FrancophonIA/ELRC3.0 huggingface dataset:
English: 7 kg to less than 14 kg One sachet of 50 mg granules taken orally every 12 hours with fat-containing food
Croatian: Od 7 kg do manje od 14 kg Jedna vrećica s 50 mg granula, uzima se kroz usta svakih 12 sati s hranom koja sadrži masti
English: Polyvinyl alcohol
Croatian: karnauba vosak
English: Each sachet contains 75 mg of ivacaftor.
Croatian: Jedna vrećica sadrži 75 mg ivakaftora.
English: 5 kg to less than 7 kg One sachet of 25 mg granules taken orally every 12 hours with fat-containing food
Croatian: Od 5 kg do manje od 7 kg Jedna vrećica s 25 mg granula, uzima se kroz usta svakih 12 sati s hranom koja sadrži masti
English: • Bottle containing 56 film-coated tablets
Croatian: • bočica koja sadrži 56 filmom obloženih tableta.
English: • Talk to your doctor if you have kidney problems, or have previously had them.
Croatian: • Obratite se svom liječniku ako imate ili ste prije imali tegobe s bubrezima.
English: Each sachet contains 50 mg of ivacaftor.
Croatian: Jedna vrećica sadrži 50 mg ivakaftora.
English: Each sachet of granules contains 75 mg of ivacaftor.
Croatian: Kalydeco 75 mg granule u vrećici Jedna vrećica sadrži 75 mg ivakaftora (ivacaftorum).
English: Kalydeco 50 mg granules in sachet: The active substance is ivacaftor.
Croatian: Kalydeco 50 mg granule u vrećici: Djelatna tvar je ivakaftor.
English: * Continue dosing with tezacaftor 100 mg/ivacaftor 150 mg or ivacaftor 150 mg tablets on alternate days.
Croatian: * Nastaviti s naizmjeničnom primjenom; jedan dan tableta tezakaftora od 100 mg / ivakaftora od 150 mg, a drugi dan tableta ivakaftora od 150 mg.
English: Kalydeco granules are indicated for the treatment of babies and children aged 6 months and older and weighing 5 kg to less than 25 kg with cystic fibrosis (CF) who have one of the following gating mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.
Croatian: Kalydeco granule namijenjene su za liječenje cistične fibroze u dojenčadi i djece u dobi od 6 i više mjeseci i tjelesne težine od 5 kg do manje od 25 kg, koja u genu CFTR imaju jednu od sljedećih mutacija zbog koje dolazi do nepravilne regulacije kanala: G551D, G1244E, G1349D, G178R, G551S,
English: Tell your child's doctor right away if your child has any of these symptoms, which may be a sign of liver problems:
Croatian: Ako Vaše dijete ima neki od sljedećih simptoma, koji mogu biti znak poremećaja jetre, odmah o tome obavijestite djetetovog liječnika:
English: Kalydeco 75 mg granules in sachet: The active substance is ivacaftor.
Croatian: Kalydeco 75 mg granule u vrećici: Djelatna tvar je ivakaftor.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR SACHET
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA VREĆICU
English: Each sachet of granules contains 50 mg of ivacaftor.
Croatian: Kalydeco 50 mg granule u vrećici Jedna vrećica sadrži 50 mg ivakaftora (ivacaftorum).
English: • Increased liver enzymes in the blood have been seen in some people receiving Kalydeco (alone or in combination with tezacaftor/ivacaftor).
Croatian: • Neki ljudi koji uzimaju Kalydeco (sam ili u kombinaciji s tezakaftorom/ivakaftorom) mogu imati povišene jetrene enzime u krvi.
English: Ivacaftor 150 mg tablet
Croatian: Ivakaftor 150 mg tableta
English: • Feeling sick (nausea)
Croatian: • glavobolja • omaglica
English: Elderly
Croatian: Nuspojave
English: Kalydeco 50 mg granules ivacaftor
Croatian: Kalydeco 50 mg granule ivacaftorum Kroz usta
English: Insert tab below to close
Croatian: Pon Uto Sri Čet Pet Sub Ned
English: Kalydeco 150 mg film-coated tablets
Croatian: NAZIV LIJEKA Kalydeco 150 mg filmom obložene tablete
English: Shellac
Croatian: • proljev
English: 6 months to less than 12 months (7 kg to < 14 kg)
Croatian: 25 mg svakih 12 sati od 6 do manje od 12 mjeseci (7 kg do < 14 kg)
English: Kalydeco in a combination regimen with tezacaftor/ivacaftor When co-administered with strong inhibitors of CYP3A, the Kalydeco evening dose should not be administered (see sections 4.4 and 4.5).
Croatian: Kad se primjenjuje istovremeno s jakim inhibitorima CYP3A, ne smije se primijeniti večernja doza lijeka Kalydeco (vidjeti dijelove 4.4 i 4.5).
English: 6- to 11-year-olds † (≥ 14 kg to < 25 kg)
Croatian: 75 mg svakih 12 sati od 6 do 11 godina (≥ 14 kg do < 25 kg)
English: Each sachet of granules contains 25 mg of ivacaftor.
Croatian: NAVOĐENJE DJELATNE TVARI Jedna vrećica granula sadrži 25 mg ivakaftora.
English: 12 months to less than 24 months (7 kg to < 14 kg)
Croatian: 50 mg svakih 12 sati od 12 do manje od 24 mjeseca (7 kg do < 14 kg)
English: Tablet core
Croatian: Tjelesna težina
English: common
Croatian: Učestalost
English: At week 24 At week 48
Croatian: 48. tjednue
English: Kalydeco 50 mg granules in sachet ivacaftor
Croatian: NAZIV LIJEKA Kalydeco 50 mg granule u vrećici ivacaftorum
English: Kalydeco 25 mg granules in sachet ivacaftor
Croatian: NAZIV LIJEKA Kalydeco 25 mg granule u vrećici ivacaftorum
English: Medicinal products affected by ivacaftor
Croatian: Lijekovi na koje utječe ivakaftor
English: See Kalydeco tablets SmPC for further details.
Croatian: Za dodatne informacije pogledajte sažetak opisa svojstava lijeka za Kalydeco tablete
English: Each sachet contains 36.6 mg of lactose (as monohydrate) Kalydeco 50 mg granules in sachet Each sachet contains 50 mg of ivacaftor.
Croatian: Pomoćna tvar s poznatim učinkom Jedna vrećica sadrži 36,6 mg laktoze (u obliku hidrata).
English: Adults (≥ 18 years old)
Croatian: 150 mg svakih 12 sati odrasli (u dobi ≥ 18 godina)
English: Oropharyngeal pain very common
Croatian: Poremećaji živčanog sustava glavobolja vrlo često omaglica vrlo često
English: Kalydeco tablets are indicated for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (CF) who have one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R (see sections 4.4 and 5.1).
Croatian: Kalydeco tablete indicirane su za liječenje cistične fibroze (CF) u odraslih, adolescenata i djece u dobi od 6 i više godina i tjelesne težine od 25 kg ili više, koji u genu CFTR imaju jednu od sljedećih mutacija (III. klase) zbog koje dolazi do nepravilne regulacije kanala: G551D, G1244E, G1349D,
English: --¹ After reconstitution, 1 dose (0.5 ml) contains 50 micrograms of gE antigen1 adjuvanted with AS01B2.
Croatian: Nakon rekonstitucije jedna doza (0,5 ml) sadrži 50 mikrograma gE antigena1 adjuvantiranog sa AS01B2.
English: 2 AS01B Adjuvant System is composed of the plant extract Quillaja saponaria Molina, fraction 21 (QS-21) (50 micrograms) and 3-O-desacyl-4'-monophosphoryl lipid A (MPL) from Salmonella minnesota (50 micrograms)
Croatian: 1 glikoprotein E (gE) virusa varicella zoster (VZV) proizveden tehnologijom rekombinantne DNK u stanicama jajnika kineskog hrčka (CHO) 2 AS01B adjuvantni sistem sadrži ekstrakt biljke Quillaja saponaria Molina, frakcija 21 (QS-21) (50 mikrograma) i 3-O-dezacil-4'-monofosforil lipid A (MPL) iz bakterije Salmonella minnesota (50 mikrograma)
English: Strength Pharmaceutical Form
Croatian: Doza Farmaceutski oblik Put primjene Unutarnje pakovanje
English: In certain cases treatment should be permanently stopped.
Croatian: U nekim slučajevima liječenje treba trajno obustaviti.
English: Further information on Alecensa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Alecensa nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Alecensa (alectinib)
Croatian: Alecensa (alektinib)
English: Response was maintained for an average of 14.9 months in the first study, and 15.2 months in the second study.
Croatian: Odgovor je održan u prosjeku 14,9 mjeseci u prvom ispitivanju i 15,2 mjeseca u drugom ispitivanju.
English: The medicine is available as capsules (150 mg).
Croatian: Lijek je dostupan u obliku kapsula (150 mg).
English: Genetic defects affecting ALK (‘ALK-positive' status) should be confirmed in advance by appropriate methods.
Croatian: Genetski nedostatci koji utječu na ALK (status „pozitivan na ALK”) moraju se unaprijed potvrditi odgovarajućim metodama.
English: This overview was last updated in 06-2018.
Croatian: Ovaj pregled informacija posljednji je put ažuriran u 6. 2018.
English: Alecensa received a marketing authorisation valid throughout the EU on 16 February 2017.
Croatian: Lijek Alecensa dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 16. veljače 2017.
English: For patients with severe liver impairment the recommended dose is 3 capsules taken twice a day with food (900 mg in total).
Croatian: Za bolesnike s ozbiljnim oštećenjem jetre preporučena doza je tri kapsule dvaput dnevno uz obrok (ukupno 900 mg).
English: Response to treatment was assessed using body scans and standardised criteria for solid tumours, with complete response being when the patient had no remaining signs of the cancer.
Croatian: Odgovor na terapiju ocijenjen je pomoću snimaka tijela i standardiziranih kriterija koji se koriste za solidne tumore, pri čemu je potpuni odgovor kada bolesnik nema preostalih znakova raka.
English: Patients whose disease progresses during or shortly after treatment with Xalkori currently have very limited treatment options and Alecensa can be of benefit in these patients.
Croatian: Bolesnici čija bolest napreduje za vrijeme ili ubrzo nakon terapije lijekom Xalkori trenutačno imaju vrlo ograničene opcije za liječenje i stoga Alecensa može koristiti tim bolesnicima.
English: The most common side effects with Alecensa (which may affect more than 2 in 10 people) are constipation, muscle pain and oedema (swelling) including of the ankles and feet, the face, the eyelids and the area around the eyes.
Croatian: Najčešće su nuspojave lijeka Alecensa (koje se mogu pojaviti u više od 2 od 10 osoba) zatvor, bol u mišićima i edem (oticanje) gležnjeva i nogu, lica, kapaka i područja oko očiju.
English: The recommended usual dose is 4 capsules taken twice a day with food (1,200 mg in total).
Croatian: Preporučena uobičajena doza je četiri kapsule dvaput dnevno uz obrok (ukupno 1 200 mg).
English: After 1 year of treatment, 68% of patients receiving Alecensa lived without their disease getting worse compared with 49% of patients receiving Xalkori.
Croatian: Nakon jedne godine liječenja 68 % bolesnika koji su primali lijek Alecensa živjelo je bez pogoršanja bolesti u usporedbi s 49 % bolesnika koji su primali lijek Xalkori.
English: What is Alecensa and what is it used for?
Croatian: Što je Alecensa i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Alecensa?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Alecensa?
English: Two main studies involved a total of 225 patients in whom the disease progressed despite previous treatment with Xalkori (crizotinib).
Croatian: U dvama glavnim ispitivanjima sudjelovalo je ukupno 225 bolesnika u kojih je bolest uznapredovala usprkos prethodnom liječenju lijekom Xalkori (krizotinib).
English: The safety profile of Alecensa was considered acceptable and in line with that of other ALK inhibitors.
Croatian: Utvrđeno je da je sigurnosni profil lijeka Alecensa prihvatljiv i u skladu s ostalim inhibitorima ALK-a.
English: In both studies Alecensa was not compared with any other treatment or placebo (a dummy treatment).
Croatian: U oba ispitivanja lijek Alecensa nije uspoređivan s drugim lijekom niti s placebom (prividnim liječenjem).
English: ALK belongs to a family of proteins called receptor tyrosine kinases (RTKs), which are involved in the growth of cells and the development of new blood vessels that supply them.
Croatian: ALK pripada obitelji proteina naziva receptorske tirozin kinaze (RTK), koji su uključeni u rast stanica i razvoj novih krvnih žila koje ih opskrbljuju.
English: In the second study, the complete or partial response rate at the time of analysis was 51% (62 out of 122 patients).
Croatian: U drugom ispitivanju postignut je potpun ili djelomičan odgovor u 51 % bolesnika (62 od 122) u vrijeme analize.
English: In the first study around 52% of patients given Alecensa (35 out of 67) were considered by the treating doctors to have shown a complete or partial response to the medicine at the time of analysis.
Croatian: U prvom ispitivanju ordinirajući liječnici zaključili su da je u približno 52 % bolesnika koji su primali lijek Alecensa (35 od 67) postignut potpun ili djelomičan odgovor na lijek u vrijeme analize.
English: As for all medicines, data on the use of Alecensa are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Alecensa kontinuirano se prate.
English: Side effects reported with Alecensa are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Alecensa pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Alecensa have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Alecensa nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Alecensa can only be obtained with a prescription and treatment must be started and supervised by a doctor who is experienced in using cancer medicines.
Croatian: Alecensa se izdaje samo na liječnički recept, a liječenje mora započeti i nadzirati liječnik s iskustvom u primjeni lijekova protiv raka.
English: An overview of Alecensa and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Alecensa i zašto je odobren u EU-u
English: Other information about Alecensa
Croatian: Ostale informacije o lijeku Alecensa
English: The European Medicines Agency decided that Alecensa's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Alecensa nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: What are the risks associated with Alecensa?
Croatian: Koji su rizici povezani s lijekom Alecensa?
English: Alecensa is a cancer medicine used to treat adults with a lung cancer called non-small-cell lung cancer (NSCLC), when the disease is advanced and has not been treated before or has been treated before with a cancer medicine called Xalkori (crizotinib).
Croatian: Alecensa je lijek protiv raka za liječenje odraslih s rakom pluća koji se zove rak pluća nemalih stanica (NSCLC) kad je bolest uznapredovala i nije prethodno liječena ili je liječena lijekom protiv raka Xalkori (krizotinib).
English: Why is Alecensa authorised in the EU?
Croatian: Zašto je lijek Alecensa odobren u EU-u?
English: The doctor may reduce the dose or stop treatment temporarily if side effects occur.
Croatian: Ako se razviju određene nuspojave, liječnik može smanjiti dozu ili privremeno prekinuti liječenje.
English: For more information about using Alecensa, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Alecensa pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Alecensa is used on its own and only if the NSCLC is ‘ALK-positive', which means that the cancer cells have certain defects affecting the gene that makes a protein called ALK (anaplastic lymphoma kinase).
Croatian: Lijek Alecensa koristi se samo ako je NSCLC pozitivan na ALK, što znači da stanice raka imaju određene nedostatke koje utječu na gen koji stvara protein kinaza anaplastičnog limfoma (engl. anaplastic lymphoma kinase, ALK).
English: Alecensa was compared with Xalkori and the main measure of effectiveness was how long patients lived without their disease getting worse.
Croatian: Lijek Alecensa uspoređivan je s lijekom Xalkori, a glavno mjerilo djelotvornosti bilo je preživljenje bez pogoršanja bolesti.
English: The active substance in Alecensa, alectinib, is an ALK inhibitor and works by blocking the activity of ALK, thereby reducing the growth and spread of the cancer.
Croatian: Djelatna tvar lijeka Alecensa, alektinib, djeluje inhibirajući djelovanje ALK-a, te stoga smanjuje rast i širenje raka.
English: The third study involved 303 patients whose ALK-positive NSCLC had not been treated before.
Croatian: Treće glavno ispitivanje obuhvatilo je 303 bolesnika s NSCLC-om pozitivnim na ALK koji nisu prethodno liječeni.
English: In patients with ALKpositive NSCLC, an abnormal form of ALK is produced that stimulates the cancer cells to divide and grow in an uncontrolled fashion.
Croatian: U bolesnika s NSCLC-om pozitivnim na ALK stvara se abnormalni oblik ALK-a koji stimulira dijeljenje i nekontrolirani rast stanica raka.
English: How is Alecensa used?
Croatian: Kako se Alecensa koristi?
English: Alecensa contains the active substance alectinib.
Croatian: Lijek Alecensa sadrži djelatnu tvar alektinib.
English: How does Alecensa work?
Croatian: Kako djeluje Alecensa?
English: What benefits of Alecensa have been shown in studies?
Croatian: Koje su koristi od lijeka Alecensa utvrđene u ispitivanjima?
English: Alecensa has been shown to be effective in treating ALK-positive NSCLC in three studies.
Croatian: U trima ispitivanjima utvrđeno je da je lijek Alecensa djelotvoran u liječenju NSCLC-a pozitivnog na ALK.
English: Alecensa was also better than Xalkori at treating previously untreated patients with ALK-positive NSCLC.
Croatian: Lijek Alecensa također se pokazao djelotvornijim od lijeka Xalkori u liječenju bolesnika s NSCLC-om pozitivnim na ALK koji prethodno nisu liječeni.
English: For the full list of side effects and restrictions with Alecensa, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Alecensa potražite u uputi o lijeku.
English: Date of first authorisation: 28th August 2015
Croatian: Datum prvog odobrenja: 28. kolovoz 2015
English: Take your box or bottle of this medicine with you.
Croatian: Uzmite sa sobom kutiju ili bocu ovog lijeka.
English: • Difficulty with writing properly.
Croatian: • poteškoće pri pravilnom pisanju
English: BID or TID BID or TID Once Daily or BID Once Daily
Croatian: BID ili TID BID ili TID jednom dnevno ili BID jednom dnevno
English: It is advised not to drink alcohol while taking this medicine.
Croatian: Preporučuje se da ne pijete alkohol dok uzimate ovaj lijek.
English: • Your doctor will tell you to take this medicine either twice or three times a day.
Croatian: • Liječnik će Vam reći da uzmete ovaj lijek dva puta ili tri puta na dan.
English: If you are an elderly patient (over 65 years of age), you should take this medicine normally except if you have problems with your kidneys.
Croatian: Ako ste bolesnik u starijoj dobi (iznad 65 godina), ovaj lijek trebate uzimati normalno, osim ako imate problema s bubrezima.
English: UNIQUE IDENTIFIER-2D BARCODE
Croatian: JEDINSTVENI IDENTIFIKATOR - 2D BARKOD
English: • Slow or reduced movement of the body.
Croatian: • usporeni ili umanjeni pokreti tijela
English: Pregabalin Accord with food, drink and alcohol
Croatian: Pregabalin Accord s hranom, pićem i alkoholom
English: Pregabalin Accord and certain other medicines may influence each other (interaction).
Croatian: Pregabalin Accord i neki drugi lijekovi mogu djelovati jedni na druge (interakcija).
English: These symptoms may occur more commonly or severely if you have been taking this medicine for a longer period of time.
Croatian: Ti simptomi mogu biti češći ili ozbiljniji ako ste ovaj lijek uzimali dulje vrijeme.
English: This medicine may be taken with oral contraceptives.
Croatian: Ovaj se lijek može uzimati s oralnim kontraceptivima.
English: • Some patients taking this medicine have reported symptoms suggesting an allergic reaction.
Croatian: • Neki bolesnici koji su uzimali ovaj lijek prijavili su simptome koji ukazuju na alergijsku reakciju.
English: Package Leaflet: Information For The User
Croatian: Uputa o lijeku: Informacije za korisnika
English: Pregabalin Accord 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 Accord se ne smije primjenjivati tijekom trudnoće osim ako to nije neophodno (ako korist liječenja za majku jasno nadilazi mogući rizik za plod).
English: Pharmacotherapeutic group: Anti-epileptics, other anti-epileptics ATC code: N03AX16
Croatian: Farmakoterapijska skupina: Antiepileptici, ostali antiepileptici; ATK oznaka: N03AX16
English: This medicine should not be taken during pregnancy or when breast-feeding, unless you are told otherwise by your doctor.
Croatian: Ovaj se lijek ne smije uzimati tijekom trudnoće ili dojenja, osim ako Vam liječnik nije rekao drugačije.
English: Middlesex HA1 4HF, United Kingdom
Croatian: Middlesex HA1 4HF, Ujedinjeno Kraljevstvo
English: • Difficulties with erection.
Croatian: • poteškoće s erekcijom
English: Continue taking this medicine until your doctor tells you to stop.
Croatian: Nastavite uzimati ovaj lijek dok Vam liječnik ne kaže da prestanete.
English: This medicine is used to treat long lasting pain caused by damage to the nerves.
Croatian: Ovaj se lijek se koristi za liječenje dugotrajne boli uzrokovane oštećenjem živaca.
English: What Pregabalin Accord is and what it is used for
Croatian: Što je Pregabalin Accord i za što se koristi
English: What Pregabalin Accord is and what it is used for What you need to know before you take Pregabalin Accord How to take Pregabalin Accord Possible side effects
Croatian: Što je Pregabalin Accord i za što se koristi Što morate znati prije nego počnete uzimati Pregabalin Accord Kako uzimati Pregabalin Accord Moguće nuspojave
English: • Feeling drunk, abnormal style of walking.
Croatian: • osjećaj pijanosti, neuobičajen način hodanja
English: This medicine may be taken with or without food.
Croatian: Ovaj se lijek može uzimati s hranom ili bez nje.
English: Oxycodone - (used as a pain-killer) Lorazepam - (used for treating anxiety) Alcohol
Croatian: Oksikodon - (koristi se protiv bolova) Lorazepam - (koristi se za liječenje tjeskobe) Alkohol
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107.c stavkom 7 Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Efficacy has not been studied in other models of neuropathic pain.
Croatian: Nije ispitivana djelotvornost u drugim modelima neuropatske boli.
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: This medicine may produce dizziness, sleepiness and decreased concentration.
Croatian: Ovaj lijek može izazvati omaglicu, pospanost i smanjenu koncentraciju.
English: • A small number of people being treated with anti-epileptics such as Pregabalin Accord have had thoughts of harming or killing themselves.
Croatian: • Mali broj ljudi koji se liječe antiepileptičkim lijekovima kao što je Pregabalin Accord razmišljali su o samoozljeđivanju ili samoubojstvu.
English: A meta-analysis of randomised placebo controlled studies of anti-epileptic medicinal products 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.