Program 80

Hauptinformation

  • Handelsname:
  • Program 80 Injektionssuspension 100 mg/ml
  • Dosierung:
  • 100 mg/ml
  • Darreichungsform:
  • Injektionssuspension
  • Verwenden für:
  • Tiere
  • Art der Medizin:
  • allopathic Droge

Dokumenten

  • Information für medizinisches Fachpersonal:
  • Das Informationsblatt für dieses Produkt ist derzeit nicht verfügbar, können Sie eine Anfrage an unseren Kundendienst zu senden und wir werden Sie benachrichtigen, sobald wir in der Lage, um es zu erhalten.


    Fordern Sie die Packungsbeilage für medizinisches Fachpersonal.

Lokalisierung

  • Erhältlich in:
  • Program 80 Injektionssuspension 100 mg/ml
    Belgien
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Ectoparasiticides für den systemischen Einsatz, chitinesynthese-Hemmer.

Weitere Informationen

Status

  • Quelle:
  • AFMPS - Agence Fédérale des Médicaments et des Produits de Santé - Belgium
  • Zulassungsnummer:
  • BE-V196996
  • Letzte Änderung:
  • 17-04-2018

Packungsbeilage

Bijsluiter – DE Versie

PROGRAM 80

PACKUNGSBEILAGE

PROGRAM 80 mg Suspension zur Injektion bei Katzen

1.

NAME UND ANSCHRIFT DES ZULASSUNGSINHABERS UND, WENN

UNTERSCHIEDLICH, DES HERSTELLERS, DER FÜR DIE

CHARGENFREIGABE VERANTWORTLICH IST

Zulassungsinhaber:

Elanco Europe Ltd

Lilly House

Priestley Road

Basingstoke, RG24 9 NL

Vereinigtes Königreich

Für die Chargenfreigabe verantwortlicher Hersteller:

Abott Biologicals B.V.

Veerweg 12

1812 AA Olst

Niederlande

2.

BEZEICHNUNG DES TIERARZNEIMITTELS

PROGRAM 80 mg Suspension zur Injektion bei Katzen

Lufenuron

3.

WIRKSTOFF UND SONSTIGE BESTANDTEILE

1 herausnehmbare Injektionsspritze enthält 0,8 ml injizierbare Suspension, die 80 mg des

Wirkstoffs Lufenuron enthält.

Enthält den Hilfsstoff Polyvinylpyrrolidon (Povidon).

4.

ANWENDUNGSGEBIET

Das Tierarzneimittel dient zur Vermeidung der Flohvermehrung bei der Katze, indem die

Entwicklung von Floheiern während 6 Monaten verhindert wird. Das Tierarzneimittel ist

wirksam gegen Floheier und Larvenstadien von Flöhen. Wirksame Blutspiegel von Lufenuron

werden innerhalb von 21 Tagen erreicht.

5.

GEGENANZEIGEN

Nicht bei Hunden anwenden. Der Hilfsstoff Polyvinylpyrrolidon (Povidon) ist für Hunde eine

starke Histamin freisetzende Substanz. Beim Hund können deshalb im Gegensatz zu Katzen

schwere Reaktionen auftreten.

6.

NEBENWIRKUNGEN

Über Nebenwirkungen wird sehr selten berichtet. In sehr seltenen Fällen kann bei einer

Injektion mit dem Produkt an der Injektionsstelle Schmerz, Ödem oder Alopezie auftreten.

Insbesondere kann eine kleine, schmerzlose Schwellung erscheinen, die innerhalb 6 Wochen

nach Verabreichung meistens wieder verschwindet. In ganz seltenen Fällen wurde über

Lethargie während einer Anzahl Stunden nach der Injektion berichtet; diese Erscheinung

verschwindet jedoch schnell.

- 1 -

Bijsluiter – DE Versie

PROGRAM 80

Falls Sie eine Nebenwirkung bei Ihrem Tier/Ihren Tieren feststellen, die nicht in der

Packungsbeilage aufgeführt ist, teilen Sie diese Ihrem Tierarzt oder Apotheker mit.

7.

ZIELTIERART

Katzen mit einem Körpergewicht von 4 kg oder mehr.

8.

DOSIERUNG FÜR JEDE TIERART, ART UND DAUER DER ANWENDUNG

Die empfohlene Dosis beträgt 10 mg Lufenuron pro Kilo Körpergewicht bei subkutaner

Verabreichung.

Dies wird dadurch erreicht, dass Katzen und entwöhnten Kätzchen mit einem Gewicht unter 4

kg der Inhalt von 1 Injektionsspritze, 0,8 ml injizierbare Suspension, verabreicht wird.

(PROGRAM 80 mg Suspension zur Injektion bei Katzen)

9.

HINWEISE FÜR DIE RICHTIGE ANWENDUNG

Injektionsspritze vor Gebrauch gründlich schütteln und anschließend sofort verabreichen. Für

volle Wirksamkeit muss der gesamte Inhalt der Injektionsspritze unmittelbar vor den

Schulterblättern subkutan injiziert werden.

Wenn die Katze zu Beginn der Behandlung eine Flohinfektion aufweist, wird die

Verwendung eines Floh-Adultizids empfohlen. Es ist wichtig, dass alle Katzen (außer noch

nicht abgesetzten Katzenwelpen) in einem Haushalt mit dem Tierarzneimittel behandelt

werden, um den Flohbefall zu stoppen. Hunde, die im selben Haushalt leben, sind

entsprechend der Empfehlungen des verantwortlichen Tierarztes zu behandeln.

10.

WARTEZEIT

Nicht zutreffend.

11.

BESONDERE LAGERUNGSHINWEISE

Arzneimittel unzugänglich für Kinder aufbewahren.

Nicht im Gefrierschrank lagern.Injektionsspritzen in der Originalverpackung aufbewahren.

Injektionsspritze nur einmal verwenden.

Nicht nach dem auf dem Etikett nach dem EXP angegebenen Verfallsdatum anwenden.

12.

BESONDERE WARNHINWEISE

Besondere Vorsichtsmaßnahmen für die Anwendung bei Tieren:

Injektion unter aseptischen Bedingungen ausführen.

Besondere Vorsichtsmaßnahmen für den Anwender:

Bei versehentlicher Selbstinjektion kann es zu lokalen Reaktionen kommen. In diesem Fall ist

ärztliche Hilfe aufzusuchen.

Überdosierung (Symptome, Notfallmaßnahmen, Gegenmittel), falls erforderlich

In einer Studie wurde das Tierarzneimittel Katzen in der fünffachen empfohlenen Dosis

dreimal im Abstand von 2 Monaten verabreicht. Die einzige unerwünschte Wirkung war ein

vorübergehende entzündliche Reaktion an der Injektionsstelle.

- 2 -

Bijsluiter – DE Versie

PROGRAM 80

Inkompatibilitäten

Da keine Kompatibilitätsstudien durchgeführt wurden, darf dieses Tierarzneimittel nicht mit

anderen Tierarzneimitteln gemischt werden.

13.

BESONDERE VORSICHTSMASSNAHMEN FÜR DIE ENTSORGUNG VON

NICHT VERWENDETEM ARZNEIMITTEL ODER VON

ABFALLMATERIALIEN, SOFERN ERFORDERLICH

Tierarzneimittel oder -reste sind entsprechend den nationalen Vorschriften zu entsorgen.

14.

GENEHMIGUNGSDATUM DER PACKUNGSBEILAGE

November 2016

15.

WEITERE ANGABEN

Kann während Trächtigkeit und Laktation angewandt werden.

Der Wirkstoff Lufenuron ist ein Insektenentwicklungshemmer (IDI) und gehört zur

chemischen Gruppe der Benzoylharnstoffe. Lufenuron ist ein Hemmstoff gegen

Chitinsynthese und Ablagerung. Wird Lufenuron dem Tier systemisch verabreicht, nehmen

die Flöhe beim Blutsaugen an der Katze Lufenuron auf und geben es an ihre Eier weiter.

Infolgedessen wird die Entwicklung der larvalen Chitinstruktur, ein für die Entwicklung von

Insekten und die Entwicklung von lebensfähigen Nachkömmlingen wesentlicher Prozess,

blockiert. Nach subkutaner Verabreichung des Tierarzneimittels wird der Wirkstoff von der

Injektionsstelle aus absorbiert und vorzugsweise im Fettgewebe abgelagert. Aus dem

Fettgewebe wird der Wirkstoff kontinuierlich, metabolisch unverändert, in den Blutkreislauf

freigesetzt. Wirksame Blutspiegel von Lufenuron werden innerhalb 21 Tagen nach Injektion

erreicht und die geringe Ausscheidungsgeschwindigkeit sorgt für eine effektive Konzentration

des Wirkstoffs im Blutkreislauf (mehr als 50-100 ppb) während 6 Monaten.

10 einzeln geblisterte Injektionsspritzen in einer Kartonschachtel abgepackt.

Es werden möglicherweise nicht alle Packungsgrößen in Verkehr gebracht.

BE-V196996

Verschreibungspflichtig

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Europe - EMA - European Medicines Agency

12-9-2018

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application  https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #FDA #MedicalDevice pic.twitter.com/Kyo5z44Os4

FDA - U.S. Food and Drug Administration

6-9-2018

#FDA is launching the Quality in 510(k) Review Program Pilot to help promote efficiency and consistency in the review of certain moderate-risk medical devices. Click the link to find out more information about this new program:  https://go.usa.gov/xPxVa 

#FDA is launching the Quality in 510(k) Review Program Pilot to help promote efficiency and consistency in the review of certain moderate-risk medical devices. Click the link to find out more information about this new program: https://go.usa.gov/xPxVa 

#FDA is launching the Quality in 510(k) Review Program Pilot to help promote efficiency and consistency in the review of certain moderate-risk medical devices. Click the link to find out more information about this new program: https://go.usa.gov/xPxVa  #MedicalDevice pic.twitter.com/dOcFpbed9K

FDA - U.S. Food and Drug Administration

5-9-2018

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application:  https://go.u

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application: https://go.u

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application: https://go.usa.gov/xPcpn  #MedicalDevice

FDA - U.S. Food and Drug Administration

13-8-2018

Today is Day 1 of the Pediatric Medical Device Development Public Meeting. Today we will discuss the programs, policies, and procedures at the #FDA intended to streamline evidence generation.  https://go.usa.gov/xU6rg 
#devices4kids #Pediatricspic.twitter

Today is Day 1 of the Pediatric Medical Device Development Public Meeting. Today we will discuss the programs, policies, and procedures at the #FDA intended to streamline evidence generation. https://go.usa.gov/xU6rg  #devices4kids #Pediatricspic.twitter

Today is Day 1 of the Pediatric Medical Device Development Public Meeting. Today we will discuss the programs, policies, and procedures at the #FDA intended to streamline evidence generation. https://go.usa.gov/xU6rg  #devices4kids #Pediatrics pic.twitter.com/3tXTgwPJPo

FDA - U.S. Food and Drug Administration

1-8-2018

Nimenrix (Pfizer Europe MA EEIG)

Nimenrix (Pfizer Europe MA EEIG)

Nimenrix (Active substance: Meningococcal group A, C, W-135 and Y conjugate vaccine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5220 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2226/T/80

Europe -DG Health and Food Safety

31-7-2018

FDA’s Pediatric Device Consortia Grant Program (PDC) facilitates the development, of medical devices for children. 18 pediatric medical devices have been approved/cleared to date.  Learn more about the PDC here:  https://go.usa.gov/xUvBC  #Pediatrics #Med

FDA’s Pediatric Device Consortia Grant Program (PDC) facilitates the development, of medical devices for children. 18 pediatric medical devices have been approved/cleared to date. Learn more about the PDC here: https://go.usa.gov/xUvBC  #Pediatrics #Med

FDA’s Pediatric Device Consortia Grant Program (PDC) facilitates the development, of medical devices for children. 18 pediatric medical devices have been approved/cleared to date. Learn more about the PDC here: https://go.usa.gov/xUvBC  #Pediatrics #MedicalDevice #FDA pic.twitter.com/HgMSCIbmra

FDA - U.S. Food and Drug Administration

31-7-2018

Many medical devices for children may be approved by the Humanitarian Device Exemption pathway. Learn how the Humanitarian Device Exemption pathway program & other pathways can bring more devices intended for children to market.  http://go.usa.gov/xUvZ7 

Many medical devices for children may be approved by the Humanitarian Device Exemption pathway. Learn how the Humanitarian Device Exemption pathway program & other pathways can bring more devices intended for children to market. http://go.usa.gov/xUvZ7 

Many medical devices for children may be approved by the Humanitarian Device Exemption pathway. Learn how the Humanitarian Device Exemption pathway program & other pathways can bring more devices intended for children to market. http://go.usa.gov/xUvZ7  #Pediatrics #medicaldevice pic.twitter.com/LEaSk1efJ5

FDA - U.S. Food and Drug Administration

20-7-2018

Isoptin® 80 mg Filmtabletten

Rote - Liste

15-7-2018

Xtandi 40 mg/- 80 mg Filmtabletten

Rote - Liste