Pandemrix - patient leaflet, side effects, dosage

What Pandemrix is and what it is used for

What Pandemrix is and what it is used for

Pandemrix is a vaccine to prevent influenza (flu) caused by A(H1N 1)v 2009 virus.

Your doctor will normally recommend a different vaccine (annual trivalent/qua­drivalent influenza vaccine) instead of Pandemrix, but if the trivalent/qua­drivalent vaccines are not available Pandemrix may still be an option if you need protection against A(H1N1)v influenza (see Take special care with Pandemrix).

if you have previously had a sudden life-threatening allergic reaction to any ingredient of this vaccine (listed in section 6) or to any of the substances that may be present in trace amounts as follows: egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or sodium deoxycholate. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.

if you have a severe infection with a high temperature (over 38°C). If this applies to you then your vaccination will usually be postponed until you are feeling better. A minor infection such as a cold should not be a problem, but your doctor or nurse will advise whether you could still be vaccinated with Pandemrix.

If you are not sure, talk to your doctor or nurse before having this vaccine.

Warnings and precautions

Talk to your doctor or nurse before you receive Pandemrix:

if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in this vaccine (listed in section 6), to thiomersal, to egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate..

if you are having a blood test to look for evidence of infection with certain viruses. In the first few weeks after vaccination with Pandemrix the results of these tests may not be correct. Tell the doctor requesting these tests that you have recently been given Pandemrix.

• if you have a bleeding problem or bruise easily. .

In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended, or may need to be delayed.

Excessive sleepiness during the day, often at the wrong times (a long-term condition called narcolepsy), has been reported very rarely after vaccination with Pandemrix in several European countries. Narcolepsy can occur with or without sudden muscle weakness that can cause falls (a condition called cataplexy).

Children and adolescents

If your child receives the vaccine, you should be aware that the side effects may be more intense after the second dose, especially temperature over 38°C. Therefore monitoring of temperature and measures to lower the temperature (such as giving paracetamol or other medicines that lower fever) after each dose are recommended.

Fainting can occur (mostly in adolescents) following, or even before, any needle injection. Therefore tell the doctor or nurse if you fainted with a previous injection.

Other medicines and Pandemrix

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines or have recently received any other vaccine.

Pandemrix can be given at the same time as seasonal influenza vaccines that do not contain an adjuvant.

Persons who have received a seasonal influenza vaccine that does not contain an adjuvant may receive Pandemrix after an interval of at least three weeks.

There is no information on administration of Pandemrix with other vaccines. However, if this cannot be avoided, the vaccines should be injected into separate limbs. In such cases, you should be aware that the side effects may be more intense.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you receive this vaccine.

Driving and using machines

Some effects mentioned under section 4. “Possible side effects” may affect the ability to drive or use machines.

Pandemrix contains thiomersal

Pandemrix contains thiomersal as a preservative and it is possible that you may experience an allergic reaction. Tell your doctor if you have any known allergies.

Pandemrix contains sodium and potassium

This medicinal product contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose, i.e. essentially sodium- and potassium-free.

3. How Pandemrix is given

Your doctor or nurse will administer the vaccine in accordance with official recommendations.

Adults, including the elderly

A dose (0.5 ml) of the vaccine will be given.

Clinical data suggest that a single dose may be sufficient.

If a second dose is administered there should be an interval of at least three weeks between the first and second dose.

Use in children and adolescents

Children from the age of 10 years onwards

A dose (0.5 ml) of the vaccine will be given.

Clinical data suggest that a single dose may be sufficient.

If a second dose is administered there should be an interval of at least three weeks between the first and second dose.

Children from 6 months to 9 years of age

A dose (0.25 ml) of the vaccine will be given.

If a second dose of 0.25 ml is given this will be administered at least three weeks after the first dose.

Children aged less than 6 months of age

Vaccination is currently not recommended in this age group.

The vaccine will be injected into a muscle (usually in the upper arm).

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

4. Possible side effects

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

Allergic reactions:

Allergic reactions may occur following vaccination, in rare cases leading to shock. Doctors are aware of this possibility and have emergency treatment available for use in such cases.

Other side effects:

The side effects listed below have occurred with Pandemrix in clinical studies in adults, including the elderly.

Very common: may affect more than 1 in 10 people

• Headache
• Tiredness
• Pain and swelling at the injection site
• Shivering
• Increased sweating

Aching muscles, joint pain

Common: may affect up to 1 in 10 people

• Redness and itching at the injection site
• Fever
• Feeling sick, diarrhoea, vomiting, stomach pain

Uncommon: may affect up to 1 in 100 people

• A hard lump and warmth at the injection site
• Swollen glands in the neck, armpit or groin
• Tingling or numbness of the hands or feet
• Sleeplessness
• Dizziness
• Itching, rash
• Generally feeling unwell
• Flu-like symptoms

These side effects usually disappear within 1–2 days without treatment. If they persist, CONSULT YOUR DOCTOR.

Additional side effects in children and adolescents

Children aged 10–17 years

The side effects listed above have also been observed with similar frequencies in clinical studies in children 10 to 17 years of age, except for redness at the injection site which was very common and sweating which was common.

In children 3 to 9 years of age who received two 0.25 ml doses of Pandemrix (H1N1) the side effects reported were similar to those reported in adults, except for redness at the injection site and gastrointestinal symptoms which were very common and shivering and sweating which were common. In addition, fever was very common in children aged 3–5 years. Some side effects (including local redness and fever) occurred more frequently after the second dose compared to the first dose.

Children aged 6–35 months

In children aged 6–35 months who received two doses of 0.25 ml of Pandemrix (H1N1), there was an increase in reports of pain, redness and swelling at the injection site as well as fever (>38°C), drowsiness, irritability and loss of appetite after the second dose compared to the first dose. All these side effects were reported very commonly after each dose.

The side effects listed below have happened after Pandemrix (H1N1)v came on the market:

Allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, may lead to shock. Doctors are aware of this possibility and have emergency treatment available for use in such cases.

Generalised skin reactions including facial swelling and urticaria (hives)

Fits due to fever

A long-term condition with excessive daytime sleepiness (narcolepsy), with or without sudden weakness (cataplexy), which may lead to falls without loss of consciousness Short-term sleepiness following vaccination

Reactions at the injection site such as pain, redness, bruising, swelling and heat (inflammation), hard lump (mass)

The side effects listed below have occurred in the days or weeks after vaccination with vaccines given routinely every year to prevent flu. They may also happen with Pandemrix.

Rare: may affect up to 1 in 1,000 people

• Severe stabbing or throbbing pain along one or more nerves
• Low blood platelet count which can result in bleeding or bruising

Very rare: may affect up to 1 in 10,000 people

• Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems)
• Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), neuritis (inflammation of nerves) and a type of paralysis known a Guillain-Barre Syndrome

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Pandemrix

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

Before the vaccine is mixed:

Do not use the suspension and the emulsion after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C).

Store in the original package in order to protect from light.

Do not freeze.

After the vaccine is mixed:

After mixing, use the vaccine within 24 hours and do not store above 25°C.

away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Pandemrix contains

Active substance:

Split influenza virus, inactivated, containing antigen* equivalent to:

A/California/07/2009 (H1N1) derived strain used NYMC X-179A 3.75 micrograms** per 0.5 ml dose

*

propagated in eggs

**

expressed in microgram haemagglutinin

Adjuvant:

The vaccine contains an ‘adjuvant’ AS03 to stimulate a better response. This adjuvant contains squalene (10.69 milligrams), DL-a-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams).

Other ingredients:

The other ingredients are: polysorbate 80, octoxynol 10, thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride, water for injections

What Pandemrix looks like and contents of the pack

Suspension and emulsion for emulsion for injection.

The suspension is a colourless light opalescent liquid.

The emulsion is a whitish to yellowish homogeneous milky liquid.

Prior to administration, the two components should be mixed. The mixed vaccine is a whitish to yellowish homogeneous milky liquid emulsion.

One pack of Pandemrix consists of:

• one pack containing 50 vials of 2.5 ml suspension (antigen)
• two packs containing 25 vials of 2.5 ml emulsion (adjuvant)

Marketing Authorisation Holder and Manufacturer

GlaxoSmithKline Biologicals s.a.

Rue de l’Institut 89

B-1330 Rixensart

Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Deutschland

GlaxoSmithKline GmbH & Co. KG

Tel: + 49 (0)89 360448701

This leaflet was last revised in {MM/YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

The following information is intended for healthcare professionals only:

Pandemrix consists of two containers: Suspension: multidose vial containing the antigen, Emulsion: multidose vial containing the adjuvant.

Prior to administration, the two components should be mixed.

Instructions for mixing and administration of the vaccine : Xr

• 1. Before mixing the two components, the emulsion (adjuvant) and suspension (antigen) should be brought to room temperature (allow a minimum of 15 minutes); each vial should be shaken and inspected visually for any foreign particulate matter and/or abnormal physical appearance. In the event of either being observed (including rubber particles from the stopper), discard the vaccine.

• 2. The vaccine is mixed by withdrawing the entire contents of the vial containing the adjuvant by means of a 5 ml syringe and by adding it to the vial containing the antigen. It is recommended to equip the syringe with a 23-G needle. However, in the case this needle size would not be available, a 21-G needle might be used. The vial containing the adjuvant should be maintained in upside down position to facilitate the withdrawal of the full content.

• 3. After the addition of the adjuvant to the antigen, the mixture should be well shaken. The mixed vaccine is a whitish to yellowish homogeneous milky liquid emulsion. In the event of other variation being observed, discard the vaccine.

• 4. The volume of the Pandemrix vial after mixing is at least 5 ml. The vaccine should be administered in accordance with the recommended posology (see section 3 “How Pandemrix is given”).

• 5. The vial should be shaken prior to each administration and inspected visually for any foreign particulate matter and/or abnormal physical appearance. In the event of either being observed (including rubber particles from the stopper), discard the vaccine.

• 6. Each vaccine dose of 0.5 ml (full dose) or 0.25 ml (half dose) is withdrawn into a 1 ml syringe for injection and administered intramuscularly. It is recommended to equip the syringe with a needle gauge not larger than 23-G.

• 7. After mixing, use the vaccine within 24 hours. The mixed vaccine can either be stored in a refrigerator (2°C – 8°C) or at room temperature not exceeding 25°C. If the mixed vaccine is stored in a refrigerator, it should be brought to room temperature (allow a minimum of 15 minutes) before each withdrawal. r'