FrancophonIA/ELRC3.0 huggingface dataset:
English: Trobalt has an effect on the potassium channels located on the nerve cells of the brain.
Croatian: Trobalt djeluje na kalijeve kanale koji se nalaze u živčanim stanicama mozga.
English: It will also include information on some less common side effects that have been reported with the medicine, such as problems with passing urine, prolonged QT interval (an alteration of the electrical activity of the heart) and hallucinations (seeing or hearing things that are not there).
Croatian: Ovaj paket treba, također, uključivati informacije o manje uobičajenim nuspojavama koje su prijavljene s lijekom, poput tegoba s mokrenjem, produljenog QT intervala (izmjena električne aktivnosti srca) i halucinacija (bolesnici vide ili čuju stvari koje ne postoje).
English: For more information on how to use Trobalt, including detailed recommendations for different patients groups, see the summary of product characteristics (also part of the EPAR).
Croatian: Za više informacija o načinu primjene Trobalta, uključujući i detaljne preporuke za različite grupe bolesnika, pogledajte sažetak opisa svojstava lijeka (također dio EPAR-a).
English: Trobalt at a maintenance dose of 600, 900 or 1,200 mg a day or placebo was taken for 8 weeks in the first study and 12 weeks in the other two studies.
Croatian: U prvom ispitivanju uziman je Trobalt u dozama održavanja od 600, 900 ili 1.200 mg na dan ili placebo tijekom 8 tjedana, te tijekom 12 tjedana u druga dva ispitivanja.
English: The most common side effects with Trobalt (seen in more than 1 patient in 10) are dizziness, somnolence (sleepiness), fatigue (tiredness) as well as pigment changes (discolouration) of parts of the eye (including the retina, the light sensitive membrane at the back of the eye) and discolouration of the nails, lips and skin, which have been reported after several years of treatment.
Croatian: Najčešće nuspojave ovog lijeka (koje se mogu javiti u više od 1 na 10 bolesnika) su vrtoglavica, somnolencija (pospanost), iscrpljenost (umor), kao i promjene pigmenta (diskoloracija) dijelova oka (uključujući i rožnicu, membranu osjetljivu na svjetlost u pozadini oka) i gubitak boje noktiju, usnica i kože, što je prijavljeno nakon nekoliko godina liječenja.
English: Trobalt is a medicine that contains the active substance retigabine.
Croatian: Trobalt je lijek koji sadrži djelatnu tvar retigabin.
English: In the first study, Trobalt at 900 mg a day and 1,200 mg a day was more effective than placebo and reduced the number of seizures per month by 29% and 35% respectively.
Croatian: U prvom ispitivanju, Trobalt u dozi od 900 mg na dan i 1.200 mg na dan bio je djelotvorniji od placeba i smanjio je broj napadaja mjesečno za 29%, odnosno 35%.
English: Lower doses should be used in older patients and in patients with moderate or severe liver or kidney problems.
Croatian: Manje se doze trebaju koristiti u starijih bolesnika s umjerenim do ozbiljnim oštećenjem jetre ili bubrega.
English: The CHMP decided that the benefits of Trobalt are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) odlučilo je da koristi Trobalta nadmašuju s njim povezane rizike te je preporučilo davanje odobrenja za stavljanje lijeka u promet.
English: In the third study, seizures were at least halved in 56% (66 out of 119 patients) of the patients taking 1,200 mg Trobalt a day, compared with 23% (31 out of 137) of the patients on placebo.
Croatian: U trećem ispitivanju, napadaji su barem prepolovljeni u 56% bolesnika (u 66 bolesnika od 119), koji su uzimali 1.200 mg Trobalta na dan, u usporedbi s 23% bolesnika (31 od 137 bolesnika), koji su uzimali placebo.
English: What is Trobalt used for?
Croatian: Za što se koristi Trobalt?
English: In the second study, seizures were at least halved in 39% (61 out of 158 patients) of the patients on 600 mg Trobalt a day and in 47% (70 out of 149 patients) of the patients on 900 mg a day, compared with 19% (31 out of 164) of the patients on placebo.
Croatian: U drugom ispitivanju, napadaji su barem prepolovljeni u 39% bolesnika (u 61 bolesnika od 158 bolesnika), koji su uzimali 600 mg Trobalta na dan, i u 47% bolesnika (kod 70 bolesnika od 149 bolesnika), koji su uzimali 900 mg
English: For the full list of all side effects reported with Trobalt, see the package leaflet.
Croatian: Potpuni popis nuspojava koje su zabilježene s Trobalt potražite u uputi o lijeku.
English: How is Trobalt used?
Croatian: Kako se Trobalt koristi?
English: How has Trobalt been studied?
Croatian: Kako je Trobalt ispitan?
English: What benefit has Trobalt shown during the studies?
Croatian: Trobalta su dokazane u ispitivanjima?
English: How does Trobalt work?
Croatian: Kako Trobalt djeluje?
English: The maximum dose is 25.2 g once a day.
Croatian: Najveća doza je 25,2 g jednom na dan.
English: The recommended starting dose is 8.4 g once a day.
Croatian: Preporučena početna doza je 8,4 g jednom na dan.
English: The full EPAR for Veltassa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Veltassa nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Hyperkalaemia can cause serious heart problems and muscle weakness.
Croatian: Hiperkalijemija može uzrokovati ozbiljne srčane probleme i slabost mišića.
English: The Veltassa mixture should be taken with food and at least 3 hours before or after any other medicines the patient takes by mouth.
Croatian: Mješavinu lijeka Veltassa treba uzimati s hranom, i to najmanje tri sata prije ili poslije drugih lijekova koje bolesnik uzima kroz usta.
English: What is Veltassa and what is it used for?
Croatian: Što je Veltassa i za što se koristi?
English: Other information about Veltassa
Croatian: Ostale informacije o lijeku Veltassa
English: What measures are being taken to ensure the safe and effective use of Veltassa?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Veltassa?
English: This is a summary of the European public assessment report (EPAR) for Veltassa.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Veltassa.
English: The doctor then adjusts the dose at intervals of at least one week, based on the patient's blood levels of potassium.
Croatian: Nakon toga liječnik prilagođava dozu u razmacima od najmanje jednog tjedna na temelju razine kalija u krvi bolesnika.
English: Veltassa is available as sachets (8.4, 16.8 and 25.2 g) of patiromer containing a powder for mixing with water or some fruit juices and taking by mouth.
Croatian: Lijek Veltassa dostupan je u obliku vrećica s patiromerom (8,4 g, 16,8 g i 25,2 g) u kojima se nalazi prah za miješanje s vodom ili voćnim sokom namijenjen za primjenu kroz usta.
English: What are the risks associated with Veltassa?
Croatian: Koji su rizici povezani s lijekom Veltassa?
English: The side effects are relatively moderate but the doctor should take them into account when considering treatment with Veltassa.
Croatian: Nuspojave su relativno umjerene, no liječnik ih treba uzeti u obzir kada razmišlja o propisivanju terapije lijekom Veltassa.
English: It is not intended to provide practical advice on how to use Veltassa.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Veltassa.
English: The European Medicines Agency decided that Veltassa's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Stav je Europske agencije za lijekove da koristi lijeka Veltassa nadmašuju s njim povezane rizike te je preporučila davanje odobrenja za njegovu primjenu u EU-u.
English: When Veltassa is taken by mouth, the active substance, patiromer, remains in the gut where it attaches tightly to potassium to form a compound that is then passed out in the stool.
Croatian: Kada se Veltassa uzme kroz usta, djelatna tvar patiromer zadržava se u crijevu, gdje se čvrsto veže na kalij s kojim stvara spoj koji se zatim izbacuje stolicom.
English: The most common side effects with Veltassa (which may affect more than 1 in 100 people) are those affecting the digestive system (constipation, diarrhoea, abdominal pain and wind) and blood tests showing low levels of magnesium in the blood.
Croatian: Najčešće nuspojave lijeka Veltassa (koje se mogu javiti u više od 1 od 100 osoba) jesu one koje djeluju na probavni sustav (zatvor, proljev, bol u abdomenu i vjetrovi) te niska razina magnezija u krvi zabilježena kontrolama krvne slike.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Veltassa 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 Veltassa nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Why is Veltassa approved?
Croatian: Zašto je lijek Veltassa odobren?
English: For more information about treatment with Veltassa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Veltassa pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: In the first part of the study, 243 patients with hyperkalaemia (with average potassium level of 5.6 mmol/litre) were treated with Veltassa.
Croatian: U prvom dijelu ispitivanja 243 bolesnika s hiperkalijemijom (s prosječnom razinom kalija od 5,6 mmol/l) liječeno je lijekom Veltassa.
English: Veltassa is a medicine used for treating adults with high levels of potassium in the blood (hyperkalaemia).
Croatian: Veltassa je lijek koji se primjenjuje za liječenje odraslih osoba s visokom razinom kalija u krvi (hiperkalijemija).
English: After 4 weeks, the average potassium level did not change in patients who received Veltassa for 4 weeks but it went back up by an average of 0.7 mmol/litre in patients who received placebo.
Croatian: Nakon 4 tjedna prosječna razina kalija nije se promijenila u bolesnika koji su dobivali lijek Veltassa ta 4 tjedna, no u bolesnika koji su dobivali placebo ona se ponovno povećala u prosjeku za 0,7 mmol/l.
English: patiromer draws potassium from the body into the gut and so reduces the amount of potassium in the blood.
Croatian: Na taj način patiromer privlači kalij iz tijela u crijevo te tako smanjuje količinu kalija u krvi.
English: What benefits of Veltassa have been shown in studies?
Croatian: Koje su koristi lijeka Veltassa dokazane u ispitivanjima?
English: Veltassa contains the active substance patiromer.
Croatian: Veltassa sadržava djelatnu tvar patiromer.
English: After 4 weeks of treatment, their potassium level fell on average by 1.0 mmol/litre.
Croatian: Nakon 4 tjedna liječenja razina kalija u njihovoj krvi smanjila se u prosjeku za 1,0 mmol/l.
English: The Agency considered that there is a need for effective treatment of hyperkalaemia and Veltassa achieves a meaningful lowering of potassium levels.
Croatian: Agencija smatra da postoji potreba za djelotvornim liječenjem hiperkalijemije te da se lijekom Veltassa postiže značajno smanjenje razine kalija.
English: The second part of the study compared Veltassa with placebo (a dummy treatment) in 107 patients whose potassium level had fallen with Veltassa treatment during the first part of the study.
Croatian: U drugom dijelu ispitivanja lijek Veltassa uspoređen je s placebom (prividno liječenje) na uzorku od 107 bolesnika kod kojih se razina kalija smanjila nakon liječenja lijekom Veltassa u prvom dijelu ispitivanja.
English: One main study involving patients with chronic kidney disease who had hyperkalaemia found that Veltassa is effective in reducing potassium levels in the blood.
Croatian: U jednom glavnom ispitivanju koje je obuhvatilo bolesnike s kroničnom bolesti bubrega kod kojih je zabilježena hiperkalijemija dokazano je da lijek Veltassa učinkovito smanjuje razinu kalija u krvi.
English: For practical information about using Veltassa, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Veltassa bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: How is Veltassa used?
Croatian: Kako se Veltassa koristi?
English: How does Veltassa work?
Croatian: Kako djeluje Veltassa?
English: For the full list of all side effects and restrictions with Veltassa, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja pri primjeni lijeka Veltassa potražite u uputi o lijeku.
English: Route of administration Immediate Packaging Content (concentration) Pack size
Croatian: Unutarnje pakiranje Sastav (koncentracija)
English: 3 bottles
Croatian: Veličina pakiranje
English: 1 bottle
Croatian: Doza
English: This overview was last updated in March 2019.
Croatian: Pregled informacija posljednji je put ažuriran u ožujku 2019.
English: This medicine is the same as NexGard, which is already authorised in the European Union (EU).
Croatian: Ovaj VMP isti je kao i NexGard, koji je već odobren u Europskoj uniji (EU).
English: The blister with the remaining chewable tablets should be returned into the carton.
Croatian: Blister s preostalim tabletama za žvakanje treba vratiti u kutiju.
English: The appropriate strength of tablets to be given is determined based on the dog's bodyweight.
Croatian: Odgovarajuća jačina tableta koje treba primijeniti određuje se na temelju tjelesne težine psa.
English: People handling the medicine should wash their hands after handling the product.
Croatian: Osobe koje rukuju VMP-om moraju oprati ruke nakon rukovanja proizvodom.
English: Afoxolaner kills parasites by causing over-stimulation of their nervous system.
Croatian: Afoksolaner ubija parazite uzrokujući prekomjernu stimulaciju njihova živčanog sustava.
English: In order for the active substance to have an effect, fleas and ticks must attach to the skin and start feeding on the dog's blood.
Croatian: Kako bi ih se izložilo djelatnoj tvari, buhe i krpelji moraju se primiti za kožu i započeti hranjenje krvlju psa.
English: This authorisation was based on the authorisation granted to NexGard in 2014 (‘informed consent').
Croatian: Odobrenje se temeljilo na odobrenju koje je 2014. izdano za MVP NexGard („informirani pristanak”).
English: Afoxolaner Merial (afoxolaner) EMA/206832/2019
Croatian: Afoxolaner Merial (afoksolaner) EMA/206832/2019
English: Further information on Afoxolaner Merial can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/afoxolaner-merial.
Croatian: Više informacija o VMP-u Afoxolaner Merial nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/veterinary/EPAR/afoxolaner-merial.
English: After being given, its actions last for at least 5 weeks against fleas and up to one month against ticks.
Croatian: Nakon što se primijeni, VMP djeluje barem 5 tjedana protiv buha i do mjesec dana protiv krpelja.
English: This means that it kills parasites that live on or in the skin or in the fur of animals, such as fleas, ticks and mites.
Croatian: To znači da ubija parazite koji žive na koži ili u krznu životinja, kao što su buhe, krpelji i grinje.
English: This results in uncontrolled activity of the nervous system and the paralysis and death of fleas, ticks and mites.
Croatian: To rezultira nekontroliranim djelovanjem živčanog sustava i paralizom te smrću buha, krpelja i grinja.
English: It blocks the normal movement of charged chloride particles (ions) in and out of nerve cells, especially those nerves that
Croatian: Inhibira normalno kretanje nabijenih čestica klorida (iona) u živčane stanice i iz njih, posebno kod onih živaca
English: Afoxolaner Merial kills fleas within 8 hours and ticks within 48 hours.
Croatian: Afoxolaner Merial ubija buhe u roku od 8 sati, a krpelje u roku od 48 sati.
English: Because parasites must start feeding on the dog in order to be killed by the medicine, there may be a risk of transmission of diseases with which they may be infected.
Croatian: Budući da se paraziti moraju početi hraniti krvlju psa da bi ih se moglo iskorijeniti VMP-om, ne može se isključiti rizik od prijenosa bolesti kojima oni mogu biti zaraženi.
English: Treatment should be repeated at monthly intervals during the flea or tick seasons, monthly for demodectic mange until the mange is successfully treated (as confirmed by two negative skin scrapings one month apart) and monthly for two months for sarcoptic mange, or longer if treatment is unsuccessful as indicated by clinical signs and skin scrapings.
Croatian: Terapiju treba ponoviti u mjesečnim intervalima tijekom sezone buha ili krpelja, jednom mjesečno kod demodikoze sve dok je se uspješno ne izliječi (što se potvrđuje dvjema negativnim strugotinama kože u razmaku od mjesec dana) i jednom mjesečno tijekom dva mjeseca kod sarkoptoze ili duže ako terapija nije uspješna, što se utvrđuje kliničkim znakovima i strugotinama kože.
English: Only one chewable tablet at a time should be removed from the blister to prevent children from accessing the product.
Croatian: Iz blistera treba izvaditi samo jednu tabletu za žvakanje kako bi se izbjegao pristup djece proizvodu.
English: The company that makes NexGard has agreed that its scientific data can be used for Afoxolaner Merial (‘informed consent').
Croatian: Tvrtka koja proizvodi NexGard pristala je da se njezini znanstveni podatci upotrijebe za VMP Afoxolaner Merial (tzv. „informirani pristanak”).
English: produce the substance gamma-aminobutyric acid (GABA) to regulate the nervous system.
Croatian: koji proizvode tvar gama-aminomaslačnu kiselinu (GABA) za regulaciju živčanog sustava.
English: Afoxolaner kills fleas before they can lay eggs and so helps to reduce contamination of the dogs' environment.
Croatian: Afoksolaner ubija buhe prije nego što uspiju izleći jajašca te tako pomaže u smanjivanju kontaminacije okruženja psa.
English: Afoxolaner Merial received a marketing authorisation valid throughout the EU on 20 May 2019.
Croatian: Za VMP Afoxolaner Merial izdano je odobrenje za stavljanje u promet koje je na snazi u EU-u od 20. svibnja 2019.
English: It may be used as part of the management of flea allergy dermatitis (an allergic reaction to flea bites).
Croatian: Može se primjenjivati kao dio strategije liječenja alergijskog dermatitisa uzrokovanog buhama (alergijske reakcije na ugrize buha).
English: The effectiveness of Afoxolaner Merial was investigated in both laboratory and field studies.
Croatian: Učinkovitost VMP-a Afoxolaner Merial ispitana je i u laboratorijskim i u terenskim ispitivanjima.
English: In an EU field study involving 146 dogs with flea and/or tick infestations, a single treatment with Afoxolaner Merial was effective in treating flea and tick infestations in dogs for up to 30 days after treatment.
Croatian: U terenskom ispitivanju u EU-u koje je obuhvatilo 146 pasa s infestacijama buhama i/ili krpeljima, jedan tretman VMP-om Afoxolaner Merial bio je učinkovit u liječenju infestacija buhama i krpeljima u pasa do 30 dana nakon terapije.
English: Afoxolaner Merial reduced the number of fleas and ticks by at least 98% and was at least as effective as a spot-on medicine containing pyriprole (another medicine against fleas and ticks).
Croatian: VMP Afoxolaner Merial smanjio je broj buha i krpelja za najmanje 98 % i bio je barem jednako učinkovit kao VMP za nakapavanje na kožu koji sadržava piriprol (drugi VMP protiv buha i krpelja).
English: Afoxolaner Merial is a veterinary medicine used to treat infestations with fleas and ticks, as well as demodectic and sarcoptic mange (skin infestations caused by two different types of mites) in dogs.
Croatian: Afoxolaner Merial je veterinarsko-medicinski proizvod koji se primjenjuje za liječenje infestacija buhama i krpeljima, kao i demodikoze i sarkoptoze (infestacija kože koje uzrokuju dvije različite vrste grinja) u pasa.
English: What is Afoxolaner Merial and what is it used for?
Croatian: Što je Afoxolaner Merial i za što se koristi?
English: Afoxolaner Merial (afoxolaner)
Croatian: Afoxolaner Merial (afoksolaner)
English: Afoxolaner Merial reduced the number of live mites by 97% 56 days after starting treatment and by 98% 84 days after starting treatment.
Croatian: VMP Afoxolaner Merial smanjio je broj živih grinja za 97 % 56 dana nakon početka terapije te za 98 % 84 dana nakon početka terapije.
English: Afoxolaner Merial is available as chewable tablets in four different strengths for use in dogs of different weights.
Croatian: VMP Afoxolaner Merial dostupan je u obliku tableta za žvakanje u četiri različite jačine za primjenu u pasa različite tjelesne težine.
English: The European Medicines Agency decided that Afoxolaner Merial's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Afoxolaner Merial nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Afoxolaner Merial reduced the number of live mites by 96% 28 days after starting treatment and by 100% 56 days after starting treatment.
Croatian: VMP Afoxolaner Merial smanjio je broj živih grinja za 96 % 28 dana nakon početka terapije te za 100 % 56 dana nakon početka terapije.
English: An overview of Afoxolaner Merial and why it is authorised in the EU
Croatian: Pregled informacija o VMP-u Afoxolaner Merial i zašto je odobren u EU-u
English: The active substance in Afoxolaner Merial, afoxolaner, acts as an ‘ectoparasiticide'.
Croatian: Djelatna tvar u VMP-u Afoxolaner Merial, afoksolaner, djeluje kao „ektoparaziticid”.
English: Other information about Afoxolaner Merial
Croatian: Ostale informacije o VMP-u Afoxolaner Merial
English: A second EU field study involved 31 dogs with demodectic mange which were treated monthly on 3 occasions with Afoxolaner Merial.
Croatian: Drugo terensko ispitivanje u EU-u uključivalo je 31 psa s demodikozom koji je tretiran VMP-om Afoxolaner Merial tri puta u mjesečnim intervalima.
English: For more information about using Afoxolaner Merial, see the package leaflet or contact your veterinarian or pharmacist.
Croatian: Za dodatne informacije o primjeni VMP-a Afoxolaner Merial pogledajte uputu o VMP-u odnosno obratite se veterinaru ili ljekarniku.
English: A third EU field study involved 38 dogs with sarcoptic mange which were treated monthly for two months with Afoxolaner Merial.
Croatian: Treće terensko ispitivanje u EU-u obuhvatilo je 38 pasa sa sarkoptozom koja je tretirana VMP-om Afoxolaner Merial jednom mjesečno tijekom dva mjeseca.
English: What are the risks associated with Afoxolaner Merial?
Croatian: Koji su rizici povezani s VMP-om Afoxolaner Merial?
English: Why is Afoxolaner Merial authorised in the EU?
Croatian: Zašto je VMP Afoxolaner Merial odobren u EU-u?
English: How is Afoxolaner Merial used?
Croatian: Kako se Afoxolaner Merial koristi?
English: Afoxolaner Merial contains the active substance afoxolaner.
Croatian: VMP Afoxolaner Merial sadržava djelatnu tvar afoksolaner.
English: What benefits of Afoxolaner Merial have been shown in studies?
Croatian: Koje su koristi od VMP-a Afoxolaner Merial utvrđene u ispitivanjima?
English: How does Afoxolaner Merial work?
Croatian: Kako djeluje Afoxolaner Merial?
English: • Wash your hands
Croatian: • Operite ruke
English: Date of first authorisation: 27 November 2001 Date of latest renewal: 06 October 2006
Croatian: Datum prvog odobrenja: 27. studenoga 2001 Datum posljednje obnove odobrenja: 06. listopada 2006
English: If a drop misses the eye, try again.
Croatian: Ako kap promaši oko, pokušajte ponovno.
English: This is especially important in women who are pregnant or are attempting to become pregnant.
Croatian: Ovo je osobito važno kod trudnica ili žena koje pokušavaju zatrudniti.
English: Unilateral treatment can result in permanent heterochromia.
Croatian: Unilateralno liječenje može dovesti do trajne heterokromije.
English: SE = Standard Error; CI = Confidence Interval;
Croatian: SP = Standardna pogreška; CI = Interval pouzdanosti;