Pharmasin 200 ad us. vet.

Hauptinformation

  • Handelsname:
  • Pharmasin® 200 ad us. vet., 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:
  • Pharmasin® 200 ad us. vet., Injektionslösung
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Makrolid-Antibiotikum für Rinder, Kälber und Schweine

Weitere Informationen

Status

  • Quelle:
  • Institut für Veterinärpharmakologie
  • Zulassungsnummer:
  • 63217
  • Letzte Änderung:
  • 02-09-2017

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

Pharmasin

200 ad us. vet., Injektionslösung

Virbac (Switzerland) AG

Makrolid-Antibiotikum für Rinder, Kälber und Schweine

ATCvet: QJ01FA90

Zusammensetzung

1 ml Injektionslösung enthält:

Wirkstoff:

200 mg Tylosinum

Hilfsstoffe

:

Propylenglycolum, Conserv.: Alcohol benzylicus (E1519) 40 mg, Aqua ad inj.

q.s. ad solutionem.

Fachinformationen Wirkstoffe (CliniPharm)

Tylosin

Eigenschaften / Wirkungen

Pharmasin enthält den Wirkstoff Tylosin und gehört zu den Makrolid-Antibiotika. Es ist ein

Fermentationsprodukt mit antibiotischem Charakter. Es wurde aus einer in Thailand

entnommenen Bodenprobe isoliert, welche einen Stamm von Streptomyces fradiae

enthielt.

Tylosin bindet sich an die ribosomale 50S-Untereinheit von Prokaryonten und verhindert

damit die Proteinsynthese. Tylosin wirkt im Allgemeinen bakteriostatisch, in hoher

Konzentration auch bakterizid. Tylosin ist wirksam gegen Mykoplasmen und grampositive

Bakterien.

Pharmakokinetik

Nach parenteraler Verabreichung reichert sich Tylosin innerhalb von wenigen Stunden in

verschiedenen Geweben an wie Euter, Uterus, Lunge, Haut, Schleimhäute. Tylosin ist

basisch, deshalb erfolgt eine Konzentration besonders auch in Makrophagen und in

entzündeten Geweben:

Die Serumwerte erreichen bei parenteraler oder oraler Verabreichung nach 1 bis

5 Stunden ihr Maximum, anschliessend fallen sie rasch ab. Hingegen können

therapeutische Gewebespiegel während bis zu 24 Stunden gemessen werden. Tylosin

wird wenig metabolisiert, vier verschiedene Metaboliten sind bekannt. Beim Schwein wird

Tylosin hauptsächlich im Kot ausgeschieden.

Indikationen

Infektionen mit Mykoplasmen und grampositiven Erregern bei Rindern, Kälbern und

Schweinen.

Die Injektionslösung ist intramuskulär oder bei Rindern auch langsam i.v. zu applizieren.

Rinder, Kälber, Schweine, Läufer, Ferkel:

0,5 ml Pharmasin 200 pro 10 kg Körpergewicht und Tag (= 10 mg Tylosin pro kg bzw.

5 ml/100 kg KGW).

Mastitis bei laktierenden Kühen:

Je eine Injektion mit der obenstehenden Dosierung an 3 aufeinanderfolgenden Tagen.

Hinweise:

Die Stopfen der Durchstechflasche sollten nicht mehr als 15-mal durchstochen werden,

gegebenenfalls ist ein geeigneter Adapter zur Mehrfachentnahme einzusetzen.

Um Unter- und Überdosierungen zu vermeiden, sollen Körpergewicht und Dosis vor

Behandlungsbeginn möglichst genau bestimmt werden.

Anwendungseinschränkungen

Kontraindikationen

-Überempfindlichkeit gegenüber Bestandteilen des Präparates oder anderen Makroliden.

-Nicht bei Pferden anwenden.

-Die intramuskuläre Injektion kann bei Küken und Truthähnen zum Tode führen.

Vorsichtsmassnahmen

-Überdosierungen beim neugeborenen Ferkel können zu Schockreaktionen führen.

-Bei wiederholten Injektionen ist die Injektionsstelle zu wechseln.

Die Anwendung des Tierarzneimittels sollte unter Berücksichtigung eines Antibiogramms

und entsprechend den offiziellen und örtlichen Regelungen zum Einsatz von Antibiotika

erfolgen.

Unerwünschte Wirkungen

VetVigilance: Pharmacovigilance-Meldung erstatten

Nach der Injektion können Verfärbungen an der Injektionsstelle auftreten und bis zu

21 Tage nach Administration persistieren.

Als mögliche unerwünschte Wirkungen wurden sehr selten beobachtet:

Schwellung/Entzündung der Injektionsstelle, Schwellung der Vulva bei Rindern. Ödem der

rektalen Schleimhaut mit leichtem Vorfall des Enddarms, Diarrhoe, Erythem und Pruritus

bei Schweinen. Anaphylaktischer Schock und Tod.

Milch:3 Tage

Essbares Gewebe:

Rinder, Kälber:

7 Tage

Schweine:

3 Tage

Injektionsstelle:

21 Tage

Wechselwirkungen

Keine bekannt.

Sonstige Hinweise

Besondere Vorsichtsmassnahmen für den Anwender

-Bei versehentlicher Selbstinjektion ist unverzüglich ein Arzt zu Rate zu ziehen.

Im Fall einer Hautexposition waschen Sie das betroffene Hautareal sofort nach dem

Kontakt mit Wasser und Seife ab.

Im Fall einer Augenexposition spülen Sie die Augen sofort mit reichlich frischem Wasser

aus.

Tylosin kann Irritationen verursachen. Makrolide, wie auch Tylosin, können

Überempfindlichkeitsreaktionen (Allergie) als Folge von Injektion, Inhalation, Ingestion

oder Haut- bzw. Augenkontakt auslösen. Überempfindlichkeitsreaktionen auf Tylosin

können zu Kreuzreaktionen mit anderen Makroliden führen und umgekehrt. Gelegentlich

können allergische Reaktionen gegenüber diesen Substanzen schwerwiegend sein. Ein

Anschwellen des Gesichts, der Lippen und der Augenlieder oder Atemschwierigkeiten

gelten als schwerwiegendere Symptome und erfordern dringend ärztliche Hilfe.

-Personen mit bekannter Überempfindlichkeit gegenüber einem der Inhaltsstoffe sollten

den Kontakt mit dem Tierarzneimittel vermeiden oder das Tierarzneimittel vorsichtig

anwenden.

Inkompatibilitäten

Nicht mit anderen Tierarzneimitteln mischen.

Haltbarkeit

Bei Raumtemperatur (15 - 25°C) lagern. In der Originalpackung lagern, um den Inhalt vor

Licht zu schützen.

Das Präparat darf nur bis zu dem auf dem Behälter mit 'EXP' bezeichneten Datum

verwendet werden.

Aufbrauchfrist nach erster Entnahme: 28 Tage.

Arzneimittel für Kinder unerreichbar aufbewahren.

Packungen

Durchstechflaschen zu 50 und 100 ml.

Abgabekategorie: A

Swissmedic Nr. 63'217

Informationsstand: 02/2014

Dieser Text ist behördlich genehmigt.

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Setting of an import tolerance for spiromesifen in coffee beans

Setting of an import tolerance for spiromesifen in coffee beans

Published on: Mon, 14 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience submitted a request to the competent national authority in Greece to set an import tolerance for the active substance spiromesifen in coffee beans. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for coffee beans. Adequate analytical methods for enforcement are available to control the residues of spiromesife...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Assessment of genetically modified soybean A2704‐12 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐009)

Assessment of genetically modified soybean A2704‐12 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐009)

Published on: Mon, 14 Jan 2019 Following the submission of application EFSA‐GMO‐RX‐009 under Regulation (EC) No 1829/2003 from Bayer CropScience N.V., the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified soybean A2704‐12, for food and feed uses, import and processing, excluding cultivation within th...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Review of the existing maximum residue levels for fluometuron according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for fluometuron according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 14 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluometuron. To assess the occurrence of fluometuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Published on: Fri, 11 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of organic form of selenium produced by Saccharomyces cerevisiae NCYC R397 (Alkosel®) for all animal species. The FEEDAP Panel has delivered two opinions (on 2007 and 2016) on the safety and efficacy of the additive. The additive is characterised as organic selenium mainly selenomethionine (63%); it was ini...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Assessment of the application for renewal of authorisation of Lantharenol® (lanthanum carbonate octahydrate) for cats

Assessment of the application for renewal of authorisation of Lantharenol® (lanthanum carbonate octahydrate) for cats

Published on: Fri, 11 Jan 2019 Lantharenol® is a feed additive consisting of lanthanum carbonate octahydrate. It is currently authorised as a zootechnical additive (decrease in phosphorous excretion via urine) for cats; this opinion concerns the renewal of the authorisation. In 2007, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of Lantharenol® as a feed additive for cats. The applicant has provided data demonstrating th...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

Review of the existing maximum residue levels for sedaxane according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for sedaxane according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sedaxane. To assess the occurrence of sedaxane residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

Review of the existing maximum residue levels for triazoxide according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for triazoxide according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance triazoxide. To assess the occurrence of triazoxide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member States. Bas...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

Review of the existing maximum residue levels for chromafenozide according to Article 12 Regulation (EC) No 396/2005

Review of the existing maximum residue levels for chromafenozide according to Article 12 Regulation (EC) No 396/2005

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance chromafenozide. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for chromafenozide within the EU. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue limits) for this active subst...

Europe - EFSA - European Food Safety Authority EFSA Journal

4-1-2019

Modification of the existing maximum residue levels for lambda‐cyhalothrin in celeries, fennel and rice

Modification of the existing maximum residue levels for lambda‐cyhalothrin in celeries, fennel and rice

Published on: Thu, 03 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Greece to modify the existing maximum residue levels (MRLs) for lambda‐cyhalothrin in celeries, fennel and rice. The data submitted in support of the request were found to be sufficient to derive tentative MRL proposals for the concerned crops. They are tentative as formally the general data gap identified in the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-2-2019


Orphan designation: Ciprofloxacin (inhalation use), Treatment of cystic fibrosis, 03/08/2007, Withdrawn

Orphan designation: Ciprofloxacin (inhalation use), Treatment of cystic fibrosis, 03/08/2007, Withdrawn

Orphan designation: Ciprofloxacin (inhalation use), Treatment of cystic fibrosis, 03/08/2007, Withdrawn

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: Rilonacept, Treatment of cryopirin-associated periodic syndromes, 10/07/2007, Withdrawn

Orphan designation: Rilonacept, Treatment of cryopirin-associated periodic syndromes, 10/07/2007, Withdrawn

Orphan designation: Rilonacept, Treatment of cryopirin-associated periodic syndromes, 10/07/2007, Withdrawn

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: Amphotericin B (for inhalation use), Prevention of pulmonary fungal infection in patients deemed at risk, 28/08/2006, Withdrawn

Orphan designation: Amphotericin B (for inhalation use), Prevention of pulmonary fungal infection in patients deemed at risk, 28/08/2006, Withdrawn

Orphan designation: Amphotericin B (for inhalation use), Prevention of pulmonary fungal infection in patients deemed at risk, 28/08/2006, Withdrawn

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: Becatecarin, Treatment of cancers of the biliary tree, 25/07/2006, Withdrawn

Orphan designation: Becatecarin, Treatment of cancers of the biliary tree, 25/07/2006, Withdrawn

Orphan designation: Becatecarin, Treatment of cancers of the biliary tree, 25/07/2006, Withdrawn

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: Iodine (131I) chlorotoxin, Treatment of glioma, 22/10/2007, Withdrawn

Orphan designation: Iodine (131I) chlorotoxin, Treatment of glioma, 22/10/2007, Withdrawn

Orphan designation: Iodine (131I) chlorotoxin, Treatment of glioma, 22/10/2007, Withdrawn

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: Isofagomine tartrate, Treatment of Gaucher disease, 23/10/2007, Withdrawn

Orphan designation: Isofagomine tartrate, Treatment of Gaucher disease, 23/10/2007, Withdrawn

Orphan designation: Isofagomine tartrate, Treatment of Gaucher disease, 23/10/2007, Withdrawn

Europe - EMA - European Medicines Agency

20-2-2019


Orphan designation: Histamine dihydrochloride, Treatment of acute myeloid leukaemia, 11/04/2005, Expired

Orphan designation: Histamine dihydrochloride, Treatment of acute myeloid leukaemia, 11/04/2005, Expired

Orphan designation: Histamine dihydrochloride, Treatment of acute myeloid leukaemia, 11/04/2005, Expired

Europe - EMA - European Medicines Agency

20-2-2019


Orphan designation: miglustat, Treatment of Niemann-Pick disease, type C, 16/02/2006, Expired

Orphan designation: miglustat, Treatment of Niemann-Pick disease, type C, 16/02/2006, Expired

Orphan designation: miglustat, Treatment of Niemann-Pick disease, type C, 16/02/2006, Expired

Europe - EMA - European Medicines Agency

20-2-2019


Orphan designation: azacitidine, Treatment of myelodysplastic syndromes, 06/02/2002, Expired

Orphan designation: azacitidine, Treatment of myelodysplastic syndromes, 06/02/2002, Expired

Orphan designation: azacitidine, Treatment of myelodysplastic syndromes, 06/02/2002, Expired

Europe - EMA - European Medicines Agency

20-2-2019


Orphan designation: azacitidine, Treatment of acute myeloid leukaemia, 29/11/2007, Expired

Orphan designation: azacitidine, Treatment of acute myeloid leukaemia, 29/11/2007, Expired

Orphan designation: azacitidine, Treatment of acute myeloid leukaemia, 29/11/2007, Expired

Europe - EMA - European Medicines Agency

20-2-2019


Orphan designation: Rufinamide, Treatment of Lennox-Gastaut syndrome, 20/10/2004, Expired

Orphan designation: Rufinamide, Treatment of Lennox-Gastaut syndrome, 20/10/2004, Expired

Orphan designation: Rufinamide, Treatment of Lennox-Gastaut syndrome, 20/10/2004, Expired

Europe - EMA - European Medicines Agency

20-2-2019


Orphan designation: Recombinant megakaryopoiesis-stimulating protein, Treatment of idiopathic thrombocytopenic purpura, 27/05/2005, Expired

Orphan designation: Recombinant megakaryopoiesis-stimulating protein, Treatment of idiopathic thrombocytopenic purpura, 27/05/2005, Expired

Orphan designation: Recombinant megakaryopoiesis-stimulating protein, Treatment of idiopathic thrombocytopenic purpura, 27/05/2005, Expired

Europe - EMA - European Medicines Agency

11-2-2019

Rocornal® 200 mg Kapseln

Rote - Liste

7-2-2019

Equisolon (Le Vet B.V.)

Equisolon (Le Vet B.V.)

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

31-1-2019

Ketoconazole HRA® 200 mg Tabletten

Rote - Liste

25-1-2019


Orphan designation: Glucagon, Treatment of congenital hyperinsulinism, 08/10/2009, Positive

Orphan designation: Glucagon, Treatment of congenital hyperinsulinism, 08/10/2009, Positive

Orphan designation: Glucagon, Treatment of congenital hyperinsulinism, 08/10/2009, Positive

Europe - EMA - European Medicines Agency

25-1-2019


Orphan designation: Mannitolum, Treatment of cystic fibrosis, 07/11/2005, Positive

Orphan designation: Mannitolum, Treatment of cystic fibrosis, 07/11/2005, Positive

Orphan designation: Mannitolum, Treatment of cystic fibrosis, 07/11/2005, Positive

Europe - EMA - European Medicines Agency

25-1-2019

ISOZID® 200 mg

Rote - Liste

10-1-2019

Mifegyne 200 mg Tabletten

Rote - Liste