Approval date: May 16, 2007
Revise date: Sep. 29, 2019
CHANG LE KANG
Leaflet of Combined Clostridium butyricum and bifidobacterium powder, Live
Please read the instructions carefully and use the drug under the
guidance of doctors.
Generic name: Combined Clostridium butyricum and bifidobacterium powder, Live
Trade name: Chang Le Kang
English name: Combined Clostridium Butyricum and Bifidobacterium Powder, Live
Chinese Pinyin: Laosuansuojun Erlianhuojun San
Clostridium butyricum, infantile bifidobacterium powder, obtained by bacteria culture, collection and lyophilization.
Auxiliary materials: starch, anhydrous glucose
The product is white or grey white powder.
Acute and chronic diarrhea, enteritis, alteration of intestinal flora, acute and chronic diarrhea and dyspepsia arising from antibiotic, chronic hepatitis, etc
500mg / sachet (within shelf life, viable count of clostridium butyricum should not be less than 1.0 x 107CFU/g, viable count of infantile bifidobacterium should not be less than 1.0 x 106CFU/g)
[Administration and dosage]
Take orally, 3 sachets for each time, twice a day, taken with cold boiled water; 3~7 days of administration for acute diarrhea; 14~21 days of administration for chronic diarrhea, or follow the doctor’s advice.
In the clinical study phase I-III, only a few patients show slight skin rash and slight discomfort in the stomach.
It is forbidden for those who have allergic history to probiotics.
1. This product is viable bacteria, so do not take it with hot boiled water.
2. Do not take the product when the character changes.
3. If the cold storage temperature is not continuous during transportation, the interval time should not be more than 7 days; it should be protected from light and heat.
[Administration by pregnant and lactating women]
The pregnant and lactating women can take this product.
[Administration by Children]
Take orally, 1 sachet each time, twice a day or follow the doctor's advice; it also can be administered with cold boiled water, fruit juice or milk.
[Drug use by Elderly patients]
The elderly patients can take this product with the same administration and dosage of the adults or follow the doctor’s advice.
The product should not be taken together with antibiotics medicine. The drug sensitive test shows that clostridium butyricum is sensitive to ampicillin, cephazoline, cefuroxime, tetracin, chloromycetin, furazolidone, and compound sinomin and norfloxacin; Bifidobacterium is sensitive to ampicillin, cefuroxime, cefotaxime, erythrocin, chloromycetin, furazolidone. Clostridium butyricum and infantile bifidobacterium have interaction of growth-promoting effect.
This product is probiotics, there is no report of toxicity caused by overdose.
[Pharmacology and toxicology]
The drug effect test in animal body showed that the product can stop the diarrhea of mice caused by ampicillin. The test in vitro showed that clostridium butyricum can inhibit the growth of several kinds of intestinal pathogenic bacteria such as vibrio cholera biotype Eltor O1, vibrio cholera O139, enter hemorrhagic E. coli O157 and etc. It can also inhibit the growth of shigella dysenteria and hog cholera salmonella.
Clostridium butyricum can stay temporarily in intestinal tract for about 10 days before being discharged out of the body. Infantile bifidobacterium is beneficial bacteria that can stay for long term after being orally administered.
Store and transport at 2-8℃, protect from light.
Medicinal composite membrane, (1) 500mg/sachet x 6 sachets/ carton;
(2) 500mg/sachet x 10 sachets/ carton; (3) 500mg/sachet x 18 sachets/ carton; (4) 500mg/sachet x 20 sachets/ carton; (5) 500mg/sachet x 30 sachets/ carton
[Shelf life] 24 months
[Standard based on] WS4-（S-018）-2004Z and “Chinese Pharmacopoeia” edition 2015, volume 3
Shandong Kexing Bio-Products Co., Ltd.
Address: No.2666 Chuangye Road, Mingshui Development Zone, Zhangqiu, Shandong, China
Post code: 250200
Web Site: www.sdkexing.com