Program Vet.

Primær information

  • Handelsnavn:
  • Program Vet. 80 mg injektionsvæske, suspension
  • Dosering:
  • 80 mg
  • Lægemiddelform:
  • injektionsvæske, suspension
  • Brugt til:
  • Dyr
  • Medicin typen:
  • Allopatiske stof

Dokumenter

  • for den brede offentlighed:
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Lokation

  • Fås i:
  • Program Vet. 80 mg injektionsvæske, suspension
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 30015
  • Sidste ændring:
  • 22-02-2018

Produktresumé

3. oktober 2016

PRODUKTRESUMÉ

for

Program Vet., injektionsvæske, suspension, fyldt engangssprøjte

0.

D.SP.NR

8735

1.

VETERINÆRLÆGEMIDLETS NAVN

Program Vet.

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

Lægemiddelstof: Lufenuron 80 mg per injektionssprøjte (0,8 ml af en 10% suspension)

Alle hjælpestoffer, se pkt. 6.1.

3.

LÆGEMIDDELFORM

Injektionsvæske, suspension, fyldt engangssprøjte, s.c.

4.

KLINISKE OPLYSNINGER

4.1

Dyrearter

Katte der vejer 4 kg, eller mere.

4.2

Terapeutiske indikationer

Program Vet. injektionsvæske er beregnet til forebyggelse af loppeformering hos kat, ved at

hæmme udviklingen af loppeæg til voksne lopper i 6 måneder. Produktet virker på loppens

æg og larvestadier. Effektive blodkoncentrationer af lufenuron opnås indenfor 21 dage.

4.3

Kontraindikationer

Må ikke bruges til hunde. Hjælpestoffet Polyvinylpyrrolidon (Povidon) er et potent

histaminudløsende stof hos hund. En alvorlig reaktion, som ikke ses hos kat, kan forekomme

hos hund.

4.4

Særlige advarsler

Ingen.

4.5

Særlige forsigtighedsregler vedrørende brugen

Injektionen bør foretages under aseptiske betingelser.

30015_spc.doc

Side 1 af 4

Særlige forsigtighedsregler for dyret

Reaktion på injektionsstedet kan forkomme hos nogle katte, i form af en lille smertefri

hævelse på injektionsstedet, som almindeligvis forsvinder indenfor 6 uger efter

administrationen.

Hvis katten har en loppeinfestation fra starten af behandlingen, anbefales det at anvende et

loppe adulticid. Det er vigtigt at alle katte (undtagen ikke fravænnede killinger) i en husstand

behandles med Program Vet. for at stoppe loppeinfestationen. Hunde i den samme

husholdning bør behandles som anbefalet af dyrlægen.

Særlige forsigtighedsregler for personer, der administrerer lægemidlet

I tilfælde af selv-inokulering kan en lokal reaktion forekomme. Søg læge ved sådanne

omstændigheder.

Andre forsigtighedsregler

Ingen

4.6

Bivirkninger

Program Vet. injektionsvæske tåles godt af alle katte, men kan forårsage smerte ved

injektionen. Det kan forårsage en forbigående mild og smertefri reaktion på

injektionsstedet. I sjældne tilfælde kan der opstå sløvhed og anorexi i få timer efter

injektionen, hvilket hurtigt forsvinder.

4.7

Drægtighed, diegivning eller æglægning

Der kan ikke forventes skadelige effekter når produktet gives under drægtighed og laktation.

4.8

Interaktion med andre lægemidler og andre former for interaktion

Ingen kendte.

4.9

Dosering og indgivelsesmåde

Den anbefalede dosis er 10 mg lufenuron per kg legemsvægt, når det administreres

parenteralt.

Kattens vægt i kg

mere end 4

Dosis

1 Program Vet. 80 mg

engangssprøjte

For at opnå fuld effektivitet af produktet, skal hele engangssprøjtens indhold injiceres

subkutant, for eksempel dorsalt foran skulderbladene.

Engangssprøjten skal rystes kraftigt for at rekonstituere suspensionen, og herefter skal

injektionen straks foretages.

4.10

Overdosering

I en undersøgelse hvor Program Vet. injektionsvæske blev givet til kat i 5 gange den

anbefalede dosis, 3 gange med 2 måneders interval, var den eneste bivirkning en forbigående

inflammatorisk reaktion på injektionsstedet.

4.11

Tilbageholdelsestid

Ikke relevant.

30015_spc.doc

Side 2 af 4

5.

FARMAKOLOGISKE EGENSKABER

Det aktive stof, lufenuron, er en insekt udviklingshæmmer (insect development inhibitor,

IDI), som hører til den kemiske klasse benzoylurea.

Farmakoterapeutisk

gruppe:

Antiparasitære

midler,

insekticider

repellenter,

ektoparasiticider til systemisk brug, kitinsynteseinhibitorer.

ATCvet kode: QP 53 BC 01

5.1

Farmakodynamiske egenskaber

Lufenuron (INN) hæmmer syntesen og deponeringen af kitin. Når det administreres systemisk

til dyret, vil lopper der infesterer katten indtage det aktive stof med deres blodmåltid og

overføre det til deres æg. Som en konsekvens heraf blokeres dannelsen af larvale

kitinstrukturer, en proces der er essentiel for insekter og udviklingen af levedygtigt afkom.

5.2

Farmakokinetiske egenskaber

Efter subkutan administration af produktet absorberes det aktive stof fra et lille depot på

injektionsstedet og deponeres fortrinsvis i fedtvævet, hvorfra det til stadighed frigives

umetaboliseret til blodet. Effektive blodkoncentrationer af lufenuron opnås indenfor 21 dage

efter den første injektion, og den lave eliminationshastighed sikrer en effektiv koncentration

af det aktive stof i blodet (over 50-100 ppb) i mindst 6 måneder.

5.3

Miljømæssige forhold

Ingen kendte.

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Polysorbat 21

Povidon 12

Natriumchlorid

Vand til injektionsvæsker

6.2

Uforligeligheder

Ingen kendte.

6.3

Opbevaringstid

5 år.

Engangssprøjten må ikke genbruges.

6.4

Særlige opbevaringsforhold

Opbevares frostfrit.

Engangssprøjterne opbevares i yderkartonen.

6.5

Emballage

Program Vet. injektionsvæske findes i fyldte engangssprøjter, 1 ml Dupharject glas

injektionssprøjter, indeholdende 0,4 ml af en steril hvid til gul vandig injektionssuspension.

Ingangssprøjterne er klar til brug og er påsat en kanyle i rustfrit stål (gauge 25; 0,5 x 16 mm).

Engangssprøjterne er pakket enkeltvis i pakker af 10 stk.

30015_spc.doc

Side 3 af 4

6.6

Særlige forholdsregler ved bortskaffelse af rester af lægemidlet eller affald

Beholder og eventuelt restindhold tilbageleveres til apotek/leverandør eller til kommunal

modtageordning.

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

Elanco Europe Ltd

Lilly House, Priestley Road

Basingstoke RG 24 9NL

Storbritannien

Repræsentant

Elanco Animal Health A/S

Lyskær 3E, 2. tv.

2730 Herlev

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

30015

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

5. august 1999

10.

DATO FOR ÆNDRING AF TEKSTEN

3. oktober 2016

11.

UDLEVERINGSBESTEMMELSE

30015_spc.doc

Side 4 af 4

  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.

    Anmode informationsbrochure for offentligheden.



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FDA - U.S. Food and Drug Administration

1-6-2018

Château Manis Électroniques Inc. recalls Chateau brand gas lighters

Château Manis Électroniques Inc. recalls Chateau brand gas lighters

Health Canada's sampling and evaluation program has determined that these lighters do not meet the Lighters Regulations in Canada and may pose a fire or burn hazard. Specifically the lighters:

Health Canada

31-5-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new policies to reduce the ability of brand drug makers to use REMS programs as a way to block timely generic drug entry, helping promote competition and access

Statement from FDA Commissioner Scott Gottlieb, M.D., on new policies to reduce the ability of brand drug makers to use REMS programs as a way to block timely generic drug entry, helping promote competition and access

FDA Commissioner on new policies to reduce ability of brand drug makers to use REMS programs to block timely generic drug entry

FDA - U.S. Food and Drug Administration

30-5-2018

12 applications for allocation of special funds related to medicinal cannabis

12 applications for allocation of special funds related to medicinal cannabis

The application deadline for the second allocation of special funds for accumulation of scientific knowledge in regard to the medicinal cannabis pilot programme has now expired. The Danish Medicines Agency received 12 applications.

Danish Medicines Agency

11-10-2018

Cybersecurity Updates Affecting Medtronic Implantable Cardiac Device Programmers: FDA Safety Communication  https://go.usa.gov/xPXRN  #fda #medicaldevice

Cybersecurity Updates Affecting Medtronic Implantable Cardiac Device Programmers: FDA Safety Communication https://go.usa.gov/xPXRN  #fda #medicaldevice

Cybersecurity Updates Affecting Medtronic Implantable Cardiac Device Programmers: FDA Safety Communication https://go.usa.gov/xPXRN  #fda #medicaldevice

FDA - U.S. Food and Drug Administration

1-10-2018

My statement on the #FDA’s new efforts to strengthen the agency’s medical device cybersecurity program as part of our mission to protect patients  http://go.usa.gov/xPBK2 pic.twitter.com/8w5m5itceW

My statement on the #FDA’s new efforts to strengthen the agency’s medical device cybersecurity program as part of our mission to protect patients http://go.usa.gov/xPBK2 pic.twitter.com/8w5m5itceW

My statement on the #FDA’s new efforts to strengthen the agency’s medical device cybersecurity program as part of our mission to protect patients http://go.usa.gov/xPBK2  pic.twitter.com/8w5m5itceW

FDA - U.S. Food and Drug Administration

26-9-2018

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application:   http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/Zsmq00NCdd

FDA - U.S. Food and Drug Administration

24-9-2018

#FDA announces the release of the Collaborative Communities Toolkit for interested stakeholder organizations to work together on healthcare challenges. Learn about the program, download the Toolkit, and submit comments:  https://go.usa.gov/xPjKX pic.twitt

#FDA announces the release of the Collaborative Communities Toolkit for interested stakeholder organizations to work together on healthcare challenges. Learn about the program, download the Toolkit, and submit comments: https://go.usa.gov/xPjKX pic.twitt

#FDA announces the release of the Collaborative Communities Toolkit for interested stakeholder organizations to work together on healthcare challenges. Learn about the program, download the Toolkit, and submit comments: https://go.usa.gov/xPjKX  pic.twitter.com/iQsKIAAQTn

FDA - U.S. Food and Drug Administration

24-9-2018

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

FDA - U.S. Food and Drug Administration

19-9-2018

Reminder: #FDA site visit proposal solicitation period for the 2018  Experiential Learning Program is currently OPEN through Wednesday,  9/26/18 @ 12 pm EST. Click the link to find more about the  program & to submit your application  https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/FN1mNN65dD

FDA - U.S. Food and Drug Administration

18-9-2018

 Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

This third meeting between regulators and representatives of industry stakeholder organisations addresses all areas of product-development support, including scientific advice, specifics for paediatric and orphan medicines and support for innovation. The meeting focuses on the implementation of the orphan notice, ‘histology-independent indications’ in the context of orphan designations, the upcoming rollout of a new tool for orphan designation applications, digital technology proposals in medicine develo...

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

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

27-6-2018

EU/3/15/1590 (Merck Europe B.V.)

EU/3/15/1590 (Merck Europe B.V.)

EU/3/15/1590 (Active substance: Recombinant human monoclonal IgG1 antibody against programmed death ligand-1) - Transfer of orphan designation - Commission Decision (2018)4088 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/150/15/T/02

Europe -DG Health and Food Safety

7-6-2018

#FDA announces draft Guidance: “Requests for Feedback and Meetings for #MedicalDevice Submissions: The Q-Submission Program”. Comment period closes in 60 days https://go.usa.gov/xQsCe 

#FDA announces draft Guidance: “Requests for Feedback and Meetings for #MedicalDevice Submissions: The Q-Submission Program”. Comment period closes in 60 days https://go.usa.gov/xQsCe 

#FDA announces draft Guidance: “Requests for Feedback and Meetings for #MedicalDevice Submissions: The Q-Submission Program”. Comment period closes in 60 days https://go.usa.gov/xQsCe 

FDA - U.S. Food and Drug Administration

7-6-2018

Reform of the orphan drug program - End of transition arrangements

Reform of the orphan drug program - End of transition arrangements

End of transition arrangements for orphan drugs designated under the previous program

Therapeutic Goods Administration - Australia