Febrofid gel 2.5% 50g

Release form, composition and packaging

Gel for external use 2.5% from colorless to light yellowish, transparent or slightly opalescent.

100 g

ketoprofen lysine salt 2.5 g,

-which corresponds to the content of ketoprofen 1.6 g

macrogol 200 - 5 g, methyl parahydroxybenzoate - 0.15 g, propyl parahydroxybenzoate - 0.05 g, carbomer - 1.5 g, trolamine - 2.5 g, purified water - up to 100 g.

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

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

pharmachologic effect

NSAIDs for external use.

It has anti-inflammatory, anti-exudative and analgesic effects.

It is used for lesions of joints, tendons, ligaments, muscles, skin, veins, lymphatic vessels and lymph nodes.

With articular syndrome, it leads to a reduction in joint pain at rest and during movement, reduces morning stiffness and swelling of the joints.

Pharmacokinetics

Ketoprofen penetrates well through the skin, which provides a local analgesic and anti-inflammatory effect.

The bioavailability of the gel is about 5%.

Plasma protein binding - 99%.

Does not accumulate in the body.

Metabolized in the liver.

About 80% of the dose taken is excreted in the urine in the form of metabolites, less than 10% is excreted unchanged.

Indications for use

As a drug for external use in symptomatic treatment:

- pain in the spine

- neuralgia

- myalgia

- inflammatory and degenerative diseases of the musculoskeletal system (including arthritis, bursitis, synovitis, tendonitis, lumbago)

- uncomplicated injuries (including sports, dislocations, sprains or ruptures of ligaments and tendons, bruises, post-traumatic pain)

- as part of combination therapy for inflammatory diseases of the veins (phlebitis, periphlebitis), lymphatic vessels, lymph nodes (lymphangitis, superficial lymphadenitis).

Contraindications for use

- weeping dermatoses, eczema

- infected abrasions, wounds, burns

- III trimester of pregnancy

- lactation period (breastfeeding)

- hypersensitivity to ketoprofen and / or other components of the drug

- hypersensitivity to other NSAIDs (ketoprofen can cause bronchospasm in persons sensitive to acetylsalicylic acid and other NSAIDs).

Dosage regimen

The drug is intended for external use.

Apply a small amount (strip 3-5 cm long) of gel 2-3 times / day to the appropriate area of ��the skin and rub in lightly.

It is not necessary to apply a dry dressing as

the gel is well absorbed through the skin, has no odor, does not contain dyes, does not leave greasy spots, does not stain clothes.

Overdose

Due to low systemic absorption, an overdose of Febrofid is unlikely.

Side effect

Possibly: allergic reactions, skin flushing, photosensitivity, skin exanthema, purpura.

Drug interactions

With frequent and prolonged use, symptoms of interaction with other drugs may appear (the same as with systemic use).

When taken together with other NSAIDs, GCS, ethanol, corticotropin, ulceration and the development of gastrointestinal bleeding are possible.

Simultaneous use with oral anticoagulants, heparin, thrombolytics, antiplatelet agents, cefoperazone, cefamandol increases the risk of bleeding.

Ketoprofen reduces the effect of antihypertensive drugs and diuretics (inhibition of prostaglandin synthesis).

Increases the hypoglycemic effect of insulin and oral hypoglycemic drugs (dose adjustment is necessary).

Co-administration with sodium valproate causes impaired platelet aggregation.

Increases the concentration of verapamil and nifedipine in blood plasma.

Application during pregnancy and lactation

In I and II trim

Name ENG

FEBROFID

Clinical and pharmacological group

NSAIDs for external use

ATX code

Ketoprofen

Dosage

2.5% x 50g

Structure

Active ingredient: Ketoprofen lysine salt, 2.5 g / 100.0 g gel.

Excipients: polyethylene glycol, methyl hydroxybenzoate, propyl hydroxybenzoate, carbomer, triethanolamine, purified water.

Indications

As a drug for external use in symptomatic treatment:

back pain

neuralgia

myalgia

inflammatory and degenerative diseases of the musculoskeletal system (including arthritis, bursitis, synovitis, tendonitis, lumbago)

uncomplicated injuries (including sports, dislocations, sprains or ruptures of ligaments and tendons, bruises, post-traumatic pain)

as part of combination therapy for inflammatory diseases of the veins (phlebitis, periphlebitis), lymphatic vessels, lymph nodes (lymphangitis, superficial lymphadenitis).

INN / Active ingredient

Ketoprofen

Storage conditions and periods

In a dark place at a temperature not exceeding 25 degrees.

Expiration date: 3 years

Contraindications

weeping dermatoses, eczema

infected abrasions, wounds, burns

III trimester of pregnancy

lactation period (breastfeeding)

hypersensitivity to ketoprofen and / or other components of the drug

hypersensitivity to other NSAIDs (ketoprofen can cause bronchospasm in persons sensitive to acetylsalicylic acid and other NSAIDs).

Specifications

Scope of the drug

Musculoskeletal system

Release form

Gel

Manufacturer country

Poland

Package quantity, pcs

one

Way of introduction

Outwardly

Vacation conditions

Without recipe

Brand name

Medana

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

Non-steroidal anti-inflammatory drug

Anatomical and therapeutic characteristics

M02AA10 Ketoprofen

Dosage form

Gel for external use

Item weight, g

fifty

Dosage (volume) of the substance in the preparation

Ketoprofen lysine salt, 2.5 g / 100.0 g

Expiration date in days

1095

Package weight, g

70

Category

:

Bruises, sprains

,

Joints

,

Treatment of diseases of the musculoskeletal system

,

Synovial fluid

,

Bone metabolism

Mode of application

:

The drug is intended for external use. < br> A small amount (strip 3-5 cm long) of gel 2-3 times / day, apply to the appropriate area of ��the skin and rub in lightly. < br> There is no need to apply a dry bandage, since the gel is good absorbed through the skin, odorless, does not contain dyes, does not leave greasy spots, does not stain clothes.

Drug action

:

Pain reliever

,

Anti-inflammatory

,

Analgesic

,

Antiexudative

Information on technical characteristics, delivery set, country of manufacture