Instruction for use: Ismigen

Dosage form: Sublingual tablets

Active substance: Staphylococcus aureus, Streptococcus pyogenes, Streptococcus viridans, Streptococcus pneumoniae, Klebsiella pneumoniae, Klebsiella ozaenae, Haemophilus influenzae B, Neisseria catarrhalis

ATX

L03AX Immunostimulants others

Pharmacological group:

Other immunomodulators

The nosological classification (ICD-10)

H66.9 Otitis media, unspecified: Chronic otitis media; Otitis; Average otitis media; Middle ear infection; Otitis media in children

J00 Acute nasopharyngitis [rhinitis]: Viral rhinitis;Inflammation of the nasopharynx; Inflammatory Nose Disease; Purulent rhinitis; Nasal congestion; Nasal congestion due to cold and flu; Difficulty with nasal breathing; Difficulty with nasal breathing for colds; Difficult nasal breathing; Difficult nasal breathing for colds; Nasal hypersecretion; Coryza; ARI with phenomena of rhinitis; Acute rhinitis; Acute rhinitis of various origins; Acute rhinitis with thick purulent-mucous exudate; Acute rhinopharyngitis; Edema of the mucous membrane of the nasopharynx; Rhinitis; Rhinorrhea; Infectious-inflammatory disease of ENT organs;Severe cold; Rhinopharyngitis

J01 Acute sinusitis: Inflammation of the paranasal sinuses; Inflammatory diseases of the paranasal sinuses; Purulent-inflammatory processes of the paranasal sinuses; Infectious-inflammatory disease of ENT organs; Infection of the paranasal sinuses; Combined sinusitis; Exacerbation of sinusitis; Acute inflammation of the paranasal sinuses; Acute bacterial sinusitis; Acute sinusitis in adults; Subacute sinusitis; Sinusitis acute; Sinusitis

J02 Acute pharyngitis: Inflammation of the nasopharynx; Inflammatory disease of the oropharynx; Inflammatory process of pharynx; Infectious diseases of ENT organs; Sore Throat Infection; Exacerbation of inflammatory diseases of the pharynx and oral cavity; Pharyngitis; Pharyngitis acute; Pharyngolaryngitis

J03 Acute tonsillitis [sore throat]

J04.0 Acute laryngitis: Lecter's laryngitis; Laryngitis acute catarrhal; Laryngitis acute phlegmonous

J06 Acute upper respiratory tract infections of multiple and unspecified locations: Frequent colds of viral diseases; Infections of ENT organs; Acute respiratory illness of influenza nature; Pain for colds; Acute catarrhal disease; Cold; Colds; Colds; Respiratory infection; Seasonal catarrhal disease; Seasonal colds; Pain in infectious and inflammatory diseases of the upper respiratory tract; Bacterial infections of the upper respiratory tract; Bacterial infections of the respiratory system; Viral respiratory disease; Viral respiratory tract infections; Inflammatory disease of the upper respiratory tract; Inflammatory diseases of the upper respiratory tract; Inflammatory diseases of the upper respiratory tract with difficult to separate sputum; Inflammatory respiratory disease; Secondary infections for colds; Difficult sputum separation in acute and chronic respiratory diseases; Upper respiratory tract infections; Infections of the upper respiratory tract; Respiratory tract infections; Respiratory and lung infections; Infectious-inflammatory diseases of the upper respiratory tract; Infectious-inflammatory diseases of the upper respiratory tract and ENT organs; Infectious-inflammatory diseases of the upper respiratory tract in adults and children; Infectious-inflammatory diseases of the upper respiratory tract; Infectious inflammation of the respiratory tract; Respiratory tract infection; Qatar upper respiratory tract; Catarrh of the upper respiratory tract; Catarrh of the upper respiratory tract; Catarrhal phenomena from the upper respiratory tract; Cough in diseases of the upper respiratory tract; Cough for colds; ARVI; ARI; ARI with phenomena of rhinitis; Acute respiratory infection; Acute infectious-inflammatory disease of the upper respiratory tract; Acute respiratory disease; Persecution in the throat or nose; Respiratory and viral infections; Respiratory diseases; Respiratory infections; Recurrent respiratory tract infections; Secondary infections with influenza; Influenza states; Feverish conditions for influenza

J22 Acute respiratory infection of lower respiratory tract, unspecified: Bacterial respiratory disease; Bacterial infections of the lower respiratory tract; Bacterial infections of the respiratory system; Viral respiratory disease; Viral respiratory tract infections; Inflammatory respiratory disease;; Difficult sputum separation in acute and chronic respiratory diseases; Respiratory tract infections; Respiratory and lung infections; Lower respiratory tract infections; Infections of the lower respiratory tract; Infectious inflammation of the respiratory tract; Infectious diseases of the respiratory tract; Infectious diseases of the lungs; Infectious diseases of the respiratory system; Respiratory tract infection; Cough for colds; Pulmonary infection; Acute respiratory tract infection; Acute respiratory viral infection; Acute inflammatory airway disease; Acute respiratory disease; Respiratory infection; Respiratory and viral infections; Respiratory syncytial viral infection in young children; Respiratory diseases; Respiratory infections

J39.9 Disease of upper respiratory tract, unspecified: Mechanical irritation of mucosa of upper respiratory tract; Acute respiratory disease; Recurrent infections of ENT organs; Chronic infection of the upper respiratory tract; Chronic infections of ENT organs; Infections of ENT organs

J40 Bronchitis not specified as acute or chronic: Asthmatic bronchitis; Allergic bronchitis; Bronchitis allergic; Asthmatic bronchitis; Rhinotraheobronchitis; Asthmatic bronchitis; Bacterial bronchitis; Bronchitis; Bronchitis of the smoker; Bronchitis of smokers; Inflammation of the lower respiratory tract; Disease of the bronchi; Qatar smoker; Cough smokers; Cough with inflammatory diseases of the lungs and bronchi; Disturbance of bronchial secretion; Impaired bronchial function; Acute tracheobronchitis; Subacute bronchitis; Tracheobronchitis; Chronic lung diseases

J42 Chronic bronchitis, unspecified: Recurrent bronchitis; Asthmatic bronchitis; Asthmatic bronchitis; Bronchitis chronic; Inflammatory respiratory disease; Disease of the bronchi; Qatar smoker; Cough with inflammatory diseases of the lungs and bronchi; Exacerbation of chronic bronchitis; Chronic bronchitis; Chronic Obstructive Pulmonary Diseases; Chronical bronchitis; Chronic bronchitis of smokers; Chronic spasmodic bronchitis; Allergic bronchitis; Bronchitis allergic

Composition

Tablets Sublingual 1 tab.

active substance: Lyophilized bacterial lysates 50 mg

(Including active components: bacterial lysates of Staphylococcus aureus, Streptococcus pyogenes, Streptococcus viridans, Streptococcus pneumoniae (types TY1 / EQ11, TY2 / EQ22, TY3 / EQ14, TY5 / EQ15, TY8 / EQ23, TY47 / EQ 24), Klebsiella pneumoniae, Klebsiella ozaenae, Haemophilus influenzae b, Neisseria catarrhalis - 7 mg, excipient: glycine - 43 mg)

Auxiliary substances: MCC - 150 mg; Calcium hydrophosphate dihydrate - 35 mg; Silicon dioxide colloidal - 10 mg; Magnesium stearate - 3 mg; Ammonium glycyrrhizinate - 1,2 mg; Flavoring mint - 0,8 mg

Description of dosage form

Tablets are flat-cylindrical with a risk, light cream color, with brown impregnations and a weak smell of mint.

Pharmachologic effect

Mode action - immunomodulating.

Pharmacodynamics

Combined immunostimulating drug of bacterial origin for sublingual (sublingual) administration.

It is a multivalent antigenic complex, which includes lysates of bacteria - the most common pathogens of respiratory infections. The lysates that make up Ismigen® are obtained by mechanical action. Ismigen®, like other immunostimulants of bacterial origin of the second generation, has a nonspecific immunostimulating and specific vaccinating action.

Ismigen®, sublingual tablets, has an effect on various parts of the immune system. Stimulates both the local cellular and humoral immune response, and the systemic immune response. Activates phagocytosis, increases the content of lysozyme in saliva, helps increase the number of immunocompetent cells.

Increases the functional and metabolic activity of macrophages (including alveolar) and polymorphonuclear leukocytes. Activates the processes of peroxidation and the expression of adhesion molecules on macrophage-monocyte cells and granulocytes LEA-1, MAS-1, p-150, ICAT-1, which provides cooperation with T-lymphocytes and antigen presenting cells and promotes the destruction of infectious agents. Stimulates the secretion of macrophage-monocyte cells PGE2, activates natural killers; Stimulates the release of anti-inflammatory cytokines - IL-1, IL-2, IL-6, IL-8, gamma-interferon, TNF-alpha; Inhibits the synthesis of IL-4, IL-12; Increases the concentration of secretory IgA in saliva, serum IgA, IgG, IgM; Reduces the concentration of serum IgE.

As a result of treatment with Ismigen ®, the incidence, severity and duration of acute infections of the respiratory tract are reduced; There is relief and leveling of symptoms such as fever, cough, shortness of breath, the need for antibacterial and anti-inflammatory therapy decreases; In patients with chronic diseases of the respiratory tract, the drug also prevents exacerbations.

Indications for the preparation Ismigen

Acute and subacute infections of the upper and lower respiratory tract: bronchitis, tonsillitis, pharyngitis, laryngitis, rhinitis, sinusitis, otitis media, including complications after the flu (treatment as part of combination therapy);

Recurrent infections of the upper and lower respiratory tract, chronic bronchitis (prevention of exacerbations).

Contraindications

Hypersensitivity to the active and / or auxiliary components of the drug;

pregnancy;

lactation;

Children's age till 3 years.

Application in pregnancy and breastfeeding

Contraindicated.

Side effects

The incidence of side effects is classified according to WHO recommendations: very often more than 10%; Often more than 1 and less than 10%; Infrequently - more than 0,1 and less than 1%; Rarely - more than 0.01 and less than 0.1%; Very rarely - less than 0.01%.

From the skin: very rarely - urticaria, impetiginozny dermatitis, folliculitis.

Other: very rarely - inflammation of the salivary gland, acute laryngitis, rhinitis.

Interaction

Ismigen® can be used concomitantly with other medicines intended for the treatment of acute and chronic respiratory diseases.

The specific features of the interaction of Ismigen with other medications have not been described to date.

Dosing and Administration

Under the tongue, take on an empty stomach. The tablet should be kept under the tongue until completely dissolved. Tablets of the sublingual should not be absorbed, chewed or swallowed.

Acute and subacute infections of the upper and lower respiratory tract - 1 table / day until the symptoms disappear (at least 10 days).

Recurrent infections of the upper and lower respiratory tract, prevention of exacerbations of chronic respiratory diseases - 1 table / day for 10 days. The preventive course includes 3 cycles of 10 days with 20-day intervals between them. Preventive course should be conducted no more than 1-2 times a year.

If you skip the next dose, you should not double it the next time you take it.

Overdose

Information on cases of overdose are absent.

Special instruction

Children aged 3 to 6 years at the time of taking each dose, until the tablet is completely dissolved in the oral cavity, should be under the supervision of adults.

Influence on the ability to drive vehicles and manage mechanisms. Does not affect.

Release form

Tablets are sublingual, 7 mg. 10 tab. In a planar cell packaging made of PVC film and aluminum foil. 1 or 3 contour squares in a pack of cardboard.

Manufacturer

Bruschettini Srl, Italy. Genoa, Via Isonzo, 6.

The name of the legal entity in whose name the registration certificate was issued is: "NIZHFARM" 

And to OJSC "NIZHFARM".

Conditions of supply of pharmacies

On perscription.

Storage conditions of the drug Ismigen

At a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life of the drug Ismigen

3 years.

Do not use after the expiry date printed on the package.