ALMIRAL Solution for injection / infusion Ref.[28119] Active ingredients: Diclofenac

Source: Υπουργείο Υγείας (CY) Revision Year: 2019 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Almiral 75 mg/3 ml solution for injection or infusion.

Pharmaceutical Form
Solution for injection or infusion. Almiral is a sterile clear, colourless, or slightly yellow, solution for intramuscular injection or for preparing an intravenous infusion.

Qualitative and quantitative composition

Each ml of solution contains 25mg of diclofenac sodium.

Excipients with known effect: benzyl alcohol (52.35mg/ml), propylene glycol (0.63mg/ml), sodium metabisulphite (0.5mg/ml).

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Diclofenac	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
Benzyl alcohol Sodium formaldehyde sulfoxylate Propylene glycol Sodium metabisulphite (E223) Sodium hydroxide Water for injection

Pack sizes and marketing

Almiral is presented in single use amber type I glass ampoule containing 3 ml of diclofenac sodium 25 mg/ml, in packs of five, ten and one hundred ampoules.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

12858

25.07.1990 / 15.10.2013

Drugs

Drug	Countries
ALMIRAL	Cyprus, Estonia, Hong Kong, Malta, Romania, Singapore

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