Gardasil Injection

GARDASIL is a vaccine (injection/shot) that helps protect against the following caused by Human Papillomavirus (HPV) (Types 6, 11, 16 and 18):

• Cervical (the lower end of the uterus or womb) vulvar (the outside of the female genitals), vaginal and anal cancer caused by HPV types 16 and 18.
• Vulvar (the outside of the female genitals) and vaginal cancers caused by HPV types 16 and 18.
• Genital warts caused by HPV types 6 and 11.
• Abnormal and pre-cancerous (changes in cells which have a risk of turning into cancer) cervical, vaginal, vulvar and anal lesions and infections caused by HPV types 6, 11, 16 and 18.

This vaccine also provides some protection against abnormal and pre-cancerous cervical lesions caused by HPV types 31, 33, 52 and 58 in girls and women 9 through 26 years of age. GARDASIL helps protect against the following caused by HPV in boys and men 9 through 26 years of age:

• Anal cancer caused by HPV types 16 and 18.
• Genital warts caused by HPV types 6 and 11.
• Abnormal and pre-cancerous external genital lesions, anal lesions and infections caused by HPV types 6, 11, 16 and 18.

You or your child cannot get HPV or any of the above diseases from GARDASIL. GARDASIL helps prevent, but does not treat these diseases.

Who should receive GARDASIL?

Children and adolescents 9 through 17 years of age and women 18 through 45 years of age can receive GARDASIL. GARDASIL works best when given before a person has any contact with certain types of Human Papillomavirus. Therefore, you should talk to your doctor or health-care provider to find out if GARDASIL is right for you or your child.

Who should not receive GARDASIL?

Anyone who:

• is allergic to any of the ingredients in the vaccine (including any of the ingredients listed under inactive ingredients).
• has an allergic reaction after receiving a dose of GARDASIL.

What should I tell my doctor or healthcare provider before I or my child is vaccinated with GARDASIL?

Your doctor or healthcare provider will decide if you or your child should receive GARDASIL. You should tell your doctor or healthcare provider if you or your child:

• has had an allergic reaction to GARDASIL
• has a bleeding disorder and cannot receive injections in the arm
• has any illness with a fever higher than 37,8 °C
• is pregnant or is planning to get pregnant
• takes or plans to take any medicines, including over-the-counter medicines
• has a weakened immune system, e.g. due to Human Immunodeficiency Virus (HIV) infection or a genetic defect, or if you take medicines that affect your immune system.

GARDASIL is given as an injection usually in the arm muscle. GARDASIL should be administered as soon as possible after being removed from refrigeration.

You or your child will receive 3 doses of the vaccine. Ideally the doses are given as:

• First dose: At a date you and your doctor or healthcare provider choose.
• Second dose: 2 months after the first dose.
• Third dose: 6 months after the first dose.

The second dose should be administered at least one month after the first dose and the third dose should be administered at least 3 months after the second dose. All three doses should be given within a 1-year period. Please speak to your doctor for more information. Alternatively, individuals 9 through 13 years of age, may receive 2 doses of the vaccine.

First injection: At chosen date.
Second injection: Ideally 6 months or 12 months after first injection. It is recommended that individuals who receive a first dose of GARDASIL complete the vaccination course with GARDASIL. Make sure that you or your child gets all doses. This allows you or your child to get the full benefits of GARDASIL. If you or your child misses a dose, your doctor or healthcare provider will decide when to give the missed dose.

What should I do if my child or I miss a dose?

Your doctor or healthcare provider will decide when to give the missed dose.

It is important that you follow the instructions of your doctor or healthcare provider regarding return visits for the follow-up doses.

GARDASIL may have side effects. The most commonly reported side effects include injection site reactions such as pain, swelling, itching, redness and generalized reactions including fever and pain in extremity. Dizziness, nausea and vomiting have also been reported. Fainting sometimes accompanied by shaking or stiffening, has been reported. Fainting can occur after vaccination, most commonly among adolescents and young adults. Although fainting episodes are uncommon, patients should be observed for 15 minutes after they receive HPV vaccine. Allergic reactions that may include difficulty breathing, wheezing (bronchospasm), hives and rash have been reported. Some of these reactions have been severe. Side effects that have been reported during general use include: Swollen glands (neck, armpit or groin), Guillain-Barré syndrome, headache, joint pain, aching muscles, unusual tiredness, weakness or confusion, chills, generally feeling unwell and bleeding or bruising more easily than normal and skin infection. If you or your child has any unusual or severe symptoms after receiving GARDASIL, contact your doctor or healthcare provider right away. Your doctor or healthcare provider has a more complete list of side effects for GARDASIL. Not all side effects reported for GARDASIL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using GARDASIL, please consult your doctor, pharmacist or other healthcare professional for advice.

Store refrigerated at 2 to 8 °C. Protect from light. Do not remove from carton until required for use. GARDASIL remains stable for up to 72 hours at 25 °C. DO NOT FREEZE. DISCARD IF THE VACCINE HAS BEEN FROZEN.

Keep all medicines out of reach and sight of children. Do not use GARDASIL after the month and year following EXP.: on the container. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). Discard the empty vial or syringe in approved biological waste containers according to local regulations.