natgillin/translations-raw huggingface dataset:
Ketoconazole 400 mg QD (Indinavir 600 mg TID)
Ketokonazol 400 mg QD (indinavir 600 mg TID)
Ketoconazole 400 mg QD (Indinavir 400 mg TID)
Ketokonazol 400 mg QD (indinavir 400 mg TID)
Anti-Mycobacterial Isoniazid 300 mg QD (Indinavir 800 mg TID)
Antimikobakterijski lijekovi Izoniazid 300 mg QD (indinavir 800 mg TID)
Blood and lymphatic system disorders
Poremećaji krvi i limfnog sustava vrlo često nepoznato*
Synergistic antiretroviral activity was observed when human T-lymphoid cells infected with the LAI variant of HIV-1 were incubated with indinavir and either zidovudine, didanosine, or NNRTIs.
Kada su humane T-limfoidne stanice zaražene LAI varijantom virusa HIV-1 inkubirane s indinavirom i zidovudinom ili didanozinom ili nenukleozidnim inhibitorima reverzne transkriptaze, primijećeno je sinergijsko antiretrovirusno djelovanje.
Indinavir Cmin:  (Relative to Indinavir 1,000 mg TID alone)
Cmin indinavira:  (u odnosu na primjenu samo indinavira u dozi od 1000 mg TID)
Combination of rifampicin with CRIXIVAN with or without concomitant low-dose ritonavir is contraindicated (see section 4.5).
Kontraindicirana je kombinacija rifampicina i lijeka CRIXIVAN uz istodobnu primjenu niske doze ritonavira ili bez nje (vidjeti dio 4.5).
Sildenafil dose should not exceed a maximum of 25 mg in a 48-hour period in patients receiving concomitant indinavir therapy.
U bolesnika koji se istodobno liječe indinavirom doza sildenafila ne smije biti viša od maksimalnih 25 mg unutar 48-satnog razdoblja.
Didanosine enteric-coated 400 mg SD (Indinavir 800 mg SD)
Didanozin, želučanootporan 400 mg SD (indinavir 800 mg SD)
Indinavir and methadone can be co-administered without dose adjustment.
Indinavir i metadon mogu se istodobno primjenjivati bez prilagođavanja doze.
Interaction with indinavir/ritonavir not studied Ritonavir may modify P-glycoprotein mediated fexofenadine efflux when coadministered resulting in increased concentrations of fexofenadine.
Ako se primjenjuju istodobno, ritonavir može izmijeniti efluks feksofenadina u kojem posreduje P-glikoprotein, što dovodi do povišenih koncentracija feksofenadina.
Indinavir AUC: ↓ 32 % Indinavir Cmin: ↓ 40 % (Relative to Indinavir 800 mg TID alone)
AUC indinavira: ↓32% Cmin indinavira: ↓40% (u odnosu na primjenu samo indinavira u dozi od 800 mg TID)
(including microscopic haematuria) occur, temporary interruption of therapy (e.g. for 1-3 days) during the acute episode of nephrolithiasis or discontinuation of therapy may be considered.
Ako se jave znakovi i simptomi nefrolitijaze, uključujući bol u slabinama koja može, ali ne mora biti praćena hematurijom (uključujući i mikroskopsku hematuriju), može se razmotriti privremeni prekid liječenja (npr. 1-3 dana) za vrijeme akutne epizode nefrolitijaze ili potpuni prekid liječenja.
Indinavir and theophylline can be co-administered without dose adjustment.
Indinavir i teofilin mogu se istodobno primjenjivati bez prilagođavanja doze.
Vardenafil dose should not exceed a maximum of 2.5 mg in a 24-hour period in patients receiving concomitant indinavir therapy.
U bolesnika koji se istodobno liječe indinavirom doza vardenafila ne smije biti viša od maksimalnih 2,5 mg unutar 24-satnog razdoblja.
This means you will take a total of two 400 mg capsules (800 mg) each day.
To znači da ćete svaki dan uzeti ukupno dvije kapsule od 400 mg (800 mg).
This means you will take a total of six 400 mg capsules (2400 mg) each day.
To znači da ćete svaki dan uzeti ukupno šest kapsula od 400 mg (2400 mg).
• stomach pain or swelling
• bol u trbuhu ili oticanje trbuha
CRIXIVAN 200 mg hard capsules
CRIXIVAN 200 mg tvrde kapsule
CRIXIVAN 400 mg hard capsules
CRIXIVAN 400 mg tvrde kapsule
Adverse reactions have also been reported during post-marketing experience* as they are derived from spontaneous reports, incidences cannot be determined.
Budući da se radi o spontano prijavljenim nuspojavama, njihovu incidenciju nije moguće utvrditi.
Tadalafil dose should not exceed a maximum of 10 mg in a 72 hour period in patients receiving concomitant indinavir therapy.
U bolesnika koji se istodobno liječe indinavirom doza tadalafila ne smije biti viša od maksimalnih 10 mg unutar razdoblja od 72 sata.
Anticoagulation parameters should be monitored when warfarin is coadministered with indinavir/ritonavir.
Kod istodobne primjene varfarina i indinavira/ritonavira treba pažljivo nadzirati parametre antikoagulacije.
Dizziness and blurred vision have been reported during treatment with CRIXIVAN.
Tijekom liječenja lijekom CRIXIVAN prijavljeni su omaglica i zamagljen vid.
Careful monitoring of digoxin levels is recommended when digoxin is concomitantly administered with indinavir/ritonavir.
Kod istodobne primjene digoksina i indinavira/ritonavira preporučuje se pažljivo praćenje koncentracija digoksina.
A dose increase of indinavir to 1,000 mg every 8 hours should be considered if given with nevirapine.
Ako se primjenjuje s nevirapinom, treba razmotriti povećanje doze indinavira na 1000 mg svakih 8 sati.
PDE5 INHIBITOR Sildenafil 25 mg SD (Indinavir 800 mg TID)
Sildenafil 25 mg SD (indinavir 800 mg TID)
HDPE bottles with a polypropylene cap and a foil induction cap containing 90 or 180 capsules.
Bočice od polietilena visoke gustoće s polipropilenskim zatvaračem i zalijepljenom zaštitnom folijom koje sadrže 90 ili 180 kapsula.
CRIXIVAN 200 mg hard capsules Indinavir
CRIXIVAN 200 mg tvrde kapsule indinavir
Fluconazole 400 mg QD (Indinavir 1,000 mg TID)
Antimikotici Flukonazol 400 mg QD (indinavir 1000 mg TID)
Saquinavir 600 mg SD (hard gel capsule formulation) (Indinavir 800 mg TID)
Sakvinavir 600 mg SD (tvrda želatinozna kapsula) (indinavir 800 mg TID)
Interaction with indinavir/ritonavir not studied Morphine levels may be decreased due to induction of glucuronidation by coadministered ritonavir.
Koncentracije morfija mogu biti smanjene jer istodobno primijenjeni ritonavir inducira glukuronidaciju.
STEROIDS Dexamethasone
STEROIDI Deksametazon
Indinavir and cimetidine can be co-administered without dose adjustment.
Indinavir i cimetidin mogu se istodobno primjenjivati bez prilagođavanja doze.
CRIXIVAN 400 mg hard capsules Indinavir
CRIXIVAN 400 mg tvrde kapsule indinavir
Between 800-mg and 1,000-mg dose levels, the deviation from dose-proportionality is less pronounced.
Odstupanje od proporcionalnosti dozi manje je izraženo kod doza između 800 mg i 1000 mg.
This means you will take a total of four 200 mg capsules (800 mg) each day.
To znači da ćete svaki dan uzeti ukupno četiri kapsule od 200 mg (800 mg).
Skin and subcutaneous tissue disorders
Poremećaji kože i potkožnog tkiva vrlo često često nepoznato*
The Interactions section of the SPC for ritonavir should also be consulted for information about potential interactions.
Za informacije o mogućim interakcijama treba pročitati i dio o interakcijama u Sažetku opisa svojstava lijeka za ritonavir.
Careful monitoring of therapeutic and adverse effects is recommended when erythromycin or itraconazole are concomitantly administered with indinavir/ritonavir.
Kod istodobne primjene eritromicina ili itrakonazola i indinavira/ritonavira preporučuje se pažljivo praćenje terapijskih učinaka i nuspojava.
Anhydrous lactose.
Bezvodna laktoza.
Indinavir Cmin:  (Relative to Indinavir 800 mg TID alone)
Cmin indinavira:  (u odnosu na primjenu samo indinavira u dozi od 800 mg TID)
The capsules are semi-translucent white and coded ‘CRIXIVAN 400 mg' in green.
Kapsule su poluprozirne bijele, s oznakom ‘CRIXIVAN ™ 400 mg' zelene boje.
There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses, in haemophiliac patients type A and B treated with PIs.
A i B liječenih inhibitorima proteaze prijavljeno je pojačano krvarenje, uključujući spontane kožne hematome i hemartroze.
Very common asthenia/fatigue, taste perversion, abdominal pain.
Opći poremećaji i reakcije na mjestu primjene vrlo često astenija/umor, promjena osjeta okusa, bol u abdomenu
The capsules are semi-translucent white and coded ‘CRIXIVAN ™ 200 mg' in blue.
Kapsule su poluprozirne bijele s oznakom ‘CRIXIVAN ™ 200 mg' plave boje.
• acid reflux
• vraćanje kiseline iz želuca
Saquinavir 1,200 mg SD (soft gel capsule formulation) (Indinavir 800 mg TID)
Sakvinavir 1200 mg SD (meka želatinozna kapsula) (indinavir 800 mg TID)
A dose reduction of ketoconazole should be considered when coadministered with indinavir/ritonavir.
U slučaju istodobne primjene s indinavirom/ritonavirom treba razmotriti smanjenje doze ketokonazola.
Careful monitoring of therapeutic and adverse effects is recommended when these medicines are concomitantly administered with indinavir.
Kod istodobne primjene navedenih lijekova i indinavira preporučuje se pažljivo praćenje terapijskih učinaka i nuspojava.
Saquinavir 800 mg SD (soft gel capsule formulation) (Indinavir 800 mg TID)
Sakvinavir 800 mg SD (meka želatinozna kapsula) (indinavir 800 mg TID)
Indinavir AUC24hr:220 % Indinavir Cmin:↑ 24-fold (Relative to Indinavir 800 mg TID alone*) Ritonavir AUC24hr: 
AUC24h indinavira: 220% Cmin indinavira:↑ 24 puta (u odnosu na primjenu samo indinavira u dozi od 800 mg TID*) AUC24h ritonavira: 
Co-administration of quetiapine with indinavir is contraindicated (see section 4.3).
Istodobna primjena kvetiapina i indinavira je kontraindicirana (vidjeti dio
ANTICONVULSANTS Carbamazepine
Karbamazepin
Indinavir AUC24hr:68 % Indinavir Cmin: ↑ 10-fold (Relative to Indinavir 800 mg TID alone*) Ritonavir AUC24hr: 
AUC24h indinavira:68% Cmin indinavira: ↑ 10 puta (u odnosu na primjenu samo indinavira u dozi od 800 mg TID*) AUC24h ritonavira: 
8 hours, produced AUC0-8hr values of 27,412 nM*h, peak plasma concentrations of 12,182 nM, and plasma concentrations at 8 hours post dose of 122 nM.
U pedijatrijskih bolesnika zaraženih HIV om režim doziranja u kojem su primali 500 mg/m indinavira u obliku tvrdih kapsula svakih 8 sati rezultirao je vrijednošću AUC0-8h od 27 412 nM*h, vršnoj koncentraciji u plazmi od 12 182 nM i koncentraciji u plazmi 8 sati nakon primjene doze od 122 nM.
• pain on urination
• bol pri mokrenju
Efavirenz AUC and Cmin : ↔
AUC i Cmin efavirenza: ↔
Careful monitoring of therapeutic and adverse effects is recommended when morphine is concomitantly administered with indinavir/ritonavir.
Kod istodobne primjene morfija i indinavira/ritonavira preporučuje se pažljivo praćenje terapijskih učinaka i nuspojava.
Hepato-biliary disorders
INHIBITORI PDE5
Indinavir and isoniazid can be co-administered without dose adjustment.
Indinavir i izoniazid mogu se istodobno primjenjivati bez prilagođavanja doze.
Interaction with indinavir/ritonavir not studied Ritonavir induces glucuronidation and as a result is expected to decrease the plasma concentrations of atovaquone.
Ritonavir inducira glukuronidaciju pa se očekuje smanjenje koncentracija atovakvona u plazmi.
Medicinal products interactions
Interakcije s drugim lijekovima
The capsules are semi-translucent white and coded ‘CRIXIVAN 200 mg' on them in blue.
Kapsule su poluprozirne bijele, s oznakom ‘CRIXIVAN ™ 200 mg' plave boje.
liver function abnormalities
Oštećenje funkcije jetre
Dose reduction of CRIXIVAN to 600 mg every 8 hours is recommended with administering itraconazole concurrently.
Kod istodobne primjene s itrakonazolom preporučuje se smanjiti dozu lijeka CRIXIVAN na 600 mg svakih 8 sati.
In some patients, resolution of the interstitial nephritis did not occur following discontinuation of indinavir therapy; renal insufficiency, renal failure, leucocyturia (see section 4.4).
U nekih bolesnika nije došlo do povlačenja intersticijskog nefritisa nakon prekida liječenja indinavirom.
Careful monitoring of therapeutic and adverse effects is recommended when carbamazepine is concomitantly administered with indinavir/ritonavir.
Kod istodobne primjene karbamazepina i indinavira/ritonavira preporučuje se pažljivo praćenje terapijskih učinaka i nuspojava.
Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of ketoconazole.
Indinavir i ritonavir inhibiraju CYP3A4 pa se očekuje povećanje koncentracija ketokonazola u plazmi.
Careful monitoring of therapeutic and adverse effects is recommended when fentanyl is concomitantly administered with indinavir/ritonavir.
Kod istodobne primjene fentanila i indinavira/ritonavira preporučuje se pažljivo praćenje terapijskih učinaka i nuspojava.
Decreases in methadone AUC has been observed with other ritonavir-boosted protease inhibitors.
Kod primjene drugih inhibitora proteaze pojačanih ritonavirom primijećeno je smanjenje AUC-a metadona.
Careful monitoring of therapeutic and adverse effects is recommended when ketoconazole is concomitantly administered with indinavir/ritonavir.
Kod istodobne primjene ketokonazola i indinavira/ritonavira preporučuje se pažljivo praćenje terapijskih učinaka i nuspojava.
Increased methadone dose may be necessary when concomitantly administered with indinavir/ritonavir.
Kod istodobne primjene s indinavirom/ritonavirom možda će biti potrebno povećanje doze metadona.
Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of carbamazepine.
Indinavir i ritonavir inhibiraju CYP3A4 pa se očekuje povišenje koncentracija karbamazepina u plazmi.
Indinavir AUC:  46 % Indinavir Cmin:  57 % (Relative to Indinavir 800 mg TID alone) An increased dose (1,000 mg TID) of indinavir does not compensate for the inducing effect of efavirenz.
AUC indinavira:  46% Cmin indinavira:  57% (u odnosu na primjenu samo indinavira u dozi od 800 mg TID)
Careful monitoring of therapeutic and adverse effects is recommended when loratidine is concomitantly administered with indinavir/ritonavir.
Kod istodobne primjene loratadina i indinavira/ritonavira preporučuje se pažljivo praćenje terapijskih učinaka i nuspojava.
An increase in thyroidal weight and thyroidal follicular cell hyperplasia, due to an increase in thyroxine clearance, was seen in rats treated with indinavir at doses  160 mg/kg/day.
U štakora koji su primali doze indinavira ≥ 160 mg/kg na dan primijećeno je povećanje težine štitnjače i folikularna hiperplazija štitnjače zbog povećanog klirensa tiroksina.
Careful monitoring of therapeutic and adverse effects is recommended when buspirone is concomitantly administered with indinavir/ritonavir.
Kod istodobne primjene buspirona i indinavira/ritonavira preporučuje se pažljivo praćenje terapijskih učinaka i nuspojava.
Efavirenz AUC: 
AUC efavirenza: 
Erythromycin, Itraconazole Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of erythromycin and itraconazole.
Indinavir i ritonavir inhibiraju CYP3A4 pa se očekuje povećanje koncentracija eritromicina i itrakonazola u plazmi.
An increased incidence of nephrolithiasis has been observed in patients with underlying liver disorders when treated with indinavir.
U bolesnika s postojećom bolešću jetre liječenih indinavirom primijećena je povećana incidencija nefrolitijaze.
Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of fentanyl.
Indinavir i ritonavir inhibiraju CYP3A4 pa se očekuje povišenje koncentracija fentanila u plazmi.
Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of loratidine.
Indinavir i ritonavir inhibiraju CYP3A4 pa se očekuje povišenje koncentracija loratadina u plazmi.
Careful monitoring of serum levels or therapeutic effects is recommended when these medicines are concomitantly administered with indinavir/ritonavir.
Kod istodobne primjene navedenih lijekova i indinavira/ritonavira preporučuje se pažljivo praćenje koncentracija u serumu ili terapijskih učinaka.
Careful monitoring of therapeutic and adverse effects is recommended when dexamethasone is concomitantly administered with indinavir/ritonavir.
Kod istodobne primjene deksametazona i indinavira/ritonavira preporučuje se pažljivo praćenje terapijskih učinaka i nuspojava.
• muscle pain
• suha usta
Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of buspirone.
Indinavir i ritonavir inhibiraju CYP3A4 pa se očekuje povišenje koncentracija buspirona u plazmi.
Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of tacrolimus.
Indinavir i ritonavir inhibiraju CYP3A4 pa se očekuje povišenje koncentracije takrolimusa u plazmi.
Careful monitoring of therapeutic and adverse effects is recommended when atovaquone is concomitantly administered with indinavir/ritonavir.
Kod istodobne primjene atovakvona i indinavira/ritonavira preporučuje se pažljivo praćenje terapijskih učinaka i nuspojava.
Careful monitoring of therapeutic and adverse effects is recommended when dexamethasone is concomitantly administered with indinavir.
Kod istodobne primjene deksametazona i indinavira preporučuje se pažljivo praćenje terapijskih učinaka i nuspojava.
Indinavir AUC and Cmin: ↔ (Relative to Indinavir 400 mg SD)  Quinidine concentration expected (CYP3A4 inhibition by indinavir)
AUC i Cmin indinavira: ↔ (u usporedbi s primjenom indinavira u dozi od 400 mg SD)
Careful monitoring of therapeutic and adverse effects is recommended when tacrolimus is concomitantly administered with indinavir/ritonavir.
Kod istodobne primjene takrolimusa i indinavira/ritonavira preporučuje se pažljivo praćenje terapijskih učinaka i nuspojava.
Tell your doctor immediately.
Odmah obavijestite liječnika.
The following side effects can be very serious:
Sljedeće nuspojave mogu biti vrlo ozbiljne:
These could be signs of an allergic reaction.
To mogu biti znakovi alergijske reakcije.
The exposure of triazolam was reduced by 36%.
Izloženost triazolamu bila je smanjena za 36%.
Return the medicine to the pharmacist.
Vratite lijek ljekarniku.
Maximum recommended dose
Maksimalna preporučena doza
The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for Inovelon.
Mehanizam ovog rizika nije poznat, a dostupni podaci ne isključuju mogućnost povećanog rizika i kod Inovelona.
Do not take a double dose to make up for forgotten dose.
Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
Wash the syringe with clean water and dry thoroughly.
Operite štrcaljku čistom vodom i dobro je osušite.
Environmental Risk Assessment (ERA):
Procjena rizika za okoliš (ERA):
If this happens to you, do not drive or operate machinery.
Ako se to dogodi, nemojte upravljati vozilima i raditi sa strojevima.
Uncontrolled open-label studies suggest sustained long-term efficacy, although no controlled study has been conducted for longer than three months.
Nekontrolirana otvorena ispitivanja pokazuju da se djelotvornost dugotrajno održala, iako nisu provedena kontrolirana ispitivanja u trajanju duljem od tri mjeseca.
Rufinamide was not genotoxic and had no carcinogenic potential.
Rufinamid nije bio genotoksičan i nije imao kancerogenog potencijala.
As such, drop attacks were used as one of the primary end points.
Kao takvi, astatički napadaji koristili su se kao jedna od primarnih mjera ishoda.
See section 3 - ‘How to use Inovelon' for advice on taking Inovelon with food and drink.
Vidjeti dio 3 - ‘Kako uzimati Inovelon' za savjet o uzimanju Inovelona s hranom i pićem.
If you miss taking more than one dose, seek advice from the doctor.
Ako propustite uzeti više od jedne doze, potražite savjet liječnika.
Do not take Inovelon:
Nemojte uzimati Inovelon:
If you take more Inovelon than you should
Ako uzmete više Inovelona nego što ste trebali
Date of latest renewal: 09 January 2012
Datum posljednje obnove odobrenja: 9. siječnja 2012.
If you forget to take a dose, continue taking the medicine as normal.
Ako ste zaboravili uzeti dozu, nastavite uzimati lijek kao i obično.
Reversibility of all findings was demonstrated after stopping treatment.
Dokazana je reverzibilnost svih nalaza nakon prestanka liječenja.
Inovelon with food and drink
Inovelon s hranom i pićem
Rufinamide was evenly distributed between erythrocytes and plasma.
Rufinamid je bio ravnomjerno distribuiran između eritrocita i plazme.
After first opening: 90 days.
3 godine Nakon prvog otvaranja: 90 dana.
The doctor may need to adjust the dose.
Liječnik će Vam možda trebati prilagoditi dozu.
Risk related to epilepsy and antiepileptic medicinal products in general:
Rizik povezan s epilepsijom i antiepileptičkim lijekovima općenito:
It may take a while to find the best dose of Inovelon for you.
Može proći neko vrijeme prije nego se utvrdi najbolja doza Inovelona za vas.
Inovelon should not be given to children younger than 1 year of age since there is not enough information on its use in this age group.
Inovelon se ne smije davati djeci mlađoj od 1 godine, budući da nema dovoljno informacija o njegovoj primjeni u ovoj dobnoj skupini.
The formation of small amounts of glutathione conjugates cannot be completely excluded.
Stvaranje malih količina konjugata glutationa ne može se potpuno isključiti.
These events led to rufinamide discontinuation in 20% of the cases.
Ti su događaji doveli do prekida primjene rufinamida u 20% slučajeva.
This medicinal product could have potential risk for the environment.
Ovaj lijek može predstavljati potencijalni rizik za okoliš.
The study was mainly designed for safety and not adequately powered to show a difference with regards to the seizure efficacy variables.
Ispitivanje je uglavnom bilo ustrojeno za utvrđivanje sigurnosti i nije imalo odgovarajuću snagu da bi pokazalo razliku s obzirom na varijable djelotvornosti u pogledu napadaja.
Talk to your doctor or pharmacist if:
Obratite se liječniku ili ljekarniku ako:
Do not use this medicine if you notice that the appearance of the medicine has changed.
Ovaj lijek se ne smije upotrijebiti ako primijetite da se izgled lijeka promijenio.
As dose increases, the bioavailability decreases.
Kako se doza povećava, tako se bioraspoloživost smanjuje.
Manufacturer: Eisai Manufacturing Ltd, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, UK.
Proizvođač: Eisai Manufacturing Ltd, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, Ujedinjeno Kraljevstvo.
Each ml of oral suspension contains:
Jedan ml oralne suspenzije sadrži:
Age characterisation in patients less than 4 years was not identified in the limited safety database due to small number of patients in the study.
Dobna karakterizacija u bolesnika mlađih od 4 godine nije bila utvrđena u ograničenoj bazi sigurnosnih podataka zbog malog broja bolesnika u ovom ispitivanju.
Rufinamide is almost exclusively eliminated by metabolism.
Rufinamid se gotovo isključivo eliminira metabolizmom.
Inovelon should be taken with food.
Inovelon treba uzimati s hranom.
No data are available (see section 5.2).
Nema dostupnih podataka (vidjeti dio 5.2).
You must only take Inovelon during your pregnancy if the doctor tells you to.
Smijete uzimati Inovelon tijekom trudnoće samo ako Vam je tako rekao liječnik.
You can also break the tablets into two equal halves and swallow with water.
Tablete također možete prelomiti na dvije jednake polovice i progutati s vodom.
Rufinamide was not teratogenic in mice, rats or rabbits.
Rufinamid nije bio teratogen u miševa, štakora i kunića.
A change in the dose of the other medicines may be needed as they may become slightly less effective when given with rufinamide.
Možda bude potrebno promijeniti doze drugih lijekova, jer mogu postati malo manje djelotvorni kad se daju s rufinamidom.
The toxicity profile of rufinamide in juvenile animals was similar to that in adult animals.
Profil toksičnosti rufinamida u mladih životinja bio je sličan onome u odraslih životinja.
Children (1-12 years)
Djeca (u dobi od 1-12 godina)
Maximum plasma levels are reached approximately 6 hours after administration.
Maksimalne razine u plazmi postižu se približno 6 sati nakon primjene.