1 PATIENT INFORMATION LEAFLET ACT-HIB powder and solvent for solution for injection Haemophilus influenzae type b Conjugate Vaccine Read all of this leaflet carefully before your child is vaccinated. Keep this leaflet. You may need to read it again. If you have any other questions, ask your doctor or pharmacist. This vaccine has been prescribed for your child. Do not pass it on to others. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. In this leaflet: 1. What Act-HIB is and what it is used for 2. Before Act-HIB is given 3. How Act-HIB is given 4. Possible side effects 5. How to store Act-HIB 6. Further information 1. What Act-HIB is and what it is used for Act-HIB is a vaccine. It is used to protect against diseases caused by a bacteria called Haemophilus influenzae type b. These diseases include: Meningitis - swelling of the outer covering of the brain. This can cause high temperature, very severe headaches, twitching of the muscles in the neck and back, a rash, fits, being sick and delirium. It can sometimes be fatal. Sepsis - a very serious generalised infection of the body. This can cause high temperature and low blood pressure. This may lead to fainting. Cellulitis - redness and swelling of the skin and the tissues under the skin. This also occurs when a cut has become infected. A type of arthritis (swelling of the joints), that is often associated with a high temperature. The larger joints (e.g. knee, elbow, shoulder, hip) are usually affected, these joints become swollen and painful. Epiglottitis - swelling of part of the back of the throat. This can cause difficulty in swallowing and breathing. Act-HIB is used to prevent your child from getting these diseases by protecting them against these diseases before they come into contact with the bacteria. Important information about the protection provided Act-HIB will only help prevent these diseases if they are caused by the bacteria Haemophilus influenzae type b. Your child could still get these diseases if they are caused by another bacteria or a virus. Although Act-HIB contains tetanus protein, this vaccine will not protect your child against tetanus, and they will still need routine tetanus vaccination. 2. Before Act-HIB is given Act-HIB must not be given to your child if they:
2 have ever had an allergic reaction to a previous injection of Act-HIB, to any of the ingredients in Act-HIB (see section 6 for information on the other ingredients), or to formaldehyde (which may be present in the vaccine in undetectable trace amounts) are allergic to any other vaccine against Haemophilus influenzae type b (An allergic reaction can include a generalised skin rash, swelling of the face and throat, difficulty in breathing, blue discoloration of the tongue or lips, low blood pressure and fainting) have an infectious illness at the moment (e.g. temperature, sore throat, cough, cold or flu). Usually, vaccination will be delayed until after your child has recovered Tell your doctor or nurse if any of the statements above apply to your child. If you are unsure about anything or if there is anything you do not understand, ask your doctor or nurse to explain. Take special care Tell your doctor before the vaccination if: your child has any blood disorders such as haemophilia (a condition where you bruise or bleed easily), because he or she may get bleeding where they are injected you have been told by your doctor that your child is intolerant to some sugars as this vaccine contains sucrose (a type of sugar) Pregnancy and breast feeding This vaccine is not intended to be given to women of child-bearing age. Using other medicines or vaccines Please tell your doctor, nurse or pharmacist if your child is taking or has recently taken any other medicines (including medicines obtained without a prescription) or has recently received any other vaccines. Act-HIB can be given at the same time as other vaccines such as diphtheria, tetanus, pertussis (whooping cough) and inactivated polio vaccine measles, mumps and rubella (German measles) vaccine meningococcal serogroup C conjugate vaccine hepatitis B vaccine but will be injected into a different part of the body. The immune response to this vaccine may be reduced if your child is receiving immunosuppressive treatment such as corticosteroids, cytotoxic drugs or radiotherapy. Important information about some of the ingredients Act-HIB contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodiumfree.
3 3. How Act-HIB is given Act-HIB is for children over 2 months of age. Although this vaccine can be given to children of any age, it would not normally be given to those over 4 years of age as they are likely to already have naturally developed protection against diseases caused by Haemophilus influenzae type b. The vaccination should be given in a suitable place where the staff are equipped to deal with any uncommon severe allergic reaction. Your nurse or doctor will prepare the vaccine and shake it well before injecting a small amount (0.5 millilitre) into a muscle or deep under the skin. This will usually be into the outer part of the upper leg or arm. Act-HIB can also be mixed with either adsorbed diphtheria, tetanus and pertussis vaccine or with TETRAVAC (Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine, adsorbed) and then be given as one single injection. Your doctor or nurse will give your child the combined vaccines as soon as they are mixed. The first course of vaccination If your child is under 12 months and has never had vaccination against Haemophilus influenzae type b before, he or she will need three injections of Act-HIB, with an interval of at least four weeks between each injection. Use in children 12 months and over A single dose of Act-HIB may be given to children who are 12 months and over and who have not received a vaccine against Haemophilus influenzae type b before (children over 12 months need only one dose of vaccine to provide full protection). Such children can be given Act-HIB at the same time as measles, mumps and rubella (German measles) vaccine, but it should be injected into a different part of the body. Booster dose Sometimes an additional dose of Act-HIB is given to children who have had a full course of vaccinations already. The extra dose is intended to increase (boost) immunity. What to do if your child misses a dose of Act-HIB If a dose is missed, your doctor will advise you on when your child should have the remaining injection(s). 4. Possible side effects Like all vaccines, Act-HIB can have side effects, although not everybody gets them. Serious allergic reactions If any of these symptoms occur after leaving the place where your child received his/her injection, you must consult a doctor IMMEDIATELY.
4 Serious allergic reactions are a very rare possibility (affects less than 1 user in 10,000) after receiving any vaccine. These reactions may include: difficulty in breathing blueness of the tongue or lips a rash swelling of the face or throat low blood pressure causing dizziness or collapse When these signs or symptoms occur they usually develop quickly after the injection is given and while the child is still in the clinic or doctor s surgery. Other side effects If your child experiences any of the following side effects and it gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist. Very common reactions (affects more than 1 user in 10): decreased appetite irritability drowsiness pain at the injection site injection site redness swelling at the injection site a hard lump under the skin at the injection site Common reactions (affects 1 to 10 users in 100): abnormal or uncontrollable crying vomiting fever (temperature above 38 C) Uncommon reactions (affects 1 to 10 users in 1000): fever (above 39 C) The following additional side effects have been reported during the commercial use of Act-HIB: allergic reactions headache a fit (convulsion) with or without fever floppiness or decreased muscle tone skin reactions: wheals (itchy, lumpy skin rash), rash, itching of the skin, skin redness swelling of the face and/or throat
5 swelling of one or both lower limbs which is often associated with blueness, redness, severe crying and sometimes a purple spotted rash of the legs; this usually disappears within 24 hours without treatment. Redness and swelling of 5 cm or more at the site of the injection Extensive swelling of vaccinated limb In babies born very prematurely (at or before 28 weeks of gestation), longer gaps than normal between breaths may occur for 2-3 days after vaccination. 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 via IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.imb.ie; e-mail: imbpharmacovigilance@imb.ie. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Act-HIB Your doctor or nurse will usually store the vaccine before it is used. They will make sure that the vaccine is stored in a refrigerator between +2 C and +8 C. Your doctor or nurse should check that the vaccine is not used after the Expiry date on the box. The vaccine should be shaken well before use. Your doctor or nurse should check that the vaccine is not discoloured and does not contain large particles and should use it within one hour of being prepared for use if kept in a refrigerator between +2 C and +8 C. Your doctor or nurse should make sure that the vaccine is kept out of the reach and sight of children. 6. Further information Each 0.5 millilitre dose of the vaccine contains at least 10 micrograms of the active ingredient which is part (the capsular polysaccharide) of the Haemophilus influenzae type b bacteria. This active ingredient has been attached to between 18 and 30 micrograms of a harmless part of the bacteria that causes tetanus. There are also some inactive ingredients; these are trometamol and sucrose (sugar). The vaccine is prepared by mixing with water for injections and sodium chloride (salt) solution. Act-HIB is available as a single dose pack containing a vial (a small glass container) of freeze-dried vaccine plus a prefilled syringe of solvent (sodium chloride solution). Act-HIB is made by Sanofi Pasteur S.A, Campus Mérieux, 1541 avenue Marcel Mérieux, F-69280, Marcy l Etoile, Lyon, France. The company licensed to sell Act-HIB in IE is Sanofi Pasteur MSD Limited, Block A, Second Floor, Cookstown Court, Old Belgard Road, Tallaght, Dublin 24
6 This leaflet was last revised in: To be completed on approval Registered trademark