v annex i summary of product characteristics

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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

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1. NAME OF THE MEDICINAL PRODUCT TRIACELLUVAX Combined diphtheria, tetanus, and acellular pertussis vaccine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION TRIACELLUVAX is a sterile preparation of a combined vaccine containing diphtheria and tetanus toxoids and three acellular Bordetella pertussis antigens, adsorbed onto aluminium hydroxide, in an isotonic sodium chloride solution containing thiomersal as a preservative. The antigen content of each 0.5 ml dose of vaccine is as follows: Diphtheria toxoid not less than 30 IU Tetanus toxoid not less than 40 IU Genetically detoxified pertussis toxin 5 micrograms FHA 2.5 micrograms Pertactin 2.5 micrograms The diphtheria and tetanus toxoids are prepared from cultures of Corynebacterium diphtheriae and Clostridium tetani respectively and have been detoxified using formaldehyde treatment. The acellular pertussis antigens are purified from cultures of a genetically modified strain of B. pertussis. The three pertussis antigens present in the vaccine are a genetically detoxified form of pertussis toxin (PT-9K/129G), the major virulence factor of B. pertussis; filamentous haemagglutinin (FHA); and the outer membrane protein pertactin (69K). FHA and pertactin are expressed in the B. pertussis strain as wild-type antigens. 3. PHARMACEUTICAL FORM Suspension for injection in a pre-filled syringe. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications TRIACELLUVAX is indicated for active immunisation of children from 6 weeks up to 7 years of age against diphtheria, tetanus and pertussis. 4.2 Posology and method of administration Primary immunisation in infants from 6 weeks of age consists of a total of three doses, administered at intervals of at least 1 month. An alternative schedule for primary immunisation consists of a total of three doses administered at 3, 5 and 12 months of age.

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Children previously immunised with three doses of TRIACELLUVAX within the first 6 months of life may be given a fourth (booster) dose, 6-12 months after the third dose. Children previously immunised with three doses of whole-cell vaccine in the first year of life may receive a first acellular booster with TRIACELLUVAX in the second year of life and a second acellular booster with TRIACELLUVAX at 4 to 6 years of age. Children previously immunised with either four doses of whole-cell pertussis vaccine or three doses of whole-cell vaccine and a first acellular pertussis vaccine booster in the second year of life may receive a booster with TRIACELLUVAX at 4 to 6 years of age. The choice of immunisation schedules should be based on official recommendations. Each 0.5 ml dose of vaccine should be administered intramuscularly, either in the anterolateral aspect of the thigh, or in the buttocks, taking care to avoid damage to the sciatic nerve (infants and toddlers). In older children, the vaccine should be administered in the deltoid muscle. TRIACELLUVAX should not be mixed with other vaccines in the same syringe. Separate injection sites should be used. In children with thrombocytopenia or bleeding disorders, the vaccine should be administered subcutaneously. 4.3 Contra-indications Hypersensitivity to the active substances or to any of the excipients. Immunisation is contra-indicated in children having experienced encephalopathy occurring within 7 days following previous vaccination with a pertussis-containing vaccine. In these circumstances the vaccination schedule should be continued using a combined diphtheria and tetanus vaccine that does not contain a pertussis component. The administration should be postponed in children with an acute febrile illness. 4.4 Special warnings and special precautions for use TRIACELLUVAX should under no circumstances be administered intravenously. Vaccination should be preceded by a clinical examination and review of the child’s medical history, having particular regard to previous vaccination and the occurrence of any undesirable effects. Should any of the following events have occurred in temporal relationship to the administration of a pertussis-containing vaccine, subsequent administration of such a vaccine should be carefully considered: • Collapse or shock-like state (hypotonic-hyporesponsive episode), occurring within 48

hours of administration.

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• Temperature of 40 °C or greater within 48 hours of administration, unexplainable by any other cause.

• Persistent crying lasting for 3 or more hours, occurring within 48 hours of administration. • Convulsion, with or without fever, occurring within 3 days of administration. In such cases the potential benefits should be weighed against possible risks, such as in circumstances where there is a high incidence of pertussis infection within the community. A decreased immune response to the vaccine may be seen in children with an impaired immune function, such as during immunosuppressive therapy (including irradiation, corticosteroids, antimetabolites, alkylating agents and cytotoxic agents), or as a consequence of a genetic defect or human immunodeficiency virus (HIV) infection. When there is no diphtheria booster in the second year of life, a 2, 4, 6 month schedule for immunisation with TRIACELLUVAX seems to be preferable. As with all injectable vaccines, appropriate medical treatment should be readily available in case of anaphylactic reactions following administration of the vaccine. It is therefore recommended that children remain under medical supervision for at least 30 minutes following vaccination. 4.5 Interaction with other medicinal products and other forms of interaction TRIACELLUVAX can be administered simultaneously with other paediatric vaccines in accordance with recommended immunisation schedules. No interference with the immunogenicity of Haemophilus influenzae type b conjugate vaccine (both HbOC and PRP-T), Hepatitis B vaccine, MMR vaccine (measles, mumps & rubella) and Oral Polio Vaccine has been observed in clinical trials in which these vaccines were administered concomitantly with TRIACELLUVAX. 4.6 Use during pregnancy and lactation Not applicable. 4.7 Effects on ability to drive and use machines Not applicable. TRIACELLUVAX is intended for paediatric use only. 4.8 Undesirable effects Over 30,000 children, predominantly infants, have received TRIACELLUVAX in clinical studies. In general, comparative studies have shown TRIACELLUVAX to have a safety profile similar to the diphtheria and tetanus vaccine and to be less reactogenic than whole-cell pertussis vaccines. Most frequently reported postimmunisation reactions included fever, redness, swelling and tenderness at the injection site, and were usually mild. As with any other acellular vaccine, an increased incidence of local reactions after the fourth dose, compared to the primary series, has been observed also with TRIACELLUVAX. More severe reactions, including hypotonic-hyporesponsive episodes, rectal temperature ≥ 40 °C and convulsions were rare.

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4.9 Overdose No case of overdose has been reported. 5. PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmaco-therapeutic group: General antiinfectives for systemic use; Bacterial vaccines; Pertussis, ATC code: J07A J. Clinical data are available to support a 2-4-6 months immunisation schedule for primary vaccination. In an Italian Efficacy Trial, TRIACELLUVAX was associated with 84% (two sided 95% confidence interval of 76.2% to 89.7%), protection against clinical pertussis, as defined by the WHO case definition (at least 21 days of paroxysmal cough with laboratory confirmation). These efficacy data are based on a mean follow up of 17.2 months after a primary series of 3 doses given to infants at 2, 4 and 6 months of age, without any booster dose. Persistence of similar protective efficacy rates was shown by an additional follow-up of 9 months still without any booster dose (stage II of the Italian Efficacy Trial). In this trial 99% and 100% of children vaccinated with three doses of TRIACELLUVAX had protective antibody titres for diphtheria and tetanus, respectively. Efficacy results from another efficacy trial, performed in Sweden, confirm the efficacy data from the Italian Trial and indicate that an alternative schedule of immunisation, including three doses at 3, 5, and 12 months of age, can also be used for primary immunisation with TRIACELLUVAX. 5.2 Pharmacokinetic properties Given the nature of the product information concerning the pharmacokinetic properties are not applicable. 5.3 Preclinical safety data Preclinical data including single-dose, repeated-dose and local tolerance studies revealed no unexpected findings and no target organ toxicity. In the repeated-dose study, no treatment related effects were observed on the following parameters: clinical signs, injection site reactions, body weight, body temperature, ophthalmological condition, haematology, clinical chemistry and gross pathology of main organs. Histopathological examination was therefore restricted to the injection site only. No histopathological investigations were performed after repeated injections at the same site. 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Sodium chloride Aluminium hydroxide Thiomersal (50 micrograms/0.5ml)

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Water for Injections Formaldehyde 6.2 Incompatibilities The vaccine should not be mixed with other vaccines in the same syringe. 6.3 Shelf-life 18 months. 6.4 Special precautions for storage Store at +2 ºC to +8 °C in a refrigerator, protected from light. Do not freeze. 6.5 Nature and content of container TRIACELLUVAX is available as a 0.5 ml single dose. It is a sterile suspension contained in a Type I clear glass pre-filled syringe with plunger (with either a needle attached or a separate needle for attachment). The plunger stopper is made of rubber. Pack sizes of one, five and ten single dose pre-filled syringes are available. 6.6 Instructions for use and handling and disposal Allow the vaccine to reach room temperature before use. Shake the contents of the syringe and visually inspect the contents for any foreign particulate matter. In the event of any particulate matter being observed, do not use. Unused vaccine should be flushed down a sink with copious amounts of water. The syringe and needle used should be disposed of in a secure container. 7. MARKETING AUTHORISATION HOLDER CHIRON S.p.A., Via Fiorentina 1, 53100, SIENA, Italy. 8. NUMBERS IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 10. DATE OF REVISION OF THE TEXT

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ANNEX II THE MANUFACTURING AUTHORISATION HOLDER

RESPONSIBLE FOR BATCH RELEASE AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

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A. MANUFACTURING AUTHORISATION HOLDER Manufacturer responsible for batch release Chiron S. p. A., Via Fiorentina, 1 53100 Siena, Italy Manufacturing Authorisation issued on 14 March 1992 by Ministero della Sanita, Lungotevere Ripa 1, 00100 Roma, Italy. B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription. [C. SPECIFIC OBLIGATIONS Official batch release: In accordance with Article 4 of Council Directive 89/342/EEC, the official batch release will be undertaken by a State Laboratory designated for that purpose.]

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ANNEX III LABELLING AND PACKAGE LEAFLET

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A. LABELLING

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TRIACELLUVAX – MONODOSE PRE-FILLED SYRINGE WITHOUT NEEDLE X1 PACK 1.1 Outer Packaging TRIACELLUVAX Combined diphtheria, tetanus, and acellular pertussis vaccine Pharmaceutical form: suspension for injection. Contains 0.5 ml (1 dose), pre-filled syringe 1 monodose pre-filled syringe without needle Composition: One dose (0.5 ml) contains: Active Ingredients; not less than 30 IU diphtheria toxoid; not less than 40 IU tetanus toxoid; 5 μg PT-9K/129G (genetically detoxified pertussis toxin); 2.5 μg filamentous haemagglutinin (FHA); 2.5 μg pertactin. Excipients; 50 μg thiomersal, aluminium hydroxide, sodium chloride, water for injections and formaldehyde. Administration: Intramuscular injection. Warning: Not for intravenous injection. Store at +2 °C to +8 °C, protected from light. Do not freeze. Shake before use. Batch No.: Expiry date: Marketing authorisation holder: CHIRON S.p.A., Via Fiorentina 1, 53100, Siena, Italy. Keep out of the reach and sight of children. Medicinal product subject to medical prescription Marketing authorisation No. EU/ 1.2. Immediate Packaging TRIACELLUVAX 1 dose (0.5 ml). For intramuscular injection. Warning: Not for intravenous injection. Batch: Exp.:

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CHIRON S.p.A., Siena , Italy.

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TRIACELLUVAX – MONODOSE PRE-FILLED SYRINGE WITHOUT NEEDLE X5 PACK 2.1 Outer Packaging TRIACELLUVAX Combined diphtheria, tetanus, and acellular pertussis vaccine Pharmaceutical form: suspension for injection. Contains 0.5 ml (1 dose), pre-filled syringe 5 monodose pre-filled syringes without needle Composition: One dose (0.5 ml) contains: Active Ingredients; not less than 30 IU diphtheria toxoid; not less than 40 IU tetanus toxoid; 5 μg PT-9K/129G (genetically detoxified pertussis toxin); 2.5 μg filamentous haemagglutinin (FHA); 2.5 μg pertactin. Excipients; 50 μg thiomersal, aluminium hydroxide, sodium chloride, water for injections and formaldehyde. Administration: Intramuscular injection. Warning: Not for intravenous injection. Store at +2 °C to +8 °C, protected from light. Do not freeze. Shake before use. Batch No.: Expiry date: Marketing authorisation holder: CHIRON S.p.A., Via Fiorentina 1, 53100, Siena, Italy. Keep out of the reach and sight of children. Medicinal product subject to medical prescription Marketing authorisation No. EU/ 2.2. Immediate Packaging TRIACELLUVAX 1 dose (0.5 ml). For intramuscular injection. Warning: Not for intravenous injection. Batch: Exp.:

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TRIACELLUVAX – MONODOSE PRE-FILLED SYRINGE WITHOUT NEEDLE X10 PACK 3.1 Outer Packaging TRIACELLUVAX Combined diphtheria, tetanus, and acellular pertussis vaccine Pharmaceutical form: suspension for injection. Contains 0.5 ml (1 dose), pre-filled syringe 10 monodose pre-filled syringes without needle Composition: One dose (0.5 ml) contains: Active Ingredients; not less than 30 IU diphtheria toxoid; not less than 40 IU tetanus toxoid; 5 μg PT-9K/129G (genetically detoxified pertussis toxin); 2.5 μg filamentous haemagglutinin (FHA); 2.5 μg pertactin. Excipients; 50 μg thiomersal, aluminium hydroxide, sodium chloride, water for injections and formaldehyde. Administration: Intramuscular injection. Warning: Not for intravenous injection. Store at +2 °C to +8 °C, protected from light. Do not freeze. Shake before use. Batch No.: Expiry date: Marketing authorisation holder: CHIRON S.p.A., Via Fiorentina 1, 53100, Siena, Italy. Keep out of the reach and sight of children. Medicinal product subject to medical prescription Marketing authorisation No. EU/ 3.2. Immediate Packaging TRIACELLUVAX 1 dose (0.5 ml). For intramuscular injection. Warning: Not for intravenous injection. Batch: Exp.:

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TRIACELLUVAX – MONODOSE PRE-FILLED SYRINGE WITH ATTACHED NEEDLE X1 PACK 4.1 Outer Packaging TRIACELLUVAX Combined diphtheria, tetanus, and acellular pertussis vaccine Pharmaceutical form: suspension for injection. Contains 0.5 ml (1 dose), pre-filled syringe 1 monodose pre-filled syringe with attached needle Composition: One dose (0.5 ml) contains: Active Ingredients; not less than 30 IU diphtheria toxoid; not less than 40 IU tetanus toxoid; 5 μg PT-9K/129G (genetically detoxified pertussis toxin); 2.5 μg filamentous haemagglutinin (FHA); 2.5 μg pertactin. Excipients; 50 μg thiomersal, aluminium hydroxide, sodium chloride, water for injections and formaldehyde. Administration: Intramuscular injection. Warning: Not for intravenous injection. Store at +2 °C to +8 °C, protected from light. Do not freeze. Shake before use. Batch No.: Expiry date: Marketing authorisation holder: CHIRON S.p.A., Via Fiorentina 1, 53100, Siena, Italy. Keep out of the reach and sight of children. Medicinal product subject to medical prescription Marketing authorisation No. EU/ 4.2. Immediate Packaging TRIACELLUVAX 1 dose (0.5 ml). For intramuscular injection. Warning: Not for intravenous injection. Batch: Exp.:

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TRIACELLUVAX – MONODOSE PRE-FILLED SYRINGE WITH ATTACHED NEEDLE X5 PACK 5.1 Outer Packaging TRIACELLUVAX Combined diphtheria, tetanus, and acellular pertussis vaccine Pharmaceutical form: suspension for injection. Contains 0.5 ml (1 dose), pre-filled syringe 5 monodose pre-filled syringes with attached needle Composition: One dose (0.5 ml) contains: Active Ingredients; not less than 30 IU diphtheria toxoid; not less than 40 IU tetanus toxoid; 5 μg PT-9K/129G (genetically detoxified pertussis toxin); 2.5 μg filamentous haemagglutinin (FHA); 2.5 μg pertactin. Excipients; 50 μg thiomersal, aluminium hydroxide, sodium chloride, water for injections and formaldehyde. Administration: Intramuscular injection. Warning: Not for intravenous injection. Store at +2 °C to +8 °C, protected from light. Do not freeze. Shake before use. Batch No.: Expiry date: Marketing authorisation holder: CHIRON S.p.A., Via Fiorentina 1, 53100, Siena, Italy. Keep out of the reach and sight of children. Medicinal product subject to medical prescription Marketing authorisation No. EU/ 5.2. Immediate Packaging TRIACELLUVAX 1 dose (0.5 ml). For intramuscular injection. Warning: Not for intravenous injection. Batch: Exp.:

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TRIACELLUVAX – MONODOSE PRE-FILLED SYRINGE WITH ATTACHED NEEDLE X10 PACK 6.1 Outer Packaging TRIACELLUVAX Combined diphtheria, tetanus, and acellular pertussis vaccine Pharmaceutical form: suspension for injection. Contains 0.5 ml (1 dose), pre-filled syringe 10 monodose pre-filled syringes with attached needle Composition: One dose (0.5 ml) contains: Active Ingredients; not less than 30 IU diphtheria toxoid; not less than 40 IU tetanus toxoid; 5 μg PT-9K/129G (genetically detoxified pertussis toxin); 2.5 μg filamentous haemagglutinin (FHA); 2.5 μg pertactin. Excipients; 50 μg thiomersal, aluminium hydroxide, sodium chloride, water for injections and formaldehyde. Administration: Intramuscular injection. Warning: Not for intravenous injection. Store at +2 °C to +8 °C, protected from light. Do not freeze. Shake before use. Batch No.: Expiry date: Marketing authorisation holder: CHIRON S.p.A., Via Fiorentina 1, 53100, Siena, Italy. Keep out of the reach and sight of children. Medicinal product subject to medical prescription Marketing authorisation No. EU/ 6.2. Immediate Packaging TRIACELLUVAX 1 dose (0.5 ml). For intramuscular injection. Warning: Not for intravenous injection. Batch: Exp.:

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TRIACELLUVAX – MONODOSE PRE-FILLED SYRINGE WITH SEPARATE NEEDLE X1 PACK 7.1 Outer Packaging TRIACELLUVAX Combined diphtheria, tetanus, and acellular pertussis vaccine Pharmaceutical form: suspension for injection. Contains 0.5 ml (1 dose), pre-filled syringe 1 monodose pre-filled syringe with separate needle Composition: One dose (0.5 ml) contains: Active Ingredients; not less than 30 IU diphtheria toxoid; not less than 40 IU tetanus toxoid; 5 μg PT-9K/129G (genetically detoxified pertussis toxin); 2.5 μg filamentous haemagglutinin (FHA); 2.5 μg pertactin. Excipients; 50 μg thiomersal, aluminium hydroxide, sodium chloride, water for injections and formaldehyde. Administration: Intramuscular injection. Warning: Not for intravenous injection. Store at +2 °C to +8 °C, protected from light. Do not freeze. Shake before use. Batch No.: Expiry date: Marketing authorisation holder: CHIRON S.p.A., Via Fiorentina 1, 53100, Siena, Italy. Keep out of the reach and sight of children. Medicinal product subject to medical prescription Marketing authorisation No: EU/ 7.2. Immediate Packaging TRIACELLUVAX 1 dose (0.5 ml). For intramuscular injection. Warning: Not for intravenous injection. Batch: Exp.:

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TRIACELLUVAX – MONODOSE PRE-FILLED SYRINGE WITH SEPARATE NEEDLE X5 PACK 8.1 Outer Packaging TRIACELLUVAX Combined diphtheria, tetanus, and acellular pertussis vaccine Pharmaceutical form: suspension for injection. Contains 0.5 ml (1 dose), pre-filled syringe 5 monodose pre-filled syringes with separate needle Composition: One dose (0.5 ml) contains: Active Ingredients; not less than 30 IU diphtheria toxoid; not less than 40 IU tetanus toxoid; 5 μg PT-9K/129G (genetically detoxified pertussis toxin); 2.5 μg filamentous haemagglutinin (FHA); 2.5 μg pertactin. Excipients; 50 μg thiomersal, aluminium hydroxide, sodium chloride, water for injections and formaldehyde. Administration: Intramuscular injection. Warning: Not for intravenous injection. Store at +2 °C to +8 °C, protected from light. Do not freeze. Shake before use. Batch No.: Expiry date: Marketing authorisation holder: CHIRON S.p.A., Via Fiorentina 1, 53100, Siena, Italy. Keep out of the reach and sight of children. Medicinal product subject to medical prescription Marketing authorisation No. EU/ 8.2. Immediate Packaging TRIACELLUVAX 1 dose (0.5 ml). For intramuscular injection. Warning: Not for intravenous injection. Batch: Exp.:

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TRIACELLUVAX – MONODOSE PRE-FILLED SYRINGE WITH SEPARATE NEEDLE X10 PACK 9.1 Outer Packaging TRIACELLUVAX Combined diphtheria, tetanus, and acellular pertussis vaccine Pharmaceutical form: suspension for injection. Contains 0.5 ml (1 dose), pre-filled syringe 10 monodose pre-filled syringes with separate needle Composition: One dose (0.5 ml) contains: Active Ingredients; not less than 30 IU diphtheria toxoid; not less than 40 IU tetanus toxoid; 5 μg PT-9K/129G (genetically detoxified pertussis toxin); 2.5 μg filamentous haemagglutinin (FHA); 2.5 μg pertactin. Excipients; 50 μg thiomersal, aluminium hydroxide, sodium chloride, water for injections and formaldehyde. Administration: Intramuscular injection. Warning: Not for intravenous injection. Store at +2 °C to +8 °C, protected from light. Do not freeze. Shake before use. Batch No.: Expiry date: Marketing authorisation holder: CHIRON S.p.A., Via Fiorentina 1, 53100, Siena, Italy. Keep out of the reach and sight of children. Medicinal product subject to medical prescription Marketing authorisation No. EU/ 9.2. Immediate Packaging TRIACELLUVAX 1 dose (0.5 ml). For intramuscular injection. Warning: Not for intravenous injection. Batch: Exp.:

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B. PACKAGE LEAFLET

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PACKAGE LEAFLET (Pre-filled syringe) (To the parent or guardians of infants or children receiving TRIACELLUVAX Combined diphtheria, tetanus and acellular pertussis vaccine) PLEASE READ THIS CAREFULLY before your child receives their vaccination. This leaflet provides a summary of the information available on your child’s vaccine. If you have any questions ask the doctor or nurse who will be giving this vaccine to your child. You should make sure your child finishes the complete vaccination course. If not, your child may not be fully protected against infection. Save this leaflet as you may want to read it again in the future. 1. NAME OF THE MEDICINAL PRODUCT TRIACELLUVAX. Combined diphtheria, tetanus and acellular pertussis vaccine 2. WHAT IS TRIACELLUVAX ? TRIACELLUVAX contains as active ingredients: diphtheria toxoid (not less than 30 IU); tetanus toxoid (not less than 40 IU); 5 micrograms genetically detoxified pertussis toxin; 2.5 micrograms filamentous haemagglutinin (FHA) and 2.5 micrograms pertactin. Other ingredients of the vaccine are: thiomersal (preservative), sodium chloride, aluminium hydroxide, water for injections and formaldehyde. Pack sizes of 1, 5 and 10 pre-filled syringes are available. Each pre-filled syringe contains 0.5 ml as a single dose. Manufacturer and marketing authorisation holder: Chiron S.p.A., via Fiorentina 1, 53100 Siena, Italy. 3. WHAT IS IN THIS VACCINE? The active ingredients of the vaccine are proteins (called antigens), prepared from the bacteria that cause the diseases diphtheria, tetanus and whooping cough. This vaccine does not contain any live bacteria and cannot cause diphtheria, tetanus or whooping cough. The diphtheria and tetanus antigens contained in this vaccine have been prepared using methods similar to those used for the preparation of other diphtheria and tetanus vaccines. However, TRIACELLUVAX is different from other whooping cough vaccines in that it contains antigens against pertussis which have been purified from a novel strain of the bacterium which causes whooping cough. This bacterium produces a non-toxic form of the whooping cough toxin.

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4. WHAT IS THE VACCINE USED FOR? TRIACELLUVAX is a combined diphtheria, tetanus and pertussis (whooping cough) vaccine. It is provided as a suspension for injection and is available as a ready-to-use disposable single dose syringe or single dose vial for use in infants from 6 weeks of age to pre-school age children. TRIACELLUVAX is used to provide protection in children against diphtheria, tetanus and whooping cough. It works by helping your child’s body develop immunity against these diseases. 5. WHAT SHOULD YOU CHECK BEFORE YOUR CHILD RECEIVES THIS VACCINE? 5.1 Special precautions You should be aware of the following precautions and of circumstances in which vaccination of your child should be avoided; • Has your child been vaccinated before and if so did he or she have a reaction to the vaccine? • Is your child allergic (highly sensitive), to any of the ingredients in the vaccine? • Does your child suffer from any condition affecting the brain? • Does your child have an infection, fever or other illness, particularly a cough, cold or the flu? 5.2 Other precautions You and your doctor should also check over the following details before your child is given this vaccine; • Has your child been vaccinated against whooping cough before and reacted as follows

within 48 hours of being given the vaccine? • Developed a high temperature. • Collapsed or went into a shock-like state. • Cried for more than three hours. • Has your child experienced convulsions within three days of being given a whooping

cough vaccine? • Does your child have a bleeding problem? • Is your child taking any medicine or has he or she recently been given any other vaccine? If the answer to any of these questions is YES, TELL YOUR DOCTOR, as vaccination may need to be delayed or may not be recommended. 6. HOW WILL THE VACCINE BE GIVEN?

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Your doctor or nurse will give the vaccine to your child. TRIACELLUVAX will normally be injected into your child’s thigh or, in the case of older children, in the arm. If your child has any bleeding problems tell the doctor or nurse before they inject the vaccine, as the vaccine may need to be given in a different way (under the skin). Your child should receive at least three doses of TRIACELLUVAX. The first three doses will be given on separate occasions at about two-month intervals. If your child needs more than three doses of the vaccine, your doctor will tell you. It is important to pay special attention to the instructions of your doctor or the nurse regarding return visits. If you forget to go back to your doctor at the recommended time, ask your doctor for advice. TRIACELLUVAX can be given at the same time as other childhood vaccines; in this case different injection sites should be used. 7. WHAT ARE THE POSSIBLE UNDESIRABLE EFFECTS? Your child may feel pain or discomfort at the site of injection. You may also see some redness and swelling at this site. Other reactions which may occur are unusual crying, fever, drowsiness, irritability, feeding problems and stomach upsets such as vomiting and/or diarrhoea. Very rarely, a child who is highly sensitive to any of the substances in the vaccine can suffer an allergic reaction following vaccination. Doctors are aware of this possibility and have treatment available for use in such an event. More severe reactions such as convulsions and collapse or shock-like state are rare and significantly lower than in infants receiving whole-cell pertussis vaccine. If these reactions continue or become severe, TELL YOUR DOCTOR. If you notice any undesirable effect not mentioned in this leaflet please inform your doctor or pharmacist. 8. HOW SHOULD THE VACCINE BE STORED? TRIACELLUVAX must be stored in a refrigerator between +2 °C to +8 °C, protected from light, preferably in the original carton. Do not freeze. Do not use the vaccine after the expiry date which is indicated on the carton and the syringe or vial label. Keep out of the reach of children. 9. HOW CAN I OBTAIN FURTHER INFORMATION?

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This leaflet does not contain the complete information about your vaccine. If you have any questions or are unsure of anything, ask your doctor who has access to additional information. This leaflet only applies to the vaccine TRIACELLUVAX, for which it has been prepared.

v annex i summary of product characteristics

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