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Rotavirus vaccine (oral)
واکسن روتاویروس (خوراکی)
🦠 Antiinfectives For Systemic UseLive attenuated oral vaccine
🤰 Pregnancy:Use with caution👶 Children:Use with caution 🇮🇷 Registered in Iran⛔ 1 contraindications 🇺🇸 FDA approved (BLA) BLA125265ATC J07BH01
Market / country: 🇺🇸 USA
Rotarix (US)
🧮 Dose calculator
Immunisation (vaccination) · Regimen source: FDA Rotarix · 2.1
- • If the infant spits out most of the dose, one replacement dose may be given at the same visit. Do not mix different rotavirus vaccines in one series. FDA Rotarix · 2.1
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to the vaccine; uncorrected congenital GI malformation predisposing to intussusception; history of intussusception; severe combined immunodeficiency (SCID). FDA Rotarix · 4
Warnings
- • Risk of intussusception (mainly within 7 days of the first dose). FDA Rotarix · 5
Formulations
- 1.5 mL oral dosing applicator — solution 🇺🇸 USA FDA Rotarix · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Darooyab: category C — only if benefit outweighs risk. Darooyab · G-3509/Rotavirus-Vaccines — مصرف در بارداری
“مصرف در بارداری واکسن روتاویروس گروه C در شرايط خاص و نظارت ويژه پزشك قابل استفاده است:”
- 🤱 BreastfeedingNo data
The source for this drug has no section for this group.
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Rotarix · 8.4
“Safety and effectiveness of ROTARIX in infants younger than 6 weeks or older than 24 weeks of age have not been evaluated.”
- 👴 Older adultsNo data
The source for this drug has no section for this group.
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)BLA125265
- DailyMed (FDA label)FDA Rotarix
- MedlinePlus (NIH)❌ None
- WHO ATC/DDDJ07BH01
- Darooyab (Iran)Rotavirus-Vaccines
🇮🇷 Registered in Iran Darooyab · G-3509/Rotavirus-Vaccines
Dosage forms with Iranian generic codes, per Darooyab.
- 52640 · ROTAVIRUS VACCINE, MONOVALENT, LIVE ATTENUATED POWDER, FOR SUSPENSION ORAL 1.5 mL · سوسپانسیون خوراکی واکسن روتاویروس تک‌ظرفیتی زنده تضعیف‌شده ۱٫۵ میلی‌لیتر
- 52771 · ROTAVIRUS VACCINE, MONOVALENT, LIVE ATTENUATED POWDER, FOR SUSPENSION ORAL 2.5 mL · سوسپانسیون خوراکی واکسن روتاویروس تک‌ظرفیتی زنده تضعیف‌شده ۲٫۵ میلی‌لیتر
- 52171 · ROTAVIRUS VACCINE, PENTAVALENT, LIVE SOLUTION ORAL 1 {dose} 2 mL · محلول خوراکی واکسن روتاویروس پنتاوالنت زنده ۱ { دوز } ۲ میلی‌لیتر
- 52996 · ROTAVIRUS VACCINE, PENTAVALENT, LIVE POWDER, FOR SUSPENSION ORAL 2.5 mL · سوسپانسیون خوراکی واکسن روتاویروس پنتاوالنت زنده ۲٫۵ میلی‌لیتر
- 52997 · ROTAVIRUS VACCINE, PENTAVALENT, LIVE POWDER, FOR SUSPENSION ORAL 5 mL · سوسپانسیون خوراکی واکسن روتاویروس پنتاوالنت زنده ۵ میلی‌لیتر
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Rotarix · 3FDA Rotarix · 2.1FDA Rotarix · 4FDA Rotarix · 5FDA Rotarix · SPL approval / marketing categoryFDA Rotarix · 8.4
- 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-3509/Rotavirus-VaccinesDarooyab · G-3509/Rotavirus-Vaccines — مصرف در بارداری
- Clinical review⚠ Unverified
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