FrancophonIA/ELRC3.0 huggingface dataset:
English: Inter-subject pharmacokinetic variability for pregabalin is low (< 20%).
Croatian: Razlike u farmakokinetici pregabalina od osobe do osobe su male (< 20%).
English: Do not use this medicine after the expiry date which is stated on the carton or bottle.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji ili boci.
English: This medicine is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults.
Croatian: Ovaj se lijek koristi za liječenje nekih oblika epilepsije (parcijalnih napadaja sa ili bez sekundarne generalizacije) u odraslih osoba.
English: • Coldness of hands and feet.
Croatian: • hladnoća šaka i stopala.
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: Other medicines and Pregabalin Accord
Croatian: Drugi lijekovi i Pregabalin Accord
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: 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: Pregabalin Accord is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.
Croatian: Pregabalin Accord nije namijenjen za samostalnu primjenu, nego se uvijek mora uzimati u kombinaciji s drugim antiepileptičkim lijekovima.
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: • Jaundice (yellowing of the skin and eyes).
Croatian: • žutica (žutilo kože i bjeloočnica)
English: What Pregabalin Accord looks like and contents of the pack
Croatian: Kako Pregabalin Accord izgleda i sadržaj pakiranja
English: Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbance, fatigue (tiredness), and can have an impact on physical and social functioning and overall quality of life.
Croatian: Periferna i centralna neuropatska bol mogu biti povezane i s promjenama raspoloženja, poremećajem spavanja te umorom (iscrpljenošću), a mogu utjecati na tjelesno i socijalno funkcioniranje i ukupnu kvalitetu života.
English: If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor or pharmacist.
Croatian: Ako Vam se čini da je djelovanje ovog lijeka prejako ili preslabo, porazgovarajte sa svojim liječnikom ili ljekarnikom.
English: • This medicine may cause blurring or loss of vision, or other changes in eyesight, many of which are temporary.
Croatian: • Ovaj lijek može uzrokovati zamagljen vid, gubitak vida ili druge promjene vida, od kojih su mnoge privremene.
English: Vision-related effects
Croatian: Učinci povezani s vidom
English: The active substance, pregabalin, is a gamma-aminobutyric acid analogue [(S)-3-(aminomethyl)-5-methylhexanoic acid].
Croatian: Djelatna tvar je pregabalin, analog gama-aminomaslačne kiseline [(S)-3-(aminometil)-5-metilheksanoična kiselina].
English: The degree of dizziness, sleepiness and decreased concentration may be increased if Pregabalin Accord is taken together with medicines containing:
Croatian: Omaglica, pospanost i smanjenje koncentracije mogu se pojačati ako se Pregabalin Accord uzima zajedno s lijekovima koji sadrže:
English: • Inappropriate behaviour.
Croatian: • neprilagođeno ponašanje
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: Pregabalin Accord may be taken with or without food.
Croatian: Način primjene Pregabalin Accord se može uzimati s hranom ili bez nje.
English: Accord Healthcare Limited Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF, United Kingdom
Croatian: Accord Healthcare Limited Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF, Velika Britanija
English: • Decrease in white blood cell count.
Croatian: • smanjen broj bijelih krvnih stanica
English: • Swelling of the body including extremities.
Croatian: • oticanje tijela, uključujući udove
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V . Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.
English: Peripheral and central neuropathic pain, Epilepsy or Generalised Anxiety Disorder:
Croatian: Periferna i centralna neuropatska bol, epilepsija ili generalizirani anksiozni poremećaj:
English: • Interrupted menstrual periods.
Croatian: • prekid menstrualnog ciklusa
English: If you stop taking Pregabalin Accord Do not stop taking this medicine unless your doctor tells you to.
Croatian: Ako prestanete uzimati lijek Pregabalin Accord Nemojte prestati uzimati ovaj lijek ako Vam to ne kaže liječnik.
English: If while taking this medicine you notice decreased urination, you should tell your doctor as stopping the medicine may improve this.
Croatian: Ako tijekom uzimanja ovog lijeka primijetite da manje mokrite, morate o tome obavijestiti svog liječnika jer se prekidom primjene lijeka to može poboljšati.
English: UNIQUE IDENTIFIER-HUMAN READABLE DATA
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM
English: In clinical trials up to 12 weeks for both peripheral and central neuropathic pain, a reduction in pain was seen by Week 1 and was maintained throughout the treatment period.
Croatian: U kliničkim ispitivanjima u trajanju do 12 tjedana je i kod periferne i kod centralne neuropatske boli smanjenje boli opaženo u prvom tjednu liječenja i održalo se tijekom cijelog trajanja liječenja.
English: Pregabalin Accord is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Croatian: Pregabalin Accord je indiciran kao dodatna terapija u odraslih osoba s parcijalnim napadajima, sa ili bez sekundarne generalizacije.
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: Adverse reactions 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: The safety and efficacy of Pregabalin Accord 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 Accord u djece mlađe od 12 godina i adolescenata (1217 godina) nisu ustanovljene.
English: If you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Pregabalin Accord: Ako ste alergični na pregabalin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Your doctor will prescribe PregabalinAccord for you to help treat your epilepsy when your current treatment is not controlling your condition.
Croatian: Liječnik će Vam propisati Pregabalin Accord za liječenje epilepsije kada lijekovi koje ste do sada uzimali bolest ne drže pod kontrolom.
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: • Difficulty with or painful urination, incontinence.
Croatian: • otežano ili bolno mokrenje, inkontinencija
English: In humans, the apparent volume of distribution of pregabalin following oral administration is approximately 0.56 L/kg.
Croatian: Prividan volumen raspodjele pregabalina nakon peroralne primjene u ljudi iznosi približno 0,56 L/kg.
English: • Muscle damage.
Croatian: • oštećenje mišića
English: • When Pregabalin Accord 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).
Croatian: • Kada se Pregabalin Accord 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).
English: The N-methylated derivative of pregabalin, the major metabolite of pregabalin found in urine, accounted for 0.9% of the dose.
Croatian: Nmetilirani derivat pregabalina, glavni metabolit pregabalina ustanovljen u mokraći, činio je 0,9% doze.
English: • This medicine has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in elderly patients.
Croatian: • Liječenje ovim lijekom povezuje se s pojavom omaglice i pospanosti, što može povećati broj slučajnih ozljeda (padova) u starijih bolesnika.
English: For three times a day take this medicine once in the morning, once in the afternoon and once in the evening, at about the same time each day.
Croatian: Ako ovaj lijek uzimate tri puta na dan, uzmite jednu dozu ujutro, jednu dozu poslijepodne te jednu navečer, svakoga dana otprilike u isto vrijeme.
English: • Vertigo, problems with balance, fall.
Croatian: • vrtoglavica, poteškoće s ravnotežom, pad
English: The pregabalin clinical programme involved over 8,900 patients exposed to pregabalin, of whom over 5,600 were in double-blind placebocontrolled trials.
Croatian: 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.
English: • Fluid in the lungs.
Croatian: • tekućina u plućima
English: Neuropathic pain
Croatian: Neuropatska bol
English: • There have been reports of reduction in brain function (encephalopathy) in some patients taking this medicine when they have other conditions.
Croatian: • Prijavljeno je smanjenje moždane funkcije (encefalopatija) u nekih bolesnika koji su uzimali ovaj lijek, a bolovali su i od drugih bolesti.
English: Pregabalin Accord is for oral use only.
Croatian: Pregabalin Accord je namijenjen samo za peroralnu primjenu.
English: 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.
Croatian: 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.
English: Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg per day after an additional 7-day interval.
Croatian: Ovisno o odgovoru i podnošljivosti lijeka u pojedinog bolesnika, doza se nakon razdoblja od 3 do 7 dana može povećati na 300 mg na dan te, po potrebi, nakon dodatnih 7 dana na maksimalnu dozu od 600 mg na dan.
English: Peripheral and central neuropathic pain
Croatian: Periferna i centralna neuropatska bol
English: Additionally Pregabalin Accord 75mg hard capsules are also available in PVC/Aluminium blisterin pack sizes of 70 hard capsules.
Croatian: Osim Pregabalin Accord tvrde kapsule od 75mg su također dostupne su u PVC / aluminijskim blisterima u veličinama pakiranja od 70 tvrdih kapsula.
English: For twice a day take this medicine once in the morning and once in the evening, at about the same time each day.
Croatian: Ako ovaj lijek uzimate dva puta na dan, uzmite jednu dozu ujutro te jednu navečer, svakoga dana otprilike u isto vrijeme.
English: • Hepatitis (inflammation of the liver).
Croatian: • zatajenje jetre • hepatitis (upala jetre)
English: Pregabalin steady-state pharmacokinetics are similar in healthy volunteers, patients with epilepsy receiving anti-epileptic medicinal products and patients with chronic pain.
Croatian: Farmakokinetika pregabalina u stanju dinamičke ravnoteže slična je u zdravih dobrovoljaca, bolesnika s epilepsijom koji uzimaju antiepileptike i bolesnika s kroničnom boli.
English: Pregabalin Accord may cause dizziness and somnolence and therefore may influence the ability to drive or use machines.
Croatian: Pregabalin Accord može izazvati omaglicu i somnolenciju te tako utjecati na sposobnost upravljanja vozilima ili rada sa strojevima.
English: Efficacy has been shown in trials in diabetic neuropathy, post herpetic neuralgia and spinal cord injury.
Croatian: Djelotvornost je dokazana u ispitivanjima u dijabetičkoj neuropatiji, postherpetičkoj neuralgiji i ozljedama leđne moždine.
English: Pregabalin Accord may have minor or moderate influence on the ability to drive and use machines.
Croatian: Pregabalin Accord može malo ili umjereno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: • Loss of appetite, weight loss, low blood sugar, high blood sugar.
Croatian: • gubitak teka, gubitak tjelesne težine, niska razina šećera u krvi, visoka razina šećera u krvi
English: Results of a 12-week placebo-controlled study of 295 paediatric patients aged 4 to 16 years performed to evaluate the efficacy and safety of pregabalin as adjunctive therapy for the treatment of partial onset seizures and a 1 year open label safety study in 54 paediatric patients from 3 months to 16 years of age with epilepsy indicate that the adverse events of pyrexia and upper respiratory infections were observed more frequently than in adult studies of patients with epilepsy (see sections 4.2, 4.8 and 5.2).
Croatian: Rezultati 12-tjednog placebom kontroliranog ispitivanja koje je provedeno u 295 pedijatrijskih bolesnika u dobi od 4 do 16 godina radi procjene djelotvornosti i sigurnosti pregabalina kao dodatne terapije za liječenje parcijalnih napadaja i jednogodišnjeg otvorenog ispitivanja sigurnosti u 54 pedijatrijska bolesnika u dobi od 3 mjeseca do 16 godina starosti s epilepsijom ukazuju da su štetni događaji pireksije i infekcija gornjih dišnih putova zabilježeni češće nego u ispitivanjima u odraslih bolesnika s epilepsijom (vidjeti dijelove 4.2, 4.8 i 5.2).
English: Dizziness, somnolence, loss of consciousness, confusion, and mental impairment Pregabalin treatment has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in the elderly population.
Croatian: Omaglica, somnolencija, gubitak svijesti, konfuzija i slabljenje mentalnih sposobnosti Liječenje pregabalinom povezuje se s pojavom omaglice i somnolencije, što može povećati broj slučajnih ozljeda (padova) u starijoj populaciji.
English: Pregabalin Accord belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD) in adults.
Croatian: Pregabalin Accord pripada skupini lijekova koji se koriste za liječenje epilepsije, neuropatske boli i generaliziranog anksioznog poremećaja (GAP) u odraslih osoba.
English: The other ingredients are: starch pregelatinise, talc (E553b), gelatin, titanium dioxide (E171), sodium laurilsulfate, black ink, (which contains shellac, propylene glycol, iron oxide black (E172), and , potassium hydroxide).
Croatian: Drugi sastojci su: prethodno geliran škrob, talk (E553b), želatina, titanijev dioksid (E171), natrijev laurilsulfat, crna tinta, (koja sadrži šelak, propilenglikol, crni željezov oksid (E172) i kalijev hidroksid).
English: 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).
Croatian: 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).
English: The adverse events observed in a pharmacokinetic and tolerability study that enrolled patients from 3 months to 16 years of age (n=65) with partial onset seizures were similar to those observed in adults.
Croatian: Štetni događaji zapaženi u ispitivanju farmakokinetike i podnošljivosti koje je uključivalo bolesnike u dobi od 3 mjeseca do 16 godina starosti (n=65) s parcijalnim napadajima bili su slični onima zapaženima u odraslih.
English: Total pregabalin daily dose * Dose regimen
Croatian: Ukupna dnevna doza pregabalina*
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 Renantiomer.
English: Treatment of central neuropathic pain due to spinal cord injury In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse reactions in general, central nervous system adverse reactions and especially somnolence was increased.
Croatian: Liječenje centralne neuropatske boli uzrokovane ozljedom leđne moždine U liječenju centralne neuropatske boli uzrokovane ozljedom leđne moždine zabilježena je povećana incidencija nuspojava općenito te nuspojava središnjeg živčanog sustava, a osobito somnolencije.
English: An increased incidence of retinal atrophy commonly observed in aged albino rats was seen after long-term exposure to pregabalin at exposures ≥ 5 times the mean human exposure at the maximum recommended clinical dose.
Croatian: Povećana incidencija atrofije mrežnice, uobičajene u starijih albino štakora, opažena je nakon dugotrajne izloženosti pregabalinu ≥ 5 puta veće od prosječne izloženosti u ljudi kod primjene najviše preporučene kliničke doze.
English: Neuropathic pain Pregabalin Accord is indicated for the treatment of peripheral and central neuropathic pain in adults.
Croatian: Neuropatska bol Pregabalin Accord je indicirana za liječenje periferne i centralne neuropatske boli u odraslih osoba.
English: • Cold sweat, tightness of the throat, swollen tongue.
Croatian: • hladan znoj, stezanje u grlu, oticanje jezika
English: 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.
Croatian: 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.
English: This medicine is used to treat Generalised Anxiety Disorder (GAD).
Croatian: Ovaj se lijek koristi za liječenje generaliziranog anksioznog poremećaja (GAP).
English: How to take Pregabalin Accord
Croatian: Kako uzimati Pregabalin Accord
English: Talk to your doctor or pharmacist before taking Pregabalin Accord.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete Pregabalin Accord.
English: The incidence of adverse reactions in general, central nervous system adverse reactions and especially somnolence was increased in the treatment of central neuropathic pain due to spinal cord injury (see section 4.4).
Croatian: Zabilježena je povećana incidencija nuspojava općenito te nuspojava središnjeg živčanog sustava, a osobito somnolencije, u liječenju centralne neuropatske boli uzrokovane ozljedom leđne moždine (vidjeti dio 4.4).
English: The pregabalin safety profile observed in three paediatric studies in patients with partial seizures with or without secondary generalization (12-week efficacy and safety study in patients with partial onset seizures, n=295; pharmacokinetic and tolerability study, n=65; 1 and year open label follow on safety study, n=54) was similar to that observed in the adult studies of patients with epilepsy .
Croatian: Sigurnosni profil pregabalina zabilježen u tri pedijatrijska ispitivanja u bolesnika s parcijalnim napadajima sa sekundarnom generalizacijom ili bez nje (12-tjedno ispitivanje djelotvornosti i sigurnosti u bolesnika s parcijalnim napadajima, n=295, ispitivanje farmakokinetike i podnošljivosti, n=65 i jednogodišnje otvoreno ispitivanje praćenja sigurnosti, n=54) bio je sličan onome zapaženom u ispitivanjima u odraslih bolesnika s epilepsijom.
English: Central nervous system influencing medicinal products Pregabalin may potentiate the effects of ethanol and lorazepam.
Croatian: Pregabalin može pojačati učinke etanola i lorazepama.
English: • Dilated pupils, cross eyes.
Croatian: • proširene zjenice, ukrižene oči
English: When taken with certain other medicines, Pregabalin Accord may potentiate the side effects seen with these medicines, including respiratory failure and coma.
Croatian: Kada se uzima s nekim drugim lijekovima, Pregabalin Accord može pojačati nuspojave tih lijekova, uključujući zatajenje disanja i komu.
English: • There have been reports of convulsions when taking this medicine or shortly after stopping this medicine.
Croatian: • Za vrijeme uzimanja ili nedugo nakon prestanka uzimanja ovog lijeka prijavljene su konvulzije.
English: It is important to take your medicine regularly at the same time each day.
Croatian: Ako ste zaboravili uzeti lijek Pregabalin Accord Važno je da ovaj lijek uzimate redovito, svakoga dana u isto vrijeme.
English: • There have been reports of heart failure in some patients when taking this medicine; these patients were mostly elderly with cardiovascular conditions.
Croatian: • U nekih je bolesnika pri uzimanju ovog lijeka prijavljeno zatajenje srca; radilo se uglavnom o starijim bolesnicima s postojećim bolestima srca i krvožilja.
English: The 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules also contain iron oxide red (E172).
Croatian: Kapsule od 75 mg, 100 mg, 200 mg, 225 mg i 300 mg također sadrže crveni željezov oksid (E172).