FrancophonIA/ELRC3.0 huggingface dataset:
English: oedema e, body temperature increased, gait abnormal, chest pain, chest discomfort, malaise, induration hypothermia, chills, thirst, drug withdrawal syndrome, injection site abscess, injection site cellulitis, injection site cyst, injection site haematoma body temperature decreased, injection site necrosis, injection site ulcer
Slovenian: povišana telesna temperatura, nenormalna drža, bolečina v prsnem košu, neprijeten občutek v prsnem košu, splošno slabo počutje, induracija hipotermija, mrazenje, žeja, sindrom odtegnitve zdravila, absces na mestu injiciranja, celulitis na mestu injiciranja, cista na mestu injiciranja, hematom na mestu injiciranja znižana telesna temperatura, nekroza na mestu injiciranja, razjeda na mestu injiciranja,
English: Metabolism and nutrition disorders hyperglycaemia, weight increased, weight decreased, decreased appetite,
Slovenian: Presnovne in prehranske motnje hiperglikemija, povečanje telesne mase, zmanjšanje telesne mase, zmanjšan apetit sladkorna bolezen d,
English: TREVICTA 350 mg prolonged release suspension for injection paliperidone
Slovenian: TREVICTA 350 mg suspenzija za injiciranje s podaljšanim sproščanjem paliperidon
English: Deltoid injections should be alternated between the two deltoid muscles.
Slovenian: Zdravilo se injicira v sredino deltoidne mišice.
English: • breast discomfort, enlargement of the glands in your breasts, breast enlargement
Slovenian: • bolečine v dojkah, povečanje žlez v dojkah, povečanje dojk
English: Each pre-filled syringe contains paliperidone palmitate equivalent to 263 mg paliperidone.
Slovenian: Ena napolnjena injekcijska brizga vsebuje paliperidonijev palmitat, v količini, ki ustreza 263 mg paliperidona.
English: Talk to your doctor, pharmacist or nurse before using TREVICTA.
Slovenian: Pred začetkom jemanja zdravila TREVICTA se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Events of leucopenia, neutropenia, and agranulocytosis have been reported with paliperidone.
Slovenian: Pri uporabi paliperidona so poročali o primerih levkopenije, nevtropenije in agranulocitoze.
English: (in men) breast swelling, difficulty in getting or maintaining erections, or other sexual dysfunction; (in women) breast discomfort, leakage of milk from the breasts, missed menstrual periods, or other problems with your cycle.
Slovenian: nelagodje v dojkah, iztekanje mleka iz dojk, izostanek menstruacije ali druge težave menstrualnega ciklusa.
English: • skin inflammation caused by mites, abscess under the skin
Slovenian: • vnetje kože, ki ga povzroča vrsta pršice (garje), podkožni absces
English: Each pre-filled syringe contains paliperidone palmitate equivalent to 350 mg paliperidone.
Slovenian: Ena napolnjena injekcijska brizga vsebuje paliperidonijev palmitat v količini, ki ustreza 350 mg paliperidona.
English: Each pre-filled syringe contains paliperidone palmitate equivalent to 525 mg paliperidone.
Slovenian: Ena napolnjena injekcijska brizga vsebuje paliperidonijev palmitat v količini, ki ustreza 525 mg paliperidona.
English: Each pre-filled syringe contains paliperidone palmitate equivalent to 175 mg paliperidone.
Slovenian: Ena napolnjena injekcijska brizga vsebuje paliperidonijev palmitat v količini, ki ustreza 175 mg paliperidona.
English: • rash on skin related to drug, thickening of skin, dandruff
Slovenian: • kožni izpuščaj zaradi zdravila, zadebelitev kože, prhljaj
English: TREVICTA 175 mg prolonged release suspension for injection paliperidone
Slovenian: TREVICTA 175 mg suspenzija za injiciranje s podaljšanim sproščanjem paliperidon
English: Unused needle should be discarded and not saved for future use.
Slovenian: Igle ne shranjujte za kasnejšo uporabo.
English: • skin discolouration, flaky, itchy scalp or skin
Slovenian: • sprememba barve kože, luščenje in srbenje lasišča ali kože
English: Adverse drug reaction Frequency
Slovenian: Neželeni učinek Pogostnost
English: < 1 x 10
Slovenian: 22G x 1 palec
English: • feeling restless
Slovenian: • čustvena otopelost
English: Gluteal injections should be alternated between the two gluteal muscles.
Slovenian: Pri injiciranju v glutealno mišico je treba izmenično injicirati v levo in desno glutealno mišico.
English: Open needle pouch and remove cap
Slovenian: Odprite zaščitni omot in odstranite zaporko
English: Significant weight gain may be bad for your health.
Slovenian: Preveliko povečanje telesne mase ima lahko neželene učinke na vaše zdravje, zato mora zdravnik redno spremljati vašo telesno maso.
English: Thin wall (TW) safety needles are designed to be used with TREVICTA.
Slovenian: Za uporabo z zdravilom TREVICTA so pripravljene varnostne injekcijske igle s tanko steno.
English: The frequency of adverse reactions is qualified as “not known” because they were not observed in paliperidone palmitate clinical trials.
Slovenian: V kliničnih preskušanjih s paliperidonijevim palmitatom teh neželenih učinkov niso opazili, zato je njihova pogostnost opredeljena kot “neznana”.
English: • experience blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing.
Slovenian: Krvni strdki lahko potujejo s krvjo v pljuča in povzročijo bolečine v prsnem košu in težko dihanje.
English: Intramuscular use
Slovenian: Navodilo za uporabo
English: Shake syringe vigorously for at least 15 seconds
Slovenian: odmerjanje na 3 mesece injekcijsko brizgo močno stresajte najmanj 15 sekund
English: TREVICTA has not been systematically studied in patients with renal impairment.
Slovenian: Pri bolnikih z okvaro ledvic zdravila TREVICTA niso sistematično preučevali.
English: They also lower the amount of sugar made by your body.
Slovenian: Zmanjšata tudi količino sladkorja, ki ga izdela telo.
English: Date of first authorisation: 24 November 2011 Date of latest renewal: 15 July 2016
Slovenian: Datum prve odobritve: 24. november 2011 Datum zadnjega podaljšanja: 15. julij 2016
English: • The recommended dosing is one tablet twice a day.
Slovenian: • Priporočeni odmerek je ena tableta dvakrat na dan.
English: This is because it may affect the baby.
Slovenian: To zdravilo namreč lahko vpliva na otroka.
English: Treatment may be continued in the well-informed patients with close monitoring.
Slovenian: Zdravljenje se lahko nadaljuje pri dobro informiranih bolnikih in ob natančnem spremljanju.
English: This medicine contains two different substances called:
Slovenian: To zdravilo vsebuje dve različni učinkovini, imenovani:
English: Overall population (n=300)
Slovenian: Celotna populacija (n = 300)
English: Significance not tested.
Slovenian: Značilnost ni testirana.
English: These changes were not considered to be clinically meaningful.
Slovenian: Teh sprememb niso ocenili kot klinično pomembne.
English: Component of a multipack, can't be sold separately.
Slovenian: Sestavni del večkratnega pakiranja in se ne prodaja posamično.
English: • difficulties in getting or maintaining an erection (erectile dysfunction).
Slovenian: • težave pri doseganju ali ohranjanju erekcije (erektilna disfunkcija).
English: This medicinal product should not be used during pregnancy.
Slovenian: Tega zdravila se med nosečnostjo ne sme uporabljati.
English: Subjects with events n (%)
Slovenian: Preiskovanci z dogodki n (%)
English: The safety and efficacy of this medicinal product in children and adolescents from birth to < 18 years of age have not been established.
Slovenian: Varnost in učinkovitost tega zdravila pri otrocih in mladostnikih od rojstva do < 18 let starosti nista ugotovljeni.
English: Frequencies are defined as very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to 1/100), rare ( 1/10,000 to 1/1,000), or very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: Pogostnosti so opredeljene takole: zelo pogosti ( 1/10), pogosti ( 1/100 do < 1/10), občasni ( 1/1.000 do 1/100), redki ( 1/10.000 do 1/1.000), ali zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Your doctor will tell you exactly the dose of this medicine to take.
Slovenian: Zdravnik vam bo svetoval koliko tega zdravila je treba točno vzeti.
English: • If you forget to take a dose of this medicine, take it as soon as you remember.
Slovenian: • Če ste pozabili vzeti odmerek tega zdravila, ga vzemite, čim se spomnite.
English: LRM = Longitudinal repeated measures (using values prior to rescue).
Slovenian: LPM = longitudinalne ponovljene meritve (z uporabo vrednosti pred reševalnim ukrepanjem).
English: 24-weeks
Slovenian: 24 tednov
English: The clinical relevance of this decrease is unknown.
Slovenian: Klinični pomen tega zmanjšanja ni znan.
English: The intent-to-treat analysis showed consistent results.
Slovenian: Analiza z-namenom-zdravljenja je pokazala skladne rezultate.
English: 2 (see sections 4.3 and 4.4)
Slovenian: 2 (glejte poglavji 4.3 in 4.4)
English: If you have a problem or take a medicine that can lower your body's defence against infections;
Slovenian: če imate kakšno težavo ali jemljete kakšno zdravilo, ki lahko zmanjša telesno obrambo pred okužbami.
English: This is not considered clinically meaningful, therefore, no dose adjustment for this medicinal product is recommended on the basis of age alone.
Slovenian: To ni ocenjeno kot klinično pomembno, zato prilagoditev odmerka tega zdravila zgolj na podlagi starosti ni potrebna.
English: Only in the initial combination therapy.
Slovenian: Samo med uvodno kombiniranim zdravljenjem.
English: If you have had allergic reactions to any other medicines that you take to control the amount of sugar in your blood;
Slovenian: če ste imeli alergijsko reakcijo na katero koli drugo zdravilo, ki ga jemljete za obvladovanje količine sladkorja v krvi.
English: The frequencies are based on the experience from clinical trials.
Slovenian: Pogostnosti temeljijo na izkušnjah iz kliničnih preskušanj.
English: Therefore, the efficacy and safety profile of saxagliptin in these patients has not been established.
Slovenian: Zato profil varnosti in učinkovitosti saksagliptina pri teh bolnikih ni ugotovljen.
English: Do not take this medicine if you are pregnant or might become pregnant.
Slovenian: Ne jemljite tega zdravila, če ste noseči, ali če bi lahko zanosili.
English: Elderly patients (65-80 years) had about 60% higher saxagliptin AUC than young patients (18-40 years).
Slovenian: Starejši bolniki (65-80 let) so imeli AUC saksagliptina približno 60 % večji kot pa mladi bolniki (18-40 let).
English: However, if it is time for your next dose, skip the missed dose and take your next dose at the usual time.
Slovenian: Če pa je že čas za naslednji odmerek, preskočite izpuščeni odmerek in vzemite naslednji odmerek ob običajnem času.
English: This medicine can be used alone or together with other antidiabetic medicines, including insulin.
Slovenian: To zdravilo se lahko uporablja samostojno ali skupaj z drugimi antidiabetičnimi zdravili, vključno z insulinom.
English: How to take this medicine
Slovenian: Kako vzeti zdravilo
English: • liver problems (hepatitis)
Slovenian: • težave z jetri (hepatitis)
English: Metformin increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4).
Slovenian: Metformin poveča transportno kapaciteto specifičnih vrst membranskih transporterjev glukoze (GLUT-1 in GLUT-4).
English: The mean Vd ranged between 63-276 L.
Slovenian: Povprečni Vd je bil med 63 in 276 l.
English: It is not known if this medicine is safe and effective when used in children and adolescents under 18 years of age.
Slovenian: Ni znano, ali je to zdravilo varno in učinkovito, če je uporabljeno pri otrocih oziroma mladostnikih, mlajših od 18 let.
English: This is to help keep your blood sugar under control.
Slovenian: To bo pripomoglo k ohranjanju urejenosti krvnega sladkorja.
English: If no adequate strength of Komboglyze is available, individual monocomponents should be used instead of the fixed dose combination.
Slovenian: Če ni na voljo ustrezna jakost zdravila Komboglyze, je treba namesto fiksne kombinacije uporabiti posamične monokomponente.
English: In the SAVOR study subgroups over 65 and over 75 years of age, efficacy and safety were consistent with the overall study population.
Slovenian: V študiji SAVOR sta se učinkovitost in varnost v podskupinah starejših od 65 in starejših od 75 let skladali s tistima v celotni študijski populaciji.
English: Frequency categories are based on information available from metformin Summary of Product Characteristics available in the European Union.
Slovenian: Kategorije pogostnosti temeljijo na informacijah, ki so na voljo iz Povzetka glavnih značilnosti metformina v Evropski Uniji.
English: Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.
Slovenian: Zdravnik vam lahko predpiše zdravilo za zdravljenje alergijske reakcije in drugo zdravilo za zdravljenje sladkorne bolezni.
English: • Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas (pancreatitis).
Slovenian: • Huda in nenehna bolečina v trebuhu, ki se lahko širi v hrbet, pa tudi slabost in bruhanje, ker je to lahko znak vnetja trebušne slinavke (pankreatitisa).
English: Komboglyze is not recommended for use in children and adolescents under 18 years.
Slovenian: Zdravila Komboglyze ni priporočljivo uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
English: They increase the levels of insulin after a meal.
Slovenian: Povečata koncentracijo insulina po obroku.
English: • Take with a meal to lower your chance of getting an upset stomach.
Slovenian: • Zdravilo vzemite s hrano, da boste zmanjšali možnost draženja želodca.
English: • The amount of this medicine that you will take varies depending on your condition and the doses you currently take of metformin and/or individual tablets of saxagliptin and metformin.
Slovenian: • Količina tega zdravila, ki jo boste jemali je različna in odvisna od vašega stanja in odmerkov metformina, ki ga trenutno jemljete in/ali samostojnih tablet saksagliptina in metformina.
English: Side effects seen when taking metformin alone: Very common (may affect more than 1 in 10 people)
Slovenian: Neželeni učinki, ki so jih zabeležili med jemanjem samega metformina: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov)
English: If pancreatitis is suspected, this medicinal product should be discontinued; if acute pancreatitis is confirmed, this medicinal product should not be restarted.
Slovenian: Če se pojavi sum na pankreatitis, je potrebno ukiniti zdravljenje s tem zdravilom; če je akutni pankreatitis potrjen, se tega zdravila ne sme ponovno začeti uporabljati.
English: If necessary, the dose of the anti-hyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Slovenian: Če je potrebno, je treba odmerek antihiperglikemičnega zdravila prilagoditi med zdravljenjem z drugim zdravilom in po njegovi prekinitvi.
English: - Swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.
Slovenian: otekanje obraza, ustnic, jezika in žrela, kar lahko povzroči težave pri dihanju ali požiranju.
English: If your doctor prescribes this medicine together with a sulphonylurea or insulin, remember to take this other medicine as directed by your doctor to achieve the best results for your health.
Slovenian: Če vam je zdravnik predpisal to zdravilo skupaj s sulfonilsečnino ali insulinom, ne pozabite vzeti tega drugega zdravila, kot vam je predpisal zdravnik, saj boste tako dosegli najboljše rezultate za vaše zdravje.
English: During treatment with this medicine, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.
Slovenian: Med zdravljenjem s tem zdravilom bo zdravnik vsaj enkrat letno preveril delovanje ledvic, če pa ste starejša oseba in/ali se vam delovanje ledvic slabša, pa še pogosteje.
English: Common • a metallic taste in your mouth.
Slovenian: Pogosti • kovinski okus v ustih.
English: Patients should be informed of the characteristic symptoms of acute pancreatitis; persistent, severe abdominal pain.
Slovenian: Bolniki morajo biti seznanjeni o značilnih simptomih akutnega pankreatitisa: vztrajna, huda bolečina v trebuhu.
English: Table 7 Primary and secondary clinical endpoints by treatment group in the SAVOR study*
Slovenian: Preglednica 7 Primarni in sekundarni klinični opazovani dogodki po terapevtski skupini v študiji SAVOR*
English: Combination requiring precautions for use
Slovenian: Kombinacija, ki zahteva previdnost
English: Komboglyze should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Slovenian: Zdravila Komboglyze se ne sme uporabljati pri bolnikih s sladkorno boleznijo tipa 1 ali za zdravljenje diabetične ketoacidoze.
English: A limited amount of data suggest the use of metformin in pregnant women is not associated with an increased risk of congenital malformations.
Slovenian: Maloštevilni podatki nakazujejo, da uporabe metformina pri nosečnicah ne spremlja večje tveganje za prirojene malformacije.
English: • decreased vitamin B12 levels
Slovenian: • zmanjšana koncentracija vitamina B12
English: These reactions were also identified in the pre-approval clinical trials, but do not meet the criteria for Table 2.
Slovenian: Ti učinki so bili prav tako ugotovljeni v kliničnih preskušanjih pred pridobitvijo dovoljenja za promet, vendar niso ustrezali kriterijem, podanim v Preglednici 2.
English: Primary endpoint was the proportion of patients reaching HbA1c < 7% without confirmed or severe hypoglycaemia.
Slovenian: Primarni opazovani dogodek je bil delež bolnikov, ki so dosegli HbA1c < 7 % brez potrjene ali hude hipoglikemije.
English: Use of DPP4 inhibitors has been associated with a risk of developing acute pancreatitis.
Slovenian: Uporaba zaviralcev DPP4 je bila povezana s tveganjem za pojav akutnega pankreatitisa.
English: • Tablet core: povidone K30, magnesium stearate.
Slovenian: • Jedro tablete: povidon K30, magnezijev stearat.
English: - For renal function with GFR levels approaching moderate renal impairment and in elderly patients, at least 2 to 4 times per year.
Slovenian: - V primeru delovanja ledvic z GFR, ki se približuje zmerni okvari ledvic, in pri starejših bolnikih, vsaj 2- do 4-krat na leto.
English: In in vitro studies, saxagliptin and its major metabolite neither inhibited CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A4, nor induced CYP1A2, 2B6, 2C9, or 3A4.
Slovenian: V študijah in vitro saksagliptin in njegov glavni presnovek nista ne zavrla CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 ali 3A4, ne inducirala CYP1A2, 2B6, 2C9 ali 3A4.
English: The following data are based on the findings in the studies with saxagliptin and metformin individually.
Slovenian: Naslednji podatki temeljijo na izsledkih študij s saksagliptinom in metforminom posamezno.
English: • in combination with other medicinal products for the treatment of diabetes, including insulin, in patients inadequately controlled with metformin and these medicinal products (see sections 4.4, 4.5 and 5.1 for available data on different combinations)
Slovenian: • v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni, vključno z insulinom, pri bolnikih, ki niso ustrezno urejeni z metforminom in temi zdravili (glejte poglavja 4.4, 4.5 in 5.1 za podatke, ki so na voljo o različnih kombinacijah);
English: If the patient wishes to become pregnant, or if a pregnancy occurs, treatment with this medicinal product should be discontinued and switched to insulin treatment as soon as possible.
Slovenian: Če bolnica želi zanositi ali če zanosi, je treba zdravljenje s tem zdravilom prekiniti in čim prej preiti na zdravljenje z insulinom.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Komboglyze in all subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom Komboglyze za vse skupine pediatrične populacije v povezavi s sladkorno boleznijo tipa 2 (glejte poglavje 4.2 za informacije o uporabi pri otrocih).
English: If you take more Komboglyze than you should If you take more Komboglyze tablets than you should, talk to a doctor or go to a hospital straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Komboglyze, kot bi smeli Če ste vzeli več tablet zdravila Komboglyze, kot bi smeli, se morate takoj posvetovati z zdravnikom ali oditi v bolnišnico.
English: The adverse reactions are listed by system organ class and absolute frequency.
Slovenian: Neželeni učinki so našteti po organskem sistemu in absolutni pogostnosti.
English: • Do not take a double dose of this medicine to make up for a forgotten dose.
Slovenian: • Ne vzemite dvojnega odmerka tega zdravila, če ste pozabili vzeti prejšnji odmerek.
English: If acidosis of either form occurs, this medicinal product must be stopped immediately and other appropriate corrective measures initiated.
Slovenian: Če se pojavi kakršna koli oblika acidoze, je treba zdravljenje s tem zdravilom nemudoma končati in uvesti ustrezne korektivne ukrepe.
English: The following statements reflect the pharmacokinetic properties of the individual active substances of Komboglyze.
Slovenian: Naslednje navedbe temeljijo na farmakokinetičnih lastnostih posameznih učinkovin zdravila Komboglyze.
English: Onset of symptoms following initiation of drug therapy may be rapid or may occur after longer periods of treatment.
Slovenian: Simptomi se lahko pojavijo hitro po uvedbi zdravila, lahko pa se pojavijo po daljšem obdobju zdravljenja.
English: What Komboglyze is and what it is used for
Slovenian: Kaj je zdravilo Komboglyze in za kaj ga uporabljamo
English: Along with diet and exercise, this helps lower your blood sugar.
Slovenian: Vse to - skupaj z dieto in telesno dejavnostjo - pomaga znižati krvni sladkor.
English: p-value = 0.0063 (between group comparisons significant at α = 0.05).
Slovenian: p-vrednost = 0,0063 (primerjava med skupinami je značilna pri α = 0,05).
English: Patients experienced relief of symptoms after discontinuation of the medicinal product and some experienced recurrence of symptoms with reintroduction of the same or another DPP4 inhibitor.
Slovenian: Bolnikom so simptomi po prenehanju jemanja zdravila izginili, nekaterim bolnikom pa so se simptomi znova pojavili po ponovni uvedbi istega ali drugega zaviralca DPP4.
English: * Intent-to-treat population
Slovenian: * Populacija z namenom zdravljenja
English: Follow the recommendations for skin and foot care that your doctor or nurse gave you.
Slovenian: Upoštevajte priporočila za nego kože in stopal, ki vam jih je dal zdravnik ali medicinska sestra.
English: No benefit was observed for MACE or all-cause mortality.
Slovenian: Ugotovili niso nobene koristi ne glede MACE ne glede umrljivosti zaradi vseh vzrokov.
English: If you have ever had heart failure or you have other risk factors for developing heart failure such as problems with your kidneys.
Slovenian: če ste kdaj imeli srčno popuščanje, ali imate kakšen drug dejavnik tveganja za pojav srčnega popuščanja, na primer težave z ledvicami.
English: • inflamed nose or throat such as with a cold or sore throat
Slovenian: • vnetje nosu ali žrela, npr. prehlad ali boleče žrelo
English: When driving or using machines, it should be taken into account that dizziness has been reported in studies with saxagliptin.
Slovenian: Pri vožnji ali upravljanju strojev je treba upoštevati, da je bila v študijah saksagliptina opisana omotica.