CERVARIX 20 мкг/20 мкг Инъекционная суспензия

Содержание инструкции

1. Cervarix injectable suspension in vial
   1. What is Cervarix and what it is used for
   2. What you need to know before using Cervarix
   3. How to use Cervarix
   4. Possible side effects
   5. How to store Cervarix
   6. Package contents and other information
2. Cervarix injectable suspension, multidose vial
   1. What is Cervarix and what it is used for
   2. What you need to know before you use Cervarix
   3. How to use Cervarix
   4. Possible side effects
   5. How to store Cervarix
   6. Contents of the pack and other information
3. Cervarix injectable suspension in pre-filled syringe
   1. What is Cervarix and what it is used for
   2. What you need to know before you use Cervarix
   3. How to use Cervarix
   4. Possible side effects
   5. How to store Cervarix
   6. Content of the pack and other information

Cervarix injectable suspension in vial

Vaccine against Human Papillomavirus [Types 16, 18] (Recombinant, adjuvanted, adsorbed)

Read this leaflet carefully before using this vaccine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never give it to others.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Cervarix is and what it is used for
• 2. What you need to know before you use Cervarix
• 3. How to use Cervarix
• 4. Possible side effects
• 5. How to store Cervarix
• 6. Contents of the pack and other information

1. What is Cervarix and what it is used for

Cervarix is a vaccine developed to protect against diseases caused by Human Papillomavirus (HPV) infection starting from the age of 9 years.
These diseases include:

• cervical cancer (cancer of the cervix, i.e. the lower part of the uterus) and anal cancer,
• precancerous lesions of the cervix, vulva, vagina and anal lesions (changes in the genitals or anal cells that carry the risk of developing into cancer).

The types of Human Papillomavirus (HPV) contained in the vaccine (HPV types 16 and 18) are responsible for
approximately 70% of cases of cervical cancer, 90% of cases of anal cancer and 70% of precancerous lesions of the vulva and vagina related to HPV. Other types of HPV can also cause anogenital cancer. Cervarix does not protect against all types of HPV.
When a woman or a man is vaccinated with Cervarix, the immune system (the body's natural defense system) produces antibodies against HPV strains 16 and 18..
Cervarix is not infectious and therefore cannot cause diseases related to HPV infection.
Cervarix does not cure diseases related to HPV infection that are already present at the time of
vaccination.
Cervarix must be used in accordance with official recommendations.

2. What you need to know before using Cervarix

Do not use Cervarix:

• if you are allergic to any of the active ingredients or any of the other ingredients of this vaccine (listed in section 6). The signs of an allergic reaction can include a itchy skin rash, shortness of breath and swelling of the face or tongue.

Warnings and precautions
Talk to your doctor or pharmacist before receiving Cervarix:

• if you have a bleeding problem or bruise easily;
• if you have any illness that reduces your resistance to infections such as HIV infection;
• if you have a serious infection with a high temperature. It may be necessary to postpone vaccination until after recovery. A mild infection such as a cold should not be a problem, but talk to your doctor first.

Fainting can occur (especially in adolescents) following, or even before, any
injection with a needle. Therefore, inform your doctor or nurse if you or your child have fainted following
a previous injection.
Like all vaccines, Cervarix may not fully protect all people who are vaccinated.
Cervarix does not protect against diseases caused by HPV types 16 or 18 if people are
already infected with Human Papillomavirus type 16 or 18 at the time of vaccination.
Even if vaccination can protect against cervical cancer, it does not replace
regular cervical screening. The vaccinated person must continue to follow their doctor's advice regarding the Pap smear/Pap test (a test to check for changes in cervical cells
caused by HPV infection) and preventive and protective measures.
Since Cervarix does not protect against all types of Human Papillomavirus, the vaccinated person must
continue to adopt appropriate precautions against exposure to HPV and against
sexually transmitted diseases.
Cervarix does not protect against other diseases not caused by Human Papillomavirus.

Other medicines and Cervarix
Cervarix can be given with another booster vaccine combined against diphtheria (d),
tetanus (T) and pertussis [acellular] (pa) with or without inactivated poliovirus (IPV), (dTpa, dTpa-IPV vaccines), with a combined vaccine against hepatitis A and hepatitis B (Twinrix), with a
hepatitis B vaccine (Engerix B), or with a meningococcal serogroup A, C, W-135, Y
conjugate vaccine with tetanus toxoid (MenACWY-TT), at a different injection site (another part of
the body, for example the other arm) during the same visit.
Cervarix may not achieve an optimal effect if used with other medicines that suppress the
immune system.
In clinical studies, oral contraceptives (e.g. the pill) did not reduce the protection obtained
with Cervarix.
Tell your doctor if you are taking, have recently taken or might take any other
medicines, or if you have been recently vaccinated with any other vaccine.

Pregnancy, breastfeeding and fertility
If you are pregnant, if pregnancy occurs during the vaccination schedule or if you are
planning a pregnancy, it is recommended to postpone or interrupt vaccination until
completion of pregnancy.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before using this vaccine.

Driving and using machines
Cervarix is not able to affect the ability to drive or operate machinery. However, do
not drive or operate machinery if you feel unwell.

Cervarix contains sodium chloride
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to use Cervarix

How the vaccine is administered
The doctor or nurse will administer Cervarix by intramuscular injection into the upper part of the arm.

How many times it is administered
Cervarix is indicated for use from 9 years of age.
The total number of injections you will receive depends on your age at the time of the first injection:
If you are between 9 and 14 years of age
you will receive two injections:
First injection: on the scheduled date
Second injection: between 5 and 13 months after the first injection
If you are 15 years of age or older
you will receive 3 injections:
First injection: on the scheduled date
Second injection: 1 month after the first injection
Third injection: 6 months after the first injection
If necessary, the vaccination schedule may be more flexible. Talk to your doctor for more
information.
When Cervarix is administered as the first dose, it is recommended that Cervarix (and not another
vaccine against the HPV virus) be administered for the complete vaccination cycle.
Cervarix is not recommended for use in children under 9 years of age.
The vaccine should never be administered intravenously.

If you miss a dose
It is important that you follow the instructions received from your doctor or nurse regarding appointments for
subsequent administrations. If you forget to return for the administration on the scheduled date, ask
your doctor for advice.
If you do not complete the full vaccination cycle (two or three injections depending on age at the time of
vaccination), you may not achieve the optimal response and protection.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.
The side effects that have been observed during clinical trials with Cervarix are the following:
♦ Very common (more than 1 in 10 doses of vaccine):
♦ pain or discomfort at the injection site

• redness or swelling at the injection site
• headache ♦ muscle pain, muscle pain or weakness (not caused by physical exercise) ♦ fatigue

♦ Common (less than 1 in 10 doses of vaccine but more than 1 in 100):
♦ gastrointestinal symptoms including nausea, vomiting, diarrhoea and abdominal pain
♦ itching, skin redness, hives
♦ joint pain
♦ fever (temperature equal to or greater than 38°C)
♦ Uncommon (less than 1 in 100 doses of vaccine but more than 1 in 1,000):

• upper respiratory tract infections (infection of the nose, throat or trachea)
• dizziness
• other reactions at the injection site such as hardening, tingling or numbness.

Side effects that have been reported during the post-marketing of Cervarix include:

• allergic reactions. These can be recognised by: itchy rash on the hands and feet, swelling of the eyes and face, difficulty breathing or swallowing, sudden drop in blood pressure and loss of consciousness. These reactions usually occur before leaving the doctor's office. However, if your child should experience any of these symptoms, contact a doctor urgently.
• swelling of the glands in the neck, armpits or groin
• fainting sometimes accompanied by tremor or stiffness.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the
national reporting system listed in Annex V*.
By reporting side effects you can help to provide more information on the safety of
this medicine.

5. How to store Cervarix

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of the month.
Store in a refrigerator (2°C–8°C).
Do not freeze.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cervarix contains

• The active substances are:

Human papillomavirus type 16 L1 protein 20 micrograms
Human papillomavirus type 18 L1 protein 20 micrograms
Human papillomavirus = HPV
adjuvanted with AS04 containing:

• 3- O-desacyl-4’-monophosphoryl lipid A (MPL) 50 micrograms

adsorbed on aluminium hydroxide, hydrate (Al(OH) ) 0.5 milligrams Al in total
L1 protein in the form of non-infectious virus-like particles (VLPs) produced by
recombinant DNA technology using a Baculovirus expression system using
Hi-5 Rix 4446 cells derived from the insect Trichoplusia ni.

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

Description of Cervarix and package contents
Injectable suspension.
Cervarix is a cloudy white suspension.
Cervarix is available in 1-dose vials (0.5 ml) in packs of 1, 10 and 100.
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 further information on this medicine, contact the local representative of the marketing
authorisation holder:

Belgique/België/Belgien
GlaxoSmithKline Pharmaceuticals SA./NV
Tél/Tel: + 32 10 85 52 00

Lietuva
GlaxoSmithKline Biologicals SA
Tel: +370 80000334

България
GlaxoSmithKline Biologicals Тел. +359
80018205

Luxembourg/Luxemburg
GlaxoSmithKline Pharmaceuticals SA./NV
Tél/Tel: + 32 10 85 52 00

Česká republika
GlaxoSmithKline s.r.o.
Tel: + 420 2 22 00 11 11
[email protected]

Magyarország
GlaxoSmithKline Biologicals SA
Tel.: +36 80088309

Danmark
GlaxoSmithKline Pharma A/S
Tlf: + 45 36 35 91 00

Malta
GlaxoSmithKline Biologicals SATel: +356
80065004
[email protected]

Deutschland
GlaxoSmithKline GmbH & Co. KG
Tel: + 49 (0)89 360448701
[email protected]

Nederland
GlaxoSmithKline BV
Tel: + 31 (0)33 2081100

Norge
GlaxoSmithKline AS
Tlf: + 47 22 70 20 00

Ελλάδα
GlaxoSmithKline Μονοπρόσωπη A.E.B.E
Τηλ: + 30 210 68 82 100

Eesti
GlaxoSmithKline Biologicals SATel: +372
8002640

Österreich
GlaxoSmithKline Pharma GmbH.
Tel: + 43 (0)1 97075 0
[email protected]

España
GlaxoSmithKline, S.A.
Tel: + 34 900 202 700
[email protected]

Polska
GSK Services Sp. z o.o.
Tel.: + 48 (22) 576 9000

France
Laboratoire GlaxoSmithKline
Tél: + 33 (0) 1 39 17 84 44
[email protected]

Hrvatska
GlaxoSmithKline Biologicals SA
Tel.: +385 800787089

Portugal
GlaxoSmithKline - Produtos Farmacêuticos, Lda.
Tel: + 351 21 412 95 00
[email protected]

România
GlaxoSmithKline Biologicals SATel: +40
800672524

Ireland
GlaxoSmithKline (Ireland) Ltd
Tel: + 353 (0)1 495 5000

Slovenija
GlaxoSmithKline Biologicals SATel: +386
80688869

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
GlaxoSmithKline Biologicals SATel: +421
800500589

Italia
GlaxoSmithKline S.p.A.
Tel: + 39 (0)45 7741 111

Suomi/Finland
GlaxoSmithKline Oy
Puh/Tel: + 358 10 30 30 30

Κύπρος
GlaxoSmithKline Biologicals SAΤηλ: +357
80070017

Sverige
GlaxoSmithKline AB
Tel: + 46 (0)8 638 93 00
[email protected]

Latvija
GlaxoSmithKline Biologicals SATel: +371
80205045

United Kingdom (Irlanda del Nord)
GlaxoSmithKline Biologicals SA
Tel: +44(0)800 221441
[email protected]

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines
Agency: http://www.ema.europa.eu/.
-------------------------------------------------------------------------------------------------------------------------
The following information is intended for healthcare professionals only:
Cervarix should be administered as soon as possible after removal from the refrigerator.
However, stability has been demonstrated when stored outside the refrigerator for up to 3 days at
temperatures between 8°C and 25°C or up to 1 day at temperatures between 25°C and 37°C. If
not used by the end of this period, the vaccine should be discarded.
During storage of the vial, a fine white deposit with a clear, colourless supernatant may be observed.
This does not constitute a sign of deterioration.
The contents of the vial must be inspected visually both before and after shaking to
verify the absence of any foreign particles and/or abnormal physical appearance, before administration.
If any of these conditions are found, discard the vaccine.
The vaccine must be shaken well before use.
Unused medicine and waste materials derived from such medicine must be disposed of in accordance
with local regulations.

Cervarix injectable suspension, multidose vial

Vaccine against Human Papillomavirus [Types 16, 18] (Recombinant, adjuvanted, adsorbed)

Read this leaflet carefully before using this vaccine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Never give it to others.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Cervarix is and what it is used for
• 2. What you need to know before you use Cervarix
• 3. How to use Cervarix
• 4. Possible side effects
• 5. How to store Cervarix
• 6. Contents of the pack and other information

1. What is Cervarix and what it is used for

Cervarix is a vaccine developed to protect against diseases caused by Human Papillomavirus (HPV) infection starting from the age of 9 years.
These diseases include:

• cervical cancer (cancer of the cervix, i.e. the lower part of the uterus) and anal cancer,
• precancerous lesions of the cervix, vulva, vagina and anal lesions (changes in the genitals or anal cells that carry the risk of developing into cancer).

The types of Human Papillomavirus (HPV) contained in the vaccine (HPV types 16 and 18) are responsible for
approximately 70% of cases of cervical cancer, 90% of cases of anal cancer and 70% of precancerous lesions of the vulva and vagina related to HPV. Other types of HPV can also cause anogenital cancer. Cervarix does not protect against all types of HPV.
When a woman or a man is vaccinated with Cervarix, the immune system (the body's natural defense system) produces antibodies against HPV strains 16 and 18..
Cervarix is not infectious and therefore cannot cause diseases related to HPV infection.
Cervarix does not cure diseases related to HPV infection that are already present at the time of
vaccination.
Cervarix must be used in accordance with official recommendations.

2. What you need to know before you use Cervarix

Do not use Cervarix:

• if you are allergic to any of the active ingredients or any of the other ingredients of this vaccine (listed in section 6). The signs of an allergic reaction can include itchy skin rash, shortness of breath and swelling of the face or tongue.

Warnings and precautions
Talk to your doctor or pharmacist before receiving Cervarix:

• if you have a bleeding problem or bruise easily;
• if you have any condition that reduces your resistance to infections such as HIV infection;
• if you have a serious infection with a high temperature. It may be necessary to postpone vaccination until you have recovered. A mild infection such as a cold should not be a problem, but talk to your doctor about it first.

Fainting can occur (especially in adolescents) following, or even before, any
injection with a needle. Therefore, inform your doctor or nurse if you or your child have fainted following
a previous injection.
Like all vaccines, Cervarix may not fully protect all people who are vaccinated.
Cervarix does not protect against diseases caused by HPV types 16 or 18 infection if people are
already infected with Human Papillomavirus type 16 or 18 at the time of vaccination.
Even if vaccination can protect against cervical cancer, it does not replace
regular cervical screening. The vaccinated person should continue to follow their doctor’s advice on the vaginal smear/Pap test (a test to check for changes in the cells of the cervix
caused by HPV infection) and on prevention and protection measures.
Since Cervarix does not protect against all types of Human Papillomavirus, the vaccinated person should
continue to take appropriate precautions against exposure to the HPV virus and against
sexually transmitted diseases.
Cervarix does not protect against other diseases not caused by Human Papillomavirus.

Other medicines and Cervarix
Cervarix can be given with another booster vaccine combined against diphtheria (d),
tetanus (T) and pertussis [acellular] (pa) with or without inactivated polio virus (IPV), (dTpa, dTpa-IPV vaccines), with a combined vaccine against hepatitis A and hepatitis B (Twinrix), with a vaccine
against hepatitis B (Engerix B), or with a meningococcal serogroup A, C, W-135, Y
conjugate vaccine with tetanus toxoid (MenACWY-TT), at a different injection site (a different part of
the body, for example the other arm) during the same visit.
Cervarix may not achieve an optimal effect if used with other medicines that suppress the
immune system.
In clinical studies, oral contraceptives (e.g. the pill) did not reduce the protection obtained with
Cervarix.
Tell your doctor if you are taking, have recently taken or might take any other
medicines, or if you have recently been vaccinated with any other vaccine.

Pregnancy, breastfeeding and fertility
If you are pregnant, if pregnancy occurs during the vaccination schedule or if you are
planning a pregnancy, it is recommended to postpone or interrupt vaccination until
completion of the pregnancy.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor for advice before using this vaccine.

Driving and using machines
Cervarix is not able to affect the ability to drive or operate machinery. However, do
not drive or operate machinery if you feel unwell.

Cervarix contains sodium chloride
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to use Cervarix

How the vaccine is administered
The doctor or nurse will administer Cervarix by intramuscular injection into the upper part of the arm.

How many times it is administered
Cervarix is indicated for use from 9 years of age.
The total number of injections you will receive depends on your age at the time of the first injection:
If you are between 9 and 14 years old
you will receive 2 injections:
First injection: on the scheduled date
Second injection: between 5 and 13 months after the first injection
If you are 15 years or older
you will receive 3 injections:
First injection: on the scheduled date
Second injection: 1 month after the first injection
Third injection: 6 months after the first injection
If necessary, the vaccination schedule can be more flexible. Talk to your doctor for more
information.
When Cervarix is administered as the first dose, it is recommended that Cervarix (and not another
vaccine against the HPV virus) be administered for the complete vaccination cycle.
Cervarix is not recommended for use in children under 9 years of age.
The vaccine should never be administered intravenously.

If you miss a dose
It is important that you follow the instructions received from your doctor or nurse regarding visits for
subsequent administrations. If you forget to return for the administration on the scheduled date, ask
your doctor for advice.
If you do not complete the full vaccination cycle (two or three injections depending on age at the time of
vaccination), you may not achieve the optimal response and protection.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.
The side effects that have been observed during clinical trials with Cervarix are the
following:
♦ Very common (more than 1 in 10 doses of vaccine):
♦ pain or discomfort at the injection site

• redness or swelling at the injection site
• headache ♦ muscle pain, muscle pain or weakness (not caused by exercise) ♦ fatigue

♦ Common (less than 1 in 10 doses of vaccine but more than 1 in 100):
♦ gastrointestinal symptoms including nausea, vomiting, diarrhoea and abdominal pain
♦ itching, skin redness, hives
♦ joint pain
♦ fever (temperature equal to or higher than 38°C)
♦ Uncommon (less than 1 in 100 doses of vaccine but more than 1 in 1,000):

• upper respiratory tract infections (infection of the nose, throat or trachea)
• dizziness
• other reactions at the injection site such as hardening, tingling or numbness.

The side effects that have been reported during the post-marketing of Cervarix include:

• allergic reactions. These can be recognised by: itchy rash on the hands and feet, swelling of the eyes and face, difficulty breathing or swallowing, sudden drop in blood pressure and loss of consciousness. These reactions usually occur before leaving the doctor's office. However, if your child should experience any of these symptoms, contact a doctor urgently.
• swelling of the glands in the neck, armpits or groin
• fainting sometimes accompanied by shaking or stiffness.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
the national reporting system listed in Annex V*.
By reporting side effects you can help to provide more information on the safety of
this medicine.

5. How to store Cervarix

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of the month.
Store in a refrigerator (2°C–8°C).
Do not freeze.
Store in the original packaging to protect the medicine from light.
Immediate use after first opening is recommended. If not used immediately, the
vaccine must be stored in a refrigerator (2°C-8°C). If not used within 6 hours it must
be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Cervarix contains

• The active substances are:

Human papillomavirus type 16 L1 protein 20 micrograms
Human papillomavirus type 18 L1 protein 20 micrograms
Human papillomavirus = HPV
adjuvanted with AS04 containing:

• 3- O-desacyl-4’-monophosphoryl lipid A (MPL) 50 micrograms

adsorbed on aluminium hydroxide, hydrate (Al(OH) ) 0.5 milligrams Al in total
L1 protein in the form of non-infectious virus-like particles (VLPs) produced by
recombinant DNA technology using a Baculovirus expression system using
Hi-5 Rix 4446 cells derived from the insect Trichoplusia ni.

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

Description of Cervarix and contents of the pack
Injectable suspension.
Cervarix is a cloudy white suspension.
Cervarix is available in multidose vials of 2 doses (1 ml) in packs of 1, 10 and 100.
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 further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

Belgique/België/Belgien
GlaxoSmithKline Pharmaceuticals SA./NV
Tél/Tel: + 32 10 85 52 00

Lietuva
GlaxoSmithKline Biologicals SATel: +370
80000334

България
GlaxoSmithKline Biologicals SAТел. +359
80018205

Luxembourg/Luxemburg
GlaxoSmithKline Pharmaceuticals SA./NV
Tél/Tel: + 32 10 85 52 00

Česká republika
GlaxoSmithKline s.r.o.
Tel: + 420 2 22 00 11 11
[email protected]

Magyarország
GlaxoSmithKline Biologicals SATel.: +36
80088309

Danmark
GlaxoSmithKline Pharma A/S
Tlf: + 45 36 35 91 00
[email protected]

Malta
GlaxoSmithKline Biologicals SATel: +356
80065004

Deutschland
GlaxoSmithKline GmbH & Co. KG
Tel: + 49 (0)89 360448701
[email protected]

Nederland
GlaxoSmithKline BV
Tel: + 31 (0)33 2081100

Norge
GlaxoSmithKline AS
Tlf: + 47 22 70 20 00

Ελλάδα
GlaxoSmithKline Μονοπρόσωπη A.E.B.E
Tηλ: + 30 210 68 82 100

Eesti
GlaxoSmithKline Biologicals SA
Tel: +372 8002640

Österreich
GlaxoSmithKline Pharma GmbH.
Tel: + 43 (0)1 97075 0
[email protected]

España
GlaxoSmithKline, S.A.
Tel: + 34 900 202 700
[email protected]

Polska
GSK Services Sp. z o.o.
Tel.: + 48 (22) 576 9000

Portugal
GlaxoSmithKline - Produtos Farmacêuticos, Lda.
Tel: + 351 21 412 95 00
[email protected]

România
GlaxoSmithKline Biologicals SATel: +40
800672524

Ireland
GlaxoSmithKline (Ireland) Ltd
Tel: + 353 (0)1 495 5000

France
Laboratoire GlaxoSmithKline
Tél: + 33 (0) 1 39 17 84 44
[email protected]

Hrvatska
GlaxoSmithKline Biologicals SATel.: +385
800787089

Slovenija
GlaxoSmithKline Biologicals SATel: +386
80688869

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
GlaxoSmithKline Biologicals SATel: +421
800500589

Italia
GlaxoSmithKline S.p.A.
Tel: + 39 (0)45 7741 111

Suomi/Finland
GlaxoSmithKline Oy
Puh/Tel: + 358 10 30 30 30

Κύπρος
GlaxoSmithKline Biologicals SAΤηλ: +357
80070017

Sverige
GlaxoSmithKline AB
Tel: + 46 (0)8 638 93 00
[email protected]

Latvija
GlaxoSmithKline Biologicals SATel: +371
80205045

United Kingdom (Northern Ireland)
GlaxoSmithKline Biologicals SA
Tel: +44 (0)800 221 441
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu/.
-------------------------------------------------------------------------------------------------------------------------
The following information is intended exclusively for healthcare professionals:
Cervarix should be administered as soon as possible after removal from the refrigerator.
However, stability has been demonstrated when stored outside the refrigerator for up to 3 days at
a temperature between 8°C and 25°C or up to 1 day at a temperature between 25°C and 37°C. If
not used by the end of this period, the vaccine must be discarded.
During storage of the vial, a fine white deposit may be observed with a clear, colourless supernatant.
This does not constitute a sign of deterioration.
The contents of the vial must be inspected visually before and after shaking to
verify the absence of any foreign particles and/or abnormal physical appearance, before administration.
If any of these conditions are found, discard the vaccine.
The vaccine must be shaken well before use.
When using the multidose vial, each 0.5 ml dose must be drawn up using
a sterile needle and syringe; precautions must be taken to avoid contamination of
the contents.
Unused medicinal product and waste materials derived from such medicinal product must be disposed of in
accordance with local regulations.

Cervarix injectable suspension in pre-filled syringe

Vaccine against Human Papillomavirus [Types 16, 18] (Recombinant, adjuvanted, adsorbed)

Read this leaflet carefully before using this vaccine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others.
• If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Cervarix is and what it is used for
• 2. What you need to know before you use Cervarix
• 3. How to use Cervarix
• 4. Possible side effects
• 5. How to store Cervarix
• 6. Contents of the pack and other information

1. What is Cervarix and what it is used for

Cervarix is a vaccine developed to protect against diseases caused by Human Papillomavirus (HPV) infection starting from the age of 9.
These diseases include:

• cervical cancer (cancer of the cervix, i.e. the lower part of the uterus) and anal cancer,
• precancerous lesions of the cervix, vulva, vagina and anal lesions (changes in the genitals or anal cells that carry the risk of developing into cancer).

The types of Human Papillomavirus (HPV) contained in the vaccine (HPV types 16 and 18) are responsible for
approximately 70% of cases of cervical cancer, 90% of cases of anal cancer and 70% of precancerous lesions of the vulva and vagina related to HPV. Other types of HPV can also cause anogenital cancer. Cervarix does not protect against all types of HPV.
When a woman or a man is vaccinated with Cervarix, the immune system (the body's natural defense system) produces antibodies against HPV strains 16 and 18.
Cervarix is not infectious and therefore cannot cause diseases related to HPV infection.
Cervarix does not cure diseases related to HPV infection that are already present at the time of
vaccination.
Cervarix must be used in accordance with official recommendations.

2. What you need to know before you use Cervarix

Do not use Cervarix:

• if you are allergic to any of the active ingredients or any of the other ingredients of this vaccine (listed in section 6). The signs of an allergic reaction can include itchy skin rash, shortness of breath and swelling of the face or tongue.

Warnings and precautions
Talk to your doctor or pharmacist before receiving Cervarix:

• if you have a bleeding problem or bruise easily;
• if you have any illness that reduces your resistance to infections such as HIV infection;
• if you have a severe infection with a high temperature. It may be necessary to postpone vaccination until after you have recovered. A mild infection such as a cold should not be a problem, but talk to your doctor about it first.

Fainting (especially in adolescents) can occur after, or even before, any
injection with a needle. Therefore, tell your doctor or nurse if you or your child have fainted after
a previous injection.
Like all vaccines, Cervarix may not fully protect all people who are vaccinated.
Cervarix does not protect against diseases caused by HPV types 16 or 18 infection if people are
already infected with Human Papillomavirus type 16 or 18 at the time of vaccination.
Even if vaccination can protect against cervical cancer, it does not replace
regular cervical screening. The vaccinated person should continue to follow their doctor’s advice on the vaginal smear/Pap test (a test to check for changes in cervical cells
caused by HPV infection) and on prevention and protection measures.
Since Cervarix does not protect against all types of Human Papillomavirus, the vaccinated person should
continue to take appropriate precautions against exposure to HPV and against
sexually transmitted diseases.
Cervarix does not protect against other diseases not caused by Human Papillomavirus.

Other medicines and Cervarix
Cervarix can be given with another booster vaccine combined against diphtheria (d),
tetanus (T) and acellular pertussis (pa) with or without inactivated poliovirus (IPV), (dTpa, dTpa-IPV vaccines), with a combined vaccine against hepatitis A and hepatitis B (Twinrix), with a vaccine
against hepatitis B (Engerix B or with a meningococcal serogroup A, C, W-135, Y conjugate vaccine
with tetanus toxoid (MenACWY-TT), at a different injection site (a different part of the body, such
as the other arm) during the same visit.
Cervarix may not achieve an optimal effect if used with other medicines that suppress the
immune system.
In clinical studies, oral contraceptives (such as the pill) did not reduce the protection obtained
with Cervarix.
Tell your doctor if you are taking, have recently taken or might take any other
medicines, or if you have recently been vaccinated with any other vaccine.

Pregnancy, breastfeeding and fertility
If you are pregnant, if pregnancy occurs during the vaccination schedule or if you are
planning a pregnancy, it is recommended to postpone or interrupt vaccination until
completion of the pregnancy.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before using this vaccine.

Driving and using machines
Cervarix is not able to affect the ability to drive or operate machinery. However, do
not drive or operate machinery if you feel unwell.

Cervarix contains sodium chloride
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially “sodium-free”.

3. How to use Cervarix

How the vaccine is administered
The doctor or nurse will administer Cervarix by intramuscular injection into the upper part of the arm.

How many times it is administered
Cervarix is indicated for use in individuals 9 years of age and older.
The total number of injections you will receive depends on your age at the time of the first injection:
If you are between 9 and 14 years of age
you will receive 2 injections:
First injection: on the scheduled date
Second injection: between 5 and 13 months after the first injection
If you are 15 years of age or older
you will receive 3 injections:
First injection: on the scheduled date
Second injection: 1 month after the first injection
Third injection: 6 months after the first injection
If necessary, the vaccination schedule may be more flexible. Talk to your doctor for more
information.
When Cervarix is administered as the first dose, it is recommended that Cervarix (and not another
vaccine against the HPV virus) be administered for the complete vaccination cycle.
Cervarix is not recommended for use in individuals under 9 years of age.
The vaccine should never be administered intravenously.

If you miss a dose
It is important that you follow the instructions received from your doctor or nurse regarding the visits for
subsequent administrations. If you forget to return for the administration on the scheduled date, ask
your doctor for advice.
If you do not complete the full vaccination cycle (two or three injections depending on age at the time
of vaccination), you may not achieve the optimal response and protection.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.
The side effects that have been reported during clinical trials conducted with Cervarix are the
following:
♦ Very common (more than 1 in 10 doses of vaccine): pain or discomfort at the injection site,
redness or swelling at the injection site, headache, muscle pain, muscle pain or weakness
(not caused by physical exertion), fatigue.
♦ Common (less than 1 in 10 doses of vaccine but more than 1 in 100): gastrointestinal symptoms
including nausea, vomiting, diarrhea and abdominal pain, itching, skin redness, urticaria, joint pain, fever (temperature equal to or higher than 38°C).

• Uncommon (less than 1 in 100 doses of vaccine but more than 1 in 1,000): upper respiratory tract infections (infection of the nose, throat or trachea), dizziness, other reactions at the injection site such as hardening, tingling or numbness.

Side effects that have been reported during the post-marketing of Cervarix include:

• allergic reactions. These can be recognised by: itchy rash on the hands and feet, swelling of the eyes and face, difficulty breathing or swallowing, sudden drop in blood pressure and loss of consciousness. These reactions usually occur before leaving the doctor's office. However, if your child should experience any of these symptoms, contact a doctor urgently.
• swelling of the glands in the neck, armpits or groin
• fainting sometimes accompanied by shaking or stiffness.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system listed in Annex V.*.
By reporting side effects you can help to provide more information on the safety of
this medicine.

5. How to store Cervarix

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of the month.
Store in a refrigerator (2°C–8°C).
Do not freeze.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Cervarix contains

• The active substances are:

Human papillomavirus type 16 L1 protein 20 micrograms
Human papillomavirus type 18 L1 protein 20 micrograms
Human papillomavirus = HPV
adjuvanted with AS04 containing:

• 3- O-desacyl-4’-monophosphoryl lipid A (MPL) 50 micrograms

adsorbed on aluminium hydroxide, hydrate (Al(OH) ) 0.5 milligrams Al in
total
L1 protein in the form of non-infectious virus-like particles (VLPs) produced by
recombinant DNA technology using a Baculovirus expression system using
Hi-5 Rix 4446 cells derived from the insect Trichoplusia ni.

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

Description of the appearance of Cervarix and content of the pack
Injectable suspension in a pre-filled syringe.
Cervarix is a cloudy white suspension.
Cervarix is available in pre-filled 1-dose syringes with or without separate 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 further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

Belgique/België/Belgien
GlaxoSmithKline Pharmaceuticals SA./NV
Tél/Tel: + 32 10 85 52 00

Lietuva
GlaxoSmithKline Pharmaceuticals SA./NV
Tél/Tel: + 32 10 85 52 00

България
GlaxoSmithKline Biologicals SA
Тел. +359 80018205

Luxembourg/Luxemburg
GlaxoSmithKline Pharmaceuticals SA./NV
Tél/Tel: + 32 10 85 52 00

Česká republika
GlaxoSmithKline s.r.o.
Tel: + 420 2 22 00 11 11
[email protected]

Magyarország
GlaxoSmithKline Biologicals SA
Tel.: +36 80088309

Danmark
GlaxoSmithKline Pharma A/S
Tlf: + 45 36 35 91 00
[email protected]

Malta
GlaxoSmithKline Biologicals SA
Tel: +356 80065004

Deutschland
GlaxoSmithKline GmbH & Co. KG
Tel: + 49 (0)89 360448701

Nederland
GlaxoSmithKline BV
Tel: + 31 (0)33 2081100
[email protected]

Eesti
GlaxoSmithKline Biologicals SA
Tel: +372 8002640

Norge
GlaxoSmithKline AS
Tlf: + 47 22 70 20 00

Ελλάδα
GlaxoSmithKline Μονοπρόσωπη A.E.B.E
Τηλ: + 30 210 68 82 100

Österreich
GlaxoSmithKline Pharma GmbH.
Tel: + 43 (0)1 97075 0
[email protected]

España
GlaxoSmithKline, S.A.
Tel: + 34 900 202 700
[email protected]

Polska
GSK Services Sp. z o.o.
Tel.: + 48 (22) 576 9000

Portugal
GlaxoSmithKline - Produtos Farmacêuticos, Lda.
Tel: + 351 21 412 95 00
[email protected]

România
GlaxoSmithKline Biologicals SA
Tel: +40 800672524

Ireland
GlaxoSmithKline (Ireland) Ltd
Tel: + 353 (0)1 495 5000

France
Laboratoire GlaxoSmithKline
Tél: + 33 (0) 1 39 17 84 44
[email protected]

Hrvatska
GlaxoSmithKline Biologicals SA
Tel.: +385 800787089

Slovenija
GlaxoSmithKline Biologicals SA
Tel: +386 80688869

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
GlaxoSmithKline Biologicals SA
Tel.: +421 800500589

Italia
GlaxoSmithKline S.p.A.
Tel:+ 39 (0)45 7741 111

Suomi/Finland
GlaxoSmithKline Oy
Puh/Tel: + 358 10 30 30 30

Κύπρος
GlaxoSmithKline Biologicals SA
Τηλ: +357 80070017

Sverige
GlaxoSmithKline AB
Tel: + 46 (0)8 638 93 00
[email protected]

Latvija
GlaxoSmithKline Biologicals SA
Tel: +371 80205045

United Kingdom (Irlanda del Nord)
GlaxoSmithKline Biologicals SA
Tel: +44 (0)800 221441
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu/.
-------------------------------------------------------------------------------------------------------------------------
The following information is intended for healthcare professionals only:
Cervarix should be administered as soon as possible after removal from the refrigerator.
However, stability has been demonstrated when stored outside the refrigerator for up to 3 days at
a temperature between 8°C and 25°C or up to 1 day at a temperature between 25°C and 37°C. If
not used by the end of this period the vaccine should be discarded.
During storage of the syringe, a fine white deposit may be observed with a clear, colourless supernatant.
This does not constitute evidence of deterioration.
The contents of the syringe should be inspected visually both before and after shaking to
verify the absence of any foreign particles and/or abnormal physical appearance before administration.
If any such condition is observed, discard the vaccine.
The vaccine must be shaken well before use.
Instructions for the pre-filled syringe

Luer Lock adapter
Hold the syringe by the body, not by the
plunger.
Unscrew the syringe cap by rotating it
counterclockwise.
Plunger
Body
Cap

Needle hub
To attach the needle to the syringe, gently connect
the needle hub to the Luer Lock Adapter and rotate a quarter turn clockwise until a click is felt.
Do not withdraw the syringe plunger from the body.
If this happens, do not administer the vaccine.
Unused medicinal product and waste materials derived from such products should be disposed of in accordance
with local regulations.