Solvent-Diluent (For Melphalan Injection)
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
SOLVENT-DILUENT (for Melphalan Injection)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
No active ingredient present
3 PHARMACEUTICAL FORM
Liquid for reconstitution of Melphalan
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
The Solvent-Diluent is used to reconstitute Melphalan Injection.
4.2 Posology and method of administration
The reconstituted injection is administered by infusion.
4.3 Contraindications
Not Applicable.
4.4 Special warnings and precautions for use
Not Applicable.
The label for this product will contain the following statements:
Keep out of the reach of children.
Store below 30°C Do not refrigerate.
Protect from light
4.5 Interaction with other medicinal products and other forms of interaction
Not Applicable.
4.6 Fertility, Pregnancy and lactation
Not Applicable.
4.7 Effects on ability to drive and use machines
Not Applicable.
4.8 Undesirable effects
Not Applicable.
4.9 Overdose
Not Applicable.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not Applicable.
5.2 Pharmacokinetic properties
Not Applicable.
5.3 Preclinical safety data
Not Applicable.
6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Excipient Sodium citrate
Specification
Ph.Eur
7.
8
Propylene glycol Ethanol (96%) Water for injections
Ph.Eur
BP
Ph.Eur
Incompatibilities
Not Applicable.
Shelf life
36 months
Special precautions for storage
Store below 30°C, protect from light, do not refrigerate.
Nature and contents of container
Clear neutral glass vial and chlorobutyl rubber stopper or fluoro-resin butyl rubber stopper with aluminium collar.
Pack size: 10 ml
Special precautions for disposal
Not Applicable.
Marketing Authorisation Holder
Aspen Pharma Trading Limited 3016 Lake Drive,
Citywest Business Campus,
Dublin 24,
Ireland.
MARKETING AUTHORISATION NUMBER(S)
PL 39699/0040
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
18 January 2004
10 DATE OF REVISION OF THE TEXT
29/10/2014