Denagard 100 ad us. vet.[L]

Hauptinformation

  • Handelsname:
  • Denagard® 100 ad us. vet.[L], Injektionslösung
  • 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:
  • Denagard® 100 ad us. vet.[L], Injektionslösung
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Injizierbare Lösung für Schweine

Weitere Informationen

Status

  • Quelle:
  • Institut für Veterinärpharmakologie
  • Zulassungsnummer:
  • Abgabekategorie
  • Letzte Änderung:
  • 03-11-2018

Packungsbeilage: zusammensetzung, kinische angaben, nebenwirkungen, wechselwirkungen, dosierung, schwangerschaft, stillzeit

Denagard

100 ad us. vet.

, Injektionslösung

Elanco Tiergesundheit AG

HINWEIS: momentan nicht lieferbar (Lieferengpass)!

Injizierbare Lösung für Schweine

ATCvet: QJ01XQ01

Zusammensetzung

Tiamulinum 100 mg, glyceroli monooleas, ethanolum 96 per centum, Antiox.: E

310 0.1 mg, sesami oleum raffinatum, ad solutionem pro 1 ml.

Fachinformationen Wirkstoffe (CliniPharm)

Tiamulin

Eigenschaften / Wirkungen

Das Antibiotikum Tiamulin, aktiver Wirkstoff von Denagard 100, ist ein synthetisches

Derivat des Pleuromutilins. Es wird ausschliesslich in der Veterinärmedizin eingesetzt.

Denagard 100 wirkt bakteriostatisch und sein Wirkungssspektrum umfasst insbesondere:

Mykoplasmen, Hämophilus und Brachyspira hyodysenteriae.

Folgende Keime, die bei Schweinen wichtige Krankheitserreger sind, werden erfasst:

Mycoplasmen: M. hyopneumoniae, M. hyosynoviae, M. hyorhinis

Treponemen: Brachyspira hyodysenteriae

Leptospiren: Leptospira spp.

Grampositive Bakterien:

Streptokokken, Clostridium perfringens, Listeria monocytogenes, Erysipelothrix,

Actinomyces pyogenes

Gramnegative Bakterien:

Pasteurella multocida, Actinobacillus pleuropneumoniae, Fusobacterium necrophorum,

Bacteroides vulgatus, Campylobacter coli

Indikationen

Therapie der enzootischen Pneumonie verursacht durch Mycoplasma hyopneumoniae

und deren Sekundärinfektionen, durch M. hyorhinis, P. multocida.

-Therapie der Pleuropneumonie versursacht durch Actinobacillus pleuropneumoniae.

-Therapie der Arthritiden verursacht durch Mycoplasma hyosynoviae.

Therapie der Schweinedysenterie verursacht durch Brachyspira hyodysenteriae sowie

Komplikationen durch Fusobacterium necrophorum oder Bacteroides vulgatus.

Enzootische Pneumonie und sekundäre Infektionen, Pleuropneumonie: 12,5 - 15 mg

Tiamulin pro kg KGW/Tag, d.h. 2,5 - 3 ml Denagard 100 pro 20 kg KGW/Tag, während 1 -

3 Tagen.

Mycoplasmen-Arthritiden: 10 - 12,5 mg Tiamulin pro kg KGW/Tag, d.h. 2 - 2,5 ml

Denagard 100 pro 20 kg KGW/Tag, während 3 Tagen.

Dysenterie: 10 mg Tiamulin pro kg KGW/Tag, d.h. 2 ml Denagard 100 pro 20 kg

KGW/Tag. Einmalige Injektion, gefolgt von einer oralen Behandlung mit Denagard

Premix.

Wenn nach der empfohlenen Behandlungsdauer keine Besserung der Symptome eintritt,

muss eine neue Diagnose gestellt werden; insbesondere in Bezug auf Denagard

unempfindliche Keime.

Verabreichungsart: intramuskuläre Injektion.

Anwendungseinschränkungen

Keine

Unerwünschte Wirkungen

VetVigilance: Pharmacovigilance-Meldung erstatten

In gewissen Fällen kann Denagard 100 Reaktionen wie Erytheme hervorrufen. In diesem

Fall die Behandlung sowie jede orale Verabreichung von Medikamenten einstellen; die

Schweine mit kaltem Wasser abspritzen und in saubere Boxen bringen.

7 Tage

Wechselwirkungen

Durch die Behandlung mit Denagard 100 kann die Toxizität von bestimmten Ionophor-

Antibiotika erhöht werden. Das Futter der zu behandelnden Tiere darf deshalb 7 Tage vor,

während und 7 Tage nach der Behandlung kein Salinomycin enthalten.

Sonstige Hinweise

Lagerung bei Raumtemperatur (<30°C) und vor Licht geschützt. Aufbrauchfrist nach 1.

Entnahme: 2 Wochen. Das Medikament darf nur bis zu dem auf dem Behälter mit "Exp."

bezeichneten Datum verwendet werden. Ausserhalb der Reichweite von Kindern

aufbewahren.

Packungen

Schachteln mit 10 Flaschen zu 100 ml

Schachtel mit 1 Flasche zu 100 ml

Abgabekategorie: A

Swissmedic Nr. 47'961

Informationsstand: 04/2009

Dieser Text ist behördlich genehmigt.

16-3-2019

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

Earth City, MO, Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. This recall was prompted due to Camber Pharmaceuticals, Inc. issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

FDA - U.S. Food and Drug Administration

8-3-2019

Safety assessment of the process ‘Jász‐Plasztik’, based on Vacurema Prime technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘Jász‐Plasztik’, based on Vacurema Prime technology, used to recycle post‐consumer PET into food contact materials

Published on: Thu, 07 Mar 2019 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the recycling process Jász‐Plasztik (EU register number RECYC0157). The input are hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers and containing no more than 5% PET from non‐food applications. They are heated in a batch reactor under vacuum and then heated in a continuous reactor under vacuum...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-3-2019

Norbrook Laboratories Limited Recalls Veterinary Products for Health Risk

Norbrook Laboratories Limited Recalls Veterinary Products for Health Risk

Norbrook Laboratories Limited of Newry, Northern Ireland is recalling two lots of Enroflox® 100 Injection (enrofloxacin), two lots of Noromectin® Injection (ivermectin) and two lots of Ivermax® 1% Injection (ivermectin) to the veterinarian/consumer level as a precautionary measure as product sterility cannot be assured. There is a concern that if the sterility of these products has been compromised, use of these products could result in introduction of infectious agents to the animal. This may result in ...

FDA - U.S. Food and Drug Administration

7-3-2019

Re‐evaluation of Quillaia extract (E 999) as a food additive and safety of the proposed extension of use

Re‐evaluation of Quillaia extract (E 999) as a food additive and safety of the proposed extension of use

Published on: Wed, 06 Mar 2019 The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on Quillaia extract (E 999) when used as a food additive and the evaluation of the safety of its proposed extension of use as a food additive in flavourings. The Scientific Committee for Food (SCF) in 1978 established an acceptable daily intake (ADI) of 0–5 mg spray‐dried extract/kg body weight (bw) per day for E 999. The Joint FAO/WHO Expert Committee on Food Additives ...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Opinion on the follow‐up of the re‐evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives

Opinion on the follow‐up of the re‐evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives

Published on: Fri, 01 Mar 2019 In this opinion, the EFSA Panel on Food Additives and Flavourings (FAF Panel) was requested by the European Commission to carry out a scientific evaluation of an extended one‐generation reproductive toxicity study (EOGRTS) to determine whether it would allow reconsideration of the temporary group acceptable daily intake (ADI) for sorbic acid (E 200) and potassium sorbate (E 202), established by the Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) in 2...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Finadyne ad us. vet., Injektionsloesung

Finadyne ad us. vet., Injektionsloesung

● Änderung Absetzfristen! ● Änderung Text: "Anwendungseinschränkungen"

Institut für Veterinärpharmakologie und toxikologie

5-3-2019

Cobactan IV 4.5% ad us. vet., Injektionspraeparat

Cobactan IV 4.5% ad us. vet., Injektionspraeparat

● Die Zulassung ist am 05.03.2019 erloschen.

Institut für Veterinärpharmakologie und toxikologie

1-3-2019

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

25-2-2019

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited.

FDA - U.S. Food and Drug Administration

21-2-2019

Vetmedin 1.25 mg ad us. vet., Kautabletten

Vetmedin 1.25 mg ad us. vet., Kautabletten

● Änderung Text: "Vorsichtsmassnahmen"

Institut für Veterinärpharmakologie und toxikologie

21-2-2019

Vetmedin 2.5 mg ad us. vet., Kautabletten

Vetmedin 2.5 mg ad us. vet., Kautabletten

● Änderung Text: "Vorsichtsmassnahmen"

Institut für Veterinärpharmakologie und toxikologie

21-2-2019

Vetmedin 5 mg ad us. vet., Kautabletten

Vetmedin 5 mg ad us. vet., Kautabletten

● Änderung Text: "Vorsichtsmassnahmen"

Institut für Veterinärpharmakologie und toxikologie

21-2-2019

Vetmedin 10 mg ad us. vet., Kautabletten

Vetmedin 10 mg ad us. vet., Kautabletten

● Änderung Text: "Vorsichtsmassnahmen"

Institut für Veterinärpharmakologie und toxikologie

13-2-2019

CADOREX 300 mg/ml ad us. vet., Injektionsloesung

CADOREX 300 mg/ml ad us. vet., Injektionsloesung

● Die Neuzulassung erfolgte am 13.02.2019.

Institut für Veterinärpharmakologie und toxikologie

5-2-2019

Phlogal ad us. vet., Salbe

Phlogal ad us. vet., Salbe

● Die Zulassung ist am 05.02.2019 erloschen.

Institut für Veterinärpharmakologie und toxikologie

4-2-2019

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

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Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced that it’s wholly owned subsidiary, Dr Reddy’s Laboratories, Inc is continuing its voluntary nationwide recall of lot ABD807 of Levetiracetram in 0.54% Sodium Chloride Injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags to the hospital level in U.S.A.

FDA - U.S. Food and Drug Administration

24-1-2019

Vetagent ad us. vet., Injektionsloesung

Vetagent ad us. vet., Injektionsloesung

● Änderung der Absetzfristen für alle Nutztierspezies! ● Änderungen Pferd: Neue Dosierung, keine i.m. Applikation mehr und neue Applikationsfrequenz ● Änderung Schaf, Ziege, Schwein, Hund und Katze: keine s.c. Applikation mehr ● Änderung Text: "Dosierung/Anwendung", "Anwendungseinschränkungen" und "Sonstige Hinweise"

Institut für Veterinärpharmakologie und toxikologie

24-1-2019

Pargenta-50 ad us. vet., Injektionsloesung

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● Änderung der Absetzfristen für alle Nutztierspezies! ● Änderungen Pferd: Neue Dosierung und neue Applikationsfrequenz ● Änderung Rind, Schaf, Ziege, Schwein: Neue Dosierung und neue Applikationsfrequenz, keine s.c. Applikation mehr ● Änderung Hund und Katze: keine s.c. Applikation mehr ● Änderung Text: "Eigenschaften/Wirkungen", "Indikationen", "Dosierung/Anwendung", "Anwendungseinschrä...

Institut für Veterinärpharmakologie und toxikologie

17-1-2019

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Published on: Wed, 16 Jan 2019 The additive cassia gum consists mainly of high-molecular weight polysaccharides composed primarily of a linear chain of 1,4-b-D-mannopyranose units with 1,6-linked a-D-galactopyranose units. In 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of cassia gum in cats and dogs. The Panel concluded, based on positive findings observed in a bacterial reverse mutation test with a semi-refined cassia...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of 3‐phytase FSF10000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species

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Published on: Tue, 15 Jan 2019 The additive 3‐phytase FSF10000 is a solid product that contains a 3‐phytase produced by a genetically modified strain of Komagataella phaffii. A liquid formulation of the additive has been previously assessed by the EFSA Panel on Additives and Products of Substances used in Animal Feed (FEEDAP) and is currently authorised as a feed additive for poultry species. The applicant requested for the use of this new formulation of the additive in chickens for fattening or reared ...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Safety assessment of the substance, montmorillonite clay modified with hexadecyltrimethylammonium bromide, for use in food contact materials

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Published on: Mon, 14 Jan 2019 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of montmorillonite clay modified with hexadecyltrimethylammonium bromide (HDTA) when used as an additive at up to ■■■■■ in polylactic acid (PLA) bottles intended for contact with water for long‐term storage at ambient temperature or below. The modified clay, which 90% w/w of the particles have a dimension of 33.1 μm or less and the average size is 9 μm, has a layered structure w...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-3-2019

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21-3-2019

Tramal® Zäpfchen, 100 mg

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18-3-2019

EU/3/14/1247 (Diamond ROC EOOD)

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EU/3/14/1247 (Active substance: Autologous dendritic cells pulsed with tumour antigen-derived synthetic peptides (MAGE-1, HER-2, AIM-2, TRP-2, gp-100, and interleukin-13 receptor alpha)) - Transfer of orphan designation - Commission Decision (2019)2146 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003818

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11-3-2019

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Europe -DG Health and Food Safety

25-2-2019

BLUEVAC BTV8 (CZ Veterinaria, S.A.)

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BLUEVAC BTV8 (Active substance: Bluetongue virus inactivated, serotype 8) - Centralised - Yearly update - Commission Decision (2019)1610 of Mon, 25 Feb 2019

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21-2-2019

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7-2-2019

Equisolon (Le Vet B.V.)

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Equisolon (Active substance: Prednisolone) - Centralised - Renewal - Commission Decision (2019)936 of Thu, 07 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/2382/R/04

Europe -DG Health and Food Safety

7-2-2019

Cilostazol-Elpen 100 mg Tabletten

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7-2-2019

Zeffix 100 mg Filmtabletten

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5-2-2019

Modafinil Heumann 100 mg Tabletten

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31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Europe - EMA - European Medicines Agency

25-1-2019

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22-1-2019

Orfiril® 100 mg/ml Injektionslösung

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Zyvoxid® 100 mg/5 ml

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