natgillin/translations-raw huggingface dataset:
Two embryo-foetal development (EFD) studies were performed in rats at 400, 1200 and 3600 mg/kg/day.
Provedene su dvije studije embrio-fetalnog razvoja (EFR) u štakora s dozama od 400, 1200 i 3600 mg/kg/dan.
Dose and frequency (1) Infants 1 to less than 6 months
Doza i učestalost primjene (1) Dojenčad od 1 do manje od 6
You should continue Levetiracetam ratiopharm treatment for as long as your doctor has told you.
Levetiracetamom ratiopharm onoliko dugo koliko je liječnik odredio.
Do not use this medicine after the expiry date stated on the cardboard box and bottle after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i boci iza oznake „EXP“.
In children and adolescents aged 4 to 16 years, vomiting (very common, 11.2 %), agitation (common, 3.4%), mood swings (common, 2.1 %), affect lability (common, 1.7 %), aggression (common, 8.2 %), abnormal behaviour (common, 5.6 %), and lethargy (common, 3.9 %) were reported more frequently than in other age ranges or in the overall safety profile.
U djece i adolescenata u dobi 4 do 16 godina povraćanje (vrlo često, 11,2%), agitacija (često, 3,4%), promjene raspoloženja (često, 2,1%), labilnost afekta (često, 1,7%), agresija (često, 8,2%), poremećaj ponašanja (često, 5,6%) i letargija (često, 3,9%) bili su prijavljeni češće nego u drugim dobnim rasponima ili u cjelokupnom sigurnosnom profilu.
Contains methyl and propyl parahydroxybenzoate and potassium.
Sadrži metil- i propilparahidroksibenzoat i kalij.
This medicine contains less than 1 mmol sodium (23 mg) per 15 ml that is to say essentially ‘sodiumfree'.
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po 15 ml, tj. zanemarive količine natrija.
Peak concentrations (Cmax) are typically 31 and 43 μg/ml following a single 1,000 mg dose and repeated 1,000 mg twice daily dose, respectively.
Vršna koncentracija (Cmax) uglavnom je 31 μg/ml nakon jedne doze od 1,000 mg i 43 μg/ml nakon ponovljene doze od 1,000 mg dva puta na dan.
Poly(vinyl alcohol), Titanium dioxide (E171), Macrogol, Talc, Blue indigo carmine aluminium lake (E132)
Poli(vinilni alkohol), titanijev dioksid (E171), makrogol, talk, blue indigo carmine aluminium lake (E132).
Dosing adjustment for adult and adolescents patients weighing more than 50 kg with impaired renal function:
Prilagođavanje doze za odrasle bolesnike i adolescente teške više od 50 kg s oštećenom bubrežnom funkcijom: Skupina
• Open the bottle: press the cap and turn it anticlockwise.
• Otvorite bočicu: pritisnite zatvarač i okrenite ga suprotno od smjera kazaljke na satu.
In this study, patients were prescribed 20 mg/kg, 25 mg/kg, 40 mg/kg or 50 mg/kg daily dose of oral solution based on their age titration schedule.
U toj je studiji bolesnicima propisana oralna otopina u dnevnoj dozi od 20 mg/kg, 25 mg/kg, 40 mg/kg ili 50 mg/kg, prema shemi titriranja ovisnoj o dobi.
Tablet core: Macrogol 6000, Colloidal anhydrous silica, Crospovidone, Cellulose powdered, Magnesium stearate.
Jezgra tablete: Makrogol 6000, bezvodni koloidni silicijev dioksid, celuloza, prah, magnezijev stearat.
Macrogol 6000, Colloidal anhydrous silica, Crospovidone A, Cellulose powdered, Magnesium stearate.
makrogol 6000, koloidni bezvodni silicijev dioksid, krospovidon A, celuloza, prah, magnezijev stearat.
• 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.
• u liječenju parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih, adolescenata, djece i dojenčadi od 1. mjeseca života s epilepsijom.
Following single oral dose administration (20 mg/kg) to epileptic children (6 to 12 years), the half-life of levetiracetam was 6.0 hours.
Nakon primjene jedne oralne doze (20 mg/kg) u djece s epilepsijom (6 do 12 godina), poluvijek levetiracetama bio je 6,0 sati.
Efficacy of levetiracetam as monotherapy was established in a double-blind, parallel group, noninferiority comparison to carbamazepine controlled release (CR) in 576 patients 16 years of age or older with newly or recently diagnosed epilepsy.
Djelotvornost levetiracetama za samostalno liječenje dokazana je kod paralelnih grupa u dvostruko slijepoj usporedbi neinferiornosti s karbamazepinom s kontroliranim otpuštanjem (CR, controlled release) na 576 bolesnika u dobi od 16 godina ili starijih s novo- ili nedavno dijagnosticiranom epilepsijom.
Methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216) Levetiracetam ratiopharm 100 mg/ml oral solution contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216) which may cause allergic reactions (possibly delayed).
Metilparahidroksibenzoat (E218) i propilparahidroksibenzoat (E216) Levetiracetam ratiopharm 100 mg/ml oralna otopina sadrži metilparahidroksibenzoat (E218) i propilparahidroksibenzoat (E216) koji mogu izazvati alergijske reakcije (koje mogu biti i odgođene).
Depression, hostility/ aggression, anxiety, insomnia, nervousness/irritability
Depresija, neprijateljsko ponašanje/ agresivnost, anksioznost, nesanica, nervoza/razdražljivost
The possible side effects of an overdose of Levetiracetam ratiopharm are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.
Moguće su nuspojave predoziranja Levetiracetamom ratiopharm pospanost, uznemirenost, agresija, smanjena pozornost, smetnje disanja i koma.
In vitro, levetiracetam and its primary metabolite have been shown not to inhibit the major human liver cytochrome P450 isoforms (CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1 and 1A2), glucuronyl transferase (UGT1A1 and UGT1A6) and epoxide hydroxylase activities.
In vitro je pokazano da levetiracetam i njegov glavni metabolit ne inhibiraju aktivnost izoformi glavnog humanog citokroma P450 (CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1 i 1A2), glukuronil transferaze (UGT1A1 i UGT1A6) i epoksid hidroksilaze.
Levetiracetam ratiopharm 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.
Levetiracetam ratiopharm 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.
The apparent body weight adjusted clearance was approximately 30 % higher than in epileptic adults.
Prividni tjelesni klirens korigiran za tjelesnu težinu bio je približno 30%
UNIQUE IDENTIFIER - 2D BARCODE In case no outer packaging is used
16. PODACI NA BRAILLEOVOM PISMU 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD U slučaju da nije korišteno vanjsko pakiranje
General dose: Levetiracetam ratiopharm is taken twice daily, in two equally divided doses, each individual dose being measured between 5 ml (500 mg) and 15 ml (1500 mg).
Uobičajena doza: Levetiracetam ratiopharm se uzima dva puta na dan, u dvije jednake doze, pri čemu svaka pojedinačna doza iznosi između 5 ml (500 mg) i 15 ml (1500 mg).
Lot See outer carton
Lot Pogledati kutiju
For children 6 years and above, Levetiracetam ratiopharm 100 mg/ml oral solution should be used for doses under 125 mg, for doses not multiple of 125 mg when dosing recommendation is not achievable by taking multiple tablets and for patients unable to swallow tablets.
U djece od 6 godina ili starije Levetiracetam ratipharm 100 mg/ml oralnu otopinu treba primjenjivati za doze ispod 125 mg, doze koje su višekratnici od 125 mg kada se preporučeno doziranje ne može postići uzimanjem većeg broja tableta te u bolesnika koji ne mogu gutati tablete.
60 mg (0.6 ml) twice daily 180 mg (1.8 ml) twice daily
60 mg (0,6 ml) dva puta na dan 180 mg (1,8 ml) dva puta na dan
What you need to know before you take Levetiracetam ratiopharm Do not take Levetiracetam ratiopharm
Što morate znati prije nego počnete uzimati Levetiracetam ratiopharm
43.6 % of the levetiracetam treated patients and 19.6 % of the patients on placebo were considered as responders.
43,6% bolesnika koji su uzimali levetiracetam i 19,6% onih koji su uzimali placebo.
Dosing adjustment for infants, children and adolescents patients weighing less than 50 kg with impaired renal function:
Prilagođavanje doze kod dojenčadi, djece i adolescenata s manje od 50 kg tjelesne težine s oštećenom bubrežnom funkcijom: Skupina
Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Acesulfame potassium (E950)
6.1 Popis pomoćnih tvari metilparahidroksibenzoat (E218) propilparahidroksibenzoat (E216) acesulfamkalij (E950)
In all of the above cases Levetiracetam ratiopharm 100 mg/ml oral solution should be used.
U svim tim slučajevima treba upotrijebiti Levetiracetam ratiopharm 100 mg/ml oralnu otopinu.
Levetiracetam ratiopharm contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, potassium and sodium.
Levetiracetam ratiopharm sadrži metilparahidroksibenzoat, propilparahidroksibenzoat, kalij i natrij
150 mg (1.5 ml) twice daily 450 mg (4.5 ml)twice daily
150 mg (1,5 ml) dva puta na dan 450 mg (4,5 ml) dva puta na dan
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for blister packs
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija za blister pakiranja
In paediatric patients (1 month to less than 4 years of age), levetiracetam efficacy was established in a double-blind, placebo-controlled study, which included 116 patients and had a treatment duration of 5 days.
U pedijatrijskih bolesnika (1 mjesec do manje od 4 godine života), djelotvornost levetiracetama dokazana je dvostruko-slijepom i placebom kontroliranom studijom u 116 bolesnika, koji su lijek dobivali 5 dana.
The pharmacokinetic results indicated that half-life was shorter (5.3 h) than for adults (7.2 h) and apparent clearance was faster (1.5 ml/min/kg) than for adults (0.96 ml/min/kg).
(7,2 h), a prividni klirens (1,5 ml/min/kg) brži je nego u odraslih (0,96 ml/min/kg).
Dose in adults and adolescents from 16 years of age:
Doza za odrasle i adolescente od navršene 16. godine života:
Infants should start the treatment with Levetiracetam ratiopharm 100 mg/ml oral solution.
Dojenčad treba započeti liječenje sa Levetiracetam ratiopharm 100 mg/ml oralnom otopinom.
Probenecid (500 mg four times daily), a renal tubular secretion blocking agent, has been shown to inhibit the renal clearance of the primary metabolite but not of levetiracetam.
Probenecid (500 mg četiri puta na dan), inhibitor bubrežne tubularne sekrecije, inhibira bubrežni klirens glavnog metabolita levetiracetama ali ne i samog levetiracetama.
Use the 1 ml syringe included in the package.
Koristite štrcaljku od 1 ml koja se nalazi u pakiranju.
Dose in adults and adolescents (from 16 years of age):
Doza za odrasle i adolescente (od 16. godine života)
• Levetiracetam ratiopharm is not indicated in children and adolescents below 16 years on its own (monotherapy).
• U djece i adolescenata mlađih od 16 godina Levetiracetam ratiopharm se ne primjenjuje samostalno (monoterapija).
Marketing Authorisation Holder ratiopharm GmbH Graf-Arco-Str. 3
Nositelj odobrenja za stavljanje gotovog lijeka u promet ratiopharm GmbH Graf-Arco-Str.
Levetiracetam ratiopharm oral solution includes methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
Levetiracetam ratiopharm 100 mg/ml oralna otopina sadrži metilparahidroksibenzoat (E218) i propilparahidroksibenzoat (E216) koji mogu izazvati alergijske reakcije (koje mogu biti i odgođene).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Multipack Carton for blister packs- without the Blue Box
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija (višestruko pakiranje) za blistere - bez plavog okvira
Neonatal and juvenile animal studies in rats and dogs demonstrated that there were no adverse effects seen in any of the standard developmental or maturation endpoints at doses up to 1800 mg/kg/day (x 6 - 17 the MRHD on a mg/m2 basis).
Neonatalne i juvenilne studije na štakorima i psima pokazale su da nema nuspojava u uobičajenim mjerama ishoda razvoja ili sazrijevanja kod primjene doza do 1800 mg/kg/dan (6-erostruka do 17
The other ingredients are: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), citric acid monohydrate, sodium hydroxide, purified water, acesulfame potassium (E 950), grape flavour.
Drugi sastojci su: metilparahidroksibenzoat (E218), propilparahidroksibenzoat (E216), citratna kiselina hidrat, natrijev hidroksid, pročišćena voda, acesulfamkalij (E950), aroma grožđa.
Take the number of tablets following your doctor's instructions.
Uzmite onoliko tableta koliko Vam je liječnik propisao.
Levetiracetam ratiopharm 250 mg film-coated tablets Poly(vinyl alcohol), Titanium dioxide (E171), Macrogol, Talc, Blue indigo carmine aluminium lake (E132)
Levetiracetam ratiopharm 250 mg filmom obložene tablete poli (vinilni alkohol), titanijev dioksid (E171), makrogol, talk, blue indigo carmine aluminium lake (E132)
(4) Following dialysis, a 3.5 to 7 mg/kg (0.035 to 0.07 ml/kg) supplemental dose is recommended.
(4) Nakon dijalize preporučuje se dodatna doza od 3,5 do 7 mg/kg (0,035 do 0,07 ml/kg).
Levetiracetam ratiopharm 250 mg film-coated tablets Levetiracetam ratiopharm 500 mg film-coated tablets Levetiracetam ratiopharm 750 mg film-coated tablets Levetiracetam ratiopharm 1000 mg film-coated tablets
Levetiracetam ratiopharm 250 mg filmom obložene tablete Levetiracetam ratiopharm 500 mg filmom obložene tablete Levetiracetam ratiopharm 750 mg filmom obložene tablete Levetiracetam ratiopharm 1000 mg filmom obložene tablete
General dose: Levetiracetam ratiopharm is taken twice daily, in two equally divided doses, each individual dose being measured between 0.07 ml (7 mg) and 0.21 ml (21 mg), per kg bodyweight of the infant.
Uobičajena doza: Levetiracetam ratiopharm se uzima dva puta na dan, u dvije jednake doze, pri čemu svaka pojedinačna doza iznosi između 0,07 ml (7 mg) i 0,21 ml (21 mg) po kilogramu tjelesne težine dojenčeta. (vidi tablicu ispod za primjere doze).
72.2 % of the levetiracetam treated patients and 45.2 % of the patients on placebo had a 50 % or greater decrease in the frequency of PGTC seizures per week.
U 72,2% bolesnika liječenih levetiracetamom i 45,2% bolesnika koji su dobivali placebo primijećeno je 50 %-tno ili više smanjenje učestalosti PGTK napadaja tjedno.
To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
O tome treba voditi računa u bolesnika koji imaju smanjenu funkciju bubrega ili u bolesnika s ograničenim unosom kalija
Levetiracetam ratiopharm 100 mg/ml oral solution is the preferred formulation for use in infants and children under the age of 6 years.
Levetiracetam ratiopharm 100 mg/ml oralna otopina je najprikladniji farmaceutski oblik za primjenu u dojenčadi i djece mlađe od 6 godina.
If you forget to take Levetiracetam ratiopharm
Ako ste zaboravili uzeti Levetiracetam ratiopharm
Rare: may affect up to 1 in 1000 people
Rijetko: mogu se javiti u manje od 1 na 1000 osoba
If you stop taking Levetiracetam ratiopharm
Ako prestanete uzimati Levetiracetam ratiopharm
Oral solution 300 ml oral solution
Oralna otopina 300 ml oralne otopine
The safety and efficacy of Levetiracetam ratiopharm in children and adolescents below 16 years as monotherapy treatment have not been established.
Kod monoterapije u djece i adolescenata mlađih od 16 godina sigurnost i djelotvornost Levetiracetama ratiopharm nije dokazana.
Dose in infants (1 month to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:
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:
Levetiracetam ratiopharm oral solution is a clear liquid.
Levetiracetam ratiopharm oralna otopina je bistra tekućina.
Use the 3 ml syringe included in the package.
Koristite štrcaljku od 3 ml koja se nalazi u pakiranju.
The 300 ml glass bottle of Levetiracetam ratiopharm oral solution (for children aged 4 years and above, adolescents and adults) is packed in a cardboard box containing a 10 ml oral syringe (graduated every 0.25 ml) and an adaptor for the syringe.
Staklena boca od 300 ml Levetiracetam ratiopharm oralne otopine (za djecu u dobi od 4 godine i stariju, adolescente i odrasle) pakirana je u kartonsku kutiju koja još sadrži štrcaljku za usta od 10 ml (s oznakom na svakih 0,25 ml) i nastavak za štrcaljku.
Three presentations are available: - A 300 ml bottle with a 10 ml oral syringe (delivering up to 1000 mg levetiracetam) graduated every 0.25 ml (corresponding to 25 mg).
- Bočica od 300 ml s 10 ml štrcaljkom za usta (kojom se dostavlja do 1000 mg levetiracetama) s podjelama po 0,25 ml (što odgovara količini od 25 mg).
• skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens
• osip kože koji može tvoriti mjehure i izgledati kao male mete (sa središnjim tamnim točkama okruženim bljeđim područjem i tamnim prstenom oko ruba) (erythema multiforme), jako rasprostranjen osip s mjehurma i kožom koja se ljušti, osobito oko usta, nosa, očiju i genitalija
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.
U 44,6% bolesnika liječenih levetiracetamom i 19,6% bolesnika koji su dobivali placebo zapaženo je 50 %-tno ili više smanjenje od početne učestalosti djelomičnih napadaja tjedno.
The NOAEL was < 200 mg/kg/day for the dams and 200 mg/kg/day for the fetuses (equal to the MRHD on a mg/m2 basis).
NOAEL je za gravidne ženke iznosila <200 mg/kg/dan, a za fetuse 200 mg/kg/dan (što je jednako najvećoj preporučenoj dozi u ljudi izraženoj u mg/m2).
In this study, levetiracetam, dose was 3000 mg/day given in 2 divided doses.
Primijenjena doza kod studije bila je 3000 mg/dan podjeljeno na dvije doze.
Tel: +39 02 891798 1
Teva Italia S.r.l. Tel: +39 02 891798 1
Use the 10 ml syringe included in the package.
Koristite štrcaljku od 10 ml koja se nalazi u pakiranju.
Oral solution 150 ml oral solution
Oralna otopina 150 ml oralne otopine
The 150 ml glass bottle of Levetiracetam ratiopharm oral solution (for infants aged 1 month to less than 6 months) is packed in a cardboard box containing a 1 ml oral syringe (graduated every 0.05 ml) and an adaptor for the syringe.
Staklena boca od 150 ml Levetiracetam ratiopharm oralne otopine (za dojenčad u dobi od 1 mjeseca do manje od 6 mjeseci) pakirana je u kartonsku kutiju koja još sadrži štrcaljku za usta od 1 ml (s oznakom na svakih 0,05 ml) i nastavak za štrcaljku.
Adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
Dodatna terapija miokloničkih napadaja u odraslih i adolescenata starijih od 12 godina života s juvenilnom miokloničkom epilepsijom.
• on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy.
• samostalno u odraslih i adolescenata od 16. godine života s novodijagnosticiranom epilepsijom,
CLcr (ml/min/1.73 m2) = ------------------------------------------Serum Creatinine (mg/dl)
CLcr (ml/min/1,73 m2) = -----------------------------------------Kreatinin u serumu (mg/dl)
• as an add-on to other antiepileptic medicines to treat: partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy, primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih, adolescenata, djece i dojenčadi od prvog mjeseca života miokloničkih napadaja (kratki, iznenadni trzaji mišića ili skupine mišića) u odraslih i adolescenata starijih od 12. godine života s juvenilnom miokloničkom epilepsijom primarno generaliziranih toničko-kloničkih napadaja (veliki napadaji, uključujući gubitak svijesti) u odraslih i adolescenata starijih od 12. godine života s idiopatskom generaliziranom epilepsijom (oblik epilepsije za koji se smatra da je genetski uvjetovan).
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.
Kod mužjaka i ženki štakora roditeljske i F1 generacije nisu primijećeni štetni učinci 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 izloženost).
• Wash the syringe afterwards with clear water by filling and emptying the syringe repeatedly.
• Nakon upotrebe isperite štrcaljku vodom na način da je opetovano punite i praznite.
Levetiracetam ratiopharm 250 mg film-coated tablets The 250 mg film-coated tablets are blue, oblong and scored on one side.
Levetiracetam ratiopharm 250 mg filmom obložene tablete 250 mg filmom obložene tablete su plave, duguljaste tablete s razdjelnom crtom na jednoj strani.
Levetiracetam ratiopharm 1000 mg film-coated tablets The 1000 mg film-coated tablets are white, oblong and scored on both sides.
Levetiracetam ratiopharm 1000 mg filmom obložene tablete 1000 mg filmom obložene tablete su bijele, duguljaste tablete s razdjelnom crtom na obje strane.
In the elderly, the half-life is increased by about 40 % (10 to 11 hours).
U starijih osoba poluvijek u plazmi povećan je za oko 40% (10 do 11 sati), što je u svezi sa smanjenjem bubrežne funkcije unutar te populacije (vidjeti dio 4.2).
The NOAEL (No Observed Adverse Effect Level) was 3600 mg/kg/day for pregnant female rats (x 12 the MRHD on a mg/m2 basis) and 1200 mg/kg/day for fetuses.
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).
One film-coated tablet of Levetiracetam ratiopharm 1000 mg contains 1000 mg levetiracetam.
Jedna filmom obložena tableta Levetiracetam ratiopharm 1000 mg sadrži 1000 mg levetiracetama.
Concomitant administration of levetiracetam and methotrexate has been reported to decrease methotrexate clearance, resulting in increased/prolonged blood methotrexate concentration to potentially toxic levels.
što uzrokuje povišenu/zadržanu koncentraciju metotreksata u krvi do potencijalno toksičnih razina.
Levetiracetam ratiopharm 100 mg/ml oral solution Levetiracetam
Levetiracetam ratiopharm 100 mg/ml oralna otopina levetiracetam
Linear and dose proportional increases were observed for peak plasma concentrations and area under the curve.
Za vršne koncentracije u plazmi i površinu ispod krivulje primijećena su linearna povećanja i proporcionalna s dozom.
7 to 14 mg/kg (0.07 to 0.14 ml/kg)once daily (2) (4)
7 do 14 mg/kg (0,07 do 0,14 ml/kg) jedanput na dan (2) (4)
A dose of 20 mg/kg/day titrating to 40 mg/kg/day for infants one month to less than six months and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for infants and children 6 months to less than 4 years old, was use in this study.
25 mg/kg/dan titrirana je do 50 mg/kg/dan u dojenčadi i djece u dobi od 6 mjeseci do manje od 4
Levetiracetam ratiopharm 750 mg film-coated tablets EU/1/11/702/018
Levetiracetam ratiopharm 750 mg filmom obložene tablete EU/1/11/702/018
Levetiracetam ratiopharm 250 mg film-coated tablets EU/1/11/702/004
Levetiracetam ratiopharm 250 mg filmom obložene tablete EU/1/11/702/004
10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets
10 filmom obloženih tableta 20 filmom obloženih tableta 30 filmom obloženih tableta 50 filmom obloženih tableta 60 filmom obloženih tableta 100 filmom obloženih tableta