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medicalmeds.eu Medicines Means which are used at a varicosity. Heparin for topical administration. Heparin Asset

Heparin Asset

Препарат Гепарин Актив. ОАО "Борисовский завод медицинских препаратов" Республика Беларусь


Producer: JSC Borisovsky Plant of Medical Supplies Republic of Belarus

Code of automatic telephone exchange: C05BA03

Release form: Soft dosage forms. Gel for external use.

Indications to use: Hypostases. Bruises. Phlebitis.


General characteristics. Structure:

Active ingredient: 30 000 ME of heparin sodium in each tuba.

Excipients: карбопол 980, methylparahydroxybenzoate, пропилпарагидроксибензоат, trietanolamine, not role oil, lavender oil, alcohol of ethyl 96%, the water purified.




Pharmacological properties:

Pharmacodynamics. Thanks to a high anion charge heparin forms complexes with cationic proteins, including with antithrombin III (AT III) – α2-глобулином of group of serinovy proteases, regulating coagulation process. Heparin is the AT III activator that leads to an inactivation of thrombin (TIA), and also the activated factors of XIIa, XIa, Huy of kallikrein. Degree of an inactivation depends on a heparin dose. Heparin exerts impact on exchange of lipoproteids, by release of endothelial lipoproteinlipase which splits krupnomolekulyarny chylomicrons. Heparin is an intermediary of allergic and anaphylactic reactions. In mast cells he acts as the factor connecting the histamine in the form of salt and regulating its release from mast cells at degranulation in response to contact with allergen. Heparin acts as the regulator of a row of enzymatic systems: hyaluronidases, enzymes of synthesis of a histamine and ribonucleases.

Pharmacokinetics. At parenteral administration heparin is deposited in endotheliocytes and cells RS (reticuloendothelial system), being allocated in a blood stream with the period of semi-elimination of 90-120 min. Initial bystry removal of heparin from a blood-groove is connected probably with process of its deposition in endotheliocytes and cells of RES. Removal of heparin is carried out, generally in the form of low-molecular fraction by filtering and secretion in tubules of kidneys. An insignificant part is removed in not changed look that can cause residual anti-coagulative activity. Heparin does not get through a placental barrier, but is emitted with breast milk. At oral administration heparin is not soaked up.

Penetration of heparin through healthy skin is described for doses    more than 300ME/g and is dozozavisimy. After topical administration in doses to 1500 ME/g system resorptive effects of heparin do not develop. After topical administration of very high doses more than 1800 ME/g can be reached therapeutic concentration of heparin in system circulation and the probability of development of system effects will increase.


Indications to use:

- for a symptomatic treatment and elimination of hypostases and bruises after a stupid injury (for example, after bruises);

- for treatment of phlebitis of superficial veins as a part of complex therapy.


Route of administration and doses:

Drug is intended for external use. Gel is applied with a thin layer (0,5-1 g on the site with a diameter of 3-5 cm) on area of defeat and carefully rubbed in skin.

Gel is applied by 2-3 times a day daily before disappearance of the inflammatory phenomena, on average from 3 to 14 days. The possibility of carrying out longer course of treatment is defined by the doctor.

After application of drug it is necessary to wash up hands (except those cases when application is carried out on area of hands).

Children. It is not recommended to apply at children is younger than 18-year age as its safety and efficiency is not proved.


Features of use:

In the presence of hemorrhages it is necessary to weigh a question of use of the drug Heparin Asset carefully.

The HP Heparin the Asset should not be applied at bleedings, to apply on open wound surfaces or on mucous membranes, and also on the infected sites in the presence of purulent processes.

In HP Heparin the Asset contain in quality of excipients methylparahydroxybenzoate and пропилпарагидроксибензоат therefore it cannot be applied at patients with an allergy to parabens.

The patients having tromboembolic episodes in the anamnesis should appoint HP Heparin the Asset with care, in connection with a possibility of its systemic action. At patients of the specified category for the purpose of differential diagnosis heparin - the induced thrombocytopenia of the II type is recommended to define quantity of thrombocytes in blood (prior to therapy; for the 1st day of therapy, then during treatment, up to the end of therapy - each 3-4 days).

Use in pediatrics. Because of limited experience of use of drug for children and for the reason that there is an insufficient number of these researches, it is not necessary to use this drug at treatment of children.

Pregnancy and period of a lactation. Specific data on use of drug during pregnancy and during feeding by a breast are not available.

Heparin does not break a placental barrier, but is removed with maternal milk. Unambiguous data that at topical administration heparin promotes development of inborn defects are not available. During breastfeeding of HP Heparin the Asset should not be applied on area of a breast. During pregnancy and feeding by a breast heparin has to be applied only in emergency cases, after careful assessment of a ratio of advantage to mother and risk to a fruit.

Influence on ability of control of vehicles and works with the equipment. The HP Heparin the Asset does not influence reactionary ability therefore and to service of cars does not render negative impact on ability to driving of the vehicle.

As excipients medicine contains methylparahydroxybenzoate and пропилпарагидроксибензоат therefore it cannot be applied at an allergy to parabens. In the presence of hemorrhagic symptoms at the patient it is necessary to weigh carefully a possibility of use of HP Heparin the Asset. Drug should not be used at bleedings, to apply on the open wounds infected sites of skin in the presence of purulent processes, mucous membranes, eyes and on sites around eyes on ulcers and bubbles. At blood coagulation disturbance gel is not recommended to apply on extensive sites of skin. At treatment of phlebitis medicine should not be rubbed in skin.


Side effects:

Portability – as local, and the general – very good.

At use of local forms of heparin risk of development heparin - induced an antibody - the mediated thrombocytopenia of the II type with reduction of quantity of thrombocytes <100.000×109/л or bystry falling of number of thrombocytes to <50% of initial level, with arterial or venous thrombosis or an embolism cannot be excluded. Therefore at use of HP Heparin the Asset is recommended to control in addition quantity of thrombocytes in blood at patients with tromboembolic episodes in the anamnesis.

At additional parenteral administration of heparin at patients without earlier existing hypersensitivity to heparin reduction of quantity of thrombocytes, as a rule, can happen in 6-14 days after an initiation of treatment.

At patients with hypersensitivity to heparin thrombocytopenia can develop within several hours.

Seldom: llergichesky reactions to heparin in the form of erubescence and an itch, burning sensations, a small tortoiseshell, a Quincke's disease, hemorrhages which quickly disappear after drug phase-out.


Interaction with other medicines:

Use of heparin can promote lengthening of a prothrombin time at the patients accepting peroral anticoagulants.

Do not appoint locally along with non-steroidal anti-inflammatory drugs, tetracyclines and antihistaminic drugs.

Nevertheless, interaction with other medicines at topical administration was not observed what, however it is impossible to exclude in case of prolonged use.


Contraindications:


Overdose:

Still cases of overdose are not described. At topical administration the overdose is improbable.

At an accidental proglatyvaniye of gel systemic side effects which expressiveness depends on amount of the drug accepted inside can develop. The heparin accepted inside is not soaked up.

Nevertheless, in case of overdose treatment has to have the symptomatic, supporting character.


Storage conditions:

At a temperature not over 25 ºС. To store in the place, unavailable to children. A period of validity - 2 years. Not to use medicine after the termination of a period of validity.


Issue conditions:

Without recipe


Packaging:

On 30 g in tubas aluminum. Each tuba together with a leaf insert is located in a pack from a cardboard.



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