The instruction for medical use
of Ketonal® medicine gel
the Trade name
of Ketonal® gel
the International unlicensed
name Ketoprofen Dosage Form 2.5% Gel, 50 g
of 1 grams of drug contains
active agent – ketoprofen of 25 mg,
excipients: carbomer, trolamin, lavenders essential oil, alcohol (96%), the water purified.
Uniform transparent gel.
Non-steroidal anti-inflammatory drugs for topical administration.
The code of automatic telephone exchange
Pharmacokinetics Ketoprofen properties gel is quickly soaked up by M02AA10. Therapeutic concentration are reached in 2 hours. The bioavailability of drug is 90%. Ketoprofen for 99% contacts proteins of blood plasma. It gets into synovial fluid and reaches therapeutic concentration there.
Ketoprofen is metabolized in a liver with formation of conjugates which are removed mainly with urine. Metabolism of ketoprofen does not depend on age, presence of a heavy renal failure or cirrhosis. Excretion of ketoprofen with urine is carried out slowly.
Ketoprofen – the nonsteroid antirheumatic means possessing expressed the anti-inflammatory and anesthetizing action.
Ketoprofen is one of the most effective inhibitors of cyclooxygenase. It also inhibits activity of a lipoxygenase and bradykinin. Stabilizing lizosomalny membranes, ketoprofen interferes with release of enzymes – mediators of inflammatory process.
– muscle pains, swelled owing to stretchings, bruises or ruptures of sinews and sheaves
– muscle pains owing to excessive physical activity
– back pains
– pain and inflammation in degenerative rheumatic diseases
the Route of administration and doses
Ketonal Is recommended to use
gel one or twice a day. Gel should be rubbed softly in skin. The dosage has to be picked up according to the area of an affected area: 5 cm of gel correspond to 100 mg of ketoprofen, 10 cm of Ketonal® of gel correspond to 200 mg of ketoprofen. Imposing of a bandage is not recommended.
Кетонал® gel can be applied in a combination with other dosage forms of Ketonala® (capsules, tablets, candles). The total daily dose irrespective of a dosage form should not exceed 200 mg.
Duration of treatment is defined by the doctor.
– reactions of hypersensitivity (itching, reddening and tranzitorny inflammation of skin of easy degree, contact dermatitis)
It is very rare
– heavy inflammatory reaction of skin (contact dermatitis)
– heavy contact long photoallergic reaction with distribution on all body surface
– a skin dieback
– a purpura
– renal failures at the patient with chronic kidney disease
– intestitsialny nephrite
– asthmatic attacks as option of allergic reaction.
– hypersensitivity to ketoprofen or excipients, hypersensitivity to other non-steroidal anti-inflammatory drugs and salicylates
– children’s age up to 15 years
– existence in the anamnesis of allergic reactions to intake of salicylates or predisposition to allergic diseases and bronchial asthma
– the third trimester of pregnancy
– gel should not be applied to the injured skin (eczema, the becoming wet dermatitis, an open or contaminated wound)
the Concomitant use of acetylsalicylic acid reduces extent of linking of ketoprofen with proteins of plasma. Probenetsid reduces clearance of ketoprofen and extent of linking with proteins. Ketoprofen, as well as other NPVS, can reduce removal of a methotrexate and promote increase in its toxicity.
Interaction with other medicines and influence on their removal are not significant.
It is necessary to protect mucous membranes, eyes and skin around eyes from hit of Ketonal® of gel.
At emergence of irritation on skin, it is necessary to stop temporarily therapy, at the expressed irritation, it is not recommended to continue therapy.
During treatment and within 2 weeks after the termination of treatment it is necessary to avoid direct sunlight and Ural federal district.
After putting gel of a hand it is necessary to wash up carefully.
Pregnancy and the period of a lactation
Ketoprofen is contraindicated in the third trimester of pregnancy as NPVS can cause lengthening of the gestational period, premature closing of Botallov Canal and pulmonary hypertensia in the newborn. Ketoprofen can be used in the first and second trimesters of pregnancy, only according to strict indications.
Ketoprofen gel is not recommended for use by nursing mothers.
The feature of influence of medicine on ability to run motor transport and potentially dangerous mechanisms
does not influence.
Symptoms: irritation, erythema and itching.
Treatment: to carefully wash out skin under flowing water.
The form of release and packing
On 50 g of gel place in tubas aluminum with internal varnish coating, with a protective membrane and the screwing-up polymeric cover. On one tuba together with the instruction for medical use of drug in the state and Russian languages place in a cardboard pack.
To Store storage conditions at a temperature not higher than 25 wasps.
To store out of children’s reach!
not to apply a period of storage after the expiration date specified on packing.
According to the prescription
of Proizvoditel Salyutas Pharm GmbH, Lang Goechren 3, 39171 Osterveddingen, Germany
of the license Lek of Pharmasyyutikals of, Verovshkova 57, 1526 Ljubljana, Slovenia
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products
Novartis Pharm Services AG Branch in
Kazakhstan Almaty, St. Zhamakaeva155A,
the Phone number – 258-12-94, the Fax number – 250-64-63
E-mail address: www.novartis.net