FrancophonIA/ELRC3.0 huggingface dataset:
English: They are supplied in aluminium/aluminium blisters in packs of 14, 28, 30, 50, 56, 60, 90, 98, 112, 180, multipacks of 196 (2 packs of 98) tablets or in aluminium/aluminium perforated unit dose blisters in packs of 60 x 1 tablets.
Slovenian: Na voljo so v aluminij/aluminij pretisnih omotih in pakiranjih po 14, 28, 30, 50, 56, 60, 90, 98, 112, 180, večkratnih pakiranjih po 196 (2 paketa po 98) tablet ali v aluminij/aluminij perforiranih enoodmernih pretisnih omotih po 60 x 1 tableta.
English: This medicine will not affect your ability to drive or use machines but take care if you experience abnormal vision.
Slovenian: To zdravilo ne vpliva na sposobnost upravljanja vozil in strojev, vendar pa bodite pozorni v primeru pojava težav z vidom.
English: - do not use Competact if you are breastfeeding or are planning to breast-feed (see section “Do not take Competact”).
Slovenian: - Zdravila Competact ne smete jemati, če dojite ali nameravate dojiti (glejte poglavje “Ne jemljite zdravila Competact”.
English: Lactic acidosis is a serious reaction which may occur very rarely (< 1/10,000) (see section 4.4) and other reactions such as bone fracture, weight increase and oedema may occur commonly (≥ 1/100 to < 1/10) (see section 4.4).
Slovenian: Laktacidoza je resen neželen učinek, ki se lahko pojavi zelo redko (< 1/10.000) (glejte poglavje 4.4), drugi neželeni učinki, kot so zlomi kosti, povečanje telesne mase in edem pa se lahko pojavijo pogosto (≥ 1/100 do < 1/10) (glejte poglavje 4.4).
English: In case of dehydration (severe diarrhoea or vomiting, fever, heat, reduced fluid intake), Competact should be temporarily discontinued and contact with a health care professional is recommended.
Slovenian: V primeru dehidracije (huda driska ali bruhanje, zvišana telesna temperatura ali zmanjšan vnos tekočine) je treba jemanje Competact začasno prekiniti; priporoča se posvet z zdravstvenim delavcem.
English: comprising 2 packs, each containing 98 film-coated tablets.
Slovenian: Sestavni del večkratnega pakiranja sta 2 pakiranji, vsako vsebuje 98 filmsko obloženih tablet.
English: - if you recently had a heart attack, have severe circulatory problems including shock, or breathing difficulties.
Slovenian: - če ste pred kratkim doživeli srčni infarkt, imate hujše težave s krvnim obtokom, če ste doživeli šok ali imate težave z dihanjem.
English: If you experience symptoms of hypoglycaemia such as weakness, dizziness, increased sweating, fast heart-beating, vision disorders or difficulty in concentration, you should take some sugar to increase your blood sugar level again.
Slovenian: Če se pri vas pojavijo simptomi hipoglikemije, kot so oslabelost, omotica, povečano znojenje, hiter srčni utrip, težave z vidom ali težave s koncentracijo, pojejte nekaj sladkega, da znova dvignete raven sladkorja v krvi.
English: - if you have a problem with your liver.
Slovenian: - če imate težave z jetri.
English: FOR CALENDARISED PACKS: 7 Tablet blister
Slovenian: ZA KOLEDARSKA PAKIRANJA: Pretisni omot s 7 tabletami
English: When clinically appropriate, direct change from metformin monotherapy to Competact may be considered.
Slovenian: Če je klinično sprejemljivo, se sme razmisliti o neposredni zamenjavi iz monoterapije z metforminom na zdravljenje z zdravilom Competact.
English: Since insulin and pioglitazone are both associated with fluid retention, concomitant administration of insulin and Competact may increase the risk of oedema.
Slovenian: Ker sta tako insulin kot pioglitazon povezana z zastajanjem tekočine, lahko sočasno jemanje insulina in zdravila Competact poveča tveganje za edeme.
English: Both pioglitazone and metformin have been shown to be present in the milk of lactating rats.
Slovenian: Tako pioglitazon kot metformin so dokazali v mleku doječih podgan.
English: Competact must therefore not be used in women who are breast-feeding (see section 4.3).
Slovenian: Zdravila Competact se torej ne sme uporabljati pri ženskah, ki dojijo (glejte poglavje 4.3).
English: If you are following a special diet for diabetes, you should continue with this while you are taking Competact.
Slovenian: Če ste na posebni dieti za sladkorno bolezen, morate z dieto med jemanjem zdravila Competact nadaljevati.
English: Maximum daily dose is 45 mg
Slovenian: Največji dnevni odmerek je 45 mg
English: The European Medicines Agency has waived the obligation to submit the results of studies with Competact in all subsets of the paediatric population in type 2 diabetes mellitus.
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom Competact za vse skupine pediatrične populacije s sladkorno boleznijo tipa 2 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Clinical trials have been conducted with Competact tablets and co-administered pioglitazone and metformin (see section 5.1).
Slovenian: Izvedli so klinična preskušanja s tabletami zdravila Competact in sočasnim dajanjem pioglitazona in metformina (glejte poglavje 5.1).
English: ACE inhibitors may decrease the blood glucose levels.
Slovenian: Zaviralci ACE lahko zmanjšajo koncentracijo glukoze v krvi.
English: As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Competact should have their renal function monitored regularly (see sections 4.3 and 4.4).
Slovenian: Zaradi izločanja metformina skozi ledvice in zaradi starostnega nagnjenja k zmanjšanju ledvičnega delovanja je pri starejših bolnikih, ki jemljejo zdravilo Competact, potrebno redno spremljati delovanje ledvic (glejte poglavji 4.3 in 4.4).
English: Your doctor will decide when you must stop and when to restart your treatment with Competact.
Slovenian: Zdravnik se bo odločil, kdaj morate z jemanjem zdravila Competact prenehati in kdaj lahko nadaljujete.
English: Bioequivalence studies in healthy volunteers have shown Competact to be bioequivalent to the administration of pioglitazone and metformin given as separate tablets.
Slovenian: Biokvivalenčne študije pri zdravih prostovoljcih so pokazale, da je zdravilo Competact bioekvivalentno sočasnemu jemanju pioglitazona in metformina kot dveh posameznih tablet.
English: On this basis M-IV contribution to efficacy is approximately three-fold that of pioglitazone, whilst the relative efficacy of M-II is minimal.
Slovenian: Na tej podlagi je delež učinkovitosti M-IV enak približno trikratniku deleža pioglitazona,
English: - if you have severely reduced kidney function.
Slovenian: - če imate hudo oslabljeno delovanje ledvic.
English: Small clinical trials have not revealed metformin to have malformative effects.
Slovenian: Neobsežna klinična preskušanja niso pokazala negativnih učinkov metformina.
English: In the 3.5 year PROactive study, 44/870 (5.1%; 1.0 fractures per 100 patient years) of pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%; 0.5 fractures per 100 patient years) of female patients treated with comparator.
Slovenian: V 3,5-letni PROactive študiji je 44/870 (5,1%, 1,0 zloma na 100 bolnik-let) žensk, zdravljenih s pioglitazonom imelo zlome, v primerjavi s 23/905 (2,5%, 0,5 zloma na 100 bolnik-let) žensk, zdravljenih s primerjalnim zdravilom.
English: Liver enzymes should be checked prior to the initiation of therapy with Competact in all patients.
Slovenian: Jetrne encime je treba pri vseh bolnikih kontrolirati pred uvedbo zdravljenja z zdravilom Competact.
English: Competact should not be used in patients with hepatic impairment (see sections 4.3 and 4.4).
Slovenian: Zdravila Competact pri bolnikih z okvarjenim delovanjem jeter ne smemo uporabljati (glejte poglavji 4.3 in 4.4).
English: Competact may cause a very rare (may affect up to 1 in 10,000), but very serious side effect called lactic acidosis (see section “Risk of lactic acidosis”).
Slovenian: Zdravilo Competact lahko povzroči zelo redek (pojavi se lahko pri do 1 od 10.000 bolnikov), a zelo resen neželeni učinek, imenovan laktacidoza (glejte poglavje "Tveganje za laktacidozo").
English: Competact should be used every day to work properly.
Slovenian: Za pravilno delovanje morate zdravilo Competact jemati vsak dan.
English: It is an anti-diabetic medicine used in adults to treat type 2 (non-insulin dependent) diabetes mellitus when treatment with metformin alone is not sufficient.
Slovenian: Je antidiabetično zdravilo za zdravljenje sladkorne bolezni tipa 2 (od insulina neodvisne sladkorne bolezni) pri odraslih, ko zdravljenje samo z metforminom ni zadostno.
English: It is recommended, therefore, that patients treated with Competact undergo periodic monitoring of liver enzymes.
Slovenian: Zato je priporočeno, da pri bolnikih, zdravljenih z zdravilom Competact, redno spremljate vrednosti jetrnih encimov.
English: 5 Isolated reports: liver function tests abnormalities or hepatitis resolving upon metformin discontinuation.
Slovenian: 5 Posamezni primeri: nenormalni testi delovanja jeter ali hepatitis, stanje se normalizira po ukinitvi zdravljenja z metforminom.
English: Pioglitazone
Slovenian: Pioglitazona
English: Blurred vision due to swelling (or fluid) at the back of the eye (macular oedema) has been reported (frequency cannot be estimated from available data).
Slovenian: Poročali so tudi o motnjah vida zaradi otekanja (ali tekočine) v zadnjem delu očesa (makularni edem) (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
English: Your doctor will ask you to have blood tests periodically during treatment with Competact.
Slovenian: Zdravnik vas bo v času zdravljenja z zdravilom Competact naročil na redne preiskave krvi.
English: abdominal pain very common very common diarrhoea very common very common flatulence uncommon loss of appetite very common very common nausea very common very common vomiting very common very common
Slovenian: bolečine v trebuhu zelo pogosti zelo pogosti driska zelo pogosti zelo pogosti flatulenca občasni izguba apetita zelo pogosti zelo pogosti slabost zelo pogosti zelo pogosti bruhanje zelo pogosti zelo pogosti
English: - if you are going to have a certain type of X-ray with an injectable dye, talk to your doctor as you must stop taking Competact for a certain period of time before and after the examination.
Slovenian: - če imate predvideno rentgensko preiskavo, pri kateri vam bodo vbrizgali barvilo, se pogovorite z zdravnikom, saj boste morali za določeno obdobje pred pregledom in po njem prenehati z jemanjem zdravila Competact.
English: If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Competact before or at the time of the injection.
Slovenian: Če vam bodo v krvni obtok injicirali kontrastno sredstvo, ki vsebuje jod, na primer zaradi rentgenskega ali drugega slikanja, morate pred časom injiciranja ali v tem času prenehati z jemanjem zdravila Competact.
English: - The other ingredients are microcrystalline cellulose, povidone (K30), croscarmellose sodium magnesium stearate, hypromellose, macrogol 8000, talc and titanium dioxide (E171).
Slovenian: - Pomožne snovi so: mikrokristalna celuloza, povidon (K 30), premreženi natrijev karmelozat, magnezijev stearat, hipromeloza, makrogol 8000, smukec in titanov dioksid (E171).
English: Musculoskeletal and connective tissue disorders bone fracture6
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva zlomi kosti6
English: - if you have uncontrolled diabetes, with for example severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see section“Risk of lactic acidosis”) or ketoacidosis.
Slovenian: - če imate nenadzorovano sladkorno bolezen, na primer s hudo hiperglikemijo (visoko ravnjo sladkorja v krvi), siljenjem na bruhanje, bruhanjem, drisko, hitro izgubo telesne mase, laktacidozo (glejte poglavje "Tveganje za laktacidozo") ali ketoacidozo.
English: The recommended dose of Competact is 30 mg/day pioglitazone plus 1,700 mg/day of metformin hydrochloride (this dose is achievable with one tablet of Competact 15 mg/850 mg, taken twice a day).
Slovenian: Priporočeni odmerek zdravila Competact je 30 mg/dan pioglitazona in 1.700 mg/dan metforminijevega klorida (dan v obliki ene tablete zdravila Competact 15 mg/850 mg dvakrat na dan).
English: 1 Post-marketing reports of hypersensitivity reactions in patients treated with pioglitazone have been reported.
Slovenian: 1 V poročilih po pridobitvi dovoljenja za promet so poročali o preobčutljivostnih reakcijah pri bolnikih zdravljenih s pioglitazonom.
English: Avoid excessive alcohol intake while taking Competact since this may increase the risk of lactic acidosis (see section “Risk of lactic acidosis”).
Slovenian: Med jemanjem zdravila Competact ne uživajte čezmernih količin alkohola, saj lahko to poveča tveganje za laktacidozo (glejte poglavje " Tveganje za laktacidozo").
English: For Competact no preclinical or clinical data on exposed pregnancies or lactation are available.
Slovenian: Predklinični ali klinični podatki o uporabi zdravila Competact med nosečnostjo ali dojenjem niso na voljo.
English: On the basis of the scientific conclusions for glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone is unchanged subject to the proposed changes to the product information.
Slovenian: Na podlagi znanstvenih zaključkov za glimepirid/pioglitazon hidroklorid, metformin/pioglitazon, pioglitazon odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) zdravilno(-e) učinkovino(-e) glimepirid/pioglitazon hidroklorid, metformin/pioglitazon,
English: Very common (may affect more than 1 in 10 people) - stomach ache - feeling sick (nausea) - vomiting - diarrhoea - loss of appetite
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov) - bolečine v trebuhu - siljenje na bruhanje (navzea) - bruhanje - driska - izguba apetita
English: What Competact looks like and contents of the pack
Slovenian: Izgled zdravila Competact in vsebina pakiranja
English: If you need to have major surgery you must stop taking Competact during and for some time after the procedure.
Slovenian: Če morate na večji kirurški poseg, morate v času posega in še nekaj časa po tem prenehati z jemanjem zdravila Competact.
English: Competact combines two antihyperglycaemic active substances with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes mellitus: pioglitazone, a member of the thiazolidinedione class and metformin hydrochloride, a member of the biguanide class.
Slovenian: Zdravilo Competact je kombinacija dveh antihiperglikemičnih učinkovin s komplementarnim mehanizmom delovanja, namenjeno pa je izboljšanju urejenosti glikemije pri bolnikih s sladkorno boleznijo tipa 2: pioglitazona iz skupine tiazolidindionov in metforminijevega klorida iz skupine bigvanidov.
English: Multipack: 196 (2 packs of 98) film-coated tablets.
Slovenian: Večkratno pakiranje: 196 filmsko obloženih tablet (2 pakiranji po 98 tablet)
English: Risk related to metformin
Slovenian: Tveganja, ki jih predstavlja metformin
English: If you experience these symptoms for the first time talk to your doctor as soon as possible.
Slovenian: Če imate ta simptom prvič, se čim prej posvetujte s svojim zdravnikom.
English: Post-marketing cases of peripheral oedema and cardiac failure have also been reported in patients with concomitant use of pioglitazone and nonsteroidal anti-inflammatory drugs, including selective COX-2 inhibitors.
Slovenian: Po prihodu zdravila na trg so o primerih perifernega edema in srčnega popuščanja poročali tudi pri bolnikih, ki so se sočasno zdravili s pioglitazonom in z nesteroidnimi protivnetnimi zdravili, vključno s selektivnimi zaviralci COX-2.
English: Competact should not be used during pregnancy.
Slovenian: Zdravila Competact se ne sme dajati ženskam v času nosečnosti.
English: Physicians should start treatment with the lowest available dose and increase the dose gradually, particularly when pioglitazone is used in combination with insulin (see section 4.4 Fluid retention and cardiac failure).
Slovenian: Zdravniki morajo začeti zdravljenje z najnižjim odmerkom, ki je na voljo in odmerek zviševati postopoma, še posebej, ko se pioglitazon uporablja v kombinaciji z insulinom (glejte poglavje 4.4
English: How to take Competact
Slovenian: Kako jemati zdravilo Competact
English: The observed excess risk of fractures for women on pioglitazone in this study is therefore 0.5 fractures per 100 patient years of use.
Slovenian: Povečano tveganje za zlome pri ženskah, zdravljenih s pioglitazonom, opaženo v tej študiji, je torej 0,5 zloma na 100 bolnik-let uporabe.
English: Talk to your doctor or pharmacist before taking Competact (see also section 4).
Slovenian: Pred začetkom jemanja zdravila Competact se posvetujte z zdravnikom ali farmacevtom (glejte tudi poglavje 4): - če imate težave s srcem.
English: Hepatobiliary disorders hepatitis5
Slovenian: Bolezni jeter, žolčnika in žolčevodov hepatitis5
English: The following side effects have been experienced by some patients taking Competact:
Slovenian: Pri nekaterih bolnikih, ki so jemali zdravilo Competact, so se pojavili naslednji neželeni učinki:
English: If a pregnancy occurs, treatment with Competact should be discontinued.
Slovenian: Če pride do nosečnosti, je potrebno zdravljenje z zdravilom Competact prekiniti.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON (WITHOUT BLUE BOX) MULTIPACKS ONLY (98 TABLETS)
Slovenian: PODATKI NA ZUNANJI OVOJNINI VMESNA ŠKATLA (BREZ "BLUE BOX") SAMO "MULTIPACK" PAKIRANJA (98 TABLET)
English: Multipack of 196 (2 packs of 98) tablets and aluminium/aluminium perforated unit dose blisters in pack of 60 x 1 tablets.
Slovenian: Večkratno pakiranje, ki vsebuje 196 (2 paketa po 98) tablet in po 60 x 1 tableta v pakiranju z aluminij/aluminij perforiranim enoodmernim pretisnim omotom.
English: There was a small reduction in mean haemoglobin (4% relative reduction) and haematocrit (4.1% relative reduction) during therapy with pioglitazone, consistent with haemodilution.
Slovenian: (4% relativno znižanje) in hematokrita (4,1% relativno znižanje), skladno s hemodilucijo.
English: Competact contains pioglitazone and metformin.
Slovenian: Zdravilo Competact vsebuje pioglitazon in metformin.
English: Competact is indicated as second line treatment of type 2 diabetes mellitus adult patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.
Slovenian: Zdravilo Competact je indicirano kot drugi izbor zdravljenja sladkorne bolezni tipa 2 pri odraslih, še posebno pri bolnikih s čezmerno telesno maso, pri katerih ni možno vzdrževati primerne koncentracije glukoze v krvi z največjim dovoljenim peroralnim odmerkom metformina samega.
English: Competact must be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable, see sections 4.2 and 4.4.
Slovenian: Competact je treba pred slikanjem ali v času slikanja ukiniti in se ga sme ponovno uvesti najmanj 48 ur pozneje, če je bilo delovanje ledvic ponovno ovrednoteno in ocenjeno kot stabilno, glejte poglavji 4.2 in 4.4.
English: Competact should be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable, see sections 4.2 and 4.5.
Slovenian: Competact je treba pred slikanjem ali v času slikanja ukiniti in se ga sme ponovno uvesti najmanj 48 ur pozneje, če je bilo delovanje ledvic ponovno ovrednoteno in ocenjeno kot stabilno, glejte poglavji 4.2 in 4.5.
English: Investigations weight increased8
Slovenian: Preiskave povečanje telesne mase8
English: No animal studies have been conducted with the combined products in Competact.
Slovenian: Raziskave s kombinacijo učinkovin v zdravilu Competact na živalih niso bile narejene.
English: - The active substances are pioglitazone and metformin hydrochloride.
Slovenian: - Zdravilni učinkovini sta pioglitazon in metforminijev klorid.
English: It is recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit juice
Slovenian: Priporočljivo je, da imate pri sebi nekaj kock sladkorja, bonbone,
English: The film-coated tablets (tablets) are white to off white, oblong, convex, embossed ‘15 / 850' on one face and ‘4833M' on the other.
Slovenian: Filmsko obložene tablete (tablete) so bele ali skoraj bele barve, podolgovate, z oznako ‘15 / 850' na eni in ‘4833M' na drugi strani.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (WITH BLUE BOX) (EXCLUDING MULTIPACKS)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA (Z "BLUE BOX") (RAZEN "MULTIPACK" PAKIRANJ)
English: Each tablet contains 15 mg of pioglitazone (as hydrochloride) and 850 mg of metformin hydrochloride.
Slovenian: Ena tableta vsebuje 15 mg pioglitazona (v obliki pioglitazonijevega klorida) in 850 mg metforminijevega klorida.
English: 6 A pooled analysis was conducted of adverse reactions of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8,100 patients in the pioglitazone-treated groups and 7,400 in the comparator-treated groups of up to 3.5 years duration.
Slovenian: 6 Opravljena je bila skupna analiza neželenih učinkov zlomov kosti iz randomiziranih, s primerjalnim zdravilom kontroliranih, dvojno slepih kliničnih preskušanj pri več kot 8.100 bolnikov v skupini,
English: Risk related to pioglitazone
Slovenian: Tveganja, ki jih predstavlja pioglitazon
English: An increased incidence in bone fractures in women was seen in a pooled analysis of adverse reactions of bone fracture from randomised, controlled, double blind clinical trials (see section 4.8)
Slovenian: V skupni analizi neželenih učinkov zlomov kosti iz randomiziranih, kontroliranih, dvojno slepih kliničnih preskušanj, so opazili povečano incidenco zlomov kosti pri ženskah (glejte poglavje 4.8).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX) MULTIPACKS ONLY (2 x 98 TABLETS)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (Z "BLUE BOX") SAMO VEČKRATNA PAKIRANJA (2 x 98 TABLET)
English: When activity, concentrations and protein binding are taken into account, pioglitazone and metabolite M-III contribute equally to efficacy.
Slovenian: Če upoštevamo aktivnost, koncentracije in vezavo na beljakovine, je delež učinkovitosti pioglitazona in presnovka
English: Frequency of adverse reactions Pioglitazone Metformin Competact
Slovenian: Pioglitazon Metformin Competact
English: The effect of pioglitazone (45 mg monotherapy vs. placebo) was studied in a small 18-week trial in type 2 diabetics.
Slovenian: Učinek pioglitazona (45 mg monoterapija v primerjavi s placebom) so preučevali v majhnem
English: If necessary, the dose of the antihyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Slovenian: Če je potrebno, odmerek antidiabetikov prilagodimo, bodisi zdravljenju z drugimi zdravili bodisi ukinitvi zdravljenja s takšnimi zdravili.
English: Allergic reactions have been reported with frequency not known (cannot be estimated from available data) in patients taking Competact.
Slovenian: Pri bolnikih, ki so jemali zdravilo Competact, so poročali o alergijskih reakcijah z neznano pogostnostjo (iz razpoložljivih podatkov je ni mogoče oceniti).
English: Preclinical data for metformin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Slovenian: Predklinični podatki o metforminu na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.