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A 250 mg Tsefekon 10s rectal suppositories (for children)




The instruction for medical use of Tsefekon® medicine D Trade name of Tsefekon® D International unlicensed name Paracetamol Dosage Form Suppositories rectal for children, 100 mg and 250 mg Structure 1 suppository contains active agent – mg paracetamol 100 or 250, excipient – fat firm (vitepsol (brand H 15, W 35), supposir (brands NA 15, NAS 50)) – before receiving a suppository weighing 1.25 g. Description Suppositories of color, white or white with yellowish or creamy shade, torpedo-shaped form Pharmacotherapeutic group Analgetics-antipyretics others. Anilides. Paracetamol. The ATX N02BE01 code the Pharmacological Pharmacokinetics Absorption properties high, is quickly soaked up from digestive tract. The period of achievement of the maximum concentration – 30-60 minutes. Gets through a blood-brain barrier. The size of volume of distribution and bioavailability at children and newborns is similar to that at adults. It is metabolized in a liver: 80% of drug enter conjugation tests with glucuronic acid and sulfates with formation of inactive metabolites, 17% are exposed to hydroxylation with formation of 8 active metabolites which conjugate with glutathione with formation of already inactive metabolites. At a lack of glutathione these metabolites can block the fermental systems of hepatocytes and cause their necrosis. CYP2E1 isoenzyme also participates in drug metabolism. At newborns and children up to 10 years the main metabolite is paracetamol sulfate, children have 12 years and are more senior – the conjugated glucuronide. Therapeutic effective concentration of paracetamol in blood plasma is reached at its appointment in a dose of 10-15 mg/kg. One or 2-3rd elimination half-life. Within 24 hours of 85-95% of paracetamol it is removed by kidneys in the form of glucuronides and sulfates, in not changed look – 3%. A significant age difference in the speed of elimination of paracetamol and in total amount of drug which is allocated with urine, no. Communication with proteins of blood plasma – 15%. The pharmacodynamics Paracetamol possesses anesthetic and febrifugal action. Drug blocks cyclooxygenase in the central nervous system, influencing the centers of pain and thermal control. In the inflamed fabrics cellular peroxidases neutralize influence of paracetamol on cyclooxygenase that explains lack of significant anti-inflammatory effect. The lack of the blocking influence on synthesis of prostaglandins in peripheral fabrics causes at it lack of negative influence on water salt metabolism (delay of sodium and water) and mucous digestive tract. Indications – fever in the acute respiratory viral diseases, flu, children’s infections, vaccine-challenged reactions and other states which are followed by fervescence – a pain syndrome of weak and moderate intensity of various genesis (including a headache, a toothache, neuralgia, myalgia, pain in injuries and burns) the Route of administration and Rektalno’s doses. After spontaneous bowel emptying or a cleansing enema, the suppository is exempted from blister strip packaging and entered into a rectum. The dosage of drug is calculated depending on age and body weight, according to the table. Age Weight the Single dose of 3-12 months of 7-10 kg 1 suppository on 100 mg 1-3 years of 11-16 kg 1-2 suppositories on 100 mg of 3-10 years of 17-30 kg 1 suppository on 250 mg of 10-12 years of 31-35 kg 2 suppositories on 250 mg the Single dose makes 10-15 mg/kg of body weight of the child, 2-3 times a day, in 4-6 hours. The maximum daily dose of paracetamol should not exceed 60 mg/kg of body weight of the child. Duration of a course of treatment: 3 days as febrifugal and up to 5 days, as anesthetic. Side effects – nausea, vomiting, an abdominal pain – allergic reactions (a skin itching, rash on skin and mucous membranes, urticaria, a Quincke’s edema) – anemia, a leukopenia, an agranulocytosis, thrombocytopenia – hepatotoxic and nephrotoxic action (interstitial nephrite and papillary necrosis), hemolytic anemia, aplastic anemia, a methemoglobinemia, a pancytopenia (at prolonged use in high doses) Contraindications – hypersensitivity to drug components – children up to 3 months of life – abnormal liver functions, including a viral hepatitis, alcoholism, Gilbert’s syndrome, Dabina-Johnson and the Rotor – a renal failure – deficiency of enzyme glyukozo-6-fosfatdegidrogenazy – a blood disease (anemia, thrombocytopenia, a leukopenia) Medicinal interactions Stimulators of microsomal oxidation in a liver (Phenytoinum, ethanol, barbiturates, flumetsinol, rifampicin, phenylbutazone, tricyclic antidepressants) ethanol and gepatotoksichny medicines increase products of hydroxylated active metabolites that causes a possibility of development of heavy intoxications even at small overdose. Inhibitors of microsomal oxidation (including Cimetidinum) reduce risk of hepatotoxic action. At reception together with salicylates the nephrotoxic effect of paracetamol increases. The combination to chloramphenicol, leads to increase in toxic properties of the last. Paracetamol strengthens effect of anticoagulants of indirect action, reduces efficiency of uricosuric drugs. Special instructions It is necessary to avoid simultaneous use of Tsefekona® D with other paratsetamolsoderzhashchy drugs as it can cause paracetamol overdose. At drug use more than 5-7 days, control of a picture of peripheral blood and a functional condition of a liver is necessary. Paracetamol distorts indicators of laboratory researches at quantitative definition of glucose and uric acid in blood plasma. Overdose Symptoms: during the first 24 h after reception – the pallor of integuments, nausea, vomiting, anorexia, abdominal pains, glucose metabolism disturbance, metabolic atsidozirovanny In 12-48 hours can appear symptoms of an abnormal liver function. In hard cases the liver failure with the progressing encephalopathy, a coma, death, an acute renal failure with tubular necrosis (including in the absence of severe damage of a liver), arrhythmia, pancreatitis develops. The hepatotoxic effect at adults is shown at reception of 10 g of paracetamol and more. Treatment: introduction of donators of SH-group and predecessors of synthesis of glutathione – methionine in 8-9 h after overdose and N-Acetylcysteinum – in 12 hours. Need of holding further therapeutic actions (further administration of methionine, intravenous administration of N-Acetylcysteinum) is defined depending on concentration of paracetamol in blood and also time which passed after its reception. A form of release and packing On 5 suppositories in blister strip packaging from a film polyvinylchloride, laminated by polyethylene. On 2 planimetric packs together with the instruction for medical use in the state and Russian languages put in a pack from cardboard. To Store storage conditions at a temperature not over 20 ºС. To store out of children’s reach! A period of storage 3 years not to use drug after an expiration date. Prescription status Without prescription JSC Nizhpharm Producer, Russian Federation 603950, Nizhny Novgorod, GSP-459, Salganskaya St., 7 ph.: (831) 278-80-88 fax: (831) 430-72-28 a web the website: the Owner of the registration certificate of JSC Nizhpharm, the Russian Federation 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 JSC Nizhpharm 050043, Republic of Kazakhstan, Almaty, mdt. Khan-Taniri, 55b ph.: (727) 2222-100 fax: (727) 398-64-95 e–mail:

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