FrancophonIA/ELRC3.0 huggingface dataset:
English: Cases of lactic acidosis, sometimes fatal, usually associated with severe hepatomegaly and hepatic steatosis, have been reported in < 1% of patients taking stavudine in combination with other antiretrovirals (see section 4.4).
Slovenian: Pri < 1% bolnikov, ki so prejemali stavudin v kombinaciji z drugimi protiretrovirusnimi zdravili, so poročali o primerih laktacidoze, ki je bila včasih usodna in je bila ponavadi povezana s hudo hepatomegalijo in steatozo jeter (glejte poglavje 4.4).
English: Patients with chronic hepatitis B or C and treated with antiretroviral agents are at increased risk for severe and potentially fatal liver side effects and may require blood tests for control of liver function.
Slovenian: Pri bolnikih s kroničnim hepatitisom B ali C, ki se zdravijo s protiretrovirusnimi zdravili obstaja večje tveganje za pojav hudih in lahko celo smrtnih neželenih učinkov, povezanih z jetri.
English: Zerit 30 mg hard capsules are light and dark orange and marked with “BMS 1966” on one side and “30” on the other side.
Slovenian: Zerit 30 mg trde kapsule so svetlo in temno oranžne in imajo oznako “BMS 1966” na eni strani in “30” na drugi strani.
English: Zerit 200 mg powder for oral solution Stavudine
Slovenian: Zerit 200 mg prašek za peroralno raztopino stavudin
English: The active substance is stavudine (200 mg).
Slovenian: Zdravilna učinkovina je stavudin (200 mg).
English: Zerit dosage
Slovenian: Odmerek zdravila Zerit
English: Contact your doctor if you notice such changes.
Slovenian: Če opazite takšne spremembe se posvetujte s svojim zdravnikom.
English: The solution appears as a colourless to slightly pink, hazy solution.
Slovenian: Raztopina je brezbarvna do rahlo rožnata in motna.
English: Methylhydroxybenzoate (E218) Propylhydroxybenzoate (E216) Silicon dioxide
Slovenian: 6.1 Seznam pomožnih snovi aroma češnje metilparahidroksibenzoat (E218) propilparahidroksibenzoat (E216) silicijev dioksid simetikon natrijev karmelozat sorbinska kislina stearatni emulgatorji saharoza
English: For maximum effect, Zerit should be taken on an empty stomach, and preferably at least one hour before a meal.
Slovenian: Da bo zdravilo Zerit najbolj učinkovito, ga morate vzeti na prazen želodec in po možnosti vsaj eno uro pred obrokom.
English: These TAMs are seen at a similar frequency with stavudine and zidovudine in virological treatment.
Slovenian: Te mutacije timidinskih analogov so pri zdravljenju virusnih okužb s stavudinom enako pogoste kot pri zdravljenju z zidovudinom.
English: Then screw the cap on tightly and shake the bottle well until the powder dissolves completely, and take or dispense the solution with the measuring cup provided.
Slovenian: Potem tesno privijte pokrovček in plastenko dobro pretresite, dokler se prašek povsem ne raztopi.
English: Each hard capsule contains 80.84 mg of lactose anhydrous.
Slovenian: Ena trda kapsula vsebuje 80,84 mg brezvodne laktoze.
English: After reconstitution with water, the solution contains 50 mg of sucrose per ml of solution.
Slovenian: Po pripravi z vodo vsebuje raztopina 50 mg saharoze na mililiter, kar je treba upoštevati pri bolnikih, ki imajo sladkorno bolezen.
English: INFORMATION IN BRAILLE Zerit 15 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Zerit 15 mg
English: Patients with a high risk of pancreatitis or those receiving products known to be associated with pancreatitis should be closely followed for symptoms of this condition.
Slovenian: Skrbno je treba spremljati bolnike, ki jih pankreatitis posebno ogroža in tiste, ki jemljejo zdravila, ki lahko povzročajo pankreatitis.
English: 1 mg/kg twice daily (every 12 hours) adult dosing
Slovenian: 1 mg/kg dvakrat na dan (na 12 ur) odmerjanje je enako kot za odrasle
English: Each hard capsule contains 159.06 mg of lactose anhydrous.
Slovenian: Ena trda kapsula vsebuje 159,06 mg brezvodne laktoze.
English: Each hard capsule contains 121.09 mg of lactose anhydrous.
Slovenian: Ena trda kapsula vsebuje 121,09 mg brezvodne laktoze.
English: The active substance is stavudine (20 mg).
Slovenian: Zdravilna učinkovina je stavudin (20 mg).
English: OUTER CARTON TEXT AND BOTTLE LABEL TEXT
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI BESEDILO NA ŠKATLI IN NALEPKI ZA PLASTENKO
English: The active substance is stavudine (15 mg).
Slovenian: Zdravilna učinkovina je stavudin (15 mg).
English: Zerit 20 mg hard capsules Each hard capsule contains 20 mg of stavudine.
Slovenian: Zerit 20 mg trde kapsule Ena trda kapsula vsebuje 20 mg stavudina.
English: The hard capsule is brown, opaque and imprinted with “BMS” over a BMS code “1965” on one side and “20” on the other side.
Slovenian: Trda kapsula je rjava, neprozorna, z oznako "BMS" nad BMS kodo “1965” na eni strani in “20” na drugi strani.
English: Unchanged stavudine was the major drug-related component in total plasma radioactivity circulating after an oral 80 mg dose of 14C-stavudine in healthy subjects.
Slovenian: Pri zdravih prostovoljcih se je po peroralnem 80-mg odmerku z radioaktivnim izotopom 14C
English: The hard capsule is red and yellow, opaque and imprinted with “BMS” over a BMS code “1964” on one side and “15” on the other side.
Slovenian: Trda kapsula je rdeča in rumena, neprozorna, z oznako "BMS" nad BMS kodo “1964” na eni strani in “15” na drugi strani.
English: Weight and metabolic parameters: an increase in weight and in levels of blood lipids and glucose may occurr during antiretroviral therapy.
Slovenian: Telesna masa in presnovni parametri: Med protiretrovirusnim zdravljenjem se lahko poveča telesna masa ter zviša koncentracija lipidov in glukoze v krvi.
English: OUTER CARTON TEXT AND BOTTLE LABEL TEXT (BOTTLE PRESENTATION)
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI BESEDILO NA ŠKATLI IN NALEPKI ZA PLASTENKO (PAKIRANJE V PLASTENKI)
English: INFORMATION IN BRAILLE Zerit 20 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Zerit 20 mg
English: (range 61 to 1,215 cells/mm3) and a median plasma HIV-1 RNA of 4.80 log10 copies/ml (range 2.6 to 5.9 log 10 copies/ml) at baseline.
Slovenian: Srednja vrednost števila celic CD4 v izhodišču je bila 272 celic/mm3 (razpon od 61 do 1.215 celic/mm3), srednja vrednost HIV-1 RNA v plazmi pa 4,80 log10 kopij/ml (razpon 2,6 do 5,9 log 10 kopij/ml).
English: NAME OF THE MEDICINAL PRODUCT Zerit 200 mg powder for oral solution
Slovenian: IME ZDRAVILA Zerit 200 mg prašek za peroralno raztopino
English: Lipoatrophy was commonly reported in patients treated with stavudine in combination with other antiretrovirals (see section 4.4).
Slovenian: Pri bolnikih, ki so se zdravili s stavudinom v kombinaciji z drugimi protiretrovirusnimi zdravili, so pogosto poročali o lipoatrofiji (glejte poglavje 4.4).
English: Adolescents, children and infants over the age of 3 months: the recommended oral dosage is Patient weight Zerit dosage < 30 kg ≥ 30 kg
Slovenian: Mladostniki, otroci in dojenčki, starejši od treh mesecev: Priporočeno odmerjanje pri peroralni uporabi je
English: Zerit 15 mg hard capsules Each hard capsule contains 15 mg of stavudine.
Slovenian: Zerit 15 mg trde kapsule Ena trda kapsula vsebuje 15 mg stavudina.
English: Zerit 15 mg hard capsules
Slovenian: Zerit 15 mg trde kapsule
English: The hard capsule is light and dark orange, opaque and imprinted with “BMS” over a BMS code “1966” on one side and “30” on the other side.
Slovenian: Trda kapsula je svetlo in temno oranžna, neprozorna, z oznako "BMS" nad BMS kodo “1966” na eni strani in “30” na drugi strani.
English: The hard capsule is dark orange, opaque and imprinted with “BMS” over a BMS code “1967” on one side and “40” on the other side.
Slovenian: Trda kapsula je temno oranžna, neprozorna, z oznako "BMS" nad BMS kodo “1967” na eni strani in “40” na drugi strani.
English: The other ingredients of the powder contained in the hard capsule are: lactose (120 mg), magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
Slovenian: Pomožne snovi praška v trdih kapsulah so: laktoza (120 mg), magnezijev stearat, mikrokristalna celuloza in natrijev karboksimetilškrob.
English: You must contact your doctor to discuss the potential side effects and the benefits and risks of your antiretroviral therapy to you and your child. Lactic acidosis (sometimes fatal) has been reported in pregnant women who received Zerit in combination with other antiretroviral treatment.
Slovenian: Posvetujte se s svojim zdravnikom o možnih neželenih učinkih ter koristih in tveganjih protiretrovirusnega zdravljenja za vas in vašega otroka.
English: INFORMATION IN BRAILLE Zerit 40 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Zerit 40 mg
English: (range 63 to 962 cells/mm3) and a median plasma HIV-1 RNA of 4.63 log10 copies/ml (range 3.0 to 5.9 log10 copies/ml) at baseline.
Slovenian: Srednja vrednost števila celic CD4 v izhodišču je bila 261 celic/mm3 (razpon od 63 do 962 celic/mm3), srednja vrednost HIV-1 RNA v plazmi pa 4,63 log10 kopij/ml (razpon 3,0 do 5,9 log10 kopij/ml).
English: Each hard capsule contains 60.54 mg of lactose monohydrate.
Slovenian: Ena trda kapsula vsebuje 60,54 mg laktoze monohidrata.
English: The other ingredients of the powder contained in the hard capsule are: lactose (180 mg), magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
Slovenian: Pomožne snovi praška v trdih kapsulah so: laktoza (180 mg), magnezijev stearat, mikrokristalna celuloza in natrijev karboksimetilškrob.
English: Each hard capsule contains 121.30 mg of lactose anhydrous.
Slovenian: Ena trda kapsula vsebuje 121,30 mg brezvodne laktoze.
English: INFORMATION IN BRAILLE Zerit 30 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Zerit 30 mg
English: The powder formulation of Zerit should be used for infants under the age of 3 months.
Slovenian: Pri dojenčkih, mlajših od 3 mesecev, moramo uporabljati zdravilo Zerit v obliki praška.
English: The other ingredients of the powder contained in the hard capsule are: lactose (240 mg), magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
Slovenian: Pomožne snovi praška v trdih kapsulah so: laktoza (240 mg), magnezijev stearat, mikrokristalna celuloza in natrijev karboksimetilškrob.
English: Warnings and precautions Talk to your doctor before taking Zerit.
Slovenian: Pred začetkom jemanja zdravila Zerit se posvetujte z zdravnikom.
English: Replace the cap.
Slovenian: Namestite zaporko nazaj.
English: The active substance is stavudine (40 mg).
Slovenian: Zdravilna učinkovina je stavudin (40 mg).
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Bristol-Myers Squibb Pharma EEIG Plaza 254
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet z zdravilom: BRISTOL-MYERS SQUIBB PHARMA EEIG Plaza 254
English: The active substance is stavudine (30 mg).
Slovenian: Zdravilna učinkovina je stavudin (30 mg).
English: Zerit 40 mg hard capsules Each hard capsule contains 40 mg of stavudine.
Slovenian: Zerit 40 mg trde kapsule Ena trda kapsula vsebuje 40 mg stavudina.
English: Zerit 30 mg hard capsules Each hard capsule contains 30 mg of stavudine.
Slovenian: Zerit 30 mg trde kapsule Ena trda kapsula vsebuje 30 mg stavudina.
English: INFORMATION IN BRAILLE Outer carton: Zerit 15 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Zunanja ovojnina: Zerit 15 mg
English: INFORMATION IN BRAILLE Outer carton: Zerit 200 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Zunanja ovojnina: Zerit 200 mg
English: At least 14 days old and < 30 kg ≥ 30 kg
Slovenian: Odmerek zdravila Zerit od rojstva* do 13. dne starosti starost vsaj 14 dni in telesna masa < 30 kg ≥ 30 kg
English: Zerit 30 mg hard capsules
Slovenian: Zerit 30 mg trde kapsule
English: Zerit 15 mg hard capsules Stavudine
Slovenian: Zerit 15 mg trde kapsule stavudin
English: Zerit 20 mg hard capsules
Slovenian: Zerit 20 mg trde kapsule
English: MARKETING AUTHORISATION HOLDER Bristol-Myers Squibb Pharma EEIG Plaza 254
Slovenian: Imetnik dovoljenja za promet z zdravilom: BRISTOL-MYERS SQUIBB PHARMA EEIG Plaza 254
English: Zerit 40 mg hard capsules
Slovenian: Zerit 40 mg trde kapsule
English: In antiretroviral naive patients
Slovenian: Bolniki, ki se še niso zdravili s protiretrovirusnimi zdravili
English: Outer carton PC:
Slovenian: PC: {številka}
English: Zerit 20 mg hard capsules Stavudine
Slovenian: Zerit 20 mg trde kapsule stavudin
English: The activity of stavudine is also affected by multi-drug resistance associated mutations such as Q151M.
Slovenian: Na delovanje stavudina vpliva tudi odpornost proti več zdravilom, ki spremlja mutacije, kakršna je Q151 M. Razen tega pa so pri bolnikih, ki so prejemali stavudin/didanozin ali stavudin/lamivudin, poročali o mutaciji K65R.
English: INFORMATION IN BRAILLE Outer carton: Zerit 20 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Zunanja ovojnina: Zerit 20 mg
English: INFORMATION IN BRAILLE Outer carton: Zerit 30 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Zunanja ovojnina: Zerit 30 mg
English: How to store Zerit
Slovenian: Shranjevanje zdravila Zerit
English: INFORMATION IN BRAILLE Outer carton: Zerit 40 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Zunanja ovojnina: Zerit 40 mg
English: Iron oxide colorant (E172)
Slovenian: Ovojnica kapsule želatina železov oksid kot barvilo (E172) koloidni silicijev dioksid natrijev lavrilsulfat titanov dioksid (E171)
English: Off-white to pale-pink, gritty powder.
Slovenian: FARMACEVTSKA OBLIKA prašek za peroralno raztopino sivobel do bledo rožnat zrnat prašek
English: Zerit 30 mg hard capsules Stavudine
Slovenian: Zerit 30 mg trde kapsule stavudin
English: Zerit 40 mg hard capsules Stavudine
Slovenian: Zerit 40 mg trde kapsule stavudin
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/009/008
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/96/009/008
English: rare: anaemia* very rare: neutropenia *, thrombocytopenia*
Slovenian: Bolezni krvi in limfatičnega sistema redki: anemija* zelo redki: nevtropenija*, trombocitopenija*
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each bottle contains stavudine 200 mg The reconstituted solution contains 1 mg of stavudine per ml.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena plastenka vsebuje 200 mg stavudina.
English: NAME OF THE MEDICINAL PRODUCT Zerit 15 mg hard capsules
Slovenian: IME ZDRAVILA Zerit 15 mg trde kapsule stavudin
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 15 mg stavudine.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka trda kapsula vsebuje 15 mg stavudina.
English: The patients usually experienced resolution of symptoms after dose reduction or interruption of stavudine.
Slovenian: Po zmanjšanju odmerka ali prekinitvi uporabe stavudina so simptomi ponavadi izzveneli.
English: ANNEX II
Slovenian: Dublin 15
English: Metabolism and nutrition disorders:
Slovenian: Bolezni jeter, žolčnika in žolčevodov:
English: NAME OF THE MEDICINAL PRODUCT Zerit 20 mg hard capsules
Slovenian: IME ZDRAVILA Zerit 20 mg trde kapsule stavudin
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 20 mg stavudine.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka trda kapsula vsebuje 20 mg stavudina.
English: Zerit 20 mg hard capsules are supplied in blister packs of 56 hard capsules or bottles of 60 hard capsules.
Slovenian: Zerit 20 mg trde kapsule so na voljo v pretisnih omotih s po 56 trdih kapsul ali v plastenkah s po 60 trdih kapsul.
English: Before treatment with Zerit, you should have told your doctor: if you suffer from kidney disease or liver disease (such as hepatitis) if you have had peripheral neuropathy (persistent numbness, tingling, or pain in the feet and/or hands) if you have suffered from pancreatitis (inflammation of the pancreas).
Slovenian: če ste kdaj imeli periferno nevropatijo (trdovratna odrevenelost, mravljinčenje ali bolečine v stopalih in/ali dlaneh)
English: * Adverse reactions observed post-marketing in association with stavudine-containing antiretroviral treatment ** See Section Description of selected adverse reactions for more details.
Slovenian: * Neželeni učinki, opaženi po prihodu zdravila na tržišče, v povezavi s protiretrovirusnimi režimi zdravljenja, ki so vsebovali stavudin.
English: In clinical trials, switching from stavudine to other nucleosides (tenofovir or abacavir) resulted in increases in limb fat with modest to no improvements in clinical lipoatrophy.
Slovenian: V kliničnih preskušanjih je pri prehodu iz zdravljenja s stavudinom na zdravljenje z drugimi nukleozidi (tenofovir ali abakavir) prišlo do povečanja količine maščevja na okončinah, medtem ko se je klinična lipoatrofija izboljšala le malo ali pa sploh ne. Zaradi možnih tveganj pri uporabi zdravila Zerit, vključno z lipoatrofijo, je treba pri vsakem bolniku oceniti koristi in tveganja ter natančno razmisliti o uporabi drugih protiretrovirusnih zdravil.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/009/005
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/96/009/005
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 40 mg stavudine.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka trda kapsula vsebuje 40 mg stavudina.
English: Zerit 15 mg hard capsules are supplied in blister packs of 56 hard capsules or bottles of 60 hard capsules.
Slovenian: Zerit 15 mg trde kapsule so na voljo v pretisnih omotih s po 56 trdih kapsul ali v plastenkah s po 60 trdih kapsul.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/009/007
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/96/009/007
English: Zerit 40 mg hard capsules are supplied in blister packs of 56 hard capsules or bottles of 60 hard capsules.
Slovenian: Zerit 40 mg trde kapsule so na voljo v pretisnih omotih s po 56 trdih kapsul ali v plastenkah s po 60 trdih kapsul.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 30 mg stavudine.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka trda kapsula vsebuje 30 mg stavudina.
English: NAME OF THE MEDICINAL PRODUCT Zerit 30 mg hard capsules
Slovenian: IME ZDRAVILA Zerit 30 mg trde kapsule stavudin
English: Microcrystalline cellulose
Slovenian: Vsebina kapsule laktoza magnezijev stearat mikrokristalna celuloza natrijev karboksimetilškrob
English: Study AI455-096 was a 48-week, randomised, double-blind study with Zerit (40 mg twice daily), in combination with lamivudine (150 mg twice daily) plus efavirenz (600 mg once daily),
Slovenian: V 48-tedenski, randomizirani, dvojno slepi študiji (AI455-096) je 76 predhodno nezdravljenih bolnikov prejemalo zdravilo Zerit (40 mg dvakrat na dan) v kombinaciji z lamivudinom (150 mg dvakrat na dan) in efavirenzom (600 mg enkrat na dan).
English: 3) and a median plasma HIV-1 RNA of 4.63 log10 copies/ml (range 3.0 to 5.9 log10 copies/ml) at baseline.
Slovenian: 4,80 log10 kopij/ml (razpon 2,6 do 5,9 log 10 kopij/ml).
English: zidovudine, used to treat HIV infection doxorubicin, used to treat cancer ribavirin, used to treat hepatitis C infection
Slovenian: Obvestite svojega zdravnika, če jemljete katero koli od navedenih zdravil, saj se lahko pojavi neželeno medsebojno delovanje: zidovudin, ki se uporablja za zdravljenje okužbe s HIV doksorubicin, ki se uporablja za zdravljenje raka ribavirin, ki se uporablja za zdravljenje okužbe s hepatitisom C.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/009/004
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/96/009/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/009/006
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/96/009/006
English: Study AI455-096 was a 48-week, randomised, double-blind study with Zerit (40 mg twice daily), in combination with lamivudine (150 mg twice daily) plus efavirenz (600 mg once daily), in 76 treatment-naive patients, with a median CD4 cell count of 261 cells/mm3
Slovenian: V 48-tedenski, randomizirani, dvojno slepi študiji (AI455-096) je 76 predhodno nezdravljenih bolnikov prejemalo zdravilo Zerit (40 mg dvakrat na dan) v kombinaciji z lamivudinom (150 mg dvakrat na dan) in efavirenzem (600 mg enkrat na dan).
English: Study AI455-099 was a 48-week, randomised, double-blind study with Zerit (40 mg twice daily), in combination with lamivudine (150 mg twice daily) plus efavirenz (600 mg once daily), in 391 treatment-naive patients, with a median CD4 cell count of 272 cells/mm3
Slovenian: V 48-tedenski, randomizirani, dvojno slepi študiji (AI455-099) je 391 predhodno nezdravljenih bolnikov prejemalo zdravilo Zerit (40 mg dvakrat na dan) v kombinaciji z lamivudinom (150 mg dvakrat na dan) in efavirenzom (600 mg enkrat na dan).
English: Zerit 30 mg hard capsules are supplied in blister packs of 56 hard capsules or bottles of 60 hard capsules.
Slovenian: Zerit 30 mg trde kapsule so na voljo v pretisnih omotih s po 56 trdih kapsul ali v plastenkah s po 60 trdih kapsul.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/009/009
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/96/009/009
English: NAME OF THE MEDICINAL PRODUCT Zerit 40 mg hard capsules
Slovenian: IME ZDRAVILA Zerit 40 mg trde kapsule stavudin
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/009/003
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/96/009/003
English: A MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release Bristol-Myers Squibb S.r.l., Contrada Fontana del Ceraso, 03012 Anagni (FR), Italy Aesica Queenborough Limited, North Road, Queenborough, Kent, ME11 5EL, United Kingdom The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Slovenian: PRILOGA II A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: The recommended dose is one tablet taken twice a day.
Slovenian: Priporočeni odmerek je ena tableta, ki se jemlje dvakrat na dan.
English: Vokanamet must not be used in:
Slovenian: Zdravilo Vokanamet se ne sme uporabljati pri:
English: What measures are being taken to ensure the safe and effective use of Vokanamet?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vokanamet?
English: The dose of canagliflozin can then be increased if needed.
Slovenian: Odmerek kanagliflozina se nato po potrebi lahko poveča.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vokanamet on 23 April 2014.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Vokanamet, veljavno po vsej Evropski uniji, izdala 23. aprila 2014.
English: The full EPAR and risk management plan summary for Vokanamet 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) in povzetek načrta obvladovanja tveganj za zdravilo Vokanamet sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Vokanamet canagliflozin / metformin
Slovenian: Vokanamet kanagliflozin/metformin
English: Vokanamet contains two different active substances, which work in different ways:
Slovenian: Zdravilo Vokanamet vsebuje dve različni zdravilni učinkovini, ki delujeta na različna načina:
English: Other information about Vokanamet
Slovenian: Druge informacije o zdravilu Vokanamet
English: A risk management plan has been developed to ensure that Vokanamet is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Vokanamet je bil pripravljen načrt obvladovanja tveganj.
English: This is a summary of the European public assessment report (EPAR) for Vokanamet.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Vokanamet.
English: The tablet strength depends on the patient's treatment before starting Vokanamet.
Slovenian: Jakost tablete je odvisna od zdravljenja, ki ga je bolnik prejemal pred začetkom zdravljenja z zdravilom Vokanamet.
English: Canagliflozin as separate tablets has been authorised in the EU under the brand name Invokana since 15 November 2013.
Slovenian: Kanagliflozin v ločenih tabletah je odobren v EU od 15. novembra 2013 pod tržnim imenom Invokana;