Oncept IL-2

Glavna informacija

  • Trgovački naziv:
  • Oncept IL-2
  • Koristi za:
  • Životinje
  • Vrsta lijekova:
  • alopatski lijek

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Oncept IL-2
    Europska Unija
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Terapijska grupa:
  • mačke
  • Područje terapije:
  • Antineoplastična i imodulirajuća sredstva
  • Terapijske indikacije:
  • Imunoterapija koristi se u kombinaciji sa operacije i radioterapije kod mačaka s фибросаркомой (2-5 cm u promjeru) bez metastaza i lumps intervencija, smanjiti rizik od recidiva i povećati vrijeme do recidiva (lokalnog recidiva ili metastaza).

Druge informacije

Status

  • Izvor:
  • EMA - European Medicines Agency
  • Status autorizacije:
  • odobren
  • Broj odobrenja:
  • EMEA/V/C/002562
  • Datum autorizacije:
  • 03-05-2013
  • EMEA koda:
  • EMEA/V/C/002562
  • Zadnje ažuriranje:
  • 24-02-2018

Uputu o lijeku

B. UPUTA O VMP

UPUTA O VMP:

Oncept IL-2

Liofilizat i otapalo za suspenziju za injekciju namijenjeni mačkama

1.

NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I

NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE

SERIJE U PROMET, AKO JE RAZLIČITO

Nositelj odobrenja za stavljanje u promet:

MERIAL

29, avenue Tony Garnier

69007 Lyon

Francuska

Proizvođač odgovoran za puštanje serije u promet:

MERIAL

Laboratoire Porte des Alpes

Rue de l'Aviation

69800 Saint Priest

Francuska

2.

NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA

Oncept IL-2 liofilizat i otapalo za suspenziju za injekciju za mačke.

3.

KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNE(IH) TVARI I DRUGIH

SASTOJAKA

Nakon rekonstitucije jedna doza od 1 ml sadrži:

Mačji interleukin-2 rekombinantni virus boginja kanarinaca (vCP1338) ....................... ≥ 10

EAID*

*ELISA infektivna doza 50%.

Liofilizat: bjelkasta homogena peleta.

Otapalo: bistra bezbojna tekućina.

4.

INDIKACIJE

Imunoterapija koja će se primjenjivati uz kirurški zahvat i radioterapiju u mačaka s fibrosarkomom

(promjera 2-5 cm) bez metastaza ili zahvaćenosti limfnih čvorova kako bi se smanjio rizik od recidiva

te povećalo vrijeme do recidiva (lokalni recidiv ili metastaze). To je dokazano u ispitivanju koje je

trajalo 2 godine.

5.

KONTRAINDIKACIJE

Nema.

6.

NUSPOJAVE

Umjerena lokalna reakcija (bol na dodir, oticanje, grebanje) pojavljuje se vrlo često prema

ispitivanjima sigurnosti. Obično se spontano povukla najkasnije u roku od 1 tjedna.

Prolazna apatija i hipertermija (iznad 39,5 °C) zabilježena je često u terenskim ispitivanjima.

Učestalost nuspojava je određena sukladno sljedećim pravilima:

vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e))

česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja)

manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja)

rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja)

vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).

Ako zamijetite bilo koju nuspojavu, čak i one koje nisu navedene u ovoj uputi o VMP ili mislite da

veterinarsko-medicinski proizvod ne djeluje, molimo obavijestite svog veterinara.

7.

CILJNE VRSTE ŽIVOTINJA

Mačke.

8.

DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, PUT I NAČIN PRIMJENE

Potkožno.

Nakon rekonstitucije liofilizata s otapalom, lagano protresite te pet injiciranja (svako od oko 0,2 ml)

primijenite oko mjesta ekscizije tumora: po jednu injekciju u svakom kutu i jednu injekciju u središtu

kvadrata od 5 cm x 5 cm na sredini kirurškog ožiljka.

Tijek liječenja: 4 primjene u intervalima od 1 tjedna (0. dan, 7. dan, 14. dan, 21. dan) nakon kojih

slijede 2 primjene u intervalima od 2 tjedna (35. dan, 49. dan).

Tijek liječenja započnite dan prije radioterapije, po mogućnosti unutar jednog mjeseca od kirurške

ekscizije.

9.

SAVJETI ZA ISPRAVNU PRIMJENU

10.

KARENCIJA(E)

Nije primjenjivo.

11.

POSEBNE MJERE PRI ČUVANJU

Čuvati izvan pogleda i dosega djece.

Čuvati i prevoziti na hladnom (2

Čuvati u originalnom pakovanju radi zaštite od svjetla.

Ne zamrzavati.

Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na etiketi

poslije EXP.

Odmah primijeniti nakon rekonstitucije.

12.

POSEBNA UPOZORENJA

Posebna upozorenja za svaku od ciljnih vrsta životinja:

Poštivanje preporučenog načina primjene na 5 injekcionih mjesta važno je za postizanje djelotvornosti

proizvoda; primjena samo 1 injekcije može dovesti do smanjene djelotvornosti (vidi dio „Doziranje za

svaku vrstu životinja, put i način primjene“).

Djelotvornost je ispitana samo u kombinaciji s kirurškim zahvatom i radioterapijom; stoga je liječenje

potrebno provesti u skladu s tijekom liječenja opisanog u dijelu „Doziranje za svaku vrstu životinja,

put i način primjene“.

Djelotvornost nije ispitana u mačaka s metastazama i sa zahvaćenim limfnim čvorovima.

Budući da neškodljivost i djelotvornost ponovljene terapije za liječenje recidiva fibrosarkoma nisu

ispitane, veterinar bi trebao razmotriti ponovljeno liječenje uzimajući u obzir odnos koristi i rizika.

Djelotvornost liječenja nije ispitana nakon 2 godine od liječenja.

Posebne mjere opreza koje mora poduzeti osoba koja primjenjuje veterinarsko-medicinski proizvod

na životinjama:

Rekombinanti virusi boginja kanarinaca nisu škodljivi za ljude. Blage lokalne i/ili sustavne nuspojave

u vezi sa samom injekcijom mogu se pojaviti, no one su kratkotrajne. Nadalje, mačji IL-2 ima vrlo

nisko biološko djelovanje na ljudske leukocite u usporedbi s ljudskim IL-2. U slučaju nehotičnog

samoinjiciranja odmah potražite pomoć liječnika i pokažite mu uputu ili etiketu.

Graviditet i laktacija:

Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena za vrijeme graviditeta i laktacije.

Predoziranje (simptomi, hitni postupci, antidoti):

Nakon predoziranja (primjene 10 doza) može se pojaviti prolazna umjerena do izrazita hipertemija,

kao i lokalne reakcije (oticanje, crvenilo ili blaga bol te u nekim slučajevima toplina na mjestu injiciranja).

Interakcija s drugim medicinskim proizvodima i drugi oblici interakcija:

Ne postoje dostupni podaci o neškodljivosti i djelotvornosti ovog imunološkog veterinarsko-

medicinskog proizvoda kada se primjenjuje s bilo kojim drugim veterinarsko-medicinskim

proizvodom. Odluku o primjeni ovog imunološkog veterinarsko-medicinskog proizvoda prije,

odnosno poslije primjene bilo kojeg drugog veterinarsko-medicinskog proizvoda treba donositi od

slučaja do slučaja.

Inkompatibilnosti:

Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom, osim otapalom priloženim za

primjenu s veterinarsko-medicinskim proizvodom.

13.

POSEBNE MJERE OPREZA PRI ODLAGANJU NEUPOTREBLJENOG PROIZVODA

ILI OTPADNIH MATERIJALA, AKO IH IMA

Otpadni materijal mora se odložiti ključanjem, spaljivanjem ili uranjanjem u odgovarajuće

dezinfekcijsko sredstvo čiju su primjenu odobrila nadležna tijela.

Veterinarsko-medicinski proizvodi se ne smiju odlagati u otvorene vode ili kućni otpad.

Pitajte vašeg veterinara kako odlagati veterinarsko-medicinske proizvode lijekove koji vam više nisu

potrebni. Te mjere pomažu u zaštiti okoliša.

14.

DATUM KADA JE UPUTA O VMP ZADNJI PUTA ODOBRENA

Detaljne informacije o ovom veterinarsko-medicinskom proizvodu dostupne su na web-stranici Europske

agencije za lijekove http://www.ema.europa.eu/

15.

OSTALE INFORMACIJE

Cjepni soj vCP1338 rekombinantni je virus boginja kanarinaca koji se eksprimira u mačjem

interleukinu-2 (IL-2). Virus eksprimira gen IL-2 na mjestu inokulacije, ali se ne replicira u mački.

Oncept IL-2 se injicira u ležište tumora, stoga oslobađa

in situ

nisku dozu mačjeg interleukina-2, koji

stimulira antitumorski imunitet bez toksičnosti koja je povezana sa sustavnim liječenjem.

Specifični mehanizmi putem kojih imunostimulacija inducira antitumorsko djelovanje nisu poznati.

Mačke različitih podrijetla koje pokazuju fibrosarkom bez metastaza ili zahvaćenosti limfnih čvorova

bile su uključene u dvije skupine randomiziranog kliničkog ispitivanja, od kojih je jedna primala

referentno liječenje – kirurški zahvat i radioterapiju – a druga Oncept IL-2 uz kirurški zahvat i

radioterapiju. Nakon dvije godine praćenja mačke liječene Onceptom IL-2 pokazale su dulji medijan

vremena do recidiva (oko 730 dana) u usporedbi s mačkama iz kontrolne skupine (287 dana).

Liječenje Onceptom IL-2 smanjilo je rizik od recidiva, od 6 mjeseci nakon početka liječenja, za oko

56% nakon 1 godine i za 65% nakon 2 godine u usporedbi s kontroliranom skupinom.

Kartonska kutija sadrži 6 bočica s po 1 dozom liofilizata i 6 bočica od 1 ml otapala.

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Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the concept.  https://go.usa.gov/xQvPA  #FDAInnovationChallengepic.twitter.com/wyTkvmptHJ

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EU/3/18/2027 (Regeneron Ireland U.C.)

EU/3/18/2027 (Regeneron Ireland U.C.)

EU/3/18/2027 (Active substance: Three human monoclonal antibodies against the Ebola virus glycoprotein) - Orphan designation - Commission Decision (2018)3395 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/008/18

Europe -DG Health and Food Safety

16-5-2018

BTVPUR AlSap 8 (Merial)

BTVPUR AlSap 8 (Merial)

BTVPUR AlSap 8 (Active substance: Bluetongue virus Serotype 8 Antigen) - Centralised - Withdrawal - Commission Decision (2018)3018 of Wed, 16 May 2018

Europe -DG Health and Food Safety

16-5-2018

BTVPUR AlSap 1 (Merial)

BTVPUR AlSap 1 (Merial)

BTVPUR AlSap 1 (Active substance: Bluetongue Virus Serotype 1 antigen) - Centralised - Withdrawal - Commission Decision (2018)3017 of Wed, 16 May 2018

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2012 (IDEA Innovative Drug European Associates Limited)

EU/3/18/2012 (IDEA Innovative Drug European Associates Limited)

EU/3/18/2012 (Active substance: Genetically modified replication-incompetent herpes simplex virus-1 expressing collagen VII) - Orphan designation - Commission Decision (2018)2408 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/244/17

Europe -DG Health and Food Safety

9-2-2018

Suvaxyn Circo (Zoetis Belgium S.A.)

Suvaxyn Circo (Zoetis Belgium S.A.)

Suvaxyn Circo (Active substance: Porcine circovirus vaccine (inactivated, recombinant)) - New authorisation - Commission Decision (2018)861 of Fri, 09 Feb 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4242

Europe -DG Health and Food Safety