natgillin/translations-raw huggingface dataset:
Due to the likely variability (time, geographical) in the occurrence of the resistance of bacteria for tilmicosin, bacteriological sampling and susceptibility testing are recommended
Zaradi verjetne variabilnosti (trajanje, geografsko) pojavljanja bakterij, odpornih proti tilmikozinu, se priporoča odvzem vzorca za bakteriologijo in določanje občutljivosti.
Quantifiable levels of tilmicosin were found in lung tissue with the maximum concentration (1.43±1.13 µg/ml) being recorded on day 10 of medication.
V pljučnem tkivu so bile izmerljive ravni tilmikozina, najvišja koncentracija (1,43±1,13 µg/ml) pa je bila zaznana 10. dan zdravljenja.
Elimination: Following oral administration, tilmicosin is excreted mainly via the bile into the faeces but a small proportion is excreted via the urine.
Izločanje: Tilmikozin se po peroralnem dajanju izloča predvsem prek žolča v iztrebke, manjši delež pa se izloči s sečem.
• The shelf life after incorporation into meal or pelleted feed: 1 month;
• rok uporabnosti po dodajanju v obrok ali peletirano hrano: 1 mesec;
The CVMP accepts that a claim for efficacy at a dose of 8 to 16 mg/kg bw/day of tilmicosin (equivalent to 200 to 400 ppm in the feed) for a period of 15 to 21 days for prevention and treatment of respiratory infections in pigs has been demonstrated.
CVMP se strinja, da je bila zahteva o učinkovitosti pri odmerku 8 do 16 mg tilmikozina na kg telesne mase dnevno (enakovredno 200 do 400 ppm v krmi) v obdobju od 15 do 21 dni za preprečevanje in zdravljenje bolezni dihal pri prašičih dokazana.
8-16 mg/kg bodyweight/day
8-16 mg/kg telesne mase/dan
The sudden decline in potency after one month at 25 ºC for tilmicosin in pelleted feeds with levels of wheat higher than 30% is troubling.
Težava je v nenadnem padcu aktivnosti tilmikozina po enem mesecu v peletirani krmi z ravnijo pšenice več kot 30 %.
In order to obtain a correct dosage the concentration of tilmicosin has to be adjusted accordingly.
Koncentracijo tilmikozina morate prilagoditi tako, da dosežete pravilni odmerek.
Therefore, to protect soil and ground water, pig manure not to be spread onto the grass land and when spread onto arable land plough to a depth of 30 cm. Environmental assessments have demonstrated that the use of Pulmotil Premix as indicated is not expected to have any impact on the environment.
Če se raztrese po orni zemlji, je treba orati do globine 30 cm. Ocene okolja so pokazale, da ni pričakovati, da bi zdravilo Pulmotil Premix, uporabljeno v skladu z indikacijami, imelo vpliv na okolje.
When administered at a dose of 200 mg tilmicosin/kg feed (equivalent to approximately 11.0 mg/kg/day), plasma concentrations above the limit of quantification (0.10 µg/ml) were found in 3 out of 20 animals examined.
Pri dajanju odmerka 200 mg tilmikozina/kg krmne mešanice (enakovredno približno 11,0 mg/kg/dan) pri 3 od 20 preiskanih živalih niso bile zaznane koncentracije v plazmi nad mejo kvantifikacije (0,10 µg/ml).
2 kg, 5 kg and 10 kg 200g/kg: 1 kg and 10 kg
Predmešanica 200 g/kg: 1 kg in 10 kg
Distribution: Following oral administration, tilmicosin is distributed throughout the body with especially high levels found in lungs.
Porazdelitev: Tilmikozin se po peroralnem dajanju porazdeli po celotnem telesu, posebno visoke ravni pa so v pljučih.
Efficacy in rabbits
Učinkovitost pri kuncih
For products containing 200g tilmicosin/kg:
Za zdravila, ki vsebujejo 200 g tilmikozina/kg:
12 mg/kg bodyweight/day
12 mg/kg telesne mase/dan
Pigs Rabbits
Prašiči Kunci
Under practical conditions, the management of respiratory disease outbreaks recognises that acutely ill animals are inappetant and require parenteral therapy.
4.4 Posebna opozorila za vsako ciljno živalsko vrsto Kadar je praktično, je treba pri obvladovanju izbruhov bolezni dihal upoštevati, da so akutno bolne živali neješče, zato potrebujejo parenteralno terapijo.
WITHDRAWAL PERIOD Pigs: 21 days
KARENCA Prašiči: 21 dni Kunci: 4 dni
Product containing 200g tilmicosin/kg is packed in either:
Zdravila, ki vsebujejo 200 g tilmikozina/kg, so pakirana v:
PHARMACEUTICAL FORM Premix for medicated feeding stuff.
FARMACEVTSKA OBLIKA Predmešanica za zdravilno krmno mešanico.
Shelf life after incorporation into meal or pelleted feed: 1 month.
Rok uporabnosti po vključitvi v obrok ali peletirano hrano: 1 mesec.
PHARMACEUTICAL FORM Premix for medicated feeding stuff
FARMACEVTSKA OBLIKA Predmešanica za zdravilno krmno mešanico
Pigs and rabbits
Prašiči in kunci
Macrolides, such as tilmicosin, may also cause hypersensitivity (allergy) following injection, inhalation, ingestion or contact with skin or eye. Hypersensitivity to tilmicosin may lead to cross reactions to other macrolides and vice versa.
Makrolidi, kot je tilmikozin, lahko povzročajo tudi preobčutljivost (alergijo) po injiciranju, vdihavanju, zaužitju ali pri stiku s kožo ali očmi.
the CVMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics is set out in Annex III for Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix and associated names.
je CVMP priporočil dopolnitev dovoljenj za promet z zdravili Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix in z njim povezana imena, katerih povzetek glavnih značilnosti zdravila in označevanja so navedeni v Dodatku III.
Rabbits: Pasteurella multocida, Staphylococcus aureus and Bordetella bronchoseptica
Prašiči: Mycoplasma hyopneumoniae, Pasteurella multocida, Actinobacillus pleuropneumoniae Kunci: Pasteurella multocida, Staphylococcus aureus in Bordetella bronchoseptica
Paper/polyethylene/aluminium/polyethylene/paper bags containing 2 kg, 5 kg or 10 kg of product.
1. vreče iz polietilena/poliamida/polietilena (notranja plast) z 10 kg zdravila ali 2. vreče iz papirja/polietilena/aluminija/polietilena/papirja z 2 kg, 5 kg ali 10 kg zdravila.
Distribution: Following oral administration, tilmicosin is distributed throughout the body with especially high levels found in the lung and in lung tissue macrophages.
Porazdelitev: Tilmikozin se po peroralnem dajanju porazdeli po celotnem telesu, posebno visoke ravni pa so v pljučih in makrofagih pljučnega tkiva.
40 g/kg Premix:
Predmešanica 40 g/kg:
The following indication can be accepted: Prevention and treatment of respiratory disease caused by Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida and other organisms sensitive to tilmicosin in pigs.
Lahko se sprejme naslednja indikacija: Preprečevanje in zdravljenje bolezni dihal, ki jih povzročajo Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida in drugi za tilmikozin občutljivi organizmi, pri prašičih.
a) The indication for use in rabbits: prevention and treatment of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica susceptible to tilmicosin.
a) indikacijo za uporabo pri kuncih: preprečevanje in zdravljenje bolezni dihal, ki jih povzročajo za tilmikozin občutljivi sevi Pasteurella multocida in Bordetella bronchiseptica.
Pigs, Rabbits
prašiči, kunci
Do not use in case of hypersensitivity to tilmicosin or to any of the excipients 4.4 Special warnings for each target species
Ne uporabite v primeru preobčutljivosti za tilmikozin ali katero koli pomožno snov.
Withdrawal periods
Rok uporabnosti
Kg Premix/tonne feed = Dose rate (mg/kg bodyweight) x bodyweight (kg) Daily feed intake (kg) x premix strength (g/kg)
= odmerek (mg/kg telesne mase) x telesna masa (kg) dnevni vnos krmne meš.
• The reference to rice hulls should be removed from the SPC.
• iz povzetka glavnih značilnosti zdravila se odstrani sklic na luščine riža.
b) The amounts to be administered and administration route: administered in the feed at 12 mg/kg bodyweight/day of tilmicosin (equivalent to 200 ppm in the feed) for 7 days.
b) odmerjanje in pot uporabe: dajanje tilmikozina v krmo v koncentraciji 12 mg na kg telesne mase (enakovredno 200 ppm v krmi) v obdobju 7 dni.
4.7 Use during pregnancy, lactation or lay
4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti Varnost tilmikozina pri vzrejnih merjascih ni bila ugotovljena.
Pigs: Prevention and treatment of respiratory disease caused by Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida and other organisms sensitive to tilmicosin.
Prašiči: preprečevanje in zdravljenje bolezni dihal, ki jih povzročajo Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida in drugi organizmi, ki so občutljivi za tilmikozin.
EXP Once opened, use within 3 months Once incorporated into meal or pelleted feed, use within 1 month
Zdravilo, vmešano v obrok ali peletirano hrano, uporabite v 1 mesecu.
2 kg, 5 kg and 10 kg 100 g/kg Premix:
2 kg, 5 kg in 10 kg
200 g/kg For a full list of excipients see section 6.1
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
40 g tilmicosin per 1000 g Member State Marketing Authorisation Holder
200 g tilmicosin per 1000 g
5-10 kg Pulmotil 40 Vet Premix/tonne
5-10 kg Pulmotil 40 Vet Premix/tono
Rabbits: Prevention and treatment of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to tilmicosin.
Kunci: preprečevanje in zdravljenje bolezni dihal, ki jih povzročajo za tilmikozin občutljivi sevi Pasteurella multocida in Bordetella bronchiseptica.
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children.
BESEDILO „ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM“ Zdravilo shranjujte nedosegljivo otrokom!
Rabbits:
Kunci:
5kg Pulmotil 40 Vet Premix /tonne
5 kg Pulmotil 40 Vet Premix/tono
Special precautions for use in animals
Živalska vrsta Pot uporabe
2-4 kg Pulmotil 100 Vet Premix /tonne
2-4 kg Pulmotil 100 Vet Premix/tono
A yellowish tan to reddish tan free-flowing granular material.
Rumeno do rdečkastorjava sipljiva zrnca.
100 g/kg
Predmešanica 100 g/kg:
Pulmotil G 20% AMV Premix for medicated feeding stuff
Pulmotil G 20% AMV predmešanica za zdravilno krmno mešanico
Pulmotil G 20% Premix for medicated feeding stuff
Pulmotil G 20% predmešanica za zdravilno krmno mešanico
1 kg Pulmotil 200 Vet Premix /tonne
1 kg Pulmotil 200 Vet Premix/tono
Ground corn cobs
Mleti koruzni storži
1-2 kg Pulmotil 200 Vet Premix /tonne
1-2 kg Pulmotil 200 Vet Premix/tono
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo - Tilmikozin lahko povzroči draženje.
4.2 Indications for use, specifying the target species Pigs: Prevention and treatment of respiratory disease caused by Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida and other organisms sensitive to tilmicosin Rabbits: Prevention and treatment of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to tilmicosin.
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Prašiči: preprečevanje in zdravljenje bolezni dihal, ki jih povzročajo Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida in drugi organizmi, ki so občutljivi za tilmikozin.
Administer in the feed at a dose of 8 to 16 mg/kg body weight/day of tilmicosin (equivalent to 200 to 400 ppm in the feed) for a period of 15 to 21 days.
Dajajte v krmno mešanico 15 do 21 dni v odmerku 8 do 16 mg tilmikozina/kg telesne mase/dan (enakovredno 200 do 400 ppm v krmni mešanici).
Administer in the feed at 12 mg/kg body weight/day of tilmicosin (equivalent to 200 ppm in the feed) for 7 days.
Dajanje v krmno mešanico 7 dni s koncentracijo 12 mg tilmikozina/kg telesne mase/dan (enakovredno 200 ppm v krmni mešanici).
Marketing Authorisation Holders.
IMETNIK DOVOLJENJA ZA PROMET {Izpolni država članica}
A preformed block bottomed 1 kg bag constructed using a paper/polyethylene/aluminium/polyethylene/paper laminate either stitched closed or heat-sealed Not all pack sizes may be marketed.
1. vreče iz polietilena/poliamida/polietilena (notranja plast) z 10 kg zdravila ali 2. vreče z oblikovanim kvadrastim dnom iz papirja/polietilena/aluminija/polietilena/papirja z 1 kg zdravila, ki so zašite ali toplotno zavarjene.
6.5 Nature and composition of immediate packaging Products containing 40 and 100g tilmicosin/kg are packed in either:
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Za zdravila, ki vsebujejo 40 in 100 g tilmikozina/kg:
Administer in the feed at a dose of 8 to 16 mg/kg body weight/day of tilmicosin activity (equivalent to 200 to 400 ppm in the feed) for a period of 15 to 21 days.
Dajajte v krmno mešanico15 do 21 dni v odmerku tilmikozina 8 do 16 mg/kg telesne mase/dan (enakovredno 200 do 400 ppm v krmni mešanici).
Pulmotil G 40 AMV Premix for medicated feeding stuff
Pulmotil G 40 AMV predmešanica za zdravilno krmno mešanico
Pulmotil G 100 AMV Premix for medicated feeding stuff
Pulmotil G 100 AMV predmešanica za zdravilno krmno mešanico
Pulmotil Prämix 20% Premix for medicated feeding stuff
Pulmotil Prämix 20% predmešanica za zdravilno krmno mešanico prašiči, kunci
Pulmotil G 200 premix Premix for medicated feeding stuff
Pulmotil G 200 premix predmešanica za zdravilno krmno mešanico
Pulmotil G40 premix Premix for medicated feeding stuff
Pulmotil G40 premix predmešanica za zdravilno krmno mešanico
Pulmotil G100 premix Premix for medicated feeding stuff
Pulmotil G100 Premix predmešanica za zdravilno krmno mešanico
Pulmotil G100 Premix Premix for medicated feeding stuff
Pulmotil G100 premix predmešanica za zdravilno krmno mešanico
Pulmotil G200 premix Premix for medicated feeding stuff
Pulmotil G200 Premix predmešanica za zdravilno krmno mešanico
Pulmotil G200 Premix Premix for medicated feeding stuff
Pulmotil G200 premix predmešanica za zdravilno krmno mešanico
2 kg Pulmotil 100Vet Premix/tonne
2 kg Pulmotil 100 Vet Premix/tono
Rabbits
Ciper
Pulmotil 40 VET Premix Premix for medicated feeding stuff
Pulmotil 40 VET Premix predmešanica za zdravilno krmno mešanico
Absorption: When administered orally to rabbits at a dose of 12 mg tilmicosin/kg b.w.
Absorpcija: Pri kuncih se tilmikozin po peroralnem dajanju odmerka 12 mg/kg telesne mase v enem odmerku hitro absorbira.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients
6.5 Vrsta ovojnine in vsebina
The European Commission granted a marketing authorisation valid throughout the European Union for Byetta on 20 November 2006.
Evropska komisija je dovoljenje za promet z zdravilom Byetta, veljavno po vsej Evropski uniji, odobrila dne 20. novembra 2006.
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 v dnevu se daje eno uro pred jutranjim obrokom, drugi pa eno uro pred večernim obrokom.
Byetta exenatide
Byetta eksenatid
Byetta should never be given after a meal.
Zdravilo Byetta se ne sme nikoli dati po obroku.
The full EPAR for Byetta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Byetta je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Little or no effect was seen with placebo.
Pri placebu je bilo opaziti majhen ali ničen učinek.
Patients were also taking either metformin or pioglitazone, or a combination of both.
Bolniki so prav tako jemali bodisi metformin ali pioglitazon ali kombinacijo obojega.
Other information about Byetta:
Druge informacije o zdravilu Byetta:
At the start of the studies, the patients' HbA1c levels were around 8.4%.
Na začetku študij so ravni HbA1c pri bolnikih znašale približno 8,4 %.
This document is a summary of the European public assessment report (EPAR) for Byetta.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Byetta.
This helps with the control of blood glucose levels.
To pomaga pri uravnavanje ravni glukoze.
It is available as prefilled injection pens that provide either 5 or 10 micrograms of exenatide in each dose.
Na voljo je v obliki napolnjenega injekcijskega peresnika, ki vsebuje bodisi 5 ali 10 mikrogramov eksenatida v posameznem odmerku.
For more information about treatment with Byetta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Byetta preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
The CHMP decided that Byetta's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Byetta večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Treatment with Byetta should start at a dose of 5 micrograms twice a day for at least a month.
Zdravljenje z zdravilom Byetta se začne z odmerkom 5 mikrogramov dvakrat na dan najmanj en mesec.
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), ki povečujejo količino insulina, ki ga kot odziv na hrano izloči trebušna slinavka.
Byetta is used to treat type 2 diabetes.
Zdravilo Byetta se uporablja za zdravljenje sladkorne bolezni tipa 2.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Byetta.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Byetta, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Byetta was as effective as injected insulin.
Zdravilo Byetta je bilo enako učinkovito kot vbrizgan insulin.
What benefit has Byetta shown during the studies?
Kakšne koristi je zdravilo Byetta izkazalo med študijami?
Patients being treated with Byetta should continue to follow their diet and exercise plans.
Bolniki, ki se zdravijo z zdravilom Byetta, bi morali nadaljevati z začrtanim programom prehrane in telesne vadbe.
It can be used with metformin, sulphonylureas, thiazolidinediones, metformin and a sulphonylurea, or metformin and a thiazolidinedione.
Uporablja se lahko v kombinaciji z metforminom, sulfonilsečninami in tiazolidindioni, metforminom in sulfonilsečnino ali metforminon in tiazolidindionom.
Byetta has been studied in eight main studies involving a total of around 3,000 patients whose blood glucose was not adequately controlled with other antidiabetes medicines.
Zdravilo Byetta so poučevali v osmih glavnih študijah, ki so vključevale okrog 3 000 bolnikov, pri katerih glukoza v krvi ni bila zadostno nadzorovana z drugimi zdravili proti sladkorni bolezni.
Byetta must not be used in people who are hypersensitive (allergic) to exenatide or any of the other ingredients.
Zdravila Byetta ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) eksenatid ali katero koli drugo sestavino zdravila.
Adding Byetta to metformin or pioglitazone is not associated with this risk.
Uporaba zdravila Byetta z metforminom ali pioglitazonom s tem tveganjem ni povezana.
What is the risk associated with Byetta?
Kakšna tveganja so povezana z zdravilom Byetta?
Byetta can also be given to patients taking basal insulin (long-acting insulin such as insulin glargine) with or without metformin and/or pioglitazone (a thiazolidinedione) and whose blood glucose levels are not adequately controlled with these medicines.
Zdravilo Byetta se lahko daje tudi bolnikom, ki jemljejo bazalni insulin (insulin z dolgotrajnim delovanjem kot insulin glargin) z metforminom ali brez njega in/ali pioglitazonom (tiazolidinedion) in pri katerih ravni glukoze v krvi niso zadostno nadzorovane s temi zdravili.
Byetta was more effective than placebo in reducing the levels of HbA1c when used in combination with other antidiabetes medicines.
Zdravilo Byetta je bilo v primerjavi s placebom učinkovitejše pri nižanju ravni HbA1c, kadar so ju uporabljali v kombinaciji z drugimi zdravili proti sladkorni bolezni.
The pen has a user manual.
Peresniku je priložen priročnik za uporabo.
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.
A dose higher than 10 micrograms twice a day is not recommended.
Odmerek se lahko nato poveča na 10 mikrogramov dvakrat na dan. Odmerek, ki presega 10 mikrogramov dvakrat na dan, ni priporočen.
When adding Byetta to a sulphonylurea or basal insulin, the doctor may need to reduce the dose of the sulphonylurea or basal insulin because there is a risk of hypoglycaemia (low blood sugar levels).
Kadar se zdravilo Byetta doda sulfonilsečnini ali bazalnemu insulinu, mora zdravnik zmanjšati njun odmerek, ker obstaja tveganje za pojav hipoglikemije (nizke ravni sladkorja v krvi).
It is used together with other antidiabetes medicines in patients whose blood glucose (sugar) levels are not adequately controlled with the maximum tolerated doses of the other medicines.
Uporablja se skupaj z drugimi zdravili proti sladkorni bolezni 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.
Why has Byetta been approved?
Zakaj je bilo zdravilo Byetta odobreno?
Byetta was more effective than placebo when it was given as add-on to insulin glargine (with or without other antidiabetes medications), as Byetta decreased HbA1c by an average of 1.7% compared with an average of 1.0% in patients taking placebo.
Zdravilo Byetta je bilo učinkovitejše od placeba, ko je bilo dodano insulinu glargin (z drugimi zdravili proti sladkorni bolezni ali brez njih), saj se je pri zdravilu Byetta raven HbA1c v povprečju znižala za 1,7 % v primerjavi s povprečnim znižanjem za 1,0 % pri bolnikih, ki so jemali placebo.
Two further studies compared adding Byetta or an insulin to metformin and sulphonylureas.
V drugih dveh študijah so primerjali dodajanje zdravila Byetta ali insulina metforminu in sulfonilsečninam.
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 glargin, v drugi študiji pa so zdravilo Byetta pri 483 bolnikih primerjali z dvofaznim insulinom.
In studies, the most common side effects with Byetta (seen in more than 1 patient in 10) were hypoglycaemia (when Byetta was used with sulphonylurea with or without metformin), nausea (feeling sick), vomiting and diarrhoea.
Najpogostejši neželeni učinki zdravila Byetta (opaženi pri več kot 1 od 10 bolnikov) so hipoglikemija (ko je bilo zdravilo Byetta uporabljeno s sulfonilsečnino z metforminom ali brez njega), navzeja (slabost), bruhanje in driska.
The active substance in Byetta, exenatide, is an ‘incretin mimetic'.
Zdravilna učinkovina zdravila Byetta, eksenatid, je „mimetik inkretina“.
In five of the studies, Byetta was compared with placebo (a dummy treatment), as an add-on to metformin (336 patients), sulphonylureas with or without metformin (1,110 patients) or thiazolidinediones with or without metformin (398 patients).
V petih študijah so zdravilo Byetta kot dodatek k metforminu (336 bolnikov), sulfonilsečninam z metforminom ali brez njega (1 110 bolnikov) ali tiazolidindionom z metforminom ali brez njega (398 bolnikov) primerjali s placebom (zdravilom brez zdravilne učinkovine).
In another study involving 259 patients, Byetta was compared with placebo, as an add-on to insulin glargine.
V naslednji študiji, ki je vključevala 259 bolnikov, so zdravilo Byetta kot dodatek insulinu glargin primerjali s placebom.
Byetta is a solution for injection that contains the active substance exenatide.
Zdravilo Byetta je raztopina za injiciranje, ki vsebuje zdravilno učinkovino eksenatid.