1. Name Of The Medicinal Product
SOLVENT-DILUENT (for Alkeran Injection)
2. Qualitative And Quantitative Composition
No active ingredient present
3. Pharmaceutical Form
Liquid for reconstitution of Alkeran
4. Clinical Particulars
4.1 Therapeutic Indications
The Solvent-Diluent is used to reconstitute Alkeran 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 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
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6.2 Incompatibilities
Not Applicable.
6.3 Shelf Life
36 months
6.4 Special Precautions For Storage
Store below 30° C, protect from light, do not refrigerate.
6.5 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
6.6 Special Precautions For Disposal And Other Handling
Not Applicable.
Administrative Data
7. Marketing Authorisation Holder
The Wellcome Foundation Ltd
Greenford
Middlesex UB6 0NN
trading as:
GlaxoSmithKline UK
Stockley Park West
Uxbridge
Middlesex UB11 1BT
8. Marketing Authorisation Number(S)
PL 00003/0324
9. Date Of First Authorisation/Renewal Of The Authorisation
19 January 2005
10. Date Of Revision Of The Text
08 July 2003
11. Legal Status
POM
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