natgillin/translations-raw huggingface dataset:
- difficulty in breathing - reduced body temperature and heartbeat.
- splošno slabo počutje s hudo utrujenostjo - težave z dihanjem - znižano telesno temperaturo in počasen srčni utrip.
Common (may affect up to 1 in 10 people): - Symptoms of low blood sugar (hypoglycaemia) may occur when Vipdomet is taken in combination with insulin or sulphonylureas (e.g. glipizide, tolbutamide, glibenclamide).
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): - Simptomi nizkega krvnega sladkorja (hipoglikemije) se lahko pojavijo, če zdravilo Vipdomet jemljete skupaj z insulinom ali s sulfonilsečninami (npr. glipizid, tolbutamid, glibenklamid).
- Severe and persistent pain in the abdomen (stomach area) which might reach through to your back as well as nausea and vomiting, as it could be a sign of an inflamed pancreas (pancreatitis).
- Huda in trdovratna bolečina v trebuhu (v predelu želodca), ki lahko izžareva v hrbet, pa tudi siljenje na bruhanje in bruhanje, so lahko znak vnetja trebušne slinavke (pankreatitisa).
Maximum daily dose is 12.5 mg
Največji dnevni odmerek je 12,5 mg.
Taking Vipdomet in combination with medicines called pioglitazone or insulin can cause too low blood sugar levels (hypoglycaemia), which may affect your ability to drive and use machines.
Pri jemanju zdravila Vipdomet v kombinaciji s pioglitazonom ali z insulinom se lahko vrednost krvnega sladkorja prekomerno zniža (hipoglikemija), kar lahko vpliva na sposobnost za vožnjo vozil in upravljanje strojev.
A large overdose of metformin or concomitant risks may lead to lactic acidosis.
Znatno preveliko odmerjanje metformina ali sočasna tveganja lahko privedejo do laktacidoze.
Your doctor may want to reduce your dose of insulin or a thiazolidinedione when you take it together with Vipdomet in order to avoid too low blood sugar (hypoglycaemia).
Zdravnik se bo morda odločil za zmanjšanje odmerka insulina ali tiazolidindiona, če ga boste jemali skupaj z zdravilom Vipdomet, da prepreči pojav prenizkega krvnega sladkorja (hipoglikemije).
Avoid excessive alcohol intake while taking Vipdomet since this may increase the risk of lactic acidosis - see section “Warnings and precautions”.
Med jemanjem zdravila Vipdomet ne uživajte čezmernih količin alkohola, saj lahko to poveča tveganje za laktacidozo (glejte poglavje "Opozorila in previdnostni ukrepi").
- in muscle, by modestly increasing insulin sensitivity, improving peripheral glucose uptake and utilisation.
- v mišicah zmerno poveča občutljivost za insulin, izboljša periferni vnos in izkoriščanje glukoze.
Vipdomet is used to lower blood sugar levels in adults with type 2 diabetes.
Zdravilo Vipdomet uporabljamo za zniževanje vrednosti krvnega sladkorja pri odraslih s sladkorno boleznijo tipa 2.
A lower dose of insulin may be considered to reduce the risk of hypoglycaemia.
Razmisliti je treba o zmanjšanju odmerka insulina, da se zmanjša tveganje za hipoglikemijo.
Some medicinal products can adversely affect renal function which may increase the risk of lactic acidosis, e.g. NSAIDs, including selective cyclo-oxygenase (COX) II inhibitors, angiotensinconverting enzyme (ACE) inhibitors, angiotensin II receptor antagonists and diuretics, especially loop diuretics.
Nekatera zdravila lahko škodljivo vplivajo na delovanje ledvic, kar lahko poveča tveganje za laktacidozo, npr. NSAID, vključno s selektivnimi zaviralci ciklooksigenaze (COX - cyclo-oxygenase) II, zaviralci angiotenzinske konvertaze (ACE - angiotensin-converting enzyme), antagonisti receptorjev angiotenzina II in diuretiki, zlasti diuretiki Henlejeve zanke.
The amount of Vipdomet will vary depending on your condition and the doses you currently take of metformin alone, metformin in combination with pioglitazone, insulin and/or individual tablets of alogliptin and metformin.
Odmerek zdravila Vipdomet je odvisen od vašega zdravstvenega stanja in odmerkov zdravil, ki jih trenutno jemljete, to je metformina samega, metformina v kombinaciji s pioglitazonom, insulina in/ali posameznih tablet alogliptina in metformina.
- in case of symptoms suggestive of liver injury during Vipdomet therapy.
- če se pojavijo simptomi poškodbe jeter med jemanjem zdravila Vipdomet.
Higher rates of hypoglycaemia were observed with triple therapy with a thiazolidinedione and metformin and in combination with insulin, as observed with other DPP-4 inhibitors.
Večji deleži hipoglikemije so bili opaženi pri trotirnem zdravljenju s tiazolidindionom in z metforminom in v kombinaciji z insulinom, tako kot pri drugih zaviralcih DPP-4.
As Vipdomet contains metformin, any patient with type 2 diabetes mellitus previously well controlled on Vipdomet who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis.
Ker zdravilo Vipdomet vsebuje metformin, je treba pri vsakem bolniku s sladkorno boleznijo tipa 2, ki je bil predhodno z uporabo zdravila Vipdomet dobro nadzorovan, nato pa so se pojavili nenormalni izvidi laboratorijskih preiskav ali klinične bolezni (še posebej nejasne ali slabo opredeljene bolezni), nemudoma ugotoviti, če ima ketoacidozo ali laktacidozo.
If acidosis of either form occurs, Vipdomet must be stopped immediately and other appropriate corrective measures initiated.
Če se pojavi acidoza v kateri koli obliki, je treba zdravljenje z zdravilom Vipdomet takoj prekiniti in uvesti ustrezno zdravljenje.
Risk related to metformin
Tveganja, povezana z metforminom
Lactic acidosis is a medical emergency and must be treated in a hospital.
Laktacidoza je nujni medicinski primer in jo je treba zdraviti v bolnišnici.
Following oral administration of an 850 mg metformin hydrochloride tablet, the peak plasma concentration was 40% lower, AUC was decreased by 25% and the time to peak plasma concentration (Tmax) was prolonged by 35 minutes.
Po peroralni uporabi 850-mg tablete metforminijevega klorida je bila največja koncentracija v plazmi manjša za 40 %, vrednost AUC manjša za 25 %, čas do nastopa največje koncentracije v plazmi (Tmax) pa daljši za 35 minut.
Metabolism and nutrition disorders lactic acidosis very rare vitamin B12 deficiency very rare hypoglycaemia common common
Presnovne in prehranske motnje laktacidoza zelo redki pomanjkanje vitamina B12
Gastrointestinal disorders gastroenteritis common abdominal pain common very common common diarrhoea common very common common vomiting very common common gastritis common gastroesophageal reflux disease common common loss of appetite very common nausea very common acute pancreatitis not known
Bolezni prebavil gastroenteritis pogosti bolečina v trebuhu pogosti zelo pogosti pogosti driska pogosti zelo pogosti pogosti bruhanje zelo pogosti pogosti gastritis pogosti gastroezofagealni refluks pogosti pogosti izguba apetita zelo pogosti navzea zelo pogosti akutni pankreatitis neznana
Pack sizes of 10, 14, 20, 28, 56, 60, 98, 112, 120, 180, 196, 200 or multipacks containing 196 (2 packs of 98) film-coated tablets.
Velikost pakiranj: 10, 14, 20, 28, 56, 60, 98, 112, 120, 180, 196, 200 ali večodmerno pakiranje s 196 (2 pakiranji s 98) filmsko obloženimi tabletami.
A single dose of 50 mg alogliptin was administered to 4 groups of patients with varying degrees of renal impairment (CrCl using the Cockcroft-Gault formula): mild (CrCl = >50 to ≤80 mL/min), moderate (CrCl = ≥30 to ≤50 mL/min), severe (CrCl = <30 mL/min) and end-stage renal disease on haemodialysis.
Enkratni odmerek 50 mg alogliptina so prejele 4 skupine bolnikov z različno stopnjo okvare ledvic (CrCl po enačbi Cockcroft-Gault): blaga (CrCl = >50 do ≤80 ml/min), zmerna (CrCl = ≥30 do ≤50 ml/min), huda (CrCl = <30 ml/min) in končna ledvična odpoved na hemodializi.
Minimal quantities of alogliptin are removed by haemodialysis (approximately 7% of the substance was removed during a 3 hour haemodialysis session).
Pri hemodializi se odstranijo le majhne količine alogliptina (med 3-urno hemodializo se ga je odstranilo le približno 7 %).
If you forget to take Vipdomet
Če ste pozabili vzeti zdravilo Vipdomet
EU/1/13/843/013 10 film-coated tablets EU/1/13/843/014 14 film-coated tablets EU/1/13/843/015 20 film-coated tablets EU/1/13/843/016 28 film-coated tablets EU/1/13/843/017 56 film-coated tablets EU/1/13/843/018 60 film-coated tablets EU/1/13/843/019 98 film-coated tablets EU/1/13/843/020 112 film-coated tablets EU/1/13/843/021 120 film-coated tablets EU/1/13/843/022 180 film-coated tablets EU/1/13/843/023 196 film-coated tablets EU/1/13/843/024 200 film-coated tablets
EU/1/13/843/013 10 filmsko obloženih tablet EU/1/13/843/014 14 filmsko obloženih tablet EU/1/13/843/015 20 filmsko obloženih tablet EU/1/13/843/016 28 filmsko obloženih tablet EU/1/13/843/017 56 filmsko obloženih tablet EU/1/13/843/018 60 filmsko obloženih tablet EU/1/13/843/019 98 filmsko obloženih tablet EU/1/13/843/020 112 filmsko obloženih tablet EU/1/13/843/021 120 filmsko obloženih tablet EU/1/13/843/022 180 filmsko obloženih tablet EU/1/13/843/023 196 filmsko obloženih tablet EU/1/13/843/024 200 filmsko obloženih tablet
Your doctor will decide when you must stop and when to restart your treatment with Vipdomet.
Zdravnik se bo odločil, kdaj morate z jemanjem zdravila Vipdomet prenehati in kdaj lahko nadaljujete.
EU/1/13/843/001 10 film-coated tablets EU/1/13/843/002 14 film-coated tablets EU/1/13/843/003 20 film-coated tablets EU/1/13/843/004 28 film-coated tablets EU/1/13/843/005 56 film-coated tablets EU/1/13/843/006 60 film-coated tablets EU/1/13/843/007 98 film-coated tablets EU/1/13/843/008 112 film-coated tablets EU/1/13/843/009 120 film-coated tablets EU/1/13/843/010 180 film-coated tablets EU/1/13/843/011 196 film-coated tablets EU/1/13/843/012 200 film-coated tablets
EU/1/13/843/001 10 filmsko obloženih tablet EU/1/13/843/002 14 filmsko obloženih tablet EU/1/13/843/003 20 filmsko obloženih tablet EU/1/13/843/004 28 filmsko obloženih tablet EU/1/13/843/005 56 filmsko obloženih tablet EU/1/13/843/006 60 filmsko obloženih tablet EU/1/13/843/007 98 filmsko obloženih tablet EU/1/13/843/008 112 filmsko obloženih tablet EU/1/13/843/009 120 filmsko obloženih tablet EU/1/13/843/010 180 filmsko obloženih tablet EU/1/13/843/011 196 filmsko obloženih tablet EU/1/13/843/012 200 filmsko obloženih tablet
Vipdomet combines two antihyperglycaemic medicinal products with complementary and distinct mechanisms of action to improve glycaemic control in patients with type 2 diabetes mellitus: alogliptin, a dipeptidyl-peptidase-4 (DPP-4) inhibitor, and metformin, a member of the biguanide class.
Zdravilo Vipdomet je kombinacija dveh antihiperglikemičnih zdravil s komplementarnim in ločenim mehanizmom delovanja, namenjeno za izboljšanje urejenosti glikemije pri bolnikih s sladkorno boleznijo tipa 2: alogliptina, zaviralca dipeptidil-peptidaze-4 (DPP-4) in metformina, ki spada v skupino bigvanidov.
Skin and subcutaneous tissue disorders pruritus common very rare common rash common common erythema very rare exfoliative skin conditions including StevensJohnson syndrome not known erythema multiforme not known angioedema not known urticaria not known very rare
Bolezni kože in podkožja pruritus pogosti zelo redki pogosti izpuščaj pogosti pogosti eritem zelo redki eksfoliativne bolezni kože, vključno s Stevens-Johnsonovim sindromom neznana multiformni eritem neznana angioedem neznana urtikarij neznana zelo redki
Combination requiring precautions for use
Kombinacije, ki jih je treba uporabljati previdno
Vipdomet is available in blister packs containing 10, 14, 20, 28, 56, 60, 98, 112, 120, 180, 196, 200 tablets and in multipacks comprising 2 packs each containing 98 film-coated tablets.
Zdravilo Vipdomet je na voljo v pretisnih omotih, ki vsebujejo 10, 14, 20, 28, 56, 60, 98, 112, 120, 180, 196, 200 tablet, ali v večodmernem pakiranju, ki vsebuje 2 pakiranji po 98 filmsko obloženih tablet.
Alogliptin has not been studied in patients with severe hepatic impairment (Child-Pugh score >9) and is, therefore, not recommended for use in such patients (see sections 4.2, 4.3 and 5.2).
Pri bolnikih s hudo okvaro jeter (ocena po Child-Pugh-u >9) uporabe alogliptina niso raziskovali, zato njegova uporaba pri teh bolnikih ni priporočljiva (glejte poglavja 4.2, 4.3 in 5.2).
Hypersensitivity reactions, including Stevens-Johnson syndrome, anaphylactic reactions, and angioedema are serious and are attributed to the alogliptin component of Vipdomet (see section 4.4).
Preobčutljivostne reakcije, vključno s Stevens-Johnsonovim sindromom, anafilaktičnimi reakcijami in angioedemom, so resne in jih je mogoče pripisati vsebnosti alogliptina v zdravilu Vipdomet (glejte poglavje 4.4).
The highest doses of alogliptin administered in clinical studies were single doses of 800 mg to healthy subjects and doses of 400 mg once daily for 14 days to patients with type 2 diabetes mellitus (equivalent to 32 times and 16 times the recommended total daily dose of 25 mg alogliptin, respectively).
Največji odmerki alogliptina, uporabljeni v okviru kliničnih študij, so bili enkratni odmerki 800 mg pri zdravih osebah in odmerki 400 mg enkrat na dan v obdobju 14 dni pri bolnikih s sladkorno boleznijo tipa 2 (kar je 32-krat oziroma 16-krat več od priporočenega dnevnega odmerka 25 mg alogliptina).
Renal clearance of metformin is >400 mL/min indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Ledvični očistek metformina je večji od 400 ml/min, kar kaže, da se metformin izloča z glomerulno filtracijo in tubulno sekrecijo.
Interactions with metformin
Medsebojno delovanje z metforminom
Therefore, haemodialysis is of little clinical benefit in removing alogliptin in overdose.
Hemodializa ima v primeru prevelikega odmerjanja tako le majhno klinično korist za odstranitev alogliptina.
The following section outlines the pharmacokinetic properties of the individual components of Vipdomet (alogliptin/metformin) as reported in their respective Summary of Product Characteristics.
V nadaljevanju so navedene farmakokinetične lastnosti posameznih učinkovin zdravila Vipdomet (alogliptin/metformin), kot so navedene v njunih povzetkih glavnih značilnosti zdravila.
A total of 7,151 patients with type 2 diabetes mellitus, including 4,202 patients treated with alogliptin and metformin, participated in 7 phase 3 double-blind, placebo- or active-controlled clinical studies conducted to evaluate the effects of co-administered alogliptin and metformin on glycaemic control and their safety.
Skupno 7.151 bolnikov s sladkorno boleznijo tipa 2, vključno s 4.202 bolnikom, zdravljenim z alogliptinom in metforminom, je bilo vključenih v 7 dvojno slepih, s placebom ali z zdravilno učinkovino nadzorovanih kliničnih študij 3. faze, z namenom ovrednotenja učinkov sočasne uporabe alogliptina in metformina na urejenost glikemije in njuno varnost.
If you stop taking Vipdomet
Če ste prenehali jemati zdravilo Vipdomet
Vipdomet is taken when your blood sugar cannot be adequately controlled by diet, exercise and other anti-diabetic medicines such as metformin alone; insulin alone; or metformin and pioglitazone taken together.
Zdravilo Vipdomet uporabljamo, če krvnega sladkorja ni mogoče dovolj dobro nadzorovati z dieto, s telesno vadbo in z drugimi zdravili za zdravljenje sladkorne bolezni, kot so metformin sam, insulin sam ali metformin in pioglitazon, ki se ju jemlje skupaj.
In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism.
Pri človeku ima metformin neodvisno od svojega delovanja na glikemijo ugodne učinke na presnovo lipidov.
crospovidone Type A, magnesium stearate, hypromellose, talc, titanium dioxide (E171) and yellow iron oxide (E172).
magnezijev stearat, hipromeloza, smukec, titanov dioksid (E171) in rumeni železov oksid
No data are available with regard to overdose of Vipdomet.
Podatki o prevelikem odmerjanju zdravila Vipdomet niso na voljo.
Clinically meaningful reductions in HbA1c compared to control were also observed regardless of baseline background treatment.
Klinično pomembna zmanjšanja vrednosti HbA1c v primerjavi s kontrolo so bila opažena tudi ne glede na osnovno zdravljenje v izhodišču.
Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Metformin je bigvanid z antihiperglikemičnim delovanjem, ki znižuje tako bazalno kot postprandialno koncentracijo glukoze v plazmi.
Two minor metabolites were detected following administration of an oral dose of [14C] alogliptin, N-demethylated alogliptin, M-I (< 1% of the parent compound), and N-acetylated alogliptin, M-II (< 6% of the parent compound).
Po uporabi peroralnega odmerka z radioaktivnim izotopom označenega [14C] alogliptina sta bila zaznana dva manj pomembna presnovka, in sicer N-demetiliran alogliptin, M-I (<1 % izvorne spojine), in N-acetiliran alogliptin, M-II (<6 % izvorne spojine).
In a clinical trial of alogliptin as mono-therapy, the incidence of hypoglycaemia was similar to that of placebo, and lower than placebo in another trial as add-on to a sulphonylurea.
V kliničnem preskušanju alogliptina kot samostojnega zdravila je bila pojavnost hipoglikemije podobna kot pri placebu in manjša od pojavnosti pri placebu v drugem preskušanju, kjer je bil alogliptin uporabljen kot dodatek k zdravljenju s sulfonilsečnino.
Intravascular administration of iodinated contrast media may lead to contrast induced nephropathy, resulting in metformin accumulation and an increased risk of lactic acidosis.
Intravaskularna aplikacija jodiranih kontrastnih sredstev lahko povzroči nefropatijo zaradi kontrastnega sredstva, ki povzroči kopičenje metformina in povečano tveganje laktacidoze.
These studies evaluated the effects of co-administered alogliptin and metformin on glycaemic control and their safety as initial combination therapy, as dual therapy in patients initially treated with metformin alone, and as add-on therapy to a thiazolidinedione or insulin.
Te študije so vrednotile učinke sočasne uporabe alogliptina in metformina na urejenost glikemije in njuno varnost v okviru začetnega kombiniranega zdravljenja, kombiniranega zdravljenja pri bolnikih, ki so se najprej zdravili samo z metforminom, in dodatka k zdravljenju s tiazolidindionom ali z insulinom.
- if you are taking another medicine for diabetes that contains a “sulphonylurea”, you should not start taking Vipdomet.
- če jemljete drugo zdravilo za zdravljenje sladkorne bolezni, ki vsebuje “sulfonilsečnino”,
What Vipdomet is Vipdomet contains two different medicines called alogliptin and metformin in one tablet:
Zdravilo Vipdomet v eni tableti združuje dve različni zdravilni učinkovini, imenovani alogliptin in metformin:
Alogliptin 25 mg once daily with insulin + metformin (n=126)
Alogliptin 25 mg enkrat na dan z insulinom + metformin (n=126)
There are no data from the use of Vipdomet in pregnant women.
Podatkov o uporabi zdravila Vipdomet pri nosečnicah ni.
Hepatic impairment Vipdomet must not be used in patients with hepatic impairment (see sections 4.3, 4.4 and 5.2).
Okvara jeter Pri bolnikih z okvaro jeter se zdravila Vipdomet ne sme uporabljati (glejte poglavja 4.3, 4.4 in 5.2).
Infections and infestations upper respiratory tract infections common common nasopharyngitis common common
Infekcijske in parazitske bolezni okužbe zgornjih dihal pogosti pogosti nazofaringitis pogosti pogosti
The other ingredients are mannitol, microcrystalline cellulose, povidone K30,
- Pomožne snovi so: manitol, mikrokristalna celuloza, povidon K30, krospovidon Tipa A,
The information provided is based on a total of 7,150 patients with type 2 diabetes mellitus, including 4,201 patients treated with alogliptin and metformin, who participated in 7 phase 3 double-blind, placebo- or active-controlled clinical studies.
Navedeni podatki temeljijo na skupno 7.150 bolnikih s sladkorno boleznijo tipa 2, vključno s 4.201 bolnikom, zdravljenim z alogliptinom in metforminom, ki so bili vključeni v 7 dvojno slepih, s placebom ali z zdravilno učinkovino nadzorovanih kliničnih študij 3. faze.
- if you have -severely reduced kidney function - if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactate acidosis (see “Risk of lactic acidosis” below) or ketoacidosis.
- 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 spodaj "Tveganje za laktacidozo") ali ketoacidozo.
Medicinal products with intrinsic hyperglycaemic activity Glucocorticoids (given by systemic and local routes), beta-2-agonists and diuretics (see also section 4.4) have intrinsic hyperglycaemic activity.
Glukokortikoidi (uporabljeni sistemsko ali lokalno), agonisti adrenergičnih receptorjev beta-2 in diuretiki (glejte tudi poglavje 4.4) imajo intrinzično hiperglikemično aktivnost.
Overall, treatment with the recommended total daily dose of 25 mg alogliptin in combination with metformin improved glycaemic control.
Zdravljenje z alogliptinom v priporočenem dnevnem odmerku 25 mg v kombinaciji z metforminom je na splošno izboljšalo urejenost glikemije.
Co-administration of 100 mg alogliptin once daily and 1,000 mg metformin hydrochloride twice daily for 6 days in healthy subjects had no clinically relevant effects on the pharmacokinetics of alogliptin or metformin.
Pri sočasni 6-dnevni uporabi alogliptina v odmerku 100 mg enkrat na dan in metforminijevega klorida v odmerku 1.000 mg dvakrat na dan pri zdravih osebah niso opazili klinično pomembnih učinkov na farmakokinetiko alogliptina ali metformina.
What Vipdomet contains - The active substances are alogliptin and metformin hydrochloride.
Kaj vsebuje zdravilo Vipdomet - Zdravilni učinkovini sta alogliptin in metforminijev klorid.
In studies performed with the individual active substances, both alogliptin and metformin were excreted in the milk of lactating rats.
Pri študijah, izvedenih s posameznima zdravilnima učinkovinama, sta se tako alogliptin kot metformin izločala v mleko doječih podgan.
No dose adjustment Maximum daily dose is 25 mg
Brez prilagajanja odmerka Največji dnevni odmerek je 25 mg.
However, dosing of alogliptin should be conservative in patients with advanced age due to the potential for decreased renal function in this population
Odmerka glede na starost ni treba prilagajati, vendar pa je pri bolnikih z višjo starostjo treba alogliptin odmerjati previdno, saj pri tej populaciji bolnikov obstaja tveganje za oslabljeno delovanje ledvic.
Concomitant treatment with alogliptin and metformin did not produce new toxicities and no effects on the toxicokinetics of either compound were observed.
Sočasno zdravljenje z alogliptinom in metforminom ni povzročilo novih toksičnih učinkov.
Studies in pregnant rats with alogliptin plus metformin as combination treatment have shown reproductive toxicity (see section 5.3) at approximately 5-20 times (for metformin and alogliptin respectively) the human exposure at the recommended dose.
Študije pri brejih podganah, ki so prejemale kombinacijo alogliptina in metformina, so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3) pri izpostavljenosti, ki je bila približno 5-20-krat večja od izpostavljenosti človeka pri priporočenem odmerku.
Symptoms of lactic acidosis include: - vomiting - stomach ache (abdominal pain) - muscle cramps - a general feeling of not being well with severe tiredness
Simptomi laktacidoze vključujejo: - bruhanje - bolečina v trebuhu (abdominalna bolečina) - mišične krče
If you need to have major surgery you must stop taking Vipdomet during and for some time before and after the procedure.
Če morate na večji kirurški poseg, morate v času posega in še nekaj časa po tem prenehati z jemanjem zdravila Vipdomet.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant doses (see section 5.3).
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na sposobnost razmnoževanja pri klinično pomembnih odmerkih (glejte poglavje 5.3).
Administration of Vipdomet with food resulted in no change in total exposure (AUC) to alogliptin or metformin.
Pri uporabi zdravila Vipdomet skupaj s hrano se skupna izpostavljenost (AUC) alogliptinu ali metforminu ni spremenila.