2.1 Immunization Series

ActHIB vaccine is to be administered as a 4 dose series (0.5mL per dose) as:

• A primary three dose series of a single dose at 2, 4, and 6 months of age.
• A single booster dose at 15 through 18 months of age.

2.2 Reconstitution

ActHIB vaccine is a solution for injection supplied as single-dose vials of lyophilized vaccine to be reconstituted only with the accompanying saline diluent (0.4% Sodium Chloride). To reconstitute ActHIB vaccine, withdraw 0.6 mL of saline diluent and inject into the vial of lyophilized ActHIB vaccine. Agitate the vial to ensure complete reconstitution. The reconstituted ActHIB vaccine will appear clear and colorless. Withdraw a 0.5 mL dose of the reconstituted vaccine and inject intramuscularly. After reconstitution, if ActHIB vaccine is not administered promptly store at 2° to 8°C (35° to 46°F) and administer within 24 hours. Stored vaccine should be re-agitated prior to injection. Refer to Figures 1, 2, 3, and 4.

Instructions for Reconstitution of ActHIB Vaccine with Saline Diluent (0.4% Sodium Chloride)
Figure 1. Disinfect the diluent vial stopper, inject the needle and withdraw 0.6 mL of 0.4% Sodium Chloride diluent as indicated.	Figure 2. Cleanse the ActHIB vaccine stopper, insert the syringe needle into the vial, and inject the total volume of diluent.	Figure 3. Agitate vial thoroughly.	Figure 4. After reconstitution, withdraw 0.5 mL of reconstituted vaccine and administer intramuscularly.

2.3 Administration

Parenteral drug products should be inspected visually for particulate matter and/or discoloration prior to administration, whenever solution and container permit. If either of these conditions exist, the vaccine should not be administered.

ActHIB vaccine is administered as a single dose (0.5 mL) by intramuscular injection into the anterolateral aspect of the thigh or deltoid.

Do not administer this product intravenously, intradermally, or subcutaneously.

ActHIB vaccine should not be mixed in the same syringe with other parenteral products.

4.1 Hypersensitivity

Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any H. influenzae type b- or tetanus toxoid-containing vaccine or any component of the vaccine is a contraindication to administration of ActHIB vaccine.[see Description (11)]

5.1 Prevention and Management of Acute Allergic Reactions

Epinephrine and other appropriate agents must be available should an acute anaphylactic reaction occur.

5.2 Guillain-Barré Syndrome
If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give any tetanus toxoid-containing vaccine, including ActHIB vaccine, should be based on careful consideration of the potential benefits and possible risks.

5.3 Altered Immunocompetence

In immunosuppressed persons, including those receiving immunosuppressive therapy, the expected antibody responses may not be obtained.

5.4 Limitations of Vaccine Effectiveness

Vaccination with ActHIB vaccine may not protect 100% of individuals.

5.5 Tetanus Immunization

Immunization with ActHIB vaccine does not substitute for routine tetanus immunization.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

More than 7,000 infants and young children (≤2 years of age) have received at least one dose of ActHIB vaccine during US clinical trials. Of these, 1,064 subjects 12 to 24 months of age who received ActHIB vaccine alone reported no serious or life threatening adverse reactions.(5) (6)

Adverse reactions associated with ActHIB vaccine generally subsided after 24 hours and did not persist beyond 48 hours after immunization.

In a US trial, the safety of ActHIB vaccine was eva luated in 110 children 15 to 20 months of age. All children received three doses of Haemophilus influenzae type b conjugate vaccine (ActHIB vaccine or a previously licensed Haemophilus b conjugate vaccine) at approximately 2, 4, and 6 months of age. The incidence of selected solicited injection site and systemic adverse reactions which occurred within 48 hours following the dose of ActHIB vaccine is shown in Table 1.

Table 1: Local and Systemic Reactions at 6, 24, and 48 Hours Following Immunization with ActHIB Vaccine in Children 15 to 20 months old (6)

Adverse Event	6 Hrs. Post-dose	24 Hrs. Post-dose	48 Hrs. Post-dose
* Induration is defined as hardness with or without swelling
Local (%)	N = 110	N = 110	N = 110
Tenderness	20.0	8.2	0.9
Erythema   (>1")	0.0	0.9	0.0
Tags： 责任编辑：admin
【大 中 小】【打印】 【繁体】【投稿】【收藏】 【推荐】【举报】【评论】 【关闭】 【返回顶部】
分享到:
上一篇：BiCNU® (carmustine for inje..	下一篇：ActHIB (haemophilus b conjugate..