Otomax Ear Drops Suspension

Hauptinformation

  • Handelsname:
  • Otomax Ear Drops Suspension Ohrentropfen Suspension
  • Darreichungsform:
  • Ohrentropfen Suspension
  • 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:
  • Otomax Ear Drops Suspension Ohrentropfen Suspension
    Belgien
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Otologicals, Kombination von Kortikosteroiden und Antiinfektiva

Weitere Informationen

Status

  • Quelle:
  • AFMPS - Agence Fédérale des Médicaments et des Produits de Santé - Belgium
  • Zulassungsnummer:
  • BE-V206631
  • Letzte Änderung:
  • 17-04-2018

Packungsbeilage

Bijsluiter – DE versie

Otomax Ear Drops Suspension

GEBRAUCHSINFORMATION

Otomax Ear Drops Suspension

1.

NAME UND ANSCHRIFT DES ZULASSUNGSINHABERS UND, WENN

UNTERSCHIEDLICH, DES HERSTELLERS, DER FÜR DIE

CHARGENFREIGABE VERANTWORTLICH IST

Zulassungsinhaber:

Für die Chargenfreigabe verantwortlicher Hersteller:

Schering-Plough Santé Animale

Z.A. La Grindolière

49503 Segré

Frankreich

2.

BEZEICHNUNG DES TIERARZNEIMITTELS

Otomax Ear Drops Suspension

3.

WIRKSTOFFE UND SONSTIGE BESTANDTEILE

1 ml Ohrentropfen enthält 2640 I.E. Gentamicinbase (als Gentamicinsulfat), 0,88 mg

Betamethason (als Betamethasonvalerat) und 8,80 mg Clotrimazol. Das Tierarzneimittel ist

eine weiche, homogene, weiße bis weißliche visköse Suspension.

4.

ANWENDUNGSGEBIETE

Beim Hund:

Zur Behandlung der akuten Otitis externa.

Ebenso zur Behandlung von kurzfristiger Verschlimmerung der akuten Anzeichen einer

chronischen Otitis externa, verursacht durch Gentamicin-empfindliche Keime wie

Staphylococcus intermedius und Clotrimazol-empfindliche Hefen, insbesondere Malassezia

pachydermatis.

5.

GEGENANZEIGEN

Otomax ear Drops Suspension sollten unter folgenden Umständen nicht angewandt

werden:

Nicht bei Hunden mit bekannter Perforation des Trommelfells anwenden.

Nicht bei tragenden und laktierenden Hündinnen anwenden.

Nicht anwenden bei bekannter Überempfindlichkeit gegen einen Bestandteil des Produktes.

Nicht gleichzeitig mit anderen bekannterweise ototoxischen Medikamenten verabreichen.

6.

NEBENWIRKUNGEN

Es können lokale Erytheme auftreten, die sich jedoch unmittelbar nach Abbruch der

Behandlung zurückbilden.

Es wurden temporäre Hörverluste und in sehr seltenen Fällen irreversible Taubheiten,

insbesondere bei älteren Hunden, beobachtet.

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Niederlande

Vertreten durch:

MSD Animal Health BVBA

Lynx Binnenhof 5

1200 Brussel

Bijsluiter – DE versie

Otomax Ear Drops Suspension

Im Falle von vestibulären oder Hörstörungen sollte die Behandlung sofort abgebrochen und

der Gehörgang vorsichtig mit einer nicht-ototoxischen Lösung gespült werden.

Durch verlängerte und extensive lokale Anwendung von Kortikosteroidpräparaten können

lokale und systemische Nebenwirkungen auftreten, wie zum Beispiel Suppression der

Nebennierenfunktion, Hautverdünnung und verzögerte Wundheilung.

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

Packungsbeilage aufgeführt ist, teilen Sie diese Ihrem Tierarzt mit.

7.

ZIELTIERARTEN

Hunde.

8.

DOSIERUNG FÜR JEDE TIERART, ART UND DAUER DER ANWENDUNG

Nur zur Anwendung am Ohr.

Vor Gebrauch gut schütteln.

Bei weniger als 15 kg schweren Hunden: 4 Tropfen zweimal täglich in den Gehörgang

einträufeln.

Bei Hunden mit einem Gewicht von über 15 kg: 8 Tropfen zweimal täglich in den Gehörgang

einträufeln.

Die Therapiedauer beträgt 7 aufeinanderfolgende Tage.

Nach Applikation kann den Ohrgrund kurz und sanft massiert werden um eine Verteilung des

Präparates im unteren Teil des Gehörgangs sicherzustellen.

Ein Tropfen des Tierarzneimittels enthält 66,9 I.E. Gentamicin, 22,3

g Betamethason und

g Clotrimazol.

9.

HINWEISE FÜR DIE RICHTIGE ANWENDUNG

Vor jedem gebrauch gut schütteln.

10.

WARTEZEIT

Nicht zutreffend.

11.

BESONDERE LAGERUNGSHINWEISE

Arzneimittel außer Reich- und Sichtweite von Kindern aufbewahren.

Nicht über 25° C lagern.

Haltbarkeit nach dem ersten Öffnen des Behältnisses: 14 Tage.

Das Arzneimittel nach Ablauf des auf Behältnis und äußerer Umhüllung angegebenen

Verfalldatums nicht mehr verwenden (EXP: zu verwenden bis MM/JJ).

Nach dem erstmaligen Öffnen sollte unter Berücksichtigung der hier angegebenen Dauer der

Haltbarkeit nach Anbruch das Datum berechnet werden, an dem alle verbleibenden Reste des

Tierarzneimittels zu verwerfen sind. Dieses Datum sollte auf dem vorgesehenen Platz auf dem

Etikett eingetragen werden.

Bijsluiter – DE versie

Otomax Ear Drops Suspension

12.

BESONDERE WARNHINWEISE

Besondere Vorsichtsmaßnahmen für die Anwendung bei Tieren:

Augenkontakt vermeiden. Bei versehentlichem Kontakt Augen gründlich mit Wasser

ausspülen.

Vor Anwendung jeglicher Medikation im Ohr sollte zur Vergewisserung, dass das Trommelfell

nicht perforiert ist, der externe Gehörgang gründlich untersucht werden, um die Möglichkeit

sowohl einer Verschleppung der Infektion in das Mittelohr als auch einer Beschädigung der

Kochlea oder des Vestibularapparates durch längeren Kontakt auszuschließen.

Vor der Behandlung sollte das äußere Ohr gründlich gereinigt und abgetrocknet werden.

Übermäßige Behaarung im Behandlungsareal sollte entfernt werden.

Die bakterielle und die mykotische Otitis treten häufig als Sekundärerkrankungen auf. Daher

sollte die zugrunde liegende Ursache festgestellt und behandelt werden.

Der Einsatz des Produktes sollte nach einer Empfindlichkeitsprüfung an isolierten Bakterien

und/oder anderen geeigneten diagnostischen Tests erfolgen. Sollte dies nicht möglich sein, ist

die Therapie auf die Kenntnis der lokalen (regional, auf Bestandsebene) epidemiologischen

Informationen zur Empfindlichkeit der Zielkeime zu stützen.

Der Einsatz des Produktes unter Abweichung von den in der SPC gegebenen Anweisungen

kann die Häufigkeit gegen Gentamicin resistenter Bakterienpopulationen erhöhen und kann

die Wirksamkeit einer Behandlung mit anderen Aminoglykosiden wegen möglicher

Kreuzresistenzen verringern.

Eine intensive und lang andauernde topische Anwendung von kortikosteroidhaltigen

Präparaten kann sowohl lokale als auch systemische Wirkungen wie eine Hemmung der

Nebennierenfunktion, eine Verdünnung der Epidermis sowie eine Verlangsamung des

Heilungsprozesses hervorrufen.

Nicht bei tragenden und laktierenden Hündinnen anwenden.

Nicht gleichzeitig mit anderen bekannterweise ototoxischen Medikamenten verabreichen.

Besondere Vorsichtsmaßnahmen für den Anwender:

Kontakt mit dem Produkt vermeiden.

Nach der Anwendung Hände gründlich waschen. Im Falle eines versehentlichen

Augenkontaktes Augen gründlich mit Wasser ausspülen.

Bei bekannter Überempfindlichkeit gegen einen Bestandteil Kontakt mit dem Produkt

vermeiden.

13.

BESONDERE VORSICHTSMASSNAHMEN FÜR DIE ENTSORGUNG VON

NICHT VERWENDETEM ARZNEIMITTEL ODER VON

ABFALLMATERIALIEN, SOFERN ERFORDERLICH

Nicht verwendete Tierarzneimittel oder davon stammende Abfallmaterialien sind

entsprechend den nationalen Vorschriften zu entsorgen.

14.

GENEHMIGUNGSDATUM DER PACKUNGSBEILAGE

Bijsluiter – DE versie

Otomax Ear Drops Suspension

November 2014

15.

WEITERE ANGABEN

Dieses Tierarzneimittel ist in 14 ml und 34 ml Polyethylenflaschen hoher Dichte (HDPE) mit

Polyethylenverschlusskappe niedriger Dichte (LDPE) und LDPE –Applikator /

Verschlusskappe oder in 8,5 ml und 17 ml Aluminiumtuben mit weißem Schraubverschluss

(HDPE) und Applikator/Verschlusskappe (LDPE) erhältlich.

Die folgenden Packungsgrößen sind verfügbar, jedoch werden möglicherweise nicht alle

Packungsgrößen vermarktet:

Schachtel mit 1 Tube zu 8,5 ml

Schachtel mit 1 Tube zu 17 ml

Schachtel mit 1 Flasche zu 14 ml

Schachtel mit 1 Flasche zu 34 ml

Schachtel mit 6 Tuben zu 8,5 ml

Schachtel mit 6 Tuben zu 17 ml

Schachtel mit 12 Tuben zu 8,5 ml

Schachtel mit 12 Tuben zu 17 ml

Möglicherweise befinden sich nicht alle Packungsgrößen im Handel.

Gentamicinsulfat ist ein Aminoglykosid-Antibiotikum, das über eine Hemmung der

Proteinsynthese bakterizid wirkt. Das Spektrum umfasst gram-positiver und gram-

negativer Bakterien wirksam, insbesondere gegen folgende aus Hundeohren isolierte

pathogene Organismen: Staphylococcus intermedius, Koagulase-positive

Staphylococcus spp. und Proteus mirabilis.

Betamethasonvalerat, ein synthetisches Dexamethason-Analogon-Kortikosteroid, hat in

der lokalen Behandlung der Otitis externa Entzündungs- und Juckreiz-hemmende

Wirkung. Es besitzt geringe mineralokortikosteroide Aktivität. Lokal angewendetes

Betamethasonvalerat wird von der Haut absorbiert. Entzündung kann die perkutane

Absorption erhöhen.

Clotrimazol ist ein Antimykotikum, das Zellmembranveränderungen verursacht,

wodurch es zu einem Verlust von intrazellulären Bestandteilen und daraufhin zu einem

Stillstand der molekularen Synthese kommt. Clotrimazol hat ein breites Wirkspektrum

und wird zur Behandlung von Hautinfektionen, hervorgerufen durch verschiedene

Spezies pathogener Dermatophyten und Hefen, eingesetzt; insbesondere gegen

Malassezia pachydermatis.

Nur für Tiere.

Zulassungsnummern: BE-V206622 (Tube) - BE-V206631 (Flasche)

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UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industr...

FDA - U.S. Food and Drug Administration

18-8-2018

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probabl...

FDA - U.S. Food and Drug Administration

18-8-2018

Arzneimittelzulassungen unter Verwendung von Studien der Firma Semler Research Center (SRC) Private Ltd. in Indien: Ruhen der Zulassungen

Arzneimittelzulassungen unter Verwendung von Studien der Firma Semler Research Center (SRC) Private Ltd. in Indien: Ruhen der Zulassungen

Das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) hat mit Bescheid vom 08.08.2016 vorläufig das Ruhen verschiedener generischer Arzneimittelzulassungen angeordnet.

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

16-8-2018

Boviseal ad us. vet., Suspension in Injektoren

Boviseal ad us. vet., Suspension in Injektoren

● Die Zulassung ist am 16.08.2018 erloschen.

Institut für Veterinärpharmakologie und toxikologie

14-8-2018

Calikids Inc. recalls children's jackets with waist drawstrings

Calikids Inc. recalls children's jackets with waist drawstrings

Drawstrings on children’s outerwear can become entangled or caught on playground slides, hand rails, school bus doors or other moving objects, posing a significant entanglement hazard to children.

Health Canada

6-11-2018

Wellvone Suspension

Rote - Liste

30-10-2018

Prevenar 13® Injektionssuspension

Rote - Liste

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

22-10-2018

IXIARO® Injektionssuspension

Rote - Liste

21-10-2018

Whether it’s funding scientific research, examining policy approaches to vexing safety issues, or launching public education campaigns, you can be assured that this is a top commitment for us, and #FDA is fully engaged in promoting and protecting the heal

Whether it’s funding scientific research, examining policy approaches to vexing safety issues, or launching public education campaigns, you can be assured that this is a top commitment for us, and #FDA is fully engaged in promoting and protecting the heal

Whether it’s funding scientific research, examining policy approaches to vexing safety issues, or launching public education campaigns, you can be assured that this is a top commitment for us, and #FDA is fully engaged in promoting and protecting the health of the nation’s women pic.twitter.com/euQki9iqsL

FDA - U.S. Food and Drug Administration

10-10-2018

Diversity in research means more treatments work for more people. Join #ResearchDiversity Day on October 23rd for a day-long discussion of diversity in study recruitment and research. Join us! @Alzheimers_NIHpic.twitter.com/AwYhetCBiw

Diversity in research means more treatments work for more people. Join #ResearchDiversity Day on October 23rd for a day-long discussion of diversity in study recruitment and research. Join us! @Alzheimers_NIHpic.twitter.com/AwYhetCBiw

Diversity in research means more treatments work for more people. Join #ResearchDiversity Day on October 23rd for a day-long discussion of diversity in study recruitment and research. Join us! @Alzheimers_NIH pic.twitter.com/AwYhetCBiw

FDA - U.S. Food and Drug Administration

10-10-2018

As Hurricane #Michael nears land, take shelter & stay safe.

Follow weather updates on your phone or radio.

 In a tornado WARNING, go to an interior, windowless room.

 If water comes in, go to the highest floor that’s not flooded but do NOT enter a clos

As Hurricane #Michael nears land, take shelter & stay safe. Follow weather updates on your phone or radio. In a tornado WARNING, go to an interior, windowless room. If water comes in, go to the highest floor that’s not flooded but do NOT enter a clos

As Hurricane #Michael nears land, take shelter & stay safe. Follow weather updates on your phone or radio. In a tornado WARNING, go to an interior, windowless room. If water comes in, go to the highest floor that’s not flooded but do NOT enter a closed attic. pic.twitter.com/KD5WZ7gamP

FDA - U.S. Food and Drug Administration

18-9-2018

 Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

This third meeting between regulators and representatives of industry stakeholder organisations addresses all areas of product-development support, including scientific advice, specifics for paediatric and orphan medicines and support for innovation. The meeting focuses on the implementation of the orphan notice, ‘histology-independent indications’ in the context of orphan designations, the upcoming rollout of a new tool for orphan designation applications, digital technology proposals in medicine develo...

Europe - EMA - European Medicines Agency

17-9-2018

Scientific guideline:  Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates....

Europe - EMA - European Medicines Agency

17-9-2018

Ampho-Moronal® Suspension

Rote - Liste

7-9-2018

 European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency, London, UK, From: 08-Jun-2018, To: 08-Jun-2018

European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency, London, UK, From: 08-Jun-2018, To: 08-Jun-2018

The 2018 face-to-face meeting of Enpr-EMA networks and coordinating members takes place after the annual open workshop on 8 June. The networks meeting will focus on the outcome of the 2018 annual workshop of the 7 June and the action plan for 2018/2019.

Europe - EMA - European Medicines Agency

7-9-2018

 2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

Enpr-EMA will hold its tenth annual workshop on 7-8 June 2018 at EMA. The workshop brings relevant stakeholders together to discuss requirements, barriers and opportunities for the conduct of high-quality clinical studies in children. The overall theme of this year’s workshop will be a ‘holistic approach to paediatric research’. Highlights of this year’s workshop include: i) short perspectives of the various stakeholders involved in paediatric research (patient/young people advisory groups, research netw...

Europe - EMA - European Medicines Agency

28-8-2018

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Active substance: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt) - Orphan designation - Commission Decision (2018)5729 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/18

Europe -DG Health and Food Safety

7-8-2018

Research: Software as a Medical Device and Cyber Security for Medical Devices

Research: Software as a Medical Device and Cyber Security for Medical Devices

Opportunity to participate in CSIRO research to inform new Australian medical device industry guidance

Therapeutic Goods Administration - Australia