Ferriphor 20% Vet.

Primær information

  • Handelsnavn:
  • Ferriphor 20% Vet. 200 mg/ml injektionsvæske, opløsning
  • Dosering:
  • 200 mg/ml
  • Lægemiddelform:
  • injektionsvæske, opløsning
  • 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:
  • Ferriphor 20% Vet. 200 mg/ml injektionsvæske, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 13252
  • Sidste ændring:
  • 22-02-2018

Produktresumé

28. januar 2014

PRODUKTRESUMÉ

for

Ferriphor 20% Vet., injektionsvæske, opløsning

0.

D.SP.NR

3152

1.

VETERINÆRLÆGEMIDLETS NAVN

Ferriphor 20% Vet.

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

1 ml indeholder:

Jern (III) dextran kompleks sv.t. 200 mg Fe (III)

Phenol

Allen hjælpestoffer er anført under pkt. 6.1.

3.

LÆGEMIDDELFORM

Injektionsvæske, opløsning

4.

KLINISKE OPLYSNINGER

4.1

Dyrearter

Svin og kvæg

4.2

Terapeutiske indikationer

Profylaktisk og kurativ behandling af anæmi som følge af jernmangel

4.3

Kontraindikationer

Bør ikke gives til heste.

4.4

Særlige advarsler

Ingen

4.5

Særlige forsigtighedsregler vedrørende brugen

Særlige forsigtighedsregler for dyret

Ved mistanke om Vitamin E-/selenmangel skal man ikke give jerntilskud. Se pkt. 5.4

”Bivirkninger”.

Særlige forsigtighedsregler for personer, der administrerer lægemidlet

Ingen.

13252_spc.doc

Side 1 af 3

Andre forsigtighedsregler

Ingen.

4.6

Bivirkninger

Brunlig misfarvning af injektionsstedet kan forekomme.

Jerndextran kan i sjældne tilfælde fremkalde fatale reaktioner ved injektion hos pattegrise.

Genetiske faktorer, mangel på vitamin E eller selen er angivet som årsager.

4.7

Drægtighed, diegivning eller æglægning

Kan anvendes.

4.8

Interaktion med andre lægemidler og andre former for interaktion

Ingen

4.9

Dosering og indgivelsesmåde

Pattegrise (2-4 dage gamle):

1 ml

Applikation:

subkutant eller intramuskulært

Søer og gylte:

3 ml

Kalve, indtil 3 uger:

5 ml

Applikation:

intramuskulært

4.10

Overdosering

Ingen

4.11

Tilbageholdelsestid

0 dage.

5.

FARMAKOLOGISKE EGENSKABER

Farmakoterapeutisk gruppe: Jern, parenterale midler. QB 03 AC.

5.1

Farmakodynamiske egenskaber

Jern er et livsvigtigt stof for dyr. Det indgår som en bestanddel i myoglobin og hæmoglobin,

som bruges i transporten og udnyttelsen af ilt i kroppen. Jern er også komponent i kroppens

livsvigtige enzymer.

5.2

Farmakokinetiske egenskaber

Efter injektion absorberes jerndextran hovedsageligt via lymfen og videreføres gennem blod

til det retikuloendoteliale system i kroppen. Dextranet bliver udskilt i urinen, og en del

metaboliseres til glukose, mens jernet bliver brugt til dannelsen af hæmoglobin.

5.3

Miljømæssige forhold

Ingen

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Phenol, natriumchlorid, saltsyre, natriumhydroxid, renset vand.

6.2

Uforligeligheder

13252_spc.doc

Side 2 af 3

Bør ikke indgives sammen med tetracykliner (kompleksdannende). Samtidig administration

med andre præparater i samme sprøjte anbefales generelt ikke, da virkning og tolerance kan

påvirkes.

6.3

Opbevaringstid

2 år.

6.4

Særlige opbevaringsforhold

Ingen

6.5

Emballage

Hætteglas á 100 ml

PP hætteglas a´ 100 ml

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

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Tyskland

Repræsentant

ScanVet Animal Health A/S

Kongevejen 66

3480 Fredensborg

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

13252

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

30. juni 1989

10.

DATO FOR ÆNDRING AF TEKSTEN

28. januar 2014

11.

UDLEVERINGSBESTEMMELSE

13252_spc.doc

Side 3 af 3

  • 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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Europe - EFSA - European Food Safety Authority Publications

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Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Antimicrobial resistance (AMR) represents a major challenge for Public Health and the scientific community, and requires immediate and drastic solutions. Acquired resistance to certain antimicrobials is already widespread to such an extent that their efficacy in the treatment of certain life‐threatening infections is already compromised. To date, the emergence and spread of AMR has been attributed to the use, misuse or indiscriminate use of antibiotics as th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Plant protection products (PPPs) are pesticides containing at least one active substance that drives specific actions against pests (diseases). PPPs are regulated in the EU and cannot be placed on the market or used without prior authorisation. EFSA assesses the possible risks of the use of active substances to humans and environment. Member States decide whether or not to approve their use at EU level. Furthermore, Member States decide at national level on ...

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

September 6, 2018: Cattle Company and Veterinarian Indicted for False Health Certificates on Livestock

September 6, 2018: Cattle Company and Veterinarian Indicted for False Health Certificates on Livestock

September 6, 2018: Cattle Company and Veterinarian Indicted for False Health Certificates on Livestock

FDA - U.S. Food and Drug Administration

29-8-2018

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Published on: Thu, 23 Aug 2018 00:00:00 +0200 Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three differen...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Published on: Mon, 20 Aug 2018 00:00:00 +0200 Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation (Directive 2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013) and the EFSA guidance documents on the risk assessment of food and feed from genetically modified (GM) plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any...

Europe - EFSA - European Food Safety Authority Publications

14-11-2018

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Active substance: tolvaptan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7604 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2788/T/20

Europe -DG Health and Food Safety

22-10-2018

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Active substance: mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches) - Centralised - Yearly update - Commission Decision (2018)6972 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

17-9-2018

Agenda:  Agenda - CHMP agenda of the 17-20 September 2018 meeting

Agenda: Agenda - CHMP agenda of the 17-20 September 2018 meeting

Europe - EMA - European Medicines Agency

11-9-2018

 Focus group meeting  on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

This meeting will allow a direct exchange of views between the Agency’s working party and stakeholders on its draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (EMA/CVMP/849775/2017). It complements the public consultation on this reflection paper ending on 31 January 2019. The reflection paper follows considerations in the report on a pilot project that aimed to develop and test non-experimental appr...

Europe - EMA - European Medicines Agency

4-9-2018

Agenda:  Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda: Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda of CHMP written procedure*20-23 August 2018

Europe - EMA - European Medicines Agency