FrancophonIA/ELRC3.0 huggingface dataset:
English: What Zonegran looks like and contents of the pack - Zonegran 25 mg hard capsules have a white opaque body and a white opaque cap and are printed with a logo and “ZONEGRAN 25” in black.
Slovenian: Izgled zdravila Zonegran in vsebina pakiranja - Zonegran 25 mg trde kapsule imajo bel, neprozoren spodnji del kapsule in bel, neprozoren zgornji del kapsule, na katerem je natisnjen logo in ''ZONEGRAN 25'' v črni barvi.
English: PP-population* ITT-population < 4 seizures during 3 month baseline period > 4 seizures during 3 month baseline period
Slovenian: ≤ 4 epileptični napadi med 3-mesečnim izhodiščnim obdobjem > 4 epileptični napadi med 3-mesečnim izhodiščnim obdobjem
English: Excipient with known effect: Each hard capsule contains 0.75 mg hydrogenated vegetable oil (from soyabean)
Slovenian: Pomožna snov z znanim učinkom: Ena trda kapsula vsebuje 0,75 mg hidrogeniranega rastlinskega olja (sojinega).
English: 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).
Slovenian: Pri odraslih bolnikih, sočasno zdravljenih z zaviralci karboanhidraze, na primer topiramatom ali acetazolamidom, moramo zdravilo Zonegran previdno uporabljati, ker ni na voljo zadostnih podatkov, da bi lahko izključili možno farmakodinamično interakcijo (glejte poglavje 4.4).
English: What Zonegran contains The active substance in Zonegran is zonisamide.
Slovenian: Kaj vsebuje zdravilo Zonegran Učinkovina v zdravilu Zonegran je zonisamid.
English: 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).
Slovenian: Previdnost pri uporabi zdravila Zonegran je potrebna pri odraslih bolnikih, ki sočasno jemljejo zaviralce karboanhidraze, kot na primer topiramat ali acetazolamid, ker je na voljo premalo podatkov, da bi lahko izključili farmakodinamične interakcije (glejte tudi poglavje 4.4 Pediatrična populacija in poglavje 4.5).
English: Excipient with known effect: Each hard capsule contains 1.5 mg hydrogenated vegetable oil (from soyabean)
Slovenian: Pomožna snov z znanim učinkom: Ena trda kapsula vsebuje 1,5 mg hidrogeniranega rastlinskega olja (sojinega).
English: 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.
Slovenian: Te študije kažejo, da je srednje znižanje pogostosti parcialnih epileptičnih napadov povezano z odmerkom zdravila Zonegran.
English: Zonegran Capules:
Slovenian: Zonegran trde kapsule:
English: Hydrogenated vegetable oil (from soyabean)
Slovenian: Hidrogenirano rastlinsko olje (sojino).
English: Confusional state Acute psychosis Aggression Suicidal ideation Hallucination
Slovenian: Psihiatrične motnje agitiranost depresija nespečnost nihanje razpoloženja anksioznost stanje zmedenosti akutna psihoza agresivnost samomorilne misli halucinacije
English: Increase at two-weekly intervals in increments of up to 100 mg
Slovenian: Povečanje v dvotedenskih intervalih po največ 100 mg
English: Do not breast-feed whilst taking, or for one month after stopping Zonegran.
Slovenian: Ne dojite med zdravljenjem ter vsaj še mesec dni po končanem zdravljenju z zdravilom Zonegran.
English: How to take Zonegran
Slovenian: Kako jemati zdravilo Zonegran
English: Increase at two-weekly intervals in increments of 1 mg/kg
Slovenian: Povečanje v dvotedenskih intervalih po največ 1 mg/kg
English: 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).
Slovenian: Z zdravili, ki vsebujejo sulfonamidno skupino, so povezani resni neželeni učinki imunskega izvora, ki vključujejo izpuščaj, alergijske reakcije in večje hematološke motnje, vključno z aplastično anemijo, ki so zelo redko lahko usodni (glejte poglavje 4.4).
English: 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).
Slovenian: Zdravilo Zonegran se pri pediatričnih bolnikih ne sme uporabljati sočasno z drugimi zaviralci karboanhidraze, kot sta topiramat in acetazolamid (glejte poglavje 4.4 Pediatrična populacija).
English: 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).
Slovenian: Zdravilo Zonegran se pri pediatričnih bolnikih ne sme uporabljati sočasno z drugimi zaviralci karboanhidraze, kot sta topiramat in acetazolamid (glejte poglavje 4.5).
English: • urinary stones.
Slovenian: • ledvični kamni;
English: Hyperchloraemic, non-anion gap, metabolic acidosis (i.e. decreased serum bicarbonate below the normal reference range in the absence of chronic respiratory alkalosis) is associated with Zonegran treatment.
Slovenian: znižan serumski bikarbonat pod normalno referenčno vrednost in v odsotnosti kronične respiratorne alkaloze).
English: Excipient with known effect: Each hard capsule contains 3 mg hydrogenated vegetable oil (from soyabean)
Slovenian: Pomožna snov z znanim učinkom: Ena trda kapsula vsebuje 3 mg hidrogeniranega rastlinskega olja (sojinega).
English: 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.
Slovenian: Z zdravili, ki vsebujejo sulfonamidno skupino, so povezani resni neželeni učinki imunskega izvora, ki vključujejo izpuščaj, alergijske reakcije in večje hematološke motnje, vključno z aplastično anemijo, ki so zelo redko lahko usodni.
English: • lung infection / inflammation, urinary tract infections.
Slovenian: • okužba / vnetje pljuč, okužbe sečil;
English: Very Common Common
Slovenian: zelo pogosti pogosti
English: • slowed thoughts, loss of concentration, speech abnormalities, abnormal skin sensation (pins and needles), tremor, involuntary movement of the eyes.
Slovenian: • upočasnjene misli, izguba koncentracije, motnje govora, nenormalni občutki na koži
English: Weight decreased Blood creatinine phosphokinase increased Alanine aminotransferase increased
Slovenian: Preiskave znižan bikarbonat zmanjšanje telesne mase zvišanje kreatin-kinaze v krvi zvišanje alaninaminotransferaze zvišanje aspartataminotransferaze nenormalne preiskave urina
English: Caution must be exercised in treating patients with mild to moderate hepatic impairment, and a slower titration of Zonegran may be required.
Slovenian: Pri zdravljenju bolnikov z blažjo do zmerno jetrno okvaro je potrebna previdnost in počasnejše prilagajanje odmerka zdravila Zonegran terapevtskemu učinku.
English: - 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.
Slovenian: - Zonegran 50 mg trde kapsule imajo bel, neprozoren spodnji del kapsule in siv, neprozoren zgornji del kapsule, na katerem je natisnjen logo in ''ZONEGRAN 50'' v črni barvi.
English: Adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation in adults
Slovenian: Adjuvantno zdravljenje parcialnih epileptičnih napadov s sekundarno generalizacijo ali brez nje pri odraslih bolnikih
English: Additionally the 100 mg capsule shell contains sunset yellow FCF (E110) and allura red (E129).
Slovenian: Poleg tega ovojnica 100-miligramske kapsule vsebuje še barvili sončno rumeno FCF (E110) in alurno rdeče AC (E129).
English: Very rare side effects (may affect up to 1 in 10,000 people):
Slovenian: Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov):
English: Decrease at weekly intervals in increments of: 20 - 28 kg 25 to 50 mg / day* 29 - 41 kg 50 to 75 mg / day* 42 - 55 kg 100 mg / day* >55 kg
Slovenian: 29 - 41 kg 50 do 75 mg/dan*
English: - 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.
Slovenian: - Zonegran 100 mg trde kapsule imajo bel, neprozoren spodnji del kapsule in rdeč, neprozoren zgornji del kapsule, na katerem je natisnjen logo in ''ZONEGRAN 100'' v črni barvi.
English: A meta-analysis of randomised placebo-controlled trials of anti-epileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour.
Slovenian: Majhno povečanje tveganja za pojav samomorilnega razmišljanja in vedenja je pokazala tudi metaanaliza randomiziranih, s placebom nadzorovanih kliničnih preskušanj antiepileptikov.
English: Blood creatine phosphokinase increased Blood creatinine increased Blood urea increased Liver function tests abnormal
Slovenian: Preiskave znižan bikarbonat zmanjšanje telesne mase zvišanje kreatinkinaze v krvi zvišanje kreatinina v krvi zvišanje uree v krvi nenormalni jetrni testi
English: • gall bladder inflammation, gallstones.
Slovenian: • vnetje žolčnika, žolčni kamni;
English: • This may be increased by up to 100 mg at intervals of one to two weeks.
Slovenian: • Ta odmerek se lahko zvečuje v korakih po največ 100 mg v enotedenskih do dvotedenskih intervalih.
English: Zonisamide is metabolised partly by CYP3A4 (reductive cleavage), and also by N-acetyl-transferases and conjugation with glucuronic acid; therefore, substances that can induce or inhibit these enzymes may affect the pharmacokinetics of zonisamide:
Slovenian: Zonisamid se delno presnavlja s CYP3A4 (reduktivna cepitev) ter z N-acetil-transferazami in konjugira z glukuronsko kislino.
English: Zonegran 100 mg hard capsules contain 100 mg zonisamide.
Slovenian: Zonegran 100 mg trde kapsule vsebujejo 100 mg zonisamida.
English: Propylene glycol Potassium hydroxide Black iron oxide (E172)
Slovenian: Ovojnica kapsule želatina titanov dioksid (E171) šelak propilenglikol kalijev hidroksid črni železov oksid (E172)
English: Titanium dioxide (E171) Allura red AC (E129) Sunset yellow FCF (E110) Shellac
Slovenian: Ovojnica kapsule želatina titanov dioksid (E171) alurno rdeče AC (E129) sončno rumeno FCF (E110) šelak propilenglikol kalijev hidroksid črni železov oksid (E172)
English: • If you forget to take a dose, don't worry: take the next dose when it is due.
Slovenian: • Če ste pozabili vzeti odmerek zdravila Zonegran, ne skrbite.
English: A very high plasma concentration of 100.1 μg/ml zonisamide was recorded approximately 31 hours after a patient took an overdose of Zonegran and clonazepam; the patient became comatose and had respiratory depression, but recovered consciousness five days later and had no sequelae.
Slovenian: Bolnik je postal komatozen, pojavila se je depresija dihanja, vendar se je po petih dneh prebudil iz kome in ni imel posledic.
English: Zonegran may cause weight loss.
Slovenian: Zdravilo Zonegran lahko povzroči izgubo telesne mase.
English: See Section 2 for important information about the ingredients: sunset yellow FCF (E110) and allura red AC (E129) and hydrogenated vegetable oil (from soyabean).
Slovenian: Za pomembne podatke o sestavi barvil sončno rumeno FCF (E110) in alurno rdeče AC (E129) in hidrogeniranem rastlinskem olju (sojinem) glejte poglavje 2.
English: Zonegran 100 mg hard capsules
Slovenian: Zonegran 100 mg trde kapsule
English: 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.
Slovenian: Zdravilo Zonegran pripada skupini zdravil (sulfonamidi), ki lahko povzročajo hude alergijske reakcije, hude kožne izpuščaje in bolezni krvi, ki zelo redko lahko povzročijo smrt (glejte poglavje 4, Možni neželeni učinki).
English: Zonegran 50 mg hard capsules contain 50 mg zonisamide.
Slovenian: Zonegran 50 mg trde kapsule vsebujejo 50 mg zonisamida.
English: Other medicines and Zonegran
Slovenian: Shranjevanje zdravila Zonegran
English: Zonegran can cause your child to sweat less and overheat and if your child is not treated this can lead to brain damage and death.
Slovenian: Zdravilo Zonegran lahko povzroči, da se vaš otrok manj znoji in se pregreje.
English: Talk to your doctor or pharmacist before taking Zonegran if you:
Slovenian: Pred začetkom jemanja zdravila Zonegran se posvetujte z zdravnikom ali farmacevtom:
English: 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
Slovenian: Za morebitno monoterapijo z zdravilom Zonegran in ukinitvijo drugih antiepileptičnih zdravil po tem, ko dosežemo nadzor nad napadi, ni dovolj podatkov.
English: Pneumonia aspiration Respiratory disorder Hypersensitivity-type Pneumonitis
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja aspiracijska pljučnica motnje dihanja preobčutljivostni pnevmonitis
English: Zonegran 25 mg hard capsules contain 25 mg of zonisamide.
Slovenian: Zonegran 25 mg trde kapsule vsebujejo 25 mg zonisamida.
English: • Give your child plenty of cold water to drink
Slovenian: • mu dajte piti veliko hladne vode,
English: Zonegran 100 mg hard capsules zonisamide
Slovenian: Zonegran 100 mg trde kapsule zonisamid
English: A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in adult and paediatric patients receiving zonisamide.
Slovenian: Pri odraslih in pediatričnih bolnikih, ki so prejemali zonisamid, so poročali o sindromu akutne miopije, povezane s sekundarnim glavkomom zaprtega zakotja.
English: Bradyphrenia Disturbance in attention Nystagmus Paraesthesia Speech disorder Tremor
Slovenian: Bolezni živčevja ataksija omotica okrnjene spominske sposobnosti zaspanost bradifrenija motnje pozornosti parestezije nistagmus motnje govora tremor konvulzije
English: Zonegran 25 mg hard capsules
Slovenian: Zonegran 25 mg trde kapsule
English: A white opaque body and a white opaque cap printed with a logo and “ZONEGRAN 25” in black.
Slovenian: Bel, neprozoren spodnji del kapsule z belim neprozornim zgornjim delom kapsule, na katerem je natisnjen logo in ''ZONEGRAN 25'' v črni barvi.
English: 200 mg /day (once a day)
Slovenian: 200 mg/dan (enkrat na dan)
English: • kidney stones.
Slovenian: • kamni v sečilih;
English: 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
Slovenian: EU/1/04/307/006 28 kapsul EU/1/04/307/004 56 kapsul EU/1/04/307/011 84 kapsul EU/1/04/307/007 98 kapsul EU/1/04/307/008 196 kapsul
English: Zonegran 50 mg hard capsules
Slovenian: Zonegran 50 mg trde kapsule
English: Zonegran 25 mg hard capsules zonisamide
Slovenian: Zonegran 25 mg trde kapsule zonisamid
English: A dietary supplement or increased food intake may be considered if the patient is losing weight or is underweight whilst on this medication.
Slovenian: V primeru, da bolnik med zdravljenjem z zdravilom Zonegran izgublja telesno maso ali pa ima premajhno telesno maso, je treba razmisliti o prehranskih dopolnilih ali povečanem vnosu hrane.
English: Zonegran can cause children to sweat less and overheat and if the child is not treated this can lead to brain damage and death.
Slovenian: Zdravilo Zonegran lahko povzroči, da se otroci manj znojijo in se pregrejejo.
English: Zonegran 50 mg hard capsules zonisamide
Slovenian: Zonegran 50 mg trde kapsule zonisamid
English: 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
Slovenian: EU/1/04/307/010 14 kapsul EU/1/04/307/009 28 kapsul EU/1/04/307/003 56 kapsul EU/1/04/307/012 84 kapsul
English: 300 mg / day (once a day)
Slovenian: 300 mg/dan (enkrat na dan)
English: 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.
Slovenian: Če bolnik ne pridobiva telesne mase v skladu z rastnimi krivuljami, je treba razmisliti o uporabi prehranskih dopolnil ali zvečanem uživanju hrane ali pa zdravljenje z zdravilom Zonegran prekiniti.
English: Pneumonia Urinary tract infection
Slovenian: Infekcijske in parazitske bolezni pljučnica okužba sečil
English: 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
Slovenian: EU/1/04/307/001 14 kapsul EU/1/04/307/005 28 kapsul EU/1/04/307/002 56 kapsul EU/1/04/307/013 84 kapsul
English: Be especially careful while driving or operating machinery, if Zonegran affects you in this way.
Slovenian: Če zdravilo Zonegran vpliva na vas na ta način, bodite med vožnjo in upravljanjem strojev še posebno previdni.
English: Urinary tract infection Pneumonia
Slovenian: Infekcijske in parazitske bolezni okužba sečil pljučnica
English: Specialist medical advice should be given to women treated with zonisamide who are of childbearing potential.
Slovenian: Ženskam v rodni dobi, zdravljenih z zonisamidom, mora svetovati zdravnik specialist.
English: A white opaque body and a red opaque cap printed with a logo and “ZONEGRAN 100” in black.
Slovenian: Bel, neprozoren spodnji del kapsule z rdečim neprozornim zgornjim delom kapsule, na katerem je natisnjen logo in ''ZONEGRAN 100'' v črni barvi.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora motnje dihanja
English: A white opaque body and a grey opaque cap printed with a logo and “ZONEGRAN 50” in black.
Slovenian: Bel, neprozoren spodnji del kapsule s sivim neprozornim zgornjim delom kapsule, na katerem je natisnjen logo in ''ZONEGRAN 50'' v črni barvi.
English: Patients must not take this medicinal product if they are allergic to peanut or soya.
Slovenian: Če so bolniki alergični na arašide ali sojo, ne smejo jemati tega zdravila.
English: • have eye problems such as glaucoma.
Slovenian: • če imate težave z očmi, na primer glavkom;
English: Zonisamide is 40 - 50 % bound to human plasma proteins, with in vitro studies showing that this is unaffected by the presence of various antiepileptic medicinal products (i.e., phenytoin, phenobarbitone, carbamazepine, and sodium valproate).
Slovenian: In vitro študije so pokazale, da prisotnost drugih antiepileptičnih zdravil (npr. fenitoina, fenobarbitona, karbamazepina in natrijevega valproata) ne vpliva na vezavo na proteine.
English: Twelve months seizure freedom PP-population ITT-population < 4 seizures during 3 month baseline period > 4 seizures during 3 month baseline period
Slovenian: ≤ 4 epileptični napadi med 3-mesečnim izhodiščnim obdobjem > 4 epileptični napadi med 3-mesečnim izhodiščnim obdobjem zonisamid karbamazepin n (populacija ITT) Podtip epileptičnega napada (6 mesecev brez epileptičnega napada - populacija PP) Vsi parcialni
English: Withdrawal
Slovenian: Odtegnitev
English: Consideration must be given to discontinuing Zonegran in patients who develop an otherwise unexplained rash.
Slovenian: Pri bolnikih, pri katerih se razvije izpuščaj, ki ga ni mogoče razložiti na noben drug način, je treba pretehtati možnost ukinitve zdravila Zonegran.
English: Six months seizure freedom
Slovenian: 6.3 Rok uporabnosti
English: Respiratory disorder
Slovenian: Okvarjeno delovanje jeter
English: Withdrawal seizures
Slovenian: Pretisni omot
English: Adverse reactions associated with Zonegran obtained from adjunctive use clinical studies and post-marketing surveillance
Slovenian: Preglednica 4 Neželeni učinki, povezani z zdravilom Zonegran, iz kliničnih študij adjuvantnega zdravljenja in opazovanja v času trženja zdravila Organski sistem (po MedDRA klasifikaciji)
English: Grand mal seizure Myasthenic syndrome Neuroleptic malignant syndrome
Slovenian: Bolezni živčevja ataksija omotica okrnjene spominske sposobnosti somnolenca bradifrenija motnje pozornosti nistagmus parestezije motnje govora tremor konvulzije amnezija koma epileptični napad grand mal miastenijski sindrom nevroleptični maligni sindrom epileptični status
English: Investigations Decreased bicarbonate
Slovenian: Odtegnitev zdravila Zonegran
English: Diff
Slovenian: MedDRA†)
English: Status epilepticus
Slovenian: Epileptični napadi ob odtegnitvi
English: EMA Number
Slovenian: Številka postopka EMA
English: It is available as tablets (25 mg).
Slovenian: Na voljo je v obliki tablet (25 mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Edurant on 28 November 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Edurant, veljavno po vsej Evropski uniji, izdala 28. novembra 2011.
English: Edurant rilpivirine
Slovenian: Edurant rilpivirin
English: What measures are being taken to ensure the safe and effective use of Edurant?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Edurant?
English: In all studies, the main measure of effectiveness was based on the reduction in viral load.
Slovenian: V vseh študijah je glavno merilo učinkovitosti temeljilo na zmanjšanju virusnega bremena.
English: The full EPAR for Edurant can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Edurant je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: A risk management plan has been developed to ensure that Edurant is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Edurant je bil pripravljen načrt obvladovanja tveganj.
English: Other information about Edurant
Slovenian: Druge informacije o zdravilu Edurant
English: This is a summary of the European public assessment report (EPAR) for Edurant.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Edurant.
English: The recommended dose of Edurant is one tablet once a day.
Slovenian: Priporočeni odmerek zdravila Edurant je ena tableta enkrat na dan.
English: For more information about treatment with Edurant, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Edurant preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: 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.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: 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.
Slovenian: Zavira dejavnost reverzne transkriptaze, tj. encima, ki ga tvori virus HIV-1, kar mu omogoča proizvodnjo več virusov v okuženih celicah.
English: 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.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: What benefit has Edurant shown during the studies?
Slovenian: Kakšne koristi je zdravilo Edurant izkazalo med študijami?