natgillin/translations-raw huggingface dataset:
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S)
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SESTAVIN Učinkovina: itrakonazol
Therefore if suspected adverse reactions related to this medicine, such as vomiting, loss of appetite or weight loss occur, the dose should be lowered, or treatment with the medicinal product should be discontinued.
Če sumite na neželene učinke, kot so bruhanje, izguba apetita ali izguba telesne mase, je treba zmanjšati odmerek ali prekiniti zdravljenje s tem zdravilom.
A graduated polypropylene oral syringe is also included.
Priložena je tudi brizga za peroralno dajanje iz polipropilen z oznakami količine.
Emesis, anorexia and weight loss have commonly been observed in treated birds, however, these adverse reactions are usually mild and dose related.
Pri zdravljenih pticah so pogosto opazili bruhanje, anoreksijo in izgubo telesne mase, vendar so ti učinki navadno blagi in odvisni od odmerka.
It also affects membrane-bound enzyme function and membrane permeability, and as this effect is irreversible it results in structural degeneration of the fungus.
Ker ta učinek ni reverzibilen, povzroči strukturno degeneracijo glivic.
No information on overdose is currently available in the target species (see section 4.6.
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Podatki o prevelikem odmerjanju pri ciljnih živalskih vrstah trenutno niso na voljo (glejte poglavje 4.6.
Therefore if suspected adverse reactions such as emesis, anorexia or weight loss occur, the dose should be lowered, or treatment with the medicinal product should be discontinued.
Če sumite na neželene učinke, kot so bruhanje, anoreksija ali izguba telesne mase, je treba zmanjšati odmerek ali prekiniti zdravljenje s tem zdravilom.
Fungitraxx 10 mg/ml oral solution itraconazole
Fungitraxx 10 mg/ml peroralna raztopina itrakonazol
Propylene glycol
peroralna raztopina
Remove the screw cap on the bottle.
S steklenice odstranite navojno zaporko.
For the treatment of African Grey Parrots use no more than 5 mg (0.5 ml) itraconazole per kg bodyweight per day for 14 days (see section 4.5).
Pri zdravljenju afriških sivih papig ne smete preseči odmerka 5 mg (0,5 ml) itrakonazola na kg telesne mase na dan, za 14 dni (glejte poglavje 4.5).
Replace the screw cap after use.
Po uporabi ponovno namestite navojno zaporko.
For the treatment of African Grey Parrots (see section 4.5) use no more than 5 mg (0.5 ml) itraconazole per kg bodyweight per day.
Pri zdravljenju afriških sivih papig (glejte poglavje 4.5) ne smete preseči odmerka 5 mg (0,5 ml) itrakonazola na kg telesne mase na dan.
PACKAGE LEAFLET FOR: Fungitraxx 10 mg/ml oral solution for ornamental birds
NAVODILO ZA UPORABO: Fungitraxx 10 mg/ml peroralna raztopina za okrasne ptice
For the treatment of African Grey Parrots use no more than 5 mg (0.5 ml) itraconazole per kg bodyweight per day for 14 days (see section “Special warnings”).
Pri zdravljenju afriških sivih papig ne smete preseči odmerka 5 mg (0,5 ml) itrakonazola na kg telesne mase na dan, za 14 dni (glejte poglavje Posebno(a) opozorilo(a)).
Fungitraxx 10 mg/ml oral solution for ornamental birds itraconazole
Fungitraxx 10 mg/ml peroralna raztopina za okrasne ptice itrakonazol
For the treatment of African Grey Parrots (see section “Special warnings”) use no more than 5 mg (0.5 ml) itraconazole per kg bodyweight per day.
Pri zdravljenju afriških sivih papig (glejte poglavje Posebno(a) opozorilo(a)) ne smete preseči odmerka 0.5 mg (0,5 ml) itrakonazola na kg telesne mase na dan.
Fungitraxx 10 mg/ml oral solution for ornamental birds
Fungitraxx 10 mg/ml peroralna raztopina za okrasne ptice
Bottle (10 ml and 50 ml)
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH Steklenica (10 ml in 50 ml)
Outer carton
Rp-Vet
Pharmaceutical Form Route of Administration Packaging
Jakost farmacevtska oblika pot uporabe
Package size
Ovojnina velikost pakiranja
No other details were provided.
Predložene niso bile nobene druge podrobnosti.
Inappropriate distance from the tissue surface
1. neustrezna razdalja od površine tkiva,
As a result, gas embolism may occur even with a reduced pressure.
Posledično se lahko plinska embolija pojavi tudi pri znižanemu tlaku.
Benefit Risk balance
Razmerje med koristmi in tveganji
The active ingredients for these products vary, with the main difference being the antifibrinolytic component.
Zdravilne učinkovine v teh zdravilih so različne, pri čemer je glavna razlika v antifibrinolitični sestavini.
The CHMP agreed that the DHPC should be circulated to all users of those products in Europe, no later than 15 January 2013.
Sklenil je, da je treba obvestilo DHPC poslati vsem uporabnikom teh zdravil v Evropi najkasneje do 15. januarja 2013.
Tisseel and Tissucol differ in terms of Factor XIII content.
Zdravili Tisseel in Tissucol se razlikujeta glede na vsebnost faktorja XIII.
It is not recommended for use in laparoscopic surgery.
Ni priporočljivo za uporabo pri laparoskopskih kirurških posegih.
Beriplast P, Tisseel, Tissucol and Artiss contain aprotinin, whereas Quixil contains tranexamic acid.
Zdravila Beriplast P, Tisseel, Tissucol in Artiss vsebujejo aprotinin, medtem ko zdravilo Quixil vsebuje traneksaminsko kislino.
The experts unanimously agreed that the risk of air embolism is not related to the medicinal product itself but to the device design and its misuse in practice.
Strokovnjaki so bili soglasni, da tveganje zračne embolije ni povezano s samim zdravilom, ampak z zasnovo pripomočka in napačno uporabo v praksi.
Excessive pressure
2. čezmerni tlak,
Beriplast P is not sprayed using automated pressure regulator.
Zdravilo Beriplast P se ne prši z uporabo samodejnega tlačnega regulatorja.
Annex II Scientific conclusions and grounds for variation to the terms of the Marketing Authorisations
Priloga II Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravilom
CHMP considered restricting spray application of these products to CO2 gas only.
Odbor CHMP je razmislil o omejitvi uporabe pršenja teh zdravil samo na plin CO2.
• The Committee considered the procedure under Article 31 of Directive 2001/83/EC fibrinogencontaining solutions for sealant authorised for administration by spray application;
• Odbor je obravnaval postopek v skladu s členom 31 Direktive 2001/82/ES za raztopine za lepilo, ki vsebujejo fibrinogen, odobrene za uporabo s pršenjem.
In minimally invasive/laparoscopic procedures (Tisseel/Tissucol), only carbon dioxide gas should be used.
Pri minimalno invazivnih/laparoskopskih posegih (Tisseel/Tissucol) se sme uporabljati samo ogljikov dioksid.
The CHMP agreed on a Direct Healthcare Professional Communication (DHPC), to communicate the outcome of the present review.
CHMP se je dogovoril glede neposrednega obvestila zdravstvenim delavcem (DHPC - Dear Healthcare Professional Communication), da se jim sporoči izid tega pregleda.
Tisseel/Tissucol and Artiss
Tisseel/Tissucol in Artiss
Artiss is only indicated for subcutaneous use.
Zdravilo Artiss je indicirano samo za subkutano uporabo.
Evicel was sprayed antero-laterally via pressure regulator with N2 (nitrogen) for a single two-second burst at approximately 2½ to 3 centimetres with reduced pressure of 8 (eight) PSI.
Zdravilo Evicel se je razpršilo anteriorno-lateralno prek tlačnega regulatorja z N2 (dušikom) z enim dvosekundnim sunkom na razdalji približno 2,5 do 3 centimetre in z znižanim tlakom 8 (osem) PSI.
Following this, the UK's Medicines and Healthcare products Regulatory Agency triggered a procedure under Article 31 on 24 May 2012, requesting the CHMP to carry out the same assessment for the other fibrin sealants available in the EU, i.e. Quixil, Tissucol, Tisseel, Artiss, Beriplast P, and associated names (see Annex I).
Po tem je regulativna agencija Združenega kraljestva za zdravila in medicinske pripomočke 24. maja 2012 sprožila postopek v skladu s členom 31, s katerim je odbor CHMP zaprosila, da opravi enako oceno za druga fibrinska lepila za tkivo, ki so na voljo v EU, tj. Quixil, Tissucol, Tisseel, Artiss, Beriplast P in povezana imena (glejte Prilogo I).
The CHMP also concluded the Article 20 review on Evicel.
Odbor CHMP je prav tako končal pregled zdravila Evicel v skladu s členom 20.
They were of the opinion that CO2 should be used instead of air as a safety precaution because of the markedly lower risk of gas embolism due to the high solubility of CO2 in the blood.
Menili so, da je treba kot varnostni ukrep uporabiti CO2 zaradi občutno manjšega tveganja zračne embolije zaradi velike topnosti CO2 v krvi.
They also recommended that appropriate educational materials and training for healthcare professionals to administer the product correctly (at the recommended distance and pressure for spray application) is required.
Prav tako so priporočali, da sta potrebna ustrezno izobraževalno gradivo in usposabljanje za zdravstvene delavce za pravilno uporabo zdravila (s priporočeno razdaljo in tlakom za nanos pršila).
This report only reflects the assessment of Tisseel/Tissucol, Artiss and Beriplast P.
To poročilo vključuje samo oceno zdravil Tisseel/Tissucol, Artiss in Beriplast P.
The anticipated benefit of mandating CO2 use in open surgery may not outweigh the risks linked to inappropriate use of Tisseel/ Tissucol and Artiss.
Pričakovana korist nujne uporabe CO2 pri odprtih kirurških posegih morda ne bo večja od tveganj, povezanih z neustrezno uporabo zdravil Tisseel/Tissucol in Artiss.
During the Article 31 procedure, the CHMP also noted a new case of gas embolism reported with the use of Evicel during laser prostatectomy.
Med postopkom v skladu s členom 31 je odbor prav tako ugotovil nov primer plinske embolije, o kateri so poročali pri uporabi zdravila Evicel med lasersko prostatektomijo.
Clear instructions to surgeons with regard to the distances and pressures recommended and the pressurised gas to be used should be provided and the use should be restricted to experienced surgeons who have been trained in the use of those products.
Kirurgom je treba dati jasna navodila glede priporočene razdalje, tlaka in plina pod tlakom, uporaba pa mora biti omejena na izkušene kirurge, usposobljene za uporabo teh zdravil.
In particular, the MAH was requested to ensure that all users of the spray application are provided with adequate educational material on the correct use of the product and are offered an educational program which teaches the content of the mentioned educational material.
Imetnik dovoljenja za promet z zdravilom je bil zlasti naprošen, naj vsem uporabnikom pršila zagotovi zadostno izobraževalno gradivo o pravilni uporabi zdravila in jim ponuditi program usposabljanja, v okviru katerega se bodo poučili o vsebini navedenega izobraževalnega gradiva.
Although there are instructions in the current product labelling for use regarding the pressure that must be set and the distance from the bleeding tissue that must be maintained during the spray application in order to avoid forcing gas into the vasculature and the risk of air embolism, there is a concern that these instructions are not always being adhered to, leading to a risk of air embolism.
Čeprav obstajajo navodila v trenutnem označevanju zdravila glede tlaka, ki ga je treba nastaviti, in razdalje od krvavečega tkiva, ki jo je treba vzdrževati med pršenjem, da se preprečita vstop plina v žile in tveganje zračne embolije, je prisoten pomislek, da se ta navodila ne upoštevajo vedno, kar povzroči tveganje zračne embolije.
The CHMP therefore considered that correct administration of sprayable fibrin sealants is essential to reduce this risk and focused its assessment on the identification of measures that would be necessary and adequate to minimise this risk.
Zato je menil, da je pravilna uporaba fibrinskih lepil za tkivo za pršenje nujna za zmanjševanje tveganja, in svojo oceno usmeril na ugotavljanje ukrepov, potrebnih in zadostnih za čim večje zmanjšanje tveganja.
Despite risk mitigation activities put in place between August 2010 and early 2011 for Quixil and Evicel, including: 1) a direct healthcare professional communication regarding a change in product labelling, 2) field safety notification for the pressure regulator including change in the instructions for use, and 3) updated customer training programs, two new cases of air embolism (and a third case was received during the referral procedure) have been reported following use of the spray application of Evicel (one non-fatal case in August 2011 and a fatal case in January 2012).
Kljub ukrepom za zmanjšanje tveganja, ki so se za zdravili Quixil in Evicel uvedli med avgustom 2011 in začetkom leta 2011, vključno z: 1) neposredno komunikacijo z zdravstvenimi delavci glede spremembe označevanja zdravila, 2) obvestilom o varnostnem popravljalnem ukrepu za tlačni regulator, vključno s spremembo navodila za uporabo, in 3) posodobljenimi programi za usposabljanje strank, so po uporabi pršila zdravila Evicel poročali o dveh novih primerih zračne embolije (enem nesmrtnem primeru avgusta 2011 in enem smrtnem primeru januarja 2012; med napotitvenim postopkom pa so prejeli še poročilo o tretjem primeru).
Considering the limited evidence of risk of air embolism with those specific products (Tisseel/Tissucol and Artiss), CHMP concluded that beyond the above mentioned risk minimisation measures no further actions were deemed justified.
Glede na omejene dokaze o tveganju zračne embolije pri teh zdravilih (Tisseel/Tissucol in Artiss) je odbor CHMP sklenil, da razen zgoraj omenjenih ukrepov za zmanjševanje tveganja niso upravičeni nobeni drugi ukrepi.
The experts agreed that sprayable fibrin sealants are recommended when there is a large surface area of surgical bleeding, generally oozing, and that not using sprayable fibrin sealants in these cases would lead to an increased use of other blood products, which would lead to a higher risk of complications.
Strokovnjaki so se strinjali, da se fibrinska lepila za tkivo za pršenje priporočajo, kadar je površina kirurške krvavitve velika, navadno z izcejanjem, in da bi neuporaba fibrinskih lepil za tkivo za pršenje v teh primerih povzročila povečano uporabo drugih krvnih produktov, kar bi pripeljalo do večjega tveganja zapletov.
This case highlights the problems with the application of sprayable fibrin sealants during endoscopic procedures, where it is not always feasible to accurately judge the distance from the target tissue when spraying.
Ta primer je izpostavil težave z uporabo pršilnih fibrinskih lepil za tkivo med endoskopskimi posegi, kadar ni vedno mogoče točno oceniti razdalje od ciljnega tkiva med pršenjem.
Scientific Discussion
Znanstvena razprava
Furthermore, the device design should have a specific gas pressure governor to be used with the spray applicator and with a limit not above the maximal optimal pressure recommended.
Poleg tega bi morala zasnova pripomočka vključevati posebni regulator zračnega tlaka, ki bi se uporabljal s pripomočkom za nanašanje pršila, in ki bi imel omejitev, ki ne presega najvišjega priporočenega optimalnega tlaka.
When applied by spraying and in order to achieve a sufficiently fine and uniform spray, the syringe containing the fibrin and thrombin components is usually connected to a supply of gas through a pressure regulator.
Če se nanese s pršenjem in tako, da se doseže zadostno fino in enakomerno pršenje, se injekcijska brizga, ki vsebuje fibrinske in trombinske sestavine, navadno priključi na vir plina prek tlačnega regulatorja.
The CHMP also noted that there appears to be evidence for the need to use the combination spray sealants in situations where there is significant blood loss from a wide surface area and the survival of the patient is threatened.
Prav tako je poudaril, da obstajajo dokazi o potrebi po uporabi kombiniranih pršilnih lepil za tkivo, kadar je prisotna velika izguba krvi na veliki površini in kadar je ogroženo življenje bolnika.
The CHMP therefore concluded that the available evidence supports the efficacy and use of fibrinogen-containing sealants in the approved indications.
Zato je sklenil, da razpoložljivi dokazi podpirajo učinkovitost in uporabo lepil za tkivo, ki vsebujejo fibrinogen, za odobrene indikacije.
• The Committee agreed on a number of risk minimisation measures, including changes to the product information regarding the use of the product as well as educational materials and training to be provided to users of the product, which adequately addressed the identified risk of air embolism;
• Odbor je določil število ukrepov za zmanjševanje tveganja, vključno s spremembami informacij o zdravilu glede uporabe zdravila ter izobraževalnega gradiva in usposabljanja, ki ga je treba zagotoviti za uporabnike zdravila, v katerem bo zadostno obravnavano ugotovljeno tveganje zračne embolije.
In addition, ARTISS is indicated as an adjunct to haemostasis on subcutaneous tissue surfaces.
Poleg tega je zdravilo Artiss indicirano kot dodatek pri vzpostavljanju hemostaze na površinah podkožnega tkiva.
The analysis of the case reports showed that symptomatic air/gas embolism had occurred only when the instructions for use were not followed; in each of the other cases there was a failure to follow at least one of the current guidelines on administration of spray application of fibrin sealants using pressurised gas:
Analiza poročil o primerih je pokazala, da je do simptomatske zračne/plinske embolije prišlo samo, kadar se niso upoštevala navodila za uporabo; pri vseh drugih primerih kirurg ni upošteval vsaj ene od trenutnih smernic o nanosu pršil fibrinskih lepil za tkivo z uporabo plina pod tlakom:
• The Committee has considered that as no gas-assisted spray device is available for Beriplast and that an attachment of air feeding lines or other device components to the manual spray tips is not possible, the risk of air embolism with Beriplast is negligible;
• Odbor je upošteval, da je glede na dejstvo, da za zdravilo Beriplast ni na voljo noben pripomoček za plinsko pršenje in da priklop cevk za dovajanje zraka ali drugih delov pripomočka na konice za ročno pršenje ni mogoč, tveganje zračne embolije pri zdravilu Beriplast zanemarljivo.
Artiss is indicated as a tissue glue to adhere/seal subcutaneous tissue in plastic, reconstructive and burn surgery, as a replacement or an adjunct to sutures or staples.
Zdravilo Artiss je kot lepilo za tkivo indicirano za adhezijo/tesnjenje podkožnega tkiva pri plastičnih, rekonstrukcijskih in opeklinskih kirurških posegih ter kot nadomestek ali dodatek k suturam ali sponkam.
The CHMP pointed out that surgeons and surgical staff should be advised on the appropriate means of achieving a tissue surface that is as dry as possible (e.g. intermittent application of compresses, swabs, use of suction devices).
Odbor CHMP je izpostavil, da je treba kirurgom in kirurškemu osebju svetovati glede ustreznih ukrepov za doseganje čim bolj suhe površine tkiva (npr. vmesna uporaba kompres, vate, uporaba aspiracijskih pripomočkov).
Based on the above, the European Commission initiated a procedure under Article 20 of Regulation (EC) No 726/2004 on 21 May 2012, requesting the CHMP to assess the above concerns and their impact on the benefit-risk for Evicel, to give its opinion on measures necessary to ensure the safe and effective use of Evicel and on whether the marketing authorisation for this product should be maintained, varied, suspended or withdrawn.
Glede na navedeno je Evropska komisija 21. maja 2012 uvedla postopek v skladu s členom 20 Uredbe (ES) št. 726/2004, s katerim je Odbor za zdravila za uporabo v humani medicini (CHMP) pozvala, naj prouči zgornje pomisleke in njihov vpliv na razmerje med tveganji in koristmi zdravila Evicel ter predloži svoje mnenje o potrebnih ukrepih za zagotavljanje varne in učinkovite uporabe zdravila Evicel ter o tem, ali se lahko dovoljenje za promet s tem zdravilom ohrani ali pa ga je treba spremeniti, začasno umakniti oziroma preklicati.
An ad-hoc expert advisory group meeting was convened in October 2012 at the request of the CHMP, during which the experts discussed the benefits of sprayable fibrin sealants as well as potential risk minimisation measures, in particular with regard to the risk of air embolism.
Na zahtevo odbora CHMP se je oktobra 2012 sestala začasna strokovna svetovalna skupina, katere strokovnjaki so razpravljali o koristih fibrinskih lepil za tkivo za pršenje in morebitnih ukrepih za čim večje zmanjšanje tveganja, predvsem povezanega z zračno embolijo.
The authorised indications for Tisseel/Tissucol and Beriplast P are the “supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis” and “to promote adhesion/sealing or as suture support”.
Odobrene indikacije za zdravila Tisseel/Tissucol in Beriplast P so „podporno zdravljenje, kadar standardne kirurške tehnike niso zadostne za izboljšanje hemostaze“ in „spodbujanje adhezije/tesnjenja ali kot podpora za suture“.
Fibrin sealants can be applied either by drip or spray method, the choice of method is left to the surgeon depending on the degree and surface area of bleeding expected or encountered and the remoteness of the location of the bleeding surface.
Fibrinska lepila za tkivo se lahko nanesejo s kapanjem ali pršenjem, za izbiro metode nanosa pa je odgovoren kirurg, ki se odloči na podlagi stopnje in površine pričakovane ali nastale krvavitve in oddaljenosti mesta krvaveče površine.
Use on open vessels or within a highly vascular cavity e.g. bone marrow.
3. uporaba odprtih vsebnikov ali znotraj zelo ožiljene votline, npr. kostnega mozga.
The CHMP recommended changes the Product Information of Tisseel, Tissucol and Artiss accordingly, to ensure the safe and effective use of those products (see Annex III).
Odbor CHMP je priporočil ustrezne spremembe informacij o zdravilih Tisseel/Tissucol in Artiss, da se zagotovi varna in učinkovita uporaba teh zdravil (glejte Prilogo III).
In order to minimise the potential risk of Beriplast P being used with a pressure regulator not recommended for use with this product, the CHMP recommended that the PI of Beriplast be amended to emphasize that Beriplast should only be reconstituted and administered according to the instructions and with the devices as provided with this product.
Da se zmanjša morebitno tveganje za uporabo zdravila Beriplast P s tlačnim regulatorjem, ki ni priporočen za uporabo s tem zdravilom, je odbor CHMP priporočil, da se informacije o zdravilu Beriplast spremenijo tako, da se izpostavi, da se sme zdravilo Beriplast prestrukturirati in uporabiti samo skladno z navodili in skupaj s pripomočki, priloženimi temu zdravilu.
It employs manual pressure derived by the syringe applicator and therefore, no gas-assisted spray device is available for Beriplast.
Pri njem se uporablja ročni tlak, ki ga ustvarja aplikator injekcijske brizge, zato za zdravilo Beriplast ni na voljo noben pripomoček za plinsko pršenje.
Therefore the CHMP agreed that the use of carbon dioxide should not be mandatory for the spray application using a pressure regulator of those products.
Zato je določil, da uporaba ogljikovega dioksida ni nujna pri uporabi pršila, kadar se pri teh zdravilih uporablja tlačni regulator.
In addition, in line with the changes requested for the other fibrin sealants used by spray, the PI was amended to reflect that appropriate means of achieving a tissue surface that is as dry as possible should be used (see Annex III).
Poleg tega so se skladno s spremembami, zahtevanimi pri drugih fibrinskih lepilih za tkivo za pršenje, informacije o zdravilu spremenile tako, da vsebujejo ustrezne ukrepe za doseganje čim bolj suhe površine tkiva (glejte Prilogo III).
Grounds for the variation to the terms of the marketing authorisation of Tisseel/Tissucol and Artiss (and associated names)
Podlaga za spremembo pogojev dovoljenja za promet z zdravili Tisseel/Tissucol ter Artiss (in povezanih imen)
Risk of air embolism associated with the spray application of fibrin sealants
Tveganje zračne embolije, povezano s fibrinskimi lepili za tkivo, ki se nanašajo s pršenjem
An attachment of air feeding lines or other device components to the manual spray tips physically is not possible.
Fizični priklop cevk za dovajanje zraka ali drugih delov pripomočka na konice za ročno pršenje ni mogoč.