Ketonal cream d / nar. approx. 5% tube 30g

Release form, composition and packaging

?

Cream for external use 5% white or almost white, homogeneous.

1 g

ketoprofen 50 mg

methyl parahydroxybenzoate - 2 mg, propyl parahydroxybenzoate - 0.5 mg, propylene glycol - 70 mg, isopropyl myristate - 50 mg, white petrolatum - 320 mg, elfakos ST9 - 30 mg, propylene glycol glyceryl oleate - 90 mg, magnesium sulfate - 5 mg. 5 mg, purified water - 382 mg ...

30 g - aluminum tubes (1) - cardboard packs.

50 g - aluminum tubes (1) - cardboard packs.

100 g - aluminum tubes (1) - cardboard packs.

pharmachologic effect

NSAIDs.

It has an analgesic, anti-inflammatory and anti-edema effect.

Inhibits the activity of COX, which leads to inhibition of the synthesis of prostaglandins.

In addition, ketoprofen inhibits lipoxygenase, bradykinin synthesis, stabilizes lysosomal membranes and prevents the release of enzymes involved in the inflammatory process.

Ketoprofen does not adversely affect the condition of the articular cartilage.

Pharmacokinetics

Absorption Ketoprofen is absorbed very slowly and practically does not accumulate in the body.

Bioavailability is 5%.

Ketoprofen penetrates into the subcutaneous tissue, ligaments and muscles, synovial fluid and reaches therapeutic concentrations there.

The concentration of the drug in blood plasma is extremely low.

Metabolism and excretion Ketoprofen is metabolized in the liver to form conjugates, which are mainly excreted in the urine.

Ketoprofen is characterized by slow urinary excretion.

Pharmacokinetics in special clinical situations Ketoprofen metabolism does not depend on age, the presence of severe renal failure or liver cirrhosis.

Indications for use

Symptomatic therapy of painful and inflammatory processes of various origins, including: - rheumatoid arthritis and periarthritis

- ankylosing spondylitis (ankylosing spondylitis)

- psoriatic arthritis

- reactive arthritis (Reiter's syndrome)

- osteoarthritis of various localization

- tendinitis, bursitis

- myalgia

- neuralgia

- sciatica

- Injuries of the musculoskeletal system (including sports), bruises of muscles and ligaments, sprains, ruptures of ligaments and muscle tendons.

Contraindications for use

- hypersensitivity to drug components

- hypersensitivity to salicylates, tiaprofenic acid or other NSAIDs, fenofibrate, UV blockers, fragrances

- violation of the integrity of the skin (eczema, weeping dermatitis, open or infected wound)

- a history of indications of bronchial asthma attacks caused by taking NSAIDs and salicylates

- a history of photosensitivity reactions

- exposure to sunlight, incl.

indirect sunlight and UV irradiation in a solarium throughout the entire treatment period and for another 2 weeks after stopping treatment

- III trimester of pregnancy

- children under 15 years of age.

With care: impaired liver and / or kidney function, erosive and ulcerative lesions of the gastrointestinal tract, blood diseases, bronchial asthma, chronic heart failure.

Dosage regimen

For external use.

A small amount of cream (about 3-5 cm) is applied with a thin layer on the skin over the lesion with light rubbing movements.

The cream is applied 2-3 times / day.

The duration of treatment without consulting a doctor should not exceed 14 days.

Overdose

Symptoms: irritation, erythema, itching.

Treatment: the drug should be discontinued.

The patient needs to see a doctor.

Side effect

Local reactions are the most common.

Determination of the frequency of adverse reactions: very often (? 1/10), often (? 1/100 and < 1/10), infrequently (? 1/1000 and < 1/100), rarely (? 1/10 000 and < 1 / 1000), very rarely (< 10,000).

Allergic reactions: very rarely - angioedema, anaphylaxis.

On the part of the skin and skin appendages: infrequently - erythema, itching, burning, eczema, t

Name ENG

KETONAL

Clinical and pharmacological group

NSAIDs for external use

ATX code

Ketoprofen

Dosage

5% x 30g

Structure

1 g of cream for external use contains: Active substance: ketoprofen - 50 mg

Excipients: methyl parahydroxybenzoate, propyl parahydroxybenzoate, propylene glycol, isopropyl myristate, petrolatum (white), elfakos ST9, propylene glycol glyceryl oleate, magnesium sulfate, water

Indications

Symptomatic therapy of painful and inflammatory processes of various origins, including:

rheumatoid arthritis and periarthritis

ankylosing spondylitis (ankylosing spondylitis)

psoriatic arthritis

reactive arthritis (Reiter's syndrome)

osteoarthritis of various localization

tendinitis, bursitis

myalgia

neuralgia

radiculitis

injuries of the musculoskeletal system (including sports), bruises of muscles and ligaments, sprains, ruptures of ligaments and muscle tendons.

INN / Active ingredient

ketoprofen

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 5 years

Contraindications

hypersensitivity to drug components

hypersensitivity to salicylates, tiaprofenic acid or other NSAIDs, fenofibrate, UV blockers, fragrances

violation of the integrity of the skin (eczema, weeping dermatitis, open or infected wound)

a history of indications of bronchial asthma attacks caused by taking NSAIDs and salicylates

a history of photosensitivity reactions

exposure to sunlight, incl.

indirect sunlight and UV irradiation in a solarium throughout the entire treatment period and for another 2 weeks after stopping treatment

III trimester of pregnancy

children under 15 years of age.

With care: impaired liver and / or kidney function, erosive and ulcerative lesions of the gastrointestinal tract, blood diseases, bronchial asthma, chronic heart failure.

Specifications

Scope of the drug

General

Release form

Cream

Manufacturer country

Germany

Package quantity, pcs

one

Way of introduction

Outwardly

Vacation conditions

Without recipe

Brand name

Sandoz

The amount of the dosage form in the primary package

30 g

Primary packaging type

Tuba

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

NSAIDs

Anatomical and therapeutic characteristics

M02AA10 Ketoprofen

Dosage form

Cream for external use

Dosage (volume) of the substance in the preparation

In 1 g: ketoprofen 50 mg

The target audience

Children

Expiration date in days

1826

Package weight, g

45

Category

:

Bruises, sprains

,

Joints

,

Treatment of diseases of the musculoskeletal system

,

Synovial fluid

,

Bone metabolism

Mode of application

:

For external use. < br> < br> Apply a small amount of cream (3-5 cm) with light rubbing movements in a thin layer on the skin of an inflamed or painful area of ​​the body 2-3 times a day. < br> < br> The duration of the course of treatment should not exceed 14 days.

Drug action

:

Pain reliever

,

Anti-inflammatory

,

Analgesic

,

Decongestant

Information on technical characteristics, delivery set, country of manufacture