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Description

The instruction for medical use of FINALGON medicine the Trade name of FINALGON the International unlicensed name Is not present the Dosage form Ointment for external use, 20 g Structure of 1 g of ointment contain active agents: nonivamid (vanililamid nonyl acid) 4 mg of a nikoboksil (butoksietilovy ether of niacin) of 25 mg excipients: diisopropyl adipate, silicon dioxide colloidal, paraffin white soft, sorbic acid, oil lemon Ceylon, the water purified. The description Almost colourless or slightly brownish, transparent or translucent, uniform, homogeneous ointment with a smell of lemon oil. Pharmacotherapeutic group Drugs for treatment of diseases of a musculoskeletal system. Drugs for topical treatment of diseases of the musculoskeletal system. Other drugs for topical treatment of diseases of the musculoskeletal system. Other drugs. The ATX M02AX10 code the Pharmacological Pharmacokinetics Drug FINALGON properties contains two vasodilating substances nonivamid and nikoboksit, is put locally, action is shown locally. Data on system influence of drug are absent. Reaction to drug (erythema and temperature increase of skin) is shown within several minutes after drawing that demonstrates fast penetration of active components of drug into skin. The pharmacodynamics Nonivamid (vanililamid nonyl acid) Represents a synthetic analog of capsaicin, has analgetic properties which are shown as a result of gradual penetration of substance into peripheral nociceptive S-fibers and the A-delta nerve fibrils at repeated putting drug on skin. Stimulating sensitive skin nerve terminations, nonivamid has the expanding effect on surrounding vessels that is followed by strong and long caumesthesia. Nikoboksil (butoksietilovy ether of niacin) Niacin is the vitamin B having vasodilating properties thanks to effect of prostaglandins. Hyperemic action of a nikoboksil begins earlier and is more intensive in comparison with similar action of a nonivamid. Nonivamid also nikoboksit the combined action have the vasodilating properties supplementing each other that allows to reduce time of emergence of skin reaction (hyperaemia). Indications – for the purpose of improvement of a blood-groove for the topical irritating administration at disturbance of peripheric circulation (in a sports injury, bruises, joint and muscles pain, damages of the copular device) – the muscular pain caused by excessive physical activity – the lumbago – an ischialgia – a bursitis – a tendovaginitis the Route of administration and doses should begin Treatment with very small amount of drug FINALGON on the small site of skin for check of individual reaction. Reaction to drug FINALGON at different people can differ also for some rather small amount of ointment for action of the warming effect whereas others can feel or feel nothing absolutely small effect. The initial dose has to be no more than 0.5 cm of ointment (approximately about a pea) on the respective site of skin (the size approximately about a palm). The maximum (recommended) dose on one drawing makes 1 cm of ointment on the site of skin of the size of a palm (about 10 cm x 20 cm). Ointment is applied to 3rd once a day if necessary. Drug FINALGON should be applied by means of the enclosed applicator with the easy rubbing movements. After putting drug FINALGON on the site of skin it is necessary to wash up carefully hands with soap. Side effects the Undesirable phenomena are given below on system and organ classes and frequency on the following classification: very often ≥ 1/10 it is frequent ≥ 1/100 to & lt, 1/10 infrequently ≥1/1000 to & lt, 1/100 is rare ≥1/10.000 to & lt, 1/1000 is very rare also lt, 1/10.000 frequency are unknown undesirable reactions which frequency is unknown as it cannot be estimated on the basis of the available data Often: – burning sensation of skin, erythema, itching, feeling of heat Infrequently: – rash Frequency is unknown: – anaphylactic reaction, hypersensitivity reactions, paresthesia, cough, dispnoe, pustules, blisters, the localized skin reactions, puffiness of the person, a small tortoiseshell of the Contraindication – hypersensitivity to any ingredient from composition of drug – high sensitivity of skin – a wound, inflammation or a disease of integuments – pregnancy and the period of breastfeeding – children’s and teenage age up to 18 years Medicinal interactions are not established Special instructions Children: for children and teenagers 18 years are younger safety and efficiency of drug FINALGON is not established. In an initiation of treatment a small amount of FINALGON ointment is applied on the small site of skin for check of individual reaction. Response to FINALGON ointment use significantly varies, some patients need the minimum quantity for achievement of the necessary warming action. Due to the local hyperaemia of integuments caused by drug reddenings, caumesthesia, an itching or burning sensation can appear. These symptoms can be especially expressed if the excess amount of drug is caused or if ointment is too intensively rubbed in skin. The excessive quantity or embrocation of FINALGON can lead to blistering. Right after putting ointment it is necessary to wash up hands, it is necessary to watch that drug did not get on those sites of skin which do not demand processing and also on other people. Drug FINALGON cannot be put on a face, eyes, an oral cavity. Otherwise there can be passing puffiness of the person, pain, inflammation of a conjunctiva, hyperaemia of eyes, burning in eyes, a disorder of vision, unpleasant feelings in a mouth and stomatitis. It is not necessary to take a hot shower or a bath to or after putting drug FINALGON. Even in several hours after putting ointment the erubescence and strong caumesthesia can be caused when sweating or heating. Drug FINALGON contains sorbic acid as excipient which can cause local reactions (for example, contact dermatitis). Fertility, pregnancy and the period of breastfeeding Due to the lack of data on use during pregnancy or during breastfeeding, it is not necessary to use drug FINALGON during these periods. Researches on effect of drug on fertility were not conducted. There Is no feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms data. Overdose Symptoms: after causing too large amount of drug FINALGON its hyperemic action can amplify, and weight of the described side effects can increase. Abuse of drug can lead to emergence of blisters on the damaged site of skin on which ointment was applied. As ethers of niacin are well absorbed in skin, the overdose by drug FINALGON can lead to system reactions, for example, to reddening of an upper body, fervescence, rushes of blood, hyperaemia with painful feelings and to a lowering of arterial pressure. Treatment: effect of drug can be softened, having wiped the surface of skin with the tampon moistened in oil (for example, vegetable) or fat cream. Symptomatic treatment. A form of release and packing On 20 g of ointment in tubas aluminum, sealed by a membrane (aluminum seal), corked by a polypropylene cover with the punch for piercing of an aluminum seal. On 1 tuba complete with the applicator and the instruction for medical use in the state and Russian languages place in a cardboard pack. To Store storage conditions at a temperature not above 25 °C. To store out of children’s reach! 4 years not to apply a period of storage after expiry date. Prescription status Without prescription Globopharm Pharmatsevticheskaya Proizvodstvennaya Producer and Brightenfurterstrasse Business company 251, A-1230 Vienna, Austria the Name and the country of the owner of the registration certificate of Sanofi-Aventis Doychland GmbH, Frankfurt, Germany the Name, the address and a contact information of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers of Sanofi-aventis Kazakhstan LLP Republic of Kazakhstan, 050013, Almaty, Furmanov St. 187 of B Republic of Kazakhstan, 050013, Almaty, Furmanov St. of 187 B
the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine of Sanofi-aventis Kazakhstan LLP

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