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Data Published in The Lancet Show Gardasil was 100 Percent,Effective in Preventing High-Grade Vulvar and Vaginal Lesions,Caused by HPV Types 16 and 18

ed antibody response to active immunization (see PRECAUTIONS, Drug Interactions). As with other intramuscular injections, GARDASIL should not be given to individuals with bleeding disorders such as hemophilia or thrombocytopenia, or to persons on anticoagulant therapy unless the potential benefits clearly outweigh the risk of administration. If the decision is made to administer GARDASIL to such persons, it should be given with steps to avoid the risk of hematoma following the injection. Information for the Patient, Parent, or Guardian The health care provider should inform the patient, parent, or guardian that vaccination does not substitute for routine cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening per standard of care. The health care provider should provide the vaccine information required to be given with each vaccination to the patient, parent, or guardian. The health care provider should inform the patient, parent, or guardian of the benefits and risks associated with vaccination. For risks associated with vaccination, see PRECAUTIONS and ADVERSE REACTIONS. GARDASIL is not recommended for use in pregnant women. The health care provider should inform the patient, parent, or guardian of the importance of completing the immunization series unless contraindicated. Patients, parents, or guardians should be instructed to report any adverse reactions to their health care provider. Drug Interactions Use with Other Vaccines Results from clinical studies indicate that GARDASIL may be administered concomitantly (at a separate injection site) with hepatitis B vaccine (recombinant) (see CLINICAL PHARMACOLOGY, Studies with Other Vaccines). Co-administration of GARDASIL with other vaccines has not been studied. Use with Hormonal Contraceptives In clinical studies, 13,293 subjects (vaccine = 6644; placebo = 6649) who had post-Month 7 foll
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