Engerix-B, Engerix-B Paediatric 1 ml Suspension for injection
PDF Leaflet Revision Date: 05 May 2023
Clinical Summary
Quick overview from the medicine insert
Indication
Active immunisation against hepatitis B virus infection.
Dosage (summary)
Adults: 20 u03bcg in 1 ml; Children: 10 u03bcg in 0.5 ml at 6, 10, 14 weeks.
Special Populations
- Renal impairment
- HIV infection
- Immunocompromised patients
Pregnancy & Breastfeeding
Use in pregnancy not recommended unless high-risk; unknown effects during lactation.
Key Drug Interactions
- Do not mix with other vaccines
- Can be given with BCG, DTP, polio, measles-mumps-rubella, Haemophilus b, and HPV vaccines
Contraindications
- Hypersensitivity to vaccine components
- Acute severe febrile infections
Common side effects
- Pain at injection site
- Fatigue
- Irritability
- Headache
- Gastrointestinal symptoms
Counselling Points
- Shake well before use
- Do not administer if appearance is abnormal
- Report any adverse reactions
Serious warnings
- Risk of syncope
- May not prevent hepatitis B if infection is present at vaccination
- Monitor for apnoea in premature infants
Important Disclaimer
The Engerix-B, Engerix-B Paediatric 1 ml Suspension for injection professional information leaflet below is the property of Glaxosmithkline South Africa and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>
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