Tuberkulin PPD RT 23 SSI

Hauptinformation

  • Handelsname:
  • Tuberkulin PPD RT 23 SSI 10TE/0.1 ml, Injektionslösung
  • Darreichungsform:
  • 10TE/0.1 ml, Injektionslösung
  • Zusammensetzung:
  • tuberculinum (PPD RT 23) 2 µg, dinatrii phosphas dihydricus, kalii dihydrogenophosphas, natrii chloridum, polysorbatum 80, conserv.: kalii 8-hydroxychinolini sulfas hydricus (2:2:2:1) 0.1 mg, aqua ad iniectabilia q.s. ad solutionem pro 1 ml.
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

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:
  • Tuberkulin PPD RT 23 SSI 10TE/0.1 ml, Injektionslösung
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Impfstoffe
  • Therapiebereich:
  • Diagnose von M.tuberculosis Infektion

Weitere Informationen

Status

  • Quelle:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Zulassungsnummer:
  • 641
  • Berechtigungsdatum:
  • 03-07-2000
  • Letzte Änderung:
  • 12-09-2017

Zusammenfassung der Merkmale des Arzneimittels

Fachinformation

Zusammensetzung, Galenische Form und Wirkstoffmenge pro Einheit, Dosierung/Anwendung,

Packungen, Stand der Information

Tuberkulin PPD RT 23 SSI

Mantoux-Test

Zusammensetzung

Tuberkulin PPD RT 23 SSI enthält pro 1 ml Lösung:

Wirkstoffe

Tuberkulin PPD-Lösung zu 2 TE (Tuberkulin-Einheiten)* pro 0,1 ml:

Tuberkulin PPD RT 23 von Mycobacterium tuberculosis 0,4 µg

* 1 Tuberkulin-Einheit (TE) entspricht 0,02 µg Tuberkulin PPD RT 23

Hilfsstoffe

Dinatriumhydrogenphosphat Dihydrat 7,6 mg

Kaliumdihydrogenphosphat 1,5 mg

Natriumchlorid 4,8 mg

Hydroxychinolinkaliumsulfat 100 mg

Polysorbat 80 50 mg

Wasser für Injektionszwecke q.s.p. 1 ml

Galenische Form und Wirkstoffmenge pro Einheit

Tuberkulin PPD (Purified Protein Derivative) RT 23 SSI ist eine klare gebrauchsfertige Lösung von

PPD ausgewählter Stämme von Mycobacterium tuberculosis. Tuberkulin PPD RT 23 SSI wird in

Mehrdosenbehältern (ca. 10 Dosen pro Behälter) in der Konzentration 2 Tuberkulineinheiten (TE)

hergestellt. 1 ml Tuberkulin-Lösung enthält 50 mg Polysorbat 80 (Tween 80) als Stabilisator, 100 mg

Konservierungsmittel (Hydroxychinolinkaliumsulfat (Chinosol)), Kochsalz und Phosphatpuffer.

Indikationen/Anwendungsmöglichkeiten

Zu Diagnosezwecken: Der Mantoux-Test mit Tuberkulin PPD RT 23 SSI ist ein anerkanntes

Hilfsmittel zur Bestimmung, ob eine Person jemals mit Mycobacterium tuberculosis infiziert wurde.

Dosierung/Anwendung

0,1ml intradermal

Der Hauttest hat anhand der Mantoux-Methode zu erfolgen. Wird der Test zu medizinisch-

diagnostischen Zwecken eingesetzt, empfiehlt sich die Verwendung von 0,1 ml Tuberkulin PPD RT

23 SSI zu 2 TE. Die Dosis beträgt 0,1 ml der Lösung PPD RT 23. Die intradermale Injektion ist am

mittleren Drittel des Unterarms vorzunehmen, da die Reaktion in Richtung Handgelenk und Ellbogen

abnimmt. Für jede Injektion ist eine neue Spritze zu verwenden.

Zur Verabreichung des Produkts empfiehlt sich die Verwendung einer Spritze mit 1 ml-Skala (0,5 x

10 mm) und einer leicht abgeschrägten Nadel (25-26 Gauge). Es ist etwas mehr als 0,1 ml der

Tuberkulin-Lösung aufzuziehen. Die überschüssige Menge sowie Luftblasen sind auszustossen, so

dass die Spritze exakt 0,1 ml der Lösung enthält. Die Injektion wird folgendermassen vorgenommen:

Haut leicht spreizen und Nadelspitze (abgeschrägte Fläche nach oben) in die obere Hautschicht

einstechen. Anschliessend die gesamte Dosis von 0,1 ml langsam injizieren. Die Injektion muss

unbedingt in die oberste Hautschicht erfolgen: Bei einer zu tiefen Injektion der Tuberkulin-PPD-

Lösung ist die Reaktion schwierig zu beurteilen. Wird die Injektion korrekt vorgenommen, bildet

sich unmittelbar danach eine kleine Erhöhung oder eine Quaddel von 8-10 mm Durchmesser, die

während rund 10 Minuten sichtbar bleibt. Bildet sich keine Erhebung, ist die Lösung möglicherweise

zu tief gespritzt worden, und der Hauttest sollte im Abstand von 4 oder mehr Zentimetern von der

ersten Injektionsstelle wiederholt werden.

Auswertung und Interpretation des Mantoux-Tests

Bei einer positiven Reaktion tritt 48-72 Stunden nach der Injektion eine Induration auf, die von einer

Rötung umgeben sein kann. Zu messen ist nur die Induration und dies etwa 3 Tage nach der

Verabreichung von Tuberkulin PPD RT 23 SSI. Die Hautreaktion kann als flache, unregelmässige

und leicht erhabene Induration ertastet werden, die mit Hilfe eines transparenten, biegsamen

Massstabs zu messen ist.

Eine positive Tuberkulin PPD RT 23 SSI Reaktion ist definiert als Induration mit einem

Durchmesser von über 6 mm.

ABLESEN DES MANTOUX-

TESTS

Durchmesser der Induration in

negativ positiv

stark positiv

0-5 mm 6-14 mm ≥15 mm

In Ländern, in denen die BCG-Impfung praktiziert wird, kann der Grenzwert für eine positive

Reaktion höher angesetzt werden.

Bei Patienten mit einem Immundefizit kann die Reaktion in bestimmten Fällen auch bei einer

Induration von unter 6 mm Durchmesser als positiv eingestuft werden.

Kontraindikationen

Überempfindlichkeitsreaktionen nach einem früheren Hauttest mit den Produkten Sensitin PPD oder

Tuberkulin PPD schliessen eine weitere Verwendung dieser Produkte aus.

Warnhinweise und Vorsichtsmassnahmen

Bei Personen, bei denen bei einem früheren Test mit den Produkten Tuberkulin PPD oder Sensitin

PPD schwere Hautreaktion aufgetreten sind, ist äusserste Vorsicht geboten.

Für jede Injektion eine neue Spritze verwenden. Angebrochene Behälter am gleichen Tag

aufbrauchen; bis zur Verwendung verschlossen bei +2° - +8°C aufbewahren und allfällige Reste

verwerfen.

Interaktionen

Impfungen mit Lebendimpfstoffen (zum Beispiel MMR-Impfung gegen Masern, Mumps und Röteln)

oder Virusinfektionen, wie Masern, HIV oder Grippe, können die Tuberkulinreaktion vorübergehend

abschwächen. Andere Erkrankungen, einschliesslich Krebs und Sarkoidose, können die Sensitivität

gegenüber Tuberkulin herabsetzen. Bei unterernährten oder immundefizienten Patienten kann die

Reaktion auf Tuberkulin PPD RT 23 SSI schwächer ausfallen als erwartet.

Personen mit aktiver Tuberkulose, deren Immunsystem durch die Turberkuloseinfektion schwer

geschwächt ist, können eine Reaktion von unter 6 mm zeigen.

Bei manchen Personen kann der Mantoux-Test positiv ausfallen, obwohl sie keine

Tuberkuloseinfektion haben oder hatten. Dies kann auf eine frühere BCG-Impfung oder Infektion

mit einem Nicht-Tuberkel-Mycobacterium, das offensichtlich keine Erkrankung ausgelöst hat,

zurückzuführen sein.

Schwangerschaft, Stillzeit

Der Tuberkulin-Test PPD RT 23 SSI kann während Schwangerschaft und Stillzeit durchgeführt

werden.

Wirkung auf die Fahrtüchtigkeit und auf das Bedienen von Maschinen

Nicht zutreffend.

Unerwünschte Wirkungen

Unmittelbar nach der Injektion können selten Schmerzen, Reizungen oder Unbehagen an der

Einstichstelle auftreten, die jedoch nach kurzer Zeit abklingen. Bei Personen, die auf Tuberkulin

extrem empfindlich reagieren, können an der Einstichstelle Bläschen oder Nekrosen auftreten. Es ist

auch über leicht erhöhte Temperatur oder Lymphknotenschwellungen berichtet worden.

Überdosierung

Nicht zutreffend.

Eigenschaften / Wirkungen

ATC-Code: V04CF01

Pharmakotherapeutische Gruppe: Tuberkulose-Diagnostika

Pharmakokinetik

Absorptions-, Distributions- oder Eliminationsstudien sind für dieses Produkt nicht sinnvoll und

wurden nicht durchgeführt.

Präklinische Daten

Tierexperimentelle Studien an Meerschweinchen und Kaninchen belegen, dass das im Präparat

enthaltene Detergens Polysorbat 80 (Tween 80) nicht zu einer Sensibilisierung führt. Die Ergebnisse

der Tierstudien wurden am Menschen bestätigt.

Sonstige Hinweise

Haltbarkeit

Das Präparat darf nach Ablauf des auf dem Behältnis und auf der äusseren Umhüllung angegebenen

Verfalldatums nicht mehr verwendet werden.

Besondere Lagerungshinweise

Die Lösungen Tuberkulin PPD RT 23 SSI sind gekühlt bei Temperaturen zwischen +2° und +8° C

und vor Licht geschützt aufzubewahren. Nach Entnahme der ersten Dosis ist die Ampulle wieder zu

verschliessen und bei einer Temperatur zwischen +2° und +8° C aufzubewahren. Die restliche

Lösung muss noch am selben Tag aufgebraucht werden; allfällige Reste sind zu verwerfen.

Zulassungsnummer

00641 (Swissmedic)

Packungen

1 Stechampulle mit 1,5ml Tuberkulin PPD RT 23 SSI Lösung 2 TE / 0,1ml

10 Stechampullen mit 1,5ml Tuberkulin PPD RT 23 SSI Lösung 2 TE / 0,1ml

Abgabekategorie B

Zulassungsinhaberin

Pro Farma AG, 6340 Baar

Herstellerin

Statens Serum Institut

Artillerivej 5

DK-2300 Kopenhagen S

Stand der Information

Februar 2016

  • 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/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/03/133 (Shire Orphan Therapies GmbH)

EU/3/03/133 (Shire Orphan Therapies GmbH)

EU/3/03/133 (Active substance: Icatibant acetate) - Transfer of orphan designation - Commission Decision (2018)6432 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/054/02/T/01

Europe -DG Health and Food Safety

1-10-2018

Gefitinib Mylan (Mylan S.A.S.)

Gefitinib Mylan (Mylan S.A.S.)

Gefitinib Mylan (Active substance: gefitinib) - Centralised - Authorisation - Commission Decision (2018)6406 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4826

Europe -DG Health and Food Safety

30-9-2018

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Active substance: edoxaban) - PSUSA - Modification - Commission Decision (2018)5089 of Sun, 30 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10387/201710

Europe -DG Health and Food Safety

26-9-2018

FORTEKOR PLUS (Elanco GmbH)

FORTEKOR PLUS (Elanco GmbH)

FORTEKOR PLUS (Active substance: pimobendan / benazepril) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6321 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2804/T/11

Europe -DG Health and Food Safety

26-9-2018

Comfortis (Elanco GmbH)

Comfortis (Elanco GmbH)

Comfortis (Active substance: Spinosad) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6323 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2233/T/18

Europe -DG Health and Food Safety

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

25-9-2018

Udenyca (ERA Consulting GmbH)

Udenyca (ERA Consulting GmbH)

Udenyca (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6290 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004413/0000

Europe -DG Health and Food Safety

25-9-2018

Voriconazole Hikma (Hikma FarmacEutica (Portugal), S.A.)

Voriconazole Hikma (Hikma FarmacEutica (Portugal), S.A.)

Voriconazole Hikma (Active substance: voriconazole) - Centralised - Yearly update - Commission Decision (2018)6286 of Tue, 25 Sep 2018

Europe -DG Health and Food Safety

25-9-2018

Inovelon (Eisai GmbH)

Inovelon (Eisai GmbH)

Inovelon (Active substance: Rufinamide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6283 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/660/T/48

Europe -DG Health and Food Safety

25-9-2018

Zonegran (Eisai GmbH)

Zonegran (Eisai GmbH)

Zonegran (Active substance: zonisamide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6285 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/577/T/90

Europe -DG Health and Food Safety

25-9-2018

Slenyto (RAD Neurim Pharmaceuticals EEC Limited)

Slenyto (RAD Neurim Pharmaceuticals EEC Limited)

Slenyto (Active substance: melatonin) - Centralised - Authorisation - Commission Decision (2018)6223 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4425

Europe -DG Health and Food Safety

25-9-2018

Brilique (AstraZeneca AB)

Brilique (AstraZeneca AB)

Brilique (Active substance: ticagrelor) - PSUSA - Modification - Commission Decision (2018)6282 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1241/PSUSA/2948/201712

Europe -DG Health and Food Safety

25-9-2018

Fycompa (Eisai GmbH)

Fycompa (Eisai GmbH)

Fycompa (Active substance: Perampanel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6280 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002434/T/0040

Europe -DG Health and Food Safety

25-9-2018

Opsumit (Janssen-Cilag International NV)

Opsumit (Janssen-Cilag International NV)

Opsumit (Active substance: macitentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6279 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002697/T/0028

Europe -DG Health and Food Safety

25-9-2018

Imfinzi (AstraZeneca AB)

Imfinzi (AstraZeneca AB)

Imfinzi (Active substance: durvalumab) - Centralised - Authorisation - Commission Decision (2018)6289 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004771/0000

Europe -DG Health and Food Safety

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

Pelgraz (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6288 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/003961/0000

Europe -DG Health and Food Safety

24-9-2018

Kanuma (Alexion Europe SAS)

Kanuma (Alexion Europe SAS)

Kanuma (Active substance: sebelipase alfa) - Centralised - Yearly update - Commission Decision (2018)6245 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

NeuroBloc (Sloan Pharma S.a.r.l.)

NeuroBloc (Sloan Pharma S.a.r.l.)

NeuroBloc (Active substance: Botulinum Toxin Type B) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6221 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000301/T/0101

Europe -DG Health and Food Safety

24-9-2018

Renvela (Genzyme Europe B.V.)

Renvela (Genzyme Europe B.V.)

Renvela (Active substance: sevelamer (carbonate)) - Centralised - Variation - Commission Decision (2018)6225 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/993/X/39

Europe -DG Health and Food Safety

24-9-2018

Deferiprone Lipomed (Lipomed GmbH)

Deferiprone Lipomed (Lipomed GmbH)

Deferiprone Lipomed (Active substance: Deferiprone) - Centralised - Authorisation - Commission Decision (2018)6233 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4710

Europe -DG Health and Food Safety

24-9-2018

Blitzima (Celltrion Healthcare Hungary Kft.)

Blitzima (Celltrion Healthcare Hungary Kft.)

Blitzima (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6228 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Inhixa (Techdow Europe AB)

Inhixa (Techdow Europe AB)

Inhixa (Active substance: enoxaparin sodium) - Centralised - Variation - Commission Decision (2018)6101 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4264/X/18, 26

Europe -DG Health and Food Safety

24-9-2018

Sevelamer carbonate Zentiva (Genzyme Europe B.V.)

Sevelamer carbonate Zentiva (Genzyme Europe B.V.)

Sevelamer carbonate Zentiva (Active substance: Sevelamer carbonate) - Centralised - Variation - Commission Decision (2018)6214 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3971/X/11

Europe -DG Health and Food Safety

24-9-2018

Rixathon (Sandoz GmbH)

Rixathon (Sandoz GmbH)

Rixathon (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6230 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Rasilez (Noden Pharma DAC)

Rasilez (Noden Pharma DAC)

Rasilez (Active substance: aliskiren) - Centralised - Yearly update - Commission Decision (2018)6229 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Cinqaero (Teva B.V.)

Cinqaero (Teva B.V.)

Cinqaero (Active substance: reslizumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6218 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3912T/18

Europe -DG Health and Food Safety