Cervarix suspension for injection, multidoseHuman Papillomav - United Kingdom[英国药品]

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Cervarix suspension for injection, multidoseHuman Papillomav

2014-10-24 00:03:19 来源: 作者: 【大中小】浏览:407次评论:0条

For doctors

What is it and how is it used?

Cervarix is a vaccine intended to protect females against the diseases caused by infection with Human Papillomaviruses (HPV).

These diseases include:

The Human Papillomavirus (HPV) types contained in the vaccine (HPV types 16 and 18) are responsible for approximately 70% of cervical cancer cases. Other HPV types can also cause cervical cancer. Cervarix does not protect against all HPV types.

When a female is vaccinated with Cervarix, the immune system (the body’s natural defence system) will make antibodies against HPV types 16 and 18. In clinical trials Cervarix has been shown to prevent HPV related diseases in women 15-25 years of age. Cervarix also stimulates production of antibodies in females 10-14 years of age.

Cervarix is not infectious and so, it cannot cause HPV related diseases.

Cervarix is not used to treat HPV related diseases already present at the time of vaccination.

Cervarix should be used in accordance with official guidelines.

What do you have to consider before using it?

Cervarix should not be given if
the person to be vaccinated:

Take special care with Cervarix
You should tell the doctor if the person to be vaccinated:

As with all vaccines, Cervarix may not fully protect all people who are vaccinated.

Cervarix does not protect people from diseases caused by infection with HPV types 16 or 18 if they are already infected with Human Papillomavirus type 16 or 18 at the time of vaccination.

Although vaccination may protect you against cervical cancer, it is not a substitute for regular cervical screening. You should continue to follow your doctor’s advice on cervical smear/Pap test (test to screen for changes in cells of the cervix caused by an HPV infection) and preventative and protective measures.

As Cervarix will not protect against all types of Human Papillomavirus, appropriate precautions against exposure to HPV and sexually transmitted diseases should continue to be used.

Cervarix will not protect against other diseases that are not caused by Human Papillomavirus.

The duration of protection after vaccination is currently unknown. In clinical trials, sustained protection has been observed in females aged 15 to 25 years for up to 6.4 years after the first dose. The need for booster dose(s) has not been investigated.

Using other medicines
Cervarix can be given with a combined booster vaccine containing diphtheria (d), tetanus (T) and pertussis [acellular] (pa) with or without inactivated poliomyelitis (IPV), (dTpa, dTpa -IPV vaccines), or with a combined hepatitis A and hepatitis B vaccine (Twinrix) or a hepatitis B vaccine (Engerix B), at a separate injection site (another part of your body, e.g. the other arm) during the same visit.

Cervarix may not have an optimal effect if used with medicines that suppress the immune system.

In clinical trials, oral contraceptives (e.g. the pill) did not reduce the protection obtained by Cervarix.

Please tell the doctor if the person to be vaccinated is taking or has recently taken any other medicines, including medicines obtained without a prescription or has recently received any other vaccine.

Pregnancy and breast-feeding
There are insufficient data concerning the use of Cervarix during pregnancy. If pregnancy occurs during the course of vaccination your doctor should be consulted. It is recommended to postpone vaccination until after completion of the pregnancy.

Ask your doctor for advice about breast-feeding before receiving Cervarix.

Driving and using machines
There is no information on the effect of Cervarix on your ability to drive or use machinery.

How is it used?

The doctor or nurse will give Cervarix as an injection into the muscle of the upper arm.

Cervarix is intended for females from 10 years of age onwards. A total of three injections will be administered by your doctor or nurse according to the following schedule:

First injection: at chosen date
Second injection: 1 month after first injection
Third injection: 6 months after first injection

If necessary, the vaccination schedule can be more flexible. Please speak to your doctor for more information.

When Cervarix is given for the first dose, it is recommended that Cervarix (and not another vaccine against HPV) be given for the complete 3-dose vaccination course.

The vaccine should never be given into a vein.

If you forget a return visit for Cervarix:
It is important that you follow the instructions of your doctor or nurse regarding return visits. If you forget to go back to your doctor at the scheduled time, ask your doctor for advice.

If you do not finish the complete vaccination course of three injections, you may not get the best response and protection from the vaccination.

What are possible side effects?

Like all medicines, Cervarix can cause side effects, although not everybody gets them.

Side effects that occurred during clinical trials with Cervarix were as follows:

Very common side effects which may occur in more than 1 per 10 doses of vaccine pain or discomfort at the injection site redness or swelling at the injection site headache aching muscles, muscle tenderness or weakness not caused by exercise tiredness

Common side effects which may occur in less than 1 per 10 but more than 1 per 100 doses of vaccine gastrointestinal symptoms including nausea, vomiting, diarrhoea and abdominal pain itching, red skin rash, hives urticaria joint pain fever 38C

Uncommon side effects which may occur in less than 1 per 100 but more than 1 per 1,000 doses of vaccine upper respiratory tract infection infection of the nose, throat or trachea dizziness other injection site reactions such as hard lump, tingling or numbness.

Side effects that have been reported during marketed use of Cervarix include:

These reactions will usually occur before leaving the doctor’s surgery. However, if your child gets any of these symptoms you should contact a doctor urgently.

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.

How should it be stored?

Keep out of the reach and sight of children.

Do not use Cervarix after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C).
Do not freeze.
Store in the original package in order to protect from light.

After first opening, immediate use is recommended. If not used immediately, the vaccine should be stored in a refrigerator (2°C – 8°C). If not used within 6 hours it should be discarded.

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.

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For doctors

What is it?

Cervarix is a vaccine. It is a suspension for injection that contains purified proteins for two types of the human papillomavirus (types 16 and 18). It is available in vials or prefilled syringes.

What is it used for?

Cervarix is used to protect against precancerous lesions (abnormal cell growth) in the cervix (the neck of the womb) and cancer of the cervix that are caused by infection with certain cancer-causing types of the human papillomavirus (HPV).

This use is based on the demonstration of Cervarix’s effectiveness (its ability to prevent lesions) in women aged 15 to 25 years, and of its immunogenicity (its ability to make the immune system produce antibodies against the viruses) in girls and women aged 10 to 25 years. Cervarix is given according to official recommendations.

The vaccine can only be obtained with a prescription.

How is it used?

Cervarix is given to individuals aged 10 years or older, as three doses. It is recommended that there is one month between the first and second doses, and five months between the second and third doses. However, the second and third doses can be given after longer gaps if necessary. It is recommended that individuals who receive the first dose of Cervarix should complete all three doses with Cervarix. The vaccine is given as an injection into the shoulder muscle.

How does it work?

Papillomaviruses are viruses that cause warts and abnormal tissue growth. There are more than 100 types of papillomavirus, some of which are associated with genital cancers. HPV types 16 and 18 cause approximately 70% of cervical cancers.

All papillomaviruses have a shell or ‘capsid’, which is made up of proteins called ‘L1 proteins’. Cervarix contains purified L1 proteins for HPV types 16 and 18, which are produced by a method known as ‘recombinant DNA technology’: they are made by a cell that has received a gene (DNA) that makes it able to produce the L1 proteins. The proteins are assembled in ‘virus-like particles’ (structures that look like HPV, so that the body can recognise them easily).

When a patient is given the vaccine, the immune system makes antibodies against the L1 proteins. The antibodies help to destroy the virus. After vaccination, the immune system is able to produce antibodies more quickly when it is exposed to the real viruses. This will help to protect against the diseases caused by these viruses.

The vaccine is made using an ‘adjuvant system’ that contains MPL, a purified lipid (a fat-like substance) extracted from bacteria, which enhances the response of the immune system to the vaccine. The vaccine is ‘adsorbed’, which means that the virus-like particles and the MPL are fixed onto an aluminium compound, to stimulate a better immune response.

How has it been studied?

The main study of Cervarix involved almost 19,000 women aged between 15 and 25 years. Cervarix was compared with another vaccine that is not active against HPV (in this case, a vaccine against hepatitis A virus). The study looked at how many women, who in the vast majority had no current infection with HPV types 16 or 18 at the start of the study, went on to develop precancerous lesions in the cervix linked to infection with these types of HPV. The women were followed up for up to four years after the first dose of the vaccines.

An additional two studies looked at the development of antibodies to HPV types 16 and 18 in 2,225 girls aged between 10 and 14 years. The studies compared the levels of antibodies before vaccination and after the third dose.

What benefits has it shown during the studies?

Cervarix was more effective than the comparator vaccine in preventing abnormal cell growth in the cervix. In the main study, after an average of 39 months, four of the more than 7,000 women who received Cervarix and who had not been infected with HPV types 16 or 18 before, developed precancerous lesions in the cervix linked to these HPV types. This compared with 56 of the more than 7,000 women who received the other vaccine. The study also showed that Cervarix provided some protection against infection with other cancer-causing types of HPV, and against lesions linked to these HPV types. These included HPV type 31.

The additional studies showed that all of the girls aged 10 to 14 years who were given Cervarix developed protective levels of antibodies against HPV types 16 and 18. This indicated that the vaccine is likely to be effective in preventing HPV infection in girls from the age of 10 years.

What is the risk associated?

The most common side effects with Cervarix (seen in more than 1 patient in 10) are headache, myalgia (muscle pain), reactions at the site of injection including pain, redness and swelling, and fatigue (tiredness). For the full list of all side effects reported with Cervarix, see the package leaflet.

Cervarix should not be used in people who may be hypersensitive (allergic) to the active substance or any of the other ingredients. Vaccination should be postponed in patients who are ill with a high fever.

Why has it been approved?

The CHMP decided that Cervarix’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Cervarix to GlaxoSmithKline Biologicals s.a. on 20 September 2007. The marketing authorisation is valid for five years, after which it can be renewed.

For more information about treatment with Cervarix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 08-2010.

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Name

Cervarix suspension for injection, multidose
Human Papillomavirus vaccine [Types 16, 18] (Recombinant,
adjuvanted, adsorbed)

Composition

1 dose (0.5 ml) contains:

1Human Papillomavirus HPV

2adjuvanted by AS04 containing 3-O-desacyl-4- monophosphoryl lipid A MPL350 micrograms

3adsorbed on aluminium hydroxide, hydrated AlOH3 0.5 milligrams Al3 in total

L1 protein in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology using a Baculovirus expression system which uses Hi-5 Rix4446 cells derived from Trichoplusia ni.

This is a multidose container. See section 6.5 for the number of doses per vial.

For a full list of excipients, see section 6.1.