natgillin/translations-raw huggingface dataset:
Paediatric population (aged 6 years and above) - recommended down-titration schedule
Tablica 3 Pedijatrijska populacija (u dobi od 6 i više godina) - preporučeni režim postupnog smanjivanja doze
Microcrystalline cellulose Hydrogenated vegetable oil (from soyabean) Sodium laurilsulfate
Sadržaj kapsule celuloza, mikrokristalična hidrogenirano biljno ulje (sojino) natrijev laurilsulfat
• This may be increased by up to 100 mg at intervals of one to two weeks.
• Ta se doza može povećavati za do 100 mg u razmacima od jednog do dva tjedna.
See Section 2 for important information about the ingredients: sunset yellow FCF (E110) and allura red AC (E129) and hydrogenated vegetable oil (from soyabean).
Vidjeti dio 2 za važne podatke o sastojcima: boje sunset yellow FCF (E110) i allura red AC (E129) i hidrogenirano biljno ulje (sojino).
Zonegran should be used with caution in adult patients treated concomitantly with carbonic anhydrase inhibitors such as topiramate and acetazolamide, as there are insufficient data to rule out a possible pharmacodynamic interaction (see section 4.4).
Zonegran treba primjenjivati oprezno u odraslih bolesnika istodobno liječenih inhibitorima karboanhidraze kao što su topiramat i acetazolamid, jer nema dovoljno podataka koji bi isključili moguću farmakodinamičku interakciju (vidjeti dio 4.4).
There are insufficient data for the withdrawal of concomitant antiepileptic medicines once seizure control with Zonegran has been achieved in the add-on situation, in order to reach monotherapy with Zonegran.
Nema dovoljno podataka o ukidanju drugih antiepileptičkih lijekova kada su, uz Zonegran kao dodatni lijek, napadaji stavljeni pod nadzor, a čime bi se omogućila monoterapija Zonegranom.
• low blood potassium levels, convulsions/seizures.
• niske razine kalija u krvi, konvulzije / napadaji
Zonegran 100 mg hard capsules contain a yellow colour called sunset yellow FCF (E110), and a red colour called allura red AC (E129), which may cause allergic reactions.
Zonegran 100 mg tvrde kapsule sadrže žutu boju pod nazivom sunset yellow FCF (E110) i crvenu boju pod nazivom allura red AC (E129), koje mogu uzrokovati alergijsku reakciju.
Blood creatine phosphokinase increased Blood creatinine increased Blood urea increased Liver function tests abnormal
Pretrage sniženi bikarbonati smanjena težina povišena kreatin fosfokinaza u krvi, povišen kreatinin u krvi, povišena urea u krvi, poremećeni nalazi pretraga funkcije jetre
Serious immune based adverse reactions that are associated with medicinal products containing a sulphonamide group include rash, allergic reaction and major haematological disturbances including aplastic anaemia, which very rarely can be fatal (see section 4.4).
Ozbiljne nuspojave imunološke naravi povezane s lijekovima koji sadrže sulfonamidnu skupinu uključuju osip, alergijsku reakciju i velike hematološke poremećaje, uključujući aplastičnu anemiju koja vrlo rijetko može imati smrtni ishod (vidjeti dio 4.4).
• suffer from kidney problems as your dose of Zonegran may need adjusting.
• patite od tegoba s bubrezima jer Vam možda treba prilagoditi dozu Zonegrana
Increase at two-weekly intervals in increments of 1 mg/kg
Povećavati u razmacima od dva tjedna s povećanjem doze za 1 mg/kg
Contains also hydrogenated vegetable oil (from soyabean), sunset yellow FCF (E110) and allura red AC (E129).
Također sadrži hidrogenirano biljno ulje (sojino), boju sunset yellow FCF (E110) i boju allura red AC (E129).
Serious immune based adverse reactions that are associated with medicinal products containing a sulphonamide group include rash, allergic reaction and major haematological disturbances, including aplastic anaemia, which very rarely can be fatal.
Ozbiljne nuspojave imunološke naravi povezane s lijekovima koji sadrže sulfonamidnu skupinu uključuju osip, alergijsku reakciju i velike hematološke poremećaje, uključujući aplastičnu anemiju koja vrlo rijetko može imati smrtni ishod.
Oral use Read the package leaflet before use.
Kroz usta Prije uporabe pročitajte uputu o lijeku.
• loss of weight, nausea, indigestion, stomach pains, diarrhoea (loose stools), constipation.
• gubitak težine, mučnina, probavne tegobe, bolovi u želucu, proljev, zatvor
• hallucinations, memory loss, coma, neuroleptic malignant syndrome (inability to move, sweating,
• halucinacije, gubitak pamćenja, koma, maligni neuroleptički sindrom (nemogućnost kretanja, znojenje, vrućica, nemogućnost zadržavanja mokraće), epileptički status (produljeni ili ponavljani napadaji)
Excipient with known effect: Each hard capsule contains 0.75 mg hydrogenated vegetable oil (from soyabean)
Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 0,75 mg hidrogeniranog biljnog ulja (sojinog).
Efficacy results for Monotherapy Study 310 Zonisamide Carbamazepine n (ITT population)
Zonisamid Karbamazepin n (ITT populacija)
Zonegran should be used with caution in adult patients being treated concomitantly with carbonic anhydrase inhibitors such as topiramate or acetazolamide, as there are insufficient data to rule out a pharmacodynamic interaction (see also section 4.4 Paediatric population and section 4.5).
Zonegran treba primjenjivati oprezno u odraslih bolesnika koji se istodobno liječe inhibitorima karboanhidraze, kao što je topiramat ili acetazolamid, jer nema dovoljno podataka koji bi isključili farmakodinamičku interakciju (vidjeti također dio 4.4, Pedijatrijska populacija i dio 4.5).
Zonegran belongs to a group of medicines (sulphonamides) that can cause severe allergic reactions, severe skin rashes, and blood disorders, which very rarely can be fatal.
Zonegran pripada skupini lijekova (sulfonamida) koji mogu uzrokovati teške alergijske reakcije, teške osipe na koži i poremećaje krvi, vrlo rijetko sa smrtnim ishodom.
• slowed thoughts, loss of concentration, speech abnormalities, abnormal skin sensation (pins and needles), tremor, involuntary movement of the eyes.
• usporene misli, gubitak koncentracije, smetnje govora, neuobičajeni osjeti vezani uz kožu (trnci),
Be especially careful while driving or operating machinery, if Zonegran affects you in this way.
Ako Zonegran na Vas tako djeluje, budite posebno oprezni kada upravljate vozilima ili rukujete strojevima.
Respiratory disorder
Poremećaj funkcije jetre
A MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
Additionally the 100 mg capsule shell contains sunset yellow FCF (E110) and allura red (E129).
Osim toga ovojnica kapsule od 100 mg sadrži boju sunset yellow FCF (E110) i boju allura red (E129).
300 - 500 mg/day (once a day)
300 do 500 mg na dan (jedanput na dan)
• live in a place or are on holiday in a place where the weather is warm.
• ako živite u podneblju gdje je toplo vrijeme ili ste na odmoru u području s takvim vremenom; od Zonegrana se možete manje znojiti što može prouzročiti povišenje Vaše tjelesne temperature.
Increase at two-weekly intervals in increments of up to 100 mg
povećavati u razmacima od dva tjedna s povećanjem doze do 100 mg
- Zonegran 100 mg hard capsules have a white opaque body and a red opaque cap and are printed with a logo and “ZONEGRAN 100” in black.
- Zonegran 100 mg tvrde kapsule imaju bijelo neprozirno tijelo i crvenu neprozirnu kapicu s otisnutim logom i oznakom “ZONEGRAN 100” u crnoj boji.
Excipient with known effect: Each hard capsule contains 1.5 mg hydrogenated vegetable oil (from soyabean)
Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 1,5 mg hidrogeniranog biljnog ulja (sojinog).
Very Common Common
vrlo često često
Potential medicinal product interactions affecting Zonegran
Moguće interakcije drugih lijekova i Zonegrana
- Zonegran 50 mg hard capsules have a white opaque body and a grey opaque cap and are printed with a logo and “ZONEGRAN 50” in black.
- Zonegran 50 mg tvrde kapsule imaju bijelo neprozirno tijelo i sivu neprozirnu kapicu s otisnutim logom i oznakom “ZONEGRAN 50” u crnoj boji.
A dietary supplement or increased food intake should be considered if the patient is failing to gain weight in accordance with growth charts, otherwise Zonegran should be discontinued.
Ako bolesnik ne uspijeva dobivati na težini u skladu s krivuljom rasta, može se razmotriti upotreba dodataka prehrani ili povećanje unosa hrane; u protivnom liječenje Zonegranom treba prekinuti.
Zonegran belongs to a group of medicines (sulphonamides) which can cause severe allergic reactions, severe skin rashes, and blood disorders, which very rarely can be fatal (see section 4.
Zonegran pripada skupini lijekova (sulfonamida) koji mogu uzrokovati teške alergijske reakcije, teške osipe na koži i poremećaje krvi, vrlo rijetko sa smrtnim ishodom (vidjeti dio 4, Moguće nuspojave).
Excipient with known effect: Each hard capsule contains 3 mg hydrogenated vegetable oil (from soyabean)
Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 3 mg hidrogeniranog biljnog ulja (sojinog).
• lung infection / inflammation, urinary tract infections.
• infekcija / upala pluća, infekcije mokraćnog sustava
100 mg / day (in two divided doses)
100 mg na dan (podijeljeno u dvije doze)
Zonegran should not be used as co-medication in paediatric patients with other carbonic anhydrase inhibitors such as topiramate and acetazolamide (see section 4.5).
U pedijatrijskih bolesnika Zonegran se ne smije primjenjivati s drugim inhibitorima karboanhidraze kao što su topiramat i acetazolamid (vidjeti dio 4.5).
Hydrogenated vegetable oil (from soyabean)
Hidrogenirano biljno ulje (sojino).
Propylene glycol Potassium hydroxide Black iron oxide (E172)
Ovojnica kapsule želatina titanijev dioksid (E171) šelak propilenglikol kalijev hidroksid željezov oksid, crni (E172)
Zonegran 100 mg hard capsules contain 100 mg zonisamide.
Zonegran 100 mg tvrde kapsule sadrže 100 mg zonisamida.
Adverse reactions associated with Zonegran obtained from adjunctive use clinical studies and post-marketing surveillance
Tablica 4 Nuspojave povezane sa Zonegranom iz kliničkih ispitivanja dodatne primjene i praćenja nakon stavljanja lijeka u promet
A white opaque body and a white opaque cap printed with a logo and “ZONEGRAN 25” in black.
Bijelo neprozirno tijelo i bijela neprozirna kapica s otisnutim logom i oznakom “ZONEGRAN 25” u crnoj boji.
Titanium dioxide (E171) Allura red AC (E129) Sunset yellow FCF (E110) Shellac
Ovojnica kapsule želatina titanijev dioksid (E171) bojilo allura red AC (E129) bojilo sunset yellow FCF (E110) šelak propilenglikol kalijev hidroksid željezov oksid, crni (E172)
Review of post-marketing data suggests that patients aged 65 years or older report a higher frequency than the general population of the following events: Stevens-Johnson syndrome (SJS) and Drug Induced Hypersensitivity syndrome (DIHS).
Analiza podataka nakon stavljanja lijeka u promet pokazuje da je u bolesnika u dobi od 65 godina ili starijih, u usporedbi s općom populacijom, zabilježena veća učestalost sljedećih događaja:
When you take Zonegran on its own:
Kada uzimate samo Zonegran:
thiazide diuretics, and sulfonylurea antidiabetes medicines,
tiazidne diuretike i lijekove protiv šećerne bolesti iz skupine sulfonilureje,
Zonegran 50 mg hard capsules contain 50 mg zonisamide.
Zonegran 50 mg tvrde kapsule sadrže 50 mg zonisamida.
Zonegran 25 mg hard capsules contain 25 mg of zonisamide.
Zonegran 25 mg tvrde kapsule sadrže 25 mg zonisamida.
Zonegran 100 mg hard capsules
Zonegran 100 mg tvrde kapsule
A white opaque body and a red opaque cap printed with a logo and “ZONEGRAN 100” in black.
Bijelo neprozirno tijelo i crvena neprozirna kapica s otisnutim logom i oznakom “ZONEGRAN 100” u crnoj boji.
Zonegran should not be used as co-medication in paediatric patients with other carbonic anhydrase inhibitors such as topiramate and acetazolamide (see section 4.4 Paediatric population).
Zonegran se u pedijatrijskih bolesnika ne smije primjenjivati istodobno s drugim inhibitorima karboanhidraze kao što su topiramat i acetazolamid (vidjeti dio 4.4, Pedijatrijska populacija).
Zonegran must be added to existing therapy for paediatric patients aged 6 years and above.
Pedijatrijskim bolesnicima u dobi od 6 i više godina, Zonegran se mora dodati već postojećoj terapiji.
Zonegran 100 mg hard capsules zonisamide
Zonegran 100 mg tvrde kapsule zonisamid
Zonegran 25 mg hard capsules zonisamide
Zonegran 25 mg tvrde kapsule zonisamid
EU/1/04/307/006 28 capsules EU/1/04/307/004 56 capsules EU/1/04/307/011 84 capsules EU/1/04/307/007 98 capsules EU/1/04/307/008 196 capsules
EU/1/04/307/006 28 kapsula EU/1/04/307/004 56 kapsula EU/1/04/307/011 84 kapsule EU/1/04/307/007 98 kapsula EU/1/04/307/008 196 kapsula
Erythema multiforme Stevens-Johnson syndrome Toxic epidermal necrolysis
Stevens-Johnsonov sindrom (SJS) i lijekom izazvani sindrom preosjetljivosti (DIHS).
These studies show that the median reduction in partial seizure frequency is related to Zonegran dose with sustained efficacy at doses of 300-500 mg per day.
Zonegrana uz održanu djelotvornost pri dozama od 300 do 500 mg na dan.
Confusional state Acute psychosis Aggression Suicidal ideation Hallucination
Psihijatrijski poremećaji agitacija, razdražljivost stanje konfuzije, depresija afektivna labilnost, anksioznost, nesanica, psihotični poremećaj ljutnja, agresija, suicidalna ideacija, pokušaj samoubojstva halucinacije
A white opaque body and a grey opaque cap printed with a logo and “ZONEGRAN 50” in black.
Bijelo neprozirno tijelo i siva neprozirna kapica s otisnutim logom i oznakom “ZONEGRAN 50” u crnoj boji.
Zonegran Capules:
Zonegran tvrde kapsule:
Zonegran 25 mg hard capsules
Zonegran 25 mg tvrde kapsule
Zonegran 50 mg hard capsules
Zonegran 50 mg tvrde kapsule
EU/1/04/307/010 14 capsules EU/1/04/307/009 28 capsules EU/1/04/307/003 56 capsules EU/1/04/307/012 84 capsules
EU/1/04/307/010 14 kapsula EU/1/04/307/009 28 kapsula EU/1/04/307/003 56 kapsula EU/1/04/307/012 84 kapsule
EU/1/04/307/001 14 capsules EU/1/04/307/005 28 capsules EU/1/04/307/002 56 capsules EU/1/04/307/013 84 capsules
EU/1/04/307/001 14 kapsula EU/1/04/307/005 28 kapsula EU/1/04/307/002 56 kapsula EU/1/04/307/013 84 kapsule
200 mg /day (once a day)
200 mg na dan (jedanput na dan)
Adjunctive therapy - with CYP3A4inducing agents
- bez lijekova induktora CYP3A4
Zonegran 50 mg hard capsules zonisamide
Zonegran 50 mg tvrde kapsule zonisamid
Pneumonia Urinary tract infection
Infekcije i infestacije pneumonija, infekcija mokraćnog sustava
Six months seizure freedom
6.3 Rok valjanosti
100 mg/day (once a day)
100 mg na dan (jedanput na dan)
Very Common
manje često
• urinary stones.
• mokraćni kamenci
• feel unusually tired or feverish, have a sore throat, swollen glands, or find that you bruise more easily, as this may mean you have a blood disorder.
• osjećate se neobično umorno ili kao da imate temperaturu, boli Vas grlo, imate otečene žlijezde ili
Leukopenia Thrombocytopenia
• bubrežni kamenci
You must only take Zonegran during your pregnancy if your doctor tells you to. Research has shown an increased risk of birth defects in children of women taking anti-epileptic medicines.
Istraživanja su pokazala povećan rizik od prirođenih mana u djece majki koje uzimaju lijekove protiv epilepsije.
• gall bladder inflammation, gallstones.
• upala žučnog mjehura, žučni kamenci
It is available as tablets (25 mg).
Dostupan je u obliku tableta (od 25 mg).
The full EPAR for Edurant can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Cjeloviti EPAR za lijek Edurant nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Edurant rilpivirine
Edurant rilpivirin
Edurant must be taken with a meal.
Edurant se mora uzimati uz obrok.
In all studies, the main measure of effectiveness was based on the reduction in viral load.
U svim ispitivanjima glavno mjerilo djelotvornosti temeljilo se na smanjenju virusnog opterećenja.
The European Commission granted a marketing authorisation valid throughout the European Union for Edurant on 28 November 2011.
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Edurant na snazi u Europskoj uniji od 28. studenoga 2011.
Edurant does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Edurant ne liječi infekciju HIV-om niti AIDS, no može odgoditi oštećenje imunosnog sustava i razvoj infekcija i bolesti povezanih s AIDS-om.
The recommended dose of Edurant is one tablet once a day.
Preporučena doza lijeka Edurant je jedna tableta jedanput na dan.
What measures are being taken to ensure the safe and effective use of Edurant?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Edurant?
Edurant was also effective in adolescents, with around 72% of patients responding to treatment after 48 weeks.
Edurant je bio učinkovit i u adolescenata, pri čemu je oko 72 % bolesnika odgovorilo na terapiju nakon 48 tjedana.
• rifampicin, rifapentine (antibiotics);
• rifampicin, rifapentin (antibiotici)
Other information about Edurant
Ostale informacije o lijeku Edurant
Edurant is an antiviral medicine.
Edurant je protuvirusni lijek.
Taking the two studies into account, 84% of patients taking Edurant responded to treatment after one year, compared with 82% of patients taking efavirenz.
Uzimajući u obzir oba ispitivanja, 84 % bolesnika koji su primali Edurant odgovorilo je na terapiju nakon godine dana, u usporedbi s 82 % bolesnika koji su primali efavirenz.
For more information about treatment with Edurant, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o terapiji lijekom Edurant pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svojem liječniku ili ljekarniku.
This is a summary of the European public assessment report (EPAR) for Edurant.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Edurant.
If Edurant is given together with rifabutin, the doctor should increase the dose of Edurant to two tablets once a day during rifabutin treatment.
Ako se Edurant primjenjuje zajedno s rifabutinom, liječnik treba povećati dozu lijeka Edurant na dvije tablete jedanput na dan tijekom terapije rifabutinom.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Edurant.
Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Edurant.
The Committee noted that Edurant causes fewer side effects in the early stages of treatment and offers the benefit of being taken as one tablet once per day.
Odbor je napomenuo da Edurant uzrokuje manje nuspojava u ranim fazama terapije i ima prednost zato što se uzima kao jedna tableta jedanput na dan.
Edurant must not be used with the following medicines as they may lead to reduced blood levels of rilpivirine, and thereby reduce the effectiveness of Edurant:
Edurant se ne smije koristiti sa sljedećim lijekovima jer oni mogu prouzročiti snižene koncentracije rilpivirina u krvi te tako smanjiti i djelotvornost lijeka Edurant:
Treatment with Edurant should be started by a doctor experienced in treating HIV infection.
Terapiju lijekom Edurant mora započeti liječnik s iskustvom u liječenju infekcija HIV-om.
A risk management plan has been developed to ensure that Edurant is used as safely as possible.
Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Edurant.
Why has Edurant been approved?
Zašto je Edurant odobren?
The most frequent side effects with Edurant (seen in more than 1 patient in 10) are headache, insomnia, dizziness, nausea (feeling sick), and increased levels of total cholesterol, low-densitylipoprotein (LDL) cholesterol, pancreatic amylase (an enzyme produced in the pancreas that breaks down starch into sugars) and transaminases (liver enzymes).
Najčešće nuspojave lijeka Edurant (prijavljene kod više od 1 na 10 osoba) su glavobolja, nesanica, vrtoglavica, mučnina (osjećaj slabosti) i povišene razine ukupnog kolesterola, lipoproteinskog kolesterola niske gustoće (LDL), gušteračne amilaze (enzima koji se proizvodi u gušterači, a razgrađuje škrob u šećere) i transaminaza (jetrenih enzima).
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Edurant, including the appropriate precautions to be followed by healthcare professionals and patients.
Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za Edurant nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
It is only used in patients who have not received anti-HIV treatment before and who have HIV levels in the blood (viral load) of no more than 100,000 HIV-1 RNA copies/ml.
Primjenjuje se samo u bolesnika koji prethodno nisu primili terapiju protiv HIV-a i u kojih razina HIV-a u krvi (virusno opterećenje) nije veća od 100 000 HIV 1-RNK kopija/ml.
It blocks the activity of reverse transcriptase, an enzyme produced by HIV-1 that allows it to make more viruses in the cells it has infected.
Inhibira djelovanje reverzne transkriptaze, enzima kojeg proizvodi HIV-1, a koji mu omogućuje proizvodnju većeg broja virusa u zaraženim stanicama.
However, the CHMP noted that there was some risk of HIV-1 developing resistance to rilpivirine and that this risk appeared to be lower in patients with a lower viral load.
No, CHMP je napomenuo da postoji određeni rizik da HIV-1 razvije otpornost na rilpivirin te da se čini da je taj rizik manji u bolesnika s nižim virusnim opterećenjem.
What is the risk associated with Edurant?
Koji su rizici povezani s lijekom Edurant?
The active substance in Edurant, rilpivirine, is a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Djelatna tvar u lijeku Edurant, rilpivirin, je nenukleozidni inhibitor reverzne transkriptaze (NNRTI).
• systemic dexamethasone (a steroid anti-inflammatory and immunosuppressant medicine) except when used as a single dose treatment;
• deksametazon (steroidni protuupalni lijek i imunosupresant), osim ako se primjenjuje kao terapija jednokratnom dozom
Edurant was given in combination with a fixed regimen of antiviral medicines and was not compared with another treatment.
Edurant je davan u kombinaciji s fiksnim režimom protuvirusnih lijekova i nije uspoređivan s drugom terapijom.
• omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (proton pump inhibitors for reducing stomach acid);
• omeprazol, esomeprazol, lanzoprazol, pantoprazol, rabeprazol (inhibitori protonske pumpe koji se primjenjuju za snižavanje želučane kiseline)
Edurant was investigated in two main studies in 1,368 previously untreated adult patients infected with HIV-1.
Edurant je ispitivan u dva glavna ispitivanja provedena na 1 368 odraslih bolesnika zaraženih HIV-om koji prethodno nisu liječeni.
Therefore, the CHMP considered that the benefits of Edurant outweigh its risks in patients with a low HIV-1 viral load, and recommended that it be granted marketing authorisation for this group of patients.
Stoga CHMP smatra da koristi od lijeka Edurant nadmašuju s njim povezane rizike u bolesnika s niskim opterećenjem virusom HIV-1 te je preporučio izdavanje odobrenja za stavljanje lijeka u promet za tu skupinu bolesnika.
Edurant was also investigated in another study in 36 previously untreated adolescents (between 12 and 18 years old) infected with HIV-1.
Edurant je također ispitivan u još jednom ispitivanju provedenom na 36 adolescenata (u dobi od 12 do 18 godina) zaraženih HIV-om koji prethodno nisu liječeni.
• carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for fits);
• karbamazepin, okskarbazepin, fenobarbital, fenitoin (lijekovi protiv napadaja)