Aqua ad iniectabilia Amino

Hauptinformation

  • Handelsname:
  • Aqua ad iniectabilia Amino Injektionslösung
  • Darreichungsform:
  • Injektionslösung
  • Zusammensetzung:
  • aqua ad iniectabilia die Lösung.
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • Biologische Medizin

Dokumenten

  • für die Allgemeinheit:
  • 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 das Informationsblatt für die Öffentlichkeit.

Lokalisierung

  • Erhältlich in:
  • Aqua ad iniectabilia Amino Injektionslösung
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Synthetika
  • Therapiebereich:
  • Trägerlösung

Weitere Informationen

Status

  • Quelle:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Zulassungsnummer:
  • 56504
  • Berechtigungsdatum:
  • 16-02-2010
  • Letzte Änderung:
  • 25-10-2018

Zusammenfassung der Merkmale des Arzneimittels

Fachinformation

Aqua ad iniectabilia Amino

Amino AG

Zusammensetzung

Aqua ad iniectabilia.

Galenische Form und Wirkstoffmenge pro Einheit

Injektionslösung zu 2 ml, 5 ml, 10 ml, 50 ml und 100 ml Aqua ad iniectabilia.

Indikationen/Anwendungsmöglichkeiten

Aqua ad iniectabilia Amino wird verwendet für die Herstellung von wässerigen, wasserlöslichen,

sterilen Arzneizubereitungen, vorwiegend zum parenteralen Gebrauch.

Eine Verwendung als sterile Spüllösung ist bei verschiedenen Indikationen nach ärztlicher

Verordnung möglich.

Dosierung/Anwendung

Die Dosierung richtet sich nach den Vorschriften der Medikamente, die in die Lösung gebracht

werden sollen. Die Herstellung der Lösung sollte aseptisch erfolgen. Die Injektionslösung ist nur

zum einmaligen, sofortigen Gebrauch bestimmt.

Kontraindikationen

Aqua ad iniectabilia Amino ist hypotonisch. Es ist deshalb ohne Zusatz einer osmotisch wirkenden

Komponente ungeeignet für die Anwendung als Infusionslösung oder als Injektionslösung.

Als Spüllösung darf Aqua ad iniectabilia Amino nicht verwendet werden, wenn eine signifikante

Resorption erfolgen kann, da es hämolytisch wirkt.

Warnhinweise und Vorsichtsmassnahmen

Nur klare Lösungen und unbeschädigte Behälter verwenden.

Interaktionen

Keine bekannt.

Schwangerschaft/Stillzeit

Aqua ad iniectabilia Amino wird als Trägerlösung angewendet. Die Packungsbeilage des

zugegebenen Arzneimittels ist zu beachten.

Wirkung auf die Fahrtüchtigkeit und auf das Bedienen von Maschinen

Keine bekannt.

Unerwünschte Wirkungen

Die parenterale Applikation einer hypotonischen Lösung kann neben Thrombophlebitis auch eine

Hämolyse sowie die Störungen des Elektrolythaushaltes bewirken.

Überdosierung

Nach versehentlicher Infusion von Aqua ad iniectabilia Amino besteht wegen der Abnahme der

Plasmatonizität akute Hämolysegefahr.

Eigenschaften/Wirkungen

ATC-Code: V07AB

Aqua ad iniectabilia Amino ist eine sterile und pyrogenfreie Injektionslösung, die als Trägerlösung

von Medikamenten verwendet wird.

Pharmakokinetik

Es liegen keine Daten vor.

Präklinische Daten

Es liegen keine Daten vor.

Sonstige Hinweise

Inkompatibilitäten

Aqua ad iniectabilia Amino ist mit den meisten Arzneimitteln kompatibel. Die Endkonzentration des

medikamentösen Zusatzes und der Einfluss des pH und des Ionengehaltes, v.a. auf die Löslichkeit

des Zusatzes, sind zu beachten. Detaillierte Informationen sind der Packungsbeilage des

entsprechenden zuzugebenden Arzneimittels zu entnehmen.

Haltbarkeit

Das Arzneimittel darf nur bis zu dem auf dem Behälter mit «EXP» bezeichneten Datum verwendet

werden.

Besondere Lagerungshinweise

Nicht über 25 °C, in der Originalverpackung und für Kinder unzugänglich aufbewahren. Nicht

einfrieren.

Hinweise für die Handhabung

Nur klare Lösungen und unbeschädigte Behältnisse verwenden. Aqua ad iniectabilia Amino

Injektionslösungen enthalten keine Konservierungsmittel. Nach Öffnen der Brechampullen oder der

Durchstechflaschen ist die Lösung sofort zu verwenden, die nicht verwendete Lösung zu verwerfen.

Zulassungsnummer

56504 (Swissmedic).

Packungen

Ampullen zu 2 ml: 10 und 100. [B]

Ampullen zu 5 ml: 10 und 100. [B]

Ampullen zu 10 ml: 10 und 100. [B]

Durchstechflaschen zu 50 ml: 1 und 10. [B]

Durchstechflaschen zu 100 ml: 1 und 10. [B]

Zulassungsinhaberin

Amino AG, Gebenstorf.

Stand der Information

September 2009.

  • 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 das Informationsblatt für die Öffentlichkeit.



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EU/3/17/1936 (Pharma Gateway AB)

EU/3/17/1936 (Pharma Gateway AB)

EU/3/17/1936 (Active substance: 1-[4-bromo-5-[1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl]-2-fluorophenyl]-3-phenylurea) - Transfer of orphan designation - Commission Decision (2018)3133 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/119/17/T/01

Europe -DG Health and Food Safety

3-4-2018

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (Active substance: 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) - Transfer of orphan designation - Commission Decision (2018)2056 of Tue, 03 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/124/12/T/01

Europe -DG Health and Food Safety

28-3-2018

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (Active substance: Sodium (1R,3R,4R,5S)-3-({2-N-acetylamino-2-deoxy-3-O-[(1S)-1-carboxylato-2-cyclohexylethyl]-beta-D-galactopyranosyl}oxy)-4-({6-deoxy-alpha-L-galactopyranosyl}oxy)-5-ethyl-cyclohexan-1-yl-(38-oxo-2,5,8,11,14,17,20,23,26,29,32,35-dodecaoxa-39-azahentetracontan-41-yl)carboxamide) - Transfer of orphan designation - Commission Decision (2018)2011 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/17/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/17/1861 (Roivant Sciences Ireland Limited)

EU/3/17/1861 (Roivant Sciences Ireland Limited)

EU/3/17/1861 (Active substance: (S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester) - Transfer of orphan designation - Commission Decision (2018)1826 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/299/16/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1714 (IQVIA RDS Ireland Limited)

EU/3/16/1714 (IQVIA RDS Ireland Limited)

EU/3/16/1714 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-a-L-talofuranosyl)-paromamine sulfate) - Transfer of orphan designation - Commission Decision (2018)1823 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/119/16/T/01

Europe -DG Health and Food Safety

19-1-2018

Pending EC decision:  Panacur AquaSol, fenbendazole, Opinion date: 18-Jan-2018

Pending EC decision: Panacur AquaSol, fenbendazole, Opinion date: 18-Jan-2018

Europe - EMA - European Medicines Agency