Human Hepatitis B Immunoglobulin

[Composition]

Active ingredients: human hepatitis B immunoglobulin

Excipients: glucose, Polysorbate 80, NaCl, glycine, WFI

[Characters]

It is a colorless or light yellow clear liquid, with opalescence but without turbidity. [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.

[Strengths]

100 IU per vial (1.0 ml): each vial contains 100 IU of Anti-HBs potency, and filling quantity is 1.0ml.

[Administration and Dosage]

Administration: The product is for intramuscular injection exclusively; intravenous infusion is contraindicated.

Dosage: 1. Prevention of Mother to Child Transmission (PMTCT): Newborns whose mothers are HBsAg positive should receive 100 IU of the product within 24 hours after birth. The dosage and timing of administration of hepatitis B vaccine please refer to the package insert or the direction of the physician.

2. Prevention from hepatitis B: each single human dose of 100 IU for children and 200 IU for adults; a repeated dose is injected at an interval of 3～4 weeks if necessary.

3. Accidental infection: inject 8～10IU/kg BW as soon as possible (at latest not more than 7 days); inject one more dose after one month.

[Adverse Reactions]

Generally no adverse reactions occur after injection. Redness and swelling or pain in the site of injection may appear in a few people. Normally no treatment is necessary, for it could be recover by itself.

[Contraindications]

1. Those hypersensitivity to human immunoglobulin, or with a history of other severe anaphylaxis.

2. Those with selective IgA deficiency with IgA antibody.

[Warnings and Precautions]

1. It should be colorless or light yellow clear liquid with opalescence. Slight precipitate may occur after long-term storage, but they should be dissipated immediately after shaking. Do not use the product if there is any precipitate or foreign matter that cannot be dissipated after shaking.

2. Do not use the product if any crack on vial or expired shelf life is found.

3. Once the container is opened, the product shall be used up at one time. Divided dosing or injection to a second person is prohibited.

[Pregnancy and Nursing Mothers]

Targeted study on this monograph has not been conducted, and there are not systematic and reliable references either.

[Pediatric Use]

See [Administration and Dosage]

[Geriatric Use]

Targeted study on this monograph has not been conducted, and there are not systematic and reliable references either.

[Drug Interactions]

Any drug that interacts with immunoglobulin may interact with this product.

[Overdosage]

Allergic reactions or pain in the injection site may occur.

[Pharmacology & Toxicology]

Containing high potency of anti-HBs, the product will exclusively bind with relevant antigen for passive immunization.

[Pharmacokinetics]

Targeted study on this monograph has not been conducted. The following data are based on relevant references:

Absorption: After intramuscular injection of the product, the anti-HBs will be released from the injection site to the blood cycle system slowly, and will achieve a maximum concentration in 2～4 days.

Kinetics: The biological half life of immunoglobulin is 28 days, and then the complex of IgG and virus will be eliminated by the reticuloendothelial system.

[Storage] Store and ship at 2-8℃, protected from light.

[Packaging] Borosilicate glass vial, sealed with bromobutyl rubber stopper, packaging of 1 vial per box.

[Shelf Life] 36 months starting from the date of production.

[Product Standard] Chinese Pharmacopeia (2015 Volume III)

[National Drug Approval Number] GYZZ S20023029