Instructions for use Lantigen B oral drops 18ml No. 1
Composition
active ingredients: 1 ml of suspension contains a mixture of bacterial lysates:
Staphylococcus aureus 79.6 AU;
Streptococcus pyogenes group A 126.2 AO;
Streptococcus pneumoniae type 3 63.2 AU;
Haemophilus influenzae type B 50.2 AU;
Branhamella catarrhalis 39.9 AU;
Klebsiella pneumoniae 39.8 AU;
Excipients: polysorbate 80, sodium methyl parahydroxybenzoate (E 219), chlorhexidine diacetate, purified water.
Dosage form
Oral drops, suspension.
Main physicochemical properties: gray-brown suspension with opalescence.
Pharmacotherapeutic group
Antimicrobials for systemic use. Vaccines. Bacterial vaccines. Other bacterial vaccines. ATX code J07A X.
Pharmacological properties
Pharmacodynamics
Lantigen B contains a suspension of bacterial antigens obtained in the process of controlled autolysis of certain types of microorganisms that are the most common causative agents of respiratory tract infections (S. pneumoniae, S. pyogenes, B. catarrhalis, S. aureus, H. influenzae, K. pneumoniae).
The drug, when administered sublingually, stimulates local immune processes by absorbing bacterial antigens through the oral and pharyngeal mucosa. This leads to the formation of secretory immunoglobulins of class A (IgA-S) by submucosal plasma cells, which play an important role in protecting the respiratory mucosa.
In vitro studies have proven that the drug exhibits its pharmacological properties through an immunostimulating effect, resulting in:
restoration of functional parameters of polymorphonuclear neutrophils to normal levels;
increased production of interleukin-1 in cultured mononuclear cells;
action as a polyclonal lymphocyte activator, which has a higher stimulating activity than the mitogen of laconosis;
active stimulation of IgM production in cultured lymphocytes.
In addition, in vivo studies have shown that Lantigen B:
increases the level of production of salivary and circulating IgA, IgM, IgG;
reduces the frequency and intensity of respiratory diseases;
reduces the need for antibiotics.
Study LAN-BR-11-001, involving 120 patients aged 18 to 65 years who had 2 to 6 upper respiratory tract infections, often associated with respiratory allergic disorders, in the previous year, and of whom 62 patients were actively treated with Lantigen B and 58 patients received placebo, showed that the number of infections during the study period was significantly (– 42%) lower in patients treated with Lantigen B compared to those receiving placebo.
Similar results were observed in a subgroup of patients with allergies.
Pharmacokinetics
Due to the nature of the drug, pharmacokinetic studies cannot be performed.
Indication
Adults
Prevention of recurrent upper respiratory tract infections.
Children
Prevention of recurrent cases of bacterial upper respiratory tract infections in children aged 1 year and older.
Contraindication
Hypersensitivity to the active substances or to any excipient of the drug.
Autoimmune diseases.
Acute intestinal infections.
Interaction with other medicinal products and other types of interactions
Interaction studies with other drugs or vaccines have not been conducted.
The immune response may be suppressed in patients with congenital or acquired immunodeficiency, during immunosuppressive therapy, or during treatment with corticosteroids.
Application features
Treatment should be discontinued in the event of an increase in body temperature, especially if it occurs at the beginning of treatment.
The patient should be informed of the possibility of a rare undesirable side effect, such as an increase in body temperature above 39 °C, isolated, without apparent cause, and not associated with the onset of an acute respiratory illness. In this case, treatment should be discontinued without resumption.
Concomitant use with other immunostimulants should be avoided.
Some patients prone to bronchial asthma have experienced asthma attacks after using preparations containing bacterial antigens. In this case, Lantigen B should not be used.
In case of hypersensitivity reactions, the use of the drug should be discontinued immediately without further use.
Sodium methyl parahydroxybenzoate (E 219), which is part of the medicinal product, may cause allergic reactions (possibly delayed) and in exceptional cases, bronchospasm.
Lantigen B is not recommended for use during pregnancy. The medicine should only be used if clearly needed and under the close supervision of a doctor (see section “Use during pregnancy or breastfeeding”).
Use in patients with impaired liver/kidney function and other organs.
There are no data on the use of Lantigen B in patients with impaired liver/kidney function.
Use during pregnancy or breastfeeding
Breastfeeding. Studies on the use of Lantigen B during breastfeeding have not been conducted, therefore it is recommended to avoid taking the drug.
Ability to influence reaction speed when driving vehicles or other mechanisms
Data is missing.
Method of administration and doses
Adults and children aged 10 and over
One dose (15 drops) of Lantigen B is instilled under the tongue twice a day (morning and evening). The required number of drops of the drug is obtained by turning the bottle upside down and pressing the dropper cap.
Children aged 1 to 10 years
One dose (15 drops) of Lantigen B is dropped under the tongue once a day in the morning, preferably on an empty stomach, or half of one dose (7–8 drops) is dropped under the tongue twice a day (morning and evening). The required number of drops of the drug is obtained by turning the bottle upside down and pressing the dropper cap.
Important: each dose should be held in the mouth for about 2 minutes, without swallowing, so that the suspension dissolves with saliva, thus facilitating the absorption of the drug.
The bottle must be shaken before use. The presence (even after shaking) of floating agglomerates is possible, which do not affect the safety of the drug.
Treatment course: two vials (36 ml) for adults and one vial (18 ml) for children according to the indicated dosage. Treatment should be stopped for 2–3 weeks. Then a second course of treatment should be carried out, using one vial (18 ml) for adults and half a vial for children according to the indicated dosage.
To achieve and maintain sufficient body protection throughout the winter season, treatment should begin in September and be repeated in January.
Children
Do not use in children under 1 year of age.
Overdose
The risks of overdose are unknown.
Side effects
After the first use of the drug, temporary worsening of symptoms such as constipation and rhinorrhea is possible.
Adverse reactions with a frequency of rare (> 1/10,000 and < 1/1000):
increase in body temperature above 39 °C, independently and without apparent reasons;
in some cases, asthma attacks are possible in patients prone to bronchial asthma;
constipation;
rhinorrhea.
Such reactions are usually minor.
Reporting of suspected adverse reactions.
Reporting suspected adverse reactions that occur after the registration of a medicinal product is important because it allows for continuous monitoring of the risk/benefit ratio of the medicinal product.
Expiration date
3 years.
After first opening the bottle, the shelf life is no more than 28 days.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, protected from light. Keep out of the reach of children.
Packaging
18 ml in bottles with a dropper cap, 1 bottle in a cardboard box.
Vacation category
According to the recipe.
Producer
BRUSCHETTINI S.R.L.
Location of the manufacturer and address of its place of business.
Bia Isonzo 6, Genoa (GE), 16147, Italy.
