FrancophonIA/ELRC3.0 huggingface dataset:
English: • Make sure you are using an effective method of contraception.
Croatian: • Obavezno koristite učinkovitu metodu kontracepcije.
English: Therefore, platelet count, fibrinogen plasma level, coagulation tests and coagulation factors should be investigated in neonates.
Croatian: Stoga u novorođenčadi treba odrediti broj trombocita i razinu fibrinogena u plazmi te provesti koagulacijske testove i odrediti koagulacijske faktore.
English: Female children, female adolescents, women of childbearing potential and pregnant women
Croatian: Djevojčice, adolescentice, žene reproduktivne dobi i trudnice
English: The risk seems to be dose-dependent but a threshold dose below which no risk exists, cannot be established based on available data.
Croatian: Čini se da rizik ovisi o dozi, ali se na temelju dostupnih podataka ne može odrediti granična doza ispod koje rizik ne postoji.
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 odgovarajućih dijelova Sažetka opisa svojstava lijeka i Upute o lijeku rezultat su arbitražnog postupka.
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 prirođenih mana i poteškoća u razvoju, koje mogu izazvati ozbiljnu onesposobljenost.
English: Birth defects which have been reported include spina bifida (where the bones of the spine are not properly developed); facial and skull malformations; heart, kidney, urinary tract and sexual organ malformations; limb defects.
Croatian: Prijavljene prirođene mane uključuju rascjep kralježnice (spina bifida; stanje kod kojega kosti kralježnice nisu pravilno razvijene); malformacije lica i lubanje; malformacije srca, bubrega, mokraćnih putova i spolnih organa; oštećenja ekstremiteta.
English: Both valproate monotherapy and valproate polytherapy are associated with abnormal pregnancy outcomes.
Croatian: I monoterapija valproatom i politerapija koja uključuje valproat povezuju se s patološkim ishodima trudnoće.
English: Treatment should only be initiated if other treatments are ineffective or not tolerated (see section 4.3, 4.4 and 4.6) and the benefit and risk should be carefully reconsidered at regular treatment reviews.
Croatian: Liječenje se smije započeti samo ako druge terapije nisu djelotvorne ili ako ih bolesnica ne podnosi (vidjeti dijelove 4.3, 4.4 i 4.6), a koristi i rizike treba pomno ponovno razmotriti prilikom redovitih ocjena liječenja.
English: If you are continuing treatment with valproate but you don't plan to have a baby make sure you are using an effective method of contraception.
Croatian: NASTAVAK LIJEČENJA BEZ PLANIRANJA TRUDNOĆE Ako nastavljate liječenje valproatom, ali ne planirate imati dijete, obavezno koristite učinkovitu metodu kontracepcije.
English: However, it it unlikely that it will reduce the risk of birth defects associated with valproate use.
Croatian: Međutim, nije vjerojatno da će smanjiti rizik od prirođenih mana povezanih s primjenom valproata.
English: Women of childbearing potential must use effective contraception during treatment and be informed of the risks associated with the use of <invented name> during pregnancy (see section 4.6).
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja te ih treba upozoriti na rizike povezane s primjenom lijeka <Zaštićeno ime> tijekom trudnoće (vidjeti dio 4.6).
English: If you are continuing treatment with valproate and you are now thinking of trying for a baby you must not stop taking either your valproate or your contraceptive medicine until you have discussed this with your prescriber.
Croatian: Ako nastavljate liječenje valproatom i sada razmišljate o trudnoći, ne smijete prestati uzimati valproat ni kontraceptiv dok o tome ne razgovarate s liječnikom koji Vam je propisao lijek.
English: Treatment should only be initiated if other treatments are ineffective or not tolerated (see section 4.4 and 4.6) and the benefit and risk should be carefully reconsidered at regular treatment reviews.
Croatian: Liječenje se smije započeti samo ako druge terapije nisu djelotvorne ili ako ih bolesnica ne podnosi (vidjeti dijelove 4.4 i 4.6), a koristi i rizike treba pomno ponovno razmotriti prilikom redovitih ocjena liječenja.
English: Risk in the neonate
Croatian: Rizik u novorođenčeta
English: Amenorrhoea, polycystic ovaries and increased testosterone levels have been reported in women using valproate (see section 4.8).
Croatian: U žena liječenih valproatom prijavljeni su amenoreja, policistični jajnici i povišene razine testosterona (vidjeti dio 4.8).
English: If you are a female of childbearing age you should use an effective method of contraception throughout your treatment.
Croatian: Ako ste žena u reproduktivnoj dobi, morate koristiti učinkovitu metodu kontracepcije cijelo vrijeme liječenja.
English: If you are taking valproate and you think you are pregnant or might be pregnant contact your doctor at once.
Croatian: Ako uzimate valproat i zatrudnite ili mislite da biste mogli biti trudni, odmah se obratite svome liječniku.
English: • The need to rapidly consult her physician if she is thinking of becoming pregnant or there is a possibility of pregnancy.
Croatian: • potrebu da se odmah obrati svome liječniku ako razmišlja o trudnoći ili ako postoji mogućnost da je trudna.
English: Hematological disorders have been shown in breastfed newborns/infants of treated women (see section 4.8).
Croatian: U dojenčadi/novorođenčadi liječenih žena primijećeni su hematološki poremećaji (vidjeti dio 4.8).
English: - Folate supplementation before the pregnancy may decrease the risk of neural tube defects common to all pregnancies.
Croatian: - Uzimanje nadomjestaka folne kiseline prije trudnoće moglo bi smanjiti rizik od oštećenja neuralne cijevi, koja su česta kod svih trudnoća.
English: <Invented name> should not be used in female children, in female adolescents, in women of childbearing potential and pregnant women unless alternative treatments are ineffective or not tolerated because of its high teratogenic potential and risk of developmental disorders in infants exposed in utero to valproate.
Croatian: <Zaštićeno ime> se u djevojčica, adolescentica, žena reproduktivne dobi i trudnica smije primjenjivati samo ako druge terapije nisu djelotvorne ili ako ih bolesnica ne podnosi, jer <Zaštićeno ime> ima visok teratogeni potencijal i postoji rizik od razvojnih poremećaja u djece izložene valproatu in utero.
English: Pregnancy Exposure Risk related to valproate
Croatian: Rizik povezan s izlaganjem valproatu tijekom trudnoće
English: [The following sentence should be inserted only where the marketing authorisation currently includes the indication prophylaxis of migraine attacks] In women planning to become pregnant or who are pregnant valproate therapies should be stopped.
Croatian: [Sljedeću rečenicu treba uključiti samo ondje gdje odobrenje za stavljanje lijeka u promet trenutno uključuje indikaciju profilakse migrenskih napadaja] U žena koje planiraju trudnoću ili su trudne, terapija valproatom mora se prekinuti.
English: • Prophylaxis of migraine attacks in pregnancy and women of childbearing potential who are not using effective methods of contraception during treatment with valproate (see sections 4.4 and 4.6).
Croatian: • Profilaksa migrenskih napadaja u trudnica i žena reproduktivne dobi koje ne koriste učinkovite kontracepcijske metode tijekom liječenja valproatom (vidjeti dijelove 4.4 i 4.6).
English: [For all products referred to in Annex I]
Croatian: [Za sve lijekove navedene u Dodatku I]
English: In women planning to become pregnant all efforts should be made to switch to appropriate alternative treatment prior to conception, if possible (see section 4.6).
Croatian: U žena koje planiraju trudnoću treba poduzeti sve moguće mjere kako bi ih se prije začeća prebacilo na drugu odgovarajuću terapiju, ako je to moguće (vidjeti dio 4.6).
English: Limited data suggests that children exposed to valproate in utero may be more likely to develop symptoms of attention deficit/hyperactivity disorder (ADHD).
Croatian: Ograničeni podaci ukazuju na to da bi u djece izložene valproatu in utero mogla postojati veća vjerojatnost razvoja simptoma poremećaja hiperaktivnosti i deficita pažnje (engl. attention deficit/hyperactivity disorder, ADHD).
English: • Stop taking your valproate and schedule an urgent appointment if you are pregnant or think you might be pregnant.
Croatian: • Prestanite uzimati valproat i hitno posjetite liječnika ako zatrudnite ili mislite da biste mogli biti trudni.
English: • Ask your doctor about taking folic acid when trying for a baby.
Croatian: • Pitajte svog liječnika o uzimanju folne kiseline kada ćete pokušavati zatrudnjeti.
English: Ask your doctor about taking folic acid when trying for a baby.
Croatian: Pitajte svog liječnika o uzimanju folne kiseline kada ćete pokušavati zatrudnjeti.
English: This compares to 2-3 babies in ever 100 born to women who don't have epilepsy.
Croatian: Među ženama koje nemaju epilepsiju, taj omjer iznosi 2-3 djeteta na 100 rođenih.
English: [For all products in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below]
Croatian: I treba izmijeniti (po potrebi ubaciti, zamijeniti ili obrisati tekst) tako da uključuju usuglašen tekst naveden u nastavku]
English: <Invented name> is contraindicated as migraine prophylaxis in pregnant women and in women of childbearing potential, who do not use effective methods of contraception, as sufficient therapeutic alternatives are present (see section 4.3).
Croatian: <Zaštićeno ime> je kontraindiciran za profilaksu migrena u trudnica i žena reproduktivne dobi koje ne koriste učinkovite metode kontracepcije jer postoji dovoljno drugih terapijskih mogućnosti (vidjeti dio 4.3).
English: • In women planning to become pregnant all efforts should be made to switch to appropriate alternative treatment prior to conception, if possible.
Croatian: • U žena koje planiraju trudnoću treba poduzeti sve moguće mjere kako bi ih se prije začeća prebacilo na drugu odgovarajuću terapiju, ako je to moguće.
English: Valproate therapy should only be continued after a reassessment of the benefits and risks of the treatment with valproate for the patient by a physician experienced in the management of
Croatian: Terapija valproatom smije se nastaviti tek nakon ponovne procjene koristi i rizika liječenja valproatom za bolesnicu, koju mora provesti liječnik s iskustvom u liječenju <epilepsije> <ili> <bipolarnog poremećaja>.
English: <Invented name> should not be used in female children, in female adolescents, in women of childbearing potential and in pregnant women unless other treatments are ineffective or not tolerated.
Croatian: <Zaštićeno ime> se u djevojčica, adolescentica, žena reproduktivne dobi i trudnica smije primjenjivati samo ako druge terapije nisu djelotvorne ili ako ih bolesnica ne podnosi.
English: In women planning to become pregnant all efforts should be made to switch to appropriate alternative treatment prior to conception, if possible.
Croatian: U žena koje planiraju trudnoću treba poduzeti sve moguće mjere kako bi ih se prije začeća prebacilo na drugu odgovarajuću terapiju, ako je to moguće.
English: <Invented name> is contraindicated for prophylaxis of migraine attacks in pregnancy and women of childbearing potential who are not using effective methods of contraception during treatment with valproate (see sections 4.4 and 4.6 above).
Croatian: <Zaštićeno ime> je kontraindiciran za profilaksu migrenskih napadaja u trudnica i žena reproduktivne dobi koje ne koriste učinkovite metode kontracepcije tijekom liječenja valproatom (vidjeti dijelove 4.4 i 4.6 gore).
English: Once you are of childbearing age, you will need to make sure you use an effective method of contraception throughout your treatment.
Croatian: Kada dosegnete reproduktivnu dob, morat ćete koristiti učinkovitu kontracepciju tijekom čitava liječenja.
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. [The sentence below should be inserted only where the marketing authorisation currently includes the epilepsy and/or bipolar indications]
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: <Invented name> treatment must be started and supervised by a doctor specialised in the treatment of <epilepsy> <or> <bipolar disorders>.
Croatian: Liječenje lijekom <Zaštićeno ime> mora započeti i nadzirati specijalist s iskustvom u liječenju <epilepsije> <ili> <bipolarnih poremećaja>.
English: <Invented name> should only be initiated and supervised by a specialist experienced in the management of migraine.
Croatian: Liječenje lijekom <Zaštićeno ime> mora započeti i nadzirati isključivo specijalist s iskustvom u liječenju migrene.
English: [The following text should be inserted in all products referred to in Annex I]
Croatian: [Tekst u nastavku treba uključiti kod svih lijekova navedenih u Dodatku I]
English: - Withdrawal syndrome (such as, in particular, agitation, irritability, hyper-excitability, jitteriness, hyperkinesia, tonicity disorders, tremor, convulsions and feeding disorders) may occur in neonates whose mothers have taken valproate during the last trimester of their pregnancy.
Croatian: - U novorođenčadi majki koje su uzimale valproat tijekom trećeg tromjesečja trudnoće mogu se javiti simptomi ustezanja (osobito agitacija, razdražljivost, prekomjerno uzbuđivanje, nervozni pokreti, hiperkinezija, poremećaji tonusa, tremor, konvulzije i poremećaji hranjenja).
English: UNPLANNED PREGNANCY WHILST CONTINUING TREATMENT [The paragraph below should be inserted only where the marketing authorisation currently includes the indication “prophylaxis of migraine attacks”].
Croatian: NEPLANIRANA TRUDNOĆA TIJEKOM LIJEČENJA [Sljedeći odlomak treba uključiti samo ondje gdje odobrenje za stavljanje lijeka u promet trenutno uključuje indikaciju “profilaksa migrenskih napadaja”].
English: Pregnancy must be excluded before start of treatment with valproate.
Croatian: Prije početka liječenja valproatom mora se isključiti trudnoća.
English: Tell your doctor at once if you become pregnant or think you might be pregnant.
Croatian: Odmah obavijestite liječnika ako zatrudnite ili mislite da biste mogli biti trudni.
English: CONTINUING TREATMENT AND CONSIDERING TRYING FOR A BABY [The paragraph below should be inserted only where the marketing authorisation currently includes the indication “prophylaxis of migraine attacks”].
Croatian: NASTAVAK LIJEČENJA I RAZMATRANJE TRUDNOĆE [Sljedeći odlomak treba uključiti samo ondje gdje odobrenje za stavljanje lijeka u promet trenutno uključuje indikaciju “profilaksa migrenskih napadaja”].
English: • Tell your doctor at once if you are pregnant or think you might be pregnant.
Croatian: • Odmah recite svome liječniku ako ste trudni ili mislite da biste mogli biti trudni.
English: • Pregnancy must be excluded before start of treatment with valproate.
Croatian: • Prije početka liječenja valproatom mora se isključiti trudnoća.
English: - Cases of hypothyroidism have been reported in neonates whose mothers have taken valproate during pregnancy.
Croatian: - U novorođenčadi majki koje su uzimale valproat tijekom trudnoće prijavljeni su slučajevi hipotireoze.
English: - Cases of hypoglycaemia have been reported in neonates whose mothers have taken valproate during the third trimester of their pregnancy.
Croatian: - U novorođenčadi majki koje su uzimale valproat tijekom trećeg tromjesečja trudnoće prijavljeni su slučajevi hipoglikemije.
English: [This statement below should be inserted at the top of the package leaflet for all products referred to in Annex I] ▼This medicine is subject to additional monitoring.
Croatian: [Ovu izjavu treba navesti na početku Upute o lijeku za sve lijekove navedene u Dodatku
English: - Cases of hemorrhagic syndrome have been reported very rarely in neonates whose mothers have taken valproate during pregnancy.
Croatian: U novorođenčadi majki koje su tijekom trudnoće uzimale valproat vrlo su rijetko prijavljeni slučajevi hemoragijskog sindroma.
English: Do not stop taking your medicine until your doctor tells you to. [The text below should be inserted in all indications].
Croatian: Nemojte prestati uzimati lijek sve dok Vam to ne kaže liječnik.
English: [The following sentence should be inserted only where the marketing authorisation currently includes the indication prophylaxis of migraine attacks]
Croatian: [Sljedeću rečenicu treba uključiti samo ondje gdje odobrenje za stavljanje lijeka u promet trenutno uključuje indikaciju profilakse migrenskih napadaja]
English: [The paragraph below should be inserted only where the marketing authorisation currently includes the indication “prophylaxis of migraine attacks”].
Croatian: [Odlomak u nastavku treba uključiti samo ondje gdje odobrenje za stavljanje lijeka u promet trenutno uključuje indikaciju “profilaksa migrenskih napadaja”].
English: [The following paragraph should be inserted only where the marketing authorisation currently includes the indication prophylaxis of migraine attacks]
Croatian: [Sljedeći odlomak treba uključiti samo ondje gdje odobrenje za stavljanje lijeka u promet trenutno uključuje indikaciju profilakse migrenskih napadaja]
English: [All text below should be inserted only where the marketing authorisation currently includes the indications for epilepsy and/or bipolar disorder].
Croatian: [Sav tekst u nastavku treba uključiti samo ondje gdje odobrenje za stavljanje lijeka u promet trenutno uključuje indikacije liječenja epilepsije i/ili bipolarnog poremećaja].
English: [The text below should be inserted only where the marketing authorisation currently includes indications for the epilepsy and/or bipolar disorder].
Croatian: [Tekst u nastavku treba uključiti samo ondje gdje odobrenje za stavljanje lijeka u promet trenutno uključuje indikacije liječenja epilepsije i/ili bipolarnog poremećaja].
English: [The sentence below should be inserted only where the marketing authorisation currently includes indications for the epilepsy and/or bipolar disorder].
Croatian: [Rečenicu u nastavku treba uključiti samo ondje gdje odobrenje za stavljanje lijeka u promet trenutno uključuje indikacije liječenja epilepsije i/ili bipolarnog poremećaja].
English: [The sentence below should be inserted only where the marketing authorisation currently includes the epilepsy and/or bipolar disorders indications]
Croatian: [Sljedeću rečenicu treba uključiti samo ondje gdje odobrenje za stavljanje lijeka u promet trenutno uključuje indikacije liječenja epilepsije i/ili bipolarnih poremećaja]
English: Every year, the European Medicines Agency will review any new information that becomes available and this overview will be updated as necessary.
Croatian: Svake godine Europska agencija za lijekove procjenjuje sve nove informacije koje postanu dostupne te se ovaj pregled informacija po potrebi ažurira.
English: Treatment may need to be delayed or stopped if certain side effects occur.
Croatian: Možda će biti potrebno odgoditi ili obustaviti liječenje ako se razviju određene nuspojave.
English: Patients with MCC that has spread and come back after initial treatment with chemotherapy have very limited treatment options.
Croatian: Bolesnici s MCC-om koji se proširio i vratio nakon početnog liječenja kemoterapijom imaju vrlo ograničene mogućnosti liječenja.
English: If no reactions have occurred by the fourth infusion, the treating doctor may decide to stop giving these medicines before subsequent infusions.
Croatian: Ako do četvrte infuzije nema reakcija, nadležni liječnik može donijeti odluku o prestanku primjene tih lijekova prije sljedećih infuzija.
English: What is Bavencio and what is it used for?
Croatian: Što je Bavencio i za što se koristi?
English: Bavencio received a conditional marketing authorisation valid throughout the European Union on 18 September 2017.
Croatian: Lijek Bavencio dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 18. rujna 2017.
English: The side effects of the combination were consistent with what was expected, and were considered acceptable given the nature of the condition being treated.
Croatian: Nuspojave ove kombinacije lijekova bile su konzistentne s očekivanjima te ih se smatralo prihvatljivima s obzirom na prirodu bolesti koja se liječi.
English: Treatment should continue as long as the patient benefits from it or side effects become unacceptable.
Croatian: Liječenje treba nastaviti sve dok bolesnik ima koristi od njega ili dok bolesnik ne razvije neprihvatljive nuspojave.
English: Further information on Bavencio can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/bavencio.
Croatian: Više informacija o lijeku Bavencio dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/bavencio Pregled informacija posljednji je put ažuriran u 10. 2019.
English: What measures are being taken to ensure the safe and effective use of Bavencio?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Bavencio?
English: In both its uses, Bavencio is given in a dose of 800 mg once every 2 weeks as an infusion (drip) into a vein that lasts around 1 hour..
Croatian: Za obje se bolesti Bavencio daje u dozi od 800 mg jednom svaka dva tjedna kao infuzija (ukapavanje) u venu koja traje oko sat vremena.
English: For MCC, Bavencio has been given ‘conditional approval'.
Croatian: Za lijek Bavencio izdano je „uvjetno odobrenje”.
English: The European Medicines Agency decided that Bavencio'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 Bavencio nadmašuju s njim povezane rizike te se može izdati odobrenje za njegovu primjenu u EU-u.
English: Although the response rates to Bavencio are not outstanding, the duration of the response (at least 6 months) is important for these patients, since the responses seen with chemotherapy medicines are of shorter duration.
Croatian: Iako stope reakcije na lijek Bavencio nisu izvanredne, trajanje reakcije (barem šest mjeseci) važno je za te bolesnike jer su reakcije zabilježene pri primjeni kemoterapijskih lijekova kraćega trajanja.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Bavencio have also 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 Bavencio također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
English: Why is Bavencio authorised in the EU?
Croatian: Zašto je lijek Bavencio odobren u EU-u?
English: Side effects reported with Bavencio are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Bavencio pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Other information about Bavencio
Croatian: Ostale informacije o lijeku Bavencio
English: Although the dose of Bavencio in these studies was based on the patients' body weight, the company also supplied supporting data to show that Bavencio could be given in a standard dose, regardless of weight.
Croatian: Iako se doza lijeka Bavencio u tim ispitivanjima temeljila na tjelesnoj težini bolesnika, tvrtka je dostavila dodatne podatke koji pokazuju da se Bavencio može davati i u standardnoj dozi, bez obzira na tjelesnu težinu.