injection, suspension
Human Papillomavirus Vaccine [Types 6, 11, 16, 18] ( recombinant, adsorbed )
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) type 6, 11, 16, and 18.
These diseases include cell changes that are precursors to cancers of the female genitals (cervix, outer parts of the genitals, and vagina), cell changes that are precursors to cancers of the anus, and genital warts ( condyloma ) in men and women, cervical and anal cancers. HPV types 16 and 18 cause about 70% of cases of cervical cancer, 75-80% of cases of anal cancer, about 70% of HPV-related cell changes that are precursors to cancer of the outer parts of the genitals and vagina, and 75% of HPV related cell changes that are precursors to cancer of the anus. HPV types 6 and 11 cause about 90% of cases of genital warts ( condyloma ).
Gardasil is intended to prevent these diseases. The vaccine is not used to treat HPV-related diseases. Gardasil has no effect in individuals who already have a persistent infection or disease associated with any of the HPV types in the vaccine. However, in individuals who are already infected with one or more of the HPV types included in the vaccine, Gardasil can still protect against diseases associated with the other HPV types in the vaccine.
Gardasil cannot cause the diseases it protects against.
Gardasil gives rise to type-specific antibodies and has been shown in clinical studies to protect against diseases caused by HPV types 6, 11, 16, and 18 in women aged
16-45 years and in men aged 16-26 years. The vaccine also gives rise to type-specific antibodies in 9-15-year-old children and adolescents.
Gardasil should be used following official recommendations.
2. What you need to know before using Gardasil
Gardasil should not be given
- you or your child are allergic (hypersensitive) to active substances or to any of the other ingredients of Gardasil (listed under “other ingredients” – see section 6).
- you or your child has developed an allergic reaction after receiving a dose of Gardasil.
- you or your child has a disease with a high fever. Mild fever or upper respiratory tract infection (eg cold) is not in itself a reason to delay vaccination.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before vaccination if you or your child
- have a bleeding disorder (a disease that causes you to bleed more than normal), e.g. haemophilia
- has a weakened immune system, e.g. due to a genetic defect , HIV – infection or medicines that affect the immune system.
Fainting, sometimes accompanied by falls, can (especially in adolescents) occur after the needle stick. Therefore, tell your doctor or nurse if you have fainted from a previous injection.
As with all vaccines, it is not certain that Gardasil will provide complete protection to everyone who is vaccinated.
Gardasil does not protect against all types of human papillomavirus. Preventive measures against sexually transmitted diseases should therefore continue to be applied.
Gardasil does not protect against other diseases not caused by human papillomavirus.
Vaccination is not a substitute for routine check-ups with cell samples from the cervix. You should continue to follow your doctor’s instructions for regular cell sample checks as well as preventive and protective measures.
What other important information should you or your child know about Gardasil?
Studies with long-term follow-up were conducted to determine how long the protection lasts. The need for a refill dose is not yet known.
Other medicines or vaccines and Gardasil
Gardasil can be given concomitantly with a hepatitis B vaccine or with a combined booster vaccine containing diphtheria (d) and tetanus (T) with either pertussis [acellular, component] (aP) and/or polio- [inactivated] (IPV)
(dTaP, dT-IPV, dTaP-IPV vaccine) at a separate injection site (another part of the body, such as the other arm or leg) at the same visit.
Gardasil may not achieve optimal effect if:
- it is used together with medicines that inhibit the immune system.
In clinical trials, contraceptive pills or other contraceptives did not reduce the protection provided by Gardasil.
Tell your doctor or pharmacist if you or your child are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Gardasil can be given to women who are breastfeeding or intending to breastfeed.
Driving and using machines
No studies on the effects of Gardasil on the ability to drive and use machines have been performed.
Gardasil contains sodium
This vaccine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free . is next to “sodium-free”.
3. How Gardasil is given
Gardasil is given as an injection by your doctor. Gardasil is intended for adolescents and adults aged 9 years and older.
If you are 9 to 13 years old
Gardasil can be given according to a 2-dose schedule:
- first injection: on the selected date
- second injection: 6 months after the first injection, a
If the second dose of vaccine is given earlier than 6 months after the first dose, a third dose should always be given.
Alternatively, Gardasil can be given according to a 3-dose schedule:
- first injection: on the selected date
- second injection: 2 months after the first injection, a
- third injection 6 months after the first injection a
The second dose should be given at least one month after the first dose and the third dose should be given at least 3 months after the second dose. All three doses should be given within 1 year. Talk to your doctor for more information.
If you are 14 years or older
Gardasil should be given according to a 3-dose schedule:
- first injection: on the selected date
- second injection: 2 months after the first injection, a
- third injection 6 months after the first injection a
The second dose should be given at least one month after the first dose and the third dose should be given at least 3 months after the second dose. All three doses should be given within a 1-year period. Talk to your doctor for more information.
It is recommended that individuals receiving a first dose of Gardasil complete the Gardasil vaccination regimen.
Gardasil is given as an injection through the skin into the muscle (preferably the muscle in the upper arm or thigh)
The vaccine must not be mixed in the same syringe with other vaccines or solutions.
If you forget a dose of Gardasil:
If you miss a planned injection, your doctor will decide when to take the missed dose. It is important that you follow the doctor’s or nurse’s instructions for return visits for the follow-up doses. If you forget or cannot return to the doctor at the appointed time, consult your doctor. If you are receiving Gardasil as the first dose, the vaccination regimen should also be completed with Gardasil and not with another HPV vaccine.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all vaccines, this vaccine can cause side effects, although not everybody gets them.
The following side effects can be seen after use with Gardasil:
Very common (may affect more than 1 in 10 people), side effects at the injection site include pain, swelling, and redness. Headaches have also been observed.
Common (may affect more than 1 in 100 people), side effects at the injection site include bruising, itching, pain in the extremities. Fever and nausea have also been reported.
Rare (may affect less than 1 in 1,000 people), hives ( urticaria ).
Very rare (may affect less than 1 in 10,000 people), breathing difficulties ( bronchospasm, ie respiratory cramps) have been reported.
When Gardasil was co-administered with combined diphtheria, tetanus, pertussis [acellular, component], and polio [inactivated] booster vaccine at the same visit, headache and swelling at the injection site was more common.
Side effects reported since its introduction on the market include:
Fainting, sometimes accompanied by tremors or stiffness, has been reported. Although fainting episodes are uncommon, patients should be observed for 15 minutes after receiving the HPV vaccine.
Allergic reactions that may include difficulty breathing, wheezing ( bronchospasm ), hives, and rash have been reported. Some of these reactions have been severe.
As with other vaccines, side effects reported during general use include the following: swollen glands (throat, armpit, or groin); muscle weakness, abnormal sensations, tingling in the arms, legs, and upper body or confusion (Guillain-Barré syndrome, acute disseminated encephalomyelitis ); dizziness, vomiting, joint pain, aching muscles, unusual tiredness or weakness, chills, general malaise, increased risk of bleeding and bruising and skin infections at the injection site.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Gardasil
Keep the vaccine out of the reach and sight of children.
Do not use this vaccine after the expiry date which is stated on the label of the vial and outer carton (after EXP). The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze. Keep the vial in the outer carton (photosensitive).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substances are highly purified non-infectious protein for the following types of human papillomavirus (6, 11, 16, and 18).
1 dose (0.5 ml) contains approx:
Human papillomavirus 1 type 6 L1 protein 2.3 20 micrograms
Human papillomavirus 1 type 11 L1 protein 2.3 40 micrograms
Human papillomavirus 1 type 16 L1 protein 2.3 40 micrograms
Human papillomavirus 1 type 18 L1 protein 2.3 20 micrograms
1 Human papillomavirus = HPV.
2 L1 protein in the form of virus-like particles produced in yeast cells ( Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) using recombinant – DNA technology.
3 Adsorbed on amorphous aluminiumhydroxifosfatsulfat- adjuvant (0.225 milligrams Al).
Amorphous aluminum hydroxyphosphate sulfate is added to this vaccine as an adjuvant. Adjuvants are substances that are added to certain vaccines to accelerate, improve and/or prolong the protective effect of the vaccine.
The other ingredients in the vaccine suspension are:
Sodium chloride, histidine, polysorbate 80, borax, and water for injections.
What the medicine looks like and contents of the pack
1 dose of Gardasil injection, the suspension contains 0.5 ml.
Before shaking, Gardasil may look like a clear liquid with a white precipitate. After careful shaking, it becomes a white cloudy liquid.
Gardasil is available in packs of 1, 10, or 20 vials.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
MSD VACCINS
162 avenue Jean Jaurès
69007 Lyon
France
Manufacturer
Merck Sharp & Dohme BV
Waarderweg, 39
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Netherlands
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