Normoflorin® D (Liquid) Instructions for Use
Marketing Authorization Holder
Bifilux, LLC (Russia)
Manufactured By
Bifilux+ SPC, LLC (Russia)
Contact Information
BIFILYUKS LLC (Russia)
Dosage Form
| Normoflorin® D | Oral liquid: bottle 100 ml |
Dosage Form, Packaging, and Product Composition
Liquid for oral administration.
| 1 ml | |
| Lactobacilli (Lactobacillus casei) | Not less than 1×109 CFU |
| Bifidobacteria (Bifidobacterium bifidum, Bifidobacterium longum) | Not less than 1×108 CFU |
Auxiliary substances: bacterial metabolites (organic acids, amino acids (including essential ones), micro- and macroelements, vitamins, antimicrobial substances of natural origin).
Does not contain genetically modified microorganisms.
| Nutritional Value | 100 ml | 30 ml (single adult dose) |
| Proteins | 2% | 0.5 g |
| Fats | 0% | 0 g |
| Carbohydrates | 4% | 1 g |
| Energy value | 105 kJ/25 kcal | 30 kJ/8 kcal |
| Potassium | 4.58% | 1.4 g |
| Calcium | 4.2% | 1.3 g |
| Magnesium | 0.02 mg/kg | 0.01 mg/kg |
Does not contain lactose, cow’s milk protein, preservatives, colorants, taste adapters.
100 ml – glass bottles with a cap (1) – cardboard boxes.
Therapeutic Category
Dietary supplement – source of bifidobacteria and lactobacilli
Properties
It rapidly suppresses the activity of pathogenic microflora, prevents the penetration of endotoxins into the body; restores the protective biofilm on all mucous membranes, intestinal motility; reduces the level of cholesterol and oxalates; breaks down lactose.
Specially selected strains in the biocomplex have a pronounced immunomodulatory effect, reduce the risk of atopic dermatitis by stimulating the production of interferons and contribute to maintaining the general pool of immunoglobulins.
It has less pronounced acidity, which allows its use in treatment programs for acid-dependent diseases (peptic ulcer, erosive lesions of mucous membranes).
The microorganisms in the biocomplex are not genetically modified. Absence of lactose and cow’s milk protein. Completely natural, without preservatives, colorants, taste adapters.
Scope of Application
Of the product Normoflorin® D
As a dietary supplement – a source of probiotic microorganisms for
- Chronic gastrointestinal diseases (gastritis, duodenitis, peptic ulcer, pancreatitis, cholecystitis, hepatitis, colitis, proctosigmoiditis) (as part of complex therapy);
- Acute intestinal infections of established (shigellosis, salmonellosis, staphylococcal enterocolitis, enterovirus and rotavirus infection, etc.) and unknown etiology (as part of complex therapy);
- Malabsorption syndrome, disaccharidase (lactase) deficiency, food allergy (as part of complex therapy);
- Metabolic syndrome and obesity (as part of complex therapy);
- For the restoration of disturbed microbiocenosis during antibacterial therapy;
- For women during pregnancy and breastfeeding;
- For allergic diseases and immunodeficiency states;
- Antibiotic-associated diarrhea (including in children);
- For increasing immunomodulatory and general strengthening activity.
ICD codes
| ICD-10 code | Indication |
| A02 | Other salmonella infections |
| A03 | Shigellosis |
| A04 | Other bacterial intestinal infections |
| A04.7 | Enterocolitis due to Clostridium difficile |
| A08.0 | Rotaviral enteritis |
| A08.3 | Other viral enteritis |
| A09 | Other and unspecified gastroenteritis and colitis of infectious origin |
| D84.9 | Immunodeficiency, unspecified |
| E63.8 | Other specified types of nutritional deficiency |
| E66 | Obesity |
| E73.0 | Congenital lactase deficiency |
| E73.1 | Secondary lactase deficiency |
| E88.8 | Other specified metabolic disorders |
| K25 | Gastric ulcer |
| K26 | Duodenal ulcer |
| K29 | Gastritis and duodenitis |
| K52 | Other noninfectious gastroenteritis and colitis |
| K63.8 | Other specified diseases of intestine |
| K73 | Chronic hepatitis, not elsewhere classified |
| K81 | Cholecystitis |
| K86.1 | Other chronic pancreatitis |
| K90 | Intestinal malabsorption |
| O99.6 | Diseases of the digestive system complicating pregnancy, childbirth and the puerperium |
| T78.4 | Allergy, unspecified |
| Y40 | Systemically acting antibiotics |
| Z39.1 | Care and examination of lactating mother |
| ICD-11 code | Indication |
| 1A01 | Intestinal infection caused by other Vibrio species |
| 1A02 | Intestinal infections due to Shigella |
| 1A03.Z | Intestinal infections caused by Escherichia coli, unspecified |
| 1A04 | Intestinal infections caused by Clostridium difficile |
| 1A09.Z | Salmonella infection, unspecified |
| 1A0Z | Bacterial intestinal infections, unspecified |
| 1A21 | Gastroenteritis due to Astrovirus |
| 1A22 | Gastroenteritis due to Rotavirus |
| 1A2Y | Other specified viral intestinal infections |
| 1A2Z | Viral intestinal infections, unspecified |
| 1A40.Z | Infectious gastroenteritis or colitis, unspecified |
| 1A9Y | Other specified infections predominantly sexually transmitted |
| 4A0Z | Unspecified primary immunodeficiencies |
| 4A8Z | Allergic conditions or hypersensitivity conditions of unspecified type |
| 5B7Z | Malnutrition, unspecified |
| 5B81.Z | Obesity, unspecified |
| 5C50.G | Trimethylaminuria |
| 5C53.1 | Disorders of the citric acid cycle |
| 5C53.2Z | Disorders of mitochondrial oxidative phosphorylation, unspecified |
| 5C53.3Z | Disorders of mitochondrial membrane transport, unspecified |
| 5C59.Z | Congenital disorders of neurotransmitter metabolism, unspecified |
| 5C61.61 | Congenital lactase deficiency |
| 5C61.62 | Secondary lactase deficiency |
| 5C63.Z | Disorders of vitamin or nonprotein cofactor absorption or transport, unspecified |
| 5D2Z | Metabolic disorders, unspecified |
| 8D40.0 | Encephalopathy due to nutritional deficiency |
| DA42.81 | Radiation gastritis |
| DA42.8Z | Gastritis due to external causes, unspecified |
| DA42.Z | Gastritis, unspecified |
| DA51.53 | Radiation duodenitis |
| DA51.5Z | Duodenitis due to external causes, unspecified |
| DA51.Z | Duodenitis, unspecified |
| DA60.Z | Gastric ulcer, unspecified |
| DA63.Z | Duodenal ulcer, unspecified |
| DA7Z | Diseases of stomach or duodenum, unspecified |
| DA92.1 | Pneumatosis intestinalis of the small intestine |
| DA96.0Z | Intestinal malabsorption, unspecified |
| DA98.Z | Polyps of small intestine, unspecified |
| DB31.1 | Pneumatosis of the colon |
| DB33.2Z | Allergic or alimentary colitis, unspecified |
| DB33.4Y | Other specified colitis or proctitis caused by external agents |
| DB33.4Z | Colitis or proctitis caused by external agents, unspecified |
| DB36.Z | Certain infections of the colon, unspecified |
| DB97.2 | Chronic hepatitis, not elsewhere classified |
| DC12.Z | Cholecystitis, unspecified |
| DC32.0 | Calcific pancreatitis |
| DC32.1 | Paraduodenal pancreatitis |
| DC32.2 | Hereditary chronic pancreatitis |
| DC32.4 | Chronic idiopathic pancreatitis |
| DC32.5 | Tropical pancreatitis |
| DC32.Z | Chronic pancreatitis, unspecified |
| DC33 | Autoimmune pancreatitis |
| DE2Z | Diseases of the digestive system, unspecified |
| JB64.6 | Diseases of the digestive system complicating pregnancy, childbirth, or the puerperium |
| PL00 | Drugs, medicaments or biological substances causing injury or harm in therapeutic use |
| QA48.1 | Care or examination of a nursing mother |
| 1A1Y | Other specified bacterial foodborne intoxications |
| XN0SE | Clostridium difficile |
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. |
Orally, 30 minutes before meals, 1-2 times/day.
| 3-5 ml (0.5-1 tsp) | 5-7 ml (1-1.5 tsp) | 7-10 ml (0.5-1 tbsp) | 10-15 ml (1-1.5 tbsp) | 15-20 ml (1.5-2 tbsp) | 20-30 ml (2-3 tbsp) |
| Prevention – at least 14 days |
Shake before use and, if desired, dilute 1:2 or more with any food liquid at room temperature, consume immediately. Do not heat!
For increased acidity, it can be diluted with still, slightly alkaline mineral water.
Contraindications
- Individual intolerance to the components.
Special Instructions
A dietary supplement. Is not a medicinal product.
Consultation with a doctor is recommended before use.
Use in Pediatrics
For children from 6 months to 14 years, the product should be taken in agreement with a pediatrician.
Drug Interactions
The product is compatible with any pharmaceutical preparations.
During antibacterial therapy, Normoflorin® D is prescribed from the first day of treatment, with an interval of 2-4 hours after taking the antibiotic.
Dispensing Status
Distributed through pharmacy networks and specialized departments of retail chains.
Storage Conditions
The product should be stored in a refrigerator, at a temperature of 4±2°C (35.6°F). When opened, store in a tightly closed bottle in the refrigerator.
Shelf Life
Shelf life – 60 days from the date of manufacture in an unopened factory package.
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