injection, suspension in the vial
Human papillomavirus vaccine [Type 16, 18] ( Recombinant , with adjuvant , adsorbed).
1. What Cervarix is and what it is used for
Cervarix is a vaccine intended to protect against diseases caused by infection with human papillomavirus (HPV) by the age of 9.
These diseases include:
- cervical cancer (cancer of the lower part of the uterus) and anal cancer,
- precursors to cancer of the uterus, vulva , vagina or anus (changes in genital or anal cells in the cervix, vulva , vagina and anus that are at risk of developing into cancer).
The types of human papillomavirus (HPV) included in the vaccine (HPV types 16 and 18) cause approximately 70% of cases of cervical cancer, 90% of cases of cancer of the rectal opening, 70% of HPV-related cell changes that are precursors to cancer in external parts of the genitals and vagina and 78% of HPV-related cell changes that are precursors to cancer of the rectal opening. Other types of HPV can also cause genital and rectal cancer. Cervarix does not protect against all types of human papillomavirus.
When a woman or man is vaccinated with Cervarix, the body’s immune system produces antibodies to HPV 16 and 18.
Cervarix is not contagious and therefore cannot cause HPV-related diseases.
Cervarix is not used to treat HPV-related diseases that already exist at the time of vaccination.
Cervarix should be used in accordance with official guidelines.
2. What you need to know before you get Cervarix
Cervarix should not be given:
- if you are allergic to active substances or any of the other ingredients of this vaccine (listed in section 6). Signs of an allergic reaction include itchy skin rash, difficulty breathing and swelling of the face or tongue.
Warnings and cautions
Talk to your doctor or pharmacist before taking Cervarix
- if you have a bleeding disorder or bruise easily
- if you have a disease that weakens the immune system,
such as an HIV – infection . - if you have a severe infection with a high fever. It may then be necessary to postpone the vaccination until you have recovered. A milder infection such as a cold should not cause a problem, but talk to a doctor first.
Fainting can occur (mainly in adolescents) after, or even before, any needle injection. Therefore, tell your doctor or nurse if you or your child have fainted from a previous injection .
As with all vaccines, Cervarix may not provide complete protection to everyone who is vaccinated.
Cervarix does not provide protection against disease caused by HPV 16 or 18 infection in those who have already been infected with HPV 16 or 18 at the time of vaccination.
Vaccination can protect against cervical cancer, but does not replace routine Pap smears. You should continue to follow your doctor’s instructions for regular cell sample checks ( screening for cell changes in the cervix caused by HPV) as well as preventive and protective measures.
Cervarix does not protect against all types of human papillomavirus. Preventive measures against exposure to HPV and sexually transmitted diseases should therefore continue to be taken.
Cervarix does not protect against diseases not caused by human papillomavirus.
Other medicines and Cervarix
Cervarix can be given concomitantly with a combined booster vaccine containing diphtheria (d), tetanus (T) and pertussis [acellular] (pa) with / without polio [inactivated] (IPV) (dTpa, dTpa-IPV vaccine), with a combined hepatitis A and hepatitisB vaccine (Twinrix) or a hepatitis B vaccine (Engerix-B) or with a tetanus-conjugated meningococcal group A, C, W-135, Y vaccine (MenACWY-TT). When the vaccines are given at the same visit, however, different injection sites (other body part, eg opposite arm) must be used.
Cervarix may not have an optimal effect if used in combination with medicines that inhibit the immune system.
In clinical trials , oral contraceptives (eg birth control pills ) did not reduce the protection given by Cervarix.
Tell your doctor if you are taking, have recently taken or might take any other medicines or have recently received any other vaccine.
Pregnancy, breastfeeding, and fertility
If you are pregnant, if you become pregnant during the vaccination series or if you are trying to become pregnant, it is recommended that you postpone or interrupt the vaccination until after the end of the pregnancy.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this vaccine.
Driving and using machines
Cervarix is unlikely to affect your ability to drive or use machines. But do not drive or use machines if you feel unwell.
Cervarix contains sodium chloride
This medicine contains less than 1 mmol sodium (23 mg) per dose , ie essentially ‘sodium-free’.
How to give Cervarix
How the vaccine should be given
Your doctor or nurse will give you Cervarix as an injection into the upper arm muscle.
How much should be given
Cervarix is intended for use from the age of 9 years.
The total number of injections you will be given depends on your age at the time of the first injection:
If you are 9-14 years old
You will receive 2 injections:
First injection: on the selected date
Second injection: given between 5 and 13 months after the first injection, a
If you are 15 years or older
You will receive 3 injections:
First injection: on the selected date
Second injection: 1 month after the first injection, a
Third injection: 6 months after first injection a
The dosing schedule may be changed if necessary. Talk to your doctor for more information.
If the first dose is given with Cervarix, it is recommended that you continue the entire vaccination series with Cervarix (and no other HPV vaccine).
Cervarix is not recommended for use under 9 years of age.
The vaccine should not be given into a vein.
If you miss a dose
It is important that you follow the instructions from the doctor / nurse regarding return visits for future doses . Consult your doctor if you forget to come on time.
If you do not complete the vaccination series (two or three injections depending on your age at the time of vaccination), you risk not getting the best response and protection from your vaccination.
4. Possible side effects
Like all medicines, this vaccine can cause side effects , although not everybody gets them.
The following adverse reactions have been reported in clinical trials:
- Very common ( side effects that may occur with more than 1 in 10 vaccine doses):
- pain or discomfort at the injection site
- redness or swelling at the injection site
- headache
- pain, soreness or weakness in the muscles that is not caused by exercise
- fatigue.
- Common ( side effects that may occur in less than 1 in 10 but in more than 1 in 100 vaccine doses):
- gastrointestinal disorders such as nausea, vomiting, diarrhea, and abdominal pain
- itching, red skin rash, hives ( hives )
- joint pain
- fever (38 ° C or more).
- Uncommon ( side effects that may occur in less than 1 in 100 but in more than 1 in 1,000 vaccine doses):
- upper respiratory tract infection ( infection of the nose, throat or trachea)
- dizziness
- other symptoms at the injection site such as local hardening, tingling or loss of sensation.
Side effects reported after Cervarix approval:
- allergic reactions recognized by:
- rash that itches on hands and feet
- swelling of eyes and face
- difficulty breathing and swallowing
- sudden drop in blood pressure and loss of consciousness.
These reactions normally occur before leaving the care facility. If your child gets any of these symptoms, contact a doctor immediately.
- swelling of glands in the throat, armpit or groin
- fainting which sometimes occurs together with tremors or stiffness.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Cervarix
Keep this vaccine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C).
Do not freeze.
Store in the original package. Sensitive to light.
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 substance is: Human papillomavirus 1 type 16 L1 protein 2, 3, 4Human papillomavirus 1 type 18 L1 protein 2, 3, 4 | 20 micrograms20 micrograms |
| 1 Human papillomavirus = HPV | ||
| 2 adjuvants AS04 containing:3-O-desacyl-4′-monophosphoryl lipid A (MPL) 3 | 50 micrograms | |
| 3 adsorbed on aluminum hydroxide, hydrated (Al (OH) 3 ) 0.5 milligrams Al 3+ (total) 4 L1 protein in the form of non-infectious virus-like particles produced by recombinant DNA technology in an expression system consisting of baculovirus with Hi-5 Rix4446 cells from the insect Trichoplusia ni | ||
| – | The other ingredients are sodium chloride (NaCl), sodium dihydrogen phosphate dihydrate (NaH 2 PO 4 · 2 H 2 O) and water for injections. |
What the medicine looks like and the contents of the pack
Injection, suspension.
Cervarix is a milky, white suspension.
Cervarix single-dose bottles (0.5 ml) are supplied in packs of 1, 10 and 100 pieces.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
GlaxoSmithKline Biologicals SA
Rue de l’Institut 89
B-1330 Rixensart, Belgium
Contact the representative of the marketing authorization holder to find out more about this medicine:
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