FrancophonIA/ELRC3.0 huggingface dataset:
English: Valproate should preferably be prescribed as monotherapy and at the lowest effective dose, if possible as a prolonged release formulation.
Croatian: Valproat je poželjno propisati u monoterapiji i u najnižoj djelotvornoj dozi, po mogućnosti u formulaciji s produljenim oslobađanjem.
English: You and your partner could receive counselling and support regarding the valproate exposed pregnancy.
Croatian: Vi i Vaš partner možete dobiti savjetovanje i podršku vezano uz izloženost valproatu tijekom trudnoće.
English: • the potential for pregnancy is assessed for all female patients.
Croatian: • procijeniti potencijal za nastanak trudnoće u svih bolesnica.
English: However, it is unlikely that it will reduce the risk of birth defects associated with valproate use.
Croatian: Međutim, nije vjerojatno da će smanjiti rizik od urođenih mana povezanih s primjenom valproata.
English: • Individual circumstances should be evaluated in each case, involving the patient in the discussion, to guarantee her engagement, discuss therapeutic options and ensure her understanding of the risks and the measures needed to minimise the risks.
Croatian: • procijeniti pojedinačne okolnosti svakog slučaja i uključiti bolesnicu u raspravu kako bi se osiguralo njezino sudjelovanje, raspraviti o terapijskim mogućnostima i osigurati da razumije rizike i mjere potrebne za minimizacije rizika.
English: [*For the printed material, please refer to the guidance of the annotated QRD template.]
Croatian: [*Za tiskani materijal vidjeti uputu u QRD predlošku s pojašnjenjima.]
English: • Autistic spectrum disorders are more often diagnosed in children exposed to valproate and there is some evidence children may be more likely to develop symptoms of Attention Deficit Hyperactivity Disorder (ADHD).
Croatian: • Poremećaji iz autističnog spektra češće se dijagnosticiraju u djece izložene valproatu, a postoje i neki dokazi da bi ta djeca mogla biti sklonija razvoju simptoma poremećaja hiperaktivnosti i deficita pažnje (engl. attention deficit/hyperactivity disorder, ADHD).
English: • Do not stop using your methods of birth control (contraception) before you have talked to your doctor and worked together on a plan to ensure your condition is controlled and the risks to your baby are reduced.
Croatian: • Nemojte prestati koristiti kontracepciju prije nego što razgovarate s Vašim liječnikom i zajedno osmislite plan kojim ćete Vaše stanje držati pod kontrolom i smanjiti rizik za Vaše dijete.
English: If you decide later you want to have a baby you must not stop taking your medicine or your method of contraception until you have discussed this with your doctor.
Croatian: Ako kasnije odlučite da želite imati dijete, nemojte prestati uzimati lijek ili prestati koristiti kontracepciju sve dok o tome ne razgovarate s Vašim liječnikom.
English: Specialized prenatal monitoring should take place to detect the possible occurrence of neural tube defects or other malformations.
Croatian: Treba uvesti specijalizirano prenatalno praćenje kako bi se otkrila moguća oštećenja neuralne cijevi ili druge malformacije.
English: Ask your doctor about taking folic acid.
Croatian: Pitajte Vašeg liječnika o uzimanju folne kiseline.
English: • If you take valproate during pregnancy you have a higher risk than other women of having a child with birth defects that require medical treatment.
Croatian: • Ako uzimate valproat tijekom trudnoće, kod Vas postoji veći rizik, nego kod drugih žena, da ćete roditi dijete s urođenim manama koje će trebati liječiti.
English: In case of pregnancy
Croatian: U slučaju trudnoće
English: • the patient has received the patient guide.
Croatian: • osigurati da bolesnica dobije vodič za bolesnike
English: During pregnancy, maternal tonic clonic seizures and status epilepticus with hypoxia may carry a particular risk of death for mother and the unborn child.
Croatian: Toničko-klonički napadaji i epileptički status praćen hipoksijom u majke tijekom trudnoće mogu predstavljati poseban rizik od smrti za majku i nerođeno dijete.
English: If you get any side effects, talk to your <doctor> <or> <,> <pharmacist> <or nurse>.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti <liječnika> <ili> <,><ljekarnika> <ili medicinsku sestru>.
English: Bipolar disorder <and> <migraine>
Croatian: Bipolarni poremećaj <i> <migrena>
English: • the patient has acknowledged that she has understood the hazards and necessary precautions associated with valproate use (Annual Risk Acknowledgement Form).
Croatian: • osigurati da je bolesnica potvrdila razumijevanje opasnosti i potrebnih mjera predostrožnosti povezanih s primjenom valproata (Godišnji obrazac potvrde o upoznatosti s rizikom).
English: Every effort should be made by the specialist to switch the female children to alternative treatment before they reach adulthood.
Croatian: Liječnik specijalist mora poduzeti sve što je moguće kako bi djevojčice prebacio na drugo odgovarajuće liječenje prije odrasle dobi.
English: Your specialist may decide to change the dose of <Invented name> or switch you to another medicine, or stop treatment with <Invented name>, a long time before you become pregnant - this is to make sure your illness is stable.
Croatian: Vaš će liječnik specijalist možda odlučiti promijeniti dozu lijeka <Zaštićeno ime> ili Vas prebaciti na drugi lijek ili prekinuti liječenje lijekom <Zaštićeno ime>, puno prije nego što zatrudnite - kako bi osigurao da je Vaša bolest stabilna.
English: If, despite the known risks of valproate in pregnancy and after careful consideration of alternative treatment, in exceptional circumstances a pregnant woman must receive valproate for epilepsy, it is recommended to:
Croatian: Ako, unatoč poznatom riziku koji valproat predstavlja u trudnoći te nakon pažljivog razmatranja drugih odgovarajućih mogućnosti liječenja, u iznimnim okolnostima trudnica mora nastaviti liječenje epilepsije s valproatom, preporuča se:
English: In order to assist healthcare professionals and patients in avoiding exposure to valproate during pregnancy, the Marketing Authorisation Holder has provided educational materials to reinforce the warnings and provide guidance regarding use of valproate in women of childbearing potential and the details of the pregnancy prevention programmeme.
Croatian: Kako bi se pomoglo zdravstvenim radnicima i bolesnicama u izbjegavanju izloženosti valproatu tijekom trudnoće, nositelj odobrenja za stavljanje lijeka u promet osigurao je edukacijske materijale kako bi dodatno naglasio upozorenja i pružio smjernice vezano uz primjenu valproata u žena reproduktivne dobi te pojedinosti programa prevencije trudnoće.
English: • Make sure you are referred to a specialist for prenatal monitoring in order to detect possible occurrences of malformations.
Croatian: • Osigurajte da Vas se uputi liječniku specijalistu za prenatalno praćenje kako bi se otkrile moguće pojave urođenih mana.
English: • Your doctor will try to switch you to another medicine, or stop treatment with <Invented name> a long time before you become pregnant.
Croatian: • Vaš liječnik će Vas pokušati prebaciti na drugi lijek, ili prekinuti liječenje lijekom <Zaštićeno ime> puno prije nego zatrudnite.
English: Treatment with valproate must not be initiated in women of child bearing potential without a negative pregnancy test (plasma pregnancy test) result, confirmed by a health care provider, to rule out unintended use in pregnancy.
Croatian: U žena reproduktivne dobi ne smije se započeti liječenje valproatom bez negativnog nalaza testa na trudnoću (test na trudnoću na uzorku plazme), koji je potvrdio liječnik, a kako bi se izbjegla neželjena primjena u trudnoći.
English: Your doctor will give you information on preventing pregnancy, and may refer you to a specialist for advice on birth control.
Croatian: Vaš liječnik će Vam dati informacije o sprječavanju trudnoće te Vas može uputiti liječniku specijalistu za savjet o kontracepciji.
English: Women of childbearing potential who are prescribed valproate must use effective contraception, without interruption during the entire duration of treatment with valproate.
Croatian: Žene reproduktivne dobi kojima je propisan valproat moraju koristiti učinkovitu kontracepciju bez prekida tijekom cijelog vremena liječenja valproatom.
English: Ask your doctor about taking folic acid when planning to have a baby.
Croatian: Pitajte Vašeg liječnika o uzimanju folne kiseline kada planirate imati dijete.
English: • the patient is counselled regarding contraception, and that the patient is capable of complying with the need to use effective contraception (for further details please refer to subsection contraception of this boxed warning), without interruption during the entire duration of treatment with valproate.
Croatian: • osigurati da bolesnica dobije savjet vezan uz korištenje kontracepcije te da je sposobna pridržavati se zahtjeva za primjenu učinkovite kontracepcije (za dodatne detalje, molimo pogledajte dio o kontracepciji u nastavku ovog uokvirenog upozorenja), bez prekida tijekom cijelog trajanja liječenja valproatom.
English: • the patients are advised not to stop valproate medication and to immediately contact a specialist in case of planned or suspected pregnancy.
Croatian: • da savjetuju bolesnice da ne prekidaju liječenje valproatom te da se odmah obrate liječniku specijalistu u slučaju sumnje na trudnoću ili planiranja trudnoće
English: • the patient understands the need to undergo pregnancy testing prior to initiation of treatment and during treatment, as needed.
Croatian: • osigurati da bolesnica razumije potrebu provođenja testova na trudnoću prije početka liječenja i tijekom liječenja, po potrebi.
English: Conditions of Pregnancy Prevention Programme: The prescriber must ensure that
Croatian: Uvjeti programa prevencije trudnoće:
English: Babies born to mothers who have been on valproate are at serious risk of birth defects and problems with development which can be seriously debilitating.
Croatian: U djece majki koje uzimaju valproat u trudnoći postoji ozbiljan rizik od urođenih mana i poteškoća u razvoju, koje mogu izazvati ozbiljnu onesposobljenost.
English: During this visit your doctor will make sure you are well aware and have understood all the risks and advices related to the use of valproate during pregnancy.
Croatian: Tijekom te posjete, Vaš liječnik će osigurati da ste dobro upućeni i da razumijete sve rizike i savjete koji se odnose na uzimanje valproata u trudnoći.
English: • If you are a parent or a caregiver of a female child treated with valproate, you should contact the doctor once your child using valproate experiences menarche.
Croatian: • Ako ste roditelj ili skrbnik djevojčice liječene valproatom, trebate se obratiti liječniku kada Vaše dijete koje uzima valproat dobije prvu menstruaciju.
English: Pregnancy Prevention Programme Valproate has a high teratogenic potential and children exposed in utero to valproate have a high risk for congenital malformations and neurodevelopmental disorders (see section 4.6).
Croatian: Program prevencije trudnoće Valproat ima visok teratogeni potencijal te postoji visok rizik od kongenitalnih malformacija i neurorazvojnih poremećaja u djece izložene valproatu in utero (vidjeti dio 4.6).
English: Individual circumstances should be evaluated in each case, when choosing the contraception method involving the patient in the discussion, to guarantee her engagement and compliance with the chosen measures.
Croatian: Prilikom odabira metode kontracepcije potrebno je procijeniti pojedinačne okolnosti svakog slučaja te uključiti bolesnicu u raspravu kako bi se osiguralo njezino sudjelovanje i pridržavanje odabranih mjera.
English: I AM TAKING <invented name> AND NOT PLANNING TO HAVE A BABY If you are continuing treatment with <Invented name> but you are not planning to have a baby make sure you are using an effective method of contraception without interruption during your entire treatment with <Invented name>.
Croatian: UZIMAM <ZAŠTIĆENO IME> I NE PLANIRAM IMATI DIJETE Ako nastavljate liječenje s lijekom <Zaštićeno ime>, ali ne planirate imati dijete, obavezno koristite učinkovitu metodu kontracepcije bez prekida cijelo vrijeme dok se liječite lijekom <Zaštićeno ime>.
English: Valproate is contraindicated as treatment for epilepsy during pregnancy unless there is no suitable alternative to treat epilepsy.
Croatian: Valproat je kontraindiciran za liječenje epilepsije tijekom trudnoće osim ako ne postoji drugo odgovarajuće liječenje.
English: An annual risk acknowledgement form needs to be used at time of treatment initiation and during each annual review of valproate treatment by the specialist.
Croatian: Godišnji obrazac potvrde o upoznatosti s rizikom treba koristiti na početku liječenja i tijekom svake godišnje procjene liječenja valproatom od strane liječnika specijalista.
English: These amendments to the relevant sections of the Summary of Product Characteristics and package leaflet are the outcome of the referral procedure.
Croatian: Ove izmjene određenih dijelova sažetka opisa svojstava lijeka i upute o lijeku ishod su arbitražnog postupka.
English: [This section should be amended to include the below wording in all indications]
Croatian: [Ovaj dio treba izmijeniti tako da se uključi sljedeći tekst u svim indikacijama]
English: Treatment of bipolar disorder <and prophylaxis of migraine attacks>
Croatian: Liječenje bipolarnog poremećaja <i profilaksa migrenskih napadaja>
English: Valproate should not be used in female children and women of childbearing potential unless other treatments are ineffective or not tolerated.
Croatian: Valproat se u djevojčica i žena reproduktivne dobi smije primjenjivati samo ako druge terapije nisu djelotvorne ili ako ih bolesnica ne podnosi.
English: Valproate is contraindicated as treatment for bipolar disorder <and migraine> during pregnancy.
Croatian: Valproat je kontraindiciran za liječenje bipolarnog poremećaja <i migrene> tijekom trudnoće.
English: The specialist should discuss the annual risk acknowledgement form, at initiation and during each annual review and ensure that the patient has understood its content.
Croatian: Specijalist treba raspraviti sadržaj Godišnjeg obrasca potvrde o upoznatosti s rizikom na početku liječenja i kod svake godišnje procjene te osigurati da bolesnica razumije njegov sadržaj.
English: Pregnancy planning.
Croatian: Planiranje trudnoće
English: • the patient has understood and acknowledged the risks of congenital malformations and neurodevelopmental disorders including the magnitude of these risks for children exposed to valproate in utero.
Croatian: • osigurati da je bolesnica razumjela i prepoznala važnost rizika od urođenih malformacija i neurorazvojnih poremećaja, uključujući i opseg tih rizika u djece izložene valproatu in utero.
English: Annex III Amendments to relevant sections of the Product Information
Croatian: Izmjene određenih dijelova informacija o lijeku
English: • the patient card is provided with every valproate dispensing and that the patients understand its content.
Croatian: • da se kartica za bolesnice osigura uz svako izdavanje lijeka te da bolesnica razumije njezin sadržaj
English: Folic acid can lower the general risk of spina bifida and early miscarriage that exists with all pregnancies.
Croatian: Folna kiselina može smanjiti opći rizik od rascjepa kralježnice i ranog spontanog pobačaja, koji je prisutan kod svih trudnoća.
English: • The prescribers must ensure that parents/caregivers of female children understand the need to contact the specialist once the female child using valproate experiences menarche.
Croatian: • Liječnik koji propisuje lijek mora osigurati da roditelji/staratelji djevojčica razumiju potrebu da se obrate liječniku specijalistu nakon što djevojčica koja se liječi valproatom dobije prvu menstruaciju.
English: Folate supplementation before the pregnancy may decrease the risk of neural tube defects which may occur in all pregnancies.
Croatian: Uzimanje nadomjestaka folne kiseline prije trudnoće moglo bi smanjiti rizik od oštećenja neuralne cijevi, koja se mogu javiti kod svih trudnoća.
English: Female children
Croatian: Djevojčice
English: Do not stop taking <Invented name> or your contraception, until you have discussed this with your doctor.
Croatian: Nemojte prestati uzimati lijek <Zaštićeno ime> ili koristiti kontracepciju sve dok o tome ne razgovarate s Vašim liječnikom.
English: • the patient understands the need to consult her physician as soon as she is planning pregnancy to ensure timely discussion and switching to alternative treatment options prior to conception, and before contraception is discontinued.
Croatian: • osigurati da bolesnica razumije da je potrebno obratiti se svom liječniku što prije ako planira trudnoću kako bi se osiguralo pravodobno razmatranje i prelazak na liječenje drugom odgovarajućom terapijom prije začeća te prije nego što se prekine kontracepcija
English: • The prescriber must ensure that parents/caregivers of female children who have experienced menarche are provided with comprehensive information about the risks of congenital malformations and neurodevelopmental disorders including the magnitude of these risks for children exposed to valproate in utero.
Croatian: • Liječnik koji propisuje lijek mora osigurati da roditelji/staratelji djevojčica nakon prve menstruaciju dobiju sveobuhvatne informacije o rizicima urođenih malformacija i neurorazvojnih poremećaja, uključujući i opseg tih rizika, u djece izložene valproatu in utero.
English: • Pregnancy must be excluded before start of treatment with <Invented name> with the result of a pregnancy test, confirmed by your doctor.
Croatian: • Trudnoća mora biti isključena na temelju rezultata testa na trudnoću, potvrđenim od strane liječnika, prije početka liječenja s lijekom <Zaštićeno ime>.
English: • First schedule an appointment with your doctor.
Croatian: • Prvo posjetite liječnika.
English: A patient guide and patient card should be provided to all women of childbearing potential using valproate.
Croatian: Vodič za bolesnice i kartica za bolesnice trebaju biti osigurani svim ženama reproduktivne dobi koje se liječe valproatom.
English: Valproate is prescribed and dispensed according to the Valproate Pregnancy Prevention Programme (sections 4.3 and 4.4).
Croatian: Valproat se propisuje i izdaje sukladno programu prevencije trudnoće kod upotrebe valproata (dijelovi 4.3 i 4.4).
English: For the indication(s) <bipolar disorder> <and> < migraine> if a woman is planning to become pregnant a specialist experienced in the management of <bipolar disorder> <migraine> must be consulted and treatment with valproate should be discontinued and if needed switched to an alternative treatment prior to conception, and before contraception is discontinued.
Croatian: Za indikaciju(e) <bipolarni poremećaj><i><migrena> ako žena planira trudnoću mora se savjetovati sa specijalistom za liječenje <bipolarnog poremećaja><migrene> , a liječenje valproatom mora se prekinuti te ako je potrebno zamijeniti s drugim odgovarajućim liječenjem prije začeća i prije prekida kontracepcije.
English: • Do not stop taking <Invented name> unless your doctor tells you to.
Croatian: • Nemojte prestati uzimati lijek <Zaštićeno ime> osim ako Vam to nije rekao Vaš liječnik.
English: • Ask your doctor about taking folic acid when trying for a baby.
Croatian: • Pitajte Vašeg liječnika o uzimanju folne kiseline kada ćete pokušavati zatrudnjeti.
English: Valproate as treatment for epilepsy is contraindicated in pregnancy unless there is no suitable alternative treatment (see sections 4.3 and 4.4).
Croatian: Valproat je kontraindiciran za liječenje epilepsije u trudnoći osim ako ne postoji drugo odgovarajuće liječenje (vidjeti dijelove 4.3 i 4.4).
English: • You must use an effective method of birth control (contraception) during your entire treatment with <Invented name>.
Croatian: • Obavezno koristite učinkovitu metodu kontracepcije (sprječavanja začeća) cijelo vrijeme dok se liječite s lijekom <Zaštićeno ime>.
English: • For epilepsy, you must not use <Invented name> if you are pregnant, unless nothing else works for you.
Croatian: <Zaštićeno ime> za liječenje epilepsije ako ste trudni, osim ako ništa drugo kod Vas ne djeluje.
English: [This section should be amended to include the following wording]
Croatian: [Ovaj dio treba izmijeniti tako da se uključi sljedeći tekst]
English: Annual treatment reviews by a specialist The specialist should at least annually review whether valproate is the most suitable treatment for the patient.
Croatian: Liječnik specijalist mora barem jednom godišnje procijeniti je li liječenje valproatom najbolji izbor za bolesnicu.
English: Every effort should be made to switch to appropriate alternative treatment prior to conception, and before contraception is discontinued (see section 4.6).
Croatian: Treba poduzeti sve moguće mjere kako bi se bolesnice prebacilo na drugo odgovarajuće liječenje prije začeća i prije ukidanja kontracepcije (vidjeti dio 4.6).
English: Every effort should be made to switch to appropriate alternative treatment prior to conception, and before contraception is discontinued (see section 4.4).
Croatian: Treba poduzeti sve moguće mjere kako bi se bolesnice prebacilo na drugo odgovarajuće liječenja prije začeća i prije ukidanja kontracepcije (vidjeti dio 4.4).
English: For the indication epilepsy, if a woman is planning to become pregnant, a specialist experienced in the management of epilepsy, must reassess valproate therapy and consider alternative treatment options.
Croatian: Za indikaciju epilepsije, ako žena planira trudnoću, specijalist s iskustvom u liječenju epilepsije mora ponovno procijeniti liječenje valproatom i razmotriti druge mogućnosti odgovarajućeg liječenja.
English: O I AM STARTING TREATMENT WITH <INVENTED NAME> O I AM TAKING <INVENTED NAME> AND NOT PLANNING TO HAVE A BABY O I AM TAKING <INVENTED NAME> AND PLANNING TO HAVE A BABY O I AM PREGNANT AND I AM TAKING <INVENTED NAME>
Croatian: Između niže navedenih situacija odaberite i pročitajte onu koja se odnosi na Vas: O ZAPOČINJEM LIJEČENJE LIJEKOM <ZAŠTIĆENO IME> O UZIMAM <ZAŠTIĆENO IME> I NE PLANIRAM IMATI DIJETE O UZIMAM <ZAŠTIĆENO IME> I PLANIRAM IMATI DIJETE O TRUDNA SAM I UZIMAM <ZAŠTIĆENO IME> ZAPOČINJEM LIJEČENJE S LIJEKOM <ZAŠTIĆENO IME>
English: The patients with a valproate exposed pregnancy and their partners should be referred to a specialist experienced in <teratology> {to be adapted depending on health care system} for evaluation and counselling regarding the exposed pregnancy (see section 4.6).
Croatian: Sve bolesnice koje su izložene valproatu u trudnoći i njihovi partneri moraju se uputiti specijalistu s iskustvom u teratogenim poremećajima za procjenu i savjetovanje vezano uz izloženost u trudnoći (vidjeti dio 4.6).
English: Your doctor will refer you to a specialist experienced in the management of bipolar disorder <or>< migraine> or epilepsy, so that alternative treatment options can be evaluated early on.
Croatian: Vaš liječnik će Vas uputiti specijalistu s iskustvom u liječenju bipolarnog poremećaja <ili><migrene> ili epilepsije, kako bi se što ranije mogle razmotriti druge odgovarajuće mogućnosti liječenja.
English: Pregnancy test
Croatian: Test na trudnoću
English: • You must get regular (at least annual) appointments with a specialist experienced in the management of bipolar disorder or epilepsy <or> < migraine>.
Croatian: • Morate redovito (najmanje jednom godišnje) posjećivati liječnika specijalista s iskustvom u liječenju bipolarnog poremećaja ili epilepsije <ili> < migrene>.
English: <Invented name> treatment must be started and supervised by a doctor specialised in the treatment of <epilepsy> <or> <bipolar disorders> <or> <migraine>.
Croatian: Liječenje lijekom <Zaštićeno ime> mora započeti i nadzirati specijalist s iskustvom u liječenju <epilepsije> <ili> <bipolarnog poremećaja> <ili> <migrene>.
English: Do not stop taking <Invented name> unless your doctor tells you to as your condition may become worse.
Croatian: <Zaštićeno ime> osim ako Vam to ne kaže Vaš liječnik jer se Vaše stanje može pogoršati.