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Aurobin 20g ointment tube

$12.00

5ffded1bc395

Description

The instruction for medical use of AUROBIN® medicine the Trade name of Aurobin® the International unlicensed name Is not present the Dosage form Ointment, 20 g Structure 1 tuba contains active agents: Prednisolonum kapronat 0.04 g, dekspantenol 0.40 g of lidocaine hydrochloride of 0.40 g, excipients: polysorbate 60, triclosan, methylparahydroxybenzoate, cetyl alcohol, glycerin, propylene glycol, makrogola stearate, liquid paraffin, dimetikon, oil neutral, stearic acid, water the Homogeneous ointment of white or almost white color purified the Description, almost flavourless. Pharmacotherapeutic group Cardiovascular system. Vazoprotektora. 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 Research Pharmacokinetics properties of pharmacokinetics with use of ointment were not carried out. At topical administration Prednisolonum can be soaked up, having systemic action (especially when using under occlusive bandages or on the injured skin and also as an enema). Drug is widely distributed on all body tissues. Prednisolonum actively contacts proteins of plasma, gets through a placental barrier and it can be found in breast milk. Drug is removed with urine in the form of the conjugated metabolites. Lidocaine is well soaked up through a mucous membrane and the injured skin. It actively contacts proteins of plasma, the period of its semi-removal is 1-2 hours. Drug is mainly metabolized in a liver. The renal failure does not influence removal of initial substance, however can lead to accumulation of its active metabolite. Lidocaine gets through a placental and blood-brain barrier and also is removed with breast milk. The pharmacodynamics Drug contains substances which are effective at treatment of inflammatory processes of perianal area. Prednisolonum represents not halogenated glucocorticosteroid with local anti-inflammatory action. It also reduces vascular permeability, increases a tone of a wall of blood vessels and weakens inflammation manifestations. Lidocaine quickly eliminates pain and burning. Dekspantenol facilitates regeneration of the injured epithelium and mucous membranes. Indications – inflammatory diseases of perianal area, including an itching of an anus, eczema and dermatitis of perianal area, hemorrhoids and anal fissures Adults and elderly people of Aurobin® it is necessary to apply the Route of administration and doses on the struck area of a body 2-4 times a day. Drug use less than 2 times a day, can provide only relief of symptoms. Treatment can continue only during the short span (5-7 days). Use at children: Ауробин® it is not necessary to use at children till 1 year. Children can appoint this drug only as an exceptional case and in the smallest quantity sufficient for achievement of therapeutic effect, duration of treatment should not exceed 5 days. 1 years are aged more senior ointment can be applied on the struck area not more often than two times a day for the purpose of decrease in a likelihood of development of undesirable effects. Treatment can continue no more than 5 days. Only for external use. Regardless of age of the patient it is necessary to avoid long exposure of ointment on the struck or extensive surfaces of skin and also in the field of skin folds. Use under occlusive bandages is not recommended. Side effects At topical administration of glucocorticosteroids can arise mainly local undesirable reactions. Depending on amount of the steroids and lidocaine absorbed by skin, effects of their system influence can be shown. At prolonged topical use of glucocorticosteroids or when drawing them on big body surfaces the oppression of function of adrenal glands can develop. Especially often this phenomenon is observed at children and when putting Aurobin® ointment on skin under occlusive dressing. Catabolism of proteins can result in negative nitrogenous balance. System absorption of lidocaine in rather large number after topical use can cause stimulation and/or oppression of the central nervous system. Frequency of emergence of the undesirable phenomena is not established (it cannot be defined on the basis of the available data). – activation of subclinical infections, masking of manifestations of an infection, opportunistic infections – reactions of hypersensitivity – suppression of function of cortical substance of adrenal glands – a gipokaliyemichesky alkalosis, a liquid delay, a hypopotassemia, a sodium delay – insomnia, a mental disorder, spasms, dizziness, a headache, increase in intracranial pressure – a cataract (the likelihood of developing a cataract is higher at children), a subkapsulyarny cataract, an exophthalmos, glaucoma, a papilledema, helcomas, a horeoretinopatiya, illegibility of sight (see also section Special Instructions) – heart failure, disturbances of warm conductivity, arterial hypertension, a peripheral vazodilatation – gastric bleeding, gastrointestinal bleeding, perforation of bodies of digestive tract, an esophagitis, pancreatitis, a peptic ulcer of a stomach – dermatitis, a folliculitis (in the place of use), rash as an acne, contact dermatitis, dryness and thinning of skin, an erythema, urticaria, a hirsutism, a hyperhidrosis, intertrigo, an itching, a skin atrophy, hypopigmentation, irritation of skin, a striya, a teleangiectasia, burning sensation of skin – the slowed-down healing of wounds – a growth inhibition, a steroid myopathy, an osteonecrosis, osteoporosis – increase in intraocular pressure, negative nitrogenous balance, a delay of reaction of skin to provocative tests of the Contraindication – hypersensitivity to active agent or any of excipients – hypersensitivity concerning local anesthetics of group of amides (bupivacaine, etidokain, mepivakain and prilokain) – primary bacterial, viral or fungal infection of skin (for example, a herpes simplex). – a rozatsea of the person, eels ordinary, dermatitis of circumoral area, an intertrigo – dry melkoplastinchaty peeling of an integument – – pregnancy and the period of a lactation – a tuberculosis cutis – skin manifestations of syphilis – it is impossible to apply children’s age till 1 year to treatment of eyes and periorbital area – simultaneous use of lidocaine according to other indication the Medicinal interactions of the Research of interaction of Aurobin® ointment with other medicines were not carried out. Simultaneous use with other antiarrhythmic drugs demands care. Special instructions in case of irritation or sensitivity treatment it is necessary to stop and begin with Aurobin® ointment the relevant auxiliary treatment. It is possible to avoid development of local or system toxicity, having refrained from putting ointment on the extensive or damaged sites of skin, skin folds, under occlusive bandages and/or for long term. At prolonged use of Aurobin® ointment on the same area of skin the development of an atrophy of skin, especially at children is possible. At development of a fungal or bacterial infection it is necessary to use the corresponding topical or system treatment. The extra care should be shown in diabetes, tuberculosis and anemia and also at patients of children’s age in connection with a possibility of suppression gipotalamo – a hypophysial and adrenal axis under the influence of the glucocorticosteroid drug which is a part. Disorders of vision during use of glucocorticosteroids of local and systemic action can arise disorders of vision. At emergence of illegibility of sight or other disorders of vision of the patient it is necessary to direct to the ophthalmologist for identification of the possible reasons which can include a cataract, glaucoma or rare diseases, such as central serous horioretinopatiya (CSH). The listed diseases can arise after use of glucocorticosteroids of local and systemic action. Aurobin® ointment contains methylhydroxybenzoate (E218), cetyl alcohol and propylene glycol (E1520) in quality of excipients. Metilgidroksibenzoat (substance, also known as paraben) can cause allergic reactions (perhaps, the slowed-down type). Cetyl alcohol can cause local reactions from skin (for example, contact dermatitis). Propylene glycol can cause irritation of skin. Pregnancy and the period of a lactation Data on safety of use of drug during pregnancy are insufficient. Thus, Aurobin® ointment should not be used during pregnancy. Corticosteroids and lidocaine are removed with breast milk. Corticosteroids can influence function of adrenal glands at newborns and can lead to a growth disorder. With breast milk small amounts of lidocaine are distinguished. In the period of a lactation the use of drug is not recommended or it is necessary to interrupt breastfeeding during treatment. Features of influence of drug on ability to run the vehicle or potentially dangerous mechanisms did not study Potential influence of this drug on ability to drive the car and to work with mechanisms. Nevertheless at use of drug the side effect as dizziness can be observed, it is necessary to be careful. Overdose Symptoms: depending on amount of the absorbed steroids and lidocaine can arise development of local or system manifestations. Treatment: symptomatic. Special antidote is absent. A form of release and packing On 20 g in tubas aluminum, corked by a polyethylene cap with the perforating tip. On 1 tuba together with the instruction for medical use in the state and Russian languages put in a cardboard pack. To Store storage conditions at a temperature from 8 of 0C up to 15 0C. To store out of children’s reach. A period of storage 2 years not to apply after an expiration date Prescription status According to the prescription JSC Gideon Richter Producer, 1103 Budapest, Dyomryoi St., 19-21, Hungary the Holder of the registration certificate of JSC Gideon Richter, Hungary the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers: Representative office of JSC Gideon Richter in RK, Almaty, Tolya Bee St. 187 of E-mail: info@richter.kz Phone number: 8-(7272)-58-26-22, 8-(7272)-58-26-23 The name, the address and a contact information of the organization (phone, the fax, e-mail) in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine: Representative office of JSC Gideon Richter in RK, Almaty, Tolya Bee St. 187 of E-mail: pv@richter.kz Phone number: 8-(7272)-58-26-22, 8-(7272)-58-26-23, 8-701-787-47-01
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