natgillin/translations-raw huggingface dataset:
Y: body weight of the patient in kg D: dose of Busilvex (see SPC section 4.2)
Y: telesna masa bolnika v kilogramih D: odmerek zdravila Busilvex (glejte Povzetek glavnih značilnosti zdravila, poglavje 4. 2)
To prepare the final solution for infusion, add (A) ml of Busilvex to (B) ml of diluent (sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%)
Za pripravo končne raztopine za infuzijo dodajte (A) ml Busilvexa v (B) ml redčila (0, 9% raztopine natrijevega klorida (9 mg/ ml) za injiciranje ali 5% raztopine glukoze za injiciranje).
Preparation of the solution for infusion Busilvex must be prepared by a healthcare professional using sterile transfer techniques. • Using a non polycarbonate syringe fitted with a needle:
• Zdravilo Busilvex mora pripraviti usposobljen zdravstveni delavec ali delavka v sterilnih pogojih.
- the calculated volume of Busilvex must be removed from the vial.
• Z nepolikarbonatno brizgo, na kateri je nameščena igla:
- the contents of the syringe must be dispensed into an intravenous bag (or syringe) which
– izračunano prostornino Busilvexa morate odstraniti iz viale.
already contains the calculated amount of the selected diluent.
– vsebino brizge morate prestaviti v vrečko ali brizgo za intravensko uporabo, v katero ste že dali izračunano količino izbranega redčila.
Busilvex must always be added to the diluent, not the diluent to Busilvex.
Buslivex morate vedno dodajati v redčilo, in ne redčila v Busilvex.
Busilvex must not be put into an intravenous bag that does not contain sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%.
Busilvexa ne smete dati v intravensko vrečko, v kateri ni 0, 9% raztopine natrijevega klorida (9 mg/ ml) za injiciranje ali 5% raztopine glukoze za injiciranje.
• The diluted solution must be mixed thoroughly by inverting several times
• Vrečko morate temeljito premešati z nekajkratnim obračanjem..
After dilution, 1 ml of solution for infusion contains 0.5 mg of busulfan
Po redčenju 1 ml raztopine za infuzijo vsebuje 0, 5 mg busulfana.
Instructions for use Prior to and following each infusion, flush the indwelling catheter line with approximately 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection or glucose (5%) solution for injection.
Pred vsako infuzijo in po njej izperite katetrsko cev s približno 5 mililitri 0, 9% raztopine natrijevega klorida (9 mg/ ml) za injiciranje ali 5% raztopine glukoze za injiciranje.
30 The residual medicinal product must be flushed in the administration tubing as rapid infusion of Busilvex has not been tested and is not recommended.
Preostalega zdravila ne smete izpirati v ceveh med uporabo, kajti hitre infuzije Busilvexa še niso preizkusili in je ne priporočamo.
In that case infusion sets with minimal priming space should be used (i.e 0.3-0.6 ml), primed with medicinal product solution prior to beginning the actual Busilvex infusion and then flushed with sodium chloride 9 mg/ml (0.9%) solution for injection or glucose (5%) solution for injection.
0, 3- 0, 6 ml), pri katerih je raztopina zdravila infundirana pred dejanskim infundiranjem Busilvexa in nato splaknjena z 0, 9 - 30 odstotno raztopino natrijevega klorida (9 mg/ ml) za injiciranje ali 5- odstotno raztopino glukoze za injiciranje.
Any unused product or waste should be disposed of in accordance with local requirements for cytotoxic medicinal products.
Neuporabljeno zdravilo ali odpadni material morate odstraniti v skladu z lokalnimi predpisi za citotoksična zdravila.
Byetta is used to treat type 2 diabetes together with other antidiabetes medicines (metformin and/ or sulphonylureas) in patients whose blood glucose (sugar) levels are not adequately controlled with the maximum tolerated doses of the other medicines.
Zdravilo Byetta se skupaj z drugimi zdravili proti sladkorni bolezni (metforminom in/ ali sulfonilsečninami) uporablja za zdravljenje sladkorne bolezni tipa 2 pri bolnikih, pri katerih ravni glukoze (sladkorja) v krvi niti z uporabo največjih odmerkov drugih zdravil, ki jih bolnik še prenaša, ni mogoče ustrezno nadzorovati.
Type 2 diabetes is also known as non-insulin- dependent diabetes.
Sladkorna bolezen tipa 2 je znana tudi kot od insulina neodvisna sladkorna bolezen.
Byetta is given by injection under the skin of the thigh, the abdomen (tummy) or the upper arm, using the injection pen.
Zdravilo Byetta se daje z injekcijo s pomočjo injekcijskega peresnika pod kožo stegna, trebuha ali nadlakti.
Treatment with Byetta should start at a dose of 5 micrograms twice a day for at least a month.
Zdravljenje z zdravilom Byetta se mora začeti z odmerkom 5 mikrogramov dvakrat na dan, kar traja vsaj en mesec.
The dose can then be increased to 10 micrograms twice a day.
Odmerek se lahko nato poveča na 10 mikrogramov dvakrat na dan.
A dose higher than 10 micrograms twice a day is not recommended.
Odmerek, ki presega 10 mikrogramov dvakrat na dan, ni priporočen.
The first dose of the day is administered within the one hour before the morning meal, and the second dose within the one hour before the evening meal.
Prvi odmerek dneva se daje največ eno uro pred jutranjim obrokom, drugi pa največ eno uro pred večernim obrokom.
Byetta should never be given after a meal.
Zdravilo Byetta se nikoli ne sme dati po obroku.
Care is needed when adding Byetta to sulphonylureas, as there is a risk of hypoglycaemia (low blood sugar levels).
Kadar se zdravilo Byetta uporablja skupaj s sulfonilsečninami, je potrebna previdnost, saj obstaja nevarnost hipoglikemije (nizke ravni krvnega sladkorja).
Adding Byetta to metformin is not associated with this risk.
Uporaba zdravila Byetta skupaj z metforminom ni povezana s tem tveganjem.
Byetta should not be used in patients who have severe problems with their kidneys.
Zdravilo Byetta se ne sme dajati bolnikom, ki imajo hude težave z ledvicami.
Patients being treated with Byetta should continue to follow their diet and exercise plans.
Bolniki, ki se zdravijo z zdravilom Byetta, naj nadaljujejo z začrtanim programom diete in telesne vadbe.
The safety and effectiveness of Byetta have not been established in patients below 18 years of age.
Varnost in učinkovitost zdravila Byatta pri bolnikih, mlajših od 18 let, ni bila potrjena.
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Sladkorna bolezen tipa 2 je bolezen, pri kateri trebušna slinavka ne proizvaja zadostne količine insulina za uravnavanje ravni sladkorja (glukoze) v krvi ali kadar ga telo ne zmore učinkovito izrabljati.
The active substance in Byetta, exenatide, is an ‘ incretin mimetic’.
Zdravilna učinkovina zdravila Byetta je eksenatid, ki je „ mimetik inkretina “.
This means that it acts in the same way as incretins (hormones produced in the gut) by increasing the amount of insulin released by the pancreas in response to food.
To pomeni, da deluje na enak način kot inkretini (v črevesu proizvedeni hormoni), in sicer z višanjem količine
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. insulina, ki ga kot odgovor na hrano izloči trebušna slinavka.
The effects of Byetta were first tested in experimental models before being studied in humans.
Učinki zdravila Byetta so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Byetta has been studied in five main studies involving almost 2,400 patients.
Zdravilo Byetta je bilo raziskano v petih glavnih študijah, ki so vključevale skoraj 2 400 bolnikov.
In three of these studies, Byetta was compared with placebo (a dummy treatment), when they were given as an ‘ add-on’ to metformin (336 patients), sulphonylureas (377 patients) or both types of medicine (733 patients).
V treh od teh študij so zdravilo Byetta primerjali s placebom (zdravilom brez zdravilne učinkovine), kadar se daje kot dopolnilno zdravilo metforminu (336 bolnikov), sulfonilsečninam (377 bolnikov) ali obema skupaj (733 bolnikov).
The other two studies compared adding Byetta or adding an insulin to existing treatment with metformin and sulphonylureas.
V drugih dveh študijah so primerjali dodajanje zdravila Byatta ali insulina k obstoječemu zdravljenju z metforminom in sulfonilsečninami.
In one study, Byetta was compared with insulin glargine in 456 patients and in the other study it was compared with biphasic insulin in 483 patients.
V eni študiji so zdravilo Byetta pri 456 bolnikih primerjali z insulinom glarginom, v drugi študiji pri 483 bolnikih pa z dvofaznim insulinom.
In all studies, the main measure of effectiveness was the change in the levels of a substance in the blood called glycosylated haemoglobin (HbA1c).
V vseh študijah je bilo glavno merilo učinkovitosti sprememba v ravneh snovi v krvi, imenovane glikoziliran hemoglobin (HbA1c).
HbA1c levels give an indication of how well the blood glucose is controlled.
Ravni HbA1c kažejo, kako dobro je raven glukoze v krvi nadzorovana.
Byetta was more effective than placebo in reducing the levels of HbA1c when used in combination with other antidiabetic medicines.
Zdravilo Byetta je bilo v primerjavi s placebom učinkovitejše pri zniževanju ravni HbA1c, kadar so ga uporabljali v kombinaciji z drugimi zdravili proti sladkorni bolezni.
After 30 weeks, the 5-microgram twice-daily dose decreased HbA1c levels by 0.46 to 0.66% and the 10-microgram twice-daily dose decreased it by 0.86 to 0.91%.
Po 30 tednih je 5- mikrogramski odmerek dvakrat na dan znižal ravni HbA1c od 0, 46 do 0, 66%, 10- mikrogramski odmerek dvakrat na dan pa ga je znižal od 0, 86 do 0, 91%.
Byetta was as effective as injected insulin.
Zdravilo Byetta je bilo enako učinkovito kot vbrizgani insulin.
The 10-microgram twice-daily dose of Byetta decreased HbA1c by 1.13%, compared to 1.10% with insulin glargine after six months.
10- mikrogramski odmerek dvakrat na dan je po šestih mesecih zdravljenja znižal raven HbA1c za 1, 13% v primerjavi z 1, 10% pri uporabi insulina glargina.
In the final study, the 10-microgram twice-daily dose of Byetta decreased HbA1c by 1.01% after a year, compared to 0.86% with biphasic insulin.
V zadnji študiji je dvakrat dnevni 10- mikrogramski odmerek zdravila Byetta po enem letu znižal raven HbA1c za 1, 01% v primerjavi z 0, 86% pri uporabi dvofaznega insulina.
In clinical studies, the most common side effects with Byetta (seen in more than 1 patient in 10) were hypoglycaemia (when it was taken with a sulphonylurea), nausea (feeling sick), vomiting and diarrhoea.
V kliničnih študijah so bili najpogostejši neželeni učinki zdravila Byetta (opaženi pri več kot 1 bolniku od 10) hipoglikemija (kadar so ga dajali skupaj s sulfonilsečninami), navzeja (slabost), bruhanje in driska.
For the full list of all side effects reported with Byetta, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Byetta, glejte navodilo za uporabo.
Byetta should not be used in people who may be hypersensitive (allergic) to exenatide or any of the other ingredients.
Zdravila Byetta ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) eksenatid ali katero koli drugo sestavino zdravila.
The Committee for Medicinal Products for Human Use (CHMP) decided that Byetta’ s benefits are greater than its risks for the treatment of type 2 diabetes mellitus in combination with metformin and/ or sulphonylureas in patients who have not achieved adequate control on maximum tolerated doses of these medicines.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da so koristi zdravila Byetta pri zdravljenju sladkorne bolezni tipa 2 v kombinaciji z metforminom in/ ali sulfonilsečninami pri bolnikih, ki niso dosegli ustreznega nadzora pri največjih odmerkih teh zdravil, ki so jih še prenesli, večje od z njim povezanih tveganj.
The Committee recommended that Byetta be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Byetta odobri dovoljenje za promet.
The European Commission granted a marketing authorisation valid throughout the European Union for Byetta to Eli Lilly Nederland B. V. on 20 November 2006.
Evropska komisija je dovoljenje za promet z zdravilom Byetta, veljavno po vsej Evropski uniji, odobrila družbi Eli Lilly Nederland B. V. dne 20. novembra 2006.
The full EPAR for Byetta can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Byetta je na voljo tukaj.
Strength 5 micrograms 5 micrograms 10 micrograms 10 micrograms
5 mikrogramov
Pharmaceutical Form Solution for injection Solution for injection Solution for injection Solution for injection
napolnjen injekcijski peresnik (steklo)
Route of administration subcutaneous use subcutaneous use subcutaneous use subcutaneous use
napolnjen injekcijski peresnik (steklo)
Packaging Pre-filled pen (glass) Pre-filled pen (glass) Pre-filled pen (glass) Pre-filled pen (glass)
napolnjen injekcijski peresnik (steklo)
Content 1,2 ml 1,2 ml 2,4 ml 2,4 ml
1 napolnjen injekcijski peresnik
Package size 1 pre-filled pen 3 pre-filled pens 1 pre-filled pen 3 pre-filled pens
3 napolnjeni injekcijski peresniki
BYETTA 5 micrograms solution for injection, prefilled pen
BYETTA 5 mikrogramov raztopina za injiciranje, napolnjen injekcijski peresnik
Each dose contains 5 micrograms(µg) synthetic exenatide in 20 microlitres(µl), (0.25 mg exenatide per ml).
En odmerek vsebuje 5 mikrogramov (µg) sintetičnega eksenatida v 20 mikrolitrih (µl), (0, 25 mg eksenatida na ml).
Each dose contains 44 µg metacresol.
En odmerek vsebuje 44 µg metakrezola.
This medicinal product contains less than 1mmol sodium per dose, i. e. essentially “ sodium-free”.
Zdravilo vsebuje manj kot 1 mmol natrija na odmerek, t. j. pravzaprav “ brez natrija ”.
Solution for injection, pre-filled pen.
Raztopina za injiciranje, napolnjen injekcijski peresnik.
BYETTA is indicated for treatment of type 2 diabetes mellitus in combination with metformin, and/ or sulphonylureas in patients who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.
Zdravilo BYETTA je indicirano za zdravljenje diabetes mellitusa tipa 2 v kombinaciji z metforminom in/ ali sulfonilureami pri bolnikih, ki niso dosegli zadostnega glikemičnega nadzora pri maksimalnih odmerkih teh peroralnih zdravil, ki jih bolniki še prenašajo.
BYETTA therapy should be initiated at 5 µg exenatide per dose administered twice daily (BID) for at least one month in order to improve tolerability.
Zdravljenje z zdravilom BYETTA začnemo s 5 µg eksenatida na odmerek danih dvakrat na dan za najmanj en mesec z namenom izboljšanja prenašanja.
The dose of exenatide can then be increased to 10 µg BID to further improve glycaemic control.
Odmerek eksenatida lahko nato povečujemo do 10 µg dvakrat na dan z namenom nadaljnjega izboljšanja glikemičnega nadzora.
Doses higher than 10µg BID are not recommended.
Odmerkov, večjih od 10 µg dvakrat na dan, ne priporočamo.
BYETTA is available as either a 5 µg or a 10 µg exenatide per dose pre-filled pen.
Zdravilo BYETTA je na voljo kot 5 µg ali 10 µg eksenatida na odmerek napolnjenega injekcijskega peresnika.
BYETTA can be administered at any time within the 60-minute period before the morning and evening meal (or two main meals of the day, approximately 6 hours or more apart).
Zdravilo BYETTA lahko damo kadarkoli v roku 60- minut pred jutranjim in večernim obrokom (ali dvema glavnima dnevnima obrokoma, ki sta približno 6 ur ali več narazen).
BYETTA should not be administered after a meal.
Zdravila BYETTA ne smemo dajati po obroku.
BYETTA is recommended for use in patients with type 2 diabetes mellitus who are already receiving metformin and/ or a sulphonylurea.
Zdravilo BYETTA priporočamo za uporabo pri bolnikih z diabetes mellitusom tipa 2, ki že dobivajo metformin in/ ali sulfonilureo.
When BYETTA is added to existing metformin therapy, the current dose of metformin can be continued as no increased risk of hypoglycaemia is anticipated, compared to metformin alone.
Kadar zdravilo BYETTA dodamo k že uvedenemu zdravljenju z metforminom, lahko nadaljujemo z predpisanim odmerkom metformina, saj ne pričakujemo povečanega tveganja za hipoglikemijo, v primerjavi s samim metforminom.
When BYETTA is added to sulphonylurea therapy, a reduction in the dose of sulphonylurea should be considered to reduce the risk of hypoglycaemia (see section 4.4.).
Kadar zdravilo BYETTA dodamo zdravljenju s sulfonilureo, moramo premisliti o zmanjšanju odmerka sulfoniluree za zmanjšanje tveganja za hipoglikemijo (glejte poglavje 4. 4).
The dose of BYETTA does not need to be adjusted on a day-by-day basis depending on self- monitored glycaemia.
2 V odvisnosti od bolnikovega nadzora glikemije odmerka zdravila BYETTA dnevno ni potrebno prilagajati.
However, blood glucose self-monitoring may become necessary to adjust the dose of sulphonylureas.
Vendar lahko postane bolnikov nadzor glukoze v krvi potreben za prilagoditev odmerka sulfonilurej.
2 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).
Specific patient groups Elderly BYETTA should be used with caution and dose escalation from 5 µg to 10 µg should proceed conservatively in patients > 70 years.
Posebne skupine bolnikov Starejši Zdravilo BYETTA moramo uporabljati previdno ter previdno višati odmerek od 5 µg do 10 µg pri bolnikih > 70 let.
Patients with renal impairment No dosage adjustment of BYETTA is necessary in patients with mild renal impairment (creatinine clearance 50 – 80 ml/ min).
Bolniki z okvarjenim delovanjem ledvic Pri bolnikih z blago okvarjenim delovanjem ledvic (očistek kreatinina 50- 80 ml/ min) odmerka zdravila BYETTA ni potrebno prilagajati.
In patients with moderate renal impairment (creatinine clearance:30-50 ml/ min), dose escalation from 5 µg to 10 µg should proceed conservatively (see section 5.2).
Pri bolnikih z zmerno okvarjenim delovanjem ledvic (očistek kreatinina 30- 50 ml/ min) previdno višamo odmerek od 5 µg do 10 µg (glejte poglavje 5. 2).
BYETTA is not recommended for use in patients with end-stage renal disease or severe renal impairment (creatinine clearance < 30 ml/ min) (see section 4.4).
Uporabe zdravila BYETTA ne priporočamo bolnikom s končno stopnjo bolezni ledvic ali hudo okvarjenim delovanjem ledvic (očistek kreatinina < 30 ml/ min) (glejte poglavje 4. 4).
Patients with hepatic impairment No dosage adjustment of BYETTA is necessary in patients with hepatic impairment (see section 5.2).
Bolniki z okvarjenim delovanjem jeter Pri bolnikih z okvarjenim delovanjem jeter odmerka zdravila BYETTA ni potrebno prilagajati (glejte poglavje 5. 2).
(see section 5.2).
Otroci in mladostniki Varnosti in učinkovitosti eksenatida pri bolnikih, mlajših od starosti 18 let niso ugotovili (glejte poglavje 5. 2).
BYETTA should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Zdravila BYETTA ne smemo uporabljati pri bolnikih z diabetes mellitusom tipa 1 ali za zdravljenje diabetične ketoacidoze.
BYETTA should not be used in type 2 diabetes patients who require insulin therapy due to betacell failure.
Zdravila BYETTA ne smemo uporabljati pri bolnikih z diabetes mellitusom tipa 2, ki zaradi slabega delovanja beta celic potrebujejo zdravljenje z insulinom.
Intravenous or intramuscular injection of BYETTA is not recommended.
Odsvetujemo intravensko ali intramuskularno injiciranje zdravila BYETTA.
In patients with end-stage renal disease receiving dialysis, single doses of BYETTA 5 µg increased frequency and severity of undesirable gastrointestinal effects.
Pri bolnikih s končno stopnjo bolezni ledvic na dializi so enkratni odmerki zdravila BYETTA 5 µg povečali pogostnost in hudost neželenih učinkov na prebavila.
BYETTA is not recommended for use in patients with end-stage renal disease or severe renal impairment (creatinine clearance < 30 ml/ min).
Uporabe zdravila BYETTA ne priporočamo bolnikom s končno stopnjo bolezni ledvic ali hudo okvarjenim delovanjem ledvic (očistek kreatinina < 30 ml/ min).
The clinical experience in patients with moderate renal impairment is very limited.
Klinične izkušnje pri bolnikih z zmerno okvarjenim delovanjem ledvic so zelo omejene.
There have been rare, spontaneously reported events of altered renal function, including increased serum creatinine, renal impairment, worsened chronic renal failure and acute renal failure, sometimes requiring hemodialysis.
Redko so spontano poročali o primerih spremenjenega delovanja ledvic, vključno z zvišanjem kreatinina v serumu, okvaro ledvic, poslabšanjem kronične odpovedi ledvic in akutno odpovedjo ledvic, z občasno potrebo po hemodializi.
Some of these events occurred in patients experiencing events that may affect hydration, including nausea, vomiting, and/ or diarrhoea and/ or receiving pharmacological agents known to affect renal function/ hydration status.
Nekateri izmed teh dogodkov so se pojavili pri bolnikih, ki so izkusili stanja, ki lahko vplivajo na hidracijo, vključno z navzeo, bruhanjem in/ ali diarejo in/ ali so prejemali farmakološke učinkovine z učinkom na delovanje ledvic/ stanje hidracije.
Concomitant agents included angiotensin converting enzymes inhibitors, angiotensin-II antagonists, nonsteroidal anti-inflammatory medicinal products and diuretics.
S podpornim zdravljenjem ter ukinitvijo potencialno
Reversibility of altered renal function has been observed with supportive treatment and discontinuation of potentially causative agents, including BYETTA.
3 vzročnih zdravil, vključno z zdravilom BYETTA, so opažali reverzibilnost spremenjenega delovanja ledvic.
BYETTA has not been studied in patients with severe gastrointestinal disease, including gastroparesis.
Uporabe zdravila BYETTA niso preučevali pri bolnikih s hudo boleznijo prebavil, vključno z gastroparezo.
Therefore, the use of BYETTA is not recommended in patients with severe gastrointestinal disease.
Zato bolnikom s hudo boleznijo prebavil ne priporočamo uporabe zdravila BYETTA.
3 There have been rare, spontaneously reported events of acute pancreatitis.
Redko so spontano poročali o primerih akutnega pankreatitisa.
Resolution of pancreatitis has been observed with supportive treatment.
Ob podpornem zdravljenju so opažali izboljšanje pankreatitisa.
If pancreatitis is suspected, BYETTA and other potentially suspect medicinal products should be discontinued.
Če obstaja sum na pankreatitis, je potrebna ukinitev zdravila BYETTA ter drugih potencialno vzročnih zdravil.
The concurrent use of BYETTA with insulin, D-phenylalanine derivatives(meglitinides), or alpha-glucosidase inhibitors has not been studied and cannot be recommended.
Sočasne uporabe zdravila BYETTA z insulinom, derivati D- fenilalanina (meglitinidi) ali zaviralci alfa- glukozidaze niso preučevali in je ne priporočamo.
The experience in patients with BMI ≤ 25 is limited.
Izkušnje pri bolnikih z ITM ≤ 25 so omejene.
This medicinal product contains metacresol, which may cause allergic reactions.
To zdravilo vsebuje metakrezol, ki lahko povzroča alergične reakcije.
Hypoglycaemia When BYETTA was used in combination with a sulphonylurea, the incidence of hypoglycaemia was increased over that of placebo in combination with a sulphonylurea.
Hipoglikemija Ob uporabi zdravila BYETTA v kombinaciji s sulfonilureo je bila incidenca hipoglikemije večja v primerjavi z placebom v kombinaciji s sulfonilureo.
In the clinical studies patients on a sulphonylurea combination, with mild renal impairment had an increased incidence of hypoglycaemia compared to patients with normal renal function.
V kliničnih študijah pri bolnikih z blago okvarjenim delovanjem ledvic, ki so jemali kombinacijo s sulfonilureo, je bila incidenca hipoglikemije večja v primerjavi z bolniki z normalnim delovanjem ledvic.
To reduce the risk of hypoglycaemia associated with the use of a sulphonylurea, reduction in the dose of sulphonylurea should be considered.
Za zmanjšanje tveganja za hipoglikemijo, povezano s uporabo sulfoniluree, je potrebno premisliti o zmanjšanju odmerka sulfoniluree.