Renalgan of amp. 5,0 No. 5

General characteristics. Structure:

General characteristic: main physical and chemical properties: transparent liquid, light yellow with slightly greenish shade; structure: 1 ml of solution contains metamizole sodium - 500 mg, a fenpiveriniya of bromide of-0,02 mg, a pitofenona of a hydrochloride - 2 mg; excipients: water for injections.

Pharmacological properties:

Pharmacodynamics. Реналган® - the combined drug. Metamizol sodium is derivative pyrazoline. Possesses soothing, febrifugal and weak antiinflammatory action. The main mechanism of action - oppression of biosynthesis of prostaglandins - modulators of painful sensitivity, thermal control and an inflammation in the central nervous system and peripheral fabrics. Pitofenon, like a papaverine, has direct myotropic effect on smooth muscles of internals and causes its relaxation. Fenpiveriny due to holinoblokiruyushchy action possesses the additional weakening action on smooth muscles. The combination of three components of drug leads to mutual strengthening of their pharmacological influence.

Pharmacokinetics. At parenteral administration within several minutes drug is evenly distributed in fabrics. Metamizol is metabolized in a liver and removed from an organism by kidneys. The elimination half-life of its main metabolite makes 1,8 - 4.6 h. Metamizol passes through a placenta and gets into breast milk.

Indications to use:

Renal, intestinal, hepatic gripes; spastic dysmenorrhea, spasms of coronary vessels and vessels of a brain; hemorrhoidal, rheumatic, postoperative pain, ischialgia, mialgiya.

Route of administration and doses:

The drug is administered intramusculary or intravenously. Intravenously adult enter 5 ml of solution, very slowly: within 5-8 min. In need of an injection repeat in 6 - 8 h. The daily dose for adults should not exceed 10 ml. To children the drug is administered 1 time a day. For children the daily dose at intramuscular introduction is established taking into account body weight:

Body weight	Age of the child	Intramuscular introduction
5-8 kg	3 months - 1 year	0,1 - 0,2 ml
24-30 kg	5-7 years	0,4 - 1,0 ml
31-45 kg	8-12 years	0,5-1,5 ml
46 - 53 kg	12-15 years	0,8-1,8 ml

At children of a dose for intravenous administration establish depending on age:

Age of the child	Single dose for intravenous administration
3-11 months.	0,1 ml
1 - 4 years	0,2 ml
5 - 7 years	0,4 ml
8 - 11 years	0,5 ml
12-14 years	0,8 ml

Features of use:

At use of drug it is not necessary to mix it with other drugs in one syringe. With care appoint drug to patients with an abnormal liver function and/or kidneys, at tendency to hypotension or a bronchospasm, and also at hypersensitivity to non-steroidal anti-inflammatory drugs. During use of drug alcohol intake is forbidden. At long (over 1 week) use of drug it is necessary to control a pattern of peripheral blood and a functional condition of a liver.
At long introduction accommodation disturbance therefore it is necessary to correlate purpose of drug to risk assessment for drivers and persons is possible. which work demands bystry and exact reactions.
Drug is not recommended to be used during pregnancy. As metabolites of metamizol are excreted with mother's milk, do not appoint drug during feeding a breast. If it is impossible to avoid its use, it is necessary to stop feeding by a breast for this period.
With care apply at treatment of patients with arterial pressure below 100 mm of mercury.

Side effects:

In therapeutic doses drug is usually well transferred. Allergic reactions are sometimes possible (skin rashes, an itch, it is extremely rare - a burning sensation in an epigastric zone, dryness in a mouth, a headache). Dizzinesses, falling of arterial pressure, tachycardia, cyanosis are possible. At prolonged use cases of disturbance of system of blood (thrombocytopenia, a leukopenia, an agranulocytosis, a granulocytopenia) are described. At tendency to a bronchospasm provoking of an attack is possible.

Interaction with other medicines:

Simultaneous use with other non-steroidal anti-inflammatory drugs can lead to mutual strengthening of toxic effects. Tricyclic antidepressants, peroral contraceptives and Allopyrinolum increase toxicity of drug. Barbiturates, phenylbutazone and other inductors of microsomal enzymes of a liver weaken effect of metamizol. Simultaneous use with cyclosporine reduces the level of the last in blood. Sedatives and tranquilizers strengthen the anesthetizing effect of drug.

Contraindications:

Hypersensitivity to derivatives of pyrazyl ketone and other components of drug; the expressed abnormal liver functions and kidneys. Genetic absence glyukozo-fosfatdegidrogenazy; tachyarrhythmia; closed-angle form of glaucoma; a prostate hypertrophy with a tendency to ischurias; gastrointestinal impassability and megacolon; diseases of system of blood, kollaptoidny states; first trimester and last 6 weeks of pregnancy; lactation period; the chest age to (up to 3 months) or body weight is less than 5 kg.

Overdose:

Symptoms: it is shown by vomiting, feeling of dryness in a mouth, perspiration, accommodation disturbance, arterial hypotension. drowsiness, confusion of consciousness, abnormal liver function and kidneys, spasms. Treatment: symptomatic.

Storage conditions:

In the place protected from light at a temperature from +8 °C to +15 °C. To store in the place, unavailable to children.

Period of validity - 2 years.

Issue conditions:

According to the recipe

Packaging:

On 5 ml of solution in an ampoule, on 5 ampoules in a pack cardboard.