Human Rabies Immunoglobulin of Hualan in China

This product is made of human blood plasma. Although the source plasma has been screened for relevant pathogens, and the viruses have been removed and inactivated during production, there are still potential risks of spreading some known and unknown pathogens. Therefore, the decision to use the product should be based on carefully consideration of the potential benefits and risks.

[Name of the Medicinal Product]

Generic Name: Human Rabies Immunoglobulin

[Composition]

Active ingredients: human rabies immunoglobulin

Excipients: glucose, glycine, Tween-80, NaCl, WFI

[Characters]

It is a clear, colorless or light yellow liquid. Opalescence may occur but without turbidity.

[Indications]

The product is indicated for passive immunization of persons with wounds bitten or scratched by rabid dogs or other animals carrying rabies virus.

[Strengths]

200 IU per container (2.0 ml): each container containing 200 IU of rabies antibody potency, filling quantity of 2.0 ml.

[Administration and Dosage]

Administration: After extensive debridement, inject hypo. 1/2 of the total dosage at the wound, and inject i.m. the rest 1/2 (at back muscles if the wound was in head). WHO recommendation: Inject as much the product as possible at the wound; dilute 2～3 folds of the product with saline for use if the product is not enough.

Dosage: 20IU/kg BW or at the direction of the physician; the product should be used up at one time. If the dosage required exceeds 10 ml, divided dosing is allowed within 1～2 days. Afterwards, proceed the injection of rabies vaccine, but at a different site of injection and with a different equipment from that of the immunoglobulin.

[Adverse Reactions]

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

[Contraindications]

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

2. Those with selective IgA deficiency with IgA antibody.

[Warnings and Precautions]

1. Intravenous injection is strictly contraindicated.

2. Dilute the product with 5% glucose injection, as required. Diabetics shall use with caution.

3. Do not use the product if any clumps not dispersed on shaking, foreign matters, or any leakage of container, expired shelf life are found.

[Pregnancy and Nursing Mothers]

Study on this monograph has not been conducted with this product, and there are not systematic and reliable references either.

[Pediatric Use]

See [Administration and Dosage]

[Geriatric Use]

Study on this monograph has not been conducted with this product, and there are not systematic and reliable references either.

[Drug Interactions]

The product should be used exclusively.

[Overdosage]

Allergic reactions or pain in the injection site may occur.

[Pharmacology & Toxicology]

Containing high potency of human rabies antibody, the product will specifically neutralize the rabies virus for passive immunization.

[Pharmacokinetics]

According to relevant references, the biological half life of human rabies immunoglobulin is 16～24 days.

[Storage] Store and ship at 2-30°C, protected from light.

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

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