INSTRUCTIONS
on the use of the drug
for medical use
Read these instructions carefully before you start taking/using this medicine.
Save the instructions, you may need them again.
If you have any questions, consult your doctor.
Registration number:
Trade name of the drug:
Broncho-munal ® P.
International nonproprietary name or generic name:
Bacterial lysates.
Dosage form:
Compound:
1 capsule contains: active substances: standardized lyophilisate of bacterial lysates (OM-85) – 20.0 mg: lyophilized bacterial lysates – 3.50 mg: Haemophilus influenzae, Streptococcus pneumoniae, Streptococcus viridans, Streptococcus pyogenes, Klebsiella pneumoniae, Klebsiella ozaenae, Staphylococcus aureus, Moraxella catarrhalis; Excipients: propyl gallate (anhydrous) – 0.042 mg; sodium glutamate (anhydrous) – 1.515 mg; mannitol – up to 20,000 mg, magnesium stearate – 3,000 mg; pregelatinized starch – 110,000 mg, mannitol – up to 200.00 mg; capsule shell: indigotine E132 – 0.009 mg, titanium dioxide E171 – 0.98 mg, gelatin – up to 50 mg.
Description: hard gelatin capsules size No. 3, blue opaque cap, white opaque body. Capsule contents: light beige powder.
Pharmacotherapeutic group:
immunostimulating agent.
ATX code: L03AX.
Pharmacological properties
The drug Broncho-munal ® P has an immunostimulating effect, strengthening immunity against respiratory tract infections.
After taking the capsule, the bacterial lysate accumulates in Peyer's patches of the mucous membrane of the gastrointestinal tract, in particular located in the small intestine. Antigen-presenting cells in Peyer's patches are activated by the bacterial lysate and subsequently stimulate other types of cells (B lymphocytes) responsible for specific immunity. This leads to an increase in the number of circulating B lymphocytes, which leads to an increase in the production of polyclonal antibodies, especially serum IgG and IgA, secreted by the mucous membrane of the respiratory tract and salivary glands.
The drug also stimulates the majority of leukocytes, which is characterized by an increase in the number of myeloid and lymphoid cells, as well as a selective increase in the expression of receptors on the surface.
In patients receiving the drug Broncho-munal ® P, the body's protective properties against bacteria and viruses are enhanced.
Clinically, Broncho-munal ® P reduces the frequency of acute respiratory tract infections, shortens the duration of their course, reduces the likelihood of exacerbations of chronic bronchitis, and also increases the body's resistance to respiratory system infections. This reduces the need to use other medications, especially antibiotics.
Indications for use
Broncho-munal ® P is used in children aged 6 months to 12 years:
as part of complex therapy of acute respiratory tract infections;
for the prevention of recurrent respiratory tract infections and exacerbations of chronic bronchitis.
Contraindications
Hypersensitivity to the components of the drug;
pregnancy;
breastfeeding period;
children under 6 months of age.
Use during pregnancy and breastfeeding
Animal studies have not shown any negative effects on pregnancy. The safety and effectiveness of the drug during pregnancy and breastfeeding have not been studied, therefore the use of Broncho-munal ® P during pregnancy and breastfeeding is contraindicated.
Directions for use and doses
The drug is taken 1 capsule per day in the morning, on an empty stomach, 30 minutes before meals.
For children under 3 years of age or if the child has difficulty swallowing the capsule, it should be opened and the contents mixed with a small amount of liquid (tea, milk or juice).
To prevent recurrent respiratory tract infections and exacerbations of chronic bronchitis, the drug is used in three courses of 10 days, the interval between courses is 20 days.
As part of complex therapy for acute respiratory tract infections, the drug is used until symptoms disappear, but for at least 10 days. When carrying out antibiotic therapy, Broncho-munal ® P should be taken in combination with antibiotics from the beginning of treatment.
For the next 2 months, prophylactic use of the drug is possible: in courses of 10 days, the interval between courses is 20 days.
Side effect
Broncho-munal ® P is usually well tolerated. Most adverse reactions are classified into the general category with moderate or moderate-severe severity. The most common side effects are gastrointestinal upset, skin reactions and respiratory problems.
According to the World Health Organization (WHO), adverse effects are classified according to their frequency as follows:
very often (≥1/10);
often (≥1/100,<1/10);
uncommon (≥1/1000,<1/100);
rare (≥1/10000,<1/1000);
very rarely (<1/10000);
frequency unknown (the frequency of events cannot be determined from the available data).
Gastrointestinal disorders
often: diarrhea, abdominal pain;
frequency unknown: nausea, vomiting.
Respiratory system disorders
often: cough;
infrequently: dyspnea.
Skin and subcutaneous tissue disorders
often: rash;
frequency unknown: urticaria, angioedema.
Immune system disorders
infrequently: hypersensitivity reactions (erythematous rash, generalized rash, erythema, edema, eyelid edema, facial edema, peripheral edema, swelling, facial swelling, itching, generalized itching).
Nervous system disorders
frequency unknown: headache.
General disorders
frequency unknown: fever, fatigue.
Overdose
There are no reports of intoxication due to drug overdose. The nature of the drug Broncho-munal ® P and the results of studies of its toxicity in animals indicate that an overdose is unlikely.
Interaction with other drugs
There was no interaction of the drug with other drugs.
The drug can be used simultaneously with other drugs, including antibiotics.
special instructions
To avoid overdose, children from 6 months to 12 years should not use the drug Broncho-munal ® capsules 7 mg, intended for adults.
Manifestations of hypersensitivity reactions to the drug are possible. If gastrointestinal disorders, skin reactions, respiratory problems or other symptoms of intolerance to the drug persist, discontinue the drug and consult a doctor.
Impact on the ability to drive vehicles and machinery
The drug does not affect the ability to concentrate and control vehicles and machinery.
Release form
Capsules 3.5 mg
10 capsules in an Al/PVC blister, 1 or 3 blisters in a cardboard box along with instructions for use.
Storage conditions
At temperatures from 15 to 25 °C.
The drug should be stored out of the reach of children.
Best before date
5 years.
Do not use the drug after the expiration date.
Conditions for dispensing from pharmacies
Over the counter.
Manufacturer
RU holder:
Sandoz d.d., Verovshkova 57, 1000, Ljubljana, Slovenia;Manufacturer: Lek d.d., Verovshkova 57, Ljubljana, Slovenia.
BRONCHO-MUNAL ® is a trademark of OM PHARMA, Geneva, Switzerland.
Consumer complaints should be directed to:
1. Federal Service for Surveillance in Healthcare (Roszdravnadzor): 109074, Moscow, Slavyanskaya square, 4, building 1.
2. ZAO Sandoz: 125315, Moscow, Leningradsky Prospekt, 72, bldg. 3.
Immunomodulatory drug of bacterial origin.
Drug: BRONCHO-MUNAL®
Active substance of the drug:
non appropriated
ATX encoding: J07AX
KFG: Immunostimulating drug of bacterial origin
Registration number: P No. 011632/01
Registration date: 03/14/08
Owner reg. credential: OM PHARMA (Switzerland)
Broncho-munal release form, drug packaging and composition.
Hard gelatin capsules, size No. 3, opaque, with a blue body and cap; The contents of the capsules are light beige powder.
1 caps.
7 mg
Hard gelatin capsules, size No. 3, opaque, with a white body and a blue cap; The contents of the capsules are light beige powder.
1 caps.
lyophilized lysate of bacteria: Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella ozaenae, Staphylococcus aureus, Streptococcus viridans, Streptococcus pyogenes, Moraxella catarrhalis
3.5 mg
Excipients: propyl gallate (anhydrous), sodium glutamate (anhydrous), mannitol, magnesium stearate, pregelatinized starch, indigotine, titanium dioxide, gelatin.
10 pieces. - blisters (1) - cardboard packs.
10 pieces. - blisters (3) - cardboard packs.
The description of the drug is based on the officially approved instructions for use.
Pharmacological action Broncho-munal
Immunomodulatory drug of bacterial origin. Modulates the body's immune response, stimulates cellular and humoral immunity.
Reduces the frequency and severity of infections, thereby reducing the need for antibiotics.
Pharmacokinetics of the drug.
Data on the pharmacokinetics of the drug Broncho-munal are not provided.
Indications for use:
Infectious diseases of the respiratory tract (as part of complex therapy as an immunomodulatory agent) in children aged 6 months to 12 years (for capsules 3.5 mg);
Infectious diseases of the respiratory tract (as part of complex therapy as an immunomodulatory agent) in adults and children over 12 years of age (for 7 mg capsules);
For the prevention of recurrent infectious and inflammatory diseases of the upper and lower respiratory tract (chronic bronchitis, tonsillitis, pharyngitis, laryngitis, rhinitis, sinusitis, otitis media).
Dosage and method of administration of the drug.
Adults and children over 12 years of age are prescribed Broncho-munal at a dose of 7 mg; Children aged 6 months to 12 years are prescribed Broncho-munal P at a dose of 3.5 mg.
The drug is taken in the morning on an empty stomach, 1 capsule/day. If the patient/child cannot swallow the capsule, it is recommended to open it and dissolve the contents of the capsule in a small amount of liquid (tea, milk or juice).
For the prevention of infectious diseases of the respiratory tract, the drug is used in three 10-day courses with 20-day intervals between them.
In the acute period of the disease, 1 capsule/day is prescribed until the symptoms of the disease disappear, but not less than 10 days. In the next 2 months, prophylactic use of the drug, 1 capsule, is possible. for 10 days with a 20-day interval between courses.
Side effects of Broncho-munal:
During the entire period of clinical use of the drug, undesirable effects were recorded extremely rarely.
From the digestive system: in some cases - epigastric pain, nausea, vomiting, diarrhea.
Allergic reactions: skin rash.
Other: in some cases - increased body temperature.
If side effects are mild, discontinuation of the drug is not required. If a hypersensitivity reaction occurs, discontinuation of the drug is recommended.
Contraindications to the drug:
Hypersensitivity to the components of the drug.
Use during pregnancy and lactation.
The use of the drug Broncho-Munal during pregnancy and lactation is possible only if the expected benefit to the mother outweighs the potential risk to the fetus or child.
Special instructions for the use of Broncho-munal.
A 4-week interval should be observed between the use of oral vaccines and taking Broncho-Munal.
Use in pediatrics
The drug is not prescribed to children under 6 months of age.
To avoid overdose, children from 6 months to 12 years of age are prescribed only Broncho-Munal P (capsules containing 3.5 mg of lyophilisate).
Impact on the ability to drive vehicles and operate machinery
No special precautions required.
Drug overdose:
No clinical symptoms of overdose were noted. There are no reports of intoxication due to drug overdose.
Interaction of Broncho-munal with other drugs.
The drug can be used simultaneously with other drugs, including antibiotics.
Terms of sale in pharmacies.
The drug is available with a prescription.
Terms of storage conditions for the drug Broncho-munal.
The drug should be stored out of the reach of children at a temperature of 15° to 25°C. Shelf life: 5 years.
Bronchomunal is a drug with pronounced immunostimulating activity. It is widely used in the treatment of diseases affecting the ENT organs and respiratory tract. Besides considered one of the most effective drugs for increasing immune defense, which is especially important for people who often suffer from viral and bacterial infections.
However, due to the relatively high cost of the original, some patients have to select an analogue from a Russian manufacturer, which costs less.
A similar need also arises if the drug is not suitable for the patient due to age or health condition (for example, an allergy to the active ingredient). At the same time, the effectiveness of the substitute should not be lower than the original product.
Bronchomunal contains a lyophilisate of bacteria that are causative agents of infectious diseases of the respiratory system, including Streptococcus pneumonia, S. viridians, S. pyogenes, Klebseiella pneumoniae, Kleb. ozaenae, Staphylococcus aureus, Moraxella catharalis, Haemophilus influenzae.
This drug activates immune defense against pathogens of infectious diseases, thereby reducing the frequency, duration, severity of the course and reducing the likelihood of complications.
Thanks to its unique composition, the humoral and cellular immunity in the mucous membranes of the respiratory organs is stimulated. In addition, nonspecific immunity increases.
The results of preclinical and clinical trials have proven the following effects of Bronchomunal on the defense mechanisms of the human body:
- the activity of macrophages in the walls of the alveoli, secreting cytokines, increases;
- the number of T-lymphocytes increases;
- the production of peripheral mononuclear cells, which perform a protective function, is activated;
- the level of secretory immunoglobulin type A on the mucous membranes of the respiratory and gastrointestinal tract increases;
- the production of protective cell adhesion molecules is stimulated;
- the titer of immunoglobulin E in the blood decreases, which prevents the development of sensitization reactions;
- metabolic processes are enhanced;
- the absorption of oxygen by cells and tissues improves.
Indications for use and dosage
According to the instructions for use, the drug is prescribed as part of immunotherapy to prevent the recurrence of infectious diseases of the respiratory system and possible complications.
Bronchomunal is used as a concomitant drug for the treatment of acute respiratory infections, acute and chronic bronchitis, tonsillitis, and bronchial asthma.
The drug is available in two dosages:
- Brochomunal, caps. 7 mg each, for adults and adolescents over 12 years of age;
- Bronchomunal-P, caps. 3.5 mg, for children from six months.
As a preventive measure and in complex treatment, 1 capsule is prescribed. per day for 10 days every month. The course of administration is 3 months in a row with a break of 20 days, the dose is selected taking into account the age of the patient (for children it is recommended if the child is sick more than 4 times a year).
The drug should be taken in the morning half an hour before breakfast with a sufficient amount of water. If a dose is missed, the next dose should be taken in the morning of the next day.
For children, the contents of the capsule can be dissolved in water. Bronchomunal can be taken together with antibacterial and antiviral drugs.
Contraindications and side effects
The main contraindication to the use of Bronchomunal is hypersensitivity to the components of the drug, acute intestinal infections.
Due to the lack of clinical data on the use of the drug in the treatment of pregnant women and women during lactation, Bronchomunal can be prescribed only if the benefit to the mother outweighs the risk of developing pathologies in the fetus.
When taking the drug, the following side effects may develop:
- immune system: skin rashes, soft tissue swelling, itching;
- nervous system: headache attacks;
- respiratory system: productive cough;
- Gastrointestinal organs: pain in the stomach, attacks of nausea and vomiting, stool disorder in the form of diarrhea.
In addition, according to reviews, increased fatigue, apathy, and an increase in body temperature above 38 are possible. If signs of a side effect appear, the drug should be interrupted and contact your doctor to select an analogue.
If vaccination has been carried out using a live vaccine, you can start taking Bronchomunal only after a month.
List of cheaper analogues
Bronchomunal has only one structural analogue - Bronchovaxom, but there are drugs that have a similar mechanism of action. The price of the original is quite high: package No. 10 costs about 600 rubles, and package No. 30 costs 1,500 rubles.
The following analogues of the domestic manufacturer are good substitutes for Bronchomunal:
- Amiksin, tab. No. 3 – 550 rub;
- Imudon, tab. No. 24 – 225 rubles;
- Anaferon, tab. No. 20 – 215 rubles;
- Methyluracil, tab. No. 10 – 155 rubles;
- Cytovir-3, caps. No. 12 – 340 rubles;
The list of foreign-made bronchomunal substitutes with a lower cost is as follows:
- Ribomunil, tab. No. 4 – 295 rub.
- Bronchovax, tab. No. 10 – 600 rub.
However, all of these drugs have a list of contraindications and side effects, so before replacing bronchomunal prescribed by a doctor with a cheaper analogue, you should consult with a specialist.
List of analogues for children
Immunomodulating and immunostimulating drugs for children are prescribed only by a pediatrician. Such medications cannot be used independently due to the immaturity of the child’s immune system. Replacing Bronchomunal with a similar remedy is also carried out exclusively by a doctor.
The closest analogue of Bronchomunal for children in composition and mechanism of action is Bronchovaxom. The cost of the children's release form in the form of 3.5 mg capsules can vary from 1100 to 1600 rubles per package No. 30.
Also widely used in pediatric practice are Ribomunil (295 rubles), Anaferon for children (300 rubles), IRS 19 (490 rubles), Imudon (225 rubles).
Bronchovax or Bronchomunal - which is better?
Bronchovaxom is a drug similar to Bronchomunal. This is the only structural analogue (generic) of the original product. Only this medicine has an identical composition, release form and dosage, and mechanism of action on the body. In view of this, there are no significant differences between the two means.
Bronchovax, as well as Bronchomunal, is recommended to be taken by patients suffering from manifestations of viral and bacterial infections more than 4 times a year. These drugs stimulate the body's immune defense and are taken both as part of complex therapy and for the prevention of seasonal infections.
The only difference between the drugs is the manufacturer. Thus, Bronchomunal is produced by Sandoz, Switzerland, and Bronchovax by Om Pharma, Switzerland.
The cost of Bronchovaxom differs slightly from that of Bronchomunal, so this drug is not considered its cheapest analogue.
Ribomunil or Bronchomunal
The most similar principle of action to Bronchomunal is Ribomunil. This is a drug of bacterial origin from the subgroup of immunostimulants, which is a ribosomal-proteoglycan complex from lysates of bacteria that cause the most common infectious diseases.
Due to the content of antigens, when taking Ribomunil, the active production of appropriate antibodies to pathogens begins, which is equivalent to the effect of a vaccine. The drug helps increase nonspecific and specific immunity.
Ribomunil has a different composition than Bronchomunal, but is also successfully used in the treatment of diseases of the respiratory system, can reduce the duration of treatment, and reduce the likelihood of using antibacterial drugs.
Like the original drug, ribomunil is used in pediatric practice in the treatment of children older than six months (release form - sachets).
IRS 19 or Bronchomunal
The composition of IRS 19 is similar to that of Bronchomunal. The drug also contains lyophilisates of bacteria. However, the spray contains a lysate of 19 bacteria, while Bronchomunal contains only 8.
For prophylaxis, bronchomunal should be taken 3 months before the expected peak of incidence, and IRS 19 – 3 weeks, which is suitable for “forgetful” patients.
It should also be taken into account that due to the increased antigenic load, side effects develop much more often when using IRS 19. In addition, the cost is not much lower than that of Bronchomunal.
Ismigen or Bronchomunal
Ismigen is an analogue of Bronchomunal from an Italian manufacturer. The drug also belongs to the group of combined immunostimulants of bacterial origin.
This is a polyvalent complex of antigens that contains lyophilisates of bacteria that most often cause respiratory diseases. It has a nonspecific immunostimulating effect and a specific vaccinating effect.
Thanks to its sublingual release form, Ismigen stimulates cellular, humoral, systemic immunity, activates phagocytosis, and helps increase lysozyme in saliva.
Unlike Bronchomunal, the analogue is more often prescribed for complex treatment and as a prophylactic agent for diseases of the upper respiratory tract, including sore throat, pharyngitis, laryngitis, rhinitis, sinusitis, and otitis. In addition, it is contraindicated for children under 3 years of age.
The cost of ismigen is about 1,300 rubles per pack of 30 tablets.
Lykopid or Bronchomunal
Likopid is a substitute for Bronchomunal from the subgroup of immunostimulants. The main active ingredient of the drug is glucosaminylmuramyl dipeptide. There are 2 dosage forms: 10 mg for adult patients, 1 mg for children.
Likopid is approved for use in pediatric practice in children over 3 years old, and Bronchomunal - from 6 months. In addition, the cost of the analogue is significantly higher than the original product: in a dose of 1 mg - 350 rubles, in a dose of 10 mg - 1700 rubles.
However, the indisputable advantage of lykopid is its wider spectrum of action. Thus, the drug is used in the treatment of acute respiratory viral infections, infectious diseases of the respiratory system, acute and chronic course of purulent-inflammatory diseases of the skin and soft tissues, and herpes virus infection.
Which is better: Immunal or Bronchomunal?
Immunal is an immunostimulant of plant origin. The main active ingredient is Echinacea purpurea juice. The instructions for use state that the drug is approved for use in adolescents over 12 years of age.
Medical experts note a significant decrease in immunity in modern children under 12 years of age. Parents try to support and restore the child’s health in all ways available to them, purchasing vitamin complexes and immunomodulators, often without consulting a pediatrician. Doctors recommend choosing such drugs taking into account their mechanism of action. "Bronchomunal", for example, increases the natural protective functions of the mucous membranes of the respiratory tract and ENT organs.
Features of the drug "Bronchomunal" for children
This drug belongs to the group of immunomodulators of bacterial origin. The drug stimulates cellular and humoral local immunity. Humoral protective functions are formed on the basis of previous diseases and the child’s immune memory. The cellular defense mechanism is an innate function that is weakened by viruses and bacteria. In fact, children's "Bronchomunal" is a vaccine, but administered not by injection, but by mouth, with a less aggressive effect, but a pronounced effect when compared with conventional vaccinations.
The developers included lyophilized lysates of pathogens of respiratory system diseases in the composition of the drug, which most often affect the child’s body and significantly weaken its innate and acquired protective functions. The children's "Bronchomunal" contains:
- pneumococci,
- gram-positive streptococci,
- hemophilus influenzae,
- low pathogenic streptococci,
- Klebsiella pneumonia and ozena,
- Staphylococcus aureus,
- positive diplococcus (oxidase).
The excipients used are magnesium stearate, gelatin, sodium glutamate, titanium dioxide and indigotine. By consuming just one 3.5 mg capsule per day, the child is protected from viruses and germs transmitted by airborne droplets - the most common method of transmission of influenza and colds.
The principle of action of the drug is based on stimulating the body’s production of type B lymphocytes. They are responsible for the ability of mucous membranes to resist the penetration of viruses and microbes into the child’s body. Increasing the number of lymphocytes during influenza or ARVI epidemics prevents infection, and if the child is already sick, it helps to avoid the development of purulent complications against the backdrop of an increase in the pathogen population.
Indications for taking "Bronchomunal"
Children's "Bronchomunal" can be used both in the complex treatment of colds and their complications, and as a prophylactic against the background of epidemiological situations, to strengthen and restore the child's immunity. The instructions for use of the drug list the indications for its use:
- ARVI and acute respiratory infections,
- bronchitis or pneumonia,
- sore throats and stomatitis,
- rhinitis, sinusitis, otitis media,
- laryngitis, pharyngitis,
- tracheobronchitis or tonsillitis,
- stimulation of immunity during an epidemic,
- prevention of relapse of these diseases.
How long the course will last and what dosage the child needs to use is determined only by the pediatrician observing him. The appointment is carried out according to individual indications - the intensity of the disease, the general condition of the patient, his weight and the functionality of the immune system.
If the natural protective functions of the body are significantly reduced, then even with high body weight, a children's dosage is prescribed so that secondary infection does not occur while taking the drug. When prescribing "Bronchomunal" for preventive purposes, when the child is healthy, an adult dosage can be prescribed to a 10-year-old child. It is important to understand that these parameters are determined by the doctor based on examination and diagnostic measures. Self-medication with Bronchomunal is unacceptable.
"Bronchomunal" can be taken in parallel with any type of antibiotics. The effectiveness of the immunomodulator and antibiotics is not reduced. It is also possible to take expectorants and antiseptics at the same time, both orally and locally - in the form of sprays or lozenges.
How to take children's "Bronchomunal"
You should take the immunomodulator "Bronchomunal" only after it has been prescribed by a pediatrician and strictly according to the instructions supplied with the drug by the manufacturer. Recommended admission rules:
- 3.5 mg for children under 12 years of age,
- frequency - once a day,
- conditions - in the morning, before breakfast.
If it is difficult for your baby to swallow a capsule with the drug or he simply does not want to do it, you can open it and dissolve the contents in a small amount of clean water, tea, or sweet natural juice. The drink should not be hot; its temperature cannot exceed room temperature. The powder from the capsules is tasteless and will not change the quality of the drink. As a rule, kids don’t even notice that something has been dissolved in their favorite drink.
"Bronchomunal" for children is approved for use by babies from 6 months. The duration of the course is determined individually. For therapeutic purposes, against the background of a progressive viral disease, the drug is taken from 10 to 14 days, depending on the intensity of symptoms. Stop taking it 2 days after the runny nose and cough disappear.
In order to strengthen the immune system, Bronchomunal should be taken in three courses - 10-20-10-20-10, where 10 are the days of administration, and 20 are the “rest” period. There should be at least 2 such courses per year. Only regular preventive measures will help increase the child’s resistance to viral and microbial infections and eliminate the development of complications after them. It is permissible to prescribe longer courses, lasting up to 30 days. But you cannot take the drug for such a long time without a doctor’s recommendation.
Possible side effects while taking the drug
During a course of taking the immunomodulator "Bronchomunal", you need to carefully monitor the child's condition. If unusual symptoms appear or the condition worsens, you should immediately stop treatment and contact the doctor who prescribed the drug or any pediatrician. Possible side effects when taking Bronchomunal, which you should definitely pay attention to:
- abdominal pain, diarrhea or constipation, nausea or vomiting,
- increased intensity of cold symptoms,
- the appearance of a rash or other sign of an allergy,
- increase in body temperature.
It is important to understand that the product contains viral bacteria. And even the fact that their vital functions and activity are weakened artificially does not exclude their negative impact on the child’s body. If the baby is severely weakened, then the risk of developing side effects is quite high. This should be taken into account not only by the doctor, but also by the parents when describing the child’s condition at an appointment with the pediatrician.
Even taken for preventive purposes in a completely healthy child can cause a response to the drug. That is why pediatricians recommend starting the course on weekends in order to monitor the manifestation of side effects and exclude the development of infection while taking the immunomodulator "Bronchomunal".
Contraindications
The regimen for taking Bronchomunal is similarly described in the instructions for use and on the manufacturer’s official website. There you can also learn about contraindications to its use. In addition, the pediatrician prescribing the drug should know about them. "Bronchomunal" should not be taken by children under 6 months of age or by infants with hypersensitivity to the ingredients included in the product.
Despite the fact that cases of drug overdose have not yet been identified, it is worth excluding the child’s access to the package with “Bronchomunal” and its uncontrolled use. Even parents of children 10-12 years old should follow this rule. The fact that no cases of overdose have been identified does not mean that exceeding the dose is not dangerous. A large number of even weakened bacteria can cause an unpredictable reaction in a child’s body with serious consequences.
Broncho-munal: instructions for use and reviews
Broncho-munal is a drug of bacterial origin with immunomodulatory and immunostimulating effects aimed at strengthening the immune system against respiratory tract infections.
Release form and composition
Dosage form - capsules: gelatin, with an opaque solid structure, size No. 3, blue cap and body, inside the capsules - light beige powder (10 pieces in a blister, 1, 2 or 3 blisters in a cardboard pack).
1 capsule contains:
- active ingredient: lyophilized lysate of bacteria: Haemophilus influenzae, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Moraxella catarrhalis, Klebsiella ozaenae, Klebsiella pneumoniae – 7 mg;
- auxiliary components: propyl gallate (anhydrous), mannitol, sodium glutamate (anhydrous), magnesium stearate, indigotine, titanium dioxide, pregelatinized starch, gelatin.
Pharmacological properties
Pharmacodynamics
The drug has an immunostimulating effect, helping to increase immunity and strengthening the body's resistance to infectious diseases of the respiratory tract.
Taking the capsule leads to the accumulation of bacterial lysate in Peyer's patches located in the mucous membrane of the gastrointestinal tract, in particular localized in the small intestine. The active substance of Broncho-munal activates antigen-presenting cells of Peyer's patches, which subsequently become stimulators for other types of cells (B-lymphocytes) responsible for the production of specific immunity. The number of circulating B lymphocytes increases, which leads to increased production of polyclonal antibodies, mainly IgG (immunoglobulin G) serum and IgA (immunoglobulin A) produced by the salivary glands and the mucous membrane of the respiratory tract.
Broncho-munal also affects nonspecific immunity, being a stimulator of leukocytes, which is accompanied by an increase in the number of cells of the lymphoid and myeloid series, as well as a selective increase in the expression of receptors located on the surface.
Patients taking the drug experience an increase in the protective properties of the body, which successfully fights viruses and bacteria that penetrate it.
When taking Broncho-munal, there is a decrease in the incidence of acute respiratory tract infections, a decrease in the duration of their course and the risk of relapses of chronic bronchitis, and also an increase in the body's resistance to pathogens of infectious diseases of the respiratory system. This reduces the need to prescribe other medications, especially antibiotics.
Pharmacokinetics
The pharmacokinetic parameters of Broncho-munal have not been studied in detail.
Indications for use
- infectious pathologies of the respiratory tract - as an immunomodulatory drug as part of complex therapy;
- chronic bronchitis and recurrent infections of the upper and lower respiratory tract (otitis, pharyngitis, tonsillitis, laryngitis, sinusitis, rhinitis) - to prevent exacerbations.
Contraindications
- age up to 12 years;
- period of pregnancy and lactation;
- individual hypersensitivity to the components of the drug.
Instructions for use of Broncho-munal: method and dosage
According to the instructions, Broncho-munal is taken orally, on an empty stomach, in the morning, 1 piece. per day.
If swallowing the capsule is difficult for the patient (child), you can open it and dissolve the contents in a small amount of milk, tea or juice.
During the acute course of the disease, the drug should be taken daily for 10 days or more, until the symptoms of infection completely disappear. Further, it is recommended to continue use to prevent relapse: 2 courses of 10 days, with a break of 20 days.
To prevent infectious pathologies of the respiratory tract, it is necessary to take three courses of the drug for 10 days, with a break of 20 days after each course.
Side effects
The occurrence of undesirable effects during the clinical use of Broncho-munal was recorded very rarely. In some cases, disorders of the digestive system were observed, in the form of epigastric pain, diarrhea, nausea, vomiting and increased body temperature.
If side effects are minor, taking capsules should be continued.
Discontinuation of the drug is required if symptoms of a hypersensitivity reaction develop.
Overdose
There are no reports of cases of acute intoxication after taking Broncho-munal in high doses. The composition of the drug and the results of animal studies that studied its toxic properties indicate a low likelihood of negative symptoms occurring in the event of an overdose.
special instructions
The break between the use of Broncho-munal and oral vaccines should be at least 4 weeks.
In acute forms of intestinal pathologies, the effectiveness of the drug decreases, so taking capsules during this period is not advisable.
Due to the risk of overdose, children aged 0.5 to 12 years are recommended to use Broncho-munal P containing 3.5 mg of bacterial lysate.
Impact on the ability to drive vehicles and complex mechanisms
Taking capsules does not require special precautions when driving vehicles and machinery.
Use during pregnancy and lactation
Animal experiments have not confirmed the presence of a negative effect of the active components of the drug on the course of pregnancy. However, studies confirming the safety and effectiveness of the use of Broncho-munal during pregnancy and lactation have not been conducted, therefore, for women carrying a child and breastfeeding mothers, taking the drug is contraindicated.
Use in childhood
Broncho-munal 7 mg capsules are not prescribed to children under 12 years of age.
Drug interactions
The simultaneous use of antibacterial and other drugs is indicated.
Analogues
Analogs of Broncho-munal are: Broncho-vaxom, Broncho-munal P, Cycloferon, Echinacea tincture, Tonsilgon N, Imudon.
Terms and conditions of storage
Store at 15–25 °C. Keep away from children.
Shelf life – 5 years.