Arthrosilen - instructions for use, dose, side effects, contraindications

Excipients: polysorbate-80 4.0 g, propylene glycol 4.0 g, povidone 3.0 g, lavender-nero-lyly flavor 0.2 g, benzene alcohol 0.3 g, water purified to 100 ml, propane-butane mixture 1.25 g .

Description:

White or almost white homogeneous foam, formed when separated from an aerosol aluminum canister with a spray nozzle.

After the gas outlet, the contents of the cylinder are a clear liquid from white to light yellow.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID)

ATX: & nbsp

M.02.A.A.10 Ketoprofen

Pharmacodynamics:

Has a local anti-inflammatory, analgesic and antiexudative action. In the form of an aerosol provides a local therapeutic effect in relation to the affected joints, tendons, ligaments, muscles. With articular syndrome reduces pain in the joints at rest and during movement, morning stiffness and swelling of the joints. Ketoprofen does not have a catabolic effect on articular cartilage.

Pharmacokinetics:After external aerosol application, the level of ketoprofen in the blood is less than 0.1 μg / ml, and the amount of free or conjugated active substance excreted by the kidneys in the next 48 hours is equivalent to 0.62% of the dose. External aerosol application allows to determine the level of ketoprofen in synovial fluid, which is equivalent to 0.2-2 μg / ml depending on the applied dose.

Indications:

Diseases of the musculoskeletal system: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthrosis of the peripheral joints and spine, rheumatic soft tissue injuries.

Muscular pain of rheumatic and non-rheumatic origin.

Traumatic (including sports) injuries of soft tissues and joints.

The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, the progression of the disease is not affected.

Contraindications:

Hypersensitivity to ketoprofen and other components of the drug, acetylsalicylic acid or other NSAIDs, fenofibrate,sunscreen products (including in history); complete or incomplete combination of bronchial asthma, recurrent nasal polyposis or paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (including in history); reaction of photosensitization (in the anamnesis); violation of the integrity of the skin (wet dermatoses, eczema, infected abrasions, wounds) at the site of the intended application; pregnancy (III trimester), the period of breastfeeding, children's age (up to 6 years). Exposure to sunlight, even on cloudy days, the solarium is contraindicated during treatment and for two weeks after the last use of the drug.

Carefully:

Hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe violations of liver and kidney function, chronic heart failure, bronchial asthma, elderly age, children's age (from 6 to 12 years), pregnancy (I and II trimester).

Pregnancy and lactation:

The use of the drug in the third trimester of pregnancy is contraindicated.

The use of the drug in the I and II trimesters of pregnancy is possible only after consulting a doctor if the intended benefit to the mother exceeds the potential risk to the fetus.

The use of the drug during breast-feeding is not recommended.

Dosing and Administration:

Outwardly.

The drug is applied to the skin surface 2 times a day in accordance with the size of the treated area and the prescriptions of the doctor, gently rubbing until completely absorbed. With iontophoresis, the drug is applied to the negative pole.

Dosage in children aged 6 to 12 years corresponds to that in adults and depends on the site of application and the doctor's recommendations.

Duration of treatment: the drug is used in both acute and chronic diseases for a period ranging from a few days to 3-4 weeks.

Before use, turn the can and shake vigorously. Spray by pressing the ribbed button.

Side effects:

Local reactions to the skin, such as erythema, rash, burning sensation, itching. Sometimes these reactions can spread beyond the application zone of the preparation and very rarely can be serious and generalized.

Allergic reactions, dermatitis, contact eczema, urticaria, bullous dermatitis, photosensitivity reactions.

Very rarely, there are systemic adverse reactions, such as renal dysfunction.

If any undesirable phenomenon develops, you should consult a doctor.

Overdose:

Extremely low systemic absorption of active components of the drug with external application makes an overdose almost impossible. In case of accidental ingestion of large amounts of the drug (more than 20 g), systemic undesirable reactions characteristic of NSAIDs may occur. It is necessary to wash the stomach, taking activated charcoal.

Interaction:

The drug may enhance the effect of drugs that cause photosensitivity.

Although interactions with other drugs that are administered topically or systemically are unlikely, in the case of prolonged treatment or high-dose treatment, consideration should be given to the possibility of competition between absorbed ketoprofen and other drugs that bind easily to plasma proteins.

Patients who take anticoagulants coumarinic series, it is recommended to conduct regular monitoring of the international normalized relationship (INR).

Special instructions:

The drug should be applied only to intact skin.

Avoid contact with eyes and mucous membranes.

In order to avoid manifestations of hypersensitivity and photosensitivity, it is recommended not to subject the treated skin areas to sunlight during the course of treatment and two weeks after its termination.

After applying the drug, you should thoroughly wash your hands.

Do not use an occlusive dressing.

Immediately stop using the drug in case of any skin reaction while using sunscreen or other cosmetic products containing octocrylene.

Effect on the ability to drive transp. cf. and fur:

Data on the negative effect of the drug on the ability to drive vehicles and engage in other potentially hazardous activities that require concentration and speed of psychomotor reactions, no.

Form release / dosage:

Aerosol for external use 15%.

Packaging:

For 25 g of the drug in an aerosol aluminum cylinder with a capacity of 25 ml with a spray nozzle and a protective cap.

1 A balloon along with instructions for use in a pack of cardboard.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

2 of the year.

Do not use the product after the date shown on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N010596 / 02

Date of registration:10.06.2010 / 18.06.2014

Expiration Date:Unlimited

The owner of the registration certificate:Dompe Pharmacetici SpA Dompe Pharmacetici SpA Italy

Manufacturer: & nbsp

Zellaerosol, GmbH Germany

Representation: & nbspCBS CJSC LTDCBS CJSC LTDItaly

Information update date: & nbsp14.09.2017

Illustrated instructions

Instructions

Arthrosilen (Artrosilene)