FrancophonIA/ELRC3.0 huggingface dataset:
English: Only use the syringe provided with Jylamvo to withdraw your dose.
Croatian: Za izvlačenje doze, upotrijebite samo štrcaljku koju ste dobili uz Jylamvo.
English: 29 May 2013 EMA/402567/2013 - Rev 1
Croatian: 29. svibnja 2013. EMA/402567/2013 - Rev 1
English: Contact our press officers Monika Benstetter or Martin Harvey Allchurch
Croatian: Obratite se našim dužnosnicima za tisak Monika Benstetter ili Martin Harvey Allchurch
English: Your doctor may also consider an appropriate alternative treatment for you.
Croatian: Vaš liječnik može također razmotriti odgovarajuću alternativnu terapiju za vas.
English: 65 cases of SJS and TEN were reported.
Croatian: Bilo je zabilježeno 65 slučajeva SJS-a i TEN-a.
English: Information to patients
Croatian: Informacije za pacijente
English: They are unpredictable and can occur at any stage during treatment, including after short-term treatment, and at recommended doses.
Croatian: Nepredviđene su i mogu se javiti u bilo kojem stadiju terapije, uključujući i nakon kratkoročne terapije te pri preporučenim dozama.
English: You should make an appointment with your treating doctor to discuss your treatment.
Croatian: Trebate zakazati sastanak sa svojim liječnikom kako biste raspravili o svojoj terapiji (liječenju).
English: The review of tetrazepam-containing medicines was initiated in January 2013 at the request of France, under Article 107i of Directive 2001/83/EC, also known as the urgent Union procedure.
Croatian: Analiza lijekova koji sadrže tetrazepam započela je u siječnju 2013. na zahtjev Francuske pod Člankom 107i Direktive 2001/83/EZ koji su također poznati kao hitni postupak Unije.
English: • In the pharmacovigilance database of the originator product, Myolastan, a total of 513 cutaneous (or allergic) reactions were identified.
Croatian: • U farmakovigilancijskoj bazi podataka originalnog lijeka Myolastana, identificirano je ukupno 513 kutanih reakcija (ili alergijskih).
English: Tetrazepam-containing medicines have been approved since the 1960s via national procedures in several EU Member States (Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Latvia, Lithuania, Luxembourg, Poland, Romania, Slovakia and Spain), and are available on prescription under various trade names, including Epsipam, Miozepam, Musapam, Musaril, Myolastan, Myopam, Panos,
Croatian: Lijekovi koji sadrže tetrazepam odobreni su od 1960. godine putem nacionalnih postupaka u nekoliko država članica EU (Austrija, Belgija, Bugarska, Češka, Francuska, Njemačka, Latvija, Litva, Luksemburg, Poljska, Rumunjska, Slovačka i Španjolska) te su dostupne na recept pod različitim komercijalnim nazivima uključujući Epsipam, Miozepam, Musapam, Musaril, Myolastan, Myopam, Panos, Relaxam, Spasmorelax, Tetra-saar, Tetramdura i Tetraratio.
English: Although the majority of cases occurred in patients taking concomitant medications, the causal link with tetrazepam was strong in a high number of cases.
Croatian: Iako se većina slučajeva dogodila kod pacijenata koji uzimaju konkomitantne lijekove, uzročna povezanost s tetrazepamom bila je snažna kod velikog broja slučajeva.
English: Tetrazepam belongs to a group of medicines called benzodiazepines.
Croatian: Tetrazepam pripada skupini lijekova zvanoj benzodiazepini.
English: • In light of the unfavourable benefit-risk balance, doctors should review their patients' treatment at their next appointment, and may consider an appropriate alternative treatment.
Croatian: • U svjetlu nepovoljnog omjera dobrobiti i rizika, liječnici trebaju razmotriti terapije koje primaju njihovi pacijenti prilikom sljedećeg sastanka te mogu razmotriti odgovarajuću alternativnu terapiju.
English: • The review found that half of the reported reactions with tetrazepam are skin disorders, which are sometimes serious, life-threatening or fatal.
Croatian: • Procjena je otkrila da su polovica prijavljenih reakcija povezanih s tetrazepamom kožne reakcije koje su ponekad ozbiljne, opasne po život ili smrtonosne.
English: The suspension of the marketing authorisations can be lifted if the companies that market these medicines provide data identifying a specific group of patients for whom the benefits of tetrazepamcontaining medicines outweigh the risks.
Croatian: Suspenzija odobrenja za stavljanje lijeka u promet može se prekinuti ako poduzeća koja stavljaju lijek u promet daju dovoljno podataka koji identificiraju specifične skupine pacijenata za koje dobrobiti lijekova koji sadržavaju tetrazepam nadmašuju rizike.
English: • Regarding its efficacy, four studies showed no difference between tetrazepam and other active medicines when used for spasticity.
Croatian: • U vezi s njegove djelotvornosti, četiri ispitivanja nisu pokazala razliku između tetrazepama i drugih djelatnih lijekova kad se koristi za liječenje spastičnosti.
English: By increasing GABA activity, benzodiazepines have a calming effect on various functions of the brain.
Croatian: Povećavanjem aktivnost tvari GABA, benzodiazepini imaju umirujući učinak na različite funkcije mozga.
English: The full list is available in Annex I on the EMA website, under the ‘All documents' tab.
Croatian: Cjeloviti popis dostupan je u Dodatku I. na web stranici Europske agencije za lijekove pod karticom „All documents” (Svi dokumenti).
English: • The risk of skin reaction is higher with tetrazepam than with other benzodiazepines.
Croatian: • Rizik od kožnih reakcija je viši s tetrazepamom od drugih benzodiazepina.
English: GABA decreases the excitability of many brain cells.
Croatian: GABA smanjuje podražljivost mnogih stanica mozga.
English: • If you are taking a tetrazepam-containing medicine, you should not suddenly stop taking tetrazepam without your doctor's advice.
Croatian: • Ako uzimate lijekove koji sadrže tetrazepam, ne smijete iznenada prekinuti uzimanje tetrazepama bez savjeta liječnika.
English: This is possibly explained by a structural difference between tetrazepam and other benzodiazepines (i.e. the substituted cyclohexenyl ring of tetrazepam).
Croatian: Moguće je objašnjenje strukturalna razlika između tetrazepama i drugih benzodiazepina (tj. supstituiranih cikloheksenilskih prstenova tetrazepama).
English: The efficacy of tetrazepam for painful contractures is supported mainly by two small double-blind placebo-controlled clinical trials showing limited efficacy.
Croatian: Djelotvornost tetrazepama u vezi bolnih grčeva podržavaju uglavnom dva mala, dvostruko slijepa placebom kontrolirana klinička ispitivanja koja pokazuju ograničenu djelotvornost.
English: • Pharmacists should refer patients on a new or repeat prescription for tetrazepam to their treating physician.
Croatian: • Ljekarnici trebaju uputiti pacijente kako bi dobili novi ili ponovljeni recept za tetrazepam od svojih liječnika.
English: Tetrazepam-containing medicines suspended across the EU
Croatian: Lijekovi koji sadrže tetrazepam suspendirani su širom EU
English: The CMDh agreed with the PRAC conclusion that the benefits of these medicines do not outweigh their risks, and adopted a final position that the marketing authorisations should be suspended throughout the EU.
Croatian: CMDh se složila sa zaključcima PRAC-a da dobrobiti ovih lijekova ne nadmašuju njihove rizike i usvojila je konačno stajalište da je potrebno suspendirati odobrenja za stavljanje lijeka u promet širom EU.
English: The Committee also noted that, in the light of the risks identified, the available data on the effectiveness of tetrazepam were not sufficiently robust to support its use in the authorised indications.
Croatian: Povjerenstvo je također zaključilo da u svjetlu identificiranih rizika, dostupni podaci o učinkovitosti tetrazepama nisu dovoljno uvjerljivi da bi podržali njegovu primjenu u odobrenim indikacijama.
English: The review of tetrazepam was triggered by the French National Agency for the Safety of Medicine and Health Products (ANSM), following reports of serious skin reactions with this medicine in France.
Croatian: Analizu tetrazepama pokrenula je Francuska državna agencija za sigurnost lijekova i zdravstvenih proizvoda (ANSM) nakon zaprimanja izvješća o ozbiljnim kožnim reakcijama povezanih s ovim lijekom u Francuskoj.
English: In particular, tetrazepam is used for its muscle relaxant effects.
Croatian: Tetrazepam se posebice koristi zbog svojih učinaka opuštanja mišića.
English: Serious skin reactions include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), erythema multiforme and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome.
Croatian: Ozbiljne kožne reakcije uključuju Stevens-Johnsonov sindrom (SJS), toksičnu epidermalnu nekrolizu (TEN), multiformni eritem i osip izazvan lijekom s eozinofilijom i sindromom sistemskih simptoma (DRESS) sindromom.
English: • As a result of the risk of unpredictable, serious skin reactions identified, tetrazepam-containing medicines will no longer be available in the EU.
Croatian: • Zbog mogućnosti pojave identificiranih nepredvidivih, ozbiljnih kožnih reakcija, lijekovi koji sadrže tetrazepam više neće biti dostupni u EU.
English: On 24 April 2013, following the recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC), the Co-ordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh) endorsed by majority the PRAC recommendation to suspend the marketing authorisations of tetrazepam-containing medicines across the European Union (EU).
Croatian: Na dan 24. travnja 2013. godine nakon preporuke od strane Povjerenstva za ocjenu rizika u farmakovigilanciji (PRAC), Koordinacijska grupa za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh), odobrila je većinu preporuka PRAC-a za suspenziju odobrenja za stavljanje lijekova koji sadrže tetrazepam u promet širom Europske unije (EU).
English: Having assessed all available data on the risk of skin reactions, including post-marketing data in the EU and the published literature, the PRAC concluded that tetrazepam is associated with a low but increased risk of serious skin reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis and DRESS syndrome) compared with other benzodiazepines.
Croatian: Nakon procjene svih dostupnih podataka o riziku od kožne reakcije uključujući i podatke nakon stavljanja lijeka u promet u EU i objavljene literature, PRAC je zaključio da je tetrazepam povezan s niskim, ali rastućim rizikom od ozbiljnih kožnih reakcija (uključujući Stevens-Johnsonov sindrom, toksičnu epidermalnu nekrolizu i sindrom DRESS) u usporedbi s drugim benzodiazepinima.
English: Benzodiazepines work by attaching to certain receptors in the brain, thereby increasing the activity of a substance called gamma-amino butyric acid (GABA).
Croatian: Benzodiazepini djeluju vezivanjem na određene receptore u mozgu i tako povećavaju aktivnost tvari zvanih gama-aminomaslačna kiselina (GABA).
English: Because the CMDh took this position by majority it was sent to the European Commission, which endorsed it and adopted a legally binding decision on 29 May 2013.
Croatian: S obzirom da je CMDh zauzela ovo stajalište većinskom odlukom svojih članova ono je priopćeno Europskoj komisiji koja ga je odobrila i usvojila pravno obvezujuću odluku 29. svibnja 2013.
English: As tetrazepam-containing medicines are all authorised nationally, the PRAC recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Croatian: Budući da su svi lijekovi s djelatnom tvari tetrazepam odobreni nacionalnim postupkom, preporuke PRAC-a priopćene su Koordinacijskoj grupi za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh), koja je usvojila konačno stajalište.
English: The review was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Croatian: Analiza je prvi put provedena od strane Povjerenstva za ocjenu rizika u farmakovigilanciji (PRAC), koje je odgovorno za procjenu sigurnosnih pitanja vezanih lijekove za upotrebu na ljudima koje je donijelo niz preporuka.
English: In view of the serious, potentially fatal, skin reactions and the limited efficacy of tetrazepam, the benefit-risk balance of tetrazepam-containing medicines is considered no longer favourable.
Croatian: S obzirom na ozbiljne, potencijalno smrtonosne kožne reakcije i ograničenu djelotvornost tetrazepama, omjer dobrobiti i rizika lijekova koji sadrže tetrazepam ne smatra se više povoljnim.
English: The CMDh position is based on the PRAC review of all available data on the risk of skin reactions with tetrazepam, including post-marketing data in the EU and the published literature, and the available information on efficacy in licensed indications:
Croatian: Stajalište CMDh-a temelji se na tome da je PRAC razmotrio sve dostupne podatke o kožnim reakcijama sa tetrazepamom uključujući i podatke nakon stavljanja lijeka u promet u EU i objavljene literature te dostupnih informacija o djelotvornosti u odobrenim indikacijama:
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Croatian: CMDh, tijelo koje predstavlja države članice EU odgovorno je za osiguravanje usklađenih sigurnosnih standarda za lijekove odobrene nacionalnim postupcima širom EU.
English: Tetrazepam, a medicine of the benzodiazepine class, is used in several EU Member States to treat painful contractures (such as in low back pain and neck pain) and spasticity (excessive stiffness of muscles).
Croatian: Tetrazepam, lijek iz klase benzodiazepina koristi se u nekoliko država članica EU za liječenje bolnih grčeva (poput bolova u donjem dijelu leđa i vratu) i spastičnosti (prekomjerne ukočenosti mišića).
English: It is taken by mouth to treat painful contractures (sustained shortening of muscle tissue), and spasticity (excessive stiffness of muscles).
Croatian: Uzima se kroz usta za liječenje bolnih grčeva (održivo skraćivanje mišićnog tkiva) i spastičnosti (prekomjerna ukočenost mišića).
English: As the CMDh position was adopted by majority vote, the CMDh position was sent to the European Commission, which endorsed it and adopted an EU-wide legally binding decision.
Croatian: S obzirom da je stajalište CMDh usvojeno većinski, priopćeno je Europskoj komisiji koja ga je odobrila i usvojila kao pravno obvezujuću odluku na razini EU.
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national marketing authorisation procedures across the EU.
Croatian: CMDh, tijelo koje predstavlja države članice EU odgovorno je za osiguravanje usklađenih sigurnosnih standarda za lijekove putem nacionalnog odobrenja za stavljanje lijeka u promet širom EU.
English: • Tetrazepam is a muscle relaxant used in painful conditions such as low back pain and neck pain as well as spasticity (excessive stiffness of muscles).
Croatian: • Tetrazepam je miorelaksans koji se koristi za liječenje stanja kao što su bolovi u leđima i vratu te spastičnosti (prekomjerne ukočenosti mišića).
English: Do not freeze.
Croatian: Ne smrzavati.
English: CI = confidence interval.
Croatian: CI = interval pouzdanosti.
English: This treatment cycle will normally be repeated every three weeks.
Croatian: Ciklus liječenja obično se ponavlja svaka tri tjedna.
English: 3 Reactions have been mild and have not generally required specific therapy.
Croatian: 3 Reakcije su bile blage i općenito nisu zahtijevale specifičnu terapiju.
English: N = total number of patients treated.
Croatian: N = ukupan broj liječenih bolesnika.
English: If you are or think you might be pregnant, tell your doctor immediately.
Croatian: Ako ste trudni ili mislite da biste mogli biti trudni, odmah se javite svojem liječniku.
English: Hair loss.
Croatian: - Ispadanje kose.
English: Volume of distribution was slightly decreased and thus half-life only increased by 14 %.
Croatian: Volumen distribucije je lagano smanjen i zbog toga je poluvrijeme povećano samo 14%.
English: Response rate (%)
Croatian: Stopa odgovora (%)
English: Mean half-life increased from 1.9 hours to 4.9 hours.
Croatian: Srednje poluvrijeme života se povećalo s 1,9 sati na 4,9 sati.
English: From a microbiological point of view, the product should be used immediately.
Croatian: S mikrobiološkog stajališta, lijek treba upotrijebiti odmah.
English: Liquid waste may be flushed with large amounts of water.
Croatian: Tekući se otpad može isprati velikim količinama vode.
English: This increase is considered unlikely to be of clinical relevance.
Croatian: Malo je vjerojatno da je taj porast klinički značajan.
English: Severe infection (sepsis).
Croatian: - Teška infekcija (sepsa).
English: decreased to about 67 % compared with control patients.
Croatian: smanjen je na oko 67% u usporedbi s kontrolnom skupinom bolesnika.
English: Topotecan was also evaluated in the paediatric population; however, only limited data on efficacy and safety are available.
Croatian: Topotekan je ispitivan i u pedijatrijskoj populaciji; međutim, dostupni su samo ograničeni podaci o njegovoj djelotvornosti i sigurnosti primjene.
English: Topotecan half-life was increased by about 30% but no clear change in volume of distribution was observed.
Croatian: Poluvrijeme topotekana povećalo se oko 30% bez opaženih jasnih promjena u volumenu distribucije.
English: Date of first authorisation: 21 September 2009 Date of latest renewal: 19 June 2014
Croatian: Datum posljednje obnove odobrenja: 19. lipnja 2014.
English: You must tell your doctor immediately if you experience any of the following serious side effects.
Croatian: Odmah morate obavijestiti liječnika ako primijetite neku od sljedećih ozbiljnih nuspojava.
English: There is little or no accumulation of topotecan with repeated daily dosing and there is no evidence of a change in the pharmacokinetics after multiple doses.
Croatian: Postoji malo ili ništa nakupljanja topotekana pri ponovljenom dnevnom doziranju i nema dokaza o promjeni farmakokinetike nakon višestrukih doza.
English: Topotecan also had a high volume of distribution, about 132 1 (SD 57), and a relatively short half-life of 2-3 hours.
Croatian: Topotekan je također imao veliki volumen distribucije, oko 132 l (SD 57), te relativno kratko poluvrijeme od 2-3 sata.
English: The concentrate must be diluted before administration.
Croatian: Koncentrat se mora razrijediti prije primjene.
English: If well tolerated, treatment may continue until disease progression (see sections 4.8 and 5.1).
Croatian: Ukoliko ga bolesnici dobro podnose, liječenje se može nastaviti sve do progresije bolesti (vidjeti dijelove 4.8 i 5.1).
English: Median time to progression (weeks)
Croatian: Medijan do progresije (tjedni)
English: Area under the curve increased approximately in proportion to the increase in dose.
Croatian: Područje ispod krivulje povećavalo se proporcionalno povećanju doze.
English: Accurate assessment of performance status at the time therapy is given is important, to ensure that patients have not deteriorated to PS 3.
Croatian: Važno je točno procijeniti funkcionalno stanje bolesnika u vrijeme davanja terapije kako bi se moglo utvrditi da se ono nije pogoršalo na PS 3.
English: Male patients who may wish to father a child should ask their doctor for family planning advice or treatment.
Croatian: Muški bolesnici koji žele postati očevi moraju se savjetovati sa svojim liječnikom o planiranju obitelji ili liječenju.
English: In these studies, there were no apparent differences in the pharmacokinetics of topotecan among children, adolescents, and young adult patients with solid tumours or leukaemia, but data are too limited to draw definite conclusions.
Croatian: U tim ispitivanjima nije bilo očigledne razlike u farmakokinetici topotekana u djece, adolescenata i mlađih odraslih osoba sa solidnim tumorima ili leukemijom, ali podataka je premalo da bi se mogli izvesti konačni zaključci.
English: Among all patients treated in clinical studies (including both those with severe neutropenia and those who did not develop severe neutropenia), 11 % (4 % of courses) developed fever and 26 % (9 % of courses) developed infection.
Croatian: Među svim bolesnicima liječenim u kliničkim ispitivanjima (uključujući one s teškom neutropenijom i one koji nisu razvili tešku neutropeniju), 11% (4% ciklusa) je razvilo vrućicu, a 26% bolesnika (9% ciklusa) je razvilo infekciju.
English: They may require hospitalisation and could even be life threatening.
Croatian: Te nuspojave mogu zahtjevati hospitalizaciju ili čak biti i opasne po život.
English: Women of child-bearing potential should use effective contraception to avoid becoming pregnant while on treatment.
Croatian: Žene u reproduktivnoj dobi moraju koristiti učinkovitu kontracepciju kako bi izbjegle trudnoću tijekom liječenja.
English: Store in a refrigerator (2°C - 8°C).
Croatian: Čuvati u hladnjaku (2°C - 8°).
English: uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), i vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Discharge of blood into tissues (extravasation).
Croatian: - Istjecanje krvi u tkiva (ekstravazacija).
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 12 hours if stored below 25°C or 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme čuvanja i uvjeti čuvanja prije uporabe odgovornost su korisnika i ne bi trebali biti dulji od 12 sati ako se čuva ispod 25°C ili 24 sata pri 2°C-8°C, osim ako se postupak razrjeđivanja proveo u kontroliranim i validiranim aseptičkim uvjetima.
English: Other severe events that were recorded as related or possibly related to topotecan treatment were anorexia (12 %), malaise (3 %) and hyperbilirubinaemia (1 %).
Croatian: Ostali teški događaji koji su bili povezani ili se mogu povezati s liječenjem topotekanom bile su anoreksija (12%), malaksalost (3%) i hiperbilirubinemija (1%).
English: Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents, ATC code: L01XX17.
Croatian: Farmakoterapijska skupina: antineoplastici, ostali antineoplastici: ATK oznaka: L01XX17 Mehanizam djelovanja
English: Other medicines and Topotecan Teva
Croatian: Drugi lijekovi i Topotekan Teva
English: In vitro, topotecan did not inhibit human P450 enzymes CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A or CYP4A, nor did it inhibit the human cytosolic enzymes dihydropyrimidine or xanthine oxidase.
Croatian: In vitro topotekan ne inhibira ljudske P450 enzime CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A ili CYP4A, niti inhibira ljudske citosolne enzime dihidropirimidin ili ksantin oksidazu.
English: These data should be evaluated in the context of the overall safety profile of the medicinal product, in particular of the significant haematological toxicity (see section 4.8).
Croatian: Ove podatke potrebno je promatrati u kontekstu cjelokupnog sigurnosnog profila lijeka, posebice s aspekta njegove značajne hematološke toksičnosti (vidjeti dio 4.8).
English: What Topotecan Teva is and what it is used for
Croatian: Što je Topotekan Teva i za što se koristi
English: Topotecan was also shown to cause embryo-foetal lethality when given to rats and rabbits.
Croatian: Pokazalo se da je topotekan uzrokovao smrt embrija i fetusa kada se davao zečevima i štakorima.
English: Tell a doctor if any of these becomes troublesome.
Croatian: Obavijestite svojega liječnika ako se neka od ovih nuspojava pogorša.
English: Topotecan Teva may reduce your ability to fight infections.
Croatian: Topotekan Teva može smanjiti sposobnost obrane od infekcija.
English: Keep the vial in the outer carton in order to protect from light.
Croatian: Bočice čuvati u vanjskom pakovanju radi zaštite od svjetlosti.