Equi-Biserol ad us. vet.

Hauptinformation

  • Handelsname:
  • Equi-Biserol ad us. vet., Infusionslösung
  • Darreichungsform:
  • Infusionslösung
  • 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:
  • Equi-Biserol ad us. vet., Infusionslösung
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Erhaltungsinfusion für Equide; Isotonische Infusionslösung zur Langzeitanwendung bei Equiden

Weitere Informationen

Status

  • Quelle:
  • Institut für Veterinärpharmakologie
  • Zulassungsnummer:
  • 61417
  • Letzte Änderung:
  • 02-09-2017

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

Equi-Biserol ad us. vet., Infusionslösung

Laboratorium Dr. G. Bichsel AG

Erhaltungsinfusion für Equide; Isotonische Infusionslösung zur

Langzeitanwendung bei Equiden

ATCvet: QB05BB02

Zusammensetzung

Zusammensetzung

Wirkstoff: Kaliumchlorid, Calciumchlorid, Magnesiumchlorid, Natriumlactat, Glucose

Hilfsstoffe: Salzsäure zur pH-Einstellung, Wasser für Injektionszwecke

Galenische Form und Wirkstoffmenge pro Einheit

Isotonische Infusionslösung

1000 ml Lösung enthalten:

Kaliumchlorid

2.24 g/l

Calciumchlorid

1.18 g/l

Magnesiumchlorid 1.63 g/l

Natriumlactat

4.71 g/l

Glucose wasserfrei15.00 g/l

(entspricht

83.3 mmol/l)

Wasser für Injektionszwecke ad 1000 ml

Elektrolyte:

42 mmol/l

30 mmol/l

8 mmol/l

8 mmol/l

62 mmol/l

Lactat

42 mmol/l

Theoretische Osmolarität: 275 mosm/l

Energiegehalt: ca. 60 kcal/l, ca. 250.5 kJ/l

Fachinformationen Wirkstoffe (CliniPharm)

Calciumchlorid - Glucose - Kaliumchlorid - Magnesiumchlorid - Natriumlactat

Eigenschaften / Wirkungen

Equi-Biserol Infusionslösung ist steril, endotoxinfrei und zur intravenösen

Langzeitanwendung (>1 Tage, nach erfolgter Rehydrierung) beim Pferd bestimmt. Die

isotonische Lösung führt durch den geringen Gehalt an Natrium und Chlorid und die

erhöhte Konzentration an Kalium, Calcium und Magnesium (im Vergleich zu Ringer-

Lactat) zur Aufrechterhaltung bzw. Wiederherstellung des Wasser- und

Elektrolytgleichgewichtes bei Pferden mit verminderter bzw. ohne Nahrungsaufnahme.

Lactat wird zu Bicarbonat abgebaut und hat durch Erhöhung der Bicarbonatkonzentration

einen leicht alkalisierenden Effekt.

Die Zufuhr von Glucose vermindert bei einer bestehenden Kohlenhydratmangelsituation

den Stickstoffverlust und reduziert den Abbau des Leberglycogens, indem leicht

verwertbare Energie zugeführt wird.

Indikationen

Erhaltungsinfusion zur Langzeitanwendung bei Equiden.

Zufuhr von Elektrolyten, leicht verwertbaren Kohlenhydraten und Wasser nach erfolgter

initialer Rehydrierung (z.B. mit Ringer-Lactat) bei fastenden und/oder anorektischen

Pferden mit gastrointestinalen Erkrankungen (Koliken - konservative oder chirurgische,

Kolitis, Diarrhoe, Magenreflux) oder anderen Patienten, die ungenügend oder gar nicht

fressen können.

Dosierung / Anwendung

Nach erfolgter Rehydrierung (z.B. mit Ringer-Lactat Lösung) wird Equi-Biserol als

Erhaltungsinfusion über längere Zeit (>1 Tage) und meist in grossen Mengen verabreicht.

Dauerinfusion: 1.5 - 4.5 ml/kg/h. Die zu infundierende Menge sowie die

Infusionsgeschwindigkeit sind abhängig von dem Gewicht und dem klinischen Zustand

des Tieres und werden ausschliesslich von dem behandelnden Tierarzt, aufgrund von

vorangegangenen und regelmässig zu wiederholenden Laboruntersuchungen bestimmt.

Equi-Biserol soll nur unter Klinikbedingungen, die das notwendige Monitoring ermöglichen,

eingesetzt werden.

Anwendungseinschränkungen

Kontraindikationen

Equi-Biserol Infusionslösung ist kontraindiziert bei:

-Hypervolämie

-Hypernatriämie, Hyperkaliämie, Hypercalcämie, Hyperchlorämie, Hyperlactatämie

-chronischer Niereninsuffizienz mit einer der oben genannten Elektrolytabweichungen

-kardiogenem Schock.

Vorsichtsmassnahmen

Equi-Biserol darf nicht zur Rehydrierung eingesetzt werden. Equi-Biserol sollte nur nach

erfolgter Rehydrierung (z.B mit Ringer-Lactat) und nach einer Hämatokritbestimmung

eingesetzt werden. Während der Behandlung ist der Elektrolytstatus regelmässig zu

bestimmen und zu überwachen.

Unerwünschte Wirkungen

VetVigilance: Pharmacovigilance-Meldung erstatten

Bei bestimmungsgemässem Gebrauch keine. Lungenödem wurde beim Pferd nicht

beobachtet.

Keine.

Wechselwirkungen

Keine bekannt.

Sonstige Hinweise

Inkompatibilitäten

Die Zugabe von Arzneimitteln zu Infusionslösungen kann zu Inkompatibilitätsreaktionen

führen. Während manche Reaktionen sofort auffallen, muss jedoch auch mit subtileren

physikalischen, chemischen oder pharmakologischen Unverträglichkeiten gerechnet

werden. Der Zusatz von phosphat- und/oder carbonathaltigen Lösungen zu Equi-Biserol

ist wegen der Ausfällung von unlöslichen Calciumsalzen zu vermeiden.

Die Zugabe vor medikamentösen Zusätzen muss auf aseptischem Weg erfolgen. In jedem

Fall ist darauf zu achten, dass eine vollständige Mischung des Zusatzes mit der Lösung

gewährleistet ist.

Eine Lagerung solcher Lösungen muss vermieden werden.

Auf die Kompatibilität muss auch geachtet werden, wenn mehrere Infusionen durch das

gleiche Infusionsbesteck wie Equi-Biserol verabreicht werden.

Haltbarkeit

Verfalldatum beachten.

Besondere Lagerungshinweise

Bei Raumtemperatur (15 - 25 °C) lagern.

Ausserhalb der Reichweite von Kindern aufbewahren!

Hinweise für die Handhabung

Nur zum Gebrauch am Tier bestimmt. Nur klare Lösungen und unbeschädigte Behältnisse

verwenden. Restlösungen verwerfen.

Packungen

PVC-Beutel:

1000 ml, 8 ×

1000 ml

5000 ml, 2 ×

5000 ml

Abgabekategorie: B

Swissmedic Nr. 61'417

Informationsstand: 03/2011

Dieser Text ist behördlich genehmigt.

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Pest categorisation of Grapholita prunivora

Pest categorisation of Grapholita prunivora

Published on: Tue, 18 Dec 2018 The European Commission requested EFSA to conduct a pest categorisation of Grapholita prunivora (Lepidoptera: Tortricidae), an oligophagous moth whose larvae feed mostly on leaves and fruit of different Rosaceae including cultivated apples, plums, cherries and pecans. It overwinters in soil and bark crevices of its host plants. G. prunivora has reliable identification methods, both for adults and immature stages. It occurs in North America, where it can impact pome and sto...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-12-2018


Draft guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 2

Draft guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 2

Draft guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 2

Europe - EMA - European Medicines Agency

18-12-2018

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

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

Published on: Mon, 17 Dec 2018 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 pencycuron. To assess the occurrence of pencycuron 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 (incl...

Europe - EFSA - European Food Safety Authority Publications

17-12-2018


Draft reflection paper on risk management requirements for elemental impurities in veterinary medicinal products

Draft reflection paper on risk management requirements for elemental impurities in veterinary medicinal products

Draft reflection paper on risk management requirements for elemental impurities in veterinary medicinal products

Europe - EMA - European Medicines Agency

17-12-2018

New format requirements for Marketing Authorization submissions from 1 January 2019

New format requirements for Marketing Authorization submissions from 1 January 2019

The NeeS submission format will be discontinued for all applications submitted under the national procedure (NP), i.e. applications for variations, renewals etc. This change is related to medicinal products for human use. Parallel import and parallel distribution are not affected by this change.

Danish Medicines Agency

15-12-2018

Schauma-Dip ad us. vet., Zitzendesinfektionsmittel

Schauma-Dip ad us. vet., Zitzendesinfektionsmittel

● Neue Zulassungsinhaberin: Halag Chemie AG

Institut für Veterinärpharmakologie und toxikologie

14-12-2018


Draft guideline on quality and equivalence of topical products

Draft guideline on quality and equivalence of topical products

Draft guideline on quality and equivalence of topical products

Europe - EMA - European Medicines Agency

14-12-2018

Response to comments on the Scientific Opinion on the scientific substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006

Response to comments on the Scientific Opinion on the scientific substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006

Published on: Thu, 13 Dec 2018 Following a request from the European Commission, EFSA was asked to review the comments received on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006. Comments originating from the applicant (Han‐Biotech GmbH) were submitted to EFSA via the E...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Project DEMETER: Concept Note for an Emerging Risks Knowledge Exchange Platform (ERKEP) Framework

Project DEMETER: Concept Note for an Emerging Risks Knowledge Exchange Platform (ERKEP) Framework

Published on: Thu, 13 Dec 2018 Researchers, governments, agencies, food producers and the civil society are increasingly concerned about ‘emerging food risks’. It is recognised that the successful identification of emerging risks is at the heart of protecting public health and the environment, and that this requires worldwide cooperation between all parties involved in the food supply chain. The objectives and research proposed in the DEMETER project are designed to support current (and future) EFSA pro...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Bovilis BTV8 ad us. vet.

Bovilis BTV8 ad us. vet.

● Die Zulassung ist am 14.12.2018 erloschen.

Institut für Veterinärpharmakologie und toxikologie

12-12-2018

December 10, 2018: Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Endoscopes After Failing to File FDA-Required Adverse Event Reports of Serious Infections

December 10, 2018: Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Endoscopes After Failing to File FDA-Required Adverse Event Reports of Serious Infections

December 10, 2018: Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Endoscopes After Failing to File FDA-Required Adverse Event Reports of Serious Infections

FDA - U.S. Food and Drug Administration

12-12-2018

Activyl TickPlus spot-on Hund XS ad us. vet., insektizide Loesung zum Auftragen auf die Haut

Activyl TickPlus spot-on Hund XS ad us. vet., insektizide Loesung zum Auftragen auf die Haut

● Umwandlung in Exportzulassung (Exportspezialität): nur für den Vertrieb im Ausland

Institut für Veterinärpharmakologie und toxikologie

12-12-2018

Activyl TickPlus spot-on Hund S ad us. vet., insektizide Loesung zum Auftragen auf die Haut

Activyl TickPlus spot-on Hund S ad us. vet., insektizide Loesung zum Auftragen auf die Haut

● Umwandlung in Exportzulassung (Exportspezialität): nur für den Vertrieb im Ausland

Institut für Veterinärpharmakologie und toxikologie

12-12-2018

Activyl TickPlus spot-on Hund M ad us. vet., insektizide Loesung zum Auftragen auf die Haut

Activyl TickPlus spot-on Hund M ad us. vet., insektizide Loesung zum Auftragen auf die Haut

● Umwandlung in Exportzulassung (Exportspezialität): nur für den Vertrieb im Ausland

Institut für Veterinärpharmakologie und toxikologie

12-12-2018

Activyl TickPlus spot-on Hund L ad us. vet., insektiztide Loesung zum Auftragen auf die Haut

Activyl TickPlus spot-on Hund L ad us. vet., insektiztide Loesung zum Auftragen auf die Haut

● Umwandlung in Exportzulassung (Exportspezialität): nur für den Vertrieb im Ausland

Institut für Veterinärpharmakologie und toxikologie

12-12-2018

Activyl TickPlus spot-on Hund XL ad us. vet., insektizide Loesung zum Auftragen auf die Haut

Activyl TickPlus spot-on Hund XL ad us. vet., insektizide Loesung zum Auftragen auf die Haut

● Umwandlung in Exportzulassung (Exportspezialität): nur für den Vertrieb im Ausland

Institut für Veterinärpharmakologie und toxikologie

12-12-2018

Carofertin ad us. vet., Injektionsemulsion

Carofertin ad us. vet., Injektionsemulsion

● Die Neuzulassung erfolgte am 12.12.2018.

Institut für Veterinärpharmakologie und toxikologie

11-12-2018

International Lubricants, Inc. recalls Kool-It Evaporator & Heater Foam Cleaner

International Lubricants, Inc. recalls Kool-It Evaporator & Heater Foam Cleaner

The recalled product does not have proper consumer chemical hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

11-12-2018

Simparica 5 mg ad us. vet., Kautabletten fuer Hunde

Simparica 5 mg ad us. vet., Kautabletten fuer Hunde

● Indikationserweiterung (Demodex canis, Otodectes cynotis) ● Änderung Text "Eigenschaften / Wirkungen", "Indikationen", "Dosierung / Anwendung" und "Unerwünschte Wirkungen"

Institut für Veterinärpharmakologie und toxikologie

14-1-2019

Consultation: Benzocaine: proposed advisory statements for medicines

Consultation: Benzocaine: proposed advisory statements for medicines

The TGA is seeking comments on proposed new required label statements for medicines containing benzocaine. Closing date: 16 October 2018

Therapeutic Goods Administration - Australia

9-1-2019


Guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), Bluetongue (BT) and Foot-and-Mouth disease (FMD) - Revision 1

Guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), Bluetongue (BT) and Foot-and-Mouth disease (FMD) - Revision 1

Guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), Bluetongue (BT) and Foot-and-Mouth disease (FMD) - Revision 1

Europe - EMA - European Medicines Agency

20-12-2018

.@US_FDA provides an update on new steps to revise #Essure's post-market study to collect long-term safety information following discontinuation of its U.S. sales. Read FDA Commissioner @SGottliebFDA's statement on the new steps here:  https://go.usa.gov/

.@US_FDA provides an update on new steps to revise #Essure's post-market study to collect long-term safety information following discontinuation of its U.S. sales. Read FDA Commissioner @SGottliebFDA's statement on the new steps here: https://go.usa.gov/

. @US_FDA provides an update on new steps to revise #Essure's post-market study to collect long-term safety information following discontinuation of its U.S. sales. Read FDA Commissioner @SGottliebFDA's statement on the new steps here: https://go.usa.gov/xEaNB  #MedicalDevice

FDA - U.S. Food and Drug Administration

20-12-2018

TGA presentations: CAPSIG Seminar, 12 September 2018

TGA presentations: CAPSIG Seminar, 12 September 2018

Overview of regulatory requirements introduced as part of PIC/s PE009-13 Guide to GMP and a summary of the new PI041-1 Data Integrity

Therapeutic Goods Administration - Australia

19-12-2018

Join us on January 17, 2019 from 1-2:30 PM EST for a webinar to help clarify the Breakthrough Devices Program final guidance for manufacturers. Find out more about the webinar:  https://go.usa.gov/xExHX  #MedicalDevice #FDApic.twitter.com/sHElqFFODy

Join us on January 17, 2019 from 1-2:30 PM EST for a webinar to help clarify the Breakthrough Devices Program final guidance for manufacturers. Find out more about the webinar: https://go.usa.gov/xExHX  #MedicalDevice #FDApic.twitter.com/sHElqFFODy

Join us on January 17, 2019 from 1-2:30 PM EST for a webinar to help clarify the Breakthrough Devices Program final guidance for manufacturers. Find out more about the webinar: https://go.usa.gov/xExHX  #MedicalDevice #FDA pic.twitter.com/sHElqFFODy

FDA - U.S. Food and Drug Administration

19-12-2018

On Dec. 18th, the @US_FDA issued the final guidance on the Breakthrough Devices Program. The guidance outlines program policies, features, and the process for manufacturers to follow when choosing to pursue the #breakthrough designation. Read more:  https

On Dec. 18th, the @US_FDA issued the final guidance on the Breakthrough Devices Program. The guidance outlines program policies, features, and the process for manufacturers to follow when choosing to pursue the #breakthrough designation. Read more: https

On Dec. 18th, the @US_FDA issued the final guidance on the Breakthrough Devices Program. The guidance outlines program policies, features, and the process for manufacturers to follow when choosing to pursue the #breakthrough designation. Read more: https://go.usa.gov/xExHq  pic.twitter.com/fAAZAQx1H5

FDA - U.S. Food and Drug Administration

19-12-2018

On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall:  https://go.usa.gov/

On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall: https://go.usa.gov/

On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall: https://go.usa.gov/xE383  #MedicalDevice #FDA pic.twitter.com/S2EbMdmwpe

FDA - U.S. Food and Drug Administration

18-12-2018

#DYK December is #SafeToysAndGiftsMonth. Check out @US_FDA's Consumer Update on how to keep kids safe with toys containing lasers:  https://go.usa.gov/xEx2r  #FDApic.twitter.com/57pZAmSb9r

#DYK December is #SafeToysAndGiftsMonth. Check out @US_FDA's Consumer Update on how to keep kids safe with toys containing lasers: https://go.usa.gov/xEx2r  #FDApic.twitter.com/57pZAmSb9r

#DYK December is #SafeToysAndGiftsMonth. Check out @US_FDA's Consumer Update on how to keep kids safe with toys containing lasers: https://go.usa.gov/xEx2r  #FDA pic.twitter.com/57pZAmSb9r

FDA - U.S. Food and Drug Administration

17-12-2018


Risk management requirements for elemental impurities in veterinary medicinal products

Risk management requirements for elemental impurities in veterinary medicinal products

Risk management requirements for elemental impurities in veterinary medicinal products

Europe - EMA - European Medicines Agency

14-12-2018

GE Healthcare Recalls CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA @US has identified this as a Class I Recall, the most serious type recall. Read more about the recall here:  https://go.usa.gov/xE38

GE Healthcare Recalls CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA @US has identified this as a Class I Recall, the most serious type recall. Read more about the recall here: https://go.usa.gov/xE38

GE Healthcare Recalls CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA @US has identified this as a Class I Recall, the most serious type recall. Read more about the recall here: https://go.usa.gov/xE383  #MedicalDevice #FDA pic.twitter.com/X4IprwU8R2

FDA - U.S. Food and Drug Administration

14-12-2018

#ICYMI: @US_FDA cleared a mobile medical app to help those with #opioid use disorder stay in recovery programs. Read more about the clearance here:  https://go.usa.gov/xE3ke  #FDA #MedicalDevice

#ICYMI: @US_FDA cleared a mobile medical app to help those with #opioid use disorder stay in recovery programs. Read more about the clearance here: https://go.usa.gov/xE3ke  #FDA #MedicalDevice

#ICYMI: @US_FDA cleared a mobile medical app to help those with #opioid use disorder stay in recovery programs. Read more about the clearance here: https://go.usa.gov/xE3ke  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration