Incellipan

Package leaflet: Information for the user

Incellipan injectable suspension in pre-filled syringe

Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures)
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you may experience while receiving this medicine. See the end of section 4 for information on how to report side effects.
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, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What Incellipan is and what it is used for

Incellipan is a vaccine intended 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 across the world. The symptoms of pandemic influenza are similar to those of seasonal influenza, but may be more severe.
It is used to prevent influenza caused by the H5N1 strain of the virus.
When a person receives the vaccine, the body's natural defence system (immune system) produces its own protection (antibodies) against the disease. None of the components of the vaccine can cause influenza.

2. What you should know before receiving Incellipan

Do not receive Incellipan

• if you are allergic
  • to the active substances or to any of the other ingredients of this medicine (listed in section 6);
  • to beta-propiolactone, polysorbate 80 or cetyltrimethylammonium bromide (CTAB), which are trace residues from the manufacturing process;
• if you have previously had a severe allergic reaction (e.g., anaphylaxis) following a previous influenza vaccination.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before receiving this vaccine.
BEFORE receiving this vaccine

• The doctor or nurse will ensure that appropriate medical treatment and supervision are readily available in case of a rare anaphylactic reaction (a very severe allergic reaction, with symptoms such as difficulty breathing, dizziness, weak and rapid pulse, and skin rash) after administration of Incellipan.
• Inform the doctor or nurse if you are anxious about the vaccination procedure or if you have previously fainted after an injection.
• Inform the doctor or nurse if you have an acute illness that includes fever among its symptoms. The doctor may decide to postpone vaccination until the fever has resolved. However, vaccination may still be given in the presence of a mild fever or a minor upper respiratory tract infection such as a cold.
• Inform the doctor or nurse if you have bleeding disorders, bruise easily, or are taking a medicine to prevent blood clots.
• You must inform the doctor or nurse if your immune system is weakened or if you are receiving treatment that affects the immune system, such as anticancer medicines (chemotherapy) or corticosteroids (see section “Other medicines and Incellipan”).
• The doctor should inform you of the possibility of seizures occurring, particularly if you have previously experienced episodes of epilepsy.

As with all vaccines, Incellipan may not fully protect all vaccinated individuals.
Children under 6 months of age
The vaccine is currently not recommended for children under 6 months of age, as safety and efficacy have not been established in this age group.
Other medicines and Incellipan
Inform the 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 any other vaccine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or nurse before receiving this vaccine. The doctor must evaluate the benefits and potential risks of administering the vaccine in your specific case.
There is no experience with the use of Incellipan in breastfeeding women. Incellipan is not expected to pass into breast milk and therefore effects on breastfed infants are not anticipated.
Driving and using machines
Some of the side effects reported in section 4 (Possible side effects) may temporarily affect your ability to drive vehicles or operate machinery. Wait until these effects have subsided before driving or operating machinery.
Incellipan contains sodium and potassium
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially 'sodium-free'.
This vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e., essentially 'potassium-free'.

3. How Incellipan is administered

The doctor or nurse will administer the vaccine in accordance with official recommendations.
Adults and children aged 6 months and older:
One dose (0.5 mL) of the vaccine will be injected into the upper arm (deltoid muscle) or
into the upper thigh, depending on age and muscle mass.
A second dose of the vaccine must be administered after an interval of at least 3 weeks.

4. Possible side effects

Like all medicines, Incellipan can cause side effects, although not everybody gets them.
Very serious side effects
Allergic reactions, which may be severe, can occur after vaccination. Immediately inform your doctor or go to the nearest hospital emergency department if you experience any of the following signs or symptoms of an allergic reaction:

• Difficulty breathing
• Dizziness
• Weak and rapid pulse
• Skin rash

If these symptoms occur, urgent medical treatment or hospitalisation may be necessary.

Other side effects
Other side effects that may occur with Incellipan include those listed below.

Adults aged 18 years and older
The following side effects were observed with Incellipan in clinical studies in adults, including elderly individuals:

Very common (may affect more than 1 in 10 people):

• Pain at the injection site
• Muscle pain (myalgia)
• Joint pain (arthralgia)
• Headache
• Fatigue
• General feeling of being unwell (malaise)

Common (may affect up to 1 in 10 people):

• Feeling unwell (nausea)
• Loss of appetite
• Chills
• Bruising at the injection site
• Hardening of the skin at the injection site (induration)
• Fever

Uncommon (may affect up to 1 in 100 people):

• Swollen lymph nodes (lymphadenopathy)
• Dizziness
• Diarrhoea
• Vomiting
• Rash
• Itching sensation
• Redness at the injection site (erythema)
• Bleeding at the injection site (haemorrhage)

Elderly subjects aged 65 years and older generally reported fewer reactions compared to younger adults.

Children from 6 months to less than 18 years of age
The following side effects have been reported in a clinical study in children aged from 6 months to less than 18 years.

From 6 months to less than 6 years of age
Very common:

• Reduced appetite
• Tenderness at the injection site
• Drowsiness
• Irritability
• Fever

Common:

• Redness at the injection site (erythema)
• Hardening of the skin at the injection site (induration)
• Vomiting
• Diarrhoea

From 6 to less than 18 years of age
Very common:

• Headache
• Nausea
• Reduced appetite
• Muscle pain (myalgia)
• Joint pain (arthralgia)
• Pain at the injection site
• Fatigue
• General feeling of being unwell (malaise)

Common:

• Redness at the injection site (erythema)
• Hardening of the skin at the injection site (induration)
• Fever
• Vomiting
• Diarrhoea

The following additional side effects have been reported with the use of seasonal influenza vaccines in general and with a pandemic vaccine similar to Incellipan:

• Temporary low platelet count which may lead to bleeding or bruising (transient thrombocytopenia)
• Allergic reactions possibly with shortness of breath, wheezing, throat swelling, or causing a dangerous drop in blood pressure which, if untreated, may lead to shock. Physicians are aware of this possibility and have emergency treatments available for such cases
• Neurological disorders such as sharp or intense pulsating pain along one or more nerves (neuralgia), tingling (paraesthesia), inflammation of nerves (neuritis), epileptic seizures (convulsions), inflammation of the central nervous system (encephalomyelitis), a type of paralysis (Guillain-Barré syndrome), fainting (syncope) or feeling like fainting (presyncope), drowsiness
• Irregular or pounding heartbeat (palpitations), faster than normal heartbeat (tachycardia)
• Inflammation of blood vessels which may cause skin rashes, joint pains, and kidney problems (vasculitis)
• Generalised skin reactions, including hives, non-specific rash, abnormal swelling of the skin, usually affecting areas around the eyes, lips, tongue, hands or feet, due to an allergic reaction (angioedema)
• Extensive swelling of the vaccinated limb
• Cough
• Limb pain, muscle weakness
• Abdominal pain
• Generalised weakness (asthenia)

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

5. How to store Incellipan

Keep this vaccine out of the sight and reach of children.
Do not use Incellipan after the expiry date stated on the carton and label following "Exp". The
expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze. Discard the vaccine if it has been frozen.
Keep the pre-filled syringe in its original packaging to protect the medicine 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 Incellipan contains

• Active substance: The active substances in the vaccine are purified viral proteins (called haemagglutinin and neuraminidase) prepared from the influenza virus strain in accordance with recommendations of the World Health Organization and the EU decision in an officially declared pandemic situation.

One dose (0.5 mL) of the vaccine contains 7.5 micrograms of haemagglutinin from the influenza virus strain A/turkey/Turkey/1/2005 (H5N1) propagated in Madin Darby canine kidney (MDCK) cells (this is the special cell culture in which the influenza virus is grown).
Adjuvant: MF59C.1 is included in this vaccine as an adjuvant. Adjuvants are substances contained in some vaccines to accelerate, enhance and/or prolong the protective effects of the vaccine. MF59C.1 is an adjuvant containing squalene, polysorbate 80, sorbitan trioleate, sodium citrate and citric acid.

• Other components: The other components are: sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections. See section 2: Incellipan contains sodium and potassium.

Description of the appearance of Incellipan and contents of the pack
Incellipan is a white, milky suspension.
It is supplied in a pre-filled syringe ready for use, containing a single injectable dose (0.5 mL), in a pack of 10 pre-filled syringes with Luer-Lock system. Needles are not included.
Marketing Authorisation Holder and Manufacturer
Seqirus Netherlands B.V.
Paasheuvelweg 28
1105 BJ Amsterdam
The Netherlands
Incellipan has been granted a "conditional" marketing authorisation. This means that additional data on this medicinal product must still be provided.
The European Medicines Agency will review new information on this medicine at least annually, and this package leaflet will be updated if necessary.
More detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu/.

The following information is intended exclusively for healthcare professionals:

Appropriate medical treatment and supervision must always be readily available in the event of a rare anaphylactic reaction following vaccine administration.
Gently shake before use. After shaking, Incellipan normally appears as a white, milky suspension.
Before administration, the vaccine should be inspected visually for particulate matter and discoloration. If foreign particles or any change in physical appearance are observed, the vaccine must not be administered.
To use the pre-filled syringe without needle equipped with Luer-Lock system, remove the tip cap by unscrewing it counterclockwise. After removing the tip cap, attach the needle to the syringe by screwing it on clockwise until it locks into place. Use a sterile needle of appropriate size for intramuscular injection. Once the needle is securely locked in place, remove the needle protector and administer the vaccine.