natgillin/translations-raw huggingface dataset:
After application of the veterinary medicinal product into the ear canal, absorption of miconazole and gentamicin through the skin is negligible.
Po dajanju zdravila za uporabo v veterinarski medicini v ušesni kanal je absorpcija mikonazola in gentamicina skozi kožo zanemarljiva.
Special precautions to be taken by the person administering the veterinary medicinal product to animals: In case of accidental skin contact, it is recommended to wash thoroughly with water.
Posebni previdnostni ukrepi, ki jih mora upoštevati oseba, ki daje zdravilo živalim: V primeru nenamernega stika kožo temeljito sperite z vodo.
Pregnancy and lactation:
Brejosti in laktacije:
C. STATEMENT OF THE MRLs Not applicable.
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL) Ni smiselno.
In very rare cases, Type-I Hypersensitivity reactions (facial swelling, allergic pruritus) have been observed.
V zelo redkih primerih so bile opažene preobčutljivostne reakcije tipa I (zatekanje obraza, alergijski pruritus).
1 dose x 100 1 dose x 200
1 odmerek x 100 1 odmerek x 200
Compatibility with ear cleaners has not been demonstrated.
Ni podatkov o združljivosti tega zdravila s čistili za ušesa.
However, serum cortisol response levels post ACTH stimulation remained in the normal range during the extended treatment period, indicating a preserved adrenal function.
Vendar pa so odzivne ravni serumskega kortizola po stimulaciji z ACTH (adrenokortikotropin) med podaljšanim obdobjem zdravljenja ostali v normalnem razponu, kar kaže na ohranjeno funkcijo nadledvičnih žlez.
Miconazole nitrate is a synthetic imidazole derivative with a pronounced antifungal activity.
Mikonazol nitrat je sintetični derivat imidazola z znanim protiglivičnim delovanjem.
Multi-dose container composed of two extruded parts, one external white polypropylene rigid tube and one internal (ethylene-methacrylic acid)-zinc copolymer (Surlyn) flexible pouch containing a steel ball, closed with a 1 ml dosing airless pump equipped with a flexible atraumatic cannula and covered by a plastic cap.
Večodmerni vsebnik, sestavljen iz dveh ekstrudiranih delov, in sicer zunanje bele polipropilenske trdne stekleničke in notranje gibljive vrečke iz (etilen-metakrilno kislinskega) - cinkovega kopolimera (surlyn) in z jekleno kroglico, ki se zapira z enomililitrsko odmerno brezzračno črpalko z gibljivo atravmatsko kanilo in je pokrita s plastičnim pokrovčkom.
Use of the veterinary medicinal product should be based on identification of infecting organisms and susceptibility testing and take into account official and local antimicrobial policies.
Uporaba zdravila za uporabo v veterinarski medicini mora temeljiti na osnovi identifikacije in testiranju občutljivosti povzročiteljev ter upoštevati uradno in lokalno antimikrobno strategijo.
Gentamicin sulphate is an aminoglycoside bactericidal antibiotic which acts by inhibiting protein synthesis.
Gentamicin sulfat je aminoglikozidni bakterijski antibiotik, ki preprečuje sintezo proteinov.
The product as presented allows treating a dog suffering from bilateral otitis.
Predstavljeno zdravilo omogoča zdravljenje psov, ki imajo obojestransko vnetje ušesa.
To administer one dose (1 ml) of the product in the affected ear:
Za dajanje enega odmerka (1 ml) zdravila v prizadeto uho:
Miconazole as nitrate
Mikonazol v obliki nitrata
SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
POSEBNO OPOZORILO, ČE JE POTREBNO Pred uporabo preberite navodilo za uporabo.
Do not use concurrently with substances known to cause ototoxicity.
Ne uporabite hkrati z učinkovinami, ki povzročajo ototoksičnost.
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY ANDUSE
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
The bacterial resistance phenotypes to gentamicin are mainly based on three mechanisms: enzymatic modification of aminoglycosides, failure of intracellular penetration of the active substance and alteration of the aminoglycoside target.
Fenotipi odpornosti bakterij na gentamicin večinoma temeljijo na treh mehanizmih: encimski prilagoditvi aminoglukozidov, neuspešnem znotrajceličnem prodiranju zdravilne sestavine in spremembi aminoglikozidne tarče.
MARKETING AUTHORISATION NUMBER(S) EU/2/08/085/001
ŠTEVILKA DOVOLJENJA ZA PROMET EU/2/08/085/001
Miconazole selectively inhibits the synthesis of ergosterol, which is an essential component of the membrane of yeasts and fungi including Malassezia pachydermatis.
Mikonazol selektivno preprečuje sintezo ergosterola, ki je bistvena sestavina membrane kvasovk in glivic, vključno z vrsto Malassezia pachydermatis.
Do not use in cases of hypersensitivity to the active substances or to any of the excipients, to corticosteroids, to other azole antifungal agents and to other aminoglycosides.
Ne uporabite v primerih preobčutljivosti na učinkovine ali na katero koli pomožno snov, na kortikosteroide, ostala azolna protiglivična sredstva in druge aminoglikozide.
Hydrocortisone aceponate belongs to the diesters' class of glucocorticosteroids.
Hidrokortizon aceponat spada v diestersko skupino glukokortikosteroidov.
Liquid paraffin.
Parafin, tekoči.
- common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports.
- občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri)
Systemic absorption of hydrocortisone aceponate, gentamicin sulphate and miconazole nitrate being negligible, it is unlikely for teratogenic, foetotoxic or maternotoxic effects to occur at the recommended dosage in dogs.
Zaradi neznatne sistemske absorpcije hidrokortizon aceponata, gentamicin sulfata in mikonazol nitrata, je možnost pojava teratogenih in fetotoksičnih učinkov ter toksičnih učinkov na mater ob uporabi priporočenih odmerkov pri psih zelo nizka.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports.
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri)
Administer one dose (1 ml) of the product in each affected ear.
Dajte en odmerek (1 ml) zdravila v vsako prizadeto uho.
After application, the base of the ear may be massaged briefly and gently to allow the preparation to penetrate to the lower part of the ear canal.
Po uporabi lahko za kratek čas in nežno masirate koren ušesa, tako da zdravilo prodre tudi v nižji del ušesnega kanala.
ROUTE(S) OF ADMINISTRATION (Reference is made to the drawing in section 1)
NAČIN UPORABE ZDRAVILA (Besedilo se sklicuje na risbo v 1.
Hydrocortisone aceponate belongs to the diester class of the glucocorticosteroids with a potent intrinsic glucocorticoid activity which means a relief of both inflammation and pruritus leading to an improvement of clinical signs observed in otitis externa.
Hidrokortizon aceponat spada v diestersko skupino glukokortikosteroidov z močnim notranjim glukokortikoidnim delovanjem, kar pomeni, da lajša tako vnetja kot srbečico, kar vodi k izboljšanju kliničnih znakov, značilnih za vnetje zunanjega sluhovoda.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release VIRBAC
A. PROIZVAJALEC ZDRAVILA ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov proizvajalca zdravila, odgovornega za sproščanje serije VIRBAC
Shelf life after first opening the multi-dose container: 10 days.
Rok uporabnosti po prvem odpiranju večodmernega vsebnika: 10 dni.
• Shake the pipette thoroughly before use.
• Kapalko pred uporabo dobro pretresite.
Multi-dose container:
Večodmerni vsebnik:
Pipette composed of high density polyethylene (body and cannula) containing a steel ball.
Kapalka, sestavljena iz polietilena visoke gostote (osrednji del in kanila) z jekleno kroglico.
Mechanisms of resistance to azoles consist of either failure in antifungal accumulation or modification of target enzyme.
Mehanizmi odpornosti na azole so posledica neuspelega kopičenja glivic ali prilagoditve ciljnega encima.
Use of the veterinary medicinal product deviating from the instructions given in the summary of product characteristics may increase the prevalence of bacteria and fungi resistant to gentamicin and miconazole respectively and may decrease the effectiveness of treatment with aminoglycosides and azole antifungal agents, due to the potential for cross-resistance.
Uporaba zdravila za uporabo v veterinarski medicini, ki odstopa od navodil, ki jih vsebuje povzetek glavnih značilnosti zdravila, lahko poveča prevalenco bakterij in glivic, odpornih na gentamicin oziroma na mikonazol, ter lahko zmanjša učinkovitost zdravljenja z aminoglikozidi in azolnimi protiglivičnimi sredstvi zaradi možne križne odpornosti.
The veterinary medicinal product is a fixed combination of three active substances (corticosteroid, antifungal and antibiotic):
Zdravilo za uporabo v veterinarski medicini je kombinacija treh zdravilnih učinkovin (kortikosteroida, antimikotika in antibiotika):
Marketing authorisation holder and manufacturer responsible for batch release: VIRBAC
Imetnik dovoljenja za promet in izdelovalec odgovoren za izdajo serije: VIRBAC
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 10 ml (10 doses).
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 10 ml (10 odmerkov)
NAME OF THE VETERINARY MEDICINAL PRODUCT Easotic ear drops, suspension for dogs Hydrocortisone aceponate - Miconazole - Gentamicin
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Easotic kapljice za uho, suspenzija za pse Hidrokortizon aceponat - mikonazol - gentamicin
In case of accidental contact, rinse with abundant quantities of water.
V primeru nenamernega stika oči temeljito sperite z veliko vode.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary ins1 dose / ear / day for 5 days
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), če je potrebno
Single-dose container:
Enoodmerni vsebnik:
Gentamicin is known to be associated with ototoxicity when administered by the systemic route at higher doses.
Znana je povezava gentamicina z ototoksičnostjo, kadar se daje po sistemski poti v odmerku, večjem od terapevtskega.
Treatment of acute otitis externa, and acute exacerbation of recurrent otitis externa associated with bacteria susceptible to gentamicin and fungi susceptible to miconazole in particular Malassezia pachydermatis.
Uporablja se za zdravljenje akutnega vnetja zunanjega sluhovoda in akutnega poslabšanja ponavljajočega se vnetja zunanjega sluhovoda, povezanega z bakterijami, ki so občutljive na gentamicin, in glivicami, ki so občutljive na mikonazol, posebej Malassezia pachydermatis.
Shelf life after first opening the immediate packaging: 10 days.
Rok uporabnosti po prvem odpiranju stične ovojnine: 10 dni.
PHARMACEUTICAL FORM Ear drops, suspension.
FARMACEVTSKA OBLIKA Kapljice za uho, suspenzija.
METHOD AND ROUTE(S) OF ADMINISTRATION For auricular use only.
NAČIN IN POT UPORABE Samo za avrikularno uporabo.
1 dose x 5
1 odmerek x 5
In case of accidental skin contact, it is recommended to wash thoroughly with water.
V primeru nenamernega stika kožo temeljito sperite z vodo.
1 dose x 50
1 odmerek x 50
The veterinary medicinal product is a fixed combination of three active substances: antibiotic, antifungal and corticosteroid.
Zdravilo za uporabo v veterinarski medicini je kombinacija treh zdravilnih učinkovin: kortikosteroida, antimikotika in antibiotika.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX OF 1 MULTI-DOSE CONTAINER OF 10 DOSES
KARTONSKA ŠKATLA Z 1 VEČODMERNIM VSEBNIKOM Z 10 ODMERKI
1 dose x 10
1 odmerek x 10
France VIRBAC 13ème rue - L.I.D - BP 27 06517 Carros Hrvatska VIRBAC
France VIRBAC 13ème rue - L.I.D - BP 27 06517 Carros
Pharmacotherapeutic group: Otologicals, corticosteroids and antiinfectives in combination.
Farmakoterapevtska skupina: Zdravila za ušesne bolezni - kortikosteroidi v kombinaciji s protimikrobnimi učinkovinami
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS MULTI-DOSE CONTAINER
PODATKI, KI MORAJO BITI NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH NALEPKA NA VEČODMERNEM VSEBNIKU
One ml contains 1.11 mg hydrocortisone aceponate, 15.1 mg miconazole (as nitrate) and 1,505 IU gentamicin (as sulphate).
En mililiter vsebuje 1,11 mg hidrokortizon aceponata, 15,1 mg mikonazola (kot nitrata) in 1505 i.e.gentamicina (kot sulfata).
NAME OF THE VETERINARY MEDICINAL PRODUCT
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Easotic
06516 Carros
06516 Carros FRANCIJA
Tlf.
SPC-ja.
QUANTITY OF THE ACTIVE SUBSTANCE(S) CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV
STATEMENT OF ACTIVE SUBSTANCES Hydrocortisone aceponate 1.11 mg/ml, Miconazole as nitrate 15.1 mg/ml, Gentamicin as sulphate 1,505 IU/ml.
NAVEDBA UČINKOVIN Hidrokortizon aceponat 1.11 mg/ml, Mikonazol v obliki nitrata 15.1 mg/ml, Gentamicin v obliki sulfata 1,505 IU/ml.
NAME OF THE VETERINARY MEDICINAL PRODUCT Easotic ear drops, suspension for dogs
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Easotic kapljice za uho, suspenzija za pse
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s))
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali)
Introduce the atraumatic canula in the ear canal.
Uvedite atravmatsko kanilo v ušesni kanal.
• Introduce the atraumatic cannula in the ear canal.
• Uvedite atravmatsko kanilo v ušesni kanal.
1,505 IU/ml.
1505 i.e./ml.
Shake the pipette thoroughly before use.
Pred uporabo jo dobro pretresite.
EXPIRY DATE EXP {month/year} Once opened use within 10 days.
Odprto zdravilo porabite v 10 dneh.
EU/2/08/085/001-006
ŠTEVILKA DOVOLJENJA ZA PROMET EU/2/08/085/001/006
MATERIALS, IF ANY
UPORABE, če je navedba smiselna
Easotic ear drops, suspension for dogs
NAVODILO ZA UPORABO Easotic kapljice za uho suspenzija za pse
PACKAGE SIZE 10 ml (10 doses).
FARMACEVTSKA OBLIKA Kapljice za uho, suspenzija VELIKOST PAKIRANJA 10 ml (10 odmerkov).
Shake the bottle thoroughly before first administration and prime the pump by pressing it. Introduce the atraumatic canula in the ear canal.
Pred prvo uporabo dobro pretresite stekleničko in s pritiskom napolnite črpalko.
76505 Saue/Harjumaa, ESTONIA
ET - 76505 Saue/Harjumaa, ESTONIA Tel: + 372 6 709 006
STATEMENT OF THE MRLs
NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVIA (MRL)
WITHDRAWAL PERIOD(S) SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO Odstranjevanje: preberite navodilo za uporabo.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PIPETTE NAME OF THE VETERINARY MEDICINAL PRODUCT Easotic
PODATKI, KI MORAJO BITI NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH KAPALKA
Slovenija VIRBAC 1ère avenue 2065 m - L.I.D 06516 Carros FRANCE
Hrvaška VIRBAC 1ère avenue 2065 m - L.I.D 06516 Carros FRANCE
Pre-filled syringe (glass) with needle guard
napolnjena injekcijska brizga (steklo) z varovalom za iglo
2 pre-filled pens + 2 alcohol wipes
2 odmerna vložka + 2 alkoholna zloženca
London, 24 January 2008 Doc.
London, 24. januar 2008 Sklic na dok.
The company that applied for authorisation is Wyeth Europa Ltd.
Družba, ki je podala vlogo za odobritev dovoljenja za promet, je Wyeth Europa Ltd.
Ref. EMEA/37537/2008
EMEA/186664/2008
International non-proprietary name (INN): gemtuzumab ozogamicin
Mednarodno nelastniško ime (INN): gemtuzumab ozogamicin
After having considered the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 24 January 2008.
Po preučitvi podlage za to zahtevo je CHMP ponovno pregledal prvotno mnenje in dne 24. januarja 2008 potrdil zavrnitev vloge za dovoljenje za promet.
In all three studies, the main measure of effectiveness was the proportion of patients who achieved ‘complete remission' after a seven-month course of treatment.
V vseh treh študijah je bil glavno merilo učinkovitosti delež bolnikov, ki so po sedemmesečnem zdravljenju dosegli „popolno remisijo“ .
QUESTIONS AND ANSWERS ON RECOMMENDATION FOR THE REFUSAL OF THE MARKETING AUTHORISATION for MYLOTARG
VPRAŠANJA IN ODGOVORI GLEDE PRIPOROČILA ZA ZAVRNITEV VLOGE ZA DOVOLJENJE ZA PROMET z zdravilom MYLOTARG
These included severe and long-lasting bone marrow suppression causing low levels of white blood cells and platelets, liver problems, and side effects related to the infusion, such as chills, fever and low blood pressure.
Le-ti so vključevali resno in dolgotrajno supresijo kostnega mozga, ki povzroča nizko raven belih krvničk in ploščic, težave z jetri ter stranske učinke, povezane z infundiranjem, kot npr. mrzlico, povišano telesno temperaturo in nizek krvni tlak.
A small proportion of the patients whose disease had come back after one previous course of treatment achieved complete remission.
Majhen delež bolnikov, pri katerih se je bolezen ponovno pojavila po enem predhodnem zdravljenju, je dosegel popolno remisijo.
However, it was difficult to compare the effectiveness of Mylotarg and other treatments used for this disease, in terms of how long remission would last, how long it would take until the disease got worse, or what the medicines' effects would be on survival.
Vendar pa je bilo težko primerjati učinkovitost zdravila Mylotarg in drugih zdravil za to bolezen z vidika trajanja remisije, dolžine obdobja do poslabšanja ali učinkov zdravila na preživetje.
The effects of Mylotarg were first tested in experimental models before being studied in humans.
Učinki zdravila Mylotarg so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Mylotarg?
Kakšne so posledice zavrnitve za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Mylotarg?
It was to be used in patients who were ‘CD33-positive', meaning that their cancerous white blood cells had a protein called CD33 on their surface.
Uporabljalo naj bi se pri bolnikih, ki so „pozitivni na CD33“, kar pomeni, da imajo njihove rakave bele krvničke na površini beljakovino, imenovano CD33.
The company also stated that it will continue to supply Mylotarg for use in existing, ongoing clinical trials.
Družba je prav tako izjavila, da bo nadaljevala z dobavo zdravila Mylotarg, namenjenega za uporabo v kliničnih preskušanjih, ki so v teku.
Mylotarg was not compared to any other treatment in any of the studies.
Zdravila Mylotarg v nobeni študiji niso primerjali s kakim drugim zdravljenjem.
The company informed the CHMP that patients currently included in compassionate use programmes will continue to receive Mylotarg until they have finished their course of treatment.
Družba je CHMP obvestila, da bodo bolniki, ki so trenutno vključeni v programe sočutne uporabe, prejemali zdravilo Mylotarg, dokler ne zaključijo zdravljenja.
When the antibody attaches to CD33, the cells absorb the antibody, as well as the cytotoxic substance that it is attached to.
Ko se protitelo veže na CD33, celice absorbirajo protitelo, prav tako pa tudi citotoksično učinkovino, ki je vezana nanj.
The effects of Mylotarg were studied in three main studies involving a total of 277 patients with CD33-positive acute myeloid leukaemia, whose disease had come back after one previous course of treatment.
Zdravilo Mylotarg so preučevali v treh glavnih študijah s skupno 277 bolniki z akutno mieloično levkemijo, pozitivno na CD33, pri katerih se je bolezen ponovila po enem predhodnem zdravljenju.
At that point in time, the CHMP was of the opinion that there was insufficient evidence to establish the effectiveness of Mylotarg in the treatment of acute myeloid leukaemia, and therefore that the medicine's benefits did not outweigh its risks.
Takrat je bil CHMP mnenja, da ni zadostnih dokazov, da bi lahko določili učinkovitost zdravila Mylotarg pri zdravljenju akutne mieloične levkemije, zato koristi zdravila ne odtehtajo z njim povezanih tveganj.
The Committee noted that there were side effects associated with Mylotarg.
Odbor je ugotovil, da so z zdravilom Mylotarg povezani stranski učinki.
The calicheamicin then breaks up the leukaemia cells' DNA, eventually killing the cells.
Kaliheamicin razbije DNK celic levkemije ter tako postopoma ubije celice.
On 20 September 2007, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Mylotarg 5 mg powder for solution for infusion, intended for the treatment of acute myeloid leukaemia.
Odbor za zdravila za uporabo v humani medicini (CHMP) je v svojem negativnem mnenju z dne 20. septembra 2007 priporočil zavrnitev vloge za dovoljenje za promet z zdravilom Mylotarg, 5 mg praškom za pripravo raztopine za infundiranje, namenjenim za zdravljenje akutne mieloične levkemije.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on certain cells in the body.
Monoklonsko protitelo je protitelo (tip beljakovine), ki je bilo oblikovano tako, da prepozna in se veže na specifično strukturo (imenovano antigen), ki se nahaja na posameznih celicah v telesu.
Mylotarg was to be used to treat patients whose disease had come back after one previous course of treatment, and who were not suitable for other types of intensive chemotherapy such as highdose cytarabine (another anticancer medicine).
Zdravilo Mylotarg bi naj bilo namenjeno zdravljenju bolnikov, katerih bolezen se je ponovno pojavila po predhodnem zdravljenju, in ki niso bili primerni za druge vrste intenzivne kemoterapije, npr. s citarabinom (drugim zdravilom proti raku) v visokem odmerku.
Mylotarg was expected to be used to treat acute myeloid leukaemia, a type of cancer of the white blood cells.
Zdravilo Mylotarg bi se naj uporabljalo za zdravljenje akutne mieloične levkemije, vrste raka belih krvničk.
What is Mylotarg?
Kaj je zdravilo Mylotarg?
The CHMP refusal was confirmed after re-examination.
Po ponovni presoji je bila zavrnitev s strani CHMP potrjena.
It contains the active substance gemtuzumab ozogamicin.
Vsebuje zdravilno učinkovino gemtuzumab ozogamicin.
Mylotarg was designated as an orphan medicinal product on 18 October 2000 for acute myeloid leukaemia.
Zdravilo Mylotarg je bilo 18. oktobra 2000 določeno kot zdravilo sirota za zdravljenje akutne mieloične levkemije.
The CHMP was concerned that the studies of Mylotarg had not shown a benefit of the medicine, because of the way they were designed.
CHMP je izrazil skrb, da študije z zdravilom Mylotarg zaradi svoje zasnove niso izkazale koristi zdravila.
Inside the cells, the cytotoxic substance, which is called calicheamicin, is released.
Znotraj celice se citotoksična učinkovina, imenovana kaliheamicin, sprosti.
What was Mylotarg expected to be used for?
Za kaj naj bi se zdravilo Mylotarg uporabljalo?
Hence, the CHMP recommended that Mylotarg be refused marketing authorisation.
Iz tega razloga je CHMP priporočil zavrnitev dovoljenja za promet z zdravilom Mylotarg.