CellDemic

Package leaflet: Information for the user

Celldemic injectable suspension in pre-filled syringe

Zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, cell culture-derived)
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 using this medicine. See the end of section 4 for information on how to report side effects.
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, consult your doctor, pharmacist or nurse.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What Celldemic is and what it is used for

Celldemic is a vaccine intended for use in adults and children aged 6 months and older,
designed to be administered in anticipation of or during outbreaks of zoonotic influenza viruses
(i.e. those that can be transmitted from animals to humans) with pandemic potential,
to prevent influenza caused by H5N1 virus ("avian influenza").
Zoonotic influenza viruses occasionally infect humans and may cause illnesses
ranging from mild upper respiratory tract infections (infection of the nose and throat) to influenza-like illness
rapidly progressing to severe lung infection, acute respiratory distress syndrome, shock, and even death.
Human infections are primarily caused by contact with infected animals, but do not spread easily between people.
Celldemic is administered before or during an H5N1 outbreak with pandemic potential. It contains
certain components of the H5N1 virus, which has been inactivated so that it cannot cause disease.
When a person receives the vaccine, the immune system recognizes the viral components in the vaccine as "foreign"
and produces antibodies against them. If the person is subsequently exposed to the virus, these antibodies,
together with other components of the immune system, are able to destroy the virus, thereby helping to protect against disease.
None of the vaccine components can cause influenza.

2. What you should know before receiving Celldemic

Do not receive Celldemic

• 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 residuals from the manufacturing process;
  • if you have previously had a severe allergic reaction (e.g., anaphylaxis) to an earlier 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) following administration of Celldemic.
• Inform the doctor or nurse if you feel 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 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 cancer medicines (chemotherapy) or corticosteroids (see section “Other medicines and Celldemic”).
• The doctor should inform you of the possibility of seizures occurring, particularly if you have previously experienced epilepsy.

As with all vaccines, Celldemic may not fully protect all vaccinated individuals.
Children under 6 months of age
The vaccine is not currently recommended for children under 6 months of age, as safety and efficacy have not been established in this age group.
Other medicines and Celldemic
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 any other vaccine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, 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 Celldemic in breastfeeding women. Celldemic is not expected to pass into breast milk, and therefore effects on the breastfed infant 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 or use machinery. Wait until these effects have resolved before driving or operating machinery.
Celldemic 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 Celldemic 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 vaccine dose must be administered after an interval of at least 3 weeks.

4. Possible side effects

Like all medicines, Celldemic can cause side effects, although not everybody will experience them.
Very serious side effects
Allergic reactions, which may be severe, can occur after vaccination. Inform your doctor immediately 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 you experience these symptoms, urgent medical treatment or hospitalization may be required.
Other side effects
Other side effects that may occur with Celldemic include those listed below.
Adults aged 18 years and older
The following side effects were observed with Celldemic in clinical studies in adults, including elderly individuals:
Very common (may affect more than 1 in 10 people):

• Pain at 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 injection site
• Hardening of the skin at injection site (induration)
• Fever

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

• Swollen lymph nodes (lymphadenopathy)
• Dizziness
• Diarrhea
• Vomiting
• Skin rash
• Itching sensation
• Redness at injection site (erythema)
• Bleeding at 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 were reported in a clinical study involving children from 6 months to less than 18 years of age.
From 6 months to less than 6 years of age
Very common:

• Reduced appetite
• Tenderness at injection site
• Sleepiness
• Irritability
• Fever

Common:

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

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

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

Common:

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

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

• Temporary low platelet count which may lead to bleeding or bruising (transient thrombocytopenia)
• Allergic reactions, possibly with shortness of breath, wheezing, swelling of the throat, 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), nerve inflammation (neuritis), epileptic seizures (convulsions), inflammation of the central nervous system (encephalomyelitis), a type of paralysis (Guillain-Barré syndrome), fainting (syncope) or feeling faint (presyncope), sleepiness
• Irregular or forceful heartbeat (palpitations), faster than normal heartbeat (tachycardia)
• Inflammation of blood vessels which may cause skin rashes, joint pain, and kidney problems (vasculitis)
• Generalized 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
• General 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 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 Celldemic

Keep this vaccine out of the sight and reach of children.
Do not use Celldemic after the expiry date stated on the carton and label after "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 medicines 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 Celldemic contains

• Active substance: The active substances in the vaccine are purified viral proteins (called haemagglutinin and neuraminidase).

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. Celldemic contains sodium and potassium.

Description of the appearance of Celldemic and contents of the pack
Celldemic is a white, milky suspension.
It is supplied in a pre-filled syringe containing a single injectable dose (0.5 mL), in packs of 10 pre-filled syringes with a Luer-Lock system. Needles are not included.

Marketing Authorisation Holder and Manufacturer
Seqirus Netherlands B.V.
Paasheuvelweg 28
1105BJ Amsterdam
The Netherlands

More detailed information on this medicinal product 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 administration of the vaccine.
Gently shake before use. After shaking, Celldemic normally appears as a white, milky suspension.
Before administration, visually inspect the vaccine for particulate matter and discoloration. Do not administer the vaccine if foreign particles and/or physical changes in appearance are observed.
To use the pre-filled syringe without needle equipped with a 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. 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.