210 mm

432745 PHARMA CODE N° 767

1. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.4. Contra-indications Infanrix-Hib contains diphtheria toxoid, tetanus Infanrix-Hib should not be administered to subjects with toxoid and three purified pertussis antigens [pertussis known hypersensitivity to any component of the vaccine

toxoid (PT), filamentous haemagglutinin (FHA) and or to subjects having shown signs of hypersensitivity after PHARMA CODE N° 767 pertactin (69 kiloDalton outer membrane protein)] previous administration of diphtheria, tetanus, pertussis or adsorbed onto aluminium salts. It also contains purified Hib vaccines. polyribosylribitol-phosphate capsular polysaccharide (PRP) As with other vaccines, the administration of Infanrix-Hib 1 of Hib, covalently bound to tetanus toxoid. should be postponed in subjects suffering from acute The diphtheria and tetanus toxins obtained from cultures severe febrile illness. The presence of a minor infection,

of Corynebacterium diphtheriae and Clostridium tetani are however, is not a contra-indication. 432745 detoxified and purified. The acellular pertussis vaccine components (PT, FHA and pertactin) are prepared by growing 2.5. Special warnings and special precautions for use GSK-BEL-Wavre-BEWAV phase I Bordetella pertussis from which the PT and FHA and Good clinical practise consists of enquiring into the medical history pertactin are extracted, purified and irreversibly detoxified. before proceeding with the vaccination (especially with regard to

The diphtheria toxoid, tetanus toxoid and acellular pertussis undesirable side effects which may have arisen during an earlier Indonesia-IDN vaccine components are adsorbed on aluminium salts. The final vaccination) and to proceed with a medical examination. vaccine is formulated in saline. Should one of the following events have occurred over time in Infanrix The Hib polysaccharide is prepared from Hib, strain 20,752 relation to the administration of a DTP vaccine, the decision and coupled to tetanus toxoid. After purification the conjugate to administer subsequent doses of the vaccine containing the 1 is lyophilised in the presence of lactose as stabiliser. pertussis component must be taken in full possession of the Infanrix-Hib meets the World Health Organization requirements for facts. There may be circumstances, such as a high incidence manufacture of biological substances, of Hib conjugate vaccines of pertussis, when the potential benefits exceed any potential Process and of diphtheria, tetanus, pertussis and combined vaccines. risks, particularly when the events are not associated with An 0.5 ml dose of the vaccine contains not less than permanent after-effects. 30 International Units (IU) of diphtheria toxoid, 40 IU of adsorbed The events cited below were previously considered as tetanus toxoid, 25 µg of PT, 25 µg of FHA, 8 µg of pertactin and contra-indications for administering whole-cell DTP vaccine, but K 10 µg of purified capsular polysaccharide of Hib covalently now it is considered the general precautions should be taken. bound to approximately 30 µg tetanus toxoid. - temperature of ≥ 40.5°C within 48 hours of vaccination, not 2. CLINICAL PARTICULARS due to another identifiable cause BIO_DRW202 2.1. Therapeutic indications - collapse or shock-like state (hypotonic-hyporesponsive

Infanrix-Hib is indicated for active immunisation of all infants episode) within 48 hours of vaccination; 300 mm from the age of 2 months - persistent, inconsolable crying lasting ≥ 3 hours, occurring No against diphtheria, tetanus, pertussis (DTP) and Hib. within 48 hours of vaccination; Infanrix-Hib does not protect against diseases due to other - convulsions with or without fever, occurring within 3 days of types of H. influenzae nor against meningitis caused by other vaccination.

organisms. As with all injectable vaccines, appropriate medical treatment

2.2. Posology should always be readily available in case of a rare anaphylactic

The primary vaccination schedule consists of three doses in reactions following the administration of the vaccine. For this the first 6 months of life and can start from the age of 2 months. reason, the vaccine should remain under medical supervision The vaccination calender prescribes that the 3 doses of the for 30 minutes after immunisation. primary vaccination are to be administered at the ages of 2,3 In the event of a serious anaplylactic reaction, epinephrine is the and 4 months. To ensure long term protection, a booster dose is first treatment of choice. Dose of epinephrine for an infant : recommended for DTP and Hib in the second year of life. 0.01 ml/kg of a 1/1,000 (1 mg/ml) solution of epinephrine administered intramuscularly (max. 0.5 ml). In the absence of 2.3. Method of administration any improvement, a second dose can be administered after Before administration, the liquid Infanrix vaccine contained in 5 minutes. the syringe and the reconstituted vaccine are to be inspected visually to verify that they do not contain any foreign bodies or Infanrix-Hib must be administered sub-cutaneously to infants present an unusual appearance. If any anomalies are observed, suffering from thrombocytopenia or haemorrhaging disorders, the liquid vaccine or the reconstituted vaccine should not be given that a haemorrhage is likely to occur after intramuscular FRONT PAGE used and should be disposed of. administration in these subjects. The vaccine is to reconstituted by adding the entire contents As with all diphtheria, tetanus and pertussis vaccines, the TYPE SIZE: 10/11,5 of the syringe of INFANRIX liquid vaccine to the vial containing vaccine should be administered by deep intramuscular injection HORIZONTAL SCALE: 100% the Hib pastille. After adding the INFANRIX liquid vaccine to the and preferably at alternate sites for each injection. pastille, the mixture must be shaken well until the pastille has Excretion of capsular polysaccharide antigen in the urine has dissolved completely in the INFANRIX liquid vaccine. been described following receipt of Hib vaccines, and therefore Page 1 of 2 Following reconstitution, the INFANRIX-Hib vaccine must be antigen detection may not have a diagnostic value in suspected injected without delay. Hib disease within 1-2 weeks of vaccination. The reconstituted vaccine is to be injected intramuscularly. Infanrix-Hib should under no circumstances be administered Biologicals However, good clinical practise specifies administering intravenously Additional Information Panel the vaccine sub-cutaneously in patients suffering from A history of febrile convulsions, a family history of convulsive fits, thrombocytopenia or who have problems with haemorrhaging a family history of SIDS and a family history of an adverse event Material weight: N/A (see Precautions) following Infanrix-Hib do not constitute contraindications. Folded dimensions: 210x25mm

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Human Immunodeficiency Virus (HIV) infection is not Following administration of Infanrix-Hib booster in the considered as a contra-indication. second year of life, 100% of infants had antibody titers of ≥0.1 IU/ml to both diphtheria and tetanus. Vaccination does not necessarily give protection against The booster response to the pertussis antigens was seen all infections or disease. In the case of clinical symptoms, in 100% of these infants. treatment should not be postponed, irrespective of the The protective efficacy of a primary vaccination course of stage of vaccination the patient is at. Infanrix against typical pertussis (as defined by World Health 2.6. Interactions with other medicaments and other Organization) was assessed up until the time of booster in a forms of interaction prospective blinded household contact study. Based on data Infanrix-Hib can be administered either simultaneously collected from secondary contacts in households where or at any time before or after a different inactivated or live there was an index case with typical pertussis, the protective vaccine. efficacy of the vaccine was 88.7%, with a two-sided 95% 1 Different injectable vaccines should always be administered at confidence interval of 76.6% to 94.6%. different injection sites. Hib component: 432745 As with other vaccines it may be expected that in patients A titre of ≥0.15 µg/ml was obtained in 95-100% of infants one receiving immunosuppressive therapy or patients with month after the completion of the primary vaccination course.

immunodeficiency an adequate immunologic response may A titre of ≥0.15 µg/ml was obtained in 100% of infants one month GSK-BEL-Wavre-BEWAV not be achieved. after the booster dose and all infants had a titre of ≥1 µg/ml with 95.5% over 10 µg/ml. 2.7. Pregnancy and lactation Indonesia-IDN As Infanrix-Hib is not intended for use in adults, information 4. PHARMACEUTICAL PARTICULARS on the safety of the vaccine when used during pregnancy or 4.1. Incompatibilities Infanrix lactation is not available. Infanrix-Hib should not be mixed with other vaccines in the 1 2.8. Undesirable effects same syringe, unless specified by the manufacturer. In controlled clinical studies, signs and symptoms were 4.2. Shelf-life actively monitored and recorded on diary cards following the The expiry date of the vaccine is indicated on the label and Process administration of the vaccine. packaging. The following table summaries the local and general solicited symptoms reported within 48 hours of vaccination as a 4.3. Special precautions for storage percentage of doses administered. The lyophilised Hib vaccine and the DTPa vaccine have to be K stored at +2°C to +8°C and be protected from light. Local and general Infanrix-Hib The DTPa vaccine should not be frozen. Discard if it has been solicited symptoms Primary + booster frozen. The lyophilised Hib vaccine is not affected by freezing.

300 mm 4.4. Instructions for use/handling BIO_DRW202 (2336 doses administered) Local symptoms: The lyophilised Hib vaccine is presented as a white pellet and - pain (severe) 0.1% the DTPa vaccine is a suspension. No - redness (>2 cm) 0.5% The DTPa vaccine and reconstituted vaccine should be inspected visually for any foreign particulate matter and/or - swelling (>2 cm) 0.6% variation of physical aspect prior to administration. In the event

General symptoms: of either being observed, discard the vaccines.

- fever ≥38°C (rectal) 7.7% The vaccine must be reconstituted by adding the entire contents of

- fever ≥ 39.5°C (rectal) 0.2% the container of the DTPa vaccine to the vial containing the pellet.

- loss of appetite 11.3% After the addition of the DTPa vaccine to the pellet, the mixture - restlessness 17.6% should be well shaken. The reconstituted vaccine must not be - unusual crying 15.7% injected before complete dissolution of the pellet. - vomiting 7.4% After reconstitution, Infanrix-Hib should be injected promptly, - diarrhoea 9.0% and it is stable for 2 hours at temperature 21°C ± 1°C. The following unsolicited symptoms have been reported with a Presentations frequency of > 1% (total of 2336 documented doses); these are Box, 1 prefilled syringes 0,5 ml (Infanrix) + 1 vial 0,5 ml (Hiberix) not necessarily related to the vaccine: • gastro-intestinal system (1.1% or less): gastroenteritis, Infanrix is a trademark. enteritis; HARUS DENGAN RESEP DOKTER • resistance mechanism (2.5% or less): viral infection, otitis media; Reg. No. DKI0376701544A1 • respiratory system (5.7% or less): pharyngitis, coughing, Imported by BACK PAGE rhinitis, respiratory disorder, PT. SmithKline Beecham Pharmaceuticals bronchitis, upper respiratory tract infection; Bogor, Indonesia TYPE SIZE: 10/11,5 • vision (1.3% or less): conjunctivitis. HORIZONTAL SCALE: 100% Convulsion or hypotonicity in infants, followed by full or International data sheet version 1.0-rev (27/10/95) spontaneously recovery, were only very rarely reported. © GlaxoSmithKline Biologicals s.a. 2001 Manufacturer/Fabricant/Fabricante: 3. PHARMACOLOGICAL PROPERTIES Page 2 of 2 GlaxoSmithKline Biologicals s.a. Rue de I’Institut 89, Relevant information for vaccines B-1330 Rixensart, Belgium. DTPa component: Tel.: (32.2) 656 81 11 Fax: (32.2) 656 80 00 Telex: 63251 Biologicals One month after the primary vaccination course more than 99.6% Additional Information Panel of infants vaccinated with Infanrix-Hib had antibody titers of ≥0.1 IU/ml to tetanus and diphtheria. The mean vaccine response Material weight: N/A to the pertussis antigens (PT, FHA, pertactin) was 97.7%. 432745 Folded dimensions: 210x25mm

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