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Bactoblis (Tablets, Powder) Instructions for Use

Therapeutic Category

Dietary supplement for maintaining oral microflora

Properties

Streptococcus salivarius is a representative of the healthy microflora of the oral cavity (including the naso- and oropharynx) – the “first line” of the body’s natural defense against infections, which forms in humans immediately after birth.

Probiotic bacteria Streptococcus salivarius K12 colonize the oropharynx, preventing the attachment of pathogenic bacteria to the oral mucosa, and produce salivaricins A2 and B – locally acting antibacterial substances that can suppress the growth of pathogenic bacteria, for example, Streptococcus pyogenes and Streptococcus pneumoniae, which are causative agents of infections.

Streptococcus salivarius K12 stimulate the production of gamma-interferon in saliva, which enhances local adaptive immunity against viruses.

Streptococcus salivarius K12 in experiments reduce the ability of fungi of the genus Candida to attach to mucous membranes.

Streptococcus salivarius K12 can reduce the growth of bacteria that cause bad breath due to their metabolic products.

The components included in the composition contribute to

  • Maintaining healthy microflora of the oral cavity and throat, maintaining the body’s natural defense against infections;
  • Reducing the frequency of chronic ENT organ infections (tonsillitis, pharyngitis, middle ear inflammation);
  • Reducing the frequency and duration of acute inflammatory processes in the oro- and nasopharynx;
  • Strengthening local immunity when staying in organized groups (especially in educational institutions);
  • Reducing the risk of developing oral candidiasis;
  • Reducing the use of antibiotics and antiseptics;
  • Prevention of halitosis.

The Streptococcus salivarius K12 strain is included in the collections of the American Type Culture Collection (ATCC BAA 1024) and the German Collection of Microorganisms and Cell Cultures (DSM 13084); conducted examination showed no negative effects on the human body. The Food and Drug Administration (FDA) has granted the product GRAS status (Generally Regarded As Safe).

Scope of Application

Of the Bactoblis sachet product

  • As a dietary supplement – a source of probiotic microorganisms (Streptococcus salivarius K12), an additional source of vitamin D3.

ICD codes

ICD-10 code Indication
E63.8 Other specified types of nutritional deficiency

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Powder

Bactoblis sachet is taken after meals, preferably in the evening after brushing teeth before bedtime.

For children aged 1.5 years and older and adults 1 sachet packet/day.

For administration to children aged 1.5-2 years, use a wet pacifier or spoon; for children over 2 years and adults, use a wet spoon. Dip the wet pacifier or spoon into the sachet packet with powder, then place the pacifier/spoon in the mouth and let the powder dissolve – approximately 30 seconds, do not drink water. Repeat the procedure until the portion in the sachet packet is finished. Do not pour the contents of the sachet packet into the child’s mouth to avoid the powder entering the respiratory tract.

After taking the dietary supplement, it is not recommended to drink or eat for one hour.

The duration of administration is 1-3 months or as recommended by a doctor. If necessary, the course can be repeated.

Contraindications

  • Individual intolerance to the components.

With caution

Persons with impaired immune status, when taking immunosuppressants – take under medical supervision.

Before use in children, it is necessary to consult a pediatrician.

Special instructions

Dietary supplement. Is not a medicinal product.

It is recommended to consult a doctor before use.

Tablets

Bactoblis+ is taken in the evening before bedtime, after brushing teeth.

For children aged 3 years and older and adults slowly dissolve 1 tablet/day until the tablet is completely dissolved. After taking the tablet, it is not recommended to drink or eat for 1 hour.

The duration of administration is 1-3 months or as recommended by a doctor. If necessary, the course can be repeated.

Contraindications

  • Individual intolerance to the components.

With caution

Persons with impaired immune status, when taking immunosuppressants – take under medical supervision.

Before use in children, it is necessary to consult a pediatrician.

Special instructions

Dietary supplement. Is not a medicinal product.

It is recommended to consult a doctor before use.

Dispensing Status

Distribution through pharmacy networks and specialized stores, departments of the retail network.

Storage Conditions

The product should be stored in a dry place, out of reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

R-Pharm JSC (Russia)

Manufactured By

Medico Domus, LLC (Serbia)

On Behalf Of

BLUESTONE PHARMA (Switzerland)

Contact Information

R-PHARM JSC (Russia)

Dosage Form

Bottle OTC Icon Bactoblis sachet Powder for oral administration: sachet packets 1500 mg 15 or 30 pcs.

Dosage Form, Packaging, and Product Composition

Powder for oral administration.

1 sachet packet Daily Intake Level
children from 1.5 to 18 years adults
Probiotic microorganisms (Streptococcus salivarius K12) 1×109CFU 1×107***-1×109**** CFU/day
Colecalciferol (vit. D3)# 5 mcg 15 mcg* 5 mcg**

# in the form of a ready-made vitamin D3 mixture (sucrose, thickener gum arabic, corn starch, medium-chain triglycerides, calcium carrier tricalcium phosphate, vitamin D3 (Colecalciferol), DL-alpha-tocopherol, water).
* physiological requirement norm for children and adolescents according to MR 2.3.1.2432-08 “Norms of physiological requirements for energy and nutrients for various population groups of the Russian Federation”;
** recommended daily intake level according to TR CU 022/2011 “Food products regarding their labeling”, Appendix 2;
*** adequate intake level according to the “Unified sanitary-epidemiological and hygienic requirements for goods subject to sanitary-epidemiological surveillance (control)”, Chapter II, Section 1, Appendix 5;
**** upper permissible intake level according to the “Unified sanitary-epidemiological and hygienic requirements for goods subject to sanitary-epidemiological surveillance (control)”, Chapter II, Section 1, Appendix 5.

Excipients: maltodextrin, fructooligosaccharides, natural flavor “Strawberry”.
May contain residues/traces of milk protein.

1500 mg – sachet packets (15) – cardboard packs.
1500 mg – sachet packets (30) – cardboard packs.

Marketing Authorization Holder

R-Pharm JSC (Russia)

Manufactured By

Medico Domus, LLC (Serbia)

On Behalf Of

BLUESTONE PHARMA (Switzerland)

Contact Information

R-PHARM JSC (Russia)

Dosage Form

Bottle OTC Icon Bactoblis+ Lozenges: 30 or 90 pcs.

Dosage Form, Packaging, and Product Composition

Lozenges weighing 950 mg.

1 tab. Daily Intake Level
children from 3 to 18 years adults
Probiotic microorganisms (Streptococcus salivarius K12) 1×109CFU 1×107***-1×109**** CFU/day
Colecalciferol (vit. D3)# 5 mcg 15 mcg* 5 mcg**

# in the form of a ready-made vitamin D3 mixture (sucrose, thickener gum arabic, corn starch, medium-chain triglycerides, calcium carrier tricalcium phosphate, vitamin D3 (Colecalciferol), DL-alpha-tocopherol, water).
* physiological requirement norm for children and adolescents according to MR 2.3.1.2432-08 “Norms of physiological requirements for energy and nutrients for various population groups of the Russian Federation”;
** recommended daily intake level according to TR CU 022/2011 “Food products regarding their labeling”, Appendix 2;
*** adequate intake level according to the “Unified sanitary-epidemiological and hygienic requirements for goods subject to sanitary-epidemiological surveillance (control)”, Chapter II, Section 1, Appendix 5;
**** upper permissible intake level according to the “Unified sanitary-epidemiological and hygienic requirements for goods subject to sanitary-epidemiological surveillance (control)”, Chapter II, Section 1, Appendix 5.

Excipients: fructose, maltodextrin, anticaking agent amorphous silicon dioxide, anticaking agent magnesium stearate, natural flavor “Strawberry”.
May contain residues/traces of milk protein

10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (9) – cardboard packs.

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