Artrosilene 5% Gel 5g/100g

Страна: Малта

Език: английски

Източник: Malta Medicines Authority

Активна съставка:

KETOPROFEN LYSINE

Предлага се от:

Dompe Farmaceutici SpA Via San Martino 12, 20122, Milan, Italy

АТС код:

M02AA10

INN (Международно Name):

KETOPROFEN LYSINE 5 % (W/W)

Лекарствена форма:

GEL

Композиция:

KETOPROFEN LYSINE 5 % (W/W)

Вид предписание :

POM

Терапевтична област:

TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN

Статус Оторизация:

Withdrawn

Дата Оторизация:

2007-01-03

Листовка

Insert leaflet
ARTROSILENE
ketoprofen lysine salt
COMPOSITION
_Artrosilene 15% cutaneous foam_
: 100 ml of Artrosilene solution contain:
Active ingredient: ketoprofen lysine salt 15 g - Excipients:
polysorbate 80, propylene
glycol, polyvinylpyrrolidone, neurolene wash, benzyl alcohol, purified
water.
One pressurised container contains:
Artrosilene solution 45.5 ml, propane-butane propellent 4.5 ml.
_ _
_Artrosilene 5% gel_
: 100 g of gel contain:
Active ingredient: ketoprofen lysine salt 5 g - Excipients:
carboxypolymethylene,
triethanolamine, polyoxyethylene sorbitanmono-oleate, ethylalcohol,
methyl p-
hydroxybenzoate, nerolene wash, purified water.
PHARMACEUTICAL FORMS
_Artrosilene 15% Cutaneous foam_
: 50 ml pressurised container
_Artrosilene 5% Gel_
: 50 g tube
PHARMACEUTICAL CLASS
Non-steroidal anti-inflammatory drug belonging to the class of
propionic acid
derivatives. Ketoprofen lysine salt exerts strong anti-inflammatory,
analgesic and
antipyretic action.
MARKETING AUTHORISATION HOLDER IN ITALY
Dompé farmaceutici S.p.A. - Via San Martino 12, 20122 Milano (Italy)
MANUFACTURER
_Artrosilene 15% cutaneous foam_
Zellaerosol GmbH, Wiesenstrasse 13, Zell I.W. (Germany)
Aerosol Service Italiana, Via del Maglio 6, Valmadrera, Lecco (Italy)
MANUFACTURER
_Artrosilene 5% Gel _
Doppel Farmaceutici Srl – via Martiri delle Foibe 1, 29016
Cortemaggiore, Piacenza
(Italy)
THERAPEUTICS INDICATIONS
For the local treatment of pain and inflammation of a rheumatic or
traumatic nature,
affecting the joints, muscles, tendons and ligaments.
CONTRAINDICATIONS
Do not use if history of allergy to ketoprofen, tiaprofenic acid,
fenofibrate, UV
blockers or perfumes is known.
Stop using Artrosilene 15% cutaneous foam or Artrosilene 5% gel
immediately if you
experience any skin reaction including cutaneous reactions after
co-application of
octorylene containing products (Octorylene is one of the excipient of
several cosmetic
and hygiene products such as shampoo, after-shave, shower and
bath-gels, skin
creams, lipsticks, anti-ageing cre

Данни за продукта

Page 1 of 3 
SUMMARY OF PRODUCT CHARACTERISTICS 
_ _
1. NAME OF PROPRIETARY DRUG 
ARTROSILENE 5% gel. 
_ _
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
100 g of gel contain the active ingredient: 
ketoprofen lysine salt 5 g 
The excipients are listed in paragraph 6.1 
_ _
3. PHARMACEUTICAL FORM 
Gel 
_ _
4. CLINICAL INFORMATION 
4.1 THERAPEUTIC INDICATIONS 
For local treatment of pain and inflammation of the joints, muscles, tendons or ligaments of a rheumatic 
or traumatic nature. 

4.2 DOSAGE AND METHOD OF ADMINISTRATION 
Depending on the size of the area to be treated, apply Artrosilene 5 % gel 2/3 times a day or as 
prescribed by the doctor, massaging gently to aid absorption. In the case of iontophoresis treatment, the 
drug should be applied to the negative pole. 
Duration of treatment: the drug is used for both acute and chronic disorders, for periods ranging between 
a few days and 3/4 weeks. 

4.3 CONTRAINDICATIONS 
Established individual hypersensitivity to the product or products of the same class. 
History of any photosensitivity reaction. 
Known hypersensitivity reactions, such as symptoms of asthma, allergic rhinitis to ketoprofen, 
fenofibrate, tiaprofenic acid, acetylsalicylic acid, or to other NSAID. 
History of skin allergy to ketoprofen, tiaprofenic acid, fenofibrate or UV blocker or parfumes. 
Sun exposure, even in case of hazy sun, including UV light from solarium, during the treatment and 2 
weeks after its discontinuation. 

4.4 WARNINGS AND PRECAUTIONS IN USE 
Artrosilene 5% gel must not be applied to sores or open wounds, only on intact skin. Avoid contact with 
the eyes and mucous membranes. 
To prevent possible reactions of hypersensitivity or photosensitisation, avoid exposure to the direct 
sunlight, included sola