FrancophonIA/ELRC3.0 huggingface dataset:
English: For the same reason you must not take disulfiram or other medicines that reduce alcohol metabolism (e.g. metronidazole) or preparations that contain alcohol (e.g. ritonavir oral solution) or additional propylene glycol while you are taking Agenerase oral solution (see also Do not take Agenerase).
Slovenian: Iz istega razloga peroralne raztopine Agenerase ne smete jemati sočasno z disulfiramom ali drugimi zdravili, ki zmanjšujejo presnovo alkohola (npr. metronidazol), s pripravki z alkoholom (npr. peroralna raztopina ritonavirja) ali s pripravki z dodatnim propilenglikolom (glejte tudi Ne jemljite zdravila Agenerase).
English: Concomitant administration should be used with caution in patients with mild and moderate hepatic impairment and is contraindicated in patients with severe hepatic impairment (see section 4.3).
Slovenian: Pri bolnikih z blažjo ali zmerno obliko oslabljenega delovanja jeter je potrebna previdnost pri sočasnem dajanju, pri bolnikih s hudo obliko oslabljenega delovanja jeter pa je sočasno dajanje kontraindicirano (glejte poglavje 4.3).
English: No dose recommendations can be given for the co-administration of amprenavir and low dose ritonavir with delavirdine.
Slovenian: Za sočasno uporabo amprenavirja, nizkih odmerkov ritonavirja in delavirdina ne moremo podati priporočenih odmerkov.
English: The Summary of Product Characteristics of Agenerase oral solution should be consulted for full prescribing information.
Slovenian: Pred predpisovanjem je potrebno preveriti popolna navodila, ki so v Povzetku glavnih značilnosti zdravila za peroralno raztopino Agenerase.
English: - There have been reports of increased bleeding in patients with haemophilia taking protease inhibitors.
Slovenian: - Pri bolnikih s hemofilijo, ki so prejemali zaviralce proteaz, so poročali o pogostnejših krvavitvah.
English: The concomitant administration of Agenerase oral solution with disulfiram or other medicinal products that reduce alcohol metabolism (e.g. metronidazole), or preparations that contain alcohol (e.g. ritonavir oral solution) or additional propylene glycol is contraindicated (see sections 4.3and 4.5).
Slovenian: Uporaba peroralne raztopine Agenerase sočasno z disulfiramom ali drugimi zdravili, ki zmanjšujejo presnovo alkohola (npr. metronidazol), s pripravki z alkoholom (npr. peroralna raztopina ritonavirja) ali s pripravki z dodatnim propilenglikolom je kontraindicirana (glejte poglavji 4.3 in 4.5).
English: No dose recommendation can be given for the co-administration of amprenavir with another protease inhibitor and efavirenz in children.
Slovenian: Za sočasno uporabo amprenavirja, drugega zaviralca proteaz in efavirenza pri otrocih ne moremo podati priporočenih odmerkov.
English: Co-administration may result in competitive inhibition of the metabolism of these active substances thus increasing their plasma level and leading to serious and / or life-threatening adverse reactions such as cardiac arrhythmia (e.g. amiodarone, astemizole, bepridil, cisapride, pimozide, quinidine, terfenadine) or peripheral vasospasm or ischaemia (e.g. ergotamine, dihydroergotamine).
Slovenian: Zaradi sočasne uporabe se lahko pojavi kompetitivna presnova teh učinkovin in posledično povečanje njihovih plazemskih vrednosti, kar lahko povzroči resne in/ali smrtno nevarne neželene reakcije, kot so aritmije (npr. amiodaron, astemizol, bepridil, cisaprid, pimozid, kinidin, terfenadin) ali periferni vazospazem ali ishemija (npr. ergotamin, dihidroergotamin).
English: NAME OF THE MEDICINAL PRODUCT Agenerase 150 mg soft capsules Amprenavir
Slovenian: IME ZDRAVILA Agenerase 150 mg mehke kapsule amprenavir
English: Based on these data, careful consideration should be given to the expected benefit of unboosted Agenerase when optimising therapy for PI experienced children.
Slovenian: Pri otrocih, ki so se že zdravili s PI-ji, je na osnovi teh podatkov pri izbiranju najboljše oblike zdravljenja treba skrbno razmisliti o koristi uporabe zdravila Agenerase brez okrepitve.
English: Oblong, opaque, off-white to cream coloured, printed with ‘GX CC1'.
Slovenian: Podolgovate, neprozorne, sivobele do krem barve, z oznako ‘GX CC1'.
English: NAME OF THE MEDICINAL PRODUCT Agenerase 50 mg soft capsules Amprenavir
Slovenian: IME ZDRAVILA Agenerase 50 mg mehke kapsule amprenavir
English: Zidovudine: the AUC and Cmax of zidovudine were increased by 31 % and 40 %, respectively, when given with amprenavir.
Slovenian: Zidovudin: Ob sočasnem dajanju z amprenavirjem sta se AUC in Cmax zidovudina zvečali, in sicer AUC za 31 % ter Cmax za 40 %.
English: You will need to take Agenerase every day.
Slovenian: Bodite posebno pozorni pri jemanju zdravila Agenerase Zdravilo Agenerase morate jemati vsak dan.
English: Hyperglycaemia
Slovenian: hiperglikemija
English: One hundred and sixty-three (163) patients with virus sensitive to Agenerase, at least one other PI, and at least one NRTI were included in PRO30017 substudy A. The primary analysis assessed the noninferiority of APV/r to the SOC PI group with respect to time-weighted average change from baseline (AAUCMB) in plasma viral load (HIV-1 RNA) at week 16 using a non-inferiority margin of 0.4 log10 copies/ml.
Slovenian: Primarna analiza je vrednotila enakovrednost APV/r v primerjavi s skupino, ki je bila standardno zdravljena s PI-ji, glede na časovno odvisne povprečne spremembe od izhodišča (AAUCMB) v plazemski virusni obremenitvi (HIV-1 RNA) v 16. tednu z uporabo enakovredne meje 0,4 log10 kopij/ml.
English: Breast feeding your baby is not recommended while you are taking Agenerase.
Slovenian: Medtem ko jemljete zdravilo Agenerase, ni priporočljivo, da otroka dojite.
English: No dosing recommendations can be made regarding the use of low dose ritonavir (normally used as an activity booster with Agenerase capsules) together with Agenerase oral solution.
Slovenian: Glede uporabe nizkega odmerka ritonavirja (običajno se uporablja za okrepitev učinka zdravila Agenerase v obliki kapsul) skupaj s peroralno raztopino Agenerase ne moremo podati priporočenih odmerkov, zato se je takšni kombinaciji potrebno izogibati.
English: Children less than 4 years of age: Agenerase oral solution is contraindicated in children less than 4 years of age.
Slovenian: Otroci, mlajši od 4 let: Peroralna raztopina Agenerase je kontraindicirana pri otrocih, mlajših od 4 let (glejte poglavji 4.3 in 5.3).
English: Agenerase should be permanently discontinued when rash is accompanied with systemic symptoms or allergic symptoms or mucosal involvement (see section 4.8).
Slovenian: Če eksantem spremljajo sistemski znaki, znaki alergije ali prizadetost sluznic, je potrebno uporabo zdravila Agenerase trajno ukiniti (glejte poglavje 4.8).
English: Hyperglycaemia, hypercholesterolaemia
Slovenian: hiperholesterolemija
English: Agenerase capsules are contraindicated in patients with severe hepatic impairment when used in combination with ritonavir (see section 4.3).
Slovenian: Uporaba kapsul Agenerase v kombinaciji z ritonavirjem je kontraindicirana pri bolnikih s hudo obliko oslabljenega delovanja jeter (glejte poglavje 4.3).
English: Lamivudine: the AUC and Cmax of lamivudine and amprenavir, respectively, were both unaltered when these two medicinal products were given concomitantly.
Slovenian: Lamivudin: Ob sočasnem dajanju z amprenavirjem sta AUC in Cmax lamivudina in amprenavirja ostali nespremenjeni.
English: Agenerase is also available as an oral solution for use in children or adults unable to swallow capsules.
Slovenian: Za uporabo pri otrocih in odraslih, ki niso zmožni pogoltniti kapsul, je zdravilo Agenerase na voljo tudi v obliki peroralne raztopine.
English: • Increases in enzymes produced by the liver called transaminases, increases of an enzyme produced by the pancreas called amylase
Slovenian: • Povečana aktivnost jetrnih encimov (transaminaze) in povečana aktivnost encima
English: Additionally, it is recommended that HIV infected women do not breast feed their infants in order to avoid transmission of HIV.
Slovenian: Dodatno je, z namenom preprečiti širjenje virusa, ravno tako priporočljivo, da matere, okužene z virusom HIV, otrok ne dojijo.
English: New onset of diabetes mellitus, hyperglycaemia or exacerbations of existing diabetes mellitus have been reported in patients receiving antiretroviral therapy, including protease inhibitors.
Slovenian: Pri bolnikih, ki so prejemali protiretrovirusna zdravila, vključno zaviralce proteaz, so poročali o pojavu sladkorne bolezni, o hiperglikemiji ali poslabšanju obstoječe sladkorne bolezni.
English: Abacavir: the AUC, Cmin and Cmax of abacavir were unaltered when given with amprenavir.
Slovenian: Abakavir: Ob sočasnem dajanju z amprenavirjem so AUC, Cmin in Cmax abakavirja ostale nespremenjene.
English: Patients should therefore be monitored for toxic reactions associated with these medicinal products when these are administered in combination with Agenerase.
Slovenian: V primeru sočasne uporabe teh zdravil in zdravila Agenerase je bolnike potrebno nadzirati glede morebitnih toksičnih reakcij, povezanih z njimi.
English: This must be taken into consideration when prescribing to patients on a controlled sodium diet.
Slovenian: Pozornost je potrebna pri bolnikih, ki so na diati z nižanjem natrija.
English: Oral/perioral paraesthesia, tremors, sleep disorders Gastrointestinal disorders Very Common:
Slovenian: oralna/perioralna parestezija, tremor, motnje spanja
English: Co-administration may result in competitive inhibition of the metabolism of these active substances thus increasing their plasma level and leading to serious and / or life-threatening adverse reactions such as cardiac arrhythmia (e.g. amiodarone, astemizole, bepridil, cisapride, pimozide, quinidine, terfenadine) or peripheral vasospasm or ischaemia (e.g. ergotamine, dihydroergotamine) (see section
Slovenian: Zaradi sočasne uporabe se lahko pojavi kompetitivna presnova teh učinkovin in posledično povečanje njihovih plazemskih vrednosti, kar lahko povzroči resne in/ali smrtno nevarne neželene reakcije, kot so aritmije (npr. amiodaron, astemizol, bepridil, cisaprid, pimozid, kinidin, terfenadin) ali periferni vazospazem ali ishemija (npr. ergotamin, dihidroergotamin) (glejte poglavje 4.3).
English: Clinically validated phenotypic interpretation systems may be used in association with the genotypic data to estimate the activity of amprenavir / ritonavir or fosamprenavir / ritonavir in patients with PIresistant isolates.
Slovenian: Analize na osnovi fenotipskega testiranja rezistence Za ocenjevanje delovanja amprenavirja /ritonavirja ali fosamprenavirja /ritonavirja pri bolnikih z izolati, odpornimi na zaviralce proteaz, se lahko uporabijo klinično ovrednoteni fenotipski interpretacijski sistemi v kombinaciji z genotipskimi podatki.
English: No dose adjustment for any of the medicinal products is necessary when either ketoconazole is or itraconazole administered in combination with amprenavir.
Slovenian: Pri sočasni uporabi ketokonazola ali itrakonazola in amprenavirja ni treba prilagajati odmerka pri nobenem zdravilu.
English: PACKAGE LEAFLET : INFORMATION FOR THE USER Agenerase 15 mg/ml oral solution Amprenavir
Slovenian: NAVODILO ZA UPORABO Agenerase 15 mg/ml peroralna raztopina amprenavir
English: Agenerase oral solution and ritonavir oral solution should not be co-administered (see section 4.3).
Slovenian: Peroralna raztopina Agenerase in peroralna raztopina ritonavirja se ne smeta uporabljati sočasno (glejte poglavje 4.3).
English: • Diarrhoea, feeling sick, vomiting, flatulence • Skin Rashes (red, raised or itchy) - Occasionally, the skin rash may be svere and you may
Slovenian: • Kožni izpuščaj (rdeč, privzdignjen nad nivo kože ali srbeč).
English: Therefore, concomitant administration with disulfiram or other medicinal products that reduce alcohol metabolism (e.g. metronidazole) or preparations that contain alcohol (e.g. ritonavir oral solution) or propylene glycol is contraindicated (see sections 4.3 and 4.4).
Slovenian: Tako je sočasna uporaba peroralne raztopine Agenerase in disulfirama ali drugih zdravil, ki zmanjšujejo presnovo alkohola (npr. metronidazol), pripravkov z alkoholom (npr. peroralna raztopina ritonavirja) ali pripravkov s propilenglikolom kontraindicirana (glejte poglavji 4.3 in 4.4).
English: Oblong, opaque, off-white to cream coloured, printed with ‘GX CC2'.
Slovenian: Podolgovate, neprozorne, sivobele do krem barve, z oznako ‘GX CC2'.
English: Atorvastatin is less dependent on CYP3A4 for metabolism.
Slovenian: Atorvastatin je pri presnovi sicer manj odvisen od CYP3A4, vendar je, pri sočasni uporabi z zdravilom Agenerase, potrebno uporabiti najnižji možni odmerek atorvastatina.
English: Steroids: oestrogens and progestogens may interact with amprenavir.
Slovenian: Steroidi: Estrogeni in progestogeni lahko medsebojno učinkujejo z amprenavirjem, vendar trenutno dostopni podatki ne zadostujejo za opredelitev narave interakcij.
English: EFFECTIVE USE OF THE MEDICINAL PRODUCT Not applicable
Slovenian: Imetnik dovoljenja za promet z zdravilom
English: Do not take Agenerase if you are allergic (hypersensitive) to amprenavir or to any of the other ingredients in if you have severe liver disease (see ‘Take special care with Agenerase').
Slovenian: - če imate hudo bolezen jeter (glejte 'Bodite posebno pozorni pri jemanju zdravila Agenerase').
English: This product contains propylene glycol, potassium and sodium See leaflet for further information
Slovenian: To zdravilo vsebuje propilenglikol, kalij in natrij.
English: No recommendations can currently be made regarding adjustment of amprenavir dose when amprenavir is co-administered with methadone due to the inherent low reliability of nonmatched historical controls.
Slovenian: Zaradi svojstvene nizke zanesljivosti neenakovredne kontrolne historične skupine trenutno ne moremo podati priporočil glede prilagoditve odmerka amprenavirja, če se uporablja sočasno z metadonom.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni kosti, sklepov, mišic in vezivnega tkiva
English: Consequently, concomitant administration of Agenerase with ritonavir and these glucocorticoids is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
Slovenian: Omenjeni sistemski kortikosteroidni učinki se lahko pojavijo tudi pri uporabi drugih kortikosteroidov, ki se presnavljajo s P450 3A, npr. budezonid, zato sočasne uporabe zdravila Agenerase v kombinaciji z ritonavirjem in tovrstnimi glukokortikoidi ne priporočamo, razen v primerih, ko možne koristi zdravljenja prevladajo nad tveganjem za pojav sistemskih kortikosteroidnih učinkov (glejte poglavje 4.4).
English: Österreich GlaxoSmithKline Pharma GmbH
Slovenian: GlaxoSmithKline GmbH & Co.
English: A reduction of rifabutin dosage of at least 50 % is recommended when administered with Agenerase.
Slovenian: Če se rifabutin daje sočasno z zdravilom Agenerase priporočamo, da se odmerek rifabutina zmanjša vsaj za 50 %.
English: Systemic corticosteroid effects including Cushing's syndrome and adrenal suppression have been reported in patients receiving ritonavir and inhaled or intranasally administered fluticasone propionate; this could also occur with other corticosteroids metabolised via the P450 3A pathway e.g. budesonide.
Slovenian: Pri bolnikih, ki so prejemali ritonavir in inhalacijske ali intranazalne oblike flutikazonpropionata, so poročali o pojavu sistemskih kortikosteroidnih učinkov, vključno s Cushingovim sindromom in z zaviralnim vplivom na nadledvično žlezo.
English: The active substance is amprenavir The Agenerase oral solution contains 15 mg/ml of amprenavir.
Slovenian: Peroralna raztopina Agenerase vsebuje 15 mg/ml amprenavirja.
English: NAME OF THE MEDICINAL PRODUCT Agenerase 150 mg soft capsules.
Slovenian: IME ZDRAVILA Agenerase 150 mg mehke kapsule
English: In vivo a) ART-naïve or PI-naïve patients
Slovenian: In vivo a) Bolniki, ki se še niso zdravili s protiretrovirusnimi zdravili ali z zaviralci proteaz; neokrepljen amprenavir/fosamprenavir
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/148/001
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/148/001
English: Increased CPK, myalgia, myositis, and rarely rhabdomyolysis have been reported with protease inhibitors, particularly in combination with nucleoside analogues.
Slovenian: V povezavi z zaviralci proteaz, zlasti v kombinaciji z nukleozidnimi analogi, so poročali o zvišanih vrednostih CPK (kreatin-fosfokinaze), mialgiji, miozitisu in redkeje o rabdomiolizi.
English: The HMG-CoA reductase inhibitors lovastatin and simvastatin are highly dependent on CYP3A4 for metabolism, thus concomitant use of Agenerase with simvastatin or lovastatin is not recommended due to an increased risk of myopathy, including rhabdomyolysis.
Slovenian: Zaradi zvečanega tveganja za miopatije, vključno z rabdomiolizo, se sočasna uporaba zdravila Agenerase s simvastatinom ali z lovastatinom ne priporoča.
English: isolates), darunavir/ritonavir (four of 25 isolates), indinavir/ritonavir (one of 25 isolates), lopinavir/ritonavir (three of 24 isolates), saquinavir (three of 24 isolates) and tipranavir/ritonavir (four of 24 isolates).. Conversely amprenavir retains activity against some isolates with resistance to other PIs and this retained activity would depend on the number and type of protease resistance mutations present in the isolates
Slovenian: Na osnovi podatkov, pridobljenih pri petindvajsetih bolnikih, ki predhodno še niso bili zdravljeni s protiretrovirusnimi zdravili in pri katerih je bilo zdravljenje z režimom, ki je vključeval fosamprenavir, neuspešno (pri enem od njih je bila v izhodišču prisotna odpornost na lopinavir in sakvinavir, pri enem pa na tipranavir), mehanizem rezistence, povezan z amprenavirjem, povzroča omejeno navzkrižno rezistenco na atazanavir/ritonavir (trije od 25 izolatov), darunavir/ritonavir (štirje od 25 izolatov), indinavir/ritonavir (eden od 25 izolatov), lopinavir/ritonavir (trije od 24 izolatov), sakvinavir (trije od 24 izolatov) in tipranavir/ritonavir (štirje od 24 izolatov).
English: The use of amprenavir in combination with ritonavir has not been studied in patients with hepatic impairment.
Slovenian: Pri bolnikih z oslabljenim delovanjem jeter uporaba amprenavirja v kombinaciji z ritonavirjem ni bila raziskana.
English: Lipid disorders should be managed as clinically appropriate (see section 4.8).
Slovenian: Motnje lipidov je potrebno klinično ustrezno zdraviti.
English: NAME OF THE MEDICINAL PRODUCT Agenerase 50 mg soft capsules.
Slovenian: IME ZDRAVILA Agenerase 50 mg mehke kapsule
English: There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses, in haemophiliac patients type A and B treated with protease inhibitors.
Slovenian: Pri bolnikih s hemofilijo A in B, ki so se zdravili z zaviralci proteaz, so poročali o pogostnejših krvavitvah, vključno s spontanimi kožnimi hematomi in hemartrozami.
English: No dose recommendations can be given for the co-administration of amprenavir and delavirdine.
Slovenian: Za sočasno uporabo amprenavirja in delavirdina ne moremo podati priporočenih odmerkov.
English: • Diarrhoea, feeling sick, vomiting, flatulence
Slovenian: • Driska, slabost, bruhanje, flatulenca (nabiranje plinov v želodcu ali črevesju).
English: Tell your doctor if you have any of these listed conditions, or are taking any of the medicines listed above.
Slovenian: Če imate katero koli zgoraj navedeno bolezen ali se zdravite s katerim koli zgoraj navedenim zdravilom, to povejte svojemu zdravniku.
English: There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses in haemophiliac patients type A and B treated with protease inhibitors.
Slovenian: Pri bolnikih s hemofilijo A in B, ki so se zdravili z zaviralci proteaz, so poročili o pogostnejših krvavitvah, vključno s spontanimi kožnimi hematomi in hemartrozami.
English: Amprenavir is a substrate of and inhibits CYP3A4.
Slovenian: Rifampicin je močan induktor CYP3A4.
English: Excipients:
Slovenian: Občasni:
English: MARKETING AUTHORISATION NUMBERS EU/1/00/148/004
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/148/004
English: Ritonavir: the AUC and Cmin of amprenavir were increased by 64% and 508% respectively and the Cmax decreased by 30% when ritonavir (100 mg twice daily) was coadministered with amprenavir capsules (600 mg twice daily) compared to values achieved after 1200 mg twice daily doses of amprenavir capsules.
Slovenian: Ritonavir: Ob sočasnem dajanju ritonavirja (100 mg dvakrat dnevno) in amprenavirja v obliki kapsul (600 mg dvakrat dnevno) so se, v primerjavi z doseženimi vrednostmi po dajanju amprenavirja v obliki kapsul v dnevnem odmerku 1200 mg dvakrat dnevno, AUC in Cmin amprenavirja zvečale: AUC za 64 % in Cmin za 508 %.
English: STORING AGENERASE
Slovenian: Peroralna raztopina
English: Agenerase is not recommended for use as monotherapy, due to the rapid emergence of resistant virus.
Slovenian: Zaradi hitrega pojava rezistence virusa se zdravila Agenerase ne priporoča za uporabo v monoterapiji.
English: PACKAGE LEAFLET : INFORMATION FOR THE USER Agenerase 150 mg soft capsules Amprenavir
Slovenian: NAVODILO ZA UPORABO Agenerase 150 mg mehke kapsule amprenavir
English: 1) What Agenerase is and what it is used for 2) Before you take Agenerase 3) How to take Agenerase 4) Possible side effects 5) How to store Agenerase 6) Further information
Slovenian: Kaj je zdravilo Agenerase in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Agenerase
English: PACKAGE LEAFLET : INFORMATION FOR THE USER Agenerase 50 mg soft capsules Amprenavir
Slovenian: NAVODILO ZA UPORABO Agenerase 50 mg mehke kapsule amprenavir
English: Always take Agenerase exactly as your doctor has told you.
Slovenian: Pri jemanju zdravila Agenerase natančno upoštevajte zdravnikova navodila.
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states (EU/EEA)
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe, imetnikov dovoljenja za promet z zdravilom v državah članicah (EU/EGP)
English: S.p.A. Viale Amelia 70 00181 Roma Italy
Slovenian: Viale Amelia 70 00181 Roma Italy
English: UK - United Kingdom
Slovenian: UK - Velika Britanija
English: Capsule, hard
Slovenian: Kapsula, trda
English: LV - Latvia
Slovenian: LV - Latvija
English: RO - Romania
Slovenian: RO - Romunija
English: CZ - Czech Republic
Slovenian: CZ - Češka
English: PT - Portugal
Slovenian: PT - Portugalska
English: HU - Hungary
Slovenian: HU - Madžarska
English: LT - Lithuania
Slovenian: LT - Litva
English: SK - Slovakia
Slovenian: SK - Slovaška
English: BG - Bulgaria
Slovenian: BG - Bolgarija
English: BE - Belgium
Slovenian: BE - Belgija
English: Box 552 2003 RN Haarlem Netherlands
Slovenian: Swensweg 5, P.O. Box 552 2003 RN Haarlem Netherlands
English: SI - Slovenia
Slovenian: SI - Slovenija
English: NLNetherlands
Slovenian: NLNizozemska
English: IT - Italy
Slovenian: IT - Italija
English: GlaxoSmithKline B.V. Huis ter Heideweg 62 NL-3705 LZ Zeist The Netherlands
Slovenian: Huis ter Heideweg 62 NL-3705 LZ Zeist The Netherlands
English: DOCPHARMA N.V. Ambachtenlaan 13H 3001 Leuven Belgium
Slovenian: Ambachtenlaan 13H 3001 Leuven Belgium
English: LULuxembourg
Slovenian: LULuksemburg
English: Ratiopharm Nederland B.V. Ronde Tocht 11
Slovenian: Ratiopharm Nederland B.V.
English: 200 mg coated tablet
Slovenian: 200 mg Obložena tableta
English: AT - Austria betapharm Arzneimittel GmbH Kobelweg 95
Slovenian: AT - Avstrija betapharm Arzneimittel GmbH Kobelweg 95
English: EL-Greece
Slovenian: EL - Grčija
English: Prolonged release capsule
Slovenian: Kapsula s podaljšanim sproščanjem
English: Kapanol 50, capsules met gereguleerde afgifte 20 mg 50 mg
Slovenian: Kapanol 50, capsules met gereguleerde afgifte 20 mg
English: Modified-release capsule
Slovenian: Kapsula s prirejenim sproščanjem
English: SUBSTITOL 200 mg trde kapsule s podaljšanim sproščanjem200 mg Prolonged-release capsule, hard Oral use
Slovenian: SUBSTITOL 200 mg trde kapsule s podaljšanim sproščanjem200 mg Kapsula s podaljšanim sproščanjem, trda