FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT FORSTEO 20 micrograms/80 microliters solution for injection in pre-filled pen
Croatian: NAZIV LIJEKA FORSTEO 20 mikrograma/80 mikrolitara otopina za injekciju u napunjenoj brizgalici
English: Glucocorticoid-induced osteoporosis
Croatian: Osteoporoza izazvana glukokortikoidima
English: Uncommon: Myalgia, arthralgia, back cramp/pain* Renal and urinary disorders
Croatian: Manje često: mialgija, artralgija, grč/bol u leđima* Poremećaji bubrega i mokraćnog sustava
English: • accidental loss or leakage of urine
Croatian: • nehotično ispuštanje mokraće • pojačan nagon na mokrenje
English: How to use FORSTEO
Croatian: Kako primjenjivati FORSTEO
English: Cleaning Your FORSTEO
Croatian: Čišćenje FORSTEO brizgalice
English: Do not use FORSTEO if you are pregnant or breast-feeding.
Croatian: Nemojte primjenjivati FORSTEO ako ste trudni ili dojite.
English: Baseline spinal and femoral neck bone mineral density mean T-scores were -2.2 and -2.1, respectively.
Croatian: Početna prosječna T-vrijednost mineralne gustoće kosti bila je -2,2 za kralježnicu, a -2,1 za vrat bedrene kosti.
English: • tiredness
Croatian: • nesvjestica
English: Icepharma hf. Sími: + 354 540 8000
Croatian: Sími: + 354 540 80 00
English: Name and address of the manufacturer responsible for batch release
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: The most commonly reported adverse reactions in patients treated with FORSTEO are nausea, pain in limb, headache and dizziness.
Croatian: Najčešće prijavljene nuspojave u bolesnika liječenih lijekom FORSTEO su mučnina, bol u udovima,
English: Eli Lilly Ges.
Croatian: Eli Lilly Norge A.S.
English: Troubleshooting
Croatian: Dojenje
English: FORSTEO is a bone formation agent to treat osteoporosis.
Croatian: Farmakodinamički učinci FORSTEO je lijek koji djeluje na stvaranje kosti te tako liječi osteoporozu.
English: Eli Lilly Nederland B.V. Tel: + 31(0) 30 6025800
Croatian: Eli Lilly farmacevtska družba, d.o.o Tel: +386 (0)1 580 00 10
English: Metacresol
Croatian: • zaduha
English: Storing Your FORSTEO
Croatian: Čuvanje FORSTEO brizgalice
English: Uncommon: Tachycardia
Croatian: Često: palpitacije Manje često: tahikardija
English: vertigo, nausea, pain in limb, dizziness, depression, dyspnoea.
Croatian: U kliničkim su ispitivanjima sljedeće nuspojave zabilježene uz razliku učestalosti od ≥ 1% kod primjene lijeka FORSTEO u odnosu na placebo: vrtoglavica, mučnina, bol u udovima, omaglica, depresija, dispneja.
English: FORSTEO 20 micrograms (µg)/ 80 microlitres solution for injection, in pre-filled pen Instructions for use
Croatian: Forsteo FORSTEO 20 mikrograma (µg)/ 80 mikrolitara otopina za injekciju u napunjenoj brizgalici
English: • increased heart rate
Croatian: • ubrzano kucanje srca
English: • increased sweating
Croatian: • pojačano znojenje • grčevi mišića
English: 5 How to store FORSTEO Content of the pack and other information
Croatian: Kako FORSTEO izgleda i sadržaj pakiranja
English: Common: Muscle cramps
Croatian: Često: grčevi mišića
English: In patients treated with teriparatide, lumbar spine, total hip and femoral neck BMD increased between 18 and 24 months by an additional 1.7 %, 0.9 %, and 0.4 %, respectively.
Croatian: lumbalnog dijela kralježnice povećao za 1,7%, BMD cijelog kuka za 0,9%, a BMD vrata bedrene kosti za 0,4%.
English: Film-coated tablet Oral use
Croatian: Put primjene Unutarnje pakovanje
English: (Invented) name Strength Pharmaceutical form Route of administration
Croatian: Doza Farmaceutski oblik
English: You may need urgent medical treatment.
Croatian: Možda će Vam biti potrebno hitno medicinsko liječenje.
English: Talk to your doctor before taking {Drug name}:
Croatian: Razgovarajte sa svojim liječnikom prije uzimanja {naziv lijeka}:
English: Remember to also mention any other ill-effects like pain in your joints.
Croatian: Sjetite se spomenuti i bilo koje druge štetne učinke poput boli u zglobovima.
English: Adopted at the 6-9 July 2015 PRAC
Croatian: Usvojeno na sjednici PRAC-a 6. - 9. srpnja
English: • Muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell, have a high temperature or have dark urine.
Croatian: • Mišićna slabost, osjetljivost ili bol, a posebice ako se istovremeno ne osjećate dobro, imate visoku temperaturu ili tamni urin.
English: • if you have ever had a skin reaction after treatment with a medicine similar to {Drug name} that reduces stomach acid.
Croatian: • ako ste ikad imali kožnu reakciju nakon terapije s lijekom sličnim {naziv lijeka} koji smanjuje želučanu kiselinu.
English: Proton pump inhibitors are associated with very infrequent cases of SCLE.
Croatian: Inhibitori protonske pumpe povezani su s vrlo rijetkim slučajevima SCLE-a.
English: Donepezil - Rhabdomyolysis (EPITT no 18261)
Croatian: Donepazil - rabdomioliza (EPITT br. 18261)
English: Dexlansoprazole; esomeprazole; lansoprazole; omeprazole; pantoprazole; rabeprazole - Subacute cutaneous lupus erythematosus (EPITT no 18119)
Croatian: Dekslanzoprazol; esomeprazol2; lanzoprazol; omeprazol; pantoprazol; rabeprazol - subakutni kožni lupus eritematodes (EPITT br. 18119)
English: They may be caused by an abnormal muscle breakdown which can be life threatening and lead to kidney problems (a condition called rhabdomyolysis).
Croatian: To može biti uzrokovano abnormalnom razgradnjom mišića koja može biti opasna po život i dovesti do problema s bubrezima (stanje koje se zove rabdomioliza).
English: EMA/PRAC/450962/2015
Croatian: EMA/PRAC/522624/2015 Corr1,2
English: The product information wording in this document is extracted from the document entitled ‘PRAC recommendations on signals' which contains the whole text of the PRAC recommendations for product information update, as well as some general guidance on the handling of signals.
Croatian: Tekst informacija o lijeku u ovom dokumentu preuzet je iz dokumenta naziva "Preporuke PRAC-a vezane uz signale" koje sadrže cijeli tekst o preporukama PRAC-a za ažuriranje informacija o lijeku kao i opću smjernicu o upravljanju signalima.
English: Musculoskeletal, connective tissue and bone disorders Frequency ‘very rare': Rhabdomyolysis* (To be inserted in the table footnote): * Rhabdomyolysis has been reported to occur independently of neuroleptic malignant syndrome and in close temporal association with donepezil initiation or dose increase.
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Učestalost „vrlo rijetko": Rabdomioliza* (Za umetnuti u fusnotu tablice): *Prijavljeno je da rabdomioliza nastupa neovisno o neuroleptičkom malignom sindromu te je usko vremenski povezana s početkom liječenja donepezilom ili povećanjem doze.
English: If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with {Drug name}.
Croatian: Ako dobijete osip na koži, posebice na područjima izloženima suncu obavijestite svojeg liječnika što je prije moguće, jer ćete možda morati prekinuti liječenje {naziv lijeka}.
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/450962/2015
Croatian: Tekst novih informacija o lijeku - izvadak iz preporuka PRAC-a vezanih uz signale EMA/PRAC/522624/2015
English: Section 2: What you need to know before you take {Drug name}
Croatian: Dio 2: Što morate znati prije nego počnete uzimati {naziv lijeka} Upozorenja i mjere opreza
English: Section 4: Possible side effects
Croatian: Dio 4.: Moguće nuspojave
English: If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping {Drug name}.
Croatian: Ako nastupe lezije, posebice na suncem izloženim područjima kože, te ako su popraćene artralgijom, bolesnik treba odmah potražiti medicinsku pomoć, a zdravstveni radnik treba razmotriti prekid liječenja lijekom {naziv lijeka}.
English: New product information wording - Extracts from PRAC recommendations on signals
Croatian: Tekst novih informacija o lijeku - izvadak iz preporuka PRAC-a vezanih uz signale
English: Frequency 'not known': Subacute cutaneous lupus erythematosus (see section 4.4).
Croatian: Učestalost „nepoznata": Subakutni kožni lupus eritematodes (pogledajte dio 4.4.).
English: Section 4: Possible side effects • Frequency 'not known': rash, possibly with pain in the joints
Croatian: Dio 4.: Moguće nuspojave • Učestalost „nepoznata": osip, moguće praćen boli u zglobovima
English: SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Croatian: Ako se nakon liječenja inhibitorom protonske pumpe javi SCLE, rizik od pojave SCLE-a veći je i tijekom liječenja drugim inhibitorom protonske pumpe.
English: Subacute cutaneous lupus erythematosus (SCLE)
Croatian: Subakutni kožni lupus eritematodes (SCLE, engl. subacute cutaneous lupus erythematosus)
English: Package Leaflet (both prescription and non-prescription)
Croatian: Uputa o lijeku (na liječnički recept i bez liječničkog recepta)
English: Summary of Product Characteristics (both prescription and non-prescription)
Croatian: Sažetak opisa svojstava lijeka (na liječnički recept i bez liječničkog recepta)
English: You must tell your doctor immediately if you notice these serious side effects mentioned.
Croatian: Ako uočite bilo koju ovdje navedenu ozbiljnu nuspojavu o istome morate odmah obavijestiti liječnika.
English: Summary of Product Characteristics
Croatian: Sažetak opisa svojstava lijeka:
English: Current Step 4 version dated July 2000.
Croatian: Trenutno korak 4. verzije datuma srpanj 2000.
English: The timetable for the implementation of the agreement is set out in Annex V.
Croatian: Vremenski raspored za implementaciju sporazuma naveden je u Dodatku V.
English: CMDh agreement
Croatian: Suglasnost CMDh-a
English: There are limited data on the long term outcomes.
Croatian: Dostupni su ograničeni podaci o dugoročnim ishodima.
English: This is a greater risk of major malformations than for the general population, for whom the risk is about 2-3%.
Croatian: Ovo je veći rizik od većih malformacija u odnosu na opću populaciju, za koju rizik iznosi otprilike 2-3%.
English: In addition, the CMDh clarified that the study should be conducted in more than one Member State.
Croatian: Nadalje, CMDh je pojasnio da ispitivanje treba provesti u više od jedne države članice.
English: - Treatment of primary generalised epileptic seizures, secondary generalised epileptic seizures and partial epileptic seizures;
Croatian: − liječenje primarno generaliziranih epileptičnih napadaja, sekundarnih generaliziranih epileptičnih napadaja i djelomičnih epileptičnih napadaja;
English: The exact gestational period of risk for these effects is uncertain and the possibility of a risk throughout the entire pregnancy cannot be excluded.
Croatian: Točno gestacijsko razdoblje rizika za ovo djelovanje nije sigurno, te se ne može isključiti mogućnost rizika tijekom cijele trudnoće.
English: Clinical Investigation of Medicinal Products in the Pediatric Population E11.
Croatian: Kliničko ispitivanje lijekova u pedijatrijske populacije E11.
English: The PRAC also confirmed the known risk of congenital anomalies.
Croatian: PRAC je također potvrdio poznati rizik od kongenitalnih anomalija.
English: Having reviewed the PRAC recommendation, the CMDh agreed with the overall scientific conclusions and grounds for recommendation.
Croatian: Nakon što je pregledao preporuku PRAC-a, CMDh je suglasan sa cjelokupnim znanstvenim zaključcima i razlozima za preporuku.
English: • The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 31 of Directive 2001/83/EC for valproate and related substances-containing medicinal products.
Croatian: • je Povjerenstvo za ocjenu rizika na području farmakovigilancije (PRAC) provelo postupak u skladu sa člankom 31. Direktive 2001/83/EZ za lijekove koji sadrže valproat i povezane tvari.
English: The most common types of malformations include neural tube defects, facial dysmorphism, cleft lip and palate, craniostenosis, cardiac, renal and urogenital defects, limb defects (including bilateral aplasia of the radius), and multiple anomalies involving various body systems.
Croatian: Najčešći tipovi malformacija uključuju defekte neuralne cijevi, facijalnu dismorfiju, rascjep usne i nepca, kraniostenozu, srčane, renalne i urogenitalne nedostatke, defekte udova (uključujući bilateralnu aplaziju radijusa), višestruke anomalije koje uključuju različite tjelesne sustave.
English: 1 Meador K, et al. Pregnancy outcomes in women with epilepsy: a systematic review and meta-analysis of published pregnancy registries and cohorts.
Croatian: Pregnancy outcomes in women with epilepsy: a systematic review and meta-analysis of published pregnancy registries and cohorts.
English: The incidence of risk appears to be higher with valproate than with other antiepileptics.
Croatian: Incidencija rizika se čini veća u slučaju primjene valproata nego u slučaju drugih antiepileptika.
English: Minor editorial amendments were also introduced in the rest of the product information for clarity.
Croatian: Uvedene su i manje uredničke dopune u preostali dio informacija o proizvodu za potrebe pojašnjenja.
English: Data derived from a meta-analysis (including registries and cohort studies) has shown that 10.73% of children of epileptic women exposed to valproate monotherapy during pregnancy suffer from congenital malformations (95% CI: 8.16 -13.29)1.
Croatian: Podaci prikupljeni iz meta analize (uključujući registre i ispitivanja kohorte) potvrđuju da je 10,73% djece epileptičnih žena izloženih monoterapiji valproatom tijekom trudnoće imalo kongenitalne malformacije (95% CI: 8,16 -13,29)1.
English: The PRAC noted that in some Member States valproate is authorised for the prevention of migraine attacks.
Croatian: PRAC je napomenuo da je valproat u pojedinim državama članicama odobren za prevenciju napadaja migrene.
English: The continuation of treatment after manic episode could be considered in patients who have responded to valproate for acute mania.
Croatian: Nastavak liječenja nakon manične epizode može se razmatrati u bolesnika koji su odgovorili na valproat u slučaju akutne manije.
English: Studies in preschool children exposed in utero to valproate show that up to 30-40% experience delays in their early development such as talking and walking later, lower intellectual abilities, poor language skills (speaking and understanding) and memory problems 2,3,4,5.
Croatian: Ispitivanja provedena u predškolske djece izložene in-utero valproatu potvrđuju da se 30-40% djece nastupila odgoda u njihovom ranom razvoju, primjerice kasniji početak govora i hodanja, slabije intelektualne sposobnosti, slabije jezične sposobnosti (govor i razumijevanje) i problemi s pamćenjem2,3,4,5.
English: The CMDh included a clarification about the population affected by the recommendations as these are also applicable to female adolescents (aged between 12 to 16-18 years) according to the ICH E11 age classification of the paediatric population10.
Croatian: CMDh je uključio pojašnjenje o populaciji obuhvaćenoj preporukama budući da su iste primjenjive na ženske adolescente (u dobi između 12 i 16-18 godina) sukladno klasifikaciji dobi ICH E11 za pedijatrijsku populaciju10.
English: Although the role of confounding factors cannot be excluded, there is evidence in children exposed to valproate that the risk of intellectual impairment may be independent from maternal IQ6.
Croatian: Iako se uloga združenih čimbenika ne može isključiti, postoji dokaz u djece izložene valproatu da je rizik od intelektualnog oštećenja neovisan od IQ-a6.
English: The CMDh also proposed a new timeline for the circulation of the DHPC in order to have it available to relevant recipients as soon as possible.
Croatian: CMDh je također predložio novi vremenski raspored za slanje DHPC-a kako bi isti bilo dostupni što je prije moguće relevantnim primateljima.
English: The CMDh considered the below PRAC recommendation with regard to valproate and related substances-containing medicinal products:
Croatian: CMDh je razmotrio niže navedenu preporuku PRAC-a u vezi s lijekovima koji sadrže valproat i druge povezane tvari:
English: The PRAC reviewed all available data from pre-clinical studies, pharmacoepidemiological studies, published literature, spontaneous reports as well as the views of the relevant experts (i.e. in neurology, psychiatry, child neuropsychiatry, obstetrics etc.) on the safety and efficacy of valproate and related substances in female children, women of childbearing potential and pregnant women.
Croatian: PRAC je pregledao sve dostupne podatke iz predkliničkih ispitivanja, farmakoepidemioloških ispitivanja, objavljene literature, spontanih izvještaja kao i mišljenja relevantnih stručnjaka (primjerice s područja neurologije, psihijatrije, dječje neuropsihijatrije, porodištva, itd.) u vezi sa sigurnošću i djelotvornošću valproata i povezanih tvari u ženske djece, žena reproduktivne dob i trudnica.
English: Intelligence quotient (IQ) measured in school aged children (age 6) with a history of valproate exposure in utero was on average 7-10 points lower than those children exposed to other antiepileptics.
Croatian: Kvocijent inteligencije (IQ) izmjeren u djece školskog uzrasta (u dobi od 6 godina) s poviješću in utero izlaganja valproatu bio je prosječno niži za 7-10 bodova u odnosu na djecu izloženu drugim
English: The CMDh considered that the timeline for the submission of the drug utililsation study protocol should be extended in order to allow MAHs to perform a joint post-authorisation study (see Annex IV).
Croatian: CMDh je zaključio da se vremenski raspored za podnošenje protokola ispitivanja iskoristivosti lijeka treba produljiti kako bi se omogućilo nositeljima odobrenja da naprave zajedničko ispitivanje nakon izdavanja odobrenja (vidjeti Dodatak IV.).
English: The risk is dose dependent but a threshold dose below which no risk exists cannot be established.
Croatian: Rizik ovisi o dozi, no ne može se utvrditi granična doza ispod koje ne postoji rizik.
English: - Treatment of manic episode in bipolar disorder when lithium is contraindicated or not tolerated.
Croatian: − liječenje maničnih epizoda bipolarnog poremećaja ako je litij kontraindiciran ili se ne podnosi.
English: The PRAC agreed that targeted and appropriate information to healthcare professionals and patients were key to ensure a full understanding of the risks and that appropriate materials should be put in place.
Croatian: PRAC je suglasan da su ciljane i primjerene informacije upućene zdravstvenim djelatnicima i bolesnicima ključne kako bi se osiguralo potpuno razumijevanje rizika, te da se odgovarajući materijali trebaju staviti na mjesto.
English: The review confirms the already known teratogenic risks associated with the use of valproate in pregnant women.
Croatian: Pregledom su potvrđeni već poznati teratogenski rizici povezani s primjenom valproata u trudnica.
English: Available data show that children exposed to valproate in utero are at increased risk of autistic spectrum disorder (approximately three-fold) and childhood autism (approximately five-fold) compared with the general study population.
Croatian: Dostupni podaci dokazuju da su djeca koja su in utero izložena valproatu, izložena povećanom riziku od spektra autističnih poremećaja (otprilike tri puta) i dječjem autizmu (otprilike pet puta) u usporedbi s općom populacijom ispitivanja.
English: Data have shown that exposure to valproate in utero can have adverse effects on mental and physical development of the exposed children.
Croatian: Podaci potvrđuju da in utero izlaganje valproatu može imati nuspojave na mentalni i fizički razvoj izložene djece.
English: However, the CMDh emphasised that the referral procedure focussed on the risks associated with valproate and related substances in pregnant women and women of childbearing potential; the benefit-risk balance of valproate and related substances was assessed only in this subpopulation, and not in the general patient population for all indications.
Croatian: No, CMDh je naglasio da se postupak upućivanja koncentrira na rizike povezane s valproatom i povezanim tvarima u trudnica i žena reproduktivne dobi; omjer koristi i rizika za valproat i povezane tvari ocijenjen je samo u ovoj podpopulaciji, a ne u općoj populaciji bolesnika za sve indikacije.
English: The previous statements warning against the risks associated with valproate during pregnancy were summarised and included in rectangle frame.
Croatian: Ranije izjave upozorenja povezane s rizicima primjene valproata tijekom trudnoće sažete su i uključene u pravokutni okvir.
English: The CMDh, having considered the PRAC recommendation dated 9 October 2014 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, agreed on the variation to the terms of the marketing authorisations of valproate and related substances containing medicinal products for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III and subject to the conditions set out in Annex IV.
Croatian: Nakon što je razmotrio preporuku PRAC-a od dana 9. listopada 2014. u skladu sa člankom 107k(1.) i (2.) Direktive 2001/83/EZ, CMDh suglasan je s izmjenom uvjeta odobrenja za stavljanje u promet lijeka valproat i lijekova koji sadrže povezane tvari, za koje su relevatni djelovi sažetka opisa svojstava i uputa o lijeku navedeni u Dodatku III. i predmetom su uvjeta navedenih u Dodatku IV.
English: Based on clinical data and also the views of the relevant experts it was concluded valproate should remain an option for female patients, but should be reserved for situations when other treatment alternatives have been tried and failed.
Croatian: Na temelju kliničkih podataka, kao i mišljenja relevantnih stručnjaka zaključeno je da valproat treba ostati terapijska mogućnost za ženske bolesnik, no primjenu treba rezervirati za situacije kada su druge mogućnosti liječenja isprobane i nisu uspjele.
English: Limited data suggests that children exposed to valproate in utero may be more likely to develop symptoms of attention deficit/hyperactivity disorder (ADHD)7,8,9.
Croatian: Ograničeni podaci ukazuju da je izglednije kako će djeca izložena in utero valproatu razviti simptome pomanjkanja pažnje/poremećaja hiperaktivnosti (ADHD)7,8,9.
English: Available data show an increased incidence of minor and major malformations in children born to mothers treated with valproate and related substances during pregnancy.
Croatian: Dostupni podaci potvrđuju povišenu incidenciju manjih i većih malformacija u djece rođene od majki liječenih valproatom i povezanim tvarima tijekom trudnoće.
English: Core elements of a direct healthcare professional communication (DHPC) were agreed, together with the timelines for its distribution.
Croatian: Usuglašeni su ključni elementi izravnog pisma zdravstvenim djelatnicima, zajedno s vremenskim rasporedom za distribuciju istih.
English: 5 Cummings C et al. Neurodevelopment of children exposed in utero to lamotrigine, sodium valproate and carbamazepine.
Croatian: Neurodevelopment of children exposed in utero to lamotrigine, sodium valproate and carbamazepine.
English: • The PRAC also concluded that there was a need for further risk minimisation measures such as educational materials aimed to better inform patients and healthcare professionals on the risks and a drug utilisation study to assess the effectiveness of the proposed risk minimisation measures.
Croatian: • je PRAC također zaključio da postoji potreba za daljnje mjere za smanjivanje rizika, poput edukacijskih materijala usmjerenih na bolje informiranje bolesnika i zdravstvenih djelatnika o rizicima kao i za ispitivanje iskoristivosti lijeka sa ciljem ocjene djelotvornosti predloženih mjera za smanjivanje rizika.
English: Christensen J et al. Prenatal valproate exposure and risk of autism spectrum disorders and childhood autism.
Croatian: Prenatal valproate exposure and risk of autism spectrum disorders and childhood autism.