natgillin/translations-raw huggingface dataset:
Only very limited data are available to support the range of indications and dose regimens and the CVMP was asked to review the data available and to recommend scientifcally justified indications and a safe and efficacious dosing regimen in horses.
Budući da su dostupni samo vrlo ograničeni podaci koji podržavaju raspon indikacija i režima doziranja, od CVMP-a zatraženo je da pregleda dostupne podatke te da preporuči znanstveno opravdane indikacije i učinkovite režime doziranja u konja.
The Committee considered that for any other indications for horses for injectable products contaning gentamicin, applicants/marketing authorisation holders (MAHs) would need to submit appropriate data, following up-to-date requirements.
Odbor je zaključio kako za bilo koju drugu indikaciju za konje za injektabilne VMP-ove koji sadrže gentamicin, podnositelji zahtjeva/nositelj odobrenja za stavljanje lijeka u promet (MAH) treba dostaviti odgovarajuće podatke u skladu s ažuriranim zahtjevima.
Pregnancy:
Gravidnost:
Lithuania Dopharma Research B.V. Zalmweg 24m 4941 VX Raamsdonksveer the Netherlands
Zalmweg 24m 4941 VX Raamsdonksveer Nizozemska
Nephrotoxicity is the main risk to the target animal from gentamicin that could occur within therapeutic doses.
Nefrotoksičnost je glavni rizik u ciljnih životinja uslijed primjene gentamicina, a može nastupiti u okviru terapijskih doza.
The use of gentamicin in foals and neonates is not recommended.
Primjena gentamicina u ždrjebadi i neonatalnih životinja nije preporučena.
Horse
Konj
Gentamicin is de-activated in the presence of inflammatory debris, low oxygen environments and low pH.
Gentamicin se deaktivira u prisutnosti upalnog debrija, okruženja male koncentracije kisika i niskog pH.
An application for the product Genta Equine 10% solution for injection for horses, containing gentamicin as the active substance was submitted to Denmark as a concerned Member State in a mutual recognition procedure (MRP) under the legal basis of Article 13(1) of Directive 2001/82/EC, i.e. a generic application.
Danska kao država članica u postupku podnijela je zahtjev za VMP Genta Equine 10% otopina za injekciju za konje, koji sadrži gentamicin kao djelatnu tvar, postupku međusobnog priznavanja (MRPu) po pravnoj osnovi članka 13. stavka 1. Direktive 2001/82/EZ, odnosno za generičku primjenu.
Croatia Krka - Farma d.o.o.
Hrvatska Krka - Farma d.o.o. Radnička cesta 48
Nephrotoxicity is especially a concern in foals.
Nefrotoksičnost je razlog za posebnu zabrinutost u ždrjebadi.
Latvia Huvepharma AD 33 James Boucher Blvd. Sofia 1407
Huvepharma AD 33 James Boucher Blvd.
• on the basis of the available data, the CVMP considered that the dosage regimen should be amended as described in Annex III;
• na osnovu dostupnih podataka, CVMP zaključio da se režim doziranja treba dopuniti kako je opisano u Prilogu III.;
Vijenac A. Cesarca 16
Cesarca 16
Gentamicin does not have effects on anaerobe bacteria and mycoplasmas.
Gentamicin ne djeluje na anaerobne bakterije i mikoplazme.
Close monitoring of horses being treated with gentamicin is strongly advised.
Izričito se preporuča pažljivo praćenje konja koji se liječe gentamicin.
The CVMP notes that pursuant to Article 36 of the Directive, its obligation is to consider the matter concerned and issue a reasoned opinion within the appropriate time limit.
Direktive, njegova obveza razmotriti predmetno pitanje te izdati pojašnjeno mišljenje unutar primjerenog vremenskog razdoblja.
Spain Laboratorios e Industrias IVEN, S.A
Španjolska Laboratorios e Industrias IVEN, S.A
Another mechanism predominates at low concentrations in which amino acid codons are misread by tRNA and proof-reading is impaired.
Drugi mehanizam predominira u malim koncentracijama u kojima tRNA pogrešno iščitava kodone amnino kiseline, te nastupa pogrešno čitanje dokaza.
Annex III
Prilogu III.;
This is primarily due to its fast bacteriocidal effect against Gram-negative bacteria for which there are only limited treatment choices available, its chemical stability and synergy with betalactam antibiotics.
Ovo je prvenstveno uzrokovano brzim baktericidnim djelovanjem protiv gram-negativnih bakterija za koje su dostupne samo ograničene mogućnosti terapije, kemijskom stabilnošću i sinergijom s beta-laktam antibioticima.
Since the reference product is only authorised in Ireland, the concept of the European reference product has been applied in this MRP.
U irskoj, koncept europskog referentnog VMP-a primijenjen je u ovom MRP-u.
Scientific conclusions and grounds for amendment of the summaries of product characteristics, labelling and package leaflets
Znanstveni zaključci i razlozi za dopunu sažetaka opisa svojstava proizvoda, etiketa i uputa za uporabu
Overall summary of the scientific evaluation of veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses (see Annex I)
Cjelokupan sažetak znanstvene ocjene veterinarskomedicinskih lijekova koji sadrže gentamicin dostupan kao otopine za injekciju predviđene za primjenu u konja (vidjeti Prilog I.)
The CVMP also considered the benefit-risk balance for injectable veterinary medicinal products containing gentamicin for horses positive when the posology for adult horses (with appropriate warnings and advice on dosing) is changed to: “Single dose of 6.6 mg/kg bw given intravenously once daily for 3-5 consecutive days.
CVMP je, također, zaključio da je omjer koristi i rizika za injektibilne veterinarsko-medicinske proizvode koji sadrže gentamicin za konje pozitivan ukoliko se doziranje u odraslih konja (popraćeno odgovarajućim upozorenjima i savjetima o doziranju) promjeni u: „Jedna doza od 6,6 mg/kg tt primijenjena intravenozno jednom dnevno tijekom 3-5 uzastopnih dana.
As such, no margin of safety has been established in neonatal foals.
Stoga, nije utvrđeno ograničenje sigurne primjene u neonatalne ždrjebadi.
Gentamicin sulphate exerts concentration-dependent bacterial killing characteristics.
Gentamicin sulfat odlikuje se svojstvima koja ubijaju bakterije ovisno o koncentraciji.
The use of the products has been limited to an indication for which gentamicin is considered efficacious on the basis of the data and information available.
Mjere za upravljanje rizikom ili smanjivanje rizika Uporaba VMP-ova ograničena je na indikaciju za koju se gentamicin smatra djelotvornim na dostupnih osnovu podataka i informacija.
Spain Laboratorios e Industrias IVEN, S.A.
Španjolska Laboratorios e Industrias IVEN, S.A.
It was understood that the indications would not be unique to these two products and other injectable veterinary medicinal products containing gentamicin for use in horses authorised in the EU have approved different doses, and the concers and considerations would apply equally to these.
Mišljenje je da indikacije ne bi bile jedinstvene za ova dva VMP-a i druge injektibilne VMP-ove, koji sadrže gentamicin za primjenu u konja, a odobreni su za stavljanje u promet u EU, te su odobreni za primjenu u različitim dozama.
Latvia KELA N.V. St. Lenaartseweg 48 2320 Hoogstraten Belgium
Lenaartseweg 48 2320 Hoogstraten Belgija
Thus only the scientific questions posed to the CVMP in the referral notification have been considered and are reported below.
Stoga se su u obavijesti o upućivanju razmotrena samo znanstvena pitanja upućena CVMP-u, te je o istima izvješteno.
Applicant/Marketing Authorisation Holder
Podnositelj zahtjeva/ nositelj odobrenja za stavljanje lijeka u promet
O-Adenyltransferases (ANT) - catalyses ATP-dependent adenylation of hydroxyl group
O-adeniltransferaze (ANT) - katalizira adenilaciju ovisnu o ATP-u hidroksil grupe
Gentamicin is a narrow-spectrum Gram-negative bactericidal antimicrobial, without effects on anaerobe bacteria and mycoplasmas.
Gentamicin je gram-negativan baktericidni antimikrobik uskog spektra, bez djelovanja na anaerobne bakterije i mikroplazme.
Gentamicin is used for first or second choice treatments in a variety of clinical situations in horses.
Gentamicin se koristi kao terapija prve ili druge linije u različitim kliničkim situacijama u konja. va kemijska stabilnost ne indikacije.
31303 Burgdorf Germany
31303 Burgdorf Njemačka
• on the basis of the available data, the CVMP considered that the indication as provided in Annex III
• na osnovu dostupnih podataka, CVMP zaključio da su opravdane indikacije koje su navedene u
• the CVMP considered that the overall benefit-risk balance is positive for the veterinary medicinal products (see annex I), subject to amendments in the product information; the CVMP recommended variations of the marketing authorisations for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses, in order to amend the summaries of product characteristics, labelling and package leaflets as set out in Annex III.
(vidjeti Prilog I.) pozitivan, što je predmetom izmjena informacija o proizvodu; CVMP je preporučio izmjene odobrenja za stavljanje lijeka u promet za veterinarsko-medicinske proizvode koji sadrže gentamicin, a primjenjuju se kao otopine za injekciju za primjenu u konja, sa ciljem izmjene sažetka opisa svojstava VMP-a, etikete i upute o VMP-u kako je navedeno u Prilogu III.
Gentamicin does not penetrate intracellularly, or into abscesses.
Gentamicin ne penetrira intrastanično ili u apcese.
Bovine (calves up to 250 kg), porcine (suckling pigs), equine not intended for human consumption, dogs and cats
Goveda (telad do 250 kg), praščići (svinje koje sisaju), konji koji se ne koriste u prehrani ljudi, psi i mačke
Gentamicin is deactivated in the presence of inflammatory debris, low oxygen environments and low pH. Gentamicin is eliminated unchanged by the kidney via glomerular filtration, including 85-95% of the dose.
Bubrezi eliminiraju nepromijenjen gentamicin putem glomerularne filtracije, uključujući 85-95% doze.
31303 Burgdorf,
31303 Burgdorf, Njemačka
Therefore, the CVMP considers that no dosing regimen should be specified for foals, and currently approved dosing regimens for foals should be deleted from the product information, due to lack of target animal safety data especially concerning nephrotoxicity.
Stoga je CVMP zaključio da se trebaju obrisati iz informacija o proizvodu, uslijed nedostatka podataka o sigurnoj primjeni u ciljnih životinja, posebice vezano uz nefrotoksičnost.
The target animal safety of injectable gentamicin products for horses is considered not proven for use in foals.
Zaključeno je kako sigurna primjena u ciljnih životinja injektibilnih VMP-ova koji sadrže gentamicin za konje nije dokazana u ždrjebadi.
The CVMP considered the benefit-risk balance for injectable veterinary medicinal products containing gentamicin for horses positive for the following indication: “For the treatment of infections of the lower respiratory tract in horses caused by Gram-negative bacteria susceptible to gentamicin.”
CVMP je zaključio da je omjer koristi i rizika za injektibilne veterinarsko-medicinske proizvode koji sadrže gentamicin za konje pozitivan za sljedeću indikaciju: „Za liječenje infekcija donjeg respiratornog trakta u konja uzrokovano aerobnim gram-negativnim bakterijama podložnima gentamicinu.”
N-Acetyltransferases (AAC) - catalyses acetyl CoA-dependent acetylation of an amino group
N-acetiltransferaze (AAC) - katalizira acetilaciju ovisnu o acetil CoA amino grupe
For the treatment of infections of the lower respiratory tract in horses caused by aerobic Gramnegative bacteria susceptible to gentamicin.
Za liječenje infekcija nižeg respiratornog trakta u konja uzrokovano aerobnim gram-negativnim bakterijama osjetljivima na gentamicin.
The CVMP considered that the lack of data and limited scientific evidence would only support a narrow indication, i.e. “For the treatment of infections of the lower respiratory tract in horses caused by aerobic Gramnegative bacteria susceptible to gentamicin.”
Odbor je stoga zaključio kako bi nedostatak podataka i ograničeni znanstveni dokazi podržavali samo uski spektar indikacija, odnosno „Za liječenje infekcija donjeg respiratornog trakta u konja uzrokovano aerobnim gram-negativnim bakterijama podložnima gentamicinu.”
It is therefore not recommended to use the product in foals.
Stoga, primjena se ne preporučuje primjena proizvoda u ždrjebadi.
Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflet
Izmjene relevantnih dijelova sažetka opisa svojstava, etiketa i uputa o VMP-u
Cattle, horses (non-food producing), pigs, dogs and cats
Goveda, konji (koji se ne koriste u prehrani ljudi), svinje, psi i mačke
Horses declared as not being intended for slaughter for human consumption.
Konji koji nisu predviđeni za klanje za prehranu ljudi
Two other mechanisms of resistance include ribosomal mutations of the binding site of aminoglycosides, the 30S subunit, and the bacteria decreasing the permeability of aminoglycosides.
O-fosfotransferaze (APH) - katalizira fosforilaciju ovisnu o ATP-u hidroksil grupe Druga dva mehanizma rezistencije uključuju ribosomalne mutacije u mjestu vezivanja aminoglikozida, 30S podjedinice i bakterija koje smanjuju permeabilnost aminoglikozida.
Cattle, pig, horse declared as not being intended for slaugther for human consumption, cat, dog
Goveda, svinje, konji koji nisu predviđeni za klanje za prehranu ljudi, mačke, psi
Only one proprietary study in support of the approved dosing regimen for a product included in the scope of this referral was provided.The CVMP considered this study was of limited value to their assessment.
Dostavljeno je samo jedno vlasničko ispitivanje u prilog odobrenom režimu doziranja za proizvod uključen u predmet ovog postupka upućivanja.
Cattle, horse, swine
Goveda, konji, svinje
Spain LABORATORIOS MAYMO, S.A.
Španjolska LABORATORIOS MAYMO, S.A. Via Augusta, 302
Safety of gentamicin has not been established in foals and there is a lack of knowledge of the extra effects of gentamicin on foal kidneys, especially neonates.
Još uvijek nije utvrđena sigurna primjena gentamicina u ždrjebadi, te postoji nedostatak znanja dodatnog djelovanja gentamicina na bubrege ždrjebadi, posebice tek neonatalne ždrjebadi. d, posebice neonatalna ždrjebad, izložena većem riziku od nefrotoksičnosti inducirane gentamicinom u usporedbi s odraslim životinjama.
The dosing regimen must not be exceeded.” The CVMP considered the benefit-risk balance for injectable veterinary medicinal products containing gentamicin for horses negative for use in foals.
CVMP je zaključio da je omjer koristi i rizika za injektibilne veterinarsko-medicinske proizvode koji sadrže gentamicin za konje negativan za primjenu u ždrjebadi.
The lack of data and limited scientific evidence would only support a narrow indication, i.e. “For the treatment of infections of the lower respiratory tract in horses caused by aerobic Gram-negative bacteria susceptible to gentamicin.” This indication is consistent with the distribution pattern of gentamicin, which is primarily in the extracellular fluid.
Nedostatak podataka i ograničeni znanstveni dokazi podržavali bi samo uski spektar indikacija, odnosno „Za liječenje infekcija donjeg respiratornog trakta u konja uzrokovano aerobnim gramnegativnim bakterijama podložnima gentamicinu.”
Non foodproducing horses, cattle and pigs
Konji koji se ne koriste u prehrani ljudi, goveda i svinje
Grounds for amendment of the summaries of product characteristics, labelling and package leaflets
Razlozi za dopunu sažetaka opisa svojstava proizvoda, etiketa i uputa o lijeku
Horses (non food producing horse).
Konji (konji koji se ne koriste za prehranu ljudi).
Horse, foal, cattle, calf, pig, dog, cat
Konj, ždrijebe, govedo, tele, svinja, pas, mačka
Special precautions for use in animals
4.5. Posebne mjere opreza prilikom primjene Posebne mjere opreza prilikom primjene na životinjama
No margin of safety has been established under the approved dosing regimen.
U odobrenim doziranjima nije utvrđeno ograničenje sigurne primjene.
Horses (non food producing horses)
Konji (koji se ne koriste u prehrani ljudi)
Dog, cat, pig, piglets, cattle, calves, horses
Pas, mačka, svinja, praščići, goveda, telad, konji
Cattle, calves, pigs, piglets, horses, cats and dogs.
Goveda, telad, svinje, praščići, konji, mačke i psi.
Cats, dogs, cattle, pigs, horses
Mačke, psi, goveda, svinje, konji
Horse, foal, cattle, calf, pig, piglet, weaner, dog and cat
Konj, ždrijebe, govedo, tele, svinja, praščić, prase, pas i mačka
Belgium Franklin Pharmaceuticals Ltd. Athboy Road
Belgija Franklin Pharmaceuticals Ltd.
Non foodproducing horses, cattle, dogs and cats
Konji koji se ne koriste u prehrani ljudi, goveda, psi i mačke
Iceland Franklin Pharmaceuticals Ltd. Athboy Road
Island Franklin Pharmaceuticals Ltd.
Cats, cattle, dogs, horses
Mačke, goveda, psi, konji
Horses, cattle, pigs, dogs and cats
Konji, goveda, svinje, psi i mačke
Cattle, horses, dogs and cats
Goveda, konji, psi i mačke
Equine not intended for human consumption, dogs, cats
Konji koji se ne koriste u prehrani ljudi, psi, mačke
Pigs, cattle, dogs, horses
Svinje, goveda, psi, konji
Denmark Franklin Pharmaceuticals Ltd. Athboy Road
Danska Franklin Pharmaceuticals Ltd.
Pigs, cats, cattle, dogs, horses
Svinje, mačke, goveda, psi, konji
Horses, cattle, dogs and cats
Konji, goveda, psi i mačke
Sweden Franklin Pharmaceuticals Ltd. Athboy Road
Švedska Franklin Pharmaceuticals Ltd.
Spain Franklin Pharmaceuticals Ltd. Athboy Road
Španjolska Franklin Pharmaceuticals Ltd.
It is important to tell your doctor if you are taking:
Važno je obavijestiti svog liječnika ako uzimate:
Consumption of alcohol and medicinal products containing alcohol should be avoided.
Potrebno je izbjegavati konzumaciju alkohola i lijekova koji sadrže alkohol.
The mean volume of distribution (Vd) ranged between 63 - 276 l.
Prosječni volumen distribucije (Vd) kretao se u rasponu između 63 - 276 l.
Patients (%) achieving
Bolesnici (%) s postignutim
Gastrointestinal symptoms3, 5
Gastrointestinal ni simptomi3, 5
It particularly affects patients whose kidneys are not working properly.
Ona osobito pogađa bolesnike čiji bubrezi ne rade kako treba.
Body Weight (kg)
N Tjelesna težina (kg)
The recommended dose is one tablet twice a day.
Preporučena doza je jedna tableta dvaput dnevno.
• at least annually in patients with normal renal function
• najmanje jedanput godišnje u bolesnika s normalnom funkcijom bubrega
• at least two to four times a year in patients with serum creatinine levels at the upper limit of normal and in elderly subjects
• najmanje dva do četiri puta godišnje u bolesnika s vrijednostima kreatinina u serumu pri gornjoj granici normale i u starijih osoba
(≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), or very rare (<1/10,000), and not known (cannot be estimated from the available data).
(≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), ili vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
• if you are being sick, have diarrhoea or fever, or if you are not able to eat or drink.
• ako povraćate, imate proljev ili vrućicu, ili ako ne možete jesti ili piti.
Therefore, serum creatinine levels should be determined before initiating treatment and regularly thereafter:
Stoga je potrebno odrediti vrijednosti kreatinina u serumu prije započinjanja liječenja te redovito nakon toga:
Follow your doctor's instructions about stopping and re-starting your medicine.
Slijedite upute liječnika o prekidu i ponovnom uzimanju lijeka.
Make sure to ask your doctor for advice regarding when you can start your treatment again;
Obavezno se posavjetujte s liječnikom kada možete ponovo započeti liječenje;
Synjardy should be discontinued, at least temporarily, until the situation is clarified.
Potrebno je barem privremeno prekinuti primjenu Synjardya dok se situacija ne razjasni.
Patients should be instructed to notify these signs immediately to their physicians if they occur, notably if patients had a good tolerance to Synjardy before.
Potrebno je uputiti bolesnike da odmah obavijeste liječnike o tim znakovima ako se pojave, naročito ako su bolesnici ranije dobro podnosili Synjardy.
Synjardy can also be combined with other medicines.
Synjardy se također može primjenjivati u kombinaciji s drugim lijekovima.
You will need to tell your doctor and stop taking this medicine before, or at the time of the X-ray and for 2 or more days after depending on how your kidneys are working.
Trebat ćete obavijestiti svog liječnika i prekinuti uzimanje ovog lijeka prije ili tijekom rendgenskog snimanja te 2 ili više dana nakon toga ovisno koliko dobro rade Vaši bubrezi.
This is a build-up of lactic acid in the blood that can cause death.
To je nakupljanje laktatne kiseline u krvi, što može izazvati smrt.
The patient should be informed and more frequent blood glucose monitoring performed, especially at the beginning of treatment with such medicinal products.
Potrebno je obavijestiti bolesnika i provoditi češće kontrole glukoze u krvi, naročito na početku liječenja takvim lijekovima.
Stop taking Synjardy and see a doctor as soon as possible if you notice any of the following serious or potentially serious side effects:
Prestanite uzimati Synjardy i obratite se liječniku što je prije moguće ako primijetite sljedeće ozbiljne ili potencijalno ozbiljne nuspojave:
• if you are going to have an operation under anaesthesia.
• ako ćete biti podvrgnuti kirurškom zahvatu pod anestezijom.
Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection1, 2
Vaginalna monilijaza, vulvovaginitis, balanitis i druge genitalne infekcije1, 2
As this medicinal product contains metformin, the treatment must be discontinued 48 hours before elective surgery with general, spinal or peridural anaesthesia.
Budući da ovaj lijek sadrži metformin, liječenje se mora obustaviti 48 sati prije elektivnog kirurškog zahvata u općoj, spinalnoj ili periduralnoj anesteziji.
Frequencies are defined as very common
Učestalosti su definirane kao: vrlo često
In case of lactic acidosis, the patient should be hospitalised immediately (see section 4.9).
U slučaju laktacidoze, bolesnika je potrebno odmah hospitalizirati (vidjeti dio 4.9).
Physicians should alert the patients on the risk and on the symptoms of lactic acidosis.
Liječnici moraju upozoriti bolesnike na rizik i simptome laktacidoze.
Signs of ‘lactic acidosis' are:
Znakovi ‘laktacidoze' su:
Please note the following particular risk of lactic acidosis.
Molimo obratite pažnju na sljedeći specifičan rizik od laktacidoze.
By blocking this protein, the medicine causes blood sugar to be removed via the urine.
Blokiranjem tog proteina ovaj lijek dovodi do uklanjanja šećera u krvi putem mokraće.
In the acute conditions listed, metformin should be temporarily discontinued.
U navedenim akutnim stanjima potrebno je privremeno prekinuti primjenu metformina.
Further symptoms are reduced body temperature and heart beat.
Daljnji simptomi su snižena tjelesna temperatura i usporeni otkucaji srca.
• a medicine used to remove water from the body (diuretic), as Synjardy may increase the risk of losing too much fluid.
• lijek koji se primjenjuje za uklanjanje vode iz tijela (diuretik), budući da Synjardy može povećati rizik od prekomjernog gubitka tekućine.
• Renal failure or renal dysfunction (creatinine clearance <60 ml/min).
• Zatajenje ili disfunkcija bubrega (klirens kreatinina < 60 ml/min.).
a derived from postmarketing experience b see section 4.4
a podatak iz iskustva nakon stavljanja lijeka u promet b vidjeti dio 4.4
In the population pharmacokinetic analysis, AUC was estimated to be 13.5% higher in Asians with a body mass index of 25 kg/m2 compared to non-Asians with a body mass index of 25 kg/m2.
U farmakokinetičkoj analizi populacije procijenjeno je da je AUC bio 13,5 % viši u Azijata s indeksom tjelesne mase 25 kg/m2 u usporedbi s ne-Azijatima s indeksom tjelesne mase od 25 kg/m2.
Due to the metformin component, Synjardy may cause a very rare, but very serious complication called lactic acidosis, particularly if your kidneys are not working properly.
Zbog sadržanog metformina Synjardy može prouzročiti vrlo rijetku, ali jako ozbiljnu komplikaciju pod nazivom laktacidoza, naročito ako Vaši bubrezi ne rade ispravno.