FrancophonIA/ELRC3.0 huggingface dataset:
English: You need to know about important signs and symptoms to look out for while you're taking Juluca.
Slovenian: Poznati morate pomembne znake in simptome, na katere morate biti pozorni, medtem ko jemljete zdravilo Juluca.
English: • liver failure (signs may include yellowing of the skin and the whites of the eyes or unusually dark urine).
Slovenian: • odpoved jeter (med znaki so lahko porumenelost kože in očesnih beločnic ali neobičajno temen urin).
English: Frequency category*
Slovenian: Organski sistem (OS) Kategorija pogostnosti*
English: It is recommended that the filmcoated tablet be swallowed whole with water and not be chewed or crushed.
Slovenian: Priporočljivo je, da bolnik filmsko obloženo tableto zaužije celo skupaj z vodo ter je ne grize in ne drobi.
English: Dolutegravir and rilpivirine have been associated with increases in serum creatinine occuring in the first week of treatment when administered with other antiretroviral medicinal products.
Slovenian: Dolutegravir in rilpivirin sta bila povezana z zvišanjem serumskega kreatinina, ki se je pojavilo v prvem tednu zdravljenja med uporabo z drugimi protiretrovirusnimi zdravili.
English: Polyvinyl alcohol- part hydrolysed Titanium dioxide (E171) Macrogol
Slovenian: Polivinilalkohol (delno hidroliziran) Titanov dioksid (E171) Makrogol
English: Symptoms usually include fever, plus some of the following:
Slovenian: Med simptomi so po navadi zvišana telesna temperatura in še kaj od naslednjega:
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100, < 1/10), občasni (≥ 1/1.000, < 1/100), redki (≥ 1/10.000, < 1/1.000), zelo redki (<
English: • difficulty breathing.
Slovenian: • težko dihanje.
English: Patients should be advised that Juluca does not cure HIV infection and that they may still develop opportunistic infections and other complications of HIV infection.
Slovenian: Bolnike je treba opozoriti, da zdravilo Juluca ne ozdravi okužbe s HIV in da se lahko pri njih še vedno pojavijo oportunistične okužbe in drugi s HIV povezani zapleti.
English: • dabigatran etexilate, used to treat or prevent blood clots.
Slovenian: • dabigatran eteksilat za zdravljenje ali preprečevanje krvnih strdkov.
English: → Read the information ‘Allergic reactions' in section 4 of this leaflet.
Slovenian: → Preberite informacije pod naslovom "Alergijske reakcije" v poglavju 4 tega navodila.
English: What Juluca is and what it is used for 2.
Slovenian: Kaj je zdravilo Juluca in za kaj ga uporabljamo 2.
English: It is not known whether the ingredients of Juluca can pass into your breast milk.
Slovenian: Ni znano ali sestavine zdravila Juluca lahko prehajajo v materino mleko.
English: In faeces, unchanged rilpivirine accounted for on average 25% of the administered dose.
Slovenian: V blatu je nespremenjeni rilpivirin predstavljal povprečno 25 % uporabljenega odmerka.
English: People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections (opportunistic infections).
Slovenian: Bolniki z napredovalo okužbo z virusom HIV (AIDS) imajo oslabljen imunski sistem in večjo verjetnost za razvoj resnih okužb (oportunistične okužbe).
English: Because gastrointestinal (GI) intolerance is considered to be due to local active substance administration, mg/kg or mg/m2 metrics are appropriate determinates of safety cover for this toxicity.
Slovenian: Gastrointestinalna intoleranca velja za posledico lokalne uporabe učinkovine, zato sta enoti mg/kg ali mg/m2 ustrezni determinanti varnostnega kritja za ta toksični učinek.
English: The pharmacokinetic data demonstrate that total exposure (AUC) to rilpivirine as a part of an antiretroviral regimen was approximately 30% lower during pregnancy compared with postpartum (6-12 weeks).
Slovenian: Farmakokinetični podatki kažejo, da je bila celokupna izpostavljenost (AUC) rilpivirinu kot delu protiretrovirusne sheme med nosečnostjo približno 30 % manjša kot po porodu (6-12 tednov).
English: • lack of energy (fatigue)
Slovenian: • pomanjkanje energije (utrujenost),
English: • The recommended dose of Juluca is one tablet once a day.
Slovenian: • Priporočeni odmerek zdravila Juluca je ena tableta enkrat na dan.
English: Repeated dose toxicity
Slovenian: Toksičnost ponavljajočih se odmerkov
English: However, clinical monitoring is recommended as methadone maintenance therapy may need to be adjusted in some patients.
Slovenian: Priporočljivo pa je klinično spremljanje, kajti nekateri bolniki lahko potrebujejo prilagoditev vzdrževalnega zdravljenja z metadonom.
English: Rilpivirine is approximately 99.7% bound to plasma proteins in vitro, primarily to albumin.
Slovenian: In vitro se rilpivirin približno 99,7-odstotno veže na beljakovine v plazmi, predvsem na albumin.
English: Autoimmune disorders (such as Graves' disease) have also been reported to occur in the setting of immune reconstitution, however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
Slovenian: V okviru imunske obnove je bil opisan tudi pojav avtoimunskih bolezni (npr. Gravesove bolezni), toda opisani čas do začetka je bolj spremenljiv in ti dogodki se lahko pojavijo veliko mesecev po uvedbi zdravljenja.
English: Potential increase via inhibition of OCT2 transporter.
Slovenian: Možno povečanje zaradi zavrtja prenašalca OCT2.
English: The primary endpoint and other outcomes (including outcomes by key baseline covariates) for the pooled SWORD-1 and SWORD-2 studies are shown in Table 3.
Slovenian: Primarni opazovani dogodek in drugi izidi (vključno z izidi glede na ključne izhodiščne sospremenljivke) za združeni študiji SWORD-1 in SWORD-2 so prikazani v preglednici 3.
English: (induction of CYP3A due to high rilpivirine dose in the study).
Slovenian: (indukcija CYP3A zaradi velikega odmerka rilpivirina v študiji).
English: Very common side effects that may show up in blood tests are:
Slovenian: Zelo pogosti neželeni učinki, ki se lahko pokažejo na preiskavah krvi, so:
English: Juluca can also affect how some other medicines work.
Slovenian: Tudi zdravilo Juluca lahko vpliva na delovanje nekaterih zdravil.
English: Clinical safety data with Juluca is limited.
Slovenian: Kliničnih podatkov o varnosti zdravila Juluca je malo.
English: Dolutegravir is present in the female and male genital tract.
Slovenian: Dolutegravir je prisoten v genitalnem traktu žensk in moških.
English: →Do not take a double dose to make up for a forgotten dose.
Slovenian: →Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: Juluca is intended for use as a complete regimen for the treatment of HIV-1 infection and should not be administered with other antiretroviral medicinal products for the treatment of HIV.
Slovenian: Zdravilo Juluca je namenjeno za uporabo kot celotna shema za zdravljenje okužbe s HIV-1, in se ga ne sme uporabljati z drugimi protiretrovirusnimi zdravili za zdravljenje HIV.
English: Boceprevir ↔ (historical controls).
Slovenian: boceprevir ↔ (retrospektivne kontrole).
English: The K103N substitution did not result in reduced susceptibility to rilpivirine by itself, but the combination of K103N and L100I resulted in a 7-fold reduced susceptibility to rilpivirine.
Slovenian: Substitucija K103N sama po sebi ni povzročila zmanjšane občutljivosti za rilpivirin, kombinacija K103N in L100I pa je povzročila v 7-kratno zmanjšanje občutljivosti za rilpivirin.
English: → Read the information ‘Other possible side effects' in section 4 of this leaflet.
Slovenian: → Preberite informacije pod naslovom "Drugi možni neželeni učinki" v poglavju 4 tega navodila.
English: It is unknown if all or part of this is due to unabsorbed active substance or biliary excretion of the glucuronidate conjugate, which can be further degraded to form the parent compound in the gut lumen.
Slovenian: Ni znano, ali je ta količina v celoti ali delno posledica neabsorbirane učinkovine ali pa je posledica biliarnega izločanja glukuronidnega konjugata, ki se v črevesni svetlini lahko dodatno razgradi, tako da nastane matična spojina.
English: → Tell your doctor immediately.
Slovenian: → Nemudoma obvestite zdravnika.
English: However, it may not be completely excluded that rilpivirine can increase the exposure to other medicinal products transported by P-gp that are more sensitive to intestinal P-gp inhibition, e.g. dabigatran etexilate.
Slovenian: Kljub temu ni mogoče povsem izključiti možnosti, da rilpivirin lahko poveča izpostavljenost drugim zdravilom, ki jih prenaša P-gp in so bolj občutljiva na zavrtje črevesnega P-gp, npr. dabigatran-eteksilat.
English: These mutations have been selected in patients with pre-existing raltegravir resistance and who were then treated with dolutegravir (listed as secondary mutations for dolutegravir).
Slovenian: Ti mutaciji sta bili izbrani pri bolnikih z že obstoječo odpornostjo proti raltegravirju, ki so nato prejemali dolutegravir (navedeno kot sekundarna mutacija za dolutegravir).
English: Pharmacotherapeutic group: Antivirals for systemic use, antivirals for treatment of HIV infections, combinations.
Slovenian: Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje virusnih infekcij, zdravila za zdravljenje infekcij s HIV, kombinacije.
English: If you forget to take Juluca
Slovenian: Če ste pozabili vzeti zdravilo Juluca
English: There is limited information available on the potential for a pharmacodynamic interaction between rilpivirine and medicinal products that prolong the QTc interval of the ECG.
Slovenian: Na voljo je malo podatkov o možnosti za farmakodinamično medsebojno delovanje med rilpivirinom in zdravili, ki podaljšajo interval QTc na EKG.
English: The effect of prolonged daily treatment with high doses of dolutegravir has been evaluated in repeat oral dose toxicity studies in rats (up to 26 weeks) and in monkeys (up to 38 weeks).
Slovenian: Vpliv dolgotrajnega vsakodnevnega zdravljenja z velikimi odmerki dolutegravirja so ocenili v študijah toksičnosti ponavljajočih se peroralnih odmerkov pri podganah (do 26 tednov) in opicah (do 38
English: • clarithromycin and erythromycin, to treat bacterial infections
Slovenian: • klaritromicin in eritromicin za zdravljenje bakterijskih okužb,
English: It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Slovenian: Priporočljivo je, da s HIV okužene ženske, v nobenem primeru ne dojijo, da ne bi prišlo do prenosa HIV na otroka.
English: If you take too many tablets of Juluca contact your doctor or pharmacist immediately.
Slovenian: Če ste vzeli preveč tablet zdravila Juluca, se nemudoma posvetujte z zdravnikom ali farmacevtom.
English: This is an uncommon (may affect up to 1 in 100 people) reaction in people taking dolutegravir.
Slovenian: To je občasna reakcija (pojavi se lahko pri največ 1 od 100 bolnikov) pri bolnikih, ki jemljejo dolutegravir.
English: African-America/African Heritage/Other Age (years)
Slovenian: Afroameričani/afriškega porekla/drugi
English: The recommended dose of Juluca is one tablet once daily.
Slovenian: Priporočeni odmerek zdravila Juluca je ena tableta enkrat na dan.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, odsotnostjo encima laktaze ali malabsorpcijo glukoze/galaktoze, ne smejo jemati tega zdravila.
English: The distribution of rilpivirine into compartments other than plasma (e.g., cerebrospinal fluid, genital tract secretions) has not been evaluated in humans.
Slovenian: Porazdelitve rilpivirina v druge razdelke razen plazme (na primer v cerebrospinalno tekočino ali v izločke genitalnega trakta) pri človeku niso ocenili.
English: Dolutegravir is the predominant circulating compound in plasma; renal elimination of unchanged active substance is low (< 1% of the dose).
Slovenian: Dolutegravir je prevladujoča spojina, ki kroži v plazmi; ledvično izločanje nespremenjene učinkovine je majhno (< 1 % odmerka).
English: Juluca may replace your current antiretroviral medicines.
Slovenian: Zdravilo Juluca lahko nadomesti protiretrovirusna zdravila, ki jih trenutno uporabljate.
English: * compared to 25 mg once daily rilpivirine alone
Slovenian: * v primerjavi s 25 mg rilpivirina samega enkrat na dan
English: There is no specific treatment for an overdose of Juluca.
Slovenian: Specifičnega zdravljenja za preveliko odmerjanje zdravila Juluca ni.
English: Virologic Outcomes of Randomized Treatment at Week 48 (Snapshot algorithm)
Slovenian: Preglednica 3: Virološki izidi randomiziranega zdravljenja po 48 tednih (algoritem Snapshot)
English: Dolutegravir activity was determined against a panel of 60 INI-resistant site-directed mutant HIV-1 viruses (28 with single substitutions and 32 with 2 or more substitutions).
Slovenian: Aktivnost dolutegravirja so določili pri skupini 60 virusov HIV-1 s točkovno mutacijo, odpornih proti INI (28 z enojnimi substitucijami in 32 z 2 ali več substitucijami).
English: Clinical status including liver aminotransferases and bilirubin should be monitored.
Slovenian: Spremljati je treba bolnikovo klinično stanje, vključno z jetrnimi aminotransferazami in bilirubinom.
English: Of these four, two subjects had a unique R263K integrase substitution, with a maximum FC of 1.93, one subject had a polymorphic V151V/I integrase substitution, with maximum FC of 0.92, and one subject had pre-existing integrase mutations and is assumed to have been integrase inhibitor experienced or infected with integrase inhibitor resistant virus by transmission.
Slovenian: Od teh štirih sta imela dva preiskovanca edinstveno substitucijo integraze R263K z največjo vrednostjo FC 1,93, en preiskovanec je imel polimorfno substitucijo integraze V151V/I z največjo vrednostjo FC 0,92, en preiskovanec pa je imel že obstoječe mutacije integraze in se predvideva, da je že predhodno dobival zaviralec integraze ali pa je bil preko prenosa okužen z virusom, odpornim proti zaviralcu integraze.
English: What Juluca is and what it is used for
Slovenian: Kaj je zdravilo Juluca in za kaj ga uporabljamo
English: Previously untreated HIV-1 infected adult patients
Slovenian: Predhodno nezdravljeni odrasli bolniki, okuženi s HIV-1
English: • methadone, used in the treatment of opioid dependence
Slovenian: • metadon, ki se uporablja za zdravljenje odvisnosti od opioidov,
English: ** Non-inferiority of dolutegravir plus rilpivirine to CAR, in the proportion of subjects classified as virologic non-responders, was demonstrated using a non-inferiority margin of 4%.
Slovenian: ** Neinferiornost kombinacije dolutegravirja in rilpivirina v primerjavi s trenutno protiretrovirusno shemo v deležu preiskovancev, opredeljenih kot virološko neodzivni, je bila določena z uporabo meje neinferiornosti 4 %.
English: For dolutegravir, when using the laboratory strain HIV-1 IIIB during passage over 112 days, mutations selected appeared slowly, with substitutions at positions S153Y and F; these mutations were not selected in patients treated with dolutegravir in the clinical studies.
Slovenian: Pri dolutegravirju so se pri uporabi laboratorijskega seva HIV-1 IIIB med prehodom v 112 dneh izbrane mutacije pojavile počasi, s substitucijami na položajih S153Y in F; v kliničnih študijah te mutacije pri bolnikih, zdravljenih z dolutegravirjem, niso bile izbrane.
English: Common side effects that may show up in blood tests are:
Slovenian: Pogosti neželeni učinki, ki se lahko pokažejo na preiskavah krvi, so:
English: In the week 48 analysis, 31 out of 62 of rilpivirine virologic failures had concomitant NNRTI and NRTI RAMs; 17 of those 31 had the combination of E138K and M184I.
Slovenian: V analizi podatkov po 48 tednih je imelo 31 od 62 bolnikov z virološkim neuspehom rilpivirina sočasne RAM proti NNRTI in NRTI; 17 od teh 31 bolnikov je imelo kombinacijo E138K in M184I.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Slovenian: Pomembni primeri so citomegalovirusni retinitis, generalizirane in/ali žariščne mikobakterijske okužbe in pljučnica, povzročena s Pneumocystis jirovecii.
English: In the case of the Q148-mutation viruses, increasing dolutegravir FC is seen as the number of secondary mutations increase.
Slovenian: V primeru virusov z mutacijo Q148 se FC dolutegravirja povečuje s povečevanjem števila sekundarnih mutacij.
English: Metabolism and nutrition disorders very common increased total cholesterol (fasted) increased LDL cholesterol (fasted)
Slovenian: Presnovne in prehranske motnje zelo pogosti zvišanje celokupnega holesterola (na tešče) zvišanje LDL holesterola (na tešče)
English: → Tell your doctor.
Slovenian: → Obvestite zdravnika.
English: Juluca can make you dizzy, tired or drowsy or and have other side effects that make you less alert.
Slovenian: Zdravilo Juluca lahko povzroči omotico, utrujenost ali zaspanost ali ima druge neželene učinke, ki lahko zmanjšajo pozornost.
English: Cmax ↑ 17% Norethindrone ↔ AUC ↔
Slovenian: Cmax ↑ 17 % noretindron ↔ AUC ↔
English: Juluca is used to treat HIV in adults aged 18 years and over who are taking other antiretroviral medicines and whose HIV-1 infection is under control for at least 6 months.
Slovenian: Zdravilo Juluca se uporablja za zdravljenje okužbe z virusom HIV pri odraslih, starih 18 let ali več, ki jemljejo druga protiretrovirusna zdravila in pri katerih je okužba z virusom HIV-1 pod nadzorom vsaj 6 mesecev.
English: Dolutegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral Deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle.
Slovenian: Dolutegravir zavira integrazo HIV z vezavo na aktivno mesto integraze in preprečevanjem prenosa vijačnice pri vgradnji retrovirusne deoksiribonukleinske kisline (DNA), ki je ključen za replikacijski ciklus HIV.
English: Using strain NL432, integrase mutations E92Q (fold change [FC] 3) and G193E (FC 3) were selected.
Slovenian: Pri uporabi seva NL432 sta bili izbrani mutaciji integraze E92Q (relativna sprememba [FC - fold change] 3) in G193E (FC 3).
English: 2 This interaction study has been performed with a dose higher than the recommended dose for rilpivirine assessing the maximal effect on the co-administered drug.
Slovenian: V tej študiji medsebojnega delovanja je bil uporabljeni odmerek rilpivirina večji od priporočenega odmerka, da bi lahko ocenili največji učinek na sočasno uporabljeno zdravilo.
English: INFORMATION IN BRAILLE juluca
Slovenian: PODATKI V BRAILLOVI PISAVI juluca
English: Systemic exposure to rilpivirine was generally lower in HIV-1 infected patients than in healthy subjects.
Slovenian: Sistemska izpostavljenost rilpivirinu je bila pri bolnikih, okuženih s HIV-1, praviloma manjša kot pri zdravih osebah.
English: Moderate and high fat meals increased the dolutegravir AUC(0-∞) by approximately 87% and Cmax by approximately 75%.
Slovenian: Zmerno in zelo mastni obroki so povečali AUC(0-∞) dolutegravirja za približno 87 % in njegovo Cmax za približno 75 %.
English: If you notice within 12 hours of the time you usually take Juluca, you must take the tablet as soon as possible.
Slovenian: Če to opazite v 12 urah po tem, ko po navadi vzamete zdravilo Juluca, vzemite tableto čim prej.
English: Within-subject variability (CVw%) is lower than between-subject variability.
Slovenian: Intraindividualna variabilnost (KVw%) je manjša kot interindividualna variabilnost.
English: • medicines that may cause a life threatening irregular heartbeat (Torsade de Pointes).
Slovenian: • zdravila, ki lahko povzročijo smrtno nevarno motnjo srčnega ritma (Torsade de Pointes).
English: • increase in bilirubin (a test of liver function) in your blood.
Slovenian: • zvišanje bilirubina (preiskave delovanja jeter) v krvi.
English: The single amino acid substitutions associated with a loss of susceptibility to rilpivirine were: K101P, Y181I and Y181V.
Slovenian: Enojne aminokislinske substitucije, povezane z izgubo občutljivosti za rilpivirin, so bile: K101P, Y181I in Y181V.
English: In the trials, the presence of the mutations V90I and V189I, at baseline, did not affect response.
Slovenian: V kliničnih preskušanjih izhodiščna prisotnost mutacij V90I in V189I ni vplivala na odziv.
English: If you are taking any of the above, ask your doctor about alternatives.
Slovenian: Če jemljete katero zgoraj naštetih zdravil, se z zdravnikom posvetujte o alternativah.
English: QT prolonging medicinal products
Slovenian: Zdravila, ki podaljšajo interval QT
English: Therefore, use of Juluca during pregnancy is not recommended (see sections 4.4, 4.6, 5.1 and 5.2).
Slovenian: Zato uporaba zdravila Juluca med nosečnostjo ni priporočljiva (glejte poglavja 4.4, 4.6, 5.1 in 5.2).
English: • aches and pains in the joints (especially in the hip, knee or shoulder)
Slovenian: • bolečine v sklepih (zlasti v kolku, kolenu ali rami),
English: • low white blood cell count
Slovenian: • majhno število belih krvnih celic,
English: Take the rilpivirine tablet at the same time you take Juluca.
Slovenian: Tableto rilpivirina vzemite hkrati z zdravilom Juluca.
English: When Juluca was taken with a meal, the absorption of both dolutegravir and rilpivirine was increased.
Slovenian: Če je bilo zdravilo Juluca uporabljeno z obrokom, se je povečala tako absorpcija dolutegravirja kot rilpivirina.
English: The pharmacokinetics of rilpivirine have not been studied in patients with renal insufficiency.
Slovenian: Farmakokinetike rilpivirina niso proučevali pri bolnikih z insuficienco ledvic.
English: The IC50 for dolutegravir against various laboratory strains using PBMC was 0.5 nM, and when using MT-4 cells it ranged from 0.7-2 nM.
Slovenian: IC50 dolutegravirja proti različnim laboratorijskim sevom z uporabo PBMC je bila 0,5 nM, ob uporabi celic MT-4 pa je segala od 0,7 do 2 nM.
English: • decreased number of platelets, which are involved in blood clotting
Slovenian: • zmanjšano število trombocitov, ki sodelujejo pri strjevanju krvi,
English: common increased bilirubin uncommon hepatitis rare acute hepatic failure**
Slovenian: pogosti zvišanje bilirubina občasni hepatitis redki akutna odpoved jeter**
English: All other drug-drug interactions shown are predicted.
Slovenian: Vsa druga prikazana medsebojna delovanja so na podlagi predvidevanj.
English: Rifabutin, a medicine to treat some bacterial infections, can lower the amount of Juluca in your body and make it less effective.
Slovenian: Rifabutin, zdravilo za zdravljenje nekaterih bakterijskih okužb, lahko zmanjša količino zdravila Juluca v telesu in zmanjša njegovo učinkovitost.
English: Each film-coated tablet contains 52 mg lactose (as monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 52 mg laktoze (v obliki monohidrata).
English: • signs or symptoms of inflammation or infection, for example fever, chills, sweats (immune reactivation syndrome).
Slovenian: • znaki ali simptomi vnetja ali okužbe, na primer zvišana telesna temperatura, mrzlica, potenje (sindrom imunske reaktivacije).
English: This combination may increase the risk for lactic acidosis in patients with moderate renal impairment (stage 3a creatinine clearance [CrCl] 45- 59 mL/min) and a cautious approach is recommended.
Slovenian: Ta kombinacija lahko pri bolnikih z zmerno okvaro ledvic (stadij 3a, očistek kreatinina [CrCl] 45-59 ml/min) poveča tveganje za laktacidozo, zato je priporočljiva previdnost.