natgillin/translations-raw huggingface dataset:
In insulin-comparator studies BYETTA (5 µg BID for 4 weeks, followed by 10 µg BID) in combination with metformin and sulphonylurea significantly (statistically and clinically) improved glycaemic control, as measured by decrease in HbA1c.
V z insulinom primerjalnih študijah je zdravilo BYETTA (5 µg dvakrat na dan 4 tedne, nato 10 µg dvakrat na dan) v kombinaciji z metforminom in sulfonilureo značilno (statistično in klinično) izboljšala glikemični nadzor merjen z zmanjšanjem HbA1c.
This treatment effect was comparable to that of insulin glargine in a 26-week study (mean insulin dose 24.9 IU/ day, range 4-95 IU/ day, at the end of study) and biphasic insulin aspart in a 52-week study (mean insulin dose 24.4 IU/ day, range 3-78 IU/ day, at the end of study).
Ta učinek zdravljenja je bil primerljiv z učinkom insulina glargin v 26- tedenski študiji (povprečni odmerek insulina 24, 9 i. e. / dan, razpon 4- 95 i. e. / dan, ob koncu študije) in dvofaznega insulina aspart v 52- tedenski študiji (povprečni odmerek insulina 24, 4 i. e. / dan, razpon 3- 78 i. e. / dan, ob koncu študije).
BYETTA lowered HbA1c from 8.21 (n=228) and 8.6% (n=222) by 1.13 and 1.01% while insulin glargine lowered from 8.24 (n=227) by 1.10% and biphasic insulin aspart from 8.67 (n=224) by 0.86%.
Zdravilo BYETTA je zmanjšalo HbA1C z 8, 21 (n=228) in 8, 6% (n=222) za 1, 13 in 1, 01%, medtem, ko je insulin glargin zmanjšal z 8, 24 (n=227) za 1, 10% in dvofazni insulin aspart z 8, 67 (n=224) za 0, 86%.
Weight loss of 2.3 kg (2.6%) was achieved with BYETTA in the 26 week study and a loss of 2.5 kg (2.7%) in a 52-week study whereas treatment with insulin was associated with weight gain.
Z zdravilom BYETTA so v 26 tedenski študiji dosegli zmanjšanje mase za 2, 3 kg (2, 6%) in v 52- tedenski študiji za 2, 5 kg (2, 7%), medtem ko je bilo zdravljenje z insulinom povezano s povečanjem mase.
Treatment differences (BYETTA minus comparator) were -4.1 kg in the 26-week study and – 5.4 kg in the 52-week study.
Razlike med zdravljenji (zdravilo BYETTA minus primerjalna snov) so bile - 4, 1 kg v 26- tedenski študiji in - 5, 4 kg v 52- tedenski študiji.
Seven-point self monitored blood glucose profiles (before and after meals and at 3 am) demonstrated significantly reduced glucose values compared to insulin in the postprandial periods after BYETTA injection.
Sedem- točkovni samo ocenjevani profili glukoze v krvi (pred in po obrokih in ob 3h zjutraj) so pokazali značilna zmanjšanja vrednosti glukoze v primerjavi z insulinom v postprandialnih obdobjih po injiciranju zdravila BYETTA.
Premeal blood glucose concentrations were generally lower in patients taking insulin compared to BYETTA.
Koncentracije glukoze v kri pred obrokom so bile na splošno nižje pri bolnikih, ki so jemali insulin v primerjavi z zdravilom BYETTA.
Mean daily blood glucose values were similar between BYETTA and insulin.
Povprečne dnevne vrednosti glukoze v krvi so bile podobne pri zdravilu BYETTA in insulinu.
In these studies the incidence of hypoglycaemia was similar for BYETTA and insulin treatment.
V teh študijah je bila incidenca hipoglikemije podobna za zdravljenje z zdravilom BYETTA in insulinom.
BYETTA has shown no adverse effects on lipid parameters.
Zdravilo BYETTA ni pokazalo neželenih učinkov na maščobne parametre.
Clinical studies with BYETTA have indicated improved beta-cell function, using measures such as the homeostasis model assessment for beta-cell function (HOMA-B) and the proinsulin to insulin ratio.
Z uporabo meril, kot so ocena modela homeostaze delovanja beta celic (HOMA- B) in razmerje proinsulina do insulina, so klinične študije z zdravilom BYETTA pokazale izboljšanje delovanja beta celic.
A reduction in body weight was seen in patients treated with BYETTA irrespective of the occurrence of nausea although the reduction was larger in the group with nausea (mean reduction 2.4kg versus 1.7kg) in the long term controlled studies of up to 52 weeks.
Pri bolnikih zdravljenih z zdravilom BYETTA so zmanjšanje telesne mase opazili neodvisno od pojava navzee, čeprav je bilo v do 52 tednov trajajočih dolgoročnih nadzorovanih študijah zmanjšanje večje v skupini z navzeo (povprečno zmanjšanje 2, 4 kg proti 1, 7 kg).
9 5.2 Pharmacokinetic properties
9 Pokazali so, da dajanje eksenatida zmanjša vnos hrane zaradi zmanjšanega apetita in povečanja občutka sitosti.
Absorption Following subcutaneous administration to patients with type 2 diabetes, exenatide reaches median peak plasma concentrations in 2 h.
Absorpcija Po subkutanem dajanju eksenatida bolnikom z diabetesom tipa 2, doseže eksenatid mediano najvišje plazemske koncentracije v 2 urah.
Mean peak exenatide concentration (Cmax) was 211 pg/ ml and overall mean area under the curve (AUC0-inf) was 1036 pg • h/ ml following subcutaneous administration of a 10 µg dose of exenatide.
Po subkutanem dajanju 10 µg odmerka eksenatida, je bila povprečna najvišja koncentracija eksenatida (Cmax) 211 pg/ ml in celotna povprečna površina pod krivuljo (AUC0- inf) 1036 pg • h/ ml.
Exenatide exposure increased proportionally over the therapeutic dose range of 5 µg to 10 µg.
Izpostavljenost eksenatidu se je povečevala sorazmerno v razponu terapevtskih odmerkov od 5 µg do 10 µg.
Distribution The mean apparent volume of distribution of exenatide following subcutaneous administration of a single dose of exenatide is 28 l.
Porazdelitev Povprečna opažena prostornina porazdelitve eksenatida po subkutanem dajanju enkratnega odmerka eksenatida je 28, l.
Metabolism and Elimination Nonclinical studies have shown that exenatide is predominantly eliminated by glomerular filtration with subsequent proteolytic degradation.
Presnova in izločanje Neklinične študije so pokazale, da se eksenatid izloča pretežno z glomerulno filtracijo z nadaljnjo proteolitično razgradnjo.
In clinical studies the mean apparent clearance of exenatide is 9 l/ h and the mean terminal half-life is 2.4 h.
V kliničnih študijah je povprečni opaženi očistek eksenatida 9 l/ h in povprečni končni razpolovni čas 2, 4 h.
Special populations Patients with renal impairment In patients with mild (creatinine clearance 50 to 80 ml/ min) or moderate renal impairment (creatinine clearance 30 to 50 ml/ min), exenatide clearance was mildly reduced compared to clearance in individuals with normal renal function (13% reduction in mild and 36% reduction in moderate renal impairment).
Posebne populacije Bolniki z okvarjenim delovanjem ledvic Pri bolnikih z blago (očistek kreatinina 50 do 80 ml/ min) ali zmerno okvarjenim delovanjem ledvic (očistek kreatinina 30 do 50 ml/ min), se je očistek eksenatida blago zmanjšal v primerjavi z očistkom pri posameznikih z normalnim delovanjem ledvic (13% zmanjšanje pri blago in 36% zmanjšanje pri zmerno okvarjenem delovanju ledvic).
Clearance was significantly reduced by 84% in patients with end-stage renal disease receiving dialysis (see section 4.2).
Očistek se je značilno zmanjšal za 84% pri bolnikih s končno stopnjo bolezni ledvic na dializi (glejte poglavje 4. 2).
Patients with hepatic insufficiency No pharmacokinetic study has been performed in patients with hepatic insufficiency.
Bolniki z okvarjenim delovanjem jeter Pri bolnikih z okvarjenim delovanjem jeter niso opravili nobenih farmakokinetičnih študij.
Exenatide is cleared primarily by the kidney, therefore hepatic dysfunction is not expected to affect blood concentrations of exenatide.
Eksenatid se izloča zlasti preko ledvic, zato ne pričakujemo, da bi jetrna okvara vplivala na koncentracije eksenatida v krvi.
Elderly Data in elderly are limited, but suggest no marked changes in exenatide exposure with increased age up to about 75 years old.
Starejši Podatki pri starejših so omejeni, vendar z večanjem starosti vse do približno 75 leta starosti ne kažejo izrazitih sprememb v izpostavitvi eksenatidu.
There are no pharmacokinetic data in patients > 75 years.
Farmakokinetičnih podatkov za bolnike > 75 let ni.
Children and adolescents In a single-dose pharmacokinetic study in 13 patients with type 2 diabetes and between the ages of 12 and 16 years, administration of exenatide (5µg) resulted in slightly lower mean AUC (16% lower) and Cmax (25% lower) compared to those observed in adults.
Otroci in mladostniki V farmakokinetični študiji enkratnega odmerka pri 13 bolnikih z diabetesom tipa 2, v starosti med 12 in 16 let, je dajanje eksenatida (5 µg) rahlo znižalo srednje vrednosti AUC (16% nižje) in Cmax (25% nižje) v primerjavi z vrednostmi, ki so jih opazili pri odraslih.
Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology, repeat-dose toxicity, or genotoxicity.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih ali genotoksičnosti ne kažejo posebnih tveganj za človeka.
This incidence was not statistically significant when adjusted for survival.
Pri samicah podgan, ki so dobivale eksenatid 2 leti, so opisovali večjo incidenco benignih ščitničnih adenomov C- celic pri največjem odmerku, 250 µg/ kg/ dan, odmerku eksenatida v plazmi, ki povzroči 130- kratno izpostavljenost humane klinične izpostavljenosti.
There was no tumorigenic response in male rats or either sex of mice.
Ta incidenca pri prilagoditvi za
10 Animal studies did not indicate direct harmful effects with respect to fertility or pregnancy.
Pri samcih podgan ali miših kateregakoli spola tumorogenega odgovora ni bilo.
metacresol mannitol glacial acetic acid sodium acetate trihydrate water for injections
metakrezol manitol koncentrirana ocetna kislina; ledocet natrijev acetat trihidrat voda za injekcije
Shelf life for pen in use:
Rok uporabnosti za injekcijski peresnik v uporabi:
In use Store below 25 ºC.
V uporabi Shranjujte pri temperaturi do 25 ºC.
The pen should not be stored with the needle attached.
Peresnika za injiciranje ne smete shranjevati s pritrjeno iglo.
Each pre-filled pen contains 60 doses of sterile preserved solution (approximately 1.2ml)
En napolnjen injekcijski peresnik vsebuje 60 odmerkov sterilne konservirane raztopine (približno 1, 2 ml).
29, 30 or 31 gauge (diameter 0.25 - 0.33mm) and 12.7, 8 or 5mm length.
Navedeni so primeri igel za enkratno uporabo, ki jih lahko uporabite z injekcijskim peresnikom BYETTA: velikosti 29, 30 ali 31 (premer 0, 25 - 0, 33 mm) in dolžine 12, 7, 8 ali 5 mm.
6.6 Special precautions for disposal and other handling.
6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
11 Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
Instructions for use BYETTA is for use by one person only.
Navodila za uporabo Zdravilo BYETTA je za uporabo le za eno osebo.
11 The instructions for using the pen, included with the leaflet, must be followed carefully.
Skrbno upoštevajte navodila za uporabo injekcijskega peresnika, ki so priložena navodilu za uporabo.
The pen is stored without needle.
Injekcijski peresnik shranjujte brez igle.
BYETTA should not be used if particles appear or if the solution is cloudy and/ or coloured.
Zdravila BYETTA ne smete uporabljati, če se v raztopini pojavijo delci ali je raztopina motna in/ ali obarvana.
BYETTA that has been frozen must not be used.
Zdravila BYETTA, ki je bilo zamrznjeno, ne smete uporabiti.
Eli Lilly Nederland B. V., Grootslag 1-5, NL-3991 RA Houten, The Netherlands.
Eli Lilly Nederland B. V., Grootslag 1- 5, 3991 RA Houten, Nizozemska.
EU/ 1/ 06/ 362/ 001 – 2
EU/ 1/ 06/ 362/ 001- 2
20 November 2006
20. november, 2006
BYETTA 10 micrograms solution for injection, prefilled pen
BYETTA 10 mikrogramov raztopina za injiciranje, napolnjen injekcijski peresnik
Each dose contains 10 micrograms(µg) synthetic exenatide in 40 microlitres(µl), (0.25 mg exenatide per ml).
En odmerek vsebuje 10 mikrogramov (µg) sintetičnega eksenatida v 40 mikrolitrih (µl), (0, 25 mg sintetičnega eksenatida na ml).
Each dose contains 88 µg metacresol.
En odmerek vsebuje 88 µg metakrezola.
The dose of BYETTA does not need to be adjusted on a day-by-day basis depending on self- monitored glycaemia.
13 V odvisnosti od bolnikovega nadzora glikemije odmerka zdravila BYETTA dnevno ni potrebno prilagajati.
13 Limited experience exists concerning the combination of BYETTA with thiazolidinediones (see section 5.1).
Izkušnje glede kombinacije zdravila BYETTA z tiazolidindioni so omejene (glejte poglavje 5. 1).
Reversibility of altered renal function has been observed with supportive treatment and discontinuation of potentially causative agents, including BYETTA.
14 vzročnih zdravil, vključno z zdravilom BYETTA, so opažali reverzibilnost spremenjenega delovanja ledvic.
14 There have been rare, spontaneously reported events of acute pancreatitis.
Redko so spontano poročali o primerih akutnega pankreatitisa.
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.
15 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.
15 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.
The reactions are listed below as MedDRA preferred term by system organ class and absolute frequency.
16 Neželeni učinki so navedeni kot MedDRA preferenčni izrazi glede na razred organskega sistema in absolutno pogostnost.
16 Table 1:
Tabela 1:
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).
17 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.
17 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.
Metabolism and nutritional disorders: dehydration, generally associated with nausea, vomiting and/ or diarrhoea.
Presnovne in prehranske motnje: dehidracija, na splošno povezana s navzeo, bruhanjem in/ ali diarejo.
Signs and symptoms of overdose may include severe nausea, severe vomiting and rapidly declining blood glucose concentrations.
18 Znaki in simptomi prevelikega odmerjanja lahko vključujejo hudo navzeo, hudo bruhanje in hitro padanje koncentracije glukoze v krvi.
19 Table 2:
19 Tabela 2:
20 5.2 Pharmacokinetic properties
20 Pokazali so, da dajanje eksenatida zmanjša vnos hrane zaradi zmanjšanega apetita in povečanja občutka sitosti.
21 Animal studies did not indicate direct harmful effects with respect to fertility or pregnancy.
Pri samcih podgan ali miših kateregakoli spola tumorogenega odgovora ni bilo.
Each pre-filled pen contains 60 doses of sterile preserved solution (approximately 2.4ml)
En napolnjen injekcijski peresnik vsebuje 60 odmerkov sterilne konservirane raztopine (približno 2, 4 ml).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
22 Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
22 The instructions for using the pen, included with the leaflet, must be followed carefully.
Skrbno upoštevajte navodila za uporabo injekcijskega peresnika, ki so priložena navodilu za uporabo.
23 ANNEX II
23 DODATEK II
KG Teichweg 3 35396 Giessen Germany
KG Teichweg 3 35396 Giessen Nemčija
The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.
Imetnik dovoljenja za promet mora vzpostaviti sistem farmakovigilance in zagotoviti njegovo delovanje preden da zdravilo v promet in dokler je zdravilo v uporabi.
25 ANNEX III
25 DODATEK III
27 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
27 PODATKI NA ZUNANJI OVOJNINI
{CARTON OF ONE} {CARTON OF THREE}
{ŠKATLA ZA ENEGA} {ŠKATLA ZA TRI}
Byetta 5 micrograms solution for injection, prefilled pen Exenatide
Byetta 5 mikrogramov raztopina za injiciranje, napolnjen injekcijski peresnik eksenatid
Contains metacresol.
Vsebuje metakrezol.
Solution for injection, pre-filled pen 1 pen (60 doses) 3 pens (3 X 60 doses)
1 injekcijski peresnik (60 odmerkov) 3 injekcijski peresniki (3 X 60 odmerkov)
Read the package leaflet and pen user manual before use.
Pred uporabo preberite priloženo navodilo in priročnik za uporabo injekcijskega peresnika.
If the seal is broken before first use, contact your pharmacist.
Če je zaščita poškodovana pred prvo uporabo, o tem obvestite svojega farmacevta.
EXP {MM/ YYYY} Discard pen 30 days after first use.
EXP {MM/ LLLL} Injekcijski peresnik zavrzite 30 dni po prvi uporabi.
Once in use:
Po začetku uporabe:
Store below 25 ºC for 30 days.
30 dni shranjujte pri temperaturi do 25 ºC.
Grootslag 1-5, 3991 RA Houten The Netherlands
Grootslag 1- 5, 3991 RA Houten Nizozemska
Lot {No.}
Lot {št.}
29 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
29 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
{PRE-FILLED PEN LABEL}
{NALEPKA NAPOLNJENEGA INJEKCIJSKEGA PERESNIKA}
Byetta 5 µg injection Exenatide Subcutaneous use
Byetta 5 µg injekcija eksenatid Za subkutano uporabo
Lot {No}
Lot {št.}
60 doses (1.2ml)
60 odmerkov (1, 2 ml)
Byetta 10 micrograms solution for injection, prefilled pen Exenatide
Byetta 10 mikrogramov raztopina za injiciranje, napolnjen injekcijski peresnik eksenatid
Store below 25 ºC for 30 days. Do not store with needle attached.
30 dni shranjujte pri temperaturi do 25 ºC.
Recap pen to protect from light.
Ne shranjujte s pritrjeno iglo.
Byetta 10 µg injection Exenatide Subcutaneous use
Byetta 10 µg injekcija eksenatid Za subkutano uporabo
60 doses (2.4ml)
60 odmerkov (2, 4 ml)
34 PACKAGE LEAFLET:
34 NAVODILO ZA UPORABO
BYETTA 5 micrograms solution for injection, pre-filled pen BYETTA 10 micrograms solution for injection, pre-filled pen (exenatide)
BYETTA 5 mikrogramov raztopina za injiciranje, napolnjen injekcijski peresnik BYETTA 10 mikrogramov raztopina za injiciranje, napolnjen injekcijski peresnik (eksenatid)
What BYETTA is and what it is used for 2.
Kaj je zdravilo BYETTA in za kaj ga uporabljamo 2.
Before you use BYETTA 3.
Kaj morate vedeti, preden boste uporabili zdravilo BYETTA 3.
How to use BYETTA 4.
Kako uporabljati zdravilo BYETTO 4.
How to store BYETTA 6.
Shranjevanje zdravila BYETTA 6.
WHAT BYETTA IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO BYETTA IN ZA KAJ GA UPORABLJAMO
BYETTA is an injectable medicine used to improve blood sugar control in adults with type 2 (non insulin dependent) diabetes mellitus.
BYETTA je zdravilo za injiciranje, ki ga uporabljamo za izboljšanje nadzora sladkorja v krvi pri odraslih s sladkorno boleznijo tipa 2 (od insulina neodvisno).
BYETTA is used with other diabetic medicines called metformin and/ or sulphonylureas. Your doctor is now prescribing BYETTA as an additional medicine to help control your blood sugar.
Vaš zdravnik vam je predpisal zdravilo BYETTA kot dodatno zdravilo, ki vam bo pomagalo nadzorovati vrednosti vašega sladkorja v krvi.
BYETTA helps your body to increase the production of insulin when your blood sugar is high.
Kadar je vaš sladkor v krvi visok, zdravilo BYETTA vašemu telesu pomaga povečati proizvodnjo insulina.
BEFORE YOU USE BYETTA
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO BYETTA
Do not use BYETTA:
Ne uporabljajte zdravila BYETTA:
- If you are allergic (hypersensitive) to exenatide or any of the other ingredients of BYETTA, listed
- Če ste alergični na (preobčutljivi za) eksenatid ali katerokoli sestavino zdravila BYETTA, ki so
at the end of this leaflet.
navedene na koncu tega navodila.
Take special care with BYETTA:
Bodite posebno pozorni pri uporabi zdravila BYETTA:
- When using it in combination with a sulphonylurea, as low blood sugar (hypoglycaemia) can
- Kadar zdravilo BYETTA uporabljate v kombinaciji s sulfonilureo, ker lahko pride do nizkega
- If you have severe problems with your stomach emptying (including gastroparesis) or food
sladkorja v krvi (hipoglikemije).
BYETTA slows stomach emptying so food passes more slowly through your stomach.
Če niste prepričani ali katerokoli izmed vaših ostalih zdravil vsebuje sulfonilureo, vprašajte svojega zdravnika ali farmacevta.
- The use of BYETTA with insulins is not recommended.
- Zdravilo BYETTA si injicirajte pod kožo in ne v veno ali v mišico.
- There is little experience with BYETTA in patients with kidney problems.
- Če imate hude težave s praznjenjem želodca (vključno z gastroparezo) ali prebavo hrane, ne
The use of BYETTA is
priporočamo jemanja zdravila BYETTA.
not recommended if you have severe kidney disease or you are on dialysis.
zdravila BYETTA ne priporočamo, če imate hudo bolezen ledvic ali ste na dializi.
- There is no experience with BYETTA in children and adolescents less than 18 years and,
- Pri otrocih in mladostnikih, mlajših od 18 let, ni izkušenj z zdravilom BYETTA, zato v tej
therefore, use of BYETTA is not recommended in this age group.
starostni skupini ne priporočamo uporabe zdravila BYETTA.
BYETTA slows stomach emptying and can affect medicines that need to pass through the stomach quickly.
Zdravilo BYETTA upočasni praznjenje želodca in lahko vpliva na zdravila, ki morajo hitro preiti skozi želodec.
Ask your doctor if the time at which you take any tablets (for example, antibiotics) should be changed.
Vprašajte svojega zdravnika, ali morate spremenite čas jemanja katerihkoli tablet (na primer antibiotikov).
For tablets that you need to take with food, it may be best if they are taken at a meal at a time when BYETTA is not being administered.
Za tablete, ki jih morate vzeti s hrano, je morda najbolje, da jih vzamete med obrokom, v času ko ne uporabite zdravila BYETTA.
Using BYETTA with food and drink:
Uporaba zdravila BYETTA skupaj s hrano in pijačo:
Use BYETTA at any time within the 60 minutes (1 hour) before your meal.
Zdravilo BYETTA uporabite kadarkoli v roku 60 minut (1 ure) pred vašim obrokom.
(See 3 “ How to use BYETTA ”).
(Glejte 3 “ Kako uporabljati zdravilo BYETTA ”).
Do not use BYETTA after your meal.
Ne uporabljajte zdravila BYETTA po vašem obroku.
It is not known if BYETTA may harm your unborn child.
Ni znano ali lahko zdravilo BYETTA poškoduje vašega nerojenega otroka.
Tell your doctor if you are, you think you might be, or are planning to become pregnant as BYETTA should not be used during pregnancy.
Če ste ali mislite, da bi lahko bili noseči, ali če nameravate zanositi, obvestite svojega zdravnika, saj med nosečnostjo zdravila BYETTA ne smete uporabljati.
It is not known if BYETTA passes into your milk.
Ni znano ali zdravilo BYETTA prehaja v materino mleko.
BYETTA should not be used if breast-feeding.
Zdravila BYETTA med dojenjem ne smete uporabljati.
If you use BYETTA in combination with a sulphonylurea, low blood sugar (hypoglycaemia) can occur.
Če uporabljate zdravilo BYETTA v kombinaciji s sulfonilureo, lahko pride do nizkega sladkorja v krvi (hipoglikemije).