Vitamine B Complex Kela

Hauptinformation

  • Handelsname:
  • Vitamine B Complex Kela 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:
  • Vitamine B Complex Kela Injektionslösung
    Belgien
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Vitamine

Weitere Informationen

Status

  • Quelle:
  • AFMPS - Agence Fédérale des Médicaments et des Produits de Santé - Belgium
  • Zulassungsnummer:
  • BE-V259384
  • Letzte Änderung:
  • 17-04-2018

Packungsbeilage

Bijsluiter – DE versie

VITAMINE B COMPLEX Kela

B. PACKUNGSBEILAGE

Bijsluiter – DE versie

VITAMINE B COMPLEX Kela

GEBRAUCHSINFORMATION

1.

NAME UND ANSCHRIFT DES ZULASSUNGSINHABERS UND, WENN

UNTERSCHIEDLICH, DES HERSTELLERS, DER FÜR DIE CHARGENFREIGABE

VERANTWORTLICH IST

KELA Laboratoria nv

Sint Lenaartseweg 48

2320 Hoogstraten

2.

BEZEICHNUNG DES TIERARZNEIMITTELS

VITAMINE B COMPLEX Kela

Einspritzbare Lösung zur intramuskulären Anwendung bei Schweinen

3.

WIRKSTOFFE UND SONSTIGE BESTANDTEILE

VITAMINE B Complex Kela enthält pro ml :

Thiamini hydrochloridum 10 mg (Vit. B

) - Riboflavini natrii phosphas 5,4 mg (Vit. B

) -

Nicotinamidum 25 mg (Vit. B

) - Dexpanthenolum 5 mg (Vit. B

) - Pyridoxini hydrochloridum 4 mg

(Vit. B

) - Cyanocobalaminum 10 μg (Vit. B

) - Methylis parahydroxybenzoas (E 218) - Excipiens

q.s.ad 1 ml.

4.

ANWENDUNGSGEBIETE

Behandlung von Vitamin-B-Mangelzuständen.

5.

GEGENANZEIGEN

Keine gekannt.

6.

NEBENWIRKUNGEN

Die Vitamine der B-Gruppe sind wenig toxisch. Bei der empfohlenen Dosierung sind Nebenwirkungen nicht

zu erwarten.

7.

ZIELTIERART

Schweine

8.

DOSIERUNG FÜR JEDE TIERART, ART UND DAUER DER ANWENDUNG

Einmalig intramuskulär einzuspritzen.

- Ferkel (bis 10 kg):

1 ml/5 kg K.g.

- Jungschweine (10-50 kg):

1 ml/10 kg K.g.

- Jungschweine (> 50 kg; einschließlich Jungsauen und Jungeber, säugende Sauen:

0.5 ml/10 kg K.g.

- Tragende Sauen, erwachsene Eber:

0.25 ml/10 kg

K.g.

9.

HINWEISE FÜR DIE RICHTIGE ANWENDUNG

Intramuskuläre Verabreichung

Bijsluiter – DE versie

VITAMINE B COMPLEX Kela

10.

WARTEZEIT

Fleisch und Abfälle : 0 Tage

11.

BESONDERE LAGERUNGSHINWEISE

Arzneimittel außer Reich- und Sichtweite von Kindern aufbewahren.

2 bis 8 °C

vor Licht geschützt aufbewahren.

Nicht nach Ablauf des Haltbarkeitsdatums verwenden, das auf der Flasche angegeben ist (hinter

„Exp“).

Haltbarkeit nach dem erstmaligen Öffnen der Flasche: 28 Tage.

12.

BESONDERE WARNHINWEISE

Es wird empfohlen

dieses Tierarzneimittel nicht mit anderen Tierarzneimitteln in derselben Spritze zu mischen

zum Vorbeugen möglicher Unvereinbarkeiten

Direkter Kontakt mit dem Tierarzneimittel vermeiden.

Der Gebrauch während der Trächtigkeit und Laktation ist nicht kontraindiziert.

Überdosierung : Die zu der B-Gruppe gehörenden Vitamine haben eine geringe Toxizität.

13.

BESONDERE VORSICHTSMASSNAHMEN FÜR DIE ENTSORGUNG VON NICHT

VERWENDETEM ARZNEIMITTEL ODER VON ABFALLMATERIALIEN, SOFERN

ERFORDERLICH

Nicht verwendete Tierarzneimittel oder bei der Anwendung entstandene Abfälle sind gemäß den

örtlichen Bestimmungen zu entsorgen.

14.

GENEHMIGUNGSDATUM DER PACKUNGSBEILAGE

Mai 2009

15.

WEITERE ANGABEN

Auslieferung : Ausschließlich auf tierärztliches Rezept erhältliches Tierarzneimittel.

Register Nr. : BE-V259384

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

9-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance the development of generic copies of complex drugs to improve patient access to medicines

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance the development of generic copies of complex drugs to improve patient access to medicines

FDA issued a new series of guidance documents that will advance the development of generic transdermal and topical delivery systems

FDA - U.S. Food and Drug Administration

11-9-2018

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Antimicrobial resistance (AMR) represents a major challenge for Public Health and the scientific community, and requires immediate and drastic solutions. Acquired resistance to certain antimicrobials is already widespread to such an extent that their efficacy in the treatment of certain life‐threatening infections is already compromised. To date, the emergence and spread of AMR has been attributed to the use, misuse or indiscriminate use of antibiotics as th...

Europe - EFSA - European Food Safety Authority Publications

3-7-2018

DKMA Update June 2018

DKMA Update June 2018

In this issue of DKMA Update you can read about new rules on private individuals' import of medicines, Danish Medicines Agency being key driver in European solution for complex clinical trials and much more.

Danish Medicines Agency

6-6-2018

January 10, 2018: Six Charged in Complex Fraud Involving Fraudulent Processing of Credit Card Payments

January 10, 2018: Six Charged in Complex Fraud Involving Fraudulent Processing of Credit Card Payments

January 10, 2018: Six Charged in Complex Fraud Involving Fraudulent Processing of Credit Card Payments

FDA - U.S. Food and Drug Administration

6-6-2018

June 5, 2018: Floridian Charged in Complex Fraud Scheme Related to the Processing of Credit Card Payments

June 5, 2018: Floridian Charged in Complex Fraud Scheme Related to the Processing of Credit Card Payments

June 5, 2018: Floridian Charged in Complex Fraud Scheme Related to the Processing of Credit Card Payments

FDA - U.S. Food and Drug Administration

10-5-2018

Medline Remedy Essentials No-Rinse Cleansing Foam: Avoid Using - Multistate Outbreak of Burkholderia Cepacia Complex

Medline Remedy Essentials No-Rinse Cleansing Foam: Avoid Using - Multistate Outbreak of Burkholderia Cepacia Complex

CDC reports that there are 10 confirmed cases of infection caused by bacteria within the Burkholderia cepacia complex, also commonly called B. cepacia, in three states: California (2), Pennsylvania (7), and New Jersey (1). These patients were already hospitalized for acute conditions and acquired the infections while hospitalized. The infections have been linked to the Medline product, Remedy Essentials No-Rinse Cleansing Foam.

FDA - U.S. Food and Drug Administration

9-5-2018

FDA Investigates Multistate Outbreak of B. cepacia Complex Linked to Medline Remedy Essentials No-Rinse Cleansing Foam (FDA Announcement)

FDA Investigates Multistate Outbreak of B. cepacia Complex Linked to Medline Remedy Essentials No-Rinse Cleansing Foam (FDA Announcement)

FDA Investigates Multistate Outbreak of B. cepacia Complex Linked to Medline Remedy Essentials No-Rinse Cleansing Foam (FDA Announcement)

FDA - U.S. Food and Drug Administration

16-3-2018

"Beyond Yourself Multi Athlete" and unauthorized bulk "Multi-Vitamines" seized from Shop Santé stores in Quebec may pose serious health risks

"Beyond Yourself Multi Athlete" and unauthorized bulk "Multi-Vitamines" seized from Shop Santé stores in Quebec may pose serious health risks

Health Canada is advising Canadians that "Beyond Yourself Multi Athlete" multivitamin and unauthorized "Multi-Vitamines" sold in bulk were seized from several Shop Santé stores in Quebec because they may pose serious health risks.

Health Canada

29-6-2018

EU/3/18/2033 (Real Regulatory Limited)

EU/3/18/2033 (Real Regulatory Limited)

EU/3/18/2033 (Active substance: Codon-optimised human ornithine transcarbamylase mRNA complexed with lipid-based nanoparticles) - Orphan designation - Commission Decision (2018)4178 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/022/18

Europe -DG Health and Food Safety