FrancophonIA/ELRC3.0 huggingface dataset:
English: Clear dosing recommendations and monitoring before and during treatment aim to minimise any possible increased risk in these patients.
Slovenian: Jasna priporočila za odmerjanje zdravila in njegovo spremljanje pred in med zdravljenjem so namenjena zmanjševanju morebitnega povečanega tveganja pri teh bolnikih.
English: Information for healthcare professionals
Slovenian: Informacije za zdravstvene delavce
English: The current product information also varies between countries and products in the EU and is no longer consistent with clinical guidelines.
Slovenian: Trenutne informacije o zdravilu se med državami in zdravili v EU razlikujejo in niso skladne s kliničnimi smernicami.
English: The product information also details risk factors for lactic acidosis which should be reviewed prior to and during treatment.
Slovenian: V informacijah o zdravilu so podrobno opisani tudi dejavniki tveganja za laktacidozo, ki jih je treba preverjati pred in med zdravljenjem.
English: If you experience severe vomiting, diarrhoea or fever, are exposed to heat, or drink less fluid than normal, you could become dehydrated.
Slovenian: Če se pri vas pojavi hudo bruhanje, driska ali povišana telesna temperatura, če ste izpostavljeni toploti ali pijete manj kot običajno, lahko dehidrirate.
English: For further information about the centrally authorised medicines, see here.
Slovenian: Za več informacij o zdravilih, ki so pridobila dovoljenje za promet po centraliziranem postopku, glejte tu.
English: • Dehydration (significant loss of body fluids) increases the risk of developing lactic acidosis.
Slovenian: • Dehidracija (znatna izguba telesnih tekočin) poveča tveganje za pojav laktacidoze.
English: However, after considering the scientific literature, clinical data, epidemiological studies and clinical guidelines from medical bodies, EMA concluded that the large patient population with moderately reduced kidney function can benefit from use of metformin.
Slovenian: Po preučitvi znanstvene literature, kliničnih podatkov, epidemioloških študij in kliničnih smernic zdravniških organov je agencija EMA zaključila, da lahko uporaba metformina koristi veliki populaciji bolnikov z zmerno okvaro delovanja ledvic.
English: The product information for metformincontaining medicines will be updated to reflect the new recommendations and to ensure that the same advice is given to all patients in the EU.
Slovenian: Informacije o zdravilu za zdravila, ki vsebujejo metformin, bodo posodobljene tako, da bodo vključevale nova priporočila in da bodo vsi bolniki v EU prejeli enake nasvete.
English: The dose of metformin should be adapted depending on the patient's kidney function.
Slovenian: Odmerek metformina je treba prilagoditi glede na delovanje bolnikovih ledvic.
English: Recommendations for patients with kidney impairment updated in product information
Slovenian: Posodobljena priporočila za bolnike z ledvično okvaro v informacijah o zdravilu
English: In addition, the combination glibenclamide/metformin (Glucovance) has been nationally authorised.
Slovenian: Poleg tega je dovoljenje z nacionalnim postopkom prejela tudi kombinacija glibenklamid/metformin (Glucovance).
English: • Several fixed-dose combination products containing metformin are available in Europe (see below).
Slovenian: • V Evropi je na voljo več zdravil s fiksno kombinacijo odmerkov, ki vsebujejo metformin (glejte spodaj).
English: Companies marketing metformin-containing medicines will be requested to closely monitor and analyse future lactic acidosis cases and report these during upcoming periodic safety reviews in order to follow up on any changes in the frequency of this side effect.
Slovenian: Družbe, ki tržijo zdravila, ki vsebujejo metformin, bodo morale skrbno spremljati in analizirati prihodnje primere laktacidoze in o njih poročati v okviru naslednjih rednih pregledov varnosti, da bo tako omogočeno spremljanje sprememb pogostnosti tega neželenega učinka.
English: Use in patients with GFR<30 ml/min is still contraindicated.
Slovenian: Uporaba pri bolnikih z GFR < 30 ml/min je še vedno kontraindicirana.
English: If these products are used in patients with reduced kidney function, restrictions and efficacy regarding the other active substance in the combination, the feasibility of dose adjustment and the alternative of using individual tablets should be considered.
Slovenian: Če se ta zdravila uporabljajo pri bolnikih z okvaro delovanja ledvic, je treba upoštevati omejitve in učinkovitost druge zdravilne učinkovine v kombinaciji, izvedljivost prilagoditve odmerka in nadomestno možnost uporabe ločenih tablet.
English: The following medicines containing combinations of metformin with other diabetes medicines in the same tablet have been authorised centrally through EMA: pioglitazone/metformin (Competact, Glubrava), dapagliflozin/metformin (Ebymect, Xigduo), sitagliptin/metformin (Efficib, Janumet, Ristfor, Velmetia), linagliptin/metformin (Jentadueto), saxagliptin/metformin (Komboglyze), alogliptin/metformin (Vipdomet), canagliflozin/metformin (Vokanamet), vildagliptin/metformin (Eucreas, Icandra, Zomarist) and empagliflozin/metformin (Synjardy).
Slovenian: Naslednja zdravila, ki v eni tableti vsebujejo kombinacijo metformina in drugega zdravila za zdravljenje sladkorne bolezni, so dovoljenja za promet z zdravilom dobila po centraliziranem postopku prek agencije EMA: pioglitazon/metformin (Competact, Glubrava), dapagliflozin/metformin (Ebymect, Xigduo), sitagliptin/metformin (Efficib, Janumet, Ristfor, Velmetia), linagliptin/metformin (Jentadueto), saksagliptin/metformin (Komboglyze), alogliptin/metformin (Vipdomet), kanagliflozin/metformin (Vokanamet), vildagliptin/metformin (Eucreas, Icandra, Zomarist) in empagliflozin/metformin (Synjardy).
English: Metformin may increase the risk of a rare but serious complication called lactic acidosis, which occurs when naturally produced lactic acid builds up in the blood faster than it can be removed.
Slovenian: Metformin lahko poveča tveganje za redek, a resen zaplet, imenovan laktacidoza, ki se pojavi, ko se naravno prisotna mlečna kislina kopiči v krvi hitreje, kot jo telo lahko odstranjuje.
English: For example, dapagliflozin/metformin (Ebymect, Xigduo) is not recommended in patients with GFR<60 ml/min; canagliflozin/metformin (Vokanamet) and empagliflozin/metformin (Synjardy) are not recommended in patients with GFR<45 ml/min and should not be started in patients with GFR<60 ml/min.
Slovenian: Na primer kombinacija dapagliflozin/metformin (Ebymect, Xigduo) ni priporočena pri bolnikih z GFR < 60 ml/min, kombinaciji kanagliflozin/metformin (Vokanamet) in empagliflozin/metformin (Synjardy) pa nista priporočeni pri bolnikih z GFR < 45 ml/min in ju ne smemo uvesti pri bolnikih z GFR < 60 ml/min.
English: Metformin is a medicine used on its own or in combination with other medicines for the treatment of type 2 diabetes.
Slovenian: Metformin je zdravilo, ki se uporablja samostojno ali v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni tipa 2.
English: However, for patients with only moderately reduced kidney function any risk can be minimised by careful checking of dose and monitoring, allowing these patients to get the benefits these medicines can provide.
Slovenian: Pri bolnikih z le zmerno okvaro delovanja ledvic se tveganje s skrbnim preverjanjem odmerka in spremljanjem lahko zmanjša, s tem pa imajo lahko ti bolniki koristi od teh zdravil.
English: • Up to now, metformin medicines were not recommended for patients with moderate to severe reduction of kidney function.
Slovenian: • Do zdaj zdravila z metforminom niso bila priporočena za bolnike z zmerno do hudo okvaro delovanja ledvic.
English: The product information for these medicines will be updated to revise the current contraindication and give information about doses, monitoring and precautions in patients with reduced kidney function.
Slovenian: Informacije o zdravilu za ta zdravila bodo posodobljena tako, da bodo trenutne kontraindikacije popravljene, navedene pa bodo informacije o odmerkih, spremljanju in previdnostnih ukrepih pri bolnikih z okvaro delovanja ledvic.
English: • These latest recommendations will result in harmonisation of product information about the use of metformin in patients with reduced kidney function and the precautions for lactic acidosis across the EU.
Slovenian: • S temi najnovejšimi priporočili se bodo uskladile informacije o zdravilu po vsej EU glede uporabe metformina pri bolnikih z okvaro delovanja ledvic in previdnostnih ukrepov pri laktacidozi.
English: Currently, the product information states that metformin must not be used in patients with reduced kidney function because these patients are considered to be at a higher risk of developing lactic acidosis as their kidneys do not remove metformin efficiently enough.
Slovenian: Trenutno informacije o zdravilu navajajo, da se metformin ne sme uporabljati pri bolnikih z okvaro delovanja ledvic, ker velja, da je pri teh bolnikih tveganje za pojav laktacidoze večje, saj njihove ledvice metformina ne odstranjujejo dovolj učinkovito.
English: Metformin is used together with diet and exercise to improve control of blood glucose (sugar) levels.
Slovenian: Uporablja se skupaj z dieto in telesno vadbo za boljše uravnavanje ravni glukoze (sladkorja) v krvi.
English: • Metformin is used on its own or with other medicines, together with diet and exercise, for the treatment of type 2 diabetes.
Slovenian: • Metformin se uporablja samostojno ali skupaj z drugimi zdravili, hkrati z dieto in telesno vadbo, za zdravljenje sladkorne bolezni tipa 2.
English: • Some fixed-dose combination products are still not recommended in patients with moderately reduced kidney function because the other active substance in the combination should not be used in these patients.
Slovenian: • Nekatera zdravila s fiksno kombinacijo odmerkov še vedno niso priporočena pri bolnikih z zmerno okvaro delovanja ledvic, ker se druga zdravilna učinkovina v kombinaciji pri teh bolnikih ne sme uporabljati.
English: • Patients with reduced kidney function may be at higher risk of lactic acidosis, a rare but serious side effect of metformin medicines caused by build-up of lactic acid in the blood.
Slovenian: • Pri bolnikih z okvaro delovanja ledvic lahko obstaja večje tveganje za pojav laktacidoze, tj. redkega, a resnega neželenega učinka zdravil z metforminom, ki se pojavi zaradi kopičenja mlečne kisline v krvi.
English: • Reduced doses should be considered for patients with moderate reduction of kidney function according to dosage recommendations provided in the updated product information.
Slovenian: • Pri bolnikih z zmerno okvaro delovanja ledvic je treba razmisliti o zmanjšanem odmerku v skladu s priporočili za odmerjanje, navedenimi v posodobljenih informacijah o zdravilu.
English: The recommendations were the result of a review by EMA of metformin-containing medicines following concerns that current scientific evidence does not justify a contraindication in patients with moderate reduction of kidney function.
Slovenian: Pregled je opravila agencija EMA, sledil pa je pomislekom, da trenutni znanstveni dokazi ne utemeljujejo kontraindikacije pri bolnikih z zmerno okvaro delovanja ledvic.
English: Solini, A. et al., ‘Age, renal dysfunction, cardiovascular disease, and antihyperglycemic treatment in type 2 diabetes mellitus: findings from the Renal Insufficiency and Cardiovascular Events Italian Multicenter Study', J Am Geriatr Soc, 2013, Vol. 61, p. 1253.
Slovenian: Solini, A. et al., „Age, renal dysfunction, cardiovascular disease, and antihyperglycemic treatment in type 2 diabetes mellitus: findings from the Renal Insufficiency and Cardiovascular Events Italian Multicenter Study“, J Am Geriatr Soc, 2013, zv.
English: Roussel, R. et al., ‘Metformin use and mortality among patients with diabetes and atherothrombosis', Arch Intern Med, 2010, Vol. 170, p. 1892.
Slovenian: Roussel, R. et al., „Metformin use and mortality among patients with diabetes and atherothrombosis“, Arch Intern Med, 2010, zv.
English: On 13 October 2016, the European Medicines Agency (EMA) concluded that metformin-containing medicines can now be used in patients with moderately reduced kidney function (GFR [glomerular filtration rate] = 30-59 ml/min) for the treatment of type 2 diabetes.
Slovenian: Evropska agencija za zdravila (EMA) je 13. oktobra 2016 zaključila, da se zdravila, ki vsebujejo metformin, od zdaj naprej lahko uporabljajo za zdravljenje sladkorne bolezni tipa 2 tudi pri bolnikih z zmerno okvaro delovanja ledvic (GFR [hitrost glomerulne filtracije] = 30-59 ml/min).
English: The contraindication for patients with severely reduced kidney function will remain (GFR less than 30 ml/min).
Slovenian: Kontraindikacija za bolnike s hudo okvaro delovanja ledvico bo ostala (GFR pod 30 ml/min).
English: These medicines should still not be used in patients with severely reduced kidney function (GFR less than 30 ml/min).
Slovenian: Ta zdravila se še vedno ne smejo uporabljati pri bolnikih s hudo okvaro delovanja ledvic (GFR pod 30 ml/min).
English: • The review of metformin-containing medicines concluded that they can now be used in patients with moderately reduced kidney function (GFR=30-59 ml/min).
Slovenian: • Pregled zdravil, ki vsebujejo metformin, je pokazal, da se ta zdravila lahko zdaj uporabljajo tudi pri bolnikih z zmerno okvaro delovanja ledvic (GFR=30-59 ml/min).
English: et al., ‘Metformin in patients with type 2 diabetes and kidney disease: a systematic review', JAMA, 2014, Vol. 312, p. 2668.
Slovenian: et al., „Metformin in patients with type 2 diabetes and kidney disease: a systematic review', JAMA, 2014, zv.
English: et al., ‘Risk of lactic acidosis or elevated lactate concentrations in metformin users with renal impairment: A population-based cohort study', Diabetes Care, 2014, Vol. 37 (8), p. 2218.
Slovenian: et al., „Risk of lactic acidosis or elevated lactate concentrations in metformin users with renal impairment: A population-based cohort study“, Diabetes Care, 2014, zv.
English: et al., ‘Incidence of lactic acidosis in patients with type 2 diabetes with and without renal impairment treated with metformin: a retrospective cohort study', Diabetes Care, 2014, Vol. 37 (8), p.
Slovenian: et al., „Incidence of lactic acidosis in patients with type 2 diabetes with and without renal impairment treated with metformin: a retrospective cohort study“, Diabetes Care, 2014, zv.
English: This recommendation has now changed to allow their use in patients with moderately reduced kidney function (GFR=30-59 ml/min).
Slovenian: To priporočilo se je zdaj spremenilo, zato se ta zdravila lahko sedaj uporabljajo pri bolnikih z zmerno okvaro delovanja ledvic (GFR = 30-59 ml/min).
English: Content (concentration)
Slovenian: Vsebina (koncentracija)
English: 10 vials
Slovenian: 10 vial
English: Type 2 (MEF-1)
Slovenian: tip 2 (sev MEF-1)
English: (Polyribosylribitol Phosphate) conjugated to Tetanus protein
Slovenian: (poliribozilribitol fosfat) konjugiran na tetanusno beljakovino
English: 3 Produced on Vero cells
Slovenian: 3 Pridobljen na celicah Vero.
English: Type 3 (Saukett)
Slovenian: tip 3 (sev Saukett)
English: Hepatitis B surface antigen5
Slovenian: površinski antigen hepatitisa B5
English: Pack size vial (glass)
Slovenian: Velikost pakiranja viala (steklo)
English: 1 Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al3+) 2 As lower confidence limit (p= 0.95)
Slovenian: 1 Adsorbiran na hidratirani aluminijev hidroksid (0,6 mg Al3+).
English: Haemophilus influenzae type b polysaccharide
Slovenian: polisaharid hemofilusa influence tipa b
English: 1 pre-filled syringe
Slovenian: 1 napolnjena injekcijska brizga
English: 10 pre-filled syringes
Slovenian: 10 napolnjenih injekcijskih brizg
English: 4 Or equivalent antigenic quantity determined by a suitable immunochemical method 5 Produced in yeast Hansenula polymorpha cells by recombinant DNA technology
Slovenian: 5 Pridobljeno v celicah kvasovke Hansenula polymorpha s tehnologijo rekombinantne DNA.
English: --1 One dose1 (0.5 ml) contains: Diphtheria Toxoid
Slovenian: --1 En odmerek1 (0,5 ml) vsebuje: davični toksoid tetanusni toksoid antigene Bordetelle pertussis toksoid oslovskega kašlja filamentozni hemaglutinin poliovirus (inaktiviran)3 tip 1 (sev Mahoney)
English: 1 pre-filled syringe + 1 needle
Slovenian: brizga 1+ 1 igla
English: 1 pre-filled syringe + 2 needles
Slovenian: brizga + 2 igli
English: Bordetella pertussis antigens Pertussis Toxoid
Slovenian: Pot uporabe Stična ovojnina
English: EMA Number
Slovenian: Številka (EU) dovoljenja za promet
English: National Competent Authorities, coordinated by the Reference Member State as applicable, should ensure the following:
Slovenian: Pristojni nacionalni organi, ki jih usklajuje referenčna država članica, kadar je to ustrezno morajo zagotoviti naslednje:
English: • Intracranial aneurysm and intracranial haemorrhage
Slovenian: • intrakranialna anevrizma in intrakranialna krvavitev.
English: The MAHs should submit/update the Risk Management Plans for all somatropin medicinal products to reflect the following potential risks:
Slovenian: Imetniki dovoljenja za promet z zdravilom morajo predložiti/posodobiti načrte za obvladovanje tveganj za vsa zdravila, ki vsebujejo somatropin, tako da bodo v teh načrtih navedena naslednja možna tveganja:
English: The MAHs within 2 months of the Commission Decision should liaise with the National Competent Authorities to agree on the timelines for submission of the Risk Management Plans.
Slovenian: Imetniki dovoljenj za promet z zdravilom se morajo v dveh mesecih po odločbi Komisije povezati s pristojnimi nacionalnimi organi in se dogovoriti o časovnem načrtu za predložitev načrtov za obvladovanje tveganj.
English: • New neoplasm
Slovenian: • novotvorba;
English: Conditions of the marketing authorisations
Slovenian: Priloga IV Pogoji dovoljenja za promet z zdravilom
English: • Second neoplasm in childhood cancer survivors
Slovenian: • sekundarna novotvorba pri tistih, ki so v otroški dobi preboleli rakavo obolenje;
English: (for the morning) and a moon (for the evening).
Slovenian: Na omotu sta sonce (za jutro) in mesec (za večer).
English: • At the request of the European Medicines Agency.
Slovenian: • na zahtevo Evropske agencije za zdravila.
English: In addition, an updated RMP should be submitted:
Slovenian: Poleg tega je treba posodobljen RMP predložiti:
English: This dose will usually be given to you in the hospital.
Slovenian: Ta odmerek boste po navadi dobili v bolnišnici.
English: Experience beyond 12 months is limited.
Slovenian: Izkušenj z uporabo več kot 12 mesecev je malo.
English: If bleeding occurs appropriate supportive measures should be taken.
Slovenian: Če se pojavi krvavitev, je treba uporabiti ustrezne podporne ukrepe.
English: nominal significance value; all others are formally statistically significant by pre-defined hierarchical testing.
Slovenian: nominalna vrednost značilnost; vsi drugi so formalno statistično značilni po vnaprej opredeljenem hierarhičnem testiranju.
English: About 30% of episodes resolved within 7 days.
Slovenian: Približno 30 % epizod je minilo v 7 dneh.
English: In absolute terms, this risk was higher than in the overall PLATO population.
Slovenian: Absolutno gledano je bilo tveganje večje kot v celotni populaciji PLATO.
English: The mechanism has not been elucidated.
Slovenian: Mehanizem tega ni razjasnjen.
English: Manufacturer:
Slovenian: Izdelovalec:
English: Your doctor will discuss with you the benefits and risks of taking Possia during this time.
Slovenian: Zdravnik se bo z vami pogovoril o koristih in tveganjih jemanja zdravila Possia med tem časom.
English: Thus no particular group was identified at risk for any subset of bleeding.
Slovenian: Tako niso identificirali nobene posebne skupine s tveganjem kakšne podskupine krvavitev.
English: If your feeling of shortness of breath gets worse or lasts a long time, tell your doctor.
Slovenian: Če se vam občutek kratke sape slabša ali traja dolgo časa, povejte zdravniku.
English: Treatment of overdose should follow local standard medical practice.
Slovenian: Zdravljenje prevelikega odmerjanja mora upoštevati standardno lokalno medicinsko prakso.
English: This is calculated as 3/9235 which equates to a frequency category of ‘rare'
Slovenian: Izračun je tako 3/9235, kar ustreza kategoriji pogostnosti "redki"
English: • If you forget to take a dose, just take your next dose as normal.
Slovenian: • Če ste pozabili vzeti odmerek, zgolj vzemite naslednji odmerek kot po navadi.
English: Take the medicine pack with you.
Slovenian: S seboj vzemite ovojnino zdravila.
English: These small changes are considered of minimal clinical significance; therefore, ticagrelor can be given with or without food.
Slovenian: Te majhne spremembe veljajo za minimalno klinično pomembne, zato je tikagrelor mogoče jemati s hrano ali brez nje.
English: • You have had a blood test that showed more than the usual amount of uric acid
Slovenian: • če ste imeli preiskavo krvi, ki je pokazala več kot običajno količino sečne kisline.
English: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Slovenian: • po prejemu novih informacij, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjšanje tveganja,
English: Figure 1 shows the estimate of the risk to the first occurrence of any event in the composite efficacy
Slovenian: Slika 1 kaže oceno tveganja do prvega pojava kateregakoli dogodka v sestavljeni končni točki učinkovitosti.
English: • Inflamed stomach (gastritis)
Slovenian: • vnetje želodca (gastritis)
English: • Bleeding - some bleeding is common.
Slovenian: • Krvavitev - nekatere krvavitve so pogoste.
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: • POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: You have been given Possia because you have had:
Slovenian: Zdravilo Possia ste dobili, ker ste imeli:
English: Your doctor will usually also tell you to take acetylsalicylic acid.
Slovenian: Zdravnik vam bo po navadi predpisal tudi jemanje acetilsalicilne kisline.
English: The primary variable of interest was the occurrence of ventricular pauses ≥3 seconds.
Slovenian: Primarna spremenljivka zanimanja je bil pojav ventrikularnih pavz ≥ 3 sekunde.
English: Possia is not recommended for children and adolescents under 18 years.
Slovenian: Otroci Zdravilo Possia ni priporočljivo za otroke in mladostnike, mlajše od 18 let.
English: • Do not take a double dose (two doses at the same time) to make up for the forgotten dose.
Slovenian: • Ne vzemite dvojnega odmerka (dveh odmerkov hkrati), če ste pozabili vzeti prejšnji odmerek.
English: Take Possia around the same time everyday (for example, one tablet in the morning and one in the evening).
Slovenian: (npr. eno tableto zjutraj in eno zvečer).
English: Your doctor will decide if it needs treatment or further
Slovenian: Zdravnik bo presodil, ali so potrebni zdravljenje ali nadaljnje preiskave.
English: No data are available (see section 5.1 and 5.2).
Slovenian: Podatkov ni na voljo (glejte poglavji 5.1 in 5.2).
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report
Slovenian: V skladu s smernico CHMP o sistemih za obvladovanje tveganj za zdravila za uporabo v humani medicini mora biti posodobljen RMP predložen hkrati z naslednjim rednim posodobljenim poročilom o varnosti zdravila (PSUR).
English: Possia may be resumed after the cause of bleeding has been identified and controlled.
Slovenian: Uporaba zdravila Possia se lahko nadaljuje, ko je vzrok krvavitve ugotovljen in obvladan.
English: Thus, the carcinogenicity findings are considered unlikely to be relevant for humans.
Slovenian: Zato ni verjetno, da bi bili izsledki o kancerogenosti pomembni za človeka.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Slovenian: Pred uporabo natančno preberite navodilo, ker vsebuje za vas pomembne podatke!