RabAvert

For preexposure administration, RABAVERT is contraindicated for persons who have had a severe allergic reaction (eg, anaphylaxis) after a previous dose of RABAVERT

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The most commonly occurring adverse reactions are injection site reactions, such as injection site erythema, induration and pain; flu-like symptoms, such as asthenia, fatigue, fever, headache, myalgia and malaise; arthralgia, dizziness, lymphadenopathy, nausea, and rash.

In a comparative trial in normal volunteers, 19 subjects received RABAVERT and 20 received Human Diploid Cell Vaccine (HDCV). The most commonly reported adverse reaction was pain at the injection site, reported in 45% of the HDCV group, and 34% of the RABAVERT group. Localized lymphadenopathy was reported in about 15% of each group. The most common systemic reactions were malaise (15% RABAVERT group vs. 25% HDCV group), headache (10% RABAVERT group vs. 20% HDCV group), and dizziness (15% RABAVERT group vs. 10% HDCV group).

In a recent study in the USA, 83 subjects received RABAVERT and 82 received HDCV. Again, the most common adverse reaction was pain at the injection site in 80% in the HDCV group and 84% in the RABAVERT group. The most common systemic reactions were headache (52% RABAVERT group vs. 45% HDCV group), myalgia (53% RABAVERT group vs. 38% HDCV group) and malaise (20% RABAVERT group vs. 17% HDCV group).

None of the adverse events were serious, almost all adverse events were of mild or moderate intensity. Statistically significant differences between vaccination groups were not found. Both vaccines were generally well tolerated.

RABAVERT is a registered trademark of the GSK group of companies.

References

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400501R0 November 2015