Yellow Fever Vaccine – Vacunas Contra Fiebre Amarilla
Si Disponible: Dispensado al Día Siguiente
Envío Gratis
Dentro de México
Requiere Receta Médica
Este Medicamento requiere prescripción médica de su médico, clínica, hospital o terapeuta.
Enfermedad Objetivo: Prevención de la fiebre amarilla causada por el Virus de la Fiebre Amarilla.
Description
Pharmaceutical Information on Yellow Fever Vaccines
1. Product Identification
- Brand Name:
- USA: YF-Vax®.
- Europe: Stamaril® (sanctioned by WHO for regions lacking YF-Vax® supply).
- India: Bio-Manguinhos Yellow Fever Vaccine (imported) and Stamaril®.
- Generic Name: Yellow fever vaccine.
- Manufacturer:
- YF-Vax®: Sanofi Pasteur (USA).
- Stamaril®: Sanofi Pasteur (France).
- Bio-Manguinhos: Fiocruz (Brazil).
- Product Code/ID: Batch and lot numbers, NDC/GTIN as applicable.
- Regulatory Approval: Approved by FDA (USA), EMA (Europe), DCGI (India), and WHO prequalified.
2. Indications and Usage
- Target Disease: Prevention of yellow fever caused by the Yellow fever virus.
- Age/Population Indications:
- Recommended for individuals aged 9 months and older in endemic areas or travelers to these areas.
- Required for international travel to regions requiring yellow fever certification.
- Vaccine Schedule:
- Single dose provides lifetime immunity, as per WHO guidelines. Booster doses may be required by some countries after 10 years.
- Efficacy:
- 99% protection within 30 days of vaccination.
3. Composition and Formulation
- Active Ingredients: Live, attenuated Yellow fever virus (17D strain).
- Adjuvants or Preservatives:
- Stabilizers: Lactose-sorbitol.
- Thiomersal-free formulations.
- Presentation: Lyophilized powder for reconstitution with sterile diluent.
4. Storage and Handling
- Temperature Requirements: Store at 2–8°C (refrigerated). Do not freeze.
- Shelf Life: 36 months from the date of manufacture when stored as recommended.
- Transport Conditions: Requires cold chain logistics.
5. Packaging Details
- Unit Size:
- Single-dose or multi-dose vials (up to 5 doses per vial).
- Box/Carton Size: Packaged in cartons containing 10–20 vials.
- Labeling: Includes product name, batch number, expiration date, and instructions in multiple languages.
6. Regulatory and Compliance
- Approval Documentation: Certificates of Analysis (CoA), WHO prequalification, and GMP compliance.
- Registration Status: Registered with COFEPRIS (Mexico), FDA (USA), EMA (Europe), and DCGI (India).
- Pharmacovigilance: Ongoing monitoring of adverse events through WHO's Vaccine Safety Network.
7. Administration Information
- Route of Administration: Subcutaneous (preferred) or intramuscular.
- Injection Site:
- Deltoid muscle (for adults and children over 1 year).
- Anterolateral thigh (for infants aged 9–12 months).
- Administration Equipment: Requires a 1 mL syringe with a 25- to 27-gauge needle.
8. Pricing and Availability
- Unit Pricing:
- USA: $50–$150 USD per dose.
- Europe: €50–€80 per dose.
- India: ₹2000–₹5000 per dose (approximately $25–$60 USD).
- Discounts or Bulk Pricing: Available for government immunization programs and international procurement initiatives.
- Lead Time for Delivery: 2–6 weeks, depending on supplier and approvals.
9. Safety and Risk Information
- Contraindications:
- Severe allergic reactions to eggs, gelatin, or previous yellow fever vaccine doses.
- Infants younger than 6 months.
- Severe immunosuppression, such as HIV/AIDS with severe immunosuppression or active cancer therapy.
- Pregnant and breastfeeding women (use only if travel to endemic area is unavoidable).
- Side Effects:
- Common: Fever, headache, muscle pain, injection site reactions (e.g., swelling or redness).
- Rare: Severe allergic reactions, vaccine-associated neurotropic disease (YEL-AND), and vaccine-associated viscerotropic disease (YEL-AVD).
- Interaction Warnings: Avoid administering with immunosuppressive therapies or other live vaccines without a minimum interval of 4 weeks.
