ter EXP. The expiry date refers to the last day of that month.
Store and transport refrigerated (2°C-8°C).
Do not freeze.
After reconstitution the product is stable for 8 hours when stored at 2°C -8°C.
After dilution the product is stable for 24 hours when stored at 2°C -8°C. From a microbiological point of view, the product should be used immediately.
Any unused product or waste material should be disposed of in accordance with local requirements.
Further information
What TEPADINA contains
■The active substance is thiotepa. One vial contains 15 mg thiotepa. After reconstitution, each ml contains 10 mg thiotepa (10 mg/ml).
■TEPADINA does not contain any other ingredients.
What TEPADINA looks like and contents of the pack
TEPADINA is a white crystalline powder supplied in a glass vial containing 15 mg thiotepa.
Each carton contains 1 vial.
Marketing Authorisation Holder
ADIENNE S.r.l.
Via Broseta 64/B
24128 Bergamo
Italy
+39 035 19964047
adienne@adienne.com
Manufacturer
RIEMSER Arzneimittel AG
7 An der Wiek
17493 Greifswald
Insel Riems
Germany
This leaflet was last approved in: {MM/YYYY}
The following information is intended for medical or healthcare professionals only.
PREPARATION GUIDE
TEPADINA 15 mg powder for concentrate for solution for infusion
Thiotepa
Read this guide prior to the preparation and administration of TEPADINA.
1. PRESENTATION
TEPADINA is supplied as 15 mg powder for concentrate for solution for infusion. TEPADINA 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 TEPADINA 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 of TEPADINA
TEPADINA is administered at different doses in combination with other chemotherapeutic medicinal products in patients prior to conventional haematopoietic progenitor cell transplantation (HPCT) for haematological diseases or solid tumours.
TEPADINA posology is reported, in adult and paediatric patients, according to the type of HPCT (autologous or allogeneic) and disease.
Posology in 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 the entire conditioning treatment.
LYMPHOMA
The recommended dose 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 dail |
