FrancophonIA/ELRC3.0 huggingface dataset:
English: 1Day 7/14 corresponding to 1 or 2 weeks after the first IMVANEX dose (analysis time point at Day 7 only in studies POXMVA-008 and POX-MVA-011; POX-MVA-005 had the first post vaccination analysis at Day 14); Day 28 corresponding to 4 weeks after the first IMVANEX dose; Day 42 corresponding to 2 weeks following the second dose of IMVANEX;
Slovenian: 1Dan 7/14 ustreza 1 ali 2 tednoma po prvem odmerku cepiva IMVANEX (časovna točka za analizo na 7. dan samo v študijah POX-MVA-008 in POX-MVA-011; za POX-MVA-005 je bila prva študija po cepljenju opravljena na 14. dan); 28. dan ustreza 4 tednom po prvem odmerku cepiva IMVANEX; 42. dan ustreza 2 tednoma po drugem odmerku cepiva IMVANEX; SCR = stopnja serokonverzije; 2 celotna množica za analizo (FAS, Full Analysis Set) (za POX-MVA-013: množica za analizo imunogenosti; IAS); 3 množica za analizo po protokolu (PPS, Per Protocol Analysis Set), 4 stopnje seropositivnosti, 5 vzorec za imunogenost ni bil odvzet, 6 kombinirano skupine 1-3.
English: Study status N SCR % SCR % (95% CI)
Slovenian: N SCR % SCR % (95-% IZ)
English: • diarrhoea, vomiting, abdominal pain, dry mouth,
Slovenian: • driska, bruhanje, bolečine v trebuhu, suha usta
English: 2 years at -20°C +/-5°C
Slovenian: 2 leti pri -20 °C +/-5 °C 5 leta pri -50 °C +/-10 °C
English: Muscle spasms Musculoskeletal pain Muscular weakness
Slovenian: Bolezni mišično skeletnega sistema in vezivnega tkiva mialgija bolečine v okončinah artralgija mišično-skeletna togost bolečine v hrbtu bolečine v vratu mišični spazmi mišično-skeletne bolečine mišična šibkost
English: ELISA S+ % GMT
Slovenian: Dan 141 ELISA S+ % GMT S+ % GMT S+ % GMT
English: Body temperature increased Pyrexia
Slovenian: • povečana telesna temperatura
English: If you miss a scheduled injection, tell your doctor or nurse and arrange another visit.
Slovenian: Če ste se pozabili cepiti s cepivom IMVANEX Če pozabite na načrtovano injiciranje, se z zdravnikom ali medicinsko sestro dogovorite za drugi termin.
English: Bavarian Nordic A/S Hejreskovvej 10a DK-3490 Kvistgaard Denmark
Slovenian: Hejreskovvej 10a DK-3490 Kvistgaard
English: Diarrhoea Vomiting Abdominal Pain Dry mouth
Slovenian: Bolezni prebavil navzea driska bruhanje bolečina v trebuhu suha usta
English: • drowsiness,
Slovenian: • zaspanost
English: Dizziness Paresthesia
Slovenian: • vnetje očesne veznice
English: N SCR % (95% CI)
Slovenian: N SCR % (95-% IZ)
English: SCR % (95% CI)
Slovenian: SCR % (95-% IZ)
English: • rash, numbness, dryness, movement impairment, vesicles at the injection site,
Slovenian: • izpuščaj, odrevenelost, izsušitev, zmanjšana gibljivost, mehurji na mestu injiciranja
English: • muscle weakness,
Slovenian: • mišična šibkost
English: Booster Dose
Slovenian: Poživitveni odmerek
English: PHARMACEUTICAL FORM AND CONTENTS
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA suspenzija za injiciranje
English: OTHER
Slovenian: AD
English: • rash, itch, skin inflammation, skin discolouration,
Slovenian: • izpuščaj, srbečica, vnetje kože, obarvanje kože
English: Talk to your doctor or nurse before receiving IMVANEX:
Slovenian: Preden boste cepljeni s cepivom IMVANEX, se posvetujte z zdravnikom ali medicinsko sestro:
English: Exp. (-20°C +/-5°C): Exp. (-50°C +/-10°C): Exp. (-80°C +/-10°C):
Slovenian: EXP (-80 °C +/-10 °C):
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi trometamol natrijev klorid voda za injekcije
English: GENERAL CLASSIFICATION FOR SUPPLY
Slovenian: POSTOPEK UPORABE subkutana uporaba
English: Nasopharyngitis Upper respiratory tract infection
Slovenian: Infekcijske in parazitske bolezni nazofaringitis okužbe zgornjih dihal sinusitis konjunktivitis influenca
English: No case of overdose has been reported.
Slovenian: 4.9 Preveliko odmerjanje Ni poročil o primerih prevelikega odmerjanja.
English: Migraine
Slovenian: • glavobol
English: Lymphadenopathy
Slovenian: • mrzlica
English: • pain, redness, swelling, hardness or itching at the injection site.
Slovenian: • bolečina, rdečina, oteklina, otrdlina ali srbečica na mestu injiciranja
English: Package leaflet: Information for the user IMVANEX suspension for injection
Slovenian: IME ZDRAVILA IN POT(I) UPORABE IMVANEX suspenzija za injiciranje cepivo proti črnim kozam
English: Name and address of the manufacturer(s) of the biological active substance(s) Bavarian Nordic A/S
Slovenian: Ime in naslov izdelovalca (izdelovalcev) biološke zdravilne učinkovine (zdravilnih učinkovin)
English: • aching muscles,
Slovenian: • bolečine v mišicah
English: Cough
Slovenian: GMT
English: Bavarian Nordic A/S Hejreskovvej 10a 3490 Kvistgaard Denmark
Slovenian: Hejreskovvej 10A 3490 Kvistgaard
English: • feeling sick,
Slovenian: Ušesne bolezni,
English: (≥1/10,000 to swelling Injection site induration Injection site pruritus Fatigue
Slovenian: (≥1/10.000 do mestu injiciranja oteklina na mestu injiciranja induracija na mestu injiciranja pruritus na mestu injiciranja utrujenost injiciranja hematom na mestu injiciranja vroč občutek na mestu injiciranja draženje na mestu injiciranja pordevanje bolečina v prsnem košu aksilarna bolečina eksfoliacija na mestu injiciranja vnetje na mestu injiciranja parestezija na mestu injiciranja reakcija na mestu injiciranja anestezija na mestu injiciranja suh občutek na mestu injiciranja zmanjšana gibljivost na mestu injiciranja gripi podobna bolezen vezikule na mestu injiciranja
English: • dizziness
Slovenian: • modrice
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora faringolaringealna bolečina rinitis kašelj
English: • nose and throat infection, upper respiratory tract infection,
Slovenian: • otekanje obraza, ust in žrela • povečanje števila belih krvničk
English: Injection site inflammation Injection site paraesthesia Injection site reaction movement impairment Influenza like illness Injection site vesicles
Slovenian: Splošne težave in spremembe na mestu aplikacije bolečina na mestu injiciranja eritem na rigor/mrzlica nodul na mestu injiciranja obarvanje mesta oteklina pod pazduho splošno slabo počutje krvavitev na mestu injiciranja izpuščaj na mestu injiciranja periferni edem astenija
English: • abnormal sleep,
Slovenian: • otekle bezgavke • nenormalno spanje
English: Sleep disorder
Slovenian: Psihiatrične motnje motnje spanja
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Pred uporabo počakajte, da doseže cepivo sobno temperaturo.
English: 3490 Kvistgaard
Slovenian: Hejreskovvej 10a 3490 Kvistgaard
English: Metabolism and nutrition disorders
Slovenian: Presnovne in prehranske motnje motnje apetita
English: • muscle pain,
Slovenian: • mišična bolečina
English: The marketing authorisation was renewed on 5 August 2003 and on 5 August 2008.
Slovenian: Dovoljenje za promet z zdravilom je bilo obnovljeno 5. avgusta 2003 in 5. avgusta 2008.
English: Other information about Optruma:
Slovenian: Druge informacije o zdravilu Optruma:
English: Optruma should not be used in women who:
Slovenian: Zdravila Optruma ne smejo uporabljati ženske, ki:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Optruma to Eli Lilly Nederland B.V. on 5 August 1998.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Optruma, veljavno po vsej Evropski uniji, odobrila družbi Eli Lilly Nederland B.V.
English: What benefit has Optruma shown during the studies?
Slovenian: Kakšne koristi je zdravilo Optruma izkazalo med študijami?
English: The Committee recommended that Optruma be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Optruma odobri dovoljenje za promet.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) OPTRUMA EPAR summary for the public
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) OPTRUMA Povzetek EPAR za javnost
English: The main measure of effectiveness was how many women had vertebral (spine) fractures during the study.
Slovenian: Glavno merilo učinkovitosti je bilo število žensk, ki so med študijo doživele zlom vretenc (hrbtenice).
English: What is the risk associated with Optruma?
Slovenian: Kakšna tveganja so povezana z zdravilom Optruma?
English: Optruma should not be used in people who may be hypersensitive (allergic) to raloxifene or any of the other ingredients.
Slovenian: Zdravila Optruma ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) raloksifen ali katero koli drugo sestavino zdravila.
English: The most common side effects with Optruma (seen in more than 1 patient in 10) are vasodilation (hot flushes) and flu-like symptoms.
Slovenian: Najpogostejši stranski učinki pri uporabi zdravila Optruma (opaženi pri več kot 1 bolnici od 10 ) so razširitev krvnih žil (navali vročine) in gripi podobni simptomi.
English: Optruma is a medicine containing the active substance raloxifene hydrochloride.
Slovenian: Optruma je zdravilo, ki vsebuje zdravilno učinkovino raloksifenijev hidroklorid.
English: • have liver disease, severe kidney disease, unexplained bleeding from the womb or endometrial cancer (cancer of the lining of the womb).
Slovenian: • imajo obolenje jeter ali hudo obolenje ledvic, nepojasnjene krvavitve iz maternice ali rak endometrija (rak maternične sluznice).
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that Optruma had shown its effectiveness in preventing and treating osteoporosis, and had no effects on the breast or womb.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je zdravilo Optruma izkazalo svojo učinkovitost pri preprečevanju in zdravljenju osteoporoze, na prsi ali maternico pa ni imelo učinka.
English: Raloxifene has the same effect as oestrogen in the bone, but it does not have an effect in the breast or the womb.
Slovenian: Raloksifen ima v kosteh enak učinek kot estrogen, nima pa učinka na prsi ali maternico.
English: Patients may also receive calcium and vitamin D supplements if they do not get enough from their diet. Optruma is intended for long-term use.
Slovenian: Bolnice lahko po potrebi jemljejo tudi kalcij in vitamin D, če ju ne dobivajo dovolj s prehrano.
English: Over four years, in comparison with placebo, Optruma decreased the number of new vertebral fractures by 46% in women who had osteoporosis and by 32% in women who had osteoporosis and an existing fracture.
Slovenian: Med štiriletnim zdravljenjem je zdravilo Optruma v primerjavi s placebom zmanjšalo število novih zlomov vretenc za 46 % pri ženskah z osteoporozo in za 32 % pri ženskah z osteoporozo in že obstoječim zlomom kosti.
English: The active substance in Optruma, raloxifene, is a selective oestrogen receptor modulator (SERM).
Slovenian: Zdravilna učinkovina zdravila Optruma, raloksifen, je selektivni modulator estrogenskih receptorjev (SERM).
English: The fourth study compared the effects of Optruma with those of placebo in the treatment of osteoporosis in 7,705 women over four years.
Slovenian: Četrta študija je trajala štiri leta, v njej pa so primerjali učinke zdravila Optruma z učinki placeba pri zdravljenju osteoporoze pri 7705 ženskah.
English: Optruma was more effective than placebo in preventing and treating osteoporosis.
Slovenian: Zdravilo Optruma je bilo učinkovitejše od placeba pri preprečevanju in zdravljenju osteoporoze.
English: Raloxifene acts as an ‘agonist' of the oestrogen receptor (a substance that stimulates the receptor for oestrogen) in some tissues in the body.
Slovenian: Raloksifen deluje kot agonist receptorjev estrogena (snov, ki stimulira receptorje za estrogen) v nekaterih telesnih tkivih.
English: Three studies looked at the prevention of osteoporosis in 1,764 women, who took either Optruma or placebo (a dummy treatment) for two years.
Slovenian: V treh študijah preprečevanja osteoporoze je sodelovalo 1764 žensk, ki so dve leti jemale bodisi zdravilo Optruma ali placebo (zdravilo brez zdravilne učinkovine).
English: Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall: oestrogen slows down bone breakdown and makes the bones less likely to fracture.
Slovenian: Osteoporoza je pogostejša pri ženskah v obdobju po menopavzi, ko upade količina ženskega hormona estrogena: ta upočasni razgradnjo kosti, zato se kosti ne zlomijo tako hitro.
English: Optruma is used for the treatment and prevention of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause.
Slovenian: Zdravilo Optruma se uporablja za zdravljenje in preprečevanje osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah po menopavzi.
English: In the prevention of osteoporosis, women receiving Optruma had an increase in bone density in the hip or spine of 1.6% over two years, and those receiving placebo had a decrease of 0.8%.
Slovenian: Pri preprečevanju osteoporoze se je pri ženskah, ki so prejemale zdravilo Optruma, v dveh letih gostota kosti v kolkih ali hrbtenici povečala za 1,6 %, pri tistih, ki so prejemale placebo, pa se je zmanjšala za 0,8 %.
English: Optruma has been studied in the treatment and in the prevention of osteoporosis in four main studies.
Slovenian: Zdravljenje in preprečevanje osteoporoze z zdravilom Optruma je bilo raziskano v štirih glavnih študijah.
English: Why has Optruma been approved?
Slovenian: Zakaj je bilo zdravilo Optruma odobreno?
English: For the full list of side effects reported with Optruma, see the Package Leaflet.
Slovenian: Za celoten opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Optruma, glejte navodilo za uporabo.
English: Optruma has been shown to significantly reduce vertebral fractures (breaks in the spine), but not hip fractures.
Slovenian: Dokazano je bilo, da zdravilo Optruma znatno zmanjšuje število zlomov vretenc (poškodb hrbtenice), ne pa tudi zlomov kolka.
English: When used to treat osteoporosis, Optruma was more effective than placebo in reducing the number of vertebral fractures.
Slovenian: Ko je bilo uporabljeno za zdravljenje osteoporoze, je bilo zdravilo Optruma pri zmanjšanju števila zlomov vretenc učinkovitejše od placeba.
English: The full EPAR for Optruma is available here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Optruma je na voljo tukaj.
English: What is Optruma used for?
Slovenian: Za kaj se zdravilo Optruma uporablja?
English: There was no effect of Optruma on hip fractures.
Slovenian: Na zlome kolkov zdravilo Optruma ni imelo učinka.
English: What is Optruma?
Slovenian: Kaj je zdravilo Optruma?
English: The Committee decided that Optruma's benefits are greater than its risks for the treatment and prevention of osteoporosis in postmenopausal women.
Slovenian: Odbor je sklenil, da so koristi zdravila Optruma pri zdravljenju in preprečevanju osteoporoze pri ženskah po menopavzi večje od z njim povezanih tveganj.
English: How is Optruma used?
Slovenian: Kako se zdravilo Optruma uporablja?
English: How has Optruma been studied?
Slovenian: Kako je bilo zdravilo Optruma raziskano?
English: How does Optruma work?
Slovenian: Kako zdravilo Optruma deluje?
English: 4-mg/4-mg tablet.
Slovenian: 4 mg/4 mg tableto.
English: The dose should start with the
Slovenian: Odmerjanje se začne s
English: The European Commission granted a marketing authorisation valid throughout the EU for Avaglim to Smithkline Beecham Ltd. on 27 June 2006.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Avaglim, veljavno po vsej Evropski uniji, odobrila družbi Smithkline Beecham Ltd. dne 27. junija 2006.
English: It is available as triangular tablets (pink: 4 mg rosiglitazone and 4 mg glimepiride; red: 8 mg rosiglitazone and 4 mg
Slovenian: Na voljo je v tabletah trikotne oblike (rožnatih: 4 mg rosiglitazona in 4 mg glimepirida; rdečih: 8 mg rosiglitazona in 4 mg
English: Avaglim is taken once a day, just before or during a meal, generally breakfast.
Slovenian: Zdravilo Avaglim se jemlje enkrat dnevno, tik pred obrokom ali pred njim (običajno je to zajtrk).
English: Rosiglitazone has been authorised in the European Union (EU) as Avandia since 2000.
Slovenian: Rosiglitazon je v Evropski uniji (EU) odobren kot zdravilo Avandia od leta 2000.
English: The marketing authorisation is valid for five years, after
Slovenian: Dovoljenje za promet z zdravilom je veljavno pet let, nato ga je mogoče podaljšati.
English: What benefit has Avaglim shown during the studies?
Slovenian: Kakšne koristi je zdravilo Avglim izkazalo med študijami?
English: This document is a summary of the European Public Assessment Report (EPAR) for Avaglim.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Avaglim.
English: The dose can be increased to the 8-mg/4-mg tablets after eight weeks if needed, but this should be done with caution, due to the risk of fluid retention.
Slovenian: Po osmih tednih zdravljenja pa se lahko po potrebi poveča na 8 mg/4 mg, vendar je pri tem potrebna previdnost zaradi tveganja za zastajanje tekočine.
English: • rosiglitazone makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces;
Slovenian: • rosiglitazon poveča občutljivost celic (maščevja, mišic in jeter) za insulin, kar pomeni, da telo insulin, ki ga proizvaja, bolje izrablja;
English: If the patient develops hypoglycaemia, then a return to separate tablets will be needed so that the dose of glimepiride can be adjusted.
Slovenian: Če se pri bolniku pojavi hipoglikemija, je potreben prehod nazaj na ločene tablete, da se lahko prilagodi odmerek glimepirida.
English: In addition, four studies were carried out, comparing the combination of both active substances to each substance on its own, in patients who had never been treated, as well as in patients whose blood glucose levels were not controlled when treated with only one of the substances.
Slovenian: Poleg tega so bile izvedene štiri študije, v katerih so primerjali kombinacijo obeh zdravilnih učinkovin z vsako od njiju posebej pri bolnikih, ki še niso bili zdravljeni, in pri bolnikih, pri katerih raven glukoze v krvi ni bila nadzorovana, kadar so prejemali samo eno od obeh učinkovin.
English: The most common side effects with Avaglim (seen in more than 1 patient in 10) are hypoglycaemia and oedema (swelling).
Slovenian: Najpogostejša neželena učinka zdravila Avaglim (opažena pri več kot 1 bolniku od 10) sta hipoglikemija in edem (oteklina).
English: • glimepiride is a sulphonylurea: it stimulates the pancreas to produce more insulin.
Slovenian: • glimepirid je sufonilsečnina: spodbuja trebušno slinavko, da proizvede več insulina.
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
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Avaglim, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede
English: It must not be used in patients who have heart failure (an inability of the heart to pump enough blood around the body), an ‘acute coronary syndrome' such as unstable angina (a severe type of chest pain that changes in intensity) or certain types of heart attack, problems with their liver, severe problems with their kidneys, type 1 diabetes, or complications of diabetes (diabetic ketoacidosis or diabetic coma).
Slovenian: Ne smejo ga uporabljati bolniki s srčnim popuščanjem (nezmožnostjo srca, da poganja dovolj krvi po telesu), „akutnim koronarnim sindromom“, kot so nestabilna angina pektoris (huda vrsta bolečine v prsih, katere jakost se spreminja) ali določene oblike srčnega napada, težavami z jetri, hudimi težavami z ledvicami, sladkorno boleznijo tipa 1 ali bolniki z zapleti sladkorne bolezni (diabetično ketoacidozo ali diabetično komo).
English: The doses of Avaglim may need to be adjusted when given with certain other medicines such as gemfibrozil or rifampicin.
Slovenian: Odmerke zdravila Avaglim bo morda treba prilagoditi, kadar ga uporabljamo z nekaterimi drugimi zdravili, na primer gemfibrozilom ali rifampicinom.
English: The studies measured the level in the blood of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Slovenian: V študijah so merili raven snovi v krvi, imenovane glikozilirani hemoglobin (HbA1c), ki kaže, kako dobro je raven glukoze v krvi
English: What is the risk associated with Avaglim?
Slovenian: Kakšna tveganja so povezana z zdravilom Avaglim?
English: Avaglim contains two active substances, which have different modes of action:
Slovenian: Zdravilo Avaglim vsebuje dve zdravilni učinkovini, ki imata različen način delovanja:
English: The patient can start with separate tablets containing only rosiglitazone or a sulphonylurea, before switching to the combination tablet once control is achieved.
Slovenian: Bolnik lahko najprej začne jemati ločene tablete, ki vsebujejo samo rosiglitazon ali samo sulfonilsečnino, ko je dosežen nadzor, pa preide na kombinirane tablete.
English: In all four studies, the combination of rosiglitazone and glimepiride was shown to be more effective than either of its components used on its own in lowering the levels of HbA1c.
Slovenian: V vseh štirih raziskavah se je kombinacija rosiglitazona in glimepirida pri zniževanju ravni HbA1c izkazala za bolj učinkovito kot katera koli ob obeh učinkovin, uporabljena samostojno.
English: Why has Avaglim been approved?
Slovenian: Zakaj je bilo zdravilo Avaglim odobreno?
English: For glimepiride, the information came from
Slovenian: Podatki za glimepirid izhajajo iz
English: Avaglim is a medicine that contains two active substances, rosiglitazone and glimepiride.
Slovenian: Avaglim je zdravilo, ki vsebuje dve zdravilni učinkovini, rosiglitazon in glimepirid.
English: Avaglim is used to treat adults who have type 2 diabetes.
Slovenian: Zdravilo Avaglim se uporablja za zdravljenje odraslih s sladkorno boleznijo tipa 2.
English: Doctors must be careful when switching patients who are at risk of developing hypoglycaemia (low blood sugar levels) to Avaglim, such as elderly patients, patients with low weight or those who have been taking certain
Slovenian: Zdravniki morajo biti previdni, kadar preidejo na zdravilo Avaglim pri bolnikih, pri katerih obstaja nevarnost za hipoglikemijo (nizko raven sladkorja v krvi), kot so na primer starejši bolniki, bolniki z nizko telesno težo ali bolniki, ki jemljejo nekatera druga zdravila.
English: Because they have been used in the EU for a number of years, studies of rosiglitazone and glimepiride used on their own were used as the basis for Avaglim.
Slovenian: Ker se rosiglitazon in glimepirid v EU samostojno uporabljata že leta, so študije, v katerih so proučevali obe učinkovini samostojno, služile kot osnova za zdravilo Avaglim.
English: Avaglim should not be used in people who may be hypersensitive (allergic) to rosiglitazone, glimepiride or any of the other ingredients.
Slovenian: Zdravila Avaglim ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) rosiglitazon, glimepirid ali katero koli drugo sestavino zdravila.
English: For the full list of all side effects reported with Avaglim, see the Package
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Avaglim, glejte navodilo za uporabo.
English: For more information about treatment with Avaglim, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Avaglim preberite navodilo za uporabo (ki je prav tako del EPAR).
English: The CHMP concluded that Avaglim's benefits are greater than its risks and recommended that it be
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Avaglim večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: Glimepiride has been available in
Slovenian: Glimepirid je v EU na voljo od leta 1995.
English: For the full list of restrictions, see the Package Leaflet.
Slovenian: Za celoten seznam glejte navodilo za uporabo.