natgillin/translations-raw huggingface dataset:
• St. John's wort (Hypericum perforatum) (used to treat depression)
• Gospinu travu (Hypericum perforatum) (koristi se za liječenje depresije)
Following Overall Treatment Evaluation (OTE) of patients at week 2, 78.0 - 80.7% of patients on esomeprazole 20 mg, compared to 72.4 - 78.3% for placebo, reported their condition as improved.
Overall Treatment Evaluation, OTE) poboljšanje stanja u 2. tjednu prijavilo je 78,0 - 80,7% bolesnika koji su primali esomeprazol 20 mg u usporedbi sa 72,478,3 bolesnika koji su primali placebo.
• You are over 55 and have new or recently changed reflux symptoms.
• Ako ste stariji od 55 godina i nedavno su Vam se pojavili novi ili se promijenili postojeći simptomi refluksa.
After five days of oral dosing with 20 mg and 40 mg of esomeprazole, intragastric pH above 4 was maintained for a mean time of 13 hours and 17 hours, respectively over 24 hours in symptomatic gastroesophageal reflux disease (GERD) patients.
U simptomatskih bolesnika s gastroezofagealnom refluksnom bolešću (GERB) je nakon pet dana peroralne primjene doze od 20 mg esomeprazola unutarželučani pH u razdoblju od 24 sata održan iznad vrijednosti 4 tijekom prosječno 13 sati, a uz dozu od 40 mg tijekom prosječno 17 sati.
• Swallow your tablet whole with half a glass of water.
• Tabletu progutajte cijelu, s pola čaše vode.
Time to sustained resolution of heartburn, defined as when 7 consecutive days of no heartburn was first recorded, was significantly shorter in the esomeprazole 20 mg group (39.7% - 48.7% by day 14 vs placebo 11.0% - 20.2%).
Vrijeme do održivog povlačenja žgaravice definirano kao 7 uzastopnih dana nakon prvog bilježenja žgaravice bilo je značajno kraće u skupini koja je primala esomeprazol 20 mg (39,7% -48,7% do 14. dana u odnosu na 11,0% -20,2% u bolesnika koji su primali placebo).
• Swallow your capsule whole with half a glass of water.
• Kapsulu progutajte cijelu, s pola čaše vode.
No studies have been performed in patients with decreased renal function.
Nisu provedena ispitivanja esomeprazola u bolesnika s oslabljenom bubrežnom funkcijom.
• Cisapride (used for indigestion and heartburn)
• Cisaprid (koristi se za probavne smetnje i žgaravicu)
• An inflammation on the inside of the mouth.
Za primjenu kroz usta.
It might be necessary to take the capsules for 2-3 consecutive days to achieve improvement of symptoms.
Za postizanje poboljšanja simptoma možda će biti potrebno uzimati kapsule tijekom 2-3 uzastopna dana.
It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of symptoms.
Za postizanje poboljšanja simptoma možda će biti potrebno uzimati tablete tijekom 2-3 uzastopna dana.
Co-administration of omeprazole (40 mg once a day) reduced mean nelfinavir AUC, Cmax, and Cmin by 36 - 39 % and mean AUC, Cmax, and Cmin for the pharmacologically active metabolite M8 was reduced by 75 - 92%.
Istodobna primjena omeprazola (40 mg jedanput na dan) smanjila je prosječne AUC, Cmax i Cmin nelfinavira za 36 - 39%, dok su prosječni AUC, Cmax i Cmin farmakološki aktivnog metabolita
Co-administration of omeprazole (40 mg once a day) reduced mean nelfinavir AUC, Cmax and Cmin by 36-39 % and mean AUC, Cmax and Cmin for the pharmacologically active metabolite M8 was reduced by 75-92%.
Istodobna primjena omeprazola (40 mg jedanput na dan) smanjila je prosječni AUC, Cmax i Cmin nelfinavira za 36-39%, dok su prosječni AUC, Cmax i Cmin farmakološki aktivnog metabolita
No gender difference is seen after repeated once-daily administration.
Nakon višekratne primjene jedanput na dan nisu primijećene razlike između spolova.
• Muscle weakness.
• slabost mišića
For saquinavir (with concomitant ritonavir), increased serum levels (80-100%) have been reported during concomitant omeprazole treatment (40 mg once a day).
Kod istodobne primjene omeprazola (40 mg jedanput na dan) i sakvinavira (primijenjenog zajedno s ritonavirom), zabilježene su povišene razine sakvinavira u serumu (80-100%).
• Cisapride (used for indigestion and heartburn).
• Cisaprid (koristi se za probavne smetnje i žgaravicu).
• You pass black stools (blood-stained faeces).
• Ako imate crnu (krvavu) stolicu.
• An infection called “thrush” which can affect the gut and is caused by a fungus.
• gljivična infekcija zvana “kandidijaza” koja može zahvatiti crijeva
This may cause weakness, being sick (vomiting) and cramps
To može uzrokovati slabost, povraćanje i grčeve.
Uncommon (may affect up to 1 in 100 people)
Manje česte (mogu se javiti u manje od 1 na 100 osoba):
cramps, tremor, and changes in heart rhythm (arrhythmias).
To može uzrokovati slabost, povraćanje, grčeve, nevoljno drhtanje i promjene u otkucajima srca (aritmije).
Talk to your doctor as soon as possible if you experience any of the following signs of infection: This medicine may in very rare cases affect the white blood cells leading to immune deficiency.
Ovaj lijek može u vrlo rijetkim slučajevima utjecati na bijele krvne stanice i tako dovesti do slabljenja imuniteta.
Common (may affect up to 1 in 10 people)
Česte (mogu se javiti u manje od 1 na 10 osoba):
An increased number of ECL cells possibly related to the increased serum gastrin levels, have been observed in some patients during long-term treatment with esomeprazole.
Tijekom dugotrajnog liječenja esomeprazolom u nekih je bolesnika primijećen povećan broj stanica nalik na enterokromafine stanice, što bi mogla biti posljedica povišene koncentracije gastrina u serumu.
How to store Nexium Control
Kako čuvati Nexium Control
• Phenytoin (used to treat epilepsy)
• Fenitoin (koristi se za liječenje epilepsije)
Pfizer Consumer Manufacturing Italy S.r.l.
Pfizer Consumer Manufacturing Italy S.r.l. Via Nettunense, 90
• Phenytoin (used to treat epilepsy).
• Fenitoin (koristi se za liječenje epilepsije).
• If your reflux symptoms get worse or do not improve after taking this medicine for 14 days in a row, you should consult a doctor.
• Ako Vam se simptomi refluksa pogoršaju ili ako se ne poboljšaju nakon uzimanja ovoga lijeka
Band
Serija
Seek urgent medical attention if you experience chest pain with light-headedness, sweating, dizziness or shoulder pain with shortness of breath.
Ako osjećate bol u prsnom košu sa ošamućenosti, znojenjem, omaglicom ili bolovima u ramenima popraćenu nedostatkom zraka potražite hitnu medicinsku pomoć.
• Skin rash, lumpy rash (hives) and itchy skin.
• kožni osip, izbočine na koži koje svrbe (koprivnjača) i svrbež kože.
Nexium Control 20 mg gastro-resistant tablets esomeprazole
Nexium Control 20 mg želučanootporne tablete esomeprazol
If your symptoms worsen or do not improve after taking this medicine for 14 days in a row, contact your doctor.
Obratite se liječniku ako Vam se simptomi pogoršaju ili ako se ne poboljšaju nakon uzimanja ovog lijeka 14 dana za redom.
What you need to know before you take Nexium Control 3.
Što je Nexium Control i za što se koristi Što morate znati prije nego počnete uzimati Nexium Control Kako uzimati Nexium Control Moguće nuspojave
• Spinning feeling (vertigo).
• upala crijeva (uzrokuje proljev).
Subacute cutaneous lupus erythematosu s (see section
subakutni kožni lupus eritematodes (vidjeti dio 4.4)
Nexium Control 20 mg gastro-resistant capsules esomeprazole
Nexium Control 20 mg želučanootporne kapsule esomeprazol
• Dry mouth.
• upala u usnoj šupljini
Each gastro-resistant hard capsule contains 20 mg esomeprazole (as magnesium trihydrate)
Jedna želučanootporna tvrda kapsula sadrži 20 mg esomeprazola (u obliku esomeprazolmagnezij trihidrata)
Each gastro-resistant hard capsule contains 20 mg esomeprazole (as magnesium trihydrate).
Jedna želučanootporna tvrda kapsula sadrži 20 mg esomeprazola (u obliku esomeprazolmagnezij trihidrata).
Each gastro-resistant capsule contains 20 mg esomeprazole (as magnesium trihydrate).
Jedna želučanootporna kapsula sadrži 20 mg esomeprazola (u obliku esomeprazolmagnezij trihidrata).
Each gastro-resistant tablet contains 20 mg esomeprazole (as magnesium trihydrate)
Jedna želučanootporna tableta sadrži 20 mg esomeprazola (u obliku esomeprazolmagnezij trihidrata)
Magnesium stearate
Naproksen i rofekoksib
Each gastro-resistant tablet contains 20 mg esomeprazole (as magnesium trihydrate).
Jedna želučanootporna tableta sadrži 20 mg esomeprazola (u obliku esomeprazolmagnezij trihidrata).
Nexium Control 20 mg gastro-resistant hard capsules esomeprazole
Nexium Control 20 mg želučanootporne tvrde kapsule esomeprazol
Tell your doctor or pharmacist if you are taking any of the following medicines:
Obratite se liječniku što prije ako se pojavi bilo koji od sljedećih znakova infekcije:
Nexium Control 20 mg gastro-resistant hard capsules
Nexium Control 20 mg želučanootporne tvrde kapsule
The appropriate strength tablet should be used according to the dog's weight.
Tabletu odgovarajuće jačine treba koristiti u skladu s tjelesnom težinom psa.
As other conditions contribute to demodectic mange, any underlying diseases should also be treated.
Budući da druga stanja doprinose demodikozi, također treba liječiti sve osnovne bolesti.
The full EPAR for MiPet Easecto can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Cjeloviti EPAR za VMP MiPet Easecto nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
In order to be exposed to the active substance, fleas and ticks must attach to the skin and commence feeding on the dog's blood.
Kako bi ih se izložilo aktivnoj tvari, buhe i krpelji moraju se prihvatiti za kožu i započeti hranjenje krvlju psa.
This summary was last updated in October 2017.
Sažetak je posljednji put ažuriran u 10. 2017.
Treatment should be continued until skin scrapings are negative on at least two consecutive occasions one month apart.
Liječenje treba nastaviti dok kožne strugotine ne budu negativne barem dva puta uzastopno u razmaku od jednog mjeseca.
The European Commission granted a marketing authorisation valid throughout the EU for MiPet Easecto on 31 January 2018.
Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP MiPet Easecto na snazi u Europskoj uniji od 31/01/2018.
However, the following side effects are seen in less than 1 dog in 10,000: mild and short-lived vomiting and diarrhoea as well as tremor (shaking), ataxia (inability to coordinate body movements) or convulsions.
Međutim, sljedeće nuspojave zabilježene su u manje od 1 na 10 000 pasa: blago i kratkotrajno povraćanje i proljev, kao i tremor (drhtanje), ataksija (nemogućnost koordiniranja kretanja tijela) ili konvulzije.
This authorisation was based on the authorisation granted to Simparica in 2015 (‘informed consent').
Odobrenje se temeljilo na odobrenju danom za VMP Simparica 2015. godine („informirani pristanak”).
For treatment of ear mite infestations a single dose should be given.
Za liječenje infestacija ušnim škugarcem treba dati jednu dozu.
This medicine is the same as Simparica, which is already authorised in the EU.
Ovaj VMP isti je kao i VMP Simparica, koji je već odobren u Europskoj uniji (EU).
MiPet Easecto is available as chewable tablets (5, 10, 20, 40, 80 and 120 mg) and can only be obtained with a prescription.
VMP MiPet Easecto dostupan je u obliku tableta za žvakanje (5, 10, 20, 40, 80 i 120 mg), a izdaje se samo na veterinarski recept.
MiPet Easecto was as effective as moxidectin/imidacloprid and the percentage of MiPet Easecto-treated dogs with no live mites was 15%, 69%, 93%, 94%, 100% and 100% on days 30, 60, 90, 120, 150 and 180, respectively.
VMP MiPet Easecto bio je jednako djelotvoran kao moksidektin/imidakloprid, a postotak pasa liječenih VMP-om MiPet Easecto koji nisu imali žive grinje nakon 30, 60, 90, 120, 150 i 180 dana iznosio je 15 %, 69 %, 93 %, 94 %, 100 % i 100 %.
It is not intended to provide practical advice on how to use MiPet Easecto.
Svrha sažetka nije davati praktične savjete o korištenju VMP-a MiPet Easecto.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that MiPet Easecto's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji odlučio je da koristi od VMP-a MiPet Easecto nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
Another study involved dogs infested with sarcoptic mange.
Još jedno ispitivanje obuhvatilo je pse zaražene sarkoptes šugom.
The company that makes Simparica has agreed that its scientific data can be used for MiPet Easecto (‘informed consent').
Proizvođač VMP-a Simparica pristao je na to da se njegovi znanstveni podatci koriste za VMP MiPet Easecto (tzv. „informirani pristanak”).
What is MiPet Easecto and what is it used for?
Što je MiPet Easecto i za što se koristi?
Other information about MiPet Easecto
Ostale informacije o VMP-u MiPet Easecto
Why is MiPet Easecto approved?
Zašto je MiPet Easecto odobren?
MiPet Easecto is a veterinary medicine used to treat infestations with ticks and fleas, demodectic and sarcoptic mange (skin infestations caused by two different types of mites) and ear mite infestations in dogs.
MiPet Easecto je vrsta VMP-a koja se koristi za liječenje infestacija krpeljima i buhama, demodikoze i sarkoptes šuge (infestacije kože koje uzrokuju dvije različite vrste grinja) i infestacije ušnim grinjama u pasa.
The active substance in MiPet Easecto, sarolaner acts as an ‘ectoparasiticide'.
Djelatna tvar u VMP-u MiPet Easecto, sarolaner, djeluje kao „ektoparaziticid”.
What are the risks associated with MiPet Easecto?
Koji su rizici povezani s VMP-om MiPet Easecto?
For treatment of tick and flea infestations MiPet Easecto should be given once every month throughout the flea and/or tick season for optimal control.
Za potrebe liječenja infestacija krpeljima i buhama VMP MiPet Easecto daje se jedanput svaki mjesec tijekom sezone buha i/ili krpelja radi optimalne kontrole.
The effectiveness of MiPet Easecto against fleas was investigated in a field study in dogs infested with at least five live fleas.
Djelovanje VMP-a MiPet Easecto protiv buha ispitano je u terenskom ispitivanju u pasa zaraženih s najmanje pet živih buha.
If the product is accidentally swallowed by a person, the advice of a doctor should be sought immediately.
U slučaju da se VMP nehotice proguta, treba odmah potražiti liječničku pomoć.
For MiPet Easecto the percentage of dogs with no live ear mites present was 91% at day 30 increasing to 99% on day 60, following two treatments.
Prilikom liječenja VMP-om MiPet Easecto postotak pasa koji nisu imali žive grinje nakon 30 dana iznosio je 91 %, s time da je taj postotak porastao do 99 % nakon 60 dana, odnosno nakon dviju terapija.
This is a summary of the European public assessment report (EPAR) for MiPet Easecto.
Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) za veterinarsko-medicinski proizvod MiPet Easecto.
MiPet Easecto can be used as part of the management of flea allergy dermatitis (an allergic reaction to flea bites).
MiPet Easecto može se koristiti i u okviru liječenja alergijskog dermatitisa uzrokovanog buhama (alergijske reakcije na ugrize buha).
After MiPet Easecto is given its activity against ticks and fleas lasts for at least 5 weeks.
Nakon primjene VMP-a MiPet Easecto, on djeluje protiv krpelja i buha najmanje pet tjedana.
For treatment of sarcoptic mange, MiPet Easecto is given monthly for two consecutive months.
Za potrebe liječenja sarkoptes šuge MiPet Easecto daje se jedanput mjesečno tijekom dva uzastopna mjeseca.
In a study involving dogs with ear mite infestation, 283 dogs were treated with MiPet Easecto and 131 dogs received moxidectin/imidacloprid (a spot-on mite treatment).
U ispitivanju koje je obuhvatilo pse s infestacijom ušnim škugarcem, 283 psa liječeno je VMP-om MiPet Easecto, a 131 pas primio je moksidektin/imidakloprid (terapiju nakapavanjem protiv grinja).
MiPet Easecto was as effective as moxidectin/imidacloprid.
VMP MiPet Easecto bio je jednako djelotvoran kao moksidektin/imidakloprid.
MiPet Easecto was as effective as moxidectin and imidacloprid in eliminating live mites in skin scrapings.
VMP MiPet Easecto bio je jednako djelotvoran kao moksidektin i imidakloprid u eliminaciji živih grinja u kožnim strugotinama.
For treatment of demodectic mange MiPet Easecto should be given once a month for at least three months.
Za potrebe liječenja demodikoze MiPet Easecto daje se jedanput mjesečno u razdoblju od barem tri mjeseca.
In a study with 98 dogs with demodectic mange, 63 dogs were treated with MiPet Easecto monthly for up to six months and 35 dogs received moxidectin/imidacloprid.
U ispitivanju koje je obuhvatilo 98 pasa s demodikozom, 63 psa liječena su VMP-om MiPet Easecto jedanput mjesečno u razdoblju od najviše šest mjeseci, a 35 pasa primilo je moksidektin/imidakloprid.
MiPet Easecto was as effective as fipronil in reducing tick counts for up to 90 days after treatment.
VMP MiPet Easecto bio je jednako djelotvoran kao fipronil u smanjivanju broja krpelja do 90 dana nakon terapije.
122 dogs were treated with MiPet Easecto for three months whilst 59 dogs were treated with another medicine, fipronil, against ticks.
Tijekom tri mjeseca 122 psa liječena su VMP-om MiPet Easecto, dok je 59 pasa liječeno drugim VMP-om, fipronilom, protiv krpelja.
How does MiPet Easecto work?
Kako djeluje MiPet Easecto?
How is MiPet Easecto used?
Kako se MiPet Easecto koristi?
MiPet Easecto was as effective as spinosad in reducing flea counts for up to 90 days after treatment.
VMP MiPet Easecto bio je jednako djelotvoran kao spinosad u smanjivanju broja buha do 90 dana nakon terapije.
Side effects with MiPet Easecto are not common.
Nuspojave VMP-a MiPet Easecto nisu česte.
189 dogs were treated with MiPet Easecto for three months whilst 96 dogs were given another medicine, spinosad.
Tijekom tri mjeseca 189 pasa liječeno je VMP-om MiPet Easecto, dok je 96 pasa primilo drugi VMP, spinosad.
53 dogs were treated with MiPet Easecto for two months whilst 26 dogs were given a medicine containing moxidectin and imidacloprid.
Tijekom dva mjeseca 53 pasa liječeno je VMP-om MiPet Easecto, dok je 26 pasa primilo VMP koji je sadržavao moksidektin i imidakloprid.
Safety information has been included in the summary of product characteristics and the package leaflet for MiPet Easecto, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
U sažetku opisa svojstava i u uputi o VMP-u MiPet Easecto nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se veterinari te vlasnici životinja ili uzgajivači trebaju pridržavati.
For practical information about using MiPet Easecto, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Praktične informacije o primjeni VMP-a MiPet Easecto vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
For more information about treatment with MiPet Easecto, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Dodatne informacije o terapiji VMP-om MiPet Easecto vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
What benefits of MiPet Easecto have been shown in studies?
Koje su koristi VMP-a MiPet Easecto utvrđene u ispitivanjima?
• Risk management plan (RMP) Not applicable.
• Plan upravljanja rizikom (RMP) Nije primjenjivo.
Str. Fabricii nr 124
Fabricii nr 124
The elimination half-life was approximately 5 hours.
Poluvijek eliminacije iznosilo je oko 5 sati.
Currently available data are described in sections 4.8, 5.1, and 5.2 but no recommendation on a posology can be made.
Trenutno dostupni podaci su opisani u dijelovima 4.8, 5.1 i 5.2, no nema preporuka za doziranje.
Date of latest renewal: 14 November 2016
Datum posljednje obnove odobrenja:14. studeni 2016
This leaflet was last revised in {month/YYYY} Other sources of information
Ova uputa je zadnji puta revidirana u {mjesec/GGGG} Ostali izvori informacija
Levetiracetam SUN must be administered twice a day, once in the morning and once in the evening, at about the same time each day.
Levetiracetam SUN se mora primijeniti dva puta na dan, jednom ujutro i jednom navečer, u približno isto vrijeme svaki dan.
You can be switched from one to the other without changing dose.
Možete biti prebačeni s jednog na drugi oblik bez prilagođavanja doze.
Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking levetiracetam as this may results in a reduction of its effect.
Ne uzimajte makrogol (lijek koji se koristi kao laksativ) jedan sat prije i jedan sat nakon uzimanja levetiracetama zbog toga što se može smanjiti učinak levetiracetama.
The pharmacokinetic and safety profiles did not identify any safety concerns.
Farmakokinetički i sigurnosni profili nisu identificirali nikakvu zabrinutost glede sigurnosti primjene.
België/Belgique/Belgien/България/Česká republika/ Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/ Κύπρος/Latvija/Lietuva/Luxembourg/Luxemburg/Magyarország/ Malta/Nederland/Norge/Österreich/Portugal/ Slovenija/Slovenská republika/Suomi/Finland/Sverige Sun Pharmaceutical Industries Europe B.V.
België/Belgique/Belgien/България/Česká republika/ Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/ Κύπρος/Latvija/Lietuva/Luxembourg/Luxemburg/Magyarország/ Malta/NederlandNorge/ Österreich/Portugal/ Slovenija/Slovenská republika/Suomi/Finland/Sverige Sun Pharmaceutical Industries Europe B.V.
What Levetiracetam SUN is and what is it used for
Što je Levetiracetam SUN i za što se koristi
EXP Use immediately after dilution.
EXP Primijenite odmah nakon razrjeđivanja.
Read all of this leaflet carefully before you or your child start using this medicine because it contains important information for you.
Vi ili Vaše dijete počnete koristiti ovaj lijek jer sadrži Vama važne podatke.
Duration of treatment
Trajanje liječenje
How to store Levetiracetam SUN Contents of the pack and other information
Kako čuvati Levetiracetam SUN Sadržaj pakiranja i druge informacije
If you have any symptoms of depression and/or thoughts about committing suicide, please contact your doctor.
Ako imate bilo kakve simptome depresije i/ili samoubilačke ideje, molimo obavijestite svog liječnika.
Conversion to or from oral to intravenous administration can be done directly without titration.
Prijelaz na ili sa peroralne na intravensku primjenu može se učiniti izravno bez titracije.
The patients had to present with unprovoked partial seizures or with generalized tonic-clonic seizures only.
Bolesnici su morali imati spontane parcijalne napadaje ili samo generalizirane toničko-kloničke napadaje.
Adverse reactions are presented in the order of decreasing seriousness and their frequency is defined as follows: very common (≥1/10); common (≥ 1/100 to <1/10); uncommon: (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000) and very rare (<1/10,000).
Nuspojave su prikazane u padajućem nizu s obzirom na ozbiljnost i njihova učestalost je definirana na sljedeći način: vrlo često: (≥ 1/10); često: (≥ 1/100 i <1/10); manje često: (≥ 1/1000 i < 1/100); rijetko: (≥ 1/10 000 i < 1/1000) i vrlo rijetko: (<
- A small number of people being treated with anti-epileptics such as Levetiracetam SUN have had thoughts of harming or killing themselves.
- mali broj ljudi liječenih antiepilepticima kao što je Levetiracetam SUN imali su misli o samoozljeđivanju ili samoubojstvu.
If not used immediately, in-use storage time and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Ako se ne primijeni odmah, vrijeme čuvanja i uvjeti prije primjene su odgovornost korisnika i normalno ne bi smjeli biti dulje od 24 sata na 2 do 8°C, osim ako razrijeđivanje nije provedeno u kontroliranim i validiranim aseptičkim uvjetima.
Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients listed in section 6.1.
Preosjetljivost na djelatnu tvar ili neki drugi pirolidonski derivat ili na neku od pomoćnih tvari navedenih u dijelu 6.1.