Boostrix polio. 3. PHARMACEUTICAL FORM Suspension for injection. 4. CLINICAL PARTICULARS

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1 Boostrix polio 1. NAME OF THE MEDICINAL PRODUCT boostrix polio Combined diphtheria, tetanus, acellular pertussis and enhanced inactivated polio vaccine. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION boostrix polio contains diphtheria toxoid, tetanus toxoid, three purified pertussis antigens [pertussis toxoid (PT), filamentous hemagglutinin (FHA) and pertactin (PRN/69 kilodalton outer membrane protein)] adsorbed onto aluminium salts. It contains three types of inactivated polio viruses (type 1: Mahoney strain; type 2: MEF-1 strain; type 3: Saukett strain. The tetanus and diphtheria toxoids are obtained by formaldehyde treatment of purified Corynebacterium diphtheriae and Clostridium tetani toxins. The acellular pertussis vaccine components are obtained by extraction and purification from phase I Bordetella pertussis cultures, followed by irreversible detoxification of the pertussis toxin by glutaraldehyde and formaldehyde treatment of pertussis toxin, and formaldehyde treatment of FHA and PRN. The diphtheria toxoid, tetanus toxoid and acellular pertussis components are adsorbed onto aluminium salts. The three polioviruses are cultivated on a continuous VERO cell line, purified and inactivated with formaldehyde. boostrix polio meets the World Health Organisation requirements for the manufacture of biological substances, of diphtheria, tetanus, pertussis combined vaccines, and of inactivated poliomyelitis vaccines. A 0.5 ml dose of vaccine contains not less than 2 IU (2.5 Lf) of adsorbed diphtheria toxoid, not less than 20 IU (5 Lf) of adsorbed tetanus toxoid, 8 µg of PT, 8 µg of FHA, 2.5 µg of pertactin, 40 D antigen units of type 1 (Mahoney), 8 D antigen units of type 2 (MEF-1) and 32 D antigen units of type 3 (Saukett) of the polio virus. 3. PHARMACEUTICAL FORM Suspension for injection. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications boostrix polio is indicated for booster vaccination against diphtheria, tetanus, pertussis and poliomyelitis of individuals from the age of seven years onwards. boostrix polio is not intended for primary immunisation. 4.2 Posology and method of administration Posology A single 0.5 ml dose of the vaccine is recommended. boostrix polio may be administered from the age of seven years onwards. boostrix polio should be administered in accordance with official recommendations and/or local practice regarding the use of vaccines that provide low (adult) dose diphtheria toxoid plus tetanus toxoid in combination with pertussis and poliomyelitis antigens. Page 1 of 6

2 Individuals with an incomplete, or no, history of a primary series of diphtheria and tetanus toxoids should not be vaccinated with boostrix polio. boostrix polio is not precluded in subjects with an incomplete, or no, history of previous pertussis or polio vaccination. However a booster response will only be elicited in individuals who have been previously primed by vaccination or by natural infection. boostrix polio can be used in the management of tetanus prone injuries in persons who have previously received a primary vaccination series of tetanus toxoid vaccine. Tetanus immunoglobulin should be administered concomitantly in accordance with official recommendations. Repeat vaccination against diphtheria, tetanus and poliomyelitis should be performed at intervals as per official recommendations. Method of administration boostrix polio is for deep intramuscular injection, preferably in the deltoid region. 4.3 Contra indication boostrix polio should not be administered to subjects with known hypersensitivity to any component of the vaccine (see sections 2 and 6.1) or to subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis or poliomyelitis vaccines. boostrix polio is contra-indicated if the subject has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine. In these circumstances, pertussis vaccination should be discontinued and the vaccination course should be continued with diphtheria, tetanus and poliomyelitis vaccines. boostrix polio should not be administered to subjects who have experienced neurological complications (for convulsions or hypotonic-hyporesponsive episodes, see section warnings and precautions) following an earlier immunisation against diphtheria and/or tetanus. As with other vaccines, administration of boostrix polio should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection is not a contra-indication. 4.4 Special warnings and special precautions for use It is good clinical practice that vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination. As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine. If any of the following events have occurred in temporal relation to receipt of pertussis containing vaccine in infancy, the decision to give subsequent doses of pertussiscontaining vaccines should be carefully considered. Temperature of 40.0 C (rectal) within 48 hours of vaccination, not due to another identifiable cause. Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination. Page 2 of 6

3 Persistent, inconsolable crying lasting 3 hours, occurring within 48 hours of vaccination. Convulsions with or without fever, occurring within 3 days of vaccination. There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks, particularly since these events are not associated with permanent sequelae. According to available clinical data, the risk of such reactions is lower with acellular pertussis vaccines than with whole cell pertussis vaccines. boostrix polio should in no circumstances be administered intravascularly. boostrix polio should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects. Firm pressure should be applied to the injection site (without rubbing) for at least two minutes. Collapse or shock-like state (hypotonic-hyporesponsive episode) and convulsions have been reported very rarely following immunisation of children with products containing one or more of the antigenic constituents of boostrix polio. A history of febrile convulsions, a family history of convulsions, a family history of Sudden Infant Death Syndrome (SIDS) and a family history of an adverse event following DTP vaccination do not constitute contra-indications. Human Immunodeficiency Virus (HIV) infection is not considered as a contra-indication. The expected immunological response may not be obtained after vaccination of immunosuppressed patients, e.g. patients on immunosuppressive therapy. 4.5 Interaction with other medicinal products and other forms of interaction Concomitant administration of boostrix polio and other vaccines has not specifically been studied. However, boostrix polio can be given concomitantly with other vaccines taking into account generally accepted vaccine practices and recommendations. As with other vaccines, it may be expected that in patients receiving immunosuppressive therapy or patients with immunodeficiency an adequate immunologic response may not be achieved. 4.6 Pregnancy and lactation Human data on the use of boostrix polio during pregnancy are not available. However, animal studies showed no reproductive toxicity or teratogenic effects. As with other inactivated vaccines, it is not expected that vaccination with boostrix polio harms the foetus. However, the vaccine should be used during pregnancy only when clearly needed, and the possible advantages outweigh the possible risks for the foetus. Data on the administration of boostrix polio to women who are breastfeeding their infants are not available. boostrix polio should be administered to women who are breastfeeding only when clearly needed. 4.7 Effects on ability to drive and use machines The vaccine is unlikely to produce an effect on the ability to drive and use machines. 4.8 Undesirable effects Clinical trials Page 3 of 6

4 More than 1500 vaccinees have received a dose of boostrix polio in clinical studies. The most common events occurring after vaccine administration were local injection site reactions (pain, redness and swelling) reported by % of subjects overall. These had their onset within the first day after vaccination. All resolved without sequelae. Adverse events with at least a suspected causal relationship to vaccination are listed below. Frequencies are reported as : Very common : 10% Common : 1% and < 10% Uncommon : 0.1% and < 1% Rare : 0.01% and < 0.1% Very rare : < 0.01% Application site Very common : injection site reaction including pain, redness, swelling. Body as a whole Very common : fatigue Common : fever Central and peripheral nervous system Very common : headache Uncommon : dizziness Gastro-intestinal system Common : loss of appetite, gastro-intestinal symptoms (such as abdominal pain, nausea, vomiting) Musculoskeletal system Uncommon : arthralgia, myalgia Psychiatric Common : drowsiness, irritability Skin and appendages Uncommon : pruritus White cell and reticuloendothelial system Uncommon : lymphadenopathy Post-marketing surveillance As observed during post-marketing surveillance with other vaccines, allergic reactions including anaphylactoid reactions may very rarely occur. 4.9 Overdose No case of overdose has been reported. Page 4 of 6

5 5. PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmaco-therapeutic group: Bacterial vaccines combined, ATC code J07CA. One month post vaccination with boostrix polio, immune responses in 1469 subjects were the following : Antigen Response Adults, adolescents and children (% vaccines) from the age of 4 years onwards* Diphtheria 0.1 IU/ml % Tetanus 0.1 IU/ml % Pertussis Pertussis toxoid Filamentous haemagglutinin Pertactin Vaccine response Vaccine response Vaccine response % % % Inactivated poliomyelitis Type 1 Type 2 Type 3 Seroprotection 8 Seroprotection 8 Seroprotection % % % *In clinical studies, seroprotection and vaccine response rates to all antigens after a booster dose of boostrix polio were similar to the licensed controlled vaccines studied. As with other adult-type Td vaccines, boostrix polio induces higher seroprotection rates and higher titres of both anti-d and anti-t antibodies in children and adolescents as compared to adults. The pertussis antigens contained in boostrix polio are an integral part of the paediatric acellular pertussis combination vaccine (Infanrix.), for which efficacy after primary vaccination has been demonstrated in a household contact efficacy study. The antibody titres to all three pertussis components following vaccination with boostrix polio are at least as high or higher than those observed during the household contact efficacy trial. Based on these comparisons, boostrix polio would provide protection against pertussis, however the degree and duration of protection afforded by the vaccine are undetermined. The immunogenicity of revaccination with boostrix polio has not been evaluated. 5.2 Pharmacokinetic properties Evaluation of pharmacokinetic properties is not required for vaccines. 5.3 Preclinical safety data Preclinical data reveal no special hazard for humans based on conventional studies of safety and of toxicity. 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Aluminum salts, Medium 199 (as stabilizer), sodium chloride, water for injections, formaldehyde, polysorbate 80, neomycin sulfate, polymyxin B sulphate are present as residuals from the manufacturing process. Page 5 of 6

6 6.2 Incompatibilities boostrix polio should not be mixed with other vaccines in the same syringe. 6.3 Shelf-life The expiry date of the vaccine is indicated on the label and packaging. 6.4 Special precautions for storage boostrix polio should be stored at +2 C to +8 C. Do not freeze. Discard if the vaccine has been frozen. 6.5 Nature and contents of container Turbid liquid suspension for injection (0.5mL) in pre-filled syringes (Type I glass, Ph.Eur.). 6.6 Instructions for use and handling Prior to use, the vaccine should be at room temperature and well shaken in order to obtain a homogeneous turbid white suspension. Prior to administration, the vaccine should be isually inspected for any foreign particulate matter and/or variation of physical aspect. In the event of either being observed, discard the vaccine. Upon removal from refrigerator, the vaccine is stable for 8 hours at + 21 C. For further information, please contact the manufacturer. Boostrix and Infanrix are trademarks. Pada proses pembuatannya bersinggungan dengan bahan bersumber babi. Presentations PFS of 0.5 ml Reg. No. DKI A1 HARUS DENGAN RESEP DOKTER Imported by PT. SmithKline Beecham Pharmaceuticals Bogor, Indonesia International Data Sheet version 1.0 (08/09/2004) GlaxoSmithKline Biologicals s.a Manufacturer/Fabricant/Fabricante: GlaxoSmithKline Biologicals s.a. Rue de I Institut 89, B-1330 Rixensart, Belgium. Tel.: (32.2) Fax: (32.2) Telex: Page 6 of 6