VACUNA GRIPE PANDEMICA H5N1 BAXTER (Pandemic Influenza Vaccine H5N1 Baxter)

Introduction

Package Leaflet: Information for the User

PANDEMIC INFLUENZA VACCINE H5N1 BAXTER

injection suspension

Pandemic influenza vaccine (H5N1) (whole virus, inactivated, prepared in cell culture)

Read all of this leaflet carefully before you are given the vaccine because it contains important information for you.

• Keep this leaflet, you may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is and what it is used for
2. What you need to know before you are given PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
3. How PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is given
4. Possible side effects

1. Storage of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
2. Contents of the pack and other information

1. What PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is and what it is used for

PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is a vaccine that is used in individuals from 6 months of age and older. It is used to prevent influenza in an officially declared pandemic situation.

Pandemic influenza is a type of influenza that occurs every few decades and spreads rapidly, affecting most countries and regions around the world. The symptoms (signs) of pandemic influenza are similar to those of 'common' influenza but are usually more severe.

The vaccine helps the body to produce its own protection (antibodies) against the disease.

2. What you need to know before you are given PANDEMIC INFLUENZA VACCINE H5N1 BAXTER

Do not use PANDEMIC INFLUENZA VACCINE H5N1 BAXTER

• if you have previously had a severe allergic reaction to PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.

• if you are allergic to any of the components or trace residues (formaldehyde, benzonase, sucrose) of this vaccine. The active substance and other components of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER are described in section 6 at the end of the leaflet. The signs of an allergic reaction may include skin rash with itching, difficulty breathing, and swelling of the face or tongue. However, in a pandemic situation, your doctor may recommend that you receive the vaccine.

Warnings and precautions

Before vaccination, you must inform your doctor

• if you have a severe infection with high fever (over 38 °C). If this is the case, vaccination is usually postponed until the symptoms have passed. A mild infection, such as a cold, should not be a problem, but your doctor will tell you if you can still be vaccinated with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.

• if you have had an allergic reaction to any component of the vaccine (see section 6 and end of the leaflet) or to formaldehyde, benzonase, or sucrose. Allergic reactions, including sudden and life-threatening reactions (anaphylaxis), have been reported with a similar influenza vaccine (swine flu vaccine) administered during a pandemic period. Such reactions have occurred in both people with allergies and people without allergies;

• if you have a weakened immune system (e.g., due to immunosuppressive treatment, corticosteroid treatment, or chemotherapy for cancer);
• if you are going to have a blood test to check for infection with certain viruses. In the first few weeks after vaccination with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER, the results of these tests may not be accurate. Inform the doctor who requested these tests that you have recently been given PANDEMIC INFLUENZA VACCINE H5N1 BAXTER;

• if you have a bleeding disorder or bruise easily.

The vaccine must never be administered into a blood vessel.

There is no information on the use of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER under the skin.

Use of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER with other medicines

Tell your doctor if you are using or have recently used or may need to use any other medicine.

PANDEMIC INFLUENZA VACCINE H5N1 BAXTER should not be administered at the same time as other vaccines. However, if this cannot be avoided, the other vaccine should be injected into the other limb. It should be noted that side effects may be more intense.

If you are being given any medicine that reduces immunity to infections or if you are receiving any treatment (such as radiotherapy) that affects the immune system, PANDEMIC INFLUENZA VACCINE H5N1 BAXTER may be administered, but the response to the vaccine may be reduced.

PANDEMIC INFLUENZA VACCINE H5N1 BAXTER should not be administered at the same time as immunoglobulins. However, if this cannot be avoided, the immunoglobulins should be injected into the other limb.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before receiving PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.

Driving and using machines

PANDEMIC INFLUENZA VACCINE H5N1 BAXTER may cause dizziness or discomfort, which may affect your ability to drive or use machines.

3. How PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is given

Infants, children, and adolescents from 6 months to 17 years and adults 18 years and older:

A dose of 0.5 ml will be administered. A second dose of 0.5 ml should be administered after an interval of at least three weeks.

Your doctor will administer PANDEMIC INFLUENZA VACCINE H5N1 BAXTER as an injection into the muscle (usually into the upper arm or upper thigh, depending on muscle mass).

The vaccine should never be administered into a vein.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

In clinical trials conducted in adults and the elderly with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER, most side effects were mild and short-lived. Generally, side effects are similar to those of the flu vaccine. In the second dose, a smaller number of side effects were observed compared to the first dose. The most common side effect was pain at the injection site, usually mild.

The following side effects were reported in clinical trials in adults and the elderly.

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

• pain at the injection site

• fatigue (feeling tired)
• headache

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

• runny nose and sore throat
• dizziness (vertigo)
• mouth and throat pain
• cough
• diarrhea
• increased sweating
• itching
• muscle or joint pain
• fever
• chills
• malaise (feeling unwell)
• hardening of the skin, redness, swelling, or small bleeding at the injection site

• abnormal reduction in sensitivity

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

• swollen glands
• insomnia (difficulty sleeping)

• dizziness
• drowsiness
• conjunctivitis (eye inflammation), eye irritation

• sudden hearing loss, ear pain
• low blood pressure, feeling of dizziness (syncope)
• difficulty breathing
• dry throat
• nasal congestion or runny nose
• nausea
• vomiting
• stomach pain, indigestion
• skin rash, hives
• irritation or itching at the injection site, bruising, or stiff arm

• chest discomfort
• flu-like illness

In clinical trials conducted in infants, children, and adolescents, the incidence and nature of symptoms after the first and second vaccinations were similar to those in adults and the elderly.

The following side effects were reported in clinical trials in infants from 6 to 35 months.

Very common (affect more than 1 in 10 vaccinated):

• drowsiness
• fever
• irritability
• pain at the injection site

Common (affect 1 to 10 in 100 vaccinated):

• runny nose and sore throat
• decreased appetite
• sleep disorder
• crying
• vomiting
• nausea
• diarrhea
• increased sweating
• hardening, redness, swelling, or bruising at the injection site

In clinical trials, the following side effects were reported in children from 3 to 8 years.

Very common (affect more than 1 in 10 users):

• pain at the injection site

Common (affect 1 to 10 in 100 vaccinated):

• runny nose and sore throat
• headache
• mouth and throat pain
• vomiting
• nausea

• joint or muscle pain
• hardening, redness, swelling, or bruising at the injection site
• fatigue (feeling tired)
• fever
• malaise

Uncommon (affect 1 to 10 in 1000 vaccinated):

• decreased appetite
• eye irritation
• cough
• runny nose
• diarrhea
• increased sweating
• arm pain
• itching at the injection site
• feeling of cold

In clinical trials, the following side effects were reported in adolescents from 9 to 17 years.

Very common (affect more than 1 in 10 vaccinated):

• headache
• pain at the injection site

Common (affect 1 to 10 in 100 vaccinated):

• runny nose and sore throat
• mouth and throat pain
• stomach pain
• nausea

• vomiting
• increased sweating
• joint or muscle pain
• hardening, redness, or swelling at the injection site
• fatigue (feeling tired)
• chills
• malaise

Uncommon (affect 1 to 10 in 1000 vaccinated):

• decreased appetite
• insomnia (difficulty sleeping)
• dizziness
• abnormal reduction in sensitivity

• vertigo (abnormal sensation of movement)
• cough
• runny nose
• diarrhea
• itching
• limb pain
• arm pain
• bruising at the injection site
• itching at the injection site
• fever
• feeling of cold

The following side effects have been reported with a similar influenza vaccine (Celvapan) in adults and children during the pandemic H1N1 influenza vaccination program.

The frequency cannot be calculated from the available data.

• allergic reactions, including severe reactions that have led to a life-threatening drop in blood pressure, which if left untreated can lead to collapse.
• seizures

• pain in arms or legs (in most cases, pain is reported in the vaccinated arm)

• inflammation of the tissue under the skin

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the national reporting system included in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER

Keep this medicine out of the sight and reach of children.

Do not use PANDEMIC INFLUENZA VACCINE H5N1 BAXTER after the expiry date stated on the carton. The expiry date is the last day of the month stated.

Store in a refrigerator (between 2 °C and 8 °C).

Store in the original packaging to protect from light.

Do not freeze.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of PANDEMIC INFLUENZA VACCINE H5N1 BAXTERActive substance:

Pandemic influenza vaccine H5N1 whole virus, inactivated, containing antigen of*:

A/Vietnam/1203/2004 (H5N1) 7.5 micrograms**

per 0.5 ml dose

• produced in Vero cells

• hemagglutinin

The other components are: trometamol, sodium chloride, water for injections, polysorbate 80.

Appearance of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER and pack contents

PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is a clear, opalescent, and whitish liquid.

The vaccine is available as 1 pack of 1 pre-filled syringe (Type I glass) containing 0.5 ml of injection suspension, with a plunger stopper that does not contain latex (halobutyl rubber), with or without needles.

Marketing authorisation holder

Ology Bioservices Ireland LTD

Wilton Park House

Wilton Place

Dublin 2

D02P447

Ireland

Manufacturer

Baxter AG

Uferstrasse 15

A-2304 Orth/Donau

Austria

Date of last revision of this leaflet:{Month/year}.

PANDEMIC INFLUENZA VACCINE H5N1 BAXTER has been authorised under exceptional circumstances. This means that due to scientific reasons, it has not been possible to obtain complete information on this medicinal product. The European Medicines Agency (EMA) will review any new information that may become available every year and this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency (EMA) website: http://www.ema.europa.eu.

This information is intended only for healthcare professionals:

The vaccine should be allowed to reach room temperature before use. Shake before use.

After shaking, the vaccine is a clear, opalescent, and whitish suspension.

Before administration, visually inspect the suspension for any foreign particles and/or abnormal physical appearance. If this is the case, discard the vaccine.

The vaccine should not be administered intravascularly.

Disposal of unused vaccine and all materials that have come into contact with it should be carried out in accordance with local regulations.

Once the syringe cap is removed, immediately attach the needle and remove the needle protector before administration.

Once the needle is attached, the vaccine should be administered immediately.