Bystrumgel gel for external use approx. 2.5% tube 50g

Release form, composition and packaging

Gel for external use 2.5% colorless, almost transparent, with a specific odor

opalescence is allowed.

100 g

ketoprofen in terms of 100% substance 2.5 g

ethanol (rectified ethyl alcohol), carbomer 940 or 980, trometamol, methyl parahydroxybenzoate (nipagin), lavender oil, orange blossom oil (neroli oil), purified water.

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

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

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

pharmachologic effect

Ketoprofen is one of the most effective COX inhibitors.

It also inhibits the activity of lipoxygenase and bradykinin.

It stabilizes lysosomal membranes and prevents the release of enzymes involved in the inflammatory process.

The main properties of ketoprofen are analgesic, anti-inflammatory and anti-edema effects.

For back pain and damage to the ligaments, the analgesic effect of ketoprofen appears 15-30 minutes after applying the gel.

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

Pharmacokinetics

Absorption and distribution

When applied topically in the form of a gel, ketoprofen does not accumulate in the body.

The bioavailability of the gel is about 5%.

Penetrates into the tissues of the joints, incl.

into the 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 excreted primarily by the kidneys.

Ketoprofen metabolism does not depend on age, the presence of severe renal failure or liver cirrhosis.

Excretion of ketoprofen by the kidneys is slow.

Indications for use

Symptomatic therapy - reduction of pain and inflammation at the time of use (does not affect the progression of the disease) - under the following conditions:

- joint pain with reactive arthritis (Reiter's syndrome)

- back and joint pain in osteoarthritis of various localization

- inflammation and swelling of soft tissues and joints with periarthritis, tendinitis, bursitis, muscle pain (myalgia), neuralgia, back pain with radiculitis

- inflammation and swelling of soft tissues and joints, pain in case of injuries of the musculoskeletal system (including sports), bruises of muscles and ligaments, sprains, ruptures of ligaments and muscle tendons.

Contraindications for use

- hypersensitivity to ketoprofen or other components of the drug, as well as to salicylates, tiaprofenic acid or other NSAIDs, fenofibrate

- a history of skin allergies to sunscreens and perfumes

- complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including a history)

- III trimester of pregnancy

- children up to age 15

- violation of the integrity of the skin in the area of ��application of the gel (eczema, acne, weeping dermatitis, open or infected wound)

- 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 with the drug.

Carefully:

- impaired liver and / or kidney function

- erosive and ulcerative lesions of the gastrointestinal tract

- blood diseases

- bronchial asthma

- chronic heart failure

- hepatic porphyria (exacerbation).

Dosage regimen

For external use.

A small amount of gel (3-5 cm) is applied with a thin layer on the skin of the inflamed or painful area of ��the body 1-2 times / day and rubbed gently.

Doses should be selected in accordance with the area of ��the affected area: 5 cm of the gel corresponds to 100 mg of ketoprofen, 10 cm to 200 mg of ketoprofen.

The maximum dose of ketoprofen is 200

Name ENG

BYSTRUMGEL

Clinical and pharmacological group

NSAIDs for external use

ATX code

Ketoprofen

Dosage

2.5% x 50g

Structure

1 g of gel contains: active substances: ketoprofen 25 mg.

Excipients: rectified ethanol (ethyl alcohol), nipagin, carbomer, trometamol, lavender oil, neroli oil, purified water.

Indications

Inflammatory or traumatic lesions of joints, tendons, ligaments and muscles:

arthritis, periarthritis

tendinitis, tendosynovitis

bursitis

bruises, damage to ligaments, dislocations, damage to the knee meniscus

torticollis

lumbago.

Phlebitis, periphlebitis.

Contraindications

Hypersensitivity to ketoprofen or other components of the drug, dermatoses, eczema, infected abrasions and wounds, pregnancy and breastfeeding, childhood.

INN / Active ingredient

ketoprofen

Storage conditions and periods

At a temperature of 15-25 degrees.

Expiration date: 2 years

Specifications

Category

Anesthesia and muscle relaxants

,

Bruises, sprains

Scope of the drug

Musculoskeletal system

Release form

Gel

Manufacturer country

Russia

Package quantity, pcs

one

Way of introduction

Locally

,

On the skin

,

Outwardly

Vacation conditions

Without recipe

Brand name

Akrikhin

The amount of the dosage form in the primary package

50 g

Primary packaging type

Tuba

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

NSAIDs

Anatomical and therapeutic characteristics

M02AA10 Ketoprofen

Dosage form

Gel for external use

Drug action

Analgesic

,

Anti-inflammatory

,

Decongestant

Expiration date in days

730

Dosage (volume) of the substance in the preparation

25 mg

Package weight, g

fifty

Mode of application

:

The drug is applied to the skin of the painful area 2 times / day, squeezing from the tube about 3-5 cm of gel or more (depending on the area of ��the painful area), spread in a uniform thin layer and gently rub in until complete absorption. < br> In order to increase the effectiveness of therapy it is possible to apply the gel under a dry occlusive dressing.

Information on technical characteristics, delivery set, country of manufacture