TWINRIX
TWINRIX is generally well tolerated. In clinical trials, the most common solicited adverse events were soreness and redness at the injection site, headache, and fatigue. They were mild and self-limiting and did not last more than 48 hours. As with any vaccine, rare adverse events may occur. (See Adverse Reactions section of the Prescribing Information for TWINRIX for other potential side effects). TWINRIX is contraindicated in people with hypersensitivity to any component of the vaccine, including yeast and neomycin.

ENGERIX-B
ENGERIX-B is generally well tolerated. In clinical trials, the most common solicited adverse events were injection-site soreness and fatigue. As with any vaccine, rare adverse events may occur. (See Adverse Reactions section of the Prescribing Information for ENGERIX-B for other potential side effects). ENGERIX-B is contraindicated in people with hypersensitivity to any component of the vaccine, including yeast.

HAVRIX
HAVRIX is generally well tolerated. In clinical trials, the most common solicited adverse events were injection-site soreness and headache. As with any vaccine, rare adverse events may occur. (See Adverse Reactions section of the Prescribing Information for HAVRIX for other potential side effects). HAVRIX is contraindicated in people with hypersensitivity to any component of the vaccine, including neomycin.

PEDIARIX
In clinical studies, adverse events in infants receiving PEDIARIX included injection-site reactions (pain, redness, or swelling), fever and fussiness. Administration of PEDIARIX was associated with higher rates of fever relative to separately administered vaccines (see Adverse Reactions section of the package insert). PEDIARIX is contraindicated in infants with known hypersensitivity to any component of the vaccine including yeast, neomycin, and polymyxin B. As with any vaccine, vaccination with PEDIARIX may not protect 100% of susceptible individuals.

INFANRIX
Hypersensitivity to any component of INFANRIX is a contraindication. Local adverse events may occur at the site of the injection and include erythema, swelling, and tenderness. Systemic adverse events may include fever, irritability, and drowsiness. As with any vaccine, vaccination with INFANRIX may not protect 100 % of susceptible individuals.

BOOSTRIX
In clinical studies, adverse events included pain, redness, and swelling at the injection site, headache, fatigue, and gastrointestinal symptoms. As with other vaccines, rare adverse events may occur. As with any vaccine, vaccination with BOOSTRIX may not protect 100% of susceptible individuals. Hypersensitivity to any component of BOOSTRIX is a contraindication.

MALARONE
MALARONE is indicated for the prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported.

For prophylaxis: In adults, the most commonly reported adverse events possibly attributable to MALARONE versus placebo were headache (5% vs 7%) and abdominal pain (3% vs 5%); in pediatric patients, headache (14% vs 14%), abdominal pain (31% vs 29%), and vomiting (7% vs 6%).

MALARONE is contraindicated for prevention of P. falciparum malaria in patients with severe renal impairment (creatinine clearance <30 mL/min). MALARONE is contraindicated in individuals with known hypersensitivity to atovaquone or proguanil HCl or any component of the formulation. Rare cases of anaphylaxis following treatment with atovaquone/proguanil have been reported.

FLUARIX
FLUARIX should not be administered to anyone with known systemic hypersensitivity reactions to eggs, egg products, egg or chicken proteins, or any component of FLUARIX, or to anyone who has had a life-threatening reaction to previous administration of any influenza vaccine. The most common adverse event in a clinical trial was pain at the injection site. Less common adverse events were muscle aches, fatigue, and headache. Most adverse events in clinical trials were mild and self-limiting. (See adverse reactions section of the Prescribing Information for FLUARIX for other potential adverse events.) As with any vaccine, vaccination with FLUARIX may not protect 100% of susceptible individuals.

BOOSTRIX*, ENGERIX-B*, HAVRIX*, INFANRIX*, PEDIARIX*, TWINRIX*, FLUARIX*, MALARONE and Tip-Lok are registered trademarks of GlaxoSmithKline.

*Manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium
Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709