- Approval Id
- c2f8b4d28c6857a5
- Drug Name
- VAQTA VACCINE 50U/ml
- Product Name
- VAQTA VACCINE 50U/ml
- Approval Number
- SIN13717P
- Approval Date
- 2009-10-30
- Registrant
- MSD PHARMA (SINGAPORE) PTE. LTD.
- Licence Holder
- MSD PHARMA (SINGAPORE) PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION
- Dosage
- **III. DOSAGE AND ADMINISTRATION**
DO NOT INJECT INTRAVASCULARLY OR INTRADERMALLY
VAQTA is for intramuscular injection. For adults, adolescents, and children older than 2 years of age, the deltoid muscle is the preferred site for intramuscular injection. For children 12 through 23 months of age, the anterolateral area of the thigh is the preferred site for intramuscular injection.
_Adults with Bleeding Disorders_
For individuals with bleeding disorders who are at risk of hemorrhage following intramuscular injection (e.g., hemophiliacs), this vaccine can be administered subcutaneously (See PRECAUTIONS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
The vaccination series consists of one primary dose and one booster dose given according to the following schedule:
_Children/Adolescents – 12 Months Through 17 Years of Age_
Individuals 12 months through 17 years of age should receive a single 0.5 mL (~25 units) dose of vaccine at elected date and a booster dose of 0.5 mL (~25 units) 6 to 18 months later.
_Adults_
Adults 18 years of age and older should receive a single 1.0 mL (~50 units) dose of vaccine at elected date and a booster dose of 1.0 mL (~50 units) 6 to 18 months later.
_Adults With Human Immunodeficiency Virus (HIV)_
HIV-infected adults should receive a single 1.0 mL (~50 units) dose of vaccine at elected date and a booster dose of 1.0 mL (~50 units) 6 months later.
_Interchangeability of the Booster Dose_
A booster dose of VAQTA may be given at 6 to 12 months following the initial dose of other inactivated hepatitis A vaccines.
_Use With Other Vaccines_
VAQTA may be given concomitantly with yellow fever, typhoid, measles, mumps, rubella, varicella, pneumococcal 7-valent conjugate, diphtheria toxoid, tetanus toxoid, acellular pertussis, and _Haemophilus influenzae_ b vaccines. Data on concomitant use with other vaccines are limited. (See DRUG INTERACTIONS, _Use With Other Vaccines_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.)
Separate injection sites and syringes should be used for concomitant administration of injectable vaccines.
_Known or Presumed Exposure to HAV/Travel to Endemic Areas_
_Use With Immune Globulin_
VAQTA may be administered concomitantly with IG using separate sites and syringes. The vaccination regimen for VAQTA should be followed as stated above. Consult the manufacturer’s product circular for the appropriate dosage of IG. A booster dose of VAQTA should be administered at the appropriate time as outlined above (see DRUG INTERACTIONS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
The vaccine should be used as supplied; no reconstitution is necessary.
Shake well before withdrawal and use. Thorough agitation is necessary to maintain suspension of the vaccine.
Parenteral drug products should be inspected visually for extraneous particulate matter and discoloration prior to administration whenever solution and container permit. After thorough agitation, VAQTA is a slightly opaque, white suspension.
It is important to use a separate sterile syringe and needle for each individual to prevent transmission of infectious agents from one person to another.
- Route Of Administration
- INTRAMUSCULAR
- Indication Info
- **II. INDICATIONS**
VAQTA is indicated for active pre-exposure prophylaxis against disease caused by HAV.
VAQTA is recommended for healthy individuals from 12 months of age and older who are at risk of contracting or spreading infection or who are at risk of life-threatening disease if infected (e.g., hepatitis C with diagnosed liver disease, adults with Human Immunodeficiency Virus \[HIV\]).
- Contraindications
- **V. CONTRAINDICATIONS**
Hypersensitivity to any component of the vaccine.
- Atc Code
- J07BC02
- Atc Item Name
- hepatitis A, inactivated, whole virus
- Pharma Manufacturer Name
- MSD PHARMA (SINGAPORE) PTE. LTD.
- Company Detail Path
- /organization/msd-pharma-singapore-pte-ltd
