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Consumer Medicine Information

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Immunisation does not replace the need for regular cervical smear testing.

*Girls aged 9 up to those born on or after 1 January 1990 are eligible for free immunisation through a doctor, medical clinic or school based programme. A patient charge applies for all ages outside this range.

GARDASIL™ [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant vaccine] GARDASIL is a prescription medicine that is fully funded for females born between 1 January 1990 and 31 December 1999. Please refer to the Ministry of Health for the eligibility criteria for girls younger than 11. A patient charge applies for all others outside this range. Indication: GARDASIL is a vaccine that helps prevent the following diseases caused by Human Papillomavirus (HPV) Types 6, 11, 16 or 18: cervical cancer (cancer of the lower end of the uterus or womb), vulvar (the outside of the female genitals) and vaginal cancers, abnormal and precancerous cervical lesions (changes in cells of the cervix which have a risk of turning into cancer) as found by a Pap test, genital warts, and HPV infection. GARDASIL helps prevent, but does not treat these diseases. You cannot get these diseases from GARDASIL. GARDASIL can be given to females aged 9 to 45 years and males aged 9 to 15 years. Contraindications: Do not, or do not let your child have GARDASIL if you or your child have had an allergy to any of the ingredients or if you or your child have had an allergic reaction after receiving a dose of the vaccine. If you are not sure whether you or your child should be given GARDASIL, talk to your doctor or health care provider. Warnings and Precautions: Tell your doctor or health care provider if you or your child: has had an allergic reaction to the vaccine, has a bleeding disorder and cannot receive injections in the arm, has any illness with a fever higher than 100°F (37.8°C), is pregnant or is planning to get pregnant, takes or plans to take any medicines, including ones you buy without a prescription from your pharmacy, supermarket, or health food shop, has a weakened immune system, for example due to a genetic defect or Human Immunodeficiency Virus (HIV) infection. Adverse Reactions: Tell your doctor or pharmacist as soon as possible if you or your child do not feel well during or after having had an injection of GARDASIL. Tell your doctor if you or your child have any of the following and they are troublesome or ongoing: pain, itching, tenderness, or soreness at the injection site, local reaction around the injection site such as soreness, redness, or swelling, fever, dizziness, nausea and vomiting, pain in the extremities. Fainting, sometimes accompanied by shaking or stiffening, has been reported. Although fainting episodes are uncommon, patients should be observed for 15 minutes after they receive HPV vaccination. As with other vaccines, side effects that have been reported during general use include: headache, swollen glands in the neck, armpit and groin, joint pain, aching muscles, unusual tiredness or weakness, chills, generally feeling unwell, and allergic reactions. If any of the above symptoms worsen or you or your child has any unusual or severe symptoms after receiving GARDASIL, contact your doctor or health care provider right away. Ingredients: The active ingredients of GARDASIL are highly purified inactive proteins from HPV Types 6, 11, 16 and 18.

For more information, please contact your health care provider or CSL Biotherapies (NZ) Ltd, PO Box 62 590, Central Park, Auckland 1544, Freephone 0800 502 757 or www.cslbiotherapies.co.nz. GARDASIL™ is a registered trademark of Merck & Co. Inc. Whitehouse Station, NJ, 08889 USA. GARD-143-09/09 TAPS CH2448 Date of Preparation: September 2009.

Disclaimer: The information in this website is provided for educational purposes only and is not intended to replace discussions with a healthcare professional. All decisions regarding GARDASIL must be made with a healthcare provider. The product information provided in this site is intended for residents of New Zealand. Audiences outside New Zealand should refer to the product information in their own country, as different regulatory regimes may apply. GARDASIL is distributed in New Zealand by CSL Biotherapies (NZ) Ltd.