natgillin/translations-raw huggingface dataset:
− Do not prescribe Zinbryta for patients with pre-existing hepatic disease or hepatic impairment as it is contraindicated in these patients.
Ne propisujte lijek Zinbryta bolesnicima s prethodnom bolešću ili oštećenjem jetre, s obzirom na to da je u tih bolesnika kontraindiciran.
Several cases of serious liver injury including immune-mediated hepatitis and fulminant liver injury have been reported.
Zabilježeno je nekoliko slučajeva teškog oštećenja jetre, uključujući hepatitis posredovan imunosnim sustavom i fulminantno oštećenje jetre.
The review was carried out 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.
Ocjenjivanje je proveo Odbor za procjenu rizika u području farmakovigilancije (PRAC), odbor odgovoran za ocjenu sigurnosnih pitanja u pogledu lijekova za humanu uporabu, koji je iznio niz preporuka.
Zinbryta is available as a solution for injection in pre-filled pens and syringes.
Lijek Zinbryta dostupan je kao otopina za injekciju u napunjenim brizgalicama i štrcaljkama.
• If you are currently on Zinbryta, your doctor will check whether you should continue your treatment or switch to an alternative.
• Ako se trenutačno liječite lijekom Zinbryta, liječnik će provjeriti smijete li nastaviti terapiju ili morate prijeći na neku drugu terapiju.
If you do not have your liver checked as required, your prescriptions may be stopped.
Ako ne provjeravate svoju jetru kako je to potrebno, liječnik može odlučiti da vam više neće propisivati lijek.
The review of the liver effects of Zinbryta was conducted by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which issued recommendations in October 2017.
Ocjenjivanje učinaka lijeka Zinbryta na jetru proveo je Odbor za procjenu rizika u području farmakovigilancije (PRAC) pri Europskoj agenciji za lijekove koji je u listopadu 2017. izdao preporuke.
− It is recommended that you do not start treatment in new patients with ALT or AST levels equal to or more than 2 times the upper limit of normal (ULN) or in patients with autoimmune conditions other than multiple sclerosis.
Ne preporučuje se započinjanje liječenja novih bolesnika s razinama ALT ili AST jednakima ili dvaput višima od gornje granice normale (ULN) ili bolesnika s autoimunim bolestima osim multiple skleroze.
Zinbryta to be used in restricted patient group, with strict liver monitoring
Lijek Zinbryta potrebno je primjenjivati u ograničenoj skupini bolesnika uz strogo praćenje rada jetre
• Zinbryta can cause unpredictable and potentially fatal immune-mediated liver injury.
• Lijek Zinbryta može uzrokovati nepredvidiva i potencijalno smrtonosna oštećenja jetre posredovana imunosnim sustavom.
• In view of the risk, the indication for Zinbryta is restricted to adult patients with relapsing forms of multiple sclerosis who have had an inadequate response to at least two disease modifying therapies (DMTs) and for whom treatment with any other DMT is contraindicated or otherwise unsuitable.
• S obzirom na rizik, indikacija za lijek Zinbryta ograničena je na liječenje odraslih bolesnika s relapsnim oblicima multiple skleroze koji nisu imali odgovarajući odgovor na barem dvije terapije koje mijenjaju tijek bolesti (DMT-ovi) i u kojih je liječenje bilo kojim drugim DMT-om kontraindicirano ili iz drugih razloga neprikladno.
− Monitor patients' serum transaminase and bilirubin levels at least monthly and as close as possible before each administration, and for up to 6 months after stopping treatment.
Pratite razine serumskih transaminaza i bilirubina u bolesnika barem jedanput mjesečno sa što manjim vremenskim odmakom prije svake primjene te do šest mjeseci nakon prestanka liječenja.
• Zinbryta can cause serious and life-threatening liver problems in some patients.
• Lijek Zinbryta može u nekih bolesnika uzrokovati teške i za život opasne probleme s jetrom.
− Exercise caution in patients taking other medicinal products with known hepatotoxic potential, including non-prescription products and herbal supplements.
Budite na oprezu u slučaju bolesnika koji uzimaju druge lijekove za koje je poznato da imaju hepatotoksični potencijal, uključujući lijekove koji se izdaju bez liječničkog recepta i biljne dodatke.
• Because of this risk, Zinbryta will now only be given to patients who have tried at least two other disease modifying treatments and cannot be treated with any other such treatments.
• Zbog tog rizika lijek Zinbryta odsada će se davati bolesnicima koji su probali barem dvije terapije koje mijenjaju tijek bolesti i koji se ne mogu liječiti nijednom drugom takvom terapijom.
Zinbryta should now only be used in patients who have had an inadequate response to at least two disease modifying therapies (DMTs) and cannot be treated with any other DMTs.
Lijek Zinbryta trebalo bi primjenjivati samo u bolesnika koji nisu imali odgovarajući odgovor na barem dvije terapije koje mijenjaju tijek bolesti (DMT-ovi) i koji se ne mogu liječiti ni jednim drugim DMT-om.
Multiple sclerosis is a disease in which inflammation damages the protective sheath around the nerve cells in the brain and spinal cord.
Multipla skleroza je bolest pri kojoj upala oštećuje zaštitne ovojnice oko živčanih stanica u mozgu i leđnoj moždini. „Relaps” znači da u bolesnika dolazi do izbijanja neuroloških simptoma.
− It is recommended that you stop treatment in patients with ALT or AST levels more than 3 times the ULN regardless of bilirubin levels.
Preporučuje se prestanak liječenja bolesnika s razinama ALT ili AST triput višima od gornje granice normalnih vrijednosti, neovisno o razinama bilirubina.
The review found that unpredictable and potentially fatal immune-mediated liver injury can occur during treatment with Zinbryta and for up to 6 months after stopping treatment.
Ocjenjivanjem je utvrđeno da se tijekom liječenja lijekom Zinbryta te do šest mjeseci nakon prestanka liječenja mogu javiti nepredvidiva i potencijalno smrtonosna oštećenja jetre posredovana imunosnim sustavom.
This overview was last updated in March 2018.
Pregled informacija posljednji je put ažuriran u ožujku 2018.
This is normal and will generally resolve within a couple of days.
To je normalno i obično prolazi nakon nekoliko dana.
Further information on Activyl Tick Plus can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Više informacija o VMP-u Activyl Tick Plus možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
On the day of treatment, children must not handle treated dogs and the dogs should not be allowed to sleep with their owners, especially children.
Na dan primjene djeca ne smiju dirati pse kojima je dan VMP, a psima se ne smije dopustiti da spavaju sa svojim vlasnicima, osobito djecom.
Hands should be washed immediately after use and any product in contact with the skin should be washed off immediately with soap and water.
Ruke treba oprati odmah nakon primjene, a svaki proizvod koji je došao u dodir s kožom mora se odmah isprati sapunom i vodom.
These effects usually resolve without treatment.
Te pojave obično nestanu bez ikakve terapije.
For larger dogs, the content can be applied in two (medium dogs), three (large dogs), or four (very large dogs) different spots along the back from the shoulders to the base of the tail.
Za veće pse sadržaj se može nanijeti na dva (srednje veliki psi), tri (veliki psi) ili četiri (vrlo veliki psi) mjesta duž leđa od ramena do baze repa.
Both treatments reduced flea and tick numbers to almost zero by the end of the study period.
Objema terapijama broj buha i krpelja smanjen je gotovo na nulu do kraja razdoblja ispitivanja.
The medicine is highly flammable and should be kept away from possible sources of ignition.
VMP je lako zapaljiv i treba ga držati podalje od mogućih izvora zapaljenja.
If Activyl Tick Plus is accidentally spilled into eyes, it should be rinsed off with water.
Ako se Activyl Tick Plus slučajno prolije po očima, treba ga isprati vodom.
For very small and small dogs, the full content of a pipette appropriate for the dog's weight is applied to the skin between the shoulder blades, after parting the fur.
Za vrlo male i male pse čitav sadržaj pipete koji odgovara težini psa nanosi se na kožu između lopatica nakon što se razmakne dlaka.
To protect children, the medicine should be kept in its sachet until use, and the used pipette should be disposed of immediately.
Radi zaštite djece VMP treba čuvati u svojoj vrećici do trenutka primjene, a iskorištenu pipetu treba odmah baciti.
Other information about Activyl Tick Plus:
Ostale informacije o VMP-u Activyl Tick Plus:
Fleas, ticks and sand flies might still be able to transmit any diseases which they may be carrying.
Buhe, krpelji i pješčane mušice i dalje mogu uzrokovati bolesti kojih su prijenosnici.
Activyl Tick Plus received a marketing authorisation valid throughout the EU on 9 January 2012.
VMP Activyl Tick Plus dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 9. siječnja 2012.
One field study involved 230 dogs where Activyl Tick Plus was compared with fipronil (another ectoparasiticide), where the medicines were given every four weeks for 12 weeks.
Jednim je terenskim ispitivanjem bilo obuhvaćeno 230 pasa i u njemu je Activyl Tick Plus uspoređen s fipronilom (drugim ektoparaziticidom), pri čemu su se lijekovi primjenjivali svaka 4 tjedna u razdoblju od 12 tjedana.
It must not be used in dogs which are known to be hypersensitive (allergic) to indoxacarb, permethrin or to any of the other ingredients.
Ne smije se upotrebljavati kod pasa koji su dokazano preosjetljivi (alergični) na indoksakarb, permetrin ili bilo koji drugi sastojak lijeka.
The medicine should be applied in a well-ventilated area and treated dogs should not be handled until the application site is dry.
VMP treba primjenjivati u dobro prozračenom prostoru, a pse kojima je nanesen ne bi trebalo dirati dok se mjesto nanošenja ne osuši.
The main measure of effectiveness was the repellent effect against sand flies as measured by the number of fed female sand flies.
Glavna mjera učinkovitosti bio je odbijajući učinak na pješčane mušice koji se mjerio brojem nahranjenih ženskih jedinki pješčanih mušica.
People should not eat, drink or smoke while handling the medicine.
Prilikom rukovanja VMP-om ne smije se jesti, piti ni pušiti.
The solution is supplied in pipettes filled with the appropriate amounts of indoxacarb and permethrin for dogs of various weights.
Otopina se nalazi u pipetama koje su napunjene odgovarajućim količinama indoksakarba i permetrina za pse različitih težina.
Activyl Tick Plus can also be used as a repellent (a substance that deters insects from approaching and settling) against sand flies (Phlebotomus perniciosus) that is active for up to 3 weeks.
Activyl Tick Plus može se upotrebljavati i kao repelent (tvar koja odbija približavanje i nastanjivanje kukaca) protiv pješčane mušice (Phlebotomus perniciosus) koji djeluje do 3 tjedna.
Activyl Tick Plus must not be used in cats as adverse reactions and even death can occur.
Activyl Tick Plus ne smije se primjenjivati u mačaka jer može izazvati nuspojave, pa čak i smrt.
The European Medicines Agency decided that Activyl Tick Plus's benefits are greater than its risks and it can be authorised for use in the EU.
Europska agencija za lijekove zaključila je da koristi od VMP-a Activyl Tick Plus nadmašuju s njim povezane rizike te da može biti odobren za primjenu u Europskoj uniji.
People who are known to be hypersensitive to indoxacarb or permethrin should avoid contact with the product.
Osobe koje su dokazano preosjetljive na indoksakarb ili permetrin trebaju izbjegavati kontakt s VMP-om.
What is Activyl Tick Plus and what is it used for?
Što je Activyl Tick Plus i za što se koristi?
The medicine can be obtained without a prescription.
VMP se izdaje bez veterinarskog recepta.
Activyl Tick Plus (indoxacarb / permethrin)
Activyl Tick Plus indoksakarb/permetrin
The most common side effects seen with Activyl Tick Plus (which may affect up to 1 in 10 animals) are transitory scratching, erythema (reddening of the skin) and hair loss at the application site.
Najčešće nuspojave zabilježene prilikom primjene VMP-a Activyl Tick Plus (koje se mogu javiti u najviše 1 od 10 životinja) jesu prolazno grebanje, eritem (crvenilo kože) i gubitak dlake na mjestu nanošenja.
The effectiveness of Activyl Tick Plus against fleas and ticks was investigated in laboratory studies and in three field studies.
Učinkovitost VMP-a Activyl Tick Plus protiv buha i krpelja ispitana je u laboratorijskim ispitivanjima i u trima terenskim ispitivanjima.
The active substances in Activyl Tick Plus, indoxacarb and permethrin, are ectoparasiticides, which kill parasites such as fleas and ticks that may be found on the skin or in the fur of animals.
Djelatne tvari u VMP-u Activyl Tick Plus, indoksakarb i permetrin, pripadaju ektoparaziticidima, koji ubijaju nametnike kao što su buhe i krpelji koji se mogu naći na koži ili u dlaci životinja.
Together, the active form of indoxacarb and permethrin interfere with the parasites' nervous system, causing paralysis and death.
Djelatne tvari indoksakarb i permetrin zajedničkim djelovanjem ometaju živčani sustav nametnika, što uzrokuje paralizu i smrt.
An overview of Activyl Tick Plus and why it is authorised in the EU
Pregled informacija o VMP-u Activyl Tick Plus i zašto je odobren u EU-u
The application of Activyl Tick Plus may produce a temporary oily appearance or hair clumping at the application site, or a dry white residue.
Primjenom VMP-a Activyl Tick Plus može doći do pojave privremenog masnog izgleda ili nakupljanja dlake na mjestu nanošenja ili suhog bijelog ostatka.
The effectiveness of Activyl Tick Plus against sand flies was shown in two laboratory studies.
Učinkovitost VMP-a Activyl Tick Plus protiv pješčanih mušica utvrđena je u dvama laboratorijskim ispitivanjima.
What are the risks associated with Activyl Tick Plus?
Koji su rizici povezani s VMP-om Activyl Tick Plus?
Activyl Tick Plus is a veterinary medicine used in dogs to treat flea and tick infestations.
Activyl Tick Plus je veterinarsko-medicinski proizvod (VMP) koji se koristi u pasa za suzbijanje infestacija buhama i krpeljima.
After application, indoxacarb and permethrin are ingested by the fleas and ticks (indoxacarb is converted in their gut into an active form).
Nakon primjene VMP-a buhe i krpelji progutaju indoksakarb i permetrin (indoksakarb se u njihovim crijevima pretvara u djelatni oblik).
In one study, Activyl Tick Plus showed repellant activity of above 95% at 1 day after treatment, falling to 92% at 3 weeks after treatment.
VMP Activyl Tick Plus u jednom je ispitivanju pokazao odbijajuće djelovanje veće od 95 % jedan dan nakon primjene, da bi se tri tjedna nakon primjene ono smanjilo na 92 %.
Why is Activyl Tick Plus authorised in the EU?
Zašto je VMP Activyl Tick Plus odobren u EU-u?
If adverse reactions occur, medical advice should be sought and the package leaflet shown to the doctor.
U slučaju nuspojava potrebno je odmah zatražiti liječnički savjet te pokazati liječniku uputu o VMP-u.
For more information about using Activyl Tick Plus, see the package leaflet or contact your veterinarian or pharmacist.
Za dodatne informacije o primjeni VMP-a Activyl Tick Plus pročitajte uputu o VMP-u, odnosno obratite se veterinaru ili ljekarniku.
In the other study, Activyl Tick Plus showed repellant activity of 98% at 2 days after treatment falling to 86% at 3 weeks.
U drugom je ispitivanju VMP Activyl Tick Plus pokazao odbijajuće djelovanje od 98 % dva dana nakon primjene, da bi se tri tjedna nakon primjene ono smanjilo na
The medicine, available as a spot-on solution, is given as a single application to the dog's skin.
VMP je dostupan u obliku otopine za nakapavanje, a primjenjuje se jednokratnim nanošenjem na kožu psa.
The effectiveness was measured by counting the number of fleas and ticks at fortnightly intervals.
Učinkovitost se mjerila utvrđivanjem broja buha i krpelja u dvotjednim razmacima.
Permethrin also acts as a repellent and so helps prevent sand flies from settling and taking a blood meal.
Permetrin djeluje i kao repelent te sprječava pješčane mušice da dođu na tijelo i nahrane se krvlju.
How is Activyl Tick Plus used?
Kako se Activyl Tick Plus koristi?
What benefits of Activyl Tick Plus have been shown in studies?
Koje su koristi VMP-a Activyl Tick Plus utvrđene u ispitivanjima?
Activyl Tick Plus contains the active substances indoxacarb and permethrin.
Activyl Tick Plus sadržava djelatne tvari indoksakarb i permetrin.
Protective gloves should be worn when handling or applying Activyl Tick Plus to dogs.
Prilikom rukovanja VMP-om Activyl Tick Plus ili njegove primjene u pasa moraju se nositi zaštitne rukavice.
No changes were introduced.
Nisu uvedene izmjene.
The European and Asian development plans have been conducted independently in the two different populations.
Europski i azijski planovi za razvoj provedeni su nezavisno u dvije različite populacije.
The results of this PASS are awaited in Q1 2015.
Rezultati ovog PASS-a očekuju se u 1. tromjesečju 2015.
These doses were therefore used in all the major controlled trials.
Te su doze stoga korištene u svim glavnim kontroliranim ispitivanjima.
Labelling The labelling was reviewed during this procedure.
Tijekom ovog postupka pregledano je označivanje.
However, strong uncertainties regarding this preventive effect do not allow any recommendation and cannot support such an indication.
No, velike nesigurnosti u vezi s ovim preventivnim djelovanjem ne dopuštaju davanje bilo kakvih preporuka i ne mogu podržati tu indikaciju.
Be careful to avoid nitrate tolerance (Class IIb, level of evidence C).
Pripazite da izbjegavate toleranciju nitrata (klasa II.b, razina dokaza C).
However this was based on limited evidence via literature10 (Ekanayaka, 2014).
No, ovo je temeljeno na ograničenom dokazu iz literature10 (Ekanayaka, 2014.).
In general, it can be stated, that the treatment should be conducted with the lowest effective dose.
Načelno, može se reći da se terapija treba provesti s najmanjom djelotvornom dozom.
Section 4.5 - Interaction with other medicinal products and other forms of interaction
Odjeljak 4.5. - Interakcije s drugim lijekovima i drugi oblici interakcija
Ikorel and Dancor medicinal products are registered and marketed in the following EU Members States: Austria, Denmark, France, Ireland, the Netherlands, Portugal and United Kingdom.
Lijekovi Ikorel i Dancor registrirani su i stavljeni u promet u sljedećim državama članicama EU-a: Austriji, Danskoj, Francuskoj, Irskoj, Nizozemskoj, Portugalu i Ujedinjenoj Kraljevini.
Therefore, a contra-indication is not considered justified, however a warning statement is requested by the CHMP.
Stoga se kontraindikacija ne smatra opravdanom, no izjavu o upozorenju zatražio je CHMP.
<Invented name> is not recommended in paediatric patients since its safety and efficacy have not been established in this patient group.
<Zaštićeno ime> ne preporuča se u pedijatrijskih bolesnika budući da njegova sigurnost i djelotvornost nisu utvrđeni u ovoj grupi bolesnika.
There were no major discrepancies between the existing wordings in the different SmPCs.
Nisu postojale veće razlike između postojećeg teksta u različitim SmPC-ovima.
Therefore the 20 mg daily dose could not be generalised.
Stoga se dnevna doza od 20 mg ne može generalizirati.
In addition, this study is limited by the enrolled population with low revascularisation.
Uz to, ovo je ispitivanje ograničeno upisanom populacijom s niskom revaskularizacijom.
The reduction in preload was proportionally more important than that of the afterload.
Smanjenje preopterećenja bilo je proporcionalno značajnije od onog u naknadnom opterećenju.
The CHMP noted that the daily dose in Asiatic patients is below the one defined in European patients.
CHMP je zaključio da je dnevna doza za azijske bolesnike manja od one definirane za europske bolesnike.
Therefore, the CHMP is of opinion that this indication is not supported due to lack of appropriate data.
Stoga CHMP smatra da ta indikacija nije podržana uslijed nedostatka odgovarajućih podataka.
The results of the IONA study were summarised following the same wording for both groups of products.
Rezultati ispitivanja IONA sažeti su, a koristi se isti tekst za obje grupe proizvoda.
The information/education to gain a knowledge that allows this diagnosis is the best risk minimisation measure identified so far.
Informiranje/educiranje radi stjecanja znanja koje omogućuje ovu dijagnozu najbolja je mjera smanjivanja rizika koja je do sada utvrđena.
Case Rep. BMJ, 2014, Mar 10.
BMJ, 2014, Mar 10.
Hyperkalaemia occurs infrequently with NSAIDs.
Hiperkalemija nastupa rijetko s NSAID-ovima.
Postural hypotension was observed, although only after the first administration, whether it was 40 or 60 mg.
Uočena je posturalna hipotenzija, iako samo nakon prve primjene, bez obzira na to da li se radilo o dozi od 40 ili 60 mg.
Furthermore, the secondary endpoint, the composite of cardiovascular death and MI, does not reach statistical significance and thus confirms the weakness and irrelevancy of the primary endpoint.
Osim toga, sekundarna završna točka, kombinacija kardiovaskularne smrti i IM-a, ne postiže statistički značaj te stoga potvrđuje slabost i nerelevantnost primarne završne točke.
The statistically significant superiority of a single 5 mg dose over placebo was not considered as relevant evidence for efficacy after repeated dosing, as it was an acute administration only, and this was not the objective of the study.
Statistički značajna superiornost jedne doze od 5 mg u odnosu na placebo nije se smatrala relevantnim dokazom djelotvornosti nakon ponovljenog doziranja jer je to bila samo akutna primjena, a to nije bio cilj ispitivanja.
The step of a retrospective assessment as part of the pharmacovigilance plan is a pre-requisite for a thorough understanding of the factors leading to the development of ulcerations.
Korak retrospektivne ocjene kao dijela farmakovigilancijskog plana jest preduvjet za temeljno razumijevanje čimbenika koji uzrokuju razvoj ulceracija.
While the IONA study does not provide adequate support for a prevention indication, the totality of the data, including IONA, provide good support for the new symptomatic indication proposed above.
Iako ispitivanje IONA ne pruža primjerenu podršku za indikaciju prevencije, sveukupni podaci, uključujući i ispitivanje IONA, pružaju dobru podlogu za novu simptomatičku indikaciju koja je prethodno predložena.
The CHMP was therefore of the view that the indication of cardiovascular prevention was not further supported.
CHMP je stoga smatrao da indikacija kardiovaskularne prevencije više nije podržana.
However, the 5 mg dose although active in Japanese patients has shown to induce modest haemodynamic changes.
No, iako je doza od 5 mg djelovala, u japanskih bolesnika, utvrđene su skromne hemodinamske promjene.
Consequently, as none of the performed studies show efficacy at doses lower than 20 mg b.i.d., and as the toxicity is dose dependant and appears at 20 mg b.i.d., the indication should be restricted to second line treatment as recommended in section 4.1 for safety reasons.
Posljedično, budući da niti jedno provedeno ispitivanje nije pokazalo djelotvornost u dozi manjoj od 20 mg b.i.d. te budući da je toksičnost ovisna o dozi i pojavljuje se pri 20 mg b.i.d., indikaciju treba ograničiti na drugu liniju terapije kako je preporučeno u odjeljku 4.1. iz sigurnosnih razloga.
The number of patients treated by nicorandil per dosage is unavailable; it is thus unknown whether a dose reduction would allow a reduction in ulceration without lack of efficacy.
Broj bolesnika liječenih nikorandilom po doziranju nije dostupan; stoga nije poznato bi li smanjenje doze omogućilo smanjenje ulceracije bez gubitka djelotvornosti.