natgillin/translations-raw huggingface dataset:
Interactions The effect of BYETTA to slow gastric emptying may reduce the extent and rate of absorption of orally administered medicinal products.
Interakcije Učinek zdravila BYETTA, da upočasni praznjenje želodca, lahko zmanjša obseg in stopnjo absorpcije zdravil za peroralno uporabo.
BYETTA should be used with caution in patients receiving oral medicinal products that require rapid gastrointestinal absorption and medicinal products with a narrow therapeutic ratio.
Zdravilo BYETTA moramo uporabljati previdno pri bolnikih, ki dobivajo zdravila za peroralno uporabo, ki zahtevajo hitro absorpcijo v prebavilih in zdravila z ozkim terapevtskim razmerjem.
Specific recommendations regarding intake of such medicinal products in relation to BYETTA is given in section 4.5.
Posebna priporočila glede jemanja takih zdravil v zvezi z zdravilom BYETTA so podana v poglavju 4. 5.
The effect of BYETTA to slow gastric emptying may reduce the extent and rate of absorption of orally administered medicinal products.
Učinek zdravila BYETTA, da upočasni praznjenje želodca, lahko zmanjša obseg in stopnjo absorpcije zdravil za peroralno uporabo.
These medicinal products should be taken in a standardised way in relation to BYETTA injection.
Ta zdravila naj se jemljejo na standardni način glede injiciranja zdravila BYETTA.
If such medicinal products are to be administered with food, patients should be advised to, if possible, take them with a meal when BYETTA is not administered.
Če se ta zdravila jemljejo s hrano, moramo bolnikom svetovati, da jih, če je mogoče, vzamejo med obrokom, ko ne vzamejo zdravila BYETTA.
For oral medicinal products that are particularly dependent on threshold concentrations for efficacy, such as antibiotics, patients should be advised to take those medicinal products at least 1 hour before BYETTA injection.
Za peroralna zdravila, katerih učinkovitost je zlasti odvisna od mejnih koncentracij, kot so antibiotiki, moramo bolnikom svetovati, da ta zdravila vzamejo najmanj 1 uro pred injiciranjem zdravila BYETTA.
BYETTA is not expected to have any clinically relevant effects on the pharmacokinetics of metformin or sulphonylureas.
Ne pričakujemo, da bi zdravilo BYETTA imelo klinično pomembne učinke na faramkokinetiko metformina ali sulfonilurej.
Hence no restriction in timing of intake of these medicinal products in relation to BYETTA injection are needed.
Zato časovne omejitve jemanja teh zdravil glede na injiciranje zdravila BYETTA niso potrebne.
Gastroresistant formulations containing substances sensitive for degradation in the stomach, such as proton pump inhibitors, should be taken at least 1 hour before or more than 4 hours after BYETTA injection.
Gastrorezistentne oblike, ki vsebujejo učinkovine, občutljive na razgradnjo v želodcu, kot so zaviralci protonske črpalke, naj bolniki vzamejo najmanj 1 uro pred ali več kot 4 ure po injiciranju zdravila BYETTA.
Paracetamol Paracetamol was used as a model medicinal product to evaluate the effect of exenatide on gastric emptying.
Paracetamol Paracetamol so uporabili kot model zdravila za vrednotenje učinkov eksenatida na praznjenje želodca.
When 1000mg paracetamol was given with 10 µg BYETTA (0 h) and 1h, 2h and 4h after BYETTA injection, paracetamol AUCs were decreased by 21%, 23%, 24% and 14% respectively; Cmax was decreased by 37%, 56%, 54% and 41%, respectively; tmax was increased from 0.6h in the control period to 0.9h, 4.2h, 3.3h, and 1.6h, respectively.
4 zdravila BYETTA, so se AUC- ji paracetamola posamezno zmanjšali za 21%, 23%, 24% in 14%; Cmax se je posamezno zmanjšal za 37%, 56%, 54%, in 41%; tmax se je posamezno povečal od 0, 6 ure v kontrolnem obdobju na 0, 9 ure, 4, 2 ure, 3, 3 ure in 1, 6 ure.
Paracetamol AUC, Cmax and tmax were not significantly changed when paracetamol was given 1 hour before BYETTA injection.
Če so paracetamol dali 1 uro pred injiciranjem zdravila BYETTA, se AUC, Cmax in tmax paracetamola niso značilno spremenili.
4 HMG CoA reductase inhibitors Lovastatin AUC and Cmax were decreased approximately 40% and 28%, respectively, and Tmax was delayed about 4 h when BYETTA (10 µg BID) was administered concomitantly with a single dose of lovastatin (40 mg) compared with lovastatin administered alone.
Zaviralci HMG CoA reduktaze Ob dajanju zdravila BYETTA (10 µg dvakrat na dan) sočasno z enkratnim odmerkom lovastatina (40 mg) so v primerjavi z dajanjem lovastatina samega, AUC in Cmax lovastatina posamezno zmanjšane za približno 40% in 28% in Tmax podaljšan za približno 4 ure.
In the 30-week placebo-controlled clinical trials, concomitant use of BYETTA and HMG CoA reductase inhibitors was not associated with consistent changes in lipid profiles (see section 5.1).
V 30- tedenskih s placebom nadzorovanih kliničnih preskušanjih sočasne uporabe zdravila BYETTA in zaviralcev HMG CoA reduktaze niso povezovali s posledičnimi spremembami v profilu maščob (glejte poglavje 5. 1).
Although no predetermined dose adjustment is required, one should be aware of possible changes in LDL-C or total cholesterol.
Čeprav vnaprejšnja prilagoditev odmerkov ni potrebna, se moramo zavedati možnih sprememb v LDL- C ali skupnem holesterolu.
Digoxin, lisinopril and warfarin A delay in tmax of about 2h was observed when digoxin, lisinopril or warfarin was administered 30 min after exenatide.
Digoksin, lizinopril in varfarin Po dajanju digoksina, lizinoprila ali varfarina 30 minut po eksenatidu so opazili podaljšanje tmax za približno 2 uri.
However, since market introduction, increased INR has been reported during concomitant use of warfarin and BYETTA.
Vendar so od uvedbe na trg med sočasno uporabo varfarina in zdravila BYETTA poročali o povišanem INR (International Normalised Ratio).
INR should be closely monitored during initiation and dose increase of BYETTA therapy in patients on warfarin and/ or cumarol derivatives (see section 4.8).
Pri bolnikih, ki jemljejo varfarin in/ ali derivate kumarola, je med uvajanjem zdravljenja in višanjem odmerka zdravila BYETTA, potrebno skrbno nadzorovati INR (glejte poglavje 4. 8).
Ethinyl estradiol and levonorgestrel Administration of a combination oral contraceptive (30 µg ethinyl estradiol plus 150 µg levonorgestrel) one hour before BYETTA (10 µg BID) did not alter the AUC, Cmax or Cmin of either ethinyl estradiol or levonorgestrel.
Etinilestradiol in levonorgestrel Dajanje kombinacije peroralnega kontraceptiva (30 µg etinilestradiola in 150 µg levonorgestrela) eno uro pred dajanjem zdravila BYETTA (10 µg dvakrat na dan) ni spremenilo AUC, Cmax ali Cmin etinilestradiola ali levonorgestrela.
Administration of the oral contraceptive 30 minutes after BYETTA did not affect AUC but resulted in a reduction of the Cmax of ethinyl estradiol by 45%, and Cmax of levonorgestrel by 27-41%, and a delay in tmax by 2-4 h due to delayed gastric emptying.
Dajanje peroralnega kontraceptiva 30 minut po dajanju zdravila BYETTA ni vplivalo na AUC, vendar je povzročilo znižanje Cmax etinildiestrola za 45% in Cmax levonorgestrela za 27- 41% ter na zakasnitev tmax za 2- 4 ure zaradi upočasnjenega praznjenja želodca.
There are no adequate data from the use of BYETTA in pregnant women.
O uporabi zdravila BYETTA pri nosečih ženskah nimamo ustreznih podatkov.
Studies in animals have shown reproductive toxicity (see section 5.3).
Študije pri živalih so pokazale reproduktivno toksičnost (glejte poglavje 5. 3).
BYETTA should not be used during pregnancy and the use of insulin is recommended.
Zdravila BYETTA ne smemo uporabljati med nosečnostjo in priporoča se uporaba insulina.
If a patient wishes to become pregnant, or pregnancy occurs, treatment with BYETTA should be discontinued.
Če bolnica želi zanositi ali zanosi, moramo zdravljenje z zdravilom BYETTA prekiniti.
BYETTA should not be used if breast feeding.
Zdravila BYETTA med dojenjem ne smemo uporabljati.
When BYETTA is used in combination with a sulphonylurea, patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines.
Kadar zdravilo BYETTA uporabljamo v kombinaciji s sulfonilureo, moramo bolnikom svetovati o previdnostnih ukrepih, da bi se med vožnjo in upravljanjem s stroji izognili hipoglikemiji.
Table 1 lists adverse reactions reported from Phase 3 studies.
V tabeli 1 so navedeni neželeni učinki, o katerih so poročali v študijah faze 3.
The table presents adverse reactions that occurred with an incidence ≥ 5% and more frequently among BYETTA-treated patients than insulin- or placebo-treated patients.
V tabeli so navedeni neželeni učinki, ki so se pojavljali z incidenco ≥ 5% in so bili pogostejši pri bolnikih zdravljenih z zdravilom BYETTA, kot pri bolnikih zdravljenih z insulinom ali placebom.
The table also includes adverse reactions that occurred with an incidence ≥ 1% and with a statistically significantly higher and/ or ≥ 2X incidence among BYETTA-treated patients than insulin- or placebo-treated patients.
Tabela vključuje tudi neželene učinke, ki so se pojavljali z incidenco ≥ 1% in s statistično značilno višjo in/ ali ≥ 2X incidenco pri bolnikih zdravljenih z zdravilom BYETTA, kot pri bolnikih zdravljenih z insulinom ali placebom.
The reactions are listed below as MedDRA preferred term by system organ class and absolute frequency.
5 Neželeni učinki so navedeni kot MedDRA preferenčni izrazi glede na razred organskega sistema in absolutno pogostnost.
Patient frequencies are defined as: very common (≥ 1/ 10) and common (≥ 1/ 100, < 1/ 10).
Pogostnosti pri bolnikih so opredeljene kot: zelo pogosto (≥ 1/ 10) in pogosto (≥ 1/ 100, < 1/ 10).
5 Table 1:
Tabela 1:
Adverse reactions reported in long term phase 3 controlled studies1
Neželeni učinki, o katerih so poročali v dolgoročnih nadzorovanih študijah faze 31
Body system/ adverse reaction terms
Organski sistem/ Neželeni učinki
Reactions
Neželeni učinki
Metabolism and nutrition disorders Hypoglycaemia (with metformin and a sulphonylurea) 2
Hipoglikemija (z metforminom in sulfonilureo) 2
Hypoglycaemia (with a sulphonylurea) Decreased appetite Nervous system disorders
Hipoglikemija (s sulfonilureo) Zmanjšan apetit Bolezni živčevja
Headache 2 Dizziness Gastrointestinal disorders
Glavobol2 Omotica Bolezni prebavil
Nausea Vomiting Diarrhoea Dyspepsia Abdominal pain Gastroesophageal reflux disease Abdominal distension Skin and subcutaneous tissue disorders
Navzea Bruhanje Diareja Dispepsija Bolečine v trebuhu Gastroezofagealna refluksna bolezen Napet trebuh Bolezni kože in podkožja
Hyperhidrosis 2 General disorders and administrative site conditions
Hiperhidroza2 Splošne težave in spremembe na mestu aplikacije
1
Občutek živčnosti Astenija2
Data from Phase 3 comparator-controlled studies versus placebo, insulin glargine or 30% soluble insulin aspart/ 70% insulin aspart protamine crystals (biphasic insulin aspart) in which patients also received metformin, thiazolidinediones or sulphonylurea in addition to BYETTA or comparator.
1 Podatki iz faze 3 primerjalnih nadzorovanih študij proti placebu, insulinu glargin ali mešanici 30% topnega insulina aspart/ 70% protaminskih kristalov insulina aspart (dvofazni insulin aspart), v katerih so bolniki dobili tudi metformin, tiazolidindione ali sulfonilureo poleg zdravila BYETTA ali primerjalne učinkovine.
2 In insulin-comparator controlled studies in which metformin and a sulphonylurea were concomitant medicinal products, the incidence for these adverse reactions was similar for insulin- and BYETTA- treated patients.
2 V z insulinom primerjalnih nadzorovanih študijah, v katerih so bolniki sočasno dobivali metformin in sulfonilureo, je bila incidenca teh neželenih učinkov podobna za bolnike zdravljene z insulinom in zdravilom BYETTA.
Hypoglycaemia In studies in patients treated with BYETTA and a sulphonylurea (with or without metformin), the incidence of hypoglycaemia was increased compared to placebo (23.5% and 25.2% versus 12.6% and 3.3%) and appeared to be dependent on the doses of both BYETTA and the sulphonylurea.
Hipoglikemija Incidenca hipoglikemije je bila višja v študijah pri bolnikih zdravljenih z zdravilom BYETTA in sulfonilureo (z ali brez metformina) v primerjavi s placebom (23, 5% in 25, 2% proti 12, 6% in 3, 3%) in je kazalo, da je odvisna od odmerkov tako zdravila BYETTA kot sulfoniluree.
Most episodes of hypoglycaemia were mild to moderate in intensity, and all resolved with oral administration of carbohydrate.
Večina epizod hipoglikemije je bila po intenzivnosti blaga do zmerna in vse so odpravili s peroralnim dajanjem ogljikovih hidratov.
Nausea The most frequently reported adverse reaction was nausea.
Navzea Neželeni učinek, o katerem so najpogosteje poročali, je bila navzea.
In patients treated with 5 µg or 10 µg BYETTA, generally 40-50% reported at least one episode of nausea.
Pri bolnikih zdravljenih s 5 µg ali 10 µg zdravila BYETTA, so na splošno v 40- 50% poročali o najmanj eni epizodi navzee.
With continued therapy, the frequency and severity decreased in most patients who initially experienced nausea.
Z nadaljevanjem zdravljenja sta se pogostnost in hudost zmanjšali pri večini bolnikov, ki so na začetku občutili navzeo.
The incidence of withdrawal due to adverse events was 8% for BYETTA-treated patients, 3% for placebo-treated and 1% for insulin-treated patients in the long-term controlled trials (16 weeks or longer).
6 Incidenca prekinitve zdravljenja zaradi neželenih učinkov v dolgoročnih nadzorovanih preskušanjih (16 tednov ali dlje) je bila pri bolnikih zdravljenih z zdravilom BYETTA 8%, 3% pri bolnikih, ki so dobivali placebo in 1% pri bolnikih zdravljenih z insulinom.
For placebo-treated or insulin-treated patients, < 1% withdrew due to nausea or vomiting.
Najpogostejša neželena učinka, ki sta vodila v prekinitev pri bolnikih zdravljenih z zdravilom BYETTA, sta bila navzea (4% bolnikov) in bruhanje (1%). < 1% bolnikov, ki so dobivali placebo ali insulin, so zdravljenje prekinili zaradi navzee ali bruhanja.
6 BYETTA-treated patients in the open-label extension studies at 82 weeks experienced similar types of adverse events observed in the controlled trials.
Bolniki zdravljeni z zdravilom BYETTA v odprtih 82 tednov trajajočih razširjenih študijah so imeli podobne neželene učinke kot so bili opaženi v nadzorovanih preskušanjih.
Injection site reactions Injection site reactions have been reported in approximately 5.1% of subjects receiving BYETTA in long-term (16 weeks or longer) controlled trials.
Reakcije na mestu injiciranja V dolgoročnih (16 tednov ali dlje) nadzorovanih preskušanjih so o reakcijah na mestu injiciranja poročali pri približno 5, 1% oseb, ki so dobivale zdravilo BYETTA.
These reactions have usually been mild and usually did not result in discontinuation of BYETTA.
Te reakcije so bile navadno blage in ponavadi niso povzročile prekinitve zdravljenja z zdravilom BYETTA.
Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients may develop anti-exenatide antibodies following treatment with BYETTA.
Imunogenost V skladu z morebitno imunogenimi lastnostmi beljakovinskih in peptidnih zdravilnih učinkovin, lahko bolniki po zdravljenju z zdravilom BYETTA razvijejo protitelesa proti eksenatidu.
Patients who developed anti-exenatide antibodies had similar rates and types of adverse events as those with no anti-exenatide antibodies.
Bolniki, ki so razvili protitelesa proti eksenatidu, so imeli podobne stopnje in vrste neželenih učinkov kot tisti brez protiteles proti eksenatidu.
In the three placebo-controlled trials (n=963) 38% of patients had low titre anti-exenatide antibodies at 30 weeks.
V treh s placebom nadzorovanih preskušanjih (n=963) je imelo 38% bolnikov po 30 tednih nizke titre protiteles proti eksenatidu.
An additional 6% of patients had higher titre antibodies at 30 weeks.
Dodatnih 6% bolnikov je po 30 tednih imelo višje titre protiteles.
About half of this 6% (3% of the total patients given BYETTA in the controlled studies), had no apparent glycaemic response to BYETTA.
Približno polovica teh 6% (3% vseh bolnikov, ki so v nadzorovanih študijah dobivali zdravilo BYETTA), je imela nejasen glikemični odgovor na zdravilo BYETTA.
In two insulin- comparator controlled trials (n=475) comparable efficacy and adverse events were observed in BYETTA-treated patients regardless of antibody titre.
V dveh z insulinom primerjalnih nadzorovanih preskušanjih (n=475) so opazili primerljivo učinkovitost in neželene učinke pri bolnikih zdravljenih z zdravilom BYETTA ne glede na titer protiteles.
Examination of antibody-positive specimens from one long-term uncontrolled study revealed no significant cross-reactivity with similar endogenous peptides (glucagon or GLP-1).
Preiskava vzorcev s pozitivnimi protitelesi iz dolgoročne nenadzorovane študije ni pokazala značilne navzkrižne reaktivnosti s podobnimi endogenimi peptidi (glukagon ali GLP- 1).
Spontaneous reports Since market introduction of BYETTA, the following additional adverse reactions have been reported:
Spontana poročila Od uvedbe zdravila BYETTA na trg so poročali o naslednjih dodatnih neželenih učinkih:
Immune system disorders: anaphylactic reaction, very rarely.
Bolezni imunskega sistema: zelo redko anafilaktična reakcija.
Metabolism and nutritional disorders: dehydration, generally associated with nausea, vomiting and/ or diarrhoea.
Presnovne in prehranske motnje: dehidracija, na splošno povezana z navzeo, bruhanjem in/ ali diarejo.
Nervous system disorders: dysgeusia, somnolence.
Bolezni živčevja: disgevzija, zaspanost.
Gastrointestinal disorders: eructation, constipation, flatulence, acute pancreatitis (see section 4.4).
Bolezni prebavil: kolcanje, zaprtje, napenjanje, akutni pankreatitis (glejte poglavje 4. 4).
Renal and urinary disorders: altered renal function, including acute renal failure, worsened chronic renal failure, renal impairment, increased serum creatinine (see section 4.4).
Bolezni sečil: sprememba delovanja ledvic, vključno z akutno odpovedjo ledvic, poslabšanjem kronične odpovedi ledvic, okvaro ledvic, zvišanjem kreatinina v serumu (glejte poglavje 4. 4).
Skin and subcutaneous tissue disorders: macular rash, papular rash, pruruitis, urticaria, angioneurotic oedema.
Bolezni kože in podkožja: makularni izpuščaj, papularni izpuščaj, srbenje, koprivnica, angionevrotski edem.
Investigations: international normalised ratio increased with concomitant warfarin, some reports associated with bleeding (see section 4.5).
Preiskave: povišano internacionalno normalizirano razmerje s sočasno uporabo varfarina, nekaj poročil povezanih s krvavitvijo (glejte poglavje 4. 5).
Signs and symptoms of overdose may include severe nausea, severe vomiting and rapidly declining blood glucose concentrations.
7 Znaki in simptomi prevelikega odmerjanja lahko vključujejo hudo navzeo, hudo bruhanje in hitro padanje koncentracije glukoze v krvi.
In the event of overdose, appropriate supportive treatment (possibly given parenterally) should be initiated according to the patient ’ s clinical signs and symptoms.
V primeru prevelikega odmerjanja je potrebno začeti z ustreznim podpornim zdravljenjem (če je mogoče, danim parenteralno) glede na bolnikove klinične znake in simptome.
Other blood glucose lowering drugs, excl. insulins, ATC code:
Zdravila za zniževanje glukoze v krvi, brez insulinov, oznaka ATC:
Mechanism of action Exenatide is an incretin mimetic that exhibits several antihyperglycaemic actions of glucagon-like peptide-1 (GLP-1).
Mehanizem delovanja Eksenatid je mimetik inkretina, ki kaže nekaj antihiperglikemičnih učinkov glukagonu podobnega peptida- 1 (GLP- 1).
The amino acid sequence of exenatide partially overlaps that of human GLP-1.
Aminokislinsko zaporedje eksenatida se delno prekriva z zaporedjem humanega GLP- 1.
Exenatide has been shown to bind to and activate the known human GLP-1 receptor in vitro, its mechanism of action mediated by cyclic AMP and/ or other intracellular signaling pathways.
Pokazali so, da se eksenatid in vitro veže na in aktivira znani humani receptor GLP- 1, katerega mehanizem delovanja posreduje ciklični AMP in/ ali druge znotrajcelične poti sporočanja.
(see section 4.4).
Ko so eksenatid uporabljali v kombinaciji samo z metforminom, niso opazili povečanja incidence hipoglikemije glede na placebo v kombinaciji z metforminom, kar je lahko zaradi tega od glukoze odvisnega insulinotropnega mehanizma (glejte poglavje 4. 4).
Pharmacodynamic effects BYETTA improves glycaemic control through the immediate and sustained effects of lowering both postprandial and fasting glucose concentrations in patients with type 2 diabetes.
Farmakodinamični učinki Zdravilo BYETTA izboljša glikemični nadzor s takojšnjimi in trajnimi učinki zniževanja tako postprandialne koncentracije glukoze kot koncentracije glukoze na tešče pri bolnikih z diabetesom tipa 2.
Clinical efficacy The clinical studies comprised 3945 subjects (2997 treated with exenatide), 56% men and 44% women, 319 subjects (230 treated with exenatide) were ≥ 70 years of age and 34 subjects (27 treated with exenatide) were ≥ 75 years of age.
Klinična učinkovitost Klinične študije so vključevale 3945 oseb (2997 zdravljenih z eksenatidom), 56% moških in 44% žensk, 319 oseb (230 zdravljenih z eksenatidom) je bilo ≥ 70 let in 34 oseb (27 zdravljenih z eksenatidom) je bilo ≥ 75 let.
BYETTA reduced HbA1c and body weight in patients treated for 30 weeks in three placebo-controlled studies, whether the BYETTA was added to metformin, a sulphonylurea or a combination of both.
Zdravilo BYETTA je zmanjšalo HbA1c in telesno maso pri bolnikih, ki so jih v treh s placebom nadzorovanih študijah zdravili 30 tednov, neodvisno od tega ali je bilo zdravilo BYETTA dodano metforminu, sulfonilurei ali kombinaciji obeh.
See Table 2.
Glejte tabelo 2.
The reduction in HbA1c was sustained and the weight loss continued for at least 82 weeks in the subset of 10 µg BID patients completing both the placebo-controlled studies and the uncontrolled study extensions (n=137).
Zmanjšanje HbA1c je bilo trajno in zmanjševanje telesne mase se je nadaljevalo najmanj 82 tednov pri skupini bolnikov z 10 µg dvakrat na dan, ki so dokončali podaljšanja tako s placebom nadzorovanih kot nenadzorovanih študij (n=137).
8 Table 2:
8 Tabela 2:
Combined results of the 30 week placebo controlled studies (intent to treat patients)
Kombinirani rezultati 30 tedenskih, s placebom nadzorovanih študij (na zdravljenje pripravljeni bolniki)
BYETTA 5µg BID
BYETTA 5 µg dvakrat na dan
BYETTA 10µg BID
BYETTA 10 µg dvakrat na dan
N Baseline HbA1c(%) HbA1c(%) change from base line
N Začetni HbA1c (%) Sprememba v HbA1c (%) glede na začetnega
Proportion of patients (%) achieving HbA1c ≤ 7%
Odstotek bolnikov, ki so dosegli HbA1c ≤ 7%
Proportion of patients (%) achieving HbA1c ≤ 7% (patients completing studies)
Odstotek bolnikov, ki so dosegli HbA1c ≤ 7% (bolniki, ki so dokončali študije)
Baseline weight(kg) Change of weight from baseline(kg)
Začetna masa (kg) Sprememba mase glede na začetno (kg)
In a placebo-controlled study of 16 weeks duration, BYETTA (n=121) or placebo (n=112) was added to existing thiazolidinedione treatment, with or without metformin.
V s placebom nadzorovani študiji, ki je trajala 16 tednov, so zdravilo BYETTA (n=121) ali placebo (n=112) dodali obstoječemu zdravljenju s tiazolidindionom, z ali brez metformina.
BYETTA (5 µg BID for 4 weeks, followed by 10 µg BID) resulted in statistically significant reductions from baseline HbA1c compared to placebo (-0.8% versus +0.1%) as well as significant reductions in body weight (-1.5 versus -0.2 kg).
Zdravilo BYETTA (5 µg dvakrat na dan 4 tedne, nato 10 µg dvakrat na dan) je statistično značilno znižalo HbA1C glede na začetno vrednost v primerjavi s placebom (- 0, 8% proti +0, 1%), kot tudi značilno zmanjšalo telesno maso (- 1, 5 proti - 0, 2 kg).
When BYETTA was used in combination with a thiazolidinedione, the incidence of hypoglycaemia was similar to that of placebo in combination with a thiazolidinedione.
Ko so zdravilo BYETTA uporabili v kombinaciji z tiazolidindionom, je bila incidenca hipoglikemije podobna tisti pri placebu v kombinaciji z tiazolidindionom.
The experience in patients > 65 years and in patients with impaired renal function is limited.
Izkušnje pri bolnikih > 65 let in pri bolnikih z okvarjenim delovanjem ledvic so omejene.