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CAVERJECT Powder for solution for injection (2017)

Active ingredients: Alprostadil

Product Name and Form

Caverject 20 micrograms powder for solution for injection.

Pharmaceutical form

Powder for solution for injection.

A white to off-white powder.

Qualitative and Quantitative Composition

Alprostadil 20 micrograms.

When reconstituted, each 1ml delivers a dose of 20 micrograms of alprostadil.

Excipients with known effect:

Each 1ml of reconstituted solution contains 8.04 mg of benzyl alcohol.

Sodium

For the full list of excipients, see section 6.1.

Chemical substance
Description
Alprostadil

Alprostadil is chemically identical to prostaglandin E1, the actions of which include vasodilatation of blood vessels in the erectile tissues of the corpora cavernosa and increase in cavernosal artery blood flow, causing penile rigidity.

List of excipients

Lactose monohydrate
Sodium citrate
α-cyclodextrine
Hydrochloric acid for pH adjustment
Sodium hydroxide for pH adjustment

Pack sizes and Marketing

Single pack containing a 5 ml clear, colourless, glass vial of Caverject 20 micrograms powder with a bromobutyl rubber stopper and an aluminium overseal with polypropylene flip-off cap.

Packs also each contain a syringe of solvent, a sterile 22G and a 30G needle plus a preinjection swab.

Marketing authorization holder
Authorization dates

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

4 August 2010

Marketing authorization number:

PL 00057/0942