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Ultraproct rectal ointment 30 g

$20.40

749b3835cc36
Brands:: Bayer (Italy)

Description

The instruction for medical use

of Ultraprokt® medicine

the Trade name
of Ultraprokt®

the International unlicensed name
Is not present

the Dosage form
Ointment rectal

the Structure
of 1 g of ointment contains
active agents: Fluocortolonum hexanoat 0.95 mg
of Fluocortolonum pivalat 0.92 mg
of Cinchocainum hydrochloride of 5.00 mg,
excipients: 2 octyllauryl alcohols, the castor oil, castor oil hydrogenated, polyethylene glycol-400-monoricinoleate, a fragrance lemon-pink.

Description
Colourless or slightly yellowish translucent ointment.

Pharmacotherapeutic group
Vasoprotectives. Means for treatment of hemorrhoids and anal cracks for topical administration. Other means for treatment of hemorrhoids and anal cracks for topical administration. Other drugs and their combinations.
The ATX C05AX03 code

the Pharmacological

Pharmacokinetics Due to properties different lipophilicity and molecular mass of Fluocortolonum pivalat and Fluocortolonum diffuse caproate with different speeds in the inflammation center that leads, on the one hand, to quick start of action, with another – to increase in duration of action.
It is supposed that after local drawing, two ethers are hydrolyzed to free Fluocortolonum and the corresponding acids at the level of a perianal integument or a mucous rectum, or after the first passing through a liver, due to effect of the esterases which are everywhere in an organism.
Less than 15% of a dose of Fluocortolonum of the pivalat are soaked up in a rectum.
The absorbed Fluocortolonum is split in a liver on metabolites which greatest number is excreted with urine.
Like corticosteroids, Cinchocainum renders local analgetic effect. For obtaining analgetic effect there is no need for creation of certain levels of Cinchocainum for plasma. The assessment of risk is carried out on the basis of presumable full absorption. Even in case of the greatest absorption, the absorbed dosage of Cinchocainum is too small for emergence of any side effects if Ultraprokt® is applied according to the instruction.
At absorption of Cinchocainum there is its biotransformation to formation of several metabolites. The main mechanisms are the oxidizing deetilirovaniye, hydroxylation and oxidizing splitting of a butiloksi-chain, with additional education of polar metabolites.
Even if to assume a possibility of full absorption, system influence will be insignificant at use of two forms of drug according to the instruction as dosages are very low.
The pharmacodynamics
of Ultraprokt® – the combined drug, renders anti-inflammatory, antipruritic, antiallergic, mestnoanesteziruyushchy effect.
As a result of effect of drug intercellular decreases swelled also fabric infiltration, proliferation of capillaries is oppressed.
The drug Ultraprokt® contains two ethers of Fluocortolonum which time of the beginning of the main action falls on different time that provides approach of fast action and long-term therapeutic effect (two-phase effect of drug).
Cinchocainum as local anesthetic reduces pain.

Indications
– internal and external hemorrhoids
– anal cracks
– a proctitis

the Route of administration and doses
Before use of Ultraprokta® of ointment should be cleaned carefully anal area. It is the best of all to apply Ultraprokt® after defecation.
As a rule, Ultraprokt® should impose ointment twice a day, in the first day for the fastest simplification of symptomatology – to three or four times. In order to avoid a recurrence it is necessary to continue to apply Ultraprokt® still, at least, within one week though with a smaller frequency (once a day), even at total disappearance of symptoms. Usually there occurs fast improvement, but it should not form the basis for too fast termination of treatment. However duration of treatment should not exceed as far as it is possible, 4 weeks.
A small amount of rectal ointment (the size approximately about a pea), it is necessary to distribute around an anus and in an anus. Before administration of ointment in a rectum on a tube it is necessary to wind the enclosed tip. However, in the presence of the strong, causing an acute pain inflammation it is recommended to apply ointment a finger in the beginning.

Side effects
Seldom
– allergic skin reactions, local irritation and burning of skin.
Perhaps
– a skin atrophy at long (more than 4 weeks)

Contraindication drug use
– hypersensitivity to active, especially to Cinchocainum to a hydrochloride or any of drug components
– tubercular or syphilitic processes in the field of putting drug
– viral diseases (chicken pox) and vaccine-challenged skin reactions
– the I trimester of pregnancy

Medicinal interactions
it is not revealed

Special indications
of the Precautionary measure and prevention
in the presence of fungal infections the additional corresponding treatment is necessary.
It is necessary to avoid accidental contact of the drug Ultraprokt® from mucous eyes. After use it is recommended to wash up hands carefully.
Development of symptoms of system absorption is improbable in connection with low doses of the active components which are contained in medicine. In case there is an absorption, classical side reactions of corticosteroids of system character, though very weak degree of manifestation can develop.
In case of prolonged use of medicines for external use the sensitization can develop. In this case it is necessary to stop treatment and to appoint the corresponding therapy.
In case of use of local corticosteroids on the extensive surfaces of skin, on the injured skin or when using occlusive bandages, corticosteroids can be soaked up in enough to cause side reactions of system character.
Pregnancy and the period of a lactation
Are available the epidemiological data indicating perhaps increased risk of development of not fusion of the sky at newborns whose mothers received treatments by glucocorticoids during the first trimester of pregnancy.
It is necessary to avoid use of the local drugs containing corticosteroids during the first trimester of pregnancy.
At the clinical indication for treatment of Ultaproktom® during pregnancy and a lactation it is necessary to weigh carefully potential risk and the expected advantage of treatment. In particular, it is necessary to avoid prolonged use of drug.
It is improbable that the quantity of a glucocorticoid which is marked out with breast milk is enough for what rendering – or actions.
Features of influence of medicine on ability to run motor transport and potentially dangerous mechanisms

the Overdose
According to results of researches regarding acute toxicity of esters of Fluocortolonum and Cinchocainum of a hydrochloride does not influence manifestation of acute intoxication at single rectal or perianal use of Ultraprokta® even is improbable at accidental overdose.
Symptoms: at accidental oral administration of drug (for example, at ingestion of several grams of ointment or several suppositories), mainly, manifestation of side effects of Cinchocainum of a hydrochloride of somatic character which depending on a dose, can be also shown in the form of heavy cardiovascular symptoms (decrease up to a stop of warm function) and symptoms of disturbance of activity of the central nervous system (spasms, braking is probable up to a stop of respiratory function).
Treatment: symptomatic

the Form of release and packing
On 10 g or 30 g in a tuba aluminum with the laminated covering. On 1 tuba with the instruction for medical use in the state and Russian languages and a special plastic tip place in a cardboard pack.

A period of storage
2 years
not to use drug after an expiration date.

To Store storage conditions at a temperature not above 25 °C.
To store in the places inaccessible for children.

Prescription status
According to the prescription

the Producer/packer Bayer Helsker Manufacturing of Neuter of l., Segreyt, Italy

the Owner of the registration certificate
of Bayer Pharm AG, Berlin, Germany

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of a product (goods): TOO Bayer KAZ Timiryazev St., 42, business center Expo-City, peahens. 15050057 Almaty, Republic of Kazakhstan, ph. +7 727 258 80 40, fax: +7 727 258 80 39, e-mail:

To Develop kz.claims@bayer.com

Additional information

Ingredient

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