Instructions for Ismizhen sublingual tablets No. 30
Composition
active ingredient: 1 tablet contains 50 mg of lyophilized bacterial lysate, which includes 7 mg of bacterial lysate from: Staphylococcus aureus 6×109 CFU, Streptococcus pyogenes 6×109 CFU, Streptococcus viridans 6×109 CFU, Klebsiella pneumoniae 6×109 CFU, Klebsiella ozaenae 6×109 CFU, Haemophilus influenzae B 6×109 CFU, Neisseria catarrhalis 6×109 CFU, Streptococcus pneumoniae 6×109 CFU (contains 1×109 CFU of the following types - TY1, TY2, TY3, TY5, TY8, TY47), and 43 mg of glycine for the lyophilization process;
Excipients: colloidal silicon dioxide; microcrystalline cellulose; calcium hydrogen phosphate dihydrate; magnesium stearate; ammonium glycerysinate; menthol powder essence.
Dosage form
Sublingual tablets.
Main physicochemical properties: whitish tablets with a score on one side, with brown inclusions, a slight characteristic odor.
Pharmacotherapeutic group
Immunostimulants. ATX code L03A X.
Pharmacological properties
Immunological and biological properties:
Ismizhen is an immunostimulant based on bacterial lysate that increases the body's resistance to infections by increasing the number of serum and secretory antibodies, activating cellular and humoral factors of nonspecific immunity. This reduces the frequency and severity of respiratory infections, and prevents the need for antibiotics.
Ismizhen has a dual mechanism of action:
activates nonspecific resistance due to membrane antigens included in the preparation, by activating dendritic cells, neutrophils, macrophages and NK cells; induces phagocytosis and cell lysis by stimulating adhesion of macrophages to bacteria;
activates specific immunity by increasing the level of IL-2 production, specific serum IgA, IgG, IgM and slgA, activation of effector CD4 and CD8 T-lymphocytes, activation of B-lymphocytes.
Ismizhen is well absorbed in the oral mucosa.
Indication
Prevention of recurrent respiratory tract infections.
Contraindication
Hypersensitivity to the components of the drug.
Autoimmune diseases.
Acute intestinal infections.
Interaction with other medicinal products and other types of interactions
No interactions with other drugs, including antibiotics and mucolytics, were observed.
The response in congenital or acquired immunodeficiency may be suppressed in patients undergoing immunosuppressive or corticosteroid therapy.
Use during pregnancy or breastfeeding
Although no toxic effects of Ismigen have been observed in animals, it is not recommended to use the drug during pregnancy or breastfeeding.
Due to its immunomodulatory effect, Ismizhen reduces the number and intensity of cases of recurrent respiratory tract infections in children who are often and long-term ill, and also reduces the number of exacerbations caused by recurrent respiratory tract infections per year and the severity of their course.
If the temperature rises significantly at the beginning of treatment, it is necessary to stop taking the drug.
The drug should not be used simultaneously with other immunostimulants.
Patients who have had a negative experience with the use of bacterial lysates may experience asthma attacks.
There is no clinical trial data to demonstrate that the drug can prevent pneumonia. Therefore, its use for the prevention of pneumonia is not recommended.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the ability to drive a car or other mechanisms.
Method of administration and doses
Adults and children from 2 years old.
Preventive treatment: the drug is used sublingually. Take 1 tablet for 1-2 minutes until completely dissolved once a day (you should refrain from eating for at least 30 minutes), for 10 days. After a 20-day break, repeat the 10-day course of taking the drug. Take another 20-day break and repeat the 10-day course. Preventive treatment can be started during the acute phase of respiratory tract infections in combination with other treatment methods.
Ismizhen is taken in three ten-day courses for three months with two 20-day breaks between them. For younger children, it is recommended to first crush the tablet, moisten it with boiled water at room temperature and put the resulting pasty mixture into the oral cavity.
During the full course, you need to take 30 tablets.
Children
The drug is used in children aged 2 years and older.
Overdose
There have been isolated cases of overdose, with insomnia and abdominal pain. Treatment is symptomatic.
Side effects
On the part of the digestive tract: vomiting, stomatitis, abdominal pain, nausea and diarrhea.
Skin and subcutaneous tissue disorders: allergic reactions including urticaria, pruritus, rash and oedema
Infections and infestations: rhinitis, bacterial tonsillitis, influenza-like illness.
General reactions: fever, fatigue and headache.
Adverse reaction reports:
Post-marketing adverse reaction reporting is important. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
Expiration date
3 years.
Storage conditions
Store in the original packaging and out of the reach of children at a temperature not exceeding +25 °C.
Packaging
10 tablets in a blister, 1 or 3 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Bruschettini s.r.l. /Bruschettini SRL
Location
Via Isonzo, 6,16147 Genova, Italy/Bia Isonzo, 6, 16147 Genoa, Italy.
Applicant
Lallemand Pharma AG/Lallemand Pharma AG.
Location
Via Selva, 2, 6900-Massagno, Switzerland./Via Selva, 2, 6900-Massagno, Switzerland.
