Dofatrim-Ject

Hauptinformation

  • Handelsname:
  • Dofatrim-Ject Injektionslösung 200 mg/ml;40 mg/ml
  • Dosierung:
  • 200 mg/ml;40 mg/ml
  • Darreichungsform:
  • Injektionslösung
  • 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:
  • Dofatrim-Ject Injektionslösung 200 mg/ml;40 mg/ml
    Belgien
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Antibiotika

Weitere Informationen

Status

  • Quelle:
  • AFMPS - Agence Fédérale des Médicaments et des Produits de Santé - Belgium
  • Zulassungsnummer:
  • BE-V215555
  • Letzte Änderung:
  • 17-04-2018

Packungsbeilage

Bijsluiter – DE versie

Dofatrim-ject

B. PACKUNGSBEILAGE

Bijsluiter – DE versie

Dofatrim-ject

PACKUNGSBEILAGE

DOFATRIM-JECT, 40 mg – 200 mg, Injektionslösung

1.

NAME UND ANSCHRIFT DES ZULASSUNGSINHABERS UND, WENN

UNTERSCHIEDLICH, DES HERSTELLERS, DER FÜR DIE CHARGENFREIGABE

VERANTWORTLICH IST

Zulassungsinhaber:

1Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Niederlande

Für die Chargenfreigabe verantwortlicher Hersteller:

1Dopharma B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Niederlande

2.

BEZEICHNUNG DES TIERARZNEIMITTELS

DOFATRIM-JECT, 40 mg – 200 mg, Injektionslösung

3.

WIRFSTOFF(E) UND SONSTIGE BESTANDTEILE

Wirkstoffe:

Trimethoprim 40 mg/ml

Sulfadoxin 200 mg/ml

4.

ANWENDUNGSGEBIET(E)

Zur Behandlung von Infektionskrankheiten, die durch Sulfadoxin- und Trimethoprim-empfindliche

Erreger hervorgerufen werden und wobei wirksame Konzentrationen am Ort der Infektion erreicht

werden.

5.

GEGENANZEIGEN

Nicht anwenden bei Tieren mit schweren Leber-und Nierenfunktionsstörungen.

Nicht verwenden bei Tieren, bei denen eine Überempfindlichkeit gegenüber Sulfonamiden bekannt

ist.

Nicht verwenden bei Tieren mit Anomalien des Blutbildes.

6.

NEBENWIRKUNGEN

Nach intramuskulaire und subkutane Verabreichung können Reizerscheinungen am Injektionsort

vorkommen.

Sulfonamide können zu Nierenschädigungen (Kristallurie, Hämaturie, ...) oder zu Veränderungen des

Blutbildes (Anämie, Thrombozytopenie) führen.

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

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

7.

ZIELTIERART(EN)

Bijsluiter – DE versie

Dofatrim-ject

Rinder und Schweine.

8.

DOSIERUNG FÜR JEDE ZIELTIERART, ART UND DAUER DER ANWENDUNG

15 mg Sulfadoxin-Trimethoprim-Kombination pro kg Körpergewicht , entsprechend

3 ml pro 50 kg. Die Behandlungsdauer beträgt beim Schwein maximal 3 Tage, beim Rind maximal 5

Tage.

Bei sehr ernsthaften Krankheitsbildern, kann bei Tieren mit einem Körpergewicht unter 200 kg die

Dosis bis 25 mg Sulfadoxin-Trimethoprim-Kombination pro kg Körpergewicht erhöht werden.

9.

HINWEISE FÜR DIE RICHTIGE ANWENDUNG

Zur intramuskuläre, subkutane oder intravenöze Anwendung. Es wird empfohlen, nicht mehr als 20 ml

an einer Injektionsstelle zu injizieren.

Um eine korrekte Dosierung zu gewährleisten, sollte das Körpergewicht der Tiere so genau wie

möglich ermittelt werden, um Unterdosierungen zu vermeiden.

10.

WARTEZEIT

Essbare Gewebe:

8 Tage.

Milch:

2 Tage.

11.

BESONDERE LAGERUNGSHINWEISE

Arzneimittel unzugänglich für Kinder aufbewahren.

Nicht einfrieren.

Nach erstmaligem Anbrechen innerhalb von 28 Tagen verwenden.

Nach dem auf dem Etikett nach der Angabe ’Verwendbar bis’ angegebenen Verfallsdatum nicht mehr

anwenden.

12.

BESONDERE WARNHINWEISE

Bei der intravenöse Injektion besteht die Gefahr des kardiorespiratorischen Schocks. Daher darf die

i.v. Injektion nur zur Behandlung von akuten Infektionen, die eine schnelles Eingreifen erfordern,

angewendet werden. Das Risiko für das Auftreten dieser Nebenwirkungen ist größer in bestimmten

klimatischen Bedingungen von hoher Temperatur und hoher Luftfeuchtigkeit.

Besondere Vorsichtsmaßnahmen für die Anwendung bei Tieren

Es muss mit Resistenzen bei einigen Mikroorganismen gerechnet werden.

Es wird empfohlen, vor der Verwendung des Produkts ein Antibiogramm anzufertigen.

Beim Auftreten von allergischen Reaktionen, sollte die Behandlung abgebrochen werden.

Besondere Vorsichtsmaßnahmen für den Anwender

Der direkte Kontakt mit der Haut des Anwenders ist wegen der Gefahr einer Sensibilisierung oder einer

Kontaktdermatitis zu vermeiden. Während der Handhabung des Tierarzneimittels sollten Handschuhe

getragen werden.

Wechselwirkungen mit anderen Arzneimitteln und andere Wechselwirkungen

Das Produkt sollte nicht gleichzeitig mit Arzneimitteln, die den Leberstoffwechsel oder die

Blutbildung beeinflussen, angewendet werden

Ein Überschuß von PABA in nekrotischem Gewebe kann die Wirkung der Kombination beeinflussen.

Anwendung während der Trächtigkeit und Laktation

Nicht anwenden während der Trächtigkeit.

Bijsluiter – DE versie

Dofatrim-ject

Überdosierung (Symptome, Notfallmaßnahmen, Gegenmittel)

Die normale Dosierung für die parenterale Verwendung ist 10-20 mg Sulfadoxin und 2-4 mg

Trimethoprim pro kg Körpergewicht, wobei das schwächste LD50 im empfindlichsten Test Tier

(Maus) Sulfadoxin 2900 mg pro kg Körpergewicht bei subkutaner und intraperitonealer

Verabreichung und 200 mg Trimethoprim pro kg Körpergewicht bei intravenöser Verabreichung ist.

Inkompatibilitäten

Keine Angaben

13.

BESONDERE VORSICHTSMASSNAHMEN FÜR DIE ENTSORGUNG VON NICHT

VERWENDETEM ARZNEIMITTEL ODER VON ABFALLMATERIALIEN, SOFERN

ERFORDERLICH

Arzneimittel sollten nicht über das Abwasser oder den Haushaltsabfall entsorgt werden. Fragen Sie

Ihren Tierarzt, wie nicht mehr benötigte Arzneimittel zu entsorgen sind. Diese Maßnahmen

dienen dem Umweltschutz.

14.

GENEHMIGUNGSDATUM DER PACKUNGSBEILAGE

Dezember 2014.

15.

WEITERE ANGABEN

Injektionsflaschen mit 100 oder 250 ml

Es werden möglicherweise nicht alle Packungsgrößen in Verkehr gebracht.

Verschreibungspflichtig.

BE-V215555

1-11-2018

Three research projects to increase our knowledge of medicinal cannabis

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Danish Medicines Agency

1-11-2018

Information required for dossiers to support demands for import of high risk plants, plant products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031

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Published on: Wed, 31 Oct 2018 00:00:00 +0100 Article 42 of the new Plant Health Law (Regulation (EU) 2016/2031 on protective measures against pests of plants), introduce a concept of “high risk plants, plant products and other objects” in relation to the presence of a pest risk of an unacceptable level for the Union territory, identified on the basis of a preliminary assessment to be followed by a risk assessment. Upon request of the European Commission (EC), the European Food Safety Authority (EFSA) d...

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Guidance on the scientific requirements for health claims related to muscle function and physical performance

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26-10-2018

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

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Published on: Thu, 25 Oct 2018 00:00:00 +0200 The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.232). It is intended to be used in feed and water for drinking for all animal species and categories. The production strain and its recombinant DNA were not detected in the additive. The product l‐threonine, manufactured by fermentation with E. coli CGMCC 7.232, does not raise any safety concern with regard to the gen...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

Safety of zinc chelate of methionine sulfate for the target species

Safety of zinc chelate of methionine sulfate for the target species

Published on: Wed, 24 Oct 2018 00:00:00 +0200 Zinc chelate of methionine sulfate is intended to be used as a nutritional additive (functional group: compounds of trace elements). The additive is zinc chelated with methionine in a molar ratio 1:1. It is intended to supply zinc as a nutritional additive to all animal species/categories. In 2017, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of zinc chelate of methionine su...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

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Europe - EFSA - European Food Safety Authority Publications

18-10-2018

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17-10-2018

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

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Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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FDA - U.S. Food and Drug Administration

12-10-2018

Voluntary Recall of Limited Amounts of Nuts & Vanilla Protein Plant Shake

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Forager Project is recalling three dates of Nuts and Vanilla – Organic Plant Protein Shake because the product contains almond flour which is not declared on the label.

FDA - U.S. Food and Drug Administration

10-10-2018

Tanning booths: ANSES issues a reminder of the proven risk of skin cancer

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France - Agence Nationale du Médicament Vétérinaire

28-9-2018

EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

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Pfizer Canada has advised Health Canada that, in a very small number of cases, some EpiPen (0.3 mg) and EpiPen Jr (0.15 mg) auto-injector devices may not slide out of their carrier tube easily, or at all. This could delay or prevent emergency treatment, possibly leading to patient disability or death.

Health Canada

26-9-2018

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

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25-9-2018

FDA Announces FY 2019 Animal Drug User Fee Rates for ADUFA and AGDUFA

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FDA - U.S. Food and Drug Administration

20-9-2018

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

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13-9-2018

Use of next‐generation sequencing in microbial risk assessment

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12-9-2018

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11-9-2018

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31-8-2018

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30-8-2018

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30-8-2018

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29-8-2018

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Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

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Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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Europe - EFSA - European Food Safety Authority Publications

27-8-2018

ELEMENT recalls boys' jackets with waist drawstrings

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Health Canada

24-8-2018

Imagine recalls Buckyballs magnet sets

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Health Canada

14-8-2018

Calikids Inc. recalls children's jackets with waist drawstrings

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Health Canada

30-7-2018

July 26, 2018: Miami-Dade Resident Charged in Connection with Performance of Illicit Silicone Injections

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FDA - U.S. Food and Drug Administration

26-7-2018

13.000 jongeren na de zomer aan slag binnen maatschappelijke diensttijd

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Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

24-7-2018

Pepperidge Farm® Announces Voluntary Recall of Four Varieties of Goldfish® Crackers

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FDA - U.S. Food and Drug Administration

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

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FDA - U.S. Food and Drug Administration

11-7-2018

MyNicNaxs, LLC Issues Voluntary Nationwide Recall of Various Dietary Supplements Due to Undeclared Active Pharmaceutical Ingredient (API)

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FDA - U.S. Food and Drug Administration

11-7-2018

Safe Use Initiative - Current Projects

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FDA - U.S. Food and Drug Administration

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

29-5-2018

Newly Added Guidance Documents

Newly Added Guidance Documents

Guidance documents represent the FDA's current thinking on a particular subject. New guidance documents are listed here for three months.

FDA - U.S. Food and Drug Administration

28-5-2018

Health Canada warns of safety hazards with several uncertified USB chargers

Health Canada warns of safety hazards with several uncertified USB chargers

As part of a planned national sampling and compliance project, Health Canada tested a number of uncertified USB chargers. The following products were found to pose an unacceptable risk of electric shock and fire and are being recalled. This table will be updated if and when new products are recalled.

Health Canada

27-4-2018

EpiPen 300 mcg adrenaline auto-injector

EpiPen 300 mcg adrenaline auto-injector

Medicine shortages

Therapeutic Goods Administration - Australia

17-4-2018

Epic Products, LLC, Issues Voluntary Nationwide Recall of All Lots of Euphoric Capsules Due to Presence of Undeclared Sildenafil and Tadalafil

Epic Products, LLC, Issues Voluntary Nationwide Recall of All Lots of Euphoric Capsules Due to Presence of Undeclared Sildenafil and Tadalafil

Overland Park, KS, Epic Products, LLC is voluntarily recalling all lots of Euphoric capsules, packaged in 1 count blister cards, 3 count bottles, and 12 count bottles to the consumer level. FDA analysis found samples of Euphoric to be tainted with undeclared sildenafil and tadalafil, active ingredients in two FDA-approved prescription drug products, also known as phosphodiesterase 5-inhibitors (PDE-5 inhibitors), used to treat male erectile dysfunction (ED). The presence of sildenafil and tadalafil in E...

FDA - U.S. Food and Drug Administration

28-11-2017

The Icelandic Medicines
Agency starts publishing educational materials on its medicinal product
information website

The Icelandic Medicines Agency starts publishing educational materials on its medicinal product information website

Following a successful pilot project, the Icelandic Medicines Agency has decided to start publishing aRMM educational materials on its website: www.serlyfjaskra.is.

IMA - Icelandic Medicines Agency

5-10-2017

Collection of scientific experience for medicinal cannabis pilot programme

Collection of scientific experience for medicinal cannabis pilot programme

One or more research projects should be carried out for the purpose of gathering scientific experience on medicinal cannabis. The projects will form part of the medicinal cannabis pilot programme.

Danish Medicines Agency

6-4-2017

More batches of EpiPen® are withdrawn

More batches of EpiPen® are withdrawn

MEDA has decided to withdraw four more batches of EpiPen®. The withdrawal concerns two batches of EpiPen® 300 micrograms/dose and two batches of EpiPen® Jr 150 micrograms/dose. The latter is used for acute hypersensitivity reactions in children. The reason for the withdrawal is that there is a risk that the auto-injector does not work.

Danish Medicines Agency

17-3-2017

Withdrawal of a batch of EpiPen® 300 micrograms

Withdrawal of a batch of EpiPen® 300 micrograms

MEDA recalls a batch of the adrenaline product EpiPen® 300 micrograms/dose, which is used for sudden allergic reactions. There is a risk that the auto-injector does not work. The withdrawal concerns product number 578818 with batch number: 5FA665B and expiry date 03/2017.

Danish Medicines Agency

8-7-2016

Public funds allocated for research into possible adverse reactions from HPV vaccination

Public funds allocated for research into possible adverse reactions from HPV vaccination

Three projects will receive public funds of DKK 7 million, which the Danish Parliament has earmarked for research into possible adverse reactions from HPV vaccination.

Danish Medicines Agency

26-2-2016

New comprehensive list of euphoriant substances regulated in Denmark

New comprehensive list of euphoriant substances regulated in Denmark

You can now find a comprehensive list of euphoriant substances that are subject to control in Denmark via the executive order on euphoriant substances.

Danish Medicines Agency

11-2-2015

Send Danish package leaflet when applying for changes to product information

Send Danish package leaflet when applying for changes to product information

When applying for changes to the product information, marketing authorisation holders must always send a Danish version of the package leaflet to the Danish Health and Medicines Authority, whether the medicinal product is marketed in Denmark or not (unless the medicinal product is subject to section 11 about omission of the package leaflet, cf. Executive order no. 869 of 21 July 2011, as amended, on the labelling etc. of medicinal products).

Danish Medicines Agency

21-10-2014

Updated guidelines on activities subject to a section 39 authorisation

Updated guidelines on activities subject to a section 39 authorisation

We have updated our guidelines on activities subject to a section 39 authorisation or a company registration.

Danish Medicines Agency

3-6-2014

Regulation on clinical trials on medicinal products adopted

Regulation on clinical trials on medicinal products adopted

The European Commission's proposal for new European legislation on clinical trials of medicinal products was adopted in early 2014. The objective is to promote the number of clinical trials in the EU.

Danish Medicines Agency

21-9-2018

Scientific guideline:  Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

Scientific guideline: Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

The objective of this document is to review available information on the use of aminopenicillins and their beta-lactamase inhibitor combinations in veterinary medicines in the EU, their effect on the emergence of antimicrobial resistance (AMR) and the potential impact of resistance on human and animal health. The document provides information for the risk profiling, as recommended by the Antimicrobial Advice ad hoc Expert Group (AMEG) of the EMA.

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

27-7-2018

Scientific guideline:  Reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation, draft: consultation open

Scientific guideline: Reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation, draft: consultation open

Established veterinary antibiotics are not always used at the authorised dose, and the dose may need to be reviewed in order to maintain their effectiveness whilst limiting the risks of antimicrobial resistance. Before a new dose is introduced, the company would typically have to conduct new studies to ensure it does not negatively affect the safety of the target animal, the consumer of animal produce, or the environment. This may reduce product availability, which could have a negative impact on antimic...

Europe - EMA - European Medicines Agency

22-7-2018

But predicates may be decades old. Our new “expanded abbreviated” 510(k) path to market  https://bit.ly/2vnc1Zl   may drive greater market competition for safer devices. It explains how objective performance criteria may be used to demonstrate substantial

But predicates may be decades old. Our new “expanded abbreviated” 510(k) path to market https://bit.ly/2vnc1Zl  may drive greater market competition for safer devices. It explains how objective performance criteria may be used to demonstrate substantial

But predicates may be decades old. Our new “expanded abbreviated” 510(k) path to market https://bit.ly/2vnc1Zl  may drive greater market competition for safer devices. It explains how objective performance criteria may be used to demonstrate substantial equivalence.

FDA - U.S. Food and Drug Administration