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

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

16-1-2018

Statement from FDA Commissioner Scott Gottlieb, M.D. responding to report from GAO and updating on FDA’s ongoing efforts to increase access to complex generic drugs

Statement from FDA Commissioner Scott Gottlieb, M.D. responding to report from GAO and updating on FDA’s ongoing efforts to increase access to complex generic drugs

GAO issued the report “Generic Drugs: FDA Should Make Public Its Plans to Issue and Revise Guidance on Nonbiological Complex Drugs,” which contains a single recommendation for the FDA -- that the agency publicly announce its plans to issue or revise guidance for these drug products. The FDA agrees and is actively working to accomplish this goal.

FDA - U.S. Food and Drug Administration

14-8-2017

Scientific guideline:  Guideline on manufacture of the finished dosage form, adopted

Scientific guideline: Guideline on manufacture of the finished dosage form, adopted

This guideline replaces the note for guidance on the manufacture of the finished dosage form (CPMP/QWP/486/95). The note for guidance has been updated to reflect the requirements as laid down in the current legislation Directive 2001/83/EC, and to follow the format and content of the Common Technical Document (CTD) Module 3 dossier. It also addresses current manufacturing practices in terms of complex supply chains and worldwide manufacture. In addition, the content and principles of the ICH Q8 guideline...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-8-2017

Scientific guideline:  Guideline on manufacture of the finished dosage form - Revision 1, adopted

Scientific guideline: Guideline on manufacture of the finished dosage form - Revision 1, adopted

This guideline replaces the note for guidance on the manufacture of the finished dosage form (CPMP/QWP/486/95). The note for guidance has been updated to reflect the requirements as laid down in the current legislation Directive 2001/83/EC, and to follow the format and content of the Common Technical Document (CTD) Module 3 dossier. It also addresses current manufacturing practices in terms of complex supply chains and worldwide manufacture. In addition, the content and principles of the ICH Q8 guideline...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-5-2018

News and press releases:  Working together for people with rare and complex diseases

News and press releases: Working together for people with rare and complex diseases

Live broadcast of workshop with European Reference Networks on 29 May

Europe - EMA - European Medicines Agency

3-5-2018

Wondering “What is enough?” when determining the participation of women in cardiovascular disease trials? We discuss this complex question during The Great Debate on 5/16 at 1 p.m. EST.  https://go.usa.gov/xQ9Xq  #NWHW #SABVpic.twitter.com/NP8ni58sA1

Wondering “What is enough?” when determining the participation of women in cardiovascular disease trials? We discuss this complex question during The Great Debate on 5/16 at 1 p.m. EST. https://go.usa.gov/xQ9Xq  #NWHW #SABVpic.twitter.com/NP8ni58sA1

Wondering “What is enough?” when determining the participation of women in cardiovascular disease trials? We discuss this complex question during The Great Debate on 5/16 at 1 p.m. EST. https://go.usa.gov/xQ9Xq  #NWHW #SABV pic.twitter.com/NP8ni58sA1

FDA - U.S. Food and Drug Administration

2-5-2018

NOVA COMPLEX HQ (Hydroquinone) Emulsion [Pharma Cosmetics]

NOVA COMPLEX HQ (Hydroquinone) Emulsion [Pharma Cosmetics]

Updated Date: May 2, 2018 EST

US - DailyMed

14-3-2018

VITAMIN B COMPLEX 150 (Vitamin B Complex) Injection [Butler Animal Health Supply LLC]

VITAMIN B COMPLEX 150 (Vitamin B Complex) Injection [Butler Animal Health Supply LLC]

Updated Date: Mar 14, 2018 EST

US - DailyMed

13-3-2018

BIOLOGICAL COMPLEX I (Variolinum) Liquid [Deseret Biologicals, Inc.]

BIOLOGICAL COMPLEX I (Variolinum) Liquid [Deseret Biologicals, Inc.]

Updated Date: Mar 13, 2018 EST

US - DailyMed

8-3-2018

BIOLOGICAL COMPLEX II (Anthracinum,) Liquid [Deseret Biologicals, Inc.]

BIOLOGICAL COMPLEX II (Anthracinum,) Liquid [Deseret Biologicals, Inc.]

Updated Date: Mar 8, 2018 EST

US - DailyMed

13-2-2018

CLINICIANS COMPLEX (Sulfur) Lotion [Cosmed Dermaceuticals, Inc.]

CLINICIANS COMPLEX (Sulfur) Lotion [Cosmed Dermaceuticals, Inc.]

Updated Date: Feb 13, 2018 EST

US - DailyMed

2-1-2018

VITAMIN B COMPLEX 100 (Vitamin B Complex) Injection [Fisiopharma SRL]

VITAMIN B COMPLEX 100 (Vitamin B Complex) Injection [Fisiopharma SRL]

Updated Date: Jan 2, 2018 EST

US - DailyMed

2-1-2018

PROFILNINE (Factor Ix Complex) Kit [GRIFOLS USA, LLC]

PROFILNINE (Factor Ix Complex) Kit [GRIFOLS USA, LLC]

Updated Date: Jan 2, 2018 EST

US - DailyMed

26-12-2017

SODIUM FERRIC GLUCONATE COMPLEX Injection [Actavis Pharma, Inc.]

SODIUM FERRIC GLUCONATE COMPLEX Injection [Actavis Pharma, Inc.]

Updated Date: Dec 26, 2017 EST

US - DailyMed

20-12-2017

BIO ACTIVE COMPLEX SPF 15 (Zinc Oxide) Cream [ALLURE LABS INC]

BIO ACTIVE COMPLEX SPF 15 (Zinc Oxide) Cream [ALLURE LABS INC]

Updated Date: Dec 20, 2017 EST

US - DailyMed

18-12-2017

FEIBA (Anti-Inhibitor Coagulant Complex) Kit [Baxalta Incorporated]

FEIBA (Anti-Inhibitor Coagulant Complex) Kit [Baxalta Incorporated]

Updated Date: Dec 18, 2017 EST

US - DailyMed

31-10-2017

Scientific guideline:  Concept paper on the development of a reflection paper on new analytical methods/technologies in the quality control of herbal medicinal products, draft: consultation open

Scientific guideline: Concept paper on the development of a reflection paper on new analytical methods/technologies in the quality control of herbal medicinal products, draft: consultation open

Quality control is a prerequisite to assure safe and effective use of (traditional) herbal medicinal products, which are complex mixtures of numerous phytochemical constituents. For the majority of herbal substances, herbal preparations and (traditional) herbal medicinal products the active constituents are not known or are only partly understood.

Europe - EMA - European Medicines Agency

12-10-2017

SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE Injection [West-Ward Pharmaceuticals Corp]

SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE Injection [West-Ward Pharmaceuticals Corp]

Updated Date: Oct 12, 2017 EST

US - DailyMed

11-9-2017

Fexeric (Keryx Biopharma UK Ltd.)

Fexeric (Keryx Biopharma UK Ltd.)

Fexeric (Active substance: ferric citrate coordination complex) - Centralised - Yearly update - Commission Decision (2017)6142 of Mon, 11 Sep 2017

Europe -DG Health and Food Safety

31-7-2017

ZO COMPLEX A TRETINOIN (EMOLLIENT) (Tretinoin) Cream [ZO Skin Health, Inc.]

ZO COMPLEX A TRETINOIN (EMOLLIENT) (Tretinoin) Cream [ZO Skin Health, Inc.]

Updated Date: Jul 31, 2017 EST

US - DailyMed

27-7-2017

ASPIRIN COMPLEX HEISSGETRÄNK

Rote - Liste

14-7-2017

VITAMIN B COMPLEX Injection [FLON LABORATORIES LLC]

VITAMIN B COMPLEX Injection [FLON LABORATORIES LLC]

Updated Date: Jul 14, 2017 EST

US - DailyMed

12-6-2017

DEPOCYT (Cytarabine) Injection, Lipid Complex [Sigma-Tau Pharmaceuticals, Inc.]

DEPOCYT (Cytarabine) Injection, Lipid Complex [Sigma-Tau Pharmaceuticals, Inc.]

Updated Date: Jun 12, 2017 EST

US - DailyMed

8-6-2017

RECOVER LIGHTENING COMPLEX WITH 4% HYDROQUINONE Lotion [The Skin Atelier, Inc.]

RECOVER LIGHTENING COMPLEX WITH 4% HYDROQUINONE Lotion [The Skin Atelier, Inc.]

Updated Date: Jun 8, 2017 EST

US - DailyMed