FrancophonIA/ELRC3.0 huggingface dataset:
English: • in the treatment of partial onset seizures with or without secondary generalisation in adults,adolescents, children and infants from 1 month of age with epilepsy.
Croatian: • u liječenju parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih, adolescenata, djece i dojenčadi od 1. mjeseca života s epilepsijom.
English: • signs of serious mental changes or if someone around you notices signs of confusion, somnolence (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements.
Croatian: • puno teži oblik osipa koji uzrokuje ljuštenje kože u više od 30 % površine tijela (toksična epidermalna nekroliza)znakove ozbiljnih mentalnih promjena ili ako netko oko vas primijeti kod vas znakove smetenosti, izrazitu pospanost, amneziju (gubitak pamćenja), slabljenje pamćenja (zaboravljivost), abnormalno ponašanje ili druge neurološke znakove uključujući nevoljne ili nekontrolirane pokrete.
English: Depression, hostility/ aggression, anxiety, insomnia, nervousness/irritabi lity
Croatian: Depresija, netrpeljivost/ agresivnost, anksioznost, nesanica, nervoza/razdražljivost
English: Add-on therapy for adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more
Croatian: Dodatna terapija za odrasle (≥18 godina) i adolescente (12 do 17 godina) tjelesne težine 50 kg ili više
English: 43.6% of the levetiracetam treated patients and 19.6% of the patients on placebo were considered as responders.
Croatian: Ocijenjeno je da je na liječenje odgovorilo 43,6% bolesnika koji su uzimali levetiracetam i 19,6% onih koji su uzimali placebo.
English: 44.6% of the levetiracetam treated patients and 19.6% of the patients on placebo had a 50% or greater reduction from baseline in the partial onset seizure frequency per week.
Croatian: U 44,6% bolesnika liječenih levetiracetamom i 19,6% bolesnika, koji su dobivali placebo zapaženo je 50 %-tno ili više smanjenje od početne učestalosti parcijalnih napadaja tjedno.
English: Levetiracetam is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.
Croatian: Levetiracetam je indiciran kao monoterapija u liječenju parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih i adolescenata od 16. godine života s novodijagnosticiranom epilepsijom.
English: Single pack containing 10, 20, 30, 50, 60, 100, 200 tablets.
Croatian: Jedno pakiranje sadrži 10, 20, 30, 50, 60, 100, 200 tableta.
English: You should continue Levetiracetam Accord treatment for as long as your doctor has told you.
Croatian: Accordom onoliko dugo koliko je liječnik odredio.
English: The NOAEL was ≥ 1800 mg/kg/day for the F0 females, and for the survival, growth and development of the F1 offspring up to weaning (x 6 the MRHD on a mg/m2 basis).
Croatian: NOAEL je iznosila ≥ 1800 mg/kg/dan za F0 ženke te za preživljenje, rast i razvoj za F1 potomstvo do odbića (6-erostruka vrijednost najveće preporučene doze za čovjeka izražena u mg/m2).
English: How to take Levetiracetam Accord
Croatian: Kako uzimati Levetiracetam Accord
English: The blisters are further packed in to carton with leaflet in pack size of 10, 20, 30, 50, 60, 100 and 200 tablets per pack.
Croatian: Blisteri se dalje pakiraju u kutije s Uputama o lijeku te sadrže 10, 20, 30, 50, 60, 100 i 200 tableta po pakiranju.
English: Dose in infants (1 month to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg
Croatian: • Doza u dojenčadi (1 mjesec do 23 mjeseca), djece (2 do 11 godina) i adolescenata (12 do 17 godina) koji imaju manje od 50 kg
English: As in adults, there is no evidence of clinically significant medicinal product interactions in paediatric patients receiving up to 60 mg /kg/day levetiracetam.
Croatian: Kako ni u odraslih, tako ni u pedijatrijskih bolesnika koji su dobivali do 60 mg/kg/dan levetiracetama, nema dokaza o klinički značajnim interakcijama s lijekovima.
English: Completed suicide,personality disorder, thinking abnormal, delirium
Croatian: Počinjeno samoubojstvo, poremećaj osobnosti, poremećaj mišljenja, delirij
English: (4) Following dialysis, a 3.5 to 7 mg /kg (0.035 to 0.07 ml/kg) supplemental dose is recommended.
Croatian: (4) Nakon dijalize preporučuje se dodatna doza od 3,5 do 7 mg/kg (0,035 do 0,07 ml/kg).
English: The NOAEL was <200 mg/kg/day for the dams and 200 mg/kg/day for the foetuses (equal to the MRHD on a mg/m2 basis).
Croatian: NOAEL je za gravidne ženke iznosila <200 mg/kg/dan, a za fetuse 200 mg/kg/dan (što je jednako MRHD-u, Maximum Recommended Human Dose, izraženom u mg/m2).
English: Drug reaction with eosinophilia and systemic symptoms (DRESS), Hypersensitivity (including angioedema and anaphylaxis)
Croatian: Reakcija na lijek s eozinofilijom i sistemskim simptomima (DRESS),
English: In several cases of alopecia, recovery was observed when levetiracetam was discontinued.Bone marrow suppression was identified in some of the cases of pancytopenia.
Croatian: U nekoliko slučajeva alopecije utvrđen je oporavak nakon što je levetiracetam ukinut.
English: Adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age with epilepsy
Croatian: Dodatna terapija u liječenju parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih, adolescenata, djece i dojenčadi od 1. mjeseca života s epilepsijom.
English: Levetiracetam oral solution is the preferred formulation for use in infants and children under the age of 6 years.
Croatian: Oralna otopina levetiracetama je najprikladniji farmaceutski oblik za primjenu u dojenčadi i djece mlađe od 6 godina.
English: anger, confusion, panic attack,emotional instability/mood swings, agitation;
Croatian: halucinacije, srditost, smetenost, napadaj panike, emocionalna nestabilnost/promjene raspoloženja, uznemirenost;
English: In vitro and in vivo experiments suggest that levetiracetam does not alter basic cell characteristics and normal neurotransmission.
Croatian: Mehanizam djelovanja levetiracetama nije u potpunosti razriješen.Eksperimenti in vitro i in vivo pokazuju da levetiracetam ne utječe na osnovna svojstva stanica i normalnu neurotransmisiju.
English: Levetiracetam Accord 250 mg film-coated tablets Levetiracetam Accord 500 mg film-coated tablets Levetiracetam Accord 750 mg film-coated tablets Levetiracetam Accord 1000 mg film-coated tablets
Croatian: Levetiracetam Accord 250 mg filmom obložene tablete Levetiracetam Accord 500 mg filmom obložene tablete Levetiracetam Accord 750 mg filmom obložene tablete Levetiracetam Accord 1000 mg filmom obložene tablete
English: (5) Following dialysis, a 5 to 10 mg /kg (0.05 to 0.10 ml/kg) supplemental dose is recommended.
Croatian: (5) Nakon dijalize preporučuje se dodatna doza od 5 do 10 mg/kg (0,05 do 0,10 ml/kg).
English: Iron oxide yellow (E172)
Croatian: 500 mg željezov oksid, žuti (E172)
English: Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with Levetiracetam overdoses.
Croatian: Kod predoziranja levetiracetama primijećena je somnolencija, agitacija, agresivnost, smanjena razina svijesti, depresija disanja i koma.
English: Choreoathetosis,d yskinesia, hyperkinesia, gait disturbance,
Croatian: Koreoatetoza, diskinezija, hiperkinezija, poremećaji hodanja, encefalopatija
English: Polyvinyl alcohol Titanium dioxide (E171) Macrogol
Croatian: Film ovojnica polivinilni alkohol titanijev dioksid (E171) makrogol talk
English: 750 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, iron oxide red (E172), sunset yellow FCF(E110)
Croatian: poli(vinilni alkohol), titanijev dioksid (E171), makrogol, talk, crveni željezov oksid (E 172), sunset yellow FCF (E110)
English: The NOAEL (No Observed Adverse Effect Level) was 3600 mg /kg/day for pregnant female rats (x 12 the MRHD on a mg/m2basis) and 1200 mg /kg/day for fetuses.
Croatian: NOAEL (No Observed Adverse Effect Level, razina pri kojoj se ne uočava štetni učinak) za gravidne štakorice iznosila je 3600 mg/kg/dan, a za fetuse 1200 mg/kg/dan (12-erostruka vrijednost najveće preporučene doze za čovjeka izražena u mg/m2).
English: In this study, levetiracetam, dose was 3000 mg /day given in 2 divided doses.
Croatian: Primijenjena doza kod studije bila je 3000 mg/dan podjeljeno na dvije doze.
English: Add-on therapy for infants aged from 6 to 23 months, children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg
Croatian: Dodatna terapija za dojenčad u dobi od 6. do 23. mjeseca, djecu (2 do 11 godina) i adolescente (12 do 17 godina) s manje od 50 kg tjelesne težine.
English: No adverse reactions on male or female fertility or reproduction performance were observed in rats at doses up to 1800 mg/kg/day (x 6 the MRHD on a mg/m2 or exposure basis) in parents and F1 generation.
Croatian: Kod mužjaka i ženki štakora roditeljske i F1 generacije nisu primijećene nuspojave na plodnost ili na reprodukciju u dozama do 1800 mg/kg/dan (6-erostruka vrijednost najveće preporučene doze za čovjeka izražena u mg/m2 ili na osnovnu izloženosti).
English: How to store Levetiracetam Accord
Croatian: Kako čuvati Levetiracetam Accord
English: With continued long-term treatment, 8.6% of the patients were seizure-free for at least 6 months and 7.8% were seizure-free for at least 1 year.
Croatian: Dugoročno je liječenje pokazalo da 8,6% bolesnika nije imalo napadaje tijekom najmanje 6 mjeseci, a njih 7,8% nije imalo napadaje tijekom najmanje 1 godine.
English: Muscular weakness, myalgia Rhabdomyolysis and blood creatine tissue disorders phosphokinase increased*
Croatian: Rabdomioliza i povišena kreatin fosfokinaza u krvi*
English: Colloidal anhydrous silica Magnesium Stearate (E470b)
Croatian: Jezgra tablete karmelozanatrij, umrežena povidon K-30 silicijev dioksid, koloidni, bezvodni magnezijev stearat (E470b)
English: (3) A 15 mg /kg (0.15 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
Croatian: (3) Prvog dana liječenja levetiracetamom preporučuje se udarna doza od 15 mg/kg (0,15 ml/kg).
English: INFORMATION IN BRAILLE Levetiracetam Accord 1000 mg
Croatian: Levetiracetam Accord 1000 mg
English: Accord Healthcare Limited Sage house, 319 Pinner road North Harrow HA1 4HF
Croatian: Sage house, 319 Pinner Road,
English: For 1000mg:
Croatian: Za 1000 mg:
English: Dose in adults and adolescents (from 16 years of age) General dose: between 1000 mg and 3,000 mg each day.
Croatian: Uobičajena doza: između 1000 mg i 3000 mg svaki dan.
English: Levetiracetam Accord 750 mg film-coated tablets Pink coloured, oval, biconvex, debossed ‘L 66' and break line on one side and plain on the other side.
Croatian: Levetiracetam Accord 750 mg filmom obložene tablete Ružičasta, ovalna, bikonveksna s utisnutom oznakom „L 66” i razdjelnom crtom na jednoj strani, te bez oznaka na drugoj strani.
English: Thrombocytopenia, leukopenia Pancytopenia, neutropenia, agranulocytosis
Croatian: Trombocitopenija, leukopenija
English: 1000 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc
Croatian: 1000 mg: poli(vinilni alkohol), titanijev dioksid (E171), makrogol, talk
English: 500 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, iron oxide yellow (E172)
Croatian: 500 mg: poli(vinilni alkohol), titanijev dioksid (E171), makrogol, talk, žuti željezov oksid (E 172)
English: Levetiracetam oral solution is the preferred formulation for use in this population.
Croatian: Najprikladniji farmaceutski oblik za primjenu u toj populaciji je oralna otopina levetiracetama.
English: (2) A 10.5 mg /kg (0.105 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
Croatian: (2) Prvog dana liječenja levetiracetamom preporučuje se udarna doza od 10,5 mg/kg (0,105 ml/kg).
English: For 250mg:
Croatian: Za 250 mg:
English: INFORMATION IN BRAILLE Levetiracetam Accord 750 mg
Croatian: Levetiracetam Accord 750 mg
English: 250 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc
Croatian: 250 mg: poli(vinilni alkohol), titanijev dioksid (E171), makrogol, talk
English: 7 to 21 mg /kg (0.07 to 0.21 ml/kg) twice daily
Croatian: 7 do 21 mg/kg (0,07 do 0,21 ml/kg) dva puta na dan
English: INFORMATION IN BRAILLE Levetiracetam Accord 250 mg
Croatian: Levetiracetam Accord 250 mg
English: NAME OF THE MEDICINAL PRODUCT Levetiracetam Accord 500 mg film-coated tablets Levetiracetam
Croatian: NAZIV GOTOVOG LIJEKA Levetiracetam Accord 500 mg filmom obložene tablete levetiracetam
English: The active ingredient is levetiracetam.
Croatian: Što Levetiracetam Accord sadrži Djelatna tvar je levetiracetam.
English: 3.5 to 7 mg /kg (0.035 to 0.07 ml/kg) twice daily
Croatian: 3,5 do 7 mg/kg (0,035 do 0,07 ml/kg) dva puta na dan
English: For 500mg:
Croatian: Za 500 mg:
English: For 750mg:
Croatian: Za 750 mg:
English: INFORMATION IN BRAILLE Levetiracetam Accord 500 mg
Croatian: Levetiracetam Accord 500 mg
English: Levetiracetam Accord 500 mg film-coated tablets Yellow coloured, oval, biconvex, debossed ‘L 65' and break line on one side and plain on the other side.
Croatian: Levetiracetam Accord 500 mg filmom obložene tablete Žuta, ovalna, bikonveksna s utisnutom oznakom „L 65” i razdjelnom crtom na jednoj strani, te bez oznaka na drugoj strani.
English: Levetiracetam Accord 1000 mg film-coated tablets White to off white, oval, biconvex, debossed ‘L 67' and break line on one side and plain on the other side.
Croatian: Levetiracetam Accord 1000 mg filmom obložene tablete Bijela do gotovo bijela, ovalna, bikonveksna s utisnutom oznakom „L 67” i razdjelnom crtom na jednoj strani, te bez oznaka na drugoj strani.
English: Hyponatraemia
Croatian: Monoterapija
English: Levetiracetam Accord 750 mg film-coated tablets Each film-coated tablet contains 750 mg levetiracetam
Croatian: Levetiracetam Accord 750 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 750 mg levetiracetama.
English: 10 to 20 mg /kg (0.10 to 0.20 ml/kg) twice daily
Croatian: 10 do 20 mg/kg (0,10 do 0,20 ml/kg) dva puta na dan
English: Levetiracetam Accord 750 mg film-coated tablets Levetiracetam
Croatian: Levetiracetam Accord 750 mg filmom obložene tablete levetiracetam
English: Levetiracetam Accord 500 mg film-coated tablets Each film-coated tablet contains 500 mg levetiracetam
Croatian: Levetiracetam Accord 500 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 500 mg levetiracetama.
English: 5 to 15 mg /kg (0.05 to 0.15 ml/kg) twice daily
Croatian: 5 do 15 mg/kg (0,05 do 0,15 ml/kg) dva puta na dan
English: 10 to 30 mg /kg (0.10 to 0.30 ml/kg) twice daily
Croatian: 10 do 30 mg/kg (0,10 do 0,30 ml/kg) dva puta na dan
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP PVC-Al blister
English: 7 to 14 mg /kg (0.07 to 0.14 ml/kg) twice daily
Croatian: 7 do 14 mg/kg (0,07 do 0,14 ml/kg) dva puta na dan
English: MINIMUMPARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP PVC/Al blister pakiranje
English: Levetiracetam Accord 250 mg film-coated tablets Each film-coated tablet contains 250 mg levetiracetam
Croatian: Levetiracetam Accord 250 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 250 mg levetiracetama.
English: 3.5 to 10.5 mg /kg (0.035 to 0.105 ml/kg) twice daily
Croatian: 3,5 do 10,5 mg/kg (0,035 do 0,105 ml/kg) dva puta na dan
English: White to off white, oval, biconvex, film coated tablet, debossed ‘L 67' and break line on one side and plain on the other side.
Croatian: Bijela do gotovo bijela, ovalna, bikonveksna filmom obložena tableta s utisnutom oznakom „L 67” i razdjelnom crtom na jednoj strani, te bez oznaka na drugoj strani.
English: 5 to 10 mg /kg (0.05 to 0.10 ml/kg) twice daily
Croatian: 5 do 10 mg/kg (0,05 do 0,10 ml/kg) dva puta na dan
English: Levetiracetam Accord 1000 mg film-coated tablet Levetiracetam
Croatian: Levetiracetam Accord 1000 mg filmom obložene tablete levetiracetam
English: - If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor - A small number of people being treated with anti-epileptics such as Levetiracetam Accord have had thoughts of harming or killing themselves.
Croatian: • ako primijetite usporen rast ili neočekivan razvoj djeteta u pubertetu, obavijestite svog liječnika.
English: White to off white, oval, biconvex, film coated tablet, debossed ‘L 64' and break line on one side and plain on the other side.
Croatian: Bijela do gotovo bijela, ovalna, bikonveksna filmom obložena tableta s utisnutom oznakom „L 64” i razdjelnom crtom na jednoj strani, te bez oznaka na drugoj strani.
English: Add-on therapy for infants aged from 1 month to less than 6 months The oral solution is the formulation to use in infants.
Croatian: Dodatna terapija za dojenčad u dobi od 1 mjeseca do manje od 6 mjeseci
English: Yellow coloured, oval, biconvex, film coated tablet, debossed ‘L 65' and break line on one side and plain on the other side.
Croatian: Žuta, ovalna, bikonveksna filmom obložena tableta s utisnutom oznakom „L 65” i razdjelnom crtom na jednoj strani, te bez oznaka na drugoj strani.
English: Pink coloured, oval, biconvex, film coated tablet, debossed ‘L 66' and break line on one side and plain on the other side.
Croatian: Ružičasta, ovalna, bikonveksna filmom obložena tableta s utisnutom oznakom „L 66” i razdjelnom crtom na jednoj strani, te bez oznaka na drugoj strani.
English: 7 to 14 mg /kg (0.07 to 0.14 ml/kg)once daily (2)
Croatian: 7 do 14 mg/kg (0,07 do 0,14 ml/kg) jedanput na dan
English: Levetiracetam Accord 1000 mg film-coated tablets Each film-coated tablet contains 1000 mg levetiracetam
Croatian: Levetiracetam Accord 1000 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 1000 mg levetiracetama.
English: Levetiracetam Accord 500 mg film-coated tablet Levetiracetam
Croatian: Levetiracetam Accord 500 mg filmom obložene tablete levetiracetam
English: Musculoskeletal and connective
Croatian: Poremećaji mišićnokoštanog sustava i vezivnog tkiva
English: EU/1/11/712/001-007 (10/20/30/50/60/100/200 tablets in PVC/alu Blister) EU/1/11/712/029-031(30/60/100 tablets in Unit dose Blister)
Croatian: EU/1/11/712/001-007 (10/20/30/50/60/100/200 tableta u PVC/Al blisteru) EU/1/11/712/029-031 (30/60/100 tableta u blisteru djeljivom na jedinične doze)
English: Levetiracetam Accord 250 mg film-coated tablets Levetiracetam
Croatian: Levetiracetam Accord 250 mg filmom obložena tableta levetiracetam
English: EU/1/11/712/015-021 (10/20/30/50/60/100/200 tablets in PVC/alu Blister) EU/1/11/712/035-037 (30/60/100tablets in Unit dose Blister)
Croatian: EU/1/11/712/015-021 (10/20/30/50/60/100/200 tableta u PVC/Al blisteru) EU/1/11/712/035-037 (30/60/100 tableta u blisteru djeljivom na jedinične doze)
English: EU/1/11/712/008-014 (10/20/30/50/60/100/200 tablets in PVC/alu Blister) EU/1/11/712/032-034 (30/60/100tablets in Unit dose Blister)
Croatian: EU/1/11/712/008-014 (10/20/30/50/60/100/200 tableta u PVC/Al blisteru) EU/1/11/712/032-034 (30/60/100 tableta u blisteru djeljivom na jedinične doze)
English: EU/1/11/712/022-028 (10/20/30/50/60/100/200 tablets in PVC/alu Blister) EU/1/11/712/038-040(30/60/100tablets in Unit dose Blister)
Croatian: EU/1/11/712/022-028 (10/20/30/50/60/100/200 tableta u PVC/Al blisteru) EU/1/11/712/038-040 (30/60/100 tableta u blisteru djeljivom na jedinične doze)
English: Levetiracetam Accord may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy.
Croatian: Ako vozite ili upravljate alatima ili vozilima potreban je oprez jer se pri uzimanju lijeka Levetiracetam Accord može javiti osjećaj pospanosti.
English: Iron oxide red (E172) Sunset yellow FCF (E110) 6.2 Incompatibilities Not applicable.
Croatian: sunset yellow FCF (E110)
English: Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more General dose: between 1,000 mg and 3,000 mg each day.
Croatian: • Doza u odraslih i adolescenata (12 do 17 godina) koji imaju 50 kg ili više:
English: Levetiracetam Accord 250 mg film-coated tablets
Croatian: Levetiracetam Accord 250 mg filmom obložene tablete levetiracetam
English: 10 to 20 mg /kg (0.10 to
Croatian: 10 do 20 mg/kg (0,10 do 0,20 ml/kg) jednaput na dan
English: --1 Live attenuated avian infectious bronchitis virus (IBV), variant strain 4-91: ≥3.6 log10 EID50* per dose * EID50: 50% embryo infective dose - the virus titre required to produce infection in 50% of the embryos inoculated.
Croatian: --1 Živi, atenuirani virus zaraznog bronhitisa kokoši (ZBK), varijantni soj 4-91: ≥ 3,6 log 10 EID50 po dozi * EID50 = 50% Embrijo infektivna doza: titar virusa koji prouzroci infekciju u 50% virusom inokuliranih embrija
English: 1 Bottle
Croatian: 1 bočica
English: 3 Bottles
Croatian: 3 bočice
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Croatian: Zaštićeno ime Doza Farmaceutski oblik
English: If so, treatment should be stopped immediately.
Croatian: Ako se to dogodi, liječenje treba odmah prekinuti.
English: After 3 weeks a break of at least 2 weeks is required.
Croatian: Nakon 3 tjedna primjene potrebna je pauza od najmanje 2 tjedna.
English: This means that there are bibliographic data providing scientific evidence of their effectiveness and safety when used in this way, covering a period of at least 10 years in the EU.
Croatian: To znači da postoje bibliografski podaci koji pružaju znanstvene dokaze o njihovoj učinkovitosti i sigurnoj uporabi kada se koriste na opisani način, tijekom razdoblja od najmanje 10 godina u EU-u.
English: In rare cases allergic skin reactions can occur.
Croatian: U rijetkim slučajevima mogu nastupiti alergijske reakcije kože.
English: Capsicum should only be used in adults over the age of 18 years and should not be used continuously for more than 3 weeks.
Croatian: Paprikin plod smije se koristiti samo u odraslih u dobi starijoj od 18 godina te se ne smije koristiti kontinuirano dulje od 3 tjedna.
English: Overstimulating the receptors makes them become ‘desensitised' and no longer able to respond to the stimuli that normally cause pain.
Croatian: Prekomjerna stimulacija receptore čini „desenzibiliziranima” te oni više ne mogu odgovoriti na podražaje koji normalno uzrokuju bol.
English: This means that it stimulates the TRPV1 receptor, which is found in the nociceptors (pain receptors) in the skin.
Croatian: To znači da stimulira receptor TRPV1 koji se nalazi u nociceptorima (receptorima za bol) u koži.
English: Capsicum annuum L. var. minimum (Miller) Heiser and small fruited varieties of Capsicum frutescens L., fructus
Croatian: Capsicum annuum L. var. minimum (Miller) Heiser i varijateti malog ploda Capsicum frutescens L., plod
English: Capsicum EMA/HMPC/331421/2015
Croatian: Paprikin plod EMA/HMPC/331421/2015
English: Capsicum contains a substance known as capsaicin.
Croatian: Paprikin plod sadrži tvar koja je poznata kao kapsaicin.
English: The capsaicin is used to overstimulate the TRPV1 receptors.
Croatian: Kapsaicin se koristi za prekomjernu stimulaciju TRPV1 receptora.
English: Capsicum
Croatian: Paprikin plod
English: In its assessment, the HMPC considered a number of clinical studies which showed improvements in pain relief following treatment with capsicum medicated plaster and skin preparations compared with placebo (a dummy treatment).
Croatian: HMPC je prilikom ocjene razmotrio niz kliničkih ispitivanja koja su pokazala poboljšanja u ublažavanju boli nakon liječenja naljepcima i pripravcima za kožu koji sadrže paprikin plod u usporedbi s placebom (prividnim liječenjem).
English: Capsicum preparations are obtained by ethanol or propanol extraction (a technique used to extract compounds from plant parts by dissolving them in alcohol).
Croatian: Pripravci paprikinog ploda dobivaju se ekstrakcijom etanolom ili propanolom (tehnikom koja se koristi za ekstrakciju spojeva iz dijelova biljaka otapanjem u alkoholu).