natgillin/translations-raw huggingface dataset:
The full EPAR for Invokana can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Invokana je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It is not intended to provide practical advice on how to use Invokana.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
What benefits of Invokana have been shown in studies?
Kakšne koristi je zdravilo Invokana izkazalo v študijah?
Invokana has been evaluated in 9 main studies involving a total of around 10,000 patients with type 2 diabetes.
Zdravilo Invokana so proučevali v 9 glavnih študijah, v katere so vključili skupno približno 10 000 bolnikov s sladkorno boleznijo tipa 2.
What is Invokana and what is it used for?
Kaj je zdravilo Invokana in za kaj se uporablja?
This is a summary of the European public assessment report (EPAR) for Invokana.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Invokana.
A risk management plan has been developed to ensure that Invokana is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Invokana je bil pripravljen načrt obvladovanja tveganj.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Invokana's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Invokana večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Invokana is available as tablets (100 and 300 mg) and can only be obtained with a prescription.
Zdravilo Invokana je na voljo v obliki tablet (100 in 300 mg) in se izdaja le na recept.
The recommended starting dose is 100 mg once a day.
Priporočeni začetni odmerek je 100 mg enkrat na dan.
What are the risks associated with Invokana?
Kakšna tveganja so povezana z zdravilom Invokana?
A study was also performed in patients with moderately reduced kidney function, and one in older patients aged between 55 and 80 years.
Izvedli so tudi študijo pri bolnikih z zmerno zmanjšanim delovanjem ledvic in študijo pri starejših bolnikih, starih od 55 do 80 let.
This leads to high levels of glucose in the blood.
Posledica so visoke ravni glukoze v krvi.
If appropriate, the dose can be increased to 300 mg once a day.
Po potrebi se lahko odmerek poveča na 300 mg enkrat na dan.
Regarding its safety, this was considered similar to other medicines of the same class (SGLT2 inhibitors).
Ugotovljeno je bilo tudi, da je varnost zdravila podobna kot pri drugih zdravilih iz iste skupine (zaviralcih SGLT2).
In patients with moderately reduced kidney function the dose should be limited to 100 mg once a day.
Pri bolnikih z zmerno zmanjšanim delovanjem ledvic je treba odmerek omejiti na 100 mg enkrat na dan.
Why is Invokana approved?
Zakaj je bilo zdravilo Invokana odobreno?
The most common side effects with Invokana are hypoglycaemia (low blood glucose levels) when used together with insulin or a sulphonylurea, vulvovaginal candidiasis (thrush, a fungal infection of the female genital area caused by Candida) urinary tract infection (infection of the structure that carries the urine) and polyuria (abnormally large production of urine) or pollakiuria (abnormally frequent urination).
Najpogostejši neželeni učinki zdravila Invokana so hipoglikemija (nizke ravni glukoze v krvi), kadar se uporablja skupaj z insulinom ali sulfonilsečnino, vulvovaginalna kandidoza (glivice oziroma glivična okužba ženskih spolovil, ki jo povzroča Candida), okužba sečil (okužba struktur za odvajanje urina) in poliurija (nastajanje neobičajno velikih količin urina) ali polakisurija (neobičajno pogosto uriniranje).
For more information about treatment with Invokana, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Invokana preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Invokana, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Invokana in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
The use of Invokana is therefore not recommended in patients with severely reduced kidney function.
Zdravila Invokana zato ni priporočljivo uporabljati pri bolnikih z močno zmanjšanim delovanjem ledvic.
Important side effects identified included dehydration and urinary tract infection, but these were considered to be manageable.
Med pomembnimi opaženimi neželenimi učinki sta bili dehidracija in okužba sečil, ki pa sta obvladljivi.
For the full list of all side effects reported with Invokana, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Invokana, glejte navodilo za uporabo.
For practical information about using Invokana, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Invokana naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Invokana treatment also led to weight loss and reductions in blood pressure, effects that are considered beneficial in patients with diabetes.
Pri zdravljenju z zdravilom Invokana so opazili tudi zmanjšanje telesne mase in znižanje krvnega tlaka, kar sta koristna učinka za bolnike s sladkorno boleznijo.
Type-2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Sladkorna bolezen tipa 2 je bolezen, pri kateri v trebušni slinavki ne nastaja dovolj insulina za uravnavanje ravni glukoze v krvi ali pri kateri telo ne more učinkovito izkoristiti insulina.
As the effects of Invokana are dependent on kidney function, the effectiveness and tolerability of the medicine are reduced in patients with reduced kidney function.
Ker so učinki zdravila Invokana odvisni od delovanja ledvic, sta pri bolnikih z zmanjšanim delovanjem ledvic učinkovitost zdravila in prenašanje zdravila zmanjšana.
SGLT2 is a protein that absorbs glucose from the urine back into the bloodstream as the blood is filtered in the kidneys.
SGLT2 je beljakovina, ki absorbira glukozo iz urina nazaj v krvni obtok, medtem ko se kri filtrira v ledvicah.
The CHMP concluded that Invokana was shown to be effective at controlling blood glucose levels.
CHMP je menil, da je bilo dokazano, da je zdravilo Invokana učinkovito pri uravnavanju ravni glukoze v krvi.
It is used in adults with type 2 diabetes to control their blood glucose (sugar) level.
Uporablja se pri odraslih s sladkorno boleznijo tipa 2 za uravnavanje ravni glukoze (sladkorja) v krvi.
In all of the studies, the main measure of effectiveness was the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
V vseh omenjenih študijah je bila glavno merilo učinkovitosti raven glikoziliranega hemoglobina v krvi (HbA1c), ki odraža uspešnost uravnavanja glukoze v krvi.
Invokana is a diabetes medicine that contains the active substance canagliflozin.
Invokana je zdravilo za zdravljenje sladkorne bolezni, ki vsebuje zdravilno učinkovino kanagliflozin.
• Invokana was also shown to be at least as effective as the diabetes medicines glimepiride and sitagliptin after 52 weeks of treatment.
• zdravilo Invokana je bilo po 52 tednih zdravljenja vsaj tako učinkovito kot zdravili za zdravljenje sladkorne bolezni glimepirid in sitagliptin;
Invokana was shown to be more effective than placebo, and at least as effective as comparator medicines, at reducing the levels of HbA1c when used alone and in combination with other diabetes medicines:
Zdravilo Invokana se je pri znižanju ravni HbA1c izkazalo za učinkovitejše od placeba in vsaj tako učinkovito kot primerjalna zdravila, kadar so ga uporabili kot samostojno zdravilo ali v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni:
Invokana can also be used as an ‘add-on' to other diabetes medicines, including insulin, when these medicines together with exercise and diet are not providing adequate control of the diabetes.
Zdravilo Invokana se lahko uporablja tudi kot dodatek k drugim zdravilom za zdravljenje sladkorne bolezni, vključno z insulinom, kadar ta zdravila skupaj s telesno dejavnostjo in dieto ne zagotavljajo zadostnega nadzora nad sladkorno boleznijo.
Three studies looked at Invokana when used as add-on to one other diabetes medicine (metformin or insulin), and three further studies looked at Invokana when used as add-on to two other diabetes medicines (including metformin), when these medicines together with exercise and diet were not providing adequate control of the diabetes.
V treh študijah so proučevali zdravilo Invokana, uporabljeno kot dodatek k drugemu zdravilu za sladkorno bolezen (metforminu ali insulinu), v preostalih treh študijah pa so proučevali zdravilo Invokana, uporabljeno kot dodatek k dvema drugima zdraviloma za sladkorno bolezen (vključno z metforminom) pri bolnikih, pri katerih ta zdravila skupaj s telesno dejavnostjo in dieto niso zagotovila zadostne urejenosti sladkorne bolezni.
The active substance in Invokana, canagliflozin, works by blocking a protein in the kidneys called sodium‑glucose co‑transporter 2 (SGLT2).
Zdravilna učinkovina v zdravilu Invokana, kanagliflozin, deluje tako, da zavira beljakovino v ledvicah, imenovano natrijev glukozni koprenašalec 2 (SGLT2).
How is Invokana used?
Kako se zdravilo Invokana uporablja?
Invokana can be used on its own in patients whose blood glucose levels are not satisfactorily controlled on diet and exercise alone and who cannot take metformin (another diabetes medicine).
Zdravilo Invokana se lahko uporablja kot samostojno zdravilo pri bolnikih, pri katerih ravni glukoze v krvi ni mogoče zadovoljivo uravnavati samo z dieto in telesno dejavnostjo, metformin (drugo zdravilo za sladkorno bolezen) pa zanje ni primeren.
One of the studies compared Invokana with placebo (a dummy treatment) when used alone in patients whose blood glucose levels were not satisfactorily controlled on diet and exercise alone.
V eni od študij so primerjali zdravilo Invokana in placebo (zdravilo brez zdravilne učinkovine), ki so ju kot samostojni zdravili dajali bolnikom, pri katerih ravni glukoze v krvi ni bilo mogoče zadovoljivo uravnavati samo z dieto in telesno dejavnostjo.
By blocking the action of SGLT2, Invokana causes more glucose to be removed via the urine, thereby reducing the levels of glucose in the blood.
Zdravilo Invokana z zaviranjem delovanja prenašalca SGLT2 povzroči večje izločanje glukoze z urinom, kar zniža ravni glukoze v krvi.
• The study in patients with moderately reduced kidney function showed that the effects of Invokana were reduced in these patients, but still clinically relevant: the reduction of HbA1c levels compared with placebo was 0.30% with the 100 mg dose.
• študija pri bolnikih z zmerno zmanjšanim delovanjem ledvic je pokazala, da je bila učinkovitost zdravila Invokana pri teh bolnikih manjša, vendar še vedno klinično pomembna: pri uporabi 100-miligramskega odmerka so se ravni HbA1c znižale za 0,30 % več kot pri placebu;
• Across the studies that looked at Invokana when used as add-on to one or two other diabetes medicines, the reductions in HbA1c levels after 26 weeks compared with placebo ranged from 0.76% to 0.92% with the 300 mg dose, and from 0.62% to 0.74% with the 100 mg dose.
• v študijah, v katerih so proučevali zdravilo Invokana, uporabljeno kot dodatek k enemu ali dvema drugima zdraviloma za zdravljenje sladkorne bolezni, so se po 26 tednih ravni HbA1c v primerjavi s placebom znižale za 0,76 % do 0,92 % pri 300-miligramskem odmerku in za 0,62 % do 0,74 % pri 100-miligramskem odmerku;
• The study in older patients showed that Invokana had clinically relevant effects also in patients above 75 years of age with HbA1c reductions compared with placebo of 0.70% and 0.57% with the 300 mg and 100 mg doses, respectively.
• študija pri starejših bolnikih je pokazala, da je imelo zdravilo Invokana klinično pomembne učinke tudi pri bolnikih, starejših od 75 let, pri katerih so se ravni HbA1c v primerjavi s placebom znižale za 0,70 % pri 300-miligramskem odmerku in za 0,57 % pri 100-miligramskem odmerku.
• When Invokana was used on its own at a dose of 100 mg, it decreased HbA1c levels by 0.91% more than placebo after 26 weeks, while the 300 mg dose led to a reduction of 1.16% more than placebo.
• pri uporabi 100-miligramskega odmerka zdravila Invokana v monoterapiji so se po 26 tednih ravni HbA1c znižale za 0,91 % več kot pri placebu, pri uporabi 300-miligramskega odmerka pa za 1,16 % več kot pri placebu;
• When Invokana was used as add-on to insulin at a dose of 300 mg, it decreased HbA1c levels by 0.73% more than placebo after 18 weeks, while the 100 mg dose led to a reduction of 0.65% more than placebo.
• pri uporabi 300-miligramskega odmerka zdravila Invokana kot dodatka k insulinu so se po 18 tednih ravni HbA1c znižale za 0,73 % več kot pri placebu, pri uporabi 100-miligramskega odmerka pa za 0,65 % več kot pri placebu;
How does Invokana work?
Kako zdravilo Invokana deluje?
Intravenous use vial (glass) closed by a Teflon faced grey chlorobutyl rubber stopper
Izmišljeno ime Jakost Farmacevtska oblika Pot uporabe Stična ovojnina Vsebina Velikost pakiranja viala (steklo) zaprta z zamaškom iz sive klorbutilne gume prevlečene s teflonom viala (steklo) zaprta z neprevlečenim sivim brombutilnim gumijastim zamaškom
EU (MA) Number Invented name
Številka (EU) dovoljenja za promet
July 2014; 109(7):950-66.
Julij 2014; 109(7): 950-66.
More frequent monitoring than monthly is not considered practically feasible.
Pogostejše spremljanje kot enkrat na mesec ni praktično izvedljivo.
Lancet, 27 January 2001; 357(9252):293-8.
Lancet, 27. januar 2001; 357(9252): 293-8.
Of note, menopause constitutes a natural end to the need for treatment.
Omeniti je treba, da menopavza predstavlja naraven konec potrebe po zdravljenju.
The PRAC also considered the views expressed by experts at an ad hoc expert group meeting.
Odbor PRAC je upošteval tudi stališča, ki so jih izrazili strokovnjaki na sestanku ad hoc skupine strokovnjakov;
The PRAC was also of the view that the reported cases of liver injury should be closely monitored; to this effect a targeted follow up questionnaire has been included in a revised risk management plan (RMP).
Odbor PRAC je tudi menil, da je treba prijavljene primere poškodbe jeter natančno spremljati; v ta namen je bil v revidirani načrt za obvladovanje tveganja (RMP) vključen ciljni vprašalnik za spremljanje.
On 30 November 2017, the European Commission triggered a procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of Esmya and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Evropska komisija je zato 30. novembra 2017 na podlagi farmakovigilančnih podatkov sprožila postopek v skladu s členom 20 Uredbe (ES) št. 726/2004 in odbor PRAC zaprosila, naj oceni vpliv zgornjih pomislekov na razmerje med tveganji in koristmi zdravila Esmya ter izda priporočilo o tem, ali naj se zadevna dovoljenja za promet z zdravilom ohranijo, spremenijo, umaknejo ali razveljavijo.
Uterine fibroids are the single most common indication for hysterectomy1.
Maternični fibroidi so najpogostejša indikacija za histerektomijo1.
The views expressed by ad-hoc experts consulted during the course of the procedure were also considered.
Upoštevana so bila tudi stališča ad hoc strokovnjakov, s katerimi so bila med postopkom opravljena posvetovanja.
Hysterectomy is a very common curative surgical procedure within gynaecology associated with a low mortality (mortality figures quoted range from 0.02% to 0.17%) and a low risk of intra- or postoperative complications (quoted from 5% to 8%).
Histerektomija je zelo pogost kurativni kirurški poseg v ginekologiji, povezan z nizko stopnjo umrljivosti (navedene stopnje umrljivosti segajo od 0,02 do 0,17 %) in majhnim tveganjem za med- ali pooperacijske zaplete (navedene stopnje segajo od 5 do 8 %).
Other surgical treatments such as myomectomy and uterine artery embolisation are also valid alternatives to hysterectomy, but they are not suitable for all cases and are also associated with a higher rate for complications than hysterectomy.
Druge vrste kirurškega zdravljenja, npr. miomektomija in embolizacija maternične arterije, so prav tako ustrezne alternative histerektomiji, vendar niso primerne za vse primere in so tudi povezane z višjo stopnjo zapletov kot histerektomija.
Guidance on treatment initiation and discontinuation based on the results of these tests are included in the product information.
Navodila o uvedbi in prenehanja zdravljenja na podlagi rezultatov teh preiskav so vključena v informacije o zdravilu.
Acknowledging the uncertainty regarding background incidence and the information in the reported cases, the seriousness of the reported cases raises concern.
Ob priznavanju nejasnosti o osnovni incidenci in informacij v primerih, o katerih so poročali, resnost prijavljenih primerov vzbuja zaskrbljenost.
• The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for Esmya (ulipristal acetate).
• odbor PRAC je obravnaval postopek v skladu s členom 20 Uredbe (ES) št. 726/2004, ki je bil na podlagi farmakovigilančnih podatkov sprožen za zdravilo Esmya (ulipristalacetat);
However, it is recognised that a surgical treatment is not suitable for all women, due to their medical history, co-morbidities or willingness to preserve fertility.
Priznava pa se, da kirurško zdravljenje ni primerno za vse ženske, in sicer zaradi njihove anamneze, soobolenj ali želje po ohranitvi plodnosti.
The MAH should implement these questionnaires and their results should be discussed in future periodic safety update reports (PSURs).
Imetnik dovoljenja za promet z zdravilom mora uvesti te vprašalnike, o njihovih rezultatih pa je treba razpravljati v prihodnjih redno posodobljenih poročilih o varnosti zdravila (PSUR).
In addition, the existing physician's guide to prescribing should be updated accordingly.
Poleg tega je treba ustrezno posodobiti obstoječa navodila o predpisovanju za zdravnike;
This last indication was authorised based on results from another study providing data for up to 4 intermittent treatment courses of 3 months each with ulipristal acetate along with data for repeated treatment courses from the previous studies.
Ta zadnja indikacija je bila odobrena na podlagi rezultatov druge študije, ki je zagotovila podatke za do štiri trimesečna intermitentna zdravljenja z ulipristalacetatom, ter podatkov o večkratnih zdravljenjih iz prejšnjih študij.
However, there is sufficient information from these cases to conclude that there is at least a reasonable possibility that Esmya may infrequently contribute to hepatic injury.
Informacije, pridobljene v teh primerih, pa zadostujejo za zaključek, da obstaja vsaj razumna možnost, da lahko zdravilo Esmya redko prispeva k poškodbi jeter.
This is the rationale that justifies the mandatory liver monitoring within the first 2 treatment courses, while during later courses, monitoring is recommended as clinically indicated.
To je razlog, ki utemeljuje obvezno spremljanje delovanja jeter pri prvih dveh ciklusih zdravljenja, pri poznejših ciklusih pa se spremljanje priporoča v skladu s kliničnimi indikacijami.
The available data raise serious concerns, and warrant risk minimisation measures to be taken.
Razpoložljivi podatki vzbujajo resne pomisleke in zahtevajo sprejetje ukrepov za zmanjševanje tveganja.
Given the estimated exposure to Esmya of approximately 200,000 to 275,000 patient-years, the number of cases of serious liver injury leading to liver transplantation appears higher than expected, although background incidence on drug induced liver injury is uncertain.
Glede na ocenjeno izpostavljenost zdravilu Esmya približno od 200 000 do 275 000 bolnikovih let se zdi število primerov resne poškodbe jeter, ki je privedla do presaditve jeter, večje od pričakovanega, čeprav je osnovna incidenca z zdravili povzročene poškodbe jeter nejasna.
The existing educational material (physician's guide) should also be updated with these recommendations, and the issuing of a Direct Healthcare Professional Communication (DHPC) is also considered appropriate, to inform healthcare professionals of the recommendations of the present review.
Ta priporočila je treba vključiti tudi v obstoječe izobraževalno gradivo (navodila za zdravnike), smiselna pa je tudi izdaja neposrednega obvestila za zdravstvene delavce (DHPC), da bi zdravstvene delavce seznanili s priporočili tega pregleda.
Data from clinical trials, non-clinical studies including in vitro testing were also reviewed.
Pregledani so bili tudi podatki iz kliničnih preskušanj in nekliničnih študij, vključno s preskušanjem in vitro.
Although uterine fibroids are benign, moderate to severe forms are often associated with significant morbidity, such as heavy bleeding, anaemia, pain, discomfort and reduced quality of life.
Čeprav so benigni, so zmerne do hude oblike pogosto povezane s pomembno obolevnostjo, npr. hudimi krvavitvami, anemijo, bolečinami, neugodjem in zmanjšano kakovostjo življenja.
However, due to exclusion criteria covering patients with elevated transaminases, or other signs of liver disease, as well as the limited size of the safety database in these studies, the absence of findings in clinical trials has to be interpreted with caution.
Vendar je treba zaradi izključitvenih meril, na podlagi katerih so bile izključene bolnice z zvišanimi ravnmi transaminaz ali drugimi znaki bolezni jeter, ter omejene velikosti zbirke podatkov o varnosti pri teh študijah odsotnost ugotovitev v kliničnih preskušanjih razlagati pravilno.
The pre-operative treatment may be considered of least benefit as it reflects a situation when surgery is planned; however reductions in myoma size as well as reductions in blood loss and anaemia are considered of clinical significance.
Predoperacijsko zdravljenje se lahko šteje za najmanj koristno, saj izraža situacijo, ko je operacija načrtovana; zmanjšanje velikosti miomov, manjša izguba krvi in znižanje stopnje anemije pa se štejejo za klinično pomembne.
Taking into account the experts' views on the topic, and after a thorough review of the available data, PRAC considered that the following risk minimisation measures should be recommended.
Ob upoštevanju stališča strokovnjakov o tej temi in temeljitem pregledu razpoložljivih podatkov je odbor PRAC presodil, da je treba priporočiti naslednje ukrepe za zmanjševanje tveganja.
• The PRAC was also of the opinion that mechanistic studies should be conducted, to further investigate a possible mechanism for hepatic toxicity.
• odbor PRAC je menil tudi, da je treba opraviti mehanistične študije za nadaljnjo proučitev mogočega mehanizma hepatotoksičnosti.
The PRAC considers it appropriate to also monitor liver function 2 to 4 weeks after the treatment has stopped, since for some of the reported cases, liver injury was reported a few weeks after the discontinuation of the treatment.
Odbor PRAC meni, da je delovanje jeter smiselno preveriti tudi po dveh do štirih tednih po koncu zdravljenja, saj je bila pri nekaterih prijavljenih primerih poškodba jeter prijavljena nekaj tednov po prenehanju zdravljenja.
Treatment should be stopped in patients showing signs or symptoms compatible with liver injury and the patient should be investigated immediately.
Zdravljenje je treba prekiniti pri vseh bolnicah, pri katerih se pokažejo znaki ali simptomi, skladni s poškodbo jeter, bolnico pa je treba takoj preiskati;