Thiotepa Fresenius Kabi 15 mg powder for concentrate for solution for infusion

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Thiotepa

Tilgjengelig fra:

Fresenius Kabi Deutschland GmbH

ATC-kode:

L01AC01

INN (International Name):

Thiotepa

Legemiddelform:

Powder for concentrate for solution for infusion

Terapeutisk område:

thiotepa

Autorisasjon status:

Not marketed

Autorisasjon dato:

2023-05-05

Informasjon til brukeren

Black
Request No.:
Dimension:
592 x 300 mm
NR-PH-0012690-2023-Mar
Product:
Font Size:
10 Pt.
THIOTEPA LYO
Market:
Packing:
Pack Insert
UK/Ireland
Artworks No.:
Supersede No.:
NA
Mockup
Date:
Version:
04
07 December 2023
Others:
Note: Details, Braille, Emboss, Die/Dash-Line, Unvarnished Area are
technical information which are not required to print.
Folding Size: 60 x 33 mm. Mockup for submission purpose only.
The following information
is intended for healthcare
professionals only.
PREPARATION GUIDE
THIOTEPA FRESENIUS KABI
15 MG POWDER FOR CONCENTRATE
FOR SOLUTION FOR INFUSION
THIOTEPA FRESENIUS KABI
100 MG POWDER FOR CONCENTRATE
FOR SOLUTION FOR INFUSION
Thiotepa
Read this guide prior to the
preparation and administration of
Thiotepa Fresenius Kabi .
1. PRESENTATION
Thiotepa Fresenius Kabi is
supplied as 15 mg and 100
mg powder for concentrate for
solution for infusion. Thiotepa
must be reconstituted and
diluted prior to administration.
2. SPECIAL PRECAUTIONS
FOR DISPOSAL AND
OTHER HANDLING
General
Procedures for proper handling
and disposal of anticancer
medicinal products should
be considered. All transfer
procedures require strict
adherence to aseptic techniques,
preferably employing a vertical
laminar flow safety hood.
As with other cytotoxic
compounds, caution need to
be exercised in handling and
preparation of thiotepa solutions
to avoid accidental contact with
skin or mucous membranes.
Topical reactions associated
with accidental exposure to
thiotepa may occur. In fact, the
use of gloves is recommended
in preparing the solution for
infusion. If thiotepa solution
accidentally contacts the skin,
immediately the skin must be
thoroughly washed with soap
and water. If thiotepa accidentally
contacts mucous membranes,
they must be flushed thoroughly
with water.
Calculation of dose and posology
in paediatric & adult patients
See section 4.2 of the SPC for the
calculation of dose and posology
in paediatric & adult patients.
Reconstitution
Thiotepa Fresenius Kabi 15 mg
powder for concentrate for
solution for infusio

Preparatomtale

Health Products Regulatory Authority
05 May 2023
CRN00C1DM
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Thiotepa Fresenius Kabi 15 mg powder for concentrate for solution for
infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of powder contains 15 mg thiotepa.
After reconstitution with 1.5 ml of water for injections, each ml of
solution contains 10 mg thiotepa (10 mg/ml).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White powder or cake
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Thiotepa Fresenius Kabi is indicated, in combination with other
chemotherapy medicinal products:

with or without total body irradiation (TBI), as conditioning
treatment prior to allogeneic or autologous
haematopoietic progenitor cell transplantation (HPCT) in
haematological diseases in adult and paediatric patients;

when high dose chemotherapy with HPCT support is appropriate for the
treatment of solid tumours in adult and
paediatric patients.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Thiotepa administration must be supervised by a physician experienced
in conditioning treatment prior to haematopoietic
progenitor cell transplantation.
Posology
Thiotepa is administered at different doses, in combination with other
chemotherapeutic medicinal products, in patients with
haematological diseases or solid tumours prior to HPCT.
Thiotepa posology is reported, in adult and paediatric patients,
according to the type of HPCT (autologous or allogeneic) and
disease.
_Adults_
_AUTOLOGOUS HPCT _
_ _
_Haematological diseases_
The recommended dose in haematological diseases ranges from 125 mg/m
2
/day (3.38 mg/kg/day) to 300 mg/m
2
/day (8.10
mg/kg/day) as a single daily infusion, administered from 2 up to 4
consecutive days before autologous HPCT depending on the
combination with other chemotherapeutic medicinal products, without
exceeding the total maximum cumulative dose of 900
mg/m
2
(24.32 mg/kg), during the time of