Tuberkulin PPD RT 23 SSI

Hauptinformation

  • Handelsname:
  • Tuberkulin PPD RT 23 SSI 2TE/0.1 ml, Injektionslösung
  • Darreichungsform:
  • 2TE/0.1 ml, Injektionslösung
  • Zusammensetzung:
  • tuberculinum (PPD RT 23) 0.4 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 2TE/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: dosierung, wechselwirkungen, nebenwirkungen

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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Europe -DG Health and Food Safety

14-3-2019


Orphan designation: Itraconazole, Treatment of naevoid basal-cell carcinoma syndrome (Gorlin syndrome), 23/08/2017, Positive

Orphan designation: Itraconazole, Treatment of naevoid basal-cell carcinoma syndrome (Gorlin syndrome), 23/08/2017, Positive

Orphan designation: Itraconazole, Treatment of naevoid basal-cell carcinoma syndrome (Gorlin syndrome), 23/08/2017, Positive

Europe - EMA - European Medicines Agency

13-3-2019

Luminity (Lantheus EU Limited)

Luminity (Lantheus EU Limited)

Luminity (Active substance: perflutren) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2049 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/654/T/27

Europe -DG Health and Food Safety

13-3-2019

Qarziba (EUSA Pharma (Netherlands) B.V.)

Qarziba (EUSA Pharma (Netherlands) B.V.)

Qarziba (Active substance: dinutuximab beta) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2061 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3918/T/10

Europe -DG Health and Food Safety

13-3-2019

Cresemba (Basilea Pharmaceutica Deutschland GmbH)

Cresemba (Basilea Pharmaceutica Deutschland GmbH)

Cresemba (Active substance: isavuconazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2069 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2734/T/20

Europe -DG Health and Food Safety

13-3-2019

Stayveer (Janssen Pharmaceutica N.V.)

Stayveer (Janssen Pharmaceutica N.V.)

Stayveer (Active substance: bosentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2065 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2644/T/25

Europe -DG Health and Food Safety

13-3-2019

Varuby (TESARO Bio Netherlands B.V.)

Varuby (TESARO Bio Netherlands B.V.)

Varuby (Active substance: rolapitant) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2068 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4196/T/15

Europe -DG Health and Food Safety

13-3-2019

Senshio (Shionogi B.V.)

Senshio (Shionogi B.V.)

Senshio (Active substance: ospemifene) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2066 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2780/T/26

Europe -DG Health and Food Safety

13-3-2019

Slenyto (RAD Neurim Pharmaceuticals EEC SARL)

Slenyto (RAD Neurim Pharmaceuticals EEC SARL)

Slenyto (Active substance: melatonin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2064 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4425/T/04

Europe -DG Health and Food Safety

13-3-2019

Actrapid (Novo Nordisk A/S)

Actrapid (Novo Nordisk A/S)

Actrapid (Active substance: Insulin human (rDNA)) - Centralised - Yearly update - Commission Decision (2019)2070 of Wed, 13 Mar 2019

Europe -DG Health and Food Safety

13-3-2019

Herceptin (Roche Registration GmbH)

Herceptin (Roche Registration GmbH)

Herceptin (Active substance: trastuzumab) - Centralised - Yearly update - Commission Decision (2019) 2059 of Wed, 13 Mar 2019

Europe -DG Health and Food Safety

13-3-2019

INOmax (Linde Healthcare AB)

INOmax (Linde Healthcare AB)

INOmax (Active substance: Nitric oxide) - Centralised - Yearly update - Commission Decision (2019)2060 of Wed, 13 Mar 2019

Europe -DG Health and Food Safety

13-3-2019

Ferriprox (Apotex Europe B.V.)

Ferriprox (Apotex Europe B.V.)

Ferriprox (Active substance: Deferiprone) - Centralised - 2-Monthly update - Commission Decision (2019)2057 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/236/II/0126/G

Europe -DG Health and Food Safety

13-3-2019

Praluent (Sanofi-Aventis groupe)

Praluent (Sanofi-Aventis groupe)

Praluent (Active substance: alirocumab) - Centralised - 2-Monthly update - Commission Decision (2019)2058 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3882/II/0042

Europe -DG Health and Food Safety

12-3-2019

Quinolone and fluoroquinolone medicinal products for systemic and inhalation use

Quinolone and fluoroquinolone medicinal products for systemic and inhalation use

Quinolone and fluoroquinolone medicinal products for systemic and inhalation use (Active substance: nalidixic acid, pipemidic acid, cinoxacin, enoxacin, pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin, rufloxacin, flumequine) - Community Referrals - Art 31 - Commission Decision (2019)2050 of Tue, 12 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1452/C/2789

Europe -DG Health and Food Safety

11-3-2019

EU/3/14/1337 (ESPL Regulatory Consulting Limited)

EU/3/14/1337 (ESPL Regulatory Consulting Limited)

EU/3/14/1337 (Active substance: Acamprosate calcium) - Transfer of orphan designation - Commission Decision (2019)1944 of Mon, 11 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004283

Europe -DG Health and Food Safety

8-3-2019

EU/3/12/968 (Clinical Network Services (NL) B.V.)

EU/3/12/968 (Clinical Network Services (NL) B.V.)

EU/3/12/968 (Active substance: Human monoclonal antibody targeting Staphylococcus aureus alpha-toxin) - Transfer of orphan designation - Commission Decision (2019)1940 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004447

Europe -DG Health and Food Safety

8-3-2019

EU/3/17/1894 (Granzer Regulatory Consulting and Services)

EU/3/17/1894 (Granzer Regulatory Consulting and Services)

EU/3/17/1894 (Active substance: Recombinant human antibody directed against misfolded human superoxide dismutase 1) - Transfer of orphan designation - Commission Decision (2019)1943 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004025

Europe -DG Health and Food Safety

8-3-2019

EU/3/14/1281 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/14/1281 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/14/1281 (Active substance: 1-(2,2-difluoro-1,3-benzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl}cyclopropanecarboxamide) - Transfer of orphan designation - Commission Decision (2019)1953 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004132

Europe -DG Health and Food Safety

8-3-2019

EU/3/08/563 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/08/563 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/08/563 (Active substance: Recombinant derivative of C3 transferase) - Transfer of orphan designation - Commission Decision (2019)1952 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004115

Europe -DG Health and Food Safety

8-3-2019

EU/3/15/1487 (Leadiant GmbH)

EU/3/15/1487 (Leadiant GmbH)

EU/3/15/1487 (Active substance: Reduced oxydised N-acetyl heparin) - Transfer of orphan designation - Commission Decision (2019)1951 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004452

Europe -DG Health and Food Safety

8-3-2019

EU/3/16/1757 (Imago BioSciences B.V.)

EU/3/16/1757 (Imago BioSciences B.V.)

EU/3/16/1757 (Active substance: N-[(2S)-5-{[(1R,2S)-2-(4-fluorophenyl)cyclopropyl]amino}-1-(4-methylpiperazin-1-yl)-1-oxopentan-2-yl]-4-(1H-1,2,3-triazol-1-yl)benzamide, bis-tosylate salt) - Transfer of orphan designation - Commission Decision (2019)1954 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003424

Europe -DG Health and Food Safety

8-3-2019

EU/3/06/381 (Clinical Network Services (NL) B.V.)

EU/3/06/381 (Clinical Network Services (NL) B.V.)

EU/3/06/381 (Active substance: Human monoclonal antibody against Pseudomonas aeruginosa serotype O11) - Transfer of orphan designation - Commission Decision (2019)1941 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004486

Europe -DG Health and Food Safety

8-3-2019

EU/3/14/1285 (Clinuvel Europe Limited)

EU/3/14/1285 (Clinuvel Europe Limited)

EU/3/14/1285 (Active substance: Afamelanotide) - Transfer of orphan designation - Commission Decision (2019)1950 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004300

Europe -DG Health and Food Safety

8-3-2019

EU/3/09/648 (Clinuvel Europe Limited)

EU/3/09/648 (Clinuvel Europe Limited)

EU/3/09/648 (Active substance: Afamelanotide) - Transfer of orphan designation - Commission Decision (2019)1949 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004299

Europe -DG Health and Food Safety

8-3-2019

EU/3/08/545 (Clinuvel Europe Limited)

EU/3/08/545 (Clinuvel Europe Limited)

EU/3/08/545 (Active substance: [Nle4, D-Phe7]-alpha-melanocyte stimulating hormone) - Transfer of orphan designation - Commission Decision (2019)1948 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004293

Europe -DG Health and Food Safety

8-3-2019

EU/3/08/541 (Clinuvel Europe Limited)

EU/3/08/541 (Clinuvel Europe Limited)

EU/3/08/541 (Active substance: [Nle4, D-Phe7]-alpha-melanocyte stimulating hormone) - Transfer of orphan designation - Commission Decision (2019)1947 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004019

Europe -DG Health and Food Safety

8-3-2019

EU/3/14/1404 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1404 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1404 (Active substance: 1-(2-isopropoxyethyl)-2-thioxo-1,2,3,5-tetrahydro-pyrrolo[3,2-d]pyrimidin-4-one) - Transfer of orphan designation - Commission Decision (2019)1942 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004496

Europe -DG Health and Food Safety