FrancophonIA/ELRC3.0 huggingface dataset:
English: Celvapan should be used in accordance with Official Guidance 4.2 Posology and method of administration
Croatian: Celvapan se treba koristiti u skladu sa službenim preporukama.
English: Infants and children aged 6-35 months
Croatian: Dojenčad i djeca u dobi od 6 do 35 mjeseci:
English: Whole virion influenza vaccine, inactivated, containing antigen of strain*: 7.5 micrograms**
Croatian: 2. KVALITATIVNI I KVANTITATIVNI SASTAV Cjepivo protiv influence (cijeli virion), inaktivirano, koje sadrži antigen soja *: A/California/07/2009 (H1N1)v
English: Vasculitis with transient renal involvement.
Croatian: Vaskulitis s prolaznim zahvaćanjem bubrega.
English: ** either SRH area > 25 mm² if baseline sample negative or 50% increase in SRH area if baseline sample > 4 mm²; > 4-fold increase in MN titer;
Croatian: * Površina SRH > 25 mm²; MN titar ≥ 1:40; ** ili površina SRH > 25 mm² ako je polazni uzorak negativan ili povećanje SRH površine za 50%
English: Very common Common Common Common
Croatian: Vrlo često Često Često Često
English: In a clinical trial the 7.5 µg dose of Celvapan (H1N1)v was administered to 69 infants and young represents the highest frequency observed either in the healthy adult or healthy older study population.
Croatian: U kliničkom je ispitivanju doza od 7,5 µg Celvapana (H1N1)v primijenjena na 69 dojenčadi i male djece u dobi od 6 do 35 mjeseci.
English: Frequency1
Croatian: Preporučeni MedDRA pojam Učestalost1
English: Pharyngolaryngeal pain
Croatian: Nazofaringitis
English: The vaccine can only be expected to protect against influenza caused by A/California/07/2009 (H1N1)v-like strains.
Croatian: Celvapan je cjepivo za sprečavanje influence (gripe) prouzročene virusom A(H1N1)v 2009.
English: Very common: Injection site pain, injection site redness, muscle pain
Croatian: Vrlo često: Bol na mjestu injekcije, crvenilo na mjestu injekcije, bol u mišićima Manje često: bolest slična influenci
English: In a clinical trial 51 children and adolescents aged 9 to 17 years and 51 children aged 3 to 8 years were administered the 7.5 µg dose of Celvapan (H1N1)v. The incidence and nature of symptoms after the first and second vaccination were similar to that observed in the adult and older population using
Croatian: U kliničkom je ispitivanju doza od 7,5 µg Celvapana (H1N1)v primijenjena na 51 djetetu i adolescentu u dobi od 9 do 17 godina i 51 djetetu u dobi od 3 do 8 godina.
English: Detailed information on this medicinal product is available on the website of the European Medicines
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: Reporting of side effects
Croatian: Način primjene
English: • Post-marketing surveillance
Croatian: • Plan upravljanja rizikom (RMP)
English: The following additional adverse reactions have been reported in the post-marketing experience in adults and children receiving Celvapan (H1N1)v.
Croatian: Slijede dodatne nuspojave zabilježene tijekom postmarketinškog praćenja odraslih i djece koja su
English: • Injection site pain
Croatian: • Oteknuće na mjestu injekcije
English: Open the bottle.
Croatian: Otvorite bocu.
English: After first opening: 7 months
Croatian: Nakon prvog otvaranja: 7 mjeseca
English: Food and alcohol
Croatian: Hrana i alkohol
English: (see table below for dose examples).
Croatian: (Vidi tablicu ispod za primjere doze).
English: Nevertheless, the concentration of this metabolite remains low.
Croatian: Koncentracija tog metabolita ipak ostaje niska.
English: The mechanism of this risk is not known.
Croatian: Mehanizam tog rizika je nepoznat.
English: • limp or difficulty walking.
Croatian: • šepanje ili poteškoće s hodom.
English: The elimination half-life was approximately 5 hours.
Croatian: Poluvrijeme eliminacije iznosilo je oko 5 sati.
English: Tell your doctor immediately, or go to your nearest emergency department, if you experience:
Croatian: Recite odmah svom liječniku ili otiđite do najbliže hitne pomoći ako iskusite:
English: Two minor metabolites were also identified.
Croatian: Također su pronađena dva manje zastupljena metabolita.
English: Suicide
Croatian: Samoubojstvo
English: These effects should however decrease over time.
Croatian: Te bi se nuspojave vremenom trebale smanjiti.
English: This dose can be started on the first day of treatment.
Croatian: Tom dozom može se započeti prvog dana liječenja.
English: Your doctor will establish the best possible treatment of overdose.
Croatian: Vaš će liječnik odrediti najbolji mogući način liječenja predoziranja.
English: No clinical data are available, potential risk for human is unknown.
Croatian: Nema dostupnih kliničkih podataka, a mogući rizik za ljude nije poznat.
English: In such case, the lowest effective dose is recommended.
Croatian: U takvom slučaju se preporučuje najniža učinkovita doza.
English: 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: Oral absolute bioavailability is close to
Croatian: Oralna apsolutna bioraspoloživost blizu je
English: This decrease is more pronounced during the third trimester (up to 60 % of baseline concentration before pregnancy).
Croatian: To smanjenje koncentracije bilo je više izraženo tijekom trećeg trimestra (do 60% u odnosu na bazičnu koncentraciju prije trudnoće).
English: Reykjavíkurvegur 76-78 220 Hafnarfjörður Iceland
Croatian: Reykjavíkurvegur 76-78 220 Hafnarfjörður Island
English: Duration of treatment:
Croatian: Trajanje liječenja:
English: • anorexia (loss of appetite);
Croatian: • anoreksija (gubitak apetita);
English: Physiological changes during pregnancy may affect levetiracetam concentration.
Croatian: Fiziološke promjene za vrijeme trudnoće mogu utjecati na koncentraciju levetiracetama.
English: However, current epidemiological studies (on about 100 children) do not suggest an increased risk of neurodevelopmental disorders or delays.
Croatian: Međutim, trenutna epidemiološka ispitivanja (na približno 100 djece) ne ukazuju na povećani rizik od neurorazvojnih poremećaja ili kašnjenja u razvoju.
English: Group with or without food.
Croatian: Može se uzeti sa ili bez hrane.
English: If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol.
Croatian: Ako je Vaše dijete mlađe od 4 tjedna, obratite se liječniku ili ljekarniku prije nego mu date ovaj lijek, osobito ako dijete prima i druge lijekove koji sadrže propilenglikol ili alkohol.
English: Therefore, macrogol should not be taken orally for one hour before and for one hour after taking levetiracetam.
Croatian: Stoga, makrogol ne treba uzeti oralno jedan sat prije i jedan sat nakon uzimanja levetiracetama.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential.
Croatian: Neklinički podaci ne upućuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, genotoksičnosti i kancerogenog potencijala.
English: • Do not stop your treatment without your doctor's advice as this could increase your seizures.
Croatian: • Nemojte prekinuti liječenje bez savjeta liječnika jer to može pojačati napadaje.
English: Levetiracetam Actavis Group must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Croatian: Levetiracetam Actavis Group se mora uzimati dva puta na dan, jednom ujutro i jednom navečer, u približno isto vrijeme svaki dan.
English: Contact your doctor if you have missed one or more doses.
Croatian: Obavijestite liječnika ako ste zaboravili uzeti jednu ili više doza.
English: BG-5600 Troyan Bulgaria
Croatian: BG-5600 Troyan Bugarska
English: The lowest effective dose should be used.
Croatian: Treba koristiti najmanju djelotvornu dozu.
English: The primary metabolite is inactive.
Croatian: Primarni je metabolit neaktivan.
English: Date of first authorisation: 5 December 2011 Date of latest renewal: 08 August 2016
Croatian: Datum posljednje obnove odobrenja: 8. kolovoz 2016.
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Croatian: Stoga bolesnici s nasljednim problemima nepodnošljivosti za fruktozu ne smiju uzimati ovaj lijek.
English: This is more likely at the beginning of treatment or after an increase in the dose.
Croatian: To se češće javlja na početku liječenja ili nakon povećanja doze.
English: Cases of encephalopathy generally occurred at the beginning of the treatment (few days to a few months) and were reversible after treatment discontinuation.
Croatian: Slučajevi encefalopatije općenito su se pojavljivali na početku liječenja (u razdoblju od nekoliko dana do nekoliko mjeseci) i bili su reverzibilni nakon prekida liječenja.
English: The requirements for submission of periodic safety update report 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) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim nadopunama objavljenima na europskom internetskom portalu za lijekove.
English: • infection;
Croatian: • infekcija;
English: Neither levetiracetam nor its primary metabolite are significantly bound to plasma proteins (< 10%).
Croatian: Levetiracetam kao ni njegov primarni metabolit ne vežu se značajno za proteine plazme (<10%).
English: Oral contraceptives and other pharmacokinetics interactions
Croatian: Oralni kontraceptivi i druge farmakokinetičke interakcije
English: • injury.
Croatian: • ozljeda.
English: Be sure to drink the whole contents of the glass (Figure 9).
Croatian: Budite sigurni da su popili cijeli sadržaj čaše (slika 9).
English: Children (4 to 12 years)
Croatian: Djeca (4 do 12 godina)
English: When you will first start taking Levetiracetam Actavis Group, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.
Croatian: Kad prvi put počnete uzimati Levetiracetam Actavis Group, liječnik će Vam propisati manju dozu tijekom 2 tjedna prije davanja najmanje uobičajene doze.
English: Age also had an influence on both parameters.
Croatian: Na oba pokazatelja utjecala je i dob.
English: Dose adjustment is not required.
Croatian: Prilagođavanje doze nije potrebno.
English: If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.
Croatian: Ako imate bilo kakve simptome depresije i/ili samoubilačke ideje, obavijestite svog liječnika.
English: The major metabolic pathway (24% of the dose) is an enzymatic hydrolysis of the acetamide group.
Croatian: Glavni je metabolički put (24 % doze) enzimska hidroliza acetamidne skupine.
English: Other unidentified components accounted only for 0.6% of the dose.
Croatian: Ostali neidentificirani metaboliti odgovaraju samo 0,6 % doze.
English: Be sure to drink the whole contents of the glass.
Croatian: Obavezno popijte cijeli sadržaj čaše.
English: Elderly (65 years and older)
Croatian: Posebne populacije Stariji (65 godina i stariji)
English: There is no evidence for any relevant gender, race or circadian variability.
Croatian: Nema dokaza da postoji značajna varijabilnost vezana uz spol, rasu ili cirkadijalni ritam.
English: Treatment with levetiracetam should be reviewed when a woman is planning to become pregnant.
Croatian: Liječenje levetiracetamom treba razmotriti kada žena planira trudnoću.
English: The results are consistent across age group.
Croatian: Rezultati su bili konzistentni u svim dobnim skupinama.
English: No impact on fertility was detected in animal studies (see section 5.3).
Croatian: U ispitivanjima provedenim na životinjama nije utvrđen utjecaj na plodnost (vidjeti dio 5.3).
English: Do not use after 7 months of first opening the bottle.
Croatian: Nemojte koristiti nakon isteka 7 mjeseca od prvog otvaranja boce.
English: Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking levetiracetam as this may result in a reduction of its effect.
Croatian: Ne uzimajte makrogol (lijek koji se koristi kao laksativ) jedan sat prije i jedan sat nakon uzimanja levetiracetama zbog toga što se može smanjiti učinak levetiracetama.
English: No data on the interaction of levetiracetam with alcohol are available.
Croatian: Ne postoje podaci o interakciji levetiracetama s alkoholom.
English: Patients are advised not to drive or use machines until it is established that their ability to perform such activities is not affected.
Croatian: Bolesnicima se savjetuje da ne upravljaju vozilima i strojevima sve dok se ne ustanovi da im sposobnost za obavljanje tih aktivnosti nije narušena.
English: • A small number of people being treated with anti-epileptics such as levetiracetam have had thoughts of harming or killing themselves.
Croatian: • Mali broj ljudi liječenih antiepilepticima kao što je levetiracetam imali su misli o samoozljeđivanju ili samoubojstvu.
English: For adults and children aged 4 years and older
Croatian: Za odrasle i djecu u dobi od 4 godine i starije
English: To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in ml/min is needed.
Croatian: Da biste mogli upotrijebiti ovu tablicu za doziranje, potrebna je procjena bolesnikova klirensa kreatinina (CLcr) u ml/min.
English: Repeat until there are no bubbles in the syringe (Figure 6).
Croatian: To ponavljajte dok u štrcaljki ne bude više mjehurića (slika 6).
English: Patients (and caregivers of patients) should be advised to seek medical advice should signs of depression and/or suicidal ideation or behaviour emerge.
Croatian: Bolesnicima (i njihovim starateljima) treba savjetovati da potraže medicinski savjet ako se pojave znakovi depresije i/ili samoubilačke ideje ili ponašanja.
English: EXP Do not use after 7 months of first opening the bottle.
Croatian: EXP Nemojte primjenjivati nakon 7 mjeseca od prvog otvaranja boce.
English: The volume of distribution of levetiracetam is approximately 0.5 to 0.7 l/kg, a value close to the total body water volume.
Croatian: Volumen distribucije levetiracetama približno je 0,5 do 0,7 l/kg, što približno odgovara ukupnom volumenu tjelesne vode.
English: * Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.
Croatian: * Prevalencija je značajno veća u japanskih bolesnika u usporedbi s bolesnicima koji nisu japanskog podrijetla.
English: Therefore, caution is recommended in those patients when performing skilled tasks, e.g. driving vehicles or operating machinery.
Croatian: Stoga je kod takvih bolesnika potreban oprez kada obavljaju poslove koji zahtijevaju vještinu, kao što je upravljanje vozilima i strojevima.
English: In addition it partially reverses the reductions in GABA- and glycine-gated currents induced by zinc and β-carbolines.
Croatian: Također djelomično poništava smanjenje GABA- i glicin-posredovanih protoka, inducirano cinkom i β-karbolinima.
English: • If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na levetiracetam, derivate pirolidona ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Therefore a 50% reduction of the daily maintenance dose is recommended when the creatinine clearance is < 60 ml/min/1.73 m2.
Croatian: Stoga se preporučuje 50%-tno smanjenje dnevne doze održavanja ako je klirens kreatinina < 60 ml/min/1,73 m2.
English: • encephalopathy (see sub-section “Tell your doctor immediately” for a detailed description of symptoms);
Croatian: • oštećenje mozga (encefalopatija, za detaljan opis simptoma pogledajte podnaslov „Recite odmah svom liječniku“);
English: One was obtained by hydroxylation of the pyrrolidone ring (1.6% of the dose) and the other one by opening of the pyrrolidone ring (0.9% of the dose).
Croatian: Jedan nastaje hidroksilacijom (1,6 % doze), a drugi otvaranjem pirolidonskog prstena (0,9 % doze).
English: Quincke's oedema [swelling of the face, lips, tongue and throat]);
Croatian: Quinckeov edem [oticanje lica, usana, jezika i grla];
English: Co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce serious adverse effects in neonates.
Croatian: Istodobna primjena bilo kojeg supstrata alkohol dehidrogenaze, kao što je etanol, može izazvati ozbiljne štetne učinke u novorođenčadi.
English: • severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction],
Croatian: • teške alergijske reakcije (DRESS, anafilaktička reakcija [teška i ozbiljna alergijska reakcija],
English: Therefore, the interaction of levetiracetam with other substances, or vice versa, is unlikely.
Croatian: Iz toga proizlazi da interakcija levetiracetama s drugim tvarima, i obrnuto, nije vjerojatna.
English: In several cases of alopecia, recovery was observed when levetiracetam was discontinued.
Croatian: U nekoliko slučajeva alopecije utvrđen je oporavak nakon što je levetiracetam ukinut.
English: ks= 0.45 in term infants to 1 year old; ks= 0.55 in children to less than 13 years and in adolescent female; ks= 0.7 in adolescent male
Croatian: ks = 0,45 za dojenčad do 1. godine života rođene u terminu; ks = 0,55 za djecu mlađu od 13 godina i za adolescente ženskog spola; ks = 0,7 za adolescente muškog spola
English: Treatment of an overdose will be symptomatic and may include haemodialysis.
Croatian: Liječenje predoziranja je simptomatsko i može uključiti hemodijalizu.
English: Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme
Croatian: Toksična epidermalna nekroliza, StevensJohnsonov sindrom, multiformni eritem
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX14
Croatian: Farmakoterapijska skupina: antiepileptici, ostali antiepileptici, ATK oznaka: N03AX14.
English: For young children gently put the tip of the syringe into the child´s mouth to the inside of the cheek.
Croatian: Maloj djeci nježno stavite vrh štrcaljke u usta na unutarnju stranu obraza.
English: The dialyser extraction efficiency is 60 % for levetiracetam and 74 % for the primary metabolite.
Croatian: Ekstrakcijska učinkovitost dijalizatora je 60% za levetiracetam i 74% za njegov primarni metabolit.
English: Read all of this leaflet carefully before you or your child start taking this medicine because it contains important information for you.
Croatian: Vi ili Vaše dijete počnete uzimati ovaj lijek jer sadrži Vama važne podatke.
English: Blood methotrexate and levetiracetam levels should be carefully monitored in patients treated concomitantly with the two drugs.
Croatian: Razine metotreksata i levetiracetama u krvi treba pažljivo pratiti u bolesnika istodobno liječenih s ova dva lijeka.
English: In both these paediatric age ranges, these data are supplemented with the post-marketing experience of the use of levetiracetam.
Croatian: U obje od tih pedijatrijskih dobnih skupina ti podaci dopunjeni su s postmarketinškim iskustvom primjene levetiracetama.
English: There was no effect on embryomortality and no increased incidence of malformations.
Croatian: Nije bilo utjecaja na smrtnost zametaka, niti se povećala pojavnost malformacija.
English: Suicide, suicide attempt, suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents (including levetiracetam).
Croatian: Samoubojstvo, pokušaj samoubojstva te samoubilačke ideje i ponašanje bili su prijavljivani kod bolesnika liječenih antiepileptičkim lijekovima (uključujući levetiracetam).
English: • decreased number of blood platelets, decreased number of white blood cells;
Croatian: • smanjen broj krvnih pločica, smanjen broj bijelih krvnih stanica;
English: However, if levetiracetam treatment is needed during breastfeeding, the benefit/risk of the treatment should be weighed considering the importance of breastfeeding.
Croatian: Međutim, ako je liječenje levetiracetamom potrebno tijekom dojenja, treba procijeniti omjer koristi i rizika liječenja uzimajući u obzir važnost dojenja.
English: A large amount of postmarketing data on pregnant women exposed to levetiracetam monotherapy (more than 1800, among which in more than 1500 exposure occurred during the 1st trimester) do not suggest an increase in the risk for major congenital malformations.
Croatian: Velika količina podataka nakon stavljanja lijeka u promet o trudnicama koje su bile izložene monoterapiji levetiracetamom (više od njih 1800 od kojih su više od 1500 bile izložene levetiracetamu tijekom prvog trimestra trudnoće) ne ukazuje na povećanje rizika za velike kongenitalne malformacije.
English: The patients had to present with unprovoked partial seizures or with generalized tonic-clonic seizures only.
Croatian: Bolesnici su morali imati spontane djelomične napadaje ili samo generalizirane toničko-kloničke napadaje.
English: Breast-feeding is not recommended during treatment.
Croatian: Tijekom liječenja ne preporučuje se dojenje.
English: Then CLcr is adjusted for body surface area (BSA) as follows:
Croatian: Potom se klirens kreatinina prilagodi za površinu tijela (PT) prema sljedećem:
English: After measuring the correct dose with an appropriate syringe, Levetiracetam Actavis Group oral solution may be diluted in a glass of water or baby's bottle.
Croatian: Nakon mjerenja točne doze pomoću odgovarajuće štrcaljke, Levetiracetam Actavis Group oralna otopina može se razrijediti u čaši vode ili u dječjoj bočici.
English: Hydrolysis of the acetamide group was measurable in a large number of tissues including blood cells.
Croatian: Hidroliza acetamidne skupine odvija se u brojnim tkivima uključujući krvne stanice.
English: The metabolite ucb L057 is pharmacologically inactive.
Croatian: Metabolit ucb L057 farmakološki je neaktivan.
English: There is no specific antidote for levetiracetam.
Croatian: Ne postoji specifični antidot za levetiracetam.
English: The apparent body weight adjusted clearance was approximately 30% higher than in epileptic adults.
Croatian: Prividni tjelesni klirens korigiran za tjelesnu težinu bio je približno 30 % veći nego u odraslih s epilepsijom.
English: as an add-on to other antiepileptic medicines to treat:
Croatian: • kao dodatna terapija uz druge antiepileptike u liječenju:
English: Levetiracetam caused mild induction of CYP2B6 and CYP3A4.
Croatian: Levetiracetam je uzrokovao blagu indukciju CYP2B6 ili CYP3A4.
English: • somnolence (sleepiness), headache.
Croatian: • somnolencija (pospanost), glavobolja.
English: Instruction for use: Instruction for use for 10 ml syringes
Croatian: Upute za uporabu: Upute za uporabu za štrcaljke od 10 ml
English: Available data in children did not suggest impact on growth and puberty.
Croatian: Dostupni podaci o primjeni ovog lijeka u djece nisu pokazali da utječe na rast i pubertet.
English: Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Croatian: Levetiracetam jest antiepileptik (lijek koji se koristi u liječenju epileptičkih napadaja).
English: • decreased number of all blood cell types;
Croatian: • smanjen broj svih vrsta krvnih stanica;
English: A meta-analysis of randomized placebo-controlled trials of anti-epileptic medicinal products has shown a small increased risk of suicidal thoughts and behaviour.
Croatian: Metaanaliza randomiziranih placebom kontroliranih ispitivanja antiepileptičkih lijekova pokazala je mali porast rizika samoubilačkih misli i ponašanja.
English: These data are supplemented with the use of levetiracetam in corresponding open-label extension studies, as well as post-marketing experience.
Croatian: Ti podaci dopunjeni su podacima iz odgovarajućih ispitivanja otvorenog produžetka o primjeni levetiracetama, kao i postmarketinškim iskustvima.