HAVRIKS 720 hepatitis A vaccine for children

HAVRIKS 720 hepatitis A vaccine for children
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Havriks 1440 (1 dose, 1 ml) is a vaccine for use in adults and adolescents aged 16 years to prevent hepatitis A vaccine works by stimulating the body to produce its own protection (antibodies) against the disease.

HAVRIKS 720 hepatitis A vaccine for children
 

What Havriks and what it is used

Havriks 1440 (1 dose, 1 ml) is a vaccine for use in adults and adolescents aged 16 years to prevent hepatitis A vaccine works by stimulating the body to produce its own protection (antibodies) against the disease.
Havriks 720 (1 dose; 0,5 ml) is a vaccine for use in children and adolescents 1 to 15 years inclusive (? to prevent hepatitis A). The vaccine works by stimulating the body to produce its own protection (antibodies) against the disease.
  assumed administration of one dose (for priming) Havriks 720 (dose for children) in adolescents aged up to 18 years inclusive.
 
Hepatitis A is an infectious disease affecting the liver. Caused by a virus of hepatitis A virus can be transmitted from one person to another through food and drink, or by swimming in water contaminated by sewage. Symptoms of hepatitis A begin 3 to 6 weeks after contact with the virus. They include nausea, fever and pain. A few days after the initial symptoms skin and sclera (white part) of the eyes may turn yellow (jaundice). The severity and type of symptoms can vary. Young children may not develop jaundice. Most people recover completely but the illness is usually severe and lead to absence from work for about a month.
 
Vaccination is the best way to prevent this disease. The vaccine contains no infectious.
 

 Before you take your child or take Havriks

 
Havriks shall not apply:
  if you have had or your child has had an allergic reaction to Havriks or any component of the vaccine. Active and excipients contained in Havriks are listed at the end of this leaflet. Symptoms of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
  if you have had or your child has had an allergic reaction after administration of the vaccine against hepatitis A.
 

Take special care with Havriks:

 
Before injection Havriks your doctor / nurse if you or your child:
  If you have health problems after previous administration of the vaccine.
  you have / your child has a severe infection with a high temperature (over 38 ° C). A minor infection such as a cold should not be a problem, but talk to your doctor about it first.
  have a weakened immune system due to disease or drug treatment.
  have a bleeding disorder or bruise easily.
  you have known allergies to something.
 
Fainting can occur following, or even before injection with a needle, so tell the doctor or nurse if you or your child fainted with a previous injection.
 

Taking other medicines or vaccines

 
Tell your doctor if you or your child is taking or has recently taken any other medicines, including medicines obtained without a prescription or have recently received any other vaccine.
 

Pregnancy and lactation

 
Take special care when applying Havriks if you are pregnant or trying to become pregnant. Your doctor will discuss with you the possible risks and benefits of vaccination with Havriks during pregnancy.
 
It is unknown whether Havriks passes into breast milk. However, the vaccine is not expected to cause problems in nursing infants.
 

How to take Havriks

 
Will be given one dose Havriks 1440 (1 ml suspension). Your child will be given one dose Havriks 720 (0,5 ml suspension).
 
In order to ensure long-term protection should be given a second (booster) dose at any time between 6 months and the fifth year, but preferably between 6 and 12 months after the first dose.
If you miss or your child misses injections under the vaccination, talk to your doctor and arrange another visit.
 
You should be done or your child finishes the complete vaccination course of two injections.
Havriks doctor will inject into the muscle of the upper arm or your thigh muscle of your child.
The vaccine should not be given (deep) in the skin or intramuscularly into the buttocks, because it can not achieve sufficient protection.
 
The vaccine should never be given into a vein.
 

 Possible side effects

 
Like all medicines, Havriks can cause side effects, although not everybody gets them.
 
Side effects that may occur are:
 
 Very common (may affect more than 1 in 10 doses of vaccine):
 
 Irritability
 Headache
 Pain and redness at the injection site, fatigue
 
 Common (may affect up to 1 in 10 doses of vaccine):
 
 Loss of appetite
 Drowsiness
 Diarrhea, nausea, vomiting
 Swelling or solid formation at the injection site
 Feeling generally unwell, fever
 
 Uncommon (may occur in up to 1 in 100 doses of vaccine):
 
 Infection of the upper respiratory tract, runny or stuffy nose
 Dizziness
 Rash
 Aching muscles, muscle stiffness, unprovoked by exercise
 Flu-like symptoms - fever, sore throat, runny nose, cough, fever
 
 Rare (may occur with up to 1 in 1,000 doses of vaccine):
  Abnormal sensations such as burning, tingling or tickling
 Itching
 Chills
 
 Very rare (less than 1 in 10,000 doses of vaccine):
  Allergic reactions. They can be local or generalized rash that can be itchy or blistering, swelling of the eyelids and face, difficulty breathing or swallowing, a sudden drop in blood pressure and loss of consciousness. These reactions usually appear in the doctor's office. However, if your child experiences any of these symptoms should seek medical advice.
 Fits or seizures
 Narrowing or blockage of blood vessels
 Hives - red, often itchy spots that first appear on the legs and sometimes on the face and other body parts.
 Joint pain.
 
If your child experiences side effects
 
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
 

 How to store Havriks

 
Store in a refrigerator (2 ° C - 8 ° C).
Store in the original package to protect from light.
 Do not freeze. Freezing destroys the vaccine. 
Keep out of reach of children. 
Havriks Do not use after the expiry date stated on the carton. The expiry date refers to the last day of that month.
 

Additional Information

 
What Havriks
 
The active ingredient is:
 
Havriks 1440
1 dose (1 ml) contains:
Hepatitis A virus antigen, HM175 strain 1440 ELISA Units
(Hepatitis A virus antigen, strain HM175)
adsorbed on aluminum hydroxide total: 0.5 milligrams Al3 +
 
Havriks 720
1 dose (0,5 ml) contains:
Hepatitis A virus antigen, HM175 strain 720 ELISA Units
(Hepatitis A virus antigen, strain HM175)
adsorbed on aluminum hydroxide total: 0.25 milligrams Al3 +
 
The other ingredients are Havriks:
 
Amino acids for injection, disodium phosphate, monopotassium phosphate, polysorbate 20, potassium chloride, sodium chloride and water for injections.
 
Havriks looks like and contents of pack
Suspension for injection. 
Havriks 1440 is a white, milky liquid in a glass vial or prefilled glass syringe (1 ml).
 
Havriks 720 is a white, slightly milky liquid in a glass vial or prefilled glass syringe (0,5 ml).
Prior to administration, the vaccine should be inspected visually for particulate matter and / or abnormal physical appearance.
 
 Before using Havriks vaccine vial or prefilled syringe should be shaken to obtain a slightly opaque, white suspension. Do not apply if the content does not meet these conditions. The vaccine should not be used in the case that has been frozen.
 Havriks is intended for intramuscular injection, preferably into the deltoid (not in gluteusite) or anterolateral thigh in infants.
 
 Good clinical practice in patients with thrombocytopenia or bleeding disorders the vaccine be administered with caution.
 
 Under no circumstances Havriks should not be administered intravenously, intra-arterial or intradermally.
 
 As with all injectable vaccines should always be ready for proper medical attention in case of rare anaphylactic reactions following vaccination. It is therefore recommended that the patient be kept under medical observation 30 minutes after immunization.
 
 Concomitant administration of immunoglobulin has no influence on the protective effect of the vaccine.
 
 Since Havriks is an inactivated vaccine, its parallel administration with other inactivated vaccines is unlikely to disrupt the immune response to them.
 
 Co-administration with other injectable vaccines or immunoglobulins have to use different injection sites for individual drugs.
 
 Injectable vaccines or immunoglobulin should be administered with different syringes and needles.
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