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Conditioning
with Confidence
in AlloHSCT
(allogeneic haematopoietic stem cell transplantation)
Prescribing InformationAdverse 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
Most common adverse events in adult patients (all grades): Infections, sepsis, Myelosuppression, pancytopenia, Febrile Neutropenia, Hypersensitivity, Decreased appetite, Insomnia, Headache, dizziness, Cardiac arrhythmias (e.g. atrial fibrillation, sinus arrhythmia), Hypertension, hypotension, flushing, Dyspnoea, epistaxis, Stomatitis/mucositis, diarrhoea, nausea, vomiting, Oral pain, gastritis, dyspepsia, constipation, dysphagia, abdominal pain, oesophageal or gastrointestinal pain, Maculo-papular rash, purpura, erythema, palmar-plantar erythrodysaesthesia syndrome, pruritus, alopecia, Pain in extremity, back pain, bone pain, Arthralgia, Acute kidney injury, haematuria, Asthenic conditions (fatigue, asthenia, lethargy), Oedema, pyrexiae, chills, Blood bilirubin increased, Transaminases (ALT/AST) increased, γ GT. increased, C-reactive protein increased, weight decreased, weight increased.
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.3
TRECONDI® Product Characteristics3
- 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®3
- TRECONDI® is reconstituted in its original glass container. Reconstituted TRECONDI® solutions can be combined into larger vials, PVC bags or PE bags.
- 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.
- 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.
- 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.3
- 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.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.3
From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
Ordering TRECONDI®
TRECONDI® is available from Alloga
Tel: +44 (0)1773 441 702
Alloga product codes:
| UK Customers | |
|---|---|
| 1g | USP6843 |
| 5g | USP6845 |
Contact Us
National Account Manager
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.