Havrix 1440 (1 dose, 1 ml) is a vaccine for use in adults and adolescents 16 years and older to prevent hepatitis A vaccine works by causing the body to produce its own protection (antibodies) against the disease.
Havrix 720 (1 dose; 0,5 ml) is a vaccine for use in children and adolescents from 1 year to 15 years inclusive * to prevent hepatitis A vaccine works by causing the body to produce its own protection (antibodies) against disease.
* Assumed administration of one dose (for priming) Havrix 720 (dose for children) in adolescents aged 18 or younger.
Hepatitis A is an infectious disease affecting the liver. Caused by a virus of hepatitis A. Hepatitis A virus can be transmitted from person to person in food and drink, or by swimming in water contaminated by sewage. The symptoms of hepatitis A begin the third to sixth week after exposure to the virus. These include nausea, fever and pain. A few days after the initial symptoms skin and whites (white part) of the eyes to 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 enough to keep people off work for about a month.
Vaccination is the best way to prevent this disease. The vaccine does not contain infectious.
2. Before you / your child to be applied Havrix
Havrix should not be applied:
if you or your child have an allergic reaction to Havrix or any component of the vaccine. The active and the excipients contained in Havrix are listed at the end of the leaflet. Symptoms of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue;
if you or your child have an allergic reaction after administration of the vaccine against hepatitis A.
Take special care with Havrix:
Before injection of Havrix, tell your doctor / nurse:
if you / your child have any health problems after previous administration of the vaccine;
if you / your child have a severe infection with a high temperature (above 38 C). A minor infection such as a cold should not be a problem, but talk to your doctor about this before immunization;
if you / your child have a weakened immune system due to disease or treatment with other drugs;
if you / your child have a bleeding disorder or bruise easily (bruising);
if you / your child have known allergies to something.
Fainting can occur following, or even before the injection needle, so tell the doctor or nurse if you or your child fainted with a previous injection.
Taking other medicines or vaccines
Please tell your doctor if you or your child have recently taken or are taking any medicines, including medicines obtained without a prescription or have recently received any other vaccine.
Pregnancy and lactation
Take special care with Havrix if you are pregnant, think you may be pregnant or planning a pregnancy. Your doctor will inform you about the possible risks and benefits of vaccination with Havrix during pregnancy.
It is unknown whether Havrix passes into breast milk. However, the vaccine is not expected to cause problems in nursing infants.
3. How to use Havrix
You will be given one dose Havrix 1440 (1 ml suspension).
Your child will be given 1 dose Havrix 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 / your child miss any of injections under the vaccination, talk to your doctor and arrange another visit.
Surely you / your child should complete the full vaccination course of two injections.
The doctor will apply Havrix as an injection into the muscle at the top of your arm or into the thigh muscle of your child.
The vaccine should never be given into a vein.
4. Possible side effects
Like all medicines, Havrix can cause side effects, although not everybody gets them.
Side effects that may occur are:
Very common (these can affect more than 1 in 10 doses of vaccine):
Pain and redness at the injection site, and fatigue.
Common (these may affect up to 1 in 10 doses of the vaccine):
Loss of appetite;
Diarrhea, nausea, vomiting;
Swelling or solid formation at the injection site;
General feeling of malaise, fever.
Uncommon (these may affect up to 1 in 100 doses of the vaccine):
Infection of the upper respiratory tract, runny or stuffy nose;
Muscle pain, muscle stiffness, unprovoked by exercise;
Flu-like symptoms - fever, sore throat, runny nose, cough, chills.
Rare (these may occur in up to 1 in 1,000 doses of vaccine):
Abnormal sensations such as burning, tingling or tickling;
Very rare (these may occur in up to 1 in 10,000 doses of vaccine):
Allergic reactions. They can be local or generalized rash that may be itchy or blistering, swelling of the eyes and face, difficulty in breathing or swallowing, sudden drop in blood pressure and loss of consciousness. These reactions usually appear in the doctor's office. However, if your child develops any of these symptoms should seek medical care;
Seizures or convulsions;
Narrowing or blockage of blood vessels;
Hives - red, often itchy spots, which first appeared on the limbs and sometimes the face and other parts of the body;
If any of the side effects gets serious, or if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Havrix
Store in a refrigerator (2 ° C - 8 ° C).
Store in the original package in order to protect from light.
Do not freeze. Freezing destroys the vaccine.
Keep out of the reach and sight of children.
Havrix not use after the expiry date stated on the carton. The expiry date refers to the last day of that month.
6. Further information
The active substance is:
1 dose (1 ml) contains:
Inactivated hepatitis A virus (Hepatitis A virus, inactivated) 1,2: 1440 ELISA Units
1Proizveden in human diploid (MRC-5) cells.
2Adsorbed on aluminum hydroxide, hydrated total: 0.5 mg Al3 +.
1 dose (0,5 ml) contains:
Inactivated hepatitis A virus (Hepatitis A virus, inactivated) 1,2: 720 ELISA Units
1Proizveden in human diploid (MRC-5) cells.
2 Adsorbed on aluminum hydroxide, hydrated total: 0.25 milligrams Al3 +.
The other ingredients of Havrix are: amino acids for injection, disodium phosphate, monopotassium phosphate, polysorbate 20, potassium chloride, sodium chloride and water for injection.
Neomycin sulfate: Havrix 720: less than 10 ng;
Havrix 1440: less than 20 ng.
Havrix looks like and contents of the pack
Suspension for injection.
Havrix 1440 is a turbid liquid suspension in a single dose vial or pre-filled glass syringe (1 ml).
Havrix 720 turbid liquid suspension in a single dose glass vial or glass prefilled syringe (0,5 ml).
During storage of the vial or prefilled syringe can be observed fine white deposit with a clear colorless supernatant.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Specific information on the medical officer
Before administration, the vaccine should be inspected visually for particulate matter and / or change in appearance;
Before taking Havrix vaccine vial or prefilled syringe should be well shaken to obtain a slightly opaque white suspension. Discard the vaccine if the content appears otherwise. Havrix is intended for intramuscular injection, preferably in the deltoid region (not in the glutes), or in the anterolateral thigh in infants;
Good clinical practice in patients with thrombocytopenia or any coagulation vaccine be administered carefully. After injection, the site can be pressed firmly (without rubbing) for at least two minutes;
Under no circumstances Havrix should not be administered intravenously, intraarterially, or intradermal / subcutaneous;
As with all injectable vaccines should always be ready to appropriate medical intervention in case of rare anaphylactic reactions following vaccination. Therefore, it is recommended that the patient be kept under medical observation 30 minutes after immunization;
Concomitant administration of immunoglobulins does not affect the protective effect of the vaccine;
Since Havrix is an inactivated vaccine its parallel use with other inactivated vaccines is unlikely to lead to disturbances in the immune response to them;
Upon co-administration with other injectable vaccines or immunoglobulins have to use different injection sites for individual medicinal products;
Injectable vaccines or immunoglobulin should be administered with different syringes and needles.