Gardasil, suspension for injection in a pre-filled syringe.H - United Kingdom[英国药品]

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Gardasil, suspension for injection in a pre-filled syringe.H

2015-01-21 21:40:12 来源: 作者: 【大中小】浏览:395次评论:0条

For doctors

What is it and how is it used?

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, vulva and vagina); and genital warts. HPV types 16 and 18 are responsible for approximately 70% of cervical cancer cases and 70% of HPV-related pre-cancerous lesions of the vulva and vagina. HPV types 6 and 11 are responsible for approximately 90% of genital wart cases.

Gardasil is intended to prevent these diseases. The vaccine is not used to treat HPV related diseases. Gardasil does not have any effect in females who already have a persistent infection or disease associated with any of the HPV types in the vaccine. However, in females who are already infected with one or more of the vaccine HPV types, Gardasil can still protect against disease associated with the other HPV types in the vaccine.

Gardasil cannot cause the diseases it protects against.

Gardasil produces type-specific antibodies and has been shown in clinical trials to prevent these HPV 6-, 11-, 16-, and 18-related diseases in adult women 16-45 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 eva luated.

Gardasil should be used in accordance with official guidelines.

What do you have to consider before using it?

Do not use Gardasil if:

the person to be vaccinated

Gardasil (listed under “other ingredients”– see section 6).

Take special care with Gardasil:

You should tell your doctor if the person to be vaccinated:

As with any vaccine, Gardasil may not fully protect 100% of those who get the vaccine.

Gardasil will not protect against every type 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.

Taking other medicines:

Gardasil can be given 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 poliomyelitis [inactivated] (IPV) (dTap, dT-IPV, dTap-IPV vaccines) at a separate injection site (another part of your body, e.g. the other arm or leg) during the same visit.

Gardasil may not have an optimal effect if:

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.

How is it used?

Gardasil is given as an injection by your doctor. Gardasil is intended for adolescents from 9 through 15 years of age and females 16 years of age onwards. 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

If an alternate vaccination schedule is necessary, the second dose should be administered at least one month after the first dose and the third dose should be administered at least 3 months after the second dose. All three doses should be given within a 1-year period. 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.

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. When Gardasil is given as your first dose, the following two doses to complete the 3-dose vaccination course should also be Gardasil, and not another HPV vaccine.

If you have any further questions on the use of this product, ask your doctor or pharmacist .

What are 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: bruising, itching, pain in extremity.

Rarely (less than 1 in 1000 patients): hives (urticaria).

Very rarely (less than 1 in 10,000 patients), difficulty breathing (bronchospasm) has been reported.

When Gardasil was given with a combined diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] booster vaccine during the same visit, there was more headache and injection-site swelling.

Side effects that have been reported during marketed use include:

Fainting, sometimes accompanied by shaking or stiffening, 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.

As with other vaccines, side effects that have been reported during general use include: swollen glands (neck, armpit, or groin), Guillain-Barré Syndrome (muscle weakness, abnormal sensations, tingling in the arms, legs and upper body), dizziness and headache, nausea and vomiting, joint pain, aching muscles, unusual tiredness or weakness, chills, generally feeling unwell, and bleeding or bruising more easily than normal.

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 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 (2ºC - 8ºC). 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.

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For doctors

What is it?

Gardasil is a vaccine. It is a suspension for injection that contains purified proteins for four types of the human papillomavirus (types 6, 11, 16 and 18). It is available in vials or prefilled syringes.

What is it used for?

Gardasil is used in patients from the age of nine years to protect against:

Gardasil is given according to official recommendations.

The vaccine can only be obtained with a prescription.

How is it used?

Gardasil is given to individuals aged nine years or older, as three doses, with two months between the first and second doses, and four months between the second and third doses. If a different schedule is needed, there should be at least one month between the first and the second doses, and at least three months between the second and the third, and all doses should be given within a year. It is recommended that individuals who receive the first dose of Gardasil should complete all three doses with Gardasil. The vaccine is given as an injection into a muscle, preferably in the shoulder or the thigh.

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 and HPV types 6 and 11 cause approximately 90% of genital warts.

All papillomaviruses have a shell, or ‘capsid’, that is made up of proteins called ‘L1 proteins’. Gardasil contains the purified L1 proteins for HPV types 6, 11, 16 and 18, which are produced by a method known as ‘recombinant DNA technology’: they are made by a yeast 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). These virus-like particles are not capable of causing infection.

When a patient is given the vaccine, the immune system makes antibodies against the L1 proteins. 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 also contains an ‘adjuvant’ (a compound containing aluminium) to stimulate a better response.

How has it been studied?

There were four main studies of Gardasil, involving a total of almost 21,000 women aged between 16 and 26 years. Gardasil was compared with placebo (a dummy vaccine). The studies looked at how many women developed genital lesions or warts that were due to HPV infection. The women were followed up for around three years after the third dose of the vaccine.

Additional studies looked at the ability of Gardasil to prevent infection with HPV types 6, 11, 16 and 18 and genital lesions caused by these HPV types in almost 4,000 women aged between 24 and 45 years, and at the development of antibodies against these HPV types in around 1,700 girls and boys aged between nine and 15 years.

What benefits has it shown during the studies?

Gardasil was effective against precancerous genital lesions of the cervix, vulva and vagina, cervical cancer, and warts related to HPV types 6, 11, 16 and 18.

Looking at the results of all four studies together, out of the more than 8,000 women vaccinated with Gardasil who had never been infected by HPV types 6, 11, 16 or 18 before, one woman developed a precancerous lesion in the cervix that might have been due to HPV type 16 or 18. In contrast, 85 of the more than 8,000 women who received the placebo vaccine developed lesions that were due to these two HPV types. A similar effect of Gardasil was seen when the analysis also included lesions of the cervix due to the other two HPV types (types 6 and 11).

For external genital lesions due to HPV types 6, 11, 16 or 18 (including warts and precancerous lesions of the vulva or the vagina), the results of three of the studies were looked at together. Two women out of almost 8,000 in the Gardasil group developed genital warts, and there were no cases of precancerous lesions of the vulva or the vagina. In contrast, there was a total of 189 cases of external genital lesions out of almost 8,000 women in the placebo group.

The studies also showed that Gardasil provided some protection against lesions in the cervix linked to other cancer-causing types of HPV, including type 31.

The additional studies confirmed the ability of Gardasil to protect against lesions and HPV infection in 24- to 45-year-old women. The studies also showed that the vaccine stimulates the production of sufficient amounts of antibodies against HPV in girls and boys aged between nine and 15 years.

What is the risk associated?

In studies, the most common side effects with Gardasil (seen in more than 1 patient in 10) were pyrexia (fever) and reactions at the site of the injection (redness, pain and swelling). For the full list of all side effects reported with Gardasil, see the Package Leaflet.

Gardasil should not be used in people who may be hypersensitive (allergic) to the active substance or any of the other ingredients. Patients who show signs of an allergy after a dose of Gardasil should not receive further doses of the vaccine. Vaccination should be postponed in patients who are ill with a high fever.

Why has it been approved?

The CHMP decided that Gardasil’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 Gardasil to Sanofi Pasteur MSD SNC on 20 September 2006. The marketing authorisation is valid for five years, after which it can be renewed.

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

This summary was last updated in 07-2010.

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Name

Gardasil, suspension for injection in a pre-filled syringe.
Human Papillomavirus Vaccine [Types 6, 11, 16, 18]
(Recombinant, adsorbed)

Composition

1 dose (0.5 ml) contains approximately:

Human Papillomavirus1Human Papillomavirus1Human Papillomavirus1Human Papillomavirus1 Type 6 L1 protein2,3 20 micrograms Type 11 L1 protein2,3 40 micrograms Type 16 L1 protein2,3 40 micrograms Type 18 L1 protein2,3 20 micrograms.

1Human 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.