FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients who have taken more Olazax than they should, have experienced the following symptoms: rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness.
Croatian: Ako uzmete više lijeka Olazax nego što ste trebali Bolesnici koji su uzeli više lijeka Olazax nego što su trebali imaju sljedeće simptome: ubrzan rad srca, uznemirenost/agresivnost, poteškoće s govorom, neuobičajene pokrete (osobito lica ili jezika) i sniženu razinu svijesti.
English: Olazax has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment.
Croatian: Pokazalo se da Olazax sprječava ponavljanje tih simptoma u bolesnika s bipolarnim poremećajem u kojih je epizoda manije reagirala na liječenje olanzapinom.
English: How to take Olazax
Croatian: Kako čuvati Olazax
English: Very common side effects (may affect more than 1 in 10 people) include weight gain; sleepiness; and increases in levels of prolactin in the blood.
Croatian: Vrlo česte nuspojave (mogu se pojaviti u više od 1 na 10 osoba) uključuju povećanje tjelesne težine, pospanost i povišene razine prolaktina u krvi.
English: Olanzapine reduced a conditioned avoidance response, a test indicative of antipsychotic activity, at doses below those producing catalepsy, an effect indicative of motor sideeffects.
Croatian: Olanzapin je smanjio uvjetovani odgovor izbjegavanja, test koji ukazuje na antipsihotičko djelovanje u dozama nižim od onih koje uzrokuju katalepsiju, učinak koji ukazuje na motoričke nuspojave.
English: If you suddenly stop taking Olazax, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur.
Croatian: Ako naglo prestanete s uzimanjem lijeka Olazax mogu se pojaviti simptomi poput znojenja, nesanice, nevoljnog drhtanja, tjeskobe ili mučnine i povraćanja.
English: The following table summarises the adverse reactions reported with a greater frequency in adolescent patients (aged 13-17 years) than in adult patients or adverse reactions only identified during shortterm clinical trials in adolescent patients.
Croatian: Sljedeća tablica sažima nuspojave prijavljene s većom učestalošću u adolescentnih bolesnika (u dobi od 13 do 17 godina) u odnosu na odrasle bolesnike ili nuspojave identificirane samo u kratkotrajnim kliničkim ispitivanjima u adolescentnih bolesnika.
English: The frequency terms listed are defined as follows: Very common (≥1/10), common (≥1/100 to
Croatian: Navedene učestalosti definirane su kako slijedi: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10).
English: Patients treated with any antipsychotic medicines, including olanzapine, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control.
Croatian: U bolesnika liječenih bilo kojim antipsihotikom, uključujući lijek Olazax, treba pratiti pojavu znakova i simptoma hiperglikemije (kao što su polidipsija, poliurija, polifagija i slabost), a bolesnike s dijabetesom melitusom ili čimbenicima rizika za razvoj dijabetesa melitusa treba redovito pratiti zbog mogućeg pogoršanja glikemije.
English: 6.4 Special precautions for storage Store below 30ºC
Croatian: 6.4 Posebne mjere pri čuvanju lijeka Čuvati na temperaturi ispod 30ºC.
English: There is a risk of feeling drowsy when you are given Olazax.
Croatian: Kad uzimate lijek Olazax postoji rizik da se osjećate omamljeno.
English: The frequency terms listed are defined as follows: 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 data available).
Croatian: Učestalost je definirana kako slijedi: 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: You should swallow the Olazax X tablets whole, with water.
Croatian: Olazax tablete morate progutati cijele s vodom.
English: Dystonia (including oculogyration)11 Tardive dyskinesia11
Croatian: distonija (uključujući okulogiraciju)11 tardivna diskinezija11 amnezija9
English: This may be harmful for people with phenylketonuria.
Croatian: Može naškoditi osobama koje boluju od fenilketonurije.
English: Olazax contains the active substance olanzapine.
Croatian: Olazax sadrži djelatnu tvar olanzapin.
English: Seizures where in most cases a history of seizures or risk factors for seizures were reported 11
Croatian: napadaji, u većini slučajeva kada su prijavljeni napadaji u anamnezi ili čimbenici rizika za nastanak napadaja11
English: High Gamma Glutamyltransferase 10
Croatian: visoka gama glutamiltransferaza visoka razina mokraćne kiseline10
English: Phenylalanine Olazax tablet contains aspartame, which is a source of phenylalanine.
Croatian: Olanzapin Glenmark tablete sadrže aspartam, koji je izvor fenilalanina.
English: Patients treated with any antipsychotic medicines, including olanzapine, should be monitored regularly for lipids in accordance with utilised antipsychotic guidelines e.g. at baseline, 12 weeks after starting olanzapine treatment and every 5 years thereafter.
Croatian: U bolesnika liječenih bilo kojim antipsihotikom, uključujući lijek Olazax, potrebno je redovito pratiti razinu lipida prema smjernicama za primjenu antipsihotika, na primjer, na početku liječenja, 12 tjedana nakon početka liječenja olanzapinom te svakih 5 godina nakon toga.
English: Caution should be exercised and follow-up organized in patients with elevated ALT and/or AST, in patients with signs and symptoms of hepatic impairment, in patients with pre-existing conditions associated with limited hepatic functional reserve, and in patients who are being treated with potentially hepatotoxic medicines.
Croatian: Potreban je oprez i kontrola u bolesnika s povišenim ALT-om i/ili ASTom, u bolesnika sa znakovima i simptomima oštećenja jetre, u bolesnika s prethodno postojećim stanjima povezanima s ograničenom funkcionalnom rezervom jetre te u bolesnika koji se liječe potencijalno hepatotoksičnim lijekovima.
English: • High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking Olazax.
Croatian: • U bolesnika koji uzimaju lijek Olazax uočena je visoka razina šećera i masnoća u krvi (trigliceridi i kolesterol).
English: Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olazax and regularly during treatment.
Croatian: Prije početka uzimanja lijeka Olazax te redovito tijekom liječenja, liječnik bi Vam trebao obaviti krvne pretrage kako bi provjerio razinu šećera i određenih masnoća u krvi.
English: Olazax 7.5 mg tablets
Croatian: Olazax 7,5 mg tablete
English: Olazax tablets are for oral use.
Croatian: Olazax obložene tablete uzimaju se kroz usta.
English: Only take other medicines while you are on Olazax if your doctor tells you that you can. You might feel drowsy if Olazax is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).
Croatian: Ako uzimate lijek Olazax u kombinaciji s antidepresivima, lijekovima za tjeskobu ili lijekovima koji Vam pomažu zaspati (trankvilizeri), možete se osjećati omamljeno.
English: 6.6 Special precautions for disposal No special requirements
Croatian: 6.6 Posebne mjere za zbrinjavanje
English: SPECIAL STORAGE CONDITIONS Store below 30°C
Croatian: ROK VALJANOSTI Rok valjanosti POSEBNE MJERE ČUVANJA Čuvati na temperaturi ispod 30ºC.
English: Transient, asymptomatic elevations of hepatic aminotransferases, ALTAST have been seen commonly, especially in early treatment.
Croatian: Često su uočeni prolazni asimptomatski porasti vrijednosti jetrenih aminotransferaza, ALT i AST, osobito u ranoj fazi liječenja.
English: Olazax contains aspartame a source of phenylalanine.
Croatian: Olanzapin Glenmark sadrži aspartam Olanzapin Glenmark sadrži izvor fenilalanina.
English: Dysarthria Stuttering11Restle
Croatian: dizartrija mucanje11
English: Olazax 20 mg tablets
Croatian: Olazax 20 mg tablete
English: < 1.467 mmol/l) to high (≥ 1.467 mmol/l).
Croatian: (< 4,39 mmol/l) do visokih vrijednosti (≥ 5,17 mmol/l).
English: Microcrystalline cellulose Aspartame E 951
Croatian: 6.1 Popis pomoćnih tvari manitol E 421 celuloza, mikrokristalična aspartam E 951
English: (≥ 5.17- < 6.2 mmol/l) to high (≥ 6.2 mmol/l) were very common.
Croatian: (≥ 6,2 mmol/l).
English: 13 Following short term treatment (median duration 22 days), weight gain ≥ 7% of baseline body weight (kg) was very common (40.6 %), ≥ 15 % of baseline body weight was common (7.1 %) and ≥ 25 % was common (2.5 %).
Croatian: 13 Nakon kratkotrajnog liječenja (medijan trajanja 22 dana), povećanje tjelesne težine ≥ 7% od početne tjelesne težine (kg) bilo je vrlo često (40,6%), porast ≥ 15% od početne tjelesne težine bio je čest (7,1%), a ≥ 25% bio je čest (2,5%).
English: east enlargement in males General disorders and administration site conditions Asthenia Fatigue Oedema Pyrexia10
Croatian: Opći poremećaji i reakcije na mjestu primjene astenija umor edem pireksija10
English: Olazax 5mg is supplied as a yellow coloured circular flat beveled edge tablet with ‘B' debossed on one side.
Croatian: Olazax 5 mg su žute, okrugle, plosnate tablete kosih rubova, s utisnutom oznakom ‘B' na jednoj strani.
English: Olazax 15 mg tablets
Croatian: Olazax 15 mg tablete
English: NAME OF THE MEDICINAL PRODUCT Olazax 7.5 mg tablets
Croatian: NAZIV GOTOVOG LIJEKA Olazax 7,5 mg tablete
English: Changes in fasting glucose from borderline at baseline (≥ 5.56 - < 7 mmol/l) to high (≥ 7 mmol/l)
Croatian: Promjene u vrijednosti glukoze natašte od početnih graničnih vrijednosti (≥ 5,56-< 7 mmol/l) do visokih vrijednosti (≥ 7 mmol/l) bile su vrlo česte.
English: Olazax 10 mg tablets
Croatian: Olazax 10 mg tablete
English: Olazax 5 mg tablets
Croatian: Olazax 5 mg tablete
English: Yellow coloured circular flat bevelled edge tablets with ‘B' debossed on one side.
Croatian: Tableta Žute, okrugle, plosnate tablete kosih rubova, s utisnutom oznakom ‘B' na jednoj strani.
English: 3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high (≥ 6.2 mmol/l).
Croatian: 3 Uočeno za početne normalne razine natašte (< 5,17 mmol/l) koje su porasle na visoke razine
English: What Olazax contains - The active substance is olanzapine - Each tablet contains 5 mg, 7.5 mg, 10 mg, 15 mg or 20 mg olanzapine - The other ingredients are mannitol (E 421), microcrystalline cellulose, aspartame (E 951),
Croatian: - Drugi sastojci su manitol (E 421), mikrokristalična celuloza, aspartam (E 951), krospovidon,
English: Excipient with known effect: Each tablet contains 0.46 mg aspartame For the full list of excipients, see section 6.1.
Croatian: Pomoćna tvar s poznatim učinkom: svaka tableta sadrži 0,46 mg aspartama.
English: Hypersensitivi ty11
Croatian: Poremećaji imunološkog sustava preosjetljivost11
English: Changes in total fasting cholesterol levels from borderline at baseline
Croatian: 15 Često su uočene promjene ukupnog kolesterola natašte od normalnih početnih vrijednosti
English: Yellow coloured circular flat bevelled edge tablets with ‘C' debossed on one side.
Croatian: Žute, okrugle, plosnate tablete kosih rubova, s utisnutom oznakom ‘C' na jednoj strani.
English: PHARMACEUTICAL FORM AND CONTENTS Tablet
Croatian: I SAŽETAK OPISA SVOJSTAVA LIJEKA
English: Excipient with known effect: Each tablet contains 0.23 mg aspartame For the full list of excipients, see section 6.1.
Croatian: Pomoćna tvar s poznatim učinkom: svaka tableta sadrži 0,23 mg aspartama.
English: Excipient with known effect: Each tablet contains 0.69 mg aspartame For the full list of excipients, see section 6.1.
Croatian: Pomoćna tvar s poznatim učinkom: svaka tableta sadrži 0,69 mg aspartama.
English: < 2.26 mmol/l) to high (≥ 2.26 mmol/l) were very common.
Croatian: (≥ 2,26 mmol/l).
English: Excipient with known effect: Each tablet contains 0.35 mg aspartame For the full list of excipients, see section 6.1.
Croatian: Pomoćna tvar s poznatim učinkom: svaka tableta sadrži 0,35 mg aspartama.
English: NAME OF THE MEDICINAL PRODUCT Olazax 20 mg tablets
Croatian: NAZIV GOTOVOG LIJEKA Olazax 20 mg tablete
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg olanzapine.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka tableta sadrži 5 mg olanzapina.
English: NAME OF THE MEDICINAL PRODUCT Olazax 5 mg tablets
Croatian: NAZIV GOTOVOG LIJEKA Olazax 5 mg tablete
English: NAME OF THE MEDICINAL PRODUCT Olazax 10 mg tablets
Croatian: NAZIV GOTOVOG LIJEKA Olazax 10 mg tablete
English: 6.5 Nature and contents of container Aluminium/aluminium blisters in cartons of 28, 56 tablets per carton Not all pack sizes may be marketed
Croatian: 6.5 Vrsta i sadržaj spremnika Aluminijsko/aluminijski blisteri u kutijama s 28 & 56 tableta
English: NAME OF THE MEDICINAL PRODUCT Olazax 15 mg tablets
Croatian: NAZIV GOTOVOG LIJEKA Olazax 15 mg tablete
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg olanzapine Excipient with known effect: Each tablet contains 0.92 mg aspartame For the full list of excipients, see section 6.1.
Croatian: Pomoćna tvar s poznatim učinkom: svaka tableta sadrži 0,92 mg aspartama.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/597/001
Croatian: ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/09/597/001
English: Amenorrhea Breast enlargement Galactorrhea in females Gynaecomasti a/breast enlargement in males
Croatian: Poremećaji reproduktivnog sustava i dojki erektilna disfunkcija u muškaraca smanjen libido u muškaraca i žena amenoreja povećanje dojki galaktoreja u žena ginekomastija/povećanj e dojki u muškaraca prijapizam12
English: categories.
Croatian: D.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/597/002
Croatian: ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/09/597/002
English: 5 Observed for fasting normal levels at baseline (< 1.69 mmol/l) which increased to high (≥ 2.26 mmol/l).
Croatian: Promjene u vrijednosti triglicerida natašte od početnih graničnih vrijednosti (≥ 1,69 -< 2,26 mmol/l) do visokih vrijednosti (≥ 2,26 mmol/l) bile su vrlo česte.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Oral use.
Croatian: OBLIK I SADRŽAJ Tableta 28 tableta 56 tableta NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte Uputu o lijeku.
English: Each tablet contains 7.5 mg olanzapine.
Croatian: TVARI Svaka tableta sadrži 5 mg olanzapina.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 20 mg olanzapine
Croatian: TVARI Svaka tableta sadrži 20 mg olanzapina.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/597/005
Croatian: ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/09/597/005
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/597/004
Croatian: ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/09/597/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/597/003
Croatian: ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/09/597/003
English: • For migraine prevention (in countries where this use is authorised)
Croatian: • U slučaju prevencije migrene (u državama u kojima je ova primjena odobrena)
English: Contact our press officer Monika Benstetter
Croatian: Obratite se našoj djelatnici za medije Monika Benstetter
English: • If you have any questions about your treatment or contraception, speak to your doctor or pharmacist.
Croatian: • Ukoliko imate bilo kakvih pitanja o terapiji ili kontracepciji, obratite se svojem liječniku ili ljekarniku.
English: Your doctor will urgently review your treatment.
Croatian: Liječnik će odmah preispitati terapiju.
English: Speak to your doctor if you have any questions about which contraceptive method is appropriate for you.
Croatian: Savjetujte se sa svojim liječnikom ako imate bilo kakvih pitanja o tome koja je kontracepcijska metoda primjerena za vas.
English: * The Coordination Group for Mutual Recognition and Decentralised Procedures - Human
Croatian: * Koordinacijska grupa za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove
English: Valproate medicines have been authorised via national procedures in all EU Member States and in Norway and Iceland.
Croatian: Lijekovi koji sadrže valproat odobreni su nacionalnim postupcima u svim državama članicama EU-a te u Norveškoj i Islandu.
English: These recommendations follow a review of recent studies showing developmental problems in up to 30 to 40% of pre-school children exposed to valproate in the womb, including delayed walking and talking, memory problems, difficulty with speech and language and lower intellectual ability.1,2,3,4,5
Croatian: Ove su preporuke donesene po završetku pregleda nedavnih ispitivanja kojima su utvrđeni razvojni problemi u 30 do 40 % predškolske djece izložene valproatu u maternici, uključujući i odgođeni početak hodanja i govorenja, probleme s pamćenjem, poteškoće s govorom i jezikom, te slabije intelektualne sposobnosti.1,2,3,4,5
English: They are marketed under several brand names including: Absenor, Convival Chrono, Convulex, Convulsofin Tabletten, Delepsine, Depakine, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Leptilan, Micropakine L.P., Orfiril, Orlept, Petilin, Valberg, Valepil and Valhel.
Croatian: Stavljeni su u promet pod nekoliko zaštićenih imena: Absenor, Convival Chrono, Convulex, Convulsofin Tabletten, Delepsine, Depakine, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Leptilan, Micropakine L.P., Orfiril, Orlept, Petilin, Valberg, Valepil i Valhel.
English: References
Croatian: Literatura
English: Healthcare professionals in the EU will be sent a dear healthcare professional letter plus additional educational material concerning these recommendations.
Croatian: Zdravstveni djelatnici u EU-u primit će pismo upućeno zdravstvenim djelatnicima kao i edukativne materijale u vezi s ovim preporukama.
English: • If you can become pregnant, you should use an effective method of contraception.
Croatian: • Ako ste žena reproduktivne dobi, trebate koristiti djelotvornu metodu kontracepcije.
English: • Tell your doctor at once if you become pregnant, think you might be pregnant or are planning to become pregnant.
Croatian: • Odmah obavijestite liječnika ako zatrudnite, mislite da ste trudni ili planirate zatrudnjeti.
English: As valproate medicines in the EU are all authorised nationally, the PRAC recommendations were forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) for a position.
Croatian: Budući da su svi lijekovi koji sadrže valproat u EU-a odobreni nacionalnim postupcima, preporuke PRAC-a su proslijeđene Koordinacijskoj grupi za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh) kako bi ona donijela svoje mišljenje.
English: There are also limited data suggesting that children exposed to valproate in the womb may be more likely to develop symptoms of attention deficit hyperactivity disorder (ADHD).6,7,8
Croatian: Postoje također i ograničeni podaci koji ukazuju na to da je izglednije kako će djeca izložena valproatu u maternici razviti simptome poremećaja hiperaktivnosti i deficita pažnje (ADHD).6,7,8
English: In addition, children exposed to valproate in the womb are at an approximately 11% risk of malformations at birth (such as neural tube defects and cleft palate)9 compared with a 2 to 3% risk for children in the general population.
Croatian: Nadalje, djeca izložena valproatu u maternici izložena su otprilike za 11 % većem riziku od malformacija pri rođenju (poput oštećenja neuralne cijevi i rascjepa nepca)9 u usporedbi s rizikom od 2 do 3 % u djece u općoj populaciji.
English: Previous data have shown that children exposed to valproate in the womb are also at increased risk of autistic spectrum disorder (around 3 times higher than in the general population) and childhood autism (5 times higher than in the general population).
Croatian: Raniji podaci pokazali su da djeca izložena valproatu u maternici mogu također biti izložena povećanom riziku od poremećaja autističkog spektra (otprilike 3 puta više nego u općoj populaciji) i dječjeg autizma (5 puta više nego u općoj populaciji).
English: The review of valproate medicines started in October 2013 at the request of the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Article 31 of Directive 2001/83/EC, following the publication of new data on the risks of malformations and developmental problems in babies exposed to valproate in the womb.
Croatian: Pregled lijekova koji sadrže valproat započet je u listopadu 2013. na zahtjev Regulatorne agencije za lijekove i zdravstvene proizvode UK-a (MHRA) sukladno članku 31. Direktive 2001/83/EC nakon objavljivanja novih podataka o rizicima od malformacija i problema u razvoju novorođenčadi koja je izložena valproatu u maternici.
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards across the EU for medicines authorised via national procedures.
Croatian: CMDh, tijelo koje predstavlja države članice EU-a, odgovorno je za osiguravanje usklađenih standarda za sigurnu primjenu na razini EU-a za lijekove odobrene nacionalnim postupcima.
English: The review was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC), the EMA's Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Croatian: Pregled je prvo proveo Odbor za ocjenu rizika na području farmakovigilancije (PRAC), odbor pri EMA-i odgovoran za ocjenu sigurne primjene humanih lijekova, koji je donio niz preporuka.
English: In some EU Member States they are also authorised to prevent migraine headaches.
Croatian: U pojedinim državama članicama EU-a ovi su lijekovi odobreni za sprječavanje migrenskih glavobolja.
English: • Valproate medicines can cause malformations and problems with early development of children if they are exposed to these medicines in the womb.
Croatian: • Lijekovi koji sadrže valproat mogu uzrokovati malformacije i probleme u ranom razvoju djece ako su izložena tim lijekovima u maternici.
English: − Stop valproate treatment in the event of pregnancy or if pregnancy is planned.
Croatian: Prekinite terapiju valproatom u slučaju trudnoće ili ako se planira trudnoća.
English: In countries where valproate medicines are also authorised for the prevention of migraine, valproate must not be used for this purpose in pregnant women, and doctors should exclude pregnancy before starting preventive treatment for migraine.
Croatian: U državama u kojima su lijekovi koji sadrže valproat također odobreni za sprječavanje migrene, valproat se ne smije koristiti u ovu svrhu u trudnica, a liječnici trebaju isključiti trudnoću prije početka preventivne terapije za migrenu.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 November 2014 EMA/709243/2014
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Valproate medicines are used to treat epilepsy and bipolar disorder.
Croatian: Lijekovi koji sadrže valproat koriste se za liječenje epilepsije i bipolarnog poremećaja.
English: Those for whom valproate is the only option for epilepsy or bipolar disorder should be advised on the use of effective contraception and treatment should be started and supervised by a doctor experienced in treating these conditions.
Croatian: Osobe za koje je valproat jedina opcija za liječenje epilepsije ili bipolarnog poremećaja treba savjetovati o primjeni učinkovite kontracepcije, a liječenje treba započeti i nadzirati liječnik iskusan u liječenju ovih stanja.
English: Doctors must not prescribe valproate for migraine prevention for women who are not on effective contraception.
Croatian: Liječnici ne smiju propisivati valproat za prevenciju migrene ženama koje ne koriste djelotvornu kontracepciju.