Solution to injections "Renalgan ^® " is applied to symptomatic treatment of a pain syndrome at spasms of smooth muscles of internals:

• gastric and intestinal gripes;
• renal gripes at a nephrolithiasis;
• spastic dyskinesia of bilious ways;
• dysmenorrhea.

Structure

1 ml of solution contains (active ingredients):

• metamizole sodium - 500 mg;
• a bromide fenpiveriniya - 0.02 mg;
• a pitofenon of a hydrochloride - 2 mg.

Excipient - water for injections.

Contraindication

• hypersensitivity to medicine components, to pyrazyl ketone derivatives (Butadionum, Tribuzonum) or to other non-steroidal anti-inflammatory medicaments (NPVS);
• a heavy liver or renal failure, a sharp hepatic porphyria, suspicion of surgical pathology, adenoma of a prostate of II and III degree, with a tendency to an ischuria congenital deficiency glyukozo-6-fosfatdegidrogenazy, a tachyarrhythmia, a closed-angle form of glaucoma, impassability of digestive tract (including mechanical impassability) and megacolon, an atony bilious or a bladder, a disease of a system of blood formation (Agranulocytosis, a leukopenia, anemia of any etiology, including aplastic anemia, an infectious neutropenia, hemolytic anemia), kollaptoidny states, dekompensirovanny heart failure, bronchial asthma, violations of functions of marrow (for example, after treatment by cytostatics), hypotonic states and hemodynamic instability.

Route of administration

"Renalgan ^® ", solution for injections to apply only intramusculary. To apply only to short-term treatment.

Solution to injections should be applied under accurate control of the doctor in connection with risk of emergence of an acute anaphylaxis at patients with hypersensitivity to metamizol or derivatives of pyrazyl ketone.

Adults and children are more senior than 15 years

to Adults and children is more senior than 15 years (with body weight more than 53 kg) to intramusculary enter from 2nd to 5 ml of solution for injections. If necessary to repeat introduction of a dose in 6–8 hours. The maximum daily dose should not exceed 10 ml of solution for injections (5 g of metamizole sodium are equivalent). Treatment duration - 2-3 days. After achievement of therapeutic effect it is possible to pass to treatment with oral anesthetics and antispasmodics. In the absence of therapeutic effect the medicament treatment should be stopped.

Patients are more senior than 65 years

Usually does not need to reduce a dose. For patients with violations of functions of a liver and the kidneys tied with age it is necessary to reduce a dose as increase in elimination half-life of metabolites of metamizol is possible.

Metamizol is emitted to

with urine in the form of metabolites. For patients with easy and moderate violation of functions of kidneys it is recommended to apply ½ doses to adults.

Patients with violations of functions of a liver

At these patients the elimination half-life of active metabolites of metamizol slows down. It is necessary to avoid application of high doses to patients with violations of functions of a liver. At short-term application there is no need to reduce doses.

sufficient experience of more prolonged use to patients with violations of functions of kidneys or a liver.

Feature of application

Pregnant

not to use Drug during pregnancy or feeding by a breast.

Children

not to use Drug to children up to 15 years.

Drivers

Because of possibility of side reactions from nervous system (dizziness, accommodation violation) should refrain from control of motor transport or work with other mechanisms which influence speed of response.

Overdose

Symptoms

At overdose prevail intoxication symptoms metamizol in a combination with cholinolytic effects. The toksiko-allergic syndrome, a gematotoksichnost, cerebral manifestations, including a hypothermia, the expressed lowering of arterial pressure, heart consciousness, short wind, sonitus, a gastralgia, weakness, an oliguria, an anury, symptoms of defeat of functions of blood formation, gastrointestinal frustration, in hard cases - symptoms of damage of a brain is most often observed. Vomiting, feeling of dryness in a mouth, nausea, pain in epigastric area, sweating reduction, accommodation violation, drowsiness, nonsense, confusion of consciousness, an abnormal liver function, kidneys, a spasm are possible, development of an agranulocytosis, a hemorrhagic syndrome, paralysis of respiratory muscles is possible.

Treatment

At suspicion on overdose should stop immediately use of medicine and to take measures for it most the fastest removal from an organism (an artificial diuresis, injection of aqueous salt solutions, if necessary - a hemodialysis, peritoneal dialysis). Symptomatic therapy. There is no specific antidote.

Side effects

Listed below side reactions are caused generally by metamizole sodium which is a part of medicine.

from the immune system: acute anaphylaxis, anaphylactic or anaphylactoid reactions. Such reactions can arise during administration of medicine or directly after the introduction termination, but can appear also in several hours. Usually they develop within the first hour after an injection. Easier reactions are shown in the form of typical reactions from skin and a mucous membrane (such as itch, burning, reddening, urticaria, hypostases - local or the general), dispnoe and, seldom, gastrointestinal complaints. Easy reactions can pass into more severe forms with generalized urticaria, heavy angioedemy (including laryngeal), into a heavy bronchospasm, violation of a warm rhythm, a lowering of arterial pressure (sometimes with preliminary increase in arterial blood pressure).

For this reason if there is any skin reaction of hypersensitivity, symptoms of violation of kidney function or gematotoksichesky reactions, use of medicine should be stopped immediately.

Asthmatic attack (at patients with analgetichesky asthma), circulator shock. Shock can be followed cold then, dizziness, drowsiness, consciousness changes, pallor of skin, squeezing in area of heart, shallow breathing or the Tachypnea, tachycardia, cooling of extremities, strong falling of arterial blood pressure. At the first signs of shock treatment it is necessary to cancel and take the appropriate measures of emergency aid.

from skin and hypodermic cellulose: the fixed medicinal dieback, makulopapulezny and other types of rashes, a Lyell's disease or Stephens-Johnson's syndrome, a Quincke's disease.

in case of any skin reaction use of metamizol should be stopped immediately.

from digestive tract: nausea, vomiting, an abdominal pain and discomfort, burning sensation in epigastric area, dryness in a mouth, a lock, exacerbation of gastritis and peptic ulcer of a stomach, in rare instances - vomiting with impurity of blood and intestinal bleedings, ultseration.

from a liver and biliary tract: hepatitis.

from the central nervous system: headache, dizziness.

from organs of sight: visual violations, accommodation violation.

from a cardiovascular system: arterial hypotension, tachycardia, violations of a warm rhythm, palpitation, cyanosis, hyperaemia. Hypotensive reactions can seldom be shown in time or after application. They can be followed or not be followed by other symptoms of anaphylactoid or anaphylactic reactions. Seldom such reactions can be result of a sharp lowering of arterial pressure. Fast intravenous administration increases risk of hypotensive reactions.

Critical lowering of arterial pressure without other signs of hypersensitivity is dose-dependent and can be shown in the form of a hyper pyrexia.

from the system of blood and lymphatic system: anemia (hemolytic anemia, aplastic anemia), a granulocytopenia, a leukopenia, thrombocytopenia, the Agranulocytosis (it can be shown by the following symptoms: fervescence for no apparent reason, fever, sore throat, stomatitis, development of a vaginitis or proctitis).

Risk of appearance of an agranulocytosis cannot be provided. The agranulocytosis can arise also at patients who applied metamizol in the past without emergence of similar side reactions.

from a respiratory system: bronchospasm.

from an urinary system: a renal failure, an oliguria, an anury, a proteinuria, coloring of urine in red color, interstitial nephrite, an ischuria, the complicated urination, development of a sharp renal failure, a polyuria.

Other: sweating reduction.

Local reactions: pain in the injection site, infiltrates in the injection site, an adynamy are possible.

to Store

in original packing at a temperature not above 25 °C, out of children's reach.

Expiration date - 2 years.