Bioaron system

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT BIOARON SYSTEM

Composition:

Active ingredients: 100 ml of the preparation contains 38.4 g of liquid aloe extract (Aloe arborescens) (1:4), 1.02 g of vitamin C;
Excipients: sucrose, concentrated aronia juice (Aronia melanocarpa), sodium benzoate, purified water.

Pharmaceutical form. Syrup.

Main physicochemical properties: red-brown colored liquid with a characteristic odor. A sediment may form during storage.

Pharmacotherapeutic group. Tonizing agents. ATC code A13A.

Pharmacological properties.

Pharmacodynamics

The mechanism of action has not been fully elucidated and is based exclusively on preclinical study results.

The presumed mechanism of action is primarily based on activation of immune system cells – B- and T-lymphocytes, neutrophils, macrophages, and the C-3 component of complement. According to bibliographic data, glycoproteins (lectins S-1 and P-2) and polysaccharides (mainly acemannan) are believed to be largely responsible for the immunological effects.

Pharmacodynamic properties are based on animal models and cultures of animal and human cells. Clinical pharmacological studies have not been conducted.

In immunological activity studies in vivo as well as ex vivo/in vitro, Bioaron SYSTEM demonstrated immunomodulatory effects, i.e., stimulating effects on both humoral and cellular responses: an increase in non-specific cellular response and initial humoral response was observed, along with stimulation of antibody production, chemokinetic cell activity, neutrophil phagocytosis, and proliferation of B- and T-lymphocytes (regardless of mitogen).

A reduction in bronchial reactivity to histamine under the influence of the active substance of Aloe arborescens liquid extract was also observed.

In in vitro studies, the medicinal product suppressed inflammatory reactions, as well as the production and release of inflammatory markers such as IL-6, TNF-α, IL-1β, histamine, bradykinin, and eicosanoids.

Bioaron SYSTEM significantly inhibited the replication of RNA viruses in vitro, including influenza virus A (H1N1 and H3N2), influenza virus B (Yamagata and Beijing), rhinovirus (HRV 14), and Coxsackievirus (CA9). A weak inhibitory effect was observed against respiratory syncytial virus (RSV) and parainfluenza virus (Para 3). No inhibitory effect was observed against the DNA virus adenovirus (Adeno 5).

Bioaron SYSTEM demonstrated antimicrobial activity in vitro against bacteria, including Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae, Streptococcus anginosus, Klebsiella pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, and against the yeast Candida albicans.

Treatment of upper respiratory tract infections

In non-interventional observational studies and one randomized clinical trial, the use of the medicinal product Bioaron SYSTEM led to normalization of T-lymphocyte subpopulations and levels of pro-inflammatory cytokines in children with respiratory tract infections compared to the control group. As a result of taking the product, immune response was restored to normal (immunomodulatory effect). Furthermore, the duration of the infectious disease was shorter and the course of illness was milder: reduced severity of symptoms associated with inflammatory response, such as rhinitis, elevated body temperature, and cough. Marked clinical improvement was observed in approximately 60% of children, compared to approximately 40% in the control group.

Prevention of upper respiratory tract infections

Prophylactic use of the medicinal product Bioaron SYSTEM in children with recurrent infections such as rhinitis, nasopharyngitis, and acute bronchitis, compared to children in the control group, reduced the frequency of recurrences, prolonged the remission period, and increased resistance to reinfection by a factor of 2.6.

Loss of appetite

Studies have shown increased appetite in 47–65% of children receiving Bioaron SYSTEM during treatment of respiratory tract infections.

Paediatric population (children and adolescents)

Studies on the medicinal product Bioaron SYSTEM were predominantly conducted in paediatric patients (children aged 3–16 years).

Clinical characteristics.

Indications.

Bioaron SYSTEM is used:

• as an adjunctive agent in upper respiratory tract infections, including treatment of colds;
• in cases of appetite loss.

Contraindications.

Absolute contraindications:

• hypersensitivity to the active substances or to any of the excipients listed in the section "Composition";
• concomitant use of immunosuppressive drugs.

Relative contraindications:

• predisposition to allergies;
• systemic diseases and autoimmune diseases (e.g. systemic sclerosis, systemic lupus erythematosus, Hashimoto's disease, Graves' disease, Basedow's disease, multiple sclerosis, insulin-dependent diabetes, rheumatoid arthritis);
• elevated levels of immunoglobulins in the blood.

In the presence of the aforementioned relative contraindications, the decision to use the medicinal product should be made by a physician based on the clinical picture and taking into account the drug's efficacy and benefit-risk ratio.

Interaction with other medicinal products and other forms of interaction.

Interactions of Bioaron SYSTEM syrup with other medicinal products or other substances are unknown. During studies, Bioaron SYSTEM was administered concomitantly with other standard medicinal products used for the treatment of respiratory infections and antibiotics; no drug interactions were reported. Additionally, no signals regarding potential drug interactions have been received during pharmacovigilance.

One dose of Bioaron SYSTEM syrup for all age groups contains 51 mg of vitamin C; the vitamin C content in the maximum daily dose of the drug (15 mL) is 153 mg. Interactions and adverse reactions associated with the use of high doses of vitamin C do not apply to the use of vitamin C as part of the medicinal product Bioaron SYSTEM.

Special precautions for use.

Use of the medicinal product Bioaron SYSTEM in patients with diabetes mellitus

A single dose (5 ml) contains approximately 3.93 g of sucrose. Use with caution in patients with diabetes mellitus.

Patients with rare hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not use this medicinal product.

Administration of Bioaron SYSTEM after vaccination

Due to the mechanism of action of the medicinal product, it should not be used immediately after prophylactic vaccinations. An interval of at least 2 weeks should be observed.

Provided the above precaution is followed, the product can be used independently of the vaccination schedule.

Use during chemotherapy for oncological diseases or after completion of treatment

The medicinal product is not recommended during chemotherapy for oncological diseases. There are no contraindications for use of this product after completion of therapy.

Children

Due to lack of data, this medicinal product should not be used in children under 3 years of age.

Bioaron SYSTEM contains 6.6 mg of sodium benzoate per dose (5 ml), equivalent to 0.13 g per 100 ml of syrup.

Use during pregnancy or breastfeeding

Due to lack of data on the use of aloe extract in pregnant or breastfeeding women, Bioaron SYSTEM is not recommended for these patient groups.

Animal studies have shown no adverse effects of Aloes arborescens on fetal development or the course of pregnancy. No toxic effects on reproductive functions have been demonstrated.

The effect of Bioaron SYSTEM on fertility has not been established.

Ability to influence reaction speed when driving or operating machinery

Given the composition of the product, this medicinal product does not affect the ability to drive or operate machinery.

Dosage and Administration

Administer orally.

For upper respiratory tract infections:

Take before meals for 14 days:

• Adults, adolescents, and children aged 7 years and older – 5 mL three times daily,
• Children aged 3 to 6 years – 5 mL twice daily.

For prophylaxis:

During non-infectious periods, take the medication before meals for 14 days:

• Adults, adolescents, and children aged 7 years and older – 5 mL three times daily,
• Children aged 3 to 6 years – 5 mL twice daily.

Treatment should be repeated after a 14-day break.

For loss of appetite:

Take 5 mL of the medication once daily, 15 minutes before the main meal.

Duration of treatment

For upper respiratory tract infections
The medicinal product should be used for 14 days. If no improvement is observed after 7 days of treatment or if symptoms worsen, the patient should consult a physician.

For prophylaxis
The medication should be administered in cycles, with a break of at least 14 days between cycles (14 days of treatment / 14 days break from administration).

For loss of appetite
The medication should be taken for 14 days. If no improvement is observed after 7 days of treatment or if symptoms worsen, the patient should consult a physician. Re-administration of the medication may be repeated after a 14-day break.

Children

The safety and efficacy of the medication in children under 3 years of age have not been established.

Overdose

According to pharmacovigilance data, there have been no reports of adverse effects following overdose with Bioaron SYSTEM. No cases of adverse effects during or after treatment, or as a result of overdose, have been reported. No cases of poisoning due to overdose of ascorbic acid have been reported. Based on known adverse effects, mild dyspeptic disorders may be expected following overdose.

Adverse reactions.

It is expected that ascorbic acid, when used at therapeutic doses, does not cause adverse effects. Based on clinical trials conducted, it can be concluded that Bioaron SYSTEM is well tolerated and does not cause serious adverse events.

Adverse reactions occurring during the use of the medicinal product Bioaron SYSTEM:

• Uncommon (≥ 1/1,000 to < 1/100) – allergic reaction,
• Rare (≥ 1/10,000 to < 1/1,000) – gastrointestinal/dyspeptic symptoms.

Shelf life. 3 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Packaging.

Bottles of 100 ml. One bottle with a measuring cup in a cardboard box.

Pharmaceutical category.

Over-the-counter (without prescription).

Manufacturer.

Fitofarm Klencz S.A.

Manufacturer's address and place of business.

Klencz 1,
63-040 Nowe Miasto nad Wartą,
Poland.