injection, suspension 
Hepatitis B (rDNA) vaccine (with adjuvant, adsorbed )

1. What Fendrix is ​​and what it is used for

Fendrix is ​​a vaccine that protects against hepatitis B.

It is used in patients with kidney disease:

  • patients undergoing hemodialysis – where the dialysis machine removes slag products from the blood
  • patients who will undergo hemodialysis in the future.

Fendrix is ​​used in adults and adolescents 15 years of age and older.

What is hepatitis B?

Hepatitis B is caused by a virus that causes liver swelling.

  • It is possible that signs do not appear until 6 weeks to 6 months after infection.
  • The main signs of illness include mild flu symptoms such as headache or fever, feeling tired, dark urine, pale stools, yellowish skin, or whites of the eyes (jaundice). These or other signs may mean that the person may need hospitalization. Most people recover completely from the disease.
  • Some people with hepatitis B do not look sick or do not feel sick – they have no signs of illness.
  • The virus is found in body fluids such as the vagina, blood, seme,n, or saliva (saliva).

Carriers of hepatitis B

  • The hepatitis B virus stays in the body throughout the life of some people.
  • This means that they can still infect other people and are called virus carriers.
  • Carriers of the virus are at risk for serious liver problems, such as cirrhosis or liver cancer.

How Fendrix works

  • Fendrix helps your body make its own protection against viruses ( antibodies ). These antibodies will protect you against the disease.
  • Fendrix contains two substances called MPL (a non-toxic purified fat derivative from bacteria) and aluminum phosphate. These make the vaccine work faster, better,r and have a longer effect.
  • As with all vaccines, treatment with Fendrix may not fully protect all vaccinated individuals.
  • Fendrix may not protect you from getting sick if you have already had the hepatitis B virus.
  • Fendrix can only protect you against infection by the hepatitis B virus. It can not protect you against other infections that can affect the liver, even if these infections have similar signs to those caused by the hepatitis B virus.

2. What you need to know before you get Fendrix

Fendrix should not be given:

  • if you are allergic to the active substance, or any of the other ingredients of this vaccine (listed in section 6). Signs of an allergic reaction may include an itchy rash, shortness of breath, and swelling of the face or tongue.
  • if you have ever had an allergic reaction to any hepatitis B vaccine
  • if you have a severe infection with fever. The vaccine can be given after you have recovered. A mild infection such as a cold is not an obstacle but tell your doctor first.

Fendrix should not be given if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Fendrix.

Warnings and cautions

Talk to your doctor or pharmacist before taking Fendrix:

  • if you have any known allergies you
  • if you have had any health problems after any previous vaccination.

Fainting can occur (mainly in adolescents) after, or even before, any needle injection. Therefore, tell your doctor or nurse if you have fainted from a previous injection.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Fendrix.

Other medicines and Fendrix

Tell your doctor if you are taking, have recently taken, or might take any other medicines or if you have recently received any other vaccine.

  • There should be at least 2-3 weeks between vaccination with Fendrix and any other vaccine.
  • Fendrix may need to be given at the same time as an injection of specific hepatitis B immunoglobulins. Your doctor will ensure that the vaccines are given at different injection sites on the body.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before giving this vaccine.

Driving and using machines

You may feel tired or have a headache after receiving Fendrix. If this happens, take special care when driving or handling any tools or machines.

3. How Fendrix is ​​given

How the vaccine is given :

  • Your doctor or nurse will give you Fendrix as an injection into a muscle. It usually occurs in your upper arm.

How much is given

  • You will receive a series of four injections.
  • The injections will be given within 6 months.
    • First injection: at an agreed date with your doctor
    • Second injection: 1 month after the first injection, a
    • Third injection: 2 months after the first injection, a
    • Fourth injection: 6 months after first injection a
  • Your doctor or nurse will tell you when to come back for your next injection.
  • Once you have received the first injection with Fendrix, your next injection will also need to be with Fendrix (not another hepatitis B vaccine).

Your doctor will tell you if you need extra doses or future refill doses. Fendrix can also be given as a supplement after treatment with another type of hepatitis B vaccine.

If you miss a dose

  • If you miss an injection, talk to your doctor and make another appointment.
  • Make sure you complete the entire schedule of four injections. Otherwise, you can not be sure that you have adequate protection against infection.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.

The following side effects may occur with this vaccine. The frequency is defined according to the method listed below.

Very common (these may occur in more than 1 in 10 vaccine doses)

  • headache
  • feeling tired
  • pain or discomfort at the injection site

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

  • redness or swelling where the injection was given
  • fever
  • indigestion

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

  • overindulge
  • red raised rashes
  • other reactions where the injection was given

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

  • allergy
  • hot flashes
  • dizziness
  • thirst
  • anxiety
  • infection caused by a virus
  • back pain, tendonitis

Also, the following side effects have also been reported with other hepatitis B vaccines:

Very rare (these may occur in up to 1 in 10,000 vaccine doses)

  • cramps
  • fainting
  • problems with the nerves around the eye ( optic neuritis )
  • multiple sclerosis
  • loss of sensation or difficulty touching certain parts of the body
  • severe headache with neck stiffness
  • numbness or weakness in the arms and legs ( neuropathy ), inflammation of the nerves ( neuritis ), weakness and paralysis in the arms and legs that often pass to the chest and face ( Guillain-Barré syndrome ), swelling or infection in the brain ( encephalitis, encephalopathy )
  • allergic reactions, including anaphylactoid reactions. These can be local or widespread rashes that can itch or become blisters, swelling of the eyes and face, difficulty breathing or swallowing a rapid drop in blood pressure, and unconsciousness. Such reactions may occur before leaving the doctor’s office, but you should always seek immediate help when these reactions occur.

5. How to store Fendrix

  • Keep this vaccine out of the reach and sight of children.
  • Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
  • Store in a refrigerator (2 ° C-8 ° C).
  • Store in the original package. Sensitive to light.
  • Do not freeze as it will destroy 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.

6. Contents of the packaging and other information

Content declaration

  • The active substance in 1 dose (0.5 ml) of Fendrix is:

Hepatitis B surface antigen 1,2,3 20 micrograms
1 as an adjuvant is used AS04C containing:
  – 3- O- desacyl-4′-monophosphoryl lipid A (MPL) 2 50 micrograms
adsorbed on aluminum phosphate (total 0.5 milligrams Al 3+ )
3 produced in yeast cells ( Saccharomyces cerevisiae ) by recombinant DNA technology.
  • The other ingredients in Fendrix are sodium chloride, water for injections.

Vaccine appearance and pack sizes

  • Injection, suspension in a prefilled syringe.
  • Fendrix is ​​a white, milky suspension packaged in a glass pre-filled syringe (0.5 ml).
  • Fendrix is ​​supplied in packs of 1, with or without a separate needle, and in packs of 10, without a needle.
  • Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

GlaxoSmithKline Biologicals sa

Rue de l’Institut 89

B-1330 Rixensart

Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorization Holder.

Belgium / Belgique / BelgienGlaxoSmithKline Pharmaceuticals sa / nvTel: + 32 10 85 52 00 LithuaniaGlaxoSmithKline Lithuania UABTel. +370 5 264 90 00info.lt@gsk.com
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Muhammad Nadeem

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