Description
The instruction for medical use
of Klodifen Torgovoye medicine a name
Klodifen
Mezhdunarodnoye the unlicensed
name Diclofenac Dosage Form 1% Gel, 5%
Structure
of 100 g of gel contain
active agent – diclofenac of sodium of 1.0 g,
excipients: carbomer 980, propylene glycol, trolamin, ethanol of 96%, methylparahydroxybenzoate, the water purified (gel of 1%)
of 100 g of gel contain
active agent – diclofenac of sodium of 5.0 g,
excipients: hydroxyethylcellulose, propylene glycol, ethanol of 96%, methylparahydroxybenzoate, water purified (gel of 5%)
the Description
the Transparent yellowish gel, uniform, which is not containing bubbles with a slight smell of alcohol
Pharmacotherapeutic group
Drugs for topical treatment of diseases of the musculoskeletal system. Non-steroidal anti-inflammatory drugs for topical administration. Diclofenac
the ATX M02AA15 Code
Pharmacological actions
Pharmacokinetics
the Quantity rezorbiruyushchegosya through skin of diclofenac is proportional to the square on which it is applied and also depends on a total dose of drug and extent of hydration of skin. At external use of drug no more than 6% of diclofenac are absorbed.
Metabolism is carried out mainly by hydroxylation with formation of several derivatives, two of which pharmacological are active, but in much smaller degree, than diclofenac. Diclofenac and its metabolites are removed mainly with urine. The general system clearance of diclofenac in blood plasma averages 263±56 ml/min., and final elimination half-life – 1-3 h.
A pharmacodynamics
Non-steroidal anti-inflammatory drug for external use.
Has the significant anti-inflammatory and analgeziruyushchy effect. The mechanism of action is connected with non-selective oppression of TsOG-1 and TsOG-2, disturbance of metabolism of arachidonic acid and suppression of biosynthesis of prostaglandins in the inflammation center. Klodifen’s use at inflammatory process leads to reduction or elimination of a pain syndrome and hypostasis of fabrics.
Indications
– posttraumatic inflammation of soft tissues and joints (owing to stretchings, retension and bruises) without disturbance of integrity of integuments
– rheumatic diseases of soft tissues (tendovaginitis, a bursitis, defeats of periartikulyarny fabrics, etc.)
– the pain syndrome connected with a disease of muscles and joints
the Route of administration and
Klodifen’s doses apply gel outwardly. The choice of concentration of Klodifen gel is defined by expressiveness of inflammatory process and a pain syndrome. At adults and children 12 years are more senior than Klodifen of 1% gel apply 3-4 times a day. The strip of gel about 4-10 cm long (2-4 g of gel) is applied to skin and slightly rubbed. The amount of the used drug depends on the size of a painful zone.
At adults and children 12 years are more senior than Klodifen of 5% gel apply 2-3 times a day. Amount of the used drug – up to 2 g (up to 4 cm of gel).
After putting drug of a hand it is necessary to wash up.
Duration of treatment depends on indications and efficiency of therapy. In 2 weeks of use of drug it is necessary to consult with the doctor about expediency of continuation of therapy. It is not necessary to use drug more than 14 days in a row at defeat of soft tissues or a rheumatic disease of soft tissues and more than 21 days – in case of the pain caused by arthritis (if the doctor did not appoint other scheme of treatment). If within 7 days positive clinical dynamics is noted or the state worsened, it is necessary will see a doctor.
Side effects
– reddening, an itching or burning sensation
Is rare:
– a photosensitization
Very seldom
– reactions of hypersensitivity (rash, eczema, an erythema, dermatitis (including contact), urticaria, bronchial asthma, a Quincke’s disease)
– bullous dermatitis, pustulous rash
– gastrointestinal disorders
– open wounds, the inflamed skin, mucous membranes
of the Contraindication
– a concomitant use of other drugs containing diclofenac
– asthma, urticaria, rhinitis caused by acetylsalicylic acid or other nonsteroid drugs
– hypersensitivity to drug components, acetylsalicylic acid or other NPVS
– disturbance of integrity of integuments
– pregnancy and the period of a lactation
– children’s age up to 12 years.
Medicinal interactions
the Probability of emergence of interactions is insignificant as a system absortion of diclofenac at external use extremely low. With care it is necessary to use drug together with other NPVP. Klodifen gel can strengthen effect of the drugs causing a photosensitization
Special instructions
Klodifen gel it is necessary to apply only to the uninjured skin, avoiding hit on open wounds. After drawing it is not necessary to apply an occlusive bandage. It is not necessary to allow hits of drug in eyes and on mucous membranes.
Klodifen gel with care is appointed at a hepatic porphyria (in an aggravation stage), GIT erosive cankers, heavy abnormal liver functions and kidneys, chronic heart failure, bronchial asthma, patients of elderly age.
The feature of influence of medicine on ability to run motor transport and potentially dangerous mechanisms
does not affect ability to drive the car and to perform the works demanding the high speed of psychomotor reactions.
Overdose
Symptoms: the overdose is improbable as system absorption of diclofenac at external use extremely low. At accidental intake, drug can cause the side effects characteristic of oral forms of diclofenac.
Treatment: gastric lavage and intake of adsorbent, symptomatic treatment.
The form of release and packing
On 45 g of drug place in tubas aluminum.
Each tuba together with the instruction for medical use in the state and Russian languages is placed in a pack from cardboard.
To Store storage conditions at a temperature not above 25C.
To store out of children’s reach!
3 years
not to apply a period of storage after an expiration date.
Prescription status
Without prescription
the Producer K.O. Slavia Pharmaceutical S.R. L. , Boulevard Theodor Palladi No. 44C, sector 3, Bucharest, Romania
S.C. Slavia Pharm S.R.L., Theodor Pallady 44C, district 3, Bucharest, Romania.
The owner of a trademark and the certificate of registration is
the UORLD MEDITSIN company, Great Britain
the Owner of the registration certificate UORLD MEDITSIN, Great Britain.
The address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
of RK, Almaty, Suyunbaya 222 St. of B
Ph. / fax: 8 (7272) 529090
Additional information
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