natgillin/translations-raw huggingface dataset:
These symptoms may occur more commonly or severely if you have been taking Pregabalin Mylan Pharma for a longer period of time. 
Ti simptomi mogu biti češći ili ozbiljniji ako ste lijek Pregabalin Mylan Pharma uzimali dulje vrijeme.
Pregabalin was excreted into breast milk with average steady-state concentrations approximately 76% of those in maternal plasma. 
Pregabalin se izlučivao u majčino mlijeko u prosječnim koncentracijama stanja dinamičke ravnoteže koje su iznosile otprilike 76% onih u majčinoj plazmi.
Therefore the effects were considered of little or no clinical relevance. 
Stoga se smatra da ti učinci imaju malen ili nikakav značaj za kliničku primjenu.
Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medicinal product. 
Stoga, bolesnicima treba savjetovati da budu oprezni dok se ne upoznaju s mogućim učincima lijeka.
In conventional safety pharmacology studies in animals, pregabalin was well-tolerated at clinically relevant doses. 
U konvencionalnim ispitivanjima sigurnosne farmakologije na životinjama pregabalin se dobro podnosio u dozama značajnima za kliničku primjenu.
If you have the impression that the effect of Pregabalin Mylan Pharma is too strong or too weak, talk to your doctor or pharmacist. 
Ako Vam se čini da je djelovanje lijeka Pregabalin Mylan Pharma prejako ili preslabo, porazgovarajte sa svojim liječnikom ili ljekarnikom.
Tell your doctor if you have a history of any serious medical conditions, including liver or kidney disease. 
Obavijestite svog liječnika ako ste bolovali od neke ozbiljne bolesti, uključujući bolesti jetre ili bubrega.
These reactions are mostly seen in elderly cardiovascular compromised patients during pregabalin treatment for a neuropathic indication. 
Te su reakcije zabilježene uglavnom u starijih kardiovaskularno kompromitiranih bolesnika tijekom liječenja pregabalinom u neuropatskim indikacijama.
Following an additional week the dose may be increased to 450 mg per day. 
Nakon sljedećih tjedan dana doza se može povećati na 450 mg na dan.
Pregabalin Mylan Pharma and certain other medicines may influence each other (interaction). 
Pregabalin Mylan Pharma i neki drugi lijekovi mogu djelovati jedni na druge (interakcija).
Pregabalin pharmacokinetics in patients younger than 3 months old have not been studied (see sections 4.2, 4.8 and 5.1). 
Farmakokinetika pregabalina u bolesnika mlađih od 3 mjeseca nije ispitana (vidjeti dijelove 4.2, 4.8 i
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)). 
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).
When pregabalin and opioids will be used in combination, measures to prevent constipation may be considered (especially in female patients and elderly). 
Kada se pregabalin primjenjuje u kombinaciji s opioidima, može se razmisliti o mjerama za sprečavanje konstipacije (osobito u žena i starijih bolesnika).
• Muscle damage 
• oštećenje mišića
• Difficulty with or painful urination, incontinence 
• otežano ili bolno mokrenje, inkontinencija
In preclinical studies, there was no indication of racemisation of pregabalin S-enantiomer to the R-enantiomer. 
U nekliničkim istraživanjima nije bilo znakova racemizacije S-enantiomera pregabalina u R-enantiomer.
Discontinuation of pregabalin may result in resolution or improvement of these visual symptoms. 
Prekid primjene pregabalina može dovesti do povlačenja ili poboljšanja tih simptoma.
Pregabalin binds to an auxiliary subunit (α2- δ protein) of voltage-gated calcium channels in the central nervous system. 
Pregabalin se veže na pomoćnu podjedinicu (α2- protein) na električni napon osjetljivih kalcijevih kanala u središnjem živčanom sustavu.
Uncommon Rare 
neuobičajeno osjećanje
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 
BID = podijeljeno u 2 doze * Ukupnu dnevnu dozu (mg/dan) treba podijeliti prema navedenom režimu doziranja kako bi se odredili miligrami po jednoj dozi
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. 
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.
White blood cell count decreased * Alanine aminotransferase increased (ALT) and aspartate aminotransferase increased (AST). 
Rijetko smanjenje broja bijelih krvnih stanica *povećanje alanin aminotransferaze (ALT) i aspartat aminotransferaze (AST).
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza EXP.
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. 
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.
• Interrupted menstrual periods 
• prekid menstrualnog ciklusa
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. 
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.
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 
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
• A small number of people being treated with anti-epileptics such as Pregabalin Mylan Pharma have had thoughts of harming or killing themselves. 
• Mali broj ljudi koji se liječe antiepileptičkim lijekovima kao što je Pregabalin Mylan Pharma razmišljali su o samoozljeđivanju ili samoubojstvu.
Ophthalmologic testing (including visual acuity testing, formal visual field testing and dilated funduscopic examination) was conducted in over 3600 patients within controlled clinical trials. 
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.
PHARMACEUTICAL FORM AND CONTENTS 
4. FARMACEUTSKI OBLIK I SADRŽAJ
In prenatal/postnatal toxicity studies, pregabalin induced offspring developmental toxicity in rats at exposures >2 times the maximum recommended human exposure. 
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.
• Pregabalin Mylan Pharma may cause blurring or loss of vision, or other changes in eyesight, many of which are temporary. 
• Pregabalin Mylan Pharma može uzrokovati zamagljen vid, gubitak vida ili druge promjene vida, od kojih su mnoge privremene.
In humans, the apparent volume of distribution of pregabalin following oral administration is approximately 0.56 l/kg. 
Prividan volumen raspodjele pregabalina nakon peroralne primjene u ljudi iznosi približno 0,56 l/kg.
The efficacy and safety of pregabalin as adjunctive treatment for epilepsy in paediatric patients below the age of 12 and adolescents has not been established. 
Djelotvornost i sigurnost pregabalina kao dodatne terapije za epilepsiju u pedijatrijskih bolesnika mlađih od 12 godina i adolescenata nisu ustanovljene.
• Convulsions 
• konvulzije
Continue taking Pregabalin Mylan Pharma until your doctor tells you to stop. 
Nastavite uzimati lijek Pregabalin Mylan Pharma dok Vam liječnik ne kaže da prestanete.
Supplementary dosage following haemodialysis (mg) 
Dopunska doza nakon hemodijalize (mg)
The pregabalin clinical programme involved over 8900 patients exposed to pregabalin, of whom over 5600 were in double-blind placebo controlled trials. 
Kliničkim programom ispitivanja pregabalina obuhvaćeno je više od 8900 bolesnika izloženih pregabalinu, od kojih je više od 5600 bilo uključeno u dvostruko slijepa, placebom kontrolirana ispitivanja.
Take your box or bottle of Pregabalin Mylan Pharma capsules with you. 
Uzmite sa sobom kutiju ili bocu Pregabalin Mylan Pharma kapsula.
Pregabalin is removed effectively from plasma by haemodialysis (50% of drug in 4 hours). 
Pregabalin se iz plazme djelotvorno uklanja hemodijalizom (50% lijeka tijekom 4 sata).
Pregabalin has been shown to cross the placenta in rats and is present in the milk of lactating rats. 
Pregabalin prolazi kroz placentu u štakora te je prisutan u mlijeku štakorica u laktaciji.
• Vertigo, problems with balance, fall 
• vrtoglavica, poteškoće s ravnotežom, pad
There have been reports in the post-marketing experience of hypersensitivity reactions, including cases of angioedema. 
Nakon stavljanja lijeka u promet prijavljene su reakcije preosjetljivosti, uključujući slučajeve angioedema.
Pregabalin was not teratogenic in mice, rats or rabbits. 
Pregabalin se nije pokazao teratogenim u miševa, štakora i kunića.
At therapeutic exposures, there was evidence of CNS clinical signs of hyperactivity and bruxism and some changes in growth (transient body weight gain suppression). 
Pri terapijskoj izloženosti zabilježeni su klinički znakovi učinka na SŽS u smislu hiperaktivnosti i bruksizma te neke promjene u rastu (prolazna supresija porasta tjelesne mase).
• When Pregabalin Mylan Pharma is taken with other medicines that may cause constipation (such as some types of pain medicines) it is possible that gastrointestinal problems may occur (e.g., constipation, blocked or paralysed bowel). 
• Kada se Pregabalin Mylan Pharma uzima s drugim lijekovima koji mogu uzrokovati zatvor (kao što su neke vrste lijekova protiv bolova), moguće je da se pojave probavne tegobe (primjerice zatvor, blokada ili paraliza crijeva).
Pregabalin appears to be additive in the impairment of cognitive and gross motor function caused by oxycodone. 
Čini se da pregabalin dodatno pridonosi oksikodonom uzrokovanom oštećenju kognitivne i grube motoričke funkcije.
Pregabalin Mylan Pharma should not be taken during pregnancy or when breast-feeding, unless you are told otherwise by your doctor. 
Pregabalin Mylan Pharma se ne smije uzimati tijekom trudnoće ili dojenja, osim ako Vam liječnik nije rekao drugačije.
Cases of encephalopathy have been reported, mostly in patients with underlying conditions that may precipitate encephalopathy. 
Prijavljeni su slučajevi encefalopatije, uglavnom u bolesnika s postojećim stanjima koja mogu izazvati encefalopatiju.
No tumours were observed in rats at exposures up to 24 times the mean human exposure at the maximum recommended clinical dose of 600 mg/day. 
U štakora nisu opaženi tumori pri izloženosti do 24 puta većoj od prosječne izloženosti u ljudi kod primjene najviše preporučene kliničke doze od 600 mg na dan.
This decrease in pregabalin oral clearance is consistent with decreases in creatinine clearance associated with increasing age. 
To smanjenje peroralnog klirensa pregabalina u skladu je sa smanjenjem klirensa kreatinina povezanim s rastućom dobi.
It is advised not to drink alcohol while taking Pregabalin Mylan Pharma. 
Preporučuje se da ne pijete alkohol dok uzimate lijek Pregabalin Mylan Pharma.
The most common adverse events observed in the 12-week study with pregabalin treatment were somnolence, pyrexia, upper respiratory tract infection, increased appetite, weight increased, and nasopharyngitis (see sections 4.2, 5.1 and 5.2). 
Najčešći štetni događaji zabilježeni u 12-tjednom ispitivanju liječenja pregabalinom bili su somnolencija, pireksija, infekcija gornjih dišnih putova, povećani apetit, povećanje tjelesne težine i nazofaringitis (vidjeti dijelove 4.2, 5.1 i 5.2).
In addition, pregabalin is effectively removed from plasma by haemodialysis (following a 4 hour haemodialysis treatment plasma pregabalin concentrations are reduced by approximately 50%). 
Nadalje, pregabalin se iz plazme djelotvorno uklanja hemodijalizom (nakon četverosatne hemodijalize koncentracije pregabalina u plazmi smanjuju se za približno 50%).
PHARMACEUTICAL FORM AND CONTENTS Hard capsule. 
4. FARMACEUTSKI OBLIK I SADRŽAJ Tvrde kapsule.
Patients are advised not to drive, operate complex machinery or engage in other potentially hazardous activities until it is known whether this medicinal product affects their ability to perform these activities. 
Bolesnicima se savjetuje da ne voze, ne rukuju složenim strojevima i ne poduzimaju druge potencijalno opasne aktivnosti dok se ne utvrdi utječe li ovaj lijek na njihovu sposobnost da to čine.
The N-methylated derivative of pregabalin, the major metabolite of pregabalin found in urine, accounted for 0.9% of the dose. 
N-metilirani derivat pregabalina, glavni metabolit pregabalina ustanovljen u mokraći, činio je 0,9% doze.
Fertility There are no clinical data on the effects of pregabalin on female fertility. 
Plodnost Nema kliničkih podataka o učincima pregabalina na plodnost žena.
In addition to the daily dose, a supplementary dose should be given immediately following every 4 hour haemodialysis treatment (see Table 1). 
Uz dnevnu dozu treba dati dopunsku dozu pregabalina odmah nakon svakog četverosatnog postupka hemodijalize (vidjeti Tablicu 1).
Pregabalin and lamotrigine were similarly safe and well tolerated. 
Sigurnost i podnošljivost pregabalina i lamotrigina bile su podjednake.
Paediatric population Pregabalin pharmacokinetics were evaluated in paediatric patients with epilepsy (age groups: 1 to 23 months, 2 to 6 years, 7 to 11 years and 12 to 16 years) at dose levels of 2.5, 5, 10 and 15 mg/kg/day in a pharmacokinetic and tolerability study. 
Farmakokinetika pregabalina procijenjena je u pedijatrijskih bolesnika s epilepsijom (dobne skupine: od 1 do 23 mjeseca, od 2 do 6 godina, od 7 do 11 godina i od 12 do 16 godina) pri razinama doza od 2,5, 5, 10 i 15 mg/kg/dan u ispitivanju farmakokinetike i podnošljivosti.
Pregabalin is excreted into human milk (see section 5.2). 
Pregabalin se izlučuje u majčino mlijeko (vidjeti dio 5.2).
• Some patients taking Pregabalin Mylan Pharma have reported symptoms suggesting an allergic reaction. 
• Neki bolesnici koji su uzimali lijek Pregabalin Mylan Pharma prijavili su simptome koji ukazuju na alergijsku reakciju.
Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after 1 week. 
Ovisno o odgovoru i podnošljivosti lijeka u pojedinog bolesnika, doza se nakon tjedan dana može povećati na 300 mg na dan.
The other ingredients are: hydroxylpropylcellulose, maize starch, talc, gelatin, titanium dioxide (E171), sodium laurilsulfate, black ink (which contains shellac, black iron oxide (E172), macrogol, potassium hydroxide and concentrated ammonia solution), yellow iron oxide (E172) and erythrosine (E127). 
Drugi sastojci su: hidroksipropilceluloza, kukuruzni škrob, talk, želatina, titanijev dioksid (E171), natrijev laurilsulfat, crna tinta (koja sadrži šelak, crni željezov oksid (E172), macrogol, kalijev hidroksid i koncentriranu otopinu amonijaka), žuti željezov oksid (E172) i eritrozin (E127).
Capsules content Hydroxylpropylcellulose Maize starch Talc 
Sadržaj kapsula hidroksipropilceluloza kukuruzni škrob talk
Pregabalin treatment can be started with a dose of 150 mg per day. 
Liječenje pregabalinom može započeti dozom od 150 mg na dan.
Pregabalin Mylan Pharma is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment. 
Pregabalin Mylan Pharma nije namijenjen za samostalnu primjenu, nego se uvijek mora uzimati u kombinaciji s drugim antiepileptičkim lijekovima.
Pregabalin Mylan Pharma with food, drink and alcohol Pregabalin Mylan Pharma capsules may be taken with or without food. 
Pregabalin Mylan Pharma s hranom, pićem i alkoholom Pregabalin Mylan Pharma kapsule mogu se uzimati s hranom ili bez nje.
For patients receiving haemodialysis, the pregabalin daily dose should be adjusted based on renal function. 
Bolesnicima na hemodijalizi dnevnu dozu pregabalina treba prilagoditi na temelju bubrežne funkcije.
No specific pharmacokinetic studies were carried out in patients with impaired liver function. 
Nisu provedena specifična farmakokinetička ispitivanja u bolesnika s oštećenjem jetrene funkcije.
Multiple dose pharmacokinetics are predictable from single-dose data. 
Farmakokinetika višestrukih doza može se predvidjeti iz podataka o farmakokinetici jedne doze.
Pregabalin has been studied in 6 controlled trials of 4-6 week duration, an elderly study of 8 week duration and a long-term relapse prevention study with a double blind relapse prevention phase of 6 months duration. 
Pregabalin je ispitivan u 6 kontroliranih ispitivanja u trajanju od 4-6 tjedana, u 8-tjednom ispitivanju u starijih osoba te u dugoročnom ispitivanju prevencije relapsa s dvostruko slijepom fazom prevencije relapsa u trajanju od 6 mjeseci.
In mice, no increased incidence of tumours was found at exposures similar to the mean human exposure, but an increased incidence of haemangiosarcoma was observed at higher exposures. 
U miševa nije utvrđena povećana incidencija tumora pri izloženosti sličnoj prosječnoj izloženosti u ljudi, ali je pri većoj izloženosti opažena povećana incidencija hemangiosarkoma.
Two-year carcinogenicity studies with pregabalin were conducted in rats and mice. 
Provedena su dvogodišnja ispitivanja kancerogenosti pregabalina na štakorima i miševima.
Clinical trials indicate that gender does not have a clinically significant influence on the plasma concentrations of pregabalin. 
Klinička ispitivanja pokazuju da spol nema klinički značajnog utjecaja na koncentracije pregabalina u plazmi.
If while taking Pregabalin Mylan Pharma you notice decreased urination, you should tell your doctor as stopping the medicine may improve this. 
Ako tijekom uzimanja lijeka Pregabalin Mylan Pharma primijetite da manje mokrite, morate o tome obavijestiti svog liječnika jer se prekidom primjene lijeka to može poboljšati.
Pregabalin steady-state pharmacokinetics are similar in healthy volunteers, patients with epilepsy receiving anti-epileptic drugs and patients with chronic pain. 
Farmakokinetika pregabalina u stanju dinamičke ravnoteže slična je u zdravih dobrovoljaca, bolesnika s epilepsijom koji uzimaju antiepileptike i bolesnika s kroničnom boli.
Pharmaceutical Trading Co. Ltd. Τηλ: + 357 99403969 
Ltd. Τηλ: + 357 99403969
What Pregabalin Mylan Pharma looks like and contents of the pack Hard capsule. 
Kako Pregabalin Mylan Pharma izgleda i sadržaj pakiranja Tvrda kapsula.
The estimated infant dose from breast milk (assuming mean milk consumption of 150 ml/kg/day) of women receiving 300 mg/day or the maximum dose of 600 mg/day would be 0.31 or 0.62 mg/kg/day, respectively. 
Procijenjena doza koju bi dojenče dobivalo iz mlijeka (uzimajući u obzir srednju konzumaciju mlijeka od oko 150 ml/kg/dan) žene koja prima 300 mg/dan ili maksimalnu dozu od 600 mg/dan iznosila bi 0,31 odnosno 0,62 mg/kg/dan.
If you experience a convulsion, contact your doctor immediately. 
Ako doživite konvulzije, odmah se javite liječniku.
INSTRUCTIONS ON USE <For multilayer label only> ‘Peel here' 
15. UPUTE ZA UPORABU <Samo za višeslojne naljepnice> ‘Odlijepiti ovdje'
Caution should be exercised in patients with a history of substance abuse and the patient should be monitored for symptoms of pregabalin misuse, abuse or dependence (development of tolerance, dose escalation, drug-seeking behaviour have been reported). 
Potreban je oprez kod primjene lijeka u bolesnika s anamnezom zlouporabe sredstava ovisnosti te takve bolesnike treba nadzirati kako bi se uočili simptomi pogrešne primjene, zlouporabe ili ovisnosti o pregabalinu (prijavljeni su slučajevi razvoja tolerancije, povećanja doze i kompulzivnog traženja lijeka) .
Treatment of pregabalin overdose should include general supportive measures and may include haemodialysis if necessary (see section 4.2 Table 1). 
Liječenje predoziranja pregabalinom mora obuhvatiti opće potporne mjere, a po potrebi može uključivati i hemodijalizu (vidjeti dio 4.2, Tablica 1).
In repeated dose toxicity studies in rats and monkeys CNS effects were observed, including hypoactivity, hyperactivity and ataxia. 
U ispitivanjima toksičnosti ponovljenih doza na štakorima i majmunima nisu opaženi učinci na SŽS, uključujući hipoaktivnost, hiperaktivnost i ataksiju.
Capsules shell Iron oxide yellow (E172) Titanium dioxide (E171) Erythrosine (E127) Gelatin 
Ovojnica kapsule željezov oksid, žuti (E172) titanijev dioksid (E171) eritrozin (E127) želatina natrijev laurilsulfat
As pregabalin clearance is directly proportional to creatinine clearance (see section 5.2), dose reduction in patients with compromised renal function must be individualised according to creatinine clearance (CLcr), as indicated in Table 1 determined using the following formula: 
Budući da je klirens pregabalina upravo razmjeran klirensu kreatinina (vidjeti dio 5.2), u svakog pojedinog bolesnika s oslabljenom funkcijom bubrega doza se mora prilagoditi sukladno njegovu klirensu kreatinina (CLcr), kako je navedeno u Tablici 1, pomoću sljedeće formule:
Effects on the oestrus cycle were observed at 5-fold the human therapeutic exposure. 
Učinci na estrusni ciklus opaženi su pri izloženosti 5 puta većoj od terapijske izloženosti u ljudi.
• Some patients with diabetes who gain weight while taking pregabalin may need an alteration in their diabetic medicines. 
• Nekim bolesnicima sa šećernom bolešću koji dobiju na težini dok uzimaju pregabalin će možda trebati promijeniti terapiju lijekovima protiv šećerne bolesti.
• Loss of appetite, weight loss, low blood sugar, high blood sugar 
• gubitak teka, gubitak tjelesne težine, niska razina šećera u krvi, visoka razina šećera u krvi
The non-genotoxic mechanism of pregabalin-induced tumour formation in mice involves platelet changes and associated endothelial cell proliferation. 
Negenotoksičan mehanizam pregabalinom potaknutog nastanka tumora u miševa uključuje promjene trombocita te s time povezanu proliferaciju endotelnih stanica.