Fentamed 50 Mikrogramm/ml - Injektionslösung

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21-06-2019

Fachinformation Fachinformation (SPC)

21-06-2019

Wirkstoff:
FENTANYLCITRAT
Verfügbar ab:
Actavis Group PTC ehf
ATC-Code:
N02AB03
INN (Internationale Bezeichnung):
fentanyl citrate
Einheiten im Paket:
5 x 2 ml, Laufzeit: 36 Monate,5 x 10 ml, Laufzeit: 36 Monate,10 x 2 ml, Laufzeit: 36 Monate,10 x 10 ml, Laufzeit: 36 Monate,5 x
Verschreibungstyp:
Arzneimittel zur Abgabe gegen besondere aerztliche Verschreibung, Suchtgifte
Therapiebereich:
Opioid anesthetics
Produktbesonderheiten:
Abgabe durch eine (öffentliche) Apotheke
Zulassungsnummer:
1-23250
Berechtigungsdatum:
1999-10-13

Lesen Sie das vollständige Dokument

Bundesamt für Sicherheit im Gesundheitswesen, Traisengasse 5, A-1200 Wien

www.ages.at, DVR: 2112611, Konto Nr.: 50670 871 619

BLZ: 12000, IBAN: AT971200050670871619; UID: ATU 54088605, BIC/SWIFT: BKAUATWW

1 von 1

Die gegenständliche Arzneispezialität wurde in einem europäischen Zulassungsverfahren

geprüft.

Die Vermarktung des Produktes in Österreich ist derzeit seitens des Zulassungsinhabers nicht

geplant, daher liegen zur Zeit keine deutschsprachigen Übersetzungen der Fach- und

Gebrauchsinformation vor.

Traisengasse 5, 1200 Wien

Bundesamt für Sicherheit im Gesundheitswesen, Traisengasse 5, A-1200 Wien

www.ages.at, DVR: 2112611, Konto Nr.: 50670 871 619

BLZ: 12000, IBAN: AT971200050670871619; UID: ATU 54088605, BIC/SWIFT: BKAUATWW

1 von 1

Die gegenständliche Arzneispezialität wurde in einem europäischen Zulassungsverfahren

geprüft.

Die Vermarktung des Produktes in Österreich ist derzeit seitens des Zulassungsinhabers nicht

geplant, daher liegen zur Zeit keine deutschsprachigen Übersetzungen der Fach- und

Gebrauchsinformation vor.

Traisengasse 5, 1200 Wien

Lesen Sie das vollständige Dokument

CMDh/223/2005

February 2014

Public Assessment Report

Scientific discussion

Fentamed 50 Mikrogramm/ml - Injektionslösung

Fentanyl citrate

AT/H/0114/001/MR

Date: 03.10.2016

This module reflects the scientific discussion for the approval of Fentamed 50

Mikrogramm/ml - Injektionslösung. The procedure was finalised at 25.07.2000.

For

information on changes after this date please refer to the module ‘Update’.

I.

INTRODUCTION

Based on the review of the quality, safety and efficacy data, the Member States have granted a

marketing authorisation for Fentamed 50 Mikrogramm/ml- Injektionslösung, from Actavis

Group PTC ehf (former: Pharma Hameln Gmbh).

Fentanyl is a short acting opioid used

- for neurolept analgesia and neurolept anaesthesia

- as an analgesic component in general anaesthesia with intubation and

ventilation of the patient

- for analgesic treatment in the intensive care unit in patients under the

condition of assisted ventilation.

A comprehensive description of the indications and posology is given in the SmPC.

marketing

authorisation

been

granted

pursuant

Article

Directive

2001/83/EC.

Fentanyl is a potent opioid analgesic (ATC-code: N02A B03) which may be used as an

analgesic supplement with general anaesthesia or as an anaesthetic agent alone.

II.

QUALITY ASPECTS

II.1

Introduction

Fentamed 50 Mikrogramm/ml- Injektionslösung is a solution for injection which is presented

in an ampoule made of colourless glass.

II.2

Drug Substance

The active substance in Fentamed 50 Mikrogramm/ml- Injektionslösung is fentanyl citrate.

The specification of the active substance meets the current scientific requirements. The

adequate quality of the active substance has been shown by submitting the appropriate control

data. The stability of the active substance has been tested under ICH conditions. The results of

the stability studies support the established retest-period.

II.3

Medicinal Product

Fentamed 50 Mikrogramm/ml- Injektionslösung contains the following excipients:

Sodium chloride

Water for injection

Hydrochloric acid or sodium hydroxide for pH adjustment

The development of the product has been sufficiently made and deemed appropriate. The

usage of all the excipients has been described.

The release specification includes the check of all parameters relevant to this pharmaceutical

form. Appropriate data concerning the control of the finished product support the compliance

with the release specifications.

The packaging of the medicinal product complies with the current legal requirements.

Stability studies under ICH conditions have been performed and data presented support the

shelf life claimed in the SmPC, with a shelf life of 36 months when stored in the original

package to protect from light.

The pharmaceutical quality of Fentamed 50 Mikrogramm/ml- Injektionslösung has been

adequately shown.

II.4

Discussion on chemical, pharmaceutical and biological aspects

Information on development, manufacture and control of active substance and medicinal

product has been presented in a satisfactory manner. The results of tests carried out indicate

satisfactory consistency and uniformity of important product quality characteristics.

III.

NON-CLINICAL ASPECTS

Pharmacodynamic, pharmacokinetic and toxicological properties of fentanyl citrate are well

known. As fentanyl citrate is a widely used, well-known active substance, the applicant has

not provided additional studies and further studies are not required. Overview based on

literature review is, thus, appropriate.

IV.

CLINICAL ASPECTS

IV.1

Introduction

The present application represents a bibliographical application according to Directive 65/65

EEC article 4.8 (a) (ii). Moreover the product is essentially similar to other intravenous

injection fluids containing fentanyl.

No specific clinical studies are therefore required.

IV.2

Pharmacokinetics

No new data have been submitted and none are required for this application.

IV.3

Pharmacodynamics

pharmacodynamic

profile

fentanyl

citrate

well

established.

additional

pharmacodynamic study has been submitted by the applicant and none is required.

IV.4

Clinical efficacy / Clinical safety

This submission is a generic application; therefore no new data on clinical efficacy or safety

have been provided and none are required.

IV.5

Discussion on the clinical aspects

The clinical overview on the clinical pharmacology, efficacy and safety is adequate.

V.

OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND

RECOMMENDATION

The pharmaceutical quality of Fentamed 50 Mikrogramm/ml- Injektionslösung has been

adequately shown.

There are no non-clinical or clinical concerns.

The benefit/risk relation is considered positive.

This module reflects the procedural steps and scientific information after the finalisation of the

initial procedure.

Scope

Procedure number

Product Information affected

Date of start of the procedure

Renewal of the marketing

authorisation

AT/H/0114/001/N001

30.07.2004

Date of end of

procedure

Approval/

non approval

Assessment report

attached

28.10.2004

Approved

Scope

Procedure number

Product Information affected

Date of start of the procedure

Renewal of the marketing

authorisation

AT/H/0114/001/R/002

16.04.2010

Date of end of

procedure

Approval/

non approval

Assessment report

attached

19.05.2011

Approved

Scope

Procedure number

Product Information affected

Date of start of the procedure

Update of PI with warnings of

Serotonin Syndrome, QRD and

further amendments

AT/H/0114/001/II/008

26.09.2014

Date of end of

procedure

Approval/

non approval

Assessment report

attached

24.11.2014

Approved

Scope

Procedure number

Product Information affected

Date of start of the procedure

Actavis signal assessment report

(PhV-20150460) to add

‘Cough’ as an Adverse Drug

Reaction (ADR).

AT/H/0114/001/II/010

12.11.2015

Date of end of

procedure

Approval/

non approval

Assessment report

attached

22.12.2015

Approved

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