VAQTA 50 U Injectable suspension

Зміст інструкції

1. VAQTA 50 U/1 mL
   1. What is VAQTA 50 U/1 mL and what is it used for
   2. What you need to know before you are given VAQTA 50 U/1 mL
   3. How VAQTA 50 U/1 mL is administered
   4. Possible side effects
   5. How to store VAQTA 50 U/1 mL
   6. Package contents and other information
2. VAQTA
   1. What is VAQTA 25 U/0.5 mL and what is it used for
   2. What you need to know before you are given VAQTA 25 U/0.5 mL
3. VAQTA 25 U/0.5 mL can be administered simultaneously with human immunoglobulins
   1. How VAQTA 25 U/0.5 mL is administered
   2. Possible side effects
   3. How to store VAQTA 25U/0,5 mL
   4. Package Contents and Other Information

VAQTA 50 U/1 mL

Injectable suspension in pre-filled syringe
Inactivated, adsorbed hepatitis A vaccine
For adults

Read this leaflet carefully before you or your child are vaccinated 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. Do not give it to other people.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What VAQTA 50 U/1 mL is and what it is used for
• 2. What you need to know before you are given VAQTA 50 U/1 mL
• 3. How VAQTA 50 U/1 mL is administered
• 4. Possible side effects
• 5. How to store VAQTA 50 U/1 mL
• 6. Contents of the pack and other information

1. What is VAQTA 50 U/1 mL and what is it used for

VAQTA 50 U/1 mL is a vaccine. Vaccines are used to protect against infectious diseases.
They work by stimulating the body to produce its own protection against the disease
for which the vaccine is specific.
VAQTA 50 U/1 mL helps to protect adults (aged 18 years and over) against the disease
caused by the hepatitis A virus.
Hepatitis A is an infection caused by a virus that affects the liver. It can be contracted through
food or drinks that contain the virus. Symptoms include jaundice (yellowing of the skin and eyes) and a general feeling of illness.
As soon as you receive an injection of VAQTA 50 U/1 mL, your body's natural defenses
will begin to produce protection (antibodies) against the hepatitis A virus. However, it is
generally necessary to allow a period of 2 to 4 weeks after the injection for you to become
protected.
VAQTA 50 U/1 mL will not prevent hepatitis caused by infectious agents other than the hepatitis A virus.
Furthermore, if you are already infected with the hepatitis A virus at the time of administration of VAQTA
50 U/1 mL, vaccination may not prevent the disease.
VAQTA 50 U/1 mL protects against hepatitis A, but cannot cause hepatitis A infection.

2. What you need to know before you are given VAQTA 50 U/1 mL

It is important that you inform your doctor or nurse if any of the following points apply to you. If there is something you do not understand, ask your doctor or nurse for an explanation.

VAQTA 50 U/1 mL must not be given

• if you are allergic to the active ingredient or to any of the other ingredients of VAQTA 50 U/1 mL (listed in section 6) or to neomycin and formaldehyde (see “Ask your doctor, pharmacist or nurse before VAQTA 50 U/1 mL is given to you”).
• if you have a severe infection with fever. Your doctor will decide when the vaccine can be given.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given VAQTA
50 U/1 mL

• If you have had an allergic reaction following a previous dose of VAQTA 50 U/1 mL.
• This vaccine may contain traces of an antibiotic called neomycin and a substance called formaldehyde, both of which are used during the manufacturing process of the vaccine and may be present in trace amounts in the vaccine.
• If you have any blood clotting disorder because of which you bruise easily or bleed for a long time after minor cuts (e.g. due to bleeding problems or treatment with anticoagulant medicines).
• If you have a weakened immune system due to cancer, treatments that affect the immune system, or any other disease. The vaccine may not be as effective as in people with a healthy immune system. If possible, it is recommended to postpone vaccination until these diseases have healed or treatment has ended.

The container of this medicine contains rubber latex. Rubber latex may cause serious
allergic reactions.
As with other vaccines, VAQTA 50 U/1 mL may not fully protect all vaccinated people.
Tell your doctor if you have a history of jaundice or if you have lived in an area where hepatitis A is common. The
doctor will assess whether to perform a test to measure hepatitis A antibodies before vaccination.

Other medicines and VAQTA 50 U/1 mL
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Other vaccines
Because VAQTA 50 U/1 mL does not contain any live bacteria or viruses, it can generally be
given at the same time as other vaccines, but using different injection sites (a
different part of the body, e.g., the other arm or leg). VAQTA 50 U/1 mL must not be
mixed in the same syringe with other vaccines.
Studies have shown that VAQTA 50 U/1 mL can be given concurrently with the
yellow fever vaccine and the polysaccharide typhoid vaccine.
Studies conducted on the pediatric formulation have shown that the vaccine can be given
concurrently with the measles, mumps, rubella, varicella, 7-valent pneumococcal conjugate and inactivated polio vaccines.
Immunoglobulins (antibodies)
Sometimes, it may be necessary to administer an injection of human immunoglobulins (antibodies) to
try to protect you until the vaccine begins to produce protection. VAQTA 50U/1 mL can
be given concurrently with human immunoglobulins (antibodies), provided that the two
injections are given at different injection sites.
Medicines that affect the immune system or the blood
Refer to the “Warnings and precautions” section.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before receiving the vaccination.

Driving and using machines
There is no data to suggest that VAQTA 50 U/1 mL may affect the ability to drive
vehicles and use machines.

VAQTA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially “sodium-free”.

3. How VAQTA 50 U/1 mL is administered

Dosage
VAQTA 50 U/1 mL must be administered by injection by doctors or nurses who have been
trained in the use of vaccines and who are equipped to manage any rare, serious allergic
reaction. Those who need to be vaccinated will receive a first dose followed by a second
dose (booster).
First dose
Adults aged 18 years or older should receive a single dose injection of 1.0 mL
(50 U). The first dose of vaccine will protect you from hepatitis A infection within 2-4 weeks.
Second dose (booster)
Individuals who have received a first dose of vaccine should receive the second dose (booster) of
1.0 mL (50 U), after 6-18 months.
Long-term protection requires a second dose of vaccine (booster dose). Healthy adults
who had received two doses of vaccine have shown to have persistent antibody levels for
at least 6 years. Antibodies to hepatitis A are expected to persist for at least 25 years after
vaccination.

Use in children and adolescents
VAQTA 50 U/1 mL is not recommended in individuals under the age of 18 years.

Method and route of administration
The doctor or nurse will administer VAQTA 50 U/1 mL by intramuscular injection into the
upper arm (deltoid muscle).
People who are at risk of bleeding following an injection (e.g., hemophiliacs) may
receive VAQTA 50 U/1 mL by subcutaneous injection, rather than into the muscle, in order to
reduce the risk of bleeding.
VAQTA 50 U/1 mL must not be administered into a blood vessel.

4. Possible side effects

Like all medicines and vaccines, this vaccine can cause side effects, although not everybody gets them.
As with all vaccines, allergic reactions may occur, which, in rare cases, can lead to
shock. These reactions may include:

• urticaria
• difficulty breathing
• swelling of the face, tongue and throat
• dizziness
• collapse When these signs or symptoms occur, they usually develop shortly after the injection is given and while you are still in the hospital or doctor's office. Ifany of these symptoms should occur after you have left the place where you werevaccinated, consult a doctor IMMEDIATELY.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 VAQTA 50 U/1 mL

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 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.
Do not use this vaccine if you notice an unusual appearance (see section 6) or if you observe the presence of
foreign particles.
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 VAQTA 50 U/1 mL contains
The active ingredient is: inactivated hepatitis A virus (produced on human diploid MRC-5 cells,
adsorbed on amorphous aluminium hydroxyphosphate sulfate).
One dose (1 ml) contains 50 U of hepatitis A virus (inactivated) adsorbed on amorphous aluminium hydroxyphosphate
sulfate (0.45 milligrams as aluminium).

The other excipients are: Sodium borate, sodium chloride and water for injections.

Description of the appearance of VAQTA 50 U/1 mL and package contents
VAQTA 50 U/1 mL is an injectable suspension (1 mL in pre-filled syringe)

• without needle - pack of 1
• with one or two separate needles - pack of 1
• with pre-attached needle - pack of 1

Not all pack sizes may be marketed.
After careful shaking, VAQTA 50 U/1 mL appears as an opaque white suspension.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
MSD Italia S.r.l.
Via Vitorchiano, 151
00189 Rome
Italy

Manufacturer
Merck Sharp & Dohme, Netherlands BV
Waarderweg 39
2031 BN Haarlem (Netherlands)

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:

---------------------------------------------------------------------------------------------------------------------------
The following information is intended for healthcare professionals only:
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Instructions for use and handling
The vaccine must be used as provided.
The vaccine must be visually inspected before administration to detect the presence
of any foreign particles and/or a change in physical appearance. Discard the product if
particles are present or if it appears discoloured. The syringe must be shaken thoroughly until a
slightly opaque white suspension is obtained.
Thorough shaking is necessary to keep the vaccine in suspension. For the syringe without a
pre-attached needle, hold the syringe body and attach the needle by rotating it clockwise until the needle
is firmly attached to the syringe and administer the vaccine immediately.

VAQTA

25 U/0.5 mL
Injectable suspension in pre-filled syringe
Inactivated, adsorbed hepatitis A vaccine
For children and adolescents

Read this leaflet carefully before you or your child are vaccinated 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, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What VAQTA 25 U/0.5 mL is and what it is used for
• 2. What you need to know before VAQTA 25 U/0.5 mL is given to you
• 3. How VAQTA 25 U/0.5 mL is given
• 4. Possible side effects
• 5. How to store VAQTA 25 U/0.5 mL
• 6. Contents of the pack and other information

1. What is VAQTA 25 U/0.5 mL and what is it used for

VAQTA 25 U/0.5 mL is a vaccine. Vaccines are used to protect against infectious diseases.
They work by stimulating the body to produce its own protection against the disease
for which the vaccine is specific.
VAQTA 25 U/0.5 mL helps to protect children from 12 months up to 17 years against the disease
caused by the hepatitis A virus.
Hepatitis A is an infection caused by a virus that affects the liver. It can be contracted through
food or drinks that contain the virus. Symptoms include jaundice (yellowing of the skin and eyes) and a general feeling of unwellness.
As soon as you or your child receive an injection of VAQTA 25 U/0.5 mL, the body's natural defenses
will begin to produce protection (antibodies) against the hepatitis A virus.
However, it generally takes a period of time of 2 to 4 weeks after the injection
for you or your child to become protected.
VAQTA 25 U/0.5 mL will not prevent hepatitis caused by infectious agents other than the hepatitis A virus.
Furthermore, if you or your child are already infected with the hepatitis A virus at the time of
administration of VAQTA 25 U/0.5 mL, vaccination may not prevent the disease.
VAQTA 25 U/0.5 mL protects against hepatitis A, but cannot cause hepatitis A infection.

2. What you need to know before you are given VAQTA 25 U/0.5 mL

It is important that you inform your doctor or healthcare professional if any of the following points apply to you. If there is anything you do not understand, ask your doctor or nurse for an explanation.

VAQTA 25U/0.5 mL must not be given

• if you or your child are allergic to the active ingredient or any of the other ingredients of VAQTA 25U/0.5 mL (listed in section 6) or to neomycin and formaldehyde (see "Consult your doctor, pharmacist or nurse before you are given VAQTA 25 U/0.5 mL”).
• if you or your child have a severe infection with fever. The doctor will decide when the vaccine can be given.

Warnings and precautions
Consult your doctor, pharmacist or nurse before you are given VAQTA 25 U/0.5 mL

• If you or your child have had an allergic reaction following a previous dose of VAQTA 25 U/0.5 mL.
• This vaccine may contain traces of an antibiotic called neomycin and a substance called formaldehyde, both of which are used during the vaccine manufacturing process and may be present in trace amounts in the vaccine.
• If you or your child have any blood clotting disorder that causes you to bruise easily or bleed for a long time after minor cuts (e.g. due to bleeding problems or treatment with anticoagulant medicines).
• If you or your child have a weakened immune system due to cancer, treatments that affect the immune system, or any other illness. The vaccine may not be as effective as in people with a healthy immune system. If possible, vaccination is recommended to be postponed until these illnesses have healed or treatment has ended.

The container of this medicinal product contains rubber latex. Rubber latex may cause
serious allergic reactions.
As with other vaccines, VAQTA 25 U/0.5 mL may not fully protect all vaccinated people.
Tell your doctor if you or your child have a history of jaundice or if you have lived in
an area where hepatitis A is common. The doctor will assess whether to perform a test for
you or your child to measure hepatitis A antibodies before vaccination.

Other medicines and VAQTA 25 U/0.5 mL
Tell your doctor or pharmacist if you or your child are taking, have recently taken or
may take any other medicines.
Other vaccines
Because VAQTA 25 U/0.5 mL does not contain any live bacteria or viruses, it can generally be
given at the same time as other vaccines, but using different injection sites (a
different part of the body, e.g., the other arm or leg). VAQTA 25 U/0.5 mL must not be
mixed in the same syringe with other vaccines.
Studies have shown that VAQTA 25 U/0.5 mL can be given concurrently with the
vaccines for measles, rubella, mumps, varicella, 7-valent pneumococcal conjugate, inactivated polio,
vaccines containing diphtheria toxoid, tetanus toxoid, acellular pertussis and Haemophilus

influenzaetype b.
In adults, VAQTA can be given concurrently with the yellow fever vaccine and the typhoid polysaccharide vaccine.
Immunoglobulins (Antibodies)
Sometimes it may be necessary to administer an injection of human immunoglobulins (antibodies) to
try to protect you or your child until the vaccine begins to produce protection.

VAQTA 25 U/0.5 mL can be administered simultaneously with human immunoglobulins

(antibodies), provided that the two injections are administered at different injection sites.
Medicines that affect the immune system or the blood
Please refer to the “Warnings and precautions” section.

Pregnancy, breastfeeding and fertility
If you or your daughter are pregnant, suspect or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before receiving the
vaccination.

Driving and operating machinery
There is no data to suggest that VAQTA 25 U/0.5 mL may affect the ability to
drive vehicles or operate machinery.

VAQTA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially “sodium-free”.

3. How VAQTA 25 U/0.5 mL is administered

Dosage
VAQTA 25 U/0.5 mL must be administered by injection by doctors or nurses who have been
trained in the use of vaccines and who are equipped to manage any rare, serious allergic reaction.
Those to be vaccinated will receive a first dose followed by a second
dose (booster).
First dose
Children from 12 months to 17 years of age should receive an injection of a single dose of 0.5 ml
(25U). The first dose of vaccine will protect you or your child from hepatitis A infection within 2-4
weeks.
Safety and efficacy in infants under 12 months have not been established.
Second dose (booster)
Individuals who have received a first dose of vaccine should receive the second dose (booster) of
0.5 mL (25U), after 6-18 months.
Long-term protection requires a second dose of vaccine (booster dose). Healthy children
who had received two doses of vaccine have shown to have persistent antibody levels for
at least 10 years. It is expected that antibodies to hepatitis A will persist for at least 25 years from
vaccination.
VAQTA 25U/0.5mL is not recommended in individuals over 18 years of age.

Method and route of administration
The doctor or nurse will administer VAQTA 25 U/0.5 mL to you or your child by
intramuscular injection into the upper arm (deltoid muscle). In children, if the deltoid muscle is not
sufficiently developed, the muscle in the
outer thigh may be used.
People who are at risk of prolonged bleeding following an injection (e.g., hemophiliacs)
may receive VAQTA 25 U/0.5 mL by subcutaneous injection, rather than into the muscle, to
reduce the risk of bleeding.
VAQTA 25 U/0.5 mL should not be administered into a blood vessel.

4. Possible side effects

Like all medicines and vaccines, VAQTA 25 U/0.5 mL can cause side effects, although not everyone will experience them.
As with all vaccines, allergic reactions may occur, which, in rare cases, can lead to shock. These reactions may include:

• urticaria
• difficulty breathing
• swelling of the face, tongue and throat
• dizziness
• collapse When these signs or symptoms occur, they usually develop immediately after the injection is administered and while you or your child are still in the hospital or doctor's office. If any of these symptoms occur after leaving the placewhere the vaccine was administered to you or your child, consult a doctor IMMEDIATELY.

Side effects reported in children between 12 and 23 months of age

Side effects reported in children between 2 and 17 years of age

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. 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 VAQTA 25U/0,5 mL

Keep this vaccine out of the sight and reach of children.
Do not use this vaccine after the expiry date stated on the 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.
Do not use this vaccine if you notice an unusual appearance (see section 6) or if you observe the presence of
foreign particles.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What VAQTA 25 U/0.5 mL contains
The active ingredient is: inactivated hepatitis A virus (produced on human diploid MRC-5 cells,
adsorbed on amorphous aluminum hydroxyphosphate sulfate).
One dose (0.5 mL) contains 25 U of hepatitis A virus (inactivated) adsorbed on aluminum
hydroxyphosphate sulfate (0.225 milligrams as amorphous aluminum).

Other ingredients are:
Sodium borate, sodium chloride and water for injections.

Description of the appearance of VAQTA 25 U/0.5 mL and package contents
VAQTA 25U/0.5 mL is an injectable suspension (0.5 mL in pre-filled syringe)

• without needle - pack of 1
• with one or two separate needles - pack of 1
• with pre-attached needle - pack of 1

Not all pack sizes may be marketed.
After thorough shaking, VAQTA 25 U/0.5 mL appears as an opaque white suspension.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
MSD Italia S.r.l.
Via Vitorchiano, 151
00189 Rome
Italy

Manufacturer
Merck Sharp & Dohme, Netherlands BV
Waarderweg 39
2031 BN Haarlem (Netherlands)

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:

---------------------------------------------------------------------------------------------------------------------------
The following information is intended for healthcare professionals only:
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Instructions for Use and Handling
The vaccine must be used as provided.
The vaccine must be visually inspected before administration to detect the presence
of any foreign particles and/or a change in physical appearance. Discard the product if
particulates are present or if it appears discolored. The syringe must be shaken thoroughly until a
slightly opaque white suspension is obtained.
Thorough shaking is necessary to maintain the vaccine in suspension.
For the syringe without a pre-attached needle, hold the syringe body and attach the needle by rotating it clockwise
until the needle is firmly attached to the syringe and administer the vaccine
immediately.