FrancophonIA/ELRC3.0 huggingface dataset:
English: You can use one of the peel-off labels found on the vial to document the batch number in your diary or for reporting any side effects.
Croatian: Možete upotrijebiti jednu od samoljepivih naljepnica koje se nalaze na bočici kako biste dokumentirali serijski broj u svoj dnevnik ili za prijavu bilo koje nuspojave.
English: The solution will be clear or slightly opalescent and colourless.
Croatian: Otopina će biti bistra ili blago opalescentna i bezbojna.
English: The product does not contain a preservative, and the reconstituted product should be used immediately, or within 3 hours after reconstitution or removal of the grey tip cap. Other in-use storage times and conditions are the responsibility of the user.
Croatian: Ovaj lijek ne sadrži konzervanse te se rekonstituirani lijek treba primijeniti odmah ili u roku od 3 sata od rekonstitucije ili uklanjanja sivog zatvarača s vrha štrcaljke.
English: You can use one of the peel-off labels found on the pre-filled syringe to document the batch number in your diary or for reporting any side effects.
Croatian: Možete upotrijebiti jednu od samoljepivih naljepnica koje se nalaze na napunjenoj štrcaljki kako biste zabilježili serijski broj u svoj dnevnik ili za prijavu bilo koje nuspojave.
English: Ensuring that the syringe plunger rod is still fully depressed, invert the vial.
Croatian: Pazeći da je klip štrcaljke potpuno potisnut u štrcaljku, okrenite bočicu naopako.
English: Contents of the pack and other information What ReFacto AF contains
Croatian: Sadržaj pakiranja i druge informacije
English: The reconstituted product is to be injected intravenously over several minutes.
Croatian: Pripremljeni lijek ubrizgava se u venu tijekom nekoliko minuta.
English: Connect the solvent syringe to the vial adapter by inserting the tip of the syringe into the adapter opening while firmly pushing and turning the syringe clockwise until the connection is secured.
Croatian: Spojite štrcaljku s otapalom na nastavak za bočicu tako što ćete uvesti vršak štrcaljke u otvor nastavka i istovremeno čvrsto pritisnuti i zakrenuti štrcaljku u smjeru kazaljke na satu sve dok se čvrsto ne spoje.
English: Total ABR for subjects who reported following a Prophylaxis regimen at Baseline c median (min, max)
Croatian: Ukupni ABR za ispitanike koji su izjavili na početku da slijede profilaktički režim liječenja medijan (minimum, maksimum)
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja kašalj dispneja
English: 1 sterile infusion set 2 alcohol swabs
Croatian: 2 vatice natopljene alkoholom 1 flaster
English: PTPs 6 to <12 years
Croatian: Prethodno liječeni bolesnici 6 do < 12 godina
English: Use the reconstituted solution within 3 hours of reconstitution or removal of the grey tip cap.
Croatian: Primijenite pripremljenu otopinu u roku od 3 sata nakon pripreme ili uklanjanja sivog zatvarača vrha.
English: 1 pre-filled syringe: 250 IU moroctocog alfa (approx. 62.5 IU/ml after reconstitution).
Croatian: 1 napunjena štrcaljka: 250 IU moroktokoga alfa (približno 62,5 IU/ml nakon pripreme otopine).
English: Early haemarthrosis, muscle bleeding or oral bleeding
Croatian: Rana hemartroza, krvarenje u mišiće ili krvarenje u usnoj šupljini
English: Press down firmly on the package until the adapter snaps into place on top of the vial, with the adapter spike penetrating the vial stopper.
Croatian: Čvrsto pritisnite pakiranje s nastavkom prema dolje sve dok se nastavak ne utisne na mjesto na vrhu bočice, a šiljak nastavka probije čep bočice.
English: The reconstituted solution may be stored at room temperature prior to administration.
Croatian: Pripremljena otopina može se prije primjene čuvati na sobnoj temperaturi.
English: ReFacto AF is administered by intravenous (IV) infusion after reconstitution of the lyophilised powder for injection with the supplied solvent [sodium chloride 9 mg/ml (0.9%) solution] syringe.
Croatian: ReFacto AF se primjenjuje intravenskom (i.v.) infuzijom nakon pripreme liofiliziranog praška za injekciju s priloženom štrcaljkom s otapalom [otopina natrijevog klorida od 9 mg/ml (0,9%)].
English: With the ReFacto AF pre-filled syringe remaining upright, swirl gently several times until the powder is dissolved.
Croatian: Držeći uspravno ReFacto AF napunjenu štrcaljku, pomoću nekoliko nježnih kružnih pokreta promiješajte dok se prašak ne otopi.
English: While holding the adapter package, place the vial adapter over the vial.
Croatian: Držeći nastavak u pakiranju, postavite nastavak za bočicu iznad bočice.
English: Slowly draw back all the solution through the vial adapter into the syringe.
Croatian: Polako uvucite cijelu količinu otopine kroz nastavak bočice u štrcaljku.
English: In a study of 37 paediatric PTPs, the pharmacokinetic parameters of ReFacto AF observed after a 50 IU/kg dose are shown in the table below.
Croatian: Farmakokinetički parametri lijeka ReFacto AF, zabilježeni nakon doze od 50 IU/kg u ispitivanju provedenom na 37 prethodno liječenih pedijatrijskih bolesnika, prikazani su u tablici ispod.
English: s r.o.
Croatian: °C.
English: Number of subjects
Croatian: Broj ispitanika
English: Pfizer bv Tel: +31 (0)10 406 43 01
Croatian: Tel: +31 (0)10 406 43 01
English: After reconstitution, each mL of solution contains approximately 62.5 IU moroctocog alfa.
Croatian: Nakon rekonstitucije, jedan ml otopine sadrži približno 62,5 IU moroktokoga alfa.
English: 1 vial: 250 IU moroctocog alfa (approx. 62.5 IU/ml after reconstitution).
Croatian: 1 bočica: 250 IU moroktokoga alfa (približno 62,5 IU /ml nakon pripreme otopine).
English: PUPs <6 years
Croatian: Prethodno neliječeni bolesnici < 6 godina
English: Icepharma hf. Sími: + 354 540 8000
Croatian: Sími: + 354 540 8000
English: - After reconstitution with the supplied solvent [sodium chloride 9 mg/ml (0.9%) solution], each vial contains 62.5, 125, 250, or 500 IU, respectively (based on the strength of moroctocog alfa,
Croatian: - Nakon pripreme s priloženim otapalom [otopinom natrijevog klorida 9 mg/ml (0,9%)], jedna bočica sadrži 62,5, 125, 250 odnosno 500 IU (ovisno o jačini moroktokoga alfa, tj., 250, 500, 1000 ili 2000 IU) moroktokoga alfa po 1 ml pripremljene otopine za injekciju.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING REFACTO AF OUTER CARTON
Croatian: NALJEPNICA NAPUNJENE ŠTRCALJKE S OTAPALOM ZA REFACTO AF
English: After reconstitution, each mL of solution contains approximately 125 IU moroctocog alfa.
Croatian: Nakon rekonstitucije, jedan ml otopine sadrži približno 125 IU moroktokoga alfa.
English: Treatment with ReFacto AF should be started by a doctor who is experienced in the care of patients with haemophilia A. Your doctor will decide the dose of ReFacto AF you will receive.
Croatian: Liječenje lijekom ReFacto AF treba započeti liječnik s iskustvom u liječenju bolesnika s hemofilijom A.
English: Pfizer Luxembourg SARL
Croatian: Pfizer Luxembourg SARL Eesti filiaal
English: ReFacto AF 250 IU powder and solvent for solution for injection ReFacto AF 500 IU powder and solvent for solution for injection ReFacto AF 1000 IU powder and solvent for solution for injection ReFacto AF 2000 IU powder and solvent for solution for injection Moroctocog alfa (recombinant human coagulation factor VIII)
Croatian: ReFacto AF 250 IU prašak i otapalo za otopinu za injekciju ReFacto AF 500 IU prašak i otapalo za otopinu za injekciju ReFacto AF 1000 IU prašak i otapalo za otopinu za injekciju ReFacto AF 2000 IU prašak i otapalo za otopinu za injekciju moroktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
English: A solvent [sodium chloride 9 mg/ml (0.9%) solution for injection] is also supplied for reconstitution.
Croatian: Priloženo je i otapalo [otopina za injekciju natrijevog klorida 9 mg/ml (0,9%)] za pripremu lijeka.
English: After reconstitution, each mL of solution contains approximately 750 IU moroctocog alfa.
Croatian: Nakon rekonstitucije, jedan ml otopine sadrži približno 750 IU moroktokoga alfa.
English: The solution should appear clear to slightly opalescent and colourless.
Croatian: Otopina treba izgledati bistra do blago opalescentna i bezbojna.
English: ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU powder and solvent for solution for injection Powder and solvent for solution for injection
Croatian: ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU prašak i otapalo za otopinu za injekciju.
English: Pfizer Luxembourg SARL filialas Lietuvoje Tel. +3705 2514000
Croatian: Slovenská republika Pfizer Luxembourg SARL, organizačná zložka Tel: +421-2-3355 5500
English: ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe
Croatian: ReFacto AF 250 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki ReFacto AF 500 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki ReFacto AF 1000 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki ReFacto AF 2000 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki ReFacto AF 3000 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki
English: ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe Each pre-filled syringe contains nominally 3000 IU* moroctocog alfa**.
Croatian: ReFacto AF 3000 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka nominalno sadrži 3000 IU* moroktokoga alfa**.
English: ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe Moroctocog alfa (recombinant human coagulation factor VIII)
Croatian: ReFacto AF 500 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki ReFacto AF 1000 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki ReFacto AF 2000 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki ReFacto AF 3000 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki moroktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
English: The data in the table below relates to PUP and PTP data from ReFacto AF studies in patients <12 years.
Croatian: Podaci u tablici ispod odnose se na podatke o prethodno neliječenim bolesnicima i prethodno liječenim bolesnicima obuhvaćenim ispitivanjima lijeka ReFacto AF na bolesnicima u dobi
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS REFACTO AF VIAL LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
English: • hives, rash, itching
Croatian: • koprivnjača, osip, svrbež
English: ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe Each pre-filled syringe contains nominally 250 IU* moroctocog alfa**.
Croatian: ReFacto AF 250 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka nominalno sadrži 250 IU* moroktokoga alfa**.
English: PTPs <6 years
Croatian: Prethodno liječeni bolesnici < 6 godina
English: ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe Each pre-filled syringe contains nominally 500 IU* moroctocog alfa**.
Croatian: ReFacto AF 500 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka nominalno sadrži 500 IU* moroktokoga alfa**.
English: Keep the vial in the original package in order to protect from light.
Croatian: Bočicu čuvati u originalnom pakiranju radi zaštite od svjetlosti.
English: After reconstitution, each mL of solution contains approximately 500 IU moroctocog alfa.
Croatian: Nakon rekonstitucije, jedan ml otopine sadrži približno 500 IU moroktokoga alfa.
English: After reconstitution, each mL of solution contains approximately 250 IU moroctocog alfa.
Croatian: Nakon rekonstitucije, jedan ml otopine sadrži približno 250 IU moroktokoga alfa.
English: Once reconstituted, ReFacto AF should be inspected for particulate matter and discolouration prior to administration.
Croatian: Nakon pripreme ReFacto AF treba pregledati prije primjene da ne sadrži čestice i da nije promijenio boju.
English: ReFacto AF 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU* moroctocog alfa**.
Croatian: ReFacto AF 2000 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 2000 IU* moroktokoga alfa**.
English: Meana ± SD
Croatian: Srednja vrijednost a  SD
English: The solution will be clear to slightly opalescent and colourless.
Croatian: Otopina će biti bistra do blago opalescentna i bezbojna.
English: See the package leaflet for further information Sucrose, calcium chloride dihydrate, L-histidine, polysorbate 80, sodium chloride
Croatian: Za dodatne informacije vidjeti uputu o lijeku. saharoza kalcijev klorid dihidrat L-histidin polisorbat 80 natrijev klorid
English: ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe Each pre-filled syringe contains nominally 2000 IU* moroctocog alfa**.
Croatian: ReFacto AF 2000 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka nominalno sadrži 2000 IU* moroktokoga alfa**.
English: ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe Each pre-filled syringe contains nominally 1000 IU* moroctocog alfa**.
Croatian: ReFacto AF 1000 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka nominalno sadrži 1000 IU* moroktokoga alfa**.
English: Detach the syringe from the vial adapter by gently pulling and turning the syringe counterclockwise.
Croatian: Odvojite štrcaljku od nastavka za bočicu tako što ćete nježno povući i zakrenuti štrcaljku u smjeru suprotnom od smjera kazaljke na satu.
English: ReFacto AF 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU* moroctocog alfa**.
Croatian: ReFacto AF 500 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 500 IU* moroktokoga alfa**.
English: ReFacto AF 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU* moroctocog alfa**.
Croatian: ReFacto AF 250 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 250 IU* moroktokoga alfa**.
English: Diarrhoea; vomiting; abdominal pain; nausea
Croatian: Poremećaji probavnog sustava proljev; povraćanje; bol u abdomenu; mučnina emećaji kože i potkožnog tkiva urtikarija; osip; pruritus hiperhidroza
English: Keep the vial in the outer carton in order to protect from light.
Croatian: Čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: Suomi/Finland
Croatian: Suomi/Finland Pfizer Oy
English: Break off the tamper-resistant plastic tip cap from the solvent syringe by snapping the perforation of the cap.
Croatian: Odlomite plastični zatvarač za zaštitu od nepažljivog rukovanja s vrška štrcaljke s otapalom tako što ćete ga prelomiti duž perforacije na zatvaraču.
English: ReFacto AF 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU* moroctocog alfa**.
Croatian: ReFacto AF 1000 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 1000 IU* moroktokoga alfa**.
English: Luxembourg/Luxemburg
Croatian: Luxembourg/Luxemburg Pfizer S.A.
English: Calcium chloride dihydrate L-Histidine
Croatian: Prašak saharoza kalcijev klorid dihidrat L-histidin polisorbat 80 natrijev klorid
English: Major surgery
Croatian: Veći kirurški postupak
English: EXP Do not use after expiry date.
Croatian: Ne smije se primijeniti nakon isteka roka valjanosti
English: i.e., 250, 500, 1000, or 2000 IU), of moroctocog alfa per 1 ml of the prepared solution for injection.
Croatian: - jedna bočica praška moroktokoga alfa od 250, 500, 1000 ili 2000 IU - jedna napunjena štrcaljka s otapalom, 4 ml sterilne otopine za injekciju natrijevog klorida od
English: ReFacto AF 250 IU powder for solution for injection ReFacto AF 500 IU powder for solution for injection ReFacto AF 1000 IU powder for solution for injection ReFacto AF 2000 IU powder for solution for injection Moroctocog alfa (recombinant human coagulation factor VIII) IV use
Croatian: ReFacto AF 2000 IU prašak za otopinu za injekciju moroktokog alfa (rekombinantni ljudski koagulacijski faktor VIII) i.v. primjena
English: However, no proper explanation for these findings in women has been identified.
Croatian: Međutim nije pronađeno odgovarajuće objašnjenje ovih nalaza u žena.
English:  This medicine has been prescribed for you only.
Croatian: Ovaj je lijek propisan samo Vama.
English: Aprovel should not be given to children under 18 years of age.
Croatian: Aprovel se ne smije davati djeci mlađoj od 18 godina.
English: It is important that you continue to take Aprovel until your doctor tells you otherwise.
Croatian: Važno je da nastavite uzimati Aprovel sve dok Vam liječnik ne kaže drukčije.
English: Patients with high blood pressure
Croatian: Bolesnici s visokim krvnim tlakom
English: The safety and efficacy of Aprovel in children aged 0 to 18 has not been established.
Croatian: Sigurnost i djelotvornost lijeka Aprovel u djece u dobi od 0 do 18 godina nisu ustanovljene.
English: The volume of distribution is 53-93 litres.
Croatian: Volumen distribucije iznosi 53-93 litre.
English: Ask your pharmacist how to throw away medicines you no longer use.
Croatian: Pitajte svog ljekarnika kako baciti lijekove koje više ne trebate.
English: Date of first authorisation: 27 August 1997 Date of latest renewal: 27 August 2007
Croatian: Datum posljednje obnove: 27. kolovoza 2007.
English: You can take Aprovel with or without food.
Croatian: Aprovel se može uzimati s hranom ili bez nje.
English: Do not store above 30°C.
Croatian: Ne čuvati na temperaturi iznad 30ºC.
English: See also information under the heading “Do not take Aprovel”.
Croatian: Vidjeti također informacije pod naslovom „Nemojte uzimati Aprovel“.
English: Similar effects have been very rarely reported with irbesartan so far.
Croatian: Do sada su vrlo rijetko prijavljeni slični učinci s irbesartanom.
English: This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.
Croatian: Ovaj lijek ne smiju uzimati djeca ni adolescenti jer sigurnost i djelotvornost lijeka nisu još u potpunosti utvrđene.
English: What Aprovel is and what it is used for
Croatian: Što je Aprovel i za što se koristi
English: No significant difference was apparent between these doses.
Croatian: Nije zapažena značajna razlika između doza.
English: ATC code: C09C A04.
Croatian: ATK oznaka: C09C A04
English: Irbesartan did not affect survival, development, or reproduction of offspring.
Croatian: Irbesartan nije utjecao na preživljenje, razvoj ni reprodukciju potomstva.
English: Other medicines and Aprovel
Croatian: Drugi lijekovi i Aprovel
English: The antihypertensive effects are maintained during long term therapy.
Croatian: Antihipertenzivni učinci održani su tijekom dugotrajnog liječenja.
English: Please see section 2 “Aprovel contains lactose”.
Croatian: Vidjeti dio 2., „Aprovel sadrži laktozu”
English: The slowing in the progression to clinical proteinuria was evident as early as three months and continued over the 2 year period.
Croatian: Smanjenje progresije kliničke proteinurije bilo je vidljivo nakon tri mjeseca i nastavilo se tijekom 2 godine.
English: What you need to know before you take Aprovel
Croatian: Što morate znati prije nego počnete uzimati Aprovel
English: The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Croatian: Bolesnika je potrebno pomno nadzirati, a liječenje treba biti potporno i simptomatsko.
English: Your doctor will normally advise you to stop taking Aprovel before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Aprovel.
Croatian: Vaš će Vam liječnik obično preporučiti da prestanete uzimati Aprovel prije nego što zatrudnite ili čim saznate da ste trudni te će Vam savjetovati da uzmete neki drugi lijek umjesto lijeka Aprovel.
English: Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water).
Croatian: Tablete treba progutati s dovoljnom količinom tekućine (npr. jednom čašom vode).
English: Aprovel with food and drink Aprovel can be taken with or without food.
Croatian: Aprovel s hranom i pićem Aprovel se može uzeti s hranom ili bez nje.
English: If you accidentally miss a daily dose, just take the next dose as normal.
Croatian: Ako slučajno zaboravite uzeti dnevnu dozu, uzmite sljedeću dozu kao što to obično i činite.
English: Therefore, this combination is not recommended (see section 4.4).
Croatian: Ta se kombinacija, stoga, ne preporučuje (vidjeti dio 4.4).
English: Aprovel contains lactose.
Croatian: Aprovel sadrži laktozu.
English: The predefined blood pressure goal was ≤ 135/85 mmHg.
Croatian: Unaprijed definirani ciljni krvni tlak bio je ≤ 135/85 mmHg.
English: Plasma protein binding is approximately 96%, with negligible binding to cellular blood components.
Croatian: Vezivanje za proteine plazme iznosi približno 96%, s neznatnim vezanjem za krvne stanice.
English: The terminal elimination half-life of irbesartan is 11-15 hours.
Croatian: Terminalno poluvrijeme eliminacije irbesartana iznosi 11-15 sati.
English: 56 x 1 tablets:
Croatian: 56 x 1 tableta:
English: An accompanying improvement in the glomerular filtration rate (GFR) was not observed during the first three months of treatment.
Croatian: Pridruženo poboljšanje brzine glomerularne filtracije nije zabilježeno tijekom prva tri mjeseca liječenja.
English: If you forget to take Aprovel
Croatian: Ako ste zaboravili uzeti Aprovel
English: The incidence of adverse events was not related to dose (in the recommended dose range), gender, age, race, or duration of treatment.
Croatian: Incidencija štetnih događaja nije bila povezana s dozom (unutar preporučenog raspona doza), spolom, dobi, rasom ni trajanjem liječenja.
English: What Aprovel is and what it is used for What you need to know before you take Aprovel How to take Aprovel
Croatian: Što se nalazi u ovoj uputi Što je Aprovel i za što se koristi Što morate znati prije nego počnete uzimati Aprovel Kako uzimati Aprovel
English: Second and third trimesters of pregnancy (see sections 4.4 and 4.6).
Croatian: Drugo i treće tromjesečje trudnoće (vidjeti dijelove 4.4 i 4.6).
English: Biotransformatin
Croatian: Biotransformacija
English: There was no evidence of mutagenicity, clastogenicity or carcinogenicity.
Croatian: Nije bilo znakova mutagenosti, klastogenosti ni kancerogenosti.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107.(c) stavkom 7. Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: Of those 23 children, 21 were evaluable for comparison of pharmacokinetics with adults (twelve children over 12 years, nine children between 6 and 12 years).
Croatian: Od 23 djece, rezultati farmakokinetike za 21 dijete mogli su se usporediti s farmakokinetikom u odraslih (12 djece u dobi iznad 12 godina i 9 djece u dobi od 6 do 12 godina).
English: Currently available data are described in section 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 4.8, 5.1 i 5.2, međutim, nije moguće dati preporuku o doziranju.