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Kirin 1’s 2g powder for suspension for injection together with the solvent of 3.2 ml of bacteriostatic water for injection with benzyl alcohol 9mg / ml


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The instruction for medical use of Kirin Torgovoye medicine a name Kirin Mezhdunarodnoye the unlicensed name Spektinomitsin Lekarstvennaya a form Powder for preparation of suspension for injections of 2.0 g complete with solvent of 3.2 ml Bacteriostatic water for injections with benzyl alcohol of 9 mg/ml Structure One bottle contains active agent – a spektinomitsina of dihydrochloride pentahydrate is equivalent to a spektinomitsin of 2000.0 mg the Bacteriostatic Water for Injections of 3.2 Ml with Benzyl Alcohol 9mg/of Ml Solvent one ampoule of solvent: benzyl alcohol of 28.8 mg, water for injections up to 3.2 ml the Description Powder from white till almost white color. Pharmacotherapeutic group Antibacterial drugs other. Spektinomitsin. The ATX J01XX04 code the Pharmacological Pharmacokinetics Absorption properties after intake low, after introduction in oil high. Communication with proteins of plasma insignificant. The maximum concentration in blood plasma makes 100 and 160 mkg/ml respectively, repeated introductions slightly increase concentration in plasma (drug does not kumulirut). The peak of concentration in blood in 1 hour after single intramuscular introduction (in oil) in a dose of 2 g and in 2 h – after introduction in a dose of 4 g, at normal function of kidneys. Concentrates in urine, in saliva is defined in insignificant concentration. Distribution volume – 0.33 l/kg. Elimination half-life makes 1-3 h, is completely removed in 48 h (mainly by kidneys – 75% in not changed look). In a renal failure (the clearance of creatinine (CC) less than 20 ml/min.) elimination half-life makes 10-30 h. It is brought during a hemodialysis to 50%. Drug does not get through a blood-brain barrier. Kirin’s pharmacodynamics – the antibiotic of a broad spectrum of activity produced by sort Streptomyces mushrooms. The aminocyclic connection similar in structure to Kanamycinum and gentamycin is not aminoglycoside and has no toxic effects inherent in them. Affects mainly gram-negative microorganisms, it is most active concerning Neisseria gonorrhoeae (including the unstable, producing penicillinase gonokokk or resistant views with the stability mediated by chromosomes). Has bacteriostatic action – breaks synthesis of protein in a bacterial cell, contacting 30S a subunit of ribosomes. In higher concentrations can bakteritsidno affect sensitive microorganisms, breaking integrity of cellular membranes. It is inactive concerning Chlamydia spp. and Treponema pallidum. Indications – an acute and chronic gonorrheal urethritis and prostatitis at men – an acute and chronic gonorrheal cervicitis and a proctitis at women the Route of administration and doses For preparation of suspension to add 3-3.2 ml of solvent to bottle contents, it is good to shake up. In 5 ml of suspension the ml of a spektinomitsin contains 400mg . The prepared suspension has to be used immediately. For administration of suspension the needle of the G20 is used. Adults: A single dose of 2 g of Kirin (5 ml of the prepared suspension) intramusculary. The dose can be increased up to 4 g – once. At chronic slow forms of gonorrhea of Kirin it can be appointed dvukhkratno, at an interval of the 24th hour. Duration of a course of treatment is defined by the attending physician. Side effects – morbidity in the injection site – allergic reactions (urticaria, an itching, a dermahemia, a fever, fever, an acute anaphylaxis) – decrease in a diuresis, increase in concentration of urea, urtikariya and oligouriya – dizziness, insomnia – nausea, vomiting, spasms in a stomach – decrease in hemoglobin, a hematocrit, clearance of creatinine, increase in activity of hepatic transaminases and alkaline phosphatase. Contraindications – hypersensitivity to a spektinomitsin – use at treatment of a siflis – the liver failure Medicinal interactions of Kirin reduces clearance of lithium that leads to strengthening of therapeutic and toxic effects of lithium. It is necessary to monitorirovat concentration of lithium in blood and to adjust its dose. Special instructions For a warning of an infection to the sexual male partner it is necessary to use condom, for prevention of reinfection the simultaneous treatment of the partner can be required. Dialysis leads to 50% to decrease in level of a spektinomitsin in plasma. At patients with reduced function of kidneys removal time significantly increases. Children’s age Safety and efficiency of use for children are not established. Pregnancy and the period of a lactation Drug of the first row for treatment of gonorrhea at pregnant women during treatment by Kirin feeding by a breast is recommended to stop Features of influence of drug on ability to run the vehicle or potentially dangerous mechanisms In dizziness it is necessary to refrain from control of motor transport and work with potentially dangerous mechanisms Overdose Symptoms: strengthening of symptoms of side effects Treatment: symptomatic the Form of release and packing On 2.0 g of drug (in terms of spektinomitsin) place in the bottles from colourless glass which are hermetically corked by rubber bungs, pressed out by aluminum caps. On each bottle paste the label self-adhesive. On 3.2 ml of solvent spill in ampoules from dark glass with a tag for opening. On each ampoule paste the label self-adhesive. On 1 bottle with drug and 1 ampoule with solvent put in the blister strip packaging from polyvinylchloride sealed by a polyethylene film. On 1 planimetric packing together with the instruction for medical use in the state and Russian languages put in a pack from cardboard. To Store storage conditions in original packing, in the dry, protected from light place at a temperature not above 25 °C. To store in places inaccessible for children! Not to apply a period of storage of 5 years after an expiration date Prescription status According to the prescription Producer LABORATORIO ITALIANO BIOCHIMICO FARMACEUTICO LISAPHARMA S.P.A., ITALY Via Licinio, 11 – 22036 Erba (Como), Italy (031) 64 12 57 (031) 64 41 82 / (031) 61 10 04 Owner of the registration certificate of Medokemi Ltd, Cyprus 1-10 Constantinoupoleos street, 3011, Limassol, Cyprus. Tel: 00 357 25 867600, Fax: 0035725560863 Name and the country of the organization – the packer of Medokemi Ltd, Cyprus the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods): Representative office of Medokemi Ltd in Republic of Kazakhstan Almaty, Mukanov St., 241 office 1B ph. / fax: 313-73-76 E-mail:

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