natgillin/translations-raw huggingface dataset:
What if I unlock the pen and press the green injection button before pulling off the base cap?
Kaj če odklenem peresnik in pritisnem zeleni gumb za injiciranje preden odstranim pokrovček z dna?
Continue holding the clear base firmly against your skin until you hear a second click.
Še naprej trdno držite prozorno podnožje na koži, dokler ne zaslišite drugega klika.
It is important that you test your blood glucose levels as instructed by your doctor, pharmacist or nurse, if you are taking Trulicity with a sulphonylurea or insulin.
Pomembno je, da redno preverjate vaše ravni glukoze v krvi kot vam je naročil zdravnik, farmacevt ali medicinska sestra, če jemljete zdravilo Trulicity s sulfonilsečnino ali z insulinom.
BEFORE YOU GET STARTED Remove
PREDEN ZAČNETE
Change (rotate) your injection site each week.
• Vsak teden spremenite (rotirajte) mesto injiciranja.
• When refrigeration is not possible, you can keep your syringe at room temperature
• Kadar shranjevanje v hladilniku ni mogoče, lahko svoj peresnik shranjujete pri sobni temperaturi (pod
Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby, as Trulicity should not be used during pregnancy.
Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, saj zdravila Trulicity med nosečnostjo ne smete jemati.
This clinical study did not include patients with end stage renal disease.
Ta klinična študija ni vključevala bolnikov s končno ledvično odpovedjo.
Do not remove the base cap and do not use the pen.
Ne odstranjujte pokrovčka z dna in ne uporabite peresnika.
Consistent with the pharmacokinetic profile, dulaglutide has a pharmacodynamic profile suitable for once weekly administration (see section 5.2).
Skladno s farmakokinetičnim profilom ima dulaglutid farmakodinamični profil, ki je primeren za aplikacijo zdravila enkrat na teden (glejte poglavje 5.2).
Clinical studies with dulaglutide have indicated enhanced beta-cell function as measured by homeostasis model assessment (HOMA2-%B).
Klinične študije z dulaglutidom so pokazale povečano delovanje beta celic, merjeno z oceno modela homeostaze (HOMA2-%B).
If you want to do so, you can use the same area of your body each week.
Če želite, lahko vsak teden uporabite isti del telesa za injiciranje.
Dulaglutide is a long-acting glucagon-like peptide 1 (GLP-1) receptor agonist.
Dulaglutid je dolgodelujoči receptorski agonist glukagonu podobnega peptida 1 (GLP-1).
The molecule consists of 2 identical disulfide-linked chains, each containing a modified human GLP-1 analogue sequence covalently linked to a modified human immunoglobulin G4 (IgG4) heavy chain fragment (Fc) by a small peptide linker.
Molekula je sestavljena iz 2 identičnih verig, povezanih z disulfidno vezjo, vsaka veriga pa vsebuje modificiran analogni niz humanega GLP-1, kovalentno spojen v modificirani del težke verige (Fc) področja humanega imunoglobulina G4 (IgG4) z majhno peptidno vezjo.
Trulicity contains an active substance called dulaglutide and is used to lower blood sugar (glucose) in adults with type 2 diabetes mellitus and can help prevent heart disease.
Zdravilo Trulicity vsebuje zdravilno učinkovino, imenovano dulaglutid, in se uporablja za zniževanje krvnega sladkorja (glukoze) pri odraslih s sladkorno boleznijo tipa 2 ter lahko pomaga preprečevati bolezni srca.
The signs include rapid weight loss, feeling sick or being sick, a sweet smell to your breath, a sweet or metallic taste in your mouth, or a different odour to your urine or sweat.
Znaki vključujejo hitro izgubo telesne mase, občutek slabosti ali siljenje na bruhanje, sladkoben vonj vaše sape, sladek ali kovinski okus v vaših ustih ali spremenjen vonj vašega urina ali znoja.
The Trulicity long-term cardiovascular outcome study was a placebo-controlled, double-blind clinical trial.
Dolgoročna študija kardiovaskularnih izidov z zdravilom Trulicity je bila s placebom nadzorovano, dvojno slepo klinično preskušanje.
Dulaglutide is associated with mean increases from baseline in pancreatic enzymes (lipase and/or pancreatic amylase) of 11 % to 21 % (see section 4.4).
Dulaglutid je povezan s povprečnim zvišanjem encimov trebušne slinavke od izhodišča (lipaza in/ali pankreasna amilaza) od 11 % do 21 % (glejte poglavje 4.4).
- you have ever had pancreatitis (inflammation of the pancreas) which causes severe pain in the stomach and back which does not go away.
- ste kadar koli imeli pankreatitis (vnetje trebušne slinavke), ki povzroča hudo bolečino v trebuhu in hrbtu, ki ne poneha.
This change is not expected to have clinical consequences.
Ni verjetno, da bi imela ta sprememba klinične posledice.
Following subcutaneous administration to patients with type 2 diabetes, dulaglutide reaches peak plasma concentrations in 48 hours.
Absorpcija Po subkutani aplikaciji bolnikom s sladkorno boleznijo tipa 2 dulaglutid doseže najvišje koncentracije v plazmi v 48 urah.
- you have diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin).
- imate diabetično ketoacidozo (zaplet sladkorne bolezni, do katerega pride, ko telo ne more razgraditi glukoze, ker nima na voljo dovolj insulina).
This is not unusual and will not affect your dose.
To ni nič neobičajnega in ne bo vplivalo na vaš odmerek.
- you have type 1 diabetes (the type when your body does not produce any insulin) as this medicine may not be right for you.
- imate sladkorno bolezen tipa 1 (tip bolezni pri kateri vaše telo sploh ne proizvaja insulina), saj to zdravilo najverjetneje ne bo pravo za vas.
When your injection is complete, the plunger should be pushed fully into the syringe, with no more medicine left in it.
Ko je injiciranje končano, mora biti bat v celoti potisnjen v injekcijsko brizgo, v kateri ni več zdravila.
With your other hand, hold the syringe like a pencil.
Z drugo roko primite injekcijsko brizgo kot svinčnik.
Dulaglutide significantly improved total treatment satisfaction compared to exenatide twice daily.
Dulaglutid je značilno izboljšal skupno zadovoljstvo z zdravljenjem v primerjavi z eksenatidom dvakrat na dan.
Body weight or body mass index
Telesna masa ali indeks telesne mase
In the absence of other signs and symptoms of acute pancreatitis, elevations in pancreatic enzymes alone are not predictive of acute pancreatitis.
Če ni drugih znakov in simptomov akutnega pankreatitisa, sama zvišanja ravni encimov trebušne slinavke ne napovedujejo akutnega pankreatitisa.
Patients with dulaglutide anti-drug antibodies generally had low titres, and although the number of patients developing dulaglutide anti-drug antibodies was low, examination of the phase III data revealed no clear impact of dulaglutide anti-drug antibodies on changes in HbA1c.
Bolniki s protitelesi proti dulaglutidu so na splošno imeli nizke titre in čeprav je bilo število bolnikov, pri katerih so se razvila protitelesa proti dulaglutidu, majhno, je pregled podatkov 3. faze razkril, da ni jasnega vpliva protiteles proti dulaglutidu na spremembe vrednosti HbA1c.
Statistically significant delays in lisinopril tmax of approximately 1 hour were observed on Days 3 and 24 of the study.
Opazili so statistično pomembne zakasnitve v tmax lisinoprila za približno 1 uro na dneva 3 in 24 študije.
In the presence of elevated glucose concentrations, dulaglutide increases intracellular cyclic AMP (cAMP) in pancreatic beta cells leading to insulin release.
Pri povečanih koncentracijah glukoze dulaglutid povečuje intracelularno ciklično AMP (cAMP) v beta celicah trebušne slinavke, s čimer povzroči sproščanje insulina.
Until then, store your pen safely to avoid an accidental needle stick injury.
Do tedaj shranite svoj peresnik na varno mesto, da boste preprečili poškodbe zaradi vboda igle.
Papendorpseweg 83, 3528 BJ Utrecht
Papendorpseweg 83, 3528 BJ UtrechtNizozemska
It is not known if dulaglutide passes into human breast milk.
Ni znano, ali dulaglutid prehaja v materino mleko.
- or with other medicines for diabetes when they are not enough to control your blood sugar levels.
- ali z drugimi zdravili za zdravljenje sladkorne bolezni, če ta ne zadoščajo za uravnavanje vaših ravni krvnega sladkorja.
Slowly push the plunger all the way in until all the medicine is injected.
Počasi potisnite bat do konca, dokler ne injicirate vsega zdravila.
Type 2 Diabetes Mellitus
Sladkorna bolezen tipa 2
• When refrigeration is not possible, you can keep your pen at room temperature (below 30°C) for up to a total of 14 days.
• Kadar shranjevanje v hladilniku ni mogoče, lahko svojo injekcijsko brizgo shranjujete pri sobni temperaturi (pod 30 °C) skupno največ 14 dni.
Do not use Trulicity - if you are allergic to dulaglutide or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na dulaglutid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Figure 2: Forest plot of analyses of individual cardiovascular event types, all cause death, and consistency of effect across subgroups for the primary endpoint
Slika 2: Drevesni diagram analiz posameznih vrst kardiovaskularnih dogodkov, smrti zaradi katerega koli vzroka, in podskupin za primarni opazovani dogodek
Dulaglutide has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.
Uporaba dulaglutida ni bila preučena pri bolnikih s hudo boleznijo prebavil, vključno s hudo gastroparezo, zato pri teh bolnikih uporaba zdravila ni priporočljiva.
The durability of effect on beta-cell function was maintained through the longest study duration of 104 weeks.
Trajanje učinka na delovanje beta celic se je ohranilo vse do 104. tedna, kolikor je trajala najdaljša študija.
Therefore, the use of dulaglutide is not recommended during pregnancy.
Uporaba dulaglutida med nosečnostjo zato ni priporočljiva.
Store in a refrigerator (2ºC - 8ºC).
Shranjujte v hladilniku (2 ºC 8 ºC).
Subcutaneous use.
subkutana uporaba.
Studies characterising the pharmacokinetics of dulaglutide in paediatric patients have not been performed.
Pediatrična populacija Študije, ki bi ugotavljale farmakokinetiko dulaglutida pri pediatričnih bolnikih, niso bile opravljene.
In the phase II and phase III clinical studies, systemic hypersensitivity events (e.g., urticaria, edema) were reported in 0.5 % of patients receiving dulaglutide.
V kliničnih študijah 2. in 3. faze so poročali o dogodkih sistemske preobčutljivosti (npr. urtikarija, edem) pri 0,5 % bolnikov, ki so prejemali dulaglutid.
Not known: the frequency cannot be estimated from the available data - Bowel obstruction - a severe form of constipation with additional symptoms such as stomach ache, bloating or vomiting.
Neznani učinki: pogostnost ne more biti ocenjena iz razpoložljivih podatkov - Zapora črevesja - resna oblika zaprtosti z dodatnimi simptomi kot so bolečina v trebuhu,
Patients receiving dulaglutide in combination with sulphonylurea or insulin may have an increased risk of hypoglycaemia.
Pri bolnikih, ki prejemajo zdravilo dulaglutid v kombinaciji s sulfonilsečnino ali insulinom, lahko obstaja povečano tveganje za hipoglikemijo.
You can use your syringe at any time of the day, with or without meals.
Injekcijski peresnik lahko uporabljate kadar koli v dnevu, z ali brez hrane.
Gender and race Gender and race had no clinically meaningful effect on the pharmacokinetics of dulaglutide.
Spol in rasa nista imela klinično pomembnega učinka na farmakokinetiko dulaglutida.
METHOD AND ROUTE(S) OF ADMINISTRATION For single use only.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Za enkratno uporabo.
The incidence of acute pancreatitis in Phase II and III clinical studies was 0.07% for dulaglutide compared to 0.14% for placebo and 0.19% for comparators with or without additional background antidiabetic therapy.
Pojavnost akutnega pankreatitisa v kliničnih študijah 2. in 3. faze je bila 0,07 % za dulaglutid v primerjavi z 0,14 % za placebo in 0,19 % za primerjalna zdravila z ali brez osnovnega antidiabetičnega zdravljenja.
This leaflet was last revised in Month YYYY
Navodilo je bilo nazadnje revidirano mesec LLLL
Cardiovascular Evaluation
Kardiovaskularna ocena
In the completed phase II and phase III initial registration studies, 4,006 patients were exposed to dulaglutide alone or in combination with other glucose lowering medicinal products.
Povzetek varnostnega profila V zaključenih začetnih registracijskih študijah 2. in 3. faze je bilo 4006 bolnikov izpostavljenih dulaglutidu samemu ali pa v kombinaciji z drugimi zdravili za znižanje glukoze.
Patient reported outcomes
Izidi, o katerih so poročali bolniki
You may inject the medicine into your stomach (abdomen) or thigh.
• Zdravilo si lahko injicirate v trebuh (abdomen) ali stegno.
When used with other medicines for diabetes, the recommended dose is 1.5 mg once a week.
Ob uporabi skupaj z drugimi zdravili za zdravljenje sladkorne bolezni je priporočeni odmerek zdravila 1,5 mg enkrat na teden.
Do not recycle the filled sharps container.
• Polnega vsebnika za ostre odpadke ne reciklirajte.
Check
Preverite
If you are taking a sulphonylurea or insulin, the dose may need to be lowered while you use dulaglutide.
Če jemljete sulfonilsečnino ali insulin, bo morda treba odmerek zmanjšati za čas, ko uporabljate dulaglutid.
Effects of overdose with dulaglutide in clinical studies have included gastrointestinal disorders and hypoglycaemia.
Učinki prevelikega odmerjanja so v kliničnih študijah z dulaglutidom vključevali gastrointestinalne motnje in hipoglikemijo.
These changes were not clinically relevant; therefore no dose adjustment of lisinopril or metoprolol is necessary when administered with dulaglutide.
Te spremembe se niso štele za klinično pomembne, zato prilagoditev odmerka lisinoprila ali metoprolola, če je to zdravilo dano sočasno z dulaglutidom, ni potrebna.
Because Trulicity can slow stomach emptying which could affect other medicines, tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicine.
Druga zdravila in zdravilo Trulicity Ker lahko zdravilo Trulicity zmanjša praznenje želodca, kar lahko vpliva na druga zdravila, obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Dulaglutide exhibits several antihyperglycaemic actions of GLP-1.
Dulaglutid kaže več antihiperglikemičnih učinkov GLP-1.
Dulaglutide is presumed to be degraded into its component amino acids by general protein catabolism pathways.
Domneva se, da se dulaglutid razgrajuje v svoje sestavne dele − aminokisline prek splošnih poti katabolizma beljakovin.
Within each incidence grouping, adverse reactions are presented in order of decreasing frequency.
V okviru razvrstitev po incidenci so neželeni učinki navedeni po padajoči pogostnosti.
After Week 1, patients were up-titrated to 1.2 mg/day and then at Week 2 to 1.8 mg/day.
Po 1. tednu so jim odmerek titrirali do 1,2 mg/dan, v 2. tednu pa do 1,8 mg/dan.
• If you have vision problems, DO NOT use your pen without help from a person trained to use the Trulicity pen.
• Če imate težave z vidom, NE uporabljajte svojega peresnika brez pomoči osebe, ki je usposobljena za uporabo peresnika Trulicity.
Statistically significant reductions in Cmax of 26 % and 13 % and delays in tmax of 2 and 0.30 hours were observed for norelgestromin and ethinyl estradiol, respectively.
Opazili pa so statistično pomembna znižanja Cmax za 26 % in 13 % ter zakasnitvi tmax za 2 in 0,30 ure za norelgestromin in etinilestradiol.
The improvement in fasting glucose was sustained through the longest study duration of 104 weeks.
Izboljšanje glukoze na tešče se je ohranilo vse do 104. tedna, kolikor je trajala najdaljša študija.
Potentially immune-mediated injection site adverse events (e.g., rash, erythema) were reported in 0.7 % of patients and were usually mild.
O potencialno imunskih reakcijah na mestu injiciranja (npr. izpuščaj, eritem) so poročali pri 0,7 % bolnikov in so bile običajno blage.
To optimise the insulin glargine dose, both groups were titrated to a target fasting serum glucose of <5.6 mmol/L.
Za optimizacijo odmerka insulina glargina sta bili obe skupini titrirani na ciljno serumsko glukozo na tešče < 5,6 mmol/l.
In clinical studies, treatment with dulaglutide was associated with a 1.6 % incidence of treatment emergent dulaglutide anti-drug antibodies, indicating that the structural modifications in the GLP-1 and modified IgG4 parts of the dulaglutide molecule, together with high homology with native GLP-1 and native IgG4, minimise the risk of immune response against dulaglutide.
V kliničnih študijah je bilo zdravljenje z dulaglutidom povezano z 1,6% incidenco protiteles proti dulaglutidu, nastalih med zdravljenjem, kar kaže na to, da strukturne modifikacije v GLP-1 in modificiranih delih IgG4 molekule dulaglutida skupaj z visoko homolognostjo z naravnim GLP-1 in naravnim IgG4 zmanjšujejo tveganje za odziv imunskega sistema na dulaglutid.
Table 1: The frequency of adverse reactions of dulaglutide
Preglednica 1: Pogostnost neželenih učinkov dulaglutida
If pancreatitis is confirmed, dulaglutide should not be restarted.
Če je pankreatitis potrjen, se zdravljenja z dulaglutidom ne sme znova uvesti.
In all studies, dulaglutide produced clinically significant improvements in glycaemic control as measured by glycosylated haemoglobin A1c (HbA1c).
V vseh študijah je dulaglutid povzročil klinično pomembna izboljšanja v glikemični urejenosti, merjeni z glikoziliranim hemoglobinom A1c (HbA1c).
No cases of severe hypoglycaemia were observed for Trulicity or placebo.
Primerov hude hipoglikemije pri zdravilu Trulicity ali pri placebu niso opazili.
At baseline, overall mean eGFR was 38 mL/min/1.73 m2, 30% of patients had eGFR < 30 mL/min/1.73 m2.
V izhodišču je skupni mediani eGFR znašal 38 ml/min/1,73 m2, 30 % bolnikov pa je imelo eGFR < 30 ml/min/1,73 m2.
If a dose is missed, it should be administered as soon as possible if there are at least 3 days (72 hours) until the next scheduled dose.
V primeru zamujenega odmerka je treba odmerek dati čimprej, če manjkajo vsaj 3 dnevi (72 ur) do naslednjega predpisanega odmerka.
Kaplan-Meier plot of time to first occurrence of the composite outcome: CV death, non-fatal myocardial infarction or non-fatal stroke, in the dulaglutide long-term cardiovascular outcome study
Kaplan-Meierjeva krivulja časa do prvega pojava sestavljenega izida: KV-smrti, miokardnega infarkta brez smrtnega izida ali možganske kapi brez smrtnega izida, v dolgoročni študiji kardiovaskularnega izida z dulaglutidom
If you use Trulicity in combination with a sulphonylurea or insulin, low blood sugar (hypoglycaemia) may occur which may reduce your ability to concentrate.
Če uporabljate zdravilo Trulicity v kombinaciji s sulfonilsečnino ali insulinom, lahko pride do nizkega krvnega sladkorja (hipoglikemija), ki lahko zmanjša vašo sposobnost koncentracije.
If you use more Trulicity than you should
Če ste uporabili večji odmerek zdravila Trulicity, kot bi smeli
In clinical trials, acute pancreatitis has been reported in association with dulaglutide (see section 4.8).
kliničnih preskušanjih so o akutnem pankreatitisu poročali v povezavi z dulaglutidom (glejte poglavje 4.8).
In the rat, there was no direct effect on mating or fertility following treatment with dulaglutide (see section 5.3).
Pri podganah po zdravljenju z dulaglutidom ni bilo neposrednega učinka na parjenje ali plodnost (glejte poglavje 5.3).
Treatment with dulaglutide provided reductions in systolic blood pressure (SBP) (-2.8 mmHg difference compared to placebo) at 16 weeks.
Zdravljenje z dulaglutidom je povzročilo znižanja sistolnega krvnega tlaka (razlika -2,8 mmHg v primerjavi s placebom) po 16 tednih.
• If you have vision problems, DO NOT use your syringe without help from a person trained to use the Trulicity syringe.
• Če imate težave z vidom, NE uporabljajte svoje injekcijske brizge brez pomoči osebe, ki je usposobljena za uporabo injekcijske brizge Trulicity.
Hypersensitivity Anaphylactic reaction#
Bolezni imunskega sistema preobčutljivost anafilaktična reakcija#
The risk of hypoglycaemia may be lowered by a reduction in the dose of sulphonylurea or insulin (see sections 4.2 and 4.8).
Tveganje hipoglikemije je mogoče zmanjšati z znižanjem odmerka sulfonilsečnine ali insulina (glejte poglavji 4.2 in 4.8).
Trulicity is injected under the skin (subcutaneous injection) of your stomach area (abdomen) or upper leg (thigh).
Zdravilo Trulicity se injicira pod kožo (subkutana injekcija) vašega trebušnega predela (trebuh/abdomen) ali zgornjega dela noge (stegno).
Coadministration of dulaglutide with an oral contraceptive (norgestimate 0.18 mg/ethinyl estradiol 0.025 mg) did not affect the overall exposure to norelgestromin and ethinyl estradiol.
Sočasna aplikacija dulaglutida s peroralnim kontraceptivom (norgestimat 0,18 mg/etinilestradiol 0,025 mg) ni vplivala na celokupno izpostavljenost norelgestrominu in etinilestradiolu.
Decreased appetite, dyspepsia, constipation, flatulence, abdominal distention, gastroesophageal reflux disease, eructation
zmanjšan apetit, dispepsija, zaprtje, flatulenca, trebušna distenzija, gastroezofagealna refluksna bolezen, spahovanje akutni pankreatitis nemehanska obstrukcija črevesja
• For complete information about proper storage, read the Information for the patient.
• Za celotne informacije o primernem shranjevanju preberite Navodilo za uporabo.
In the clinical pharmacology studies described below, dulaglutide did not affect the absorption of the orally administered medications tested to any clinically relevant degree.
V klinično farmakoloških študijah opisanih spodaj, dulaglutid ni vplival na absorpcijo zdravil za peroralno uporabo, testiranih v vseh klinično pomembnih stopnjah.
Of these, 1,206 were ≥ 65 years of which 119 were ≥ 75 years.
V teh študijah je bilo 1206 bolnikov starih ≥ 65 let, od teh pa je bilo 119 bolnikov starih ≥ 75 let.
Dulaglutide should not be used during breast-feeding.
Dulaglutida se med dojenjem ne sme uporabljati.
For potentially vulnerable populations 0.75 mg once weekly can be considered as a starting dose.
Za potencialno ranljive skupine bolnikov se lahko odmerek 0,75 mg upošteva kot začetni odmerek.
In clinical pharmacology studies conducted in patients with type 2 diabetes mellitus up to 6 weeks, the majority of gastrointestinal events were reported during the first 2-3 days after the initial dose and declined with subsequent doses.
V kliničnih farmakoloških študijah, ki so jih opravili pri bolnikih s sladkorno boleznijo tipa 2 v obdobju do 6 tednov, so o večini gastrointestinalnih neželenih učinkov poročali v prvih 2-3 dneh po začetnem odmerku, po nadaljnjem odmerjanju pa je poročanje o neželenih učinkih upadalo.
Pharmacotherapeutic group: Drugs used in diabetes, blood glucose lowering drugs, excl. insulins, ATC code: A10BJ05
Farmakoterapevtska skupina: zdravila za zdravljenje diabetesa, antidiabetiki razen insulinov, oznaka ATC: A10BJ05.
If you forget to inject a dose, and if there are at least 3 days before your next dose is due, then inject your dose as soon as possible.
Če si pozabite injicirati odmerek, in ostanejo vsaj še 3 dnevi do naslednjega predpisanega odmerka, si svoj odmerek injicirajte takoj, ko je to mogoče.
Leave the Base Cap on until you are ready to inject.
Pokrovčka z dna ne odstranjujte, dokler niste pripravljeni na injiciranje.
Treatment with dulaglutide resulted in significant reductions in mean post prandial glucose from baseline (changes from baseline to primary time point -1.95 mmol/L to -4.23 mmol/L).
Zdravljenje z dulaglutidom je povzročilo značilna znižanja povprečnih koncentracij postprandialne glukoze od izhodišča (spremembe od izhodišča so prve časovne točke -1,95 mmol/l do -4,23 mmol/l).
In the absence of other signs and symptoms of acute pancreatitis, elevations in pancreatic enzymes alone are not predictive of acute pancreatitis (see section 4.8).
Če ni drugih znakov in simptomov akutnega pankreatitisa, sama zvišanja ravni encimov trebušne slinavke ne napovedujejo akutnega pankreatitisa (glejte poglavje 4.8).