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Description
The instruction for use
of medicine for experts
Pyrogenal
the Trade name
Pyrogenal
the International unlicensed name
Is not present
the Dosage form
Solution for injections of intramuscular introduction 10, 25, 50, 100 mkg/ml
Structure
Active agent – lipopolysaccharide the bacterial, allocated from cells Salmonella typhi in concentration of 10 mkg, 25 mkg, 50 mkg or 100 mkg
excipient – phosphatic and salt buffered solution (concentration of the phosphatic buffer of 0.5·10-3 mol/l and sodium of chloride of 0.9%).
Description
Colourless transparent liquid
Pharmacotherapeutic group
Other immunoexcitants.
The code of automatic telephone exchange L03AX
the Pharmacological
Pharmacokinetics At properties administration of pyrogenal in an organism of 85-90% is fixed on a surface of the circulating leukocytes of blood, its about 10% remains in the circulating plasma and about 5% are absorbed on membranes of erythrocytes.
After administration of drug in disease stage of latency (45-90 min.) the leukopenia which is replaced by the leukocytosis keeping within 24-48 hours develops.
Depending on individual sensitivity and a dose the temperature increase to 37.5-38ºæ is possible. When prescribing drug for pyrotherapy the temperature increase reaches 39.5-40ºæ. Temperature reaction usually continues from 6 to 8 hours. Drug is removed from an organism with urine.
A pharmacodynamics
the Pharmacological effect of pyrogenal which is the cornerstone of the mechanism of its medical action is diverse, it is caused by the chain reaction which is expressed as the interconnected changes defining activity of many fabric elements. Pyrogenal accelerates reproduction of cells of reticuloendothelial system (RES), activates functions of cells of a phagocytal system, accelerates process of antibody formation, interferon, activates fermental and hormonal systems, increases the general and specific stability of an organism.
After administration of pyrogenal there comes, as a rule, the short leukopenia which is replaced by the leukocytosis having more long character. This leukocytosis as well as strengthening of phagocytal activity of leukocytes, does not depend on fervescence. These changes are caused by direct influence of pyrogenal on microphages who under its influence change the superficial potential.
Targets for pyrogenal is the system of phagocytal cells: monocytes (Mo), macrophages (Mf), neutrophils (Nf). Pyrogenal stimulates development of the active oxygen radicals which are powerful factors of antimicrobial protection.
Immunomodulatory properties of pyrogenal are connected with its ability to stimulate products of the interleukin-1 (IL 1) having very high activity.
IL 1 causes phagocytosis activation, fervescence (pyrogenous effect), proliferation of a number of cells of an organism (fibroblasts, endothelial cells, the haematogenic cells, etc.), products IL 2, growth of lymphocytes, necessary for maintenance (first of all T-cells). Thus, owing to activation of cells of a macrophagic and monocytic row and the cytokines cosecreted by them, the functional activity of both the cellular, and humoral immune response amplifies.
In connective tissue under the influence of pyrogenal there is a suppression of development of fibroblasts and formation of collagenic fibers that leads to rejuvenation of cellular composition of friable connective tissue and resorption of keloid hems, and in nervous tissue to slowing down of formation of glial scarrings.
Besides direct action on the changes happening in an organism, separate processes develop as a result of the secondary reactions arising in an organism at administration of pyrogenal. So, stimulating activity of a gialuronizada, there is a suppression of formation of collagenic fibers from fibroblasts. Under the influence of liposomal enzymes there is an activation of fibrinolytic and kinin systems of blood owing to what the permeability of vessels increases, blood supply and angenesis improves.
The increase in permeability of vessels and fabrics arising at administration of pyrogenal facilitates penetration of chemotherapeutic drugs into the damage center that causes use it in combination with specific means.
The significant anti-inflammatory effect of pyrogenal is connected with activation of functions of bark of adrenal glands and discharge of corticosteroids which concentration depends on promoting effect of pyrogenal on a hypothalamus and a front part of a hypophysis.
Characteristic of effect of pyrogenal – lack of specificity therefore it can be applied in various diseases to acceleration of recovery processes when inflammatory infiltrates and commissures are a source of functional disturbances and pain.
Indications
– traumatic injuries of a spinal cord, spinal hernias, diseases of the central and peripheral nervous system, cerebral arachnoidites
– the torpid and current form of tuberculosis in a resorption phase
– chronic diseases of a liver
– a stricture of an urethra and ureters, chronic prostatitises and uretrita
– inflammatory diseases of appendages of a uterus, secondary infertility
– nonspecific means in therapy of patients with venereal diseases
– heavy burns of eyes, uveites, iridocyclites, a herpesviridae infection of eyes, turbidity of a cornea, an optic neuritis, a viral keratitis and konjyuktivita
– psoriasis, a chronic dermatosis
– cosmetology (healing of big defects of skin without formation of a rough hem)
– pyrotherapy.
The route of administration and doses
apply Pyrogenal intramusculary once a day irrespective of time of day and meal. Injections make every other day. For receiving a necessary dose drug is dissolved with sterile 0.9% solution of sodium of chloride for injections.
Doses need to be selected individually. Establish the dose causing fervescence to 37.5-38ºæ and enter it before the temperature increase termination then the dose is gradually raised on 25-50 MPD (minimum pyrogenous dose). The maximum single dose for adults 1000 MPD.
An initial single and daily dose for adults – 2.5 mkg. In the next days the injections gradually increase a dose by 2.5-5 mkg. The maximum single and daily dose – 100 mkg. Full course from 10 to 30 injections.
The maximum single and daily dose – 30-50 mkg taking into account body weight. The course of treatment makes from 10 to 15 injections.
In case of the admission of the next injection the course of treatment is continued according to the scheme, without doubling a dose.
If necessary courses of injections are repeated not less than in 2-3 months.
For receiving small doses it is recommended to dissolve pyrogenal of concentration of 10 mkg ml.
Example: For receiving a dose of 2.5 mkg or 5 mkg
– in an ampoule, with the maintenance of 10 mkg to add to 1 ml the syringe of 1 ml sterilely of 0.9% of solution of sodium of chloride, to mix carefully. 2 ml of solution with concentration of 5 mkg ml, 0.5 ml of the received solution will turn out will contain a dose of 2.5 mkg, 1 ml of the received solution will contain a dose of 5 mkg, 1.5 ml – a dose of 7.5 mkg.
The specified volumes will be a single dose.
When prescribing pyrogenal for pyrotherapy the drug is administered intramusculary once a day, since 5-10 mkg, with gradual increase in a dose to 100-150 mkg. Injections make every other day or two days on doctor’s orders.
Side effects
– temperature increase
– a weak fever, an easy indisposition
– a headache, a back pain
–
Contraindication vomiting
– acute feverish diseases
– chronic diseases in a stage of aggravation and a decompensation, except for the diseases which are the indication to prescribing of pyrogenal
– a blood disease
– pregnancy and the period of a lactation.
Medicinal interactions
Drug is well combined with all medicines which are traditionally applied at treatment of the specified diseases. Enhances efficiency of specific chemotherapeutic drugs in complex therapy.
Pyrogenal cannot be mixed with other medicines in one syringe.
Special instructions
to the People having chronic diseases of a cardiovascular system, kidneys and diabetes and also persons are more senior than 60 years pyrogenal it is necessary to appoint with care from a dose 1.5-2.0 mkg and to raise only at good tolerance.
With convulsive readiness or febrile spasms in the anamnesis drug either is not appointed, or appointed under cover of anticonvulsant therapy.
In pediatrics
of Clinical data on pyrogenal use intramusculary children have no use.
Danger of influence of medicine on ability to run the vehicle or potentially dangerous mechanism.
There are no data.
Overdose
Symptoms: temperature increase, back pain, headache.
Treatment: it is recommended to lower a dose.
A form of release and packing
Solution for intramuscular injections in ampoules on 10, 25, 50, 100 mkg/ml. On 10 ampoules in packing with the instruction for use.
To Store storage conditions at a temperature from 2 to 10ºС, in the place protected from light.
To store out of children’s reach!
2 years
not to use an expiration date after the expiration date specified on packing.
Prescription status
According to the prescription
the Producer GU NIIEM of N.F. Gamalei (Medgamal branch GU NIIEM of N.F. Gamalei of the Russian Academy of Medical Science)
Russia, 123098, Moscow, Gamalei St., 18
Ph.: 8 (495) 193-30-50, 190-44-59
Fax: 8 (495) 190-66-71
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