CYCLOPHOSPHAMIDE Powder for solution for injection/infusion

Active ingredients: Cyclophosphamide

Product name and form

Cyclophosphamide 1000 mg Powder for Solution for Injection or Infusion.

Pharmaceutical Form

Powder for solution for injection/infusion.

White crystalline powder.

Qualitative and quantitative composition

Each vial of Cyclophosphamide 1000 mg Powder for Solution for Injection or Infusion contains 1069.0 mg cyclophosphamide monohydrate equivalent to 1000 mg cyclophosphamide.

Strength after reconstitution: 20 mg cyclophosphamide (anhydrous)/ml solution (for reconstitution volumes, see 6.6.).

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Cyclophosphamide has been demonstrated to have a cytostatic effect in many tumour types. The active metabolites of cyclophosphamide are alkylating agents which transfer alkyl groups to DNA during the process of cell division, thus preventing normal synthesis of DNA.

List of Excipients

None.

Pack sizes and marketing

Cyclophosphamide, Powder for Solution for Injection or Infusion, is available in the following pack sizes: 1, 5 or 10 clear colourless 100 ml Type I-glass vials containing 1000 mg cyclophosphamide sealed with bromobutyl rubber stopper, and secured with a flip-off seal with a sea green PP button

Not all pack sizes may be marketed.

Vials are packed with or without a protective plastic overwrap (Onco-Safe). “Onco-Safe” does not come into contact with the medicinal product and provides additional transport protection, which increases the safety for the medical and pharmaceutical personnel.

Marketing authorization holder

Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

Marketing authorization dates and numbers

PL 04416/1394

Date of first authorisation: 18 August 2014