Gardesil - patient information

FINAL PATIENT INFORMATION LEAFLET
PATIENT INFORMATION LEAFLET Information for the Patient about GARDASIL™ [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine]
Read all of this leaflet carefully before you or your child is vaccinated.
Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or your pharmacist. This vaccine has been prescribed for you or your child. Do not pass it on to others.
SCHEDULING STATUS
S2
PROPRIETARY NAME AND DOSAGE FORM
GARDASIL™ Injection [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine]
WHAT GARDASIL CONTAINS
Each 0,5 ml dose contains approximately 20 microgram of Human Papillomavirus Virus (HPV) 6 L1 protein, 40 microgram of HPV 11 L1 protein, 40 microgram of HPV 16 L1 protein, and 20 microgram of HPV 18 L1 protein as the active ingredients.
In addition, GARDASIL contains the following inactive ingredients: Each 0,5 ml dose of the vaccine contains approximately 225 microgram of aluminium (as amorphous aluminium hydroxyphosphate sulfate adjuvant), 9,56 mg of sodium chloride, 0,78 mg of L-histidine, 50 microgram of polysorbate 80 and 35 microgram of sodium borate. The product does not contain a preservative or antibiotics.
™ Trademark of MERCK & CO., Inc., Whitehouse Station, NJ, 08889 USA COPYRIGHT © 2005 MERCK & CO., Inc. All rights reserved
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WHAT GARDASIL IS USED FOR
GARDASIL is a vaccine (injection/shot) that helps protect against the following diseases caused by Human Papillomavirus (HPV) Types 6, 11, 16, and 18:
• Cervical cancer (cancer of the lower end of the uterus or womb) • 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 • Vaginal and vulvar (the outside of the female genitals) cancers • HPV infection You or your child cannot get these diseases from GARDASIL. GARDASIL helps prevent, but does not treat these diseases.
Why is vaccination with GARDASIL important?
In the absence of vaccination, it is estimated that the majority of sexually active people will catch Human Papillomavirus during their lifetime. A male or female of any age who takes part in any kind of sexual activity that involves genital contact is at risk. The only way to fully protect yourself from Human Papillomavirus is to avoid this kind of sexual activity.
Many people who have Human Papillomavirus may not show any signs or symptoms. This means that they can transmit (pass on) the virus to others without knowing it.
BEFORE YOU USE GARDASIL Who should receive GARDASIL?
Children and adolescents 9 through 17 years of age and women 18 through 26 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 with your doctor or health-care provider to find out if GARDASIL is right for you or your child.
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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 the vaccine What should I tell my doctor or health-care provider before I or my child is vaccinated with GARDASIL?
Your doctor or health-care provider will decide if you or your child should receive the vaccine.
You should 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 over-the- counter medicines • has a weakened immune system, for example due to a genetic defect or Human Immunodeficiency Virus (HIV) infection. What are cervical cancer, precancerous lesions, and genital warts?
Cancer of the cervix is a serious and sometimes life-threatening disease. It begins when a female catches certain types of Human Papillomavirus. These types can cause the cells in the lining of the cervix to change from normal to precancerous lesions. If these are not treated, they can turn cancerous. You or your child cannot get cervical cancer without first having a Human Papillomavirus infection. Worldwide, cervical cancer is the second most common cancer among women, causing 288,000 deaths per year. There are more than 490,000 new cases of cervical cancer diagnosed each year.
Genital warts are caused by certain types of Human Papillomavirus. They commonly appear as skin-colored, irregular growths. They are found on the inside or outside of the genitals in both males and
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can come back after females. They can hurt, itch, bleed, and cause discomfort. Sometimes they treatment.
What is Human Papillomavirus?
Human Papillomavirus is a common virus. Of the many different types of Human Papillomavirus, some are harmless and others can cause diseases of the genital areas. While most people clear the virus, those who do not can develop cervical cancer, precancerous lesions, or genital warts.
Will I receive any benefit from GARDASIL if I am already infected with Human Papillomavirus?
It is possible to receive benefit from GARDASIL if you have been infected with Human Papillomavirus. In clinical studies for GARDASIL, some people already had certain types of Human Papillomavirus that GARDASIL helps protects against. Talk to your doctor or health-care provider for more information.
Use in children
GARDASIL can be used in children as young as 9 years of age.
Use in pregnancy
It is not known whether the vaccine is harmful to an unborn baby when administered to a pregnant woman. If you are pregnant, you should be vaccinated with GARDASIL only if your doctor or health-care provider decides it is clearly needed.
Women who become pregnant before completion of the 3-dose schedule should complete their vaccination schedule after childbirth.
Use in breast-feeding
GARDASIL may be given to women who are breast-feeding or intend to breast-feed.
Can I drive or operate machinery following vaccination with GARDASIL?
There is no information to suggest that GARDASIL affects your ability to drive or operate machinery.
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Can other vaccines and medications be given at the same time as GARDASIL?
This vaccine should not be used interchangeably with other Human Papillomavirus (HPV) vaccines (as such use has not been studied).
GARDASIL can be given at the same time as hepatitis B vaccine (recombinant); however the vaccine should not be mixed in the same syringe with any other vaccines or solutions.
Please inform your doctor or health-care provider if you or your child are taking or have recently taken any other medicines, even those not prescribed.
If you or your child are taking other medicines on a regular basis, including complementary or traditional medicines, the use of GARDASIL with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional for advice.
HOW TO USE GARDASIL
GARDASIL is given as an injection.
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 health-care provider choose • Second dose: 2 months after the first dose • Third dose: 6 months after the first dose Make sure that you or your child gets all 3 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 health-care provider will decide when to give the missed dose.
What should I do if my child or I miss a dose?
Your doctor or health-care provider will decide when to give the missed dose.
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It is important that you follow the instructions of your doctor or health-care provider regarding return visits for the follow-up doses.
What other important information about GARDASIL should I know?
There are more than 100 Human Papillomavirus types: GARDASIL will not protect against all types. Human Papillomavirus Types, 6, 11, 16, and 18 have been selected for GARDASIL because they cause over 70 % of cervical cancers and 90 % of genital warts worldwide.
As with any vaccine, GARDASIL may not fully protect everyone who gets the vaccine. Continue to follow your doctor or health-care provider’s instructions on regular Pap tests.
GARDASIL will not protect against diseases that are not caused by HPV.
POSSIBLE SIDE EFFECTS
Any vaccine may have unintended or undesirable effects, so-called side effects. GARDASIL has been shown to be generally well tolerated. The most commonly reported side effects include injection-site reactions such as pain, swelling, bleeding, itching, and redness and generalized reactions including fever.
Difficulty breathing (bronchospasm) has been reported very rarely.
If you or your child has any unusual or severe symptoms after receiving GARDASIL, contact your doctor or health-care provider right away.
Your doctor or health-care provider has a more complete list of side effects for GARDASIL.
Not all side effects reported for this medicine are included in this leaflet. Should your general health worsen while using this vaccine, please consult your doctor, pharmacist or other health care professional for advice.
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STORING AND DISPOSING OF GARDASIL
Store refrigerated at 2°C to 8°C. Protect from light. Do not remove from carton until required for use.
DO NOT FREEZE. DISCARD IF THE VACCINE HAS BEEN FROZEN.
GARDASIL remains stable for up to 72 hours at 25 °C. KEEP ALL MEDICINES OUT OF REACH AND SIGHT OF CHILDREN.
Do not use this medicine after the month and year following EXPIRES/VERVAL 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.
PRESENTATION OF GARDASIL
GARDASIL is supplied in a 3 ml glass vial or a 1,5 ml glass syringe. 1 or 10 syringes or vials are packed into labelled cartons.
IDENTIFICATION OF GARDASIL
GARDASIL is a white cloudy liquid.
REGISTRATION NUMBER
Reg. no. 41/30.1/0145
NAME, BUSINESS ADDRESS AND TELEPHONE NUMBER OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
MSD (Pty) Ltd 16th Road
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HALFWAY HOUSE
011 655 3000
DATE OF PUBLICATION
8 February 2008
WPPI-GRD-I-122005
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