FrancophonIA/ELRC3.0 huggingface dataset:
English: The PRAC recommended the improvement of a HCP guide to make sure that valproate prescribers are aware of the risks associated with the use of this product in female children, women of childbearing potential and pregnant women and requested that the patients are also informed about these risks appropriately.
Croatian: PRAC je preporučio da se vodič za zdravstvene radnike poboljša kako bi se zajamčilo da su liječnici koji propisuju valproat svjesni rizika povezanih s primjenom ovog lijeka u djevojčica, žena u reproduktivnoj dobi i trudnica te je zatražio da se i bolesnice na odgovarajući način obavijesti o tim rizicima.
English: The CMDh therefore clarified that the amendments to the product information and the other routine measures to inform on the risk to the foetus when valproate is taken in pregnancy to all Healthcare professionals (HCP) and patients are applicable to all medicinal products containing valproate and related substances, irrespective of the route of administration.
Croatian: Stoga je CMDh pojasnio da su izmjene informacija o lijeku i druge rutinske mjere kojima se svi zdravstveni radnici i bolesnice obavještavaju o rizicima za fetus prilikom primjene valproata za vrijeme trudnoće primjenjive na sve lijekove koji sadrže valproat i povezane tvari, bez obzira na put primjene.
English: The CMDh acknowledges correspondence received from a MAH (Laboratoires Aguettant, France) of medicinal products containing valproate injectable (intravenous; IV) formulations, and requesting further clarity for the implementation of the pharmacovigilance activities and risk minimization measures adopted by the PRAC for these IV formulation indicated for the temporary management of epilepsy when administration via oral route is not possible.
Croatian: CMDh potvrđuje primitak dopisa nositelja odobrenja za stavljanje lijeka u promet (Laboratoires Aguettant, Francuska) o lijekovima koji sadrže formulacije za ubrizgavanje valproata injekcijom (intravenske formulacije) u kojem se traži dodatno pojašnjenje u pogledu provedbe farmakovigilancijskih aktivnosti i mjera minimizacije rizika koje je PRAC donio za te intravenske formulacije indicirane za privremeno liječenje epilepsije kada peroralna primjena nije moguća.
English: Therefore, the adapted PASS study on the drug utilisation, the two surveys targeting HCPs or patients, the PASS from registries in order to characterise the foetal anticonvulsant syndrome in children with anti-epileptic drugs in utero exposure, the retrospective observational study on the association between paternal exposure to valproate and the risk of congenital anomalies and neurodevelopmental disorders including autism in offspring and, the observational study to evaluate and identify the best practice for discontinuation and switching of valproate treatment, are not applicable to the injectable formulations.
Croatian: Stoga se na injektabilne formulacije ne primjenjuju prilagođeno ispitivanje PASS o potrošnji lijeka, dva anketiranja zdravstvenih radnika ili bolesnica, ispitivanje PASS na temelju registara s ciljem karakterizacije fetalnog antikonvulzivnog sindroma u djece prilikom in utero izlaganja antiepilepticima, retrospektivno opservacijsko ispitivanje povezanosti izlaganja očeva valproatu i rizika od kongenitalnih anomalija i neurorazvojnih poremećaja, uključujući autizam u potomstva, te opservacijsko ispitivanje kojem je cilj ocijeniti i utvrditi najbolju praksu za prekid liječenja valproatom i prelazak na drugu terapiju.
English: The MAH requests CMDh to clarify the implementation of the PRAC outcome for injectable forms by further differentiating the routine/additional risk minimization activities to be considered for the noninjectable products and those also applicable to the injectable products.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet traži od CMDh-a da pojasni provedbu zaključka PRAC-a u pogledu injektabilnih oblika lijeka tako da se napravi dodatna razlika između rutinskih/dodatnih aktivnosti minimizacije rizika koje treba razmotriti za lijekove koji nisu injektabilni i aktivnosti primjenjivih na injektabilne lijekove.
English: The current ongoing drug utilisation study (DUS) should be adapted and continued to assess the effectiveness of the updated risk minimisation measures including the pregnancy prevention programme conditions and to further characterise the prescribing patterns for valproate.
Croatian: Ispitivanje potrošnje lijeka koje je u tijeku treba prilagoditi i nastaviti kako bi se ocijenila učinkovitost ažuriranih mjera minimizacije rizika, uključujući uvjete iz programa prevencije trudnoće, te kako bi se dodatno opisali načini propisivanja valproata.
English: Indeed, the HCP guide will provide a reminder to the HCP of the conditions that apply for the administration of valproate (e.g. pregnancy prevention plan), the need to discuss the risks with the patient and check her pregnancy status.
Croatian: Naime, u vodiču za zdravstvene radnike nalazit će se podsjetnik zdravstvenim radnicima o uvjetima koji su primjenjivi u slučaju primjene valproata (npr. plan prevencije trudnoće) te o potrebi da se s bolesnicom razgovara o rizicima i provjeri status trudnoće.
English: In view of the above, the Committee considers that the benefit-risk balance of medicinal products containing substances related to valproate remains favourable subject to the agreed conditions to the marketing authorisations, and taking into account the agreed amendments to the product information and other risk minimisation measures.
Croatian: S obzirom na prethodno navedeno, Odbor smatra da je omjer koristi i rizika za lijekove koji sadrže tvari povezane s valproatom i dalje povoljan, uz pridržavanje dogovorenih uvjeta odobrenja za stavljanje lijeka u promet i uzimajući u obzir dogovorene izmjene informacija o lijeku i druge mjere minimizacije rizika.
English: In addition, the guide should familiarise the prescribers with key actions to mitigate the risks associated with the use of valproate in exposed girls and women by using the patient guide and the risk acknowledgment form.
Croatian: Osim toga, vodič treba upoznati liječnike koji propisuju lijek s ključnim mjerama za ublažavanje rizika povezanih s primjenom valproata u djevojaka i žena izloženih riziku, a to uključuje vodič za bolesnice i obrazac potvrde o upoznatosti s rizikom.
English: In view of the above, the PRAC recommended amendments to the product information, in particular to contraindicate its use to women of childbearing potential that do not fulfil the conditions of a pregnancy prevention program, and communication to healthcare professionals through a direct healthcare professional communication (DHPC).
Croatian: Uzimajući u obzir prethodno navedene činjenice, PRAC je preporučio izmjene informacija o lijeku, ponajprije kako bi primjena lijeka bila kontraindicirana u žena u reproduktivnoj dobi koje ne ispunjavaju uvjete programa prevencije trudnoće, te radi komunikacije sa zdravstvenim radnicima putem Pisma zdravstvenim radnicima (DHPC).
English: A post-authorisation safety study (PASS) using data preferably from existing registries should be performed to further characterise the foetal anticonvulsant syndrome in children with valproate in utero exposure as compared to other anti-epileptic drugs.
Croatian: Treba provesti ispitivanje sigurnosti primjene lijeka nakon dobivanja odobrenja za stavljanje lijeka u promet (PASS), po mogućnosti na temelju podataka iz postojećih registara s ciljem dodatne karakterizacije fetalnog antikonvulzivnog sindroma u djece prilikom in utero izlaganja valproatu u usporedbi s drugim antiepilepticima.
English: The annual risk acknowledgement form for injectable formulations of valproate and related substances containing products is intended to act as a periodic reminder and acknowledgement of the risks of valproate for women of childbearing potential (WCBP).
Croatian: Godišnji obrazac potvrde o upoznatosti s rizikom za injektabilne formulacije lijekova koji sadrže valproat i povezane tvari treba služiti kao povremeni podsjetnik i potvrda o upoznatosti s rizicima primjene valproata u žena u reproduktivnoj dobi.
English: For the female patients, there may be situations in which valproate treatment is initiated with the IV formulation (before discharge on valproate oral administration).
Croatian: Moguće su situacije kada će liječenje bolesnica valproatom započeti intravenskom formulacijom (prije prelaska na propisanu peroralnu primjenu).
English: Additionally, as the IV valproate formulations will likely be administered by different HCPs than the usual treating physicians, having a HCP guide in place for these products is crucial and therefore such HCP guide will also be provided to prescribers of IV formulation of valproate containing products.
Croatian: Nadalje, kako je vjerojatno da će intravenske formulacije valproata primjenjivati zdravstveni radnici koji nisu liječnici koji obično provode liječenje, od ključne je važnosti da za te lijekove postoji vodič za zdravstvene radnike i stoga će se vodič za zdravstvene radnike dostaviti i propisivačima intravenskih formulacija lijekova koji sadrže valproat.
English: Therefore the CMDh recommends the variation to the terms of the marketing authorisations for medicinal products containing substances related to valproate.
Croatian: Stoga CMDh preporučuje izmjene uvjeta odobrenja za stavljanje u promet lijekova koji sadrže tvari povezane s valproatom.
English: In addition, the PRAC considered the views of patient organisations, patients, families and carers, and the views of healthcare professionals in a public hearing and dedicated meeting.
Croatian: Osim toga, PRAC je na javnoj raspravi i posebnom sastanku razmotrio stajališta organizacija bolesnika, bolesnika, obitelji i skrbnika, te mišljenja zdravstvenih radnika.
English: This patient card should be attached at the outer carton to prompt as a reminder the discussion between the pharmacist and the patient at the time of the product dispensing.
Croatian: Kartica za bolesnika treba biti pričvršćena za vanjsko pakiranje lijeka kako bi se potaknuo razgovor između ljekarnika i bolesnice prilikom izdavanja lijeka.
English: Regarding the visual reminder on the outer packaging, it is considered that it is crucial to remind to the HCPs that valproate should not be administered to women of childbearing potential (WCBP) who do not fulfil the pregnancy prevention plan requirements, or to pregnant patients, thus initiating a discussion about the risks of valproate with the patient.
Croatian: U pogledu vizualnog podsjetnika na vanjskom pakiranju lijeka, smatra se da je bitno podsjetiti zdravstvene radnike da se valproat ne smije primjenjivati u žena u reproduktivnoj dobi koje ne ispunjavaju uvjete iz plana prevencije trudnoće ni u trudnih bolesnica, čime se potiče razgovor s bolesnicom o rizicima primjene valproata.
English: The MAHs are strongly encouraged to collaborate on the requested measures and to perform joint studies.
Croatian: Nositelje odobrenja za stavljanje lijeka u promet snažno se potiče na suradnju u pogledu traženih mjera i provođenje zajedničkih ispitivanja.
English: In cases of patients for whom treatment is initiated with IV valproate formulations and then transferred to oral forms of valproate products, the patient card will be disclosed at the time of dispensing the oral valproate-containing products.
Croatian: Bolesnicama u kojih se započelo s liječenjem intravenskim formulacijama valproata te potom prešlo na oblike lijekova koji sadrže valproat za peroralnu primjenu, kartica za bolesnika uručit će se prilikom izdavanja lijekova za peroralnu primjenu.
English: The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for medicinal products containing substances related to valproate.
Croatian: Odbor je, slijedom toga, preporučio izmjene uvjeta odobrenja za stavljanje u promet lijekova koji sadrže tvari povezane s valproatom.
English: • For their use in pregnancy for the treatment of epilepsy, the PRAC concluded that these medicinal products are contraindicated unless there is no suitable alternative treatment option.
Croatian: • PRAC je zaključio da je primjena predmetnih lijekova u liječenju epilepsije za vrijeme trudnoće kontraindicirana, osim u slučajevima u kojima ne postoji odgovarajuća mogućnost alternativnog liječenja.
English: The CMDh, as a consequence, considers that the benefit-risk balance of medicinal products containing substances related to valproate remains favourable subject to the amendments to the product information and to the conditions described above.
Croatian: Slijedom toga, CMDh smatra da je omjer koristi i rizika lijekova koji sadrže tvari povezane s valproatom i dalje povoljan, uz izmjene informacija o lijeku i pod prethodno opisanim uvjetima.
English: • In addition, the PRAC recommended other changes to the product information such as warnings and precautions for use and updated information on the risks related to exposure during pregnancy to better inform the healthcare professionals and patients.
Croatian: • Osim toga, PRAC je radi boljeg informiranja zdravstvenih radnika i bolesnica preporučio druge izmjene informacija o lijeku poput upozorenja i mjera opreza pri uporabi te ažuriranja informacija o rizicima povezanima s izlaganjem za vrijeme trudnoće.
English: • The PRAC also concluded that there was a need to update the educational materials aimed to fully inform patients and healthcare professionals on the risks to the unborn child when exposed in utero to valproate, and to implement some further risk minimisation measures such as a visual reminder on the outer packaging, a patient card and an acknowledgment form to raise awareness about the risks and the need for contraception.
Croatian: • Kako bi se podigla razina osviještenosti u pogledu rizika i potrebe za kontracepcijom, PRAC je također zaključio da je potrebno ažurirati edukacijske materijale kojima je cilj u cijelosti informirati bolesnice i zdravstvene radnike o rizicima za nerođeno dijete prilikom in utero izlaganja valproatu, te provesti dodatne mjere minimizacije rizika, kao što su vizualni podsjetnik na vanjskom pakiranju lijeka, kartica za bolesnika i obrazac potvrde.
English: A survey among HCP to assess their knowledge and behaviour with regard to the new product information restrictions and whether they received the direct healthcare professional communication (DHPC) and educational materials, and another survey among patients to assess the receipt of the educational materials should be performed.
Croatian: Potrebno je anketirati zdravstvene radnike kako bi se ocijenilo njihovo poznavanje novih ograničenja iz informacija o lijeku i postupanje, te provjerilo jesu li primili Pismo zdravstvenim radnicima (DHPC) i edukacijske materijale.
English: This was not shown for teratogenic effects as malformations in the first generation offspring was not observed in the second and third generation offspring (Choi et al, 2016)2.
Croatian: zabilježene u drugoj i trećoj generaciji (Choi et al, 2016.)2.
English: Jia H, Morris CD, Williams RM, Loring JF, Thomas EA. HDAC inhibition imparts beneficial transgenerational effects in Huntington's disease mice via altered DNA and histone methylation.
Croatian: HDAC inhibition imparts beneficial transgenerational effects in Huntington's disease mice via altered DNA and histone methylation.
English: Educational measures are necessary in order to ensure that healthcare professionals and patients are informed about the risks associated with valproate in http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Valproate_and_related_substa nces/human_referral_prac_000032.jsp&mid=WC0b01ac05805c516f pregnant women and women of childbearing potential and on the measures necessary to minimise the risk of exposure on valproate in pregnancy.
Croatian: Neophodne su edukacijske mjere kako bi se zajamčila obaviještenost zdravstvenih radnika i bolesnica o rizicima povezanima s primjenom valproata u trudnica i žena u reproduktivnoj dobi te o potrebnim mjerama minimizacije rizika od izloženosti valproatu za vrijeme trudnoće.
English: valproate indeed may induce transgenerational alterations of gene expression to the offspring and the types of consequent effects.
Croatian: PRAC smatra da su potrebna dodatna istraživanja kako bi se utvrdilo može li valproat zaista izazvati transgeneracijske promjene ekspresije gena u potomstvu, te vrste učinaka koji nastaju kao posljedica toga.
English: In addition in an effort to increase the knowledge on the association between paternal exposure to valproate and the risk of congenital anomalies and neurodevelopmental disorders including autism in offspring, a retrospective observational study is recommended.
Croatian: Osim toga, preporučuje se provođenje retrospektivnog opservacijskog ispitivanja kako bi se bolje razumjela povezanost između izlaganja očeva valproatu i rizika od kongenitalnih anomalija i neurorazvojnih poremećaja, uključujući autizam u potomstva.
English: PRAC also recommended postauthorisation studies to assess the effectiveness of the risk minimisation measures.
Croatian: Kako bi se ocijenila učinkovitost mjera minimizacije rizika, PRAC je također preporučio provođenje ispitivanja nakon davanja odobrenja.
English: EU/1/01/177/002 SonoVue
Croatian: EU/1/01/177/0
English: solvent: 5 ml
Croatian: Otapalo: 5 ml
English: 1 vial + 1 pre-filled syringe + 1 'MiniSpike' rec. device
Croatian: 1 bočica + 1 napunjena štrcaljka + 1 'MiniSpike' sustav prijenosa
English: Powder and solvent for dispersion for injection
Croatian: 8 µl/ml prašak i otapalo za disperziju za injekciju
English: Intravenous use, Intravesical use powder: vial (glass); solvent: pre-filled syringe (glass)
Croatian: Prašak:bočica (staklo), Otapalo; napunjena štrcaljka
English: Pack size
Croatian: SonoVue
English: (× 0.85 for female patients)
Croatian: (× 0,85 za bolesnice)
English: Swallow the capsule whole with water.
Croatian: Kapsulu progutajte cijelu s vodom.
English: • alcohol.
Croatian: • alkohol
English: BID or TID BID or TID Once daily or BID Once daily
Croatian: BID ili TID BID ili TID jednom dnevno ili BID jednom dnevno
English: + Supplementary dose is a single additional dose.
Croatian: + Dopunska doza je jedna dodatna doza.
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 February 2017.
Croatian: Datum prvog odobrenja: 27. veljače 2017.
English: Single dose +
Croatian: jedna doza+
English: These symptoms may occur more commonly or severely if you have been taking pregabalin for a longer period of time.
Croatian: Ti simptomi mogu biti češći ili ozbiljniji ako ste pregabalin uzimali dulje vrijeme.
English: • lorazepam (used for treating anxiety).
Croatian: • lorazepam (koristi se za liječenje tjeskobe)
English: Pregabalin should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus).
Croatian: Pregabalin se ne smije primjenjivati tijekom trudnoće, osim ako to nije neophodno (ako korist liječenja za majku jasno nadilazi mogući rizik za plod).
English: This should be considered when prescribing pregabalin in this condition.
Croatian: Ovo je potrebno razmotriti prilikom propisivanja pregabalina u ovom stanju.
English: • Some patients taking pregabalin have reported symptoms suggesting an allergic reaction.
Croatian: • Neki bolesnici koji su uzimali pregabalin prijavili su simptome koji ukazuju na alergijsku reakciju.
English: 1.23 × [140 - age (years)] × weight (kg) serum creatinine (µmol/l)
Croatian: 1,23 × [140 - dob (godine)] × težina (kg) kreatinin u serumu (µmol/l)
English: BID = Two divided doses.
Croatian: BID = podijeljeno u 2 doze.
English: Very common: may affect more than 1 in 10 people • Dizziness, drowsiness, headache.
Croatian: Vrlo česte: mogu se javiti u više od 1 na 10 osoba • omaglica, omamljenost, glavobolja
English: Angioedema, allergic reaction
Croatian: Rijetko angioedem, alergijska reakcija
English: The dose, which has been adjusted for you and your condition, will generally be between 150 mg and 600 mg each day.
Croatian: Doza, koja je prilagođena Vama i Vašoj bolesti, u pravilu će iznositi između 150 mg i 600 mg svakoga dana.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PAPER FOLDING BOX
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KARTONSKA KUTIJA
English: B-dul Theodor Pallady nr.50, sector 3, Bucharest, cod 032266 Romania
Croatian: B-dul Theodor Pallady nr.50, sector 3, Bukurešt, cod 032266
English: Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim problemima nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi trebali uzimati ovaj lijek.
English: TID = Three divided doses.
Croatian: TID = podijeljeno u 3 doze.
English: Therefore, you should be careful until you are used to any effect the medicine might have.
Croatian: Stoga morate biti oprezni dok se ne naviknete na sve moguće učinke lijeka.
English: Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications.
Croatian: Suicidalne ideje i ponašanje prijavljeni su u bolesnika liječenih antiepilepticima u nekoliko indikacija.
English: Pregabalin binds to an auxiliary subunit (α2-δ protein) of voltage-gated calcium channels in the central nervous system.
Croatian: Pregabalin se veže na pomoćnu podjedinicu (α2-δ protein) na električni napon osjetljivih kalcijevih kanala u središnjem živčanom sustavu.
English: Pregabalin terminal half-life averaged about 3 to 4 hours in paediatric patients up to 6 years of age, and 4 to 6 hours in those 7 years of age and older.
Croatian: Terminalni poluvijek pregabalina bio je prosječno 3 do 4 sata u pedijatrijskih bolesnika u dobi do 6 godina, a 4 do 6 sati u onih u dobi od 7 godina ili starijih.
English: Pregabalin oral bioavailability is estimated to be ≥ 90% and is independent of dose.
Croatian: Procjenjuje se da bioraspoloživost peroralno primijenjenog pregabalina iznosi ≥ 90% i ne ovisi o dozi.
English: Pregabalin pharmacokinetics in patients younger than 3 months old have not been studied (see sections 4.2, 4.8 and 5.1).
Croatian: Farmakokinetika pregabalina u bolesnika mlađih od 3 mjeseca nije ispitana (vidjeti dijelove 4.2, 4.8 i 5.1).
English: The active substance, pregabalin, is a gamma-aminobutyric acid analogue [(S)-3-(aminomethyl)-5methylhexanoic acid].
Croatian: Djelatna tvar je pregabalin, analog gama-aminomaslačne kiseline [(S)-3-(aminometil)-5metilheksanoična kiselina].
English: The rate of pregabalin absorption is decreased when given with food resulting in a decrease in Cmax by approximately 25 - 30% and a delay in tmax to approximately 2.5 hours.
Croatian: Brzina apsorpcije pregabalina smanjuje se kada se lijek primjenjuje s hranom, što dovodi do smanjenja Cmax za približno 25-30%, dok je tmax odgođen na približno 2,5 sata.
English: • Coldness of hands and feet.
Croatian: • hladnoća šaka i stopala
English: Peripheral and central neuropathic pain, epilepsy or generalised anxiety disorder Take the number of hard capsules as instructed by your doctor.
Croatian: Periferna i centralna neuropatska bol, epilepsija ili generalizirani anksiozni poremećaj Uzmite onoliko tvrdih kapsula koliko Vam je odredio liječnik.
English: The AUC was lower by 30% in paediatric patients below a weight of 30 kg due to an increased body weight adjusted clearance of 43% for these patients in comparison to patients weighing ≥ 30 kg.
Croatian: AUC je bio niži za 30% u pedijatrijskih bolesnika tjelesne težine manje od 30 kg zbog povećanog klirensa prilagođenog tjelesnoj težini od 43% za te bolesnike u odnosu na bolesnike tjelesne težine ≥30 kg.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijava nuspojava: navedenog u Dodatku V.