Product Overview
[Drug Name]
Generic Name: Bacillus subtilis Combined Live Bacteria Granules
Trade Name: Mamiai Bacillus subtilis Combined Live Bacteria Granules 1g*15 bag
Pinyin Code: kucaoganjunerlianhuojunkeli (mamiai)
[Main Ingredients]
This product is a compound preparation. Each bag (1g) contains lyophilized live bacteria powder: 37.5mg, vitamin C: 10mg, vitamin B1: 0.5mg, vitamin B2: 0.5mg, vitamin B6: 0.5mg, vitamin B12: 1.0µg, niacinamide: 2.0mg, calcium lactate: 20mg (equivalent to 2.6mg calcium), zinc oxide.
[Properties]
Pale yellow fine granules
[Indications/Main Functions]
This product is indicated for indigestion, loss of appetite, malnutrition, diarrhea, constipation, abdominal distension caused by intestinal flora imbalance, abnormal intestinal fermentation, enteritis, and intestinal mucosal damage caused by antibiotic use.
[Specifications]
1g*15 bag
[Dosage and Administration]
This product is for children only. For children under 2 years old, take 1 bag at a time, 1-2 times daily. For children over 2 years old, take 1-2 bags at a time, 1-2 times daily. Take with warm water or milk below 40°C. It can also be taken directly.
[Adverse Reactions]
This product may rarely cause increased diarrhea, which resolves after discontinuation.
[Contraindications]
This product is contraindicated in those who are allergic to it.
[Precautions]
1. Avoid choking when taking this product directly. Infants and children under 3 years old should not take this product directly.
2. This product is a live bacterial preparation. Do not expose it to high temperatures. The water temperature should not exceed 40°C when dissolving it.
3. This product is contraindicated in those who are allergic to this product. Use with caution in those with allergies.
4. Do not use if the properties of this product change.
5. Keep out of reach of children.
6. Children must be supervised by an adult.
7. If you are currently taking other medications, consult your doctor or pharmacist before using this product.
[Drug Interactions]
1. Taking this product with antibacterial drugs may weaken their efficacy and should be taken separately.
2. Bismuth preparations, tannic acid, medicinal charcoal, tinctures, etc. can inhibit or adsorb live bacteria and should not be used together.
3. Concomitant use with other medications may cause drug interactions; consult your doctor or pharmacist for details.
[Pediatric Use]
This product is for children. The live bacteria in this product are intestinal probiotics, and the amounts of various vitamins, zinc, and calcium added are based on the recommended daily intake. Therefore, it is safe for children.
[Use in Elderly Patients]
Not yet determined
[Use in Pregnant and Lactating Women]
Not yet determined
[Overdose]
Not yet determined
[Pharmacology and Toxicology]
This product contains two live bacteria—Bacillus subtilis and Enterococcus—that directly replenish the normal physiological flora, inhibit pathogenic bacteria, promote nutrient digestion and absorption, and inhibit the production and absorption of enterogenic toxins, thereby regulating intestinal flora imbalance. This product also contains multiple vitamins, trace elements, and the mineral calcium essential for infant growth and development, replenishing deficiencies caused by indigestion or diarrhea.
[Pharmacokinetics]
Thirty minutes after intravenous administration of the labeled compound in rats, the radioactivity in the liver and kidneys was 27.3% and 17.3% of the administered radioactivity, respectively. In rabbits, the maximum blood concentration was reached 30 seconds after intravenous administration and disappeared after 2 minutes. The biological half-life in rabbit blood was approximately 0.4 minutes. Within 24 hours of intravenous administration, the radioactivity in the body was almost completely eliminated. The main metabolite in urine was guanidinohexanoic acid. The half-life of this product in human blood, as determined by RP-HPLC, is 66.8 ±3 seconds. The decomposition product is ethyl p-hydroxybenzoate.
[Storage]
Sealed, light-proof, and stored in a cool, dry place.
[Packaging]
This product is packaged in composite aluminum foil, 1 gram per bag; 15 bags per box.
[Expiry Period]
24 months
[Approval Number]
National Medical Product Approval Number: S20020037
[Manufacturer]
Beijing Hanmi Pharmaceutical Co., Ltd.
