Hepatitis B vaccine
واکسن هپاتیت B
🦠 Antiinfectives For Systemic UseRecombinant vaccine
Market / country: 🇺🇸 USA
Engerix-B (US)
🧮 Dose calculator
Immunisation (vaccination) · Regimen source: FDA Engerix-B · 2.3
- • 3 doses at months 0, 1 and 6. Haemodialysis: 2 mL at months 0, 1, 2 and 6. IM, not in the buttock. FDA Engerix-B · 2.3FDA Engerix-B · 2.2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Anaphylaxis to a previous hepatitis B vaccine dose or a component (including yeast). FDA Engerix-B · 4
Formulations
- 0.5 mL (10 mcg) or 1 mL (20 mcg) — injection 🇺🇸 USA FDA Engerix-B · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label: available data do not suggest an increased risk of major birth defects or miscarriage; no adequate controlled studies. FDA Engerix-B · 8.1
“Available data do not suggest an increased risk of major birth defects and miscarriage in women who received ENGERIX-B during pregnancy”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Engerix-B · 8.2
“Risk Summary There is no information regarding the presence of ENGERIX-B in human milk, the effects on the breastfed child, or the effects on milk production.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Engerix-B · 8.4
“Safety and effectiveness of ENGERIX‑B have been established in all pediatric age-groups.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Engerix-B · 8.5
“Clinical studies of ENGERIX‑B used for licensure did not include sufficient numbers of participants aged 65 years and older to determine whether they respond differently from younger participants.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)BLA103239
- DailyMed (FDA label)FDA Engerix-B
- MedlinePlus (NIH)Hepatitis B (Recombinant) VaccineHepatitis B (recombinant) vaccine, Adjuvanted
- WHO ATC/DDDJ07BC01
- Darooyab (Iran)Hepatitis-B-Vaccines
🇮🇷 Registered in Iran Darooyab · G-3469/Hepatitis-B-Vaccines
Dosage forms with Iranian generic codes, per Darooyab.
- 07058 · VACCINE-HEPATITIS B VIRUS 100MCG 10DOSE VIAL · ویال واکسن–هپاتیت B ویروس ۱۰۰ میکروگرم ۱۰ دوز
- 01841 · VACCINE-HEPATITIS B VIRUS 100MCG 1DOSE VIAL · ویال واکسن–هپاتیت B ویروس ۱۰۰ میکروگرم ۱ دوز
- 01715 · VACCINE-HEPATITIS B VIRUS 10MCG 1DOSE VIAL · ویال واکسن–هپاتیت B ویروس ۱۰ میکروگرم ۱ دوز
- 01844 · VACCINE-HEPATITIS B VIRUS 10MCG 20DOSE VIAL · ویال واکسن–هپاتیت B ویروس ۱۰ میکروگرم ۲۰ دوز
- 02690 · VACCINE-HEPATITIS B VIRUS 20MCG 1DOSE AMP · آمپول واکسن–هپاتیت B ویروس ۲۰ میکروگرم ۱ دوز
- 01532 · VACCINE-HEPATITIS B VIRUS 20MCG/ML 10DOSE VIAL · ویال واکسن–هپاتیت B ویروس ۲۰ میکروگرم / میلیلیتر ۱۰ دوز
- 51828 · HEPATITIS B VIRUS INJECTION PARENTERAL 1 {dose} 1 mL · فرآورده تزریقی هپاتیت B ویروس ۱ { دوز } ۱ میلیلیتر
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Engerix-B · 3FDA Engerix-B · 2.3FDA Engerix-B · 2.2FDA Engerix-B · 4FDA Engerix-B · 8.1FDA Engerix-B · 8.2FDA Engerix-B · 8.4FDA Engerix-B · 8.5FDA Engerix-B · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-3469/Hepatitis-B-Vaccines
- Clinical review⚠ Unverified