Authoritativeness & Active Profile

Manufacturer: Japan Bio Products Co., Ltd. (JBP)

Regulatory Standard: MHLW Japan Approved (Approval No. 11400AMZ00318000)

Primary Indication: Improvement of hepatic function in chronic hepatic disease

Active Bio-Matrix: Water-soluble substance of human placenta (112 mg per 2 mL ampoule)

Growth Factors Present: HGF, EGF, FGF, IGF, TGF-beta (Quantified batch-tested)

Peptide Profile: Low molecular weight peptides (< 10,000 Daltons for rapid absorption)

Pharmaceutical Specifications

Format: Injectable aqueous solution

Volume: 2.0 mL per ampoule

Packaging Configuration: 50 ampoules per factory-sealed box

pH Parameter: 5.5 – 6.5 (Maintains physiological compatibility)

Osmotic Pressure Ratio: Approx. 1 (Isotonic to human saline)

Excipients: Pepsin, Lactose (trace amounts for stabilization), pH adjusters

Storage Requirements: Room temperature (1°C–30°C). Avoid direct sunlight.

Shelf Life: 36 months from manufacturing date

Safety & Viral Clearance Protocols

Source Material Validation: 100% full-term Japanese donor placentas. Negative screening for syphilis, gonorrhea, and tuberculosis prior to collection.

Nucleic Acid Amplification Testing (NAT): Negative for HBV-DNA, HCV-RNA, HIV-1-RNA, and Parvovirus B19-DNA.

Thermal Sterilization: Terminal high-pressure steam sterilization at 121°C for exactly 20 minutes.

Protein Fractionation: Proprietary JBP acid/pepsin digestion eliminates blood types, hormones, and high-molecular-weight proteins (allergens).

Variant Creutzfeldt-Jakob Disease (vCJD): Strict donor travel history screening protocols implemented to prevent prion transmission.

Administration Protocols & Contraindications

Delivery Route: Subcutaneous (SC) or Intramuscular (IM) injection only. Recommended needle gauge: 27G – 30G.

Standard Dosage (Hepatic Support): 1 ampoule (2 mL) once daily. May be increased to 2-3 times daily (maximum 6 mL/day) strictly based on physician assessment.

Injection Technique: Aspiration required prior to injection to ensure no blood vessel penetration. Daily rotation of SC/IM injection sites is mandatory to prevent tissue induration.

Documented Adverse Reactions: Pain at injection site (7.06%), hypersensitivity/rash (0.24%), gynecomastia (rare, <0.1%).

Authenticity Verification

JBP Anti-Counterfeit System: Authentic Japan Edition packaging features the proprietary 3D holographic JBP seal on the outer box closure.

Lot Traceability: Each box and internal ampoule tray contains a synchronized Lot Number and Expiry Date for MHLW batch tracking.

Ampoule Identification: Authentic glass ampoules utilize distinct dual white score rings at the neck for clean fracture lines without glass particulate generation.