Human Hepatitis B Immunoglobulin used for interruption of mother-to-child hepatitis B

PRODUCT DESCRIPTION

Hepatitis B human immunoglobulin Active ingredient is human Immunoglobulin, excipient is glucose, polysorbate 80, sodium chloride, glycine, injection water。

Indications:

The product is mainly used to prevent hepatitis B, and indicated for:

1.       Newborns whose mothers are HbsAg positive

2.       People with accidental infection

3.       Close contacts with hepatitis B patients or hepatitis B virus carriers.

Administration and Dosage:

Administration: The product is for intramuscular injection exlusively; Intravenous infusion is contraindicated.

Dosage:

1. Prevention of Mother lo Child Transmission (PMTCT) : Newborns whose mothers are HBsAg positive should reccive 100 IU of the product within 24hoursafter birth. The dosage and timing of administration of hepatitis B vaccine please referto the package insert or the direction of the physician.

2. Prevention from hepatitis B: each single human dose of 100 TU for children and200 IU for adults; A repeated dose is injected at an interval of 3~-4 weeks if necessary.

3. Accidental infection: inject 8--101U/kg BW as soon as possible (at latest not more than 7 days) ; inject one more dose after one month.

Basic information

1.       Specification: 100IU/1.0 ML per syringe, each syringe contains Anti-HBs potency 100 iu

2.       Characters: Colourless

3.       Quality Standard: Chinese Pharmacupoeia(2020 Volume III)

4.       Certificate: GMP

5.       HS Code:3002150090

6.       Shelf Life: 36 months

7.       Packing: Borusilicate glass vial, sealed with brumobulyl rubber slopper.packaging of l syringe per box.

8.       Storage: Keep in the dark at 2-8 degree, protected from light.

9.       Caution: Consult with The Doctor.

10.      Registration Dossier: Available