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VAQTA ADULT

Active substance(s): VIRUS HEPATITIS A / VIRUS HEPATITIS A

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70044730
051216-1
95965
551472A01
N/A
N/A

Black

Technical Info

Profile

4096

70044730/00-1

Package Leaflet: Information for the User

VAQTA® Adult

AMS Blue Braille Grid Version: 29.1 - 05-04-16

Suspension for injection
Hepatitis A vaccine, inactivated, adsorbed.
For Adults
Read all of this leaflet carefully before you are vaccinated 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, pharmacist or nurse.
• This vaccine has been prescribed for you only. Do not pass it on to others.
• If you get any side effects talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Vaqta Adult is and what it is used for
2. What you need to know before Vaqta Adult is given
3. How Vaqta Adult is given
4. Possible side effects
5. How to store Vaqta Adult
6. Contents of the pack and other information
1. What VAQTA Adult is and what it is used for.
Vaqta Adult is one of a general group of medicines called vaccines. Vaccines
are used to protect against infectious diseases. They work by causing the
body to produce its own protection against the targeted disease.
This vaccine helps to protect against hepatitis A infection.
Hepatitis A is a virus that attacks the liver, which can be caught from food or
drink that contains the virus. Symptoms of hepatitis A include a yellowing of
the skin and eyes (jaundice) and feeling generally unwell.
When an injection of this vaccine is given, the body’s natural defences will
produce protection (antibodies) against the hepatitis A infection. However,
it usually takes 2 to 4 weeks after receiving the injection before you will be
protected.
This vaccine will not protect you against other viruses that infect the liver
(such as hepatitis B, hepatitis C or hepatitis E). This vaccine protects against
hepatitis A but cannot cause hepatitis A infection.
The vaccination may not work properly if the person to be vaccinated is
already infected with the hepatitis A virus.
Vaqta Adult is for adults aged 18 years and over. This vaccine is not suitable
for anyone younger than 18 years of age.
2. What you need to know before VAQTA Adult is given
Do not use Vaqta Adult:
• if you are allergic to the active substance or any of the other
ingredients of Vaqta Adult (listed in section 6) or to neomycin or
formaldehyde (see section “Warnings and precautions”).
• if you are ill with a high temperature. The vaccination should be
delayed until you have recovered.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before Vaqta Adult is given:
• if you have ever had an allergic reaction to a previous dose of Vaqta
Adult. This vaccine may contain traces of an antibiotic called neomycin
and a substance called formaldehyde, both of which are used during
vaccine production and may be present in the vaccine in trace amounts.
• if you have a poor or reduced immune system, due to:
− corticosteroids, cytotoxic drugs or radiotherapy. Your doctor or
nurse may wait until the treatment has finished.
− HIV (human immunodeficiency virus infection) or any disease that
affects the immune system. The vaccine may not protect as well as
it protects people whose immune system is healthy.
• if you have any problems with the blood that causes easy bruising or
bleeding for a long time after minor cuts. Your doctor or nurse may
still advise that you should have Vaqta Adult but extra care is needed
because of the risk of bleeding at the injection site. Your doctor or
nurse may give Vaqta Adult as an injection under the skin instead of
into muscle (see section 3) to try to reduce the risk of deep bleeding.

Profile:
Profile Revision:
Profile Revision Date:
Dimensions (mm):

BO210x275
1
180808
210 x 275mm

The container of this medicinal product contains latex rubber. May cause
severe allergic reactions.
As with other vaccines, Vaqta Adult may not completely protect all persons
who are vaccinated.
Please tell your doctor if you have a history of jaundice or have lived in an
area where hepatitis A is common. Your doctor will determine whether you
should be tested for hepatitis A antibodies prior to vaccination.
Other medicines and VAQTA Adult
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines (or other vaccines).
This vaccine can be given at the same time as any of the following provided
that they are given in different parts of the body (for example another arm)
and are not mixed in the same syringe.
• Vi polysaccharide typhoid vaccine,
• Yellow fever vaccine,
• Immunoglobulins (antibodies obtained from blood donors)
Studies with a paediatric formulation have shown that the vaccine may be
given at the same time as measles, mumps, rubella, varicella, pneumococcal
7-valent conjugate, inactivated polio, diphtheria toxoid, tetanus toxoid,
acellular pertussis or Haemophilus influenzae type b vaccines.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice whether
you should receive the vaccine.
Driving or using machines
There are no data to suggest that Vaqta Adult affects the ability to drive or
operate machinery.
Vaqta Adult contains less than 1 mmol sodium (3.55 mg) per dose i.e.
essentially ‘sodium-free’.
3. How VAQTA Adult is given
The vaccine will be injected by a doctor or nurse who has been trained in
the use of vaccines and who is equipped to deal with any rare severe allergic
reaction to the injection.
Short term protection against hepatitis A is achieved within 2 to 4 weeks after
receiving this vaccination. This may take a little longer if the injection is given
under the skin, rather than into the muscle.
Long-term protection against hepatitis A requires a second dose (booster
injection) of an inactivated hepatitis A vaccine. This is usually given between
6 and 18 months after the first dose. This booster will protect you against
hepatitis A for at least 6 years. It is predicted that hepatitis A antibodies will
remain at least 25 years after vaccination.
If necessary, Vaqta Adult can be given as a booster injection 6 to 12 months
after you received a first dose of another inactivated hepatitis A vaccine.
Method of administration
The doctor or nurse will shake the syringe immediately before use and check
that the liquid is white and cloudy and that there are no large particles.
The vaccine is given as an injection into a muscle in the upper outer part of
the arm. Your doctor or nurse will avoid giving you the injection either into
the skin or into a blood vessel. People who are at risk of bleeding a lot after an
injection (see section 2) may sometimes be given Vaqta Adult as an injection
under the skin but not into muscle to try to reduce the risk of bleeding.
Use in children and adolescents
Vaqta Adult is not recommended for individuals less than 18 years of age.
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, in rare cases leading to shock, may
occur. These reactions may include:
- hives
- difficulty in breathing
- swelling of the face, tongue and throat
- dizziness
- collapse.

70044730
051216-1
95965
551472A01
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Technical Info

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AMS Blue Braille Grid Version: 29.1 - 05-04-16

70044730/00-1

When these signs or symptoms occur they usually develop very quickly after
the injection is given and while you are still in the clinic or doctor’s surgery. If
any of these symptoms occurs after leaving the place where you received
the injection, contact a doctor IMMEDIATELY.
Frequency of side
effects
Very common: may
affect more than 1 in
10 people
Common: may affect
up to 1 in 10 people

Side effects
injection-site tenderness, pain, warmth, swelling,
redness

- h eadache
- arm pain (in the injected arm)
-w
 eakness/tiredness, fever (38.3°C or over),
bleeding under the skin at the injection site
(ecchymosis), pain and soreness
Uncommon: may affect - s ore throat, upper respiratory infections
up to 1 in 100 people
- s welling of the lymph nodes
-d
 izziness, abnormal skin sensations such as
tingling
- e ar ache
- h ot flushes
- r unny or blocked nose and airways, cough
- f eeling sick (nausea), diarrhoea, excessive gas in
the stomach and intestines, vomiting
- h ives, itching, redness
-m
 uscle pain, stiffness, shoulder pain,
musculoskeletal pain (pain that affects the
muscles, ligaments and tendons, along with the
bones) back pain, joint pain, leg pain, neck pain,
muscle weakness
- itching at the injection-site, stiffness/tightness,
pain, bruising at the injection-site, chills,
stomach ache, feeling generally unwell, hardness
(induration) and numbness at the injection-site,
cold sensation, flu-like illness
Rare: may affect up to - b
 ronchitis, inflammation of the stomach and
1 in 1,000 people
intestines (gastroenteritis)
- loss of appetite
- lacking energy, trouble sleeping
- s leepiness, migraine, tremor
- itching eyes, sensitivity to light, increased flow
of tears
- v ertigo
- s welling of the throat, problems with the sinuses
-d
 ryness of the mouth, mouth ulcers
- n ight sweats, rash, skin disorders
-m
 uscle cramp, elbow pain, hip pain, jaw pain,
spasm
-p
 roblems with periods
- injection-site burning, lump (≤2.5 centimetres),
muscle twitching, rash, swelling of the stomach,
chest pain, pain in the side; irritability
Not known: frequency - G
 uillain-Barré syndrome (muscle weakness,
abnormal sensations, tingling in the arms, legs
cannot be estimated
and upper body)
from the available data
- t hrombocytopenia (reduction in blood platelets
which increases risks of bleeding and bruising)
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 Yellow Card Scheme at: www.mhra.gov.uk/
yellowcard. By reporting side effects you can help provide more information
on the safety of this medicine.
5. How to store VAQTA Adult
Keep this vaccine out of the sight and reach of children.
The vaccine should not be used after the expiry date (Exp) which is stated on
the carton and syringe or vial label.

Profile:
Profile Revision:
Profile Revision Date:
Dimensions (mm):

BO210x275
1
180808
210 x 275mm

The vaccine must be stored in a refrigerator between 2°C and 8°C (making
sure that it does not freeze) so that the vaccine keeps its effectiveness.
Do not use this vaccine if you notice that it has an unusual appearance (see
section 6) or contains particulate matter.
Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.
6. Contents of the pack and other information
What Vaqta Adult contains
The active ingredient is: Inactivated hepatitis A virus (produced on MRC-5
human diploid cells, adsorbed on aluminium hydroxyphosphate sulphate).
One dose (1 mL) contains 50U hepatitis A virus (inactivated) adsorbed on
aluminium hydroxyphosphate sulphate (0.45 milligram as aluminium).
The other ingredients are:
• sodium borate
• sodium chloride
• water for injections
What Vaqta Adult looks like and contents of the pack
A pre-filled syringe or vial containing 1 millilitre (one dose) of the vaccine.
The vaccine is available in single packs of the vial or pre-filled syringe with or
without a needle.
Not all presentations may be marketed.
After thorough agitation Vaqta Adult is an opaque white suspension.
Marketing Authorisation Holder
The Marketing Authorisation Holder in the UK is:
Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon
Hertfordshire EN11 9BU
United Kingdom
Manufacturer
The manufacturer responsible for batch release at the following
manufacturing sites is:
Merck Sharp and Dohme B.V.,
Waarderweg 39,
PO Box 581,
2003 PC Haarlem,
Netherlands
This leaflet was last revised in January 2017.
© Merck Sharp & Dohme Limited, 2017. All rights reserved.
PIL.VAQ-A.16.UK.4931-COO
--------------------------------------------------------------------------------------------------------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 should be used as supplied.
The vaccine should be inspected visually prior to administration for any
foreign particulate matter and/or abnormal physical appearance. Discard the
product if particulates are present or if it appears discoloured. The syringe
should be well shaken until a slightly opaque white suspension is obtained.
Thorough agitation is necessary to maintain suspension of the vaccine. For
syringe without attached needle, hold the syringe barrel and attach the
needle by twisting in clockwise direction until the needle fits securely on the
syringe and give the vaccine immediately.
© Merck Sharp & Dohme Limited, 2017. All rights reserved.
PIL.VAQ-A.16.UK.4931-COO

70045163
071216-1
95838
551854A01
N/A
N/A

Black

70045163/00-1

4841

Package Leaflet: Information for the User
Technical Info

Profile

AMS Blue Braille Grid Version: 29.1 - 05-04-16

VAQTA® Adult,

Suspension for injection
Hepatitis A vaccine, inactivated, adsorbed.
For Adults

Read all of this leaflet carefully before you are vaccinated 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, pharmacist or nurse.
• This vaccine has been prescribed for you only. Do not pass it on to others.
• If you get any side effects talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Vaqta Adult is and what it is used for
2. What you need to know before Vaqta Adult is given
3. How Vaqta Adult is given
4. Possible side effects
5. How to store Vaqta Adult
6. Contents of the pack and other information
1. What VAQTA Adult is and what it is used for.
Vaqta Adult is one of a general group of medicines called vaccines. Vaccines are used to protect
against infectious diseases. They work by causing the body to produce its own protection against
the targeted disease.
This vaccine helps to protect against hepatitis A infection.
Hepatitis A is a virus that attacks the liver, which can be caught from food or drink that contains
the virus. Symptoms of hepatitis A include a yellowing of the skin and eyes (jaundice) and feeling
generally unwell.
When an injection of this vaccine is given, the body’s natural defences will produce protection
(antibodies) against the hepatitis A infection. However, it usually takes 2 to 4 weeks after
receiving the injection before you will be protected.
This vaccine will not protect you against other viruses that infect the liver (such as hepatitis
B, hepatitis C or hepatitis E). This vaccine protects against hepatitis A but cannot cause hepatitis
A infection.
The vaccination may not work properly if the person to be vaccinated is already infected with the
hepatitis A virus.
Vaqta Adult is for adults aged 18 years and over. This vaccine is not suitable for anyone younger
than 18 years of age.
2. What you need to know before VAQTA Adult is given
Do not use Vaqta Adult:
• if you are allergic to the active substance or any of the other ingredients of Vaqta Adult
(listed in section 6) or to neomycin or formaldehyde (see section “Warnings and
precautions”).
• if you are ill with a high temperature. The vaccination should be delayed until you have
recovered.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before Vaqta Adult is given:
• if you have ever had an allergic reaction to a previous dose of Vaqta Adult. This vaccine
may contain traces of an antibiotic called neomycin and a substance called
formaldehyde, both of which are used during vaccine production and may be present in
the vaccine in trace amounts.
• if you have a poor or reduced immune system, due to:
- corticosteroids, cytotoxic drugs or radiotherapy. Your doctor or nurse may wait until
the treatment has finished.
- HIV (human immunodeficiency virus infection) or any disease that affects the
immune system. The vaccine may not protect as well as it protects people whose
immune system is healthy.
• if you have any problems with the blood that causes easy bruising or bleeding for
a long time after minor cuts. Your doctor or nurse may still advise that you should have
Vaqta Adult but extra care is needed because of the risk of bleeding at the injection
site. Your doctor or nurse may give Vaqta Adult as an injection under the skin instead of
into muscle (see section 3) to try to reduce the risk of deep bleeding.

Profile:
Profile Revision:
Profile Revision Date:
Dimensions (mm):

BO210x295
1
281009
210 x 295

The container of this medicinal product contains latex rubber. May cause severe allergic reactions.
As with other vaccines, Vaqta Adult may not completely protect all persons who are vaccinated.
Please tell your doctor if you have a history of jaundice or have lived in an area where hepatitis
A is common. Your doctor will determine whether you should be tested for hepatitis A antibodies
prior to vaccination.
Other medicines and VAQTA Adult
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines (or other vaccines).
This vaccine can be given at the same time as any of the following provided that they are given in
different parts of the body (for example another arm) and are not mixed in the same syringe.
• Vi polysaccharide typhoid vaccine,
• Yellow fever vaccine,
• Immunoglobulins (antibodies obtained from blood donors)
Studies with a paediatric formulation have shown that the vaccine may be given at the same time
as measles, mumps, rubella, varicella, pneumococcal 7-valent conjugate, inactivated polio,
diphtheria toxoid, tetanus toxoid, acellular pertussis or Haemophilus influenzae type b vaccines.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice whether you should receive the vaccine.
Driving or using machines
There are no data to suggest that Vaqta Adult affects the ability to drive or operate machinery.
Vaqta Adult contains less than 1 mmol sodium (3.55 mg) per dose i.e. essentially
‘sodium-free’.
3. How VAQTA Adult is given
The vaccine will be injected by a doctor or nurse who has been trained in the use of vaccines and
who is equipped to deal with any rare severe allergic reaction to the injection.
Short term protection against hepatitis A is achieved within 2 to 4 weeks after receiving this
vaccination. This may take a little longer if the injection is given under the skin, rather than into
the muscle.
Long-term protection against hepatitis A requires a second dose (booster injection) of an
inactivated hepatitis A vaccine. This is usually given between 6 and 18 months after the first dose.
This booster will protect you against hepatitis A for at least 6 years. It is predicted that hepatitis
A antibodies will remain at least 25 years after vaccination.
If necessary, Vaqta Adult can be given as a booster injection 6 to 12 months after you received
a first dose of another inactivated hepatitis A vaccine.
Method of administration
The doctor or nurse will shake the syringe immediately before use and check that the liquid is
white and cloudy and that there are no large particles.
The vaccine is given as an injection into a muscle in the upper outer part of the arm. Your doctor
or nurse will avoid giving you the injection either into the skin or into a blood vessel. People who
are at risk of bleeding a lot after an injection (see section 2) may sometimes be given Vaqta Adult
as an injection under the skin but not into muscle to try to reduce the risk of bleeding.
Use in children and adolescents
Vaqta Adult is not recommended for individuals less than 18 years of age.
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, in rare cases leading to shock, may occur. These reactions
may include:
- hives
- difficulty in breathing
- swelling of the face, tongue and throat
- dizziness
- collapse.
When these signs or symptoms occur they usually develop very quickly after the injection is given
and while you are still in the clinic or doctor’s surgery. If any of these symptoms occurs
after leaving the place where you received the injection, contact a doctor
IMMEDIATELY.

70045163
071216-1
95838
551854A01
N/A
N/A

Black

70045163/00-1

Technical Info

Profile

Frequency of side effects Side effects
Very common: may affect more injection-site tenderness, pain, warmth, swelling, redness
than 1 in 10 people
Common: may affect up to 1 in 10 people
-

AMS Blue Braille Grid Version: 29.1 - 05-04-16

Uncommon: may affect up to
1 in 100 people

-

-

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

Not known: frequency
cannot be estimated from the
available data

-

headache
arm pain (in the injected arm)
weakness/tiredness, fever (38.3°C or over), bleeding
under the skin at the injection site (ecchymosis), pain
and soreness
sore throat, upper respiratory infections
swelling of the lymph nodes
dizziness, abnormal skin sensations such as tingling
ear ache
hot flushes
runny or blocked nose and airways, cough
feeling sick (nausea), diarrhoea, excessive gas in the
stomach and intestines, vomiting
hives, itching, redness
muscle pain, stiffness, shoulder pain, musculoskeletal
pain (pain that affects the muscles, ligaments and
tendons, along with the bones) back pain, joint pain, leg
pain, neck pain, muscle weakness
itching at the injection-site, stiffness/tightness, pain,
bruising at the injection-site, chills, stomach ache,
feeling generally unwell, hardness (induration) and
numbness at the injection-site, cold sensation, flu-like
illness
bronchitis, inflammation of the stomach and intestines
(gastroenteritis)
loss of appetite
lacking energy, trouble sleeping
sleepiness, migraine, tremor
itching eyes, sensitivity to light, increased flow of tears
vertigo
swelling of the throat, problems with the sinuses
dryness of the mouth, mouth ulcers
night sweats, rash, skin disorders
muscle cramp, elbow pain, hip pain, jaw pain, spasm
problems with periods
injection-site burning, lump (≤2.5 centimetres), muscle
twitching, rash, swelling of the stomach, chest pain, pain
in the side; irritability
Guillain-Barré syndrome (muscle weakness, abnormal
sensations, tingling in the arms, legs and upper body)
thrombocytopenia (reduction in blood platelets which
increases risks of bleeding and bruising)

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 Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store VAQTA Adult
Keep this vaccine out of the sight and reach of children.
The vaccine should not be used after the expiry date (Exp) which is stated on the carton and
syringe or vial label.
The vaccine must be stored in a refrigerator between 2°C and 8°C (making sure that it does not
freeze) so that the vaccine keeps its effectiveness.
Do not use this vaccine if you notice that it has an unusual appearance (see section 6) or contains
particulate matter.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
Profile:
Profile Revision:
Profile Revision Date:
Dimensions (mm):

BO210x295
1
281009
210 x 295

6. Contents of the pack and other information
What Vaqta Adult contains
The active ingredient is: Inactivated hepatitis A virus (produced on MRC-5 human diploid cells,
adsorbed on aluminium hydroxyphosphate sulphate).
One dose (1 mL) contains 50U hepatitis A virus (inactivated) adsorbed on aluminium
hydroxyphosphate sulphate (0.45 milligram as aluminium).
The other ingredients are:
• sodium borate
• sodium chloride
• water for injections
What Vaqta Adult looks like and contents of the pack
A pre-filled syringe or vial containing 1 millilitre (one dose) of the vaccine. The vaccine is
available in single packs of the vial or pre-filled syringe with or without a needle.
Not all presentations may be marketed.
After thorough agitation Vaqta Adult is an opaque white suspension.
Marketing Authorisation Holder
The Marketing Authorisation Holder in the UK is:
Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon
Hertfordshire EN11 9BU
United Kingdom
Manufacturer
The manufacturer responsible for batch release at the following manufacturing sites is:
Merck Sharp and Dohme B.V.,
Waarderweg 39,
PO Box 581,
2003 PC Haarlem,
Netherlands
This leaflet was last revised in January 2017.
© Merck Sharp & Dohme Limited, 2017. All rights reserved.
PIL.VAQ-A.16.UK.4931-COO
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 should be used as supplied.
The vaccine should be inspected visually prior to administration for any foreign particulate matter
and/or abnormal physical appearance. Discard the product if particulates are present or if it
appears discoloured. The syringe should be well shaken until a slightly opaque white suspension is
obtained.
Thorough agitation is necessary to maintain suspension of the vaccine. For syringe without
attached needle, hold the syringe barrel and attach the needle by twisting in clockwise direction
until the needle fits securely on the syringe and give the vaccine immediately.
PIL.VAQ-A.16.UK.4931-COO

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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