FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, a lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycaemia when used in combination with Segluromet (see sections 4.2, 4.4, and 4.8).
Slovenian: Za zmanjšanje tveganja za hipoglikemijo bo zato v kombinaciji z zdravilom Segluromet morda potreben manjši odmerek insulina ali insulinskega sekretagoga (glejte poglavja 4.2, 4.4 in 4.8).
English: Coadministration of metformin with
Slovenian: Sočasna uporaba metformina z
English: There was, however, an increased incidence of benign stromal uterine polyps in female rats treated with 900 mg/kg/day.
Slovenian: Pri podganjih samicah, ki so prejemale 900 mg/kg/dan, je bila večja pojavnost benignih stromalnih materničnih polipov.
English: Diabetic ketoacidosis
Slovenian: Diabetična ketoacidoza (DKA)
English: INTERMEDIATE CARTON WITHOUT BLUE BOX - MULTIPACKS - SEGLUROMET 7.5 mg/850 mg
Slovenian: VMESNA ŠKATLA BREZ MODREGA OKENCA - MULTI PAKIRANJE - ZA ZDRAVILO SEGLUROMET 7,5 mg/850 mg
English: Segluromet 7.5 mg/1,000 mg film-coated tablets EU/1/18/1265/022
Slovenian: Segluromet 7,5 mg/1.000 mg filmsko obložene tablete EU/1/18/1265/022
English: INTERMEDIATE CARTON WITHOUT BLUE BOX - MULTIPACKS - SEGLUROMET 2.5 mg/850 mg
Slovenian: VMESNA ŠKATLA BREZ MODREGA OKENCA - MULTI PAKIRANJE - ZA ZDRAVILO SEGLUROMET 2,5 mg/850 mg
English: Consideration may also be given to stopping treatment with ertugliflozin/metformin in patients who develop events which may precede amputation such as lower-extremity skin ulcer, infection, osteomyelitis or gangrene.
Slovenian: Pri bolnikih, pri katerih se pojavijo dogodki, ki lahko vodijo do amputacije, kot so kožne razjede na spodnjih okončinah, okužba, osteomielitis ali gangrena, je treba razmisliti o prekinitvi zdravljenja z ertugliflozinom/metforminom.
English: Segluromet 2.5 mg/850 mg film-coated tablets EU/1/18/1265/001
Slovenian: Segluromet 2,5 mg/850 mg filmsko obložene tablete EU/1/18/1265/001
English: Except for emesis, there were no adverse toxicity findings in dogs at 379 times the human unbound exposure (AUC) at the MRHD of 15 mg/day.
Slovenian: Pri psih med izpostavljenostjo, ki je bila 379-kratnik izpostavljenosti nevezanemu zdravilu (AUC) pri človeku ob MRHD 15 mg/dan, razen bruhanja niso ugotovili neželenih toksičnih učinkov.
English: INTERMEDIATE CARTON WITHOUT BLUE BOX - MULTIPACKS - SEGLUROMET 7.5 mg/1000 mg
Slovenian: VMESNA ŠKATLA BREZ MODREGA OKENCA - MULTI PAKIRANJE - ZA ZDRAVILO SEGLUROMET 7,5 mg/1.000 mg
English: Segluromet 2.5 mg/1,000 mg film-coated tablets EU/1/18/1265/008
Slovenian: Segluromet 2,5 mg/1.000 mg filmsko obložene tablete EU/1/18/1265/008
English: Segluromet 7.5 mg/850 mg film-coated tablets EU/1/18/1265/015
Slovenian: Segluromet 7,5 mg/850 mg filmsko obložene tablete EU/1/18/1265/015
English: Do not drive or use any tools or machines if you feel dizzy while taking Segluromet.
Slovenian: Če se med jemanjem zdravila Segluromet počutite omotični, ne upravljajte vozil in ne uporabljajte nobenega orodja ali strojev.
English: The plasma protein binding of ertugliflozin was unaffected in patients with moderate hepatic impairment.
Slovenian: Pri bolnikih z zmerno okvaro jeter niso ugotovili vpliva na vezavo ertugliflozina na beljakovine v plazmi.
English: INTERMEDIATE CARTON WITHOUT BLUE BOX - MULTIPACKS - SEGLUROMET 2.5 mg/1000 mg
Slovenian: VMESNA ŠKATLA BREZ MODREGA OKENCA - MULTI PAKIRANJE - ZA ZDRAVILO SEGLUROMET 2,5 mg/1.000 mg
English: • stomach ache
Slovenian: • suha usta,
English: Each tablet contains 7.5 mg of ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1000 mg of metformin hydrochloride.
Slovenian: Ena tableta vsebuje 7,5 mg ertugliflozina (v obliki ertugliflozin L-piroglutaminske kisline) in 1.000 mg metforminijevega klorida.
English: Therefore, a lower dose of insulin or insulin secretagogue may be required to minimise the risk of hypoglycaemia when used in combination with Segluromet (see sections 4.2 and 4.5).
Slovenian: Da bi zmanjšali tveganje za hipoglikemijo, bo pri uporabi v kombinaciji z zdravilom Segluromet morda potreben manjši odmerek insulina ali insulinskega sekretagoga (glejte poglavji 4.2 in 4.5).
English: Skin and subcutaneous tissue disorders Very rare
Slovenian: Presnovne in prehranske motnje pogosti redki zelo redki hiperglikemija*
English: Each tablet contains 2.5 mg of ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1000 mg of metformin hydrochloride.
Slovenian: Ena tableta vsebuje 2,5 mg ertugliflozina (v obliki ertugliflozin L-piroglutaminske kisline) in 1.000 mg metforminijevega klorida.
English: Effects on bone (shorter femur length, increased trabecular bone in the femur) as well as effects of delayed puberty were observed at an exposure 817 times the MHRD of 15 mg/day based on AUC.
Slovenian: Pri izpostavljenosti, ki je bila na podlagi AUC 817-kratnik tiste ob MRHD 15 mg/dan, so opažali vplive na kosti (krajša dolžina stegnenice, povečana trabekularna kost stegnenice) in zapoznelo puberteto.
English: Dose-dependent increases in the amount of glucose excreted in urine were observed in healthy subjects and in patients with type 2 diabetes mellitus following single- and multiple-dose administration of ertugliflozin.
Slovenian: Pri zdravih osebah in bolnikih s sladkorno boleznijo tipa 2 so po uporabi enega ali več odmerkov ertugliflozina opažali od odmerka odvisno povečanje količine v urinu izločene glukoze.
English: Change from baseline (LS mean
Slovenian: Sprememba od izhodišča (povprečje LS
English: • stomach pain
Slovenian: • bolečine v trebuhu,
English: o Each Segluromet 2.5 mg/850 mg film-coated tablet contains 2.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 850 mg of metformin hydrochloride.
Slovenian: o Ena filmsko obložena tableta (tableta) zdravila Segluromet 2,5 mg/850 mg vsebuje 2,5 mg ertugliflozina (v obliki ertugliflozin L-piroglutaminske kisline) in 850 mg metforminijevega klorida.
English: Ertugliflozin 15 mg + Sitagliptin 100 mg
Slovenian: ertugliflozin 5 mg ertugliflozin 15 mg sitagliptin 100 mg ertugliflozin 5 mg + sitagliptin 100 mg ertugliflozin 15 mg + sitagliptin 100 mg
English: Segluromet 7.5 mg/1000 mg tablets ertugliflozin/metformin hydrochloride
Slovenian: Segluromet 7,5 mg/1000 mg tablete ertugliflozin/metforminijev klorid
English: Segluromet 2.5 mg/850 mg tablets ertugliflozin/metformin hydrochloride
Slovenian: Segluromet 2,5 mg/850 mg tablete ertugliflozin/metforminijev klorid
English: Segluromet 7.5 mg/850 mg tablets ertugliflozin/metformin hydrochloride
Slovenian: Segluromet 7,5 mg/850 mg tablete ertugliflozin/metforminijev klorid
English: Each tablet contains 7.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 850 mg metformin hydrochloride.
Slovenian: Ena tableta vsebuje 7,5 mg ertugliflozina (v obliki ertugliflozin L-piroglutaminske kisline) in 850 mg metforminijevega klorida.
English: Segluromet 7.5 mg/1,000 mg film-coated tablets Each tablet contains 7.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1,000 mg metformin hydrochloride.
Slovenian: Segluromet 7,5 mg/1.000 mg filmsko obložene tablete Ena tableta vsebuje 7,5 mg ertugliflozina (v obliki ertugliflozin L-piroglutaminske kisline) in 1.000 mg metforminijevega klorida.
English: o Each Segluromet 7.5 mg/850 mg film-coated tablet contains 7.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 850 mg of metformin hydrochloride.
Slovenian: o Ena filmsko obložena tableta (tableta) zdravila Segluromet 7,5 mg/850 mg vsebuje 7,5 mg ertugliflozina (v obliki ertugliflozin L-piroglutaminske kisline) in 850 mg metforminijevega klorida.
English: Each tablet contains 2.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 850 mg of metformin hydrochloride.
Slovenian: Ena tableta vsebuje 2,5 mg ertugliflozina (v obliki ertugliflozin L-piroglutaminske kisline) in 850 mg metforminijevega klorida.
English: Segluromet 2.5 mg/1,000 mg film-coated tablets Each tablet contains 2.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1,000 mg of metformin hydrochloride.
Slovenian: Segluromet 2,5 mg/1.000 mg filmsko obložene tablete Ena tableta vsebuje 2,5 mg ertugliflozina (v obliki ertugliflozin L-piroglutaminske kisline) in 1.000 mg metforminijevega klorida.
English: Segluromet 2.5 mg/1000 mg tablets ertugliflozin/metformin hydrochloride
Slovenian: Segluromet 2,5 mg/1000 mg tablete ertugliflozin/metforminijev klorid
English: Talk to your doctor, pharmacist, or nurse before and while taking Segluromet, if you:
Slovenian: Pred začetkom jemanja zdravila Segluromet in med njegovim jemanjem se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: EU/1/18/1265/022 (14 film-coated tablets) EU/1/18/1265/023 (28 film-coated tablets) EU/1/18/1265/024 (30x1 film-coated tablets) EU/1/18/1265/025 (56 film-coated tablets) EU/1/18/1265/026 (60 film-coated tablets) EU/1/18/1265/027 (168 film-coated tablets) EU/1/18/1265/028 (180 film-coated tablets) EU/1/18/1265/032 (196 (4 x 49) film-coated tablets)
Slovenian: EU/1/18/1265/022 (14 filmsko obloženih tablet) EU/1/18/1265/023 (28 filmsko obloženih tablet) EU/1/18/1265/024 (30 x 1 filmsko obložena tableta) EU/1/18/1265/025 (56 filmsko obloženih tablet) EU/1/18/1265/026 (60 filmsko obloženih tablet) EU/1/18/1265/027 (168 filmsko obloženih tablet) EU/1/18/1265/028 (180 filmsko obloženih tablet) EU/1/18/1265/032 (196 (4 x 49) filmsko obloženih tablet)
English: Change from baseline (LS mean Difference from placebo (LS mean
Slovenian: Razlika v primerjavi s placebom (povprečje LS
English: Renal-related adverse reactions (e.g., acute kidney injury, renal impairment, acute prerenal failure) may occur in patients treated with ertugliflozin, particularly in patients with moderate renal impairment where the incidence of renal-related adverse reactions was 2.5%, 1.3%, and 0.6% in patients treated with ertugliflozin 5 mg, ertugliflozin 15 mg, and placebo, respectively.
Slovenian: To velja zlasti za bolnike z zmerno okvaro ledvic, pri katerih je bila pojavnost z ledvicami povezanih neželenih učinkov za 5 mg ertugliflozina 2,5 %, za 15 mg ertugliflozina 1,3 % in za placebo 0,6 %.
English: Segluromet 7.5 mg/1000 mg film-coated tablets ertugliflozin/metformin hydrochloride
Slovenian: Segluromet 7,5 mg/1000 mg filmsko obložene tablete ertugliflozin/metforminijev klorid
English: EU/1/18/1265/008 (14 film-coated tablets) EU/1/18/1265/009 (28 film-coated tablets) EU/1/18/1265/010 (30x1 film-coated tablets) EU/1/18/1265/011 (56 film-coated tablets) EU/1/18/1265/012 (60 film-coated tablets) EU/1/18/1265/013 (168 film-coated tablets) EU/1/18/1265/014 (180 film-coated tablets) EU/1/18/1265/030 (196 (4 x 49) film-coated tablets)
Slovenian: EU/1/18/1265/008 (14 filmsko obloženih tablet) EU/1/18/1265/009 (28 filmsko obloženih tablet) EU/1/18/1265/010 (30 x 1 filmsko obložena tableta) EU/1/18/1265/011 (56 filmsko obloženih tablet) EU/1/18/1265/012 (60 filmsko obloženih tablet) EU/1/18/1265/013 (168 filmsko obloženih tablet) EU/1/18/1265/014 (180 filmsko obloženih tablet) EU/1/18/1265/030 (196 (4 x 49) filmsko obloženih tablet)
English: Segluromet 7.5 mg/850 mg film-coated tablets ertugliflozin/metformin hydrochloride
Slovenian: Segluromet 7,5 mg/850 mg filmsko obložene tablete ertugliflozin/metforminijev klorid
English: Segluromet 2.5 mg/1000 mg film-coated tablets ertugliflozin/metformin hydrochloride
Slovenian: Segluromet 2,5 mg/1000 mg filmsko obložene tablete ertugliflozin/metforminijev klorid
English: Segluromet 2.5 mg/850 mg film-coated tablets ertugliflozin/metformin hydrochloride
Slovenian: Segluromet 2,5 mg/850 mg filmsko obložene tablete ertugliflozin/metforminijev klorid
English: Monitor for signs and symptoms after initiating therapy.
Slovenian: Po uvedbi zdravljenja spremljajte znake in simptome.
English: EU/1/18/1265/015 (14 film-coated tablets) EU/1/18/1265/016 (28 film-coated tablets) EU/1/18/1265/017 (30x1 film-coated tablets) EU/1/18/1265/018 (56 film-coated tablets) EU/1/18/1265/019 (60 film-coated tablets) EU/1/18/1265/020 (168 film-coated tablets) EU/1/18/1265/021 (180 film-coated tablets) EU/1/18/1265/031 (196 (4 x 49) film-coated tablets)
Slovenian: EU/1/18/1265/015 (14 filmsko obloženih tablet) EU/1/18/1265/016 (28 filmsko obloženih tablet) EU/1/18/1265/017 (30 x 1 filmsko obložena tableta) EU/1/18/1265/018 (56 filmsko obloženih tablet) EU/1/18/1265/019 (60 filmsko obloženih tablet) EU/1/18/1265/020 (168 filmsko obloženih tablet) EU/1/18/1265/021 (180 filmsko obloženih tablet) EU/1/18/1265/031 (196 (4 x 49) filmsko obloženih tablet)
English: EU/1/18/1265/001 (14 film-coated tablets) EU/1/18/1265/002 (28 film-coated tablets) EU/1/18/1265/003 (30x1 film-coated tablets) EU/1/18/1265/004 (56 film-coated tablets) EU/1/18/1265/005 (60 film-coated tablets) EU/1/18/1265/006 (168 film-coated tablets) EU/1/18/1265/007 (180 film-coated tablets) EU/1/18/1265/029 (196 (4 x 49) film-coated tablets)
Slovenian: EU/1/18/1265/001 (14 filmsko obloženih tablet) EU/1/18/1265/002 (28 filmsko obloženih tablet) EU/1/18/1265/003 (30 x 1 filmsko obložena tableta) EU/1/18/1265/004 (56 filmsko obloženih tablet) EU/1/18/1265/005 (60 filmsko obloženih tablet) EU/1/18/1265/006 (168 filmsko obloženih tablet) EU/1/18/1265/007 (180 filmsko obloženih tablet) EU/1/18/1265/029 (196 (4 x 49) filmsko obloženih tablet)
English: How to store Segluromet
Slovenian: Shranjevanje zdravila Segluromet
English: o Each Segluromet 7.5 mg/1,000 mg film-coated tablet contains 7.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1,000 mg of metformin hydrochloride.
Slovenian: o Ena filmsko obložena tableta (tableta) zdravila Segluromet 7,5 mg/1.000 mg vsebuje 7,5 mg ertugliflozina (v obliki ertugliflozin L-piroglutaminske kisline) in 1.000 mg metforminijevega klorida.
English: OUTER CARTON FOR SEGLUROMET 2.5 mg/850 mg
Slovenian: ZUNANJA ŠKATLA ZA ZDRAVILO SEGLUROMET 2,5 mg/850 mg
English: General disorders and administration site conditions Common
Slovenian: Splošne težave in spremembe na mestu aplikacije pogosti žeja
English: OUTER CARTON FOR SEGLUROMET 7.5 mg/850 mg
Slovenian: ZUNANJA ŠKATLA ZA ZDRAVILO SEGLUROMET 7,5 mg/850 mg
English: o Each Segluromet 2.5 mg/1,000 mg film-coated tablet contains 2.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1,000 mg of metformin hydrochloride.
Slovenian: o Ena filmsko obložena tableta (tableta) zdravila Segluromet 2,5 mg/1.000 mg vsebuje 2,5 mg ertugliflozina (v obliki ertugliflozin L-piroglutaminske kisline) in 1.000 mg metforminijevega klorida.
English: OUTER CARTON FOR SEGLUROMET 2.5 mg/1000 mg
Slovenian: ZUNANJA ŠKATLA ZA ZDRAVILO SEGLUROMET 2,5 mg/1.000 mg
English: Genital mycotic infections
Slovenian: Glivične okužbe spolovil
English: OUTER CARTON FOR SEGLUROMET 7.5 mg/1000 mg
Slovenian: ZUNANJA ŠKATLA ZA ZDRAVILO SEGLUROMET 7,5 mg/1.000 mg
English: N = 248 N = 247
Slovenian: n = 248
English: • feeling sick (nausea)
Slovenian: • občutek slabosti (siljenje na bruhanje),
English: Dark brown, 18 x 10 mm oval, film-coated tablet debossed with “7.5/850” on one side and plain on the other side.
Slovenian: Segluromet 7,5 mg/850 mg filmsko obložene tablete temno rjava, ovalna, filmsko obložena tableta, velikosti 18 x 10 mm, na eni strani z vtisnjeno oznako "7.5/850" in brez oznake na drugi strani
English: Red, 19.1 x 10.6 mm oval, film-coated tablet debossed with “7.5/1000” on one side and plain on the other side.
Slovenian: Segluromet 7,5 mg/1.000 mg filmsko obložene tablete rdeča, ovalna, filmsko obložena tableta, velikosti 19,1 x 10,6 mm, na eni strani z vtisnjeno oznako "7.5/1000" in brez oznake na drugi strani
English: • dry mouth
Slovenian: • srbenje nožnice,
English: You should not use Segluromet if you are breast-feeding.
Slovenian: Če dojite, ne uporabljajte zdravila Segluromet.
English: Pink, 19.1 x 10.6 mm oval, film-coated tablet debossed with “2.5/1000” on one side and plain on the other side.
Slovenian: Segluromet 2,5 mg/1.000 mg filmsko obložene tablete rožnata, ovalna, filmsko obložena tableta, velikosti 19,1 x 10,6 mm, na eni strani z vtisnjeno oznako "2.5/1000" in brez oznake na drugi strani
English: Segluromet
Slovenian: Odmerjanje
English: Epivir lamivudine
Slovenian: Epivir lamivudin
English: The European Commission granted a marketing authorisation valid throughout the European Union for Epivir on 8 August 1996.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Epivir, veljavno po vsej Evropski uniji, izdala 8. avgusta 1996.
English: The study measured how long the patients lived without their disease getting worse.
Slovenian: V njej so opazovali, kako dolgo so bolniki živeli, ne da bi se bolezen poslabšala.
English: The combination also reduced viral loads in all studies after two to four weeks of treatment, but this effect was temporary.
Slovenian: Kombinacija je v vseh študijah po dveh do štirih tednih zdravljenja zmanjšala tudi virusno obremenitev, vendar pa je bil ta učinek le začasen.
English: The full EPAR for Epivir 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 Epivir je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Similar results were seen in HIV-infected patients aged under 15 years.
Slovenian: Podobni rezultati so bili opaženi pri bolnikih, mlajših od 15 let.
English: It is available as tablets (150 and 300 mg) and as an oral solution (10 mg/ml).
Slovenian: Na voljo je v obliki tablet (150 in 300 mg) in peroralne raztopine (10 mg/ml).
English: The recommended dose of Epivir for adults and children weighing at least 25 kg is 300 mg a day.
Slovenian: Priporočeni odmerek zdravila Epivir za odrasle in otroke, ki tehtajo vsaj 25 kg, je 300 mg na dan.
English: What measures are being taken to ensure the safe and effective use of Epivir?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Epivir?
English: This can be taken either as a single daily dose or divided into 150 mg twice a day.
Slovenian: Ta odmerek se lahko vzame naenkrat ali razdeli na dva 150-miligramska odmerka dvakrat na dan.
English: This document is a summary of the European Public Assessment Report (EPAR) for Epivir.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Epivir.
English: Epivir has also been studied in 615 patients aged between nine months and 15 years.
Slovenian: Zdravilo Epivir so proučevali tudi pri 615 bolnikih, starih od devet mesecev do 15 let.
English: Other information about Epivir
Slovenian: Druge informacije o zdravilu Epivir
English: A risk management plan has been developed to ensure that Epivir is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Epivir je bil pripravljen načrt obvladovanja tveganj.
English: This study looked at how many patients had developed an illness associated with AIDS or had died after a year's treatment.
Slovenian: V tej študiji so proučevali, pri koliko bolnikih se je razvila bolezen, povezana z aidsom, ali koliko jih je umrlo po enoletnem zdravljenju.
English: The CHMP decided that Epivir's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Epivir večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: In the fifth adult study, adding Epivir to existing treatment reduced the risk of disease progression or death: after a year, 9% of the patients taking Epivir had developed an AIDS-related illness or died (128 out of 1,369), compared with 20% of those taking placebo (95 out of 471).
Slovenian: V peti študiji pri odraslih je dodajanje zdravila Epivir obstoječemu zdravljenju zmanjšalo tveganje poslabšanja bolezni ali smrti: po enem letu se je pri 9 % bolnikov, ki so jemali zdravilo Epivir, razvila bolezen, povezana z aidsom, ali pa so ti umrli (128 od 1 369), v primerjavi z 20 % tistih, ki so jemali placebo (95 od 471).
English: In children weighing less than 25 kg the recommended dose depends on their weight.
Slovenian: Pri otrocih, ki tehtajo manj kot 25 kg, je priporočeni odmerek odvisen od telesne mase.
English: All of the studies found that combinations including Epivir were more effective than the comparator medicines.
Slovenian: V vseh študijah so ugotovili, da so bile kombinacije z zdravilom Epivir učinkovitejše od primerjalnih zdravil.
English: Epivir has been studied in five main studies involving almost 3,000 adults (aged 18 years or over).
Slovenian: Zdravilo Epivir so proučevali v petih glavnih študijah, v katere je bilo vključenih skoraj 3 000 odraslih (starejših od 18 let).
English: For more information about treatment with Epivir, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Epivir preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The most common side effects with Epivir (seen in between 1 and 10 patients in 100) are diarrhoea, nausea (feeling sick), vomiting, headache, insomnia (difficulty sleeping), cough, nasal symptoms, rash, muscle disorders, arthralgia (joint pain), alopecia (hair loss), fever, abdominal pain (stomach ache) or cramps, malaise (feeling unwell) and fatigue (tiredness).
Slovenian: Najpogostejši neželeni učinki zdravila Epivir (opaženi pri 1 do 10 bolnikih izmed 100) so driska, slabost, bruhanje, glavobol, nespečnost (težave s spanjem), kašelj, nazalni simptomi, izpuščaji, mišična obolenja, artralgija (bolečine v sklepih), alopecija (izpadanje las), povišana telesna temperatura, bolečine ali krči v trebuhu, neugodje (slabo počutje) in utrujenost.
English: Epivir, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Slovenian: Zdravilo Epivir, uporabljeno v kombinaciji z drugimi protivirusnimi zdravili, zmanjša količino virusa HIV v krvi in jo ohranja na nizki ravni.
English: CD4 T-cells are white blood cells that are important in helping to fight infections, but which are killed by HIV.
Slovenian: T-celice CD4 so bele krvničke, ki so pomembne za obrambo pred okužbami, vendar pa jih virus HIV uničuje.
English: Treatment with Epivir should be started by a doctor who has experience in the management of HIV infection.
Slovenian: Zdravljenje z zdravilom Epivir mora uvesti zdravnik, ki ima izkušnje z zdravljenjem okužb z virusom HIV.
English: Patients who cannot swallow tablets should use the oral solution, or alternatively they may crush the tablets and add them to a small amount of food or drink immediately before swallowing it.
Slovenian: Bolniki, ki ne morejo pogoltniti celih tablet, naj uporabijo peroralno raztopino ali pa naj tablete zdrobijo in jih tik pred zaužitjem zmešajo z majhno količino hrane ali pijače.
English: Epivir is a medicine containing the active substance lamivudine.
Slovenian: Epivir je zdravilo, ki vsebuje zdravilno učinkovino lamivudin.
English: The studies examined the effects of Epivir on the levels of HIV in the blood (viral load) and the number of CD4 T-cells in the blood (CD4 cell count).
Slovenian: V študijah so proučevali učinke zdravila Epivir na ravni virusa HIV v krvi (virusno obremenitev) in število T-celic CD4 v krvi (število celic CD4).
English: What benefit has Epivir shown during the studies?
Slovenian: Kakšne koristi je zdravilo Epivir izkazalo med študijami?
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 Epivir.
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.