Voltaren Emulgel gel for external use 2% tube 50 g

Release form, composition and packaging

?

Gel for external use 2% homogeneous, creamy, from white to white with a yellowish sheen.

100 g

diclofenac diethylamine 2.32 g,

which corresponds to the content of diclofenac sodium 2 g

carbomers * - 1.1-1.7 g, cetostearomacrogol - 2 g, cocoyl caprilocaprate - 2.5 g, diethylamine * - 0.89-1.37 g, isopropanol - 17.5 g, liquid paraffin - 2.5 g, oleyl alcohol - 0.75 g, eucalyptus flavor - 0.1 g, propylene glycol - 5 g, butylhydroxytoluene - 0.02 g, purified water * - 64.22-65.32 g.

* when using different production equipment and different batch sizes (1000 kg and 2500 kg), the amounts of carbomers, diethyleneamine and purified water can be slightly adjusted within the indicated figures.

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

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

150 g - laminated tubes (1) - cardboard packs.

pharmachologic effect

NSAIDs for external use.

Diclofenac has a pronounced analgesic and anti-inflammatory and antipyretic effect.

By indiscriminately inhibiting COX-1 and COX-2, it disrupts the metabolism of arachidonic acid.

VoltarenВ® EmulgelВ® is used to eliminate pain and inflammation in joints, muscles and ligaments of traumatic or rheumatic origin, helping to reduce pain and swelling associated with the inflammatory process, increasing joint mobility.

Pharmacokinetics

Absorption The amount of diclofenac absorbed through the skin is proportional to the area of ��the treated surface and depends on both the total dose of the applied drug and the degree of skin hydration. After applying Voltaren® Emulgel®, 2% gel for external use (2 applications per day) to the skin surface of 400 cm2, the concentration of the active substance in the plasma corresponds to its concentration when using 1% diclofenac gel (4 applications per day). On the 7th day, the relative bioavailability of the drug (AUC ratio) is 4.5% (for the equivalent dose of diclofenac sodium salt). The absorption did not change when the moisture-permeable dressing was worn. Distribution When the drug was applied to the affected joint area, the concentration of diclofenac in plasma, synovial membrane and synovial fluid was determined.Cmax in plasma was approximately 100 times lower than after oral administration of the same amount of diclofenac. The binding of diclofenac to plasma proteins is 99.7%, mainly to albumin (99.4%). Diclofenac is predominantly distributed and retained deep in tissues prone to inflammation, such as joints, where its concentration is 20 times higher than in plasma. Metabolism Diclofenac metabolism is carried out in part by glucuronidation of an unchanged molecule, but mainly through single and multiple hydroxylation, which leads to the formation of several phenolic metabolites, most of which are converted to glucuronide conjugates. Two phenolic metabolites are biologically active, but to a significantly lesser extent than diclofenac.Withdrawal The total systemic plasma clearance of diclofenac is 263 ± 56 ml / min. The final T1 / 2 is 1-2 hours. T1 / 2 of metabolites, including two pharmacologically active ones, is also short and is 1-3 hours. One of the metabolites (3'-hydroxy-4'-methoxydiclofenac) has a longer T1 / 2, however, this metabolite is completely inactive. Most of diclofenac and its metabolites are excreted in the urine.

Indications for use

- back pain in inflammatory and degenerative diseases of the spine (radiculitis, osteoarthritis, lumbago, sciatica)

- joint pain (including the joints of the fingers, knee) with rheumatoid arthritis, osteoarthritis

- muscle pain (due to sprains, overexertion, bruises, injuries)

- inflammation and swelling of soft tissues and joints due to trauma and rheumatic diseases (ten

Name ENG

VOLTAREN EMULGEL

Clinical and pharmacological group

NSAIDs for external use

ATX code

Diclofenac

Dosage

2% x 50g

Structure

1 g of gel contains: Active ingredients: diclofenac sodium 20 mg.

Excipients: carbomers * - 1.1-1.7 g, cetostearomacrogol - 2 g, cocoyl caprilocaprate - 2.5 g, diethylamine * - 0.89-1.37 g, isopropanol - 17.5 g, liquid paraffin - 2.5 g, oleyl alcohol - 0.75 g, eucalyptus flavor - 0.1 g, propylene glycol - 5 g, butylhydroxytoluene - 0.02 g, purified water * - 64.22-65.32 g.

Indications

Degenerative and chronic inflammatory diseases of the musculoskeletal system (osteochondrosis, osteoarthritis, periarthropathy), articular syndrome (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout), post-traumatic inflammation of the soft tissues and musculoskeletal system (sprains, bruises). Spinal pain, neuralgia, myalgia, arthralgia, pain syndrome and inflammation after operations and injuries, algodismenorrhea, pain syndrome with adnexitis, proctitis, colic (biliary and renal), pain syndrome with infectious and inflammatory diseases of the ENT organs, pain syndrome with gout , migraine. For topical use: inhibition of miosis during cataract surgery, prevention of cystoid macular edema associated with removal and implantation of the lens, inflammatory processes of the eye of a non-infectious nature,post-traumatic inflammatory process with penetrating and non-penetrating wounds of the eyeball.

Storage conditions and periods

At a temperature not higher than 30 degrees.

Expiration date: 3 years

Contraindications

Erosive and ulcerative lesions of the gastrointestinal tract in the acute phase, aspirin triad", hematopoietic disorders of unknown etiology, hypersensitivity to diclofenac and the components of the dosage form used, or other NSAIDs.

Not recommended for use in children under 6 years of age.

INN / Active ingredient

Diclofenac

Specifications

Category

Bruises, sprains

Scope of the medicinal product

Musculoskeletal system

Release form

Gel

Manufacturer country

Switzerland

Package quantity, pcs

one

Minimum age from

6 years

Way of introduction

On the skin

Vacation conditions

Without recipe

Brand name

Voltaren

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

M02AA15 Diclofenac

Dosage form

Gel for external use

The target audience

Children

Expiration date in days

1095

Dosage (volume) of the substance in the preparation

2 g

Package weight, g

60

Mode of application

:

For oral administration for adults, a single dose is 25-50 mg 2-3 times / day.

The frequency of administration depends on the dosage form used, the severity of the course of the disease and is 1-3 times / day, rectally - 1 time / day.

For the treatment of acute conditions or relief of an exacerbation of a chronic process, an intramuscular dose of 75 mg is used.

For children over 6 years of age and adolescents, the daily dose is 2 mg / kg.

Topically applied in a dose of 2-4 g (depending on the area of ��the painful area) to the affected area 3-4 times / day.

When used in ophthalmology, the frequency and duration of administration are determined individually.

The maximum daily oral dose for adults is 150 mg / day.

Drug action

:

Analgesic

,

Anti-inflammatory

,

Antipyretic

,

Decongestant

Information on technical characteristics, delivery set, country of manufacture "