Oxyglobin

Glavna informacija

  • Trgovački naziv:
  • Oxyglobin
  • Koristi za:
  • Životinje
  • Vrsta lijekova:
  • alopatski lijek

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Oxyglobin
    Europska Unija
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Terapijska grupa:
  • psi
  • Područje terapije:
  • Zamjenske krvi i perfuzijske otopine
  • Terapijske indikacije:
  • Oxyglobin pruža prenose kisik u prilog pasa poboljšanje kliničkih znakova anemije u roku od najmanje 24 sata, bez obzira na glavne bolesti.

Druge informacije

Status

  • Izvor:
  • EMA - European Medicines Agency
  • Status autorizacije:
  • odobren
  • Broj odobrenja:
  • EMEA/V/C/000045
  • Datum autorizacije:
  • 29-11-1999
  • EMEA koda:
  • EMEA/V/C/000045
  • Zadnje ažuriranje:
  • 24-02-2018

Uputu o lijeku

B. UPUTA O VMP

UPUTA O VMP

Oxyglobin 130 mg/ml otopina za infuziju za pse

1.

IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I

NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA OTPUŠTANJE

PROIZVODNE

SERIJE, AKO JE RAZLIČITO

OPK Biotech Netherlands BV

Nositelj odobrenja za stavljanje u promet:

Teleportboulevard 140

1043EJ, Amsterdam

Nizozemska

Dales Pharmaceutical Ltd.

Nositelj odobrenja za proizvodnju za otpuštanje proizvodne serije:

Snaygill Industrial Estate

Keighley Road

Skipton

North Yorkshire, BD23 2RW

Ujedinjeno Kraljevstvo

2.

NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA

Oxyglobin 130 mg/ml otopina za infuziju za pse

3.

NAVOĐENJE DJELATNE TVARI I DRUGIH SASTOJAKA

Hemoglobin glutamer-200 (goveđi) – 130 mg/ml.

4.

INDIKACIJE

Oxyglobin pomaže u provođenju kisika psima, poboljšavajući kliničke znake anemije za vrijeme od

najmanje 24 sata, neovisno o osnovnim uvjetima.

5.

KONTRAINDIKACIJE

Ne primjenjivati na životinjama koje su prethodno liječene proizvodom Oxyglobin.

Ekspanderi volumena plazme, kao što je Oxyglobin kontraindicirani su na psima predisponiranim na

preopterećenje kardiovaskularnog sustava sa stanjima kao što su oligurija, anurija ili uznapredovale

srčane bolesti (npr. kongestivno zatajenje srca) ili druge teške srčane bolesti. Oxyglobin je predviđen

samo za jednokratnu primjenu.

6.

NUSPOJAVE

Za vrijeme ispitivanja neškodljivosti i djelotvornosti, primijećeni su štetni događaji povezani s

proizvodom Oxyglobin i/ili osnovnom bolesti koja uzrokuje anemiju. Nuspojave koje su primijećene

uključuju blagu do umjerenu dekoloraciju mukozne membrane, bjeloočnice i urina uzrokovani

metabolizmom i/ili izlučivanjem hemoglobina. Općenito primijećene nuspojave su bile povraćanje,

gubitak apetita, groznica i preopterećenje kardiovaskularnog sustava s povezanim kliničkim znakovima

kao što su tahipneja, dispneja, hrapav zvuk u plućima i plućni edem; preopterećenje kardiovaskularnog

sustava je kontrolirano smanjenjem brzine primjene. Povremeno primijećeni štetni događaji su bili

dijareja, dekoloracija kože, srčane aritmije i vrlo rijetko nistagmus.

Ako zamijetite ozbiljne nuspojave ili druge nuspojave koje nisu opisane u uputi o VMP, molimo da se javite

veterinaru.

7.

CILJNE VRSTE ŽIVOTINJA

8.

DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA,

NAČIN I PUT(EVI)

PRIMJENE

Preporučena doza proizvoda Oxyglobin je 30 ml/kg težine primijenjeno intravenozno brzinom do 10

ml/kg/h. U određenim kliničkim situacijama, možda će biti prikladna doza od 15-30 ml/kg.

Optimalna doza temelji se na stupnju i kroničnosti anemije i željenom trajanju utjecaja proizvoda.

(Vidjeti tablicu A Farmakokinetički parametri)

Tablica A:

Farmakokinetički parametri pri razinama višestrukih doza nakon jedne infuzije

proizvoda Oxyglobin

Doza

(ml/kg)

Koncentracija u plazmi neposredno

nakon infuzije* (g/dl)

Trajanje (sati): Razine

Oxyglobina preko 1 g/dl**

Klirens plazme

(dana)***

2,0–2,5

23–39

4–6

3,4–4,3

66–70

5–7

3,6–4,8

74–82

5–9

* raspon temeljen na srednjoj vrijednosti ± standardno odstupanje

** raspon temeljen na procijenjenoj srednjoj vrijednosti s granicama od 95% predviđenog intervala

*** raspon temeljen na 5 krajnjih poluživota

9.

SAVIJETI ZA ISPRAVNU PRIMJENU

Uklonite omot prije primjene. Primijeniti u roku od 24 sata. Oxyglobin se treba primijeniti uporabom

aseptičnih tehnika pomoću standardnog kompleta za intravensku infuziju i katetera. Kao i kod

intravenske primjene tekućine, Oxyglobin je potrebno prije primjene zagrijati na 37 °C. Ne grijati u

mikrovalnoj pećnici. Ne pregrijavati.

Ne miješati s drugim tekućinama ili veterinarsko-medicinskim proizvodima u istom infuzijskom

kompletu. Ne dodavati druge veterinarsko-medicinske proizvode ili druge otopine u vrećicu. Ne

kombinirati sadržaj sa sadržajem drugih vrećica.

10.

KARENCIJA

Nije primjenjivo.

11.

POSEBNE MJERE PREDOSTROŽNOST

I ZA ČUVANJE

Čuvati izvan dosega i pogleda djece.

Ne čuvati iznad 30 °C. Ne zamrzavati. Primijeniti u roku od 24 sata od uklanjanja pakovanja. Ne

koristiti poslije isteka roka valjanosti naznačenog na etiketi.

12.

POSEBNO(A) UPOZORENJE(A)

Ne primjenjivati na životinjama koje su prethodno liječene proizvodom Oxyglobin.

Potrebno je provesti usporedno liječenje uzroka anemije.

Životinja se ne smije pretjerano hidrirati prije primjene proizvoda. Radi svojstava ekspandiranja

plazme proizvoda Oxyglobin, potrebno je uzeti u obzir mogućnost preopterećenja kardiovaskularnog

sustava osobito kad se daju dodatne intravenske tekućine, a naročito koloidne otopine. Potrebno je

pažljivo nadgledati znakove preopterećenja kardiovaskularnog sustava ili centralni venski pritisak.

Ako centralni venski pritisak naraste do nedopuštene razine i/ili su primijećeni znakovi

preopterećenja kardiovaskularnog sustava, infuziju proizvoda Oxyglobin je potrebno privremeno

obustaviti i ponovo primijeniti smanjenom brzinom nakon smanjenja simptoma i/ili smanjenja

centralnog venskog pritiska.

Liječenje proizvodom Oxyglobin rezultira blagim padom hematokrita neposredno nakon infuzije.

Neškodljivost i djelotvornost proizvoda Oxyglobin nisu procijenjene kod pasa s trombocitopenijom s

aktivnim krvarenjem, oligurijom ili anurijom ili uznapredovanom srčanom bolesti.

Neškodljivost proizvoda Oxyglobin nije utvrđena za vrijeme graviditeta ili laktacije ženki. Primjena

na takvim životinjama se ne preporučuje.

13.

POSEBNE MJERE PREDOSTROŽNOSTI ZA ODLAGANJE NEUPOTRIJEBLJENOG

PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA

Bilo koji neupotrijebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom

tih veterinarsko-medicinskih proizvoda moraju se odlagati u skladu s lokalnim propisima.

14.

DATUM KADA JE UPUTA O VMP ZADNJI PUTA ODOBRENA

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

Europske Medicinske Agencije (EMEA)

http://www.ema.europa.eu/.

15.

OSTALE INFORMACIJE

Klinička patologija

Kemija: Prisustvo proizvoda Oxyglobin u serumu može interferirati s kolorimetrijskim očitanjima i

rezultatima umjetnog porasta ili smanjenja serumskih kemijskih pretraga ovisno o primijenjenoj dozi,

vremenu proteklom od infuzije, vrsti analizatora i primijenjenim reagensima. (Kontaktirajte distributera

za posebne podatke.)

Hematologija: Nema interferencija. Potvrdite je li izmjeren hemoglobin i nije li računan od broja

crvenih krvnih zrnaca.

Koagulacija: Protrombinsko vrijeme (PT) i aktivno parcijalno tromboplastinsko vrijeme (aPTT) mogu

se točno izmjeriti pomoću metoda kao što su mehaničko i magnetsko raspršenje ili raspršenje svjetla.

Optičke metode nisu pouzdane za testove koagulacije u prisustvu proizvoda Oxyglobin.

Urinske pretrage: Ispitivanje sedimenta je točno. Dok je prisutna značajna dekoloracija urina, ispitivanja

metodom „dipstick“ (tj. pH, glukoza, ketoni, protein) su netočna.

Vrećica za infuziju od 60 ml.

Vrećica za infuziju od 125 ml.

Ne moraju sve veličine pakovanja biti u prometu.

Za bilo koju informaciju o ovom veterinarsko-medicinskom proizvodu molimo da kontaktirate lokalnog

zastupnika nositelja odobrenja za stavljanje u promet.

Deutschland

Albrecht GmbH

Hauptstr. 6-8

88326 Aulendorf

Tel.: +49 (0) 752 52 05 10

Faks: +49 (0) 752 57 00 5

Dechra Veterinary Products Limited

Sansaw Business Park, Hadnall,

Shrewsbury, Shropshire, SY4 4AS

Tel.: +44 (0) 19 39 21 12 00

Faks: +44 (0) 19 39 21 12 01

France

Dechra Veterinary Products SAS

60, Avenue du Centre,

78180 Montigny-le-Bretonneux

Tel: +33 1 3048 7140

Fax: +33 1 3081 9963

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EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Active substance: Adeno-associated viral vector serotype 8 containing the human acid alpha-glucosidase gene) - Orphan designation - Commission Decision (2018)2403 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/255/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2005 (IQVIA RDS Ireland Limited)

EU/3/18/2005 (IQVIA RDS Ireland Limited)

EU/3/18/2005 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1893 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/222/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2004 (IQVIA RDS Ireland Limited)

EU/3/18/2004 (IQVIA RDS Ireland Limited)

EU/3/18/2004 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1892 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/217/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1891 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/225/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1890 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/224/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2001 (Soligenix UK Ltd)

EU/3/18/2001 (Soligenix UK Ltd)

EU/3/18/2001 (Active substance: Recombinant modified ricin toxin A-chain subunit) - Orphan designation - Commission Decision (2018)1889 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/242/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2006 (IQVIA RDS Ireland Limited)

EU/3/18/2006 (IQVIA RDS Ireland Limited)

EU/3/18/2006 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1894 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/234/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2000 (Amicus Therapeutics UK Ltd)

EU/3/18/2000 (Amicus Therapeutics UK Ltd)

EU/3/18/2000 (Active substance: Recombinant human acid alpha-glucosidase) - Orphan designation - Commission Decision (2018)1877 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/230/17

Europe -DG Health and Food Safety