FrancophonIA/ELRC3.0 huggingface dataset:
English: These estimated doses are approximately 7% of the total daily maternal dose on a mg/kg basis.
Croatian: Te procijenjene doze iznose otprilike 7% ukupne dnevne majčine doze na osnovi mg/kg.
English: The potential risk for humans is unknown.
Croatian: Nije poznat potencijalan rizik za ljude.
English: • Feeling drunk, abnormal style of walking
Croatian: • osjećaj pijanosti, neuobičajen način hodanja
English: Monotherapy (newly diagnosed patients)
Croatian: Monoterapija (novodijagnosticirani bolesnici)
English: The maximum dose of 600 mg per day may be achieved after an additional week.
Croatian: Maksimalna doza od 600 mg na dan može se postići nakon dodatnih tjedan dana.
English: Creatinine clearance (CLcr) (ml/min)
Croatian: Klirens kreatinina (CLcr) (ml/min)
English: Pregabalin mean elimination half-life is 6.3 hours.
Croatian: Prosječno poluvrijeme eliminacije pregabalina iznosi 6,3 sata.
English: • Difficulties with erection
Croatian: • poteškoće s erekcijom
English: A decision must be made whether to discontinue breast-feeding or to discontinue pregabalin therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje pregabalinom, uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 June 2015
Croatian: Datum prvog odobrenja: 25. lipanj 2015.
English: If you are an older patient (over 65 years of age), you should take Pregabalin Mylan Pharma normally except if you have problems with your kidneys.
Croatian: Ako ste bolesnik u starijoj dobi (iznad 65 godina), lijek Pregabalin Mylan Pharma trebate uzimati normalno, osim ako imate problema s bubrezima.
English: • Inappropriate behaviour
Croatian: • neprilagođeno ponašanje
English: The safety and efficacy in children and adolescents (under 18 years of age) has not been established and therefore, pregabalin should not be used in this age group.
Croatian: Sigurnost i djelotvornost u djece i adolescenata (mlađih od 18 godina) nisu ustanovljene te stoga pregabalin ne treba koristiti u ovoj dobnoj skupini.
English: • The dose, which has been adjusted for you and your condition, will generally be between 150 mg and 600 mg each day.
Croatian: • Doza, koja je prilagođena Vama i Vašoj bolesti, u pravilu će iznositi između 150 mg i 600 mg svakoga dana.
English: The effect of pregabalin on newborns/infants is unknown.
Croatian: Učinak pregabalina na novorođenčad/dojenčad nije poznat.
English: Mylan B.V., Dieselweg 25, 3752 LB Bunschoten, The Netherlands For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Croatian: Mylan B.V., Dieselweg 25, 3752 LB Bunschoten, Nizozemska Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje gotovog lijeka u promet.
English: The clinical relevance of these findings is unknown (see section 5.3).
Croatian: Klinički značaj ovih nalaza nije poznat (vidjeti dio 5.3).
English: Following a dose of radiolabelled pregabalin, approximately 98% of the radioactivity recovered in the urine was unchanged pregabalin.
Croatian: Nakon primjene doze radioaktivno označenog pregabalina oko 98% radioaktivnosti ustanovljene u mokraći bio je nepromijenjen pregabalin.
English: McDermott Laboratories Limited trading as Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 Ireland
Croatian: McDermott Laboratories Limited trading as Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 Irska
English: The marketing authorisation holder (MAH) 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: • Changes in the recording of electrical changes (ECG) in the heart which correspond to heart rhythm disturbances
Croatian: • promjene na elektrokardiogramu (EKG-u) koje odgovaraju poremećajima srčanog ritma
English: Pregabalin terminal half-life averaged about 3 to 4 hours in paediatric patients up to 6 years of age, and 4 to 6 hours in those 7 years of age and older.
Croatian: Terminalni poluvijek pregabalina bio je prosječno 3 do 4 sata u pedijatrijskih bolesnika u dobi do 6 godina, a 4 do 6 sati u onih dobi od 7 godina ili starijih.
English: The adverse reactions listed may also be associated with the underlying disease and/or concomitant medicinal products.
Croatian: Navedene nuspojave mogu biti povezane i s osnovnom bolešću i/ili istodobno primijenjenim lijekovima.
English: A meta-analysis of randomised placebo controlled studies of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour.
Croatian: Meta-analiza randomiziranih placebom kontroliranih ispitivanja antiepileptika ukazala je i na malo povećan rizik od suicidalnih ideja i ponašanja.
English: Interactions and the elderly
Croatian: Interakcije u starijih osoba
English: • Hepatitis (inflammation of the liver).
Croatian: • hepatitis (upala jetre).
English: Pregabalin Cmax and AUC parameters increased in a linear manner with increasing dose within each age group.
Croatian: Parametri Cmax i AUC pregabalina povećavali su se linearno s povećanjem doze unutar svake dobne skupine.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • Uoči svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
English: Pregabalin is not bound to plasma proteins.
Croatian: Pregabalin se ne veže za proteine u plazmi.
English: Mylan Hungary Kft Mylan utca 1, Komárom, 2900, Hungary
Croatian: Mylan utca 1, Komárom, 2900, Mađarska
English: There is no evidence to suggest an associated risk to humans.
Croatian: Nema dokaza koji bi ukazivali na posljedičan rizik za ljude.
English: The AUC was lower by 30% in paediatric patients below a weight of 30 kg due to an increased body weight adjusted clearance of 43% for these patients in comparison to patients weighing ≥30 kg.
Croatian: AUC je bio niži za 30% u pedijatrijskih bolesnika s tjelesnom težinom manjom od 30 kg zbog povećanog klirensa prilagođenog tjelesnoj težini od 43% za te bolesnike u odnosu na bolesnike s tjelesnom težinom ≥30 kg.
English: Pregabalin Mylan Pharma should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus).
Croatian: Pregabalin Mylan Pharma se ne smije primjenjivati tijekom trudnoće osim ako to nije neophodno (ako korist liječenja za majku jasno nadilazi mogući rizik za plod).
English: Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications.
Croatian: Suicidalne ideje i ponašanje prijavljeni su u bolesnika liječenih antiepilepticima u različitim indikacijama.
English: If you take more Pregabalin Mylan Pharma than you should Call your doctor or go to the nearest hospital emergency unit immediately.
Croatian: Ako uzmete više lijeka Pregabalin Mylan Pharma nego što ste trebali Odmah nazovite svog liječnika ili otiđite u hitnu službu najbliže bolnice.
English: Inter-subject pharmacokinetic variability for pregabalin is low (<20%).
Croatian: Razlike u farmakokinetici pregabalina od osobe do osobe su male (< 20%).
English: Adverse reactions were usually mild to moderate in intensity.
Croatian: Nuspojave su obično bile blagog do umjerenog intenziteta.
English: Epilepsy or Generalised Anxiety Disorder:
Croatian: Epilepsija ili generalizirani anksiozni poremećaj:
English: These symptoms include swelling of the face, lips, tongue, and throat, as well as diffuse skin rash.
Croatian: Ti simptomi uključuju oticanje lica, usana, jezika i grla, kao i prošireni osip kože.
English: In accordance with current clinical practice, if pregabalin has to be discontinued, it is recommended this should be done gradually over a minimum of 1 week independent of the indication (see sections 4.4 and 4.8).
Croatian: Sukladno postojećoj kliničkoj praksi, ako se liječenje pregabalinom mora prekinuti, preporučuje se ukidati ga postupno tijekom najmanje tjedan dana, bez obzira na indikaciju (vidjeti dijelove 4.4 i 4.8).
English: • Alcohol
Croatian: Alkohol
English: Therefore, you should be careful until you are used to any effect the medicine might have.
Croatian: Stoga, morate biti oprezni dok se ne naviknete na sve moguće učinke lijeka.
English: Reduced lower gastrointestinal tract function
Croatian: Oslabljena funkcija donjeg dijela gastrointestinalnog trakta
English: 200 hard capsules
Croatian: 200 tvrdih kapsula
English: Pregabalin oral bioavailability is estimated to be ≥ 90% and is independent of dose.
Croatian: Procjenjuje se da bioraspoloživost peroralno primijenjenog pregabalina iznosi  90% i ne ovisi o dozi.
English: • Your doctor will tell you to take Pregabalin Mylan Pharma either twice or three times a day.
Croatian: • Liječnik će Vam reći da uzmete lijek Pregabalin Mylan Pharma dva puta ili tri puta na dan.
English: Therefore, there is no need for routine monitoring of plasma concentrations of pregabalin.
Croatian: Stoga nije potrebno rutinski kontrolirati koncentracije pregabalina u plazmi.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u Dodatku V*.
English: You should not drive, operate complex machinery or engage in other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.
Croatian: Ne biste trebali voziti, rukovati složenim strojevima ni poduzimati druge potencijalno opasne aktivnosti dok ne utvrdite utječe li ovaj lijek na Vašu sposobnost da to činite.
English: Women of childbearing potential/Contraception in males and females As the potential risk for humans is unknown, effective contraception must be used in women of child bearing potential.
Croatian: Žene reproduktivne dobi / kontracepcija u muškaraca i žena Budući da potencijalan rizik za ljude nije poznat, žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju.
English: The active substance is pregabalin.
Croatian: Djelatna tvar je pregabalin.
English: • Before taking this medicine you should tell your doctor if you have a history of alcoholism or any drug abuse or dependence.
Croatian: • Prije uzimanja ovog lijeka morate obavijestiti svog liječnika ako ste imali problema s alkoholizmom, zlouporabom lijekova ili ovisnošću.
English: The rate of pregabalin absorption is decreased when given with food resulting in a decrease in Cmax by approximately 25-30% and a delay in tmax to approximately 2.5 hours.
Croatian: Brzina apsorpcije pregabalina smanjuje se kada se lijek primjenjuje s hranom, što dovodi do smanjenja Cmax za približno 25-30%, dok je tmax odgođen na približno 2,5 sata.
English: Before taking this medicine you should tell your doctor if you have a history of heart disease.
Croatian: Prije uzimanja ovog lijeka morate obavijestiti svog liječnika ako ste bolovali od neke bolesti srca.
English: Very common: may affect more than 1 in 10 people • Dizziness, drowsiness, headache
Croatian: Vrlo česte: mogu se javiti u više od 1 na 10 osoba Omaglica, omamljenost, glavobolja.
English: • Decrease in white blood cell count
Croatian: • smanjen broj bijelih krvnih stanica
English: Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Croatian: Stoga bolesnike treba nadzirati kako bi se uočili eventualni znakovi suicidalnih ideja i ponašanja te razmotriti primjenu odgovarajuće terapije.
English: Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Croatian: Bolesnicima (i njihovim njegovateljima) treba savjetovati da zatraže medicinsku pomoć ako se pojave znakovi suicidalnih ideja ili ponašanja.
English: BID or TID BID or TID
Croatian: BID ili TID BID ili TID jednom dnevno ili BID jednom dnevno
English: Each hard capsule contains either 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg of pregabalin.
Croatian: Jedna tvrda kapsula sadrži 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg ili 300 mg pregabalina.
English: These platelet changes were not present in rats or in humans based on short term and limited long term clinical data.
Croatian: Takve promjene trombocita nisu prisutne u štakora, a na temelju podataka iz kratkoročne i ograničenih podataka iz dugoročne kliničke primjene, niti u ljudi.
English: Concerning discontinuation of long-term treatment of pregabalin, data suggest that the incidence and severity of withdrawal symptoms may be dose-related.
Croatian: Što se tiče prekida dugotrajnog liječenja pregabalinom, podatci upućuju da incidencija i težina simptoma ustezanja mogu biti povezani s dozom.
English: No specific pharmacodynamic interaction studies were conducted in elderly volunteers.
Croatian: Nisu provedena specifična ispitivanja farmakodinamičkih interakcija u starijih dobrovoljaca.
English: Pregabalin should be used with caution in these patients.
Croatian: Pregabalin u tih bolesnika treba primjenjivati uz oprez.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: • Jaundice (yellowing of the skin and eyes).
Croatian: • žutica (žutilo kože i bjeloočnica).
English: If you experience swollen face or tongue or if your skin turns red and starts to blister or peel you should seek immediate medical advice.
Croatian: Primijetite li oticanje lica ili jezika, ili se na koži pojavi crvenilo, mjehurići ili ljuštenje, morate odmah potražiti savjet liječnika.
English: The safety and efficacy of Pregabalin Mylan Pharma in children below the age of 12 years and in adolescents (12-17 years of age) have not been established.
Croatian: Sigurnost i djelotvornost lijeka Pregabalin Mylan Pharma u djece mlađe od 12 godina i adolescenata (12-17 godina) nisu ustanovljene.
English: • Swelling of the body including extremities
Croatian: • oticanje tijela, uključujući udove
English: These symptoms may occur more commonly or severely if you have been taking Pregabalin Mylan Pharma for a longer period of time.
Croatian: Ti simptomi mogu biti češći ili ozbiljniji ako ste lijek Pregabalin Mylan Pharma uzimali dulje vrijeme.
English: Pregabalin was excreted into breast milk with average steady-state concentrations approximately 76% of those in maternal plasma.
Croatian: Pregabalin se izlučivao u majčino mlijeko u prosječnim koncentracijama stanja dinamičke ravnoteže koje su iznosile otprilike 76% onih u majčinoj plazmi.
English: Therefore the effects were considered of little or no clinical relevance.
Croatian: Stoga se smatra da ti učinci imaju malen ili nikakav značaj za kliničku primjenu.
English: Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medicinal product.
Croatian: Stoga, bolesnicima treba savjetovati da budu oprezni dok se ne upoznaju s mogućim učincima lijeka.
English: In conventional safety pharmacology studies in animals, pregabalin was well-tolerated at clinically relevant doses.
Croatian: U konvencionalnim ispitivanjima sigurnosne farmakologije na životinjama pregabalin se dobro podnosio u dozama značajnima za kliničku primjenu.
English: If you have the impression that the effect of Pregabalin Mylan Pharma is too strong or too weak, talk to your doctor or pharmacist.
Croatian: Ako Vam se čini da je djelovanje lijeka Pregabalin Mylan Pharma prejako ili preslabo, porazgovarajte sa svojim liječnikom ili ljekarnikom.
English: Tell your doctor if you have a history of any serious medical conditions, including liver or kidney disease.
Croatian: Obavijestite svog liječnika ako ste bolovali od neke ozbiljne bolesti, uključujući bolesti jetre ili bubrega.
English: These reactions are mostly seen in elderly cardiovascular compromised patients during pregabalin treatment for a neuropathic indication.
Croatian: Te su reakcije zabilježene uglavnom u starijih kardiovaskularno kompromitiranih bolesnika tijekom liječenja pregabalinom u neuropatskim indikacijama.
English: Following an additional week the dose may be increased to 450 mg per day.
Croatian: Nakon sljedećih tjedan dana doza se može povećati na 450 mg na dan.
English: Pregabalin Mylan Pharma and certain other medicines may influence each other (interaction).
Croatian: Pregabalin Mylan Pharma i neki drugi lijekovi mogu djelovati jedni na druge (interakcija).
English: Pregabalin pharmacokinetics in patients younger than 3 months old have not been studied (see sections 4.2, 4.8 and 5.1).
Croatian: Farmakokinetika pregabalina u bolesnika mlađih od 3 mjeseca nije ispitana (vidjeti dijelove 4.2, 4.8 i
English: In table 2 below all adverse reactions, which occurred at an incidence greater than placebo and in more than one patient, are listed by class and frequency (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), not known (cannot be estimated from the available data)).
Croatian: Tablici 2. ispod, sve nuspojave koje su se javile s većom incidencijom u odnosu na placebo i u više od jednog bolesnika popisane prema organskim sustavima i učestalosti pojavljivanja (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), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: When pregabalin and opioids will be used in combination, measures to prevent constipation may be considered (especially in female patients and elderly).
Croatian: Kada se pregabalin primjenjuje u kombinaciji s opioidima, može se razmisliti o mjerama za sprečavanje konstipacije (osobito u žena i starijih bolesnika).
English: • Muscle damage
Croatian: • oštećenje mišića
English: • Difficulty with or painful urination, incontinence
Croatian: • otežano ili bolno mokrenje, inkontinencija
English: In preclinical studies, there was no indication of racemisation of pregabalin S-enantiomer to the R-enantiomer.
Croatian: U nekliničkim istraživanjima nije bilo znakova racemizacije S-enantiomera pregabalina u R-enantiomer.
English: Discontinuation of pregabalin may result in resolution or improvement of these visual symptoms.
Croatian: Prekid primjene pregabalina može dovesti do povlačenja ili poboljšanja tih simptoma.
English: Pregabalin binds to an auxiliary subunit (α2- δ protein) of voltage-gated calcium channels in the central nervous system.
Croatian: Pregabalin se veže na pomoćnu podjedinicu (α2- protein) na električni napon osjetljivih kalcijevih kanala u središnjem živčanom sustavu.
English: Uncommon Rare
Croatian: neuobičajeno osjećanje
English: BID = Two divided doses * Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose + Supplementary dose is a single additional dose
Croatian: BID = podijeljeno u 2 doze * Ukupnu dnevnu dozu (mg/dan) treba podijeliti prema navedenom režimu doziranja kako bi se odredili miligrami po jednoj dozi
English: In a clinical trial to assess the effect of pregabalin on sperm motility, healthy male subjects were exposed to pregabalin at a dose of 600 mg/day.
Croatian: U kliničkom ispitivanju u kojemu se procjenjivao učinak pregabalina na pokretljivost spermija, zdravi su muški ispitanici bili izloženi pregabalinu u dozi od 600 mg na dan.
English: White blood cell count decreased * Alanine aminotransferase increased (ALT) and aspartate aminotransferase increased (AST).
Croatian: Rijetko smanjenje broja bijelih krvnih stanica *povećanje alanin aminotransferaze (ALT) i aspartat aminotransferaze (AST).
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza EXP.
English: Population pharmacokinetic analysis showed that creatinine clearance was a significant covariate of pregabalin oral clearance, body weight was a significant covariate of pregabalin apparent oral volume of distribution, and these relationships were similar in paediatric and adult patients.
Croatian: Populacijska farmakokinetička analiza pokazala je da je klirens kreatinina bio značajna kovarijabla peroralnog klirensa pregabalina, tjelesna težina bila je značajna kovarijabla prividnog peroralnog volumena distribucije pregabalina, a ti su odnosi bili slični kod pedijatrijskih i odraslih bolesnika.
English: • Interrupted menstrual periods
Croatian: • prekid menstrualnog ciklusa
English: Adverse effects on male reproductive organs and sperm parameters were reversible and occurred only at exposures sufficiently in excess of therapeutic exposure or were associated with spontaneous degenerative processes in male reproductive organs in the rat.
Croatian: Štetni učinci na spolne organe mužjaka i obilježja sperme bili su reverzibilni, a javljali su se samo pri izloženosti dovoljno većoj od terapijske, ili su bili povezani sa spontanim degenerativnim procesima na spolnim organima mužjaka štakora.
English: Mylan Hungary Kft, Mylan utca 1, Komárom, 2900, Hungary McDermott Laboratories Limited t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Croatian: Mylan Hungary Kft, Mylan utca 1, Komárom, 2900, Mađarska McDermott Laboratories Limited t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Irska
English: • A small number of people being treated with anti-epileptics such as Pregabalin Mylan Pharma have had thoughts of harming or killing themselves.
Croatian: • Mali broj ljudi koji se liječe antiepileptičkim lijekovima kao što je Pregabalin Mylan Pharma razmišljali su o samoozljeđivanju ili samoubojstvu.
English: Ophthalmologic testing (including visual acuity testing, formal visual field testing and dilated funduscopic examination) was conducted in over 3600 patients within controlled clinical trials.
Croatian: Oftalmološke pretrage (uključujući mjerenje oštrine vida, formalno ispitivanje vidnog polja i fundoskopski pregled nakon širenja zjenica) su u sklopu kontroliranih kliničkih ispitivanja provedene u više od 3600 bolesnika.
English: PHARMACEUTICAL FORM AND CONTENTS
Croatian: 4. FARMACEUTSKI OBLIK I SADRŽAJ
English: In prenatal/postnatal toxicity studies, pregabalin induced offspring developmental toxicity in rats at exposures >2 times the maximum recommended human exposure.
Croatian: U ispitivanjima prenatalne/postnatalne toksičnosti pregabalin je izazvao razvojnu toksičnost za mladunčad štakora pri razini izloženosti > 2 puta većoj od maksimalne preporučene izloženosti u ljudi.
English: • Pregabalin Mylan Pharma may cause blurring or loss of vision, or other changes in eyesight, many of which are temporary.
Croatian: • Pregabalin Mylan Pharma može uzrokovati zamagljen vid, gubitak vida ili druge promjene vida, od kojih su mnoge privremene.