TRECONDI® INDICATION
TRECONDI®, in combination with fludarabine, is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT) in adult patients and in paediatric patients older than one month with malignant and non-malignant diseases.
Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk.
Adverse events should also be reported to medac drug safety at: drugsafety@medac.de
TRECONDI® PRODUCT CHARACTERISTICS1
- Powder for solution for infusion
- Active ingredient is treosulfan
- Shelf life of 5 years for unopened vials
- Unopened vials have no special storage conditions
- After reconstitution with 0.45% sodium chloride solution, chemical and physical stability has been demonstrated for 3 days at 25°C3
- Do not store reconstituted solutions in a refrigerator (2°C to 8°C) as this might cause precipitation
- 2 hour infusion time
INSTRUCTIONS FOR USE
Instructions for reconstitution of TRECONDI®1
1. TRECONDI® is reconstituted in its original glass container. Reconstituted TRECONDI® solutions can be combined into larger vials, PVC bags or PE bags.
2. Warm the solvent, sodium chloride 4.5mg/mL (0.45%) solution, to 25°C – 30°C (not higher), for example by using a water bath.
3. Remove the TRECONDI® powder carefully from the inner surface of the vial by shaking. That action is very important as powder attached to the surface causes clumping. If so, the vial must be vigorously shaken so that the clumping dissolves.
4. Reconstitute each vial of TRECONDI® containing 1g treosulfan in 20mL of pre-warmed (maximum 30°C) sodium chloride 4.5mg/mL (0.45%) solution by shaking. Reconstitute each vial of TRECONDI® containing 5g treosulfan in 100mL of pre-warmed (maximum 30°C) sodium chloride 4.5mg/mL (0.45%) solution by shaking.
ADDITIONAL INFORMATION FOR RECONSTITUTION
- For the preparation of a 0.45% sodium chloride solution equivalent volumes of 0.9% sodium chloride solution (9mg/ml) and water for injection can be mixed.1
- Alternatively commercially available products may also be used.
- The reconstituted solution contains 50mg treosulfan per mL and appears as a clear colourless solution. Solutions showing any sign of precipitation should not be used.1
- If sterile filtration during cytostatic preparation is necessary: polytetrafluoroethylene filters are compatible with TRECONDI®.3
TRECONDI® has mutagenic and carcinogenic potential. Remnants of the medicinal product as well as all materials that have been used for reconstitution and administration must be destroyed according to standard procedures applicable to antineoplastic agents, with due regard to current laws related to the disposal of hazardous waste.1
References
1. Trecondi® Summary of Product Characteristics (SmPC)
2. www.nice.org.uk/guidance/ta640
3. Data on File
ORDERING TRECONDI®
TRECONDI® is available from Alloga
Tel: +44 (0)1773 441 702
Alloga product codes:
1g – USP6843 – GB Customers 1g – USP8873 – NI Customers
5g – USP6845 – GB Customers 5g – USP8875 – NI Customers
CONTACT US
TRECONDI® National Account Manager
Jane McNeil
Mobile: 07795 614282
Email: jane.mcneil@medacpharma.co.uk
Medicines Information
For enquiries about Trecondi®, please contact the Medicines Information Department at medac Pharma LLP.
Tel: +44 (0)1786 458086
Email: info@medacpharma.co.uk
Our normal enquiry service is available from 9am to 5pm Monday to Friday. However, we do offer an emergency service outside these hours for urgent enquiries.