FrancophonIA/ELRC3.0 huggingface dataset:
English: At one year, 83.5 % (p= 0.006) of patients receiving ibandronic acid 150 mg once monthly and 73.9 % of patients receiving ibandronic acid 2.5 mg daily were identified as responders (defined as a decrease ≥50% from baseline).
Slovenian: Po enem letu je bilo odzivnih 83,5 % bolnikov (p = 0,006), ki so prejemali 150 mg ibandronske kisline enkrat mesečno, in 73,9 % bolnikov, ki so jemali 2,5 mg ibandronske kisline dnevno
English: Therefore, Ibandronic Acid Teva should not be used during pregnancy.
Slovenian: Zato se zdravila Ibandronska kislina Teva med nosečnostjo ne sme uporabljati.
English: There is no evidence for clinically relevant interethnic differences between Asians and Caucasians in ibandronic acid disposition.
Slovenian: O klinično pomembnih medetničnih razlikah v biološki uporabnosti ibandronske kisline med Azijci in
English: In particular, products containing calcium, including milk and other multivalent cations (such as aluminium, magnesium, iron), are likely to interfere with absorption of Ibandronic Acid Teva, which is consistent with findings in animal studies.
Slovenian: Zlasti pripravki, ki vsebujejo kalcij, vključno z mlekom in druge večvalentne katione (kot so aluminij, magnezij, železo), vključno z mlekom, lahko vplivajo na absorpcijo zdravila Ibandronska kislina
English: Osteonecrosis of the jaw
Slovenian: Osteonekroza čeljustnic
English: Cases of ONJ have been reported in the post-marketing setting for ibandronic acid.
Slovenian: Pri zdravljenju z ibandronsko kislino so poročali o primerih osteonekroze čeljustnic v obdobju po prihodu zdravila na trg.
English: A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported very rarely in the post-marketing setting in patients receiving Ibandronic Acid Teva for osteoporosis.
Slovenian: Pri bolnikih, ki so prejemali zdravilo Ibandronska kislina Teva za zdravljenje osteoporoze, so v obdobju po prihodu zdravila na trg zelo redko poročali o neželenem učinku, imenovanem osteonekroza čeljustnic (poškodba kosti v čeljusti).
English: No dose adjustment is necessary for patients with mild or moderate renal impairment where creatinine clearance is equal or greater than 30 ml/min.
Slovenian: Za bolnike z blago ali zmerno okvaro ledvic (očistek kreatinina (CLcr) enak ali večji kot 30 ml/min)
English: There is no meaningful reduction in bioavailability provided ibandronic acid is taken 60 minutes before the first food of the day.
Slovenian: Če vzamemo ibandronsko kislino 60 minut pred prvim obrokom, biološka uporabnost ni pomembno zmanjšana.
English: • The active substance is ibandronic acid.
Slovenian: - Zdravilna učinkovina je ibandronska kislina.
English: Ibandronic Acid Teva 150 mg film-coated tablets Ibandronic acid
Slovenian: Ibandronska kislina Teva 150 mg filmsko obložene tablete ibandronska kislina
English: Ibandronic acid 150 mg once monthly (N=291)
Slovenian: ibandronska kislina 150 mg enkrat mesečno (n =
English: Ibandronic Acid Teva 50 mg film-coated tablets ibandronic acid
Slovenian: Ibandronska kislina Teva 50 mg filmsko obložene tablete ibandronska kislina
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 50 mg ibandronic acid (as sodium monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 50 mg ibandronske kisline (v obliki natrijevega monohidrata).
English: There is no meaningful reduction in bioavailability provided ibandronic acid is taken 60 minutes before a meal.
Slovenian: Če se ibandronska kislina vzame 60 minut pred obrokom, biološka uporabnost ni pomembno zmanjšana.
English: Milk or antacids should be given to bind Ibandronic Acid Teva.
Slovenian: Za vezavo zdravila Ibandronska kislina Teva je treba zaužiti mleko ali antacide.
English: What Ibandronic Acid Teva looks like and contents of the pack The Ibandronic Acid Teva film-coated tablets are white, biconvex, capsule-shaped, engraved “50” on one side and plain on the other.
Slovenian: Ibandronska kislina Teva filmsko obložene tablete so bele, bikonveksne, v obliki kapsul, z vtisnjeno oznako »50« na eni strani in gladke na drugi.
English: Ibandronic Acid Teva should not be used during breast-feeding.
Slovenian: Ibandronska kislina Teva se ne sme uporabljati med dojenjem.
English: Osteonecrosis of the jaw (ONJ) has been reported very rarely in the post-marketing setting in patients receiving Ibandronic Acid Teva for osteoporosis (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali zdravilo Ibandronska kislina Teva za zdravljenje osteoporoze, so v obdobju po prihodu zdravila na trg zelo redko poročali o osteonekrozi čeljustnic (glejte poglavje 4.8).
English: INFORMATION IN BRAILLE Ibandronic Acid Teva 150 mg film-coated tablets
Slovenian: PODATKI V BRAILLOVI PISAVI Ibandronska kislina Teva 150 mg filmsko obložene tablete
English: INFORMATION IN BRAILLE Ibandronic Acid Teva 50 mg film-coated tablets
Slovenian: PODATKI V BRAILLOVI PISAVI Ibandronska kislina Teva 50 mg filmsko obložene tablete
English: Other things that can increase the risk of fractures include: - not enough calcium and vitamin D in the diet, - smoking, or drinking too much alcohol, - not enough walking or other weight-bearing exercise, - a family history of osteoporosis.
Slovenian: Drugi dejavniki, ki lahko povečajo tveganje za zlome, so: - premajhen vnos kalcija in vitamina D s hrano,
English: There was no evidence for a direct foetal toxic or teratogenic effect of ibandronic acid in orally treated rats and rabbits and there were no adverse effects on the development in F1 offspring in rats at an extrapolated exposure of at least 35 times above human exposure.
Slovenian: Pri ekstrapolaciji izpostavljenosti, ki je 35-krat presegala izpostavljenost pri ljudeh, niso opazili škodljivih vplivov na razvoj podganjih potomcev F1.
English: Ocular inflammation*†
Slovenian: Očesne bolezni očesno vnetje*†
English: NAME OF THE MEDICINAL PRODUCT Ibandronic Acid Teva 50 mg film-coated tablets
Slovenian: IME ZDRAVILA Ibandronska kislina Teva 50 mg filmsko obložene tablete
English: Ibandronic acid is a highly potent bisphosphonate belonging to the nitrogen-containing group of bisphosphonates, which act selectively on bone tissue and specifically inhibit osteoclast activity without directly affecting bone formation.
Slovenian: Ti selektivno delujejo na kostno tkivo in specifično zavirajo osteoklastno aktivnost brez neposrednega vpliva na proces tvorbe kosti.
English: Azotaemia (uraemia)
Slovenian: Bolezni sečil azotemija (uremija)
English: Ocular inflammation events such as uveitis, episcleritis and scleritis have been reported with ibandronic acid.
Slovenian: Vnetje oči Pri zdravljenju z difosfonati, vključno z ibandronsko kislino, so poročali o vnetnih stanjih oči, kot so uveitis, episkleritis, skleritis.
English: Calcium supplements, antacids and some oral medicinal products containing multivalent cations (such as aluminium, magnesium, iron) are likely to interfere with the absorption of Ibandronic Acid Teva.
Slovenian: Dodatki kalcija, antacidi in nekatera peroralna zdravila, ki vsebujejo večvalentne katione Dodatki kalcija, antacidi in nekatera peroralna zdravila, ki vsebujejo večvalentne katione (kot so aluminij, magnezij, železo), lahko vplivajo na absorpcijo zdravila Ibandronska kislina Teva, zato bolniki najmanj 6 ur pred zaužitjem zdravila Ibandronska kislina Teva in še eno uro po njem ne smejo jemati drugih peroralnih zdravil.
English: On the basis of the pharmacodynamic and pharmacokinetic profile and reported adverse reactions, it is expected that Ibandronic Acid Teva has no or negligible influence on the ability to drive and use machines.
Slovenian: da zdravilo Ibandronska kislina Teva nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Ocular inflammation†
Slovenian: Očesne bolezni očesno vnetje†*
English: Ibandronic Acid Teva belongs to a group of medicines called bisphosphonates.
Slovenian: Kaj je zdravilo Ibandronska kislina Teva in za kaj ga uporabljamo Ibandronska kislina Teva spada v skupino zdravil, ki jih imenujemo difosfonati.
English: Before receiving treatment, tell your doctor/nurse (health care professional) if: - you have any problems with your mouth or teeth such as poor dental health, gum disease or a planned tooth extraction.
Slovenian: Pred zdravljenjem obvestite zdravnika/medicinsko sestro (zdravstvenega delavca), če: - imate težave v ustih ali z zobmi, kot so slabo zdravstveno stanje zobovja, bolezni dlesni ali načrtujete izdrtje zoba; - nimate redne zobozdravstvene oskrbe ali že dolgo niste bili na pregledu pri zobozdravniku; - ste kadilec (ker lahko kajenje poveča tveganje za težave z zobovjem); - ste se že zdravili z difosfonati (ki se uporabljajo za zdravljenje ali preprečevanje bolezni kosti); - jemljete zdravila, imenovana kortikosteroidi (kot sta prednizolon ali deksametazon); - imate raka.
English: NAME OF THE MEDICINAL PRODUCT Ibandronic Acid Teva 150 mg film-coated tablets
Slovenian: IME ZDRAVILA Ibandronska kislinaTeva 150 mg filmsko obložene tablete
English: For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) a dosage adjustment to one
Slovenian: Pri bolnikih z blago ledvično okvaro (CLcr ≥ 50 in < 80 ml/min) prilagajanje odmerka ni potrebno.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično skeletnega sistema in vezivnega tkiva artralgija, mialgija,
English: Do not take Ibandronic Acid Teva
Slovenian: Zdravila Ibandronska kislina Teva ne smete jemati:
English: Do not take Ibandronic Acid Teva with food.
Slovenian: Zdravilo Ibandronska kislina Teva skupaj s hrano in pijačo Ne jemljite zdravila Ibandronska kislina Teva skupaj s hrano.
English: BMD - mean change relative to baseline lumbar spine at year 3 BMD - mean change relative to baseline total hip at year 3
Slovenian: MKG - povprečna sprememba glede na izhodiščno vrednost za ledveno hrbtenico po treh letih
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN
English: At two years 93.4 % (p<0.001) of patients receiving ibandronic acid 150 mg once monthly and 78.4 %, of patients receiving ibandronic acid 2.5 mg daily had total hip BMD increases above or equal to baseline.
Slovenian: Po dveh letih se je MKG kolka povišala ali ostala enaka izhodiščni vrednosti pri 93,4 % bolnikov (p < 0,001), ki so prejemali 150 mg ibandronske kisline enkrat mesečno, in 78,4 % bolnikov, ki so prejemali 2,5 mg ibandronske kisline dnevno.
English: (see sections 5.1 and 5.2).
Slovenian: Pediatrična populacija (glejte poglavji 4.2 in 5.2)
English: Keep taking Ibandronic Acid Teva for as long as your doctor tells you.
Slovenian: Zdravilo Ibandronska kislina Teva jemljite, dokler vam je to naročil zdravnik, ker deluje samo, če ga jemljemo redno.
English: Your doctor may do regular blood tests while you are taking Ibandronic Acid Teva.
Slovenian: Med zdravljenjem z zdravilom Ibandronska kislina Teva bo zdravnik verjetno naredil običajne preiskave krvi, da bo preveril, če prejemate pravi odmerek zdravila.
English: 50 mg film-coated tablet every second day is recommended (see section 5.2).
Slovenian: Pri bolnikih z zmerno ledvično okvaro (CLcr ≥ 30 in < 50 ml/min) se priporoča zmanjšanje odmerka na eno 50 mg filmsko obloženo tableto vsak drugi dan (glejte poglavje 5.2).
English: 84 film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA filmsko obložena tableta 28 filmsko obloženih tablet 84 filmsko obloženih tablet
English: Angioedema, Face oedema, Urticaria
Slovenian: Bolezni kože in podkožja izpuščaj angioedem, edem obraza, urtikarija
English: Musculoskele tal and connective tissue disorders
Slovenian: Bolezni mišično skeletnega sistema in vezivnega tkiva atipični subtrohanterni zlomi stegnenice in zlomi diafize stegnenice†
English: Reproductive toxicity
Slovenian: Vpliv na sposobnost razmnoževanja
English: Influenza like illness*
Slovenian: Splošne težave in spremembe na mestu aplikacije bolezen, podobna gripi*
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA
English: Adverse experiences such as oesophagitis, oesophageal ulcers and oesophageal erosions, in some cases severe and requiring hospitalization, rarely with bleeding or followed by oesophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates.
Slovenian: Pri bolnikih, ki so prejemali peroralne difosfonate, so poročali o neželenih učinkih, kot so ezofagitis ter razjede in erozije na požiralniku, ki so bili v nekaterih primerih hudi in so zahtevali hospitalizacijo.
English: Furthermore, ibandronic acid 150 mg once monthly was proven superior to ibandronic acid 2.5 mg daily for increases in lumbar spine BMD in a prospectively planned analysis at one year, p=0.002, and at two years, p<0.001.
Slovenian: V prospektivno načrtovani analizi po enem letu, p = 0,002, in dveh letih, p < 0,001 se je ibandronska kislina v odmerku 150 mg enkrat mesečno izkazala za bolj učinkovito od ibandronske kisline v odmerku 2,5 mg dnevno, kar se tiče povišanja MKG ledvene hrbtenice.
English: Biochemical markers of bone turn-over
Slovenian: incidenca novih zlomov vretenc
English: Rash
Slovenian: Čet
English: NAME OF THE MEDICINAL PRODUCT Ibandronic Acid Teva 150 mg film-coated tablets ibandronic acid
Slovenian: Navodilo za uporabo Ibandronska kislina Teva 150 mg filmsko obložene tablete ibandronska kislina
English: Adverse reactions such as oesophagitis, oesophageal ulcers and oesophageal erosions, in some cases severe and requiring hospitalisation, rarely with bleeding or followed by oesophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates.
Slovenian: odinofagija, retrosternalna bolečina ali novonastala ali poslabšana zgaga, prekinejo zdravljenje z zdravilom Ibandronska kislina Teva in poiščejo zdravniško pomoč.
English: • Keep this leaflet.
Slovenian: *Za nadaljnje informacije glejte spodnje besedilo.
English: It does not interfere with osteoclast recruitment.
Slovenian: Ibandronska kislina ne vpliva na zbiranje osteoklastov.
English: Ibandronic acid 2.5 mg daily (N=294)
Slovenian: ibandronska kislina 2,5 mg dnevno (n =
English: Medicinal product-Food Interactions
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: [dead bone tissue] in the jaw bone)
Slovenian: (nekroza [odmrtje kostnega tkiva] čeljustnice);
English: Back pain
Slovenian: Pet Sob Ned
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 for the products listed in Annex A;
Slovenian: • odbor PRAC je obravnaval postopek v skladu s členom 20 Uredbe (ES) št. 726/2004 za zdravila, navedena v Prilogi A;
English: All RMPs should be updated accordingly via an appropriate variation to be submitted no later than one month of the European Commission decision;
Slovenian: Vse načrte za obvladovanje tveganja je treba ustrezno posodobiti prek ustrezne vloge za spremembo, ki jo je treba predložiti najpozneje en mesec po sklepu Evropske komisije;
English: Hence, it is currently not possible to establish whether the increased amputation risk is a class effect or not.
Slovenian: Zato trenutno ni mogoče ugotoviti, ali je povečano tveganje za amputacijo učinek razreda zdravil ali ne.
English: The mechanism of action that would allow understanding which patients are at risk is therefore still unclear.
Slovenian: Mehanizem delovanja, ki bi omogočil razumevanje, kateri bolniki so ogroženi, torej še ni jasen.
English: • The PRAC therefore considered that the risk may constitute a possible class effect;
Slovenian: • odbor PRAC je zato menil, da je tveganje morda morebiten učinek razreda zdravil;
English: Consequently, the EC requested on 6 July 2016 to extend the current procedure to include all of the authorised products of the class of SGLT2 inhibitors.
Slovenian: Zato je Evropska komisija dne 6. julija 2016 zahtevala podaljšanje trenutnega postopka in vanj vključila vsa odobrena zdravila iz razreda zaviralcev SGLT2.
English: The CANVAS and CANVAS-R studies and the CREDENCE and DECLARE Studies are planned to be completed in 2017 and 2020, respectively.
Slovenian: V skladu z načrti bosta študiji CANVAS in CANVAS-R zaključeni leta 2017, študiji CREDENCE in DECLARE pa leta 2020.
English: • The PRAC was also of the opinion that a mechanism of action, allowing to understand which patients are at risk, is still unclear;
Slovenian: • odbor PRAC je prav tako menil, da mehanizem delovanja, ki bi omogočil razumevanje, kateri bolniki so ogroženi, še ni jasen;
English: In addition, an analysis of the ongoing renal study CANVAS-R with a similar population as CANVAS showed a numerical imbalance with regards to amputation events.
Slovenian: Poleg tega je analiza potekajoče ledvične študije CANVAS-R, ki vključuje podobno populacijo kot študija CANVAS, pokazala številčno neravnovesje v zvezi z amputacijami.
English: • Because no specific risk factors could be identified apart from general amputation risk factors potentially contributing to the events, the PRAC recommended that patients should be advised on routine preventative foot care and maintaining adequate hydration as a general advice to prevent amputation;
Slovenian: • ker poleg splošnih dejavnikov tveganja za amputacijo ni bilo mogoče določiti specifičnih dejavnikov tveganja, ki bi prispevali k dogodkom, je odbor PRAC priporočil, da je treba bolnikom svetovati rutinsko preventivno nego stopal in vzdrževanje primerne hidratacije kot splošen nasvet za preprečevanje amputacije;
English: All members of the class share the same mode of action and there is no confirmed underlying mechanism that is canagliflozin-specific.
Slovenian: Vsi člani razreda imajo enak način delovanja in osnovni mehanizem, ki bi bil specifičen za kanagliflozin, ni potrjen.
English: Therefore the CHMP recommends the variation to the terms of the marketing authorisations for Invokana, Vokanamet, Forxige, Edistride, Xigduo, Ebymect, Jardiance and Synjardy.
Slovenian: Zato priporoča spremembo pogojev dovoljenj za promet z zdravili Invokana, Vokanamet, Forxige, Edistride, Xigduo, Ebymect, Jardiance in Synjardy.
English: Sodium-glucose co-transporter 2 (SGLT2) inhibitors are used together with diet and exercise in patients with type 2 diabetes, either alone or in combination with other diabetes medicines.
Slovenian: Zaviralci natrijevih glukoznih koprenašalcev 2 (SGLT2) se uporabljajo poleg prehrane in telesne vadbe pri bolnikih s sladkorno boleznijo tipa 2, bodisi samostojno bodisi v kombinaciji z drugimi zdravili za sladkorno bolezen.
English: Further to the information received by the EMA, the Independent Data Monitoring Committee (IDMC) for the CANVAS and CANVAS-R studies, which has access to all un-blinded CV outcome and safety data, recommended that the study should continue, that action to minimize this potential risk should be taken and that participants should be informed adequately about this risk.
Slovenian: Glede na informacije, ki jih je prejela agencija EMA, je neodvisni odbor za spremljanje podatkov za študiji CANVAS in CANVAS-R, ki ima dostop do nezakritih kardiovaskularnih izidov in podatkov o varnosti, priporočil, da se študija nadaljuje, da je treba uvesti ukrepe za zmanjševanje tega morebitnega tveganja in da je treba udeležence o tveganju ustrezno obvestiti.
English: • The PRAC was therefore of the view that the risk of lower limb amputation should be included in the product information for all products listed in Annex A, with a warning highlighting to healthcare professional and patients the importance of routine preventative foot care.
Slovenian: • odbor PRAC je torej menil, da je treba tveganje za amputacijo spodnjih okončin vključiti v informacije o zdravilu za vsa zdravila, navedena v Prilogi A, z opozorilom za zdravstvene delavce in bolnike o pomenu rutinske preventivne nege stopal.
English: Final analysis of these studies, after un-blinding, will provide further information on the benefit/risk of SGLT2 inhibitors particularly of the risk of lower limb amputations.
Slovenian: Končna analiza teh študij bo po razkritju zagotovila več informacij o razmerju med tveganji in koristmi zaviralcev SGLT2, zlasti o tveganju za amputacije spodnjih okončin.
English: The warning for canagliflozin also includes information that, in patients developing amputation preceding events, consideration may be given to discontinue treatment.
Slovenian: Opozorilo za kanagliflozin vključuje tudi informacije o tem, da je treba pri bolnikih, pri katerih se pojavijo znaki, ki napovedujejo amputacijo, razmisliti o prekinitvi zdravljenja.
English: • The PRAC reviewed the totality of the data submitted by the marketing authorisation holders in relation to the risk of lower limb amputation in patients treated with Sodium-glucose cotransporter 2 (SGLT2) inhibitors for type 2 diabetes mellitus;
Slovenian: • odbor PRAC je proučil vse podatke, ki so jih predložili imetniki dovoljenj za promet z zdravilom v povezavi s tveganjem za amputacijo spodnjih okončin pri bolnikih, zdravljenih z zaviralci natrijevih glukoznih koprenašalcev 2 (SGLT2) zaradi sladkorne bolezni tipa 2;
English: • The PRAC also considered that additional information on amputation events should be collected through appropriate case report forms (CRFs) for clinical trials, follow-up questionnaires for post-marketing cases, use of common MedDRA preferred term (PT) lists for amputation preceding events, and appropriate meta-analyses of large studies including cardiovascular outcome studies.
Slovenian: • odbor PRAC je menil tudi, da je treba zbrati dodatne informacije o amputacijah, in sicer z ustreznimi obrazci za poročila o primerih v kliničnih preskušanjih, vprašalniki za spremljanje primerov v obdobju trženja, uporabo seznamov prednostnih izrazov MedDRA za znake, ki napovedujejo amputacijo, in ustreznimi metaanalizami velikih študij, vključno s študijami kardiovaskularnih izidov.
English: Furthermore, the PRAC considered that a class effect could not be excluded, as all SGLT2 inhibitors share the same mechanism of action, as the potential mechanism leading to an increased amputation risk is not known, and as an underlying cause specific to canagliflozin containing medicines only cannot be identified at the moment.
Slovenian: Nadalje je odbor PRAC menil, da učinka razreda zdravil ni mogoče izključiti, ker imajo vsi zaviralci SGLT2 enak mehanizem delovanja, ker morebitni mehanizem, ki vodi do povečanega tveganja za amputacijo, ni znan in ker osnovnega vzroka, značilnega samo za zdravila, ki vsebujejo kanagliflozin, ta trenutek ni mogoče določiti.
English: The CHMP, as a consequence, considers that the benefit-risk balance of Invokana, Vokanamet, Forxige, Edistride, Xigduo, Ebymect, Jardiance and Synjardy remain favourable subject to the amendments to the product information described above.
Slovenian: Odbor CHMP posledično meni, da je razmerje med tveganji in koristmi zdravil Invokana, Vokanamet, Forxige, Edistride, Xigduo, Ebymect, Jardiance in Synjardy še naprej ugodno, pod pogojem, da se upoštevajo zgoraj opisane spremembe informacij o zdravilu.
English: • The PRAC considered that the available data on amputation in the CANVAS and CANVAS-R trials confirm that treatment with canagliflozin may contribute to an increased risk of amputation of the lower limb, mainly of the toe;
Slovenian: • odbor PRAC je menil, da razpoložljivi podatki o amputacijah iz preskušanj CANVAS in CANVAS-R potrjujejo, da zdravljenje s kanagliflozinom lahko prispeva k povečanemu tveganju za amputacijo spodnjih okončin, predvsem prstov;
English: The communication also asked healthcare professionals to consider treatment discontinuation in patients who develop amputation preceding events.
Slovenian: V sporočilu so zdravstvene delavce prosili, naj pri bolnikih, pri katerih se pojavijo znaki, ki napovedujejo amputacijo, razmislijo o prekinitvi zdravljenja.
English: For canagliflozin, lower limb amputations (mainly of the toe) have been also included, as an adverse drug reaction, in the product information;
Slovenian: Za kanagliflozin so bile amputacije spodnjih okončin (zlasti prstov) kot neželeni učinek že vključene v informacije o zdravilu;