"The European Medicines Agency (EMA) has launched a review of the six direct-acting antivirals approved for use in the European Union for treating chronic hepatitis C virus infection, the agency said today.
They are daclatasvir (Dak"...
DOSAGE AND ADMINISTRATION
Preparation For Administration
Shake well before use. With thorough agitation, HAVRIX is a homogeneous, turbid, white suspension. Do not administer if it appears otherwise. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.
For the prefilled syringes, attach a sterile needle and administer intramuscularly.
For the vials, use a sterile needle and sterile syringe to withdraw the vaccine dose and administer intramuscularly. Changing needles between drawing vaccine from a vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated. Use a separate sterile needle and syringe for each individual.
Do not administer this product intravenously, intradermally, or subcutaneously.
Recommended Dose And Schedule
Children and Adolescents
Primary immunization for children and adolescents (12 months through 18 years of age) consists of a single 0.5-mL dose and a 0.5-mL booster dose administered anytime between 6 and 12 months later. The preferred sites for intramuscular injections are the anterolateral aspect of the thigh in young children or the deltoid muscle of the upper arm in older children.
Primary immunization for adults consists of a single 1-mL dose and a 1-mL booster dose administered anytime between 6 and 12 months later. In adults, the injection should be given in the deltoid region.
Dosage Forms And Strengths
Suspension for injection available in the following presentations:
- 0.5-mL single-dose vials and prefilled TIP-LOK® syringes.
- 1-mL single-dose vials and prefilled TIP-LOK syringes.
Storage And Handling
HAVRIX is available in single-dose vials and prefilled disposable TIP-LOK syringes (packaged without needles) (Preservative Free Formulation):
720 EL.U./0.5 mL
NDC 58160-825-01 Vial in Package of 10: NDC 58160-825-11
NDC 58160-825-43 Syringe in Package of 10: NDC 58160-825-52
NDC 58160-826-01 Vial in Package of 10: NDC 58160-826-11
NDC 58160-826-05 Syringe in Package of 1: NDC 58160-826-34
NDC 58160-826-43 Syringe in Package of 10: NDC 58160-826-52
Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. Discard if the vaccine has been frozen. Do not dilute to administer.
Manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium, US License No. 1617. Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/15/2015
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