TWINRIX vaccine for hepatitis A in adults - GLAXOSMITHKLINE

TWINRIX ADULT AND WHAT IT IS USED

Twinrix Adult is a vaccine for use in adults and adolescents over 16 years to prevent two diseases: hepatitis A and hepatitis B. The vaccine works by stimulating the body to produce its own protection (antibodies) against these diseases.

 Hepatitis A:

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.

 Hepatitis B:

It is caused by the hepatitis B virus leads to liver enlargement (inflammation). The virus is found in body fluids (blood, semen, vaginal secretions or saliva).

Vaccination is the best way to protect against these diseases. The vaccine contains no infectious.

 BEFORE YOU TAKE TWINRIX ADULT

Do not take Twinrix Adult:

 if you have had an allergic reaction to Twinrix Adult, or any component of the vaccine. Active and excipients contained in Twinrix Adult 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 an allergic reaction to any vaccine against hepatitis A and hepatitis B.

 If you have a severe infection with a high temperature (over 38 ° C). Minor infection such as a cold should not be a problem, but your doctor first.

Take special care with Twinrix Adult:

 If you have health problems after previous administration of the vaccine.

  if you have a weakened immune system due to disease or drug treatment

  if you have a bleeding disorder or bruise easily.

Fainting can occur (usually adolescents) after or even before, any needle injection. Therefore tell your doctor or nurse if you fainted at the previous injection.

A poor response to the vaccine, possibly without achieving protection against hepatitis A was found in obese people. It is also and weaker immune response to the vaccine, possibly without achieving protection against hepatitis B in the elderly, more common in men than women, smokers, people with overweight in subjects with long standing illnesses in people treated with certain medications. After completing a course of vaccinations your doctor may advise you to have a blood test to see if sufficient protection is achieved. If no adequate response to the vaccine may need additional doses of Twinrix Adult.

Taking other medicines or vaccines

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

Pregnancy and lactation

Take special care with Twinrix Adult, if you are pregnant or trying to become pregnant. Your doctor will discuss with you the possible risks and benefits of vaccination with Twinrix Adult pregnancies.

It is not known whether Twinrix Adult passes into breast milk. While this vaccine is not expected to cause problems in nursing children.

Important information about some of the ingredients of Twinrix Adult

Please tell your doctor if you have had an allergic reaction to neomycin (an antibiotic).

 HOW TO TAKE TWINRIX ADULT

Twinrix Adult will be administered on a regimen that includes total of three injections over six months. Each injection is given on a separate visit. The first dose will be given on an elected date. The remaining two doses will be given one month and six months after the first dose.

 First dose: at elected date 

 Second dose: 1 month later 

 Third dose: 6 months after the first dose.

Twinrix Adult can be applied to a scheme, which includes the use of three injections within one month. This scheme can be used in adults only when they need

rapid protection against hepatitis A and hepatitis B (eg traveling abroad). The first dose will be given on an elected date. The remaining two doses will be given 7 days and 21 days after the first dose. It is recommended that a fourth dose at 12 months.

  First dose: at elected date

  Second dose: 7 days later

 Third dose: 21 days after the first dose

 The fourth dose 12 months after the first dose.

If you require additional doses, and immunization, the doctor will tell you.

As stated in Section 2, a poor immune response to the vaccine, possibly without achieving protection against hepatitis B is more common in older people more often in men than women, smokers, people with overweight subjects with long standing illnesses or in people treated with certain medications. After completing a course of vaccinations your doctor may advise you to have a blood test to see if sufficient protection is achieved. If no adequate response to the vaccine may need extra doses.

If you miss any of the injections under the vaccination, talk to your doctor and arrange another visit.

Make sure you finish the complete vaccination course of three injections. Otherwise it can not be fully protected against the diseases that this vaccine prevents.

The doctor will give Twinrix Adult intramuscularly (into the muscle at the top of your hand).

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, Twinrix Adult can cause side effects, although not everybody gets them.

May occur following side effects:

Very common (may occur in one or more than 1 in 10 doses of vaccine):

 Headache

 Pain and redness at the injection site

 Tiredness

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

 Diarrhea, nausea

 Swelling, bruising or itching at the injection site

 Malaise

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

 Dizziness

 Vomiting, abdominal pain

 Muscle aches

 Infection of the upper respiratory tract

 Fever equal to or more than 37,5 º C

Rare (may occur in up to 1 in 1,000 doses of vaccine):

 Swollen glands in the neck, armpit or groin (lymphadenopathy)

 Loss of skin sensitivity to pain or touch (hypoaesthesia)

 pins and needles (paraesthesia)

 Rash, itching

 Joint pain

 Loss of appetite

 Low blood pressure

 Flu-like symptoms such as fever, sore throat, runny nose, cough and chills

Very Rare (may occur in up to 1 in 10,000 doses)

Side effects occurred very rarely during clinical studies or routine use of the vaccine or the individual vaccines for hepatitis A and hepatitis B include:

 Reducing the number of blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)

 Purple or reddish-brown spots visible through the skin (thrombocytopenic purpura)

 Swelling or infection of the brain (encephalitis)

 Degenerative brain disease (encephalopathy)

 Inflammation of nerves (neuritis)

 Numbness or weakness in the hands and feet (neuropathy), paralysis

 Fits or seizures

 Swelling of the face, mouth or throat (angioedema)

 Purple or reddish-purple bumps on the skin (lichen planus), severe skin rash (erythema multiforme), urticaria

 Swelling of joints, muscle weakness

 Infection of the brain which can lead to severe headache with stiff neck and sensitivity to light (meningitis)

 Inflammation of some blood vessels (vasculitis)

 Severe allergic reactions (anaphylaxis, anaphylactoid reactions and serum sickness). Signs of serious allergic reactions may be rashes that may be itchy or blistering, swelling of the eyes and face, difficulty breathing or swallowing, a sudden drop in blood pressure and loss of consciousness. Such reactions may occur before leaving the doctor's office. However, if you have any of these symptoms should immediately contact a physician.

 Receiving Abnormal laboratory liver tests

 Multiple sclerosis, swelling of the spinal cord (myelitis)

 Drooping eyelid and sagging muscles on one side of the face (facial paralysis)

 A temporary inflammation of the nerves, causing pain, weakness and paralysis in the extremities and often progressing to the chest and face (Guillain-Barre)

 A disease of the optic nerve (optic neuritis)

 Pain at the site immediately after injection, burning and stinging

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 TWINRIX ADULT

Keep out of reach of children.

Do not use Twinrix Adult after the expiry date stated on the carton. The expiry date refers to the last day of that month.

Store in a refrigerator (2 ° C - 8 ° C).

Store in the original package to protect from light.

Do not freeze. Freezing destroys the vaccine.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

 ADDITIONAL INFORMATION

What Twinrix Adult

The active ingredients are:

 Hepatitis A virus (inactivated) 720 ELISA Units 1.2

 Hepatitis B surface antigen3, 4 20 micrograms

 Produced on human diploid (MRC-5) cells

  adsorbed on aluminum hydroxide, hydrated 0.05 milligrams Al3 +

 Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology

  Adsorbed on aluminum phosphate 0.4 milligrams Al3 + 

The other ingredients in Twinrix Adult are: sodium chloride, water for injections. 

Twinrix Adult looks like and contents of pack

Suspension for injection in pre-filled syringe. 

Twinrix Adult is a white, milky liquid in a glass prefilled syringe (1 ml). 

Twinrix Adult is available in packs of 1, 10 and 25 pre-filled syringes with or without needles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer: Belgium

The following information is intended for healthcare professionals only:

During storage may be seen white deposit with a clear colorless supernatant.

The vaccine should be well shaken to obtain a slightly opaque, white suspension and visually inspected for particulate matter and / or abnormal physical appearance. The vaccine should not be used if there is any change in appearance.