Foclivia

Package leaflet: Information for the user

Foclivia injectable suspension in pre-filled syringe

Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Please read all of this leaflet carefully before receiving this vaccine because 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 nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What Foclivia is and what it is used for

Foclivia is a vaccine to be administered to prevent influenza during an officially declared pandemic.
Pandemic influenza is a type of influenza that occurs at intervals ranging from less than 10 years to many decades. It spreads rapidly around the world. The signs of pandemic influenza are similar to those of ordinary influenza, but more severe.
It is intended for use to prevent influenza caused by the H5N1 type virus.
When a person is given the vaccine, the body's natural defence system (immune system) produces substances (antibodies) against the disease. None of the components of the vaccine cause influenza.
As with all vaccines, Foclivia may not fully protect all vaccinated individuals.

2. What you should know before receiving Foclivia

Do not receive Foclivia

• if you have had a severe allergic reaction (i.e. life-threatening) to any component of Foclivia,
• if you are allergic (hypersensitive) to influenza vaccines or to any of the excipients of Foclivia,
• if you are allergic to eggs or chicken proteins, or to ovalbumin,
• if you are allergic to kanamycin sulfate and neomycin sulfate (antibiotics), hydrocortisone, formaldehyde, or cetyltrimethylammonium bromide (CTAB).
• Signs of an allergic reaction may include itchy rash, shortness of breath, and swelling of the face or tongue.
• However, in the event of a pandemic, you might still receive the vaccine, provided that emergency medical treatment is available in case an allergic reaction occurs.

Warnings and precautions
Talk to your doctor or nurse before receiving this vaccine:

• if you have a fever,
• if you have any illness or infection,
• if you are receiving immunosuppressive therapy, e.g. corticosteroids or chemotherapy for cancer, or if you have any disease that makes you more susceptible to infections (immunodeficiency).

Inform your doctor or nurse if you have bleeding disorders or bruise easily.
Your doctor should inform you about the possibility of experiencing seizures, particularly if you have a history of epilepsy.
Fainting may occur after, or even before, any injection. Inform your doctor or nurse if you have previously fainted following injections.
Foclivia may not fully protect all vaccinated individuals, especially elderly people and those with weakened immune systems, such as patients with HIV, or those with chronic underlying conditions such as diabetes, lung disease, or heart problems. Inform your doctor if your immune system is weak or if you have a chronic underlying condition.
In such cases, INFORM YOUR DOCTOR OR NURSE, as vaccination may not be recommended or may need to be postponed.

Other medicines and Foclivia
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those without a prescription, or if you have recently received another vaccine. Foclivia may be administered concurrently with non-adjuvanted seasonal influenza vaccines. There is no available information on the administration of Foclivia with non-influenza vaccines. If co-administration of Foclivia with other vaccines cannot be avoided, the vaccines should be injected in separate limbs. In such cases, you should know that adverse reactions may be more pronounced.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or nurse before receiving this vaccine. Your doctor must evaluate the potential benefits and risks of administering the vaccine.

Driving and using machines
Some of the adverse reactions listed in section 4 “Possible side effects” may affect your ability to drive vehicles or operate tools and machinery.

Foclivia contains sodium and potassium
Foclivia contains less than 1 mmol of sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose. It can therefore be considered essentially sodium- and potassium-free.

3. How Foclivia is administered

Your doctor or nurse will administer the vaccine in accordance with official recommendations.
One dose (0.5 mL) of the vaccine will be injected into the upper arm (deltoid muscle) or
into the upper thigh, depending on muscle mass.
A second dose of the vaccine will be administered after an interval of at least 3 weeks.

4. Possible side effects

Like all medicines, Foclivia can cause side effects, although not everybody experiences them.
Contact your doctor immediately or go to the nearest hospital emergency department if you experience
the following side effect; urgent medical treatment or hospitalisation may be required:

• difficulty breathing, dizziness, weak and rapid pulse, and skin rash, which are symptoms of an anaphylactic reaction (a very severe allergic reaction)

The side effects listed below have been observed with the use of Foclivia in clinical studies:
Very common (affects more than 1 in 10 people):

• Pain/tenderness at the injection site
• Hardening of the skin at the injection site
• Redness at the injection site
• Swelling at the injection site
• Bruising at the injection site*
• Muscle pain
• Headache
• Fatigue
• General feeling of being unwell
• Chills
• Sweating*
• Nausea*
• Change in eating habits**
• Diarrhoea
• Vomiting
• Sweating and unusual sweating**
• Drowsiness**
• Irritability**
• Unusual crying**
• Fever***

Common (affects from 1 to 10 in 100 people):

• Joint pain
• Bleeding at the injection site
• Loss of appetite

Uncommon (affects from 1 to 10 in 1,000 people):

• Hives (urticaria)

These side effects are generally mild and usually resolve within 3 days without treatment. If they persist, CONSULT YOUR DOCTOR.
Side effects in patients with underlying chronic diseases such as diabetes, lung disease, heart problems, or weakened immune system (immunocompromised), such as patients with HIV
Nausea, joint pain, diarrhoea, and loss of appetite have been reported very commonly in this population. In addition, vomiting has been reported commonly.
Other rare side effects observed after routine administration:
The additional side effects listed below occurred in the days or weeks following vaccination with another vaccine called Focetria H1N1v, similar to Foclivia and containing the same adjuvant. These side effects may occur with Foclivia.

• Generalised skin reactions including
• Itching
• Skin rashes or swelling of the skin and mucous membranes
• Angioedema (abnormal swelling of the skin, usually around the eyes, lips, tongue, hands or feet, due to an allergic reaction)
• Gastrointestinal disorders such as
• Abdominal pain
• Dizziness, drowsiness
• Neurological disorders such as
• Severe shooting or pulsating pain in one or more nerves
• Tingling
• Seizures
• Neuritis (inflammation of nerves)
• Syncope or presyncope (fainting or feeling faint)
• Swollen lymph nodes, palpitations (irregular or forceful heartbeat), tachycardia (faster than normal heartbeat), weakness, limb pain, cough and asthenia (unusual weakness)
• Allergic reactions possibly causing shortness of breath, wheezing, throat swelling, or leading to a dangerous drop in blood pressure which, if untreated, may lead to shock. Your doctor is aware of this possibility and has emergency treatments available for such cases.

In addition, the side effects listed below occurred in the days or weeks following vaccination with adjuvanted and non-adjuvanted influenza vaccines routinely administered each year to prevent seasonal flu. These side effects could occur with Foclivia.

• Low platelet count, which could lead to bleeding or bruising
• Vasculitis (inflammation of blood vessels which may cause skin rashes, joint pain, and kidney problems)
• Erythema multiforme (a type of skin allergic reaction occurring in response to medicines, infections, or illness)
• Neurological disorders such as encephalomyelitis (inflammation of the central nervous system) and a form of paralysis known as Guillain-Barré syndrome
• Swelling, pain, and redness at the injection site larger than 10 cm and lasting more than one week (a reaction similar to cellulitis at the injection site)
• Extensive swelling of the limb used for injection, lasting more than one week

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or nurse.
You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Foclivia

Keep this vaccine out of the sight and reach of children.
Do not use Foclivia after the expiry date stated on the carton and label after EXP. The expiry date refers to the last day of the month.
Store in a refrigerator (2°C - 8°C). Do not freeze. Discard the vaccine if it has been frozen.
Keep in the original packaging to protect from light.
Do not dispose of any medicine via 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 Foclivia contains

• Active substance The active substances in the vaccine are purified viral proteins (called haemagglutinin and neuraminidase). These proteins are isolated from the surface of influenza virus particles, which are grown in healthy chicken eggs and inactivated with formaldehyde. The viral proteins are derived from the influenza virus strain corresponding to the recommendations of the World Health Organization and to the EU decision in the event of an officially declared pandemic.

One dose (0.5 mL) of the vaccine contains at least 7.5 micrograms of haemagglutinin from the following recommended influenza virus strain:
A/Vietnam/1194/2004 (H5N1)

• Adjuvant The vaccine contains an "adjuvant" (a compound containing squalene) to stimulate a stronger immune response. The adjuvant also contains polysorbate 80 and sorbitan trioleate in citrate buffer (sodium citrate, citric acid).
• Excipients The excipients are: sodium chloride, potassium chloride, monobasic potassium phosphate, dibasic sodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, water for injections.

Description of Foclivia and contents of the pack
Foclivia is a white, milky liquid.
It is supplied in a pre-filled syringe containing a single injectable dose (0.5 mL), in packs of 1 or 10, with or without needles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Seqirus S.r.l.
Via del Pozzo 3/A, S. Martino
53035 Monteriggioni (SI)
Italy

Manufacturer
Seqirus Netherlands B.V.
Paasheuvelweg 28
1105 BJ Amsterdam
The Netherlands

The marketing authorisation for Foclivia has been granted under "exceptional circumstances".
This means that, for scientific reasons, it has not been possible to obtain complete information about this medicinal product.
The European Medicines Agency (EMA) will review any new information on the medicine annually, and this patient information leaflet will be updated as necessary.
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu

The following information is intended exclusively for healthcare professionals:

Instructions for vaccine administration:
The vaccine must not be administered for any reason via intravascular or intradermal route.
Data on the use of Foclivia via the subcutaneous route are not available.
When using a pre-filled syringe without a needle and equipped with a Luer Lock system, remove the
protective cap by unscrewing it counterclockwise. Once the protective cap has been removed, insert a
needle into the syringe and screw it on clockwise until it locks into place. Once the needle is securely
locked, remove the needle shield and administer the vaccine.
Pre-filled syringe containing a single 0.5 mL dose for injection
Gently shake before use. After shaking, the normal appearance of Foclivia is a white, milky suspension.
Unused vaccines or waste materials must be disposed of in accordance with local regulations.

Package leaflet: Information for the user

Foclivia injectable suspension

Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Please read this leaflet carefully before receiving 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 nurse.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What Foclivia is and what it is used for

Foclivia is a vaccine to be administered to prevent influenza during an officially declared pandemic.
Pandemic influenza is a type of influenza that occurs at intervals ranging from less than 10 years to several decades. It spreads rapidly around the world. The symptoms of pandemic influenza are similar to those of seasonal influenza, but more severe.
It is intended for use in preventing influenza caused by the H5N1 type virus.
When a person is given the vaccine, the body's natural defence system (immune system) produces substances (antibodies) against the disease. None of the components of the vaccine causes influenza.
As with all vaccines, Foclivia may not fully protect all vaccinated individuals.

2. What you should know before receiving Foclivia

Do not receive Foclivia

• if you have had a severe allergic reaction (i.e. life-threatening) to any of the components of Foclivia,
• if you are allergic (hypersensitive) to influenza vaccines or to any of the excipients of Foclivia,
• if you are allergic to eggs or chicken proteins, ovalbumin,
• if you are allergic to kanamycin sulfate and neomycin sulfate (antibiotics), hydrocortisone, formaldehyde, or cetyltrimethylammonium bromide (CTAB).
• Signs of an allergic reaction may include itchy rash, shortness of breath, and swelling of the face or tongue.
• However, during a pandemic situation, you might still receive the vaccine, provided that emergency medical treatment is available in case an allergic reaction occurs.

Warnings and precautions
Talk to your doctor or nurse before receiving this vaccine:

• if you have a fever,
• if you have any illness or infection,
• if you are receiving immunosuppressive therapy, e.g. corticosteroids or chemotherapy for cancer, or if you have any disease that makes you more susceptible to infections (immunodeficiency).

Inform your doctor or nurse if you have bleeding disorders or bruise easily.
Your doctor should inform you about the possibility of seizures, particularly if you have a history of epilepsy.
Fainting may occur after, or even before, any injection. Inform your doctor or nurse if you have previously fainted following injections.
Foclivia may not fully protect all vaccinated individuals, especially elderly individuals and those with weakened immune systems, such as patients with HIV, or those with underlying chronic conditions such as diabetes, lung disease, or heart problems. Inform your doctor if your immune system is weak or if you have an underlying chronic condition.
In such cases, INFORM YOUR DOCTOR OR NURSE, as vaccination may not be recommended or may need to be postponed.

Other medicines and Foclivia
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription, or if you have recently received another vaccine. Foclivia may be administered concurrently with non-adjuvanted seasonal influenza vaccines. There is no available information on the administration of Foclivia with non-influenza vaccines. If co-administration of Foclivia with other vaccines cannot be avoided, the vaccines should be injected in separate limbs. In such cases, you should be aware that adverse reactions may be more pronounced.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or nurse before receiving this vaccine. Your doctor must evaluate the potential benefits and risks of administering the vaccine.

Driving and using machines
Some of the adverse reactions listed in section 4 “Possible side effects” may affect your ability to drive vehicles or operate tools and machinery.

Foclivia contains sodium and potassium
Foclivia contains less than 1 mmol of sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose. It can therefore be considered essentially sodium-free and potassium-free.

3. How Foclivia is administered

Your doctor or nurse will administer the vaccine in accordance with official recommendations.
One dose (0.5 mL) of the vaccine will be injected into the upper arm (deltoid muscle) or
into the upper thigh, depending on muscle mass.
A second dose of the vaccine will be administered after an interval of at least 3 weeks.

4. Possible side effects

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

Contact your doctor immediately or go to the nearest hospital emergency department if you experience the following side effect; urgent medical treatment or hospitalisation may be required:

• Difficulty breathing, dizziness, weak and rapid pulse, and skin rash, which are symptoms of an anaphylactic reaction (a very severe allergic reaction)

The following side effects have been reported with the use of Foclivia in clinical studies:
Very common (may affect more than 1 in 10 people):

• Pain/tenderness at the injection site
• Hardening of the skin at the injection site
• Redness at the injection site
• Swelling at the injection site
• Bruising at the injection site*
• Muscle pain
• Headache
• Fatigue
• General feeling of being unwell
• Chills
• Sweating*
• Nausea*
• Changes in eating habits**
• Diarrhoea
• Vomiting
• Sweating and unusual sweating**
• Drowsiness**
• Irritability**
• Unusual crying**
• Fever***

Common (may affect from 1 to 10 in 100 people):

• Joint pain
• Bleeding at the injection site
• Loss of appetite

Uncommon (may affect from 1 to 10 in 1,000 people):

• Hives (urticaria)

These side effects are generally mild and usually resolve within 3 days without treatment. If they persist, CONSULT YOUR DOCTOR.
Side effects in patients with chronic underlying conditions such as diabetes, lung disease, heart problems, or weakened immune systems (immunocompromised), such as patients with HIV
Nausea, joint pain, diarrhoea, and loss of appetite have been reported very commonly in this population. In addition, vomiting has been reported commonly.
Other rare side effects observed after routine administration:
The additional side effects listed below occurred in the days or weeks following vaccination with another vaccine called Focetria H1N1v, similar to Foclivia and containing the same adjuvant. These side effects may also occur with Foclivia.

• Generalised skin reactions including

• Itching

• Skin rashes or swelling of the skin and mucous membranes

• Angioedema (abnormal swelling of the skin, usually around the eyes, lips, tongue, hands or feet, due to an allergic reaction)

• Gastrointestinal disorders such as

• Abdominal pain

• Dizziness, drowsiness

• Neurological disorders such as

• Severe shooting or pulsating pain in one or more nerves

• Tingling

• Seizures

• Neuritis (inflammation of nerves)

• Syncope or presyncope (fainting or feeling faint)

• Swollen lymph nodes, palpitations (irregular or forceful heartbeat), tachycardia (faster than normal heartbeat), weakness, limb pain, cough, and asthenia (unusual weakness)

• Allergic reactions possibly causing shortness of breath, wheezing, throat swelling, or leading to a dangerous drop in blood pressure which, if untreated, may lead to shock. Your doctor is aware of this possibility and has emergency treatments available for such cases.

In addition, the following side effects occurred in the days or weeks following vaccination with adjuvanted and non-adjuvanted seasonal influenza vaccines routinely administered each year. These side effects could also occur with Foclivia.

• Low platelet count which could lead to bleeding or bruising
• Vasculitis (inflammation of blood vessels which may cause skin rashes, joint pain, and kidney problems)
• Erythema multiforme (a type of skin allergic reaction occurring in response to medicines, infections, or illness)
• Neurological disorders such as encephalomyelitis (inflammation of the central nervous system) and a form of paralysis known as Guillain-Barré syndrome
• Swelling, pain, and redness at the injection site larger than 10 cm and lasting more than one week (a reaction resembling cellulitis at the injection site)
• Extensive swelling of the limb used for injection, lasting more than one week

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse.
You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Foclivia

Keep this vaccine out of the sight and reach of children.
Do not use Foclivia after the expiry date stated on the carton and label after EXP. The expiry date refers to the last day of the month.
Store in a refrigerator (2°C - 8°C). Do not freeze. Discard the vaccine if it has been frozen.
Keep in the original packaging to protect it from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Foclivia contains

• Active substance The active substances in the vaccine are purified viral proteins (called haemagglutinin and neuraminidase). These proteins are isolated from the surface of influenza virus particles, which are grown in fertilized chicken eggs from healthy flocks and inactivated with formaldehyde. The viral proteins are derived from the influenza virus strain corresponding to the recommendations of the World Health Organization and the EU decision in the event of an officially declared pandemic.

One dose (0.5 mL) of the vaccine contains at least 7.5 micrograms of haemagglutinin from the following recommended influenza virus strain:
A/Vietnam/1194/2004 (H5N1)

• Adjuvant The vaccine contains an "adjuvant" (a compound containing squalene) to stimulate a stronger immune response. The adjuvant also contains polysorbate 80 and sorbitan trioleate in citrate buffer (sodium citrate, citric acid).
• Excipients The excipients are: sodium chloride, potassium chloride, monobasic potassium phosphate, dibasic sodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, water for injections.

Description of the appearance of Foclivia and contents of the pack
Foclivia is a white, milky liquid.
It is supplied in a vial containing a single injectable dose (0.5 mL).
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Seqirus S.r.l.
Via del Pozzo 3/A, S. Martino
53035 Monteriggioni (SI)
Italy

Manufacturer
Seqirus Netherlands B.V.
Paasheuvelweg 28
1105 BJ Amsterdam
The Netherlands

The marketing authorization for Foclivia has been granted under "exceptional circumstances".
This means that, for scientific reasons, it has not been possible to obtain complete information about this medicinal product.
The European Medicines Agency (EMA) will review any new information on the medicinal product annually, and this package leaflet will be updated if necessary.
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu

The following information is intended exclusively for healthcare professionals:

Single-dose vial: 1 vial containing a single dose (0.5 mL) for injection
Instructions for vaccine administration:
Under no circumstances must the vaccine be administered intravascularly or intradermally.
Data on the subcutaneous route of administration of Foclivia are not available.
Shake gently before use. After shaking, the normal appearance of Foclivia is a white, milky suspension.
Unused vaccines or waste materials must be disposed of in accordance with local regulations.

Package leaflet: information for the user

Foclivia injectable suspension in multidose container

Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Please read this leaflet carefully before receiving 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 nurse.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What Foclivia is and what it is used for

Foclivia is a vaccine to be administered to prevent influenza during an officially declared pandemic.
Pandemic influenza is a type of influenza that occurs at intervals ranging from less than 10 years to many decades. It spreads rapidly around the world. The symptoms of pandemic influenza are similar to those of seasonal influenza, but more severe.
It is intended for use in preventing influenza caused by the H5N1 type virus.
When a person is given the vaccine, the body's natural defence system (immune system) produces substances (antibodies) against the disease. None of the components of the vaccine cause influenza.
As with all vaccines, Foclivia may not fully protect all vaccinated individuals.

2. What you should know before receiving Foclivia

Do not receive Foclivia

• if you have had a severe allergic reaction (i.e. life-threatening) to any of the components of Foclivia,
• if you are allergic (hypersensitive) to influenza vaccines or to any of the excipients of Foclivia,
• if you are allergic to eggs or chicken proteins, or to ovalbumin,
• if you are allergic to kanamycin sulfate and neomycin sulfate (antibiotics), hydrocortisone, formaldehyde, or cetyltrimethylammonium bromide (CTAB).
• Signs of an allergic reaction may include itchy rash, shortness of breath, and swelling of the face or tongue.
• However, during a pandemic situation, you might still receive the vaccine, provided that emergency medical treatment is available in case an allergic reaction occurs.

Warnings and precautions
Talk to your doctor or nurse before receiving this vaccine:

• if you have a fever,
• if you have any illness or infection,
• if you are receiving immunosuppressive therapy, e.g. corticosteroids or chemotherapy for cancer, or if you have any disease that makes you more susceptible to infections (immunodeficiency).

Inform your doctor or nurse if you have bleeding disorders or bruise easily.
Your doctor should inform you about the possibility of seizures, especially if you have a history of epilepsy.
Fainting may occur after, or even before, any injection. Inform your doctor or nurse if you have previously fainted following an injection.
Foclivia may not fully protect all vaccinated individuals, particularly elderly people and those with weakened immune systems, such as HIV patients, or those with chronic underlying conditions such as diabetes, lung disease, or heart problems. Inform your doctor if your immune system is weak or if you have a chronic underlying condition.
In such cases, INFORM YOUR DOCTOR OR NURSE, as vaccination may not be recommended or may need to be postponed.

Other medicines and Foclivia
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those without a prescription, or if you have recently received another vaccine. Foclivia can be administered concurrently with non-adjuvanted seasonal influenza vaccines. There is no available information on the administration of Foclivia with non-influenza vaccines. If co-administration of Foclivia with other vaccines cannot be avoided, the vaccines should be injected in different limbs. In such cases, you should know that adverse reactions may be more pronounced.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or nurse for advice before receiving this vaccine. Your doctor must evaluate the potential benefits and risks of administering the vaccine.

Driving and using machines
Some of the adverse reactions listed in section 4 “Possible adverse reactions” may affect your ability to drive vehicles or operate tools or machinery.

Foclivia contains thiomersal
Foclivia contains thiomersal as a preservative and may cause allergic reactions. Inform your doctor if you have documented allergies.

Foclivia contains sodium and potassium
Foclivia contains less than 1 mmol of sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose. It can be considered sodium-free and potassium-free.

3. How Foclivia is administered

Your doctor or nurse will administer the vaccine in accordance with official recommendations.
One dose (0.5 mL) of the vaccine will be injected into the upper arm (deltoid muscle) or
into the upper thigh, depending on muscle mass.
A second dose of the vaccine will be administered after an interval of at least 3 weeks.

4. Possible side effects

Like all medicines, Foclivia can cause side effects, although not everybody gets them.
Contact your doctor immediately or go to the nearest hospital emergency department if you experience the following side effect; urgent medical treatment or hospitalisation may be required:

• Difficulty breathing, dizziness, weak and rapid pulse, and rash, which are symptoms of an anaphylactic reaction (a very serious allergic reaction)

The side effects listed below have been observed with the use of Foclivia in clinical studies:
Very common (may affect more than 1 in 10 people):

• Pain/tenderness at the injection site
• Hardening of the skin at the injection site
• Redness at the injection site
• Swelling at the injection site
• Bruising at the injection site*
• Muscle pain
• Headache
• Fatigue
• General feeling of being unwell
• Chills
• Sweating*
• Nausea*
• Change in eating habits**
• Diarrhoea
• Vomiting
• Sweating and unusual sweating**
• Drowsiness**
• Irritability**
• Unusual crying**
• Fever***

Common (may affect from 1 to 10 in 100 people):

• Joint pain
• Bleeding at the injection site
• Loss of appetite

Uncommon (may affect from 1 to 10 in 1,000 people):

• Hives (urticaria)

These side effects are generally mild and usually resolve within 3 days without treatment. If they persist, CONSULT YOUR DOCTOR.
Side effects in patients with pre-existing chronic conditions such as diabetes, lung disease, heart problems, or weakened immune system (immunocompromised), such as patients with HIV
Nausea, joint pain, diarrhoea, and loss of appetite have been reported very commonly in this population. In addition, vomiting has been reported commonly.
Other rare side effects observed after routine administration:
The additional side effects listed below occurred in the days or weeks following vaccination with another vaccine called Focetria H1N1v, similar to Foclivia and containing the same adjuvant. These side effects may occur with Foclivia.

• Generalised skin reactions including

• Itching

• Skin rashes or swelling of the skin and mucous membranes

• Angioedema (abnormal swelling of the skin, typically around the eyes, lips, tongue, hands or feet, due to an allergic reaction)

• Gastrointestinal disorders such as

• Abdominal pain

• Dizziness, drowsiness

• Neurological disorders such as

• Severe stabbing or pulsating pain in one or more nerves

• Tingling

• Seizures

• Neuritis (inflammation of nerves)

• Syncope or presyncope (fainting or feeling faint)

• Swollen lymph nodes, palpitations (irregular or strong heartbeat), tachycardia (faster than normal heartbeat), weakness, limb pain, cough, and asthenia (unusual weakness)

• Allergic reactions possibly causing shortness of breath, wheezing, throat swelling, or leading to a dangerous drop in blood pressure which, if untreated, may result in shock. Your doctor is aware of this possibility and has emergency treatments available for such cases.

In addition, the side effects listed below occurred in the days or weeks following vaccination with adjuvanted and non-adjuvanted seasonal influenza vaccines routinely administered each year. These side effects could possibly occur with Foclivia.

• Low platelet count which could lead to bleeding or bruising
• Vasculitis (inflammation of blood vessels which may cause skin rashes, joint pain, and kidney problems)
• Erythema multiforme (a type of skin allergic reaction occurring in response to medicines, infections, or illness)
• Neurological disorders such as encephalomyelitis (inflammation of the central nervous system) and a form of paralysis known as Guillain-Barré syndrome
• Swelling, pain, and redness at the injection site larger than 10 cm and lasting more than one week (a reaction similar to cellulitis at the injection site)
• Extensive swelling of the limb used for injection, lasting more than one week

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

5. How to store Foclivia

Keep this vaccine out of the sight and reach of children.
Do not use Foclivia after the expiry date stated on the carton and label following EXP. The expiry date refers to the last day of the month.
Store in a refrigerator (2°C - 8°C). Do not freeze. Discard the vaccine if it has been frozen.
Keep in the original packaging to protect it from light.
Do not dispose of any medicine via 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 Foclivia contains

• Active substance
  The active substances in the vaccine are purified viral proteins (called haemagglutinin and neuraminidase). These proteins are isolated from the surface of influenza virus particles, which are grown in fertilized chicken eggs from healthy flocks and inactivated with formaldehyde. The viral proteins are derived from the influenza virus strain corresponding to the recommendations of the World Health Organization and the EU decision in the event of an officially declared pandemic.

One dose (0.5 mL) of the vaccine contains at least 7.5 micrograms of haemagglutinin from the following recommended influenza virus strain:
A/Vietnam/1194/2004 (H5N1)

• Adjuvant
  The vaccine contains an "adjuvant" (a compound containing squalene) to stimulate a stronger immune response. The adjuvanti also contains polysorbate 80 and sorbitan trioleate in citrate buffer (sodium citrate, citric acid).

• Excipients
  The excipients are: thiomersal, sodium chloride, potassium chloride, monobasic potassium phosphate, dibasic sodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, water for injections.

Description of the appearance of Foclivia and contents of the pack
Foclivia is a white, milky liquid.
It is supplied in a vial containing ten injectable doses (0.5 mL each).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Seqirus S.r.l.
Via del Pozzo 3/A, S. Martino
53035 Monteriggioni (SI)
Italy

Manufacturer
Seqirus Netherlands B.V.
Paasheuvelweg 28
1105BJ Amsterdam
The Netherlands

The marketing authorisation for Foclivia has been granted under "exceptional circumstances".
This means that, for scientific reasons, it has not been possible to obtain complete information about this medicinal product.
The European Medicines Agency (EMA) will review any new information on the medicinal product annually, and this package leaflet will be updated if necessary.
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu

The following information is intended exclusively for healthcare professionals:

Multi-dose vial:
Vial containing 10 doses (0.5 mL each) for injection.
Instructions for vaccine administration:
The vaccine must not be administered intravascularly or intradermally for any reason.
Data on the use of Foclivia via subcutaneous administration are not available.
Gently shake the multi-dose vial each time before withdrawing a dose (0.5 mL) of the vaccine into a syringe. After shaking, the normal appearance of Foclivia is a white, milky suspension.
Although the multi-dose vial of Foclivia contains a preservative that prevents microbial proliferation, it is the user’s responsibility to minimize the risk of vial contamination each time a dose is withdrawn.
Record the date and time of the first dose withdrawal on the vial label.
Between uses, store the multi-dose vial under the recommended storage conditions between 2°C and 8°C. The multi-dose vial should preferably be used within 24 hours after the first withdrawal.
Data are available suggesting that the multi-dose vial may be used for up to a maximum of 72 hours after the first withdrawal, although prolonged storage should not be the preferred option.
Unused vaccines or waste materials must be disposed of in accordance with applicable local regulations.