11 years, and 18 adolescents aged 12 to 17 years.
Croatian: Ispitivanje EUR-1008-M provedeno je u 34 bolesnika s EPI-jem uslijed CF-a, od kojih je 26 bilo djece, uključujući 8 djece u dobi od 7 do 11 godina i 18 adolescenata u dobi od 12 do 17 godina.
English: Enzyme doses expressed as lipase units/kg of body weight per meal must be reduced in older patients because they tend to ingest less fat per kilogram of body weight.
Croatian: Enzimske doze izražene kao jedinice lipaze/kg tjelesne težine po obroku treba smanjiti u starijih bolesnika jer su skloni unositi manje masti po kilogramu tjelesne težine.
English: If this occurs, call for urgent medical attention straightaway.
Croatian: Ako se to dogodi, odmah zatražite hitnu medicinsku pomoć.
English: Clinical studies of Enzepi did not include sufficient numbers of subjects aged 65 and over to determine whether they respond different from younger subjects.
Croatian: U klinička ispitivanja lijeka Enzepi nije uključen dovoljan broj ispitanika u dobi od 65 i više godina da bi se moglo odrediti odgovaraju li oni na liječenje drugačije od mlađih ispitanika.
English: Adequate caloric intake during pregnancy is important for normal maternal weight gain and foetal growth.
Croatian: Važan je odgovarajući unos kalorija tijekom trudnoće za normalni prirast tjelesne mase majke i fetalni rast.
English: Reduced maternal weight gain and malnutrition can be associated with adverse pregnancy outcomes.
Croatian: Smanjen prirast tjelesne mase majke i malnutricija mogu biti povezani s štetnim ishodima s obzirom na trudnoću.
English: Cases of blood glucose fluctuations have been reported with Enzepi, most of them non-serious and recovered after diabetic treatment adjustment.
Croatian: Uz Enzepi prijavljeni su slučajevi fluktuacije glukoze u krvi, većina nije bila ozbiljna i nestali su nakon prilagodbe liječenja dijabetesa.
English: Adare Pharmaceuticals Srl Via Martin Luther King 13 20060 Pessano Con Bornago ITALY
Croatian: Adare Pharmaceuticals Srl Via Martin Luther King 13 20060 Pessano Con Bornago Italija
English: Potential for hyperuricaemia
Croatian: Mogućnost hiperuricemije
English: The collection was performed in an approved, controlled environment that enabled supervised dietary intake and quantitative stool collection.
Croatian: Uzimanje uzoraka obavljeno je u odobrenom, kontroliranom okruženju koje je omogućilo praćenje unosa hrane i kvantitativno uzimanje uzoraka stolice.
English: 6.6 Special precautions for disposal and other handling Use in paediatric population
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Primjena u pedijatrijskoj populaciji
English: Median (minimum - maximum)
Croatian: Sažetak statističkih podataka Srednja vrijednost (SD) Medijan (minimum - maksimum)
English: During the study, patients were instructed to consume 100 g (± 15 g) of fat per day and to maintain a consistent dietary fat intake for meals and snacks.
Croatian: Za vrijeme ispitivanja, bolesnici su upućeni na konzumiranje 100 g (±15 g) masnoća na dan i održavanje konstantanog unosa masnoća tijekom obroka i međuobroka.
English: As a risk to newborns/infants cannot be excluded, a decision must be made whether to discontinue breastfeeding or to discontinue/abstain from Enzepi therapy taking into account the benefit of breast-feeding for the child and the benefit of continued Enzepi therapy for the breastfeeding woman.
Croatian: Budući da se ne može isključiti rizik za novorođenče/dojenče, potrebno je odlučiti hoće li se prekinuti dojenje ili prekinuti liječenje/suzdržati se od nastavka liječenja lijekom Enzepi uzimajući u obzir korist dojenja za dijete i korist nastavka liječenja za dojilju.
English: Crushing, chewing or holding the Enzepi capsules in your or your child's mouth may cause irritation in your or your child's mouth or change the way Enzepi works in your or your child's body.
Croatian: Drobljenje, žvakanje ili držanje kapsula lijeka Enzepi u Vašim ustima ili ustima Vašeg djeteta može prouzročiti nadraženost u Vašim ustima ili ustima Vašeg djeteta ili promijeniti način na koji Enzepi djeluje u Vašem tijelu ili u tijelu Vašeg djeteta.
English: In clinical trials, most of them were mild to moderate in severity.
Croatian: U kliničkim ispitivanjima, većina nuspojava bile su blagog do umjerenog intenziteta.
English: Enzepi should always be taken with a meal or snack.
Croatian: Enzepi treba uvijek uzimati uz obrok ili međuobrok.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Do not chew the capsules.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Ne žvakati kapsule.
English: The primary efficacy endpoint was the percentage of “responders”, defined as those patients without steatorrhoea (<30% faecal fat content) and without signs and symptoms of malabsorption after one and two weeks of treatment with Enzepi.
Croatian: Primarna mjera ishoda djelotvornosti bila je postotak bolesnika koji su odgovorili na liječenje, što je definirano kao bolesnici bez steatoreje (<30% sadržaj fekalnih masti) i bez znakova i simptoma malapsorpcije nakon jednog ili dva tjedna liječenja lijekom Enzepi.
English: The number of responders (patients with less than 30% faecal fat content and without signs and symptoms of malabsorption) at baseline was 10/19 (52.6%), 13/19 (68.4%) after 1 week of treatment (stabilization) and 11/19 (57.9%) after the second week of open-label treatment with Enzepi.
Croatian: Broj bolesnika koji su odgovorili na liječenje (bolesnici s manje od 30% sadržaja fekalne masnoće i bez znakova i simptoma malapsorpcije) na početku ispitivanja bio je 10/19 (52,6%), 13/19 (68,4%) nakon 1 tjedna liječenja (stabilizacija) i 11/19 (57,9%) nakon drugog tjedna otvorenog liječenja lijekom Enzepi.
English: Rarely, a more serious allergic reaction may include a feeling of warmth, dizziness and fainting, trouble breathing; these are symptoms of a severe, potentially life-threatening condition called ‘anaphylactic shock'.
Croatian: Rijetko, ozbiljnije alergijske reakcije mogu uključivati osjećaj topline, omaglice i nesvjestice, poteškoće s disanjem; to su simptomi teškog stanja, potencijalno opasnog po život, koje se naziva "anafilaktički šok".
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION Periodic safety update reports The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i svim sljedećim nadopunama objavljenim na europskom internetskom portalu za lijekove.
English: The dose of Enzepi was adjusted during the 12month study as the patient's grew and gained weight.
Croatian: Doza lijeka Enzepi prilagođena je tijekom 12mjesečnog ispitivanja kako je bolesnik rastao i dobivao na težini.
English: Manufacturer Adare Pharmaceuticals Srl Via Martin Luther King, 13 20060, Pessano Con Bornago Milan
Croatian: Adare Pharmaceuticals Srl Via Martin Luther King, 13 20060, Pessano Con Bornago Milano
English: Other medicines and Enzepi Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Capsules should be swallowed whole and not chewed or crushed.
Croatian: Kapsule se moraju progutati cijele i ne smiju se žvakati niti drobiti.