FrancophonIA/ELRC3.0 huggingface dataset:
English: Typical opioid side effects are to be expected with PecFent; often these will stop or become less intense with continued use of the medicine.
Slovenian: Ti s stalno uporabo zdravila pogosto izginejo ali postanejo manj intenzivni.
English: Once in the bloodstream, fentanyl acts on receptors in the brain and spinal cord to relieve pain.
Slovenian: Fentanil začne z vstopom v krvni obtok delovati na receptorje v možganih in hrbtenjači ter tako nadzoruje bolečino.
English: For the full list of side effects reported with PecFent, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila PecFent, glejte navodilo za uporabo.
English: How does PecFent work?
Slovenian: Kako zdravilo PecFent deluje?
English: There were also deficiencies identified in the manufacturing process of the medicine.
Slovenian: Pomanjkljivosti so bile ugotovljene tudi v postopku izdelave zdravila.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 July 2016
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22.
English: In addition, the safety profile and the way the medicine is expected to work in the body had not been sufficiently characterised.
Slovenian: Poleg tega varnostni profil in pričakovani način delovanja zdravila v telesu nista bila zadovoljivo opredeljena.
English: Withdrawal of the marketing authorisation application for Begedina (begelomab) EMA/579473/2016
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Begedina (begelomab) EMA/579462/2016
English: In its letter notifying the Agency of the withdrawal of application, the company stated that it acknowledges the need to obtain additional data from a confirmatory study.
Slovenian: Družba je v dopisu, s katerim je Agencijo obvestila o umiku vloge, navedla, da se strinja, da je treba pridobiti dodatne podatke iz potrditvene študije.
English: What is Begedina?
Slovenian: Kaj je zdravilo Begedina?
English: Begedina is a medicine that contains the active substance begelomab.
Slovenian: Begedina je zdravilo, ki vsebuje zdravilno učinkovino begelomab.
English: In the studies, Begedina was not compared with any other treatment.
Slovenian: V teh študijah zdravila Begedina niso primerjali z nobenim drugim zdravilom.
English: The medicine was for use in patients whose disease did not respond to treatment with steroids.
Slovenian: Zdravilo naj bi se uporabljalo pri bolnikih, pri katerih se bolezen ni odzvala na zdravljenje s steroidi.
English: Begedina was expected to be used for the treatment of acute graft-versus-host disease (a condition in which transplanted cells attack the patient's body) in adults who have had haematopoietic progenitor cell transplantation (transplant of cells that can develop into different types of blood cells) from a donor.
Slovenian: Zdravilo Begedina naj bi se uporabljalo za zdravljenje akutne bolezni presadka proti gostitelju (stanja, pri katerem presajene celice napadejo bolnikovo telo) pri odraslih, ki so jim presadili darovalčeve krvotvorne matične celice (presajene celic, ki se lahko razvijejo v različne vrste krvnih celic).
English: activity of T cells from the transplant that attack the patient's organs, thereby helping to control graftversus-host disease.
Slovenian: aktivnost celic T s presadka, ki napadajo bolnikove organe, in tako nadzorovalo bolezen presadka proti gostitelju.
English: The company presented the results of two studies with Begedina involving a total of 29 adults with acute graft-versus-host disease that did not respond to steroid treatment.
Slovenian: Družba je predstavila rezultate dveh študij z zdravilom Begedina, ki sta skupaj vključevali 29 odraslih z akutno boleznijo presadka proti gostitelju, ki se ni odzvala na zdravljenje s steroidi.
English: On 4 July 2016, Adienne S.r.l.
Slovenian: Družba Adienne S.r.l.
English: Begedina was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 26 November 2010 for treatment of graft-versus-host disease.
Slovenian: Zdravilo Begedina je bilo dne 26. novembra 2010 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih boleznih) za zdravljenje bolezni presadka proti gostitelju.
English: Withdrawal of the marketing authorisation application for Begedina (begelomab)
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Begedina (begelomab)
English: It was to be available as a concentrate to be made into a solution for infusion (drip) into a vein.
Slovenian: Na voljo naj bi bilo v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: The CHMP considered that the data provided were insufficient to demonstrate a beneficial effect of Begedina.
Slovenian: CHMP je menil, da predloženi podatki ne zadoščajo za dokaz koristnega učinka zdravila Begedina.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Begedina.
Slovenian: Družba je obvestila CHMP, da zavrnitev nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Begedina.
English: By attaching to CD26, this medicine is expected to reduce the rate at which the T cells multiply.
Slovenian: S pritrditvijo na CD26 naj bi to zdravilo zmanjšalo hitrost razmnoževanje celic T. S tem naj bi se zmanjšalo število in
English: Based on the review of the available data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Begedina could not have been approved for the treatment of acute graft-versus-host disease that did not respond to steroid treatment.
Slovenian: Na podlagi pregleda razpoložljivih podatkov je odbor CHMP v času umika izrazil določene zadržke in je začasno menil, da zdravila Begedina ni mogoče odobriti za zdravljenje bolnikov z akutno boleznijo presadka proti gostitelju, ki se ni odzvala na zdravljenje s steroidi.
English: What was Begedina expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Begedina uporabljalo?
English: The active substance in Begedina, begelomab, is a monoclonal antibody (a type of protein) that has been designed to attach itself to a receptor called CD26, which is present on T cells.
Slovenian: Zdravilna učinkovina v zdravilu Begedina, begelomab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da se pritrdi na receptor, imenovan CD26, ki je prisoten na površini celic T. Te so vrsta belih krvnih celic, ki so vključene v bolezen presadka proti gostitelju.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Begedina.
Slovenian: Zato je CHMP v času umika menil, da družba ni predložila zadostnih podatkov v podporo vlogi za zdravilo Begedina.
English: officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Begedina, for the treatment of graft-versus-host disease.
Slovenian: je dne 4. julija 2016 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Begedina, namenjenim zdravljenju bolezni presadka proti gostitelju.
English: How was Begedina expected to work?
Slovenian: Kako naj bi zdravilo Begedina delovalo?
English: The referral procedure started on 12 October 2011.
Slovenian: Napotitveni postopek se je začel 12. oktobra 2011.
English: The final opinion was converted into a Decision by the European Commission on 17 December 2012.
Slovenian: Končno mnenje je bilo spremenjeno v Sklep Evropske komisije dne 17. decembra 2012.
English: 1 Article 35 of Directive 2001/82/EC, as amended
Slovenian: 1 Člen 35 Direktive 2001/82/ES, kakor je bila spremenjena.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II.
Slovenian: Seznam zadevnih imen zdravila je predložen v Prilogi I. Znanstveni zaključki so navedeni v Prilogi II.
English: The Committee appointed Dr M. Holzhauser-Alberti as rapporteur and Dr C. Muñoz Madero as co-rapporteur.
Slovenian: Odbor je imenoval dr. M. Holzhauser-Albertija za poročevalca in dr. C. Muñoz Madera za soporočevalca.
English: International non-proprietary name (inn): enrofloxacin Background information
Slovenian: Mednarodno nelastniško ime (INN): enrofloksacin Osnovne informacije
English: Supplementary information was provided in writing by an applicant and marketing authorisation holders on 16 January 2012.
Slovenian: Predlagatelj in imetniki dovoljenja za promet z zdravilom so 16. januarja 2012 predložili dodatne informacije v pisni obliki.
English: The dosage is 10 mg enrofloxacin per kg bodyweight during 5 days.
Slovenian: Velikost odmerka je 10 mg enrofloksacina na kg telesne mase 5 dni.
English: The pharmaceutical form is an oral solution administered via the drinking water.
Slovenian: Farmacevtska oblika zdravila je peroralna raztopina, ki se daje s pitno vodo.
English: On 14 May 2012, the European Commission requested the CVMP to review its opinion, mainly to clarify some aspects related to antimicrobial resistance and the prudent use of antimicrobials in veterinary medicine.
Slovenian: Evropska komisija je 14. maja 2012 zahtevala, da CVMP ponovno preuči svoje mnenje ter pojasni nekatere vidike odpornosti proti mikrobom in preudarne uporabe protimikrobnih sredstev v veterinarski medicini.
English: HIPRALONA ENRO-S and its generics are veterinary medicinal products which contain enrofloxacin as active substance, and are indicated in rabbits for the treatment of respiratory infections caused by Pasteurella multocida.
Slovenian: Zdravilo HIPRALONA ENRO-S in njegova generična zdravila so zdravila za uporabo v veterinarski medicini, ki vsebujejo zdravilno učinkovino enrofloksacin in so indicirana za zdravljenje okužb dihal pri kuncih, ki jih povzroča Pasteurella multocida.
English: Based on the evaluation of the available data, on 11 April 2012, the CVMP adopted by majority an opinion recommending the maintenance of the marketing authorisations for the veterinary medicinal product HIPRALONA ENRO-S and its generics in accordance with the previously approved product information.
Slovenian: Na osnovi ocene razpoložljivih podatkov je CVMP 11. aprila 2012 z večino sprejel mnenje, v katerem priporoča ohranitev dovoljenj za promet z zdravilom za uporabo v veterinarski medicini HIPRALONA ENRO-S in njegovimi generičnimi zdravili v skladu s predhodno odobrenimi informacijami o zdravilu.
English: On 13 September 2012, the CVMP adopted by majority a revised opinion confirming the recommendation, included in its opinion of 11 April 2012, that the marketing authorisations for the veterinary medicinal product HIPRALONA ENRO-S and its generics should be maintained in accordance with the previously approved product information.
Slovenian: CVMP je 13. septembra 2012 z večino sprejel ponovno preučeno mnenje, s katerim potrjuje priporočilo, ki je bilo vključeno v njegovo mnenje z dne 11. aprila 2012, da je treba ohraniti dovoljenja za promet z zdravilom za uporabo v veterinarski medicini HIPRALONA ENRO-S in njegovimi generičnimi zdravili v skladu s predhodno odobrenimi informacijami o zdravilu.
English: On 30 September 2011, France initiated a referral procedure under Article 35 of Directive 2001/82/EC, as amended, for the veterinary medicinal product HIPRALONA ENRO-S and its generics indicated for use in rabbits, due to concerns that the use of the products in rabbit production would increase Escherichia coli and Staphylococcus aureus resistance to enrofloxacin.
Slovenian: Francija je zaradi pomislekov, da bi uporaba zdravil pri proizvodnji kuncev povečala odpornost Escherichia coli in Staphylococcus aureus na enrofloksacin, 30. septembra 2011 sprožila napotitveni postopek v skladu s členom 35 Direktive 2001/82/ES, kakor je bila spremenjena, za zdravilo za uporabo v veterinarski medicini HIPRALONA ENRO-S in njegova generična zdravila, indicirana za uporabo pri kuncih.
English: The use of Enviage in children and adolescents is not recommended.
Slovenian: Uporaba zdravila Enviage pri otrocih in mladostnikih ni priporočena.
English: If you forget to take Enviage
Slovenian: Če ste pozabili vzeti zdravilo Enviage
English: Before you drive a vehicle, use machinery, or carry out other activities that require concentration, you should make sure you know how you react to the effects of Enviage.
Slovenian: Preden se namenite upravljati vozilo, uporabljati stroje ali opravljati druge dejavnosti, ki zahtevajo zbranost, morate dobro poznati svoj odziv na učinke zdravila Enviage.
English: If you forget to take a dose of Enviage, take it as soon as you remember and then take the next dose at its usual time.
Slovenian: Če pozabite vzeti odmerek zdravila Enviage, ga vzemite takoj, ko se spomnite nanj in nato vzemite naslednji odmerek ob običajnem času.
English: Enviage has been studied in 1,864 patients aged 65 years or older, and in 426 patients aged 75 years or older.
Slovenian: Zdravilo Enviage so proučevali pri 1.864 bolnikih, starih 65 let ali več, in pri 426 bolnikih, starih 75 let ali več.
English: Your doctor may prescribe Enviage together with other medicines used to treat high blood pressure.
Slovenian: Zdravnik vam lahko predpiše zdravilo Enviage skupaj z drugimi zdravili za zdravljenje visokega krvnega tlaka.
English: Enviage has been evaluated for safety in more than 7,800 patients, including over 2,300 treated for over 6 months, and more than 1,200 for over 1 year.
Slovenian: Varnost zdravila Enviage so ocenjevali pri več kot 7.800 bolnikih, med drugim pri več kot 2.300 bolnikih, ki so bili zdravljeni več kot 6 mesecev, in pri več kot 1.200 bolnikih, ki so bili zdravljeni več kot 1 leto.
English: If angioedema occurs, Enviage should be promptly discontinued and appropriate therapy and monitoring provided until complete and sustained resolution of signs and symptoms has occurred.
Slovenian: Če pride do angioedema, je treba zdravljenje z zdravilom Enviage takoj prekiniti in poskrbeti za ustrezno zdravljenje in spremljanje bolnika, dokler znaki in simptomi niso v celoti in trajno odpravljeni.
English: If any of these apply to you, tell your doctor before you take Enviage.
Slovenian: Če kaj od navedenega velja za vas, povejte zdravniku, preden začnete jemati zdravilo Enviage.
English: In experimental animals, it has been shown that P-gp is a major determinant of Enviage bioavailability.
Slovenian: Na poskusnih živalih se je pokazalo, da je P-gp glavna determinanta biološke uporabnosti zdravila Enviage.
English: Preliminary data suggest that irbesartan may decrease Enviage AUC and Cmax.
Slovenian: Predhodni podatki nakazujejo, da irbesartan lahko zmanjša AUC in Cmax zdravila Enviage.
English: Enviage helps to lower high blood pressure.
Slovenian: Enviage pomaga zniževati visok krvni tlak.
English: Enviage was not teratogenic in rats or rabbits (see section 5.3).
Slovenian: Zdravilo Enviage ni bilo teratogeno pri podganah ali kuncih (glejte poglavje 5.3).
English: Beneficial effects of Enviage on mortality and cardiovascular morbidity and target organ damage are currently unknown.
Slovenian: Ugodni vplivi zdravila Enviage na umrljivost, kardiovaskularno obolevnost in prizadetost tarčnih organov trenutno niso znani.
English: In diabetic hypertensive patients, Enviage monotherapy was safe and effective.
Slovenian: Pri sladkornih bolnikih s hipertenzijo je bila monoterapija z zdravilom Enviage varna in učinkovita.
English: Enviage should be taken with a light meal once a day, preferably at the same time each day.
Slovenian: Zdravilo Enviage je treba jemati z lahkim obrokom enkrat na dan, najbolje vsak dan ob istem času.
English: Do not use Enviage after the expiry date which is stated on the carton and blister.
Slovenian: Zdravila Enviage ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu.
English: Enviage was secreted in the milk of lactating rats.
Slovenian: Zdravilo Enviage se je izločalo v mleko doječih podgan.
English: The MAH must ensure that the system of pharmacovigilance, as described in version 8.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Slovenian: Imetnik dovoljenja za promet mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 8.0 in predložen v modulu 1.8.1 vloge za pridobitev dvoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
English: Food intake Meals with a high fat content have been shown to reduce the absorption of Enviage substantially.
Slovenian: Uživanje hrane Pokazalo se je, da obroki z veliko vsebnostjo maščob bistveno zmanjšajo absorpcijo zdravila Enviage.
English: As for any medicine that acts directly on the RAS, Enviage should not be used during the first trimester of pregnancy or in women planning to become pregnant and is contraindicated during the second and third trimesters (see section 4.3).
Slovenian: Tako kot velja za katerokoli drugo zdravilo, ki deluje neposredno na sistem renin-angiotenzin, tudi zdravila Enviage ne smete uporabljati v prvem trimesečju nosečnosti oziroma pri ženskah, ki načrtujejo nosečnost, poleg tega je kontraindiciran v drugem in tretjem trimesečju nosečnosti (glejte poglavje 4.3).
English: Like all medicines, Enviage can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Enviage neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: The proportion of patients who had UACR reduced at least 50% from baseline to endpoint was 24.7% and 12.5% for Enviage and placebo, respectively.
Slovenian: Delež bolnikov, ki so imeli UACR zmanjšano za vsaj 50 % od izhodiščne vrednosti, je bil pri zdravilu Enviage 24,7 %, pri placebu pa 12,5 %.
English: In this leaflet: What Enviage is and what it is used for
Slovenian: KAJ JE ZDRAVILO ENVIAGE IN ZA KAJ GA UPORABLJAMO
English: In a 3-month study of 302 patients with mild stable heart failure, all of whom were receiving standard therapy for stable heart failure, addition of Enviage 150 mg was well tolerated.
Slovenian: V 3-mesečni študiji, ki je vključevala 302 bolnika z blagim, stabilnim srčnim popuščanjem, od katerih so vsi prejemali standardno terapijo pri stabilnem srčnem popuščanju, so bolniki dodajanje zdravila Enviage v odmerku 150 mg dobro prenašali.
English: The recommended dose of Enviage is 150 mg once daily.
Slovenian: Priporočeni odmerek zdravila Enviage je 150 mg enkrat dnevno.
English: Enviage is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy (see section 5.2).
Slovenian: Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Enviage pri otrocih in mladostnikih pod 18 let ni priporočljiva (glejte poglavje 5.2).
English: In the event of severe and persistent diarrhoea, Enviage therapy should be stopped.
Slovenian: V primeru hude ali persistentne driske je treba zdravljenje z zdravilom Enviage prekiniti.
English: The incidence of cough was similar in placebo (0.6%) and Enviage treated (0.9%) patients.
Slovenian: Incidenca kašlja je bila podobna pri bolnikih, ki so prejemali placebo (0,6 %), in pri bolnikih, ki so bili zdravljeni z zdravilom Enviage (0,9 %).
English: Enviage in combination with the angiotensin receptor antagonist valsartan showed an additive antihypertensive effect in the study specifically designed to investigate the effect of the combination therapy.
Slovenian: Zdravilo Enviage je v kombinaciji z antagonistom angiotenzina II valsartanom izrazilo aditiven učinek zniževanja krvnega tlaka v študiji, ki je bila načrtovana posebej za raziskovanje učinka kombinacije zdravil.
English: However, in one study where Enviage was used in combination with an ACEI in a diabetic population, increases in serum potassium were more frequent (5.5%).
Slovenian: Vendar pa je v eni študiji, v kateri so zdravilo Enviage uporabljali v kombinaciji z zaviralci angiotenzinske konvertaze pri sladkornih bolnikih, pogosteje prihajalo do zvišanja vrednosti kalija v serumu (5,5 %).
English: Co-administration of aliskiren with either valsartan (↓28%), metformin (↓28%), amlodipine (↑29%) or cimetidine (↑19%) resulted in between 20% and 30% change in Cmax or AUC of Enviage.
Slovenian: Ob sočasni uporabi aliskirena z valsartanom (↓28 %), metforminom (↓28 %), amlodipinom (↑29 %) ali s cimetidinom (↑19 %) sta se Cmax ali AUC zdravila Enviage spremenila za 20 % do 30 %.
English: Enviage did not affect the serum concentration of creatinine but was associated with an increased frequency (4.2% vs. 1.9% for placebo) of serum potassium concentration ≥6.0 mmol/l, although this was not statistically significant.
Slovenian: Zdravilo Enviage ni vplivalo na koncentracijo kreatinina v serumu, povezano pa je bilo z večjo pogostnostjo (4,2 % v primerjavi z 1,9 % pri placebo) koncentracije kalija v serumu ≥ 6,0 mmol/l, čeprav razlika ni bila statistično značilna.
English: Grapefruit juice should not be taken together with Enviage.
Slovenian: Grenivkinega soka se ne sme jemati skupaj z zdravilom Enviage.
English: INFORMATION IN BRAILLE Enviage 300 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Enviage 300 mg
English: Enviage belongs to a new class of medicines called renin inhibitors.
Slovenian: Zdravilo Enviage sodi v novo skupino zdravil z imenom zaviralci renina.
English: In clinical studies Enviage has not been investigated in hypertensive patients with severe renal impairment (serum creatinine ≥ 150 μmol/l or 1.70 mg/dl in women and ≥ 177 μmol/l or 2.00 mg/dl in men and/or estimated glomerular filtration rate (GFR) < 30 ml/min), history of dialysis, nephrotic syndrome or renovascular hypertension.
Slovenian: V kliničnih študijah zdravila Enviage niso raziskovali pri hipertenzivnih bolnikih s hudo okvaro ledvic (kreatinin v serumu ≥ 150 μmol/l oziroma 1,70 mg/dl pri ženskah in ≥ 177 μmol/l oziroma 2,00 mg/dl pri moških in/ali ocenjeno hitrostjo glomerulne filtracije (GFR) < 30 ml/min), pri bolnikih, ki so se že zdravili z dializo, pri bolnikih z nefrotskim sindromom ali z renovaskularno hipertenzijo.
English: In patients with marked volume- and/or salt-depletion (e.g. those receiving high doses of diuretics) symptomatic hypotension could occur after initiation of treatment with Enviage.
Slovenian: Pri bolnikih s hudim pomanjkanjem natrija in/ali hipovolemijo (na primer pri tistih, ki prejemajo velike odmerke diuretikov) lahko po uvedbi zdravljenja z zdravilom Enviage pride do simptomatske hipotenzije.
English: In controlled clinical trials, angioedema occurred rarely during treatment with Enviage with rates comparable to treatment with placebo or hydrochlorothiazide.
Slovenian: V kontroliranih kliničnih preskušanjih je med zdravljenjem z zdravilom Enviage redko prišlo do angioedema in sicer s pogostnostjo, ki je bila primerljiva z zdravljenjem s placebom ali s hidroklorotiazidom.
English: In clinical studies in hypertensive patients, Enviage had no clinically important effects on total cholesterol, high density lipoprotein cholesterol (HDL-C), fasting triglycerides, fasting glucose or uric acid.
Slovenian: V kliničnih študijah s hipertenzivnimi bolniki zdravilo Enviage ni klinično pomembno vplivalo na vrednosti celokupnega holesterola, holesterola lipoproteinov visoke gostote (HDL holesterola), trigliceridov na tešče, glukoze na tešče in sečne kisline.
English: Warfarin The effects of Enviage on warfarin pharmacokinetics have not been evaluated.
Slovenian: Varfarin Učinkov zdravila Enviage na farmakokinetične lastnosti varfarina niso ocenjevali.
English: If pregnancy is detected during therapy, Enviage should be discontinued accordingly.
Slovenian: V primeru, da se med zdravljenjem z zdravilom Enviage izkaže, da je ženska noseča, je treba zdravljenje v skladu s tem prekiniti.
English: Do not take Enviage if you are pregnant.
Slovenian: Če ste noseči, ne jemljite zdravila Enviage.