FrancophonIA/ELRC3.0 huggingface dataset:
English: 10 Push plunger head down to deliver dose.
Slovenian: 10 Potisnite bat navzdol, da bi injicirali cel odmerek.
English: 4 Inspect the syringe and solution.
Slovenian: SLIKA 6 4 Preverite videz injekcijske brizge in raztopine.
English: Cases of capillary leak syndrome have been reported in the post marketing setting with G-CSF use.
Slovenian: V obdobju trženja zdravila so poročali o primerih sindroma kapilarne prepustnosti med uporabo GCSF.
English: • experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash and itchy skin
Slovenian: • se vam pojavi alergijska reakcija, vključno s šibkostjo, padcem krvnega tlaka, težavami z dihanjem, otekanjem obraza (anafilaksa), pordelostjo in navali vročine, izpuščajem na koži in srbeča koža.
English: G-CSF can promote growth of myeloid cells in vitro and similar effects may be seen on some non-myeloid cells in vitro.
Slovenian: Granulocitne kolonije spodbujajoči faktor (G-SCF) lahko spodbudi rast mieloičnih celic in vitro; podobni učinki bi se lahko pojavili pri nekaterih nemieloičnih celicah in vitro.
English: You may take UDENYCA out of the refrigerator and keep it at room temperature (not above 30°C) for no longer than 72 hours.
Slovenian: Zdravilo UDENYCA smete vzeti iz hladilnika in ga hraniti pri sobni temperaturi (pod 30 °C) največ 3 dni dolgo.
English: There is insufficient information on the excretion of pegfilgrastim/ metabolites in human milk, a risk to the newborns/infants cannot be excluded.
Slovenian: Ni dovolj podatkov o izločanju pegfilgrastima/presnovkov v materino mleko.
English: Grasp the body of the syringe like a dart (just under the finger grips) with your thumb and index fingers (see Figure 11).
Slovenian: S palcem in kazalcem primite injekcijsko brizgo na sredini valja, kot da bi prijeli puščico za pikado (takoj pod blazinicami prstov) (poglejte sliko 11).
English: The syringes are provided with an automatic needle guard.
Slovenian: Injekcijske brizge so na voljo z avtomatičnim ščitnikom igle.
English: Pegfilgrastim contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say, essentially 'sodium-free'.
Slovenian: Zdravilo UDENYCA vsebuje manj kot 1 mmol (23 mg) natrija na 6 mg odmerek, kar v bistvu pomeni ˝brez natrija˝.
English: UDENYCA 6 mg solution for injection in pre-filled syringe pegfilgrastim
Slovenian: UDENYCA 6 mg raztopina za injiciranje v napolnjeni injekcijski brizgi pegfilgrastim
English: UDENYCA contains the active substance pegfilgrastim.
Slovenian: Zdravilo UDENYCA vsebuje učinkovino pegfilgrastim.
English: DO NOT freeze or shake the pre-filled syringe.
Slovenian: Napolnjene injekcijske brizge NE SMETE zamrzniti ali stresati.
English: NAME OF THE MEDICINAL PRODUCT UDENYCA 6 mg solution for injection in pre-filled syringe
Slovenian: IME ZDRAVILA UDENYCA 6 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: FIGURE 2
Slovenian: SLIKA 2
English: FIGURE 5
Slovenian: SLIKA 5
English: Immediately after injecting, discard the used syringe into a sharps disposal container (see Figure 17).
Slovenian: 11 Zavrzite injekcijsko brizgo in oskrbite mesto injiciranja Takoj po injiciranju zavrzite injekcijsko brzigo v vsebnik za ostre predmete (poglejte sliko 17).
English: FIGURE 10
Slovenian: SLIKA 10
English: Rare side effects (may affect up to 1 in 1,000 people)
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1 000 bolnikov)
English: • inflammation of the blood vessels in the skin (cutaneous vasculitis)
Slovenian: • kožni vaskulitis (vnetje krvnih žil v koži).
English: One 6 mg dose (a single pre-filled syringe) of pegfilgrastim is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy.
Slovenian: Za vsak cikel kemoterapije priporočajo en 6-miligramski odmerek (eno napolnjeno injekcijsko brizgo) pegfilgrastima, ki je dan vsaj 24 ur po citotoksični kemoterapiji.
English: Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythaema, flushing, and hypotension occurred on initial or subsequent treatment with pegfilgrastim (uncommon).
Slovenian: Med začetnim ali nadaljnjim zdravljenjem s pegfilgrastimom so se pojavile reakcije preobčutljivostne vrste, vključno z izpuščajem na koži, urtikarijo, angioedemom, dispnejo, eritemom, zardevanjem in hipotenzijo (občasno).
English: FIGURE 15
Slovenian: SLIKA 15
English: FIGURE 9
Slovenian: SLIKA 9
English: Transient elevations in LFT's for ALT or AST1
Slovenian: Preiskave zvišanje laktatdehidrogenaze in alkalne fosfataze1, prehodno zvišanje jetrnih funkcijskih testov za ALT ali AST1
English: PHARMACEUTICAL FORM Solution for injection.
Slovenian: FARMACEVTSKA OBLIKA raztopina za injiciranje Bistra, brezbarvna raztopina za injiciranje.
English: - The other ingredients are acetic acid and sodium acetate (for pH adjustment), sorbitol (E420),
Slovenian: - Pomožne snovi so ocetna kislina in natrijev acetat (za uravnavo pH), sorbitol (E420), polisorbat
English: • are planning to have a baby
Slovenian: • načrtujete zanositev
English: DO NOT use the pre-filled syringe if it has been dropped with the needle cap removed.
Slovenian: NE UPORABLJAJTE injekcijske brizge, ki je padla in ob tem ni imela pritrjenega pokrova.
English: Pegfilgrastim contains sorbitol.
Slovenian: Zdravilo UDENYCA vsebuje sorbitol.
English: FIGURE 13
Slovenian: SLIKA 13
English: FIGURE 4
Slovenian: SLIKA 4
English: DO NOT use if the solution appears discoloured or cloudy.
Slovenian: Raztopine NE UPORABLJAJTE, če je videti motna in razbarvana.
English: FIGURE 3
Slovenian: SLIKA 3
English: FIGURE 14
Slovenian: SLIKA 14
English: FIGURE 7
Slovenian: SLIKA 7
English: FIGURE 11
Slovenian: SLIKA 11
English: Solution for injection in pre-filled syringe (0.6 ml).
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Raztopina za injiciranje v napolnjeni injekcijski brizgi (0,6 ml).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml solution.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Vsaka napolnjena injekcijska brizga vsebuje 6 mg pegfilgrastima v 0,6 ml raztopine .
English: Before administration, pegfilgrastim solution should be inspected visually for particulate matter.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje Pred uporabo morate raztopino pegfilgrastim pregledati glede vidnih delcev.
English: For the full list of excipients, see section 6.1.
Slovenian: Za navodila glede ravnanja z zdravilom pred dajanjem injekcije glejte poglavje 6.6.
English: Talk to your doctor, pharmacist or nurse before using UDENYCA if you:
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila UDENYCA se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če:
English: Discard syringe if frozen more than once.
Slovenian: Če ste injekcijsko brizgo zamrznili več kot enkrat, jo zavrzite.
English: This will ensure you have received the full dose (see Figure 15).
Slovenian: Ko bo bat na koncu injekcijske brizge, pomeni, da ste injicirali cel odmerek (poglejte sliko 15).
English: Sodium acetate trihydrate (for pH adjustment) Acetic acid (for pH adjustment) Sorbitol (E420)
Slovenian: 6.1 Seznam pomožnih snovi natrijev acetat trihidrat (za uravnavo pH) ocetna kislina (za uravnavo pH) sorbitol (E420) polisorbat 20 voda za injekcije
English: Unless your doctor directs you otherwise, you must stop breast-feeding if you use UDENYCA.
Slovenian: Če uporabljate zdravilo UDENYCA, morate prenehati dojiti, razen če vam zdravnik ne naroči drugače.
English: Pulmonary haemorrhage2
Slovenian: Bolezni živčevja glavobol1
English: Thrombocytopenia1 Leukocytosis1
Slovenian: Bolezni krvi in limfatičnega sistema trombocitopenija1, levkocitoza1
English: With the exception of the youngest age group (0-5 years), the mean AUC in paediatric subjects appeared similar to that for adult patients with high-risk stage II-IV breast cancer and receiving 100 μg/kg pegfilgrastim after the completion of doxorubicin/docetaxel (see sections 4.8 and 5.1).
Slovenian: do IV. stadiju, ki so dobile 100 µg/kg pegfilgrastima po dokončanju doksorubicina/docetaksela (glejte poglavji 4.8 in 5.1).
English: It should be given at least 24 hours after your last dose of chemotherapy, at the end of each chemotherapy cycle.
Slovenian: Običajni odmerek je ena 6-miligramska subkutana injekcija (podkožna injekcija), ki jo morate prejeti vsaj 24 ur po zadnjem odmerku kemoterapije na koncu vsakega cikla kemoterapije.
English: Removal of the air is not needed (see Figure 7).
Slovenian: Eden ali več mehurčkov v injekciski brizgi so običajni, odstranjevanje zraka ni potrebno (poglejte sliko 7).
English: Uncommon elevations in liver function tests (LFTs) for ALT (alanine aminotransferase) or AST (aspartate aminotransferase), have been observed in patients after receiving pegfilgrastim following cytotoxic chemotherapy.
Slovenian: Občasno so se bolnikom, ki so po citotoksični kemoterapiji dobili pegfilgrastim, pojavila zvišanja jetrnih funkcijskih testov za alanin-aminotransferaze (ALT) ali aspartat-aminotransferaze (AST).
English: (see Figure 8)
Slovenian: • zadnjica (poglejte sliko 8)
English: White blood cell (WBC) counts of 100 x 109/l or greater have been observed in less than 1% of patients receiving pegfilgrastim.
Slovenian: Pri manj kot 1 % bolnikov, ki dobivajo pegfilgrastim, so opazili število belih krvničk, ki je enako 100 x 109/l ali večje.
English: Bone pain Musculoskeletal pain (myalgia, arthralgia, pain in extremity, back pain,
Slovenian: artralgija, bolečina v okončini, bolečina v hrbtu, kostno-mišična bolečina, bolečina v vratu)
English: • have any of the following or combination of the following side effects: - swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness These could be symptoms of condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body.
Slovenian: • se vam pojavi kateri od naslednjih neželenih učinkov ali kombinacija teh neželenih učinkov: oteklost ali zabuhlost, ki jo lahko spremlja manj pogostejše odvajanje urina, težko dihanje, oteklost trebuha in občutek polnosti ter splošen občutek utrujenosti.
English: • increased spleen size
Slovenian: • povečana vranica.
English: Stop using UDENYCA and seek medical attention immediately if you notice any of the symptoms described in section 4.
Slovenian: Če opazite katerega od simptomov, opisanih v poglavju 4, prenehajte uporabljati zdravilo UDENYCA in nemudoma poiščite zdravniško pomoč.
English: 1 single-use pre-filled syringe with automatic needle guard.
Slovenian: 1napolnjena injekcijska brizga z avtomatskim ščitnikom za enkratno uporabo.
English: How to store UDENYCA
Slovenian: Shranjevanje zdravila UDENYCA
English: About this pre-filled syringe with automatic needle guard
Slovenian: Informacije o napolnjeni injekcijski brizgi z avtomatičnim ščitnikom igle.
English: The safety and efficacy of pegfilgrastim have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g., nitrosoureas.
Slovenian: Pri bolnikih, ki dobivajo kemoterapijo, povezano z odloženo mielosupresijo, na primer nitrozouree, varnosti in učinkovitosti pegfilgrastim a niso ovrednotili.
English: What you need to know before you use UDENYCA 3.
Slovenian: Kaj je zdravilo UDENYCA in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo UDENYCA Kako uporabljati zdravilo UDENYCA Možni neželeni učinki
English: The syringe should be disposed of after giving the injection.
Slovenian: Po dajanju odmerka brizgo odvrzite.
English: GENERAL CLASSIFICATION FOR SUPPLY
Slovenian: Informacije o shranjevanju
English: E-mail: EUAgent@eraconsulting.com
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM ERA Consulting GmbH
English: The injections should be given into the thigh, abdomen or upper arm. For instructions on handling of the medicinal product before administration, see section
Slovenian: Injekcije se morajo dati v stegno, trebuh ali zgornji del roke.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva bolečina v kosteh kostno-mišična bolečina1 (mialgija,
English: DO NOT shake the pre-filled syringe.
Slovenian: Injekcijske brizge NE SMETE STRESATI.
English: Vascular disorders
Slovenian: OZNAKA BRIZGE
English: Date of first authorisation: 30 November 2009 Date of latest renewal: 26 August 2014
Slovenian: Datum prve odobritve: 30. november 2009 Datum zadnjega podaljšanja: 26. avgust 2014
English: Nevirapine: exposure: ↑100%
Slovenian: Nevirapinu: izpostavljenost: ↑ 100 %
English: Patients 16 years and older
Slovenian: Bolniki stari 16 let in starejši
English: Táncsics Mihály út 82 Hungary
Slovenian: Táncsics Mihály út 82 Madžarska
English: ND = Not Determined, ↑ = Increased, ↓ = Decreased, ↔ = No Effect
Slovenian: ND = ni določeno, ↑ = povečanje, ↓ = zmanjšanje,
English: Your doctor might need to monitor whether your other medicines are still working and adjust doses.
Slovenian: Zdravnik mora preveriti, ali vaša druga zdravila še učinkujejo, in prilagoditi njihove odmerke.
English: In these cases, more frequent liver monitoring is required.
Slovenian: V tem primeru je potrebno jetrno funkcijo spremljati pogosteje.
English: This is especially important within the first 14 days of treatment (see more information in “How to take Nevirapine
Slovenian: To je še posebej pomembno prvih 14 dni zdravljenja (glejte podrobnejše informacije v odstavku »Kako jemati Nevirapin Teva«).
English: If Nevirapine Teva has been prescribed for your child, please note that all information in this leaflet is addressed to your child (in this case please read “your child” instead of “you”).
Slovenian: Če je bilo zdravilo Nevirapin Teva predpisano vašemu otroku, se vse informacije v tem navodilu za uporabo nanašajo na vašega otroka (v tem primeru prosim berite “vaš otrok” namesto “vi”).
English: This is therefore an important period which requires close monitoring by your doctor.
Slovenian: Zato je to pomembno obdobje, v katerem mora zdravnik zdravljenje skrbno spremljati.
English: Frequency is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Slovenian: Razdelitev po pogostnosti: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000).
English: ANALGESICS/OPIOIDS
Slovenian: ANALGETIKI/ OPIOIDI
English: Long-term efficacy appears to be most likely in patients whose nevirapine trough levels exceed 3.5 μg/ml.
Slovenian: Dolgoročna učinkovitost je najverjetnejša pri bolnikih, pri katerih so najmanjše ravni nevirapina nad 3,5 μg/ml.
English: Monitoring of hepatic tests should be done every two weeks during the first 2 months of treatment, at the 3rd month and then regularly thereafter.
Slovenian: Preiskave jetrne funkcije je potrebno narediti vsaka dva tedna prva dva meseca zdravljenja, po tretjem mesecu in nato redno.
English: In the multinational 2NN study, a population pharmacokinetic substudy of 1,077 patients was performed that included 391 females.
Slovenian: V sklopu večdržavne študije 2NN so izvedli populacijsko farmakokinetično podštudijo, ki je zajela 1077 bolnikov, od tega 391 žensk.
English: For this reason, and to reduce the risk of HIV transmission, barrier contraception (e.g., condoms) is recommended.
Slovenian: Iz tega razloga in zato, da bi zmanjšali nevarnost prenosa HIV, se priporoča uporabo mehanske kontracepcije (npr. kondoma).
English: 14 tablets 60 tablets 120 tablets
Slovenian: 14 tablet 60 tablet 120 tablet
English: 1.28 compared to historical controls.
Slovenian: 1,28 v primerjavi s prejšnjimi, kontrolnimi vrednostmi.
English: Always take this medicine exactly as your doctor has told you.
Slovenian: To zdravilo jemljite natančno tako, kot vam je naročil zdravnik.
English: In this 48week study no unexpected safety findings were observed in either dosing group.
Slovenian: V tej 48-tedenski raziskavi v nobeni od skupin z različnim odmerjanjem niso poročali o nepričakovanih izsledkih, povezanih z varnostjo.
English: The dose is one 200 mg tablet per day for the first 14 days of treatment (“lead-in” period).
Slovenian: Odmerek je ena tableta po 200 mg na dan prvih 14 dni zdravljenja (″uvajalno'' obdobje).
English: - reduces the chances of your HIV infection becoming resistant to your antiretroviral medicines.
Slovenian: - zmanjša verjetnost za razvoj odpornosti, da bo okužba s HIV pri vas postala odporna proti protiretrovirusnim zdravilom, ki jih jemljete.
English: Pharmacokinetic data on 33 patients (age range 0.77 - 13.7 years) in the intensive sampling group demonstrated that clearance of nevirapine increased with increasing age in a manner consistent with increasing body surface area.
Slovenian: Farmakokinetični podatki o 33 bolnikih (starostni razpon 0,77 - 13,7 leta) v intenzivni vzorčni skupini so pokazali, da se očistek nevirapina veča s starostjo, skladno s povečevanjem telesne površine.
English: ANTIBIOTICS
Slovenian: Antibiotiki
English: The 14-day “lead-in” period has been shown to lower the risk of skin rash.
Slovenian: Pokazalo se je, da 14-dnevno ”uvajalno” obdobje zmanjša tveganje kožnega izpuščaja.
English: Where other antiretroviral medicines are accessible, the single dose nevirapine regimen should be combined with additional effective antiretroviral medicines (as recommended in internationally recognized guidelines).
Slovenian: Če so na voljo druga protiretrovirusna zdravila, je treba režim zdravljenja z enkratnim odmerkom nevirapina kombinirati z dodatnimi učinkovitimi protiretrovirusnimi zdravili (kot priporočajo mednarodno sprejete smernice).
English: ANTIVIRALS FOR CHRONIC HEPATITIS B AND C
Slovenian: PROTIRETROVIRUSNA ZDRAVILA ZA KRONIČNI HEPATITIS B IN C
English: Decreased blood phosphorus and increased blood pressure were observed in clinical studies with coadministration of tenofovir/emtricitabine.
Slovenian: Zmanjšano raven fosforja v krvi in zvišan krvni tlak so odkrili v kliničnih študijah pri sočasnem dajanju tenofovirja/emtricitamina.
English: Cartons containing 60 or 120 tablets.
Slovenian: Škatle vsebujejo 60 ali 120 tablet.
English: Your doctor will carefully monitor the effect of Nevirapine Teva and any of these medicines if you are taking them together.
Slovenian: Vaš zdravnik bo skrbno spremljal učinek zdravila Nevirapin Teva in katerega od naštetih zdravil, če ju boste jemali hkrati.
English: The limited data available from a phase IIa study in HIV-infected patients have shown a clinically non significant 20% decrease of TPV
Slovenian: Omejeni podatki iz raziskave faze IIa pri bolnikih okuženih s HIV kažejo na klinično nepomembno 20 %
English: - if you are allergic to nevirapine or any of the other ingredients of this medicine (listed in section
Slovenian: - če ste alergični na nevirapin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Slovenian: Kakršnekoli vnetne simptome je potrebno obravnavati in kadar je potrebno, uvesti zdravljenje.
English: Excipient with known effect: Each tablet contains 168 mg of lactose (as monohydrate).
Slovenian: Pomožna snov z znanim učinkom: ena tableta vsebuje 168 mg laktoze (v obliki monohidrata).
English: Both, the primary (p = 0.92) and secondary endpoints showed no statistically significant differences between efavirenz and nevirapine 200 mg twice daily.
Slovenian: Niti primarni (p = 0,92) niti sekundarni opazovani dogodki niso odkrili statistično značilnih razlik med efavirenzom in nevirapinom po 200 mg dvakrat na dan.
English: YOU SHOULD DISCONTINUE TAKING NEVIRAPINE TEVA AND YOU MUST CONTACT your doctor IMMEDIATELY as such reactions can be potentially life-threatening or lead to death.
Slovenian: TAKOJ MORATE PRENEHATI JEMATI ZDRAVILO NEVIRAPIN TEVA IN SE NEMUDOMA POSVETOVATI s svojim zdravnikom, ker so lahko takšne reakcije življenjsko nevarne ali povzročijo smrt.
English: Cartons containing 14 tablets (Calendar Pack).
Slovenian: Škatle vsebujejo 14 tablet (koledarsko pakiranje).
English: In these patients nevirapine must not be restarted.
Slovenian: Pri teh bolnikih se zdravljenja z nevirapinom ne sme ponoviti.
English: It is important that you continue taking Nevirapine Teva correctly, as described above, unless your doctor instructs you to stop.
Slovenian: Pomembno je, da nadaljujete s pravilnim jemanjem zdravila Nevirapin Teva kot je opisano v tem navodilu, razen kadar vam zdravnik naroči, da prenehate.
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Slovenian: Če se pri njih zasledi znake poslabšanja jetrne bolezni, je potrebno presoditi o prekinitvi ali ukinitvi tega zdravljenja.
English: The majority of severe rashes occurred within the first 6 weeks of treatment and some required hospitalisation, with one patient requiring surgical intervention (see section 4.4).
Slovenian: Huda oblika izpuščaja se je večinoma pojavila v prvih 6 tednih zdravljenja in jo je bilo včasih potrebno zdraviti v bolnišnici, en bolnik pa je potreboval kirurški poseg (glejte poglavje 4.4).
English: Clarithromycin exposure was significantly decreased, 14-OH metabolite exposure increased.
Slovenian: Izpostavljenost klaritromicina se je pomembno zmanjšala, izpostavljenost presnovku 14-OH
English: Because the clarithromycin active metabolite has reduced activity against Mycobacterium aviumintracellulare complex overall activity against the pathogen may be altered.
Slovenian: Ker je klaritromicinov aktivni presnovek zmanjšal delovanje proti kompleksu Mycobacterium aviumintracellulare, se skupno delovanje proti povzročitelju lahko spremeni.
English: A reduction in red blood cells (anaemia), which may be related to nevirapine therapy, is also more commonly observed in children.
Slovenian: Zmanjšanje števila rdečih krvničk (anemija), ki je lahko povezana z zdravljenjem z nevirapinom, je prav tako pri otrocih pogostnejša.
English: White, oval, biconvex tablets.
Slovenian: Bele, ovalne, bikonveksne tablete.
English: Teva GyógyszergyárZrt Tel.: +36 1 288 64 00
Slovenian: Teva Gyógyszergyár Zrt Tel.: +36 1 288 64 00
English: The choice of a subsequent therapy after nevirapine should be based on clinical experience and resistance testing (see section 5.1).
Slovenian: Izbira zdravila, ki ga bomo uporabili po nevirapinu, mora temeljiti na kliničnih izkušnjah in preskusu odpornosti (glejte poglavje 5.1.
English: The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Slovenian: Razpolovna črta je namenjena lažjemu lomljenju tablete, kar omogoča lažje zaužitje in ne razdeljevanju na dva enaka odmerka.
English: However, due to the high interpatient variability some patients may experience large increases in rifabutin exposure and may be at higher risk for rifabutin toxicity.
Slovenian: Toda zaradi razlike med bolniki se lahko pri nekaterih močno poveča izpostavljenost rifabutinu, kar poveča nevarnost njegovih toksičnih učinkov.
English: Patients should be informed that hepatic reactions are a major toxicity of nevirapine requiring close monitoring during the first 18 weeks.
Slovenian: Bolnikom je potrebno povedati, da so jetrne reakcije pomemben toksični pojav ob uporabi nevirapina, zaradi katerega je prvih 18 tednov potrebno skrbno spremljati zdravljenje.
English: The frequency category was estimated from a statistical calculation based on the total number of patients exposed to nevirapine in randomised controlled clinical studies (n= 2,718).
Slovenian: Kategorijo pogostnosti so ocenili s statističnim izračunom na podlagi skupnega števila bolnikov, ki so bili izpostavljeni nevirapinu v nadzorovanih kliničnih študijah z naključno izbranimi bolniki (n = 2718).
English: In addition, nevirapine has not been shown to cause glucose disturbances.
Slovenian: Poleg tega se ni pokazalo, da bi nevirapin povzročalo motnje glukoze.