FrancophonIA/ELRC3.0 huggingface dataset:
English: The following information is intended for healthcare professionals only:
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju: NAVODILA ZA PRIPRAVO IN UPORABO Suspenzijo mora pripraviti in dati zdravstveni delavec.
English: Macimorelin Aeterna Zentaris is indicated as a single-dose diagnostic test. No information is available on the safety and effects of macimorelin during long-term use.
Slovenian: Zdravilo Macimorelin Aeterna Zentaris je indicirano za diagnostično preiskavo z enim odmerkom.
English: • your body is lacking any other hormone e.g. cortisol, thyroid or sex hormones, vasopressin (in diabetes insipidus), this should be adequately replaced before testing for growth hormone deficiency.
Slovenian: • Če vam v telesu manjka kakšen drug hormon, npr. kortizol, ščitnični hormoni ali spolni hormoni,
English: Abdominal pain
Slovenian: PODATKI NA PRIMARNI OVOJNINI
English: NAME OF THE MEDICINAL PRODUCT Macimorelin Aeterna Zentaris 60 mg granules for oral suspension in sachet
Slovenian: Macimorelin Aeterna Zentaris 60 mg zrnca za peroralno suspenzijo v vrečici
English: Patients on replacement therapy with growth hormone (GH, somatotropin) or on medicinal products directly affecting the pituitary secretion of somatotropin (e.g. somatostatin analogues, clonidine, levopoda and dopamine agonists) should be advised to discontinue such treatment at least 1 month before receiving a test dose of macimorelin.
Slovenian: Bolnikom na nadomestnem zdravljenju z rastnim hormonom (GH, somatotropinom) ali zdravili, ki neposredno vplivajo na izločanje somatotropina v hipofizi (npr. analogi somatostatina, klonidin,
English: Lactose monohydrate Colloidal anhydrous silica Crospovidone type A Saccharin sodium dihydrate Sodium stearyl fumarate
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi laktoza monohidrat koloidni brezvodni silicijev dioksid krospovidon tipa A natrijev saharinat dihidrat natrijev stearilfumarat 6.2 Inkompatibilnosti Navedba smiselno ni potrebna.
English: Macimorelin induced GH release was lower in patients with higher BMI.
Slovenian: Pri bolnikih z višjo vrednostjo ITM je bilo z macimorelinom inducirano izločanje rastnega hormona manjše.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING SACHET
Slovenian: EDINSTVENA OZNAKA - V BERLJIVI OBLIKI PC: {številka}
English: Palpitations
Slovenian: ZDRAVILA
English: Information about lactose and sodium
Slovenian: Podatki o laktozi in natriju To zdravilo vsebuje laktozo.
English: Other medicines and Macimorelin Aeterna Zentaris Tell your doctor if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: If you are not sure, talk to your doctor or nurse before you are given Macimorelin Aeterna Zentaris.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom ali medicinsko sestro, preden prejmete zdravilo
English: PK/PD relationship
Slovenian: Farmakokinetično/farmakodinamično razmerje
English: Macimorelin Aeterna Zentaris contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se z njim posvetujte, preden vzamete to zdravilo.
English: PHARMACEUTICAL FORM AND CONTENTS Granules for oral suspension in sachet 1 sachet (1,817 mg granules)
Slovenian: 1 vrečica (1.817 mg zrnc)
English: A CHMP scientific advisory group (SAG) meeting was held in October 2011 and its views were considered by the CHMP in the framework of this review.
Slovenian: Odbor CHMP se je oktobra 2011 sestal z znanstveno svetovalno skupino (SAG) in upošteval njeno mnenje v okviru tega pregleda.
English: Aminocaproic acid
Slovenian: Aminokaprojska kislina
English: The marketing authorisations for aprotinin were suspended when concerns over its safety were raised in a previous review in 2007.
Slovenian: Dovoljenja za promet z aprotininom so bila začasno umaknjena, ko so bili med prejšnjim pregledom leta 2007 predstavljeni dvomi o njegovi varnosti.
English: • The Committee considered that the product information should be updated.
Slovenian: • odbor je presodil, da je treba posodobiti informacije o zdravilih.
English: The product information was modified to ensure that the information to healthcare professionals and patients is up to date.
Slovenian: Informacije o zdravilih so bile spremenjene, da bi zdravstvenim delavcem in bolnikom zagotovili najnovejše informacije.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC, for aprotinin, aminocaproic acid and tranexamic acid (see Annex I).
Slovenian: • odbor je upošteval postopek po členu 31 Direktive 2001/83/ES za aprotinin, aminokaprojsko kislino in traneksamično kislino (glejte Prilogo I);
English: The latest quality review of documents templates were taken into account during this review.
Slovenian: Med tem pregledom je bil upoštevan zadnji pregled kakovosti predloge za dokumente.
English: Aminocaproic acid is a lysine analogue authorised for several indications since 1963.
Slovenian: Aminokaprojska kislina je analog lizina in je že od leta 1963 odobrena za več indikacij.
English: These concerns echoed those of a few published observational studies.
Slovenian: Ta odkritja so se ujemala z odkritji objavljenih opazovalnih študij.
English: EACA had not previously been associated with an increased risk of mortality and this has remained unchanged postpublication of the BART study.
Slovenian: Aminokaprojske kisline prej niso povezovali s povečanim tveganjem za smrtnost in to se tudi po objavi študije BART ni spremenilo.
English: A list of indications for which the CHMP considered that the benefit risk balance remains positive is presented below.
Slovenian: Seznam indikacij, za katere je CHMP menil, da zanje ostaja razmerje med tveganji in koristmi pozitivno, je na voljo spodaj.
English: Aprotinin, a naturally occurring polypeptide, is an inhibitor of proteolytic enzymes.
Slovenian: Aprotinin - polipeptid, ki je naravno prisoten v telesu - je zaviralec proteolitičnih encimov.
English: Therefore the CHMP concluded that the balance of risks and benefits for aminocaproic acid is positive under normal conditions of use subject to the revision of the indications as follows:
Slovenian: je odbor CHMP zaključil, da je razmerje med tveganji in koristmi za aminokaprojsko kislino pozitivno pri običajnih pogojih uporabe in z naslednjo revizijo indikacij:
English: It has a broad action on proteolytic enzymes such as plasmin, trypsin, and kallikrein.
Slovenian: Ima širok spekter delovanja na proteolitične encime, kot so plazmin, tripsin in kalikrein.
English: For some indications modifications to the wording were proposed, in order to bring them in line with current scientific knowledge on the use of EACA.
Slovenian: Za nekatere indikacije so bile predlagane spremembe besedila, da bi jih uskladili s sedanjimi znanstvenimi dognanji o uporabi aminokaprojske kisline.
English: Data available from randomised clinical trials and observational studies, including meta-analysis were considered.
Slovenian: Proučeni so bili razpoložljivi podatki iz randomiziranih kliničnih preskušanj in opazovalnih študij, vključno z metaanalizo.
English: The lysine analogues epsilon aminocaproic acid (EACA, also referred as aminocaproic acid) and tranexamic acid (TXA) inhibit more specifically the conversion of plasminogen to plasmin.
Slovenian: Analoga lizina epsilon aminokaprojska kislina (EACA, imenuje se tudi aminokaprojska kislina) in traneksamična kislina (TXA) bolj specifično zavirata pretvorbo plazminogena v plazmin.
English: In March 2010 Germany triggered an article 31 referral to assess the benefits and risks of the antifibrinolytic drugs aprotinin, EACA and TXA in all their approved indications.
Slovenian: Marca 2010 je Nemčija sprožila napotitveni postopek po členu 31 za oceno razmerja med tveganji in koristmi pri uporabi antifibrinolitičnih zdravil aprotinina, aminokaprojske kisline in traneksamične kisline za vse odobrene indikacije.
English: The preliminary results of a randomised controlled clinical trial, the ‘Blood conservation using antifibrinolytics: a randomised trial in a cardiac surgery population' (BART) study, had shown that although the use of aprotinin was associated with less serious bleeding than either of the comparator drugs, an increase in 30 day all-cause mortality had been observed among patients receiving aprotinin compared to patients taking other medicines.
Slovenian: Predhodni rezultati randomiziranega nadzorovanega kliničnega preskušanja, študije „Ohranjanje krvi z uporabo antifibrinolitikov: randomizirano preskušanje pri bolnikih po operaciji srca“ (BART), so pokazali, da so pri bolnikih, zdravljenih z aprotinininom, v 30-dnevnem obdobju opazili povečanje smrtnosti zaradi vseh vzrokov v primerjavi z bolniki, ki so jemali druga zdravila, čeprav je bila uporaba aprotinina povezana z manj resnimi krvavitvami kot katero koli od primerjalnih zdravil.
English: The results of the BART trial did not have a negative impact on the benefit risk profile of EACA.
Slovenian: Rezultati preskušanja BART niso negativno vplivali na profil koristi in tveganj za aminokaprojsko kislino.
English: Leukopenia, thrombocytopenia, BUN (blood urea nitrogen) increased and renal failure are adverse events which can be serious and have been reported, but these risks had not been considered in the current authorised product information.
Slovenian: Levkopenija, trombocitopenija, povišana raven sečninskega dušika v krvi in odpoved ledvic so neželeni učinki, ki so lahko resni in o katerih so poročali, toda ta tveganja niso bila upoštevana v podatkih o zdravilih, ki so trenutno odobrena.
English: Antifibrinolytics (e.g. aprotinin, aminocaproic acid and tranexamic acid), are a class of haemostatic agents used to prevent excessive blood loss.
Slovenian: Antifibrinolitiki (npr. aprotinin, aminokaprojska kislina in traneksamična kislina) so skupina hemostatikov, ki se uporabljajo za preprečevanje prekomerne izgube krvi.
English: The safety profile of EACA has evolved since its authorisation, and safety data has accumulated over the years.
Slovenian: Po odobritvi aminokaprojske kisline se je varnostni profil te učinkovine še povečal in podatkov o varnosti je bilo skozi leta čedalje več.
English: Taking into account all the available information on safety and efficacy, the Committee agreed on the variation of the marketing authorisation with the balance of the risks and benefits considered positive in the following revised indications for EACA:
Slovenian: Ob upoštevanju vseh razpoložljivih informacij o varnosti in učinkovitosti je Odbor pristal na spremembo dovoljenj za promet z zdravili, ker meni, da je razmerje med tveganji in koristmi pozitivno za naslednje revidirane indikacije za aminokaprojsko kislino:
English: Separate opinions and conclusions were issued by the CHMP for the three antifibrinolytics (aprotinin, EACA and TXA).
Slovenian: Odbor CHMP je za tri antifibrinolitike (aprotinin, aminokaprojsko kislino in traneksamično kislino) izdal ločena mnenja in sklepe.
English: Several data sources informed the opinion of the Committee, including available data from clinical studies, published literature, spontaneous reports and other data submitted by marketing authorisation holders (MAHs) of medicinal products containing aprotinin, EACA or TXA.
Slovenian: Na mnenje Odbora je vplivalo več virov podatkov, vključno z razpoložljivimi podatki iz kliničnih študij, objavljene literature in spontanih poročil ter z drugimi podatki, ki so jih predložili imetniki dovoljenj za promet z zdravili, ki vsebujejo aprotinin, aminokaprojsko kislino ali traneksamično kislino.
English: • The Committee considered that evidence from randomised clinical trials and observational studies support the use of aminocaproic acid in patients undergoing dental or surgical procedures or at risk of complications from bleeding.
Slovenian: • odbor meni, da dokazi iz randomiziranih kliničnih preskušanj in opazovalnih študij podpirajo uporabo aminokaprojske kisline pri bolnikih, ki imajo posege na zobeh in druge kirurške posege ter pri bolnikih, ki so v nevarnosti za zaplete zaradi krvavitve;
English: The CHMP considered also the adverse reactions profile, including new adverse events (some of which serious) associated with the use of EACA.
Slovenian: Upošteval je tudi profil neželenih učinkov, vključno z novimi neželenimi učinki (med katerimi je nekaj resnih), povezanih z uporabo aminokaprojske kisline;
English: • The Committee considered all data provided by the MAHs in writing, including data available from literature reviews.
Slovenian: • odbor je obravnaval vse podatke, ki so jih pisno predložili imetniki dovoljenj za promet z zdravili, vključno s podatki iz pregledov strokovne literature;
English: Overall summary of the scientific evaluation of referral on antifibrinolytics Aminocaproic acid containing medicinal products (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja napotitve za antifibrinolitike Zdravila, ki vsebujejo aminokaprojsko kislino (glejte Prilogo I)
English: On the basis of the above, the Committee recommended the variation to the terms of the marketing authorisation for the medicinal products containing aminocaproic acid referred to in Annex I for which the amendments to the product information are set out in annex III of the opinion.
Slovenian: Na podlagi navedenega je Odbor priporočil spremembo pogojev za dovoljenja za promet z zdravili, ki vsebujejo aminokaprojsko kislino, naštetimi v Prilogi I. Spremembe informacij o zdravilih so navedene v Prilogi III tega mnenja.
English: • In view of the identified serious limitations of the efficacy data, the available new evidence and/or current medical knowledge on the use of EACA, and considering the adverse reactions profile (some of which serious) associated with the use of EACA, the CHMP considered that for some of the therapeutic indications the benefits no longer outweigh the risks and therefore they should be removed.
Slovenian: • ob upoštevanju ugotovljenih resnih omejitev podatkov o učinkovitosti, razpoložljivih novih dokazov in/ali sedanjega medicinskega znanja o uporabi aminokaprojske kisline ter profila neželenih učinkov (med katerimi je nekaj resnih), povezanih z uporabo aminokaprojske kisline, je odbor CHMP menil, da za nekatere terapevtske indikacije koristi ne odtehtajo več tveganj, zato je te indikacije treba odstraniti;
English: In view of the identified serious limitations of the efficacy data, the available new evidence and/or current medical knowledge on the use of EACA, and considering the adverse reactions profile (some of which serious) associated with the use of EACA, the CHMP considered that some of these indications should be removed.
Slovenian: Ob upoštevanju ugotovljenih resnih omejitev podatkov o učinkovitosti, razpoložljivih novih dokazov in/ali sedanjega medicinskega znanja o uporabi aminokaprojske kisline ter profila neželenih učinkov (med katerimi je nekaj resnih), povezanih z uporabo aminokaprojske kisline, je odbor CHMP menil, da je treba nekatere od teh indikacij odstraniti.
English: Aminocaproic acid has also been associated with hypotension, nasal and conjunctival congestion, gastrointestinal disturbances (diarrhoea, nausea, vomiting, abdominal pain), dizziness, headache, tinnitus and ejaculation disorders; blood disorders (agranulocytosis, coagulation disorders), muscular damage, convulsions, anaphylactic reactions, renal impairment, and thrombotic complications.
Slovenian: Aminokaprojska kislina je bila povezana tudi s hipotenzijo, kongestijo nosu in veznice, prebavnimi motnjami (driska, slabost, bruhanje, bolečine v trebuhu), omotico, glavobolom, tinitusom in motnjami ejakulacije, boleznimi krvi (agranulocitoza, motnje koagulacije), poškodbami mišic, konvulzijami, anafilaktičnimi reakcijami, okvaro ledvic in trombotičnimi zapleti.
English: This document presents the conclusions on EACA.
Slovenian: V tem dokumentu so predstavljeni sklepi o aminokaprojski kislini.
English: In addition to cardiac surgery, the CHMP considered that sufficient evidence is available on the safety and efficacy of EACA in other indications, including in patients undergoing dental or surgical procedures or at risk of complications from bleeding.
Slovenian: Po mnenju odbora CHMP je poleg srčnih operacij na voljo dovolj dokazov o varnosti in učinkovitosti aminokaprojske kisline tudi za druge indikacije, vključno s posegi na zobeh in drugimi kirurškimi posegi ter v primeru nevarnosti za zaplete zaradi krvavitve.
English: Scientific conclusions and grounds for variation to the terms of the marketing authorisations for aminocaproic acid containing medicinal products presented by the EMA
Slovenian: Znanstveni zaključki in razlogi za spremembo pogojev dovoljenj za promet z zdravili z vsebnostjo aminokaprojske kisline, ki jih je predstavila Evropska agencija za zdravila
English: The CHMP recommended that information on leukopenia, thrombocytopenia, BUN increased and renal failure should be appropriately reflected through warnings and recommendations in the product information.
Slovenian: Odbor CHMP je priporočil, da morajo biti informacije o levkopeniji, trombocitopeniji, povišani ravni sečninskega dušika v krvi in okvari ledvic ustrezno predstavljene v informacijah o zdravilih kot opozorila in priporočila.
English: • The Committee considered the available scientific data, including evidence from new studies, on the efficacy of EACA.
Slovenian: • odbor CHMP je obravnaval razpoložljive znanstvene podatke o učinkovitosti aminokaprojske kisline, vključno z odkritji iz novih študij.
English: Grounds for amendment of the marketing authorisations of aminocaproic acid containing medicinal products listed in Annex I
Slovenian: Podlaga za spremembo dovoljenj za promet z zdravili, ki vsebujejo aminokaprojsko kislino, naštetimi v Prilogi I
English: In particular the therapeutic indications were updated to reflect current scientific knowledge on the use of EACA; other changes to the product information were inclusion of information on leukopenia, thrombocytopenia, blood urea nitrogen increased and renal failure as warnings and recommendations.
Slovenian: Posodobljene so bile zlasti terapevtske indikacije glede na sedanje znanstveno znanje o uporabi aminokaprojske kisline, druge spremembe informacij o zdravilih pa so vključitev informacij o levkopeniji, trombocitopeniji, povišani ravni sečninskega dušika v krvi in odpovedi ledvic v obliki opozoril in priporočil.
English: patients of all ages in haemorrhage caused by local or general fibrinolysis, including in Postsurgical haemorrhages in: - urology (surgery of the bladder and prostate) - gynaecology (cervical surgery), in patients where tranexamic acid is not available or not tolerated - obstetrics (post-partum and post-miscarriage haemorrhages) after correction of the coagulation defect - heart surgery (with or without bypass placement)
Slovenian: pri bolnikih vseh starosti za zdravljenje krvavitve, ki jo povzroči lokalna ali splošna fibrinoliza, vključno z: pooperativnimi krvavitvami - v urologiji (operacija sečnega mehurja in prostate), - v ginekologiji (operacija materničnega vratu), pri bolnicah, ki ne prenašajo traneksamične kisline ali pa ta ni na voljo,
English: The marketing authorisations of EACA and TXA were not affected by the initial 2007 review.
Slovenian: Prvi pregled v letu 2007 ni vplival na dovoljenja za promet z aminokaprojsko kislino in traneksamično kislino.
English: Postsurgical haemorrhages in: - urology (surgery of the bladder and prostate) - gynaecology (cervical surgery), in patients where tranexamic acid is not available or not tolerated - obstetrics (post-partum and post-miscarriage haemorrhages) after correction of the coagulation defect - heart surgery (with or without bypass placement) - gastroenterology - odonto-stomatology (dental extractions in haemophiliacs, patients undergoing anticoagulant therapy)
Slovenian: Aminokaprojska kislina je indicirana za uporabo pri bolnikih vseh starosti za zdravljenje krvavitve, ki jo povzroči lokalna ali splošna fibrinoliza, vključno z: pooperativnimi krvavitvami - v urologiji (operacija sečnega mehurja in prostate), - v ginekologiji (operacija materničnega vratu), pri bolnicah, ki ne prenašajo traneksamične kisline ali pa ta ni na voljo, - v porodništvu (krvavitve po porodu in po spontanem splavu) po korekciji koagulacijske napake, - pri srčnih operacijah (z vstavitvijo obvoda ali brez nje), - v gastroenterologiji, - v odontostomatologiji (izdrtje zob pri hemofilikih, bolniki, ki se zdravijo z antikoagulanti); smrtno nevarnimi krvavitvami, ki jih povzročijo trombolitiki (streptokinaza itn.); krvavitvami, povezanimi s trombocitopenijo, trombopenično purpuro, levkemijo; nekirurško hematurijo spodnjega dela sečil (zaradi cistitisa itn.); močnimi menstrualnimi krvavitvami, menoragijo in hemoragično metropatijo; angionevrotskim edemom.
English: The European Commission issued a decision on 6 February 2009.
Slovenian: Evropska komisija je odločbo izdala dne 6. februarja 2009.
English: Ref. EMEA/124262/2009
Slovenian: : EMEA/122016/2009
English: Implanon can protect for up to three years; at the end of this period the implant must be removed.
Slovenian: Zdravilo Implanon lahko daje zaščito do treh let; ob koncu tega obdobja je treba implantat odstraniti.
English: On 6 October 2008, the Dutch regulatory agency referred the matter to the CHMP.
Slovenian: Nizozemska regulatorna agencija je 6. oktobra 2008 zadevo napotila na CHMP.
English: London, 09 February 2009 Doc.
Slovenian: London, 9. februarja 2009 Sklic dok.
English: Additionally, the data on effectiveness in obese women in particular in the third year of use was considered insufficient.
Slovenian: Poleg tega je bilo prisotno mnenje, da so podatki glede učinkovitosti pri ženskah s prekomerno maso, še zlasti v tretjem letu uporabe, nezadostni.
English: This changes the body's hormonal balance and help to prevent ovulation.
Slovenian: S tem se spremeni telesno ravnovesje hormonov, kar pomaga preprečevati ovulacijo.
English: Why was Implanon reviewed?
Slovenian: Zakaj je bilo zdravilo Implanon pregledano?
English: Implanon is a female contraceptive.
Slovenian: Zdravilo Implanon je žensko kontracepcijsko sredstvo.
English: The CHMP also endorsed the changes to the product information for the medicine as agreed by the Coordination Group for the Mutual and Decentralised Procedures.
Slovenian: CHMP je poleg tega odobril spremembe v informacijah o zdravilu, o čemer se je dogovorila Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek.
English: The company wanted the renewal of authorisation to be recognised in all the EU Member States, as well as Norway and Iceland where the product is already authorised.
Slovenian: Družba je želela, da bi bilo podaljšanje dovoljenja za promet z zdravilom priznano v vseh državah članicah Evropske unije ter na Norveškem in Islandiji, kjer je zdravilo že odobreno.
English: The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Implanon.
Slovenian: Evropska agencija za zdravila (EMEA) je končala postopek arbitraže, do katerega je prišlo po nesoglasju med državami članicami Evropske unije glede odobritve zdravila Implanon.
English: It is presented as a small rod that is implanted by a doctor or a nurse using a special applicator just under the skin of the upper arm.
Slovenian: Na voljo je v obliki majhne palice, ki jo zdravnik ali sestra vsadita s posebnim aplikatorjem tik pod kožo nadlahti.
English: The grounds for the referral were concerns regarding the side effects related to insertion and removal of the implant, the risk of breast cancer, the incidence of irregular bleedings leading to premature removal of the implant.
Slovenian: Razlogi za napotitev so bili zadržki glede neželenih učinkov, povezanih z vstavitvijo in odstranitvijo implantata, tveganjem za raka na dojkah, pojavnostjo nerednih krvavitev, ki povzročijo prezgodnjo odstranitev implantata.