1. What Gardasil is and what it is used for
Gardasil is a vaccine. Vaccination with Gardasil is intended to protect against diseases caused by Human Papillomavirus (HPV) types 6, 11, 16, and 18.
These diseases include cervical cancer, pre-cancerous lesions of the female genitals (cervix and vulva), and genital warts. HPV types 16 and 18 are responsible for ~70% of cervical cancer cases and HPV types 6, 11, for approximately 90% of genital wart cases.
Gardasil cannot cause the diseases it protects against.
Gardasil produces type-specific antibodies and have in clinical trials been shown to prevent these HPV 6-, 11-, 16-, and 18-related diseases in adult women 16-26 years of age. The vaccine also produces antibodies in 9- to 15- year old children and adolescents. Whether these type-specific antibodies prevent disease in adult males has not been evaluated.
Gardasil should be used in accordance with official guidelines.
The most benefit from Gardasil is expected before infection with any of the Human Papillomavirus types covered by the vaccine. However, in individuals who are already infected by one or more of the vaccine HPV types, the vaccine will protect against the remaining vaccine related HPV types.
2. Before you use Gardasil
Do not use Gardasil if:
the person to be vaccinated
- is allergic (hypersensitive) to any of the active substances or any of the other ingredients of Gardasil (listed under \"other ingredients\"- see section 6).
- has developed an allergic reaction after receiving a dose of Gardasil.
- suffers from an illness with high fever. However, a mild fever or upper respiratory infection (for example cold) itself is not a reason to delay vaccination.
Take special care with Gardasil:
You should tell your doctor if the person to be vaccinated:
- has a bleeding disorder (a disease that makes you bleed more than normal), for example haemophilia
- has a weakened immune system, for example due to a genetic defect or HIV infection
As with any vaccine, Gardasil may not fully protect 100% of those who get the vaccine.
Gardasil will not protect against all types of Human Papillomavirus. Therefore appropriate precautions against sexually transmitted disease should continue to be used.
Gardasil will not protect against other diseases that are not caused by Human Papillomavirus.
Vaccination is not a substitute for routine cervical screening. You should continue to follow your doctor\'s advice on cervical smear/Pap tests and preventative and protective measures.
What other important information should I know about Gardasil?
The duration of protection is currently unknown. Longer term follow-up studies are ongoing to determine whether a booster dose is needed.
3. Taking Gardasil with other medicines:
Gardasil can be given with Hepatitis B vaccine at a separate injection site (another part of your body, e.g. the other arm or leg) at the same visit.
Gardasil may not have an optimal effect if:
- used with medicines that suppress the immune system.
In clinical trials, oral or other contraceptives (e.g. the pill) did not reduce the protection obtained by Gardasil.
Please tell your doctor or pharmacist if the person for whom the vaccine is intended is taking or has recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding:
Consult your doctor if the person to be vaccinated is pregnant, trying to become pregnant or becomes pregnant during the course of vaccination.
Gardasil may be given to women who are breast-feeding or intend to breast-feed.
Driving and using machines:
There is no information to suggest that Gardasil affects your ability to drive or use machinery.
4. How to use Gardasil
Gardasil is given as an injection by your doctor. The person to be vaccinated will receive three doses of the vaccine.
First injection: at chosen date
Second injection: ideally 2 months after first injection
Third injection: ideally 6 months after first injection
The dosing schedule can be more flexible, please speak to your doctor for more information.
The person to be vaccinated should complete the three-dose vaccination course; otherwise the person to be vaccinated may not be fully protected.
Gardasil will be given as an injection through the skin into the muscle (preferably the muscle of the upper arm or thigh).
The vaccine should not be mixed in the same syringe with any other vaccines and solutions.
5. If you forget to take Gardasil:
If you miss a scheduled injection, your doctor will decide when to give the missed dose.
It is important that you follow the instructions of your doctor or nurse regarding return visits for the follow-up doses. If you forget or are not able to go back to your doctor at the scheduled time, ask your doctor for advice.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
6. Possible side effects
Like all vaccines and medicines, Gardasil can cause side effects, although not everybody gets them.
The following side effects can be seen after the use of Gardasil:
Very commonly (more than 1 in 10 patients), side effects found at the injection site include: pain, swelling, and redness. Fever was also seen.
Commonly (more than 1 in 100 patients), side effects found at the injection site include: bleeding, itching.
Very rarely (less than 1 in 10,000 patients), difficulty breathing (bronchospasm) has been reported.
Rarely (less than 1 in 1000 patients), hives (urticaria).
Side effects that have been reported during marketed use include:
Dizziness, nausea, and vomiting have also been reported.
Fainting has been reported. 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.
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
7. How to store Gardasil
Keep this vaccine out of the reach and sight of children.
The vaccine should not be used after the expiry date which is stated on the syringe label and the outer carton (after EXP). The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the syringe in the outer carton in order to protect from light.
Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.
8. Further information
If you have any further questions on Gardasil after reading this leaflet, please ask your doctor or pharmacist.
What Gardasil contains
The active substances are: highly purified non-infectious protein for each of the Human Papillomavirus types (6, 11, 16, and 18).
1 dose (0.5 ml) contains approximately:
Human Papillomavirus1 Type 6 L1 protein2,3
Human Papillomavirus1 Type 11 L1 protein2,3
Human Papillomavirus1 Type 16 L1 protein2,3
Human Papillomavirus1 Type 18 L1 protein2,3
Human Papillomavirus = HPV
2L1 protein in the form of virus like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology.
3adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (225 micrograms Al).
The other ingredients in the vaccine suspension are:
Sodium chloride, L-histidine, polysorbate 80, sodium borate, and water for injections.
What Gardasil looks like and contents of the pack
1 dose of Gardasil suspension for injection contains 0.5 ml.
Prior to agitation, Gardasil may appear as a clear liquid with a white precipitate. After thorough agitation, it is a white, cloudy liquid.