AKIS Solution for injection

Active ingredients: Diclofenac

Product name and form

AKIS 75 mg/ml solution for injection.

Pharmaceutical Form

Solution for injection.

Clear to slightly amber coloured transparent solution.

Qualitative and quantitative composition

The active ingredient is diclofenac sodium.

Each 1 ml ampoule contains: 75 mg of diclofenac sodium.

For a full list of excipients, see section 6.1.

Active Ingredient
Description

Diclofenac is a non-steroidal anti-inflammatory drug. The mechanism of action of diclofenac in AK may be related to the inhibition of the cycloxygenase pathway leading to reduced prostaglandin E2 (PGE2) synthesis. In addition, immunohistochemistry (IHC) from skin biopsies ac revealed that the clinical effects of diclofenac in AK are primarily due to anti-inflammatory, anti-angiogenic and possibly anti-proliferative effects and apoptosis-inducing mechanisms.

List of Excipients

Hydroxypropylbetadex
Polysorbate 20
Water for injections

Pack sizes and marketing

Transparent type I glass ampoule.

Package of 1, 3 and 5 ampoules.

Not all pack sizes may be marketed.

Marketing authorization holder

IBSA Farmaceutici Italia Srl, Via Martiri di Cefalonia 2, 26900, Lodi (Italy)

Marketing authorization dates and numbers

PL 21039/0042

13/10/2017

Drugs

Drug
Countries
Poland, United Kingdom