natgillin/translations-raw huggingface dataset:
As with all antiepileptic medicines, sudden discontinuation of levetiracetam should be avoided as this may lead to breakthrough seizures that could have serious consequences for the woman and the unborn child. Monotherapy should be preferred whenever possible because therapy with multiple antiepileptic medicines AEDs could be associated with a higher risk of congenital malformations than monotherapy, depending on the associated antiepileptics.
Poželjna je monoterapija kad god je to moguće jer bi terapija kombinacijama antiepileptika mogla biti povezana s većim rizikom od kongenitalnih malformacija u odnosu na monoterapiju, ovisno o dotičnim antiepilepticima.
Antiepileptic medicinal products
Antiepileptici
In both population pharmacokinetic analyses, there was about a 20% increase of apparent clearance of levetiracetam when it was co-administered with an enzyme-inducing antiepileptic medicinal product.
U obje farmakokinetičke analize populacije prividni klirens levetiracetama se povećao za oko 20 %
Levetiracetam Actavis Group oral solution should be used for doses under 250 mg, for doses not multiple of 250 mg when dosing recommendation is not achievable by taking multiple tablets and for patients unable to swallow tablets.
(1) Za doze ispod 250 mg, za doze koje nisu višekratnici od 250 mg, odnosno kada preporučeno doziranje ne može biti postignuto uzimanjem većeg broja tableta i kod bolesnika koji ne mogu gutati tablete treba koristiti Levetiracetam Actavis Group oralnu otopinu.
• 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 se može formirati u mjehuriće i izgledati kao male mete (sa središnjim tamnim točkama okruženim bljeđim područjem i tamnim prstenom oko ruba) (erythema multiforme), jako rasprostranjen osip s mjehurićima i kožom koja se ljušti, osobito oko usta, nosa, očiju i genitalija (Stevens-Johnsonov sindrom), i mnogo teži oblik koji uzrokuje ljuštenje kože na više od 30% površine tijela (toksična epidermalna nekroliza);
49 mg (0.5 ml) twice daily 147 mg (1.5 ml) twice daily
49 mg (0,5 ml) dva puta na dan 147 mg (1,5 ml) dva puta na dan
With continued long-term treatment, 47.4% of the patients were free of tonic-clonic seizures for at least 6 months and 31.5% were free of tonic-clonic seizures for at least 1 year.
S nastavkom dugotrajnog liječenja 47,4 % bolesnika bilo je barem 6 mjeseci i 31,5 % barem 1 godinu bez toničko-kloničkih napadaja.
Maltitol liquid (E965) Acesulfame potassium (E950) Grape flavour (contains propylene glycol) Purified water
acesulfamkalij (E950) aroma grožđa (sadrži propilenglikol)
The 300 ml glass bottle of Levetiracetam Actavis Group (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).
Staklena boca od 300 ml lijeka Levetiracetam Actavis Group (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).
The NOAEL was ≥ 1,800 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).
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).
Add-on therapy for infants from 1 month to less than 6 months
Dodatna terapija za dojenčad u dobi od 1 mjeseca do manje od 6 mjeseci
The initial therapeutic dose is 500 mg twice daily.
Početna terapijska doza iznosi 500 mg dva puta na dan.
35 mg (0.35 ml) twice daily 105 mg (1.05 ml) twice daily
35 mg (0,35 ml) dva puta na dan 105 mg (1,05 ml) dva puta na dan
Dose changes can be made in 500 mg twice daily increases or decreases every two to four weeks.
Doza se može povećavati ili smanjivati za po 500 mg dva puta na dan svaka dva do četiri tjedna.
Liver function test abnormal
Abnormalni nalazi jetrene funkcije
(1) A 750 mg loading dose is recommended on the first day of treatment with levetiracetam.
(1) Prvog dana liječenja levetiracetamom preporučuje se udarna doza od 750 mg.
For children above 4 years, measure the appropriate dosage using the 10 ml syringe included in the package.
Za djecu od navršene 4 godine nadalje odgovarajuću dozu izmjerite pomoću štrcaljke od 10 ml koja se nalazi u pakiranju.
Adjunctive therapy in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.
Dodatna terapija primarno generaliziranih toničko-kloničkih napadaja u odraslih i adolescenata starijih od 12 godina života s idiopatskom generaliziranom epilepsijom.
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:
Dodatna terapija djelomičnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih, adolescenata, djece i dojenčadi od 1. mjeseca života nadalje koji pate od epilepsije.
Citric acid monohydrate Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Ammonium glycyrrhizate
6.1 Popis pomoćnih tvari natrijev citrat citratna kiselina hidrat metilparahidroksibenzoat (E218) propilparahidroksibenzoat (E216) amonijev glicirizat glicerin glicerol (E422)
(5) Following dialysis, a 5 to 10 mg/kg (0.05 to 0.10 ml/kg) supplemental dose is recommended.
(5) Nakon dijalize preporučuje se dodatna doza od 5 do 10 mg/kg (0,05 do 0,10 ml/kg).
Infants 6 to 23 months, children and adolescents weighing less than 50 kg
mjeseca, djeca i adolescenti teški manje od 50 kg
Monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.
Monoterapija u liječenju djelomičnih napadaja sa sekundarnom generalizacijom ili bez nje u bolesnika od navršene 16. godine života s novodijagnosticiranom epilepsijom.
Levetiracetam is a highly soluble and permeable compound.
Levetiracetam je lako topiva i permeabilna tvar.
In adults, levetiracetam efficacy has been demonstrated in 3 double-blind, placebo-controlled studies at 1,000 mg, 2,000 mg, or 3,000 mg/day, given in 2 divided doses, with a treatment duration of up to 18 weeks.
Djelotvornost levetiracetama dokazana je u odraslih u 3 dvostruko slijepa i placebom kontrolirana ispitivanja gdje su bolesnici tijekom liječenja 18 tjedana dobivali 1000 mg, 2000 mg ili 3000 mg/dan,
Three presentations are available: - A 300 ml bottle with a 10 ml oral syringe (delivering up to 1,000 mg levetiracetam) graduated every 0.25 ml (corresponding to 25 mg).
Dostupne su tri veličine pakiranja: - Bočica od 300 ml s 10 ml štrcaljkom za usta (koja isporučuju do 1000 mg levetiracetama) s podjelama po 0,25 ml (što odgovara količini od 25 mg).
A significant correlation between saliva and plasma concentrations has been shown in adults and children (ratio of saliva/plasma concentrations ranged from 1 to 1.7 for oral tablet formulation and after 4 hours post-dose for oral solution formulation).
(omjer koncentracija u slini i plazmi je u rasponu od 1 do 1,7 za lijek u obliku oralne tablete te nakon 4 sata od uzimanja lijeka u obliku oralne otopine).
The initial therapeutic dose is 10 mg/kg twice daily.
Početna terapijska doza iznosi 10 mg/kg dva puta na dan.
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 MRHD-u, engl.
What you need to know before you take Levetiracetam Actavis Group Do not take Levetiracetam Actavis Group
Što morate znati prije nego počnete uzimati Levetiracetam Actavis Group
BSA subject (m2)
PT bolesnika (m2)
Pull the syringe by the dosing body out of the bottle (Figure 2).
Uklonite štrcaljku iz boce držeći je za graduirano tijelo (slika 2).
Oral use.
Oralna otopina.
The initial therapeutic dose is 7 mg/kg twice daily.
Početna terapijska doza je 7 mg/kg dva puta na dan.
Starting dose: 0.1 ml/kg twice daily Maximum dose: 0.3 ml/kg twice daily
Početna doza: 0,1 ml/kg dva puta na dan Najveća doza: 0,3 ml/kg dva puta na dan
Weight decreased , weight increase
povećanje tjelesne težine
IJsland / Islande / Island Tél/Tel: +354 5503300
Actavis Group PTC ehf. Islande / Island Tél/Tel: +354 5503300
With continued long-term treatment, 28.6% of the patients were free of myoclonic seizures for at least 6 months and 21.0% were free of myoclonic seizures for at least 1 year.
S nastavkom dugotrajnog liječenja 28,6 % bolesnika bilo je barem 6 mjeseci i 21,0 % barem 1 godinu bez miokloničkih napadaja.
With continued long-term treatment, 11.4% of the patients were seizure-free for at least 6 months and 7.2% were seizure-free for at least 1 year.
S nastavkom dugotrajnog liječenja 11,4% bolesnika bilo je barem 6 mjeseci, a 7,2 % barem 1 godinu bez napadaja.
• in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
• u liječenju miokloničkih napadaja u odraslih i adolescenata od 12. godine života s juvenilnom miokloničnom epilepsijom.
For children 6 months to 4 years, measure the appropriate dosage using the 3 ml syringe included in the package.
Za djecu od navršenih 6 mjeseci do manje od 4 godine, odgovarajuću dozu izmjerite pomoću štrcaljke od 3 ml koja se nalazi u pakiranju.
If you stop taking Levetiracetam Actavis Group
Ako prestanete uzimati Levetiracetam Actavis Group
Levetiracetam Actavis Group 100 mg/ml oral solution contains maltitol liquid.
Levetiracetam Actavis Group 100 mg/ml oralna otopina sadrži tekući maltitol.
If you forget to take Levetiracetam Actavis Group
Ako ste zaboravili uzeti Levetiracetam Actavis Group
The administration of levetiracetam to patients with renal impairment may require dose adjustment.
U bolesnika s oštećenjem bubrega može biti potrebno prilagođavanje doze levetiracetama
Turn the bottle upside down with the syringe still in place (Figure 4).
Okrenite bocu naopako; štrcaljka treba i dalje biti pričvršćena (slika 4).
Starting dose: 0.07 ml/kg twice daily Maximum dose: 0.21 ml/kg twice daily
Početna doza: 0,07 ml/kg dva puta na dan Najveća doza: 0,21 ml/kg dva puta na dan
The most frequently reported adverse reactions were nasopharyngitis, somnolence, headache, fatigue and dizziness.
Sažetak sigurnosnog profila Najčešće prijavljene nuspojave bile su nazofaringitis, somnolencija, glavobolja, umor i omaglica.
Results related to behavioral and emotional functioning indicated a worsening in levetiracetam treated patients on aggressive behaviour as measured in a standardised and systematic way using a validated instrument (CBCL - Achenbach Child Behaviour Checklist).
Rezultati ocjene funkcioniranja ponašanja i emocionalnog funkcioniranja uputili su na pogoršanje u smislu agresivnijeg ponašanja u skupini koja je uzimala levetiracetam, ocijenjenog validiranim instrumentom
The 300 ml glass bottle of Levetiracetam Actavis Group (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 300 ml lijeka Levetiracetam Actavis Group (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.
(4) Following dialysis, a 3.5 to 7 mg/kg (0.035 to 0.07 ml/kg) supplemental dose is recommended.
Nakon dijalize preporučuje se dodatna doza od 3,5 do 7 mg/kg (0,035 do 0,07 ml/kg).
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.
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.
• convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness),
• konvulzije, poremećaj ravnoteže, omaglica (osjećaj nestabilnosti), bezvoljnost (nedostatak energije i elana), tremor (nevoljno drhtanje);
In the elderly, the half-life is increased by about 40% (10 to 11 hours).
U starijih osoba poluvijek u plazmi povećano je za oko 40 % (10 do 11 sati), što je u svezi sa smanjenjem bubrežne funkcije unutar te populacije (vidjeti dio 4.2).
In this study, levetiracetam, dose was 3,000 mg/day given in 2 divided doses.
Primijenjena doza kod ispitivanja bila je 3000 mg/dan podjeljeno na dvije doze.
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 miokloničnom epilepsijom.
Hyponatraemia
Hiponatremija
300 ml oral solution with a 10 ml oral syringe.
300 ml oralne otopine sa štrcaljkom za usta od 10 ml.
- A 300 ml bottle with a 3 ml oral syringe (delivering up to 300 mg levetiracetam) graduated every 0.1 ml (corresponding to 10 mg).
- Bočica od 300 ml s 3 ml štrcaljkom za usta (koja isporučuje do 300 mg levetiracetama) s podjelama po 0,1 ml (što odgovara količini od 10 mg).
No adverse reactions on male or female fertility or reproduction performance were observed in rats at doses up to 1,800 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 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 izloženost).
Diplopia, vision blurred
Diplopija, zamagljen vid
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
• bol u trbuhu, proljev, dispepsija (loša probava), povraćanje, mučnina;
- A 300 ml bottle with a 1 ml oral syringe (delivering up to 100 mg levetiracetam) graduated every 0.05 ml (corresponding to 5 mg).
- Bočica od 300 ml s 1 ml štrcaljkom za usta (koja isporučuje do 100 mg levetiracetama) s podjelama po 0,05 ml (što odgovara količini od 5 mg).
confusion, panic attack, emotional instability/mood swings, agitation;
halucinacije, srditost, smetenost, napadaj panike, emocionalna nestabilnost/promjene raspoloženja, uznemirenost;
The NOAEL (No Observed Adverse Effect Level) was 3,600 mg/kg/day for pregnant female rats (x 12 the MRHD on a mg/m2 basis) and 1,200 mg/kg/day for fetuses.
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).
(3) A 15 mg/kg (0.15 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
(3) Prvog dana liječenja levetiracetamom preporučuje se udarna doza od 15 mg/kg (0,15 ml/kg).
CLcr (ml/min/1.73 m2) = -----------------------------------Serum Creatinine (mg/dl)
visina (cm) x ks CLcr (ml/min/1,73 m2) = -----------------------------------kreatinin u serumu (mg/dl)
Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with levetiracetam overdoses.
Kod predoziranja levetiracetamom primijećena je somnolencija, agitacija, agresivnost, smanjena razina svijesti, depresija disanja i koma.
In addition, the oral solution should be used for initial treatment in children weighing less than 25 kg,
Osim toga, oralnu otopinu treba upotrijebiti za početak liječenja u djece lakše od 25 kg, u bolesnika koji ne mogu gutati tablete ili za davanje doza manjih od 250 mg.
General dose: Levetiracetam Actavis Group is taken twice daily, in two equally divided doses, each individual dose being measured between 0.1 ml (10 mg) and 0.3 ml (30 mg), per kg bodyweight of the child. (see table below for dose examples).
Uobičajena doza: Levetiracetam Actavis Group se uzima dva puta na dan, u dvije jednake doze, pri čemu svaka pojedinačna doza iznosi između 0,1 ml (10 mg) i 0,3 ml (30 mg) po kilogramu tjelesne težine djeteta.
How to take Levetiracetam Actavis Group
Kako uzimati Levetiracetam Actavis Group
Levetiracetam Actavis Group 100 mg/ml oral solution Levetiracetam
Levetiracetam Actavis Group 100 mg/ml oralna otopina levetiracetam
in adults and adolescents from 12 years of age with idiopathic generalised epilepsy
godine života s idiopatskom generaliziranom epilepsijom.
• amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ataxia
• amnezija (gubitak pamćenja), smetnje pamćenja (zaboravljivost), poremećaj koordinacije/ataksija (poremećaj koordinacije pokreta), parestezije (trnci), smetnje u koncentraciji (gubitak koncentracije);
Levetiracetam Actavis Group 100 mg/ml oral solution is a clear, faint yellowish-brown solution.
Levetiracetam Actavis Group 100 mg/ml oralna otopina je bistra, blijedo žućkasto-smeđa otopina.
220 Hafnarfjörður Iceland
Actavis Group PTC ehf. 220 Hafnarfjörður Island
The 300 ml glass bottle of Levetiracetam Actavis Group (for infants and young children aged from 6 months to less than 4 years) is packed in a cardboard box containing a 3 ml oral syringe (graduated every 0.1 ml) and an adaptor for the syringe.
Staklena boca od 300 ml lijeka Levetiracetam Actavis Group (za dojenčad u dobi od 6 mjeseci i stariju i djecu u dobi od 2 do 4 godine) pakirana je u kartonsku kutiju koja još sadrži štrcaljku za usta od 3 ml (s oznakom na svakih 0,1 ml) i nastavak za štrcaljku.
Package Leaflet: Information for the patient Levetiracetam Actavis Group 100 mg/ml oral solution
Uputa o lijeku: Informacija za bolesnika Levetiracetam Actavis Group 100 mg/ml oralna otopina levetiracetam
{MM/YYYY}
I DOHVATA
250 to 750 mg twice daily
250 do 750 mg dva puta na dan
Levetiracetam is rapidly absorbed after oral administration.
Levetiracetam se brzo apsorbira nakon peroralne primjene.
(2) A 10.5 mg/kg (0.105 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
(2) Prvog dana liječenja levetiracetamom preporučuje se udarna doza od 10,5 mg/kg (0,105 ml/kg).
The oral solution may be diluted in a glass of water or baby's bottle and may be taken with or without food.
Oralna otopina može se razrijediti u čaši vode ili u dječjoj bočici.
For infants 1 month to less than 6 months, measure the appropriate dosage using the 1 ml syringe included in the package.
Doza u dojenčadi (1 mjesec do manje od 6 mjeseci): Za dojenčad od navršenog 1. mjeseca do manje od 6 mjeseci odgovarajuću dozu izmjerite pomoću štrcaljke od 1 ml koja se nalazi u pakiranju.
7 to 21 mg/kg (0.07 to 0.21 ml/kg) twice daily
7 do 21 mg/kg (0,07 do 0,21 ml/kg) dva puta na dan
End-stage renal disease patients undergoing dialysis
Bolesnici u završnoj fazi bubrežne bolesti na dijalizi
Suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour, hallucination, anger, confusional state , panic attack, affect lability/mood swings, agitation
halucinacije, srditost, konfuzno stanje, napadaj panike, labilnost afekta/promjene raspoloženja, agitacija
500 mg twice daily
500 mg dva puta na dan
Dose in children 6 months and older:
Doza u djece od navršenih 6 mjeseci nadalje:
Special populations
Starije osobe
3.5 to 7 mg/kg (0.035 to 0.07 ml/kg) twice daily
3,5 do 7 mg/kg (0,035 do 0,07 ml/kg) dva puta na dan
Methotrexate
Metotreksat
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 proporcionalno s dozom.
0.85 ml twice daily
0,85 ml dva puta na dan
The patients were randomized to carbamazepine CR 400 - 1,200 mg/day or levetiracetam 1,000 - 3,000 mg/day, the duration of the treatment was up to 121 weeks depending on the response.
Bolesnici su randomizirani za dobivanje 400 do 1200 mg karbamazepina s kontroliranim otpuštanjem (CR) na dan ili 1000 do 3000 mg levetiracetama na dan,
300 ml oral solution with a 1 ml oral syringe and an adaptor.
300 ml oralne otopine sa štrcaljkom za usta od 1 ml i nastavkom.
500 to 1,000 mg twice daily
500 do 1000 mg dva puta na dan
200 mg (2 ml) twice daily
200 mg (2 ml) dva puta na dan 600 mg (6 ml) dva puta na dan
750 mg twice daily
750 mg dva puta na dan
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
300 ml oral solution with a 3 ml oral syringe and an adaptor.
300 ml oralne otopine sa štrcaljkom za usta od 3 ml i nastavkom.
Nervous system Somnolence,
Poremećaji živčanog sustava
• asthenia/fatigue (tiredness).
• osip; • astenija/umor (zamaranje).
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
To uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi.Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
250 mg twice daily
250 mg dva puta na dan
How to store Levetiracetam Actavis Group
Kako čuvati Levetiracetam Actavis Group
15 ml twice daily
15 ml dva puta na dan
300 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a cardboard box also containing a 10 ml graduated oral syringe (polypropylene, polyethylene).
Smeđa staklena boca od 300 ml (staklo tip III) s bijelim sigurnosnim zatvaračem za djecu (polipropilen) u kartonskoj kutiji koja također sadrži graduiranu štrcaljku za usta od 10 ml
1.25 ml twice daily
1,25 ml dva puta na dan
500 to 1,500 mg twice daily
500 do 1500 mg dva puta na dan
10 to 20 mg/kg (0.10 to 0.20 ml/kg) twice daily
10 do 20 mg/kg (0,10 do 0,20 ml/kg) dva puta na dan
5 to 15 mg/kg (0.05 to 0.15 ml/kg) twice daily
5 do 15 mg/kg (0,05 do 0,15 ml/kg) dva puta na dan
10 to 30 mg/kg (0.10 to 0.30 ml/kg) twice daily
10 do 30 mg/kg (0,10 do 0,30 ml/kg) dva puta na dan
250 to 500 mg twice daily
250 do 500 mg dva puta na dan
7.5 ml twice daily
7,5 ml dva puta na dan
Excretion via faeces accounted for only 0.3% of the dose.
Samo 0,3 % doze izlučuje se fecesom.
[140-age (years)] x weight (kg)
[140-dob (godine)] x težina (kg) CLcr (ml/min) = ----------------------------------------- (x 0,85 za žene) 72 x kreatinin u serumu (mg/dl)
7 to 14 mg/kg (0.07 to 0.14 ml/kg) twice daily
7 do 14 mg/kg (0,07 do 0,14 ml/kg) dva puta na dan
Common: may affect up to 1 in 10 people
Često: mogu se javiti u manje od 1 na 10 osoba
• symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling in the legs, ankles or feet, as this may be a sign of sudden decrease of kidney function;
• simptome kao što je smanjen volumen mokraće, umor, mučninu, povraćanje, smetenost i oticanje u nogama, gležnjevima ili stopalima jer to može biti znak naglog smanjenja bubrežne funkcije • kožni osip koji može tvoriti mjehure i izgledati poput malih meta (središnje tamne mrlje okružene svijetlim područjem, s tamnim prstenom oko ruba) (multiformni eritem) • rasprostranjeni osip s mjehurićima i kožom koja se ljušti, posebice oko usta, nosa, očiju i genitalija (Stevens-Johnsonov sindrom)
3.5 to 10.5 mg/kg (0.035 to 0.105 ml/kg) twice daily
3,5 do 10,5 mg/kg (0,035 do 0,105 ml/kg) dva puta na dan
0.35 ml twice daily
0,35 ml dva puta na dan
5 to 10 mg/kg (0.05 to 0.10 ml/kg) twice daily
5 do 10 mg/kg (0,05 do 0,10 ml/kg) dva puta na dan
100 mg (1 ml) twice daily
100 mg (1 ml) dva puta na dan 300 mg (3 ml) dva puta na dan
No dose adjustment is needed in patients with mild to moderate hepatic impairment.
U bolesnika s blagim do umjerenim oštećenjem jetre nije potrebno prilagođavanje doze.
0.8 ml twice daily
0,8 ml dva puta na dan
0.6 ml twice daily
0,6 ml dva puta na dan
Uncommon: may affect up to 1 in 100 people
Manje često: mogu se javiti u manje od 1 na 100 osoba
• in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.
• u liječenju primarno generaliziranih toničko-kloničkih napadaja u odraslih i adolescenata od 12.