AERUS - instructions for use, doses, side effects, contraindications

Active component: aprotinin, concentrated solution * - 0.00043 ml, in terms of aprotinin - 85 KIE (Kallikrein Inhibiting Units) (0.013 mg); auxiliary components: propellant HFC-134A (1,1,1,2-tetrafluoroethane) CH2FCF3- 0.045 ml, peppermint mint oil - 0.000045 ml, ethanol 96% - 0.0075 ml, glycerol 96% - 0.0035 ml.

* As an auxiliary substance, a concentrated solution of aprotinin contains purified water (EurPh).

Description:Transparent colorless or slightly yellow solution.

Pharmacotherapeutic group:Proteolysis inhibitor

ATX: & nbsp

B.02.A.B Inhibitors of plasma proteinases

B.02.A.B.01 Aprotinin

Pharmacodynamics:

The main active substance of the drug AERUS® - aprotinin - is a low molecular weight natural polypeptide (58 amino acids) isolated from light bovine animals and has an inhibitory effect on proteolytic enzymes. Aprotinin inhibits trypsin, chymotrypsin, plasmin, plasma and tissue kallikrein, mast cell tryptase, cathepsin, leukocyte elastase (proteinase 3), prostasin and other proteases due to the formation of stable complexes with them.

The effect of aprotinin is due to the following mechanisms. First, it has an antiviral effect by inhibiting the proteolysis of a specific viral protein, which leads to direct inhibition of the reproduction of the virus. Secondly, aprotinin reduces the level of virus and bacterial induced proteolysis in tissues, preventing the development of pathological inflammatory processes that result from an excess of proteases and a lack of their inhibitors.

Aprotinin reduces the concentration of reactive oxygen species in the focus of viral inflammation by inhibiting the proteolytic formation of xanthine oxidase (CO), i.e. acts as an antioxidant.The inhibition of the KO-dependent pathway of peroxidation leads to a reduction in the pathological inflammatory processes that form in the respiratory organs in viral infections.

Aprotinin inhibits the activation of a number of cytokines and chemokines, inhibits tissue migration of leukocytes, which has a pronounced anti-inflammatory effect in the focus of infection.

Aerosol inhalations of aprotinin do not exert local toxicity in respiratory organs and do not suppress the development of antiviral immunity in infected patients.

Pharmacokinetics:

When inhaled, absorption of aprotinin into the blood is unlikely. In the case of intravenous administration aprotinin through the bloodstream enters the kidneys. In the human body, aprotinin molecules are completely cleaved into shorter peptides and amino acids, after which the products are excreted in the urine. The half-life of aprotinin from the bloodstream is about 2 hours. Excretions of unchanged aprotinin by the kidneys do not occur even at high doses of administration - about 1 million KIE.

Indications:Treatment of infectious and inflammatory diseases of viral etiology (influenza and other acute respiratory viral infections).

Contraindications:

Hypersensitivity to aprotinin and other components of the drug.

Syndrome of disseminated intravascular coagulation.

Allergic reactions (including on the protein of cattle).

Pregnancy, lactation.

Children under 18 years of age (due to lack of clinical experience in children).

Pregnancy and lactation:

Adequate and strictly controlled clinical trials on the safety of the drug during pregnancy have not been conducted. The use of the drug during pregnancy is contraindicated.

If it is necessary to use the drug during lactation it is recommended to stop breastfeeding.

Dosing and Administration:

For 1 inhalation dose (1 dose of 85 CIE) in each nasal passage every 2-4 hours (800 - 2000 KIE / day). The maximum daily dose of 50-65 KIE / day per kg of body weight. The basic recommended course of inhalation: inhalation through the nose, exhalation through the mouth - with viral inflammation in the nasal cavity; inhalation through the mouth and exhalation in the nose - in the presence of symptoms of viral inflammation in the oropharynx, trachea and bronchi. Combined inhalation is possible at a single dose in the nasal passages and through the mouth.Duration of the course is from 3 to 8 days, depending on the severity of the disease with a frequency of every 2-4 hours.

Directions for proper use

Before the first use, press the metering valve twice.

Before each use, observe the following procedure:

1. Remove the protective cover and shake the can.

2. Take a deep breath.

3. The inhaler should be held in the position shown in the figure, if inhaled through the mouth, compress the mouthpiece with your lips or, if inhaled through the nose, insert the nose nozzle into the nostril.

4. Simultaneously with a deep breath, energetically push the dosing valve, which will allocate one aerosol dose. Hold the breath for 1-2 seconds, then remove the mouthpiece from the mouth, nose from the nose and exhale.

5. After use, put back the protective cover on the mouthpiece, which is installed on the dosing head to protect it from damage.

6. If the product has not been used for three days, it is necessary to press the metering valve once before a new application.

Side effects:

In comparison with intravenous administration with inhalation administration of aprotinin, the risk of side effects is unlikely.

The following side effects were observed with intravenous administration of aprotinin.

From the side of the cardiovascular system: lowering blood pressure, tachycardia, pale skin.

From the central nervous system: psychotic reaction, hallucinations, confusion.

Allergic reactions: rash, rhinitis, conjunctivitis, anaphylactic reactions (up to anaphylactic shock).

From the digestive system: nausea, vomiting.

Local Reactions: dryness, bleeding of mucous membranes of the respiratory tract.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

Data on drug overdose are absent.

Interaction:

If you are taking any other drugs, you should consult your doctor before starting treatment.

Caution should be exercised while using aprotinin with beta-lactam antibiotics because of the possibility of their direct chemical interaction.

Special instructions:

Patients with an increased risk of developing allergic reactions prior to the use of the drug AERUS® are recommended taking antihistamines. If the allergic reaction develops, the drug should be stopped immediately and consult a doctor.

Oral and nasal nozzle must be kept clean and can be washed with warm water or 40% aqueous ethanol solution. If soap or other cleaning agents are used to flush the nozzle, then the nozzle should be rinsed thoroughly with a stream of water.

Mouth and nasal packing can not be used from the kit Aerus® preparation with other solutions for inhalation, a drug Aerus® undesirable to use with other nozzles.

The can is under constant pressure. Protect from direct sunlight, temperatures above 50 ° C and below 0 ° C. After the end of the application, do not open the can with force and do not burn. Do not spray near naked flames or hot objects. Keep away from sources of ignition.

Avoid contact with eyes. If you accidentally hit the eye should be washed with water.

Effect on the ability to drive transp. cf. and fur:Clinical studies to assess the effect of aprotinin in inhalation on the ability to drive vehicles and other mechanisms have not been conducted. Given the possible side effects, it is advisable to exercise caution when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions until an individual patient's response to aprotinin.

Form release / dosage:

Aerosol for inhalation dosed 85 CIE / dose.

Packaging:For 35,000 KIU (350 doses) or 25,000 KIU (250 doses) in a metal (aluminum) balloon with a dispenser (valve) with a capacity of 30 ml or 20 ml respectively. One cylinder, together with instructions for use and a set of 2 nozzles for nasal and oral use with safety caps are placed in a plastic contour mesh package, and then placed in a cardboard box.

Storage conditions:

In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:5 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-000280/10

Date of registration:25.01.2010 / 02.05.2017

Expiration Date:Unlimited

The owner of the registration certificate:BINNOFARM, CJSC BINNOFARM, CJSC Russia

Manufacturer: & nbsp

WAKE SPOL.s.r.o. Czech Republic

Representation: & nbspPLAST OAO PLAST OAO Russia

Information update date: & nbsp24.09.2017

Illustrated instructions

Instructions

Aeros® (Aerus®)