Product Overview
[Drug Name]
Generic Name: Bacterial Lysates
Trade Name: Fanfushu
English Name: Bacterial Lysates
Chinese Pinyin: XiJunRongJieChanWu
[Ingredients]
One adult capsule contains 7 mg (one pediatric capsule contains 3.5 mg) of lyophilized lysates of the following bacteria: Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae, Klebsiella pneumoniae, Staphylococcus aureus, Streptococcus pyogenes, Streptococcus viridans, and Neisseria catarrhalis.
[Indications]
For immunotherapy. It can prevent recurrent respiratory infections and acute exacerbations of chronic bronchitis. It can be used as a combination therapy for the treatment of acute respiratory infections.
[Dosage and Administration]
1. For prevention and/or consolidation treatment: Take one capsule orally daily on an empty stomach for 10 consecutive days per month. A course of treatment consists of three consecutive months. Take for 10 days, then rest for 20 days; then take for 10 days, then rest for 20 days; then take for another 10 days. 2. Acute Treatment: Take one tablet orally once daily on an empty stomach until symptoms disappear (but at least 10 days). If antibiotics are needed, it is best to take Fanfushu from the start of treatment. 3. For Children 6 Months to 12 Years: Use pediatric-sized Fanfushu capsules, following the same dosing regimen as for adults. Each pediatric-sized Fanfushu capsule contains half the active ingredient of the adult-sized capsule. 4. Note: Fanfushu capsules can be opened. If patients have difficulty swallowing the capsules, the capsules can be opened and the contents added to a beverage (juice, milk, etc.).
[Adverse Reactions]
3-4% of patients experience gastrointestinal disturbances, skin reactions, respiratory discomfort, and other reactions such as fever, fatigue, and allergic reactions.
[Contraindications]
Patients with allergies to the ingredients in this drug.
[Precautions]
Treatment should be discontinued if persistent gastrointestinal disturbances, skin reactions, or respiratory discomfort occur. Use with caution in pregnant and lactating women. Not recommended for infants under 6 months of age.
[Drug Interactions]
No interactions have been reported to date.
[Pharmacological Actions]
This product is an immunomodulator. In animal studies, it has enhanced resistance to experimental infections, stimulated macrophages and B lymphocytes, and increased immunoglobulin secretion in the respiratory mucosa. In humans, it has been shown to accelerate T lymphocyte circulation, increase salivary secretory IgA levels, enhance nonspecific responses to polyclonal mitogens, and enhance responses to mixed allogeneic lymphocytes. Preclinical data demonstrate the safety of this product, and multiple toxicity studies have not revealed any toxic effects.
[Storage]
Store in the original packaging away from heat (15-25°C). Shelf life: 60 months.
[Strength]
7.0 mg/capsule
[Approval Number]
National Medical Standard SJ20150042
[Manufacturer]
Company Name: OM Pharma SA
