Suvaxyn MH-One

Hauptinformation

  • Handelsname:
  • Suvaxyn MH-One Emulsion zur Injection
  • Darreichungsform:
  • Emulsion zur Injection
  • 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:
  • Suvaxyn MH-One Emulsion zur Injection
    Belgien
  • Sprache:
  • Deutsch

Weitere Informationen

Status

  • Quelle:
  • AFMPS - Agence Fédérale des Médicaments et des Produits de Santé - Belgium
  • Zulassungsnummer:
  • BE-V325656
  • Letzte Änderung:
  • 17-04-2018

Packungsbeilage

Notice – Version DE

SUVAXYN MH-ONE

GEBRAUCHSINFORMATION

Suvaxyn MH-One

Emulsion zur Injektion für Schweine

1.

NAME

UND

ANSCHRIFT

DES

ZULASSUNGSINHABERS

UND,

WENN

UNTERSCHIEDLICH, DES HERSTELLERS, DER FÜR DIE CHARGENFREIGABE

VERANTWORTLICH IST

Zulassungsinhaber

Zoetis Belgium SA

Rue Laid Burniat, 1

B-1348 Louvain-la-Neuve

Für die Chargenfreigabe verantwortlicher Hersteller:

Zoetis Manufacturing & Research Spain, S.L.

Ctra. Camprodón s/n "la Riba"

17813 Vall de Bianya (Girona)

Spanien

2.

BEZEICHNUNG DES TIERARZNEIMITTELS

Suvaxyn MH-One

Emulsion zur Injektion für Schweine

3.

WIRKSTOFF(E) UND SONSTIGE BESTANDTEILE

Qualitative Zusammensetzung

Quantitative Zusammensetzung

pro Dosis (2,0 ml)

Wirkstoff

Mycoplasma hyopneumoniae,

inaktiviert, Stamm P-5722-3

RP* (unverdünnt)

≥ 1,00

Adjuvan(tien)s

Carbopol # 941

4,00 mg

Squalan**

3,24 mg

Sonstige Bestandteile

Thiomersal

0,20 mg

*Relative Potency-Einheit, die mittels ELISA-Antigenquantifizierung (in vitro Potency-Test) durch

Vergleich mit einem Referenzimpfstoff bestimmt wird.

** Bestandteil von MetaStim

(das auch Pluronic L-121 und Polysorbat 80 enthält)

4.

ANWENDUNGSGEBIET(E)

Zur aktiven Immunisierung von Schweinen ab einem Mindestalter von 7 Tagen, um Lungenläsionen,

die durch Mycoplasma hyopneumoniae verursacht werden, zu reduzieren.

Beginn der Immunität: 2 Wochen nach Impfung.

Dauer der Immunität: 6 Monate.

5.

GEGENANZEIGEN

Nicht bei trächtigen oder laktierenden Tieren anwenden.

Notice – Version DE

SUVAXYN MH-ONE

6.

NEBENWIRKUNGEN*

Systemische Nebenwirkungen, wie Erhöhung der Körpertemperatur (bis zu 1,9° C), Depression,

Zittern und Erregbarkeit treten sehr häufig bis zu 4 Stunden nach der Impfung auf. Diese Reaktionen

klingen spontan innerhalb von 24 Stunden ohne Behandlung ab. Gelegentlich treten anaphylaktische

und neurologische Reaktionen auf.

Sehr häufig werden lokale Gewebereaktionen in Form von palpablen (aber nicht sichtbaren)

Schwellungen an der Injektionsstelle bis zu 2 Tage nach Impfung beobachtet. Der Durchmesser dieser

lokalen Gewebereaktion kann bis zu 0,3 cm betragen.

* Die Angaben zur Häufigkeit von Nebenwirkungen sind folgendermaßen definiert:

- Sehr häufig (mehr als 1 von 10 behandelten Tieren zeigen Nebenwirkungen während der

Behandlung)

- Häufig (mehr als 1 aber weniger als 10 von 100 behandelten Tieren)

- Gelegentlich (mehr als 1 aber weniger als 10 von 1000 behandelten Tieren)

- Selten (mehr als 1 aber weniger als 10 von 10.000 behandelten Tieren)

- Sehr selten (weniger als 1 von 10.000 behandelten Tieren, einschließlich Einzelfallberichte).

Falls Sie Nebenwirkungen (insbesondere solche, die nicht in der Packungsbeilage aufgeführt sind) bei

geimpften Tieren feststellen, teilen Sie diese Ihrem Tierarzt mit.

7.

ZIELTIERART(EN)

Schweine ab einem Mindestalter von 7 Tagen.

8.

DOSIERUNG FÜR JEDE TIERART, ART UND DAUER DER ANWENDUNG

Eine Dosis (2,0 ml) pro Tier sollte bei Schweinen ab einem Alter von 7 Lebenstagen intramuskulär in

den Nacken verabreicht werden.

9.

HINWEISE FÜR DIE RICHTIGE ANWENDUNG

Der Impfstoff sollte vor Gebrauch und zeitweilig während des Impfvorganges gut geschüttelt werden.

Entsprechend der guten Anwendungspraxis sollte der Impfstoff vor der Verabreichung in der Hand

oder in der Hosentasche auf Körpertemperatur angewärmt werden, um mögliche Abwehrreaktionen

bei der Injektion einer kalten Flüssigkeit zu vermeiden.

10.

WARTEZEIT

Null Tage.

11.

BESONDERE LAGERUNGSHINWEISE

Arzneimittel unzugänglich für Kinder aufbewahren.

Kühl lagern und transportieren (2°C – 8°C).

Vor Licht schützen.

Nicht einfrieren.

Sie dürfen das Arzneimittel nach dem auf dem Etikett und dem Karton angegebenen Verfalldatum

nicht mehr anwenden.

Haltbarkeit nach dem ersten Öffnen des Behältnisses: sofort verbrauchen.

12.

BESONDERE WARNHINWEISE

Besondere Vorsichtsmaßnahmen für die Anwendung bei Tieren

Notice – Version DE

SUVAXYN MH-ONE

Nur gesunde Tiere impfen.

Um den Impfzeitpunkt herum sollte Stress bei den Tieren vermieden werden.

Es liegen keine Informationen zur Unschädlichkeit und Wirksamkeit des Impfstoffes bei gleichzeitiger

Anwendung eines anderen veterinärmedizinischen Produktes vor. Ob der Impfstoff vor oder nach

Verabreichung eines anderen veterinärmedizinischen Produktes verwendet werden sollte, muss daher

fallweise entschieden werden.

Nicht mit anderen Tierarzneimitteln mischen.

Nach Verabreichung einer 2-fachen Maximaldosis bei Schweinen ab einem Alter von 3 Wochen gemäß

der empfohlenen Art der Anwendung werden keine anderen Symptome beobachtet als unter

"Nebenwirkungen“ aufgeführt. Allerdings können die Symptome länger andauern (Erhöhung der

Körpertemperatur bis zu 2 Tagen und lokale Gewebereaktionen bis zu 3 Tagen) und der Durchmesser

der Lokalreaktion kann 1,0 cm erreichen. Verabreichung einer Überdosierung des Impfstoffes bei

Ferkeln im Alter von 1 Woche wurde nicht untersucht.

Besondere Vorsichtsmaßnahmen für den Anwender

Dieses Produkt enthält tierisches Öl. Bei versehentlicher Selbstinjektion ist unverzüglich ein Arzt zu

Rate zu ziehen und die Packungsbeilage oder das Etikett vorzuzeigen.

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

05/2017

15.

WEITERE ANGABEN

ATC Vet-Code: Q109AB13

Inaktivierte bakterielle Impfstoffe - Schweine

Es werden möglicherweise nicht alle Packungsgrößen in Verkehr gebracht.

Falls weitere Informationen über das Arzneimittel gewünscht werden, setzen Sie sich bitte mit dem

örtlichen Vertreter des Zulassungsinhabers in Verbindung.

Verschreibungspflichtig.

BE-V325656

11-5-2018

One's Better Living recalls Q Sweety Owl Plush Toys

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8-5-2018

What to Know When Buying or Using a Breast Pump

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FDA - U.S. Food and Drug Administration

27-4-2018

Octane Fitness LLC, recalls Octane Fitness XT-One Elliptical Cross Trainer

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Health Canada

24-4-2018

One lot of Traditional Medicinals "Throat Coat Lemon Echinacea" herbal tea recalled because of potential contamination with Salmonella

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Health Canada

21-4-2018

OC Raw Dog, LLC RECALLS one lot of Chicken, Fish & Produce BECAUSE OF POSSIBLE HEALTH RISK

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FDA - U.S. Food and Drug Administration

17-4-2018

Statement by Dr. Susan Mayne on FDA efforts to reduce consumer exposure to arsenic in rice

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FDA - U.S. Food and Drug Administration

16-4-2018

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FDA - U.S. Food and Drug Administration

6-4-2018

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Health Canada

5-4-2018

Global Commodities Corporation Recalls Buenas Grated Coconut due to Possible Health Risk

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21-3-2018

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FDA - U.S. Food and Drug Administration

21-3-2018

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Health Canada

20-3-2018

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FDA - U.S. Food and Drug Administration

16-3-2018

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FDA - U.S. Food and Drug Administration

14-3-2018

March 12, 2018: Champaign, Illinois, Resident Sentenced to One Year in Prison for Producing and Selling Over 80,000 Homemade Tramadol Capsules to Customers without Verifying Prescriptions

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FDA - U.S. Food and Drug Administration

8-3-2018

Chipped pills in additional packages of Alysena 21 and 28 birth control pills

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Health Canada

3-3-2018

Steve’s Real Food Voluntarily Recalls Raw Frozen Dog Food Turkey Canine Recipe Due to Possible <em>Salmonella</em> Contamination

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FDA - U.S. Food and Drug Administration

1-3-2018

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FDA - U.S. Food and Drug Administration

23-2-2018

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FDA - U.S. Food and Drug Administration

21-2-2018

Sugar in food

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France - Agence Nationale du Médicament Vétérinaire

16-5-2018

Apples, bananas, and peaches, oh my!

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FDA - U.S. Food and Drug Administration

4-5-2018

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2-5-2018

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US - DailyMed

26-4-2018

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26-4-2018

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FDA - U.S. Food and Drug Administration

25-4-2018

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23-4-2018

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US - DailyMed

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14-4-2018

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10-4-2018

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US - DailyMed

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US - DailyMed

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US - DailyMed

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Europe -DG Health and Food Safety

23-3-2018

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Europe - EMA - European Medicines Agency

20-3-2018

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FDA - U.S. Food and Drug Administration

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US - MedicineNet

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Updated Date: Mar 8, 2018 EST

US - DailyMed

2-3-2018

CARE ONE OMEPRAZOLE (Omeprazole) Tablet, Delayed Release [American Sales Company]

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Updated Date: Mar 2, 2018 EST

US - DailyMed

1-3-2018

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US - MedicineNet

28-2-2018

Drug That Kills Flu in One Day Approved In Japan

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US - MedicineNet

26-2-2018

EU/3/18/1974 (Takeda Pharma A/S)

EU/3/18/1974 (Takeda Pharma A/S)

EU/3/18/1974 (Active substance: 6-{[(1R,2S)-2-aminocyclohexyl]amino}-7-fluoro-4-(1-methyl-1H-pyrazol-4-yl)-1,2-dihydro-3H-pyrrolo[3,4-c]pyridin-3-one monocitrate) - Orphan designation - Commission Decision (2018)1257 of Mon, 26 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/193/17

Europe -DG Health and Food Safety

22-2-2018

Mark your calendars for #PatientEngagement in the National Evaluation System for Health Technology (NEST) one-day workshop sponsored by the UMD CERSI & FDA. Click the link for more info:  https://goo.gl/CqZF4k  #NEST #MedicalDevice #safety

Mark your calendars for #PatientEngagement in the National Evaluation System for Health Technology (NEST) one-day workshop sponsored by the UMD CERSI & FDA. Click the link for more info: https://goo.gl/CqZF4k  #NEST #MedicalDevice #safety

Mark your calendars for #PatientEngagement in the National Evaluation System for Health Technology (NEST) one-day workshop sponsored by the UMD CERSI & FDA. Click the link for more info: https://goo.gl/CqZF4k  #NEST #MedicalDevice #safety

FDA - U.S. Food and Drug Administration

21-2-2018

Lung Cancer One of Many Reasons Not to Smoke

Lung Cancer One of Many Reasons Not to Smoke

Title: Lung Cancer One of Many Reasons Not to SmokeCategory: Health NewsCreated: 2/18/2018 12:00:00 AMLast Editorial Review: 2/20/2018 12:00:00 AM

US - MedicineNet