HAVRIX 0.5 ML Injectable suspension

Зміст інструкції

1. HAVRIX
   1. What is Havrix (720 Bambini) and what it is used for
   2. What you need to know before you receive Havrix (720 Bambini)
   3. How to administer Havrix (720 Bambini)
   4. Possible side effects
   5. How to store Havrix (720 Bambini)
   6. Contents of the pack and other information
2. HAVRIX
   1. What Havrix (1440 Adulti) is and what it is used for
   2. What you need to know before you receive Havrix (1440 Adults)
   3. How to administer Havrix (1440 Adults)
   4. Possible side effects
   5. How to store Havrix (1440 Adults)
   6. Package contents and other information

HAVRIX

Children Injectable suspension in pre-filled syringe
Hepatitis A vaccine (inactivated) (adsorbed)
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, pharmacist or nurse.
• This vaccine has been prescribed only for you or your child. Do not give it to other people.
• If any side effects occur, including those not listed in this leaflet, ask your doctor, pharmacist or nurse. See section 4.

but it can be administered to children and adolescents, so you may read it for your child.

Contents of this leaflet:

• 1. What Havrix (720 Children) is and what it is used for
• 2. What you need to know before you receive Havrix (720 Children)
• 3. How to administer Havrix (720 Children)
• 4. Possible side effects
• 5. How to store Havrix (720 Children)
• 6. Contents of the pack and other information

1. What is Havrix (720 Bambini) and what it is used for

What is Havrix (720 Bambini) used for
Havrix (720 Bambini) is a vaccine used in children and adolescents between 1 year and 15 years of age to protect against infection caused by the hepatitis A virus.
Havrix (720 Bambini) can also be administered to adolescents between 16 and 18 years of age, if necessary.

What is hepatitis A

• Hepatitis A is a liver disease caused by the hepatitis A virus.
• The hepatitis A virus can be transmitted from person to person or through contact with contaminated water, food and beverages.
• The symptoms of hepatitis A range from mild to severe and may include fever, malaise, loss of appetite, diarrhea, nausea, abdominal discomfort, dark urine and jaundice (yellowing of the eyes and skin). Most people recover completely, but sometimes the disease can be severe and require hospitalization and rarely can lead to acute liver failure.

How Havrix (720 Bambini) works

• Havrix (720 Bambini) helps the body produce its own protection (antibodies) against the virus. These antibodies help protect you from the disease.
• Like all vaccines, Havrix (720 Bambini) may not fully protect all vaccinated individuals.

2. What you need to know before you receive Havrix (720 Bambini)

Havrix (720 Bambini) must not be given if:

• you have previously had an allergic reaction to any of the ingredients of the vaccine (listed in section 6) or to neomycin or formaldehyde,
• you have previously had an allergic reaction to any hepatitis A vaccine. Signs of an allergic reaction can include a itchy rash, feeling short of breath and swelling of the face and tongue.

Havrix (720 Bambini) must not be given if any of the above conditions apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before Havrix (720 Bambini) is given.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you receive Havrix (720 Bambini) if:

• you have a serious infection with a high temperature (fever). The vaccine can be given after you have recovered. A mild infection such as a cold should not be a problem but talk to your doctor about it first,
• you have a weakened immune system due to a disease or treatment with medicines. Your doctor will assess whether additional doses are needed,
• you have bleeding problems or bruise easily.

Fainting can occur after, or even before, any injection with a needle. Therefore, inform your doctor, pharmacist or nurse if you have fainted with a previous injection.

Other medicines and Havrix (720 Bambini)
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Havrix (720 Bambini) can be given at the same time as other vaccinations and immunoglobulins. A different injection site must be used for each vaccine.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you may be pregnant, or are planning to become pregnant, ask your doctor, pharmacist or nurse for advice before receiving Havrix (720 Bambini).

Driving and using machines
Havrix (720 Bambini) does not or has a minimal influence on the ability to drive and operate machines.

Havrix (720 Bambini) contains phenylalanine, polysorbate 20, sodium and potassium
This vaccine contains 0.083 mg per dose of phenylalanine.
Phenylalanine can be harmful if you have phenylketonuria (PKU), a rare genetic disorder that causes a build-up of phenylalanine in the body because the body cannot break it down properly.
This vaccine contains 0.025 mg of polysorbate 20 per dose. Polysorbates can cause allergic reactions. Tell your doctor if you have known allergies.
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.
This vaccine contains less than 1 mmol (39 mg) of potassium per dose, i.e. essentially “potassium-free”.

3. How to administer Havrix (720 Bambini)

How to administer the vaccine

• The doctor or nurse will administer Havrix (720 Bambini) as an injection into the muscle. Usually in the upper part of the arm muscle in children and adolescents.
• In young children, the injection may be administered into the thigh muscle.
• Havrix (720 Bambini) may be exceptionally injected under the skin if you suffer from thrombocytopenia or if you suffer from severe bleeding disorders.

Recommended dose

• You will receive 1 dose of Havrix (720 Bambini) (0.5 ml suspension) on the date agreed with your doctor or nurse.
• A second dose (booster) is recommended between 6 months and 12 months after the first dose, but it may be administered up to five years after the first dose, in order to ensure long-term protection.

If you receive more Havrix (720 Bambini) than you should
Overdosage is very unlikely because the vaccine is supplied in a single-dose syringe and is
administered by a doctor or nurse. Few cases of accidental administration have been reported and the side effects reported were similar to those reported with normal vaccine administration
(listed in paragraph 4).

If you forget to take a dose of Havrix (720 Bambini)
Contact your doctor who will decide if a dose is necessary and when to administer it.

4. Possible side effects

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

Serious side effects
Tell your doctor immediately if you notice any of the following serious side effects –
urgent medical treatment may be needed:

• allergic reactions - signs may include local or widespread skin rashes that may cause itching or blistering, swelling of the eyes and face, difficulty breathing or swallowing, a sudden drop in blood pressure and loss of consciousness. These reactions can occur before you leave the doctor's office. Tell your doctor immediately if you notice any of the serious side effects listed above.

Side effects that have been observed during clinical trials with Havrix (720 Children) are
as follows:
Very common(may affect more than 1 in 10 doses of vaccine)
‐ irritability
‐ pain and redness at the injection site

Common(may affect up to 1 in 10 doses of vaccine)
‐ loss of appetite
‐ headache
‐ drowsiness
‐ nausea (feeling unwell)
‐ general feeling of being unwell
‐ fever of 37.5 °C or higher
‐ swelling at the injection site

Uncommon(may affect up to 1 in 100 doses of vaccine)
‐ stuffy or runny nose
‐ vomiting (feeling unwell)
‐ diarrhoea
‐ skin rash
‐ hard lump at the injection site

Side effects that have been observed after marketing of Havrix (720
Children) are as follows:
‐ seizures or convulsions
‐ inflammation of the blood vessels leading to narrowing or blockage (vasculitis)
‐ severe allergic reaction causing swelling of the face, tongue or throat which may cause
difficulty swallowing or breathing
‐ hives, red patches, often itchy that start on the limbs and sometimes on the face and the rest of the
body
‐ joint pain

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through
the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse . By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Havrix (720 Bambini)

Keep this vaccine out of the sight and reach of children.
Do not use this vaccine after the expiry date that is stated on the packaging. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Store in the original packaging to protect it from light.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Havrix (720 Children) contains
The active substance is hepatitis A virus (inactivated) adsorbed on hydrated aluminium hydroxide. Each dose
of 0.5 ml of vaccine contains 720 ELISA units of hepatitis A virus.
The other ingredients are amino acids for injectable preparations (containing phenylalanine), dibasic sodium phosphate,
monobasic potassium phosphate, polysorbate 20 (E432), potassium chloride, sodium chloride, water
for injectable preparations (see section 2).

Description of Havrix (720 Children) and contents of the pack
Injectable suspension.
Havrix (720 Children) is a turbid injectable liquid.
Havrix (720 Children) is available in a pre-filled 1 dose syringe with or without needles in packs of
1, 5, 10 and 25.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline S.p.A. – Viale dell’Agricoltura, 7 - 37135 Verona - Italy

Manufacturer
GlaxoSmithKline Biologicals s.a. - Rue de l’Institut, 89 - Rixensart, Belgium

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Austria Havrix (Hepatitis A vaccine)
Junior 720 IU/0.5 ml
Belgium, Cyprus, Luxembourg Havrix Junior 720
Bulgaria HAVRIX 720 suspension for injection (Junior
monodose)
Хаврикс 720 инжекционна суспензия (доза за деца)
Czech Republic Havrix Junior monodose
Denmark, Finland, Iceland, Norway Havrix
Estonia Havrix, 720 ELISA units/ml suspension for injection
France HAVRIX INFANTS AND CHILDREN 720 U/0.5
ml
Germany Havrix 720 Children
Greece, Italy HAVRIX
Hungary Havrix 720 Junior
Ireland Havrix Junior Monodose
Latvia Havrix 720 ELISA units/0.5 ml suspension
for injections
Lithuania Havrix 720 ELISA units/0.5 ml injection suspension
Malta Havrix Junior Monodose Vaccine
Netherlands Havrix Junior
Poland HAVRIX 720 JUNIOR
Portugal Havrix 720 Júnior
Romania HAVRIX JUNIOR 720 HEPATITIS A VACCINE
Slovak Republic HAVRIX 720 Junior monodose
Slovenia HAVRIX 720 PAEDIATRIC
Spain Havrix 720 Junior injectable suspension in prefilled syringe
Sweden Havrix 720 ELISA U/0.5 ml

Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency.
<----------------------------------------------------------------------------------------------------------------------------->
The following information is intended for healthcare professionals only:
Havrix (720 Children) is a turbid liquid suspension. During storage, a fine white sediment may form with a clear supernatant.
The vaccine should be visually inspected before use to check for the absence of foreign particles and/or changes in physical appearance. Before administering Havrix (720 Children),
the syringe should be shaken well to obtain a slightly cloudy white suspension. If the contents
appear different, discard the vaccine.
Instructions for the pre-filled syringe

Luer Lock adapter
Hold the syringe by the body, not by the
plunger.
Unscrew the syringe cap by rotating it counter-
clockwise.
Plunger
Body
Cap

Needle hub
To attach the needle to the syringe, gently connect
the needle hub to the Luer Lock adapter and rotate a quarter turn clockwise until a click is felt.
Do not pull the syringe plunger out of the body.
If this happens, do not administer the vaccine.
Disposal
Unused medicinal product and waste materials derived from such medicinal product should be disposed of in accordance with
local regulations.

HAVRIX

Adults Injectable suspension in pre-filled syringe
Hepatitis A vaccine (inactivated) (adsorbed)

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, pharmacist or nurse.
• This vaccine has been prescribed only for you or your child. Do not give it to other people.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

but it can be administered to adolescents from 16 years of age, so you may need to read it for your child.

Contents of this leaflet:

• 1. What Havrix (1440 Adults) is and what it is used for
• 2. What you need to know before you receive Havrix (1440 Adults)
• 3. How to administer Havrix (1440 Adults)
• 4. Possible side effects
• 5. How to store Havrix (1440 Adults)
• 6. Contents of the pack and other information

1. What Havrix (1440 Adulti) is and what it is used for

What Havrix (1440 Adulti) is used for
Havrix (1440 Adulti) is a vaccine used to protect adolescents from 16 years of age and adults
from infection caused by the hepatitis A virus.

What is hepatitis A
‐ Hepatitis A is a liver disease caused by the hepatitis A virus.
‐ The hepatitis A virus can be transmitted from person to person or through contact with
contaminated water, food and beverages.
‐ The symptoms of hepatitis A range from mild to severe and may include fever, malaise, loss
of appetite, diarrhea, nausea, abdominal discomfort, dark-colored urine and jaundice (yellowing of the
eyes and skin). Most people recover completely, but sometimes the
disease can be severe and require hospitalization and rarely can lead to
acute liver failure.

How Havrix (1440 Adulti) works
‐ Havrix (1440 Adulti) helps the body produce its own protection (antibodies) against the virus.
These antibodies help to protect you from the disease.

• Like all vaccines, Havrix (1440 Adulti) may not completely protect all vaccinated individuals.

2. What you need to know before you receive Havrix (1440 Adults)

Havrix (1440 Adults) must not be administered if:

• you have previously had an allergic reaction to any of the ingredients of the vaccine (listed in section 6) or to neomycin or formaldehyde,
• you have previously had an allergic reaction to any vaccine against hepatitis A.

The signs of an allergic reaction may include a itchy rash, feeling of shortness of breath
and swelling of the face and tongue.
Havrix (1440 Adults) must not be administered if any of the above conditions have occurred.
If you are not sure, talk to your doctor, pharmacist or nurse before Havrix (1440 Adults) is
administered.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before receiving Havrix if:

• you have a serious infection with a high temperature (fever). The vaccine can be administered after you have recovered. A mild infection such as a cold should not be a problem but talk to your doctor about it first,
• you have a weakened immune system due to an illness or treatment with medications. The doctor will assess whether additional doses are necessary,
• you have bleeding problems or bruise easily.

Fainting can occur after, or even before, any injection with a needle. Therefore, inform your
doctor, pharmacist or nurse if you have fainted with a previous injection.

Other medicines and Havrix (1440 Adults)
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might
take any other vaccine or medicine.
Havrix (1440 Adults) can be administered simultaneously with other vaccinations and
immunoglobulins. A different injection site must be used for each vaccine.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect or are planning a pregnancy, ask your
doctor, pharmacist or nurse for advice before receiving Havrix (1440 Adults).

Driving and using machines
Havrix (1440 Adults) does not affect or has a minimal effect on the ability to drive vehicles and use
machinery.

Havrix (1440 Adults) contains phenylalanine, polysorbate 20, sodium and potassium
This vaccine contains 0.166 mg per dose of phenylalanine.
Phenylalanine may be harmful if you have phenylketonuria (PKU), a rare genetic disease that
causes a build-up of phenylalanine because the body cannot process it correctly.
This vaccine contains 0.050 mg of polysorbate 20 per dose. Polysorbates can cause allergic
reactions. Tell your doctor if you have known allergies.
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.
This vaccine contains less than 1 mmol (39 mg) of potassium per dose, i.e. essentially “potassium-free”.

3. How to administer Havrix (1440 Adults)

How to administer the vaccine

• The doctor or nurse will administer Havrix (1440 Adults) via intramuscular injection. Usually in the upper arm.
• Havrix (1440 Adults) can exceptionally be injected under the skin if you suffer from thrombocytopenia or if you have severe bleeding disorders.

Recommended dose

• You will receive 1 dose of Havrix (1440 Adults) (1 ml suspension) on the date agreed with the doctor or nurse.
• A second dose (booster) is recommended between 6 months and 12 months after the first dose, but it can be administered up to five years after the first dose, in order to ensure long-term protection.

If you receive more Havrix (1440 Adults) than you should
Overdosage is very unlikely because the vaccine is supplied in a single-dose syringe and is administered by a doctor or nurse. Few cases of accidental administration have been reported and the side effects reported were similar to those reported with normal vaccine administration (listed in paragraph 4).

If you forget to take a dose of Havrix (1440 Adults)
Contact your doctor who will decide if a dose is necessary and when to administer it.

4. Possible side effects

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

Serious side effects
Tell your doctor immediately if you notice any of the following serious side effects –
urgent medical attention may be needed:

• allergic reactions - signs can include local or widespread skin rashes that may cause itching or blistering, swelling of the eyes and face, difficulty breathing or swallowing, a sudden drop in blood pressure and loss of consciousness. These reactions can occur before you leave the doctor's office. Tell your doctor immediately if you notice any of the serious side effects listed above.

Side effects that have been reported during clinical trials with Havrix (1440 Adults) were
as follows:
Very common(may affect more than 1 in 10 people)

• headache – pain and redness at the injection site – fatigue

Common(may affect up to 1 in 10 people)
– loss of appetite
– nausea (feeling unwell)
– vomiting (feeling unwell)
– diarrhoea
– general feeling of being unwell
– fever of 37.5 °C or higher
– swelling or hard lump at the injection site

Uncommon(may affect up to 1 in 100 people)
– upper respiratory tract infection
– stuffy or runny nose
– dizziness
– muscle aches, muscle stiffness not caused by exercise
– flu-like symptoms, such as high fever, sore throat, runny nose, cough and chills

Rare(may affect up to 1 in 1,000 people)
– decreased or loss of skin sensation to pain or touch
– tingling
– itching
– chills

Side effects reported after marketing of Havrix have been the
following:
– seizures or convulsions
– inflammation of blood vessels leading to narrowing or blockage (vasculitis)
– severe allergic reaction causing swelling of the face, tongue or throat which can cause
difficulty swallowing or breathing
– hives, red patches, often itchy that start on the limbs and sometimes on the face and the rest of the
body
– joint pain

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse . By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Havrix (1440 Adults)

Keep this vaccine out of the sight and reach of children.
Do not use this vaccine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Store in the original package to protect it from light.
Do not dispose of any medicine in waste water 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 Havrix (1440 Adults) contains
The active ingredient is hepatitis A virus (inactivated) adsorbed on hydrated aluminum hydroxide. Each dose
of 1 ml of vaccine contains 1440 ELISA units of hepatitis A virus.
The other ingredients are amino acids for injectable preparations (containing phenylalanine), dibasic sodium phosphate,
monobasic potassium phosphate, polysorbate 20 (E432), potassium chloride, sodium chloride, water
for injectable preparations (see section 2).

Description of Havrix (1440 Adults) and package contents
Injectable suspension.
Havrix (1440 Adults) is a turbid injectable liquid.
Havrix (1440 Adults) is available in a pre-filled 1 dose syringe with or without needles in packs of
1, 5, 10 and 25.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline S.p.A. – Viale dell’Agricoltura, 7 - 37135 Verona - Italy

Manufacturer
GlaxoSmithKline Biologicals s.a. - Rue de l’Institut, 89 - Rixensart, Belgium

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Austria Havrix (Hepatitis A Vaccine)
1440 IU/1 ml
Belgium, Germany, Hungary, Luxembourg,
Netherlands
Havrix 1440
Bulgaria HAVRIX 1440 suspension for injection (Adult dose)
Хаврикс 1440 инжекционна суспензия (доза за
възрастни)
Cyprus Havrix Adults 1440
Czech Republic, Denmark, Finland,
Iceland, Norway
Havrix
Estonia Havrix, 1440 ELISA units/ml injection suspension
France HAVRIX 1440 U/1ml ADULTES
Greece, Italy HAVRIX
Ireland Havrix Monodose
Latvia Havrix 1440 ELISA units/ml suspension for injection
Lithuania Havrix 1440 ELISA units/ml injection suspension
Malta Havrix Monodose Vaccine
Poland HAVRIX ADULT
Portugal Havrix 1440 Adulto
Romania HAVRIX ADULT 1440 HEPATITIS A VACCINE
Slovak Republic HAVRIX 1440 Adult dose
Slovenia HAVRIX 1440
Spain Havrix 1440 Adult injectable suspension in prefilled syringe
Sweden Havrix 1440 ELISA U/1 ml

Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency.
<----------------------------------------------------------------------------------------------------------------------------->
The following information is intended for healthcare professionals only:
Havrix (Adults 1440) is a turbid liquid suspension. During storage, a fine white sediment may form with a clear supernatant.
The vaccine must be visually inspected before use to check for the absence of foreign particles and/or changes in physical appearance. Before administering Havrix (1440 Adults), the
syringe must be shaken well to obtain a slightly opaque white suspension. If the contents
appear different, discard the vaccine.
Instructions for the pre-filled syringe

Luer Lock Adapter
Hold the syringe by the body, not by the
plunger.
Unscrew the syringe cap by rotating it in an
anti-clockwise direction.
Plunger
Body
Cap

Needle hub
To attach the needle to the syringe, gently connect
the needle hub to the Luer Lock Adapter and rotate a quarter turn clockwise until a click is felt.
Do not pull the syringe plunger out of the body.
If this happens, do not administer the vaccine.
Disposal
Unused medicinal product and waste materials derived from such medicinal product should be disposed of in accordance with local regulations.