natgillin/translations-raw huggingface dataset:
When it is added to existing therapy of a sulphonylurea or insulin, a reduction in the dose of sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see sections 4.4 and 4.8).
Če je zdravilo Trulicity dodano obstoječemu zdravljenju s sulfonilsečnino ali insulinu, je treba razmisliti o zmanjšanju odmerka sulfonilsečnine ali insulina za zmanjšanje tveganja hipoglikemije (glejte poglavji 4.4 in 4.8).
Trulicity can be taken out of the fridge for up to 14 days at a temperature not above 30ºC.
Zdravilo Trulicity lahko vzamete iz hladilnika in ga hranite pri temperaturi, ki ne presega 30 °C, največ 14 dni.
If you stop using Trulicity
Če ste prenehali jemati zdravilo Trulicity
Change in body weight
Sprememba v telesni masi
Trulicity contains sodium
Zdravilo Trulicity vsebuje natrij
When it is used in combination with a sulphonylurea or insulin, patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines (see section 4.4).
Bolnike je treba opozoriti, naj ob uporabi zdravila Trulicity v kombinaciji s sulfonilsečnino ali insulinom upoštevajo previdnostne ukrepe, da se izognejo hipoglikemiji med vožnjo in upravljanjem s stroji (glejte poglavje 4.4).
The instructions for using the syringe, included with the package leaflet, must be followed carefully.
Navodila za uporabo injekcijske brizge, ki so priložena navodilu za uporabo zdravila, je treba natančno upoštevati.
When initiating treatment with Trulicity, you may in some cases experience loss of fluids/dehydration, e.g. in case of vomiting, nausea and/or diarrhoea which may lead to a decrease in kidney function.
Pri uvedbi zdravljenja z zdravilom Trulicity morda lahko pride do izgube tekočine/dehidracije, npr. ob bruhanju, slabosti in/ali driski, kar lahko privede do zmanjšanega delovanja ledvic.
Dulaglutide was studied in a 52 week active controlled monotherapy study in comparison to metformin.
Dulaglutid so preučevali v 52-tedenski aktivno nadzirani študiji monoterapije v primerjavi z metforminom.
After coadministration of steady state digoxin with 2 consecutive doses of dulaglutide, overall exposure (AUCτ) and tmax of digoxin were unchanged; and Cmax decreased by up to 22 %.
Po sočasnem dajanju digoksina v stanju dinamičnega ravnovesja in dveh zaporednih odmerkov dulaglutida sta celokupna izpostavljenost (AUCτ) in tmax digoksina ostala nespremenjena, Cmax digoksina pa se je zmanjšal do 22 %.
Steady-state plasma concentrations were achieved between 2 to 4 weeks of once-weekly administration of dulaglutide (1.5 mg).
Plazemske koncentracije v stanju dinamičnega ravnovesja so bile dosežene po 2 do 4 tednih aplikacije dulaglutida (1,5 mg) enkrat na teden.
For complete information about proper storage, read the Information for the patient.
Za celotne informacije o primernem shranjevanju preberite Navodilo za uporabo.
atrioventricular block (AVB)
Preiskave sinusna tahikardija, atrioventrikularni blok prve stopnje (AVB)
These changes are consistent with the gastric emptying delay of dulaglutide and within the pharmacokinetic variability of metformin and thus are not clinically relevant.
povzročeno z dulaglutidom in so zajete v farmakokinetični variabilnosti metformina, zato niso klinično pomembne.
The dose can be administered at any time of day, with or without meals.
Odmerek se lahko aplicira v katerem koli delu dneva, neodvisno od obrokov hrane.
LIST OF EXCIPIENTS Excipients: Sodium citrate; citric acid, anhydrous; mannitol; polysorbate 80; water for injections
Pomožne snovi: natrijev citrat, brezvodna citronska kislina, manitol, polisorbat 80, voda za injekcije.
This medicine contains less than 1 mmol sodium (23 mg) per 0.75 mg or 1.5 mg, that is to say essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 0,75 mg ali 1,5 mg, kar v bistvu pomeni »brez natrija«.
But be sure to choose a different injection site within that area.
vendar pa morate na tem delu izbirati različna mesta injiciranja.
What if there is a drop of liquid on the tip of the needle when I remove the needle cover?
Kaj če opazim kapljico tekočine na konici igle, ko odstranim pokrovček igle?
Gently release the skin.
• Nežno izpustite kožno gubo.
Following dulaglutide coadministration, S- and R-warfarin exposure and R-warfarin Cmax were unaffected, and S-warfarin Cmax decreased by 22 %.
Po sočasni aplikaciji dulaglutida ni prišlo do vpliva na izpostavljenost S- in R-varfarina ter na Cmax za Rvarfarin, opazili pa so 22% zmanjšanje Cmax S-varfarina.
The mean absolute bioavailability of dulaglutide following single-dose subcutaneous administration of single 1.5 mg and 0.75 mg doses was 47 % and 65%, respectively.
Povprečna absolutna biološka uporabnost dulaglutida po subkutani aplikaciji enkratnih odmerkov 1,5 mg in 0,75 mg je bila 47 % in 65 %.
Heart rate increase
- povečan srčni utrip
Another person may give you the injection in your upper arm.
• Druga oseba vam lahko da injekcijo v nadlaket.
Storage and Handling Disposal of Syringe Commonly Asked Questions Other Information Where to Learn More
Shranjevanje in rokovanje Odlaganje injekcijske brizge Pogosto zastavljena vprašanja Druge informacije
Coadministration of multiple dulaglutide doses with steady state lisinopril caused no clinically relevant changes in the AUC or Cmax of lisinopril.
Ko so aplicirali več odmerkov dulaglutida s sočasno aplikacijo lisinoprila v stanju dinamičnega ravnovesja, to ni klinično pomembno vplivalo na AUC ali Cmax lisinoprila.
The mean baseline dose of insulin glargine was 37 units/day for patients receiving placebo and 41 units/day for patients receiving Trulicity 1.5mg.
Povprečni izhodiščni odmerek insulina glargina je bil 37 enot/dan za bolnike, ki so prejemali placebo, in 41 enot/dan za bolnike, ki so prejemali zdravilo
The most frequent adverse reactions leading to discontinuation for 0.75 mg and 1.5 mg dulaglutide, respectively, were nausea (1.0%, 1.9 %), diarrhoea (0.5%, 0.6 %), and vomiting (0.4%, 0.6 %), and were generally reported within the first 4-6 weeks.
Najpogostejši neželeni učinki, zaradi katerih je prišlo do prekinitve za dulaglutid v odmerkih 0,75 mg in 1,5 mg so bili slabost (1,0 % oziroma 1,9 %), driska (0,5 % oziroma 0,6 %) in bruhanje (0,4 % oziroma 0,6 %), o njih pa so na splošno poročali v prvih 4-6 tednih.
Dulaglutide dosing of male and female juvenile rats did not produce memory deficits at 91-fold the human exposure.
Odmerjanje dulaglutida mladim podganjim samcem in samicam, ki je bilo 91-krat večje od izpostavljenosti pri človeku, ni povzročilo okvar spomina.
The mean apparent clearance of dulaglutide 0.75 mg and 1.5 mg at steady state was 0.111 L/h and 0.107 L/h with an elimination half-life of 4.5 and 4.7 days, respectively.
Povprečni navidezni očistek dulaglutida 0,75 mg in 1,5 mg v stanju dinamičnega ravnovesja je bil 0,111 l/h in 0,107 l/h z razpolovnim časom izločanja 4,5 in 4,7 dni.
A similar percentage of patients achieved HbA1c targets of < 8.0 % at 26 and 52 weeks with both dulaglutide doses as well as insulin glargine.
Podoben odstotek bolnikov je dosegel ciljne vrednosti HbA1c < 8,0 % v 26. in 52. tednu, tako z odmerki dulaglutida kot insulina glargina.
Following coadministration of multiple dose dulaglutide with steady state metformin (immediate release formula [IR]), metformin AUCτ increased up to 15 % and Cmax decreased up to 12 %, respectively, with no changes in tmax.
(zdravilo s takojšnjim sproščanjem [IR - immediate release]), je AUCτ metformina narasla do 15 %, Cmax pa se je zmanjšal do 12 %, brez sprememb v tmax.
This medicinal product contains less than 1 mmol sodium (23 mg) per 1.5 mg dose, i.e. essentially ‘sodium- free'.
Vsebnost natrija To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek 1,5 mg, kar v bistvu pomeni »brez natrija«.
In a 52 week study, Trulicity 1.5 mg and 0.75 mg were compared to titrated insulin glargine as add-on to prandial insulin lispro to evaluate the effect on glycaemic control and safety of patients with moderate to severe chronic kidney disease (eGFR [by CKD-EPI] <60 and ≥15 mL/min/1.73 m2).
Uporaba pri bolnikih z okvarjenim delovanjem ledvic V 52-tedenski študiji so odmerka zdravila Trulicity 1,5 mg in 0,75 mg primerjali s titriranim insulinom glarginom kot dodatkom prandialnemu insulinu lispro, za ocenjevanje učinka na glikemični nadzor in varnost bolnikov z zmerno do hudo ledvično boleznijo (eGFR [po CKD-EPI] < 60 in ≥ 15 ml/min/1,73 m2).
If there are less then 3 days before your next dose is due, skip the dose and inject the next one on your regular scheduled day.
Če pa ostanejo manj kot 3 dnevi do vašega naslednjega predpisanega odmerka, preskočite odmerek in vzemite naslednji odmerek na naslednji predpisani dan.
Cases of anaphylactic reaction have been rarely reported with marketed use of dulaglutide.
V času trženja dulaglutida so redko poročali o primerih anafilaktične reakcije.
These observations are not clinically relevant.
Te ugotovitve niso klinično pomembne.
Marketing Authorisation Holder Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Imetnik dovoljenja za promet z zdravilom Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska
Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology or repeat-dose toxicity.
Neklinični podatki na osnovi običajnih študij farmakološke varnosti in toksičnosti pri ponavljajočih se odmerkih ne kažejo posebnega tveganja za človeka.
Please read these Instructions for use and the Information for the patient carefully and completely before using your pre-filled syringe.
Natančno in v celoti preberite ta navodila za uporabo in navodilo za bolnika, preden začnete z uporabo svoje napolnjene injekcijske brizge Trulicity.
• Store your syringe in the refrigerator.
• Svoj peresnik shranjujte v hladilniku.
• If you have any questions or problems with your Trulicity pen, contact your doctor, pharmacist or nurse.
• Če imate vprašanja ali težave z vašo napolnjeno injekcijsko brizgo Trulicity, se obrnite na zdravnika, farmacevta ali medicinsko sestro.
1 UNCAP Pull off and discard the needle cover.
• Snemite in zavrzite pokrovček igle.
What you need to know before you use Trulicity
Kaj morate vedeti, preden boste uporabili zdravilo Trulicity Ne uporabljajte zdravila Trulicity
Type 2 diabetes patients were randomly allocated to either Trulicity 1.5 mg (4,949) or placebo (4,952) both in addition to standards of care for type 2 diabetes (the 0.75 mg dose was not administered in this study).
Bolnikom s sladkorno boleznijo tipa 2 je bilo naključno dodeljeno zdravljenje z zdravilom Trulicity 1,5 mg (4949) ali s placebom (4952), oboje poleg standardnega zdravljenja za sladkorno bolezen tipa 2.
It is unknown whether dulaglutide is excreted in human milk.
Ni znano, ali se dulaglutid izloča v materino mleko.
Dulaglutide improves glycaemic control through the sustained effects of lowering fasting, pre-meal and postprandial glucose concentrations in patients with type 2 diabetes starting after the first dulaglutide administration and is sustained throughout the once weekly dosing interval.
Dulaglutid izboljšuje glikemično urejenost prek trajnih učinkov zniževanja koncentracije glukoze pri bolnikih s sladkorno boleznijo tipa 2, in sicer koncentracije glukoze na tešče, pred obroki in po zaužitju hrane.
Drops of liquid on the tip of the needle are not unusual and will not affect your dose.
Kapljice tekočine niso nič neobičajnega in ne bodo vplivale na vaš odmerek.
Dulaglutide 1.5 mg once weekly and insulin glargine (n=150)
Dulaglutid 1,5 mg enkrat na teden in insulin glargin (n=150)
A significant and sustained reduction in HbA1c levels from baseline to month 60 was observed with Trulicity vs placebo, in addition to standard of care (-0.29 % vs 0.22 %; estimated treatment difference -0.51 % [-0.57; -0.45]; p < 0.001).
Pri zdravilu Trulicity so v primerjavi s placebom (oboje so bolniki prejemali poleg standardnega zdravljenja), opazili pomembno in trajno znižanje vrednosti HbA1c od izhodišča do 60. meseca (-0,29 % v primerjavi z 0,22 %; ocenjena razlika med zdravljenjema -0,51 % [-0,57; -0,45]; p < 0,001).
The severe hypoglycaemia event incidences were 2.4% and 3.4%, and rates were 0.05 and 0.06 events/patient/year.
Pojavnost dogodkov hude hipoglikemije je znašala 2,4 % oziroma 3,4 %, stopnje pa 0,05 oziroma 0,06 dogodkov/bolnika/leto.
A drop of liquid on the tip of the needle is not unusual and will not affect your dose.
Kapljica tekočine ni nič neobičajnega in ne bo vplivala na vaš odmerek.
Contact your doctor if you have any questions or concerns.
V primeru vprašanj ali pomislekov se obrnite na zdravnika.
Combination therapy with SGLT2 inhibitor with or without metformin The safety and efficacy of dulaglutide as add-on to sodium-glucose co-transporter 2 inhibitor (SGLT2i) therapy (96% with and 4% without metformin) were investigated in a placebo controlled study of 24 weeks duration.
Varnost in učinkovitost dulaglutida kot dodatka zdravljenju z zaviralcem natrijevih glukoznih koprenašalcev 2 (SGLT2i) (pri 96 % z metforminom in pri 4 % brez metformina) so preučevali v študiji, nadzorovani s placebom, ki je trajala 24 tednov.
A greater percentage of patients achieved HbA1c targets of < 7.0 % or ≤ 6.5 % at 26 weeks and < 7.0 % at 52 weeks than with insulin glargine.
Večji odstotek bolnikov je dosegel ciljne vrednosti HbA1c < 7,0 % ali ≤ 6,5 % v 26. tednu in < 7,0 % v 52. tednu kot z insulinom glarginom.
Two cases of severe hypoglycaemia were observed with Trulicity 1.5mg and two cases of severe hypoglycaemia were observed with insulin glargine.
Opazili so dva primera hude hipoglikemije z zdravilom Trulicity 1,5 mg in dva primera hude hipoglikemije z insulinom glarginom.
Trulicity is used: on its own if your blood sugar is not properly controlled by diet and exercise alone, and you can't take metformin (another diabetes medicine).
- samostojno, če vaš krvni sladkor ni ustrezno uravnan samo z dieto in telesno vadbo in ne smete jemati metformina (drugo zdravilo za zdravljenje sladkorne bolezni).
Unlock by turning the lock ring.
Odklenite z obračanjem zaklepnega obroča.
Gently grasp a fold of skin at the injection site.
Nežno primite kožno gubo na mestu injiciranja.
The pre-filled syringe is for single-use only.
Napolnjeni peresnik je namenjen le za enkratno uporabo.
# p < 0.05 dulaglutide treatment group compared to liraglutide.
# p < 0,05 skupina, zdravljena z dulaglutidom v primerjavi z liraglutidom.
For dulaglutide 0.75 mg, adverse reaction met frequency for next lower incidence grouping.
† Samo za dulaglutid v odmerku 1,5 mg. Za dulaglutid v odmerku 0,75 mg je neželeni učinek ustrezal pogostnosti za naslednjo najnižjo razvrstitev po incidenci.
100 mg once daily (n=315)
100 mg enkrat na dan (n=315)
Combination therapy with titrated basal insulin, with or without metformin In a 28 week placebo controlled study, Trulicity1.5 mg was compared to placebo as add-on to titrated basal insulin glargine (88% with and 12% without metformin) to evaluate the effect on glycaemic control and safety.
Kombinirano zdravljenje s titriranim bazalnim insulinom z metforminom ali brez njega V 28-tedenski študiji, nadzorovani s placebom, so primerjali zdravilo Trulicity 1,5 mg s placebom kot dodatek titriranemu bazalnemu insulinu glarginu (88 % z metforminom in 12 % brez metformina) za oceno učinka glikemičnega nadzora in varnosti.
PLACE AND UNLOCK PRESS AND HOLD
NAMESTITE IN ODKLENITE PRITISNITE IN DRŽITE
Treatment with Trulicity 1.5mg in combination with glimepiride resulted in a statistically significant reduction in HbA1c compared to placebo with glimepiride at 24 weeks.
Zdravljenje z zdravilom Trulicity 1,5 mg v kombinaciji z glimepiridom je v 24. tednu povzročilo statistično pomembno zmanjšanje HbA1c, v primerjavi s placebom z glimepiridom.
Hypoglycaemia* (when used in combination with insulin, glimepiride, metformin† or metformin plus glimepiride)
Presnovne in prehranske motnje hipoglikemija* (ob uporabi v kombinaciji z insulinom, glimepiridom, metforminom† ali metforminom in glimepiridom)
You should use it on the same day each week if you can. To help you remember, you may wish to tick the day of the week when you inject your first dose on the box that your syringe comes in, or on a calendar.
Da si boste lažje zapomnili, si lahko dan v tednu, ko vzamete svoj prvi odmerek zdravila Trulicity, označite na škatlici vašega injekcijskega peresnika ali pa na koledarju.
Use a new pen for your injection.
Za injiciranje uporabite nov peresnik.
1500-2000 mg/day (n=268)
2000 mg/dan (n=268)
No cases of severe hypoglycaemia were observed.
Primerov hude hipoglikemije niso opazili.
Contents of the pack and other information
Shranjevanje zdravila Trulicity Vsebina pakiranja in dodatne informacije
Ten patients reported severe hypoglycaemia with Trulicity 1.5 mg, seven with Trulicity 0.75 mg, and fifteen with insulin glargine.
Deset bolnikov je poročalo o hudi hipoglikemiji z zdravilom Trulicity 1,5 mg, sedem z zdravilom Trulicity 0,75 mg in petnajst z insulinom glarginom.
No patients reported cases of severe hypoglycaemia with Trulicity 1.5 mg, six with Trulicity 0.75 mg, and seventeen with insulin glargine.
Noben bolnik ni poročal o hudi hipoglikemiji z zdravilom Trulicity 1,5 mg, šest z zdravilom Trulicity 0,75 mg in sedemnajst z insulinom glarginom.
Insulin glargine+ once daily (n=296)
Insulin glargin+ enkrat na dan (n=296)
*Produced in CHO cells by recombinant DNA technology.
*Pridobljeno s tehnologijo rekombinantne DNA v celicah jajčnikov kitajskega hrčka.
The effect of dulaglutide on blood pressure as assessed by Ambulatory Blood Pressure Monitoring was evaluated in a study of 755 patients with type 2 diabetes.
Učinek dulaglutida na krvni tlak, ocenjen med 24-urnim merjenjem krvnega tlaka, je bil ocenjen v študiji s
Inject your dose using another pen.
Svoj odmerek si injicirajte z drugim peresnikom.
Pull off and discard the grey base cap.
• Snemite in zavrzite sivi pokrovček dna.
Table 11: Results of a 52 week active controlled study with two doses of dulaglutide in comparison to insulin glargine (in patients with moderate to severe chronic kidney disease)
Preglednica 11: Rezultati 52-tedenske študije, nadzorovane z aktivno primerjavo, z dvema odmerkoma dulaglutida v primerjavi z insulinom glarginom (pri bolnikih z zmerno do hudo kronično ledvično boleznijo)
Baseline HbA1c
Izhodiščna vrednost HbA1c
The mean volume of distribution after subcutaneous administration of dulaglutide 0.75 mg and 1.5 mg at steady state in patients with type 2 diabetes mellitus were approximately 19.2 L and 17.4 L.
Povprečni volumen porazdelitve po subkutani aplikaciji dulaglutida 0,75 mg in 1,5 mg v stanju dinamičnega ravnovesja je bil pri bolnikih s sladkorno boleznijo tipa 2 približno 19,2 l in 17,4 l. Biotransformacija
There are no or limited amount of data from the use of dulaglutide in pregnant women.
V zvezi z uporabo dulaglutida pri nosečnicah ni podatkov ali pa so podatki omejeni.
Combination therapy with sulphonylurea
Kombinirano zdravljenje s sulfonilsečnino
Very common: may affect more than 1 in 10 people - Nausea (feeling sick) - Vomiting (being sick) - Diarrhoea - Abdominal (stomach) pain.
Zelo pogosti lahko se pojavijo pri več kot 1 od 10 bolnikov - navzea (občutek slabosti s siljenjem na bruhanje) - bruhanje - driska
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja angioedem#
No cases of severe hypoglycaemia with dulaglutide were observed.
Primerov hude hipoglikemije pri uporabi dulaglutida niso opazili.
What if there is a drop of liquid on the tip of the needle when I remove the base cap?
Kaj če opazim kapljico tekočine na konici igle, ko odstranim pokrovček z dna?
When used alone, the recommended dose is 0.75 mg once a week.
Ob samostojni uporabi je priporočeni odmerek 0,75 mg enkrat na teden.
Insulin glargine+ once daily (n=194)
Insulin glargin+ enkrat na dan (n=194)
Combination therapy with metformin and pioglitazone In a placebo and active (exenatide twice daily) controlled study, both in combination with metformin and pioglitazone, Trulicity 1.5 mg and 0.75 mg demonstrated superiority for HbA1c reduction in comparison to placebo and exenatide, accompanied by a significantly a greater percentage of patients achieving HbA1c targets of < 7.0 % or ≤ 6.5 %
Kombinirano zdravljenje z metforminom in pioglitazonom V študiji, nadzorovani s placebom in aktivno primerjavo (eksenatid dvakrat na dan), obakrat v kombinaciji z metforminom in pioglitazonom, se je zdravilo Trulicity 1,5 mg in 0,75 mg izkazalo za superiorno tudi pri zniževanju HbA1c v primerjavi s placebom in z eksenatidom, bistveno večji odstotek bolnikov je dosegel ciljne vrednosti HbA1c < 7,0 % ali ≤ 6,5%.
Fasting blood glucose
Krvna glukoza na tešče
Remove the needle from the skin.
Izvlecite iglo iz kože.
The incidences when dulaglutide 0.75 mg and 1.5 mg, respectively, were used in combination with prandial insulin were 85.3% and 80.0% and rates were 35.66 and 31.06 events/patient/year.
Pogostnost ob uporabi dulaglutida 0,75 mg in 1,5 mg v kombinaciji s prandialnim insulinom je bila 85,3 % oziroma 80,0 %, stopnje pa 35,66 oziroma 31,06 dogodkov/bolnika/leto.
The mean peak (Cmax) and total (AUC) exposures were approximately 114 ng/ml and 14,000 ngh/ml, respectively, after multiple subcutaneous 1.5 mg doses of dulaglutide in patients with type 2 diabetes.
Povprečna najvišja koncentracija (Cmax) in skupna izpostavljenost (AUC) sta pri bolnikih s sladkorno boleznijo tipa 2 po več subkutanih odmerkih dulaglutida 1,5 mg znašali približno 114 ng/ml in 14000 ng•h/ml.
• Dispose of the syringe as directed.
• Zavrzite injekcijsko brizgo v skladu z navodili.
The Trulicity treatment arm included patients ≥ 65 years (n = 2,619) and ≥ 75 years (n = 484),
Skupina, zdravljena z zdravilom Trulicity, je vključevala bolnike, stare ≥ 65 let (n = 2619) in ≥ 75 let (n = 484), ter bolnike z blago (n = 2435), zmerno (n = 1031) ali hudo (n = 50) okvaro ledvic.
Insulin glargine+ once daily (n=262)
Insulin glargin+ enkrat na dan (n=262)
Sitagliptin 100 mg once daily (n=315)
Sitagliptin 100 mg enkrat na dan (n=315)
In a 2-year carcinogenicity study in rats, at ≥ 7 times the human clinical exposure following 1.5 mg dulaglutide per week, dulaglutide caused statistically significant, dose-related increases in the incidence of thyroid C-cell tumours (adenomas and carcinomas combined).
V 2-letni študiji karcinogenosti pri podganah je dulaglutid povzročil statistično značilna in z odmerkom povezana povečanja incidence ščitničnih tumorjev C-celic (adenomov in karcinomov skupaj) pri izpostavljenosti, ki je bila ≥ 7kratni izpostavljenosti človeka pri klinični uporabi 1,5 mg dulaglutida na teden.
During the fertility studies, a reduction in the number of corpora lutea and prolonged oestrous cycle were observed at dose levels that were associated with decreased food intake and body weight gain in maternal animals; however, no effects on indices of fertility and conception or embryonic development were observed.
Med raziskavami plodnosti so opazili zmanjšano število rumenih telesc in podaljšan estrusni cikel pri ravneh odmerka, povezanih z zmanjšanim vnosom hrane in zmanjšanim pridobivanjem telesne mase pri materi;
Warnings and precautions Talk to your doctor, pharmacist or nurse before using Trulicity if:
Pred začetkom uporabe zdravila Trulicity se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če:
• Do not use your syringe.
• Injekcijske brizge ne uporabite.
Mean change in HbA1c
Povprečna sprememba vrednosti HbA1c
In reproductive toxicology studies, skeletal effects and a reduction in foetal growth were observed in the rat and rabbit at exposures of dulaglutide 11- to 44-fold higher than those proposed clinically, but no foetal malformations were observed.
Pri študijah o vplivu na sposobnost razmnoževanja je izpostavljenost dulaglutidu (11- do 44-višja od izpostavljenosti človeka pri predlagani klinični uporabi) pri brejih podganah in kuncih povzročila zmanjšano rast plodu in/ali učinke na skelet, vendar pa ni bilo dokazov o malformacijah fetusa.
Trulicity is to be injected subcutaneously in the abdomen, thigh or upper arm.
Zdravilo Trulicity je treba injicirati subkutano v trebuh, stegno ali nadlaket.
<7.0 %(%) ≤6.5 %(%) (mmol/L)
< 7,0 % in ≤ 6,5 % (Preglednica 9).
2 INSERT
PRILOGA I