Pethidin HCl Amino 50 mg/1 ml

Hauptinformation

  • Handelsname:
  • Pethidin HCl Amino 50 mg/1 ml Injektionslösung
  • Darreichungsform:
  • Injektionslösung
  • Zusammensetzung:
  • pethidini hydrochloridum 50 mg, Wasser iniectabilia q.s. zu einer Lösung anstelle von 1 ml.
  • 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.


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Lokalisierung

  • Erhältlich in:
  • Pethidin HCl Amino 50 mg/1 ml Injektionslösung
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Synthetika
  • Therapiebereich:
  • Analgetikum

Weitere Informationen

Status

  • Quelle:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Zulassungsnummer:
  • 13369
  • Berechtigungsdatum:
  • 22-01-1947
  • Letzte Änderung:
  • 24-10-2018

Zusammenfassung der Merkmale des Arzneimittels: dosierung, wechselwirkungen, nebenwirkungen

Fachinformation

Pethidin HCl Amino

AMINO

Untersteht dem Bundesgesetz über die Betäubungsmittel und die psychotropen Stoffe

Zusammensetzung

Wirkstoff: Pethidini hydrochloridum.

Hilfsstoff: Aqua ad iniectabilia.

Galenische Form und Wirkstoffmenge pro Einheit

Injektionslösung; 50 mg/ml.

Indikationen/Anwendungsmöglichkeiten

Starke Schmerzen verschiedener Genese wie postoperative Schmerzen, Tumorschmerzen,

therapieresistente Schmerzzustände des Bewegungsapparates/Nervenschmerzen, Koliken der

abführenden Gallenwege und des Urogenitalsystems, Gefässspasmen. In der Gynäkologie zur

Erleichterung und Beschleunigung der Geburt bei Rigidität und Spasmen des Muttermundes,

Krampfwehen und Durchtrittsschmerzen.

Dosierung/Anwendung

I.m. und s.c. Injektion: 25–100 mg (½–2 ml).

Wiederholungsgaben sind individuell anzupassen. Im Allgemeinen werden nach 3–4 Stunden 25–

100 mg injiziert.

Bei akuten Koliken oder Schmerzzuständen 25–50 mg (½–1 ml) langsam (1–2 Minuten) i.v., evtl. in

10 ml 10%iger Glucose- oder physiologischer NaCl-Lösung. Bei schwächlichen Patienten, bei denen

i.v. Applikation wegen der Schwere der Schmerzen unbedingt erforderlich ist, injiziert man am

besten 1 ml Pethidin mit Glucose- oder physiologischer NaCl-Lösung verdünnt i.v. und 1 ml i.m.

Maximale Tagesdosis: 500 mg.

Da entsprechende Studien bei Kindern fehlen, soll Pethidin nur bei Erwachsenen angewendet

werden.

Kontraindikationen

Pethidin HCl Injektionslösung ist kontraindiziert bei Überempfindlichkeit gegenüber Pethidin sowie

bei Patienten, welche mit MAO-Hemmern behandelt werden.

Kontraindikationen bestehen während der Stillphase und bei Säuglingen, bei Krankheiten (wie

Asthma, Cor pulmonale), bei denen eine dosisabhängige Dämpfung des Atemzentrums vermieden

werden muss, bei erhöhtem intrakranialem Druck, bei schweren Leberstörungen, bei Pankreatitis.

Warnhinweise und Vorsichtsmassnahmen

Pethidin kann nach längerer Anwendung zu psychischer und physischer Abhängigkeit führen

(Entzugssyndrom beachten)! Vorsicht bei supraventrikulärer Tachykardie, Krampfneigung, Leber-

und Nierenfunktionsstörungen.

Interaktionen

Pethidin darf nicht bei gleichzeitiger Behandlung mit MAO-Hemmern verabreicht werden. Dies gilt

besonders auch für neuere MAO-Hemmer wie das Parkinson-Mittel Selegilin; auch bei gleichzeitiger

Behandlung mit neueren, als Antidepressiva eingesetzten MAO-Hemmern soll Pethidin nicht

verwendet werden.

Die sedierende und atemdepressive Wirkung des Pethidins wird durch zentraldämpfende Pharmaka

wie Sedativa-Hypnotika, Psychopharmaka (Phenothiazine, Reserpin, trizyklische Antidepressiva)

sowie durch Alkohol verstärkt. β-Blocker können die zentralen Effekte von Pethidin potenzieren.

Schwangerschaft/Stillzeit

Bei der Anwendung in der Schwangerschaft ist Vorsicht geboten:

Obwohl Pethidin sehr rasch im Blut der Nabelschnur nachzuweisen ist, sind bislang bei

therapeutischer Anwendung in der Schwangerschaft über keine nachteiligen Wirkungen auf die

Föten berichtet worden. Wird das Medikament jedoch vor bzw. während der Geburt gegeben, kann

es zu Atmungsdepression beim Neugeborenen führen. Wie bei allen Narcotica kann auch bei der

Verabreichung von Pethidin über längere Zeit und insbesondere in höheren Dosen bei Schwangeren,

wie auch bei Föten eine Abhängigkeitsentwicklung mit möglichen Entzugserscheinungen auftreten.

Stillzeit

Da Pethidin in die Muttermilch übergeht, soll es bei stillenden Frauen nicht verwendet werden.

Wirkung auf die Fahrtüchtigkeit und auf das Bedienen von Maschinen

Die Reaktionsfähigkeit kann beeinträchtigt sein.

Unerwünschte Wirkungen

Die vor allem nach i.v.-Injektionen auftretenden Nebenwirkungen vorwiegend vagotroper Art

können durch kleine Gaben von Atropin rasch beseitigt werden.

Zentralnervensystem

Häufig: Übelkeit, Erbrechen, Schwindel, Sedation, Kopfschmerzen, Mundtrockenheit.

Magen-Darm-Trakt

Gelegentlich: Obstipation.

Herz-Kreislaufsystem

Häufig: Vasodilatation, leichte Hypotonie mit Neigung zu orthostatischen Beschwerden.

Gelegentlich: Bradykardie, Venenentzündungen (nach i.v.-Injektion), Herzklopfen, Tachykardie.

Atemzentrum

Dosisabhängige Atemdepression.

Allergische Reaktionen

Selten: Allergische Hauterscheinungen (Exanthem).

Uro-Genitalsystem

Harnretention.

Überdosierung

Bei Überdosierung treten folgende Symptome auf:

Schwindel, rauschähnliche Zustände, Mundtrockenheit, Mydriasis, Muskelzittern, Krampfanfälle,

Kreislaufkollaps mit Cyanose, Koma mit Atemdepression. Antidot sind Morphinantagonisten wie

Levallorphan, Nalorphin oder Naloxon.

Eigenschaften/Wirkungen

ATC-Code: N02AB02

Pethidin gehört zur Gruppe der stark wirksamen Analgetika vom Opiat-Typ und ist etwa 5–10 mal

schwächer wirksam als Morphin. Pethidin bindet sich selektiv an opioid-spezifische Rezeptoren im

Gehirn und reguliert die Schmerzleitung und Schmerzempfindung durch Stimulation des endogenen

schmerzhemmenden Systems. Zentrale Wirkungen sind ferner Euphorie, Sedierung,

Atemdepression, Erbrechen sowie Antidiurese. Pethidin besitzt neben analgetischen noch papaverin-

ähnliche und parasympatholytische Wirkungen. So werden die peripheren Gefässe erweitert.

Pharmakokinetik

Pethidin wird zu 40% an Plasmaproteine gebunden. Pethidin durchdringt auch die Plazentaschranke.

Die Metabolisierung erfolgt in der Leber. Nur 5% der Substanz wird unverändert durch den Harn

ausgeschieden. Die Halbwertszeit liegt bei 3,5 Stunden. Die Elimination ist bei saurem Harn erhöht.

Kinetik spezieller Patientengruppen

Bei Leberzirrhose kann die Halbwertszeit verlängert werden, bei Niereninsuffizienz kommt es zu

Akkumulation insbesondere des Metaboliten Norpethidin. Dies kann zu Symptomen der

Überdosierung führen.

Präklinische Daten

Mutagenes und tumorerzeugendes Potential

Untersuchungen zum Nachweis von Genmutationen liegen nicht vor. In-vivo-Untersuchungen

ergaben deutliche Hinweise auf chromosomenbrechende Eigenschaften von Pethidin. Daher besteht

der Verdacht auf einer mutagenen Wirkung beim Menschen.

Langzeituntersuchungen am Tier auf ein tumorerzeugendes Potential liegen nicht vor.

Sonstige Hinweise

Inkompatibilitäten

Da keine Verträglichkeitsstudien durchgeführt wurden, darf dieses Arzneimittel nicht mit anderen

Arzneimitteln gemischt werden.

Information

Das Medikament unterliegt dem Bundesgesetz über die Betäubungsmittel und die psychotropen

Stoffe.

Haltbarkeit

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

werden.

Besondere Lagerungshinweise

Bei Raumtemperatur (15–25 °C) lagern, vor Licht schützen.

Zulassungsnummer

13369 (Swissmedic).

Packungen

Pethidin HCl Amino Inj Lös 50 mg Amp 10 × 1 ml. (A+)

Pethidin HCl Amino Inj Lös 50 mg Amp 100 × 1 ml. (A+)

Pethidin HCl Amino Inj Lös 100 mg Amp 10 × 2 ml. (A+)

Pethidin HCl Amino Inj Lös 100 mg Amp 100 × 2 ml. (A+)

Zulassungsinhaberin

Amino AG, Gebenstorf.

Stand der Information

April 2006.

  • 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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19-12-2018


Orphan designation: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt, Treatment of acute myeloid leukaemia, 24/08/2018, Positive

Orphan designation: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt, Treatment of acute myeloid leukaemia, 24/08/2018, Positive

Orphan designation: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt, Treatment of acute myeloid leukaemia, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018

Minoxicutan Männer 50 mg/ml

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11-12-2018

REYATAZ® 50 mg Pulver zum Einnehmen

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10-12-2018

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)8630 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002507

Europe -DG Health and Food Safety

10-12-2018

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (Active substance: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt) - Transfer of orphan designation - Commission Decision (2018)8636 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002385

Europe -DG Health and Food Safety

7-12-2018

Syneudon® 50 mg

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7-12-2018

Benepali® 50 mg

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7-12-2018

Diabact UBT 50 mg Tabletten

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4-12-2018

Saroten® Tabs 50 mg

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28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-guanidino-1-hexanone hexahydrochloride, decision type: , therapeutic area: , PIP number: P/0134/2018

Europe - EMA - European Medicines Agency

28-11-2018

Xadago 50 mg / 100 mg Filmtabletten

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27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Europe - EMA - European Medicines Agency

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration

22-11-2018


Orphan designation: 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 (venetoclax), Treatment of chronic lym

Orphan designation: 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 (venetoclax), Treatment of chronic lym

Orphan designation: 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 (venetoclax), Treatment of chronic lymphocytic leukaemia, 06/12/2012, Withdrawn

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/18/2086 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/18/2086 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/18/2086 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetate) - Orphan designation - Commission Decision (2018)7795 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/106/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

21-11-2018

Amiodaron-hameln 50 mg/ml

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19-11-2018

Leponex® 50 mg

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2-11-2018

Tramundin® 50 mg Filmtabletten

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