Purevax Rabies

Glavna informacija

  • Trgovački naziv:
  • Purevax Rabies
  • Koristi za:
  • Životinje
  • Vrsta lijekova:
  • alopatski lijek

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Purevax Rabies
    Europska Unija
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Terapijska grupa:
  • mačke
  • Područje terapije:
  • Immunologicals
  • Terapijske indikacije:
  • Aktivna imunizacija mačaka starijih od 12 tjedana kako bi se spriječila smrtnost zbog zaraze bjesnoće. Početak imuniteta: 4 tjedna nakon primarnog cijepljenja. Trajanje imuniteta nakon primarne cijepljenja: 1 godina. Trajanje imunosti nakon ponovne vakcinacije: 3 godine.

Druge informacije

Status

  • Izvor:
  • EMA - European Medicines Agency
  • Status autorizacije:
  • odobren
  • Broj odobrenja:
  • EMEA/V/C/002003
  • Datum autorizacije:
  • 18-02-2011
  • EMEA koda:
  • EMEA/V/C/002003
  • Zadnje ažuriranje:
  • 24-02-2018

Uputu o lijeku

B. UPUTA O VMP

UPUTA O VMP

Purevax Rabies suspenzija za injekcije

1.

NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I

NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE

PROIZVODNE SERIJE, 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

Purevax Rabies suspenzija za injekcije

3.

NAVOĐENJE DJELATNE TVARI I DRUGIH SASTOJAKA

Svaka doza od 1 ml sadrži:

Rekombinirani virus boginja kanarinca(vCP65) ...........................................................

FAID*

* Za flourescentnu podlogu infektivna doza je 50 %

Svjetlo ružičasta do blijedo žuta homogena suspenzija.

4.

INDIKACIJA

Kako bi se spriječila smrtnost izazvana infekcijom virusa bjesnoće aktivno se imuniziraju mačke stare

12 tjedana i starije.

Početak imuniteta: 4 tjedna nakon prvog ciklusa iz kalendara cijepljenja.

Trajanje imuniteta nakon prvog cijepljenja: 1 godina.

Trajanje imuniteta nakon revakcinacije: 3 godine.

5.

KONTRAINDIKACIJE

Nema

6.

NUSPOJAVE

Vrlo rijetko može se javiti blaga prolazna apatija, kao i blaga anoreksija ili povišena temperatura

(iznad 39,5 °C), koje obično traju 1 ili 2 dana. Većina je ovih reakcija zabilježena tijekom 2 dana

nakon vakcinacije.

Vrlo rijetko se može javiti i prolazna lokalna reakcija (bol pri palpaciji, ograničen otok koji može

postati čvorast, hipertermija na mjestu vakcinacije, a u nekim slučajevima eritem), koja obično nestaje

tijekom 1 ili najviše 2 tjedna.

Vrlo rijetko može se javiti hipersenzibilna reakcija, koja može zahtijevati odgovarajući simptomatski

tretman.

Učestalost nuspojava je određena sukladno sljedećim pravilima:

vrlo česte (više od 1 na 10 životinja pokazuju nuspojavu(e) za vrijeme trajanja jednog tretmana)

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

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

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

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

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

javite veterinaru.

7.

CILJNE VRSTE ŽIVOTINJA

Mačke.

8.

DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, METODE I NAČIN

PRIMJENE

Subkutana primjena.

Injicirajte jednu dozu 1 ml cjepiva u skladu sa sljedećim rasporedom cijepljenja:

Prvo cijepljenje: 1 injekcija od 12 tjedana starosti,

Revakcinacija: 1. godina nakon prvog cijepljenja, a zatim u razmacima od po 3 godine.

Kod putovanja u zemlje koje zahtijevaju serološko testiranje na bjesnoću:iskustvo pokazuje da neke

cijepljene životinje, dok su zaštićene, možda neće iskazivati titar protutijela od 0,5 IU/ml koji se

zahtijeva u nekim zemljama. Tada veterinar može uzeti u obzir dvije vakcinacije. Najpogodnije

vrijeme za uzimanje uzoraka krvi je oko 28 dana nakon cijepljenja.

9.

SAVIJETI ZA ISPRAVNU PRIMJENU

Prilikom cijepljenja treba primijeniti uobičajene aseptičke procedure.

10.

KARENCIJA

Nije primjenjivo.

11.

POSEBNE MJERE PREDOSTROŽNOSTI KOD ČUVANJA

Držati izvan pogleda i dosega djece.

Čuvaj i prevozi rashlađeno (2

C – 8

Zaštiti od svjetla.

Ne zamrzavaj. .

Ne koristiti ovaj veterinarsko medicinski proizvod poslije isteka roka valjanosti naznačenog na

naljepnici iza „EXP“.

Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja: odmah upotrijebi.

12.

POSEBNO(A) UPOZORENJE(A)

Posebne mjere opreza prilikom primjene na životinjama:

Cijepi samo zdrave životinje.

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

životinjama:

Poznato je da je rekombinirani virus boginja kanarinca siguran su za ljude. U slučaju nehotičnog

samo iniciranja prolazno se mogu pojaviti blage lokalne i/ili sistemske reakcije.

U slučaju nehotičnog samo injiciranja, odmah potraži pomoć liječnika i pokaži mu uputu o VMP ili

etiketu.

Graviditet i laktacija:

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

Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija:

Dostupni podaci o djelotvornosti dokazuju da se ovo cjepivo smije primijeniti najmanje 14 dana prije

ili poslije primijene MERIAL-ovog ne adjuviranog cijepiva protiv leukemije mačaka.

Podaci o neškodljivosti i djelotvornosti su dostupni i dokazujuda se ovo cjepivo smije pomiješati i

primijeniti s ne adjuviranim cjepivima MERIAL koja sadrže različite kombinacije komponenti protiv

virusnog rinotraheitisa mačaka, kaliciviroze, panleukopenije i klamidioze mačaka.

Ne miješati ni s jednim drugim veterinarsko medicinskim proizvodom osim s onim prethodno

navedenim.

Predoziranje:

Nakon primjene 10 doza nisu primijećeni drugačiji neželjeni učinci od onih koji su navedeni u

odjeljku „Nuspojave“. Neželjeni učinci mogu trajati i duže.

13.

POSEBNE MJERE OPREZA PRILIKOM ODLAGANJA NEUPOTREBLJENOG

VETERINARSKO-MEDICINSKOG PROIZVODA ILI OTPADNOG MATERIJALA

DOBIVENOG KOD PRIMJENE OVOG PROIZVODA, AKO IH IMA

Bilo koji neupotrijebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni kod primjene

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

15.

OSTALE INFORMACIJE

Cjepivo protiv zaraze bjesnoćom.

Cijepni soj vCP65 je rekombinirani virus boginja kanarinca koji izražava glikoprotein G gen od

virusa bjesnoće. Nakon inokulacije virus izražava zaštitne proteine, ali se u mački ne množi.

Posljedica toga je da cjepivo stimulira aktivni imunitet protiv virusa bjesnoće kod mačaka.

Kutija s 10 bočica sa po jednom dozom.

Kutija s 50 bočica sa po jednom dozom.

Kutija s 2 bočice sa po jednom dozom.

Ne moraju sve veličine pakovanja biti na tržištu.

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Published on: Mon, 15 Oct 2018 00:00:00 +0200 A rapid qualitative assessment has been done by performing a theoretical analysis on the transmission of low pathogenic avian influenza (LPAI) via fresh meat from poultry reared or kept in captivity for the production of meat (raw poultry meat) or raw table eggs. A predetermined transmission pathway followed a number of steps from a commercial or non‐commercial poultry establishment within the EU exposed to LPAI virus (LPAIV) to the onward virus transmission...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Novel foods could represent a sustainable alternative to traditional farming and conventional foodstuffs. Starting in 2018, Regulation (EU) 2283/2015 entered into force, laying down provisions for the approval of novel foods in Europe, including insects. This Approved Regulation establishes the requirements that enable Food Business Operators to bring new foods into the EU market, while ensuring high levels of food safety for European consumers. The present ...

Europe - EFSA - European Food Safety Authority Publications

30-5-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on federal preparedness and FDA’s response efforts to the Ebola virus outbreak in the Democratic Republic of Congo

Statement from FDA Commissioner Scott Gottlieb, M.D., on federal preparedness and FDA’s response efforts to the Ebola virus outbreak in the Democratic Republic of Congo

FDA committed to helping the people of the Democratic Republic of Congo effectively confront and end the current Ebola virus outbreak

FDA - U.S. Food and Drug Administration

30-5-2018

Procleix West Nile Virus (WNV) Assay

Procleix West Nile Virus (WNV) Assay

Product approval information is indicated for the qualitative detection of West Nile Virus (WNV) RNA in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors.

FDA - U.S. Food and Drug Administration

23-5-2018

FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)

FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)

The U.S. Food and Drug Administration (FDA) is alerting the public that serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women treated with dolutegravir (Juluca, Tivicay, Triumeq) used to treat human immunodeficiency virus (HIV).

FDA - U.S. Food and Drug Administration

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) - Centralised - 2-Monthly update - Commission Decision (2018)5630 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2231/II/10

Europe -DG Health and Food Safety

3-8-2018

EU/3/18/2042 (MeiraGTx UK II Limited)

EU/3/18/2042 (MeiraGTx UK II Limited)

EU/3/18/2042 (Active substance: Adenovirus associated viral vector serotype 2/8 containing the human CNGA3 gene) - Orphan designation - Commission Decision (2018)5274 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/18

Europe -DG Health and Food Safety

30-7-2018

Zalmoxis (MolMed S.p.A.)

Zalmoxis (MolMed S.p.A.)

Zalmoxis (Active substance: Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (?LNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)) - Centralised - Renewal - Commission Decision (2018)5118 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2801/R/10

Europe -DG Health and Food Safety

11-7-2018

Hiprabovis IBR Marker Live (Laboratorios Hipra, S.A.)

Hiprabovis IBR Marker Live (Laboratorios Hipra, S.A.)

Hiprabovis IBR Marker Live (Active substance: Live gE- tk- double-gene deleted Bovine Herpes Virus type 1 (BoHV-1), strain CEDDEL) - Centralised - Yearly update - Commission Decision (2018)4520 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

4-7-2018

ERYSENG PARVO (Laboratorios Hipra, S.A.)

ERYSENG PARVO (Laboratorios Hipra, S.A.)

ERYSENG PARVO (Active substance: Inactivated porcine parvovirus, strain NADL-2 / Inactivated Erysipelothrix rhusiopathiae, strain R32E11) - Centralised - Yearly update - Commission Decision (2018) 4354 of Wed, 04 Jul 2018

Europe -DG Health and Food Safety

29-6-2018

Porcilis PCV M Hyo (Intervet International B.V.)

Porcilis PCV M Hyo (Intervet International B.V.)

Porcilis PCV M Hyo (Active substance: Porcine circovirus and Mycoplasma hyopneumoniae vaccine (inactivated)) - Centralised - 2-Monthly update - Commission Decision (2018)4166 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/3796/II/7

Europe -DG Health and Food Safety

19-6-2018

Aftovaxpur Doe (Merial)

Aftovaxpur Doe (Merial)

Aftovaxpur Doe (Active substance: purified, inactivated foot-and-mouth disease virus strains O1 Manisa, O1 BFS, O Taiwan 3/97, A22 Iraq, A24 Cruzeiro, A Turkey 14/98, Asia 1 Shamir, SAT2 Saudi Arabia) - Centralised - Renewal - Commission Decision (2018)3891 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2292/R/8

Europe -DG Health and Food Safety

1-6-2018

BTVPUR AlSap 2-4 (Merial)

BTVPUR AlSap 2-4 (Merial)

BTVPUR AlSap 2-4 (Active substance: Bluetongue Virus Serotype 2 antigen - Bluetongue Virus Serotype 4 antigen) - Withdrawal (sunset clause) - No Commission Decision

Europe -DG Health and Food Safety

29-5-2018

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

5-12-2017

Rabitec (IDT Biologika GmbH)

Rabitec (IDT Biologika GmbH)

Rabitec (Active substance: Rabies vaccine (live, oral) for foxes and raccoon dogs) - New authorisation - Commission Decision (2017)1365 of Tue, 05 Dec 2017 European Medicines Agency (EMA) procedure number: EMEA/V/C/4387

Europe -DG Health and Food Safety