injection, suspension
9-valent vaccine against human papillomavirus ( recombinant, adsorbed )
1. What Gardasil 9 is and what it is used for
Gardasil 9 is a vaccine for children and adolescents from 9 years and adults. The vaccine is intended to protect against diseases caused by human papillomavirus (HPV) type 6, 11, 16, 18, 31, 33, 45, 52, and 58.
These diseases include cell changes that are precursors to cancer or already developed cancer of the female genitals (cervix, external parts of the genitals, and vagina), cell changes that are precursors to cancer, or already developed cancer of the anus and genital warts ( condyloma ) in men and women.
Gardasil 9 has been studied in men aged 9 to 26 years and women aged 9 to 45 years.
Gardasil 9 protects against the HPV types that in most cases are the cause of these diseases.
Gardasil 9 is intended to prevent these diseases. The vaccine is not used to treat HPV-related diseases. Gardasil 9 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 9 may still protect against diseases associated with the other HPV types in the vaccine.
Gardasil 9 cannot cause HPV-related diseases.
When you are vaccinated with Gardasil 9, the immune system (the body’s own defenses against disease) is stimulated to produce antibodies against the nine HPV types in the vaccine, to provide protection against diseases caused by the virus.
If you or your child receive the first dose of Gardasil 9, you must complete the entire vaccination series with Gardasil 9.
If you or your child have already received an HPV vaccine, ask your doctor if Gardasil 9 is right for you.
Gardasil 9 should be used in accordance with official recommendations.
2. What you need to know before you or your child receive Gardasil 9
Gardasil 9 should not be given if you or your child:
- is allergic (hypersensitive) to active substances or to any of the other ingredients of this vaccine (listed in section 6).
- have developed an allergic reaction after receiving a dose of Gardasil or Silgard (HPV type 6, 11, 16 and 18) or Gardasil 9.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before you or your child receive Gardasil 9 if you or your child:
- have a bleeding disorder (a disease that causes you to bleed more than normal), e.g. hemophilia .
- has a weakened immune system, e.g. due to a genetic defect , HIV – infection or taking medicines that affect the immune system.
- have a disease with high fever. Mild fever or upper respiratory tract infection (eg cold) is not in itself a reason to delay vaccination.
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 9 will provide complete protection to everyone who is vaccinated.
Gardasil 9 does not protect against all types of human papillomavirus. Preventive measures against sexually transmitted diseases should therefore continue to be applied.
Vaccination does not replace routine gynecological cell sampling. If you are a woman, you should continue to follow your doctor’s instructions for regular cell examinations as well as preventive and protective measures.
What other important information should you or your child know about Gardasil 9?
It is not yet known how long the vaccination protection will last. Studies with long-term follow-up are ongoing to determine if a refill dose is needed.
Other medicines and Gardasil 9
Tell your doctor or pharmacist if you or your child have recently taken or might take any other medicines, including medicines obtained without a prescription.
Gardasil 9 can be given at the same time as a booster dose of combined 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 9 may not work optimally if used in combination with medicines that inhibit the immune system.
Hormonal contraceptives (eg birth control pills ) did not reduce the protection provided by Gardasil 9.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this vaccine.
Gardasil 9 can be given to women who are breastfeeding or intending to breastfeed.
Driving and using machines
Gardasil 9 may to some extent temporarily affect the ability to drive or use machines (see section 4. “Possible side effects”).
Gardasil 9 contains sodium chloride
The vaccine contains less than 1 mmol (23 mg) sodium per dose, ie it is essentially ‘sodium-free.
3. How Gardasil 9 is given
Gardasil 9 is given as an injection by your doctor or nurse. Gardasil 9 is intended for adolescents and adults aged 9 years and older.
If you are 9 to 14 years old at the first injection
Gardasil 9 can be given according to a two-dose schedule:
- First injection: any date
- Second injection: given between 5 and 13 months after the first injection
If the second dose of vaccine is given earlier than 5 months after the first dose, a third dose should always be given.
Gardasil 9 can be given according to a three-dose schedule:
- First injection: any date
- Second injection: given 2 months after the first injection one (not earlier than one month after the first dose)
- Third injection: given 6 months after the first injection (no earlier than 3 months after the second dose)
All three doses should be given within a one-year period. Talk to your doctor for more information.
If you are 15 years and older at the first injection
Gardasil 9 should be given according to a three-dose schedule:
- First injection: any date
- Second injection: given 2 months after the first injection (not earlier than one month after the first dose )
- Third injection: given 6 months after the first injection (not earlier than 3 months after the second dose)
All three doses should be given within a one-year period. Talk to your doctor for more information.
It is recommended that people receiving a first dose of Gardasil 9 complete the vaccination series with Gardasil 9.
Gardasil 9 is given as an injection through the skin into the muscle (preferably the muscle of the upper arm or thigh).
If you forget a dose of Gardasil 9
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 Gardasil 9 is given as the first dose, the vaccination series should be completed with Gardasil 9, and not any other 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 may occur after using Gardasil 9:
Very common (affects more than 1 in 10 people): side effects at the injection site (pain, swelling, and redness ) and headache.
Common (affects up to 1 in 10 people): side effects at the injection site (bruising, itching ), fever, fatigue, dizziness, and nausea.
Uncommon (affects up to 1 in 100 people): swollen glands (throat, armpits, or groin), hives ( urticaria ), fainting sometimes accompanied by tremors or stiffness, vomiting, joint pain, aching muscles, unusual tiredness or weakness, chills, general malaise.
Rare (affects up to 1 in 1,000 people): allergic reactions.
Has been reported (occurs in an unknown number of users): severe allergic reactions ( anaphylactic reaction ).
When Gardasil 9 was co-administered with a booster dose of diphtheria, tetanus, pertussis [acellular, component], and polio [inactivated] vaccine at the same visit, swelling at the injection site was more common.
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.
The following side effects have been reported with GARDASIL or SILGARD and may also occur after using GARDASIL 9:
Allergic reactions have been reported. Some of these reactions have been severe. Symptoms may include difficulty breathing and wheezing.
As with other vaccines, side effects reported during general use include the following: muscle weakness, abnormal sensations, creep in the arms, legs, and upper body, or confusion (Guillain-Barré syndrome, acute disseminated encephalomyelitis ); increased risk of bleeding and bruising as well as 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 9
Keep this vaccine out of the reach and sight of children.
Use the vaccine before the expiry date which is stated on the carton and on the vial label 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. Sensitive to light.
The vaccine 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, 18, 31, 33, 45, 52, and 58).
| Human papillomavirus 1 type 6 L1 protein2,3 | 30 micrograms |
| Human Papillomavirus 1 Type 11 L1 Protein 2.3 | 40 micrograms |
| Human papillomavirus 1 type 16 L1 protein2,3 | 60 micrograms |
| Human Papillomavirus 1 Type 18 L1 Protein 2.3 | 40 micrograms |
| Human papillomavirus 1 type 31 L1 protein2,3 | 20 micrograms |
| Human papillomavirus 1 type 33 L1 protein 2.3 | 20 micrograms |
| Human papillomavirus 1 type 45 L1 protein2,3 | 20 micrograms |
| Human papillomavirus 1 type 52 L1 protein 2.3 | 20 micrograms |
| Human papillomavirus 1 type 58 L1 protein 2.3 | 20 micrograms |
| 1 Human papillomavirus = HPV2 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 (0.5 milligrams Al). |
Amorphous aluminum hydroxide/phosphate/sulfate is included in the vaccine as an adjuvant. Adjuvants are included to enhance the immune system of the vaccine.
The other ingredients 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 9 solution for injection, the suspension contains 0.5 ml.
Before shaking, Gardasil 9 may look like a clear liquid with a white precipitate. After careful shaking, the liquid becomes white and cloudy.
Gardasil 9 is available in packs of 1 pc.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, France
Manufacturer
Merck Sharp & Dohme, BV, Waarderweg, 39, 2031 BN Haarlem, The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorization Holder.
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