Instructions for Broncho-munal P hard capsules 3.5 mg No. 30
Composition
active ingredients: 1 capsule contains 3.5 mg of lyophilized lysate of bacteria Haemophilus influenzae, Streptococcus (Diplococcus) pneumoniae, Klebsiella pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and viridans, Moraxella (Branhamella/Neisseria) catarrhalis;
excipients: propyl gallate, sodium glutamate, mannitol (E 421), magnesium stearate, pregelatinized starch;
shell: indigotine (E 132), titanium dioxide (E 171), gelatin.
Dosage form
The capsules are hard.
Main physicochemical properties: opaque capsule No. 3 of white-blue color, containing a slightly beige powder.
Pharmacotherapeutic group
Other agents acting on the respiratory system. ATX code R07AX.
Pharmacological properties
Pharmacodynamics
The drug contains a lyophilized lysate of bacteria that most often cause respiratory tract infections, including Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella ozaenae, Staphylococcus aureus, Streptococcus viridans, Streptococcus pyogenes, Moraxella catarrhallis.
The drug stimulates the body's natural defenses against respiratory tract infections, reducing the frequency, duration, and severity of respiratory tract infections, and also reduces the need for antibiotics.
The drug activates the cellular and humoral immune response of the respiratory tract mucosa and other immunocompetent structures of the body. It also stimulates the nonspecific immune response of the body. In preclinical and clinical studies, the following effects of the drug on the body's defense mechanisms have been demonstrated:
– stimulates alveolar macrophages, which secrete cytokines that protect the body from infections;
– increases the number of CD4 T-lymphocyte populations;
– activates peripheral mononuclear cells that perform a protective function;
– increases the concentration of secretory IgA on the mucous membranes of the respiratory tract and digestive tract;
– stimulates the formation of protective adhesive molecules;
– reduces the content of IgE in blood plasma, which can inhibit the development of hypersensitivity reactions.
Pharmacokinetics
After oral administration of the drug, the bacterial lysate accumulates in Peyer's patches of the digestive tract mucosa.
Peyer's patch cells absorb antigen and present it to subepithelial lymphoid cells, thus inducing a humoral immune response that leads to increased production of IgA in the mucosa and prevents the penetration of microorganisms.
Antigens also stimulate lymphoid cells responsible for cellular defense, which then migrate through the regional lymph nodes into the thoracic duct, and then into the bloodstream.
With the bloodstream, they migrate to the mucous membrane of the digestive tract, respiratory tract, and mucous membranes of other organs, where they perform a protective function, increasing the ability of immune defense.
Indication
Use as an adjuvant therapy for all respiratory tract infections, as well as prophylactically for recurrent infections of the respiratory tract and ENT organs (chronic bronchitis, tonsillitis, pharyngitis, laryngitis, rhinitis, sinusitis, otitis).
Contraindication
Hypersensitivity to the components of the drug.
Interaction with other medicinal products and other types of interactions
No interactions of the drug with other drugs have been reported.
Application features
The drug can be started no earlier than 4 weeks after vaccination with a live vaccine.
The excipient mannitol may have a mild laxative effect.
The product contains less than 1 mmol (23 mg)/dose of sodium in the form of monosodium glutamate, i.e. practically sodium-free.
Use during pregnancy or breastfeeding
The safety of the drug during pregnancy or breastfeeding has not been established. The drug should not be used in the first trimester of pregnancy. Women should inform their doctor if they are planning or already pregnant.
In the II and III trimesters of pregnancy and during breastfeeding, the drug can be prescribed only if the expected benefit to the mother outweighs the potential risk to the fetus. It is unknown whether the components of the drug are excreted in breast milk.
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect.
Method of administration and doses
Children aged 6 months to 12 years.
Prevention of respiratory tract infections: 1 capsule (3.5 mg) per day for 10 days, 3 consecutive months (it is advisable to start taking the drug on the same day each month to maintain 20-day intervals between courses).
Treatment of exacerbations: 1 capsule per day for 10 to 30 consecutive days until symptoms disappear. In each of the next 2 months - 1 capsule for 10 days. The interval between courses should be 20 days. If antibiotics are necessary, the drug is recommended to be used simultaneously with antibiotics.
For children who cannot swallow the capsule, pour the contents of the capsule into a container with a small amount of liquid (tea, milk or juice) and give the child to drink.
The drug should be taken in the morning on an empty stomach.
If you forget to give your child medicine, you should give it the next morning.
The use of the drug in children under 6 months of age is not recommended due to the immaturity of their immune system. Children over 12 years of age should use Broncho-munal®, 7 mg capsules.
Overdose
No clear clinical symptoms of drug overdose were observed. No cases of overdose have been reported. In case of overdose, consult a doctor.
Adverse reactions
On the part of the digestive tract: often (≥ 1/100, < 1/10) - diarrhea; infrequently (≥ 1/1000, < 1/100) - nausea, vomiting, abdominal pain.
On the part of the immune system: rarely (≥ 1/10,000, < 1/1,000) - hypersensitivity reactions.
General disorders: rarely - fever.
If hypersensitivity reactions occur, the drug should be discontinued.
Expiration date
5 years.
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging to protect from moisture.
Keep out of reach of children.
Packaging
10 capsules in a blister, 1 (10 × 1) blister in a cardboard box.
Vacation category
According to the recipe.
Producer
Lek Pharmaceuticals dd, Slovenia (responsible for the release of the series).
Location of the manufacturer and its business address
Verovskova 57, 1526 Ljubljana, Slovenia.
