natgillin/translations-raw huggingface dataset:
Etravirine 200 mg twice daily N = 575
200 mg etravirina dvakrat na dan, drugo trimesečje N = 13
Tablet
Odmerjanje
Rash has been reported with etravirine.
Pri uporabi etravirina so poročali o pojavu izpuščaja.
PROTON PUMP INHIBITORS Omeprazole
Zaviralci fuzije enfuvirtid
St John's wort is expected to decrease the plasma concentrations of etravirine.
Pričakovati je, da bi sočasna uporaba povzročila znižanje plazemskih koncentracij etravirina.
Contact your doctor if you are uncertain about what to do if you miss a dose or vomit.
Če ste negotovi, kaj morate storiti v primeru izpuščenega odmerka ali bruhanja, se posvetujte z zdravnikom.
rd trimester of pregnancy, and postpartum.
trimesečjem nosečnosti ter v obdobju po porodu Farmakokinetika etravirina povprečna ± SD (mediana)
An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy.
Telesna masa in zvišane koncentracije lipidov in glukoze v krvi Med zdravljenjem okužbe z virusom HIV se lahko poveča telesna masa ter zviša koncentracija lipidov in glukoze v krvi.
100 mg twice daily four 25 mg tablets twice daily or one 100 mg tablet twice daily
≥ 16 do < 20 kg 100 mg dvakrat na dan štiri 25 mg tablete dvakrat na dan ali ena 100 mg tableta dvakrat na dan
Repeat it one or two times.
Ponovite enkrat ali dvakrat.
Date of first authorisation: 08/09/2015
Datum pridobitve dovoljenja za promet: 08.09.2015
No spread was demonstrated between chickens.
Med piščanci ni bilo dokazanega širjenja.
Do not use Vectormune ND if you notice visible signs of unacceptable decolourisation in the vials.
Ne uporabite Vectormune ND, če opazite vidne znake nesprejemljivega razbarvanja v viali.
Do not re-freeze under any circumstances.
Pod nobenim pogojem ne zamrzujte ponovno.
Frozen glass ampoules may explode during sudden temperature changes.
Zmrznjene steklene ampule lahko eksplodirajo ob nenadnih temperaturnih spremembah.
Chicken and embryonated chicken eggs.
Piščanci in oplojena kokošja jajca.
Thaw rapidly the contents of the ampoules by gentle agitation in water at 27-39 °C.
Hitro odtajajte vsebino ampul z nežnim mešanjem v vodi pri 27-39°C.
Each dose of reconstituted vaccine (0.05 ml in-ovo or 0.2 ml subcutaneous) contains:
Vsak odmerek rekonstituiranega cepiva (0,05 ml in-ovo ali 0,2 ml subkutano) vsebuje:
ATCvet code: QI01AD.
Oznaka ATC vet: QI01AD.
Be familiar with all safety and precautionary measures for handling liquid nitrogen in order to prevent personal injury.
Bodite seznanjeni z vsemi varnostnimi in previdnostnimi ukrepi za ravnanje s tekočim dušikom, da preprečite telesne poškodbe.
Do not re-use opened containers of diluted vaccine.
Ne uporabljajte ponovno že odprtih vsebnikov razredčenega cepiva.
Volume of one dose (ml)
Volumen enega odmerka (ml)
Inhalation of the liquid nitrogen is dangerous.
Vdihovanje tekočega dušika je nevarno.
The 200 ml presentation may be used for manual vaccination.
Pakiranje 200 ml se lahko uporabi za ročno cepljenje.
Repeat the operations in point 2-7 for the appropriate number of ampoules to be thawed.
Ponovite postopek od točke 2-7, da odmrznete ustrezno število ampul.
(ml)
(MRL)
The usual aseptic precautions should be applied to all administration procedures.
Upoštevajte običajne aseptične previdnostne ukrepe pri vseh postopkih dajanja.
The vaccine strain was shown to be excreted by chickens and there was a slow spread to turkeys which was not detectable at 35 days but was detectable after 42 days of a contact study.
Dokazano je bilo, da piščanci izločajo vakcinalni sev in opaženo je bilo počasno širjenje na purane, ki je bilo nezaznavno 35. dan, vendar ga je bilo mogoče zaznati po 42. dnevu kontaktne raziskave.
Transfer the suspension into the solvent bag.
Prenesite suspenzijo v vrečko vehikla.
Read also the product information of Cevac Transmune before use.
Pred uporabo preberite tudi informacije o cepivu Cevac Transmune.
Pharmacotherapeutic group: Immunologicals for Aves, live viral vaccines for domestic fowls.
Farmakoterapevtska skupina: Imunološka zdravila za ptice, živo virusno cepivo za domače kokoši.
Store and transport frozen in liquid nitrogen (-196 °C).
Suspenzija: Shranjujte in prevažajte zamrznjeno v tekočem dušiku (-196 °C).
In-ovo and subcutaneous use.
In-ovo in subkutana uporaba.
The solvent is a clear red solution.
Vehikel je bistra rdeča raztopina.
Use the vaccine immediately, slowly mix regularly to ensure uniform suspension of cells and use within a period not exceeding 2 hours.
Cepivo uporabite takoj, redno počasi mešajte, da zagotovite suspenzijo celic in uporabite znotraj 2 ur.
Safety trials show the excreted vaccine strain is not harmful in turkeys; however, special precautions should be taken to avoid spreading of the vaccine strain to turkeys.
Varnostni poizkusi kažejo, da izločen vakcinalni sev ni škodljiv za purane; vendar je potrebno upoštevati posebne previdnostne ukrepe, da bi se izognili širjenju vakcinalnega seva na purane.
The vaccine may be injected by an automatic syringe.
Cepivo se lahko injicira z avtomatsko brizgo.
Bovine serum Dimethyl sulfoxide Water for injection
Goveji serum Dimetilsulfoksid Voda za injekcije
The liquid nitrogen containers must be checked regularly for liquid nitrogen level and must be refilled as needed.
Redno je potrebno preverjati nivo tekočega dušika v posodah za tekoči dušik ter jih po potrebi napolniti.
As soon as they are completely thawed, open ampoules holding them at arms length in order to prevent any risk of injury should the ampoule break.
Takoj, ko so popolnoma odtajane, ampule odprite tako, da jih držite stran od sebe za dolžino roke, da preprečite nevarnost poškodbe v primeru poka ampule.
SC or in-ovo use.
SC ali in-ovo uporaba.
Store below 25 °C.
Shranjujte pri temperaturi pod 25 °C.
The canes with ampoules are stored in a liquid nitrogen container.
Vrste z ampulami so shranjene v posodi s tekočim dušikom.
Do not mix with any other veterinary medicinal product, except Cevac Transmune (where it is marketed) and the solvent (Cevac Solvent Poultry) supplied for use with the veterinary medicinal product.
Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini, razen s cepivom Cevac Transmune (kjer je na voljo na trgu) in z vehiklom (Cevac Solvent Poultry), ki je priložen za uporabo s tem zdravilom za uporabo v veterinarski medicini.
Overview table for dilution possibilities of different presentations:
Pregledna tabela možnosti razredčitve:
Laying birds: Do not use in birds in lay and within 4 weeks before the start of the laying period.
Ptice v obdobju nesnosti: Ne uporabite pri pticah v obdobju nesnosti in 4 tedne pred začetkom obdobja nesnosti.
The safety and efficacy of the mixed vaccines are not different from those described for the vaccines administered separately.
Varnost in učinkovitost kombiniranega cepiva sta enaki kot sta opisani za dajanje posameznega cepiva.
Personnel involved in the treatment of vaccinated birds should follow hygiene principles and take particular care in handling litter from vaccinated chickens.
Osebe, ki sodelujejo pri ravnanju s cepljenimi pticami, naj upoštevajo osnove higiene in še posebno pazijo pri ravnanju z odpadki cepljenih piščancev.
The speed of automatic injection is at least 2,500 eggs per hour, therefore solvent presentation of at least or more than 400 ml is recommended to prime and inject for longer than 10 minutes.
Hitrost avtomatskega injiciranja je vsaj 2500 jajc na uro, zato se za injiciranje dlje kot 10 minut priporoča uporaba najmanj 400 ml vehikla za injiciranje.
In-ovo equipment should be calibrated to ensure that a 0.05 ml dose is applied to each egg.
In-ovo oprema mora biti kalibrirana, da se zagotovi aplikacija odmerka 0,05 ml v vsako jajce.
Store and use liquid nitrogen only in a dry and well-ventilated place.
Shranjujte in uporabljajte tekoči dušik le v suhem in dobro prezračenem prostoru.
After matching the dose size of the vaccine with the solvent size, quickly remove the exact number of ampoules needed from the liquid nitrogen container.
Po izbiri ustrezne količine vehikla glede na velikost odmerka cepiva, iz posode s tekočim dušikom hitro odstranite točno potrebno število ampul.
Preparation of vaccine suspension for injection:
Priprava suspenzije cepiva za injiciranje:
Lay: Do not use in birds in lay and within 4 weeks before the start of the laying period.
Nesnost: Ne uporabite pri pticah v obdobju nesnosti in 4 tedne pred začetkom obdobja nesnosti.
Duration of immunity for broilers and layers: A single vaccination is sufficient to provide protection during the risk period of infection with Marek's disease.
Trajanje imunosti pri brojlerjih in nesnicah: enkratno cepljenje zadostuje za zaščito v obdobju tveganja okužbe z Marekovo boleznijo.
For active immunisation of 18 day-old embryonated chicken eggs or one-day-old chicks to reduce mortality and clinical signs caused by Newcastle disease virus and to reduce mortality, clinical signs and lesions caused by Marek's disease virus with a phenotype “virulent”.
Za aktivno imunizacijo 18 dnevnih oplojenih kokošjih jajc ali enodnevnih piščancev za zmanjšanje smrtnosti in kliničnih znakov povzročenih z virusom atipične kokošje kuge in za zmanjšanje smrtnosti, kliničnih znakov in lezij povzročenih z virusom Marekove bolezni s fenotipom ''virulenten''.
No symptoms were observed after the administration of a 10-fold dose of vaccine.
Po dajanju 10-kratnega odmerka cepiva ni bilo opaženih kliničnih znakov.
Solvent presentation smaller than 400 ml is not recommended to be used for in-ovo application as it may not be enough to prime the machine and to inject longer than 10 minutes.
Za in-ovo dajanje z avtomatsko napravo ni priporočljiva uporaba manj kot 400 ml vehikla, saj morda ne bo dovolj vehikla za pripravo naprave in injiciranje za dlje kot 10 minut.
Remove the washing from the ampoule and inject it gently into the solvent bag.
Odstranite izprano iz ampule in nežno vbrizgajte v vrečko vehikla.
For inovo application an automatic in-ovo egg injector can be used.
Za in-ovo odmerjanje lahko uporabite avtomatski in-ovo aplikator za jajca.
Withdraw a portion of the diluted vaccine into the syringe to rinse the ampoule.
Izvlecite del razredčenega cepiva v brizgo, da izperete ampulo.
Shelf life of the veterinary medicinal product as packaged for sale: suspension: 2 years, solvent: 30 months.
Rok uporabnosti zdravila v pakiranju za prodajo: suspenzija: 2 leti.
The efficacy of the vaccine was challenged with the Marek virus strain MD70 which has a phenotype “virulent”.
Učinkovitost zdravila je bila izzvana z virusom Marekove bolezni s sevom MD70, ki ima fenotip
Liquid nitrogen containers and vaccine ampoules should be handled by properly trained personnel only.
Posode s tekočim dušikom in ampule s cepivom lahko uporablja le ustrezno usposobljeno osebje.
It should be ensured that the vaccine suspension is mixed regularly in a gentle way during the vaccination session to guarantee that the vaccine suspension remains homogenous and that the correct vaccine virus titer is administered (e.g. when automatic in-ovo injection machines are used or during long vaccination sessions).
Potrebno je zagotoviti, da se med cepljenjem suspenzija cepiva redno nežno meša, da zagotovo suspenzija cepiva ostane homogena in, da se aplicira pravilen titer virusa cepiva (npr. ob uporabi avtomatskih in-ovo injekcijskih naprav ali med dolgotrajnim postopkom cepljenja).
Discard any ampoules that have been accidentally thawed.
Zavrzite vse ampule, ki so bile po nesreči odmrznjene.
Five ampoules per cane.
Pet ampul v vrsto.
The diluted vaccine prepared as described is mixed by gentle agitation so as to be ready for use.
Razredčeno cepivo pripravljeno, kot je opisano, nežno mešajte z rahlim stresanjem, dokler ni pripravljeno za uporabo.
Orange-yellowish semi-transparent frozen suspension.
Oranžno-rumenkasta pol-prozorna zmrznjena suspenzija.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product, except Cevac Transmune (where it is marketed).
Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini, razen s cepivom Cevac Transmune (kjer je na voljo na trgu).
Vaccine ampoule presentation (No. of vaccine ampoules multiplied by doses needed)
Za in-ovo dajanje: Št. ampul cepiva pomnoženo s št. potrebnih odmerkov
Dipotassium hydrogen phosphate Potassium dihydrogen phosphate Phenol red
Kalijev hidrogenfosfat Kalijev dihidrogenfosfat Fenolno rdeče Voda za injekcije
Match the dose size of the vaccines and the sterile solvent according to the table below.
Odmerite odmerek cepiva in sterilnega vehikla v skladu s spodnjo tabelo:
Vectormune ND suspension and solvent for suspension for injection for chickens
Vectormune ND suspenzija in vehikel za suspenzijo za injiciranje za piščance
Duration of immunity for broilers and layers: A single vaccination is sufficient to provide protection during the risk period of infection with Marek's disease virus with a phenotype “virulent”.
Trajanje imunosti pri brojlerjih in nesnicah: enkratno cepljenje zadostuje za zaščito v obdobju tveganja okužbe z Marekovo boleznijo s fenotipom ''virulenten''.
The excipients (including adjuvants) listed in section 6.1 of the SPC considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Pomožne snovi (vključno z dodatki), navedene v poglavju 6.1 SPC, ne spadajo v področje uporabe
Cell-associated live recombinant viral turkey herpes virus (rHVT/ND) expressing the fusion protein of Newcastle disease virus D-26 lentogenic strain: 2,500-8,000 PFU*/dose
NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN Celično vezan živ rekombinantni puranji herpes virus (rHTV/ND), ki izraža fuzijski protein virusa atipične kokošje kuge (Newcastle bolezni) D-26 lentogen sev: 2500 - 8000 PFU*/odmerek *PFU: enote, ki tvorijo plak
Once the ampoule is open, slowly draw up the content into the 5 ml sterile syringe already containing 2 ml of solvent with a needle of at least 18 gauge diameter.
Ko je ampula odprta, počasi izvlecite vsebino v 5 ml sterilno brizgo, ki že vsebuje 2 ml vehikla, z iglo debeline vsaj 18 G.
The mixed products protect against Newcastle disease virus, Marek's disease virus with a phenotype “virulent” and Avian Infectious Bursal Disease (IBD) viruses.
Kombinacija obeh zdravil varuje proti virusu Newcastle bolezni, virusu Marekove bolezni s fenotipom ''virulenten'' in virusu aviarnega kužnega burzitisa (IBD).
The diluted vaccine prepared as described is mixed by gentle agitation.
Razredčeno cepivo pripravljeno, kot je opisano, nežno mešajte z rahlim stresanjem.
PARTICULARS TO APPEAR ON THE IMMEDIATE OR OUTER PACKAGES Solvent bags of 200 ml, 400 ml or 800 ml
PODATKI NA ZUNANJI OVOJNINI Vrečke z vehiklom 200 ml, 400 ml ali 800 ml
Onset of immunity against Marek's disease for broilers and layers: 1 week of age.
Nastop imunosti proti Marekovi bolezni pri brojlerjih in nesnicah: 1 teden starosti.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Cevac Transmune by in ovo or subcutaneous vaccination for broilers.
Podatki o varnosti in učinkovitosti so pokazali, da se to cepivo lahko meša in daje s cepivom Cevac Transmune in ovo ali subkutano pri brojlerjih.
Suspension and solvent for suspension for injection.
Suspenzija in vehikel za suspenzijo za injiciranje.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Cevac Transmune by in ovo or subcutaneous vaccination.
Podatki o varnosti in učinkovitosti so pokazali, da se to cepivo lahko meša in daje s cepivom Cevac Transmune in ovo ali subkutano.
Type I glass ampoule containing 1,000, 2,000 or 4,000 doses of the vaccine.
Steklene ampule tipa I s 1000, 2000 ali 4000 odmerki cepiva.
1,000 doses 2,000 doses 4,000 doses
1000 odmerkov 2000 odmerkov 4000 odmerkov
Transfer the dissolved vaccines into the solvent bag and mix by gentle agitation.
Prenesite raztopljeno cepivo v vrečko vehikla in nežno mešajte z rahlim stresanjem.
Draw up 2 ml of sterile solvent into another 5 ml syringe then dissolve the content of Cevac Transmune vial in it.
Izvlecite 2 ml sterilnega vehikla v 5 ml brizgo, nato v brizgi raztopite še vsebino viale cepiva Cevac Transmune.
Draw up 2 ml of solvent into a 5 ml syringe.
Izvlecite 2 ml vehikla v 5 ml brizgo.
One single dose of 0.05 ml is injected into each 18-day-old embryonated broiler chicken egg.
En odmerek 0,05 ml se injicira v vsako 18 dni staro oplojeno brojlersko jajce.
PACKAGE LEAFLET: Vectormune ND suspension and solvent for suspension for injection for chickens
NAVODILO ZA UPORABO Vectormune ND suspenzija in vehikel za suspenzijo za injiciranje za piščance
Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po EXP.Rok uporabnosti zdravila se nanaša na zadnji dan v navedenem mesecu.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
Personal protective equipment consisting of protective gloves, spectacles and boots should be worn when handling the veterinary medicinal product, before withdrawing from liquid nitrogen, during the ampoule thawing and opening operations.
Pri ravnanju z zdravilom za uporabo v veterinarski medicini, pred odvzemom iz tekočega dušika, pri odtajevanju ampul in med postopki odpiranja, nosite osebno zaščitno opremo, ki sestoji iz zaščitnih rokavic, zaščitnih očal in škornjev.
Draw up 2 ml of sterile solvent into a 5 ml syringe then draw up the thawed content of Vectormune ND ampoule in it.
Izvlecite 2 ml sterilnega vehikla v 5 ml brizgo, nato v brizgo dodajte še odtajano vsebino ampule cepiva Vectormune ND.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN
Solvent: Polyvinylchloride bag containing 200 ml, 400 ml or 800 ml in individual over-pouch.
Polivinilkloridna vrečka z 200 ml, 400 ml ali 800 ml v posameznih zaščitnih vrečkah.
Once the ampoule is open slowly draw up the content into the 5 ml sterile syringe already containing 2 ml solvent with a needle of at least 18 gauge diameter.
Ko je ampula odprta, počasi izvlecite vsebino v 5 ml sterilno brizgo, ki že vsebuje 2 ml vehikla,
Onset of immunity against Newcastle disease for broilers and layers: 3 weeks of age.
Nastop imunosti proti Newcastle bolezni pri brojlerjih in nesnicah: 3 teden starosti.
Duration of immunity against Newcastle disease for layers: 18 weeks of age
Trajanje imunosti proti Newcastle bolezni pri nesnicah: 18 teden starosti
Name and address of the manufacturer of the biological active substance
Ime in naslov proizvajalca (proizvajalcev) biološke (bioloških) učinkovine (učinkovin) CEVA-Phylaxia Co.Ltd.
Glass ampoule of 1,000; 2,000 or 4,000 doses of the vaccine.
Suspenzija: Steklene ampule tipa I s 1000, 2000 ali 4000 odmerki cepiva.
Duration of immunity against Newcastle disease for broilers: 9 week of age.
Trajanje imunosti proti Newcastle bolezni pri brojlerjih: 9 teden starosti.
One single injection of 0.2 ml per chick is applied for broilers or layers at one day of age.
Ena injekcija 0,2 ml na piščanca pri brojlerjih in nesnicah v starosti enega dne.
For subcutaneous administration:
Subkutano dajanje:
Liquid nitrogen containers and vaccine ampoules should be handled only by properly trained personnel.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Posode s tekočim dušikom in ampule cepiva lahko uporablja le ustrezno usposobljeno osebje.
Duration of immunity against Newcastle disease for layers: 18 week of age.
Trajanje imunosti proti Newcastle bolezni pri nesnicah: 18 teden starosti.
One single injection of 0.2 ml per chick is applied for broilers at one day of age.
Subkutano dajanje: Posamezen odmerek 0,2 ml na piščanca se injicira pri brojlerjih pri starosti en dan.
Special precautions for use in animals:
Posebna opozorila za vsako živalsko vrsto:
Sterile solvent
Sterilen vehikel
Polyvinylchloride bag containing 200 ml of solvent in individual over-pouch.
Polivinilkloridna vrečka z 200 ml vehikla v posameznih zaščitnih vrečkah.
Polyvinylchloride bag containing 800 ml of solvent in individual over-pouch.
Polivinilkloridna vrečka z 800 ml vehikla v posameznih zaščitnih vrečkah.
Volume of one dose
Količina vehikla
Polyvinylchloride bag containing 400 ml of solvent in individual over-pouch.
Polivinilkloridna vrečka z 400 ml vehikla v posameznih zaščitnih vrečkah.
{MM/YYYY}
(IBD).
Further information on Aranesp's current uses can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Več informacij o trenutnih uporabah zdravila Aranesp je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Aranesp has been authorised since June 2001.
Zdravilo Aranesp je bilo odobreno junija 2001.
The main measure of effectiveness was a reduction in the number of transfusions of red blood cells.
Glavno merilo učinkovitosti je bilo zmanjšanje števila transfuzij rdečih krvničk.
This means that darbepoetin alfa has a longer duration of action, and can be given less often than natural erythropoietin.
To pomeni, da darbepoetin alfa deluje dlje časa in se lahko daje redkeje kot naravni eritropoetin.
• adults and children with ‘chronic renal failure' (long-term, progressive decrease in the ability of the kidneys to work properly);
• odrasli in otroci s „kronično odpovedjo ledvic“ (dolgotrajno napredujoče upadanje sposobnosti ledvic za pravilno delovanje);
In addition, one study conducted in the United States was not in line with EU recommendations for treatment of patients with myelodysplastic syndromes.
Poleg tega ena študija, izvedena v Združenih državah, ni bila v skladu s priporočili EU za zdravljenje bolnikov z mielodisplastičnimi sindromi.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 March 2018 EMA/165563/2018 EMEA/H/C/000332
marec 2018 EMA/165563/2018 EMEA/H/C/000332
What is Aranesp?
Kaj je Aranesp?
The CHMP was of the opinion that changes to the study design of one study and the exclusion of a high number of patients from the analysis of the results raise questions about the validity of the data.
Odbor CHMP je menil, da se zaradi spremembe zasnove ene študije in izključitve velikega števila bolnikov iz analize rezultatov zastavljajo vprašanja glede veljavnosti podatkov.
• adults who are receiving chemotherapy for ‘non-myeloid' cancer (cancer not originating in the bone marrow).
• odrasli, ki prejemajo kemoterapijo za zdravljenje „nemieloičnega“ raka (raka, ki ne izvira iz kostnega mozga).
The medicine was to be used in patients who did not need frequent blood transfusions and who had a low or intermediate risk of their condition progressing to acute myeloid leukaemia (AML, a type of cancer affecting white blood cells).
Zdravilo naj bi se uporabljalo pri bolnikih, ki ne potrebujejo pogoste transfuzije krvi in pri katerih je majhno ali srednje tveganje, da bo njihova bolezen napredovala v kronično mieloično levkemijo (AML, vrsta raka, ki prizadene bele krvničke).
The applicant presented data from two main studies in 356 anaemic patients with myelodysplastic syndromes.
Vlagatelj je predložil podatke iz dveh glavnih študij, v kateri je bilo vključenih 356 anemičnih bolnikov z mielodisplastičnimi sindromi.
In the second study, all patients received Aranesp for 13 weeks and the study measured the level of haemoglobin, the main constituent of red blood cells, in the blood.
V drugi študiji so vsi bolniki 13 tednov prejemali zdravilo Aranesp, merila pa se je raven hemoglobina, ki je glavna sestavina rdečih krvničk, v krvi.
It contains the active substance darbepoetin alfa.
Vsebuje zdravilno učinkovino darbepoetin alfa.