FrancophonIA/ELRC3.0 huggingface dataset:
English: Repatha 140 mg solution for injection in pre-filled syringe The 140 mg dose should be delivered using a single pre-filled syringe.
Slovenian: Repatha 140 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Odmerek 140 mg je treba injicirati z eno napolnjeno injekcijsko brizgo.
English: Fourteen adolescent patients aged ≥ 12 to < 18 years with homozygous familial hypercholesterolaemia have been included in clinical trials.
Slovenian: V klinična preskušanja je bilo vključenih 14 mladostnikov s homozigotno družinsko hiperholesterolemijo, starih od ≥ 12 do < 18 let.
English: The needle cover of the glass pre-filled syringe is made from dry natural rubber (a derivative of latex), which may cause allergic reactions.
Slovenian: Pokrovček igle na stekleni napolnjeni injekcijski brizgi je izdelan iz suhe naravne gume (derivat lateksa), ki lahko povzroči alergijske reakcije.
English: No dose adjustment is necessary in patients with mild hepatic impairment (Child-Pugh class A).
Slovenian: Bolnikom z blago okvaro jeter (Child-Pugh A) odmerka ni treba prilagoditi.
English: Plunger rod
Slovenian: Okvara jeter
English: 140 mg Q2W
Slovenian: 140 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON AUTOMATED MINI-DOSER (without blue box)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA AVTOMATSKI ODMERNIK (brez modrega okenca)
English: • Do not touch the bottom of the cartridge after cleaning with alcohol wipe.
Slovenian: • Ko ste dno vložka očistili z alkoholnim zložencem, se ga ne dotikajte več.
English: Changes in other lipid parameters (TC, non-HDL-C, TC/HDL-C, and ApoB/ApoA1) also demonstrated a treatment effect of Repatha administration in patients with homozygous familial hypercholesterolaemia.
Slovenian: Tudi spremembe drugih lipidnih parametrov (TC, ApoB, ne-HDL-H, TC/HDL-H in ApoB/ApoA1) so pokazale terapevtski učinek dolgoročne uporabe zdravila Repatha pri bolnikih s homozigotno družinsko hiperholesterolemijo.
English: Fourteen patients aged ≥ 12 to < 18 years with homozygous familial hypercholesterolaemia were included in clinical studies.
Slovenian: V klinične študije je bilo vključenih 14 bolnikov s homozigotno družinsko hiperholesterolemijo, starih od ≥ 12 do < 18 let.
English: Repatha 420 mg solution for injection in cartridge evolocumab
Slovenian: Repatha 420 mg raztopina za injiciranje v vložku evolokumab
English: Right pull tab
Slovenian: Desni potezni jeziček
English: • Do not freeze the automated mini-doser and cartridge.
Slovenian: • Avtomatskega odmernika in vložka ne zamrznite.
English: • Peel the paper off of the tray.
Slovenian: • Odlepite papir s pretisnega omota.
English: • Do not use if the medicine is cloudy or discoloured or contains flakes or particles.
Slovenian: • Če je zdravilo motno, obarvano ali vsebuje kosme ali delce, ga ne uporabite.
English: 3 SureClick pre-filled pens.
Slovenian: 3 napolnjeni injekcijski peresniki SureClick.
English: • Clear tray containing the automated mini-doser and cartridge
Slovenian: • prozorni pladenj, na katerem sta avtomatski odmernik in vložek
English: Flashing Light
Slovenian: Utripajoča lučka
English: Apheresis
Slovenian: Okence
English: Solid Light
Slovenian: Valj brizge
English: Your pre-filled syringe may be left outside the refrigerator to reach room temperature (up to 25ºC) before injection.
Slovenian: Pred injiciranjem lahko napolnjeno injekcijsko brizgo pustite zunaj hladilnika, da doseže sobno temperaturo (do 25°C).
English: Effect of Repatha on LDL-C in patients with homozygous familial hypercholesterolaemia - mean percent change from baseline to OLE week 216 (and associated 95% CI)
Slovenian: Preglednica 7: Vpliv zdravila Repatha na LDL-H pri bolnikih s homozigotno družinsko hiperholesterolemijo - povprečna odstotna sprememba od izhodišča do 216. tedna (in povezanega 95 % IZ) odprtega podaljšanja
English: DO NOT tap the syringe needle.
Slovenian: NE TRKAJTE po igli brizge.
English: • Do not touch or contaminate the needle cover area.
Slovenian: • Ne dotikajte se predela pokrovčka igle in pazite, da ga ne onesnažite.
English: Keep the used syringe and sharps container out of the sight and reach of children.
Slovenian: Uporabljene brizge in vsebnik za ostre odpadke shranjujte nedosegljive otrokom!
English: Repatha significantly reduced LDL-C from baseline to mean of weeks 10 and 12 compared with placebo (p < 0.001).
Slovenian: Zdravilo Repatha je v primerjavi s placebom značilno znižalo LDL-H od izhodišča do povprečja 10. in 12. tedna (p < 0,001).
English: • Do not use the pre-filled pen if medicine is cloudy or discoloured or contains large lumps,
Slovenian: • Ne uporabite napolnjenega injekcijskega peresnika, če je zdravilo motno, spremenjene barve,
English: • New pre-filled pen.
Slovenian: • nov napolnjen injekcijski peresnik.
English: Storing your automated mini-doser and cartridge
Slovenian: Shranjevanje avtomatskega odmernika in vložka
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK CARTON PRE-FILLED PEN (with blue box)
Slovenian: OVOJNINA ZA SKUPNO PAKIRANJE NAPOLNJENIH INJEKCIJSKIH PERESNIKOV (z modrim okencem)
English: • Cotton ball or gauze pad.
Slovenian: • kosem vate ali zloženec iz gaze.
English: put the grey needle cap back onto the pre-filled syringe.
Slovenian: NE NAMEŠČAJTE sivega pokrovčka igle nazaj na napolnjeno injekcijsko brizgo.
English: Make sure the cartridge fits securely in the automated mini-doser before you close the door.
Slovenian: Preden vratca zaprete, preverite, ali se vložek dobro prilega v avtomatski odmernik.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK CARTON AUTOMATED MINI-DOSER (with blue box)
Slovenian: OVOJNINA ZA SKUPNO PAKIRANJE ZA AVTOMATSKI ODMERNIK (z modrim okencem)
English: Repatha 140 mg solution for injection in pre-filled pen The 140 mg dose should be delivered using a single pre-filled pen.
Slovenian: Repatha 140 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Odmerek 140 mg je treba injicirati z enim napolnjenim injekcijskim peresnikom.
English: You should stay on your cholesterol lowering diet while taking this medicine.
Slovenian: Med uporabo tega zdravila se morate še naprej držati diete za zniževanje holesterola.
English: Cartridge bottom Medicine
Slovenian: Dno vložka Zdravilo
English: flakes, or particles.
Slovenian: ali vsebuje velike grude, kosme ali delce.
English: Turn tray over
Slovenian: Pretisni omot obrnite
English: Repatha 140 mg solution for injection in pre-filled syringe evolocumab
Slovenian: Repatha 140 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku evolokumab
English: No statin dose adjustments are necessary when used in combination with Repatha.
Slovenian: Če je statin uporabljen v kombinaciji z zdravilom Repatha, odmerka statina ni treba prilagoditi.
English: You must remove both green pull tabs to turn the loaded automated mini-doser on. You will hear beeping and see a flashing blue status light.
Slovenian: Slišali boste piskanje in videli utripajočo modro lučko stanja.
English: Step 1: Prepare A Remove the Repatha pre-filled syringe carton from the refrigerator and wait 30 minutes.
Slovenian: A Vzemite škatlo z napolnjeno injekcijsko brizgo zdravila Repatha iz hladilnika in počakajte
English: Repatha significantly reduced TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1, VLDL-C, TG and Lp(a), and increased HDL-C and ApoA1 at week 52 compared with placebo (p < 0.001) (table 4).
Slovenian: Zdravilo Repatha je 52. teden v primerjavi s placebom značilno znižalo TC, ApoB, ne-HDL-H, TC/HDL-H, ApoB/ApoA1, VLDL-H, trigliceride in Lp(a) ter zvišalo HDL-H in ApoA1 (p < 0,001) (glejte preglednico 4).
English: Less impact from body weight was seen with repeated subcutaneous evolocumab 420 mg monthly doses.
Slovenian: Med ponavljajočo se subkutano uporabo 420 mg evolokumaba enkrat na mesec je bil vpliv telesne mase manjši.
English: DO NOT choose an area where the skin is tender, bruised, red, or hard.
Slovenian: NE INJICIRAJTE v predel, kjer je koža občutljiva, podpluta, pordela ali zatrdela.
English: Back pain
Slovenian: • Bolečine v hrbtu
English: Treatment effects of Repatha compared with ezetimibe in patients with primary hypercholesterolaemia and mixed dyslipidaemia - mean percent change from baseline to average of weeks 10 and 12 (%, 95% CI)
Slovenian: Preglednica 3: Terapevtski učinki zdravila Repatha v primerjavi z ezetimibom pri bolnikih s primarno hiperholesterolemijo in mešano dislipidemijo - povprečni odstotek znižanja od izhodišča do povprečja 10. in 12. tedna (%, 95 % IZ)
English: Treatment effects of Repatha compared with placebo in patients with primary hypercholesterolaemia and mixed dyslipidaemia - mean percent change from baseline to average of weeks 10 and 12 (%, 95% CI)
Slovenian: Preglednica 2: Terapevtski učinki zdravila Repatha v primerjavi s placebom pri bolnikih s primarno hiperholesterolemijo in mešano dislipidemijo - povprečni odstotek znižanja od izhodišča do povprečja 10. in 12. tedna (%, 95 % IZ)
English: Instructions for use: Repatha single use automated mini-doser and cartridge Guide to parts Cartridge White plunger
Slovenian: Navodila za uporabo: Avtomatski odmernik in vložek zdravila Repatha za enkratno uporabo
English: In hamsters and cynomolgus monkeys at exposures much higher than patients receiving 420 mg evolocumab once monthly, no effect on male or female fertility was observed.
Slovenian: Pri hrčkih in opicah cynomolgus niso opazili vpliva na plodnost samcev ali samic ob izpostavljenostih, veliko večjih kot so pri bolnikih, zdravljenih s 420 mg evolokumaba enkrat na mesec.
English: Light Off beep-beep-beep
Slovenian: Lučka ugasnjena bip-bip-bip
English: Repatha significantly reduced LDL-C from baseline to mean of weeks 10 and 12 compared with both placebo and ezetimibe (p < 0.001).
Slovenian: Zdravilo Repatha je tako v primerjavi s placebom kot z ezetimibom značilno znižalo LDL-H od izhodišča do povprečja 10. in 12. tedna (p < 0,001).
English: Each SureClick pre-filled pen contains 140 mg of evolocumab in 1 mL of solution.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 140 mg evolokumaba v 1 ml raztopine.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL PRE-FILLED PEN
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: Treatment effects of Repatha compared with placebo in patients with primary hypercholesterolaemia and mixed dyslipidaemia - mean percent change from baseline to week 52 (%, 95% CI)
Slovenian: Preglednica 4: Terapevtski učinki zdravila Repatha v primerjavi s placebom pri bolnikih s primarno hiperholesterolemijo in mešano dislipidemijo - povprečni odstotek znižanja od izhodišča do 52. tedna (%, 95 % IZ)
English: • Keep the automated mini-doser and cartridge out of the sight and reach of children.
Slovenian: • Avtomatski odmernik in vložek shranjujte nedosegljiva otrokom!
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each SureClick pre-filled pen contains 140 mg of evolocumab in 1 mL of solution.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN En napolnjen injekcijski peresnik SureClick vsebuje 140 mg evolokumaba v 1 ml raztopine.
English: NonHDL-C
Slovenian: neHDL-H
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON PRE-FILLED SYRINGE
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA NAPOLNJENI INJEKCIJSKI PERESNIK
English: How to store Repatha
Slovenian: Shranjevanje zdravila Repatha
English: Nasopharyngitis
Slovenian: Trigliceridi
English: NAME OF THE MARKETING AUTHORISATION HOLDER Amgen Europe B.V.
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Amgen Europe B.V.
English: • Keep the Repatha pre-filled syringe out of the sight and reach of children.
Slovenian: • Napolnjeno injekcijsko brizgo zdravila Repatha shranjujte nedosegljivo otrokom!
English: HoFH
Slovenian: HoDH
English: F Inspect the cartridge.
Slovenian: F Preglejte vložek.
English: Treatment effects of Repatha compared with placebo in patients with homozygous familial hypercholesterolaemia - mean percent change from baseline to week 12 (%, 95% CI)
Slovenian: Preglednica 6: Terapevtski učinki zdravila Repatha v primerjavi s placebom pri bolnikih s homozigotno hiperholesterolemijo - povprečni odstotek znižanja od izhodišča do 12. tedna (%, 95 % IZ)
English: Repatha significantly reduced TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1, VLDL-C, TG and Lp(a) and increased HDL-C and ApoA1 from baseline to mean of weeks 10 and 12 compared to placebo (p < 0.05) (see table 2).
Slovenian: Zdravilo Repatha je od izhodišča do povprečja 10. in 12. tedna v primerjavi s placebom značilno znižalo TC, ApoB, ne-HDL-H, TC/HDL-H, ApoB/ApoA1, VLDL-H, trigliceride in Lp(a) ter zvišalo HDL-H in ApoA1 (p < 0,05) (glejte preglednico 2).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled syringe contains 140 mg of evolocumab in 1 mL of solution.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN En napolnjen injekcijski peresnik vsebuje 140 mg evolokumaba v 1 ml raztopine.
English: NAME OF THE MEDICINAL PRODUCT Repatha 140 mg solution for injection evolocumab
Slovenian: Repatha 140 mg raztopina za injiciranje evolokumab
English: • Do not reuse the automated mini-doser and cartridge.
Slovenian: • Avtomatskega odmernika in vložka ne uporabljajte znova.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1016/007
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1016/007
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1016/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1016/002
English: Single use
Slovenian: Način uporabe
English: Repatha significantly reduced TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1 and Lp(a), from baseline to mean of weeks 10 and 12 compared to ezetimibe (p < 0.001) (see table 3).
Slovenian: Zdravilo Repatha je od izhodišča do povprečja 10. in 12. tedna v primerjavi z ezetimibom značilno znižalo TC, ApoB, ne-HDL-H, TC/HDL-H, ApoB/ApoA1 in Lp(a) (p < 0,001) (glejte preglednico 3).
English: Used Needle
Slovenian: Uporabljena igla
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1016/006
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1016/006
English: Wait
Slovenian: Afereza
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1016/005
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1016/005
English: Non-apheresis
Slovenian: ne-HDLH
English: Adverse reactions with Repatha
Slovenian: Preglednica 1: Neželeni učinki z zdravilom Repatha
English: E Remove the pre-filled syringe from the tray.
Slovenian: E Vzemite napolnjeno injekcijsko brizgo iz pretisnega omota.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PRE-FILLED SYRINGE BLISTER
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: Shake the Repatha pre-filled syringe.
Slovenian: NE STRESAJTE napolnjene injekcijske brizge zdravila Repatha.
English: Thigh
Slovenian: neHDLH
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1016/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1016/001
English: Belly area placement
Slovenian: Sestavni deli Vložek
English: Window Medicine
Slovenian: NAČIN IZDAJANJA ZDRAVILA
English: In cynomolgus monkeys at exposures much higher than patients receiving 420 mg evolocumab once monthly, no effects on embryo-foetal or postnatal development (up to 6 months of age) were observed.
Slovenian: Pri opicah cynomolgus niso opazili vplivov na embrio-fetalni in postnatalni razvoj (do 6 mesecev starosti) ob izpostavljenostih, veliko večjih kot so pri bolnikih, zdravljenih s 420 mg evolokumaba enkrat na mesec.
English: Using your automated mini-doser and cartridge
Slovenian: Uporaba avtomatskega odmernika in vložka
English: The status light turns solid green, and the device beeps, when done.
Slovenian: Ko je končano, začne lučka stanja svetiti stalno zeleno in pripomoček zapiska.
English: Repatha significantly reduced TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1 and Lp(a), from baseline to mean of weeks 10 and 12 compared with both placebo and ezetimibe (p < 0.001) (see table 3).
Slovenian: Zdravilo Repatha je od izhodišča do povprečja 10. in 12. tedna tako v primerjavi s placebom kot z ezetimibom značilno znižalo TC, ApoB, ne-HDL-H, TC/HDL-H, ApoB/ApoA1 in Lp(a) (p < 0,001) (glejte preglednico 3).
English: NAME OF THE MEDICINAL PRODUCT Repatha 140 mg solution for injection in pre-filled syringe evolocumab
Slovenian: Repatha 140 mg raztopina za injiciranje v napolnjeni injekcijski brizgi evolokumab
English: Used plunger
Slovenian: Pogosti nazofaringitis
English: The recommended dose is 1 tablet once a day before the first meal of the day.
Slovenian: Priporočeni odmerek je ena tableta enkrat dnevno tik pred prvim dnevnim obrokom.
English: Further information on Zynquista can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zynquista.
Slovenian: Nadaljnje informacije o zdravilu Zynquista so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/zynquista.
English: What measures are being taken to ensure the safe and effective use of Zynquista?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zynquista?
English: After 3 months, the doctor may increase the dose to 2 tablets once a day if additional blood sugar control is needed.
Slovenian: Po treh mesecih lahko zdravnik odmerek poveča na dve tableti enkrat dnevno, če je potrebno dodatno uravnavanje ravni sladkorja v krvi.
English: The European Medicines Agency decided that Zynquista's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Zynquista večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: In addition, precautions have been recommended to reduce the risk of diabetic ketoacidosis.
Slovenian: Poleg tega je treba upoštevati previdnostne ukrepe za zmanjšanje tveganja diabetične ketoacidoze.
English: As for all medicines, data on the use of Zynquista are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Zynquista stalno spremljajo.
English: Zynquista is available as 200 mg tablets.
Slovenian: Zdravilo Zynquista je na voljo v obliki 200-miligramskih tablet.
English: Other information about Zynquista
Slovenian: Druge informacije o zdravilu Zynquista
English: In the third study involving 1,405 patients, only the higher dose of Zynquista (400 mg) was studied.
Slovenian: V tretji študiji, ki je vključevala 1 405 bolnikov, so proučevali samo večji odmerek zdravila Zynquista (400 mg).
English: Side effects reported with Zynquista are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Zynquista, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: The main measure of effectiveness was the proportion of patients who had HbA1c levels less than 7.0% and no episodes of severe hypoglycaemia (low blood glucose levels) or diabetic ketoacidosis.
Slovenian: Glavno merilo učinkovitosti je bil delež bolnikov z ravnmi HbA1c pod 7,0 % in brez epizod hude hipoglikemije (nizkih ravni glukoze v krvi) ali diabetične ketoacidoze.
English: Why is Zynquista authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Zynquista odobreno v EU?
English: Zynquista's common side effects, which are related to the way the medicine works, such as increased genital infections, are considered manageable and similar to those of other medicines of a similar class.
Slovenian: Pogosti neželeni učinki zdravila Zynquista, ki so povezani z njegovim načinom delovanja, kot je povečanje genitalnih okužb, veljajo za obvladljive in so podobni kot pri drugih zdravilih podobnega razreda.
English: An overview of Zynquista and why it is authorised in the EU
Slovenian: Pregled zdravila Zynquista in zakaj je odobreno v EU
English: What benefits of Zynquista have been shown in studies?
Slovenian: Kakšne koristi zdravila Zynquista so se pokazale v študijah?
English: The company that markets Zynquista will provide information on measures to reduce the risk of diabetic ketoacidosis, including a patient alert card and guide for patients and their carers, as well as a guide for healthcare professionals, including a prescriber's checklist.
Slovenian: Podjetje, ki trži zdravilo Zynquista, bo zagotovilo informacije o previdnostnih ukrepih za preprečevanje diabetične ketoacidoze, vključno z opozorilno kartico za bolnike in priročnikom za bolnike in njihove negovalce, ter navodila za zdravstvene delavce, vključno s kontrolnim seznamom za zdravnike, ki bodo predpisovali to zdravilo.
English: The most common side effect with Zynquista (which may affect more than 1 in 10 people) is genital infection in women.
Slovenian: Najpogostejši neželeni učinek zdravila Zynquista (ki se lahko pojavi pri več kot 1 bolniku od 10) je genitalna okužba pri ženskah.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zynquista have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Zynquista upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: On this basis, Zynquista 400 mg added to insulin was effective in around 29% of patients, compared with 15% of patients receiving placebo plus insulin.
Slovenian: Na podlagi tega je bilo zdravilo Zynquista 400 mg, ki so ga dodali insulinu, učinkovito pri približno 29 % bolnikov v primerjavi s 15 % bolnikov, ki so prejemali placebo in insulin.
English: For more information about using Zynquista, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Zynquista glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: It is used in overweight patients (body mass index of at least 27 kg/m2) when insulin on its own does not control blood sugar well enough.
Slovenian: Uporablja se pri bolnikih s prekomerno telesno maso (z indeksom telesne mase vsaj 27 kg/m2), če insulin sam ne zadostuje za ustrezno uravnavanje ravni sladkorja v krvi.
English: What is Zynquista and what is it used for?
Slovenian: Kaj je zdravilo Zynquista in za kaj se uporablja?
English: The medicine should be used with precautions to reduce the risk of diabetic ketoacidosis (a serious complication of diabetes with high levels of ketones in the blood).
Slovenian: Pri uporabi zdravila je treba upoštevati previdnostne ukrepe za zmanjšanje tveganja diabetične ketoacidoze (resnega zapleta sladkorne bolezni, pri katerem se v krvi pojavijo visoke ravni ketonov).
English: What are the risks associated with Zynquista?
Slovenian: Kakšna tveganja so povezana z zdravilom Zynquista?
English: Other common side effects (which may affect up to 1 in 10 people) include diabetic ketoacidosis, diarrhoea and genital infection in men.
Slovenian: Drugi pogosti neželeni učinki (ki se lahko pojavijo pri največ 1 bolniku od 10) so diabetična ketoacidoza, driska in genitalna okužba pri moških.
English: The company will also conduct a study to estimate the frequency of diabetic ketoacidosis in patients with type 1 diabetes treated with the medicine.
Slovenian: Izvedlo bo tudi študijo za oceno pogostnosti diabetične ketoacidoze pri bolnikih s sladkorno boleznijo tipa 1, zdravljenih s tem zdravilom.
English: In two of these studies, involving a total of 1,575 patients, two doses of Zynquista (200 and 400 mg) were compared with placebo when given in addition to insulin.
Slovenian: V dveh študijah, ki sta skupaj vključevali 1 575 bolnikov, so dva odmerka zdravila Zynquista (200 in 400 mg) primerjali s placebom, ki so ga bolnikom dajali poleg insulina.
English: The main measure of effectiveness was the level of glycosylated haemoglobin (HbA1c), which indicates how well blood glucose is controlled.
Slovenian: Glavno merilo učinkovitosti je bila raven glikoziliranega hemoglobina (HbA1c), ki kaže, kako dobro je uravnavana raven glukoze v krvi.