Havrix adult

Havrix Adult, suspension for injection
Vaccine against hepatitis A virus, inactivated, adsorbed
Please read this leaflet carefully before receiving the vaccine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This vaccine has been prescribed for a specific individual only. Do not pass it on to others.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

The content of this leaflet has been prepared with the assumption that it will be read by the
person receiving the vaccine. However, since this vaccine may also be administered to individuals
aged 16 years and older, it is possible that parents or guardians may review the information.
Leaflet contents:

1. What Havrix Adult vaccine is and what it is used for
2. Important information before receiving Havrix Adult vaccine
3. How to use Havrix Adult vaccine
4. Possible side effects
5. How to store Havrix Adult vaccine
6. Contents of the pack and other information

1. What Havrix Adult vaccine is and what it is used for

What is Havrix Adult vaccine used for?
Havrix Adult vaccine is used to prevent hepatitis A virus infection (HAV) in individuals aged 16 years and older who are at risk of exposure to the hepatitis A virus (HAV).

What is hepatitis A?
‐ Hepatitis A is a liver disease caused by the hepatitis A virus (HAV).
‐ The HAV virus spreads from person to person, or through contact with contaminated water, food, and drinks.
‐ Symptoms of hepatitis A range from mild to severe and may include fever, malaise, loss of appetite, diarrhoea, nausea, abdominal discomfort, darkening of the urine, and jaundice (yellowing of the eyes and skin). Most patients recover completely, but sometimes the disease can be severe and require hospitalization, and in rare cases may lead to acute liver failure.

How Havrix Adult works:
‐ Havrix Adult helps the body develop its own protection (antibodies) against the virus. These antibodies help protect the body against the disease.
‐ As with all vaccines, Havrix Adult may not fully protect all vaccinated individuals.

2. Important information before using Havrix Adult vaccine

When not to use Havrix Adult vaccine
- if the patient is allergic to the active substance or to any of the other ingredients of this
vaccine (listed in section 6), or to neomycin or formaldehyde,
- if an allergic reaction occurred after any previous vaccination against hepatitis A virus.
Symptoms of an allergic reaction may include itchy skin rash, difficulty breathing,
swelling of the face or tongue.
Do not administer Havrix Adult vaccine if any of the above situations apply to the patient. If in doubt,
consult a doctor, pharmacist, or nurse before administering Havrix Adult vaccine.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before receiving Havrix Adult vaccine if:
- the patient has a severe infection with high fever. In such a case, vaccination should be postponed. A mild infection, such as a cold, should not prevent vaccination, but the doctor should be informed about it first,
- the patient has a weakened immune system due to disease and/or medications being used. The doctor will decide whether additional doses are needed,
- the patient has bleeding disorders or bruises easily.

Fainting may occur during or even before any injectable vaccination. Therefore, inform the doctor, pharmacist, or nurse if the patient has ever fainted during an injection.

Havrix Adult vaccine and other medicines
Tell your doctor, pharmacist, or nurse about all medicines the patient is currently taking or has recently taken, including any medicines planned for future use, as well as any recently received vaccines.
Havrix Adult vaccine can be given at the same time as certain other vaccines and immunoglobulins, provided that different injection sites are used.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor, pharmacist, or nurse before receiving this vaccine.

Driving and operating machinery
Havrix Adult vaccine has no effect or has a negligible effect on the ability to drive and operate machinery.

Havrix Adult contains phenylalanine, polysorbate 20, sodium, and potassium
This vaccine contains 0.166 mg of phenylalanine per dose.
Phenylalanine may be harmful in patients with phenylketonuria, a rare inherited disorder in which phenylalanine accumulates in the body because it is not properly metabolized.

This vaccine contains 0.050 mg of polysorbate 20 per dose. Polysorbates may cause allergic reactions.
Inform the doctor if the patient has any known allergies.

This vaccine contains less than 1 mmol (23 mg) of sodium per dose; therefore, the vaccine is considered "sodium-free".
This vaccine contains potassium, less than 1 mmol (39 mg) per dose; therefore, the vaccine is considered "potassium-free".

3. How to use the Havrix Adult vaccine

How Havrix Adult vaccine is administered

• Havrix Adult is administered by intramuscular injection, usually into the upper arm.
• In patients with reduced platelet count or with severe coagulation disorders,
  Havrix Adult may exceptionally be administered subcutaneously.

Dosage

• The patient will receive 1 dose of the Havrix Adult vaccine (1 ml of suspension) on a date agreed with
  the doctor or nurse.
• The second dose (booster dose) should be given between 6 and 12 months after the first dose, but may be administered up to five years after the first dose to ensure long-term protection.

Accidental overdose of Havrix Adult vaccine
Overdose is highly unlikely, as the vaccine is supplied in a vial or syringe containing a single dose and is administered by a doctor or nurse. A few cases of accidental overdose have been reported, and the adverse reactions reported were similar to those observed with normal administration of the vaccine (listed in section 4).

If a dose of Havrix Adult vaccine has not been received on time
You should contact your doctor, who will decide whether a further dose is needed.

4. Possible adverse reactions

Like all medicines, this vaccine may cause adverse reactions, although not everyone will experience them.

Serious adverse reactions

Seek immediate medical advice if any of the following serious adverse reactions occur – urgent treatment may be required:

• Allergic reactions – symptoms may include localised or widespread rash, which may be itchy or blistering, swelling of the eyes and face, difficulty breathing or swallowing, sudden drop in blood pressure, and loss of consciousness.

These reactions may occur before leaving the doctor's office.

If any of the serious adverse reactions listed above occur, seek immediate medical advice.

During clinical trials of Havrix Adult, the following adverse reactions were reported:

Very common (may occur in more than 1 in 10 doses):

• Headache
• Pain and redness at the injection site
• Fatigue

Common (may occur in up to 1 in 10 doses):

• Loss of appetite
• Nausea
• Vomiting
• Diarrhoea
• General malaise
• Fever ≥ 37.5°C
• Swelling or hardening at the injection site

Uncommon (may occur in up to 1 in 100 doses):

• Upper respiratory tract infection
• Blocked nose or runny nose
• Dizziness
• Muscle pain, muscle stiffness not caused by exercise
• Influenza-like symptoms such as high temperature, sore throat, runny nose, cough, and chills

Rare (may occur in up to 1 in 1000 doses):

• Decreased or loss of skin sensitivity to pain or touch
• Tingling sensation
• Itching
• Chills

The following adverse reactions have been reported after marketing of Havrix Adult:

• Seizures
• Narrowing or blockage of blood vessels
• Severe allergic reaction causing swelling of the face, tongue or throat, which may lead to difficulty in swallowing or breathing
• Urticaria (hives), red, often itchy patches, starting on the limbs and sometimes spreading to the face and rest of the body
• Joint pain

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department for Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49-21-301, Fax: +48 22 49-21-309, Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the responsible entity.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Havrix Adult vaccine

Keep the vaccine out of the sight and reach of children.
Do not use this vaccine after the expiry date stated on the packaging. The expiry date (EXP) refers to the last day of the specified month.
Batch number (Lot).
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Keep in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Havrix Adult vaccine contains
The active substance is inactivated hepatitis A virus, adsorbed onto aluminium hydroxide.
Each 1 ml dose of the vaccine contains 1440 ELISA units of hepatitis A virus.
Other components are: amino acids for injection (including phenylalanine), monosodium phosphate,
potassium dihydrogen phosphate, polysorbate 20 (E432), potassium chloride, sodium chloride, water for injection (see section 2).

What Havrix Adult vaccine looks like and contents of the pack
Injection suspension.
Havrix Adult is a milky liquid for injection.
Havrix Adult is available in a single-dose vial, in pack sizes of 1, 5, 10, 25 and 100 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
GlaxoSmithKline Biologicals S.A.
rue de l’Institut 89
1330 Rixensart, Belgium
For further information, contact the local representative of the Marketing Authorisation Holder:
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
Tel. +48 (22) 576-90-00

This medicinal product is authorised in the European Economic Area under the following names:
Austria Havrix (Hepatitis A vaccine)
1440 EI.U/1 ml
Belgium, Germany, Hungary, Luxembourg, Havrix 1440
Netherlands
Bulgaria HAVRIX 1440 suspension for injection (Adult dose)
Хаврикс 1440 инжекционна суспензия (доза за възрастни)
Cyprus Havrix Adults 1440
Czech Republic, Denmark, Finland, Iceland, Havrix
Norway
Estonia Havrix, 1440 ELISA units/ml injection suspension
France HAVRIX 1440 U/1ml ADULTES

Other sources of information
Detailed information about this vaccine is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

Information intended exclusively for healthcare professionals:

Havrix Adult is a cloudy, liquid suspension. During storage, a fine white sediment and a clear liquid above may form.
Before administration, the vaccine should be inspected for the presence of foreign particles and (or) physical changes. Prior to use, the vial of Havrix Adult vaccine should be shaken to obtain a white, slightly opaque suspension. The vaccine must not be administered if it appears different.
Disposal
Any unused medicinal product or waste material derived from it must be disposed of in accordance with local regulations.
Havrix Adult, suspension for injection in pre-filled syringe
Hepatitis A virus vaccine (inactivated, adsorbed)
Please read the entire leaflet carefully before using the vaccine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This vaccine has been prescribed for a specific individual. Do not pass it on to others.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

The content of this leaflet has been formulated with the assumption that it will be read by the person receiving the vaccine. However, since this vaccine may be administered to adolescents aged 16 years and older, it is possible that parents or guardians may also read this information.
Contents of the leaflet:

1. What Havrix Adult vaccine is and what it is used for
2. Important information before using Havrix Adult vaccine
3. How to use Havrix Adult vaccine
4. Possible side effects
5. How to store Havrix Adult vaccine
6. Contents of the package and other information

1. What Havrix Adult vaccine is and what it is used for

What Havrix Adult vaccine is used for
Havrix Adult vaccine is used to prevent hepatitis A virus infection (HAV) in individuals aged 16 years and older who are at risk of contracting hepatitis A virus (HAV).
What is hepatitis A:
‐ Hepatitis A is a liver disease caused by the hepatitis A virus (HAV).
‐ The HAV virus spreads from person to person or through contact with contaminated water, food, and drinks.
‐ Symptoms of hepatitis A range from mild to severe and may include fever, malaise, loss of appetite, diarrhea, nausea, abdominal discomfort, darkening of urine, and jaundice (yellowing of the eyes and skin). Most patients recover completely, but sometimes the disease can be severe, requiring hospitalization, and in rare cases may lead to acute liver failure.
How Havrix Adult works:
‐ Havrix Adult helps the body produce its own protection (antibodies) against the virus. These antibodies help protect the body against disease.
‐ As with all vaccines, Havrix Adult may not protect all vaccinated individuals.

2. Important information before using Havrix Adult vaccine

When not to use Havrix Adult vaccine
‐ if the patient is allergic to the active substance or any of the other ingredients of this vaccine (listed in section 6) or to neomycin or formaldehyde,
‐ if an allergic reaction occurred after any previous hepatitis A vaccination.
Symptoms of an allergic reaction may include itchy skin rash, difficulty breathing, swelling of the face or tongue.
Do not administer Havrix Adult vaccine if any of the above situations apply to the patient. If in doubt, consult your doctor, pharmacist, or nurse before administering Havrix Adult vaccine.
Warnings and precautions
Before receiving Havrix Adult vaccine, discuss with your doctor, pharmacist, or nurse if:
‐ the patient has a severe infection with high fever. In such a case, vaccination will be postponed. A mild infection, such as a cold, should not be a contraindication to vaccination, but you should inform the doctor first,
‐ the patient has a weakened immune system due to illness and (or) medications being taken. The doctor will decide whether additional doses are needed,
‐ the patient has bleeding problems or bruises easily.
Fainting may occur during or even before administration of any injectable vaccine. Therefore, inform the doctor, pharmacist, or nurse if the patient has ever fainted during an injection.
Havrix Adult and other medicines
Inform the doctor, pharmacist, or nurse about all medicines currently or recently taken by the patient, any medicines the patient plans to take, and any recently received vaccines.
Havrix Adult vaccine can be administered simultaneously with certain other vaccines and immunoglobulins, provided that injection sites are different.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor, pharmacist, or nurse before using this vaccine.
Driving and operating machinery
Havrix Adult vaccine has no effect or has a negligible effect on the ability to drive and operate machinery.
Havrix Adult contains phenylalanine, polysorbate 20, sodium, and potassium
This vaccine contains 0.166 mg of phenylalanine per dose.
Phenylalanine may be harmful to patients with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body because the body does not eliminate it properly.
This vaccine contains 0.050 mg of polysorbate 20 per dose. Polysorbates may cause allergic reactions.
Inform the doctor if the patient has any known allergies.
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, meaning the vaccine is considered "sodium-free."
This vaccine contains potassium, less than 1 mmol (39 mg) per dose, meaning the vaccine is considered "potassium-free."

3. How to use Havrix Adult vaccine

How Havrix Adult is administered
‐ Havrix Adult is administered by intramuscular injection, usually into the upper arm.
‐ In patients with low platelet counts or serious coagulation disorders, Havrix Adult vaccine may exceptionally be administered subcutaneously.
Dosage
‐ The patient will receive one dose of Havrix Adult vaccine (1 ml suspension) on a date agreed with the doctor or nurse.
‐ A second dose (booster dose) is recommended between 6 and 12 months after the first dose, but may be given up to five years after the first dose to ensure long-term protection.
Accidental overdose of Havrix Adult vaccine
Overdose is very unlikely because the vaccine is supplied in a single-dose vial or syringe and is administered by a doctor or nurse. A few cases of accidental overdose have been reported, and the adverse reactions reported were similar to those reported with normal administration of the vaccine (listed in section 4).
If the next dose of Havrix Adult vaccine is not received on time
Contact the doctor, who will decide whether another dose is needed.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everyone will experience them.
Serious side effects
Immediately inform the doctor if any of the following serious side effects occur – urgent treatment may be required:
‐ allergic reactions – symptoms may include local or widespread rashes, which may be itchy or blistering, swelling of the eyes and face, difficulty breathing or swallowing, sudden drop in blood pressure, and loss of consciousness.
These reactions may occur before leaving the doctor's office.
If any of the serious side effects listed above occur, inform the doctor immediately.
The following side effects occurred during clinical trials of Havrix Adult:
Very common (may occur in more than 1 in 10 doses of the vaccine):

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

Common (may occur in no more than 1 in 10 doses of the vaccine):

• decreased appetite
• nausea
• vomiting
• diarrhea
• general malaise
• fever ≥ 37.5°C
• swelling or hardening at the injection site

Uncommon (may occur in no more than 1 in 100 doses of the vaccine):

• upper respiratory tract infection
• stuffy nose or runny nose
• dizziness
• muscle pain, muscle stiffness, not caused by exercise
• influenza-like symptoms such as high fever, sore throat, runny nose, cough, and chills

Rare (may occur in no more than 1 in 1,000 doses of the vaccine):

• decreased or loss of skin sensitivity to pain or touch
• tingling
• itching
• chills

The following side effects have been reported after Havrix Adult vaccine was marketed:
‐ seizures
‐ narrowing or blockage of blood vessels
‐ severe allergic reaction causing swelling of the face, tongue, or throat, which may cause difficulty swallowing or breathing
‐ urticaria (hives), red, often itchy patches that start on the limbs and sometimes spread to the face and rest of the body
‐ joint pain
Reporting of side effects
If any adverse reactions occur, including those not listed in this leaflet, inform the doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Havrix Adult vaccine

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

6. Contents of the package and other information

What Havrix Adult vaccine contains
The active substance in the vaccine is hepatitis A virus (inactivated), adsorbed on aluminium hydroxide. Each 1 ml dose of vaccine contains 1440 ELISA units of hepatitis A virus.
Other ingredients: amino acids for injection (including phenylalanine), sodium hydrogen phosphate, potassium dihydrogen phosphate, polysorbate 20 (E432), potassium chloride, sodium chloride, water for injections (see section 2).
What Havrix Adult vaccine looks like and contents of the pack
Suspension for injection.
Havrix Adult vaccine is a cloudy liquid for injection.
Havrix Adult vaccine is available as a single-dose pre-filled syringe with or without needles, in packs of 1, 5, 10, and 25 units.
Not all pack sizes may be marketed.
Marketing authorization holder and manufacturer
GlaxoSmithKline Biologicals S.A.
rue de l’Institut 89
1330 Rixensart, Belgium
For further information, contact the local representative of the marketing authorization holder:
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. +48 (22) 576-90-00
This medicine is authorized for marketing in the European Economic Area under the following names:

Greece, Italy HAVRIX
Ireland Havrix Monodose
Latvia Havrix 1440 ELISA units/ml suspension for injection
Lithuania Havrix 1440 ELISA units/ml injectable suspension
Malta Havrix Monodose Vaccine
Poland HAVRIX ADULT
Portugal Havrix 1440 Adulto
Romania HAVRIX ADULT 1440 VACCIN HEPATITIC A
Slovak Republic HAVRIX 1440 Dosis adulta
Slovenia HAVRIX 1440
Spain Havrix 1440 Adulto, injectable suspension in pre-filled syringe
Sweden Havrix 1440 ELISA U/1 ml
Other sources of information
Detailed information on this vaccine is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

Information intended exclusively for healthcare professionals:

Havrix Adult vaccine is a cloudy, liquid suspension. During storage, a fine white sediment and a clear liquid above may form.
Before administration, the vaccine should be inspected visually for the presence of foreign particles and/or other physical changes. Prior to use, the Havrix Adult pre-filled syringe should be shaken to obtain a white, slightly opaque suspension. Do not administer if the vaccine appears different.

Instructions for the pre-filled syringe

Hold the pre-filled syringe by the barrel, not by the plunger.
Luer Lock adapter
Remove the syringe cap by twisting it counterclockwise.
Plunger
Barrel
Cap

Needle adapter
Attach the needle to the pre-filled syringe by connecting the needle adapter to the Luer Lock adapter (LLA) and turning it one-quarter turn clockwise until a click is felt, indicating secure attachment.
Do not remove the plunger from the syringe barrel. If this occurs, do not administer the vaccine.

Disposal
Any unused portions of the medicinal product or waste materials must be disposed of in accordance with local regulations.