FrancophonIA/ELRC3.0 huggingface dataset:
English: sanofi-aventis groupe 54, rue La Boétie - F-75008 Paris France
Croatian: 54, rue La Boétie - F-75008 Paris
English: EU/1/98/069/008 4x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/069/009 30x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/069/010 100x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/069/012 10x1 film-coated tablets in all aluminium perforated unit-dose blisters
Croatian: EU/1/98/069/009 30x1 filmom obloženih tableta u perforiranom aluminijskom blisteru s jediničnim dozama
English: - omeprazole or esomeprazole, medicines to treat upset stomach, - fluconazole or voriconazole, medicines to treat fungal infections, - efavirenz, or other anti-retroviral medicines (used to treat HIV infections), - carbamazepine, a medicine to treat some forms of epilepsy, - moclobemide, medicine to treat depression, - repaglinide, medicine to treat diabetes, - paclitaxel, medicine to treat cancer, - opioids: while you are treated with clopidogrel, you should inform your doctor before being prescribed any opioid (used to treat severe pain).
Croatian: Posebno je važno obavijestiti liječnika ako uzimate - lijekove koji mogu povećati rizik od krvarenja, na primjer: o oralne antikoagulanse, lijekove koji smanjuju zgrušavanje krvi, o nesteroidne protuupalne lijekove, koji se obično primjenjuju za liječenje bolnih i/ili upalnih stanja mišića ili zglobova, o heparin ili bilo koji drugi lijek koji se daje putem injekcije za smanjivanje zgrušavanja krvi, o tiklopidin, drugi antitrombocitni lijek, o selektivne inhibitore ponovne pohrane serotonina (uključujući, ali ne ograničeno na fluoksetin ili fluvoksamin), lijekove koji se obično koriste za liječenje depresije, - omeprazol ili esomeprazol, lijekove za smanjenje želučanih tegoba, - flukonazol ili vorikonazol, lijekove koji se primjenjuju za liječenje gljivičnih infekcija, - efavirenz ili druge antiretrovirusne lijekove (primjenjuju se za liječenje HIV infekcije), - karbamazepin, lijek koji se primijenjuje za liječenje nekih oblika epilepsije, - moklobemid, lijek za liječenje depresije, - repaglinid, lijek za liječenje dijabetesa, - paklitaksel, lijek za liječenje raka
English: EU/1/98/069/008 - Cartons of 4x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/069/009 - Cartons of 30x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/069/010 - Cartons of 100x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/069/012 - Cartons of 10x1 film-coated tablets in all aluminium perforated unit-dose blisters
Croatian: EU/1/98/069/009 - kutije s 30x1 filmom obloženih tableta u perforiranim aluminijskim blisterima s jediničnim dozama
English: - signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots, and/or confusion (see section 2 ‘Warnings and precautions').
Croatian: "Upozorenja i mjere opreza"); - oticanje u ustima ili kožni poremećaji kao što su osip i svrbež te mjehurići na koži; ovi simptomi mogu biti znakovi alergijske reakcije.
English: Belgium Effik Benelux
Croatian: Effik Benelux
English: Mithra Pharmaceuticals Sa Midien
Croatian: Mithra Pharmaceuticals Sa
English: Jenapharm Gmbh & Co Kg Maxim
Croatian: Jenapharm Gmbh & Co Kg
English: Teva Pharma S.L.U
Croatian: Teva Pharma S.L.U Verezana
English: Luxembourg Mithra Pharmaceuticals Sa Deltanogest
Croatian: Luksemburg Mithra Pharmaceuticals Sa
English: Teva Pharmaceuticals Cr, S.R.O.
Croatian: Češka Republika Teva Pharmaceuticals Cr, S.R.O.
English: Ladee Pharma Baltics Uab Lasca
Croatian: Ladee Pharma Baltics Uab
English: Luxembourg Ratiopharm Gmbh
Croatian: Luksemburg Ratiopharm Gmbh
English: Sandoz Farmacéutica, S.A. Ceciliana
Croatian: Sandoz Farmacéutica, S.A.
English: Exeltis Czech S.R.O.
Croatian: Češka Republika Exeltis Czech S.R.O.
English: Belgium Exeltis Germany Gmbh Serisima Continu Dienogest 2mg Tablet, Ethinylestradiol 0.03mg Tablet $
Croatian: Exeltis Germany Gmbh Serisima Continu Dienogest 2mg tableta, etinilestradiol 0,03mg tableta $ placebo 0mg tableta
English: Dr. Kade Pharmazeutische Fabrik Gmbh
Croatian: Pharmazeutische Fabrik Gmbh
English: Sandoz S.R.O.
Croatian: Češka Republika Sandoz S.R.O.
English: Motion Ratiopharm Dienogest 2mg Tablet, Ethinylestradiol 0.03mg Tablet
Croatian: Motion Ratiopharm Dienogest 2mg tableta, etinilestradiol 0,03mg tableta
English: Velvet-Ratiopharm Dienogest 2mg Tablet, Ethinylestradiol 0.03mg Tablet
Croatian: Velvet-Ratiopharm Dienogest 2mg tableta, etinilestradiol 0,03mg tableta
English: Hormosan Pharma Gmbh Luvyna
Croatian: Hormosan Pharma Gmbh
English: Dienogest 2mg Tablet, Ethinylestradiol 0.03mg Tablet $ Placebo 0mg Tablet
Croatian: Dienogest 2mg tableta, etinilestradiol 0,03mg tableta $ placebo 0mg tableta
English: Mistral Continuous Dienogest 2mg, Ethinylestradiol 0.03mg $ Lactose Anhydrous 37.26mg
Croatian: Mistral Continuous Dienogest 2mg, etinilestradiol 0,03mg $ laktoza bezvodna 37,26mg
English: Dermapharm Gmbh
Croatian: Dermapharm Gmbh Dienovel
English: Dienogest 2mg Tablet, Ethinylestradiol 0.03mg Tablet $ Lactose Monohydrate 60.9mg Tablet
Croatian: Dienogest 2mg tableta, etinilestradiol 0,03mg tableta $ laktoza hidrat 60,9mg tableta
English: Dienogest 2mg Tablet, Ethinylestradiol 0.03mg Tablet $ Lactose 37.26mg Tablet
Croatian: Dienogest 2mg tableta, etinilestradiol 0,03mg tableta $ laktoza 37,26mg tableta
English: Dienogest 2mg Tablet, Ethinylestradiol 0.03mg Tablet $ Lactose Monohydrate 55.5mg Tablet
Croatian: Dienogest 2mg tableta, etinilestradiol 0,03mg tableta $ laktoza hidrat 55,5mg tableta
English: Dienogest 2mg Tablet, Ethinylestradiol 0.03mg Tablet $ Lactose Monohydrate 55mg Tablet
Croatian: Dienogest 2mg tableta, etinilestradiol 0,03mg tableta $ laktoza hidrat 55mg tableta
English: Dienogest 2mg, Ethinylestradiol 0.03mg $ Lactose Anhydrous 37.26mg
Croatian: Dienogest 2mg, etinilestradiol 0,03mg $ laktoza bezvodna 37,26mg
English: BID or TID
Croatian: BID ili TID
English: B 1930 Zaventem Belgium
Croatian: B 1930 Zaventem Belgija
English: weight x
Croatian: težina x
English: Call your doctor or go to the nearest hospital emergency unit immediately.
Croatian: Odmah nazovite svog liječnika ili otiđite u hitnu službu najbliže bolnice.
English: Lyrica and certain other medicines may influence each other (interaction).
Croatian: Lyrica i neki drugi lijekovi mogu djelovati jedni na druge (interakcija).
English: Sealed Pack Do not use if box has been opened.
Croatian: Ne koristiti ako je kutija otvarana.
English: Once Daily
Croatian: jednom dnevno
English: Not required Not required Not required
Croatian: Nije potrebno Nije potrebno Nije potrebno
English: • Your doctor will tell you to take Lyrica either twice or three times a day.
Croatian: • Liječnik će Vam reći da uzmete lijek Lyrica dva puta ili tri puta na dan.
English: If you are an elderly patient (over 65 years of age), you should take Lyrica normally except if you have problems with your kidneys.
Croatian: Ako ste bolesnik u starijoj dobi (iznad 65 godina), lijek Lyrica trebate uzimati normalno, osim ako imate problema s bubrezima.
English: (years)
Croatian: (godine)
English: The body is also marked with a black band.
Croatian: Tijelo je također označeno crnom trakom.
English: What Lyrica is and what it is used for
Croatian: Što je Lyrica i za što se koristi
English: Lyrica should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus).
Croatian: Lyrica se ne smije primjenjivati tijekom trudnoće osim ako to nije neophodno (ako korist liječenja za majku jasno nadilazi mogući rizik za plod).
English: Other medicines and Lyrica
Croatian: Drugi lijekovi i Lyrica
English: Warnings and Precautions Talk to your doctor or pharmacist before taking Lyrica.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete Lyricu.
English: Lyrica is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.
Croatian: Lyrica nije namijenjena za samostalnu primjenu, nego se uvijek mora uzimati u kombinaciji s drugim antiepileptičkim lijekovima.
English: Repeat steps 2 to 4 as needed to achieve the required dose (Table 3).
Croatian: Ponovite korake 2 do 4 po potrebi kako biste postigli potrebnu dozu (Tablica 3).
English: Lyrica may be taken with oral contraceptives.
Croatian: Lyrica se može uzimati s oralnim kontraceptivima.
English: If you take more Lyrica than you should
Croatian: Ako uzmete više lijeka Lyrica nego što ste trebali
English: What Lyrica is and what it is used for What you need to know before you take Lyrica How to take Lyrica
Croatian: Što je Lyrica i za što se koristi Što morate znati prije nego počnete uzimati Lyricu Kako uzimati Lyricu
English: These symptoms may occur more commonly or severely if you have been taking Lyrica for a longer period of time.
Croatian: Ti simptomi mogu biti češći ili ozbiljniji ako ste lijek Lyrica uzimali dulje vrijeme.
English: Not required
Croatian: Nije potrebno
English: Pfizer Europe MA EEIG (as MA Holder logo)
Croatian: Pfizer Europe MA EEIG (logo nositelja odobrenja)
English: If you have the impression that the effect of Lyrica is too strong or too weak, talk to your doctor or pharmacist.
Croatian: Ako Vam se čini da je djelovanje lijeka Lyrica prejako ili preslabo, porazgovarajte sa svojim liječnikom ili ljekarnikom.
English: Lyrica oral solution contains small amounts of ethanol (alcohol), less than 100 mg/ml.
Croatian: Lyrica oralna otopina sadrži malu količinu etanola (alkohola), manje od 100 mg/ml.
English: Lyrica should not be taken during pregnancy or when breast-feeding, unless you are told otherwise by your doctor.
Croatian: Lyrica se ne smije uzimati tijekom trudnoće ili dojenja, osim ako Vam liječnik nije rekao drugačije.
English: female for mol/l)
Croatian: za mol/l)
English: Continue taking Lyrica until your doctor tells you to stop.
Croatian: Nastavite uzimati lijek Lyrica dok Vam liječnik ne kaže da prestanete.
English: Concomitant use with opioids
Croatian: Istodobna primjena s opioidima
English: Once Daily or BID
Croatian: jednom dnevno ili BID
English: It is advised not to drink alcohol while taking Lyrica.
Croatian: Preporučuje se da ne pijete alkohol dok uzimate lijek Lyrica.
English: The safety and efficacy of Lyrica 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 Lyrica u djece mlađe od 12 godina i adolescenata (12-17 godina) nisu ustanovljene.
English: Note: Steps 4-7 may need to be repeated up to three times to obtain the total dose (Table 1).
Croatian: Napomena: Možda ćete morati ponoviti korake 4 do 7 najviše tri puta kako biste dobili cjelokupnu dozu (Tablica 1).
English: What Lyrica looks like and contents of the pack
Croatian: Kako Lyrica izgleda i sadržaj pakiranja
English: What you need to know before you take Lyrica
Croatian: Što morate znati prije nego počnete uzimati Lyricu
English: [For example, a 150 mg (7.5 ml) dose will require two withdrawals from the bottle to achieve the entire dose.
Croatian: [Primjerice, za dozu od 150 mg (7,5 ml) bit će potrebna dva navlačenja iz boce kako biste postigli cjelokupnu dozu.
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: • Some patients taking Lyrica have reported symptoms suggesting an allergic reaction.
Croatian: • Neki bolesnici koji su uzimali lijek Lyrica prijavili su simptome koji ukazuju na alergijsku reakciju.
English: Lyrica may produce dizziness, sleepiness and decreased concentration.
Croatian: Lyrica može izazvati omaglicu, pospanost i smanjenu koncentraciju.
English: Following repeated administration, steady state is achieved within 24 to 48 hours.
Croatian: Nakon ponovljene primjene se stanje dinamičke ravnoteže postiže za 24 do 48 sati.
English: • Lyrica may cause blurring or loss of vision, or other changes in eyesight, many of which are temporary.
Croatian: • Lyrica može uzrokovati zamagljen vid, gubitak vida ili druge promjene vida, od kojih su mnoge privremene.
English: Supplementary dose following haemodialysis (mg) 25 (1.25 ml)
Croatian: Dopunska doza nakon hemodijalize (mg) 25 (1,25 ml)
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 bočici.
English: Total pregabalin daily dose* Dose regimen
Croatian: Ukupna dnevna doza pregabalina* Režim doziranja
English: • A small number of people being treated with anti-epileptics such as Lyrica have had thoughts of harming or killing themselves.
Croatian: • Mali broj ljudi koji se liječe antiepileptičkim lijekovima kao što je Lyrica razmišljali su o samoozljeđivanju ili samoubojstvu.
English: Take your box or bottle of Lyrica capsules with you.
Croatian: Uzmite sa sobom kutiju ili bočicu Lyrica kapsula.
English: The degree of dizziness, sleepiness and decreased concentration may be increased if Lyrica is taken together with medicines containing:
Croatian: Omaglica, pospanost i smanjenje koncentracije mogu se pojačati ako se Lyrica uzima zajedno s lijekovima koji sadrže:
English: See section 6.6 for information on administration.
Croatian: Vidjeti dio 6.6 za informacije o primjeni lijeka.
English: It is important to take your Lyrica capsules regularly at the same time each day.
Croatian: Važno je da Lyrica kapsule uzimate redovito, svakoga dana u isto vrijeme.
English: 473 ml oral solution
Croatian: 473 ml oralne otopine
English: The capsule body is marked with a black band.
Croatian: Tijelo kapsule označeno je crnom crtom.
English: 100 x 1 hard capsules in PVC/Aluminium perforated unit dose blisters.
Croatian: 100 x 1 tvrda kapsula u PVC/aluminijskom perforiranom blisteru djeljivom na jedinične doze.
English: If while taking Lyrica you notice decreased urination, you should tell your doctor as stopping the medicine may improve this.
Croatian: Ako tijekom uzimanja lijeka Lyrica primijetite da manje mokrite, morate o tome obavijestiti svog liječnika jer se prekidom primjene lijeka to može poboljšati.
English: creatinine serum
Croatian: serumu u kreatinin
English: Pfizer Service Company, Hoge Wei 10, B1930 Zaventem, Belgium
Croatian: Proizvođač: Pfizer Service Company, Hoge Wei 10, B1930 Zaventem, Belgija.
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: Using the oral syringe, first withdraw 5 ml and empty contents of syringe directly into the mouth, then refill the oral syringe with 2.5 ml and empty the remaining contents into the mouth.]
Croatian: U štrcaljku za usta najprije navucite 5 ml i ispraznite sadržaj štrcaljke izravno u usta, a zatim u štrcaljku navucite još 2,5 ml te i preostali sadržaj ispraznite u usta.]
English: Date of last renewal: 06 July 2009
Croatian: Datum posljednje obnove odobrenja: 6. srpnja 2009.
English: Peripheral and central neuropathic pain, epilepsy or Generalised Anxiety Disorder:
Croatian: Periferna i centralna neuropatska bol, epilepsija ili generalizirani anksiozni poremećaj:
English: Pregabalin Cmax and AUC parameters increased in a linear manner with increasing dose within each age group.
Croatian: Parametri Cmax i AUC pregabalina povećali su se linearno s povećanjem doze unutar svake dobne skupine.
English: Oral Solution Pfizer Service Company Hoge Wei 10
Croatian: Oralna otopina Pfizer Service Company Hoge Wei 10
English: HDPE bottle containing 200 hard capsules.
Croatian: HDPE boca koja sadrži 200 tvrdih kapsula.
English: Remove air bubbles from the syringe by pushing the plunger up to the appropriate graduation mark.
Croatian: Izbacite mjehuriće zraka iz štrcaljke tako da klip gurnete do odgovarajuće oznake.
English: Take your box or bottle of Lyrica oral solution with you.
Croatian: Uzmite sa sobom kutiju ili bočicu Lyrica oralne otopine.
English: Pregabalin binds to an auxiliary subunit (2- 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: Your doctor will prescribe Lyrica for you to help treat your epilepsy when your current treatment is not controlling your condition.
Croatian: Liječnik će Vam propisati lijek Lyrica za liječenje epilepsije kada lijekovi koje ste do sada uzimali bolest ne drže pod kontrolom.
English: Lyrica is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Croatian: Lyrica je indicirana kao dodatna terapija u odraslih osoba s parcijalnim napadajima, sa ili bez sekundarne generalizacije.
English: Do not take Lyrica: If you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Lyricu: ako ste alergični na pregabalin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Invert the bottle (with the syringe attached) and fill the syringe with the liquid by pulling the syringe plunger down to just beyond the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (Figure 4).
Croatian: Preokrenite bočicu (s nataknutom štrcaljkom) i napunite štrcaljku tekućinom tako da povučete klip štrcaljke do iza oznake koja označava količinu u mililitrima (ml) koju Vam je propisao liječnik (Slika 4).
English: There have been reports in the postmarketing experience of hypersensitivity reactions, including cases of angioedema.
Croatian: Nakon stavljanja lijeka u promet prijavljene su reakcije preosjetljivosti, uključujući slučajeve angioedema.
English: Peripheral and central neuropathic pain: Lyrica is used to treat long lasting pain caused by damage to the nerves.
Croatian: Periferna i centralna neuropatska bol: Lyrica se koristi za liječenje dugotrajne boli uzrokovane oštećenjem živaca.
English: Pfizer Manufacturing Deutschland GmbH, Betriebsstātte Freiburg, Mooswaldallee 1, 79090 Freiburg, Germany.
Croatian: Pfizer Manufacturing Deutschland GmbH, Betriebsstātte Freiburg, Mooswaldallee 1, 79090 Freiburg, Njemačka.
English: 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Anti-epileptics, other anti-epileptics ATC code: N03AX16
Croatian: Farmakoterapijska skupina: Antiepileptici, ostali antiepileptici; ATK oznaka: N03AX16
English: Lyrica is available in eight pack sizes made of PVC with an aluminium foil backing: a 14 capsules pack containing 1 blister strip, a 21 capsules pack containing 1 blister strip, a 56 capsules pack containing 4 blister strips, a 70 capsules pack containing 5 blister strips, a 84 capsules pack containing 4 blister strips, a 100 capsules pack containing 10 blister strips, a 112 capsules pack containing 8 blister strips and 100 x 1 capsules as perforated unit dose blisters.
Croatian: Lyrica je dostupna u osam veličina pakiranja u PVC blisterima s pokrovom od aluminijske folije: pakiranje od 14 kapsula u 1 blisteru, pakiranje od 21 kapsule u 1 blisteru, pakiranje od 56 kapsula u 4 blistera, pakiranje od 70 kapsula u 5 blistera, pakiranje od 84 kapsule u 4 blistera, pakiranje od 100 kapsula u 10 blistera, pakiranje od 112 kapsula u 8 blistera i pakiranje od 100 x 1 kapsule u perforiranom blisteru djeljivom na jedinične doze.
English: What Lyrica contains
Croatian: Što Lyrica sadrži
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojave: navedenog u Dodatku V.
English: Lyrica may be taken with or without food.
Croatian: Lyrica se može uzimati s hranom ili bez nje.
English: The maximum dose of 600 mg (30 ml) per day may be achieved after an additional week.
Croatian: Maksimalna doza od 600 mg (30 ml) na dan može se postići nakon dodatnih tjedan dana.
English: Lyrica may have minor or moderate influence on the ability to drive and use machines.
Croatian: Lyrica može malo ili umjereno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: • When Lyrica 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 Lyrica 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: Do not stop taking Lyrica unless your doctor tells you to.
Croatian: Nemojte prestati uzimati lijek Lyrica ako Vam to ne kaže liječnik.
English: When taken with certain other medicines which have sedative effects (including opioids), Lyrica may potentiate these effects, and could lead to respiratory failure, coma and death.
Croatian: Kada se uzima s nekim drugim lijekovima koji imaju sedativni učinak (uključujući opioide), Lyrica može pojačati te učinke i dovesti do zatajenja disanja, kome i smrti.
English: Rinse the syringe by drawing water into the syringe and pushing the syringe plunger to the bottom of the syringe barrel, at least three times (Figure 8).
Croatian: Isperite štrcaljku tako da u nju navučete vodu i gurnete klip do kraja trupa štrcaljke, najmanje tri puta (Slika 8).
English: It is important to take your Lyrica oral solution regularly at the same time each day.
Croatian: Važno je da Lyrica oralnu otopinu uzimate redovito, svakoga dana u isto vrijeme.
English: Results of a 12-week placebo-controlled study of 295 paediatric patients aged 4 to 16 years and a 14-day placebo-controlled study of 175 paediatric patients aged 1 month to younger than 4 years of age 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 i 14-dnevnog placebom kontroliranog ispitivanja koje je provedeno u 175 pedijatrijskih bolesnika u dobi od 1 mjeseca do manje od 4 godine 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 pireksija 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: Lyrica belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD) in adults.
Croatian: Lyrica pripada skupini lijekova koji se koriste za liječenja epilepsije, neuropatske boli i generaliziranog anksioznog poremećaja (GAP) u odraslih osoba.
English: This increased risk was observed at low doses of pregabalin (≤ 300 mg, aOR 1.52 [95% CI, 1.04 - 2.22]) and there was a trend for a greater risk at high doses of pregabalin (> 300 mg, aOR 2.51 [95% CI 1.24 - 5.06]).
Croatian: Taj povećani rizik je zapažen kod niskih doza pregabalina (≤ 300 mg, prilagođen omjer izgleda 1.52 [95% CI, 1.04 - 2.22]) te je postojao trend većeg rizika kod viših doza pregabalina (> 300 mg, prilagođen omjer izgleda 2.51 [95% CI 1.24 - 5.06]).