Program Vet.

Primær information

  • Handelsnavn:
  • Program Vet. 40 mg injektionsvæske, suspension
  • Dosering:
  • 40 mg
  • Lægemiddelform:
  • injektionsvæske, suspension
  • Brugt til:
  • Dyr
  • Medicin typen:
  • Allopatiske stof

Dokumenter

  • for den brede offentlighed:
  • 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.

Lokation

  • Fås i:
  • Program Vet. 40 mg injektionsvæske, suspension
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 30014
  • 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 40 mg per injektionssprøjte (0,4 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 under 4 kg og fravænnede killinger.

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.

30014_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

mindre end 4

Dosis

1 Program Vet. 40 mg

injektionssprøjte

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.

30014_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

Må ikke opbevares frossen.

Opbevares i original emballage/beholder.

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).

30014_spc.doc

Side 3 af 4

Engangssprøjterne er pakket enkeltvis i pakker af 10 stk.

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)

30014

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

2. juli 1998

10.

DATO FOR ÆNDRING AF TEKSTEN

3. oktober 2016

11.

UDLEVERINGSBESTEMMELSE

30014_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.



  • Dokumenter på andre sprog er tilgængelige her

14-8-2018

Genius Premium Craft Boxes recalls Do-It-Yourself Slime Kits

Genius Premium Craft Boxes recalls Do-It-Yourself Slime Kits

Health Canada’s sampling and evaluation program has determined the Do-It-Yourself Slime Kits do not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

7-8-2018

August 6, 2018: Nurse Practitioner Sentenced for Illegally Prescribing Drugs at Substance Abuse Treatment Program

August 6, 2018: Nurse Practitioner Sentenced for Illegally Prescribing Drugs at Substance Abuse Treatment Program

August 6, 2018: Nurse Practitioner Sentenced for Illegally Prescribing Drugs at Substance Abuse Treatment Program

FDA - U.S. Food and Drug Administration

20-7-2018

Camco Manufacturing, Inc. recalls Camco RV Awning Water Proofer

Camco Manufacturing, Inc. recalls Camco RV Awning Water Proofer

Health Canada's inspection program found the recalled product does not meet the labelling and child-resistant packaging requirements for consumer chemical products as set out in the Consumer Chemicals and Containers Regulations, 2001.

Health Canada

20-7-2018

J2Labz recalls Sugar Shack Vaping Liquid

J2Labz recalls Sugar Shack Vaping Liquid

Health Canada's sampling and evaluation program has determined that these vaping products do not meet the packaging and labelling requirements of the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

6-7-2018

Expanded Recall: Peg Perego Canada Inc. recalls Various Book Strollers

Expanded Recall: Peg Perego Canada Inc. recalls Various Book Strollers

Health Canada's sampling and evaluation program has determined that these strollers do not meet the Carriages and Strollers Regulations in Canada. Specifically, the strollers do not meet the latching system requirements for folding strollers as they do not have a safety device independent of the latching device to prevent folding.

Health Canada

27-6-2018

Canadian Tire Corporation, Limited recalls MASTER Chef BBQ Igniter lighters

Canadian Tire Corporation, Limited recalls MASTER Chef BBQ Igniter 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

26-6-2018

Home Hardware Stores Ltd. recalls Home Flexible Multi-Purpose Lighter

Home Hardware Stores Ltd. recalls Home Flexible Multi-Purpose Lighter

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

20-6-2018

Bumbleride Inc recalls Bumbleride Speed 3-wheel jogging stroller

Bumbleride Inc recalls Bumbleride Speed 3-wheel jogging stroller

Health Canada's sampling and evaluation program has determined that this jogging stroller does not meet the sharp edge requirements of the Carriages and Strollers Regulations in Canada. The metal edge of the back hinge located on the right side of the jogging stroller can be sharp, posing a potential risk of cut or laceration.

Health Canada

14-6-2018

FDA Releases FSMA Draft Guidance on the Supply-Chain Program Preventive Control for Animal Food

FDA Releases FSMA Draft Guidance on the Supply-Chain Program Preventive Control for Animal Food

FDA issued draft guidance to help animal food facilities needing a supply-chain program meet those requirements under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule.

FDA - U.S. Food and Drug Administration

5-6-2018

FDA and USDA announce key step to advance collaborative efforts to streamline produce safety requirements for farmers

FDA and USDA announce key step to advance collaborative efforts to streamline produce safety requirements for farmers

FDA and USDA announce key step to advance collaborative efforts to streamline produce safety requirements for farmers by aligning USDA program with FDA’s Produce Safety Rule requirements.

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

29-5-2018

Expanded Recall: Stroller Boutique recalls Anex Sport stroller

Expanded Recall: Stroller Boutique recalls Anex Sport stroller

Health Canada’s sampling and evaluation program has determined these strollers do not meet the Carriages and Strollers Regulations in Canada. Specifically, the strollers contain barium in excess of allowable limits. Additionally, these strollers do not meet Health Canada's stability requirements. These strollers may tip-over while in use, posing a fall hazard.

Health Canada

23-5-2018

Ten Thousand Villages Canada recalls Choo-Choo Train & Blocks Set

Ten Thousand Villages Canada recalls Choo-Choo Train & Blocks Set

Health Canada's sampling and evaluation program has determined that the recalled toy does not meet the Canadian safety requirements for toys. The numbered blocks are small parts and the toy may further break apart exposing more small parts, posing a choking hazard for young children.

Health Canada

15-5-2018

May 7, 2018: Abingdon Nurse Practitioner Pleads Guilty to Conspiring to Illegally Prescribe Buprenorphine, Clonazepam, and Gabapentin at Substance Abuse Treatment Program

May 7, 2018: Abingdon Nurse Practitioner Pleads Guilty to Conspiring to Illegally Prescribe Buprenorphine, Clonazepam, and Gabapentin at Substance Abuse Treatment Program

May 7, 2018: Abingdon Nurse Practitioner Pleads Guilty to Conspiring to Illegally Prescribe Buprenorphine, Clonazepam, and Gabapentin at Substance Abuse Treatment Program

FDA - U.S. Food and Drug Administration

11-1-2018

Is My Dog or Cat a Healthy Weight? Important Questions to Ask the Vet

Is My Dog or Cat a Healthy Weight? Important Questions to Ask the Vet

Just as obesity has become a serious problem in people, it's also a growing problem in pets, one that can seriously harm your pet's health.

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

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