FrancophonIA/ELRC3.0 huggingface dataset:
English: Pack size
Slovenian: Jakost
English: Overall summary of the scientific evaluation
Slovenian: Splošni povzetek znanstvenega vrednotenja
English: • The CHMP considered the procedure under Article 31 of Directive 2001/83/EC for metformin containing medicinal products.
Slovenian: • odbor CHMP je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES za zdravila, ki vsebujejo metformin;
English: These patients form a large population which currently may have not access to the benefits of metformin across the Union.
Slovenian: Ti bolniki tvorijo veliko populacijo iz celotne EU, ki trenutno morda nima dostopa do metformina in njegovih koristi.
English: Whereas
Slovenian: ob upoštevanju naslednjega:
English: On 25 January 2016 the Netherlands therefore triggered a referral under Article 31 of Directive 2001/83/EC, and requested the CHMP to assess the impact of the above concerns on the benefit-risk balance of metformin containing products and to issue an opinion on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Slovenian: Zato je Nizozemska 25. januarja 2016 sprožila napotitev v skladu s členom 31 Direktive 2001/83/ES in odbor CHMP zaprosila, naj oceni vpliv navedenih pomislekov na razmerje med tveganji in koristmi zdravil, ki vsebujejo metformin, ter izda mnenje o tem, ali je treba zadevna dovoljenja za promet z zdravilom ohraniti, spremeniti, začasno preklicati ali ukiniti.
English: The risk of lactic acidosis is very rare in clinical practice and in the majority of cases only observed in emergency care.
Slovenian: Tveganje za laktacidozo je v klinični praksi zelo redko in so ga v večini primerov opazili le pri nujni medicinski oskrbi.
English: Moreover, metformin treatment slows the further deterioration of renal function and provides additional significant micro-and macrovascular benefits in this patient population.
Slovenian: Poleg tega zdravljenje z metforminom upočasni nadaljnje slabšanje delovanja ledvic in tej populaciji bolnikov zagotavlja dodatne pomembne mikro- in makrovaskularne koristi.
English: Metformin, alone or in combination with other medicines, is considered the first choice in the treatment for Type 2 diabetes mellitus (T2DM) and it is widely used in the EU.
Slovenian: Metformin, ki se jemlje samostojno ali v kombinaciji z drugimi zdravili, velja za prvo izbiro pri zdravljenju sladkorne bolezni tipa 2 in se v EU pogosto uporablja.
English: Recent scientific data have concluded that the main causes of lactic acidosis are cardiogenic or hypovolemic shock, severe heart failure, severe trauma, and sepsis; therefore lactic acidosis is not primarily caused by metformin treatment.
Slovenian: Najnovejši znanstveni podatki kažejo, da so glavni vzroki za laktacidozo kardiogeni ali hipovolemični šok, hudo srčno popuščanje, huda travma in sepsa, zato zdravljenje z metforminom ni primarni vzrok za laktacidozo;
English: Grounds for CHMP opinion
Slovenian: Podlaga za mnenje odbora CHMP
English: As there is a clear relationship between renal function and metformin exposure, a recommendation for a daily dose of 2000 mg/day and 1000 mg/day dose in patients with moderate renal impairment stages 3a and 3b, respectively, can be concluded from the data provided.
Slovenian: Ker obstaja jasna povezava med delovanjem ledvic in izpostavljenostjo metforminu, se lahko iz predloženih podatkov izpelje priporočilo za dnevni odmerek 2000 mg/dan za bolnike z zmerno ledvično okvaro stopnje 3a in 1000 mg/dan za bolnike z zmerno ledvično okvaro stopnje 3b.
English: It is considered in the interest of the Union that the adequacy of the current recommendations for metformin containing products is re-evaluated with respect to the use in patients with moderate renal failure, taking into account the available information on the risk of lactic acidosis.
Slovenian: V interesu EU je, da se primernost trenutnih priporočil za zdravila, ki vsebujejo metformin, v zvezi z uporabo pri bolnikih z zmerno ledvično okvaro ponovno ovrednoti, pri čemer je treba upoštevati razpoložljive informacije o tveganju za laktacidozo.
English: Moreover, recent clinical guidelines in the treatment of T2DM recommend the use of metformin in moderate renal impairment.
Slovenian: Poleg tega najnovejše klinične smernice za zdravljenje sladkorne bolezni tipa 2 priporočajo uporabo metformina pri zmerni ledvični okvari.
English: Currently the use of metformin in patients with renal failure is not harmonised across the EU, being contraindicated in patients with different stages of moderate renal failure depending on the member state and product.
Slovenian: Trenutno uporaba metformina pri bolnikih z ledvično okvaro po EU ni usklajena, saj je kontraindiciranost pri bolnikih z različnimi stopnjami zmerne ledvične okvare odvisna od države članice in zdravila.
English: Based on the review of all available data on safety and efficacy, the benefit-risk balance of medicinal products containing metformin remains favourable and it is recommended that the marketing authorisations are varied regarding the use in renal impairment.
Slovenian: Na podlagi vseh razpoložljivih podatkov o varnosti in učinkovitosti ostaja razmerje med tveganji in koristmi zdravil, ki vsebujejo metformin, še naprej ugodno, priporoča pa se, da se dovoljenja za promet z zdravilom v zvezi z uporabo pri ledvični okvari spremenijo.
English: The benefits of metformin in the treatment of T2DM in patients with moderate renal impairment have been demonstrated in terms of the reduction of cardiovascular risk and all-cause mortality.
Slovenian: Ugodni učinki metformina pri zdravljenju sladkorne bolezni tipa 2 pri bolnikih z zmerno ledvično okvaro so dokazani v smislu zmanjšanja kardiovaskularnega tveganja in smrtnosti iz vseh vzrokov.
English: In addition, published epidemiological studies indicate that metformin is often used in clinical practice in patients with moderate renal impairment as reflected in current clinical guidelines without a marked increase in risk of lactic acidosis or other serious side effects.
Slovenian: Poleg tega objavljene epidemiološke študije kažejo, da se metformin pri bolnikih z zmerno ledvično okvaro v klinični praksi pogosto uporablja, kar odražajo tudi sedanje klinične smernice, ne da bi se bistveno povečalo tveganje za laktacidozo ali druge resne neželene učinke;
English: • The CHMP considered that publications in the medical literature have shown that metformin at reduced dose may be safely used in patients with moderate renal impairment.
Slovenian: • odbor CHMP je menil, da objave v medicinski literaturi kažejo, da se metformin v zmanjšanem odmerku pri bolnikih z zmerno ledvično okvaro lahko varno uporablja.
English: Apart from lactic acidosis, the overall safety profile of metformin in patients with moderate renal impairment is similar to the safety profile in patients with normal renal function.
Slovenian: Z izjemo laktacidoze je splošni varnostni profil metformina pri bolnikih z zmerno ledvično okvaro podoben varnostnemu profilu pri bolnikih z normalnim delovanjem ledvic.
English: • The CHMP reviewed the totality of the data submitted by the MAHs on the safety and efficacy of metformin containing medicinal products for the treatment of Type 2 diabetes mellitus in subjects with moderate renal impairment (GFR 30-59 ml/min) with a focus on the risk of lactic acidosis.
Slovenian: • odbor CHMP je pregledal vse podatke, ki so jih predložili imetniki dovoljenja za promet z zdravilom, o varnosti in učinkovitosti zdravil, ki vsebujejo metformin, za zdravljenje sladkorne bolezni tipa 2 pri bolnikih z zmerno ledvično okvaro (GFR 30-59 ml/min), pri tem pa se je osredotočil na tveganje za laktacidozo;
English: • The CHMP considered the evidence from epidemiological studies, which have shown that lactic acidosis is a very rare condition that occurs most often in patients with acute renal or cardiorespiratory illness or sepsis.
Slovenian: • odbor CHMP je obravnaval dokaze iz epidemioloških študij, ki so pokazali, da je laktacidoza zelo redko stanje, ki se najpogosteje pojavlja pri bolnikih z akutno ledvično ali kardiorespiratorno boleznijo ali sepso.
English: In addition, routine pharmacovigilance activities will be extended to include a cumulative review and a targeted follow up questionnaire on lactic acidosis cases to be submitted in subsequent PSURs.
Slovenian: Poleg tega bodo redne farmakovigilančne dejavnosti zajemale tudi kumulativni pregled in namenski vprašalnik o nadaljnjem spremljanju primerov laktacidoze, ki bosta predložena v naslednjih poročilih PSUR.
English: Overall, metformin has been used safely in patients with moderate renal impairment at reduced doses without causing significant metformin or lactate plasma elevations.
Slovenian: Na splošno se metformin v zmanjšanem odmerku pri bolnikih z zmerno ledvično okvaro uporablja varno, ne da bi povzročal bistveno zvišanje ravni metformina ali laktata v plazmi.
English: • The CHMP considered that there is evidence from clinical and epidemiological studies indicating the benefits of the use of metformin containing medicinal products in patients with moderate renal impairment (GFR 30-59 ml/min).
Slovenian: • odbor CHMP je menil, da obstajajo dokazi iz kliničnih in epidemioloških študij, ki kažejo na ugodne učinke uporabe zdravil, ki vsebujejo metformin, pri bolnikih z zmerno ledvično okvaro (GFR 30-59 ml/min);
English: In addition, routine risk minimisation will be extended to include cumulative review of lactic acidosis in the PSURs and a targeted questionnaire.
Slovenian: Poleg tega bo rutinsko zmanjševanje tveganja vključevalo tudi kumulativni pregled laktacidoze v poročilih PSUR in temu namenjen vprašalnik.
English: Therefore the CHMP recommends the variation to the terms of the marketing authorisations for metformin containing products
Slovenian: Zato priporoča spremembo pogojev dovoljenj za promet z zdravili, ki vsebujejo metformin.
English: The most common side-effects observed in association with metformin use in diabetic individuals are mild to moderate gastrointestinal events including diarrhea, nausea, vomiting, abdominal pain, and decreased appetite.
Slovenian: Najpogostejši neželeni učinki, ki so jih opazili v povezavi z uporabo metformina pri posameznikih s sladkorno boleznijo, so blagi do zmerni učinki na prebavila, vključno z drisko, slabostjo, bruhanjem, bolečinami v trebuhu in zmanjšanim tekom.
English: In addition, although causality cannot be ruled out, other factors rather than metformin are most likely the causes of lactic acidosis.
Slovenian: Poleg tega so najverjetnejši vzrok laktacidoze drugi dejavniki in ne metformin, čeprav vzročne povezave ni mogoče izključiti.
English: • The CHMP was of the view that the risk of lactic acidosis can be minimised in patients with moderate renal impairment with clear dosing recommendations, additional monitoring of GFR levels before and during treatment and updated warnings and precautions in the Summary of Product Characteristics (SmPC) and Package Leaflet (PL).
Slovenian: • odbor CHMP je menil, da se tveganje za laktacidozo pri bolnikih z zmerno ledvično okvaro lahko zmanjša z jasnimi priporočili za odmerjanje, dodatnim spremljanjem ravni GFR pred in med zdravljenjem ter s posodobljenimi opozorili in previdnostnimi ukrepi v povzetku glavnih značilnosti zdravila in navodilu za uporabo.
English: In conclusion, the possible elevated risk of lactic acidosis could be sufficiently minimised in patients with moderate renal impairment (GFR greater than 30 ml/min) with a clear dosing recommendation, additional monitoring of GFR levels before and during treatment, and updated warnings and precautions in the SmPC and package leaflet.
Slovenian: Iz tega sledi, da se morebitno povečano tveganje za laktacidozo pri bolnikih z zmerno ledvično okvaro (GFR nad 30 ml/min) lahko v zadostni meri zmanjša z jasnimi priporočili za odmerjanje, dodatnim spremljanjem ravni GFR pred in med zdravljenjem ter s posodobljenimi opozorili in previdnostnimi ukrepi v povzetku glavnih značilnosti zdravila in navodilu za uporabo.
English: In view of the above, the CHMP concluded that the benefit-risk balance of metformin containing medicinal products is favourable subject to changes to the product information as described above.
Slovenian: Z upoštevanjem zgoraj navedenega je odbor CHMP zaključil, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo metformin, ugodno, pod pogojem, da se upoštevajo zgoraj opisane spremembe informacij o zdravilu.
English: The CHMP, as a consequence, considers that the benefit-risk balance of metformin containing products remains favourable subject to the amendments to the product information.
Slovenian: Odbor CHMP posledično meni, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo metformin, še naprej ugodno, pod pogojem, da se upoštevajo zgoraj opisane spremembe informacij o zdravilu.
English: The educational programme is aimed:
Slovenian: Izobraževalni program je namenjen:
English: See section 5.1.
Slovenian: Glejte poglavje 5.1.
English: No interaction studies have been performed.
Slovenian: Študij medsebojnega delovanja niso izvedli.
English: The clinical relevance of these effects is unknown.
Slovenian: Klinični pomen teh učinkov je neznan.
English: Your surgeon will know which bones to avoid.
Slovenian: Vaš kirurg bo vedel, za katere kosti gre.
English: Date of latest renewal: 20 July 2012
Slovenian: Datum prve odobritve: 9. september 2002 Datum zadnjega podaljšanja: 20. julij 2012
English: • adequate fracture reduction and stabilization to ensure mechanical stability
Slovenian: • primerna redukcija in stabilizacija zloma, kar zagotavlja mehansko stabilnost;
English: No clinical data are available; potential risk for human is unknown.
Slovenian: Klinični podatki niso na voljo, možno tveganje za ljudi ni znano.
English: 10 DATE OF REVISION OF THE TEXT
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA
English: Warnings and precautions to be discussed with your doctor
Slovenian: Opozorila in previdnostni ukrepi, o katerih se morate pogovoriti s svojim zdravnikom
English: REVERSE {number} {YYYY MM}
Slovenian: HRBTNA STRAN {številka} {LLLL MM}
English: This radiographic finding may be asymptomatic or symptomatic.
Slovenian: Ta radiološka najdba je lahko asimptomatska ali simptomatska.
English: The product must be used within 2 hours after preparation.
Slovenian: Uporabite v 2 urah po pripravi.
English: 6422 PJ Heerlen The Netherlands tel +31 (0) 45 566 8000 fax +31 (0) 45 566 8012
Slovenian: 6422 PJ Heerlen Nizozemska tel. +31 (0) 45 566 8000 fax +31 (0) 45 566 8012
English: The doctor will determine how much InductOs you will receive, depending on the size and number of fractures.
Slovenian: Zdravnik bo določil, koliko zdravila InductOs boste prejeli glede na velikost in število zlomov.
English: Talk to your doctor if you have any of the following:
Slovenian: Posvetujte se s svojim zdravnikom, če imate kaj od naslednjega:
English: The oedema was delayed in onset and usually occurred in the first week post-operation.
Slovenian: Edem je nastopil pozno in se je običajno pojavil v prvem tednu po operaciji.
English: While no harmful effects have been noted, the long-term effects are unknown.
Slovenian: Pri tem niso opazili nikakršnih neželenih učinkov, vendar njihovi dolgoročni učinki niso znani.
English: The remaining patients participated in studies using InductOs for indications not currently approved in the EU.
Slovenian: Preostali bolniki so sodelovali v študijah uporabe zdravila InductOs za indikacijo, ki trenutno v EU še ni odobrena.
English: Additional educational materials for healthcare professionals are available on the following URL: [URL to be included] <and the <Member State> website>.
Slovenian: Dodatna izobraževalna gradiva za zdravstvene delavce so na voljo na naslednji povezavi: [povezava bo vključena tu] <in na spletni strani <države članice>>.
English: Dispense onto matrix and wait 15 min.
Slovenian: Nanesite na ogrodje in počakajte 15 min.
English: Unknown
Slovenian: Neznana
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden prejmete to zdravilo.
English: The healthcare professional educational material should contain:
Slovenian: Izobraževalni material za zdravstvene delavce mora vsebovati:
English: • The product should not be placed in direct contact with certain types of bones.
Slovenian: • Zdravilo ne sme biti v neposrednem stiku z določenimi kostmi.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Slovenian: Preden prejmete to zdravilo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: What you need to know before you receive InductOs
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo InductOs
English: Wait a MINIMUM of 15 minutes before using the prepared InductOs product.
Slovenian: Počakajte NAJMANJ 15 minut, preden uporabite pripravljeno zdravilo InductOs.
English: These data are supplemented with information from use of InductOs in the general population.
Slovenian: Ti podatki so dopolnjeni z informacijami o uporabi dravila InductOs pri splošni populaciji.
English: Immune response
Slovenian: Imunski odgovor
English: All patients who were tested for neutralizing antibodies to bone morphogenetic protein-2 were negative.
Slovenian: Vsi bolniki, ki so bili testirani za nevtralizirajoča protitelesa proti kostnemu morfogenetskemu proteinu-2, so bili negativni.
English: The selected pieces can be further cut as required.
Slovenian: Izbrane kose lahko po potrebi dodatno razrežete.
English: • Whenever the risk management system is modified, especially as the result of new information being received that lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo, tudi če ste ga dobili brez recepta.
English: For these special populations, the physician is advised to give a careful consideration to the benefits and risks for the specific patient before using InductOs.
Slovenian: Za te posebne skupine bolnikov se zdravniku svetuje, da skrbno oceni razmerje med tveganji in koristmi za posameznega bolnika, preden uporabo zdravilo InductOs.
English: The MAH shall ensure that in each Member State where InductOs is marketed, all healthcare professionals who are expected to use InductOs are provided with the following educational package:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, kjer se zdravilo InductOs trži, vsi zdravstveni delavci, za katere se pričakuje, da bodo uporabljali zdravilo InductOs, prejeli naslednji izobraževalni paket:
English: • adequate neurovascular status (e.g. absence of compartment syndrome, low risk of amputation)
Slovenian: • primeren nevrovaskularni status (npr. odsotnost utesnitvenega sindroma, majhno tveganje amputacije);
English: There were no other alterations in foetal external, visceral, or skeletal morphology.
Slovenian: Drugih sprememb zunanje, visceralne ali skeletne morfologije plodov ni bilo.
English: 5 Observed during use in acute tibia fractures * Additional information provided below
Slovenian: 5Opaženo med uporabo pri akutnih zlomih golenice * Dodatne informacije so na voljo spodaj
English: InductOs should be used by an appropriately qualified surgeon.
Slovenian: Zdravilo InductOs naj uporablja le ustrezno usposobljen kirurg.
English: These results were independently corroborated by a radiology panel blinded to treatment.
Slovenian: Te rezultate je neodvisno potrdila skupina radiologov, ki niso imeli dostopa do podatkov o zdravljenju.
English: This medicinal product must not be mixed with other medicinal products, except those mentioned in section 6.6.
Slovenian: Zdravila ne smemo mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6.6. 6.3 Rok uporabnosti
English: Tell your doctor immediately, or go immediately to the emergency department of your nearest hospital if you have localised swelling, which may result in breathing difficulties, after InductOs has been used in surgery of the upper (neck) region of your spine.
Slovenian: Svojemu zdravniku takoj povejte ali takoj pojdite na urgenco najbližje bolnišnice, če imate lokalizirano oteklino, ki lahko povzroči težave z dihanjem, če so zdravilo InductOs uporabili v operaciji zgornjega (vratnega) predela vaše hrbtenice.
English: InductOs must not be used in concentrations higher than 1.5 mg/ml (see section 4.9).
Slovenian: Zdravilo InductOs se ne sme uporabljati v koncentracijah, višjih od 1,5 mg/ml (glejte poglavje 4.9).
English: • at increasing awareness about the risk of heterotopic ossification and the potential risk of medication errors and incorrect use of InductOs and providing guidance on how to manage these risks.
Slovenian: • za zvečanje zavedanja tveganja za heterotopično osifikacijo in možnega tveganja napak pri zdravljenju in nepravilne uporabe zdravila InductOs ter za podajanje smernic, kako ta tveganja obvladati.
English: Detailed information on this medicine is available on the European Medicines Agency web site http://www.ema.europa.eu
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: Bone formation outside the intervertebral disc space is not desirable as it may have a deleterious impact on local neurovascular structures.
Slovenian: Tvorba kosti zunaj medvretenčnega prostora ni zaželena, ker lahko poškoduje lokalne nevrovaskularne strukture.
English: Considering the type of product, systemic exposure of the suckling infant is not expected, however a risk to the newborn/infant cannot be excluded.
Slovenian: Glede na vrsto izdelka sistemske izpostavljenosti doječih otrok ne pričakujemo, vendar pa tveganja za novorojenca/dojenčka ni mogoče izključiti.
English: • if you are still growing (skeletally immature).
Slovenian: • če še rastete (če vaše okostje še ni zrelo);
English: Clinical pharmacology studies demonstrate that the matrix alone is not osteoinductive and is no longer present in biopsies taken as early as 16 weeks post-implantation.
Slovenian: Klinične farmakološke študije kažejo, da matriks sam ni osteoinduktiven in že 16 tednov po implantaciji ni več prisoten v takrat odvzetih biopsijskih vzorcih.
English: 1 matrix
Slovenian: 1 matriks
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Slovenian: • preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1
English: It is not known if InductOs passes into breast milk.
Slovenian: Ni znano, ali zdravilo InductOs prehaja v materino mleko.
English: Localised infection
Slovenian: Lokalizirana okužba
English: • Very common (may affect more than 1 in 10 people):
Slovenian: • zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
English: Radiographic, biomechanical and histologic evaluation of the induced bone indicates that it functions biologically and biomechanically as native bone.
Slovenian: Radiografski, biomehanski in histološki testi induciranega kostnega tkiva kažejo, da to tako biološko kot biomehansko deluje kot nativna kost.
English: What InductOs is and what it is used for
Slovenian: Kaj je zdravilo InductOs in za kaj ga uporabljamo