FrancophonIA/ELRC3.0 huggingface dataset:
English: The CMDh, having considered the PRAC recommendation dated 16 May 2013 with regards to the Almitrine containing medicinal products for oral use, agrees with the recommendation therein as stated below:
Croatian: Nakon razmatranja preporuke Povjerenstva za ocjenu rizika na području farmakovigilancije (PRAC, Pharmacovigilance Risk Assessment Committee) od 16. svibnja 2013. vezane za medicinske proizvode za oralnu primjenu koji sadrže almitrin, Koordinacijska grupa za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh, Mutual Recognition & Decentralised Procedures - Human) slaže se s preporukom kako je navedeno u nastavku:
English: • The PRAC considered that the use of oral almitrine is associated with serious adverse peripheral neuropathy and weight loss reactions sometimes with sequelae.
Croatian: • PRAC je uzeo u obzir da je oralna primjena almitrina povezana s ozbiljnim nuspojavama periferne neuropatije i gubitka težine, ponekad s posljedicama.
English: Bardsley P.A., Howard P., Tang O., Empey D., Harisson B., Peake M.D., O'Reilly J., Riordan J.F., Wilkinson J., Arnaud F., Jarratt J.A.
Croatian: Bardsley P.A., Howard P., Tang O., Empey D., Harisson B., Peake M.D., O'Reilly J., Riordan J.F., Wilkinson J., Arnaud F., Jarratt J.A. Sequential treatment with low dose Almitrine bismesylate in hypoxaemic chronic obstructive airways disease.
English: • Central nervous events (sleep disorders such as insomnia, drowsiness, agitation, anxiety, palpitations, dizziness) Based on the available publications of clinical studies with sequential treatment scheme891011 (i.e. two months of treatment followed by one month treatment interruption), the rate of withdrawal remained predominant in the almitrine groups as compared to placebo groups in the majority of the publications.
Croatian: Na temelju dostupnih publikacija kliničkih ispitivanja sa sekvencijalnom shemom liječenja891011 (odnosno dvomjesečnim liječenjem praćenim jednomjesečnim prekidom liječenja), stopa ustezanja
English: Based on the above the PRAC considered that the use of oral almitrine is associated with serious adverse peripheral neuropathy and weight loss reactions sometimes with sequelae.
Croatian: Na temelju gore navedenog PRAC je zaključio da je oralna primjena almitrina povezana s ozbiljnim nuspojavama periferne neuropatije i gubitka težine, ponekad s posljedicama.
English: The PRAC considered that the use of oral almitrine is associated with serious adverse peripheral neuropathy and weight loss reactions sometimes with sequelae.
Croatian: Opći zaključak PRAC je uzeo u obzir da je oralna primjena almitrina povezana s ozbiljnim nuspojavama periferne neuropatije i gubitka težine, ponekad s posljedicama.
English: Bardsley P.A., Howard P., De-Backer W., Vermeire P., Mairesse M., Ledent C., Radermecker M., Bury T., Ansquer J.. Two years treatment with Almitrine bismesylate in patients with hypoxic chronic obstructive airways disease.
Croatian: 4 Bardsley P.A., Howard P., De-Backer W., Vermeire P., Mairesse M., Ledent C., Radermecker M., Bury T., Ansquer J..
English: This summary was last updated in 06-2016.
Croatian: Sažetak je posljednji put ažuriran 06.2016.
English: The medicine can only be obtained with a prescription.
Croatian: Lijek se može nabaviti samo uz recept.
English: For patients weighing less than 50 kg, the dose depends on body weight.
Croatian: Za bolesnike koji imaju manje od 50 kg, doza ovisi o tjelesnoj težini.
English: It is available as tablets (250 mg, 500 mg, 750 mg and 1,000 mg).
Croatian: Dostupan je u obliku tableta (250 mg, 500 mg, 750 mg i 1000 mg).
English: This is a type of epilepsy where excessive electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear.
Croatian: To je vrsta epilepsije kod koje pretjerana električna aktivnost u jednom dijelu mozga uzrokuje simptome kao što su iznenadni trzaji jednog dijela tijela, oštećenje sluha, njuha ili vida, otupljenost ili iznenadni osjećaj straha.
English: Lower doses are used in patients who have problems with their kidneys (such as older patients).
Croatian: Manje doze koriste se u bolesnika koji imaju probleme s bubrezima (na primjer stariji bolesnici).
English: The exact way in which levetiracetam works is unclear but it attaches to a protein called synaptic vesicle protein 2A, which is involved in the release of chemical messengers from nerve cells.
Croatian: Točno djelovanje levetiracetama nije jasno, ali povezuje se s proteinom pod nazivom sinaptički vezikularni protein 2A koji sudjeluje u otpuštanju kemijskih glasnika iz živčanih stanica.
English: The full EPAR for Levetiracetam Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjelovito europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Levetiracetam Accord nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Patients who cannot take tablets should be given a solution containing levetiracetam.
Croatian: Bolesnicima koji ne mogu uzimati tablete potrebno je dati otopinu koja sadržava levetiracetam.
English: • primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to be inherited).
Croatian: • primarno generaliziranih toničko-kloničkih napadaja (veliki napadaji, uključujući gubitak svijesti) u bolesnika starijih od 12. godine života s idiopatskom generaliziranom epilepsijom (vrsta epilepsije za koju se vjeruje da je nasljedna).
English: This helps Levetiracetam Accord to stabilise electrical activity in the brain and prevent seizures.
Croatian: To lijeku Levetiracetam Accord pomaže da stabilizira električnu aktivnost u mozgu i spriječi napadaje.
English: What measures are being taken to ensure the safe and effective use of Levetiracetam Accord?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Levetiracetam Accord?
English: For more information about treatment with Levetiracetam Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Levetiracetam Accord pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: • myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12 years of age with juvenile myoclonic epilepsy;
Croatian: • miokloničkih napadaja (kratki, snažni trzaji mišića ili skupine mišića) u bolesnika starijih od 12. godine života s juvenilnom miokloničkom epilepsijom;
English: The European Commission granted a marketing authorisation valid throughout the European Union for Levetiracetam Accord on3 October 2011.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Levetiracetam Accord u promet koje vrijedi na prostoru Europske unije od 3. listopada 2011.
English: This means that Levetiracetam Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Keppra.
Croatian: To znači da je Levetiracetam Accord sličan „referentnom lijeku” koji je već odobren u Europskoj uniji pod nazivom Keppra.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Levetiracetam Accord have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Levetiracetam Accord nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Levetiracetam Accord can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation.
Croatian: Levetiracetam Accord može se primjenjivati samostalno u bolesnika od 16. godine života s novodijagnosticiranom epilepsijom, u liječenju parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje.
English: Because Levetiracetam Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Levetiracetam Accord generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: • partial-onset seizures with or without generalisation in patients from 1 month of age;
Croatian: • parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u dojenčadi od prvog mjeseca života;
English: When Levetiracetam Accord is added to another epilepsy treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day.
Croatian: Kada se Levetiracetam Accord dodaje drugom antiepileptičkom liječenju, početna doza u bolesnika od 12. godine života koji imaju više od 50 kg iznosi 500 mg dvaput dnevno.
English: What are the benefits and risks of Levetiracetam Accord?
Croatian: Koje su koristi i rizici lijeka Levetiracetam Accord?
English: The daily dose can be increased up to 1,500 mg twice a day.
Croatian: Dnevna doza može se povećati do 1500 mg dvaput dnevno.
English: Other information about Levetiracetam Accord
Croatian: Ostale informacije o lijeku Levetiracetam Accord
English: This is a summary of the European public assessment report (EPAR) for Levetiracetam Accord.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Levetiracetam Accord.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Levetiracetam Accord.
Croatian: Objašnjava kako je Odbor za za humanu uporabu (CHMP) ocijenio lijek kako bi preporučio njegovo odobrenje u EU-u te uvjete za primjenu lijeka Levetiracetam Accord.
English: Because Levetiracetam Accord is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Keppra.
Croatian: Budući da je Levetiracetam Accord generički lijek, ispitivanja na ljudima bila su ograničena na utvrđivanje činjenice je li lijek bioekvivalentan referentnom lijeku Keppra.
English: Therefore, the CHMP's view was that, as for Keppra, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da korist nadmašuje identificiran rizik, kao i za Keppru.
English: The Committee recommended that Levetiracetam Accord be given marketing authorisation.
Croatian: Odbor je preporučio davanje odobrenja za stavljanje lijeka Levetiracetam Accord u promet.
English: When Levetiracetam Accord is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Croatian: Kad se Levetiracetam Accord samostalno uzima, početna doza je 250 mg dvaput dnevno, a nakon dva tjedna povećava se na 500 mg dvaput dnevno.
English: Levetiracetam Accord is a medicine that contains the active substance levetiracetam.
Croatian: Levetiracetam Accord je lijek koji sadržava djelatnu tvar levetiracetam.
English: What is Levetiracetam Accord?
Croatian: Što je Levetiracetam Accord?
English: Levetiracetam Accord can also be used as an add-on to other epilepsy medicines to treat:
Croatian: Levetiracetam Accord kao dodatna terapija uz druge antiepileptike u liječenju:
English: Levetiracetam Accord tablets are swallowed with liquid.
Croatian: Levetiracetam Accord tablete gutaju se s tekućinom.
English: The CHMP concluded that, in accordance with EU requirements, Levetiracetam Accord has been shown to have comparable quality and to be bioequivalent to Keppra.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a, lijek Levetiracetam Accord dokazao usporedivu kakvoću te da je bioekvivalentan/usporediv s Kepprom.
English: The dose can be further increased at two-week intervals according to the patient's response, to a maximum dose of 1,500 mg twice a day.
Croatian: Doza se u intervalima od dva tjedna može dodatno povećati do najviše 1500 mg dvaput dnevno na temelju odgovora bolesnika.
English: The active substance in Levetiracetam Accord, levetiracetam, is an epilepsy medicine.
Croatian: Djelatna tvar levetiracetam u lijeku Levetiracetam Accord lijek je protiv epilepsije.
English: Levetiracetam Accord is a ‘generic medicine'.
Croatian: Levetiracetam Accord „generički je lijek”.
English: What is Levetiracetam Accord used for?
Croatian: Za što se koristi Levetiracetam Accord?
English: Why has Levetiracetam Accord been approved?
Croatian: Zašto je lijek Levetiracetam Accord odobren?
English: How is Levetiracetam Accord used?
Croatian: Kako se Levetiracetam Accord koristi?
English: How has Levetiracetam Accord been studied?
Croatian: Kako je Levetiracetam Accord ispitivan?
English: Your doctor may have to adjust your dose.
Croatian: Liječnik će možda morati prilagoditi Vašu dozu.
English: This leaflet was last revised in {MM/YYYY}.
Croatian: Ova je uputa zadnji puta revidirana u <{MM/YYYY}>.
English: The teratological importance of these findings is unclear.
Croatian: Nejasna je teratološka važnost tih nalaza.
English: *Absolute GFR not adjusted for body surface area
Croatian: *Apsolutni GFR nije prilagođen za površinu tijela
English: Uncomplicated influenza in adults
Croatian: Nekomplicirana gripa u odraslih
English: Key efficacy results are presented in Table 4.
Croatian: Ključni rezultati djelotvornosti prikazani su u tablici 4.
English: E-mail: safety@biocryst.com
Croatian: E-pošta: safety@biocryst.com
English: Chemical and physical in-use stability has been demonstrated for 72 hours at 5 ºC and 25 ºC.
Croatian: Kemijska i fizička stabilnost u primjeni dokazana je za razdoblje od 72 sata pri 5 ºC i 25 ºC.
English: Other medicines and Alpivab
Croatian: Drugi lijekovi i Alpivab
English: Adults and adolescents (13 years and older)
Croatian: Odrasli i adolescenti (13 godina i više)
English: CI = Confidence Interval
Croatian: CI = interval pouzdanosti
English: Not known, frequency cannot be estimated from the available data
Croatian: Nepoznato, učestalost se ne može procijeniti na temelju dostupnih podataka
English: These medicines prevent the influenza virus from spreading inside the body.
Croatian: Ti lijekovi sprječavaju širenje virusa gripe u tijelu.
English: As a precautionary measure, it is preferable to avoid the use of peramivir during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavanje uporabe peramivira tijekom trudnoće.
English: Based on a population pharmacokinetic analysis, the central volume of distribution was 12.56 L.
Croatian: Na temelju analize populacijske farmakokinetike, središnji volumen distribucije iznosio je 12,56 L.
English: There is no specific antidote to treat an overdose of this medicine.
Croatian: Ne postoji specifični antidot za liječenje predoziranja ovim lijekom.
English: Recommended single dose
Croatian: Preporučena jednokratna doza
English: The safety and efficacy of peramivir in children aged under 2 years has not yet been established.
Croatian: Sigurnost i djelotvornost peramivira u djece u dobi do dvije godine još nisu ustanovljene.
English: Treatment of an overdose should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Croatian: Liječenje predoziranja treba se sastojati od općenitih potpornih mjera, uključujući praćenje vitalnih znakova i kliničkog stanja bolesnika.
English: • if you are allergic to peramivir or any of the other ingredients of this medicine (listed in section
Croatian: • ako ste alergični na peramivir ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: In-vitro binding of peramivir to human plasma proteins is less than 30 %.
Croatian: In vitro vezivanje peramivira za proteine ljudske plazme manje je od 30 %.
English: • Patients with reduced kidney function may require a reduced dose.
Croatian: • Bolesnicima sa smanjenom funkcijom bubrega može biti potrebna smanjena doza.
English: This is because Alpivab may prevent these vaccines from working well enough.
Croatian: To je stoga što Alpivab može spriječiti zadovoljavajuće djelovanje tih cjepiva.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from peramivir therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti treba li prekinuti dojenje ili prekinuti liječenje / suzdržati se od liječenja peramivirom, uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: What Alpivab is and what it is used for 2.
Croatian: Što je Alpivab i za što se koristi 2.
English: Each carton contains 3 vials.
Croatian: Svaka kutija sadrži 3 bočice.
English: Resistance to peramivir
Croatian: Otpornost na peramivir
English: From a microbiological point of view, the product, once diluted, should be used immediately.
Croatian: S mikrobiološkog stajališta, proizvod je nakon razrjeđivanja potrebno odmah primijeniti.
English: 4.7 Effects on ability to drive and use machines Peramivir has no or negligible influence on the ability to drive and use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Peramivir ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: What you need to know before you are given Alpivab 3.
Croatian: Što morate znati prije nego što primite Alpivab 3.
English: Alpivab is not likely to change your ability to drive and use machines.
Croatian: Nije vjerojatno da će Alpivab promijeniti Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: The contribution of peramivir to these events has not been established.
Croatian: Nije utvrđen doprinos peramivira tim događajima.
English: Peramivir has not been shown to prevent such complications.
Croatian: Nije dokazano da peramivir sprječava takve komplikacije.
English: Contact your doctor immediately if any of the following side effects occur:
Croatian: Odmah se obratite svom liječniku ako se pojavi bilo koja od sljedećih nuspojava:
English: Serum creatinine measurements were used to calculate creatinine clearance (Cockcroft-Gault equation).
Croatian: Mjerenja kreatinina u serumu upotrijebljena su za izračun vrijednosti klirensa kreatinina (Cockcroft-Gaultova jednadžba).
English: Symptoms may include confusion, difficulty thinking or hallucinations.
Croatian: Simptomi mogu uključivati smetenost, teškoće pri razmišljanju ili halucinacije.
English: Table 4: Key efficacy results from study 0722T0621 (ITTI Population) Peramivir 600 mg n=97
Croatian: Tablica 4: Ključni rezultati djelotvornosti iz ispitivanja 0722T0621 (populacija ITTI) Peramivir 600 mg n = 97
English: Table 5: Pharmacokinetic parameters in paediatric subjects
Croatian: Tablica 5: Farmakokinetički parametri u pedijatrijskih ispitanika
English: In-vitro activity
Croatian: In vitro djelovanje
English: Haemodialysis initiated at 2 hours after dosing reduced systemic exposure of peramivir by 73 to 81 %.
Croatian: Hemodijaliza koja je započela 2 sata nakon doziranja smanjila je sistemsku izloženost peramiviru za 73 % do 81 %.
English: Alpivab is not recommended in children aged under 2 years.
Croatian: Primjena lijeka Alpivab ne preporučuje se u djece mlađe od 2 godine.
English: Tell your doctor if you are pregnant or breast-feeding.
Croatian: Obavijestite svog liječnika ako ste trudni ili dojite.
English: In general, nephrotoxicity was observed in rabbits, no unexpected toxicity was observed, and no other target organ toxicity was identified in juvenile animals.
Croatian: Općenito, uočena je nefrotoksičnost u kunića, nije zabilježena neočekivana toksičnost te nije utvrđena nijedna druga toksičnost za ciljane organe u mladunčadi životinja.
English: Randomisation was 4:1 for peramivir and oseltamivir.
Croatian: Randomizacija je bila 4:1 za peramivir i oseltamivir.
English: It must be colourless and without particulate matter.
Croatian: Mora biti bezbojan i bez lebdećih čestica.
English: What Alpivab looks like and contents of the pack
Croatian: Kako Alpivab izgleda i sadržaj pakiranja
English: This is equivalent to 10.6 % of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: To odgovara 10,6 % preporučenog maksimalnog dnevnog unosa soli za odraslu osobu.
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 24 hours at 2 ºC to 8 ºC, unless dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se proizvod ne upotrijebi odmah, razdoblje i uvjeti čuvanja prije primjene odgovornost su korisnika, a uobičajeno ne bi smjelo premašiti razdoblje od 24 sata pri temperaturi od 2 ºC do 8 ºC, osim ako je razrjeđivanje provedeno u kontroliranim i validiranim aseptičnim uvjetima.
English: Table 1: Peramivir dose based on age and body weight Age and body weight
Croatian: Tablica 1: Doza peramivira na osnovi dobi i tjelesne težine Dob i tjelesna težina
English: • reduced sense of touch or sensation
Croatian: • smanjenje osjećaja dodira ili osjeta
English: You must not receive Alpivab
Croatian: Ne smijete primiti Alpivab
English: Pharmacokinetic sampling in this study was limited to approximately 3 hours after administration of peramivir.
Croatian: Farmakokinetičko uzorkovanje u tom ispitivanju bilo je ograničeno na približno tri sata nakon primjene peramivira.
English: The recommended single intravenous dose of peramivir depends on age and body weight as shown in Table 1.
Croatian: Preporučena jednokratna intravenska doza peramivira ovisi o dobi i tjelesnoj težini, kao što je prikazano u tablici 1.
English: The following steps should be followed to prepare a diluted solution of peramivir:
Croatian: Potrebno je slijediti sljedeće korake za pripremu razrijeđene otopine peramivira:
English: Peramivir is an inhibitor of influenza virus neuraminidase, an enzyme that releases viral particles from the plasma membrane of infected cells and is also important for viral entry into uninfected cells, which causes further spread of infectious virus in the body.
Croatian: Peramivir je inhibitor neuraminidaze virusa gripe, enzima koji otpušta virusne čestice iz plazmatske membrane zaraženih stanica te je ujedno važan za prodiranje virusa u nezaražene stanice, što uzrokuje daljnje širenje zaraznog virusa u tijelu.
English: Pharmacotherapeutic group: Antivirals for systemic use, neuraminidase inhibitors ATC code: J05AH03
Croatian: Farmakoterapijska skupina: antivirusni lijekovi za sistemsku primjenu, inhibitori neuraminidaze ATK oznaka: J05AH03
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1269/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1269/001
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Alpivab in one or more subsets of the paediatric population for the treatment of influenza (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Alpivab u jednoj ili više podskupina pedijatrijske populacije u liječenju gripe (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: The recommended 600 mg single intravenous dose resulted in shortening of the median time to alleviation of symptoms by 21 hours (see section 5.1).
Croatian: Preporučena jednokratna intravenska doza od 600 mg dovela je do skraćivanja medijana vremena potrebnog za ublažavanje simptoma za 21 sat (vidjeti dio 5.1).
English: Alpivab contains the active substance peramivir which belongs to a group of medicines called neuraminidase inhibitors.
Croatian: Alpivab sadržava djelatnu tvar peramivir, koja pripada skupini lijekova pod nazivom inhibitori neuraminidaze.