natgillin/translations-raw huggingface dataset:
Vipdomet 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.
Vipdomet 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.
Vipdomet 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.
Vipdomet 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.
The safety and efficacy of Vipdomet in children and adolescents <18 years old have not been established.
Varnost in učinkovitost zdravila Vipdomet pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
- in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.
- v kombinaciji z insulinom (tj. trotirno kombinirano zdravljenje) kot dodatek k dieti in telesni vadbi za izboljšanje urejenosti glikemije pri bolnikih, pri katerih s stabilnim odmerkom insulina in samim metforminom urejenost glikemije ni zadostna.
Vipdomet is not a substitute for insulin in insulin-requiring patients.
Pri bolnikih, ki potrebujejo zdravljenje z insulinom, zdravilo Vipdomet ne more nadomestiti insulina.
- by delaying intestinal glucose absorption.
- upočasni absorpcijo glukoze v črevesju.
Isolated cases of hepatitis or liver function test abnormalities resolving on discontinuation of metformin have been reported.
Poročali so o posameznih primerih hepatitisa ali nenormalnostih pri preiskavah delovanja jeter, ki so spontano izzvenele po prenehanju zdravljenja z metforminom.
- as an adjunct to diet and exercise to improve glycaemic control in adult patients, inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of alogliptin and metformin.
- kot dodatek k dieti in telesni vadbi za izboljšanje urejenosti glikemije pri odraslih bolnikih z neustrezno urejeno sladkorno boleznijo pri zdravljenju samo z metforminom v največjem odmerku, ki ga prenašajo, in pri bolnikih, ki se že zdravijo s kombinacijo alogliptina in metformina.
How to take Vipdomet
Kako jemati zdravilo Vipdomet
There was no change in the time to peak plasma concentration (Tmax) for alogliptin, but there was a delayed Tmax for metformin of 1.5 hours.
Pri alogliptinu niso opazili spremembe časa do nastopa največje koncentracije (Tmax) v plazmi, pri metforminu pa se je Tmax podaljšal za 1,5 ure.
In a pooled analysis of the data from 12 studies, the overall incidence of any episode of hypoglycaemia was similar in patients ≥65 years old treated with 25 mg alogliptin (3.8%) to that in patients <65 years old (3.6%).
V združeni analizi podatkov iz 12 študij je bila celotna pojavnost vseh epizod hipoglikemije pri bolnikih, starih 65 let ali starejših, ki so se zdravili s alogliptinom v odmerku 25 mg (3,8 %), podobna kot pri bolnikih, mlajših od 65 let (3,6 %).
Preclinical data for metformin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
Acute pancreatitis is a serious adverse reaction and is attributed to the alogliptin component of Vipdomet (see section 4.4).
Akutni pankreatitis je resen neželeni učinek, ki ga je mogoče pripisati vsebnosti alogliptina v zdravilu Vipdomet (glejte poglavje 4.4).
Do not take Vipdomet: - if you are allergic to alogliptin, metformin or any of the other ingredients of this medicine (listed in section 6) - if you have had a serious allergic reaction to any other similar medicines that you take to control your blood sugar.
Ne jemljite zdravila Vipdomet: - če ste alergični na alogliptin, metformin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Absolute bioavailability of a 500 mg or 850 mg metformin hydrochloride tablet is approximately 50-60% in healthy subjects.
Pri zdravih osebah je absolutna biološka uporabnost 500-mg ali 850-mg tablete metforminijevega klorida približno 50-60 %.
Nonfatal Myocardial Infarction
Neusodni miokardni infarkt
For patients inadequately controlled on the maximal tolerated dose of metformin hydrochloride alone, the recommended dose is one tablet of 12.5 mg/850 mg or 12.5 mg/1,000 mg twice daily, corresponding to 25 mg alogliptin plus 1,700 mg or 2,000 mg metformin hydrochloride daily, depending on the dose of metformin hydrochloride already being taken.
Pri bolnikih z neustrezno urejeno sladkorno boleznijo pri zdravljenju samo z metforminijevim kloridom v največjem odmerku, ki ga prenašajo, je priporočeni odmerek ena tableta 12,5 mg/850 mg ali 12,5 mg/1.000 mg dvakrat na dan, kar ustreza 25 mg alogliptina in 1.700 ali 2.000 mg metforminijevega klorida na dan, odvisno od odmerka metforminijevega klorida, ki ga bolnik že jemlje.
Therefore, a lower dose of insulin may be considered to reduce the risk of hypoglycaemia when this medicinal product is used in combination with Vipdomet (see section 4.2).
Zaradi zmanjšanja tveganja za pojav hipoglikemije bo tako morda treba razmisliti o zmanjšanju odmerka insulina, če se ta uporablja v kombinaciji z zdravilom Vipdomet (glejte poglavje 4.2).
Nervous system disorders headache common common metallic taste common
Bolezni živčevja glavobol pogosti pogosti kovinski okus pogosti
Vipdomet should be taken twice daily because of the pharmacokinetics of its metformin component.
Zdravilo Vipdomet je treba zaradi farmakokinetike metformina jemati dvakrat na dan. Treba ga je jemati ob obrokih, da se zmanjšajo neželeni učinki metformina na prebavila.
Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase.
Metformin z delovanjem na glikogen-sintazo stimulira znotrajcelično sintezo glikogena.
- in combination with pioglitazone (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and pioglitazone.
- v kombinaciji s pioglitazonom (tj. trotirno kombinirano zdravljenje) kot dodatek k dieti in telesni vadbi pri odraslih bolnikih z neustrezno urejeno sladkorno boleznijo pri zdravljenju z metforminom v največjem odmerku, ki ga prenašajo, in s pioglitazonom.
The co-administration of alogliptin and metformin has been studied as dual therapy in patients initially treated with metformin alone, and as add-on therapy to a thiazolidinedione or insulin.
Sočasna uporaba alogliptina in metformina je bila raziskana v okviru kombiniranega zdravljenja pri bolnikih, ki so se najprej zdravili samo z metforminom, in v okviru dodatka k zdravljenju s tiazolidindionom ali z insulinom.
Very common (may affect more than 1 in 10 people): - Stomach ache - Diarrhoea - Loss of appetite - Feeling sick - Being sick.
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): - Bolečina v želodcu.
The results of bioequivalence studies in healthy subjects demonstrated that Vipdomet film-coated tablets are bioequivalent to the corresponding doses of alogliptin and metformin co-administered as separate tablets.
Rezultati študij bioekvivalence pri zdravih osebah so pokazali, da so filmsko obložene tablete zdravila Vipdomet bioekvivalentne ustreznim odmerkom alogliptina in metformina, sočasno uporabljenim v obliki ločenih tablet.
For the different dose regimens Vipdomet is available in strengths of 12.5 mg/850 mg and 12.5 mg/1,000 mg film-coated tablets.
Za različne režime odmerjanja je zdravilo Vipdomet na voljo v različnih jakostih, in sicer v obliki 12,5 mg/850 mg in 12,5 mg/1.000 mg filmsko obloženih tablet.
LOCF = last observation carried forward *Non inferiority and superiority statistically demonstrated † Least squares means adjusted for prior antihyperglycaemic therapy status and baseline values
PPS = bolniki po protokolu (“per protocol set”) LOCF = prenos zadnjih opaženih vrednosti naprej (“last observation carried forward”) * Ne-inferiornost in superiornost statistično dokazana † Srednja vrednost najmanjših kvadratov, prilagojena gleda na predhodno antihiperglikemično zdravljenje in vrednosti v izhodišču
However, the results of bioequivalence studies have demonstrated that Vipdomet film-coated tablets are bioequivalent to the corresponding doses of alogliptin and metformin co-administered as separate tablets.
Vendar pa so rezultati študij bioekvivalence pokazali, da so filmsko obložene tablete zdravila Vipdomet bioekvivalentne ustreznim odmerkom alogliptina in metformina, sočasno uporabljenim v obliki ločenih tablet.
The no-observed-adverse-effect level (NOAEL) in the repeated dose toxicity studies in rats and dogs up to 26- and 39-weeks in duration, respectively, produced exposure margins that were approximately 147- and 227-fold, respectively, the exposure in humans at the recommended total daily dose of 25 mg alogliptin.
Pri študijah toksičnosti pri ponavljajočih se odmerkih, ki so pri podganah trajale do 26 tednov, pri psih pa do 39 tednov, je bila mejna vrednost izpostavljenosti brez opaženih neželenih učinkov (NOAEL; “no-observed-adverse-effect level”) pri podganah 147-krat pri psih pa 227-krat večja od izpostavljenosti človeka pri priporočenem 25 mg odmerku alogliptina.
Adults (≥18 years old) with normal renal function (glomerular filtration rate (GFR)≥90 mL/min) The dose should be individualised on the basis of the patient's current treatment regimen.
Odrasli (stari 18 let in starejši) z normalnim delovanjem ledvic (ocenjena stopnja glomerulne filtracije (GFR - glomerular filtration rate) ≥90 ml/min)
Clinical studies conducted to support the efficacy and safety of Vipdomet involved the co-administration of alogliptin and metformin as separate tablets.
Klinične študije, izvedene z namenom ugotovitve učinkovitosti in varnosti zdravila Vipdomet, so vrednotile sočasno uporabo alogliptina in metformina v obliki ločenih tablet.
For patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin, the dose of Vipdomet should provide alogliptin dosed at 12.5 mg twice daily (25 mg total daily dose) and a dose of metformin similar to the dose already being taken.
Pri bolnikih z neustrezno urejeno sladkorno boleznijo pri dvojnem kombiniranem zdravljenju z insulinom in metforminom v največjem odmerku, ki ga prenašajo, je treba z odmerkom zdravila Vipdomet zagotoviti alogliptin v odmerku 12,5 mg dvakrat na dan (skupni dnevni odmerek 25 mg) in metformin v enakem odmerku, ki ga bolnik že jemlje.
PHARMACEUTICAL FORM AND CONTENTS 98 film-coated tablets
FARMACEVTSKA OBLIKA IN VSEBINA 98 filmsko obloženih tablet Večodmernega pakiranja ne bo na trgu.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/843/001-026
EU/1/13/843/001-026
For patients switching from separate tablets of alogliptin and metformin (as dual therapy or as part of triple therapy with insulin), both alogliptin and metformin should be dosed at the total daily dose already being taken; the individual dose of alogliptin should be halved as it will be taken twice daily whilst the dosing of metformin should remain unchanged.
Pri bolnikih, ki prehajajo z ločenih tablet alogliptina in metformina (kombinirano zdravljenje ali del trotirnega zdravljenja z insulinom), je treba tako odmerek alogliptina kot odmerek metformina določiti na osnovi skupnega dnevnega odmerka, ki ga bolnik že jemlje.
Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive or diuretic therapy or when starting treatment with a nonsteroidal anti-inflammatory drug (NSAID).
V primerih, ko lahko pride do oslabljenega delovanja ledvic, na primer po uvedbi zdravljenja z antihipertenzivi, diuretiki ali nesteroidnimi protivnetnimi zdravili (NSAID), je potrebna posebna previdnost.
Significantly more patients receiving 12.5 mg alogliptin and 1.000 mg metformin hydrochloride twice daily (59.5%) achieved target HbA1c levels of < 7.0% compared to those receiving either 12.5 mg alogliptin twice daily alone (20.2%, p<0.001) or 1,000 mg metformin hydrochloride twice daily alone (34.3%, p<0.001) at Week 26.
V 26. tednu je ciljne vrednosti HbA1c <7,0 % doseglo pomembno več bolnikov, ki so prejemali alogliptin v odmerku 12,5 mg in metforminijev klorid v odmerku 1.000 mg dvakrat na dan (59,5 %), v primerjavi z bolniki, ki so prejemali samo alogliptin v odmerku 12,5 mg dvakrat na dan (20,2 %, p<0,001) ali samo metforminijev klorid v odmerku 1.000 mg dvakrat na dan (34,3 %, p<0,001).
Hepatic impairment Vipdomet should not be used in patients with hepatic impairment (see section 4.2).
Okvara jeter Pri bolnikih z okvaro jeter se zdravila Vipdomet ne sme uporabljati (glejte poglavje 4.2).
Due to the increased risk of hypoglycaemia in combination with pioglitazone, a lower dose of pioglitazone may be considered to reduce the risk of hypoglycaemia when this medicinal product is used in combination with Vipdomet (see section 4.2).
Zaradi zmanjšanja tveganja za pojav hipoglikemije bo tako morda treba razmisliti o zmanjšanju odmerka pioglitazona, če se zdravilo uporablja v kombinaciji z zdravilom Vipdomet (glejte poglavje 4.2).
Vipdomet is not known to affect your ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni znano, če zdravilo Vipdomet vpliva na sposobnost za vožnjo in upravljanje s stroji.
Factors that may increase the risk of lactic acidosis (see section 4.4) should be reviewed before considering initiation of metformin in patients with GFR<60 mL/min.
Pri bolnikih z GFR <60 ml/min je treba pred uvedbo metformina pregledati dejavnike, ki lahko povečajo tveganje za laktacidozo (glejte poglavje 4.4).
- by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis.
- z zaviranjem glukoneogeneze in glikogenolize zmanjšuje nastajanje glukoze v jetrih.
Therefore, close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when cationic medicinal products that are eliminated by renal tubular secretion are co-administered.
Pri sočasni uporabi kationskih zdravil, ki se izločajo z ledvično tubulno sekrecijo, je zato treba skrbno nadzirati urejenost glikemije in razmisliti o prilagoditvi odmerka znotraj priporočenega odmerjanja in spremembah zdravljenja sladkorne bolezni.
Clinical studies conducted to support the efficacy of Vipdomet involved the co-administration of alogliptin and metformin as separate tablets.
Klinične študije, izvedene z namenom ugotovitve učinkovitosti zdravila Vipdomet, so vrednotile sočasno uporabo alogliptina in metformina v obliki ločenih tablet.
The pharmacokinetics of alogliptin in children and adolescents <18 years old has not been established.
Farmakokinetika alogliptina pri otrocih in mladostnikih, mlajših od 18 let, ni bila raziskana.
INFORMATION IN BRAILLE Vipdomet 12.5 mg/850 mg
PODATKI V BRAILLOVI PISAVI Vipdomet 12,5 mg/850 mg
In addition, mean change from baseline in FPG at Week 52 for 25 mg alogliptin plus 30 mg pioglitazone and metformin was significantly greater than that for 45 mg pioglitazone and metformin (p<0.001).
Poleg tega je bila povprečna sprememba vrednosti glukoze v plazmi na tešče glede na izhodiščno vrednost v 52. tednu pri uporabi alogliptina v odmerku 25 mg v kombinaciji s 30 mg pioglitazona in z metforminom pomembno večja od tiste pri uporabi 45 mg pioglitazona in metformina (p<0,001).
Liver function test abnormalities very rare hepatic dysfunction including hepatic failure not known
Bolezni jeter, žolčnika in žolčevodov hepatitis zelo redki nenormalnosti pri preiskavah delovanja jeter zelo redki okvara delovanja jeter, vključno z odpovedjo jeter neznana
In rats no treatment-related foetal abnormalities occurred following concomitant administration at exposure margins of approximately 28- to 29-fold for alogliptin and 2- to 2.5-fold for metformin at the maximum recommended human dose of 25 mg/day and 2,000 mg/day, respectively.
Pri podganah pri mejah izpostavljenosti, ki so bile približno 28- do 29-krat večje od izpostavljenosti človeka pri priporočenem odmerku alogliptina 25 mg/dan in 2- do 3-krat večje od izpostavljenosti človeka pri priporočenem odmerku metformina 2.000 mg/dan niso ugotovili z uporabo zdravila povezanih nepravilnosti pri plodovih.
Microcrystalline cellulose Povidone K30
Jedro tablete manitol mikrokristalna celuloza povidon K30 krospovidon Tipa A magnezijev stearat
No adverse effects on fertility were observed in animal studies conducted with alogliptin or with metformin (see section 5.3).
Pri študijah z alogliptinom ali metforminom na živalih niso opazili neželenih učinkov na plodnost (glejte poglavje 5.3).
Co-administration of 12.5 mg alogliptin and 1,000 mg metformin hydrochloride twice daily resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose at Week 26 when compared to either 12.5 mg alogliptin twice daily alone or 1,000 mg metformin hydrochloride twice daily alone.
Pri sočasni uporabi alogliptina v odmerku 12,5 mg in metforminijevega klorida v odmerku 1.000 mg dvakrat na dan, so bila v 26. tednu dosežena statistično pomembna izboljšanja glede na izhodiščne vrednosti HbA1c in vrednosti glukoze v plazmi na tešče, in sicer tako v primerjavi z uporabo samega alogliptina v odmerku 12,5 mg dvakrat na dan kot tudi samega metforminijevega klorida v odmerku 1.000 mg dvakrat na dan.
Not known: - Liver problems such as nausea or vomiting, stomach pain, unusual or unexplained tiredness,
Neznana pogostnost: - Težave z jetri, kot so siljenje na bruhanje, bruhanje, bolečina v trebuhu, neobičajna ali nepojasnjena utrujenost, izguba apetita, temen urin ali rumeno obarvanje kože ali očesnih beločnic.
Very rare: - Decreased vitamin B12 levels or anaemia; symptoms include tiredness, lethargy, feeling faint,
Zelo redki: - Znižane vrednosti vitamina B12 ali anemija.
If pancreatitis is suspected, Vipdomet should be discontinued; if acute pancreatitis is confirmed, Vipdomet should not be restarted.
Če je akutno vnetje trebušne slinavke potrjeno, se zdravljenja z zdravilom Vipdomet ne sme več uvesti.
Based on mean dialysate concentrations, approximately 7% of the active substance was removed during a 3-hour haemodialysis session.)
Na osnovi povprečnih koncentracij dializata se je med 3-urnim postopkom dialize odstranilo približno
More patients receiving 25 mg alogliptin and metformin (48.5%) achieved target HbA1c levels of ≤7.0% compared to those receiving glipizide and metformin (42.8%) (p=0.004).
Ciljne vrednosti HbA1c ≤7,0 % je doseglo več bolnikov, ki so prejemali alogliptin v odmerku 25 mg in metformin (48,5 %), v primerjavi z bolniki, ki so prejemali glipizid in metformin (42,8 %) (p=0,004).
No metabolites have been identified in humans.
Njegovih presnovkov pri človeku niso ugotovili.
What Vipdomet is used for
Za kaj uporabljamo zdravilo Vipdomet
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON (WITHOUT BLUE BOX) MULTIPACKS ONLY (2X98 TABLETS)
ŠKATLA V VEČODMERNEM PAKIRANJU (BREZ MODREGA OKENCA) SAMO VEČODMERNO PAKIRANJE (2X98 TABLET)
Significantly more patients receiving 25 mg alogliptin plus 30 mg pioglitazone and metformin (33.2%) achieved target HbA1c levels of ≤7.0% compared to those receiving 45 mg pioglitazone and metformin (21.3%) at Week 52 (p<0.001).
V 52. tednu je ciljne vrednosti HbA1c ≤7,0 % doseglo pomembno več bolnikov, ki so prejemali alogliptin v odmerku 25 mg v kombinaciji s 30 mg pioglitazona in z metforminom (33,2 %), v primerjavi z bolniki, ki so prejemali 45 mg pioglitazona in metformin (21,3 %) (p<0,001).
When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and, thus, the elimination half-life is prolonged leading to increased levels of metformin in the plasma.
Razpolovni čas izločanja se tako podaljša, kar vodi v zvišanje vrednosti metformina v plazmi.
INFORMATION IN BRAILLE Vipdomet 12.5 mg/1000 mg
PODATKI V BRAILLOVI PISAVI Vipdomet 12,5 mg/1000 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX) MULTIPACKS ONLY (2X98 TABLETS)
PODATKI NA ZUNANJI OVOJNINI ŠKATLA (Z MODRIM OKENCEM) SAMO VEČODMERNO PAKIRANJE ( 2X98 TABLET)
The combination revealed teratogenic potential in small numbers of foetuses (microphthalmia, small eye bulge and cleft palate) at higher doses of metformin (exposure margins of approximately 20-fold and 5- to 6-fold the maximum recommended human dose for alogliptin and metformin, respectively).
Pri večjih odmerkih metformina (meje izpostavljenosti približno 20-krat večje od izpostavljenosti človeka pri priporočenem odmerku alogliptina in 5- do 6-krat večje od izpostavljenosti človeka pri priporočenem odmerku metformina) je kombinacija pokazala majhen teratogeni potencial pri manjšem številu plodov (mikroftalmija, majhna očesna izboklina in palatoshiza).
INFORMATION IN BRAILLE Vipdomet 12.5 mg/1,000 mg
PODATKI V BRAILLOVI PISAVI Vipdomet 12,5 mg/1.000 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (WITH BLUE BOX) (EXCLUDING MULTIPACKS)
PODATKI NA ZUNANJI OVOJNINI ŠKATLA (Z MODRIM OKENCEM) (BREZ VEČODMERNEGA PAKIRANJA)
Each 12.5 mg/850 mg film-coated tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin and 850 mg metformin hydrochloride.
Ena 12,5 mg/850 mg filmsko obložena tableta vsebuje alogliptinijev benzoat v količini, ki ustreza 12,5 mg alogliptina, in 850 mg metforminijevega klorida.
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or history of a serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, and angioedema, to any dipeptidyl-peptidase-4 (DPP-4) inhibitor (see sections 4.4 and 4.8) - Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis) - Diabetic pre-coma - Severe renal failure (GFR <30 mL/min) - Acute conditions with the potential to alter renal function such as: - dehydration - severe infection - shock - Acute or chronic disease which may cause tissue hypoxia (see section 4.4) such as: - cardiac or respiratory failure - recent myocardial infarction - shock - Hepatic impairment (see section 4.4) - Acute alcohol intoxication, alcoholism (see sections 4.4 and 4.5)
- Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1, ali anamneza hude preobčutljivostne reakcije, vključno z anafilaktično reakcijo, anafilaktičnim šokom in angioedemom po uporabi katerega koli zaviralca dipeptidil-peptidaze (DPP-4dipeptidyl-peptidase) (glejte poglavji 4.4 in 4.8).
- if you have a severe infection or are seriously dehydrated (have lost a lot of water from your body) - if you recently had a heart attack or have severe circulatory problems including shock - if you have severe breathing difficulties - if you have liver disease - if you drink alcohol excessively (either every day or in large quantities only from time to time)
- če ste pred kratkim doživeli srčni napad ali imate hude težave s krvnim obtokom, vključno s šokom.
What Vipdomet looks like and contents of the pack - Vipdomet 12.5 mg/850 mg film-coated tablets (tablets) are light yellow, oblong (approximately 21.0 mm long by 10.1 mm wide), biconvex, film-coated tablets with “12.5/850” debossed on one side and “322M” debossed on the other side.
Izgled zdravila Vipdomet in vsebina pakiranja - Vipdomet 12,5 mg/850 mg filmsko obložene tablete (tablete) so svetlo rumene, podolgovate (približno 21,0 mm dolge in 10,1 mm široke), obojestransko izbočene, filmsko obložene tablete z vtisnjeno oznako “12.5/850” na eni in “322M” na drugi strani.