The instruction for medical use of Galavitâ medicine the Trade name of Galavit® the International unlicensed name Is not present the Dosage form Suppositories rectal 100 mg Structure One suppository contains active agent – Galavitâ 100 mg, excipients: vitepsol W-35 (glycerides of fatty acids, vitepsol H-15 (glycerides of fatty acids) the Description Suppositories of a torpedo-shaped form, from color, white to white with a yellowish shade, without visible impregnations on longitudinal section. The pharmacotherapeutic group Immunomodulators the ATX L03 Code the Pharmacological Pharmacokinetics of Galavit® properties is quickly soaked up, gets into bodies, fabrics and biological liquids. The maximum concentration in blood plasma after rectal administration is reached in 23 min. Communication with proteins of plasma – 6%. The maximum concentration of drug is in kidneys, minimum in muscles and tissues of a brain. Absolute bioavailability of Galavita® at rectal administration of 61%. Drug gets through a blood-brain and placental barrier. It is brought out of an organism, generally through kidneys. After rectal administration the elimination half-life of drug makes 40-60 minutes. The pharmacodynamics of Galavit® is applied as immunomodulatory and anti-inflammatory drug in complex therapy of immunodeficiency. The mechanism of effect of drug is connected with its ability to influence functional and metabolic activity of phagocytal cells (monocytes/macrophages, neutrophils, natural killers). Besides, Galavit® normalizes antibodyformation, indirectly stimulates development of endogenous interferon (IFN-α, IFN-γ). In inflammatory diseases drug reversibly for 6-8 hours inhibits excess synthesis by hyper elicited macrophages of a factor of necrosis опухолей-α, interleukin-1, interleukin-6 and other pro-inflammatory cytokines, active forms of oxygen which level defines extent of inflammatory reactions, their recurrence and also severity of intoxication and level of an oxidatic stress. Normalization of a functional condition of macrophages leads to restoration of the antigen presenting and regulating function of macrophages, decrease in level of an autoaggression. Stimulates bactericidal activity of neutrocytes, strengthening phagocytosis and increasing nonspecific resistance of an organism to infectious diseases. The main pharmacological effects (immunomodulatory and anti-inflammatory) are observed within 72 hours. Indications At adults and children are more senior than 12 years as a part of complex therapy – the chronic recurrent diseases caused by a herpes virus 1 and 2 types – the diseases caused by human papillomavirus – infectious and inflammatory urogenital diseases (an urethritis of a chlamydial and mecotic etiology, chlamydial prostatitis, an acute and chronic salpingo-oophoritis, an endometritis) – pyoinflammatory diseases of bodies of a small pelvis – postoperative rehabilitation of patients with a hysteromyoma – complications of the postoperative period at women of reproductive age – postoperative is purulent – septic complications and their prevention (including, at oncological patients) – a chronic recurrent furunculosis, an ugly face – asthenic states, neurotic and somatoformny disorders, decrease in physical effeciency (including, at athletes) mental, behavioural and post-abstinent disorders in alcohol and drug addiction – nonspecific prevention and treatment of flu and acute respiratory infections the Route of administration and doses to Adults and children are more senior than 12 years. Rektalno. The suppository is exempted from planimetric packing and then entered into a rectum. Previously it is recommended to release intestines. The dose and duration of use of drug depends on character, weight and duration of a disease. – In the chronic recurrent diseases caused by a virus of herpes 1 and 2 like 5 days on 1 suppository once a day then on 1 suppository every other day. Duration of treatment is up to 5 weeks. – In the diseases caused by human papillomavirus: 5 days on 1 suppository once a day, then on 1 suppository every other day. Duration of a course is up to 5 weeks. – In urogenital diseases – an urethritis of a chlamydial and mecotic etiology, chlamydial prostatitis: 1 day on 1 suppository twice, then on 1 suppository every other day. A course up to 4 weeks (depending on weight of pathological process). In a salpingo-oophoritis, an endometritis during an acute period: 2 days on 2 suppositories once (to enter consistently one by one), then on one with an interval of 72 hours. In the chronic period: 5 days on 1 suppository once a day, then for one every 72 hour. A course of treatment up to 7 weeks. – In acute and chronic purulent diseases of bodies of a small pelvis – in an acute period: in the 1st day 2 suppositories once (consistently one by one), then the next 3 days on one suppository daily, then on one every other day – 5 days. A course – up to 2 weeks. In the chronic period: 5 days on 1 suppository once a day, then for one every 72 hour. A course up to 7 weeks. – For postoperative rehabilitation of patients with a hysteromyoma and at complications of the postoperative period at women of reproductive age: 5 days on 1 suppository once a day, then on one – every other day. A course – up to 4 weeks. – For prevention and treatment of surgical complications in to – and the postoperative period (including, at oncological patients): appoint on 1 suppository once a day – 5 suppositories before operation, 5 – after operation on one every other day and 5 suppositories – c an interval of 72 hours. At a severe disease an initial dose 2 suppositories once or 2 times a day on one. A course – up to 4 weeks. – In a chronic recurrent furunculosis, an ugly face: 5 days on one suppository once a day, then on one – every other day. A course up to 5 weeks. – At asthenic states, neurotic and somatoformny disorders, in mental, behavioural and post-abstinent disorders, at patients with alcohol and drug addiction: 5 days on one suppository daily, then on one – in 72 hours. A course up to 7 weeks. For increase in physical effeciency: on 1 suppository every other day – 5 suppositories, then on one – in 72 hours, a course – up to 8 weeks. – For nonspecific prevention and treatment of flu and acute respiratory infections on one suppository once a day. Course of 5 days. For patients of advanced age of a dose are not adjusted. Side effects Seldom (from 0.01% to 0.1%) – allergic reactions from skin and hypodermic fabrics: skin rash, an itching, a small tortoiseshell of the Contraindication – individual sensitivity to drug – pregnancy and the period of a lactation – children’s age up to 12 years Medicinal interactions At simultaneous use the decrease in course doses of antibiotics is possible. Cases of incompatibility with other medicines are noted. The special instructions Use in pediatrics do not appoint Drug to children up to 12 years. Pregnancy and the period of a lactation do not appoint Drug to pregnant women, women during breastfeeding of Feature of influence of medicine on ability to run the vehicle and potentially dangerous mechanisms does not influence. Overdose of Data on cases of overdose there is no drug Galavit®. The form of release and packing On 5 suppositories place in blister strip packaging from a film polyvinylchloride. On 1 or 2 planimetric packs together with the instruction for medical use in the state and Russian languages place in a pack from cardboard. To Store storage conditions in the dry, protected from light place at a temperature not above 25 °C. To store out of children’s reach! 3 years not to apply a period of storage after an expiration date. Prescription status Without prescription LLC Selvim Producer, Russian Federation, 308013, Belgorod, Rabochaya St., 14. Owner of the registration certificate of LLC Selvim, Russian Federation, 123290, Moscow, Magistralny Deadlock of the 1st, 5A, lump. 91. Ph. / fax (495) 269-03-43, 269-03-44. The address of the organization accepting claims on quality of products from consumers in the territory of RK ALDIMED LLP, 050051, Republic of Kazakhstan, Almaty, mdt. Samal-1, house 1. Ph. / fax (727) 263-27-34.