Cervarix suspension for injection in pre-filled syringeHuman Papillomavirus vaccine [Types 16, 18] (Recombinant,adjuvanted, adsorbed)

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

These diseases include:

• cervical cancer (cancer of the cervix i.e. lower part of the uterus or womb),
• precancerous cervical lesions (changes in cells of the cervix that have a risk of turning into cancer).

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.

Cervarix should not be given if

the person to be vaccinated:

• is allergic (hypersensitive) to any of the active substances or any of the other ingredients of Cervarix. The active substances and other ingredients of Cervarix are listed at the end of the leaflet (see section 6). Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
• has a severe infection with a high temperature. It might be necessary to postpone the vaccination until recovery. A minor infection such as a cold should not be a problem, but talk to the doctor first.

Take special care with Cervarix

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

• has a bleeding problem or bruises easily.
• has any disease which reduces her resistance to infection such as HIV infection

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.

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.

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:

• allergic reactions. These can be recognised by: itchy rash of the hands and feet, swelling of the eyes and face, difficulty in breathing or swallowing, sudden drop in blood pressure and loss of consciousness.

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.

• swollen glands in the neck, armpit or groin
• fainting sometimes accompanied by shaking or stiffness.

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.

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.

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.

What Cervarix contains

• The active substances are:

Human PapillomavirusHuman Papillomavirus1 type 16 L1 protein2,3,41 type 18 L1 protein2,3,420 micrograms 20 micrograms

1Human Papillomavirus HPV

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

3adsorbed on aluminium hydroxide, hydrated AlOH33 0.5 milligrams Al in total

4L1 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 the insect Trichoplusia ni.

• The other ingredients are sodium chloride (NaCl), sodium dihydrogen phosphate dihydrate (NaH 2PO 4.2 H 2O) and water for injections.

What Cervarix looks like and contents of the pack

Suspension for injection in pre-filled syringe.

Cervarix is a turbid white suspension.

Cervarix is available in pre-filled syringes with or without needles in packs of 1 and 10.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

GlaxoSmithKline Biologicals s.a.
Rue de l'Institut 89
B-1330 Rixensart, Belgium

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien GlaxoSmithKline s.a.n.v. TélTel 32 2 656 21 11 LuxembourgLuxemburg GlaxoSmithKline s.a.n.v. TélTel 32 2 656 21 11

Magyarország GlaxoSmithKline Kft. Tel. 36-1-2255300 . .10 1408 . 359 2 953 10 34

Malta GlaxoSmithKline Malta Tel 356 21 238131 eská republika GlaxoSmithKline s.r.o. Tel 420 2 22 00 11 11 gsk.czmailgsk.com

Danmark GlaxoSmithKline Pharma AS Tlf 45 36 35 91 00 dk-infogsk.com Nederland GlaxoSmithKline BV Tel 31 030 69 38 100 nlinfogsk.com

Deutschland GlaxoSmithKline GmbH Co. KG Tel 49 089 360448701 produkt.infogsk.com Norge GlaxoSmithKline AS Tlf 47 22 70 20 00 firmapostgsk.no

Eesti GlaxoSmithKline Eesti OÜ Tel 372 667 6900 estoniagsk.com Österreich GlaxoSmithKline Pharma GmbH. Tel 43 1 970 75-0 at.infogsk.com

GlaxoSmithKline A.E.B.E T 30 210 68 82 100 Polska GSK Commercial Sp. z o.o. Tel. 48 22 576 9000

España GlaxoSmithKline, S.A. Tel 34 902 202 700 es-cigsk.com Portugal GlaxoSmithKline, Produtos Farmacêuticos, Lda. Tel 351 21 412 95 00 FI.PTgsk.com

România GlaxoSmithKline GSK SRL Tel 40 021 3028 208 France Laboratoire GlaxoSmithKline Tél 33 0 1 39 17 84 44 diamgsk.com

Ireland GlaxoSmithKline Ireland Ltd Tel 353 01 4955000 Slovenija GlaxoSmithKline d.o.o. Tel 386 0 1 280 25 00 medical.x.sigsk.com

Ísland GlaxoSmithKline ehf. Sími 354-530 3700 Slovenská republika GlaxoSmithKline Slovakia s.r.o. Tel 421 02 48 26 11 11 recepcia.skgsk.com

Italia GlaxoSmithKline S.p.A. Tel 39 04 59 21 81 11 SuomiFinland GlaxoSmithKline Oy PuhTel 358 10 30 30 30 Finland.tuoteinfogsk.com

GlaxoSmithKline Cyprus Ltd 357 22 39 70 00 Sverige GlaxoSmithKline AB Tel 46 08 638 93 00 info.produktgsk.com

Latvija GlaxoSmithKline Latvia SIA Tel 371 67312687 lv-epastsgsk.com United Kingdom GlaxoSmithKline UK Tel 44 0808 100 9997 customercontactukgsk.com

Lietuva

GlaxoSmithKline Lietuva UAB
Tel: +370 5 264 90 00
info.lt@gsk.com

This leaflet was last approved in

Cervarix should be administered as soon as possible after being removed from the refrigerator. However, stability data generated indicate that Cervarix presented in monodose containers remains stable and can be administered in case it has been stored outside the refrigerator up to three days at temperatures between 8°C and 25°C or up to one day at temperatures between 25°C and 37°C.

A fine white deposit with a clear colourless supernatant may be observed upon storage of the syringe. This does not constitute a sign of deterioration.

The content of the syringe should be inspected visually both before and after shaking for any foreign particulate matter and/or abnormal physical appearance prior to administration.
In the event of either being observed, discard the vaccine.

The vaccine should be well shaken before use.

Instructions for administration of the vaccine presented in pre-filled syringe

1. Holding the syringe barrel in one hand avoid holding the syringe plunger, unscrew the syringe cap by twisting it anticlockwise. Syringe plunger Syringe barrel Syringe cap

2. To attach the needle to the syringe, twist the needle clockwise into the syringe until you feel it lock. 3. Remove the needle protector, which on occasion can be a little stiff. Needle protector

4. Administer the vaccine.

Any unused product or waste material should be disposed of in accordance with local requirements.