Nebalgan

General characteristics. Structure:

Active agents:
                                                1                           ml 1 amp.
metamizol sodium                       of 500                       mg 2.5 g
pitofenona hydrochloride            of 2                          mg 2 mg
fenpiveriniya bromide               of 20                       mkg 100 mkg

Pharmacological properties:

Combined analgeziruyushchy and the antispasmodic, a combination of components of drug leads to mutual strengthening of their pharmacological action.
Metamizole sodium - derivative pyrazyl ketone, has analgeziruyushchy and febrifugal effect.
Pitofenona a hydrochloride possesses direct myotropic action on smooth muscles (papaverinopodobny action).
Fenpiveriniya bromide possesses m-holinoblokiruyushchim action and has additional myotropic effect on smooth muscles.

Indications to use:

Pain syndrome (poorly or moderately expressed) at spasms of smooth muscles of internals: renal colic, spasm of an ureter and bladder; bilious colic, intestinal colic; dyskinesia of biliary tract, postcholecystectomy syndrome, chronic colitis; альгодисменорея, diseases of bodies of a small pelvis.
For short-term treatment: arthralgia, mialgiya, neuralgia, ischialgia.
As auxiliary HP: a pain syndrome after surgical interventions and diagnostic procedures.

Route of administration and doses:

Parenterally (in/in, in oil).

To adults and teenagers 15 years at acute heavy gripes are more senior enter in/in slowly (on 1 ml within 1 min.) 2 ml; if necessary enter repeatedly in 6-8 h. In oil - 2-5 ml of solution 2-3 raznut. The daily dose should not exceed 10 ml. Treatment duration - no more than 5 days.

Calculation of a dose for children at in/in and introduction in oil: 3-11 months (5-8 kg) - only in oil - 0.1-0.2 ml; 1-2 years (9-15 kg) - in/in - 0.1-0.2 ml, in oil - 0.2-0.3 ml; 3-4 years (16-23 kg) - in/in - 0.2-0.3, in oil - 0.3-0.4 ml; 5-7 years (24-30 kg) - in/in - 0.3-0.4 ml, in oil - 0.4-0.5 ml; 8-12 years (31-45 kg) - in/in - 0.5-0.6 ml, in oil - 0.6-0.7 ml; 12-15 years - in/in and in oil - 0.8-1 ml.

Before administration of injection solution it should be warmed in a hand.

Features of use:

During treatment drug does not recommend to accept ethanol.

At long treatment (more than a week) control of a picture of peripheral blood and a functional condition of a liver is necessary.

At suspicion on an agranulocytosis or in the presence of thrombocytopenia it is necessary to stop administration of drug.

Use for stopping of acute abdominal pains is inadmissible (before clarification of the reason).

The intolerance meets very seldom, however the threat of development of an acute anaphylaxis in/in administrations of drug is rather higher later, than after administration of drug inside. Patients with atopic bronchial asthma and pollinoses have an increased risk of development of allergic reactions.

Parenteral administration should be used only when intake is impossible (or absorption from a GIT is broken). Extra care at introduction is required more than 2 ml of solution (risk of sharp decrease in the ABP). It is necessary to carry out to an injection slowly, in situation "lying" also under control of the ABP, ChSS and ChD.

At treatment of children up to 5 years and the patients receiving cytostatics, reception of metamizole sodium has to be carried out only under observation of the doctor.

For introduction in oil it is necessary to use a long needle.

Coloring of urine in red color due to allocation of a metabolite is possible (clinical value has no).

Influence on ability to driving of motor transport and to control of mechanisms
During treatment the drivers of vehicles and persons who are engaged in potentially dangerous types of activity demanding speed of physical and mental reaction should be careful.

Side effects:

Allergic reactions: a small tortoiseshell (including on a conjunctiva and mucous membranes of a nasopharynx), a Quincke's disease, in rare instances - a malignant exudative erythema (Stephens-Johnson's syndrome), a toxic epidermal necrolysis (Lyell's disease), a bronkhospastichesky syndrome, an acute anaphylaxis.
From an urinary system: a renal failure, an oliguria, an anury, a proteinuria, intersticial nephrite, coloring of urine in red color.
From cardiovascular system: decrease in the ABP.
From system of a hemopoiesis: thrombocytopenia, a leukopenia, an agranulocytosis (it can be shown by the following symptoms: unmotivated rise in temperature, fever, pharyngalgia, swallowing difficulty, stomatitis, and also development of the phenomena of a vaginitis or proctitis).
Anticholinergic effects: dryness in a mouth, the lowered sweating, accommodation paresis, tachycardia, the complicated urination.
Local reactions: at introduction in oil infiltrates in an injection site are possible.

Interaction with other medicines:

Solution for injections pharmaceutical is incompatible with other medicines.

At joint appointment histamine with H1 blockers, phenyl propyl ketones, fenotiazina, tricyclic antidepressants, amantadiny and quinidine strengthening of m-holinoblokiruyushchego of action is possible.

Strengthens effects of ethanol; simultaneous use with Chlorpromazinum or other derivatives of a fenotiazin can lead to development of the expressed hyperthermia.

Tricyclic antidepressants, oral contraceptives and Allopyrinolum increase toxicity of drug.

Phenylbutazone, barbiturates and other inductors of liver enzymes at co-administration reduce efficiency of metamizole sodium.

Sedative and anxiolytic medicines (tranquilizers) strengthen analgeziruyushchy effect of metamizole sodium.

X-ray contrast medicines, colloid blood substitutes and penicillin should not be used during treatment by the drugs containing metamizole sodium.

At co-administration of cyclosporine concentration of the last in blood decreases.

Metamizole sodium, forcing out peroral hypoglycemic medicines, indirect anticoagulants, GKS and indometacin from communication with protein, can increase expressiveness of their action.

Thiamazolum and cytostatics increase risk of development of a leukopenia.

The effect is strengthened by codeine, H2 blockers - histamine receptors and propranolol (slows down a metamizole sodium inactivation).

Contraindications:

Hypersensitivity (including to pyrazyl ketone derivatives), oppression of a marrowy hemopoiesis, the expressed liver and/or renal failure, deficit glyukozo-6-fosfatdegidrogenazy, tachyarrhythmias, heavy stenocardia, dekompensirovanny chronic heart failure, closed-angle glaucoma, a prostate hyperplasia (with clinical manifestations), intestinal impassability, megacolon, a collapse, pregnancy (especially in the I trimester and in the last 6 weeks), the lactation period.

For in/in introductions - the infantile age (up to 3 months) or body weight is less than 5 kg. For tablets - children's age (up to 5 years).

With care: a renal/liver failure, bronchial asthma, tendency to arterial hypotonia, hypersensitivity to NPVS; the urticaria or acute rhinitis provoked by reception of acetylsalicylic acid or other NPVS.

Use at pregnancy and feeding by a breast
It is contraindicated at pregnancy (especially in the I trimester and in the last 6 weeks).
Use for nursing mothers demands the breastfeeding termination.

Use at abnormal liver functions
It is contraindicated at the expressed liver failure. With care: moderate or slight liver failure

Use at renal failures
It is contraindicated at the expressed renal failure. With care: moderate or slight renal failure

Use for children
Contraindications for in/in introductions - infantile age (up to 3 months) or body weight are less than 5 kg; for tablets - children's age (up to 5 years).
Treatment of children up to 5 years has to be carried out only under observation of the doctor.

Overdose:

Symptoms: vomiting, decrease in the ABP, drowsiness, confusion of consciousness, nausea, pains in epigastric area, an abnormal liver function and kidneys, a spasm.

Treatment: gastric lavage, purpose of absorbent carbon, symptomatic therapy.

Storage conditions:

List B. To store in the dry, protected from light place.

Issue conditions:

According to the recipe

Packaging:

Solution for инъекц. 2.5 of +10 mg +100 mkg / 5 ml: amp. 5 pieces.