Healive

Inactivated hepatitis A vaccine (human diploid cell).

Each 0.5 ml dose for pediatric use contains Inactive HAV antigen (TZ84 strain)^{1, 2}  250 u³.
¹produced in human diploid (2BS) cells.
²adsorbed on aluminum hydroxide.
³In the absence of an International standardized reference, the antigen content is expressed using an in-house reference.
Hepatitis A Vaccine (Human Diploid Cell), inactivated is a slightly milky-white suspension.
Excipients/Inactive ingredients: Aluminum (as aluminum hydroxide), sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride and water for injection.
No preservative is used in Healive.

Pharmacotherapeutic Group: Viral vaccine, ATC code: J07BC02.
Pharmacology: Pharmacodynamics: Healive confers immunity against hepatitis A virus by inducing antibody titres greater than those obtained after passive immunization with immunoglobulin. Antibody appears shortly after the first injection and 14 days after vaccination 56.7%-93% of immunocompetent subjects are seroprotected (titre above 20 mlU/ml). One month after the first dose, 69.4%-95.5% of subjects have antibody titres above 20 mlU/ml.
The efficacy of Healive was evaluated in different community outbreaks. These studies indicated that administration of a single dose of Healive contributed to termination of the outbreaks. In one study, the peak of HAV outbreak began to decrease in 2 weeks after the primary infection. In another study, the protective efficacy was 100% in students who received vaccination.
In order to ensure long term protection, a booster dose should be given between 6 and 12 months after the primary dose. In clinical trials, virtually all vaccinees were seropositive one month after the booster dose.
The long-term persistence of protective antibody levels to hepatitis A virus after a second dose (booster) of Healive has not been fully evaluated. Nevertheless, serological data show continuing protection against hepatitis A for up to 5 years in subjects who administered after the full immunization.
Pharmacokinetics: Not applicable to vaccine for prophylaxis.
Toxicology: Preclinical Safety Data: Long-term toxicity study has been conducted for Healive on mice and rats. No toxicity was observed in mentioned studies.

Healive 1.0 ml dose is indicated for active immunization against infection caused by hepatitis A virus in susceptible adults and adolescents of 16 years of age and above, and 0.5 ml dose in children over 1 but below 16 years old.
The use of Healive should be based on official recommendations.

The recommended dosage and schedule are presented below:

Click on icon to see table/diagram/image

In order to provide long-term protection, a second dose (booster) of a Hepatitis A vaccine (Human Diploid Cell), Inactivated should be given. The second dose is preferably given 6-12 months after the first dose.
Method of Administration: Healive should be administered by intramuscular injection in the deltoid region.

Few cases of overdose have been reported with Healive during the post-marketing surveillance. Adverse reactions reported following overdose were similar to those reported with normal vaccination.

Subjects with known allergic reaction to any component of the vaccine, including excipients, formaldehyde and gentamycin sulfate.

Vaccination shall be postponed to subjects with acute diseases, severe chronic diseases, and chronic diseases at acute attack stage or fever.
Healive should be given with caution to individuals on anticoagulant therapy.
Do not use the vaccine if the container shows abnormalities, such as crack, illegible label, exceeding expiry date or turbidity.
Appropriate medical treatments, such as Adrenaline, should be readily available for immediate use in case of rare severe anaphylactic reaction following vaccination. The recipients shall be observed for at least 30 minutes on site after injection.
It is possible that subjects may be in the incubation period of a hepatitis A infection at the time of immunisation. It is not known whether Healive will prevent hepatitis A in such cases.
Effects on Ability to Drive and Use Machine: There is no clinical or scientific data for effects on ability to drive and use machine.

Pregnancy: Animal reproduction studies have not been conducted with Healive. It is not known whether Healive can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. However, as with all inactivated viral vaccine, the risks to the foetus are considered to be negligible. Healive should be given to pregnant woman only if clearly needed after consult a doctor.
Lactation: It is not known whether Healive is excreted in human milk. Because many drugs excreted in human milk, caution should be exercised when Healive is administered to woman at breastfeeding.

Frequencies per dose are defined as follows: Very common: ≥10%.
Common: ≥1% an <10%.
Uncommon: ≥0.1% and <1%.
Rare: ≥0.01% and <0.1%.
Very rare: <0.01%.
Clinical trial data: Applicable site disorders: Uncommon: Injection site reaction, such as redness and swelling, pain at the injection site.
Body as a whole-general disorders: Common: Fever.
Uncommon: Fatigue.
Hearing and vestibular disorders: Rare: Ear pain.
Immune system disorders: Rare: Anaphylaxis.
Nervous system disorders: Uncommon: Headache.
Gastrointestinal disorders: Uncommon: Vomiting, abdominal pain.
Rare: Diarrhea.
Respiratory system disorders: Uncommon: Coughing.
Skin and appendages disorders: Rare: Rash.
General disorders: Uncommon: Sore throat.
Rare: Crying.
Post-marketing surveillance: Application site disorders: Induration at the injection site.
Psychiatric disorders: Agitation.
Nervous system disorders: Convulsions, tetany, somnolence.
Respiratory system disorders: Upper respiratory tract infection.
Skin and appendages disorders: Pruritus, urticaria, urticaria acute, erythema induratum, angioedema.
Vascular (extracardiac) disorders: Purpura allergic.

No studies of Healive on interaction with other medicinal products have been conducted. It is not known whether Healive can use interact with other medicinal products.

Incompatibilities: In the absence of compatibility studies, the vaccine must not be mixed with other medicinal products.
Vaccine Vial Monitor: The Vaccine Vial Monitor (VVM) is part of the label used for all Healive batches supplied by Sinovac. The colour dot that appears on the label of the vial is a VVM. This is a time-temperature sensitive dot that provides an indication of the cumulative heat to which the vial has  been exposed. It warns the end user when exposure to heat is likely to have degraded  the vaccine beyond an acceptable level.
The interpretation of the VVM is simple. Focus on the central square. Its colour will change progressively. As long as the colour of this is lighter than the colour of the ring, then the vaccine can be used. As soon as the colour of the central square is the same colour as the ring of a darker colour than the ring, then the vial should be discarded.
It is absolutely critical to ensure that the storage conditions specified above (in particular the cold chain) are complied with.
Sinovac will assume no liability in the event Healive has not been stored in compliance with the storarge instructions. Furthermore, Sinovac assumes no responsibility in case a VVM is defective for any reason.

Shelf-Life: 42 months.
Store and ship between +2°C and +8°C, protected from light. Do not freeze. Shake well before use.

Vaccines, Antisera & Immunologicals

J07BC02 - hepatitis A, inactivated, whole virus ; Belongs to the class of hepatitis viral vaccines.

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