Nospanum 40 mg / 2 ml 5's solution for injection in ampoules

The instruction for medical use of No-shpa medicine the Trade name of No-shpa the International unlicensed name Drotaverinum Dosage Form Solution for injections of 40 mg / 2 ml contain Structure of 2 ml of solution: active agent - Drotaverinum a hydrochloride of 40.0 mg excipients: sodium metabisulphite, ethanol of 96%, water for injections. Description Transparent liquid of chartreuse color. Pharmacotherapeutic group Drugs for treatment of functional disorders of a GIT. Papaverine and its derivatives. Drotaverinum. The ATX A03AD02 code the Pharmacological Pharmacokinetics Drotaverinum properties is quickly soaked up both after peroral, and after parenteral administration. It highly contacts plasma albumine (95-98%), alpha and beta globulins. The maximum concentration in blood serum is reached in 45-60 minutes after oral administration. After presistemny metabolism 65% of the accepted Drotaverinum dose come to a system blood stream in not changed form. Drotaverinum is metabolized in a liver, its biological elimination half-life makes 8-10 hours. In 72 hours, drug is almost completely removed from an organism, at the same time about 50% are removed with urine, and about 30% with a stake. Drotaverinum is removed generally in the form of metabolites, not changed drug form in urine is not found. The pharmacodynamics of No-shpa represents derivative isoquinoline which has spasmolytic effect directly on smooth muscles. The inhibition of enzyme of phosphodiesterase and the subsequent increase in the tsAMF level are determinal factors of the mechanism of effect of drug and lead to relaxation of smooth muscles by means of an inactivation of the easy chain of a kinase of myosin (ECKM). No-shpa enzyme inhibits IV in vitro phosphodiesterase (FDE) without inhibition of isoenzymes of FDE III and FDE V. Practically, FDE IV plays an important role in decrease in sokratitelny ability of unstriated muscles, in this regard the FDE IV selection inhibitors can be useful at treatment of the hyperkinetic disturbances and various diseases which are followed by spastic conditions of smooth muscles of digestive tract. FDE III enzyme hydrolyzes tsAMF in cells of smooth muscles of a myocardium and vessels. Irrespective of type of a vegetative innervation, No-shpa equally affects smooth muscles of digestive tract, biliary tract, an urinogenital system and vessels. Due to the vasodilating action of No-shpa improves blood supply of fabrics. Indications – spasms of smooth muscles in diseases of biliary tract: a cholecystolithiasis, a cholangiolithiasis, cholecystitis, a pericholecystitis, a cholangitis, a papillitis – spasms of smooth muscles of mochevyvovdyashchy ways: a nephrolithiasis, an ureterolithiasis, a pyelitis, cystitis, bladder tenesmus as auxiliary therapy (when the patient cannot take a pill): – at spasms of smooth muscles of digestive tract: a peptic ulcer of a stomach and duodenum, gastritis, spasms of the cardia and the gatekeeper, enteritis, colitis – in gynecologic diseases: dysmenorrhea (painful periods) Route of administration and doses Adult: the usual dose makes 40-240 mg a day (divided into 1-3 receptions) intramusculary. For removal of acute gripes at renal and stone or cholelithiasis: 40-80 mg intravenously. Side effects Seldom (≥1/10,000, & lt, 1/1000) – a headache, dizziness, insomnia – nausea, a severe constipation – a cardiopalmus, a lowering of arterial pressure – allergic reactions (Quincke's disease, a small tortoiseshell, rash, an itching). – Frequency is unknown to reaction in the injection site of an injection – the lethal and non-lethal acute anaphylaxis was registered at the patients receiving treatment in the form of Contraindication injections – hypersensitivity to active agent or to any of drug excipients – hypersensitivity to sodium bisulphite – a heavy liver or renal failure – heavy heart failure (syndrome of low warm emission) – children's and teenage age up to 18 years Medicinal interactions the phosphodiesterase Inhibitors similar to a papaverine reduce protivoparkinsonichesky effect of a levodopa. Therefore at simultaneous use of No-shpy® with a levodopa strengthening of a tremor and rigidity is possible, it is necessary to be careful. With other antispasmodics, including m-holinoblokatory: mutual strengthening of spasmolytic action. Special instructions In hypotension the use of drug demands the increased care. Due to danger of collapse at intravenous administration of drug of the patient has to be only in a prone position. Metabisulphite which can cause allergic reactions, including anaphylactic symptoms and a bronchospasm in sensitive persons, especially in persons with bronchial asthma or allergic reactions in the anamnesis is a part of drug sodium. Patients with hypersensitivity to sodium metabisulphite should not enter injections. Use of drug during pregnancy demands extra care. Children Clinical trials with participation of children were not conducted. Pregnancy Preclinical trials did not show any signs of direct or indirect negative impact on a pregnancy course, embryonic development, childbirth or a course of a puerperal period. Nevertheless, pregnant women can appoint drug only after careful weighing of a ratio of advantage and risk. Drotaverinum should not be applied during childbirth. The lactation period Owing to lack of these clinical trials is not recommended to appoint drug during breastfeeding. Reproductive function of Data on influence of drug on reproductive function are absent. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms When assigning therapeutic doses parenterally, in particular intravenously, patients it is necessary to warn that they have to avoid potentially dangerous activity, such as driving and other mechanisms. Overdose Symptoms: the excess dose of Drotaverinum can lead to cardiac conduction abnormalities and a warm rhythm, including interventricular blockade and cardiac arrest that can lead to death. Treatment: in case of overdose of the patient has to be under careful observation and receive the symptomatic and supporting treatment, including induction of vomiting and/or gastric lavage. The form of release and packing On 2 ml of drug place in ampoules of brown glass with one point of a break. On ampoules paste labels from paper self-adhesive. On 5 ampoules place in blister strip packaging from a film polyvinylchloride. On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages place in a cardboard box. To Store storage conditions in the place protected from light at a temperature from 15C to 25C. To store out of children's reach! Not to apply a period of storage of 5 years after an expiration date. Prescription status According to the prescription the HINOIN Producer Plant Pharmaceutical and Chemical of Products of closed joint stock company, Hungary the location Address: 3510 Miskolc, Csanyikvolgy, Hungary the Owner of the registration certificate Sanofi-aventis of closed joint stock company, Budapest, Hungary the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers of Sanofi-aventis Kazakhstan LLP Republic of Kazakhstan, 050013 Almaty, N. Nazarbayev Ave. of 187 B phone number: +7 (727) 244-50-96 fax: +7 (727) 258-25-96 e-mail: quality.info@sanofi.com the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine of Sanofi-aventis Kazakhstan LLP Republic of Kazakhstan, 050013, Almaty, N. Nazarbayev Ave. of 187 B phone number: +7 (727) 244-50-96 fax: +7 (727) 258-25-96 e-mail: Kazakhstan.Pharmacovigilance@sanofi.com