injection, suspension in pre-filled syringe 
Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine ( adsorbed )

Read this leaflet carefully before you / your child receives this vaccine. It contains information that is important to you.

  • Save this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, nurse, or pharmacist.
  • This vaccine has been prescribed for you / your child only. Do not pass it on to others.
  • If you / your child experiences side effects, talk to a doctor, nurse, or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet has been written on the condition that the person receiving the vaccine reads it. The vaccine can also be given to children and adolescents, so you may need to read it to your child.

In this leaflet you will find information about: 
1. What Ambirix is ​​and what it is used for 
2. What you need to know before you receive Ambirix 
3. How to use Ambirix 
4. Possible side effects 
5. How to store Ambirix 6. Contents of the pack 
and other ingredients information

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

Ambirix is ​​a vaccine used in infants, children, and adolescents from 1 year up to 15 years. It provides protection against two different infectious diseases: hepatitis A and hepatitis B.

  • Hepatitis A: Infection with the hepatitis A virus can cause swelling of the liver (inflammation ). The virus is usually spread through food or drink that contains the virus. Sometimes you can also get the virus in another way, such as when you swim in water that is contaminated with wastewater or from another infected person. The virus is found in body fluids, such as feces, serum, or saliva. Symptoms begin 3 to 6 weeks after infection. Some people may feel sick, have a fever, aches, and pains. After a few days, they may become very tired, have dark urine, pale stools, and yellowish skin or whites of the eyes (jaundice). The severity and type of symptoms may vary. Young children do not always get all the symptoms. Most children recover completely, but the disease is often severe enough to make children ill for at least a month.
  • Hepatitis B: Infection with the hepatitis B virus can cause swelling of the liver (inflammation ). The virus is usually spread from another infected person. It is found in body fluids such as blood, semen, vaginal secretions, or saliva (saliva). Symptoms may not appear until 6 weeks to 6 months after infection. Infected people do not always look sick or feel sick. Some people may feel sick, have a fever, aches, and pains. However, some can be very bad. They can become very tired, have dark urine, pale stools, and yellowish skin or whites of the eyes (jaundice). Some people may need hospital care.
    Most adults recover completely after the disease, but some (mainly children) who may not have had any symptoms may continue to carry infection one. They are called “hepatitis B carriers” and can still infect other people throughout their lives. Carriers also risk serious liver problems, such as cirrhosis of the liver ( cirrhosis ) and liver cancer.

How Ambirix works

  • Ambirix helps the body produce its own protection ( antibodies ) against these infectious diseases. The vaccine does not contain any live virus (see section 6 for the contents of the vaccine) and therefore may not cause hepatitis A or B infections.
  • As with all vaccines, some people respond less well to the vaccine than others.
  • Ambirix may not protect you from getting sick if you have previously been infected with the hepatitis A or B virus.
  • Ambirix can only protect you against infection with the hepatitis A or B virus. It can not protect against other infections that can affect the liver – even though these infections can give you similar symptoms as you get from hepatitis A or B virus.

2. What you need to know before you receive Ambirix

Ambirix should not be given if:

  • you are allergic to Ambirix 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.
  • you have previously had an allergic reaction to any hepatitis A or hepatitis B vaccine
  • you have a severe infection with a high fever. The vaccine can be given after recovery. A mild infection such as a common cold is probably not a problem, but talk to your doctor first.

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

Warnings and Precautions:

Talk to your doctor, nurse, or pharmacist before receiving Ambirix about:

  • you need adequate protection against hepatitis A and hepatitis B infection within 6 months – your doctor may recommend another vaccine.
  • you have a bleeding disorder or easily get bruises – injection one can possibly be given as an injection just under the skin instead of in a muscle to reduce bleeding / the number of bruises.
  • you have problems with the immune system (eg due to illness, treatment, or dialysis ) – the vaccine may not work well enough. This means that you may not have protection against one or both of the hepatitis A and B viruses. Your doctor will take blood samples to see if any further injections are required to give you adequate protection.
  • you have fainted before or before an injection – in case this happens again. 
    Fainting can occur (mainly in adolescents) after, or even before, any needle injection.

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

Other medicines and Ambirix

Tell your doctor if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription and herbal medicines or vaccines. If you are not sure, ask your doctor, nurse, or pharmacist.

If you are taking medicines that affect the body’s immune system, Ambirix can still be given if it is considered necessary. The vaccine may not work well enough. This means that you may not have protection against one or both of the hepatitis A and B viruses. Your doctor will take blood samples to see if any further injections are required to give you adequate protection.

Ambirix may need to be given at the same time as other vaccines against measles, mumps, rubella, diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b, or some treatment for hepatitis infections called “immunoglobulins”. The doctor will make sure that the vaccines are given in different places 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, nurse, or pharmacist for advice before taking this vaccine. Ambirix is ​​not usually given to women who are pregnant or breastfeeding.

Driving and using machines

You may become tired or dizzy after taking Ambirix. Should this occur, do not drive, cycle, or use any tools or machines.

Ambirix contains neomycin and sodium

This vaccine contains neomycin ( antibiotic ). Ambirix should not be given if you are allergic to neomycin.

This vaccine contains less than 1 mmol sodium per dose, ie essentially ‘sodium-free’ . is almost “sodium-free”.

How to use Ambirix

How injection is given

  • Your doctor or nurse will give Ambirix as an injection into a muscle, usually your upper arm.
  • They will make sure that Ambirix is ​​not given in a vein.
  • In very young children, an injection can be given into the thigh muscle.

How much is given

  • You will usually receive a total of two injections. Each injection is given at a separate visit.
  • The injections will be given within 12 months:
    • The first injection one – on the appointed date in agreement with the doctor.
    • The second injection one – between 6 and 12 months after the first injection on.

Your doctor will inform you if you need extra doses and about future booster doses.

Forgot dose

  • If you miss the second injection one, talk to your doctor, and get a new appointment as soon as possible.
  • Be sure to complete the vaccination program on two injections. Otherwise, you may not have protection against the diseases.

4. Possible side effects

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

Serious side effects are

Tell your doctor immediately if you notice any of the following serious side effects – you may need immediate treatment:

  • Allergic and anaphylactoid reactions – Signs may include a rash that may itch or cause blisters, swelling of the eyes and face, difficulty breathing or swallowing sudden drop in blood pressure, and unconsciousness.

Tell your doctor immediately if you notice any of the above serious side effects.

Adverse reactions that occurred during clinical trials with Ambirix were as follows:

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

  • headache
  • loss of appetite
  • feeling tired or irritable
  • pain and redness at the injection site.

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

  • fever
  • drowsiness
  • gastrointestinal problems
  • swelling at the injection site.

In addition, the following adverse reactions have been reported in clinical trials with very similar combined hepatitis A and hepatitis B vaccines:

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

  • general malaise
  • diarrhea, nausea
  • the reaction at the injection site.

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

  • dizziness
  • abdominal pain
  • vomiting
  • upper respiratory tract infection
  • muscle aches ( myalgia ).

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

  • low blood pressure
  • joint pain ( arthralgia )
  • itching ( pruritus ), rash
  • tingling and crawling ( paresthesia )
  • swollen glands in the neck, armpits, or groin ( lymphadenopathy )
  • flu-like symptoms, such as fever, sore throat, runny nose, cough, and chills.

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

  • hives ( urticaria ).

Contact a doctor if you get similar side effects.

Side effects that occurred with routine use of Ambirix were as follows:

  • fainting
  • lost sensitivity to pain or touch ( hypesthesia ).

In addition, the following side effects have occurred with routine use of very similar combined or individual hepatitis A and hepatitis B vaccines:

  • multiple sclerosis
  • swelling of the spinal cord ( myelitis )
  • abnormal liver values
  • swelling or inflammation of the brain ( encephalitis )
  • inflammation of certain blood vessels ( vasculitis )
  • degenerative brain disease ( encephalopathy )
  • swelling of the face, mouth, and throat ( angioneurotic edema )
  • severe headache with stiffness in the neck and sensitivity to light ( meningitis )
  • transient neuritis that causes pain, weakness, and paralysis of the arms and legs, often progressing to the chest and face ( Guillain-Barré syndrome )
  • seizures or seizures
  • nerve inflammation ( neuritis )
  • the disease of the optic nerve, an ( optic neuritis )
  • numbness or weakness in the arms and legs ( neuropathy )
  • immediate pain at the injection site, burning and burning sensation
  • paralysis, drooping eyelids, and paralysis of the muscles in one half of the face (facial paralysis)
  • the disease that mainly affects the joints with pain and swelling ( arthritis ),
  • muscle weakness
  • dark violet or red-violet skin lumps ( lichen planus), severe skin rash (erythema multiforme)
  • reduction in the number of platelets, which increases the tendency to bleed and the risk of bruising ( thrombocytopenia ), dark violet or reddish-brown spots visible through the skin (thrombocytopenic purpura).

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Ambirix

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). Do not freeze. Freezing destroys the vaccine.

Store in the original package. Sensitive to light.

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 substances are:
 
  – Hepatitis A virus (inactivated) 1,2 720 ELISA units
  – Hepatitis B surface antigen 3,4 20 micrograms



  1 Produced in human diploid cells (MRC-5)
  Adsorbed on hydrated aluminum hydroxide 0.05 milligrams Al 3+
  3 Produced in yeast cells ( Saccharomyces cerevisiae ) by recombinant DNAtechnology
  Adsorbed on aluminum phosphate 0.4 milligrams of Al 3+



The other ingredients in Ambirix are sodium chloride and water for injections.

What the medicine looks like and the contents of the pack

Injection, suspension in a prefilled syringe.

Ambirix is ​​a white, slightly milky liquid packaged in a 1 ml glass pre-filled syringe.

Ambirix is ​​supplied in packs of 1 or 10 pre-filled syringes (with or without needles) and 50 pre-filled syringes without needles.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

GlaxoSmithKline Biologicals SA

Rue de l’Institut 89

B-1330 Rixensart

Belgium

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienGlaxoSmithKline Pharmaceuticals sa / nvTel: + 32 10 85 52 00 LithuaniaGlaxoSmithKline Lithuania UABTel. +370 5 264 90 00info.lt@gsk.com
BulgariaThe GlaxoSmithKlein ЕООДTel: + 359 2 953 10 34 Luxembourg / LuxemburgGlaxoSmithKline Pharmaceuticals sa / nvTel: + 32 10 85 52 00
Czech RepublicGlaxoSmithKline sroTel: + 420 2 22 00 11 11cz.info@gsk.com HungaryGlaxoSmithKline Kft.Tel .: + 36-1-2255300
DenmarkGlaxoSmithKline Pharma A / STel: + 45 36 35 91 00dk-info@gsk.com MaltaGlaxoSmithKline (Malta) LtdTel: + 356 21 238131
GermanyGlaxoSmithKline GmbH & Co. KGTel: + 49 (0) 89 360448701produkt.info@gsk.com The NetherlandsGlaxoSmithKline BVTel: + 31 (0) 30 69 38 100
EestiGlaxoSmithKline Eesti OÜTel: +372 667 6900estonia@gsk.com NorwayGlaxoSmithKline ASTel: + 47 22 70 20 00
GreeceGlaxoSmithKline AEBE ConverterTηλ: + 30 210 68 82 100 AustriaGlaxoSmithKline Pharma GmbH.Tel: + 43 1 970 75-0at.info@gsk.com
SpainGlaxoSmithKline, SATel: + 34 900 202 700es-ci@gsk.com PolandGSK Services Sp. z ooTel .: + 48 (22) 576 9000
FranceGlaxoSmithKline LaboratoryTel: + 33 (0) 1 39 17 84 44diam@gsk.com PortugalSmith Kline & French Portuguesa, Pharmaceutical Products, Lda.Tel: + 351 21 412 95 00FI.PT@gsk.com
CroatiaGlaxoSmithKline dooTel .: + 385 (0) 1 6051999 RomaniaGlaxoSmithKline (GSK) SRLTel: + 40 (0) 21 3028 208
IrelandGlaxoSmithKline (Ireland) LtdTel: + 353 (0) 1 495 5000 SloveniaGlaxoSmithKline dooTel: + 386 (0) 1 280 25 00medical.x.si@gsk.com
IcelandVistor hf.Phone: +354 535 7000 Slovak RepublicGlaxoSmithKline Slovakia sroTel: + 421 (0) 2 48 26 11 11recepcia.sk@gsk.com
ItalyGlaxoSmithKline SpATel: + 39 04 59 21 81 11 Finland / FinlandGlaxoSmithKline OyPuh / Tel: + 358 10 30 30 30
ΚύπροςGlaxoSmithKline (Cyprus) Ltd:Ηλ: + 357 22 39 70 00gskcyprus@gsk.com
LatviaGlaxoSmithKline Latvia SIATel: + 371 67312687lv-epasts@gsk.com United KingdomGlaxoSmithKline UKTel: + 44 (0) 800 221 441customercontactuk@gsk.com

Muhammad Nadeem

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