FrancophonIA/ELRC3.0 huggingface dataset:
English: A 1.3-fold increase in incidence rate of solid tumour SPM has been observed in patients receiving lenalidomide in combination with dexamethasone until progression or for 18 months (1.58 per 100 person-years) compared to thalidomide in combination with melphalan and prednisone (1.19 per 100 person-years).
Croatian: U bolesnika koji su primali lenalidomid u kombinaciji s deksametazonom do napredovanja bolesti ili tijekom 18 mjeseci (1,58 na 100 osoba-godina), opažen je porast stope incidencije solidnih tumora kao drugih primarnih zloćudnih bolesti od 1,3 puta u usporedbi s talidomidom u kombinaciji s melfalanom i prednizonom (1,19 na 100 osoba-godina).
English: Excipientwith known effect Each hard capsule contains 67mg of lactose.
Croatian: Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 67 mg laktoze.
English: Resume lenalidomide at dose level -1 once daily
Croatian: Nastaviti s lenalidomidom pri 1. razini doze jednom dnevno
English: Dose level -1
Croatian: 1. razina doze
English: Lenalidomide Accord 15 mg hard capsules EU/1/18/1316/008
Croatian: Lenalidomid Accord 15 mg tvrde kapsule EU/1/18/1316/008
English: Lenalidomide Accord 15 mg are gelatin hard capsules size “2” approximately 17.4 mm to 18.2 mm in length, opaque orange cap and opaque white body with “LENALIDOMIDE” printed on cap in black and “15 mg” printed on body in green, containing white to off white coloured powder.
Croatian: Lenalidomid Accord 15 mg su želatinske tvrde kapsule veličine „2“ dugačke približno 17,4 mm do 18,2 mm, s neprozirnom narančastom kapicom i neprozirnim bijelim tijelom, s crnim natpisom „LENALIDOMIDE“ na kapici i zelenim natpisom „15 mg“ na tijelu, koje sadrže bijeli do bjelkasti prašak.
English: • Patient cards
Croatian: • kartice za bolesnike
English: Lenalidomide Accord 2.5 mg are gelatin hard capsules size “5” approximately 11.0 mm to 11.8 mm in length, grey cap and opaque white body with “LENALIDOMIDE” printed on cap in black and “2.5 mg” printed on body in green, containing white to off white coloured powder.
Croatian: Lenalidomid Accord 2,5 mg su želatinske tvrde kapsule veličine „5“ dugačke približno 11,0 mm do 11,8 mm, sa sivom kapicom i neprozirnim bijelim tijelom, s crnim natpisom „LENALIDOMIDE“ na kapici i zelenim natpisom „2.5 mg“ na tijelu, koje sadrže bijeli do bjelkasti prašak.
English: Lenalidomide Accord 5 mg are gelatin hard capsules size “5” approximately 11.0 mm to 11.8 mm in length, opaque white cap and body with “LENALIDOMIDE” printed on cap in black and “5 mg” printed on body in green, containing white to off white coloured powder.
Croatian: Lenalidomid Accord 5 mg su želatinske tvrde kapsule veličine „5“ dugačke približno 11,0 mm do 11,8 mm, s neprozirnom bijelom kapicom i tijelom, s crnim natpisom „LENALIDOMIDE“ na kapici i zelenim natpisom „5 mg“ na tijelu, koje sadrže bijeli do bjelkasti prašak.
English: Gelatin hard capsules size “1” approximately 19.0 mm to 19.8 mm in length, opaque green cap and opaque white body with “LENALIDOMIDE” printed on cap in black and “20 mg” printed on body in green, containing white to off white coloured powder.
Croatian: Želatinske tvrde kapsule veličine „1“ dugačke približno 19,0 mm do 19,8 mm, s neprozirnom zelenom kapicom i neprozirnim bijelim tijelom, s crnim natpisom „LENALIDOMIDE“ na kapici i zelenim natpisom „20 mg“ na tijelu, koje sadrže bijeli do bjelkasti prašak.
English: HR [95% CI]c; p-valued Rd vs MPT
Croatian: HR [95 % CI]c; p-vrijednostd
English: Gelatin hard capsules size “2” approximately 17.4 mm to 18.2 mm in length, opaque orange cap and opaque white body with “LENALIDOMIDE” printed on cap in black and “15 mg” printed on body in green, containing white to off white coloured powder.
Croatian: Želatinske tvrde kapsule veličine „2“ dugačke približno 17,4 mm do 18,2 mm, s neprozirnom narančastom kapicom i neprozirnim bijelim tijelom, s crnim natpisom „LENALIDOMIDE“ na kapici i zelenim natpisom „15 mg“ na tijelu, koje sadrže bijeli do bjelkasti prašak.
English: Patients in the Rd and Rd18 arms took lenalidomide 25 mg once daily on days 1 to 21 of 28-day cycles according to protocol arm. Dexamethasone 40 mg was dosed once daily on days 1, 8, 15, and 22 of each 28-day cycle.
Croatian: Bolesnici u skupinama Rd i Rd18 uzimali su lenalidomid 25 mg jednom dnevno od 1. do 21. dana 28-dnevnih ciklusa prema planu ispitivanja.
English: Gelatin hard capsules size “3” approximately 15.4 mm to 16.2 mm in length, leaf green cap and opaque white body with “LENALIDOMIDE” printed on cap in black and “10 mg” printed on body in green, containing white to off white coloured powder.
Croatian: Želatinske tvrde kapsule veličine „3“ dugačke približno 15,4 mm do 16,2 mm, sa zelenom kapicom boje lista i neprozirnim bijelim tijelom, s crnim natpisom „LENALIDOMIDE“ na kapici i zelenim natpisom „10 mg“ na tijelu, koje sadrže bijeli do bjelkasti prašak.
English: • The need to use condoms if sexual partner is pregnant or a WCBP not using effective contraceptions (even if man has had a vasectomy)
Croatian: • potreba za uporabom prezervativa ako je partnerica trudna ili u reproduktivnoj dobi a ne primjenjuje djelotvornu metodu kontracepcije (čak i ako se muški partner podvrgnuo vazektomiji) o tijekom liječenja lijekom Lenalidomid Accord o tjedan dana nakon zadnje doze
English: Lenalidomide Accord 5 mg hard capsules EU/1/18/1316/003
Croatian: Lenalidomid Accord 5 mg tvrde kapsule EU/1/18/1316/003
English: NAME OF THE MEDICINAL PRODUCT Lenalidomide Accord 10 mg hard capsules lenalidomide
Croatian: Lenalidomid Accord 10 mg tvrde kapsule lenalidomid
English: NAME OF THE MEDICINAL PRODUCT Lenalidomide Accord 7.5 mg hard capsules lenalidomide
Croatian: Lenalidomid Accord 7,5 mg tvrde kapsule lenalidomid
English: This may lead to very serious infection.
Croatian: • oštećenje stijenke želuca ili crijeva, što može dovesti do vrlo ozbiljne infekcije.
English: Resume lenalidomide at next lower dose level
Croatian: U sljedećem ciklusu liječenje nastaviti pri sljedećoj nižoj razini doze
English: Leucopenias
Croatian: Trombocitopenija
English: Gelatin hard capsules size “5” approximately 11.0 mm to 11.8 mm in length, grey cap and opaque white body with “LENALIDOMIDE” printed on cap in black and “2.5 mg” printed on body in green, containing white to off white coloured powder.
Croatian: Želatinske tvrde kapsule veličine „5“ dugačke približno 11,0 mm do 11,8 mm, sa sivom kapicom i neprozirnim bijelim tijelom, s crnim natpisom „LENALIDOMIDE“ na kapici i zelenim natpisom „2.5 mg“ na tijelu, koje sadrže bijeli do bjelkasti prašak.
English: Gelatin hard capsules size “5” approximately 11.0 mm to 11.8 mm in length, opaque white cap and body with “LENALIDOMIDE” printed on cap in black and “5 mg” printed on body in green, containing white to off white coloured powder.
Croatian: Želatinske tvrde kapsule veličine „5“ dugačke približno 11,0 mm do 11,8 mm, s neprozirnom bijelom kapicom i tijelom, s crnim natpisom „LENALIDOMIDE“ na kapici i zelenim natpisom „5 mg“ na tijelu, koje sadrže bijeli do bjelkasti prašak.
English: Iron oxide red (E172) Iron oxide yellow (E172) Titanium dioxide (E171)
Croatian: Lenalidomid Accord 15 mg tvrde kapsule želatina željezov oksid, crveni (E172) željezov oksid, žuti (E172) titanijev dioksid (E171)
English: Tumour flare reaction
Croatian: Reakcija razbuktavanja tumora
English: capsule shell: gelatin, titanium dioxide (E171) printing ink: black and green ink (which contains shellac, propylene glycol, iron oxide black (E172), iron oxide yellow (E172), titanium dioxide (E171), indigo carmine (E132) and potassium hydroxide)
Croatian: - tinta za označavanje: crna i zelena tinta (koja sadrži šelak, propilenglikol, željezov oksid, crni (E172), željezov oksid, žuti (E172), titanijev dioksid (E171), indigo karmin (E132) i kalijev hidroksid)
English: Overall survival (months) Mediana OS time, months (95% CI)b
Croatian: PFS prema procjeni ispitivača (mjeseci) Medijana trajanja PFS-a, mjeseci (95 % CI)b
English: NAME OF THE MEDICINAL PRODUCT Lenalidomide Accord 25 mg hard capsules lenalidomide
Croatian: Lenalidomid Accord 25 mg tvrde kapsule lenalidomid
English: Grade 3−4 ADRs/Frequency
Croatian: Nuspojave lijeka 3. do 4. stupnja / učestalost
English: EU/1/18/1316/008 7x1 hard capsules EU/1/18/1316/009 21x1 hard capsules
Croatian: EU/1/18/1316/008 7x1 tvrda kapsula EU/1/18/1316/009 21x1 tvrda kapsula
English: • if you have any signs of an infection, such as a cough or fever
Croatian: • ako imate bilo kakve znakove infekcije kao što je kašalj ili vrućica
English: The median overall PFS was 44.4 months (39.6, 52.0) in the lenalidomide arm versus 23.8 months (95% CI 21.2, 27.3) in the placebo arm. For PFS2, the observed HR was 0.80 (95% CI 0.66, 0.98; p = 0.026) for lenalidomide versus placebo.
Croatian: Medijan ukupnog PFS-a bio je 44,4 mjeseci (39,6; 52,0) u skupini lenalidomida naspram 23,8 mjeseci (95 % CI 21,2; 27,3) u skupini placeba.
English: NAME OF THE MEDICINAL PRODUCT Lenalidomide Accord 2.5 mg hard capsules lenalidomide
Croatian: Lenalidomid Accord 2,5 mg tvrde kapsule lenalidomid
English: Iron oxide black (E172) Titanium dioxide (E171)
Croatian: Lenalidomid Accord 2,5 mg tvrde kapsule želatina željezov oksid, crni (E172) titanijev dioksid (E171)
English: EU/1/18/1316/006 7x1 hard capsules EU/1/18/1316/007 21x1 hard capsules
Croatian: EU/1/18/1316/006 7x1 tvrda kapsula EU/1/18/1316/007 21x1 tvrda kapsula
English: Lenalidomide maintenance after ASCT is associated with a higher frequency of grade 4 neutropenia compared to placebo maintenance (32.1% vs 26.7% [16.1% vs 1.8% after the start of maintenance treatment] in CALGB 100104 and 16.4% vs 0.7% in IFM 2005-02, respectively).
Croatian: naspram 26,7 % [16,1 % naspram 1,8 % nakon početka terapije održavanja] u ispitivanju CALGB 100104 i 16,4 % naspram 0,7 % u ispitivanju IFM 2005-02).
English: • Circulatory problems
Croatian: • problemi s krvotokom
English: EU/1/18/1316/003 7x1 hard capsules EU/1/18/1316/004 21x1 hard capsules
Croatian: EU/1/18/1316/003 7x1 tvrda kapsula EU/1/18/1316/004 21x1 tvrda kapsula
English: Lenalidomide Accord 5 mg and Lenalidomide Accord 25 mg hard capsules Gelatin
Croatian: Lenalidomid Accord 5 mg i Lenalidomid Accord 25 mg tvrde kapsule želatina titanijev dioksid (E171)
English: • Muscle weakness
Croatian: • slabost u mišićima
English: EU/1/18/1316/001 7x1 hard capsules EU/1/18/1316/002 21x1 hard capsules
Croatian: EU/1/18/1316/001 7x1 tvrda kapsula EU/1/18/1316/002 21x1 tvrda kapsula
English: Renal impairment
Croatian: Često vaskulitis
English: - capsule shell: gelatin, indigo carmine (E132), iron oxide yellow (E172) and titanium dioxide (E171) - printing ink: black and green ink (which contains shellac, propylene glycol, iron oxide black (E172), iron oxide yellow (E172), titanium dioxide (E171), indigo carmine (E132) and potassium hydroxide)
Croatian: • Drugi sastojci su: - sadržaj kapsule: laktoza, mikrokristalična celuloza, umrežena karmelozanatrij, koloidni bezvodni silicijev dioksid, magnezijev stearat. - ovojnica kapsule: želatina, indigo karmin (E132), željezov oksid, žuti (E172) i titanijev dioksid (E171) - tinta za označavanje: crna i zelena tinta (koja sadrži šelak, propilenglikol, željezov oksid, crni (E172), željezov oksid, žuti (E172), titanijev dioksid (E171), indigo karmin (E132) i kalijev hidroksid)
English: Neutropenia^,◊, Febrile neutropenia^,◊,
Croatian: Vrlo često neutropenija^,◊, febrilna neutropenija^,◊, trombocitopenija^,◊,, anemija,
English: NAME OF THE MEDICINAL PRODUCT Lenalidomide Accord 5 mg hard capsules lenalidomide
Croatian: Lenalidomid Accord 5 mg tvrde kapsule lenalidomid
English: NAME OF THE MEDICINAL PRODUCT Lenalidomide Accord 20 mg hard capsules 2.
Croatian: Lenalidomid Accord 20 mg tvrde kapsule:
English: capsule shell: gelatin, iron oxide red (E172), titanium dioxide (E171), indigo carmine (E132) printing ink: black and green ink (which contains shellac, propylene glycol, iron oxide black (E172), iron oxide yellow (E172), titanium dioxide (E171), indigo carmine (E132) and potassium hydroxide)
Croatian: • Drugi sastojci su: - sadržaj kapsule: laktoza, mikrokristalična celuloza, umrežena karmelozanatrij, koloidni bezvodni silicijev dioksid, magnezijev stearat. - ovojnica kapsule: želatina, željezov oksid, crveni (E172), titanijev dioksid (E171), indigo karmin (E132) - tinta za označavanje: crna i zelena tinta (koja sadrži šelak, propilenglikol, željezov oksid, crni (E172), željezov oksid, žuti (E172), titanijev dioksid (E171), indigo karmin (E132) i kalijev hidroksid)
English: • The other ingredients are: - capsule contents: lactose, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.
Croatian: • Drugi sastojci su: - sadržaj kapsule: laktoza, mikrokristalična celuloza, umrežena karmelozanatrij, koloidni bezvodni silicijev dioksid, magnezijev stearat. - ovojnica kapsule: želatina, željezov oksid, crni (E172), titanijev dioksid (E171)
English: It may harm them, even if their symptoms seem the same as yours.
Croatian: Može im naškoditi, čak i ako su njihovi znakovi bolesti jednaki Vašima.
English: The higher the dose, the higher the risks but all doses carry a risk.
Croatian: Što je veća doza, veći su i rizici, ali sve doze sa sobom nose rizik.
English: Key messages:
Croatian: Ključne poruke:
English: Important advice for women
Croatian: Važni savjeti za žene
English: Your doctor will discuss this with you but you must also follow the advice in section 2 of this leaflet.
Croatian: Vaš će liječnik razgovarati s Vama o tome, ali morate se također pridržavati i savjeta u dijelu 2. ove upute.
English: Pharmacist must ensure that
Croatian: Ljekarnik mora osigurati:
English: What you need to know before you take <invented name>
Croatian: Što morate znati prije nego počnete uzimati <Zaštićeno ime>
English: • It is estimated that up to 30-40% of preschool children whose mothers took valproate during pregnancy may have problems with early childhood development.
Croatian: • Procjenjuje se da bi do 30-40% djece predškolske dobi čije su majke uzimale valproat tijekom trudnoće moglo imati poteškoća u ranom razvoju.
English: [This sentence below should be adapted to National requirements] Make sure you read the patient guide that you will receive from your doctor.
Croatian: [Sljedeću rečenicu treba prilagoditi nacionalnim zahtjevima] Obavezno pročitajte vodič za bolesnice koji ćete dobiti od Vašeg liječnika.
English: • It can cause serious birth defects and can affect the way in which the child develops as it grows.
Croatian: • Može uzrokovati ozbiljne urođene mane i utjecati na to kako se dijete razvija dok raste.
English: <Invented name> is contraindicated in the following situations:
Croatian: <Zaštićeno ime> je kontraindiciran u sljedećim situacijama:
English: I AM TAKING <invented name> AND PLANNING TO HAVE A BABY
Croatian: UZIMAM <ZAŠTIĆENO IME> I PLANIRAM IMATI DIJETE
English: These conditions also concern women who are not currently sexually active unless the prescriber considers that there are compelling reasons to indicate that there is no risk of pregnancy.
Croatian: Ovi se uvjeti također odnose na žene koje trenutno nisu seksualno aktivne, osim ako liječnik smatra da postoje iznimni razlozi koji upućuju na to da nema rizika od trudnoće.
English: Your doctor will advise you further.
Croatian: Vaš liječnik će Vas savjetovati o daljnjim koracima.
English: Because valproate has been used for many years we know that in women who take valproate around 10 babies in every 100 will have birth defects.
Croatian: Budući da se valproat koristi već mnogo godina, znamo da će u žena liječenih valproatom približno 10 djece na svakih 100 rođenih imati urođene mane.
English: The daily dose should be divided into at least two single doses (see section 4.6).
Croatian: Dnevnu dozu treba podijeliti na najmanje dvije zasebne doze (vidjeti dio 4.6).
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Croatian: Nadležna tijela država članica mogu naknadno ažurirati informacije o lijeku, gdje je prikladno u suradnji s referentnom državom članicom, sukladno postupcima navedenima u poglavlju 4 Glave III Direktive 2001/83/EC.
English: If a woman plans a pregnancy
Croatian: Ako žena planira trudnoću
English: • Use the lowest effective dose and divide the daily dose of valproate into several small doses to be taken throughout the day.
Croatian: • Primijeniti najnižu djelotvornu dozu i podijeliti dnevnu dozu na nekoliko manjih doza koje se uzimaju tijekom dana.
English: At least one effective method of contraception (preferably a user independent form such as an intra-uterine device or implant) or two complementary forms of contraception including a barrier method should be used.
Croatian: Treba koristiti barem jednu učinkovitu metodu kontracepcije (po mogućnosti oblik kontracepcije neovisan o korisniku kao što je intrauterini uložak ili implantat) ili dva komplementarna oblika kontracepcije uključujući barijernu metodu.
English: Teratogenicity and Developmental Effects
Croatian: Teratogenost i učinci na razvoj
English: The risks of valproate when taken during pregnancy (irrespective of the disease for which valproate is used)
Croatian: Rizici valproata kad se uzima tijekom trudnoće (bez obzira na bolest za koju se koristi valproat)
English: <Invented name> , <INN> can seriously harm an unborn child when taken during pregnancy.
Croatian: <Zaštićeno ime>, <INN> može ozbiljno naštetiti nerođenom djetetu ako se uzima tijekom trudnoće.
English: Your specialist can put several actions in place so that your pregnancy goes as smoothly as possible and any risks to you and your unborn child are reduced as much as possible.
Croatian: Vaš liječnik specijalist može poduzeti više mjera koje će omogućiti da trudnoća prođe što jednostavnije i da se što više smanje rizici za Vas i Vaše nerođeno dijete.
English: Your doctor will advise you further (see below under “Pregnancy, breast-feeding and fertility - Important advice for women”).
Croatian: Vaš liječnik će Vas savjetovati o daljnjim koracima (vidjeti dio ispod „Trudnoća, dojenje i plodnost - Važni savjeti za žene“).
English: • Valproate carries a risk if taken during pregnancy.
Croatian: • Valproat nosi rizike ako se uzima u trudnoći.
English: If this is the first time you have been prescribed <Invented name> your doctor will have explained the risks to an unborn child if you become pregnant.
Croatian: Ako je ovo prvi put da Vam je propisan <Zaštićeno ime>, liječnik Vam je objasnio rizike za nerođeno dijete ako zatrudnite.
English: • Before prescribing this medicine to you, your doctor will have explained what might happen to your baby if you become pregnant whilst taking valproate.
Croatian: • Prije nego što Vam propiše ovaj lijek, liječnik će Vam objasniti što bi se moglo dogoditi Vašem djetetu ako zatrudnite dok uzimate valproat.
English: Children affected can be slow to walk and talk , intellectually less able than other children, and have difficulty with language and memory.
Croatian: Ta će djeca možda kasnije prohodati i progovoriti, mogu imati manje razvijene intelektualne sposobnosti od ostale djece te poteškoće s jezičnim vještinama i pamćenjem.
English: Treatment of epilepsy
Croatian: Liječenje epilepsije
English: [Quick Response (QR) code: A QR code should be included in the packaging material and/or the package leaflet, and its location should take into account the overall readability.]
Croatian: Quick Response code): QR kod treba biti sadržan na pakiranju i/ili uputi o lijeku, a kod njegove lokacije treba uzeti u obzir ukupnu čitljivost.]
English: • If you have any further questions, ask your doctor or pharmacist.
Croatian: • Ako imate dodatnih pitanja, obratite se Vašem liječniku ili ljekarniku.
English: Even if she has amenorrhea she must follow all the advice on effective contraception.
Croatian: Čak i ako bolesnica ima amenoreju mora slijediti sve savjete o učinkovitoj kontracepciji.
English: Talk to your doctor or family planning clinic if you need advice on contraception.
Croatian: Razgovarajte s Vašim liječnikom ili otiđite u centar za planiranje obitelji ako trebate savjet o kontracepciji.
English: You can also report side effects directly via the national reporting system listed in Appendix V*.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V*.
English: <Invented name> is contraindicated in the following situations: Treatment of epilepsy
Croatian: <Zaštićeno ime> je kontraindiciran u sljedećim situacijama: Liječenje epilepsije
English: How to take <invented name>
Croatian: Kako uzimati <Zaštićeno ime>
English: If valproate is the only suitable treatment, the need for using effective contraception and all other conditions of pregnancy prevention programme should be discussed.
Croatian: Ako je liječenje valproatom jedino odgovarajuće, potrebno je razgovarati o potrebi korištenja učinkovite kontracepcije i o svim drugim uvjetima programa prevencije trudnoće.
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 urođene mane uključuju rascjep kralježnice (spina bifida; stanje kod kojega kosti kralježnice nisu pravilno razvijene); malformacije (poremećaj oblika) lica i lubanje; malformacije srca, bubrega, mokraćnih putova i spolnih organa; oštećenje udova.
English: If switching is not possible, the woman should receive further counselling regarding the valproate risks for the unborn child to support her informed decision making regarding family planning.
Croatian: Ako prebacivanje nije moguće, ženu se mora dodatno savjetovati vezano uz rizik koji korištenje valproata predstavlja za nerođeno dijete, a kako bi se podržala njezina informirana odluka o planiranju obitelji.
English: The use of a prolonged release formulation may be preferable to other treatment formulations in order to avoid high peak plasma concentrations (see section
Croatian: Formulacija s produljenim oslobađanjem mogla bi biti pogodnija za liječenje od ostalih formulacija kako bi se izbjegle visoke vršne koncentracije u plazmi (vidjeti dio 4.2)
English: MAHs of all valproate and related substances containing products authorised in the EU should amend the product information (insertion, replacement or deletion of the text, as appropriate) to reflect the wording as provided below, and in conjunction to the Scientific conclusions:
Croatian: Nositelji odobrenja u EU za sve lijekove koji sadrže valproat i povezane tvari trebaju izmijeniti informacije o lijeku (po potrebi umetnuti, zamijeniti ili izbrisati tekst) kako bi odgovarale tekstu navedenom u nastavku, a u skladu sa znanstvenim zaključcima:
English: • Tell your doctor if you want to have a baby.
Croatian: • Obavijestite Vašeg liječnika ako želite imati dijete.
English: In the exceptional circumstances when <Invented name> is the only available treatment option during pregnancy, you will be monitored very closely both for the management of your underlying condition and to check how your unborn child is developing.
Croatian: U iznimnim okolnostima kad je <Zaštićeno ime> jedina dostupna mogućnost liječenja tijekom trudnoće, bit ćete pod pomnim nadzorom radi liječenja Vaše osnovne bolesti i provjere razvoja Vašeg nerođenog djeteta.
English: If you are planning to have a baby, first schedule an appointment with your doctor.
Croatian: Ako planirate imati dijete, prvo posjetite liječnika.
English: However the available evidence does not suggest it prevents the birth defects or malformations due to valproate exposure.
Croatian: Međutim, dostupni podaci ne ukazuju da ona sprječava urođene mane ili malformacije uzrokovane izlaganjem valproatu.
English: These patients must be provided with comprehensive information on pregnancy prevention and should be referred for contraceptive advice if they are not using effective contraception.
Croatian: Bolesnicama se moraju osigurati sveobuhvatne informacije o prevenciji trudnoće te ih treba uputiti da zatraže savjet o kontracepciji ako ne koriste učinkovitu kontracepciju.