FrancophonIA/ELRC3.0 huggingface dataset:
English: Regarding the clinical use of the products, the CHMP was of the opinion, based on the last case of air embolism reported during an endoscopy procedure with Evicel, where the surgeon had limited visibility of the tissue surface, that the use of fibrin sealants with compressed gas should only be considered if it is possible to accurately judge the spraying distance.
Slovenian: Glede klinične uporabe teh zdravil je odbor CHMP na podlagi zadnjega primera zračne embolije, o katerem so poročali med endoskopijo z zdravilom Evicel, ko je imel kirurg omejen pogled na površino tkiva, menil, da je uporaba fibrinskih lepil za tkivo s stisnjenim plinom upravičena samo, če je mogoče natančno oceniti razdaljo pri pršenju.
English: With regards to safety, the CHMP noted that the main risk with sprayable fibrin sealants is the risk of air embolism, due air entering the vasculature.
Slovenian: Pri varnosti je odbor CHMP poudaril, da je glavno tveganje pri fibrinskih lepilih za tkivo za pršenje tveganje zračne embolije, saj pri tem v žile vstopa zrak.
English: The CHMP reviewed all cases of gas embolism reported with the use of sprayable fibrin sealants (including the cases reported with Quixil and Evicel).
Slovenian: Odbor je pregledal vse primere zračne embolije, o katerih so poročali pri uporabi fibrinskih lepil za tkivo za pršenje (vključno s primeri, o katerih so poročali pri zdravilih Quixil in Evicel).
English: For Tisseel and Tissucol, which are also recommended for use in laparoscopic procedures, a label for the pressure regulator with a symbol that informs about the correct pressure and distance laparoscopic procedures should also be provided.
Slovenian: Pri zdravilih Tisseel in Tissucol, ki se priporočata tudi za uporabo pri laparoskopskih posegih, je treba priložiti tudi oznako za tlačni regulator s simbolom, ki označuje pravilni tlak in razdaljo pri laparoskopskih posegih.
English: In addition, the MAH should ensure that all users of the spray application of those products are provided with labels for the pressure regulator with a symbol that informs about the correct pressure and distance in open surgery.
Slovenian: Poleg tega mora zagotoviti, da vsi uporabniki pršila s temi zdravili prejmejo oznake za tlačni regulator s simbolom, ki označuje pravilni tlak in razdaljo pri odprtem kirurškem posegu.
English: • The Committee considered all the cases of air embolism associated with the use of fibrinogensealants by spray application that have been reported and concluded that the reported cases had only occurred when the instructions for use were not followed.
Slovenian: • Odbor je upošteval vse sporočene primere zračne embolije, povezane z uporabo fibrinogenskih lepil za tkivo za pršenje, in sklenil, da so se sporočeni primeri zgodili samo, kadar se niso upoštevala navodila za uporabo.
English: From 2008 until May 2012, a total of eight cases of life-threatening air embolism were associated with the spray application of the fibrin sealants Quixil or Evicel (of which three had a fatal outcome, in one case no product was administered).
Slovenian: Od leta 2008 do maja 2012 je bilo z uporabo pršila fibrinskega lepila za tkivo Quixil ali Evicel povezanih skupno osem primerov smrtno nevarne zračne embolije (od katerih so imeli trije smrtni izid; v enem primeru se ni uporabilo nobeno zdravilo).
English: In one of the Quixil cases, the air embolism was caused by using pressurised air to dry the wound area, with a fatal outcome, although no product was administered.
Slovenian: Pri enem od primerov z zdravilom Quixil je zračno embolijo povzročil zrak pod tlakom, ki se je uporabil za sušenje rane, kar je povzročilo smrt, čeprav se ni uporabilo nobeno zdravilo.
English: Grounds for the variation to the terms of the marketing authorisation of Beriplast P
Slovenian: Podlaga za spremembo pogojev dovoljenja za promet z zdravilom Beriplast P
English: A single not well documented non-fatal case of a potential air embolism in association with Tisseel was reported in 2009.
Slovenian: Leta 2009 so poročali o enem slabo dokumentiranem nesmrtnem primeru morebitne zračne embolije, povezane z zdravilom Tisseel.
English: Tisseel/Tissucol use different pressure regulators for open surgery (pressurized air) and minimally invasive/laparoscopic procedures (pressurized CO2), respectively.
Slovenian: Pri zdravilih Tisseel/Tissucol se za odprti kirurški poseg (zrak pod tlakom) in minimalno invazivne/laparoskopske posege (CO2 pod tlakom) uporabljata različna tlačna regulatorja.
English: Finally, Tisseel/Tissucol and Artiss should only be sprayed using a pressure regulator that caps the maximum pressure at 2.0 bar in open wound surgery and using a pressure regulator device that deliver a maximum pressure of 1.5 bar and carbon dioxide gas only in minimally invasive/laparoscopic procedures.
Slovenian: Zdravila Tisseel/Tissucol in Artiss se smejo pršiti samo z uporabo tlačnega regulatorja, ki izklopi tlak pri 2,0 bara pri odprtem kirurškem posegu, in uporabo pripomočka za regulacijo tlaka, ki dovaja maksimalni tlak 1,5 bara in samo plin ogljikovega dioksida pri minimalno invazivnih/laparoskopskih posegih.
English: However, technical requirements when limiting spray application to CO2 gas were considered to add uncertainties to the clinical use of those products, e.g. in minimally invasive/laparoscopic surgery where the maximal pressure to be applied is 1.5 bar, the pressure regulator intended for open wound surgery that allows a higher pressure, could be used by mistake, or the handling associated with CO2 cylinders and respective pressure reducing connectors in the operating theatre.
Slovenian: Vendar je menil, da tehnične zahteve pri omejevanju pršenja s plinom CO2 prispevajo k negotovostim pri klinični uporabi teh zdravil, npr. pri minimalno invazivnih/laparoskopskih kirurških posegih, ko je najvišji dovoljeni tlak 1,5 bara, se lahko po nesreči uporabi tlačni regulator, namenjen za odprte kirurške posege, ki omogoča visok tlak, ali k ravnanju, povezanim z jeklenko CO2 in ustrezajočimi priključki za zniževanje tlaka v operacijski dvorani.
English: The CHMP however recommended the inclusion in the Product information of the warning that the risk of gas embolism appears to be higher when fibrin sealants are sprayed using air, as compared to CO2 and cannot be excluded with Tisseel/Tissucol and Artiss when sprayed in open wound surgery.
Slovenian: Vendar je priporočil, da se v informacije o zdravilu vključi opozorilo, ki navaja, da je tveganje plinske embolije večje, kadar se fibrinsko lepilo za tkivo prši z zrakom v primerjavi s CO2, in ga ni mogoče izključiti pri zdravilih Tisseel/Tissucol in Artiss, kadar se uporabljajo pri odprtih kirurških posegih.
English: • The Committee reviewed all the data provided by the MAH in writing and in the oral explanation and the outcome of the ad-hoc expert advisory group meeting;
Slovenian: • Odbor je pregledal vse podatke, ki jih je zagotovil imetnik dovoljenja za promet z zdravilom v pisni obliki in po ustnem pojasnilu, in zaključke sestanka začasne strokovne skupine.
English: On 15 November 2012, the CHMP concluded the review of Quixil (for which four cases of lifethreatening air embolism were reported) and agreed that the benefit-risk balance of Quixil as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis is positive under normal conditions of use, subject to changes to the product information and implementation of risk minimisation measures, including educational materials and training to be provided to users of the product.
Slovenian: Odbor CHMP je 15. novembra 2012 zaključil pregled za zdravilo Quixil (pri katerem so poročali o štirih primerih zračne embolije) in sklenil, da je razmerje med tveganji in koristmi zdravila Quixil kot podpornega zdravljenja za izboljšanje hemostaze pri kirurških posegih, kadar standardne kirurške tehnike niso zadostne, pozitivno pri normalnih pogojih uporabe, da je treba spremeniti informacije o zdravilu ter uvesti ukrepe za čim večje zmanjšanje tveganja, vključno z izobraževalnim gradivom in usposabljanjem, ki ga je treba zagotoviti uporabnikom zdravila.
English: Having considered all available data, the MAH's responses and the ad-hoc advisory group recommendations, the CHMP identified and agreed upon a number of risk minimisation measures to be implemented by the MAH to reduce the risk of air/gas embolism associated with the spray use of Tisseel, Tissucol and Artiss.
Slovenian: Po obravnavi vseh razpoložljivih podatkov, odzivov imetnikov dovoljenj za promet z zdravili in priporočil začasne svetovalne skupine je odbor CHMP ugotovil in odobril številne ukrepe za čim večje zmanjšanje tveganja, ki jih mora uvesti imetnik dovoljenja za promet z zdravilom za zmanjšanje tveganja zračne/plinske embolije, povezane s pršenjem zdravil Tisseel, Tissucol in Artiss.
English: • The Committee, as a consequence, concluded that the benefit-risk balance of the spray application of Beriplast P is positive under normal conditions of use, subject to changes to the product information.
Slovenian: • Odbor je posledično sklenil, da je razmerje med tveganji in koristmi pršila Beriplast P pozitivno pri normalnih pogojih uporabe, če se uvedejo spremembe informacij o zdravilu,
English: The risk of air embolism with this product was therefore considered negligible by the CHMP.
Slovenian: Odbor CHMP je zato menil, da je tveganje zračne embolije pri tem zdravilu zanemarljivo.
English: However the CHMP noted that to date, only one non-fatal case of air embolism has been reported for these products as compared to the 8 cases of air embolism (including 3 cases with fatal outcome) reported with Quixil and Evicel.
Slovenian: Vendar je poudaril, da so pri teh zdravilih do danes poročali samo o enem nesmrtnem primeru zračne embolije, medtem ko so pri zdravilih Quixil in Evicel poročali o osmih primerih zračne embolije (vključno s tremi primeri s smrtnim izidom).
English: • The Committee, as a consequence, concluded that the benefit-risk balance of the spray application of fibrinogen-sealants is positive under normal conditions of use, subject to the agreed risk minimisation measures, including changes to the product information.
Slovenian: • Odbor je posledično sklenil, da je razmerje med tveganji in koristmi pršila fibrinogenskih lepil za tkivo pozitivno pri normalnih pogojih uporabe, če se uvedejo odobreni ukrepi za zmanjševanje tveganja, vključno s spremembami informacij o zdravilu,
English: The MAHs provided responses to a request from the CHMP to discuss the merits and feasibility of any risk minimisation measures which could be introduced in order to improve the benefit/risk of Tisseel, Tissucol and Artiss spray application.
Slovenian: Imetniki dovoljenj za promet z zdravilom so predložili odzive na zahtevo odbora CHMP, ki vsebujejo razprave o utemeljitvah in izvedljivosti ukrepov za čim večje zmanjšanje tveganja, ki bi se lahko uvedli za izboljšanje razmerja med tveganji in koristmi pri nanosu pršil Tisseel, Tissucol in Artiss.
English: Therefore the CHMP recommended the variation to the terms of the Marketing Authorisations for the Beriplast P medicinal products (and associated names) referred to in Annex I, in accordance to the amendments to the Summary of Product Characteristics and Package Leaflet set out in Annex III.
Slovenian: je odbor CHMP priporočil spremembo pogojev dovoljenj za promet z zdravilom Beriplast P (in povezanih imen) iz Priloge I skladno s spremembami povzetka glavnih značilnosti zdravila in navodila za uporabo, določenih v Prilogi III.
English: Therefore the CHMP recommended the variation to the terms of the Marketing Authorisations for the Tisseel/Tissucol and Artiss medicinal products (and associated names) referred to in Annex I, in accordance to the amendments to the Summary of Product Characteristics and Package Leaflet set out in Annex III and subject to the conditions set out in Annex IV.
Slovenian: je odbor CHMP priporočil spremembo pogojev dovoljenj za promet z zdravili Tisseel/Tissucol in Artiss (in povezanih imen) iz Priloge I skladno s spremembami povzetka glavnih značilnosti zdravila in navodila za uporabo, določenih v Prilogi III, in pod pogoji, določenimi v Prilogi IV.
English: The Committee agreed that the benefit-risk balance of Evicel was positive under normal conditions of use, subject to similar risk minimisation measures (including changes to the Product Information) as for Quixil.
Slovenian: Sklenil je, da je razmerje med tveganji in koristmi zdravila Evicel pozitivno pri normalnih pogojih uporabe in da je treba uvesti podobne ukrepe za čim večje zmanjšanje tveganja (vključno s spremembami informacij o zdravilu) kot pri zdravilu Quixil.
English: Having considered all the available data, including the MAH responses provided in writing and during oral explanations and the conclusions of the Ad-hoc Expert meeting, the CHMP agreed that the benefitrisk balance of Tisseel, Tissucol and Artiss in their approved indications, is positive under normal conditions of use, subject to the changes to the product information, (see Annex III), together with the agreed risk minimisation measures (see Annex IV) and the agreed Direct Healthcare Professional Communication.
Slovenian: Na podlagi vseh razpoložljivih podatkov, vključno z odzivi imetnika dovoljenja za promet z zdravilom v pisni obliki in v obliki ustnega pojasnila ter zaključki sestanka začasne strokovne skupine, je odbor CHMP sklenil, da je razmerje med tveganji in koristmi zdravil Tisseel, Tissucol in Artiss pri njihovih odobrenih indikacijah pozitivno pri normalnih pogojih uporabe ter da je treba spremeniti informacije o zdravilih (glejte Prilogo III) skupaj s potrjenimi ukrepi za zmanjševanje tveganja (glejte Prilogo IV) in dogovorjenim neposrednim obvestilom za zdravstvene delavce.
English: Having considered all the available data, including the MAH written responses and the conclusions of the Ad-hoc Expert meeting, the CHMP agreed that the benefit-risk balance of Beriplast P as supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis (including endoscopic treatment of bleeding gastro-duodenal ulcer) and as a tissue to promote adhesion/sealing or as suture support, is positive under normal conditions of use, subject to the changes to the product information, (see Annex III).
Slovenian: Na podlagi vseh razpoložljivih podatkov, vključno z odzivi imetnika dovoljenja za promet z zdravilom v pisni obliki in zaključki sestanka začasne strokovne skupine, je odbor CHMP sklenil, da je razmerje med tveganji in koristmi zdravila Beriplast P kot podpornega zdravljenja, kadar standardne kirurške tehnike niso zadostne za izboljšanje hemostaze (vključno z endoskopskim zdravljenjem krvavečih gastrično-duodenalnih ulkusov), in kot tkiva za spodbujanje adhezije/tesnjenja ali kot podpore za suture pozitivno pri normalnih pogojih uporabe, če se v informacije o zdravilu vključijo spremembe (glejte Prilogo III).
English: • The Committee reviewed all the data provided by the MAH in writing and the outcome of the adhoc expert advisory group meeting;
Slovenian: • Odbor je pregledal vse podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom v pisni obliki, in podatke sestanka začasne strokovne skupine.
English: Appropriate means of achieving a tissue surface that is as dry as possible should be used and changes in blood pressure, pulse, oxygen saturation and end tidal CO2 should be monitored during application of those products by spray because of the possibility of occurrence of air or gas embolism.
Slovenian: Zaradi možnosti pojava zračne ali plinske embolije je treba med pršenjem teh zdravil uporabiti ustrezna sredstva za doseganje čim bolj suhe površine tkiva ter spremljati spremembe krvnega tlaka, srčnega utripa, nasičenosti s kisikom in tlaka CO2 na koncu izdiha.
English: With regard to the efficacy of sprayable fibrin sealants, the CHMP assessed the available information, including data submitted by the MAHs.
Slovenian: Odbor CHMP je ocenil razpoložljive podatke glede učinkovitosti fibrinskih lepil za tkivo za pršenje, vključno s podatki, ki so jih predložili imetniki dovoljenj za promet z zdravilom.
English: Date of first authorisation: 16 January.2007 Date of latest renewal: 21 November 2011
Slovenian: Datum prve odobritve: 16. januar 2007 Datum zadnjega podaljšanja: 21. november 2011
English: (It is also better to avoid Copalia in early pregnancy, see Pregnancy section).
Slovenian: (Zdravilu Copalia se je bolje izogibati tudi v zgodnji nosečnosti, glejte poglavje Nosečnost).
English: In two long-term follow-up studies the effect of Copalia was maintained for over one year.
Slovenian: V dveh dolgoročnih spremljevalnih študijah se je učinek zdravila Copalia ohranil več kot eno leto.
English: See also information under the heading “Do not take Copalia”.
Slovenian: Glejte tudi informacije pod naslovom “Ne jemljite zdravila Copalia”.
English: Copalia with food and drink
Slovenian: Zdravilo Copalia skupaj s hrano in pijačo
English: Copalia and older people (age 65 years or over) Your doctor should exercise caution when increasing your dose.
Slovenian: Zdravilo Copalia in starejši ljudje (stari 65 let ali več) Zdravnik mora biti pri zviševanju vašega odmerka previden.
English: Your doctor will normally advise you to stop taking Copalia before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Copalia.
Slovenian: Zdravnik vam bo praviloma svetoval, da prenehate z jemanjem zdravila Copalia še preden zanosite oziroma takoj, ko ugotovite da ste noseči in vam bo svetoval jemanje drugega zdravila namesto zdravila Copalia.
English: What Copalia is and what it is used for
Slovenian: Kaj je zdravilo Copalia in za kaj ga uporabljamo
English: Copalia is not recommended in early pregnancy (first 3 months), and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Slovenian: Jemanje zdravila Copalia v zgodnjem obdobju nosečnosti (v prvih 3 mesecih) ni priporočljivo, če pa ste noseči več kot 3 mesece, ga ne smete jemati, ker lahko uporaba po tretjem mesecu nosečnosti povzroči resno škodo vašemu otroku.
English: It is recommended to take Copalia with some water.
Slovenian: Zdravilo Copalia je priporočljivo vzeti z malo vode.
English: Patients taking Copalia and driving vehicles or using machines should take into account that dizziness or weariness may occasionally occur.
Slovenian: Bolniki, ki jemljejo zdravilo Copalia in vozijo motorna vozila ali uporabljajo stroje, morajo upoštevati, da se lahko občasno pojavi omotica ali utrujenost.
English: The safety of Copalia has been evaluated in five controlled clinical studies with 5,175 patients, 2,613 of whom received valsartan in combination with amlodipine.
Slovenian: Varnost zdravila Copalia so ocenjevali v petih kontroliranih kliničnih študijah s 5.175 bolniki, od katerih jih je 2.613 prejemalo valsartan v kombinaciji z amlodipinom.
English: Do not take Copalia if you are allergic to amlodipine or to any other calcium channel blockers.
Slovenian: Ne jemljite zdravila Copalia če ste alergični na amlodipin ali na katerikoli zaviralec kalcijevih kanalčkov.
English: Children and adolescents The use of Copalia in children and adolescents is not recommended (aged below 18 years old).
Slovenian: Otroci in mladostniki Zdravila Copalia ni priporočljivo uporabljati pri otrocih in mladostnikih (starih manj kot 18 let).
English: The safety and efficacy of Copalia in children aged below 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila Copalia pri otrocih, starih manj kot 18 let, nista bili dokazani.
English: The usual dose of Copalia is one tablet per day.
Slovenian: Običajni odmerek zdravila Copalia je ena tableta na dan.
English: Other medicines and Copalia
Slovenian: Druga zdravila in zdravilo Copalia
English: To date there is no experience of the safe use of Copalia in patients who have had a recent kidney transplantation.
Slovenian: Doslej ni izkušenj glede varnosti uporabe zdravila Copalia pri bolnikih, ki jim je bila nedavno presajena ledvica.
English: Stopping your treatment with Copalia may cause your disease to get worse.
Slovenian: Če prenehate jemati zdravilo Copalia, se lahko vaša bolezen poslabša.
English: Other possible side effects of Copalia:
Slovenian: Drugi možni neželeni učinki zdravila Copalia:
English: The recommended dose of Copalia is one tablet per day.
Slovenian: Priporočeni odmerek zdravila Copalia je ena tableta na dan.
English: If you think you may be allergic, talk to your doctor before taking Copalia.
Slovenian: Če domnevate, da bi lahko bili alergični, se posvetujte z zdravnikom, preden vzamete zdravilo Copalia.
English: Abrupt withdrawal of Copalia has not been associated with a rapid increase in blood pressure.
Slovenian: Nenadna prekinitev zdravila Copalia ni povezana s hitrim zvišanjem krvnega tlaka.
English: What you need to know before you take Copalia
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Copalia
English: You can take Copalia with or without food.
Slovenian: Zdravilo Copalia lahko vzamete s hrano ali brez nje.
English: If you have taken too many tablets of Copalia, or if someone else has taken your tablets, consult a doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Copalia, kot bi smeli Če ste vzeli preveč tablet zdravila Copalia, ali je vaše tablete vzel kdo drug, se takoj posvetujte z zdravnikom.
English: No drug-drug interaction studies have been performed with Copalia and other medicinal products.
Slovenian: Študij medsebojnega delovanja z zdravilom Copalia in drugimi zdravili niso izvedli.
English: For convenience, patients receiving valsartan and amlodipine from separate tablets/capsules may be switched to Copalia containing the same component doses.
Slovenian: Zaradi praktičnosti je možno bolnike, ki dobivajo valsartan in amlodipin v ločenih tabletah/kapsulah, prevesti na zdravilo Copalia, ki vsebuje enaka odmerka sestavin.
English: If a diurectic is also used, the risk of lithium toxicity may presumably be increased further with Copalia.
Slovenian: Če je uporabljen tudi diuretik, uporaba zdravila Copalia predvidoma poveča toksične učinke litija.
English: Do not take Copalia with grapefruit or grapefruit juice.
Slovenian: Zdravila Copalia ne zaužijte skupaj z grenivko ali z grenivkinim sokom.
English: Frequency Copalia Amlodipine Valsartan
Slovenian: Pogostnost Copalia Amlodipin Valsartan
English: You should never take Copalia again.
Slovenian: V tem primeru zdravila Copalia nikoli več ne smete več jemati.
English: The amlodipine component of Copalia inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Slovenian: Amlodipin v zdravilu Copalia zavira transmembranski vstop kalcijevih ionov v srčne in žilne gladke mišice.
English: What Copalia is and what it is used for What you need to know before you take Copalia How to take Copalia
Slovenian: Kaj je zdravilo Copalia in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Copalia Kako jemati zdravilo Copalia Možni neželeni učinki
English: Copalia has not been studied in any patient population other than hypertension.
Slovenian: Zdravilo Copalia ni raziskano pri nobeni drugi populaciji razen pri bolnikih s hipertenzijo.
English: • Concomitant use of Copalia with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Slovenian: • Sočasna uporaba zdravila Copalia in zdravil, ki vsebujejo aliskiren, je kontraindicirana pri bolnikih s sladkorno boleznijo ali z okvaro ledvic (GFR <60 ml/min/1,73m2) (glejte poglavji 4.5 in 5.1).
English: Copalia is available in packs containing 7, 14, 28, 30, 56, 90, 98 or 280 tablets and in multipacks comprising 4 cartons, each containing 70 tablets, or 20 cartons, each containing 14 tablets.
Slovenian: Zdravilo Copalia je na voljo v pakiranjih, ki vsebujejo 7, 14, 28, 30, 56, 90, 98 ali 280 tablet in v skupnih pakiranjih s 4 škatlami, od katerih vsaka vsebuje 70 tablet, ali z 20 škatlami, od katerih vsaka vsebuje 14 tablet.
English: If you forget to take Copalia
Slovenian: Če ste pozabili vzeti zdravilo Copalia