FrancophonIA/ELRC3.0 huggingface dataset:
English: London, 20 March 2007 Doc.
Slovenian: London, 20.03.2007 Ref. dok.
English: The main study of the medicine's effects involved 139 adults with invasive candidiasis.
Slovenian: Glavna raziskava učinkov zdravila je vključevala 139 odraslih bolnikov z invazivno kandidiazo.
English: This protein is involved in the formation and the repair of the cell wall and is essential for the survival of the fungal cells.
Slovenian: Ta beljakovina sodeluje pri tvorbi in popravljanju celične stene in je zato ključnega pomena za preživetje glivičnih celic.
English: Invasive candidiasis is a life-threatening disease.
Slovenian: Invazivna kandidiaza je življenjsko nevarna bolezen.
English: This means that it is made by a bacterium that has received a gene (DNA), which makes it able to produce the substance.
Slovenian: To pomeni, da nastaja v vrsti bakterij, ki je prejela gen (DNA), ki ji omogoča tvoriti omenjeno učinkovino.
English: QUESTIONS AND ANSWERS ON RECOMMENDATION FOR THE REFUSAL OF THE MARKETING AUTHORISATION for MYCOGRAB
Slovenian: VPRAŠANJA IN ODGOVORI GLEDE PRIPOROČILA ZA ZAVRNITEV VLOGE ZA DOVOLJENJE ZA PROMET za zdravilo MYCOGRAB
English: This weakens the cell wall, making the fungal cells fragile and unable to grow.
Slovenian: Zaradi tega postane celična stena šibka, glivične celice pa postanejo krhke in ne morejo rasti.
English: Efungumab is produced by a method known as ‘recombinant DNA technology'.
Slovenian: Učinkovino efungumab se izdeluje z metodo, ki se imenuje „tehnologija rekombinantne DNA“.
English: The effects of Mycograb were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Mycograb so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: In March 2007, following the re-examination, the CHMP removed their concern regarding the cytokine release syndrome and hypertension, as these would be manageable in clinical practice.
Slovenian: V marcu leta 2007 je CHMP po ponovnem pregledu umaknil svoje zadržke glede sindroma sproščanja citokinov in hipertenzije, ker je le-te v klinični praksi mogoče obvladovati.
English: The powder needs to be dissolved in sterile water before being injected into a vein.
Slovenian: Prašek je treba pred injiciranjem v veno raztopiti v sterilni vodi.
English: At this point in time, the committee was of the opinion that the benefits of Mycograb in the treatment of invasive candidiasis did not outweigh its risks.
Slovenian: V tistem času je bil Odbor mnenja, da koristni učinki zdravila Mycograb pri zdravljenju invazivne kandidiaze ne odtehtajo njegovih tveganj.
English: It has been designed to attach to a specific protein on the surface of the fungal cells, called Heat Shock Protein 90 (hsp90).
Slovenian: Zasnovano je bilo tako, da se veže na točno določeno beljakovino na površini glivičnih celic, ki jo imenujemo stresna beljakovina 90 (hsp90).
English: Too few patients have received Mycograb for its safety to be sufficiently assessed.
Slovenian: Zdravilo Mycograb je prejemalo premajhno število bolnikov, da bi bilo mogoče zadovoljivo oceniti njegovo varnost.
English: Because the number of patients with invasive fungal infections is low, Mycograb was designated an ‘orphan medicine' (a medicine used in rare diseases) on 5 December 2001.
Slovenian: Ker je število bolnikov z invazivnimi glivičnimi okužbami majhno, je bilo zdravilo Mycograb dne 5. decembra 2001 določeno kot „zdravilo sirota“ (zdravilo, ki se uporablja proti redkim boleznim).
English: It also had concerns about the safety of Mycograb.
Slovenian: Odbor je imel poleg tega tudi zadržke glede varnosti zdravila Mycograb.
English: The company that applied for authorisation is NeuTec Pharma plc.
Slovenian: Podjetje, ki je podalo vlogo za dovoljenje za promet, je NeuTec Pharma plc.
English: What were the major concerns that led the CHMP to recommend the refusal of the marketing authorisation?
Slovenian: Kateri so bili glavni zadržki, zaradi katerih je CHMP priporočil zavrnitev dovoljenja za promet?
English: In invasive candidiasis, the fungal infection spreads to the internal organs such as the liver, spleen and kidneys via the bloodstream.
Slovenian: Pri invazivni kandidiazi se glivična okužba preko krvnega obtoka razširi na notranje organe, kot so jetra, vranica in ledvice.
English: On 16 November 2006, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Mycograb 2 mg/ml powder for solution for injection intended for the treatment of invasive candidiasis in adult patients, in combination with amphotericin B or a lipid formulation of amphotericin B.
Slovenian: Dne 16. novembra 2006 je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel negativno mnenje in priporočil zavrnitev vloge za dovoljenje za promet z zdravilom Mycograb 2 mg/ml v obliki praška za raztopino za injiciranje, namenjenega za uporabo pri zdravljenju invazivne kandidiaze pri odraslih bolnikih v kombinaciji z amfotericinom B ali lipidno formulacijo amfotericina B.
English: After having considered the grounds for this request, the CHMP reexamined the initial opinion, and confirmed the refusal of the marketing authorisation on 20 March
Slovenian: Ko je CHMP pretehtal razloge za to prošnjo, je ponovno pregledal podano mnenje in dne 20. marca 2007 potrdil zavrnitev vloge za dovoljenje za promet z zdravilom.
English: In November 2006, the CHMP was concerned about some aspects of the quality of the medicine (such as the way the molecules of efungumab may fold or aggregate in the solution for injection and the level of some substances that could stimulate an immune response in patients).
Slovenian: Novembra leta 2006 je CHMP izrazil zadržke zaradi nekaterih vidikov kakovosti zdravila (na primer glede načina, na katerega se molekule efungumaba zvijajo ali tvorijo skupke v raztopini za injiciranje, in zaradi ravni nekaterih snovi, ki bi lahko pri bolniku spodbudile imunski odziv).
English: The company informed the CHMP that there are no consequences on patients currently included in clinical trials or compassionate use programmes with Mycograb.
Slovenian: Podjetje je CHMP obvestilo, da za bolnike, ki so trenutno vključeni v klinična preizkušanja ali sočutno uporabo zdravila Mycograb, ni nobenih posledic.
English: What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Mycograb?
Slovenian: Kakšne so posledice zavrnitve vloge za bolnike, ki sodelujejo v kliničnih preizkušanjih/programih sočutne uporabe zdravila Mycograb?
English: The medicine is associated with ‘cytokine release syndrome', a condition that can cause nausea, vomiting, pain and also hypertension (high blood pressure), but the reason for this is not clear.
Slovenian: Zdravilo se povezuje s „sindromom sproščanja citokinov“, katerega vzroki niso jasni, povzroča pa bruhanje, bolečine in hipertenzijo (visok krvni tlak).
English: Mycograb was to be used together with amphotericin B (another antifungal medicine) to treat adult patients with invasive candidiasis.
Slovenian: Zdravilo Mycograb naj bi se uporabljalo skupaj z amfotericinom B (druga vrsta protiglivičnega zdravila) pri zdravljenju odraslih bolnikov z invazivno kandidiazo.
English: What is Mycograb?
Slovenian: Kaj je zdravilo Mycograb?
English: By attaching to hsp90, efungumab blocks the protein's normal activities.
Slovenian: Ko se efungumab veže na hsp90, s tem zavre normalno delovanje beljakovine.
English: This disease is caused by infection with a common fungus (yeast) called Candida.
Slovenian: Bolezen povzroča okužba z obče prisotno glivico (kvasovko), imenovano Candida.
English: Mycograb is a white powder that contains the active substance efungumab.
Slovenian: Zdravilo Mycograb je bel prašek, ki vsebuje zdravilno učinkovino efungumab.
English: The effectiveness was measured by looking at the percentage of patients responding to treatment, based on improvement of their symptoms (including fever) and elimination of the fungus from samples, as measured on day 10 (5 days after the end of Mycograb or placebo treatment).
Slovenian: učinkovine), ki so ju pet dni dajali skupaj z amfotericinom B. Učinkovitost so merili z odstotkom bolnikov, ki so se odzvali na zdravljenje z izboljšanjem simptomov (vključno s povišano telesno temperaturo) in ki pri meritvah na 10. dan (pet dni po koncu zdravljenja z zdravilom Mycograb ali placebom) v vzorcih niso imeli glivic.
English: Hence, the CHMP recommended that Mycograb be refused marketing authorisation.
Slovenian: Zato je CHMP priporočil zavrnitev vloge za dovoljenje za promet z zdravilom Mycograb.
English: What was Mycograb expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Mycograb uporabljalo?
English: How is Mycograb expected to work?
Slovenian: Kako naj bi zdravilo Mycograb delovalo?
English: The active substance in Mycograb, efungumab, is an antifungal agent.
Slovenian: Zdravilna učinkovina zdravila Mycograb je efungumab, ki je protiglivično sredstvo.
English: The study compared the effects of Mycograb to those of a placebo (a dummy treatment), when they were given with amphotericin B for 5 days.
Slovenian: V raziskavi so primerjali učinke zdravila Mycograb z učinki placeba (zdravila brez zdravilne
English: The results did not support the second method.
Slovenian: Rezultati ne podpirajo uporabe druge metode.
English: • Risk management plan(RMP)
Slovenian: • Načrt za obvladovanje tveganj (RMP)
English: Therefore the studies were performed as open-label studies.
Slovenian: Študije so bile torej izvedene kot odprte študije.
English: • only to use undamaged packages which have not been opened (post-sterilisation is not possible).
Slovenian: • da uporabite le nepoškodovana pakiranja, ki še niso bila odprta (ponovna sterilizacija ni mogoča).
English: Use only undamaged packages.
Slovenian: Uporabite lahko le nepoškodovana pakiranja.
English: Date of first authorisation: 8 June 2004 Date of latest renewal: 30 April 2009
Slovenian: Datum zadnjega podaljšanja: 30. april 2009
English: Find out which size of TachoSil is needed.
Slovenian: Ugotovite, katera velikost zdravila TachoSil je potrebna.
English: In case of shock, the current medical standards for shock treatment should be observed.
Slovenian: V primeru šoka upoštevajte veljavne medicinske standarde za zdravljenje šoka.
English: For viral safety see section 4.4.
Slovenian: Za varnost pred virusi glejte poglavje 4.4.
English: The active components are made from human blood.
Slovenian: Zdravilni učinkovini sta izdelani iz humane krvi.
English: Do not use this medicine after the expiry date which is stated on the label after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg onake »EXP«.
English: This is followed by the fibrinogen-thrombin reaction which initiates the last phase of physiological blood coagulation.
Slovenian: Temu sledi fibrinogensko-trombinska reakcija, ki sproži zadnjo fazo fiziološke koagulacije krvi.
English: Pharmacotherapeutic group: Local haemostatics, ATC code: B02BC30
Slovenian: Farmakoterapevtska skupina: Hemostatiki za lokalno zdravljenje, oznaka ATC: B02BC30
English: The marketing authorisation holder shall submit PSUR for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora PSUR za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: Do not resterilise.
Slovenian: Ne sterilizirajte ponovno.
English: If the dates for submission of a PSUR and the update of an RMP coincide, they can be submitted at the same time.
Slovenian: Če predložitev PSUR in posodobitev RMP sovpadata, se lahko predložita sočasno.
English: Specific data have not been obtained on the use of this product in gastrointestinal anastomoses surgery.
Slovenian: Specifični podatki o uporabi tega zdravila v gastrointestinalni anastomozni kirurgiji niso bili pridobljeni.
English: Do not use intravascularly.
Slovenian: Ne uporabljajte intravaskularno.
English: The fibrin is then cross linked by endogenous factor XIII, creating a firm, mechanically stable network with good adhesive properties and therefore provides sealing as well.
Slovenian: Fibrin se nato navzkrižno poveže z endogenim faktorjem XIII in tvori trdno, mehansko stabilno mrežo z dobrimi adhezivnimi lastnostmi in zato omogoči tudi zapiranje rane.
English: These allergic reactions may occur especially if TachoSil is used repeatedly or if you are allergic to any of the ingredients in TachoSil.
Slovenian: Te alergijske reakcije se lahko še zlasti pojavijo, če se zdravilo TachoSil uporablja večkrat, ali če ste alergični na katero koli sestavino zdravila TachoSil.
English: A-4020 Linz, Austria
Slovenian: A-4020 Linz, Avstrija
English: Therefore, intravascular pharmacokinetic studies were not performed in man.
Slovenian: Posledično intravaskularnih farmakokinetičnih študij pri ljudeh niso izvedli.
English: The safety of TachoSil for use in human pregnancy or breastfeeding has not been established in controlled clinical trials.
Slovenian: Varnost uporabe zdravila TachoSil med nosečnostjo ali dojenjem pri ljudeh ni bila dokazana v nadzorovanih kliničnih preskušanjih.
English: Single dose toxicity studies in different species of animals have shown no signs of acute toxic effects.
Slovenian: Študije toksičnosti po enkratni uporabi zdravila pri različnih živalskih vrstah niso pokazale znakov akutnih toksičnih učinkov.
English: No evidence of local intolerability has been observed in animal studies.
Slovenian: Pri študijah na živalih niso opazili znakov lokalne intolerance.
English: Strong (pulsating) bleeding should be stopped surgically.
Slovenian: Močno (pulzirajočo) krvavitev morate ustaviti kirurško.
English: The yellow side of TachoSil is therefore the active side.
Slovenian: Rumena stran zdravila TachoSil je torej učinkovita stran.
English: All medicines based on human blood may uncommonly cause allergic reactions.
Slovenian: Vsa zdravila, izdelana na osnovi humane krvi, lahko občasno povzročijo alergijske reakcije.
English: Experimental animal studies are insufficient to assess the safety with respect to reproduction, development of the embryo or foetus, the course of gestation and peri- and postnatal development.
Slovenian: Eksperimentalne študije na živalih ne zadoščajo za oceno varnosti glede vpliva na sposobnost razmnoževanja, razvoj zarodka ali ploda, potek nosečnosti ter perinatalnega in postnatalnega razvoja.
English: If more than one matrix is needed, they should overlap.
Slovenian: Če je potreben več kot en matriks, se morajo matriksi prekrivati.
English: Open the inner sterile package and remove the matrix.
Slovenian: Odprite stično sterilno ovojnino in iz nje vzemite matriks.
English: This also applies to any unknown or emerging viruses or other types of infections.
Slovenian: To velja tudi za neznane ali nove viruse in druge vrste okužb.
English: Remove the light pressure carefully after 3-5 minutes.
Slovenian: Nežni pritisk previdno popustite po 3 do 5 minutah.
English: If a trocar is used for getting access to the wound, the inside of the trocar should be dry.
Slovenian: Če za dostop do rane uporabite trokar, mora biti njegova notranjost suha.
English: See section 6.6 for more detailed instructions.
Slovenian: Za podrobnejša navodila za uporabo glejte poglavje 6.6.
English: Due to practical reasons (comparison to standard surgical and standard haemostatic treatment), blinding was not possible in the TachoSil trials.
Slovenian: Zaradi praktičnih razlogov (primerjava s standardnim kirurškim in standardnim hemostatskim zdravljenjem) slepih preskušanj z zdravilom TachoSil ni bilo mogoče izvesti.
English: Prior to application the wound area should be cleansed, e.g. from blood, disinfectants and other fluids.
Slovenian: Pred namestitvijo morate področje rane očistiti, npr. krvi, razkužil in drugih tekočin.
English: The quantity of TachoSil to be applied should always be oriented towards the underlying clinical need for the patient.
Slovenian: Pri določanju potrebne količine zdravila TachoSil je vedno treba upoštevati osnovno klinično potrebo bolnika.
English: The safety data of TachoSil generally reflect the type of post-operative complications related to the surgical settings in which the trials were conducted and the underlying disease of the patients.
Slovenian: Podatki o varnosti zdravila TachoSil v splošnem odražajo vrsto pooperativnih zapletov, ki so povezani s kirurškim okoljem, v katerem so preskušanja potekala, in osnovnimi boleznimi bolnikov.
English: TachoSil is indicated in adults for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing, for suture support in vascular surgery where standard techniques are insufficient, and for supportive sealing of the dura mater to prevent postoperative cerebrospinal leakage following neurological surgery (see section 5.1).
Slovenian: Zdravilo TachoSil je indicirano pri odraslih za podporno zdravljenje v kirurgiji, in sicer za izboljšanje hemostaze, hitrejšo zatesnitev tkiv, podporo šivom v žilni kirurgiji, kjer standardne kirurške tehnike ne zadostujejo, in podporo tesnjenju dure mater za preprečevanje uhajanja cerebrospinalne tekočine po nevrokirurškem posegu (glejte poglavje 5.1).
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Slovenian: Standardni ukrepi za preprečevanje okužb zaradi uporabe zdravil, pripravljenih iz humane krvi ali plazme, vključujejo izbiro darovalcev, testiranje posameznih darovanj in zbirov plazme na specifične označevalce okužbe in vključitev učinkovitih proizvodnih postopkov za inaktivacijo/odstranitev virusov.
English: If these symptoms occur, the administration has to be discontinued immediately.
Slovenian: V primeru pojava teh simptomov je treba zdravilo nemudoma prenehati uporabljati.
English: It is not known whether recent radiation therapy affects the efficacy of TachoSil when used for dura mater sealing.
Slovenian: Ni znano, če zdravljenje z obsevanjem vpliva na učinkovitost zdravila TachoSil, če se ga uporablja za tesnjenje dure mater.
English: What TachoSil is and what it is used for
Slovenian: Kaj je zdravilo TachoSil in za kaj ga uporabljamo
English: If more than one matrix is used they should overlap.
Slovenian: Če uporabite več kot en matriks, se morajo matriksi prekrivati.
English: Read this before you open the package: TachoSil comes in sterile packages and therefore it is important:
Slovenian: Pred odprtjem ovojnine preberite naslednje informacije: Zdravilo TachoSil je pakirano sterilno, zato je pomembno:
English: When the active side comes into contact with fluids (such as blood, lymph or saline solution) the fibrinogen and the thrombin are activated and form a fibrin network.
Slovenian: Ko učinkovita stran pride v stik s tekočinami (kot so kri, limfa ali fiziološka raztopina) se fibrinogen in trombin aktivirata in tvorita fibrinsko mrežo.
English: Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Slovenian: Izdelovalci teh zdravil v postopke obdelave krvi prav tako vključujejo postopke, ki inaktivirajo ali odstranijo viruse.
English: Data from the eight controlled clinical trials conducted by the MAH has been pooled into an integrated dataset.
Slovenian: Podatke iz osmih nadzorovanih kliničnih preskušanj, ki jih je izvedel imetnik dovoljenja za promet z zdravilom, so združili v skupen nabor podatkov.
English: For epilesional use.
Slovenian: Samo za epilezijsko uporabo.
English: What you need to know before TachoSil is used
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo TachoSil
English: The equine collagen antibodies that developed in some patients after TachoSil use were not reactive with human collagen.
Slovenian: Protitelesa proti konjskemu kolagenu, ki so se razvila pri nekaterih bolnikih po uporabi zdravila TachoSil, niso bila reaktivna s humanim kolagenom.
English: Anaphylactic shock, Hypersensitivity
Slovenian: Bolezni imunskega sistema anafilaktični šok, preobčutljivost
English: Once the package is opened, post-sterilisation is not possible.
Slovenian: Po odprtju ovojnine ponovna sterilizacija ni več mogoča.
English: Other medicines and TachoSil 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: In this study, superiority over current practise practice (which included suture, duraplasty and fibrin and polymer sealants or combinations of these) could not be documented.
Slovenian: V tej študiji niso mogli dokazati superiornosti v primerjavi z obstoječo prakso zdravljenja (ki vključuje šive, duraplastiko in uporabo fibrinskih ter polimernih lepil za tkiva ali kombinacijo le-teh).
English: The frequency of all of the events listed below has been categorised as not known (cannot be estimated from the available data).
Slovenian: Pogostnost vseh navedenih neželenih učinkov je neznana (je ni mogoče oceniti na podlagi razpoložljivih podatkov).
English: Fibrinogen is converted into fibrin monomers which spontaneously polymerise to a fibrin clot, which holds the collagen matrix tightly to the wound surface.
Slovenian: Fibrinogen se pretvori v fibrinske monomere, ki spontano polimerizirajo v fibrinski strdek, ki tesno drži kolagenski matriks na površini rane.
English: Use a moistened glove or a moist pad to keep TachoSil in place.
Slovenian: Uporabite navlažene rokavice ali vlažno blazinico, da ostane zdravilo TachoSil na mestu.
English: There is very limited clinical data available regarding re-exposure to TachoSil.
Slovenian: Kliničnih podatkov o ponovni izpostavljenosti zdravilu TachoSil je zelo malo.
English: In isolated cases these allergic reactions may progress to anaphylactic shock.
Slovenian: V posameznih primerih se te alergijske reakcije lahko stopnjujejo do anafilaktičnega šoka.
English: In this study two application techniques for TachoSil were evaluated: application of TachoSil over the dura and application of TachoSil on both sides of the dura.
Slovenian: V tej študiji so vrednotili dve tehniki uporabe zdravila TachoSil: namestitev zdravila TachoSil preko dure in namestitev zdravila TachoSil na obeh straneh dure.
English: Fibrin sealants/haemostatics are metabolized in the same way as endogenous fibrin by fibrinolysis and phagocytosis.
Slovenian: Fibrinska tesnila/hemostatiki se presnavljajo na enak način kot endogeni fibrin, to je s fibrinolizo in fagocitozo.
English: TachoSil is made of protein-containing components.
Slovenian: Zdravilo TachoSil je izdelano iz beljakovinskih sestavin.
English: Intravascular administration is contraindicated.
Slovenian: Intravaskularna uporaba je kontraindicirana.
English: From the experience in humans there have been isolated cases where remnants were observed as coincidental findings with no signs of functional impairment.
Slovenian: Pri uporabi zdravila pri ljudeh so poročali o posameznih primerih, pri katerih so ostanke opazili naključno, brez prisotnih znakov funkcionalne okvare.
English: Intestinal obstruction (in abdominal surgeries)
Slovenian: Bolezni prebavil obstrukcija črevesja (pri abdominalnih operacijah)