ITAMI Medicated plaster Ref.[50023] Active ingredients: Diclofenac

Source: Health Products Regulatory Authority (IE)  Revision Year: 2019  Publisher: Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica 3/A, Abano Terme (Padova), 35031, Italy

Product name and form

Itami 140 mg medicated plaster.

Pharmaceutical Form

Medicated plaster.

White 10x14 cm sized self-adhesive plaster made of non-woven fabric on one and paper on other side.

Qualitative and quantitative composition

Each medicated plaster contains diclofenac as 140 mg diclofenac sodium.

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

Backing layer:

Polyester non-woven fabric

Adhesive layer:

Basic butylated methacrylate copolymer
Acrylate Copolymer
PEG 12 stearate
Sorbitan oleate

Protective liner:

Mono silicone coated paper

Pack sizes and marketing

The medicated plasters are individually enclosed in sealed sachets made of paper/Al/copolymer ethylene-acrylic acid, provided with easy open and packed in a cardboard box.

Each pack contains 2, 5 or 10 medicated plasters.

Not all pack sizes may be marketed.

Marketing authorization holder

Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica 3/A, Abano Terme (Padova), 35031, Italy

Marketing authorization dates and numbers

PA0814/002/001

Date of first authorisation: 10th November 2017

Drugs

Drug Countries
ITAMI Croatia, Ireland, Poland, Tunisia
 
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