Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
 

0.25 mg vial

Yondelis 0.25 mg powder for concentrate for solution for infusion.

1 mg vial

Yondelis 1 mg powder for concentrate for solution for infusion.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
0.25 mg vial

Each vial contains 0.25 mg of trabectedin.

1 mg vial

Each vial contains 1 mg of trabectedin.

0.25 mg and 1 mg vials

1 ml of reconstituted solution contains 0.05 mg of trabectedin.

Excipients:

0.25 mg vial

Each vial contains 2 mg of potassium and 0.1 g of sucrose.

1 mg vial

Each vial contains 8 mg of potassium and 0.4 g of sucrose.

0.25 mg and 1 mg vials

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Powder for concentrate for solution for infusion.

White to off-white powder.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Yondelis is indicated for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines